WO1997026034A1 - Method and apparatus for minimizing the risk of air embolism in the thoracic cavity - Google Patents

Method and apparatus for minimizing the risk of air embolism in the thoracic cavity Download PDF

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Publication number
WO1997026034A1
WO1997026034A1 PCT/US1997/000731 US9700731W WO9726034A1 WO 1997026034 A1 WO1997026034 A1 WO 1997026034A1 US 9700731 W US9700731 W US 9700731W WO 9726034 A1 WO9726034 A1 WO 9726034A1
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WO
WIPO (PCT)
Prior art keywords
gas
patient
thoracic cavity
instrument delivery
outlet
Prior art date
Application number
PCT/US1997/000731
Other languages
French (fr)
Inventor
Michi E. Garrison
Brian S. Donlon
Original Assignee
Heartport, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Heartport, Inc. filed Critical Heartport, Inc.
Priority to AU17498/97A priority Critical patent/AU1749897A/en
Publication of WO1997026034A1 publication Critical patent/WO1997026034A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1011Multiple balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/40Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466Delivery devices therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0041Catheters; Hollow probes characterised by the form of the tubing pre-formed, e.g. specially adapted to fit with the anatomy of body channels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0218Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0293Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors with ring member to support retractor elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238Type of minimally invasive operation
    • A61B2017/00243Type of minimally invasive operation cardiac
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/40Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
    • A61B2090/401Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment using air flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2403Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with pivoting rigid closure members
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445Annuloplasty rings in direct contact with the valve annulus
    • A61F2/2448D-shaped rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2496Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133Tip steering devices

Definitions

  • the present invention is directed to apparatus and methods for minimizing the risk of air embolism when performing a procedure in a patient's thoracic cavity.
  • a specific application of the invention is described in conjunction with devices and methods for repairing and replacing a mitral valve in a patient's heart, however, the invention may be used in conjunction with any other procedure including repair or replacement of mitral, aortic and other heart valves, repair of septal defects, pulmonary thrombectomy, electrophysiological mapping and ablation, coronary artery bypass grafting, angioplasty, atherectomy, treatment of aneurysms, myocardial drilling and revascularization, as well as neurovascular and neurosurgical procedures.
  • Various types of surgical procedures are currently performed to investigate, diagnose, and treat cardiovascular diseases. Using current techniques, many of these procedures require a gross thoracotomy, usually in the form of a median sternotomy, to gain access to the patient's thoracic cavity. A saw is used to cut the sternum longitudinally thereby allowing two opposing halves of the anterior or ventral portion of the rib cage to be spread apart. A large opening in the thoracic cavity is created through which the surgical team may directly visualize and operate upon the heart and other thoracic contents. Surgical intervention in the heart generally requires isolation of the heart and coronary blood vessels from the remainder of the arterial system and arrest of cardiac function.
  • the heart is usually isolated from the arterial system by introducing an external aortic cross-clamp through a sternoto y and applying the clamp to the aorta between the brachiocephalic artery and the coronary ostia. Cardioplegic fluid is then injected into the coronary arteries, either directly into the coronary ostia or through a puncture in the aortic root, to arrest cardiac function. In some cases, cardioplegic fluid is injected into the coronary sinus for retrograde perfusion of the myocardium. The patient is then placed on cardiopulmonary bypass to maintain peripheral circulation of oxygenated blood. Another method of arresting the patient's heart is disclosed in U.S. Patent No.
  • U.S. Patent No. 5,433,700 describes an endovascular catheter system for establishing arrest of cardiac function.
  • the endovascular catheter system does not require a gross thoracotomy and facilitates less invasive methods of performing cardiopulmonary procedures.
  • valves may be replaced, by excising the valve leaflets of the natural valve and securing a replacement valve in the valve position usually by suturing the replacement valve to the natural valve annulus.
  • the mitral valve located between the left atrium and left ventricle of the heart, is most easily reached through the wall of the left atrium, which normally resides on the posterior side of the heart, opposite the side of the heart that is exposed by a median sternotomy. Therefore, in order to access the mitral valve via a sternotomy, the heart is rotated to bring the left atrium into an anterior position accessible through the sternotomy. An opening, or atriotomy, is then made in the right side of the left atrium, anterior to the right pulmonary veins. The atriotomy is retracted by means of sutures or a retraction device, exposing the mitral valve directly posterior to the atriotomy.
  • One of the aforementioned techniques may then be used to repair or replace the valve.
  • An alternative technique for mitral valve access may be used when a median sternotomy and/or rotational manipulation of the heart are undesirable.
  • a large incision is made in the right lateral side of the chest, usually in the region of the fifth intercostal space.
  • One or more ribs may be removed from the patient, and other ribs near the incision are retracted outward to create a large opening into the thoracic cavity.
  • the left atrium is then exposed on the posterior side of the heart, and an atriotomy is formed in the wall of the left atrium, through which the mitral valve may be accessed for repair or replacement.
  • the large opening provided by a median sternotomy or right thoracotomy enables the surgeon to see the mitral valve directly through the left atriotomy, and to position his or her hands within the thoracic cavity in close proximity to the exterior of the heart for manipulation of surgical instruments, removal of excised tissue, and/or introduction of a replacement valve through the atriotomy for attachment within the heart.
  • these invasive, open-chest procedures produce a high degree of trauma, a significant risk of complications, an extended hospital stay, and a painful recovery period for the patient.
  • heart valve surgery produces beneficial results for many patients, numerous others who might benefit from such surgery are unable or unwilling to undergo the trauma and risks of current techniques.
  • a problem which occurs in conventional open-heart procedures is that air enters the heart during the procedure and must be removed from the heart after completing the procedure. Air which remains in the circulatory system after the heart is closed may produce air emboli which could travel to the brain and cause a stroke or death.
  • Conventional de- airing techniques include mechanical manipulations and venting of the heart to remove air trapped in the heart.
  • U.S. Patent No. 5,370,631 discloses an apparatus for de- airing the heart which includes a slotted-needle and a resilient bulb.
  • Carbon dioxide has been used to displace air in the patient's thoracic cavity to help prevent air emboli. In animal studies, carbon dioxide has been shown to be as much as twelve times more soluble in blood than air. Thus, displacing air with carbon dioxide may be beneficial in reducing the harmful effects of gas emboli.
  • carbon dioxide In open-heart procedures, carbon dioxide has been introduced into the thoracic cavity through the median sternotomy. Since the patient's chest is open, the carbon dioxide in the chest cavity readily disperses out of the chest and, therefore, carbon dioxide must be continuously or periodically replaced, Ng and Rosen, Carbon Dioxide in the prevention of air embolism during open-heart surgery, Thorax 23:194-196 (1968).
  • an instrument delivery member is inserted into a patient's thoracic cavity between adjacent ribs thereby forming a percutaneous intercostal penetration.
  • the instrument delivery member has a gas outlet for injecting a gas, preferably carbon dioxide, into the patient's thoracic cavity.
  • the gas displaces air from the patient's thoracic cavity thereby reducing the risk of air emboli.
  • the instrument delivery member also has a through hole sized to permit an instrument to pass therethrough.
  • the present invention is particularly useful when performing the mitral valve replacement and repair procedures described in U.S. Patent Application Serial No. 08/485,600 and U.S. Patent Application Serial No. 08/163,241 both of which are assigned to the assignee of the present application and which are incorporated herein by reference.
  • the methods facilitate surgical intervention within the heart or great vessels without the need for a gross thoracotomy.
  • the procedure is carried out through small incisions within intercostal spaces of the rib cage without cutting, removing, or significantly deflecting the patient's ribs or sternum thereby reducing the trauma, risks, recovery time and pain that accompany conventional techniques.
  • the devices and methods permit removal of tissue from the thoracic cavity and introduction of surgical instruments, replacement valves and the like into the thoracic cavity, to facilitate heart valve repair and replacement.
  • the devices and methods facilitate replacement of a heart valve with various types of prostheses, including mechanical and biological prostheses, homografts, and allografts.
  • the instrument delivery member includes a plurality of gas outlets which are angled toward the distal end to help retain gas in the patient's thoracic cavity.
  • the gas outlets are angled substantially perpendicular to the longitudinal axis of the instrument delivery member with the gas passing adjacent the distal end.
  • a vacuum pump may also be provided for withdrawing air from the patient's thoracic cavity or for capturing gas escaping from the patient's thoracic cavity.
  • the concentration of gas in the patient's thoracic cavity is preferably monitored so that a threshold gas concentration is maintained.
  • the gas concentration is preferably at least 70 % and more preferably at least 90 % by volume.
  • the air concentration may be maintained at no more than 50 % and more preferably no more than 5 % by volume.
  • the humidity and temperature in the patient's thoracic cavity are also preferably monitored to maintain a desirable humidity and temperature.
  • the relative humidity in the patient's thoracic cavity is preferably at least 10 % and more preferably at least 50 %.
  • the temperature of the gas is also preferably maintained at a temperature below body temperature and preferably below 20 (degrees) C.
  • the pressure of the gas in the patient's thoracic cavity is also preferably monitored and regulated.
  • the gas pressure is preferably maintained at a pressure higher than the pressure outside the thoracic cavity to prevent air does from entering the thoracic cavity.
  • a number of instrument delivery members such as cannulas or trocars, are inserted into the patient to perform a mitral valve procedure.
  • the present invention provides seals at the instrument delivery members to prevent the escape of gas so that the pressure can be maintained in the thoracic cavity. Such seals are commonly used in laparoscopic procedures.
  • the pressure in the thoracic cavity is not used to retract the thoracic cavity and, as such, the pressure in the thoracic cavity is kept between 1 and 14 mm Hg and more preferably between 1 and 10 mm Hg and most preferably between 1 and 8 mm Hg all of which are below the pressures used in laparoscopic procedures which are typically between 15 and 20 mm Hg.
  • the instrument delivery member includes a gas inlet and a gas outlet positioned to receive gas issuing from the gas inlet.
  • the gas passing from the gas inlet to the gas outlet preferably passes across the throughhole, and preferably transects the throughhole, to act as a gas shield which minimizes gas losses through the instrument delivery member.
  • the gas shield advantageously permits the introduction of instruments through the instrument delivery member without significantly hindering use of instruments.
  • the gas which is used for the gas shield may be any gas such as carbon dioxide or air.
  • a blower, fan or compressor is coupled to the gas inlet and may also be coupled to the gas outlet for closed circuit circulation.
  • a vent for venting gas from the left ventricle when performing a procedure on the patient's heart such as a mitral valve repair or replacement.
  • the vent includes first and second lumens and first and second outlets fluidly coupled to the first and second lumens, respectively.
  • the first lumen and first outlet are used for injecting gas into the patient's heart and for evacuating gas from the heart when the heart is being closed after the mitral valve replacement or repair procedure.
  • the second lumen and second outlet are used for sampling gas in the patient's thoracic cavity.
  • the vent is positioned in the left ventricle and a gas, such as carbon dioxide, is injected into the patient through the first lumen.
  • a gas such as carbon dioxide
  • the gas displaces air in the left ventricle so that when the heart is closed the presence of air is minimized to minimize the risk of air emboli.
  • the gas is preferably injected into the heart using the temperature, pressure, humidity and gas concentration monitoring and control system described above.
  • the first lumen and first outlet are used to evacuate gasses from the heart .
  • the second outlet and second lumen are used to collect gasses in the thoracic cavity for measuring pressure, temperature, humidity, and/or gas concentrations.
  • the second outlet is spaced apart from the distal end so that the measurements are not overly influenced by the gas being injected into the left ventricle through the first lumen and first outlet.
  • an enclosure is provided around the patient for providing a sealed operating space.
  • a gas such as carbon dioxide
  • the enclosure includes a seal, such as a drape, which engages the patient and provides a substantially air tight seal.
  • the enclosure includes arm pass-throughs which are used by the surgeon to perform the medical procedure in the enclosure.
  • percutaneous intercostal penetration and "intercostal penetration” as used herein refer to a penetration, in the form of a small cut, incision, hole, or the like through the chest wall between two adjacent ribs, wherein the patient's rib cage and sternum remain substantially intact, without cutting, removing, or significantly displacing the ribs or sternum.
  • These terms are intended to distinguish a gross thoracotomy such as a median sternotomy, wherein the sternum and/or one or more ribs are cut or removed from the rib cage, or one or more ribs are retracted significantly, to create a large opening into the thoracic cavity. It is understood that one or more ribs may be retracted or deflected a small amount and/or a small amount of intercostal cartilage may be removed without departing from the scope of the invention.
  • FIG. 1 shows a patient prepared for a mitral valve replacement with a number of instrument delivery members extending into the patient's thoracic cavity and a gas delivery system coupled to one of the instrument delivery members;
  • Fig. 2 shows a cross-sectional view of the patient of Fig. 1 with a gas outlet coupled to one of the instrument delivery members for injecting a gas into the patient's thoracic cavity,-
  • Fig. 3 is an isometric view of the instrument delivery member having a gas delivery assembly
  • Fig 4. is an isometric view of the gas delivery assembly of Fig. 3;
  • Fig. 5 is a cross-sectional view of a second preferred embodiment of the instrument delivery member;
  • Fig. 6 is an end view of the instrument delivery member of Fig. 5:
  • Fig. 7 is a cross-sectional view of a gas path showing the orientation of a gas outlet of the instrument delivery member of Fig. 5;
  • Fig. 8 is a cross-sectional view of a patient with a vent extending through the instrument delivery member and into the patient's left ventricle;
  • Fig. 9 is a plan view of the vent of Fig. 8;
  • Fig. 9A is a side view of an alternate embodiment of the left ventricle vent of Fig. 9;
  • Fig. 10 is a side view of the vent of Fig. 8;
  • Fig. 11 is a cross-sectional view of the vent of Fig. 8 showing first and second lumens;
  • Fig. 12 is a view looking through the instrument delivery member with a mitral valve being attached to the patient's valve annulus;
  • Fig. 13 shows vent catheters extending through a lumen of an endoaortic partitioning catheter
  • Fig. 14 is an isometric view of another preferred instrument delivery member having a gas inlet and a gas outlet positioned to receive gas issuing from the gas inlet;
  • Fig. 15 is a top view of the instrument delivery member of Fig. 14;
  • Fig. 16 is a schematic of the gas delivery system, monitoring system and control system
  • Fig. 17 is a view looking through the instrument delivery member with an atriotomy being closed and a vent extending through the atriotomy;
  • Fig. 18 is an isometric view of an enclosure extending around a patient.
  • Fig. 1 a system for minimizing the risk of air emboli when performing a procedure in a patient's thoracic cavity is shown.
  • a specific application of the invention is developed herein with respect to a minimally invasive mitral valve replacement procedure, however, the apparatus and methods of the present invention may be used in conjunction with any other procedure including repair or replacement of aortic and other heart valves, repair of septal defects, pulmonary thrombectomy, electrophysiological mapping and ablation, coronary artery bypass grafting, angioplasty, atherectomy, treatment of aneurysms, myocardial drilling and revascularization, as well as neurovascular and neurosurgical procedures .
  • an instrument delivery member 2 includes a throughhole 4 for introduction of surgical instruments into a patient's thoracic cavity.
  • the instrument delivery member 2 is preferably a hollow tube, such as a cannula, trocar sleeve, a 3-sided channel-shaped member, a ring retractor, a wound retractor having a pair of adjustable parallel blades, or any other device which facilitates introduction of a medical instrument into a patient between adjacent ribs.
  • the instrument delivery member 2 is positioned between adjacent ribs in the patient and a number of other instrument delivery members 6-10 are positioned at various other positions thereby forming a number of percutaneous intercostal penetrations.
  • a retractor 12 passes through instrument delivery member 9 and various sensors 13, which are described in greater detail below, pass through instrument delivery member 6.
  • a thoracoscope 14 passes through instrument delivery member 8 and is coupled to a monitor 16 for viewing the patient's thoracic cavity. Any other viewing device may be used in conjunction with, or as a substitute for, the thoracoscope 14.
  • a first removable plug 18 is positioned in the delivery member 7 with the first plug 18 separated from the instrument delivery member 7 for clarity.
  • a replacement valve 20 is mounted to a holder 22, however, a repair device, such as a ring for annuloplasty, may, of course, be used when repairing rather than replacing the mitral valve.
  • a gas delivery system 24 is coupled to the instrument delivery member 2 for delivering a gas into the patient's thoracic cavity.
  • the gas delivery system 24 supplies gas, such as carbon dioxide, for introduction into the patient's thoracic cavity to minimize the risk of an air embolism when performing a procedure in the patient's thoracic cavity.
  • a monitoring system 26 is coupled to the sensors 13 for monitoring the various conditions sensed by the sensors 13.
  • a control system 28 receives the information from the sensors 13 via the monitoring system 26 and sends control information to the gas delivery system 24 based upon the sensor data.
  • the gas delivery system 24, control system 28 and monitoring system 26 are described in greater detail below in connection with Fig. 16.
  • a vacuum pump 30 is coupled to the instrument delivery member 9 having the retractor 12 for withdrawing air from the thoracic cavity when the gas is injected into the thoracic cavity.
  • the vacuum pump 30 is also coupled to a line 32 which is positioned adjacent to the instrument delivery member 2 for withdrawing gas which escapes through the instrument delivery member.
  • a vent needle 34 extends through the instrument delivery member 10 and into the patient used for venting gasses from the thoracic cavity as described in further detail below.
  • the vent needle 34 is preferably perforated along the longitudinal axis (not shown) of the needle for venting gasses from the left ventricle. Use of the vent needle 34 is described in greater detail below in connection with preferred methods of operation.
  • the retractor 12 engages an atriotomy AI formed in the patient's heart for retracting the atriotomy open.
  • a number of sutures 36 extend through the instrument delivery member 2 and are used for attaching the repair valve 20 in the manner described in U.S. Patent Application Serial No. 08/485,600.
  • the instrument delivery member 2 includes a gas outlet 38, preferably a number of gas outlets, and a gas inlet 40 coupled to the gas delivery system 24 for delivering the gas into the thoracic cavity.
  • a gas such as carbon dioxide, is introduced into the patient's thoracic cavity through the gas outlet 38.
  • the instrument delivery member 2 and a gas delivery assembly 42 are shown.
  • the instrument delivery member 2 preferably includes a sidewall 44 and the throughhole 4 defines a longitudinal axis 46.
  • the throughhole 4 extends from a proximal end and terminates at an opening 48 at a distal end 50.
  • the instrument delivery member 2 preferably has an oval throughhole, any other cross-section may be used such as a race-track, rectangular, trapezoidal, elliptical or circular cross-sectional shape.
  • the throughhole 4 is preferably sized to allow an annuloplasty ring or replacement valve mounted on a holder to pass therethrough.
  • the throughhole 4 preferably has a cross- sectional shape having a width of preferably about 10-30 mm, and more preferably 15-25 mm, and a height of preferably about 25-75 mm, more preferably 30-50 mm.
  • the width or height of the throughhole is preferably at least 2 cm, more preferably at least 2.5 cm and most preferably at least 3 cm.
  • Typical laparoscopic trocars have much smaller openings since gas losses must be minimized when operating at the higher pressures used in laparoscopic procedures .
  • the exact width and height will often be determined by the width (or diameter) and height of the annuloplasty ring or replacement valve and holder being used in the procedure. It is sometimes desirable to begin the procedure with a instrument delivery member 2 of the minimum size necessary to assess the condition of the native valve. For example, an instrument delivery member 2 having a width of about 15-20 mm may be used initially. When the size of the annuloplasty ring or prosthetic valve has been selected, the smaller instrument delivery member may be replaced, if necessary, with a larger instrument delivery member to accommodate the prosthesis.
  • the instrument delivery member 2 is configured for placement in an intercostal space preferably without retraction of ribs, or at least minimal retraction of ribs, and preferably has an external width of less than about 30 mm, and preferably less than about 25 mm.
  • a sidewall 44 which has an elongate tubular structure with a length sufficient to extend into the thoracic cavity
  • the sidewall may simply be the elements of a ring retractor or any of the other instrument delivery members described above so long as the instrument delivery member provides access to the patient's thoracic cavity for surgical instruments.
  • the instrument delivery member has a flange 52 at its proximal end which engages the outside of the patient's chest.
  • the instrument delivery member 2 has a length sufficient to extend from outside of the chest, through the intercostal space, and into the chest cavity just beyond the interior of the chest wall.
  • the instrument delivery member 2 preferably has a length of about 20-70 mm and more preferably about 30-50 mm from the flange 52 to the distal end.
  • the instrument delivery member 2 includes a suture organizing ring 54 attached to the flange 52.
  • Organizing ring 54 has a plurality of circumferentially-spaced radial slots 56 or suture holders in which a suture thread may be received and retained. Slots 56 have tapered upper ends 58 for guiding a suture thread to the slot.
  • Suture organizing ring 54 allows sutures placed in the heart for attachment of a prosthesis to be drawn through the throughhole and temporarily placed in slots 56 to keep the sutures individually separated and untangled.
  • an obturator (not shown) may be inserted into the throughhole 4.
  • the instrument delivery member 2 may also be made of a flexible or deformable material to allow it to be shaped by the user or to conform to the shape of the intercostal space.
  • the gas delivery assembly includes a sleeve 60 which clips onto the sidewall 44.
  • the sidewall 44 may include ribs (not shown) for enhanced engagement with the gas delivery assembly 42.
  • the gas outlet 38, and preferably a plurality of gas outlets, are provided on a horseshoe-shaped ring 61.
  • the gas delivery assembly 42 is mounted to the sidewall 44 so that a plurality of gas outlets 38 are directed across the opening 48.
  • the opening 48 lies in a plane perpendicular to the longitudinal axis 46 so that the gas outlets 38 are also directed substantially perpendicular to the longitudinal axis.
  • the opening 48 may also be skewed with respect to the longitudinal axis with the gas outlets 38 also being skewed so that the gas outlets 38 are configured to issue gas directly across the opening 48.
  • the gas injected into the patient helps retain the gas in the thoracic cavity by creating a gas curtain at the opening 48 of the instrument delivery member.
  • two or more gas delivery assemblies may be provided.
  • the gas outlets 38 may also be angled toward the distal end or, alternatively, angled toward the proximal end with a baffle to redirect the gas so that the gas does not simply exit through the proximal opening in the instrument delivery member 2.
  • the gas outlets 38 are preferably positioned so that they direct gas across substantially the entire width or height of the throughhole 4 so that gas losses through the throughhole are minimized.
  • a plug 62 is removably mounted to the instrument delivery member 2 to close, or at least partially close, the throughhole 4 thereby minimizing gas losses through the throughhole 4.
  • the second plug 62 preferably includes a resilient surface 63, preferably an elastic band, which engages the instrument delivery member 2 to provide a snug fit when sutures are positioned through the throughhole 4.
  • the second plug 62 has an opening 64 so that instruments may still be passed through the throughhole while reducing losses through the throughhole.
  • a third plug 66 closes the opening 64 so that substantially all gas losses through the throughhole 4 are eliminated.
  • the opening 64 may be any other shape such as H- shaped, an oval ring, Z-shaped or a figure "8.”
  • FIG. 5-7 another instrument delivery member 2A is shown which includes integrally formed gas outlets 38A wherein similar reference numbers are used to represent similar features described in the embodiment of Figs. 3-4.
  • the discussion above concerning instrument delivery member 2 is equally applicable here and the preferred features for the instrument delivery member 2 are also preferred with the instrument delivery member 2A.
  • the instrument delivery member 2A includes a gas inlet 66 configured to be coupled to a gas line 68 which, in turn, is coupled to the gas delivery system 24.
  • the instrument delivery member 2A includes integrally formed gas outlets 38A whereas the instrument delivery member 2 includes the removable gas delivery assembly 42.
  • the gas inlet 66 is coupled to a chamber 70 which extends circumferentially around the instrument delivery member 2A between an inner wall 72 and an outer wall 74.
  • a plurality of gas channels 74 extend from the common chamber 70 and 76 terminate at the gas outlets 38A which direct the gas in the direction of arrows 78.
  • the gas outlets 38A are preferably directed toward the distal end and, further, are directed toward the middle of the instrument delivery member 2A.
  • the gas outlets 2A cooperate with one another to hinder escape of gasses through the instrument delivery member 2A.
  • the gas outlets 38A are particularly useful for providing a pressure in the thoracic cavity above the pressure outside the thoracic cavity to help keep air out of the thoracic cavity.
  • the gas outlet 38A may be oriented in any other manner so long as the gas outlet 38A tends to prevent gas from escaping through the open proximal end of the instrument delivery member 2A.
  • the gas outlets 38A may also be provided only along a section of the instrument delivery member 2A.
  • a cross-sectional view of the patient is shown with a vent 78 extending into the left ventricle LV.
  • the vent 78 preferably has a distal end 80 which extends to the apex of the left ventricle LV for venting the left ventricle LV.
  • the distal end 80 preferably includes a soft tip for preventing trauma to the left ventricle.
  • the first outlet 86 is preferably used for injecting gas into the left ventricle and for venting gas from the left ventricle.
  • the second outlet is preferably coupled to a monitoring system 26 for monitoring the conditions in the patient's thoracic cavity such as the gas concentration, humidity, temperature and pressure. Use of the vent 78 is described below in connection with discussion of preferred methods of present invention.
  • a distal portion 81 of the vent 78 is shown in a natural, unbiased shape.
  • the distal portion 81 of the vent 78 is configured to position the distal end 80 at the apex of the left ventricle LV when the proximal portion extends through the valve annulus.
  • the approximate position of the valve annulus is shown at broken line 79 which also indicates the beginning of the distal portion 81.
  • the vent 78 preferably includes a first lumen 82, a second lumen 84 and first and second outlets 86, 88 fluidly coupled to the first and second lumens 26, respectively.
  • the first and second outlets 86, 88 are preferably spaced apart between 0.5 and 8 cm, and more preferably between 2 and 4 cm, so that gas samples taken through the first outlet are not overly influenced by gas injected into the left ventricle through the first outlet 88.
  • the first outlet 86 is preferably positioned near the distal end 80 and the second outlet 88 is preferably between at least 0.5, more preferably at least 5 cm and most preferably at least 8 cm from the distal end.
  • the distal portion 81 preferably extends between 1 and 10 cm, and more preferably between 1 and 5 cm in the axial direction A, and extends in the radial direction B between 0 and 15 cm and more preferably 2 and 8 cm, and extends between 0 and 5 cm and more preferably between 0.5 and 3 cm in the other radial direction C.
  • the proximal end of the vent 78 is flexible so that the user may position the vent 78 where it will not interfere with the medical procedure. Referring to Fig. 9A, the distal end of another left ventricle vent 78A is shown.
  • the left ventricle vent 78A has the same preferred dimensions as the left ventricle vent 78, however, the first and second outlets 86A, 88A are both positioned near the proximal end with an angle D therebetween.
  • the angle D is preferably at least 90 degrees and preferably greater than 90 degrees so that gas issuing from the first outlet 86A does not overly influence gas samples taken at second outlet 88A.
  • a spacer 98 prevents contact between the valve 20, which in this case is a mechanical valve, and the vent 78.
  • the spacer 98 preferably includes a pair of holes 100 for removing the spacer 98 before closing the heart.
  • the spacer 98 may be dispensed with and the vent 78 may be coated with a lubricious coating of silicone, teflon or polyurethane to prevent damage to the valve 20 when the vent 78 is withdrawn.
  • the instrument delivery member 2 includes a clip 102 for holding the vent 78 after the vent 78 is positioned in the left ventricle LV. The clip 102 prevents movement of the vent 78 and also positions the vent 78 away from the center of the throughhole 4 so that other instruments may be used through the instrument delivery member 2.
  • a left ventricle vent 104 and an aortic vent 106 are shown extending through an endoaortic partitioning catheter 108 which is described in U.S. Patent Application Serial No. 08/415,366 to Stevens et al. which is assigned to the assignee of the present invention and which is incorporated herein by reference.
  • the endoaortic partitioning catheter 108 has an occluding member 110 which occludes the ascending aorta. Cardioplegic fluid is introduced to the coronary arteries through the endoaortic partitioning catheter 110 for arresting cardiac function.
  • the endoaortic partitioning catheter 110 provides a working lumen (not shown) through which instruments, such as the left ventricle vent 104 and aortic vent 106, may pass.
  • the aortic vent 106 has a curved distal end 112 which generally conforms to the shape of the occluding member 110 for venting gasses around the occluding member 110.
  • the aortic vent 106 has an opening 114 at the distal end 112 for venting gasses from the ascending aorta AO.
  • the proximal end of the aortic vent 106 is relatively stiff so that the aortic vent 106 may be rotated from the proximal end. Rotation of the aortic vent causes the distal end 112 to circumscribe the outer surface of the occluding member 110 for venting gasses around the occluding member 110.
  • the patient When using the aortic vent 106, the patient is preferably tilted feet downward so that gasses in the ascending aorta rise toward the occluding member 110 for venting.
  • the left ventricle vent 104 has an opening 116 near a curved, distal end 118 for venting the left ventricle.
  • the curved end 118 prevents damage to the aortic valve and the left ventricle when the left ventricle vent 104 passes through the aortic valve and the left ventricle.
  • the curved distal end 118 is preferably curved in an arc greater than 180; so that the curved portion also contacts the aortic valve when the catheter is withdrawn.
  • Both the aortic vent 106 and left ventricle vent 104 are described below in connection with preferred methods of the present invention. Both the aortic vent 106 are and the left ventricle vent 104 are preferably coupled to the vacuum pump 30 for withdrawing gasses from the patient's heart.
  • another instrument delivery member 2B is shown which includes both a gas inlet 120 and a gas outlet 122.
  • the instrument delivery member 2B is substantially the same as the instrument delivery members 2 and 2A described above and discussion of the features of the instrument delivery members 2 and 2A are equally applicable here.
  • the gas outlet 122 is positioned to receive gas issuing from the gas inlet 120 so that a gas shield is formed which minimizes escape of gasses from the thoracic cavity.
  • the gas inlet and outlet preferably extend across substantially the entire width and/or length of the throughhole 4 and include tapered entrances 124, 126 so that a laminar flow of gas is achieved.
  • the bottom surfaces of the gas inlet and outlet 120, 122 are preferably flush with the flange 52 so that the flange 52 helps provide the gas shield across the throughhole 4.
  • the gas inlet 120 preferably has a relatively small internal height of between 0.25 and 5 mm and more preferably between .5 and 3 mm.
  • the gas outlet 122 may have a somewhat larger internal height of preferably between 1 and 10 mm and more preferably between 2 and 5 mm.
  • the gas outlet 122 is preferably positioned and sized to withdraw substantially all of the gas issuing from the gas inlet 122 so that a gas shield is maintained across the throughhole 4.
  • the gas inlet and outlet 120, 122 are coupled to a fan, blower or compressor (not shown) for delivering the gas and forming the gas shield with a closed system.
  • a filter
  • the gas used for the gas shield may be any gas, such as carbon dioxide or even air, since the gas shield primarily functions to reduce gas losses through the instrument delivery member 2B.
  • the gas shield may be formed with carbon dioxide with the outlet 122 delivering the carbon dioxide into the patient.
  • the instrument delivery member 2B may include the gas delivery assembly 42 with the gas delivery assembly 42 being coupled to the outlet 122.
  • the gas inlet and gas outlet 120, 122 may also be used in connection with the embodiment of Figs.
  • the instrument delivery member 2B may include baffles and the like so that the gas outlet 122 is not positioned geometrically opposite the gas inlet 120 but, nonetheless, receives the gas issuing from the gas inlet 120.
  • the gas inlet and outlet 120, 122 near the proximal end the gas inlet and outlet may also be positioned near the distal end of the instrument delivery member 2B similar to orientation of the gas delivery assembly 42.
  • the gas delivery system 24, monitoring system 26 and control system 28 are shown.
  • the monitoring system 26 preferably includes a temperature sensor 128, a humidity sensor 130, a pressure sensor 132 and a gas sensor 134 such as a carbon dioxide or oxygen sensor.
  • the sensors 128, 130, 132, 134 extend through the instrument delivery member 6, however, more than one of the instrument delivery member may be used for the sensors 13 if necessary.
  • a sampling tube such as any of the vents described herein, may be periodically or continuously positioned within the patient for sampling gas which is then delivered to the various sensors outside of the patient.
  • the temperature and humidity sensors 128 are also coupled to the gas delivery line for measuring the temperature and humidity of the gas before injection into the patient's thoracic cavity.
  • the gas delivery system 24 includes a source of gas
  • a discharge valve or regulator 144 which is controlled by the control system 28, controls the flow of gas.
  • the heater/cooler 138 is coupled to the discharge line for heating and/or cooling the gas.
  • a valve 146 regulates the amount of heated or cooled gas added to the gas line from the source of gas 136. It is preferred to cool the gas since lower temperatures are advantageous when performing procedures on the heart and because cooling the gas increases the gas density which may further reduce gas losses from the thoracic cavity.
  • the entire flow of gas from the source of gas 136 may be passed through the heater/cooler 138 rather than only a portion of the gas stream.
  • Valves 144, 146 and 147 for regulating the gas stream are controlled by the control system 28.
  • the monitoring system 26 may also include a flow rate indicator (not shown) for measuring the flow rate downstream from the valve 147.
  • the humidifier 140 prevents excessive drying of the patient's tissue during the medical procedure. In a preferred method described below, the thoracic cavity is flooded with gas throughout the procedure which might excessively dry the patient's tissue. In order to prevent excess drying, the humidifier 140 adds water vapor to the gas stream.
  • the humidifier 140 may be any conventional humidifier such as a misting nozzle, a mixing chamber, or an atomizer.
  • the humidifier 140 preferably draws liquid from a source of sterilized saline or water (not shown) .
  • a valve 148 which is controlled by the control system 28, regulates the addition of humidified gas to the gas stream in response to the humidity measurements by the humidity sensor 130.
  • the source of therapeutics adds therapeutic agents, such as anti-inflammatories, to the gas stream for, for example, reducing post operative adhesions.
  • a surfactant may also be introduced into the patient's thoracic cavity before filling the heart with blood to reduce the surface tension of bubbles in the heart.
  • a preferred surfactant would be the phospholipid pulmonary surfactant found in the lungs. Reduction of the surface tension facilitates removal of gasses since gas bubbles are less likely to adhere to the heart and other vessels and will pool at locations where the various vents may be used.
  • Other therapeutics which might be delivered include topical anesthetics.
  • the introduction of therapeutics is regulated by a valve 150 which is controlled by the control system 28.
  • the monitoring system 26 includes the temperature, humidity, pressure and gas concentration sensors 128, 130, 132, 134.
  • the sensors 13 have lines which lead to the thoracic cavity which may be electrical wires, when using a pressure transducer for example, or may be sample lines which withdraw gas from the thoracic cavity and are sampled outside the body. A single sample line may branch off to the various sensors or, alternatively, the sensors may be connected together in series.
  • the left ventricle vent 104 may be coupled to any of the sensors for measuring various parameters in the thoracic cavity.
  • the gas sensor detects the concentration of the gas injected into the thoracic cavity or, alternatively, detects the concentration of air remaining in the thoracic cavity.
  • the gas concentration sensor 134 is preferably a sensor with the ability to measure 0-100% carbon dioxide concentration in a gas sample at 1-2 atm pressure, 0-37 (degrees) C and up to 90% relative humidity with a response time of less than about 60 seconds. If necessary for accuracy, the sensor may require that the sample is dried with a dehumidifier (not shown) .
  • a number of conventional carbon dioxide sensors may be used which use infra-red sensors, mass spectroscopy, thermal conductivity and electrochemical cell sensors, laser absorption and emission technologies.
  • the control system 28 receives data from the sensors 13 and is coupled to the various parts of the gas delivery system 24 for controlling the delivery of gas .
  • the control system 28 preferably includes a display 152 for visual indication of the various sensor data such as pressure, temperature, humidity, and gas concentration in the patient's thoracic cavity as well as the gas flow rate into the patient.
  • the control system 28 also preferably includes one or more alarms 154 which indicate when the temperature, humidity, pressure, gas concentration and/or gas flow rate is at an unacceptable level.
  • the alarm 154 may be any conventional alarm such as a visual and/or audible alarm.
  • the control system 28 is preferably adapted to maintain the temperature, humidity, pressure and/or gas concentration at predetermined values.
  • cardiopulmonary bypass is initiated by placing a venous cannula in a major peripheral vein, such as a femoral vein, and placing an arterial cannula in a major peripheral artery, such a femoral artery.
  • the venous and arterial cannulae are connected to a cardiopulmonary bypass system which includes an oxygenator for oxygenating blood withdrawn from the patient through the venous cannula, a filter for removing emboli from the blood, and a pump for returning the blood to the patient's arterial system through the arterial cannula.
  • a cardiopulmonary bypass system which includes an oxygenator for oxygenating blood withdrawn from the patient through the venous cannula, a filter for removing emboli from the blood, and a pump for returning the blood to the patient's arterial system through the arterial cannula.
  • cardiopulmonary bypass With cardiopulmonary bypass established, cardiac function is arrested.
  • conventional, open-chest, external aortic cross clamping and aortic cannulation through the aortic wall may be utilized, closed-chest clamping and cardioplegia delivery techniques are preferred.
  • arrest of cardiac function may be induced on a patient by introducing an aortic catheter into a femoral artery or other major peripheral artery, transluminally positioning the distal end of the aortic catheter in the ascending aorta, and expanding the occluding member 110 (Fig. 13) to occlude the ascending aortic lumen between the coronary ostia and the brachiocephalic artery.
  • a cardioplegic agent preferably a potassium chloride solution mixed with blood
  • a venting catheter may be introduced into the right side of the heart or into the pulmonary artery from a peripheral vein, as described in copending application Serial No. 08/415,238, filed March 30, 1995, which is incorporated herein by reference.
  • a retrograde cardioplegia catheter may be introduced from another peripheral vein into the coronary sinus for retrograde delivery of cardioplegic fluid through the coronary sinus.
  • the right lung In order to obtain access to the heart from the right lateral side of the chest, the right lung is collapsed by inserting an endotracheal tube into the right main stem bronchus and applying a vacuum to deflate the lung. When requiring access to the left lateral side of the chest, when using for the vent needle 34 for example, the left lung is also collapsed.
  • the instrument delivery members 2 and 6-10 are positioned in the chest to provide access into the chest cavity. In most cases, two to six instrument delivery members 2, 6-10 are required.
  • the instrument delivery members 2, 6-10 are configured for placement within an intercostal space without requiring significant retraction of the ribs.
  • a small puncture or incision is made in the intercostal space at the desired location and, with an obturator positioned therein, the instrument delivery members 2, 6-10 are advanced through the puncture or incision.
  • the thoracoscope 14 may be a rigid thoracoscope with a straight end or an angled end such as those available from Olympus Corp., Medical Instruments Division, Lake Success, NY.
  • a thoracoscope with an articulated end steerable by means of an actuator at the proximal end of the device may be used, such as the Welch Allyn DistalVuTM (formerly Baxter DistalCa TM 360) , available from Welch Allyn, Inc., of Skaneateles Falls, NY.
  • Thoracoscopic surgical instruments are then introduced to form an opening in the pericardium.
  • Thoracoscopic scissors and graspers are then used to cut an opening in the pericardium.
  • the right lateral wall of the left atrium is in a direct line of sight from the right lateral chest looking through inner lumen of instrument delivery member 2.
  • the heart is ready to be opened at an atriotomy incision in the left atrial wall between and just anterior to the pulmonary veins PV.
  • the patient's thoracic cavity is preferably flooded with gas using the instrument delivery members 2, 2A or 2B so that the likelihood the chest cavity is filled with the gas rather than air.
  • the control system 28 is activated and gas, such as carbon dioxide, is introduced into the patient's thoracic cavity through the instrument delivery members 2, 2A or 2B and the temperature, pressure, humidity and gas concentration are monitored by sensors 13 and fed back to the control system 28.
  • gas such as carbon dioxide
  • the vacuum pump 30 may be used to remove air during the initial flooding or throughout the procedure.
  • one of the instrument delivery member plugs 19 may be removed so that air is initially ejected through one of the instrument delivery members 6-10. If a gas shield is provided, the compressor, blower or fan is activated so that the gas shield passes across the throughhole 4 of the instrument delivery members 2, 2A or 2B.
  • the second plug 62 is positioned in the throughhole 4 to prevent gas losses through the throughhole 4.
  • the gas shield provided by instrument delivery member 2B also prevent gas losses from the thoracic cavity.
  • the control system 28 automatically adjusts the temperature, gas flow rate, humidity, pressure and gas concentrations to maintain predetermined levels.
  • the operator of the gas delivery system 24 monitors the display 152 and may manually control the various elements of the gas delivery system 24 rather than permitting automatic adjustment. The operator may, of course, also change the predetermined levels for any of the parameters during the procedure.
  • a gas flow rate of 6.0 1/min has been found to provide a 90% carbon dioxide concentration in a model.
  • the surgeon cuts the heart to form the atriotomy.
  • the endoscopic atrial retractor 12 is positioned in atriotomy AI and pulled anteriorly to retract atriotomy AI open. With atriotomy AI retracted, direct visualization of mitral valve MV is possible through the instrument delivery member 2, 2A, or 2B. Under either direct visualization or video-based viewing using the thoracoscope 14 and monitor 16, the condition of mitral valve MV is then assessed to determine whether the valve may be repaired or whether replacement is necessary.
  • annuloplasty in which an annuloplasty ring is attached around the native valve to contract the annulus
  • quadrangular resection in which a portion of a valve leaflet is excised and the remaining portions of the leaflet are sewn back together
  • commissurotomy in which the valve commissures are incised to separate the valve leaflets, shortening of the chordae tendonae, reattachment of severed chordae tendonae or papillary muscle tissue, and decalcification of the valve leaflets or annulus .
  • annuloplasty rings may be used in conjunction with any repair procedures where contracting or stabilizing the valve annulus is desirable.
  • the native valve is replaced with the replacement valve 20.
  • the techniques for introducing and securing the replacement valve within the heart will be analogous to those described above for annuloplasty ring, and are further described in copending application Serial No. 08/281,962, filed July 28, 1994, which is incorporated herein by reference.
  • a surfactant such as the phospholipid pulmonary surfactant found in the lung
  • TEE transesophageal echocardiography
  • the needle vent 34, vent 78 and/or left ventricle vent 104 are positioned in the left ventricle and the aortic vent 106 is positioned in the ascending aorta.
  • the needle vent 34 preferably has a manually manipulatable bulb (not shown) for withdrawing gas from the left ventricle.
  • the needle vent 34 may be coupled to the vacuum pump 30.
  • the vent 38 is preferably positioned through the replacement valve, or through the native mitral valve, when a repair is performed, so that the left ventricle can be flood with a gas, such as carbon dioxide, and vented before atriotomy closure.
  • gas in the ascending aorta is preferably vented using the aortic vent 106.
  • the patient is tilted feet downward so that gas in the left ventricle and ascending aorta migrates toward the occluding member 110.
  • the aortic vent 106 is then used to vent gas around the ascending aorta. Referring to Fig. 13, the aortic vent 106 is preferably rotated so that the opening 114 circumscribes the occluding member 110 between the occluding member 110 and the aortic lumen.
  • both the aortic vent 106 and left ventricle vent 104 both the aorta and left ventricle may be vented with the same catheter.
  • the heart is preferably mechanically manipulated during venting of the various chambers in the heart in a manner similar to the open-chest procedures except that the mechanical manipulators extend through the instrument delivery members 2, 6-10.
  • a discussion of conventional de-airing procedures is described in Taber et al. "Prevention of air embolism during open-heart surgery: A study of the role of trapped air in the left ventricle" Surgery 68 (4) :685-691 (1970) and van der Linden and Casimir- Ahn, "When Do Cerebral Emboli Appear During Open Heart
  • the patient After removing gasses from the ascending aorta, the patient is then tilted head downward so that gas in the left ventricle rises to the apex where the gas can be removed using the needle vent 34, vent 78 or left ventricle vent 104.
  • the gas at the apex of the left ventricle is then vented.
  • the needle vent 34 is preferably moved to various other locations in the heart where pooled air may be a problem or where ultrasound or fluoroscopy have identified pooled air or gas.
  • Other locations where the needle vent may be used include the right upper pulmonary vein, the right coronary sinus of Valsalva, the left atrial appendage, which may be also be inverted or closed with sutures, and the left upper pulmonary vein.
  • the atriotomy is then preferably closed using thoracoscopic needle drivers and a curved needle on a suture.
  • an endoscopic stapling device such as an AutoSutureTM Powered Multifire Endo TA60, available from United States Surgical Corp. of Norwalk, CT, or an endoscopic fascia stapler, may be inserted through an anterior instrument port and positioned around atriotomy AI to drive a series of staples into the atrial wall to close the atriotomy.
  • the opening formed in the pericardium may be closed with sutures or staples in a manner similar to that used for closing atriotomy AI . However, in most cases, closure of the pericardium is not necessary, and the opening may be left without adverse effect .
  • cardiac function is then restored by discontinuing delivery of cardioplegic fluid, terminating occlusion of the ascending aortic lumen, and perfusing the myocardium with warm blood.
  • the occluding member 110 is used, the occluding member 110 is deflated and warm blood is allowed to flow into the coronary arteries. If sinus rhythm does not return immediately, electrical defibrillation is used to stimulate the heart and/or pacing leads may be used to pace the heart for a period of time.
  • the aortic catheter is removed from the patient along with any venting catheters or retrograde cardioplegia delivery catheter which may have been used. Chest tubes may be inserted into the chest to provide drainage. The patient is then weaned from cardiopulmonary bypass, and the arterial and venous cannulae are removed from the patient.
  • the method described above generally provides a gas, such as carbon dioxide, when the heart is initially opened so that air cannot enter the heart during the procedure.
  • a gas such as carbon dioxide
  • the gas may be injected into the patient when the first instrument delivery member 2, 6-10 is inserted into the patient. In this manner, air is prevented from entering the thoracic cavity throughout the procedure.
  • the gas may be used to displace air in the thoracic cavity and the heart just before the atriotomy is closed.
  • the gas may be introduced through the instrument delivery member 2, 2A or 2B, vent 78, or needle vent 34.
  • the vacuum pump 30 may be used to withdraw air which is displaced by the gas .
  • the gas concentration is monitored so that the gas concentration is at an acceptable level before closing the atriotomy. In this manner, the amount of time the thoracic cavity is exposed to the gas is minimized.
  • FIG. 18 another embodiment of an apparatus for preventing air embolism when performing a procedure in a patient's thoracic cavity is shown.
  • An enclosure 158 extends around the patient and is supported by an operating table 160.
  • a drape 162 extends around the patient's chest and provides a substantially air-tight seal.
  • the drape 162 may include an adhesive strip (not shown) for forming the substantially air-tight seal.
  • the enclosure 158 includes a number of arm pass-throughs 164 on both sides of the enclosure 158.
  • the arm pass-throughs 164 are substantially air tight and permit the surgeon to perform procedures in the enclosure.
  • a tool box 166 is slidably coupled to the exterior of the enclosure 158 for passing tools into the enclosure 158.
  • An advantage of the enclosure 158 is that a retractor 118 may be mounted to the enclosure 158.
  • the enclosure 158 is preferably coupled to the gas delivery system 24 and control system 26 described above in connection with the previously disclosed embodiments via a line 168.
  • the enclosure 158 is particularly useful when providing a pressure in the enclosure 158 which is higher than the pressure outside the enclosure 158 so that air does not enter the enclosure 158.
  • the enclosure 158 also minimizes the amount of gas which is released into the operating room so that surgeon exposure to the gas is minimized.
  • the gas outlets may be angled toward the proximal end with baffles to redirect the gas toward the distal end, the gas outlets which pass across the throughhole may contact a baffle which directs the gas toward the distal end, the gas outlet may simply be a hose which is clipped to the sidewall or any other part of the instrument delivery member so long as the gas outlet is coupled to the remainder of the instrument delivery member, and the left ventricular vent may include only one lumen rather than two.
  • the present invention is equally applicable to procedures in which the patient's heart is not stopped. Therefore, the above description should not be taken as limiting the scope of the invention which is defined by the claims.

Abstract

An instrument delivery member (2) for use in the thoracic cavity and a method for its use, is disclosed. The delivery member (2) has a gas inlet (40) coupled to a sidewall (44) of the instrument delivery member (2). Gas delivered through the inlet (68) passes through the delivery member and out a plurality of gas outlets (38) such that the gas exiting through the gas outlets (38) passes across the through hole (4) of the delivery member (2) to form a gas shield.

Description

METHOD AND APPARATUS FOR MINIMIZING THE RISK OF AIR EMBOLISM IN THE
THORACIC CAVITY
FIELD OF THE INVENTION The present invention is directed to apparatus and methods for minimizing the risk of air embolism when performing a procedure in a patient's thoracic cavity. A specific application of the invention is described in conjunction with devices and methods for repairing and replacing a mitral valve in a patient's heart, however, the invention may be used in conjunction with any other procedure including repair or replacement of mitral, aortic and other heart valves, repair of septal defects, pulmonary thrombectomy, electrophysiological mapping and ablation, coronary artery bypass grafting, angioplasty, atherectomy, treatment of aneurysms, myocardial drilling and revascularization, as well as neurovascular and neurosurgical procedures.
BACKGROUND OF THE INVENTION
Various types of surgical procedures are currently performed to investigate, diagnose, and treat cardiovascular diseases. Using current techniques, many of these procedures require a gross thoracotomy, usually in the form of a median sternotomy, to gain access to the patient's thoracic cavity. A saw is used to cut the sternum longitudinally thereby allowing two opposing halves of the anterior or ventral portion of the rib cage to be spread apart. A large opening in the thoracic cavity is created through which the surgical team may directly visualize and operate upon the heart and other thoracic contents. Surgical intervention in the heart generally requires isolation of the heart and coronary blood vessels from the remainder of the arterial system and arrest of cardiac function. The heart is usually isolated from the arterial system by introducing an external aortic cross-clamp through a sternoto y and applying the clamp to the aorta between the brachiocephalic artery and the coronary ostia. Cardioplegic fluid is then injected into the coronary arteries, either directly into the coronary ostia or through a puncture in the aortic root, to arrest cardiac function. In some cases, cardioplegic fluid is injected into the coronary sinus for retrograde perfusion of the myocardium. The patient is then placed on cardiopulmonary bypass to maintain peripheral circulation of oxygenated blood. Another method of arresting the patient's heart is disclosed in U.S. Patent No. 5,433,700, which is assigned to the assignee of the present application and is herein incorporated by reference. U.S. Patent No. 5,433,700 describes an endovascular catheter system for establishing arrest of cardiac function. The endovascular catheter system does not require a gross thoracotomy and facilitates less invasive methods of performing cardiopulmonary procedures.
Once the patient is placed on cardiopulmonary bypass, various surgical techniques may be used to repair a diseased or damaged valve, including annuloplasty (contracting the valve annulus) , quadrangular resection (narrowing the valve leaflets) , commissurotomy (cutting the valve commissures to separate the valve leaflets) , shortening mitral or tricuspid valve chordae tendonae, reattachment of severed mitral or tricuspid valve chordae tendonae or papillary muscle tissue, and decalcification of valve and annulus tissue. Alternatively, the valve may be replaced, by excising the valve leaflets of the natural valve and securing a replacement valve in the valve position usually by suturing the replacement valve to the natural valve annulus. Various types of replacement valves are in current use, including mechanical and biological prostheses, homografts, and allografts, as described in Bodnar and Frater, Replacement Cardiac Valves 1- 357 (1991), which is incorporated herein by reference. A comprehensive discussion of heart valve diseases and the surgical treatment thereof is found in Kirklin and Barratt- Boyes, Cardiac Surgery , pp. 323-459 (1986) , the complete disclosure of which is incorporated herein by reference.
The mitral valve, located between the left atrium and left ventricle of the heart, is most easily reached through the wall of the left atrium, which normally resides on the posterior side of the heart, opposite the side of the heart that is exposed by a median sternotomy. Therefore, in order to access the mitral valve via a sternotomy, the heart is rotated to bring the left atrium into an anterior position accessible through the sternotomy. An opening, or atriotomy, is then made in the right side of the left atrium, anterior to the right pulmonary veins. The atriotomy is retracted by means of sutures or a retraction device, exposing the mitral valve directly posterior to the atriotomy. One of the aforementioned techniques may then be used to repair or replace the valve. An alternative technique for mitral valve access may be used when a median sternotomy and/or rotational manipulation of the heart are undesirable. In this technique, a large incision is made in the right lateral side of the chest, usually in the region of the fifth intercostal space. One or more ribs may be removed from the patient, and other ribs near the incision are retracted outward to create a large opening into the thoracic cavity. The left atrium is then exposed on the posterior side of the heart, and an atriotomy is formed in the wall of the left atrium, through which the mitral valve may be accessed for repair or replacement.
Using such open-chest techniques, the large opening provided by a median sternotomy or right thoracotomy enables the surgeon to see the mitral valve directly through the left atriotomy, and to position his or her hands within the thoracic cavity in close proximity to the exterior of the heart for manipulation of surgical instruments, removal of excised tissue, and/or introduction of a replacement valve through the atriotomy for attachment within the heart. However, these invasive, open-chest procedures produce a high degree of trauma, a significant risk of complications, an extended hospital stay, and a painful recovery period for the patient. Moreover, while heart valve surgery produces beneficial results for many patients, numerous others who might benefit from such surgery are unable or unwilling to undergo the trauma and risks of current techniques.
A problem which occurs in conventional open-heart procedures is that air enters the heart during the procedure and must be removed from the heart after completing the procedure. Air which remains in the circulatory system after the heart is closed may produce air emboli which could travel to the brain and cause a stroke or death. Conventional de- airing techniques include mechanical manipulations and venting of the heart to remove air trapped in the heart. U.S. Patent No. 5,370,631, for example, discloses an apparatus for de- airing the heart which includes a slotted-needle and a resilient bulb.
Carbon dioxide has been used to displace air in the patient's thoracic cavity to help prevent air emboli. In animal studies, carbon dioxide has been shown to be as much as twelve times more soluble in blood than air. Thus, displacing air with carbon dioxide may be beneficial in reducing the harmful effects of gas emboli. In open-heart procedures, carbon dioxide has been introduced into the thoracic cavity through the median sternotomy. Since the patient's chest is open, the carbon dioxide in the chest cavity readily disperses out of the chest and, therefore, carbon dioxide must be continuously or periodically replaced, Ng and Rosen, Carbon Dioxide in the prevention of air embolism during open-heart surgery, Thorax 23:194-196 (1968).
Thus, a problem with previous use of carbon dioxide in open heart procedures is that air is free to enter the open chest cavity and high carbon dioxide concentrations cannot be maintained in the chest cavity for extended periods of time without requiring continuous or periodic injection of carbon dioxide. SUMMARY OF THE INVENTION In accordance with the principles of the present invention, methods and apparatus for reducing the risk of air embolism when performing a procedure in a patient's thoracic cavity are provided. In an aspect of the present invention an instrument delivery member is inserted into a patient's thoracic cavity between adjacent ribs thereby forming a percutaneous intercostal penetration. The instrument delivery member has a gas outlet for injecting a gas, preferably carbon dioxide, into the patient's thoracic cavity. The gas displaces air from the patient's thoracic cavity thereby reducing the risk of air emboli. The instrument delivery member also has a through hole sized to permit an instrument to pass therethrough. The present invention is particularly useful when performing the mitral valve replacement and repair procedures described in U.S. Patent Application Serial No. 08/485,600 and U.S. Patent Application Serial No. 08/163,241 both of which are assigned to the assignee of the present application and which are incorporated herein by reference. The methods facilitate surgical intervention within the heart or great vessels without the need for a gross thoracotomy. The procedure is carried out through small incisions within intercostal spaces of the rib cage without cutting, removing, or significantly deflecting the patient's ribs or sternum thereby reducing the trauma, risks, recovery time and pain that accompany conventional techniques. The devices and methods permit removal of tissue from the thoracic cavity and introduction of surgical instruments, replacement valves and the like into the thoracic cavity, to facilitate heart valve repair and replacement. The devices and methods facilitate replacement of a heart valve with various types of prostheses, including mechanical and biological prostheses, homografts, and allografts. In a preferred embodiment of the present invention, the instrument delivery member includes a plurality of gas outlets which are angled toward the distal end to help retain gas in the patient's thoracic cavity. In an alternative embodiment, the gas outlets are angled substantially perpendicular to the longitudinal axis of the instrument delivery member with the gas passing adjacent the distal end. A vacuum pump may also be provided for withdrawing air from the patient's thoracic cavity or for capturing gas escaping from the patient's thoracic cavity.
The concentration of gas in the patient's thoracic cavity is preferably monitored so that a threshold gas concentration is maintained. When using carbon dioxide, the gas concentration is preferably at least 70 % and more preferably at least 90 % by volume. Alternatively, the air concentration may be maintained at no more than 50 % and more preferably no more than 5 % by volume. The humidity and temperature in the patient's thoracic cavity are also preferably monitored to maintain a desirable humidity and temperature. The relative humidity in the patient's thoracic cavity is preferably at least 10 % and more preferably at least 50 %. The temperature of the gas is also preferably maintained at a temperature below body temperature and preferably below 20 (degrees) C.
The pressure of the gas in the patient's thoracic cavity is also preferably monitored and regulated. The gas pressure is preferably maintained at a pressure higher than the pressure outside the thoracic cavity to prevent air does from entering the thoracic cavity. When performing the procedure described in U.S. Patent Application Serial No. 08/485,600, which is incorporated herein by reference, a number of instrument delivery members, such as cannulas or trocars, are inserted into the patient to perform a mitral valve procedure. The present invention provides seals at the instrument delivery members to prevent the escape of gas so that the pressure can be maintained in the thoracic cavity. Such seals are commonly used in laparoscopic procedures. Unlike laparoscopic surgery, however, the pressure in the thoracic cavity is not used to retract the thoracic cavity and, as such, the pressure in the thoracic cavity is kept between 1 and 14 mm Hg and more preferably between 1 and 10 mm Hg and most preferably between 1 and 8 mm Hg all of which are below the pressures used in laparoscopic procedures which are typically between 15 and 20 mm Hg.
In another aspect of the present invention, the instrument delivery member includes a gas inlet and a gas outlet positioned to receive gas issuing from the gas inlet. The gas passing from the gas inlet to the gas outlet preferably passes across the throughhole, and preferably transects the throughhole, to act as a gas shield which minimizes gas losses through the instrument delivery member. The gas shield advantageously permits the introduction of instruments through the instrument delivery member without significantly hindering use of instruments. The gas which is used for the gas shield may be any gas such as carbon dioxide or air. A blower, fan or compressor is coupled to the gas inlet and may also be coupled to the gas outlet for closed circuit circulation.
In yet another aspect of the invention, a vent is provided for venting gas from the left ventricle when performing a procedure on the patient's heart such as a mitral valve repair or replacement. The vent includes first and second lumens and first and second outlets fluidly coupled to the first and second lumens, respectively. The first lumen and first outlet are used for injecting gas into the patient's heart and for evacuating gas from the heart when the heart is being closed after the mitral valve replacement or repair procedure. The second lumen and second outlet are used for sampling gas in the patient's thoracic cavity.
In a specific application of the vent, the vent is positioned in the left ventricle and a gas, such as carbon dioxide, is injected into the patient through the first lumen. The gas displaces air in the left ventricle so that when the heart is closed the presence of air is minimized to minimize the risk of air emboli. The gas is preferably injected into the heart using the temperature, pressure, humidity and gas concentration monitoring and control system described above.
When the heart is closed, the first lumen and first outlet are used to evacuate gasses from the heart . The second outlet and second lumen are used to collect gasses in the thoracic cavity for measuring pressure, temperature, humidity, and/or gas concentrations. The second outlet is spaced apart from the distal end so that the measurements are not overly influenced by the gas being injected into the left ventricle through the first lumen and first outlet.
In yet another aspect of the invention, an enclosure is provided around the patient for providing a sealed operating space. A gas, such as carbon dioxide, is maintained in the sealed operating space so that air does not enter the patient's cardiopulmonary system during a medical procedure. The enclosure includes a seal, such as a drape, which engages the patient and provides a substantially air tight seal. The enclosure includes arm pass-throughs which are used by the surgeon to perform the medical procedure in the enclosure. An advantage of the enclosure is that it may also be used in conventional open heart procedures since a gas environment is created around the patient.
The terms "percutaneous intercostal penetration" and "intercostal penetration" as used herein refer to a penetration, in the form of a small cut, incision, hole, or the like through the chest wall between two adjacent ribs, wherein the patient's rib cage and sternum remain substantially intact, without cutting, removing, or significantly displacing the ribs or sternum. These terms are intended to distinguish a gross thoracotomy such as a median sternotomy, wherein the sternum and/or one or more ribs are cut or removed from the rib cage, or one or more ribs are retracted significantly, to create a large opening into the thoracic cavity. It is understood that one or more ribs may be retracted or deflected a small amount and/or a small amount of intercostal cartilage may be removed without departing from the scope of the invention.
These and other advantages of the invention will become apparent from the following detailed description of the invention. BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1. shows a patient prepared for a mitral valve replacement with a number of instrument delivery members extending into the patient's thoracic cavity and a gas delivery system coupled to one of the instrument delivery members;
Fig. 2 shows a cross-sectional view of the patient of Fig. 1 with a gas outlet coupled to one of the instrument delivery members for injecting a gas into the patient's thoracic cavity,-
Fig. 3 is an isometric view of the instrument delivery member having a gas delivery assembly;
Fig 4. is an isometric view of the gas delivery assembly of Fig. 3; Fig. 5 is a cross-sectional view of a second preferred embodiment of the instrument delivery member;
Fig. 6 is an end view of the instrument delivery member of Fig. 5:
Fig. 7 is a cross-sectional view of a gas path showing the orientation of a gas outlet of the instrument delivery member of Fig. 5;
Fig. 8 is a cross-sectional view of a patient with a vent extending through the instrument delivery member and into the patient's left ventricle; Fig. 9 is a plan view of the vent of Fig. 8;
Fig. 9A is a side view of an alternate embodiment of the left ventricle vent of Fig. 9;
Fig. 10 is a side view of the vent of Fig. 8; Fig. 11 is a cross-sectional view of the vent of Fig. 8 showing first and second lumens;
Fig. 12 is a view looking through the instrument delivery member with a mitral valve being attached to the patient's valve annulus;
Fig. 13 shows vent catheters extending through a lumen of an endoaortic partitioning catheter;
Fig. 14 is an isometric view of another preferred instrument delivery member having a gas inlet and a gas outlet positioned to receive gas issuing from the gas inlet; Fig. 15 is a top view of the instrument delivery member of Fig. 14;
Fig. 16 is a schematic of the gas delivery system, monitoring system and control system;
Fig. 17 is a view looking through the instrument delivery member with an atriotomy being closed and a vent extending through the atriotomy; and
Fig. 18 is an isometric view of an enclosure extending around a patient.
DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to Fig. 1, a system for minimizing the risk of air emboli when performing a procedure in a patient's thoracic cavity is shown. A specific application of the invention is developed herein with respect to a minimally invasive mitral valve replacement procedure, however, the apparatus and methods of the present invention may be used in conjunction with any other procedure including repair or replacement of aortic and other heart valves, repair of septal defects, pulmonary thrombectomy, electrophysiological mapping and ablation, coronary artery bypass grafting, angioplasty, atherectomy, treatment of aneurysms, myocardial drilling and revascularization, as well as neurovascular and neurosurgical procedures . The procedure for performing the minimally invasive mitral valve repair and replacement will be discussed to the extent necessary to adequately describe the present invention and a complete discussion is provided in U.S. Patent Application Serial No. 08/485,600, filed June 7, 1995, which is incorporated herein by reference. Referring still to Fig. 1, an instrument delivery member 2 includes a throughhole 4 for introduction of surgical instruments into a patient's thoracic cavity. The instrument delivery member 2 is preferably a hollow tube, such as a cannula, trocar sleeve, a 3-sided channel-shaped member, a ring retractor, a wound retractor having a pair of adjustable parallel blades, or any other device which facilitates introduction of a medical instrument into a patient between adjacent ribs. The instrument delivery member 2 is positioned between adjacent ribs in the patient and a number of other instrument delivery members 6-10 are positioned at various other positions thereby forming a number of percutaneous intercostal penetrations. A retractor 12 passes through instrument delivery member 9 and various sensors 13, which are described in greater detail below, pass through instrument delivery member 6. A thoracoscope 14 passes through instrument delivery member 8 and is coupled to a monitor 16 for viewing the patient's thoracic cavity. Any other viewing device may be used in conjunction with, or as a substitute for, the thoracoscope 14. A first removable plug 18 is positioned in the delivery member 7 with the first plug 18 separated from the instrument delivery member 7 for clarity. A replacement valve 20 is mounted to a holder 22, however, a repair device, such as a ring for annuloplasty, may, of course, be used when repairing rather than replacing the mitral valve.
A gas delivery system 24 is coupled to the instrument delivery member 2 for delivering a gas into the patient's thoracic cavity. The gas delivery system 24 supplies gas, such as carbon dioxide, for introduction into the patient's thoracic cavity to minimize the risk of an air embolism when performing a procedure in the patient's thoracic cavity. A monitoring system 26 is coupled to the sensors 13 for monitoring the various conditions sensed by the sensors 13. A control system 28 receives the information from the sensors 13 via the monitoring system 26 and sends control information to the gas delivery system 24 based upon the sensor data. The gas delivery system 24, control system 28 and monitoring system 26 are described in greater detail below in connection with Fig. 16.
A vacuum pump 30 is coupled to the instrument delivery member 9 having the retractor 12 for withdrawing air from the thoracic cavity when the gas is injected into the thoracic cavity. The vacuum pump 30 is also coupled to a line 32 which is positioned adjacent to the instrument delivery member 2 for withdrawing gas which escapes through the instrument delivery member. A vent needle 34 extends through the instrument delivery member 10 and into the patient used for venting gasses from the thoracic cavity as described in further detail below.
Referring to Fig. 2, a cross-sectional view of the patient is shown. The vent needle 34 is preferably perforated along the longitudinal axis (not shown) of the needle for venting gasses from the left ventricle. Use of the vent needle 34 is described in greater detail below in connection with preferred methods of operation. The retractor 12 engages an atriotomy AI formed in the patient's heart for retracting the atriotomy open. A number of sutures 36 extend through the instrument delivery member 2 and are used for attaching the repair valve 20 in the manner described in U.S. Patent Application Serial No. 08/485,600. The instrument delivery member 2 includes a gas outlet 38, preferably a number of gas outlets, and a gas inlet 40 coupled to the gas delivery system 24 for delivering the gas into the thoracic cavity. A gas, such as carbon dioxide, is introduced into the patient's thoracic cavity through the gas outlet 38. Referring to Figs. 3 and 4, the instrument delivery member 2 and a gas delivery assembly 42 are shown. The instrument delivery member 2 preferably includes a sidewall 44 and the throughhole 4 defines a longitudinal axis 46. The throughhole 4 extends from a proximal end and terminates at an opening 48 at a distal end 50. Although the instrument delivery member 2 preferably has an oval throughhole, any other cross-section may be used such as a race-track, rectangular, trapezoidal, elliptical or circular cross-sectional shape. The throughhole 4 is preferably sized to allow an annuloplasty ring or replacement valve mounted on a holder to pass therethrough. The throughhole 4 preferably has a cross- sectional shape having a width of preferably about 10-30 mm, and more preferably 15-25 mm, and a height of preferably about 25-75 mm, more preferably 30-50 mm. Furthermore, the width or height of the throughhole is preferably at least 2 cm, more preferably at least 2.5 cm and most preferably at least 3 cm. Typical laparoscopic trocars have much smaller openings since gas losses must be minimized when operating at the higher pressures used in laparoscopic procedures . The exact width and height will often be determined by the width (or diameter) and height of the annuloplasty ring or replacement valve and holder being used in the procedure. It is sometimes desirable to begin the procedure with a instrument delivery member 2 of the minimum size necessary to assess the condition of the native valve. For example, an instrument delivery member 2 having a width of about 15-20 mm may be used initially. When the size of the annuloplasty ring or prosthetic valve has been selected, the smaller instrument delivery member may be replaced, if necessary, with a larger instrument delivery member to accommodate the prosthesis.
The instrument delivery member 2 is configured for placement in an intercostal space preferably without retraction of ribs, or at least minimal retraction of ribs, and preferably has an external width of less than about 30 mm, and preferably less than about 25 mm. Although it is preferred to provide a sidewall 44 which has an elongate tubular structure with a length sufficient to extend into the thoracic cavity, the sidewall may simply be the elements of a ring retractor or any of the other instrument delivery members described above so long as the instrument delivery member provides access to the patient's thoracic cavity for surgical instruments. The instrument delivery member has a flange 52 at its proximal end which engages the outside of the patient's chest. The instrument delivery member 2 has a length sufficient to extend from outside of the chest, through the intercostal space, and into the chest cavity just beyond the interior of the chest wall. The instrument delivery member 2 preferably has a length of about 20-70 mm and more preferably about 30-50 mm from the flange 52 to the distal end.
The instrument delivery member 2 includes a suture organizing ring 54 attached to the flange 52. Organizing ring 54 has a plurality of circumferentially-spaced radial slots 56 or suture holders in which a suture thread may be received and retained. Slots 56 have tapered upper ends 58 for guiding a suture thread to the slot. Suture organizing ring 54 allows sutures placed in the heart for attachment of a prosthesis to be drawn through the throughhole and temporarily placed in slots 56 to keep the sutures individually separated and untangled. In order to facilitate introducing instrument delivery member 2 through a puncture or small incision between the ribs, an obturator (not shown) may be inserted into the throughhole 4. The instrument delivery member 2 may also be made of a flexible or deformable material to allow it to be shaped by the user or to conform to the shape of the intercostal space.
Still referring to Figs. 3 and 4, the gas delivery assembly includes a sleeve 60 which clips onto the sidewall 44. The sidewall 44 may include ribs (not shown) for enhanced engagement with the gas delivery assembly 42. The gas outlet 38, and preferably a plurality of gas outlets, are provided on a horseshoe-shaped ring 61. The gas delivery assembly 42 is mounted to the sidewall 44 so that a plurality of gas outlets 38 are directed across the opening 48. In the preferred embodiment, the opening 48 lies in a plane perpendicular to the longitudinal axis 46 so that the gas outlets 38 are also directed substantially perpendicular to the longitudinal axis. The opening 48 may also be skewed with respect to the longitudinal axis with the gas outlets 38 also being skewed so that the gas outlets 38 are configured to issue gas directly across the opening 48. By orienting the gas outlets 38 in this manner, the gas injected into the patient helps retain the gas in the thoracic cavity by creating a gas curtain at the opening 48 of the instrument delivery member. Although it is preferred to provide one gas delivery assembly, two or more gas delivery assemblies may be provided. Furthermore, although it is preferred to direct the gas in a direction perpendicular to the longitudinal axis 46, the gas outlets 38 may also be angled toward the distal end or, alternatively, angled toward the proximal end with a baffle to redirect the gas so that the gas does not simply exit through the proximal opening in the instrument delivery member 2. Finally, the gas outlets 38 are preferably positioned so that they direct gas across substantially the entire width or height of the throughhole 4 so that gas losses through the throughhole are minimized.
A plug 62 is removably mounted to the instrument delivery member 2 to close, or at least partially close, the throughhole 4 thereby minimizing gas losses through the throughhole 4. The second plug 62 preferably includes a resilient surface 63, preferably an elastic band, which engages the instrument delivery member 2 to provide a snug fit when sutures are positioned through the throughhole 4. The second plug 62 has an opening 64 so that instruments may still be passed through the throughhole while reducing losses through the throughhole. A third plug 66 closes the opening 64 so that substantially all gas losses through the throughhole 4 are eliminated. Alternatively, a number of different plugs having different sized openings, or no openings at all like second plug 62A, may be provided. Furthermore, the opening 64 may be any other shape such as H- shaped, an oval ring, Z-shaped or a figure "8."
Referring to Figs. 5-7, another instrument delivery member 2A is shown which includes integrally formed gas outlets 38A wherein similar reference numbers are used to represent similar features described in the embodiment of Figs. 3-4. The discussion above concerning instrument delivery member 2 is equally applicable here and the preferred features for the instrument delivery member 2 are also preferred with the instrument delivery member 2A.
The instrument delivery member 2A includes a gas inlet 66 configured to be coupled to a gas line 68 which, in turn, is coupled to the gas delivery system 24. The instrument delivery member 2A includes integrally formed gas outlets 38A whereas the instrument delivery member 2 includes the removable gas delivery assembly 42. The gas inlet 66 is coupled to a chamber 70 which extends circumferentially around the instrument delivery member 2A between an inner wall 72 and an outer wall 74. A plurality of gas channels 74 extend from the common chamber 70 and 76 terminate at the gas outlets 38A which direct the gas in the direction of arrows 78. The gas outlets 38A are preferably directed toward the distal end and, further, are directed toward the middle of the instrument delivery member 2A. The gas outlets 2A cooperate with one another to hinder escape of gasses through the instrument delivery member 2A. The gas outlets 38A are particularly useful for providing a pressure in the thoracic cavity above the pressure outside the thoracic cavity to help keep air out of the thoracic cavity. Although it is preferred to angle the gas outlet 38A toward the distal end, the gas outlet 38A may be oriented in any other manner so long as the gas outlet 38A tends to prevent gas from escaping through the open proximal end of the instrument delivery member 2A. Furthermore, although it is preferred to provide a number of gas outlets 38A around the entire periphery of the instrument delivery member 2A, the gas outlets 38A may also be provided only along a section of the instrument delivery member 2A.
Referring to Fig. 8, a cross-sectional view of the patient is shown with a vent 78 extending into the left ventricle LV. The vent 78 preferably has a distal end 80 which extends to the apex of the left ventricle LV for venting the left ventricle LV. The distal end 80 preferably includes a soft tip for preventing trauma to the left ventricle. The first outlet 86 is preferably used for injecting gas into the left ventricle and for venting gas from the left ventricle. The second outlet is preferably coupled to a monitoring system 26 for monitoring the conditions in the patient's thoracic cavity such as the gas concentration, humidity, temperature and pressure. Use of the vent 78 is described below in connection with discussion of preferred methods of present invention.
Referring to Figs. 9-11, a distal portion 81 of the vent 78 is shown in a natural, unbiased shape. The distal portion 81 of the vent 78 is configured to position the distal end 80 at the apex of the left ventricle LV when the proximal portion extends through the valve annulus. The approximate position of the valve annulus is shown at broken line 79 which also indicates the beginning of the distal portion 81. The vent 78 preferably includes a first lumen 82, a second lumen 84 and first and second outlets 86, 88 fluidly coupled to the first and second lumens 26, respectively. The first and second outlets 86, 88 are preferably spaced apart between 0.5 and 8 cm, and more preferably between 2 and 4 cm, so that gas samples taken through the first outlet are not overly influenced by gas injected into the left ventricle through the first outlet 88. The first outlet 86 is preferably positioned near the distal end 80 and the second outlet 88 is preferably between at least 0.5, more preferably at least 5 cm and most preferably at least 8 cm from the distal end. The distal portion 81 preferably extends between 1 and 10 cm, and more preferably between 1 and 5 cm in the axial direction A, and extends in the radial direction B between 0 and 15 cm and more preferably 2 and 8 cm, and extends between 0 and 5 cm and more preferably between 0.5 and 3 cm in the other radial direction C. The proximal end of the vent 78 is flexible so that the user may position the vent 78 where it will not interfere with the medical procedure. Referring to Fig. 9A, the distal end of another left ventricle vent 78A is shown. The left ventricle vent 78A has the same preferred dimensions as the left ventricle vent 78, however, the first and second outlets 86A, 88A are both positioned near the proximal end with an angle D therebetween. The angle D is preferably at least 90 degrees and preferably greater than 90 degrees so that gas issuing from the first outlet 86A does not overly influence gas samples taken at second outlet 88A.
Referring to Figs. 12, a view through the throughhole 4 of the instrument delivery member 2 is shown. A spacer 98 prevents contact between the valve 20, which in this case is a mechanical valve, and the vent 78. The spacer 98 preferably includes a pair of holes 100 for removing the spacer 98 before closing the heart. Alternatively, the spacer 98 may be dispensed with and the vent 78 may be coated with a lubricious coating of silicone, teflon or polyurethane to prevent damage to the valve 20 when the vent 78 is withdrawn. The instrument delivery member 2 includes a clip 102 for holding the vent 78 after the vent 78 is positioned in the left ventricle LV. The clip 102 prevents movement of the vent 78 and also positions the vent 78 away from the center of the throughhole 4 so that other instruments may be used through the instrument delivery member 2.
Referring to Fig. 13, a left ventricle vent 104 and an aortic vent 106 are shown extending through an endoaortic partitioning catheter 108 which is described in U.S. Patent Application Serial No. 08/415,366 to Stevens et al. which is assigned to the assignee of the present invention and which is incorporated herein by reference. The endoaortic partitioning catheter 108 has an occluding member 110 which occludes the ascending aorta. Cardioplegic fluid is introduced to the coronary arteries through the endoaortic partitioning catheter 110 for arresting cardiac function. The endoaortic partitioning catheter 110 provides a working lumen (not shown) through which instruments, such as the left ventricle vent 104 and aortic vent 106, may pass.
The aortic vent 106 has a curved distal end 112 which generally conforms to the shape of the occluding member 110 for venting gasses around the occluding member 110. The aortic vent 106 has an opening 114 at the distal end 112 for venting gasses from the ascending aorta AO. The proximal end of the aortic vent 106 is relatively stiff so that the aortic vent 106 may be rotated from the proximal end. Rotation of the aortic vent causes the distal end 112 to circumscribe the outer surface of the occluding member 110 for venting gasses around the occluding member 110. When using the aortic vent 106, the patient is preferably tilted feet downward so that gasses in the ascending aorta rise toward the occluding member 110 for venting. The left ventricle vent 104 has an opening 116 near a curved, distal end 118 for venting the left ventricle. The curved end 118 prevents damage to the aortic valve and the left ventricle when the left ventricle vent 104 passes through the aortic valve and the left ventricle. The curved distal end 118 is preferably curved in an arc greater than 180; so that the curved portion also contacts the aortic valve when the catheter is withdrawn. Use of the aortic vent 106 and left ventricle vent 104 is described below in connection with preferred methods of the present invention. Both the aortic vent 106 are and the left ventricle vent 104 are preferably coupled to the vacuum pump 30 for withdrawing gasses from the patient's heart. Referring to Figs. 14 and 15, another instrument delivery member 2B is shown which includes both a gas inlet 120 and a gas outlet 122. The instrument delivery member 2B is substantially the same as the instrument delivery members 2 and 2A described above and discussion of the features of the instrument delivery members 2 and 2A are equally applicable here. The gas outlet 122 is positioned to receive gas issuing from the gas inlet 120 so that a gas shield is formed which minimizes escape of gasses from the thoracic cavity. The gas inlet and outlet preferably extend across substantially the entire width and/or length of the throughhole 4 and include tapered entrances 124, 126 so that a laminar flow of gas is achieved. The bottom surfaces of the gas inlet and outlet 120, 122 are preferably flush with the flange 52 so that the flange 52 helps provide the gas shield across the throughhole 4. The gas inlet 120 preferably has a relatively small internal height of between 0.25 and 5 mm and more preferably between .5 and 3 mm. The gas outlet 122 may have a somewhat larger internal height of preferably between 1 and 10 mm and more preferably between 2 and 5 mm. The gas outlet 122 is preferably positioned and sized to withdraw substantially all of the gas issuing from the gas inlet 122 so that a gas shield is maintained across the throughhole 4.
The gas inlet and outlet 120, 122 are coupled to a fan, blower or compressor (not shown) for delivering the gas and forming the gas shield with a closed system. A filter
(not shown) , preferably a hydrophobic filter, filters the gas in the closed system. The gas used for the gas shield may be any gas, such as carbon dioxide or even air, since the gas shield primarily functions to reduce gas losses through the instrument delivery member 2B. The gas shield may be formed with carbon dioxide with the outlet 122 delivering the carbon dioxide into the patient. For example, the instrument delivery member 2B may include the gas delivery assembly 42 with the gas delivery assembly 42 being coupled to the outlet 122. Thus, although the instrument delivery member 2B is an independent device for minimizing gas losses from the patient's thoracic cavity, the gas inlet and gas outlet 120, 122 may also be used in connection with the embodiment of Figs. 3-4 and 5-7 so that gas is injected into the patient with the same member that is used for forming the gas shield. Although it is preferred to provide the gas inlet 120 at a geometrically opposite side of the instrument delivery member 2B from the gas outlet 122, the instrument delivery member 2B may include baffles and the like so that the gas outlet 122 is not positioned geometrically opposite the gas inlet 120 but, nonetheless, receives the gas issuing from the gas inlet 120. Furthermore, although it is preferred to provide the gas inlet and outlet 120, 122 near the proximal end, the gas inlet and outlet may also be positioned near the distal end of the instrument delivery member 2B similar to orientation of the gas delivery assembly 42.
Referring to Fig. 16, the gas delivery system 24, monitoring system 26 and control system 28 are shown. The monitoring system 26 preferably includes a temperature sensor 128, a humidity sensor 130, a pressure sensor 132 and a gas sensor 134 such as a carbon dioxide or oxygen sensor. Referring to Fig. 1, the sensors 128, 130, 132, 134 extend through the instrument delivery member 6, however, more than one of the instrument delivery member may be used for the sensors 13 if necessary. Alternatively, a sampling tube, such as any of the vents described herein, may be periodically or continuously positioned within the patient for sampling gas which is then delivered to the various sensors outside of the patient. The temperature and humidity sensors 128 are also coupled to the gas delivery line for measuring the temperature and humidity of the gas before injection into the patient's thoracic cavity. The gas delivery system 24 includes a source of gas
136, such as carbon dioxide, a heater and/or cooler 138, a humidifier 140 and a source of therapeutics 142. Although it is preferred to use carbon dioxide any other suitable gas may be used which is absorbed by the body more readily than air so that the risk of harm due to gas emboli is reduced. A discharge valve or regulator 144, which is controlled by the control system 28, controls the flow of gas. The heater/cooler 138 is coupled to the discharge line for heating and/or cooling the gas. A valve 146 regulates the amount of heated or cooled gas added to the gas line from the source of gas 136. It is preferred to cool the gas since lower temperatures are advantageous when performing procedures on the heart and because cooling the gas increases the gas density which may further reduce gas losses from the thoracic cavity. Although it is preferred to provide a separate heating and cooling branch, the entire flow of gas from the source of gas 136 may be passed through the heater/cooler 138 rather than only a portion of the gas stream. Valves 144, 146 and 147 for regulating the gas stream are controlled by the control system 28. The monitoring system 26 may also include a flow rate indicator (not shown) for measuring the flow rate downstream from the valve 147. The humidifier 140 prevents excessive drying of the patient's tissue during the medical procedure. In a preferred method described below, the thoracic cavity is flooded with gas throughout the procedure which might excessively dry the patient's tissue. In order to prevent excess drying, the humidifier 140 adds water vapor to the gas stream. The humidifier 140 may be any conventional humidifier such as a misting nozzle, a mixing chamber, or an atomizer. The humidifier 140 preferably draws liquid from a source of sterilized saline or water (not shown) . A valve 148, which is controlled by the control system 28, regulates the addition of humidified gas to the gas stream in response to the humidity measurements by the humidity sensor 130.
The source of therapeutics adds therapeutic agents, such as anti-inflammatories, to the gas stream for, for example, reducing post operative adhesions. A surfactant may also be introduced into the patient's thoracic cavity before filling the heart with blood to reduce the surface tension of bubbles in the heart. A preferred surfactant would be the phospholipid pulmonary surfactant found in the lungs. Reduction of the surface tension facilitates removal of gasses since gas bubbles are less likely to adhere to the heart and other vessels and will pool at locations where the various vents may be used. Other therapeutics which might be delivered include topical anesthetics. The introduction of therapeutics is regulated by a valve 150 which is controlled by the control system 28.
The monitoring system 26 includes the temperature, humidity, pressure and gas concentration sensors 128, 130, 132, 134. Referring to Fig. 1, the sensors 13 have lines which lead to the thoracic cavity which may be electrical wires, when using a pressure transducer for example, or may be sample lines which withdraw gas from the thoracic cavity and are sampled outside the body. A single sample line may branch off to the various sensors or, alternatively, the sensors may be connected together in series. As mentioned above, the left ventricle vent 104 may be coupled to any of the sensors for measuring various parameters in the thoracic cavity. Referring again to Fig. 16, the gas sensor detects the concentration of the gas injected into the thoracic cavity or, alternatively, detects the concentration of air remaining in the thoracic cavity. When using carbon dioxide, the gas concentration sensor 134 is preferably a sensor with the ability to measure 0-100% carbon dioxide concentration in a gas sample at 1-2 atm pressure, 0-37 (degrees) C and up to 90% relative humidity with a response time of less than about 60 seconds. If necessary for accuracy, the sensor may require that the sample is dried with a dehumidifier (not shown) . A number of conventional carbon dioxide sensors may be used which use infra-red sensors, mass spectroscopy, thermal conductivity and electrochemical cell sensors, laser absorption and emission technologies.
The control system 28 receives data from the sensors 13 and is coupled to the various parts of the gas delivery system 24 for controlling the delivery of gas . The control system 28 preferably includes a display 152 for visual indication of the various sensor data such as pressure, temperature, humidity, and gas concentration in the patient's thoracic cavity as well as the gas flow rate into the patient. The control system 28 also preferably includes one or more alarms 154 which indicate when the temperature, humidity, pressure, gas concentration and/or gas flow rate is at an unacceptable level. The alarm 154 may be any conventional alarm such as a visual and/or audible alarm. The control system 28 is preferably adapted to maintain the temperature, humidity, pressure and/or gas concentration at predetermined values. Although it is preferred to provide the entire monitoring system 26, individual pieces of the gas delivery system 24 and monitoring system 26 may be used without departing from the scope of the present invention. Furthermore, although it is preferred to provide a combined system, the various components may, of course, also be provided separately.
Preferred methods of the present invention will now be described in connection with the preferred embodiments. It is understood that the preferred embodiments provide preferred apparatus for performing the methods of the present invention, however, other apparatus may be used without departing from the scope of the invention as defined by the claims. The following preferred methods are described in connection with a mitral valve replacement or repair, however, any of the other procedures mentioned above may also be performed without departing from the scope of the invention. A complete discussion of a preferred method of mitral valve replacement is described in U.S. Patent Application Serial No. 08/485,600, filed June 7, 1995. The patient is prepared for surgery by inducing general anesthesia, establishing cardiopulmonary bypass, and inducing arrest of cardiac function. Devices and techniques for inducing arrest if cardiac function and establishing cardiopulmonary bypass are described in co-pending application Serial Nos. 08/282,192, filed July 28, 1994, 08/159,815, filed November 30, 1993, and 08/173,899, filed December 27, 1993, which are incorporated herein by reference. After general anesthesia is induced, cardiopulmonary bypass is initiated by placing a venous cannula in a major peripheral vein, such as a femoral vein, and placing an arterial cannula in a major peripheral artery, such a femoral artery. The venous and arterial cannulae are connected to a cardiopulmonary bypass system which includes an oxygenator for oxygenating blood withdrawn from the patient through the venous cannula, a filter for removing emboli from the blood, and a pump for returning the blood to the patient's arterial system through the arterial cannula. With cardiopulmonary bypass established, cardiac function is arrested. Although conventional, open-chest, external aortic cross clamping and aortic cannulation through the aortic wall may be utilized, closed-chest clamping and cardioplegia delivery techniques are preferred. As described in the aforementioned copending applications, arrest of cardiac function may be induced on a patient by introducing an aortic catheter into a femoral artery or other major peripheral artery, transluminally positioning the distal end of the aortic catheter in the ascending aorta, and expanding the occluding member 110 (Fig. 13) to occlude the ascending aortic lumen between the coronary ostia and the brachiocephalic artery. A cardioplegic agent, preferably a potassium chloride solution mixed with blood, is delivered through a lumen of the aortic catheter into the ascending aorta where the cardioplegic fluid flows into the coronary arteries thereby perfusing the myocardium and arresting cardiac function. A venting catheter may be introduced into the right side of the heart or into the pulmonary artery from a peripheral vein, as described in copending application Serial No. 08/415,238, filed March 30, 1995, which is incorporated herein by reference. In addition, a retrograde cardioplegia catheter may be introduced from another peripheral vein into the coronary sinus for retrograde delivery of cardioplegic fluid through the coronary sinus. In order to obtain access to the heart from the right lateral side of the chest, the right lung is collapsed by inserting an endotracheal tube into the right main stem bronchus and applying a vacuum to deflate the lung. When requiring access to the left lateral side of the chest, when using for the vent needle 34 for example, the left lung is also collapsed.
With cardiac function arrested and the patient's circulation supported by extracorporeal cardiopulmonary bypass, the patient is ready for a medical procedure such as a mitral valve repair or replacement. Referring to Fig. 1, the instrument delivery members 2 and 6-10 are positioned in the chest to provide access into the chest cavity. In most cases, two to six instrument delivery members 2, 6-10 are required. The instrument delivery members 2, 6-10 are configured for placement within an intercostal space without requiring significant retraction of the ribs. To introduce the instrument delivery members 2, 6-10 a small puncture or incision is made in the intercostal space at the desired location and, with an obturator positioned therein, the instrument delivery members 2, 6-10 are advanced through the puncture or incision.
With the instrument delivery members 2, 6-10 in position, surgery may begin. Much, if not all, of the procedure may be carried out under direct vision by illuminating the chest cavity with a light source or light guide positioned in one of the instrument delivery members. A fiberoptic bundle may also be attached to or embedded in the wall of one of instrument delivery members to transmit light into the chest from a light source outside the chest in the manner disclosed in copending application Serial No. 08/227,366, filed April 13, 1994, which is incorporated herein by reference. In most cases, however, it will be desirable to use the thoracoscope 14 to provide illumination and visualization of the chest cavity, preferably by means of a video camera mounted to thoracoscope 14, which transmits a video image to the monitor 16 (Fig. 1) . The thoracoscope 14 may be a rigid thoracoscope with a straight end or an angled end such as those available from Olympus Corp., Medical Instruments Division, Lake Success, NY. Alternatively, a thoracoscope with an articulated end steerable by means of an actuator at the proximal end of the device may be used, such as the Welch Allyn DistalVu™ (formerly Baxter DistalCa ™ 360) , available from Welch Allyn, Inc., of Skaneateles Falls, NY.
Thoracoscopic surgical instruments are then introduced to form an opening in the pericardium. Thoracoscopic scissors and graspers are then used to cut an opening in the pericardium. With an opening formed in the pericardium, the right lateral wall of the left atrium is in a direct line of sight from the right lateral chest looking through inner lumen of instrument delivery member 2. At this time the heart is ready to be opened at an atriotomy incision in the left atrial wall between and just anterior to the pulmonary veins PV. Before making the atriotomy incision, the patient's thoracic cavity is preferably flooded with gas using the instrument delivery members 2, 2A or 2B so that the likelihood the chest cavity is filled with the gas rather than air. The control system 28 is activated and gas, such as carbon dioxide, is introduced into the patient's thoracic cavity through the instrument delivery members 2, 2A or 2B and the temperature, pressure, humidity and gas concentration are monitored by sensors 13 and fed back to the control system 28. The vacuum pump 30 may be used to remove air during the initial flooding or throughout the procedure. Alternatively, one of the instrument delivery member plugs 19 may be removed so that air is initially ejected through one of the instrument delivery members 6-10. If a gas shield is provided, the compressor, blower or fan is activated so that the gas shield passes across the throughhole 4 of the instrument delivery members 2, 2A or 2B.
If the instrument delivery member is not being used for introduction of instruments, the second plug 62 is positioned in the throughhole 4 to prevent gas losses through the throughhole 4. The gas shield provided by instrument delivery member 2B also prevent gas losses from the thoracic cavity. The control system 28 automatically adjusts the temperature, gas flow rate, humidity, pressure and gas concentrations to maintain predetermined levels. The operator of the gas delivery system 24 monitors the display 152 and may manually control the various elements of the gas delivery system 24 rather than permitting automatic adjustment. The operator may, of course, also change the predetermined levels for any of the parameters during the procedure. A gas flow rate of 6.0 1/min has been found to provide a 90% carbon dioxide concentration in a model.
When the conditions in the patient's thoracic cavity are acceptable, such as the gas concentration, temperature, pressure, and humidity, the surgeon cuts the heart to form the atriotomy. The endoscopic atrial retractor 12 is positioned in atriotomy AI and pulled anteriorly to retract atriotomy AI open. With atriotomy AI retracted, direct visualization of mitral valve MV is possible through the instrument delivery member 2, 2A, or 2B. Under either direct visualization or video-based viewing using the thoracoscope 14 and monitor 16, the condition of mitral valve MV is then assessed to determine whether the valve may be repaired or whether replacement is necessary. If the surgeon determines that repair is suitable, a number of repair procedures may be performed including annuloplasty, in which an annuloplasty ring is attached around the native valve to contract the annulus, quadrangular resection, in which a portion of a valve leaflet is excised and the remaining portions of the leaflet are sewn back together, commissurotomy, in which the valve commissures are incised to separate the valve leaflets, shortening of the chordae tendonae, reattachment of severed chordae tendonae or papillary muscle tissue, and decalcification of the valve leaflets or annulus . Several of these procedures may be performed on the same valve. In particular, annuloplasty rings may be used in conjunction with any repair procedures where contracting or stabilizing the valve annulus is desirable.
If none of the repair procedures will adequately treat the diseased valve, the native valve is replaced with the replacement valve 20. The techniques for introducing and securing the replacement valve within the heart will be analogous to those described above for annuloplasty ring, and are further described in copending application Serial No. 08/281,962, filed July 28, 1994, which is incorporated herein by reference. Once a prosthetic valve of the appropriate size is identified, the valve is attached to the valve annulus. When the annuloplasty ring or replacement valve has been secured within the heart, the atriotomy AI is ready for closure. Before, during and even after closure of the atriotomy, the heart is preferably vented to remove gas from the heart. Before filling the heart with blood, a surfactant, such as the phospholipid pulmonary surfactant found in the lung, may be introduced into the thoracic cavity. Furthermore, the amount of retained air or gas may be observed using transesophageal echocardiography (TEE) . A description of using TEE for locating retained air in the heart is disclosed in Orihashi et al. "Retained Intracardiac Air in Open Heart Operations Examined by Transesophageal Echocardiography", Ann Thorac Surg 55:1467-71 (1993) and Oka et al . "Detection of Air Emboli in the Left Heart by M-Mode Transesophageal Echocardiography Following Cardiopulmonary Bypass," Anesthesiology 63(l) :109-3 (1985) , which are incorporated herein by reference.
The needle vent 34, vent 78 and/or left ventricle vent 104 are positioned in the left ventricle and the aortic vent 106 is positioned in the ascending aorta. The needle vent 34 preferably has a manually manipulatable bulb (not shown) for withdrawing gas from the left ventricle. Alternatively, the needle vent 34 may be coupled to the vacuum pump 30. Referring to Figure 17, the vent 38 is preferably positioned through the replacement valve, or through the native mitral valve, when a repair is performed, so that the left ventricle can be flood with a gas, such as carbon dioxide, and vented before atriotomy closure.
Before removing gas in the left ventricle, gas in the ascending aorta is preferably vented using the aortic vent 106. The patient is tilted feet downward so that gas in the left ventricle and ascending aorta migrates toward the occluding member 110. The aortic vent 106 is then used to vent gas around the ascending aorta. Referring to Fig. 13, the aortic vent 106 is preferably rotated so that the opening 114 circumscribes the occluding member 110 between the occluding member 110 and the aortic lumen. Although it is preferred to provide both the aortic vent 106 and left ventricle vent 104, both the aorta and left ventricle may be vented with the same catheter. The heart is preferably mechanically manipulated during venting of the various chambers in the heart in a manner similar to the open-chest procedures except that the mechanical manipulators extend through the instrument delivery members 2, 6-10. A discussion of conventional de-airing procedures is described in Taber et al. "Prevention of air embolism during open-heart surgery: A study of the role of trapped air in the left ventricle" Surgery 68 (4) :685-691 (1970) and van der Linden and Casimir- Ahn, "When Do Cerebral Emboli Appear During Open Heart
Operations? A Transcranial Doppler Study," Ann Thorac Surg 51:237-41 (1991) which are incorporated herein by reference.
After removing gasses from the ascending aorta, the patient is then tilted head downward so that gas in the left ventricle rises to the apex where the gas can be removed using the needle vent 34, vent 78 or left ventricle vent 104. The gas at the apex of the left ventricle is then vented. When using the needle vent 34, the needle vent 34 is preferably moved to various other locations in the heart where pooled air may be a problem or where ultrasound or fluoroscopy have identified pooled air or gas. Other locations where the needle vent may be used include the right upper pulmonary vein, the right coronary sinus of Valsalva, the left atrial appendage, which may be also be inverted or closed with sutures, and the left upper pulmonary vein.
The atriotomy is then preferably closed using thoracoscopic needle drivers and a curved needle on a suture. Alternatively, an endoscopic stapling device such as an AutoSuture™ Powered Multifire Endo TA60, available from United States Surgical Corp. of Norwalk, CT, or an endoscopic fascia stapler, may be inserted through an anterior instrument port and positioned around atriotomy AI to drive a series of staples into the atrial wall to close the atriotomy. The opening formed in the pericardium may be closed with sutures or staples in a manner similar to that used for closing atriotomy AI . However, in most cases, closure of the pericardium is not necessary, and the opening may be left without adverse effect .
To complete the operation, cardiac function is then restored by discontinuing delivery of cardioplegic fluid, terminating occlusion of the ascending aortic lumen, and perfusing the myocardium with warm blood. When the occluding member 110 is used, the occluding member 110 is deflated and warm blood is allowed to flow into the coronary arteries. If sinus rhythm does not return immediately, electrical defibrillation is used to stimulate the heart and/or pacing leads may be used to pace the heart for a period of time. Once the heart is beating normally, the aortic catheter is removed from the patient along with any venting catheters or retrograde cardioplegia delivery catheter which may have been used. Chest tubes may be inserted into the chest to provide drainage. The patient is then weaned from cardiopulmonary bypass, and the arterial and venous cannulae are removed from the patient.
Another preferred method of minimizing the risk of air embolism is now described. The method described above generally provides a gas, such as carbon dioxide, when the heart is initially opened so that air cannot enter the heart during the procedure. As an alternative, the gas may be injected into the patient when the first instrument delivery member 2, 6-10 is inserted into the patient. In this manner, air is prevented from entering the thoracic cavity throughout the procedure.
In yet another preferred method, the gas may be used to displace air in the thoracic cavity and the heart just before the atriotomy is closed. The gas may be introduced through the instrument delivery member 2, 2A or 2B, vent 78, or needle vent 34. When using the vent 78, the vacuum pump 30 may be used to withdraw air which is displaced by the gas . The gas concentration is monitored so that the gas concentration is at an acceptable level before closing the atriotomy. In this manner, the amount of time the thoracic cavity is exposed to the gas is minimized.
Referring to Fig. 18, another embodiment of an apparatus for preventing air embolism when performing a procedure in a patient's thoracic cavity is shown. An enclosure 158 extends around the patient and is supported by an operating table 160. A drape 162 extends around the patient's chest and provides a substantially air-tight seal. The drape 162 may include an adhesive strip (not shown) for forming the substantially air-tight seal. The enclosure 158 includes a number of arm pass-throughs 164 on both sides of the enclosure 158. The arm pass-throughs 164 are substantially air tight and permit the surgeon to perform procedures in the enclosure. A tool box 166 is slidably coupled to the exterior of the enclosure 158 for passing tools into the enclosure 158. An advantage of the enclosure 158 is that a retractor 118 may be mounted to the enclosure 158. The enclosure 158 is preferably coupled to the gas delivery system 24 and control system 26 described above in connection with the previously disclosed embodiments via a line 168. The enclosure 158 is particularly useful when providing a pressure in the enclosure 158 which is higher than the pressure outside the enclosure 158 so that air does not enter the enclosure 158. The enclosure 158 also minimizes the amount of gas which is released into the operating room so that surgeon exposure to the gas is minimized.
It is understood that while the invention has been described specifically in the context of mitral valve repair and replacement, the devices and methods disclosed herein will have equal application to a number of other procedures on a patient's cardiovascular system. Furthermore, the preferred embodiments are developed as merely preferred embodiments of the invention and modifications may be made which fall within the scope of the invention as defined by the claims. For example, the gas outlets may be angled toward the proximal end with baffles to redirect the gas toward the distal end, the gas outlets which pass across the throughhole may contact a baffle which directs the gas toward the distal end, the gas outlet may simply be a hose which is clipped to the sidewall or any other part of the instrument delivery member so long as the gas outlet is coupled to the remainder of the instrument delivery member, and the left ventricular vent may include only one lumen rather than two. In addition, although it is preferred to place the patient on cardiopulmonary bypass when performing procedures the present invention is equally applicable to procedures in which the patient's heart is not stopped. Therefore, the above description should not be taken as limiting the scope of the invention which is defined by the claims.

Claims

WHAT IS CLAIMED IS:
1. A method of minimizing the risk of air emboli in a patient's circulatory system when performing a procedure in the patient's thoracic cavity, comprising the steps of: inserting an instrument delivery member into a patient's thoracic cavity thereby forming a first percutaneous penetration, the instrument delivery member having a throughhole sized to permit an instrument to pass therethrough; coupling an outlet from a source of gas to the instrument delivery member; injecting the gas from the source of gas into the patient's thoracic cavity through the outlet coupled to the first instrument delivery member.
2. The method of claim 1, further comprising the step of : inserting an instrument for performing a procedure on the patient's heart through the first instrument delivery member.
3. The method of claim 1, wherein: the coupling step is carried out with the source of gas being a source of carbon dioxide.
4. The method of claim 1, further comprising the step of : withdrawing the gas through an inlet of a vacuum line, the vacuum line being coupled to a vacuum pump.
5. The method of claim 1, further comprising the step of : monitoring a gas concentration in the patient's thoracic cavity; the passing step being carried out to maintain a minimum gas concentration in the patient's thoracic cavity.
6. The method of claim 1, further comprising the step of: humidifying the gas before the injecting step.
7. The method of claim 1, further comprising the step of : measuring a temperature in the patient's thoracic cavity; and changing the temperature of the gas injected into the patient in response to the temperature in the patient's thoracic cavity measured during the measuring step.
8. The method of claim 1, further comprising the step of: measuring the pressure in the patient's thoracic cavity; the injecting step being carried out so that a pressure in the patient's thoracic cavity exceeds atmospheric pressure thereby resisting introduction of air into the patient's thoracic cavity.
9. The method of claim 1, wherein: the inserting step is carried out with the outlet being integrally formed with the instrument delivery member.
10. The method of claim 1, wherein: the injecting step is carried out with a plurality of outlets coupled to the instrument delivery member.
11. An instrument delivery member adapted to inject a gas into a patient's thoracic cavity to minimize the risk of air embolism, comprising: a sidewall forming a throughhole sized and configured to permit a medical instrument to pass therethrough, the sidewall having a proximal end, a distal end and a longitudinal axis; a gas inlet coupled to the sidewall and configured to be coupled to a source of gas; a gas outlet coupled to the sidewall for injecting a gas into a patient's thoracic cavity, the gas outlet being fluidly coupled to the gas inlet.
12. The instrument delivery tube of claim 11, further comprising: a plurality of gas outlets positioned and configured to direct a gas shield across the substantially the entire throughhole so that gas losses through the throughhole are minimized.
13. The instrument delivery tube of claim 11, wherein: the plurality of gas outlets are directed toward the distal end to resist escape of gas through a proximal end of the throughhole.
14. The instrument delivery tube of claim 11, wherein: the gas outlet is configured to deliver a gas shield across substantially the entire throughhole so that gas losses through the throughhole are minimized.
15. The instrument delivery tube of claim 11, wherein: the gas outlet is configured to deliver the gas in a direction substantially perpendicular to the longitudinal axis.
16. The instrument delivery tube of claim 11, wherein: the throughhole has a cross-section in a direction perpendicular to the longitudinal axis, the cross-section having a width and a length, at least one of the width and length being at least 2 cm.
17. The instrument delivery tube of claim 11, further comprising: a plurality of suture holders coupled to the sidewall.
18. A method of retaining a gas in a patient's thoracic cavity for performing a surgical procedure therein, comprising: providing an instrument delivery tube having a throughhole, a proximal end, a distal end, a longitudinal axis, a gas inlet, and a gas outlet positioned to receive gas from the gas inlet, the throughhole being configured to permit a surgical instrument to pass therethrough; inserting the instrument delivery tube between adjacent ribs of a patient; coupling the gas inlet to a source of gas; passing gas from the source of gas to the gas inlet and out through the gas outlet, wherein the gas passing from the gas inlet to the gas outlet provides a gas shield.
19. The method of claim 18, wherein: the passing step is carried out with the gas from the gas inlet passing across the throughhole between the proximal and distal ends of the sidewall .
20. The method of claim 18, further comprising the step of : injecting carbon dioxide into the patient; wherein the passing step is carried out with the gas from the source of gas also being carbon dioxide.
21. The method of claim 18, wherein: the passing step is carried out with the gas from the source of gas being air.
22. The method of claim 18, wherein: the providing step is carried out with the instrument delivery tube having a plurality of suture holders.
23. An instrument delivery tube, comprising: a sidewall having a proximal end, a distal end, and a throughhole defining a longitudinal axis, the throughhole being configured to permit a surgical instrument to pass therethrough; a gas inlet coupled to the sidewall; and a gas outlet positioned to receive gas from the gas inlet, wherein a gas passing from the gas inlet to the gas outlet forms a gas shield passing through the longitudinal axis.
24. The instrument delivery tube of claim 23, wherein: the gas inlet and gas outlet are positioned along the sidewall between the proximal and distal ends.
25. The instrument delivery tube of claim 23, wherein: the gas inlet and gas outlet are integrally formed with the sidewall .
26. A method of minimizing the risk of air emboli when performing a procedure in a patient's thoracic cavity, comprising the steps of: positioning a number of instrument delivery members between adjacent ribs in a patient thereby forming a number of percutaneous penetration; passing a gas into the patient's thoracic cavity; inserting surgical instruments through the number of instrument delivery members; and performing a procedure in the patient's thoracic cavity using the surgical instruments.
27. The method of claim 26, wherein: the inserting step is carried out with one of the surgical instruments being a visualizing device for viewing the patient's thoracic cavity.
28. The method of claim 26, further comprising the step of : maintaining a pressure in the patient's thoracic cavity above a pressure outside the patient's thoracic cavity.
29. The method of claim 26, wherein: the passing step is carried out with the gas passing through an outlet coupled to at least one of the instrument delivery members.
30. The method of claim 26, wherein: the passing step is carried out with the gas being carbon dioxide.
31. The method of claim 26, wherein: the passing step is carried out to maintain a minimum gas concentration.
32. The method of claim 26, further comprising the step of : collecting the gas after the passing step.
33. The method of claim 32, wherein: the collecting step is carried out with a vacuum pump having an inlet coupled to at least one of the instrument delivery members.
34. A method of minimizing the risk of air emboli when performing a procedure in a patient's thoracic cavity, comprising the steps of: injecting a gas into a patient's thoracic cavity; measuring a pressure in the patient's thoracic cavity; maintaining the pressure in the patient's thoracic cavity at a pressure above the pressure outside the patient's thoracic cavity; performing a medical procedure in the patient's thoracic cavity during the maintaining step.
35. The method of claim 34, wherein: the maintaining step is carried out with the pressure in the patient's thoracic cavity being maintained at a pressure of at least 1 mm Hg.
36. The method of claim 35, wherein: the maintaining step is carried out with the pressure in the patient's thoracic cavity being maintained at a pressure of between 1 and 8 mm Hg.
37. The method of claim 36, further comprising the steps of : coupling a gas outlet to an instrument delivery member having a throughhole; inserting the instrument delivery member between adjacent ribs in a patient; and inserting a surgical instrument through the throughhole for performing the medical procedure.
38. A method of minimizing the risk of air emboli when performing a procedure in a patient's thoracic cavity, comprising the steps of: injecting a gas into a patient's thoracic cavity; monitoring the humidity in the patient's thoracic cavity; and humidifying the gas before the injecting step in response to the monitoring step.
39. A vent for venting a patient's heart, comprising: a proximal end, a distal end, a first lumen, a first outlet fluidly coupled to the first lumen, a second lumen, and a second outlet fluidly coupled to the second lumen, the first and second outlets being spaced apart between 0.5 and 5 c .
40. The vent of claim 39, wherein: the first outlet is no more than 1 cm from the distal end.
41. The vent of claim 39, wherein: the second outlet is between 1 and 5 cm from the distal end.
42. A method of preventing an air embolism when performing a procedure in a patient's heart, comprising the steps of : positioning a vent in a patient's cardiopulmonary system; injecting carbon dioxide into the patient's cardiopulmonary system through the vent; performing a medical procedure on the patient; coupling a vacuum pump to the vent; and activating the vacuum pump to withdraw gas from the patient's cardiopulmonary system.
43. A vent for venting a patient's left ventricle, comprising: a proximal end, a distal end, a first lumen, a first outlet fluidly coupled to the first lumen, a second lumen, a second outlet fluidly coupled to the second lumen, and a distal portion, the distal portion being sized and configured so that the first outlet is positioned at an apex of a patient's left ventricle when the proximal end of the vent extends through the patient's mitral valve annulus.
44. The vent of claim 43, wherein: the distal portion has a longitudinal length of between 1 and 5 cm and a first radial length of between 2 and 8 and a second radial length of between 0.5 and 3 cm
45. A method of preventing an air embolism when performing a procedure in a patient's thoracic cavity, comprising the steps of: providing an enclosure around a patient's thoracic cavity, the enclosure having a seal which substantially prevents a flow of air into the enclosure, the enclosure having arm pass-throughs which are substantially air-tight but permit a surgeon to manipulate instruments in the enclosure; injecting a gas into the enclosure; performing a procedure on the patient using the arm pass-throughs.
46. An apparatus for use in performing a procedure in a patient's thoracic cavity, comprising: an enclosure; a seal configured to provide a substantially air¬ tight engagement with a patient; arm pass-throughs which are substantially air-tight and permit a surgeon to manipulate instruments in the enclosure.
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Cited By (38)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19732785A1 (en) * 1997-07-30 1999-02-18 Aesculap Ag & Co Kg Trocar for passing surgical instruments through body wall or between ribs
WO1999029249A1 (en) * 1997-11-20 1999-06-17 Cardia Innovation Ab A method and a device for producing an atmosphere in a region, and use of carbon dioxide for the manufacture of a medicament
EP0956827A1 (en) * 1998-05-06 1999-11-17 Erbe Elektromedizin GmbH Electrosurgical apparatus
WO2001045790A1 (en) * 1999-12-21 2001-06-28 Cardia Innovation Ab A method and a device for creating a protecting atmosphere
US7736388B2 (en) 1999-04-09 2010-06-15 Evalve, Inc. Fixation devices, systems and methods for engaging tissue
US7753923B2 (en) 1999-04-09 2010-07-13 Evalve, Inc. Leaflet suturing
US7811296B2 (en) 1999-04-09 2010-10-12 Evalve, Inc. Fixation devices for variation in engagement of tissue
US7981123B2 (en) 1997-09-12 2011-07-19 Evalve, Inc. Surgical device for connecting soft tissue
US8029518B2 (en) 1999-04-09 2011-10-04 Evalve, Inc. Methods and devices for capturing and fixing leaflets in valve repair
US8052592B2 (en) 2005-09-27 2011-11-08 Evalve, Inc. Methods and devices for tissue grasping and assessment
US8123703B2 (en) 1999-04-09 2012-02-28 Evalve, Inc. Steerable access sheath and methods of use
US8216256B2 (en) 1999-04-09 2012-07-10 Evalve, Inc. Detachment mechanism for implantable fixation devices
US8343174B2 (en) 1999-04-09 2013-01-01 Evalve, Inc. Locking mechanisms for fixation devices and methods of engaging tissue
AT13234U1 (en) * 2012-07-12 2013-08-15 Werzowa Wolfgang Device for supplying the body with gas
ITUB20156844A1 (en) * 2015-12-09 2017-06-09 Fond Cardiocentro Ticino Fcct DEVICE FOR AIR REMOVAL FROM ANATOMIC CAVITY IN A SURGICAL INTERVENTION
WO2017097443A1 (en) * 2015-12-09 2017-06-15 Fondazione Cardiocentro Ticino (FCCT) Device for removing air from an anatomical cavity in a surgical intervention
US10188392B2 (en) 2014-12-19 2019-01-29 Abbott Cardiovascular Systems, Inc. Grasping for tissue repair
US10238494B2 (en) 2015-06-29 2019-03-26 Evalve, Inc. Self-aligning radiopaque ring
US10238495B2 (en) 2015-10-09 2019-03-26 Evalve, Inc. Delivery catheter handle and methods of use
US10314586B2 (en) 2016-12-13 2019-06-11 Evalve, Inc. Rotatable device and method for fixing tricuspid valve tissue
US10363138B2 (en) 2016-11-09 2019-07-30 Evalve, Inc. Devices for adjusting the curvature of cardiac valve structures
US10376673B2 (en) 2015-06-19 2019-08-13 Evalve, Inc. Catheter guiding system and methods
US10390943B2 (en) 2014-03-17 2019-08-27 Evalve, Inc. Double orifice device for transcatheter mitral valve replacement
US10398553B2 (en) 2016-11-11 2019-09-03 Evalve, Inc. Opposing disk device for grasping cardiac valve tissue
US10413408B2 (en) 2015-08-06 2019-09-17 Evalve, Inc. Delivery catheter systems, methods, and devices
US10426616B2 (en) 2016-11-17 2019-10-01 Evalve, Inc. Cardiac implant delivery system
US10524912B2 (en) 2015-04-02 2020-01-07 Abbott Cardiovascular Systems, Inc. Tissue fixation devices and methods
US10631871B2 (en) 2003-05-19 2020-04-28 Evalve, Inc. Fixation devices, systems and methods for engaging tissue
US10667804B2 (en) 2014-03-17 2020-06-02 Evalve, Inc. Mitral valve fixation device removal devices and methods
US10667815B2 (en) 2015-07-21 2020-06-02 Evalve, Inc. Tissue grasping devices and related methods
US10736632B2 (en) 2016-07-06 2020-08-11 Evalve, Inc. Methods and devices for valve clip excision
US10743876B2 (en) 2011-09-13 2020-08-18 Abbott Cardiovascular Systems Inc. System for fixation of leaflets of a heart valve
US10779837B2 (en) 2016-12-08 2020-09-22 Evalve, Inc. Adjustable arm device for grasping tissues
US11065119B2 (en) 2017-05-12 2021-07-20 Evalve, Inc. Long arm valve repair clip
US11071564B2 (en) 2016-10-05 2021-07-27 Evalve, Inc. Cardiac valve cutting device
US11304715B2 (en) 2004-09-27 2022-04-19 Evalve, Inc. Methods and devices for tissue grasping and assessment
US11490790B2 (en) 2018-07-18 2022-11-08 Cook Medical Technologies Llc Device for shielding endoscopic optics with a fluid barrier
US11931263B2 (en) 2021-09-03 2024-03-19 Evalve, Inc. Delivery catheter handle and methods of use

Families Citing this family (213)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6125852A (en) 1993-02-22 2000-10-03 Heartport, Inc. Minimally-invasive devices and methods for treatment of congestive heart failure
US7213601B2 (en) * 1993-02-22 2007-05-08 Heartport, Inc Minimally-invasive devices and methods for treatment of congestive heart failure
DE19510707A1 (en) * 1995-03-15 1996-09-19 Uwe Dipl Ing Dey Maintaining cleanliness inside medical working instrument inserted in live body
US5849005A (en) * 1995-06-07 1998-12-15 Heartport, Inc. Method and apparatus for minimizing the risk of air embolism when performing a procedure in a patient's thoracic cavity
US6006134A (en) 1998-04-30 1999-12-21 Medtronic, Inc. Method and device for electronically controlling the beating of a heart using venous electrical stimulation of nerve fibers
US6406420B1 (en) 1997-01-02 2002-06-18 Myocor, Inc. Methods and devices for improving cardiac function in hearts
US6183411B1 (en) 1998-09-21 2001-02-06 Myocor, Inc. External stress reduction device and method
US6045497A (en) 1997-01-02 2000-04-04 Myocor, Inc. Heart wall tension reduction apparatus and method
US6077214A (en) * 1998-07-29 2000-06-20 Myocor, Inc. Stress reduction apparatus and method
US6050936A (en) 1997-01-02 2000-04-18 Myocor, Inc. Heart wall tension reduction apparatus
US7883539B2 (en) 1997-01-02 2011-02-08 Edwards Lifesciences Llc Heart wall tension reduction apparatus and method
US6033379A (en) * 1997-01-08 2000-03-07 Medtronic, Inc. Balloon catheter
US6106497A (en) * 1997-01-31 2000-08-22 Medical Instrument Development Laboratories System and method for preventing an air embolism in a surgical procedure
US5893838A (en) 1997-08-15 1999-04-13 Therox, Inc. System and method for high pressure delivery of gas-supersaturated fluids
US6332893B1 (en) 1997-12-17 2001-12-25 Myocor, Inc. Valve to myocardium tension members device and method
FR2776947B1 (en) * 1998-04-03 2000-06-09 Parfum Indigo IMPROVED NEBULIZER AND NEBULIZATION CONTROL SYSTEM
US7744557B2 (en) * 1998-05-19 2010-06-29 Lexion Medical, Llc Method and apparatus for delivering an agent to the abdomen
US7731704B2 (en) * 1998-05-19 2010-06-08 Lexion Medical, Llc Method and apparatus for delivering an agent to the abdomen
US7918816B2 (en) * 1998-05-19 2011-04-05 Lexion Medical, Llc Method and apparatus for delivering an agent to the abdomen
US6068609A (en) * 1998-05-19 2000-05-30 Douglas E. Ott Method and apparatus for conditioning gas for medical procedures having humidity monitoring and recharge alert
US20050107767A1 (en) * 1998-05-19 2005-05-19 Ott Douglas E. Method and apparatus for delivering an agent to the abdomen
US9028437B2 (en) * 1998-05-19 2015-05-12 Lexion Medical, Llc Method for delivering an agent to the abdomen
US6260552B1 (en) 1998-07-29 2001-07-17 Myocor, Inc. Transventricular implant tools and devices
WO2000018448A2 (en) * 1998-09-30 2000-04-06 A-Med Systems, Inc. Method and apparatus for preventing air embolisms
US6152144A (en) * 1998-11-06 2000-11-28 Appriva Medical, Inc. Method and device for left atrial appendage occlusion
US7044134B2 (en) 1999-11-08 2006-05-16 Ev3 Sunnyvale, Inc Method of implanting a device in the left atrial appendage
US7713282B2 (en) 1998-11-06 2010-05-11 Atritech, Inc. Detachable atrial appendage occlusion balloon
US7128073B1 (en) 1998-11-06 2006-10-31 Ev3 Endovascular, Inc. Method and device for left atrial appendage occlusion
US6231561B1 (en) 1999-09-20 2001-05-15 Appriva Medical, Inc. Method and apparatus for closing a body lumen
US6689150B1 (en) 1999-10-27 2004-02-10 Atritech, Inc. Filter apparatus for ostium of left atrial appendage
US6551303B1 (en) 1999-10-27 2003-04-22 Atritech, Inc. Barrier device for ostium of left atrial appendage
US6652555B1 (en) 1999-10-27 2003-11-25 Atritech, Inc. Barrier device for covering the ostium of left atrial appendage
US6994092B2 (en) 1999-11-08 2006-02-07 Ev3 Sunnyvale, Inc. Device for containing embolic material in the LAA having a plurality of tissue retention structures
US7018406B2 (en) 1999-11-17 2006-03-28 Corevalve Sa Prosthetic valve for transluminal delivery
US8579966B2 (en) 1999-11-17 2013-11-12 Medtronic Corevalve Llc Prosthetic valve for transluminal delivery
US8016877B2 (en) 1999-11-17 2011-09-13 Medtronic Corevalve Llc Prosthetic valve for transluminal delivery
US20030205233A1 (en) * 1999-12-02 2003-11-06 A-Med Systems, Inc. Surgical drape and panel assembly
US6702732B1 (en) 1999-12-22 2004-03-09 Paracor Surgical, Inc. Expandable cardiac harness for treating congestive heart failure
US8241274B2 (en) 2000-01-19 2012-08-14 Medtronic, Inc. Method for guiding a medical device
US7749245B2 (en) 2000-01-27 2010-07-06 Medtronic, Inc. Cardiac valve procedure methods and devices
DE60110747T2 (en) * 2000-02-10 2006-02-23 Potencia Medical Ag MECHANICAL DEVICE FOR IMPOTENCE TREATMENT
EP1261294B1 (en) 2000-03-10 2006-11-29 Paracor Medical, Inc. Expandable cardiac harness for treating congestive heart failure
US6537198B1 (en) 2000-03-21 2003-03-25 Myocor, Inc. Splint assembly for improving cardiac function in hearts, and method for implanting the splint assembly
US6613008B2 (en) * 2000-06-13 2003-09-02 A-Med Systems, Inc. Integrated system for cardiopulmonary bypass and related methods
US6840246B2 (en) * 2000-06-20 2005-01-11 University Of Maryland, Baltimore Apparatuses and methods for performing minimally invasive diagnostic and surgical procedures inside of a beating heart
WO2002005888A1 (en) 2000-06-30 2002-01-24 Viacor Incorporated Intravascular filter with debris entrapment mechanism
US6343605B1 (en) 2000-08-08 2002-02-05 Scimed Life Systems, Inc. Percutaneous transluminal myocardial implantation device and method
JP2004508879A (en) 2000-09-21 2004-03-25 アトリテック, インコーポレイテッド Apparatus for implanting a device in the atrial appendage
US6723038B1 (en) 2000-10-06 2004-04-20 Myocor, Inc. Methods and devices for improving mitral valve function
US6733525B2 (en) * 2001-03-23 2004-05-11 Edwards Lifesciences Corporation Rolled minimally-invasive heart valves and methods of use
US7374571B2 (en) 2001-03-23 2008-05-20 Edwards Lifesciences Corporation Rolled minimally-invasive heart valves and methods of manufacture
US6622730B2 (en) 2001-03-30 2003-09-23 Myocor, Inc. Device for marking and aligning positions on the heart
US6814713B2 (en) * 2001-04-25 2004-11-09 A-Med Systems, Inc. Systems for performing minimally invasive cardiac medical procedures
US7338514B2 (en) 2001-06-01 2008-03-04 St. Jude Medical, Cardiology Division, Inc. Closure devices, related delivery methods and tools, and related methods of use
EP1392394A4 (en) * 2001-06-04 2005-05-18 Albert Einstein Healthcare Network Cardiac stimulating apparatus having a blood clot filter and atrial pacer
US8623077B2 (en) 2001-06-29 2014-01-07 Medtronic, Inc. Apparatus for replacing a cardiac valve
US7544206B2 (en) 2001-06-29 2009-06-09 Medtronic, Inc. Method and apparatus for resecting and replacing an aortic valve
US8771302B2 (en) 2001-06-29 2014-07-08 Medtronic, Inc. Method and apparatus for resecting and replacing an aortic valve
FR2826863B1 (en) 2001-07-04 2003-09-26 Jacques Seguin ASSEMBLY FOR PLACING A PROSTHETIC VALVE IN A BODY CONDUIT
US7011671B2 (en) 2001-07-18 2006-03-14 Atritech, Inc. Cardiac implant device tether system and method
FR2828091B1 (en) 2001-07-31 2003-11-21 Seguin Jacques ASSEMBLY ALLOWING THE PLACEMENT OF A PROTHETIC VALVE IN A BODY DUCT
WO2003022131A2 (en) 2001-09-07 2003-03-20 Mardil, Inc. Method and apparatus for external heart stabilization
US7097659B2 (en) 2001-09-07 2006-08-29 Medtronic, Inc. Fixation band for affixing a prosthetic heart valve to tissue
US6723088B2 (en) * 2001-12-20 2004-04-20 Board Of Regents, The University Of Texas Laparoscopic porting
US7174896B1 (en) 2002-01-07 2007-02-13 Paracor Medical, Inc. Method and apparatus for supporting a heart
US7022063B2 (en) 2002-01-07 2006-04-04 Paracor Medical, Inc. Cardiac harness
US6764510B2 (en) 2002-01-09 2004-07-20 Myocor, Inc. Devices and methods for heart valve treatment
CA2474324C (en) 2002-01-25 2011-09-20 Atritech, Inc. Atrial appendage blood filtration systems
US7048754B2 (en) 2002-03-01 2006-05-23 Evalve, Inc. Suture fasteners and methods of use
WO2003090608A2 (en) * 2002-04-24 2003-11-06 Applied Medical Resources Corporation Surgical digitizing apparatus and method
US7976564B2 (en) 2002-05-06 2011-07-12 St. Jude Medical, Cardiology Division, Inc. PFO closure devices and related methods of use
US6712795B1 (en) * 2002-06-07 2004-03-30 Lester Cohen Surgical procedure and apparatus
DE10233861A1 (en) * 2002-07-19 2004-02-12 Storz Endoskop Produktions Gmbh Device, insufflation device, measuring device and method for insufflating a body cavity with an insufflation gas
US7247134B2 (en) 2002-11-12 2007-07-24 Myocor, Inc. Devices and methods for heart valve treatment
US7112219B2 (en) 2002-11-12 2006-09-26 Myocor, Inc. Devices and methods for heart valve treatment
US7736299B2 (en) 2002-11-15 2010-06-15 Paracor Medical, Inc. Introducer for a cardiac harness delivery
US7182752B2 (en) 2003-04-08 2007-02-27 Surgiquest, Incorporated Continuous gas flow trocar assembly
US7854724B2 (en) 2003-04-08 2010-12-21 Surgiquest, Inc. Trocar assembly with pneumatic sealing
US7285112B2 (en) * 2003-04-08 2007-10-23 Surgiquest, Incorporated Gas flow trocar arrangement
US7338473B2 (en) * 2003-04-08 2008-03-04 Surgiquest, Incorporated Pneumoseal trocar arrangement
US20040267306A1 (en) 2003-04-11 2004-12-30 Velocimed, L.L.C. Closure devices, related delivery methods, and related methods of use
US8372112B2 (en) 2003-04-11 2013-02-12 St. Jude Medical, Cardiology Division, Inc. Closure devices, related delivery methods, and related methods of use
US7654975B2 (en) * 2003-04-24 2010-02-02 Northgate Technologies, Inc. Mixed-gas insufflation system
US7597704B2 (en) 2003-04-28 2009-10-06 Atritech, Inc. Left atrial appendage occlusion device with active expansion
US7735493B2 (en) 2003-08-15 2010-06-15 Atritech, Inc. System and method for delivering a left atrial appendage containment device
US9579194B2 (en) 2003-10-06 2017-02-28 Medtronic ATS Medical, Inc. Anchoring structure with concave landing zone
US7297141B2 (en) * 2004-01-20 2007-11-20 Ethicon Endo-Surgery, Inc. Method for accessing an operative space
ITTO20040135A1 (en) 2004-03-03 2004-06-03 Sorin Biomedica Cardio Spa CARDIAC VALVE PROSTHESIS
BRPI0510107A (en) 2004-04-23 2007-09-25 3F Therapeutics Inc implantable protein valve
US8801746B1 (en) 2004-05-04 2014-08-12 Covidien Lp System and method for delivering a left atrial appendage containment device
US7766898B2 (en) * 2004-05-24 2010-08-03 Merit Medical Systems, Inc. Non-circular side port bore for introducer sheath
US20060052867A1 (en) 2004-09-07 2006-03-09 Medtronic, Inc Replacement prosthetic heart valve, system and method of implant
US9186175B2 (en) 2004-10-28 2015-11-17 Nico Corporation Surgical access assembly and method of using same
US9387010B2 (en) 2004-10-28 2016-07-12 Nico Corporation Surgical access assembly and method of using same
US8562672B2 (en) 2004-11-19 2013-10-22 Medtronic, Inc. Apparatus for treatment of cardiac valves and method of its manufacture
US7811253B2 (en) 2004-12-09 2010-10-12 Applied Medical Resources Corporation Insufflation gas warmer and humidifier
DE102005003632A1 (en) 2005-01-20 2006-08-17 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Catheter for the transvascular implantation of heart valve prostheses
ITTO20050074A1 (en) 2005-02-10 2006-08-11 Sorin Biomedica Cardio Srl CARDIAC VALVE PROSTHESIS
US20060206051A1 (en) * 2005-03-01 2006-09-14 Hamilton Dwight A Gas irrigator for surgical procedures
US7914569B2 (en) 2005-05-13 2011-03-29 Medtronics Corevalve Llc Heart valve prosthesis and methods of manufacture and use
US7972359B2 (en) 2005-09-16 2011-07-05 Atritech, Inc. Intracardiac cage and method of delivering same
US20070078510A1 (en) 2005-09-26 2007-04-05 Ryan Timothy R Prosthetic cardiac and venous valves
US20070135826A1 (en) 2005-12-01 2007-06-14 Steve Zaver Method and apparatus for delivering an implant without bias to a left atrial appendage
US20070181157A1 (en) * 2006-02-07 2007-08-09 Dadourian Daniel G Apparatus and methods for flushing medical devices
US8075615B2 (en) 2006-03-28 2011-12-13 Medtronic, Inc. Prosthetic cardiac valve formed from pericardium material and methods of making same
JP2007296002A (en) * 2006-04-28 2007-11-15 Fujinon Corp Endoscopic system
JP2007296164A (en) * 2006-05-01 2007-11-15 Fujinon Corp Endoscopic system
ATE498364T1 (en) * 2006-09-08 2011-03-15 Surgiquest Inc TROCALER ARRANGEMENT WITH PNEUMATIC CLOSURE
US8834564B2 (en) 2006-09-19 2014-09-16 Medtronic, Inc. Sinus-engaging valve fixation member
US8414643B2 (en) 2006-09-19 2013-04-09 Medtronic Ventor Technologies Ltd. Sinus-engaging valve fixation member
US11304800B2 (en) 2006-09-19 2022-04-19 Medtronic Ventor Technologies Ltd. Sinus-engaging valve fixation member
US8414550B2 (en) 2006-09-29 2013-04-09 Lexion Medical, Llc System and method to vent gas from a body cavity
WO2008047354A2 (en) 2006-10-16 2008-04-24 Ventor Technologies Ltd. Transapical delivery system with ventriculo-arterial overflow bypass
NZ549911A (en) * 2006-10-19 2009-04-30 Syft Technologies Ltd Improvements in or relating to SIFT-MS instruments
WO2008070797A2 (en) 2006-12-06 2008-06-12 Medtronic Corevalve, Inc. System and method for transapical delivery of an annulus anchored self-expanding valve
US8070799B2 (en) 2006-12-19 2011-12-06 Sorin Biomedica Cardio S.R.L. Instrument and method for in situ deployment of cardiac valve prostheses
US8470024B2 (en) 2006-12-19 2013-06-25 Sorin Group Italia S.R.L. Device for in situ positioning of cardiac valve prosthesis
US8623074B2 (en) 2007-02-16 2014-01-07 Medtronic, Inc. Delivery systems and methods of implantation for replacement prosthetic heart valves
US7896915B2 (en) 2007-04-13 2011-03-01 Jenavalve Technology, Inc. Medical device for treating a heart valve insufficiency
FR2915087B1 (en) 2007-04-20 2021-11-26 Corevalve Inc IMPLANT FOR TREATMENT OF A HEART VALVE, IN PARTICULAR OF A MITRAL VALVE, EQUIPMENT INCLUDING THIS IMPLANT AND MATERIAL FOR PLACING THIS IMPLANT.
US9050036B2 (en) * 2007-06-19 2015-06-09 Minimally Invasive Devices, Inc. Device for maintaining visualization with surgical scopes
US8192351B2 (en) 2007-08-13 2012-06-05 Paracor Medical, Inc. Medical device delivery system having integrated introducer
US8747458B2 (en) 2007-08-20 2014-06-10 Medtronic Ventor Technologies Ltd. Stent loading tool and method for use thereof
US20090054853A1 (en) * 2007-08-22 2009-02-26 Huyser Richard F Surgical tool system that forms a sterile gas barrier at the site at which the tool of the system is used and that activates energy-activated agents discharged at the site
US8808367B2 (en) 2007-09-07 2014-08-19 Sorin Group Italia S.R.L. Prosthetic valve delivery system including retrograde/antegrade approach
US8114154B2 (en) 2007-09-07 2012-02-14 Sorin Biomedica Cardio S.R.L. Fluid-filled delivery system for in situ deployment of cardiac valve prostheses
US10856970B2 (en) 2007-10-10 2020-12-08 Medtronic Ventor Technologies Ltd. Prosthetic heart valve for transfemoral delivery
US9848981B2 (en) 2007-10-12 2017-12-26 Mayo Foundation For Medical Education And Research Expandable valve prosthesis with sealing mechanism
US8192534B2 (en) * 2007-10-13 2012-06-05 Neema Hekmat Open lumen air filtration for liquid lines
US9089422B2 (en) 2008-01-24 2015-07-28 Medtronic, Inc. Markers for prosthetic heart valves
EP3572044B1 (en) 2008-01-24 2021-07-28 Medtronic, Inc. Stents for prosthetic heart valves
US8628566B2 (en) 2008-01-24 2014-01-14 Medtronic, Inc. Stents for prosthetic heart valves
US9393115B2 (en) 2008-01-24 2016-07-19 Medtronic, Inc. Delivery systems and methods of implantation for prosthetic heart valves
US9149358B2 (en) 2008-01-24 2015-10-06 Medtronic, Inc. Delivery systems for prosthetic heart valves
US8157853B2 (en) 2008-01-24 2012-04-17 Medtronic, Inc. Delivery systems and methods of implantation for prosthetic heart valves
US9044318B2 (en) 2008-02-26 2015-06-02 Jenavalve Technology Gmbh Stent for the positioning and anchoring of a valvular prosthesis
BR112012021347A2 (en) 2008-02-26 2019-09-24 Jenavalve Tecnology Inc stent for positioning and anchoring a valve prosthesis at an implantation site in a patient's heart
US20090264989A1 (en) 2008-02-28 2009-10-22 Philipp Bonhoeffer Prosthetic heart valve systems
US8585646B2 (en) 2008-03-03 2013-11-19 Lexion Medical, Llc System and method to vent gas from a body cavity
US8313525B2 (en) 2008-03-18 2012-11-20 Medtronic Ventor Technologies, Ltd. Valve suturing and implantation procedures
US8430927B2 (en) 2008-04-08 2013-04-30 Medtronic, Inc. Multiple orifice implantable heart valve and methods of implantation
US8696743B2 (en) 2008-04-23 2014-04-15 Medtronic, Inc. Tissue attachment devices and methods for prosthetic heart valves
US8312825B2 (en) 2008-04-23 2012-11-20 Medtronic, Inc. Methods and apparatuses for assembly of a pericardial prosthetic heart valve
EP2119417B2 (en) 2008-05-16 2020-04-29 Sorin Group Italia S.r.l. Atraumatic prosthetic heart valve prosthesis
US8998981B2 (en) 2008-09-15 2015-04-07 Medtronic, Inc. Prosthetic heart valve having identifiers for aiding in radiographic positioning
US8721714B2 (en) 2008-09-17 2014-05-13 Medtronic Corevalve Llc Delivery system for deployment of medical devices
WO2010042915A2 (en) 2008-10-10 2010-04-15 Surgiquest, Inc. Low-profile surgical access devices with anchoring
EP2341849B1 (en) 2008-10-10 2019-12-18 SurgiQuest, Incorporated System for improved gas recirculation in surgical trocars with pneumatic sealing
US8137398B2 (en) 2008-10-13 2012-03-20 Medtronic Ventor Technologies Ltd Prosthetic valve having tapered tip when compressed for delivery
US8986361B2 (en) 2008-10-17 2015-03-24 Medtronic Corevalve, Inc. Delivery system for deployment of medical devices
EP2375961B1 (en) * 2008-11-03 2019-01-09 G.I. View Ltd. Remote pressure sensing system and method thereof
JP5537563B2 (en) 2008-12-10 2014-07-02 ミニマリー インべーシブ デバイシーズ, インコーポレイテッド Visibility optimization assembly and surgical system
EP2201911B1 (en) 2008-12-23 2015-09-30 Sorin Group Italia S.r.l. Expandable prosthetic valve having anchoring appendages
US20100198019A1 (en) * 2009-01-30 2010-08-05 Tyco Healthcare Group Lp Suture management apparatus for surgical portal apparatus including interlocking cap
EP2246011B1 (en) 2009-04-27 2014-09-03 Sorin Group Italia S.r.l. Prosthetic vascular conduit
US9168105B2 (en) 2009-05-13 2015-10-27 Sorin Group Italia S.R.L. Device for surgical interventions
US8403982B2 (en) 2009-05-13 2013-03-26 Sorin Group Italia S.R.L. Device for the in situ delivery of heart valves
US8353953B2 (en) 2009-05-13 2013-01-15 Sorin Biomedica Cardio, S.R.L. Device for the in situ delivery of heart valves
US8808369B2 (en) 2009-10-05 2014-08-19 Mayo Foundation For Medical Education And Research Minimally invasive aortic valve replacement
US9078562B2 (en) 2010-01-11 2015-07-14 Minimally Invasive Devices, Inc. Systems and methods for optimizing and maintaining visualization of a surgical field during the use of surgical scopes
US9226826B2 (en) 2010-02-24 2016-01-05 Medtronic, Inc. Transcatheter valve structure and methods for valve delivery
US8652204B2 (en) 2010-04-01 2014-02-18 Medtronic, Inc. Transcatheter valve with torsion spring fixation and related systems and methods
US8246605B2 (en) 2010-05-10 2012-08-21 Cook Medical Technologies Llc Clear flush check flow
IT1400327B1 (en) 2010-05-21 2013-05-24 Sorin Biomedica Cardio Srl SUPPORT DEVICE FOR VALVULAR PROSTHESIS AND CORRESPONDING CORRESPONDENT.
CA2799459A1 (en) 2010-05-25 2011-12-01 Jenavalve Technology Inc. Prosthetic heart valve and transcatheter delivered endoprosthesis comprising a prosthetic heart valve and a stent
US9421032B2 (en) * 2010-06-16 2016-08-23 Covidien Lp Seal port with blood collector
US20120184897A1 (en) * 2010-07-19 2012-07-19 Minimally Invasive Devices, Llc Integrated systems and methods for maintenance and management of an intra-abdominal gas environment during laparoscopic surgery
US9155831B2 (en) 2010-08-04 2015-10-13 University Of Florida Research Foundation, Inc. Apparatuses and methods for detecting gas contamination
EP2600759A4 (en) 2010-08-04 2013-08-28 Minimally Invasive Devices Llc Systems and methods for optimizing and maintaining visualization of a surgical field during the use of surgical scopes
US8597180B2 (en) * 2010-08-12 2013-12-03 Covidien Lp Expandable thoracic access port
US9918833B2 (en) 2010-09-01 2018-03-20 Medtronic Vascular Galway Prosthetic valve support structure
WO2012075487A2 (en) 2010-12-03 2012-06-07 Minimally Invasive Devices, Llc Devices, systems, and methods for performing endoscopic surgical procedures
EP2486894B1 (en) 2011-02-14 2021-06-09 Sorin Group Italia S.r.l. Sutureless anchoring device for cardiac valve prostheses
ES2641902T3 (en) 2011-02-14 2017-11-14 Sorin Group Italia S.R.L. Sutureless anchoring device for cardiac valve prostheses
WO2012122263A2 (en) 2011-03-08 2012-09-13 Surgiquest, Inc. Trocar assembly with pneumatic sealing
AU2012239900B2 (en) * 2011-04-08 2016-11-03 M. Robert Garfield Iii Methods and devices for detecting bowel perforation
US20120303048A1 (en) 2011-05-24 2012-11-29 Sorin Biomedica Cardio S.R.I. Transapical valve replacement
CA2855003C (en) 2011-11-08 2019-01-15 Boston Scientific Scimed, Inc. Handle assembly for a left atrial appendage occlusion device
US10004856B2 (en) 2011-12-01 2018-06-26 Buffalo Filter Llc Filtration system and method
US20150073440A1 (en) * 2011-12-21 2015-03-12 Empire Technology Development, Llc Suture collector
EP2609893B1 (en) 2011-12-29 2014-09-03 Sorin Group Italia S.r.l. A kit for implanting prosthetic vascular conduits
US10537691B2 (en) * 2012-01-27 2020-01-21 Lexion Medical, Llc Surgical method for performing an open surgical site surgery
US20140073907A1 (en) 2012-09-12 2014-03-13 Convergent Life Sciences, Inc. System and method for image guided medical procedures
GB2510321B (en) * 2012-11-12 2018-01-31 Biosurgical S L Agitation apparatus
DE102013101229A1 (en) * 2013-02-07 2014-08-07 Colin Krüger Covering of device for filling breast space of patient with filling gas during heart surgery, has covering main portion established to keep breast space of patient open during heart surgery and provided with gas inlet and gas outlet
WO2014151824A1 (en) 2013-03-14 2014-09-25 Minimally Invasive Devices, Inc. Fluid dispensing control systems and methods
EP2991586A1 (en) 2013-05-03 2016-03-09 Medtronic Inc. Valve delivery tool
US9867694B2 (en) 2013-08-30 2018-01-16 Jenavalve Technology Inc. Radially collapsible frame for a prosthetic valve and method for manufacturing such a frame
US9730701B2 (en) 2014-01-16 2017-08-15 Boston Scientific Scimed, Inc. Retrieval wire centering device
US9782549B2 (en) 2014-10-22 2017-10-10 Ethicon, Inc. Distance indicators for medicinal spray devices
EP3236861A4 (en) 2014-12-23 2018-08-01 Fisher&Paykel Healthcare Limited Wound retractor and diffuser
WO2016140039A1 (en) * 2015-03-04 2016-09-09 オリンパス株式会社 Insertion tool and medical treatment system
EP3288495B1 (en) 2015-05-01 2019-09-25 JenaValve Technology, Inc. Device with reduced pacemaker rate in heart valve replacement
WO2017083660A1 (en) 2015-11-13 2017-05-18 Cardiac Pacemakers, Inc. Bioabsorbable left atrial appendage closure with endothelialization promoting surface
EP4183371A1 (en) 2016-05-13 2023-05-24 JenaValve Technology, Inc. Heart valve prosthesis delivery system and method for delivery of heart valve prosthesis with introducer sheath and loading system
DK3554429T3 (en) 2016-12-16 2021-10-18 Cook Medical Technologies Llc AIR REDUCTION PROCEDURE IN STENT TRANSPLANT INSERTING DEVICE
WO2018138658A1 (en) 2017-01-27 2018-08-02 Jenavalve Technology, Inc. Heart valve mimicry
EP3614933A1 (en) 2017-04-27 2020-03-04 Boston Scientific Scimed, Inc. Occlusive medical device with fabric retention barb
JP7013591B2 (en) 2017-12-18 2022-01-31 ボストン サイエンティフィック サイムド,インコーポレイテッド Closure device with expandable members
WO2019144072A1 (en) 2018-01-19 2019-07-25 Boston Scientific Scimed, Inc. Occlusive medical device with delivery system
WO2019213274A1 (en) 2018-05-02 2019-11-07 Boston Scientific Scimed, Inc. Occlusive sealing sensor system
EP3793450A1 (en) 2018-05-15 2021-03-24 Boston Scientific Scimed, Inc. Occlusive medical device with charged polymer coating
WO2019224577A1 (en) 2018-05-23 2019-11-28 Sorin Group Italia S.R.L. A cardiac valve prosthesis
US11672541B2 (en) 2018-06-08 2023-06-13 Boston Scientific Scimed, Inc. Medical device with occlusive member
US11123079B2 (en) 2018-06-08 2021-09-21 Boston Scientific Scimed, Inc. Occlusive device with actuatable fixation members
US11534574B2 (en) 2018-06-21 2022-12-27 Apparent Llc Annulus plane catheter
CN112566566A (en) 2018-07-06 2021-03-26 波士顿科学医学有限公司 Closed medical device
EP3840670B1 (en) 2018-08-21 2023-11-15 Boston Scientific Scimed, Inc. Projecting member with barb for cardiovascular devices
CN109528255A (en) * 2018-11-19 2019-03-29 北京大学深圳医院 A kind of Sternal distraction device
US11540838B2 (en) 2019-08-30 2023-01-03 Boston Scientific Scimed, Inc. Left atrial appendage implant with sealing disk
JP1652078S (en) * 2019-08-30 2020-02-03
JP1661152S (en) * 2019-12-10 2020-06-08
EP4125634A1 (en) 2020-03-24 2023-02-08 Boston Scientific Scimed Inc. Medical system for treating a left atrial appendage

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4617933A (en) * 1980-02-19 1986-10-21 Hasson Harrith M Laparoscope cannula with improved suture receiving means
US4869717A (en) * 1988-04-25 1989-09-26 Adair Edwin Lloyd Gas insufflation needle with instrument port
US5139478A (en) * 1987-11-11 1992-08-18 K.U. Leuven Research & Development Gas insufflation system for use in endoscopy and a surgical endoscope therefor
US5246419A (en) * 1992-09-04 1993-09-21 Omnivision, Inc. Intra-abdominal insufflation apparatus
US5383860A (en) * 1993-03-02 1995-01-24 M.I.S. Technology International, Inc. Two-part conductive cannula with adaptive disposable non-invasive element
US5419314A (en) * 1989-11-02 1995-05-30 Christopher; Kent L. Method and apparatus for weaning ventilator-dependent patients
US5474533A (en) * 1994-04-11 1995-12-12 The Ohio State University Intrathoracic mechanical, electrical and temperature adjunct to cardiopulmonary cerebral resuscitation, shock, head injury, hypothermia and hyperthermia
US5531758A (en) * 1994-03-25 1996-07-02 Ethicon Endo-Surgery, Inc. Sliding reducer seal for surgical trocar

Family Cites Families (43)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1127325A (en) * 1965-08-23 1968-09-18 Henry Berry Improved instrument for inserting artificial heart valves
DE2451383C3 (en) * 1974-10-26 1979-05-03 Hans-Joachim Dr.Med. 2000 Hamburg Lindemann Regulator for an insufflation device
FR2298313A1 (en) * 1975-06-23 1976-08-20 Usifroid LINEAR REDUCER FOR VALVULOPLASTY
FR2326734A1 (en) * 1975-10-04 1977-04-29 Wolf Gmbh Richard GAS INSUFFLATION APPARATUS APPLICABLE IN PARTICULAR TO THE FILLING OF A BODY CAVITY
US4042979A (en) * 1976-07-12 1977-08-23 Angell William W Valvuloplasty ring and prosthetic method
US4173981A (en) * 1977-05-23 1979-11-13 University Of Utah Cannula for arterial and venous bypass cannulation
US4489446A (en) * 1982-07-14 1984-12-25 Reed Charles C Heart valve prosthesis
NL8502382A (en) * 1985-08-30 1987-03-16 Martinus Jacobus Antonius Joha CATHETER SUITABLE FOR MULTIPLE PURPOSES.
GB2181057B (en) * 1985-10-23 1989-09-27 Blagoveshchensk G Med Inst Prosthetic valve holder
CA1303298C (en) * 1986-08-06 1992-06-16 Alain Carpentier Flexible cardiac valvular support prosthesis
US5032128A (en) * 1988-07-07 1991-07-16 Medtronic, Inc. Heart valve prosthesis
US4917698A (en) * 1988-12-22 1990-04-17 Baxter International Inc. Multi-segmented annuloplasty ring prosthesis
EP0595791B1 (en) * 1989-02-13 1999-06-30 Baxter International Inc. Anuloplasty ring prosthesis
US4962757A (en) * 1989-02-28 1990-10-16 Baxter International Inc. Suture loop for catheters
US5011481A (en) * 1989-07-17 1991-04-30 Medtronic, Inc. Holder for annuloplasty ring
US5290300A (en) * 1989-07-31 1994-03-01 Baxter International Inc. Flexible suture guide and holder
US5041130A (en) * 1989-07-31 1991-08-20 Baxter International Inc. Flexible annuloplasty ring and holder
US5350420A (en) * 1989-07-31 1994-09-27 Baxter International Inc. Flexible annuloplasty ring and holder
US5109859A (en) * 1989-10-04 1992-05-05 Beth Israel Hospital Association Ultrasound guided laser angioplasty
US5199944A (en) * 1990-05-23 1993-04-06 Ioan Cosmescu Automatic smoke evacuator system for a surgical laser apparatus and method therefor
US5197979A (en) * 1990-09-07 1993-03-30 Baxter International Inc. Stentless heart valve and holder
US5308320A (en) * 1990-12-28 1994-05-03 University Of Pittsburgh Of The Commonwealth System Of Higher Education Portable and modular cardiopulmonary bypass apparatus and associated aortic balloon catheter and associated method
US5064431A (en) * 1991-01-16 1991-11-12 St. Jude Medical Incorporated Annuloplasty ring
US5207213A (en) * 1991-02-01 1993-05-04 Circon Corporation Laparoscope having means for removing image impeding material from a distal lens
US5137509A (en) * 1991-04-17 1992-08-11 Dexide, Inc. Surgical insufflation instrument
US5188619A (en) * 1991-04-24 1993-02-23 Gene E. Myers Enterprises, Inc. Internal thoractic artery catheter
US5139485A (en) * 1991-05-03 1992-08-18 Ethicon, Inc. Verress needle with enhanced acoustical means
US5290257A (en) * 1992-01-02 1994-03-01 Zhong Being Tang Method and apparatus for de-airing the heart
US5306296A (en) * 1992-08-21 1994-04-26 Medtronic, Inc. Annuloplasty and suture rings
US5201880A (en) * 1992-01-27 1993-04-13 Pioneering Technologies, Inc. Mitral and tricuspid annuloplasty rings
US5258021A (en) * 1992-01-27 1993-11-02 Duran Carlos G Sigmoid valve annuloplasty ring
US5814012A (en) * 1992-03-16 1998-09-29 Birtcher Medical Systems, Inc. Method and apparatus for relieving excess insufflation pressure
WO1993020741A1 (en) * 1992-04-08 1993-10-28 Jako Geza J Percutaneous surgical endoscopy
US5396880A (en) * 1992-04-08 1995-03-14 Danek Medical, Inc. Endoscope for direct visualization of the spine and epidural space
US5332402A (en) * 1992-05-12 1994-07-26 Teitelbaum George P Percutaneously-inserted cardiac valve
GR930100244A (en) * 1992-06-30 1994-02-28 Ethicon Inc Flexible endoscopic surgical port
US5250038A (en) * 1992-10-09 1993-10-05 Cook Incorporated Multiple lumen vascular access introducer sheath
US5203776A (en) * 1992-10-09 1993-04-20 Durfee Paul J Catheter
US5403305A (en) * 1993-04-08 1995-04-04 Carbomedics, Inc. Mitral valve prosthesis rotator
US5411474A (en) * 1993-07-14 1995-05-02 Douglas E. Ott Method and apparatus for conditioning insufflation gas for laparoscopic surgery
US5478329A (en) * 1994-05-06 1995-12-26 Ternamian; Artin M. Trocarless rotational entry cannula
US5849005A (en) * 1995-06-07 1998-12-15 Heartport, Inc. Method and apparatus for minimizing the risk of air embolism when performing a procedure in a patient's thoracic cavity
US5779662A (en) * 1996-05-20 1998-07-14 Linvatec Corporation Laparoscopic tissue resection system

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4617933A (en) * 1980-02-19 1986-10-21 Hasson Harrith M Laparoscope cannula with improved suture receiving means
US5139478A (en) * 1987-11-11 1992-08-18 K.U. Leuven Research & Development Gas insufflation system for use in endoscopy and a surgical endoscope therefor
US4869717A (en) * 1988-04-25 1989-09-26 Adair Edwin Lloyd Gas insufflation needle with instrument port
US5419314A (en) * 1989-11-02 1995-05-30 Christopher; Kent L. Method and apparatus for weaning ventilator-dependent patients
US5246419A (en) * 1992-09-04 1993-09-21 Omnivision, Inc. Intra-abdominal insufflation apparatus
US5383860A (en) * 1993-03-02 1995-01-24 M.I.S. Technology International, Inc. Two-part conductive cannula with adaptive disposable non-invasive element
US5531758A (en) * 1994-03-25 1996-07-02 Ethicon Endo-Surgery, Inc. Sliding reducer seal for surgical trocar
US5474533A (en) * 1994-04-11 1995-12-12 The Ohio State University Intrathoracic mechanical, electrical and temperature adjunct to cardiopulmonary cerebral resuscitation, shock, head injury, hypothermia and hyperthermia

Cited By (72)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19732785C2 (en) * 1997-07-30 2001-06-28 Aesculap Ag & Co Kg Instrument guide tube for the introduction of surgical instruments
DE19732785A1 (en) * 1997-07-30 1999-02-18 Aesculap Ag & Co Kg Trocar for passing surgical instruments through body wall or between ribs
US7981123B2 (en) 1997-09-12 2011-07-19 Evalve, Inc. Surgical device for connecting soft tissue
US9510837B2 (en) 1997-09-12 2016-12-06 Evalve, Inc. Surgical device for connecting soft tissue
US8740918B2 (en) 1997-09-12 2014-06-03 Evalve, Inc. Surgical device for connecting soft tissue
WO1999029249A1 (en) * 1997-11-20 1999-06-17 Cardia Innovation Ab A method and a device for producing an atmosphere in a region, and use of carbon dioxide for the manufacture of a medicament
US6494858B1 (en) 1997-11-20 2002-12-17 Cardia Innovation Ab Method and a device for producing an atmosphere in a region, and use of carbon dioxide for the manufacture of a medicament
EP0956827A1 (en) * 1998-05-06 1999-11-17 Erbe Elektromedizin GmbH Electrosurgical apparatus
US7811296B2 (en) 1999-04-09 2010-10-12 Evalve, Inc. Fixation devices for variation in engagement of tissue
US8500761B2 (en) 1999-04-09 2013-08-06 Abbott Vascular Fixation devices, systems and methods for engaging tissue
US9510829B2 (en) 1999-04-09 2016-12-06 Evalve, Inc. Fixation devices, systems and methods for engaging tissue
US7753923B2 (en) 1999-04-09 2010-07-13 Evalve, Inc. Leaflet suturing
US7998151B2 (en) 1999-04-09 2011-08-16 Evalve, Inc. Leaflet suturing
US8029518B2 (en) 1999-04-09 2011-10-04 Evalve, Inc. Methods and devices for capturing and fixing leaflets in valve repair
US9044246B2 (en) 1999-04-09 2015-06-02 Abbott Vascular Inc. Methods and devices for capturing and fixing leaflets in valve repair
US8057493B2 (en) 1999-04-09 2011-11-15 Evalve, Inc. Fixation devices, systems and methods for engaging tissue
US8123703B2 (en) 1999-04-09 2012-02-28 Evalve, Inc. Steerable access sheath and methods of use
US8187299B2 (en) 1999-04-09 2012-05-29 Evalve, Inc. Methods and apparatus for cardiac valve repair
US8216256B2 (en) 1999-04-09 2012-07-10 Evalve, Inc. Detachment mechanism for implantable fixation devices
US8343174B2 (en) 1999-04-09 2013-01-01 Evalve, Inc. Locking mechanisms for fixation devices and methods of engaging tissue
US8409273B2 (en) 1999-04-09 2013-04-02 Abbott Vascular Inc Multi-catheter steerable guiding system and methods of use
US8740920B2 (en) 1999-04-09 2014-06-03 Evalve, Inc. Fixation devices, systems and methods for engaging tissue
US7736388B2 (en) 1999-04-09 2010-06-15 Evalve, Inc. Fixation devices, systems and methods for engaging tissue
US8734505B2 (en) 1999-04-09 2014-05-27 Evalve, Inc. Methods and apparatus for cardiac valve repair
US6994685B2 (en) 1999-12-21 2006-02-07 Cardia Innovation Ab Method and a device for creating a protecting atmosphere
JP4657553B2 (en) * 1999-12-21 2011-03-23 カルディア イノヴェイション アクチボラゲット Equipment for generating a protective atmosphere
WO2001045790A1 (en) * 1999-12-21 2001-06-28 Cardia Innovation Ab A method and a device for creating a protecting atmosphere
US10624618B2 (en) 2001-06-27 2020-04-21 Evalve, Inc. Methods and devices for capturing and fixing leaflets in valve repair
US10653427B2 (en) 2001-06-27 2020-05-19 Evalve, Inc. Fixation devices, systems and methods for engaging tissue
US10828042B2 (en) 2003-05-19 2020-11-10 Evalve, Inc. Fixation devices, systems and methods for engaging tissue
US10667823B2 (en) 2003-05-19 2020-06-02 Evalve, Inc. Fixation devices, systems and methods for engaging tissue
US10646229B2 (en) 2003-05-19 2020-05-12 Evalve, Inc. Fixation devices, systems and methods for engaging tissue
US10631871B2 (en) 2003-05-19 2020-04-28 Evalve, Inc. Fixation devices, systems and methods for engaging tissue
US11484331B2 (en) 2004-09-27 2022-11-01 Evalve, Inc. Methods and devices for tissue grasping and assessment
US11304715B2 (en) 2004-09-27 2022-04-19 Evalve, Inc. Methods and devices for tissue grasping and assessment
US8052592B2 (en) 2005-09-27 2011-11-08 Evalve, Inc. Methods and devices for tissue grasping and assessment
US10792039B2 (en) 2011-09-13 2020-10-06 Abbott Cardiovascular Systems Inc. Gripper pusher mechanism for tissue apposition systems
US10743876B2 (en) 2011-09-13 2020-08-18 Abbott Cardiovascular Systems Inc. System for fixation of leaflets of a heart valve
AT13234U1 (en) * 2012-07-12 2013-08-15 Werzowa Wolfgang Device for supplying the body with gas
US10390943B2 (en) 2014-03-17 2019-08-27 Evalve, Inc. Double orifice device for transcatheter mitral valve replacement
US10667804B2 (en) 2014-03-17 2020-06-02 Evalve, Inc. Mitral valve fixation device removal devices and methods
US11666433B2 (en) 2014-03-17 2023-06-06 Evalve, Inc. Double orifice device for transcatheter mitral valve replacement
US10188392B2 (en) 2014-12-19 2019-01-29 Abbott Cardiovascular Systems, Inc. Grasping for tissue repair
US11229435B2 (en) 2014-12-19 2022-01-25 Abbott Cardiovascular Systems Inc. Grasping for tissue repair
US11109863B2 (en) 2014-12-19 2021-09-07 Abbott Cardiovascular Systems, Inc. Grasping for tissue repair
US11006956B2 (en) 2014-12-19 2021-05-18 Abbott Cardiovascular Systems Inc. Grasping for tissue repair
US10524912B2 (en) 2015-04-02 2020-01-07 Abbott Cardiovascular Systems, Inc. Tissue fixation devices and methods
US10893941B2 (en) 2015-04-02 2021-01-19 Abbott Cardiovascular Systems, Inc. Tissue fixation devices and methods
US10376673B2 (en) 2015-06-19 2019-08-13 Evalve, Inc. Catheter guiding system and methods
US10238494B2 (en) 2015-06-29 2019-03-26 Evalve, Inc. Self-aligning radiopaque ring
US10856988B2 (en) 2015-06-29 2020-12-08 Evalve, Inc. Self-aligning radiopaque ring
US10667815B2 (en) 2015-07-21 2020-06-02 Evalve, Inc. Tissue grasping devices and related methods
US11759209B2 (en) 2015-07-21 2023-09-19 Evalve, Inc. Tissue grasping devices and related methods
US11096691B2 (en) 2015-07-21 2021-08-24 Evalve, Inc. Tissue grasping devices and related methods
US10413408B2 (en) 2015-08-06 2019-09-17 Evalve, Inc. Delivery catheter systems, methods, and devices
US10238495B2 (en) 2015-10-09 2019-03-26 Evalve, Inc. Delivery catheter handle and methods of use
US11109972B2 (en) 2015-10-09 2021-09-07 Evalve, Inc. Delivery catheter handle and methods of use
CN108367135A (en) * 2015-12-09 2018-08-03 卢加诺技术传递股份有限公司 Device for removing air from anatomical cavity in surgical intervention
WO2017097443A1 (en) * 2015-12-09 2017-06-15 Fondazione Cardiocentro Ticino (FCCT) Device for removing air from an anatomical cavity in a surgical intervention
ITUB20156844A1 (en) * 2015-12-09 2017-06-09 Fond Cardiocentro Ticino Fcct DEVICE FOR AIR REMOVAL FROM ANATOMIC CAVITY IN A SURGICAL INTERVENTION
US10736632B2 (en) 2016-07-06 2020-08-11 Evalve, Inc. Methods and devices for valve clip excision
US11653947B2 (en) 2016-10-05 2023-05-23 Evalve, Inc. Cardiac valve cutting device
US11071564B2 (en) 2016-10-05 2021-07-27 Evalve, Inc. Cardiac valve cutting device
US10363138B2 (en) 2016-11-09 2019-07-30 Evalve, Inc. Devices for adjusting the curvature of cardiac valve structures
US10398553B2 (en) 2016-11-11 2019-09-03 Evalve, Inc. Opposing disk device for grasping cardiac valve tissue
US10426616B2 (en) 2016-11-17 2019-10-01 Evalve, Inc. Cardiac implant delivery system
US10779837B2 (en) 2016-12-08 2020-09-22 Evalve, Inc. Adjustable arm device for grasping tissues
US10314586B2 (en) 2016-12-13 2019-06-11 Evalve, Inc. Rotatable device and method for fixing tricuspid valve tissue
US11406388B2 (en) 2016-12-13 2022-08-09 Evalve, Inc. Rotatable device and method for fixing tricuspid valve tissue
US11065119B2 (en) 2017-05-12 2021-07-20 Evalve, Inc. Long arm valve repair clip
US11490790B2 (en) 2018-07-18 2022-11-08 Cook Medical Technologies Llc Device for shielding endoscopic optics with a fluid barrier
US11931263B2 (en) 2021-09-03 2024-03-19 Evalve, Inc. Delivery catheter handle and methods of use

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US6309382B1 (en) 2001-10-30

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