US20040147802A1 - Staged implantation of ventricular assist devices - Google Patents
Staged implantation of ventricular assist devices Download PDFInfo
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- US20040147802A1 US20040147802A1 US10/478,410 US47841004A US2004147802A1 US 20040147802 A1 US20040147802 A1 US 20040147802A1 US 47841004 A US47841004 A US 47841004A US 2004147802 A1 US2004147802 A1 US 2004147802A1
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- United States
- Prior art keywords
- ventricular assist
- assist device
- cannula
- lead
- heart
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
- A61M60/148—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
- A61M60/178—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/205—Non-positive displacement blood pumps
- A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/80—Constructional details other than related to driving
- A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
- A61M60/857—Implantable blood tubes
- A61M60/859—Connections therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
- A61M2039/0291—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body method or device for implanting it in the body
Definitions
- the present invention relates to systems and devices for the implantation of ventricular assist devices and, more particularly, to such systems and devices suited to a staged regime.
- Blood pumps are known for the purpose of assisting the pumping function of a heart in a mammal.
- ventricular assist devices assist, by pumping, the action of the left ventricle of the heart.
- Blood pumps suited for this task include those disclosed in U.S. Pat. No. 6,227,797 (Watterson et al) and U.S. Pat. No. 5,470,208 (Kletschka).
- the “assist” function provided by a ventricular assist device permits the heart to recover function to the point where the ventricular assist device can be removed and the patient's own heart takes over full pumping function.
- an implantation regime for a ventricular assist device comprising:
- said first ventricular assist device is adapted for short term use.
- said first ventricular assist device is adapted for short term use comprising a period extending in the range 0 to 6 months.
- said first ventricular assist device is adapted for short term use comprising a period extending in the range 0 to 3 months.
- said second ventricular assist device is adapted for long term use.
- said second ventricular assist device is adapted for long term use comprising a period of 1 to 20 years.
- said second ventricular assist device is adapted for long term use comprising a period of 1 to 10 years.
- said first ventricular assist device is made by a low cost process.
- components of said first ventricular assist device are made by an injection moulding process.
- components of said first ventricular assist device are made by a vacuum casting process.
- said first ventricular assist device includes a pump casing made from plastic components.
- said first ventricular assist device includes a pump rotor made from a plastic material.
- said second ventricular assist device includes a pump casing made from a metallic material.
- said second ventricular assist device includes a rotor made from a metallic material.
- said second ventricular assist device includes a pump casing made from a ceramic material.
- said second ventricular assist device includes a rotor made from a ceramic material.
- said device comprises a sac-type device.
- said heart is connectable to said first ventricular assist device by means of a respective first cannula and second cannula interposed between said heart and said first connector and said heart and said second connector respectively.
- said second ventricular assist device is connectable to said heart via said first cannula and said second cannula by means of said second ventricular assist device first connector and said second ventricular assist device second connector respectively.
- test procedure comprising the connection of a first ventricular assist device so as to assist a diseased heart for a first predetermined period of time; monitoring operation of said heart over said predetermined period of time so as to determine whether said heart can operate without the further assistance of said first ventricular assist device.
- said first ventricular assist device incorporates short term life features (necessitated by reduced cost of manufacturing) which render said first ventricular assist device suited to operation over a short life span.
- said short term life features include use of plastic materials in one or more of the pump casing and pump rotor of said first ventricular assist device.
- said short life span comprises a period of up to 6 months.
- said short life span comprises a period of up to 3 months.
- a method of mechanically assisting a heart to pump blood comprising releasably, sealingly connecting via a first cannula and a second cannula a first ventricular assist device so as to at least assist said heart to pump said blood; during a first predetermined period of time, ascertaining if mechanical assistance continues to be required and, if so, substituting a second ventricular assist device for said first ventricular assist device at the end of said first predetermined period of time.
- a first ventricular assist device adapted for short term use and a second ventricular assist device adapted for long term use.
- a first cannula having a proximal end for connection to the aorta; a second cannula having a proximal end for connection to a ventricle; said first cannula having a distal end including connection means for releasably, sealingly connecting said distal end of said first cannula to either an inlet of a first ventricular assist device or an inlet of a second ventricular assist device; a second cannula having a distal end including connection means for releasably, sealingly connecting said distal end of said second cannula to either an outlet of said first ventricular assist device or an outlet of said second ventricular assist device; said second ventricular assist device adapted for substitution for said first ventricular assist device following a first predetermined period of operation of said first ventricular assist device.
- an embolisation device adapted for insertion into either said first cannula or said second cannula; said embolisation device including a stem having an end adapted to deliver a coagulating material to a sealing position within said proximal end of said first cannula or said second cannula.
- a percutaneous lead for carriage of power to said device; said lead having a surface; said surface including regions which permit incorporation of the percutaneous lead surface into the surrounding tissue and a region or regions which will not allow incorporation.
- the region allowing incorporation may extend the entire length of the percutaneous lead or none of it or it may extend over regions near the ventricular assist device sufficient only to help anchor the device in place or near to the site where the percutaneous lead exits the body and provide good closure to the wound so as to prevent or reduce the occurrence of infection.
- other areas on the surface of the percutaneous lead may have properties which prevent incorporation so as to facilitate easy removal of the lead at the end of the predetermined period of implantation of the first ventricular assist device.
- a method of mechanically assisting a heart to pump blood comprising releasably, sealingly connecting a first ventricular device via a first cannula and a second cannula so as to at least assist said heart to pump said blood during a first predetermined period of time, ascertaining if mechanical assistance continues to be required and, if so, substituting a second ventricular assist device at the end of said first predetermined period of time and wherein first and second ventricular assist devices are implantable into a patient's body and are both pumping devices and wherein said first ventricular assist device is adapted for short term use and wherein said second ventricular assist device is adapted for long term use.
- said cannular are capable of being reused for connection of said first ventricular assist device or said second ventricular assist device.
- said first ventricular assist device incorporates short term life features which renders said first ventricular assist device suited to operation over a short life span.
- said short term life features include use of plastic material in one or more of the pump casing and pump rotor of said first ventricular assist device.
- said cannulae are capable of being either permanently or temporarily scaled so as to allow permanent implantation of the cannulae without need to be connected to either said first ventricular assist device or said second ventricular assist device.
- said first cannula includes an end for connection to the aorta and a distal end connecting to either an inlet of a first ventricular assist device or an inlet of a second ventricular assist device, in use; and said second cannula includes an end for connection to a ventricle and a distal end connecting to either an outlet of said first ventricular assist device or an outlet of said second ventricular assist device, in use.
- said second ventricular assist device is adapted for substitution of said first ventricular assist device following a first predetermined period of operation of said first ventricular assist device.
- the first cannula or the second cannula are adapted to receive the insertion of an embolisation device.
- said first ventricular assist device is made by an injection moulding process.
- said first ventricular assist device is made by a vacuum casting process.
- said first ventricular assist device includes a pump rotor made from a plastic material.
- said second ventricular assist device includes a pump casing made from a metallic material.
- said second ventricular assist device includes a pump casing made from a ceramic material.
- said second ventricular assist device includes a rotor made from ceramic material.
- said short term use is a period of time between 3 to 6 months.
- said long term use is a period of time between 1 to 10 years.
- said method includes a test procedure to determine whether heart can operate without the further assistance of said first ventricular assist device.
- test procedure includes a monitoring operation of said heart over said predetermined period of time.
- Preferably said method includes the use of an insulated percutaneous lead for supplying power to either a first or second ventricalar assist device.
- a portion of an outer surface of said lead prevents incorporation of surrounding tissue.
- a portion of an outer surface of said lead allows incorporation of surrounding tissue.
- said surface comprises one surface texture.
- said lead includes at least two surface textures on predetermined portions of the surface of said lead, wherein a first surface texture allows incorporation of said lead into tissue and wherein a surface texture prevents incorporation of said lead into tissue.
- an amount of tissue incorporation of said lead can be varied to suit needs by arrangement of the surface textures.
- said surface textures comprises at least one application of a surface treatment to said lead.
- said surface texture is modified as to the degree to which said incorporation of portions of said lead into tissue surrounding said lead is promoted therein.
- said surface treatment includes an application of velour to the surface of said lead.
- said first surface texture has a labyrinth arrangement.
- said incorporation of portions of said lead into tissue surrounding is promoted controlled by selection of depth and shape of said surface textures.
- the portion allowing incorporation may extend to a length sufficient to anchor said lead to a site where said lead exits the body or proximal to said site.
- the second surface texture prevents incorporation so as to facilitate easy removal of the lead.
- said method includes an embolisation device for insertably sealing a cannula, wherein said embolisation device comprises a scaling cap at a first end, a carrier surface at a second end and an elongate stem adapted to be inserted within the cannula.
- the carrier surface is adapted to carry a coagulating material.
- said embolisation device seals a cannula at a scaling point close to the heart.
- sealing cap is adapted to be sealingly connected to a corresponding connector on the cannula.
- the elongated stem is of a length so that when the device is entirely inserted within said cannula, the carrier surface is positioned to deliver coagulating material to the sealing point.
- said embolisation device is connected removably and releasably to the cannula, in use.
- an embolisation device for insertably sealing a cannula, wherein said embolisation device comprises a sealing cap at a first end, a carrier surface at a second end; wherein the carrier surface is adapted to carry a coagulating material and induces an embolism at a position proximal to said second end and an elongate stem adapted to be inserted within the cannula.
- said emolisation device seals a cannula at a sealing point proximal to a heart of a patient, in use.
- said scaling cap is adapted to be sealingly connected to a corresponding connector of the cannula.
- the elongated stem is of a length so that when the device is entirely inserted within said cannula, the carrier surface is positioned to deliver coagulating material to a sealing point at some point proximal to a heart of a patient, in use.
- said scaling point is sufficiently close to the heart so that there is no requirement to remove the cannula from the body.
- said embolisation device is connected removably and releasably to the cannula, is use.
- FIG. 1 is a flow diagram illustrating steps in an implantation regime in accordance with a first preferred embodiment of the present invention.
- FIG. 2 is a side section view of cannulae and an embolisation tool in accordance with a particular embodiment of the present invention.
- FIG. 3 is a cross-section through a patient's chest and abdomen showing the ventricular assist device in place and the path of the percutaneous lead from the exit site in the skin to the ventricular assist device.
- FIG. 1 comprising sub-diagrams 1 A, 1 B, 1 C and 1 D there is illustrated steps in an implantation regime 10 according to a first preferred embodiment of the present invention.
- FIG. 1A a patient 11 having a heart 12 in need of at least an assisted pumping action is fitted with a first ventricular assist device 13 arranged, in this instance, to provide a pumped blood flow “in parallel” across left ventricle 14 of heart 12 .
- first cannula 15 and second cannula 16 as illustrated in FIG. 1.
- first cannula 15 sealingly connects via first connector 17 to ventricular assist device 13 whilst second cannula 16 sealingly connects to ventricular assist device 13 by way of second connector 18 .
- the length of cannulae 15 , 16 is such as to permit first ventricular assist device 13 to be placed in the abdomen 19 of patient 11 .
- first ventricular assist device 13 is to be utilized for a relatively short predetermined period of time, typically up to approximately 3 to 6 months. This predetermined period of time will be sufficient to monitor the function of heart 12 so as to determine whether the assistance provided by first ventricular assist device 13 is sufficient to allow full or substantial recovery of heart 12 to the point where no ventricular assist device is required.
- cannulae 15 , 16 are sealed internally at a point sufficiently close to the heart 12 that there is no need to remove cannulae 15 , 16 at the time that first ventricular assist device 13 is removed.
- Sealing can be effected by use of a first embolisation tool 21 and a second embolisation tool 22 for respective first cannula 15 and second cannula 16 .
- Each tool 21 , 22 comprises an elongate stem 23 , 24 respectively having sealing caps 17 A, 18 A respectively at a first end (refer FIG. 2) and a carrier surface 25 , 26 at respective second ends.
- the carrier surfaces 25 , 26 are adapted to carry a coagulating material 27 .
- the sealing caps 17 A, 18 A are adapted to be sealingly connected to first connector 17 and second connector 18 respectively upon insertion of the entire length of stems 23 , 24 into cannulae 15 , 16 .
- the length of stems 23 , 24 is selected so that when tools 21 , 22 are entirely inserted within cannulae 15 , 16 the carrier surfaces 25 , 26 are positioned so as to deliver coagulating material 27 to sealing positions 28 , 29 which are sufficiently close to the heart 12 that, upon sealing of cannulae 15 , 16 at positions 28 , 29 there is no requirement to remove cannulae 15 , 16 from the body.
- first ventricular assist device 13 typically it will be clear within a predetermined period of between one and three months of use of first ventricular assist device 13 as to whether sufficient recovery of heart 12 will be made that the option of removal of first ventricular assist device 13 and appropriate sealing or removal of cannulae 15 , 16 can take place as outlined in step B of FIG. 1.
- first ventricular assist device 13 is removed and immediately replaced with second ventricular assist device 30 .
- the replacement is performed by disconnecting first connector 31 of first VAD 13 from first connector 17 of first cannula 15 and disconnecting second connector 33 of first VAD 13 from first connector 18 of second cannula 16 , withdrawing first ventricular assist device 13 from abdomen 19 and immediately substituting therein second ventricular assist device 30 and then connecting first connector 32 of second ventricular assist device 30 to first cannula 15 and second connector 34 of second ventricular assist device 30 to second cannula 16 by way of respective first connections 17 , 18 of cannulae 15 , 16 .
- cannulae 15 , 16 are clamped so no air can enter or blood leak out.
- the clamps are maintained while second ventricular assist device 30 is connected to the same cannulae. The clamps are removed once connection is completed.
- FIG. 3 With reference to FIG. 3 there is illustrated an exemplary ventricular assist device 13 , 30 having respective first connectors 31 , 32 and respective second connectors 33 , 34 for the passage of blood through the device.
- the ventricular assist device 13 , 30 requires power which is conducted through percutaneous lead 40 from outside of the body via exit site 44 .
- the outer surface of the percutaneous lead 40 may be treated so as to prevent the incorporation into surrounding tissue 41 of the percutaneous lead 40 .
- Such surface treatment may extend the entire length of the percutaneous lead 40 , or may be terminated just below the surface 43 of the skin 42 so as to allow full incorporation at the exit site 44 and hence a barrier to infection.
- An example of surface treatment of the percutaneous lead 40 is the use of silicone rubber which naturally resists incorporation.
- Incorporation at or near the exit site 44 may be achieved through the use of adhesively bonded woven velour 45 or other material or surface treatment which will provide tissue ingrowth as the outermost surface of the percutaneous lead in this region.
- the surface treatment can comprise texturing of surface 46 of lead 40 .
- the texturing of surface 46 of lead 40 can be such that ingrowth of tissue 41 can be only mildly anchored, for example by the use of a pyramid-shaped texture whereby there is little anchoring of tissue to surface 46 .
- the texturing can include a labyrinth arrangement such as illustrated in inset 2 of FIG. 3 wherein tissue 41 can follow a labyrinth path through the interstices 48 of labyrinth texture 47 .
- the texture can extend the entire length of lead 40 within the body from the exit site 44 through to device 13 , 30 .
- the texturing may be at selected and predetermined locations.
- the texturing itself can be tailored whereby the degree of tissue ingrowth into the surface 46 is controlled and tailored as a function of displacement along the surface of lead 40 .
- the surface can be tailored to provide a high degree of ingrowth such as that provided by inset 2 or can be tailored to provide only minimal ingrowth as, for example, provided in inset 1 .
- first ventricular assist device 13 may take place without patient ventilation or formal heart bypass during the procedure because there is no need to open the chest cavity of patient 11 .
- This arrangement thereby may significantly limit risk to the patient as compared with the situation where general anaesthesia or heart bypass is required.
- Second ventricular assist device 30 is intended for long term operation which is to say for many years, ideally extending to beyond the expected lifetime of patient 11 .
- first ventricular assist device 13 and second ventricular assist device 30 will, ideally, share the same surgically created pocket in abdomen 19 .
- first ventricular assist device 13 is intended for short term use and thereby can have its characteristics selected for short term use whilst second ventricular assist device 30 is intended for long term use and therefore can have its characteristics selected for long term use.
- first ventricular assist device 13 can take the form of almost any blood pump including those disclosed in U.S. Pat. No. 6,227,797 (Watterson et al) and U.S. Pat. No. 5,470,208 (Kletschka) provided only that the blood pump is sized to fit in the pocket created in abdomen 19 .
- the first ventricular assist device 13 may comprise an axial or centrifugal pump, or sac-type device. Its impeller may be suspended in any number of ways including mechanically, magnetically and hydrodynamically or by a combination of these. In the case of a sac-type device urging of the blood through the device may be caused by the reciprocating action of a pusher-plate or similar mechanism in a sac-type device.
- the components comprising the pump casing and internal surfaces and rotating parts can be made from plastic materials including polymeric materials.
- Coatings can be applied so as to increase blood compatibility. It is noted that some plastic materials such as covalently bonded heparin are particularly suited to receive and support such coatings. The Carmeda process can be utilized to perform the covalent bonding of Heparin. In addition or alternatively the coating may constitute a slow-release antibiotic.
- the first ventricular assist device 13 adapted for short term use need not be hermetically sealed. Instead it may comprise one or more components in respect of which slow permeation of body fluids is acceptable. Examples of slow permeation materials which may be suitable include polypropylene, epoxy or nylon.
- second ventricular assist device 30 is constructed for long term (which is to say much greater than 3 months and typically, of the order of many years) reliable operation and can embody, for example, the principles of rotor support described in U.S. Pat. No. 6,227,797 (Watterson et al) and U.S. Pat. No. 5,470,208 (Kletschka).
- suitable materials from which to construct the pump casing and/or the pump rotor for reliable, long term operation include hermetically welded titanium alloy.
Abstract
Description
- The present invention relates to systems and devices for the implantation of ventricular assist devices and, more particularly, to such systems and devices suited to a staged regime.
- Blood pumps are known for the purpose of assisting the pumping function of a heart in a mammal.
- In one particular form a class of pumps known as “ventricular assist devices” assist, by pumping, the action of the left ventricle of the heart.
- Blood pumps suited for this task include those disclosed in U.S. Pat. No. 6,227,797 (Watterson et al) and U.S. Pat. No. 5,470,208 (Kletschka).
- At the present time such pumps are relatively expensive, partly due to current relatively low production runs and partly because of the relatively expensive materials which must be utilized for the task of pumping blood so as to maximize reliability of the pump and minimize the possibility of blood damage.
- It has been observed that, in some patients, the “assist” function provided by a ventricular assist device permits the heart to recover function to the point where the ventricular assist device can be removed and the patient's own heart takes over full pumping function.
- Unfortunately, to date, no way has been found to predict the likelihood of a temporary assist leading to satisfactory or sufficient recovery of heart pump function.
- It is an object of the present invention, in at least preferred embodiments, to provide a cost effective regime for the use of blood pumps and which takes into account the abovementioned problems.
- Accordingly, in one broad form of the invention there is provided an implantation regime for a ventricular assist device comprising:
- (a) providing a first ventricular assist device for connection via a first ventricular assist device first connector and a first ventricular assist device second connector to a heart so as to assist heart function for a first predetermined period of time;
- (b) providing a second ventricular assist device for connection via a second ventricular assist device first connector and a second ventricular assist device second connector to a heart so as to assist heart function for a second indeterminate period of time commencing immediately and contiguously following said first predetermined period of time.
- Preferably said first ventricular assist device is adapted for short term use.
- Preferably said first ventricular assist device is adapted for short term use comprising a period extending in the range 0 to 6 months.
- Preferably said first ventricular assist device is adapted for short term use comprising a period extending in the range 0 to 3 months.
- Preferably said second ventricular assist device is adapted for long term use.
- Preferably said second ventricular assist device is adapted for long term use comprising a period of 1 to 20 years.
- Preferably said second ventricular assist device is adapted for long term use comprising a period of 1 to 10 years.
- Preferably said first ventricular assist device is made by a low cost process.
- In a particular preferred form components of said first ventricular assist device are made by an injection moulding process.
- In an alternative preferred form components of said first ventricular assist device are made by a vacuum casting process.
- Preferably said first ventricular assist device includes a pump casing made from plastic components.
- Preferably said first ventricular assist device includes a pump rotor made from a plastic material.
- Preferably said second ventricular assist device includes a pump casing made from a metallic material.
- Preferably said second ventricular assist device includes a rotor made from a metallic material.
- Preferably said second ventricular assist device includes a pump casing made from a ceramic material.
- Preferably said second ventricular assist device includes a rotor made from a ceramic material.
- In an alternative particular form said device comprises a sac-type device.
- Preferably said heart is connectable to said first ventricular assist device by means of a respective first cannula and second cannula interposed between said heart and said first connector and said heart and said second connector respectively.
- Preferably said second ventricular assist device is connectable to said heart via said first cannula and said second cannula by means of said second ventricular assist device first connector and said second ventricular assist device second connector respectively.
- In a further broad form of the invention there is provided a test procedure comprising the connection of a first ventricular assist device so as to assist a diseased heart for a first predetermined period of time; monitoring operation of said heart over said predetermined period of time so as to determine whether said heart can operate without the further assistance of said first ventricular assist device.
- Preferably said first ventricular assist device incorporates short term life features (necessitated by reduced cost of manufacturing) which render said first ventricular assist device suited to operation over a short life span.
- Preferably said short term life features include use of plastic materials in one or more of the pump casing and pump rotor of said first ventricular assist device.
- Preferably said short life span comprises a period of up to 6 months.
- Preferably said short life span comprises a period of up to 3 months.
- In yet a further broad form of the invention there is provided a method of mechanically assisting a heart to pump blood; said method comprising releasably, sealingly connecting via a first cannula and a second cannula a first ventricular assist device so as to at least assist said heart to pump said blood; during a first predetermined period of time, ascertaining if mechanical assistance continues to be required and, if so, substituting a second ventricular assist device for said first ventricular assist device at the end of said first predetermined period of time.
- In yet a further broad form of the invention there is provided, in combination, a first ventricular assist device adapted for short term use and a second ventricular assist device adapted for long term use.
- In yet a further broad form of the invention there is provided a first cannula having a proximal end for connection to the aorta; a second cannula having a proximal end for connection to a ventricle; said first cannula having a distal end including connection means for releasably, sealingly connecting said distal end of said first cannula to either an inlet of a first ventricular assist device or an inlet of a second ventricular assist device; a second cannula having a distal end including connection means for releasably, sealingly connecting said distal end of said second cannula to either an outlet of said first ventricular assist device or an outlet of said second ventricular assist device; said second ventricular assist device adapted for substitution for said first ventricular assist device following a first predetermined period of operation of said first ventricular assist device.
- In yet a further broad form of the invention there is provided an embolisation device adapted for insertion into either said first cannula or said second cannula; said embolisation device including a stem having an end adapted to deliver a coagulating material to a sealing position within said proximal end of said first cannula or said second cannula.
- In yet a further broad form of the invention there is provided a percutaneous lead for carriage of power to said device; said lead having a surface; said surface including regions which permit incorporation of the percutaneous lead surface into the surrounding tissue and a region or regions which will not allow incorporation. The region allowing incorporation may extend the entire length of the percutaneous lead or none of it or it may extend over regions near the ventricular assist device sufficient only to help anchor the device in place or near to the site where the percutaneous lead exits the body and provide good closure to the wound so as to prevent or reduce the occurrence of infection. In addition other areas on the surface of the percutaneous lead may have properties which prevent incorporation so as to facilitate easy removal of the lead at the end of the predetermined period of implantation of the first ventricular assist device.
- In yet a further broad form of the invention there is provided a method of mechanically assisting a heart to pump blood; said method comprising releasably, sealingly connecting a first ventricular device via a first cannula and a second cannula so as to at least assist said heart to pump said blood during a first predetermined period of time, ascertaining if mechanical assistance continues to be required and, if so, substituting a second ventricular assist device at the end of said first predetermined period of time and wherein first and second ventricular assist devices are implantable into a patient's body and are both pumping devices and wherein said first ventricular assist device is adapted for short term use and wherein said second ventricular assist device is adapted for long term use.
- Preferably said cannular are capable of being reused for connection of said first ventricular assist device or said second ventricular assist device.
- Preferably said first ventricular assist device incorporates short term life features which renders said first ventricular assist device suited to operation over a short life span.
- Preferably said short term life features include use of plastic material in one or more of the pump casing and pump rotor of said first ventricular assist device.
- Preferably said cannulae are capable of being either permanently or temporarily scaled so as to allow permanent implantation of the cannulae without need to be connected to either said first ventricular assist device or said second ventricular assist device.
- Preferably said first cannula includes an end for connection to the aorta and a distal end connecting to either an inlet of a first ventricular assist device or an inlet of a second ventricular assist device, in use; and said second cannula includes an end for connection to a ventricle and a distal end connecting to either an outlet of said first ventricular assist device or an outlet of said second ventricular assist device, in use.
- Preferably said second ventricular assist device is adapted for substitution of said first ventricular assist device following a first predetermined period of operation of said first ventricular assist device.
- Preferably the first cannula or the second cannula are adapted to receive the insertion of an embolisation device.
- Preferably said first ventricular assist device is made by an injection moulding process.
- Preferably said first ventricular assist device is made by a vacuum casting process.
- Preferably said first ventricular assist device includes a pump rotor made from a plastic material.
- Preferably said second ventricular assist device includes a pump casing made from a metallic material.
- Preferably said second ventricular assist device includes a pump casing made from a ceramic material.
- Preferably said second ventricular assist device includes a rotor made from ceramic material.
- Preferably said short term use is a period of time between 3 to 6 months.
- Preferably said long term use is a period of time between 1 to 10 years.
- Preferably said method includes a test procedure to determine whether heart can operate without the further assistance of said first ventricular assist device.
- Preferably said test procedure includes a monitoring operation of said heart over said predetermined period of time.
- Preferably said method includes the use of an insulated percutaneous lead for supplying power to either a first or second ventricalar assist device.
- Preferably a portion of an outer surface of said lead prevents incorporation of surrounding tissue.
- Preferably a portion of an outer surface of said lead allows incorporation of surrounding tissue.
- Preferably said surface comprises one surface texture.
- Preferably said lead includes at least two surface textures on predetermined portions of the surface of said lead, wherein a first surface texture allows incorporation of said lead into tissue and wherein a surface texture prevents incorporation of said lead into tissue.
- Preferably an amount of tissue incorporation of said lead can be varied to suit needs by arrangement of the surface textures.
- Preferably said surface textures comprises at least one application of a surface treatment to said lead.
- Preferably said surface texture is modified as to the degree to which said incorporation of portions of said lead into tissue surrounding said lead is promoted therein.
- Preferably said surface treatment includes an application of velour to the surface of said lead.
- Preferably said first surface texture has a labyrinth arrangement.
- Preferably said incorporation of portions of said lead into tissue surrounding is promoted controlled by selection of depth and shape of said surface textures.
- Preferably the portion allowing incorporation may extend to a length sufficient to anchor said lead to a site where said lead exits the body or proximal to said site.
- Preferably the second surface texture prevents incorporation so as to facilitate easy removal of the lead.
- Preferably said method includes an embolisation device for insertably sealing a cannula, wherein said embolisation device comprises a scaling cap at a first end, a carrier surface at a second end and an elongate stem adapted to be inserted within the cannula.
- Preferably the carrier surface is adapted to carry a coagulating material.
- Preferably said embolisation device seals a cannula at a scaling point close to the heart.
- Preferably said sealing cap is adapted to be sealingly connected to a corresponding connector on the cannula.
- Preferably the elongated stem is of a length so that when the device is entirely inserted within said cannula, the carrier surface is positioned to deliver coagulating material to the sealing point.
- Preferably said embolisation device is connected removably and releasably to the cannula, in use.
- In yet a further broad form of the invention there is provided an embolisation device for insertably sealing a cannula, wherein said embolisation device comprises a sealing cap at a first end, a carrier surface at a second end; wherein the carrier surface is adapted to carry a coagulating material and induces an embolism at a position proximal to said second end and an elongate stem adapted to be inserted within the cannula.
- Preferably said emolisation device seals a cannula at a sealing point proximal to a heart of a patient, in use.
- Preferably said scaling cap is adapted to be sealingly connected to a corresponding connector of the cannula.
- Preferably the elongated stem is of a length so that when the device is entirely inserted within said cannula, the carrier surface is positioned to deliver coagulating material to a sealing point at some point proximal to a heart of a patient, in use.
- Preferably said scaling point is sufficiently close to the heart so that there is no requirement to remove the cannula from the body.
- Preferably said embolisation device is connected removably and releasably to the cannula, is use.
- One embodiment of the present invention will now be described with reference to the accompanying drawings wherein:
- FIG. 1 is a flow diagram illustrating steps in an implantation regime in accordance with a first preferred embodiment of the present invention.
- FIG. 2 is a side section view of cannulae and an embolisation tool in accordance with a particular embodiment of the present invention.
- FIG. 3 is a cross-section through a patient's chest and abdomen showing the ventricular assist device in place and the path of the percutaneous lead from the exit site in the skin to the ventricular assist device.
- With reference to FIG. 1 comprising sub-diagrams1A, 1B, 1C and 1D there is illustrated steps in an
implantation regime 10 according to a first preferred embodiment of the present invention. - In FIG. 1A a patient11 having a
heart 12 in need of at least an assisted pumping action is fitted with a first ventricular assistdevice 13 arranged, in this instance, to provide a pumped blood flow “in parallel” acrossleft ventricle 14 ofheart 12. - In this instance the fluid connection is effected by
first cannula 15 andsecond cannula 16 as illustrated in FIG. 1. - More particularly
first cannula 15 sealingly connects viafirst connector 17 to ventricular assistdevice 13 whilstsecond cannula 16 sealingly connects to ventricular assistdevice 13 by way ofsecond connector 18. - In this instance the length of
cannulae device 13 to be placed in theabdomen 19 ofpatient 11. - As will be discussed further below the intention is that first ventricular assist
device 13 is to be utilized for a relatively short predetermined period of time, typically up to approximately 3 to 6 months. This predetermined period of time will be sufficient to monitor the function ofheart 12 so as to determine whether the assistance provided by first ventricular assistdevice 13 is sufficient to allow full or substantial recovery ofheart 12 to the point where no ventricular assist device is required. - In this event, as shown in FIG. 1B, at the end of the predetermined period of
time 20 the first ventricular assistdevice 13 is removed from the abdomen 19 andfirst connector 17 andsecond connector 18 sealed. - In a particularly preferred form, as illustrated in FIG. 2,
cannulae heart 12 that there is no need to removecannulae device 13 is removed. - Sealing can be effected by use of a
first embolisation tool 21 and asecond embolisation tool 22 for respectivefirst cannula 15 andsecond cannula 16. - Each
tool elongate stem 23, 24 respectively having sealing caps 17A, 18A respectively at a first end (refer FIG. 2) and acarrier surface - The carrier surfaces25, 26 are adapted to carry a coagulating
material 27. The sealing caps 17A, 18A are adapted to be sealingly connected tofirst connector 17 andsecond connector 18 respectively upon insertion of the entire length of stems 23, 24 intocannulae - The length of stems23, 24 is selected so that when
tools cannulae material 27 to sealingpositions heart 12 that, upon sealing ofcannulae positions cannulae - Typically it will be clear within a predetermined period of between one and three months of use of first ventricular assist
device 13 as to whether sufficient recovery ofheart 12 will be made that the option of removal of first ventricular assistdevice 13 and appropriate sealing or removal ofcannulae - Once the
predetermined period 20 has expired and it is judged thatheart 12 is unlikely to recover then, as per steps C and D in FIG. 1 first ventricular assistdevice 13 is removed and immediately replaced with second ventricular assistdevice 30. - The replacement is performed by disconnecting first connector31 of
first VAD 13 fromfirst connector 17 offirst cannula 15 and disconnecting second connector 33 offirst VAD 13 fromfirst connector 18 ofsecond cannula 16, withdrawing first ventricular assistdevice 13 fromabdomen 19 and immediately substituting therein second ventricular assistdevice 30 and then connecting first connector 32 of second ventricular assistdevice 30 tofirst cannula 15 and second connector 34 of second ventricular assistdevice 30 tosecond cannula 16 by way of respectivefirst connections cannulae - Ideally, immediately prior to disconnection of
first ventricular device 13,cannulae device 30 is connected to the same cannulae. The clamps are removed once connection is completed. - With reference to FIG. 3 there is illustrated an exemplary ventricular assist
device - The
ventricular assist device percutaneous lead 40 from outside of the body viaexit site 44. - To facilitate the removal of the
percutaneous lead 40 which carries electrical energy and control to the ventricular assist device 13 (and subsequently second ventricular assist device 30), the outer surface of thepercutaneous lead 40 may be treated so as to prevent the incorporation into surroundingtissue 41 of thepercutaneous lead 40. Such surface treatment may extend the entire length of thepercutaneous lead 40, or may be terminated just below the surface 43 of theskin 42 so as to allow full incorporation at theexit site 44 and hence a barrier to infection. An example of surface treatment of thepercutaneous lead 40 is the use of silicone rubber which naturally resists incorporation. Incorporation at or near theexit site 44 may be achieved through the use of adhesively bonded wovenvelour 45 or other material or surface treatment which will provide tissue ingrowth as the outermost surface of the percutaneous lead in this region. Alternatively the surface treatment can comprise texturing ofsurface 46 oflead 40. - As shown in
inset 1 in FIG. 1 the texturing ofsurface 46 oflead 40 can be such that ingrowth oftissue 41 can be only mildly anchored, for example by the use of a pyramid-shaped texture whereby there is little anchoring of tissue to surface 46. Alternatively the texturing can include a labyrinth arrangement such as illustrated ininset 2 of FIG. 3 whereintissue 41 can follow a labyrinth path through theinterstices 48 oflabyrinth texture 47. - As previously stated the texture can extend the entire length of
lead 40 within the body from theexit site 44 through todevice - The texturing itself can be tailored whereby the degree of tissue ingrowth into the
surface 46 is controlled and tailored as a function of displacement along the surface oflead 40. - The surface can be tailored to provide a high degree of ingrowth such as that provided by
inset 2 or can be tailored to provide only minimal ingrowth as, for example, provided ininset 1. - It is to be noted that, because of the location of both first ventricular assist
device 13 and second ventricular assistdevice 30 inabdomen 19, permitted by appropriate selection ofcannulae device 30 for first ventricular assistdevice 13 may take place without patient ventilation or formal heart bypass during the procedure because there is no need to open the chest cavity ofpatient 11. This arrangement thereby may significantly limit risk to the patient as compared with the situation where general anaesthesia or heart bypass is required. - Second ventricular assist
device 30 is intended for long term operation which is to say for many years, ideally extending to beyond the expected lifetime ofpatient 11. - In particular both first ventricular assist
device 13 and second ventricular assistdevice 30 will, ideally, share the same surgically created pocket inabdomen 19. - Broadly, it will be appreciated that first ventricular assist
device 13 is intended for short term use and thereby can have its characteristics selected for short term use whilst second ventricular assistdevice 30 is intended for long term use and therefore can have its characteristics selected for long term use. - By way of example first ventricular assist
device 13 can take the form of almost any blood pump including those disclosed in U.S. Pat. No. 6,227,797 (Watterson et al) and U.S. Pat. No. 5,470,208 (Kletschka) provided only that the blood pump is sized to fit in the pocket created inabdomen 19. In particular the first ventricular assistdevice 13 may comprise an axial or centrifugal pump, or sac-type device. Its impeller may be suspended in any number of ways including mechanically, magnetically and hydrodynamically or by a combination of these. In the case of a sac-type device urging of the blood through the device may be caused by the reciprocating action of a pusher-plate or similar mechanism in a sac-type device. - Its components can be made using mass production techniques and utilising less expensive materials than for the long life second ventricular assist device.
- In particular the components comprising the pump casing and internal surfaces and rotating parts can be made from plastic materials including polymeric materials.
- Coatings (such coatings not necessarily having a significantly long life) can be applied so as to increase blood compatibility. It is noted that some plastic materials such as covalently bonded heparin are particularly suited to receive and support such coatings. The Carmeda process can be utilized to perform the covalent bonding of Heparin. In addition or alternatively the coating may constitute a slow-release antibiotic.
- In a further particular form the first ventricular assist
device 13 adapted for short term use need not be hermetically sealed. Instead it may comprise one or more components in respect of which slow permeation of body fluids is acceptable. Examples of slow permeation materials which may be suitable include polypropylene, epoxy or nylon. - Conversely, second ventricular assist
device 30 is constructed for long term (which is to say much greater than 3 months and typically, of the order of many years) reliable operation and can embody, for example, the principles of rotor support described in U.S. Pat. No. 6,227,797 (Watterson et al) and U.S. Pat. No. 5,470,208 (Kletschka). In this instance, suitable materials from which to construct the pump casing and/or the pump rotor for reliable, long term operation include hermetically welded titanium alloy. - The above describes only some embodiments of the present invention and modifications, obvious to those skilled in the art can be made thereto without departing from the scope and spirit of the present invention.
Claims (43)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/713,675 US8388649B2 (en) | 2001-05-21 | 2007-03-05 | Staged implantation of ventricular assist devices |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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AUPR5142A AUPR514201A0 (en) | 2001-05-21 | 2001-05-21 | Staged implantation of ventricular assist devices |
AUPR5142 | 2001-05-21 | ||
PCT/AU2002/000625 WO2002094348A1 (en) | 2001-05-21 | 2002-05-21 | Staged implantation of ventricular assist devices |
Related Child Applications (1)
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US11/713,675 Active 2026-11-25 US8388649B2 (en) | 2001-05-21 | 2007-03-05 | Staged implantation of ventricular assist devices |
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US11/713,675 Active 2026-11-25 US8388649B2 (en) | 2001-05-21 | 2007-03-05 | Staged implantation of ventricular assist devices |
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EP (1) | EP1395310B1 (en) |
JP (1) | JP4164369B2 (en) |
AT (1) | ATE419025T1 (en) |
AU (1) | AUPR514201A0 (en) |
CA (1) | CA2448287C (en) |
DE (1) | DE60230613D1 (en) |
IL (1) | IL158957A0 (en) |
WO (1) | WO2002094348A1 (en) |
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US9694122B2 (en) * | 2003-01-31 | 2017-07-04 | L-Vad Technology, Inc. | Rigid body aortic blood pump implant |
CN109876217A (en) * | 2019-01-29 | 2019-06-14 | 哈尔滨工业大学(深圳) | Ventricular assist device line outlet waterproof construction |
Also Published As
Publication number | Publication date |
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DE60230613D1 (en) | 2009-02-12 |
JP4164369B2 (en) | 2008-10-15 |
WO2002094348A1 (en) | 2002-11-28 |
CA2448287A1 (en) | 2002-11-28 |
CA2448287C (en) | 2011-01-04 |
US20070161847A1 (en) | 2007-07-12 |
EP1395310A4 (en) | 2006-05-03 |
EP1395310A1 (en) | 2004-03-10 |
ATE419025T1 (en) | 2009-01-15 |
IL158957A0 (en) | 2004-05-12 |
WO2002094348B1 (en) | 2003-01-03 |
JP2004526546A (en) | 2004-09-02 |
EP1395310B1 (en) | 2008-12-31 |
US8388649B2 (en) | 2013-03-05 |
AUPR514201A0 (en) | 2001-06-14 |
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