WO1999062457A9 - Cardiac massage apparatus and method - Google Patents
Cardiac massage apparatus and methodInfo
- Publication number
- WO1999062457A9 WO1999062457A9 PCT/US1999/009203 US9909203W WO9962457A9 WO 1999062457 A9 WO1999062457 A9 WO 1999062457A9 US 9909203 W US9909203 W US 9909203W WO 9962457 A9 WO9962457 A9 WO 9962457A9
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- struts
- sleeve
- shaft
- cardiac massage
- pericardium
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
- A61H31/00—Artificial respiration or heart stimulation, e.g. heart massage
- A61H31/004—Heart stimulation
- A61H31/007—Manual driven
-
- 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
- A61M60/191—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart mechanically acting upon the outside of the patient's native heart, e.g. compressive structures placed around the heart
-
- 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
- A61M60/289—Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] devices
-
- 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
- A61M60/40—Details relating to driving
- A61M60/465—Details relating to driving for devices for mechanical circulatory actuation
- A61M60/468—Details relating to driving for devices for mechanical circulatory actuation the force acting on the actuation means being hydraulic or pneumatic
-
- 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
- A61M60/865—Devices for guiding or inserting pumps or pumping devices into the patient's body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00243—Type of minimally invasive operation cardiac
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
- A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
- A61H31/00—Artificial respiration or heart stimulation, e.g. heart massage
- A61H2031/001—Artificial respiration or heart stimulation, e.g. heart massage fixed on the chest by suction
Definitions
- the present invention relates generally to medical devices and methods More particularly, the present invention relates to devices and methods for performing minimally invasive direct cardiac massage Sudden cardiac arrest is a leading cause of death in most industrial societies While m many cases it is theoretically possible to re-establish cardiac function, irreversible damage to vital organs, particularly the bram and the heart itself, will usually occur p ⁇ or to restoration of normal cardiac activity
- CCM cardiopulmonarv resuscitation
- the balloon-type and shoe-type heart-engaging members described in the patents may be difficult to deploy in the potential space between the posterior surface of the rib cage and the pericardium.
- inflatable balloon members may lack sufficient rigidity to impart the necessary compressive force
- rigid shoe-like members risk damage to the pericardium
- cup-shaped compressive members may compress so much of the heart volume that the end diastolic volume is compromised.
- the heart-engaging component(s) of the devices should reliably deploy and expand within the region between the posterior rib cage and the pericardium and should minimize risk to the pericardium from perforation and other damage.
- the devices and methods should be simple to introduce to the patient in the first place, and in at least some circumstances, should eliminate the need to separately make an incision before introducing the device.
- the apparatus and method further should be compatible both with manual actuation, i.e., manual reciprocation of a handle or shaft attached to the heart-engaging member, and with automatic or powered systems for reciprocating the member. At least some of these objectives will be met by the invention described hereinafter.
- Published PCT application WO 98/05289 and U.S. Patent No. 5,385,528 describe an inflatable device for performing direct cardiac massage.
- U.S. Patent No. 3,496,932 describes a sharpened stylet for introducing a cardiac massage device to a space between the sternum and the heart. Cardiac assist devices employing inflatable cuffs and other mechanisms are described in U.S. Patent Nos.
- the present invention provides improved devices and methods for performing cardiac massage, particularly minimally invasive direct cardiac massage where the heart is directly compressed through a small incision formed through an intercostal space over the pericardium.
- Devices according to the present invention comprise a support and a heart-engaging member attached to the support.
- the support may be any assembly, structure, system, or other mechanical framework which is suitable for positioning and manipulating the heart-engaging member so that it can engage and compress the heart.
- the support could be a simple handle or shaft having the heart-engaging member attached at a distal end thereof. Once the heart-engaging member is deployed, cardiac massage can be performed by simple manual pumping or reciprocation of the handle or shaft.
- the support comprises a shaft together with a sheath which is coaxially received over the shaft.
- the shaft and sheath may be manipulated relative to each other to deploy and retract the heart- engaging member, as described in more detail hereinbelo ⁇ v.
- supports which comprise powered drivers, such as electric, pneumatic, or other motors can be provided as part of the support, where the driver may be disposed externally, internally, or both externally and internally relative to the patient when the heart-engaging member is deployed over the pericardium.
- the heart- engaging member of the present invention comprises a plurality of struts which are reciprocatably attached to the support.
- the struts are retractable to a radially contracted configuration and advancable along arcuate, diverging paths to define a surface which non-traumatically engages the pericardium to compress the heart when advanced against the pericardium.
- the struts will typically be composed of a resilient material, more typically be composed of a shape memory alloy, such as nickel titanium alloy, and will usually be formed to deploy radially outwardly and advance along the desired arcuate, diverging paths as they are advanced from a constraining member, usually a tubular sheath.
- the struts may be advanced and retracted relative to the sheath using any suitable mechanical system, typically a shaft which reciprocates together with the struts through a lumen of the sheath.
- any suitable mechanical system typically a shaft which reciprocates together with the struts through a lumen of the sheath.
- the struts may be articulated structures comprising two or more hinged elements, where the elements may be flexible or rigid.
- each strut may comprise at least a proximal segment and a distal segment attached to each other by a mechanical hinge or flexible connector.
- at least some of the struts could comprise a linkage that which causes radial opening of the distal segment as the strut is being deployed.
- the geometry of the retracted strut configuration will be selected to facilitate introduction through the intercostal space before strut deployment.
- the struts will be contracted within a space having a maximum width of 2 cm, preferably a maximum width of 1.2 cm.
- the heart-engaging surface which is defined will have a surface area of at least 5 cm 2 , preferably being in the range from about 10 cm 2 to 100 cm 2 , usually in the range from 20 cm" to 75 cm “ .
- the surface will be generally circular or slightly oval with a diameter or average diameter in the range from 3 cm to 18 cm, preferably from 5 cm to 10 cm.
- the struts may be radially deployed with only a minimum axial advancement. That is, the struts will make a sharp radially outward turn from the support as they are advanced into the region between the pericardium and the posterior rib cage. Typically, the distal tips of the struts will advance no more than 5 cm in the axial direction before they are fully radially deployed. More preferably, the maximum axial distance will be 2 cm or less, even more preferably being 1.5 cm or less, and still more preferably being 1 cm or less.
- the surface defined by the plurality of struts will comprise a flexible sheet attached to at least some of the struts.
- the sheet will usually, although not necessarily, be inelastic or non-distensible, permitting it to readily conform to the surface of the pericardium as the struts are advanced while constraining the deployed tips of the struts and preventing the struts from bending back from the heart.
- the tips of the struts may be constrained by a filament, strip, suture, or other element which ties the tips together and prevents over deployment and expansion of the struts.
- the sheet may be continuous, i.e., in the form of a continuous fabric, membrane, or the like, or may be discontinuous, i.e., in the form of a net, perforate sheet, permeable or impe ⁇ rieable sheet, or the like.
- the strut may be flat (when not engaged against the pericardium) or may be slightly concave to conform to the exterior surface of the pericardium.
- an inflatable bladder may be attached to at least some of the struts.
- the inflatable bladder may comprise a generally flat structure extending over all the struts, or may comprise an annular or torroidal structure extending over only the outer regions of the struts.
- the bladder may be inflatable using a liquid or gas, preferably be inflatable with a physiologically acceptable liquid, such as saline, contrast medium, or the like.
- the support may include a blunt member which can bluntly dissect a space between the anterior surface of the intercostal muscle and the posterior surface of the rib cage in order to facilitate deployment of the struts into the space.
- the blunt member may be provided as a leading edge or tip of the support which enters through the intercostal space into the region over the pericardium. The struts may then be advanced through or over the blunt member, or the blunt member may be retracted prior to strut deployment.
- a blunt member will be provided as the leading edge of the support.
- the blunt member may include a blade which may be axially advanced from the blunt member, point, or other cutting element to make an incision partially through the skin overlying the intercostal space before the blunt member is introduced through the intercostal space.
- the blade or other cutting element will be automatically retractable so that the blade cannot enter into the space immediately above the pericardium in order to reduce the risk of injury to the pericardium and the heart.
- Methods according to the present invention for performing cardiac massage comprise advancing a plurality of struts through an intercostal space to a region over a pericardium.
- the struts are opened along arcuate, radially diverging paths (to form a trumpet horn geometry) between a posterior rib surface and the pericardium.
- the open struts are then engaged against the pericardium to periodically compress the heart and induce artificial blood circulation.
- the struts are introduced by first bluntly dissecting a passage between the ribs, typically by making a small incision in (but not through) the skin and advancing a blunt member through the intercostal space, where the blunt member advances ahead of the struts.
- a blade may be advanced from the blunt member to partially cut through the intercostal tissue, where the blade is retracted prior to advancing the blunt member against the pericardium.
- a flexible sheath may be unfurled as the struts are open.
- an inflatable bladder may be attached to at least some of the struts and be inflated as the struts are deployed and/or to effect deployment of the struts.
- cardiac massage is performed by engaging a plurality of struts arranged in radially diverging arcuate paths against the pericardium.
- the struts are then reciprocated against the pericardium to induce artificial circulation.
- a flexible sheet or an inflatable bladder will be suspended between at least some of the struts as the struts are reciprocated.
- the region between a posterior rib surface and a pericardium may be bluntly dissected by advancing a blunt member through an intercostal space into said region.
- the advancement is enhanced by deploying a blade from the blunt member to partially cut through the intercostal tissue prior to advancing the blunt member.
- the blade is automatically retracted back into the blunt member before the blunt member can pass completely through the tissue in the intercostal space.
- a cardiac massage device comprising of a sleeve, a shaft, and a flared bell structure attached to the distal end of the shaft.
- the flared bell structure will have the general shape of a trumpet horn, i.e., having an outwardly curving surface emanating from the point of attachment to the shaft.
- the flared bell structure will comprise plurality of flexible struts, where each strut has an unconstrained configuration characterized by an arcuate geometry with a proximal end attached to the shaft and a distal region turned outwardly at an angle in the range from 45° to 135°, usually 60° to 120°, and often 75° to 105°, relative to the axis of the shaft.
- the shaft is slidably mounted in the sleeve, e.g.
- the flared bell structure in a central lumen of the sleeve, and the flared bell structure is collapsible so that it can be radially constrained by proximally retracting the shaft to draw the structure into the sleeve and expanded by distally advancing the shaft so that the flared bell structure emerges from the sleeve.
- the struts, or at least some of the struts will include reinforcing beams having one end attached near the proximal end of the strut and another end attached proximally of the distal end of the strut.
- the other end of the beam is attached at the point located from 15% to 50% of the strut length from the distal end of the strut.
- This embodiment of the cardiac massage device will usually have a blunt cap which is removably disposed over a distal end of the sleeve when the flared bell structure is retracted into the sleeve.
- the purpose of the end cap is to permit blunt entry of the cardiac massage device into the chest cavity over the heart. Mounting of the end cap on a slidable rod permits the end cap to retract to a position generally within the conical space defined by the flared bell structure when the bell structure is contacted against the pericardium, as described in more detail below.
- the shaft may be provided with indicia on its outer surface indicating the relative position of the shaft and the sleeve. That is, the indicia, typically visible bands placed on the shaft, will be aligned with some point on the sleeve when the shaft and sleeve are in some particular relative configuration.
- the indicia will usually include at least one visible band which will lie adjacent to the sleeve on the shaft as it is advanced sufficiently so that the flared bell structure is fully deployed in the chest cavity.
- a second band or other indicia will be aligned with the sleeve when the shaft has been sufficiently retracted to permit closing of the flared bell structure by withdrawing it fully into the sleeve.
- a distal portion of the sleeve may be formed of a compliant material, such as an elastomeric material.
- a relatively soft cowling may be attached to the distal end of the sleeve to provide the desired compliance.
- a lock structure may also be provided on the cardiac massage device to prevent premature advancement of the flared bell structure prior to the distal end of the sleeve advancing into the chest cavity by an adequate amount.
- the lock structure comprises a first anchor or other engaging structure on the shaft and latch or other structure on this sleeve for selectively engaging and locking the anchor on the shaft. In this way, relative movement of the shaft and sleeve can be prevented until the device is properly positioned for use.
- a flange or other ring structure may be formed on the sleeve, where the flange is positioned a predetermined distance from the distal end of the sleeve.
- the predetermined distance is selected to permit optimum deployment of the flared bell structure beneath the patient's ribs and above the chest cavity.
- the predetermined distance is in the range of 1 cm to 3 cm, but this distance may vary depending on the dimensions of the flared bell structure.
- the present invention provides yet another method for performing cardiac massage.
- a sleeve is advanced through an intercostal space in a patient's chest wall so that enters a region over the pericardium.
- a flared bell structure may then be distally advanced from the distal end of the sleeve, and the flared bell structure may be engaged against the pericardium to perform the cardiac massage by periodically compressing the heart.
- the flared bell structure will be locked relative to the sleeve while the sleeve is being advanced. After the sleeve is in place, the lock will preferably be manually released so that the flared bell structure may be deployed into the chest cavity.
- the flange on the sleeve will engage the chest wall to indicate that the sleeve has been advanced to its intended depth and configuration.
- This method may further comprise advancing the flared bell structure by moving a shaft forwardly which ca ⁇ ies the flared bell structure at its distal end.
- the method may still further comprise observing a mark on the shaft in order to determine whether and when the flared bell structure has been completely deployed from the sleeve.
- the method will be completed by retracting the shaft to draw the flared bell structure back into the sleeve prior to withdrawing the sleeve from the patient.
- the withdrawing step may further comprise observing a mark on the shaft to determine when the flared bell structure has been drawn back sufficiently into the sleeve to permit safe and complete withdrawal.
- Fig. 1 is a perspective view of a cardiac massage device constructed in accordance with the principles of the present invention.
- Figs. 2A and 2B illustrate alternative configurations for single struts which may be employed in the device of Fig. 1.
- Fig. 3 is a cross-sectional view of the distal end of the device of Fig. 1, showing a pair of struts carrying flexible sheet therein with the struts being shown in a partially deployed configuration in broken line.
- Fig. 4 illustrates the struts and sheet of Fig. 3 shown in a fully deployed configuration.
- Figs. 5 and 6 illustrate cardiac massage devices having struts with enlarged distal, atraumatic tips, where the tips are axially offset from each other in order to minimize the peripheral space required to accommodate the enlarged tips.
- Figs. 7 and 8 illustrate a cardiac massage device having a radially directing blunt member with struts shown in a retracted configuration (Fig. 7) and in a radially deployed configuration (Fig. 8).
- Fig. 9 illustrates a cardiac massage device according to the present invention with an inflatable bladder extending over the deployed struts.
- Fig. 10 illustrates a cardiac massage device according to the present invention with a torroidal bladder spanning the distal tips of the deployed struts.
- Figs. 11 and 12 illustrate a cardiac massage device having a blunt member at its distal end with a blade retracted (Fig. 11) and a blade advanced (Fig. 12).
- Fig. 13 is a cross-sectional view illustrating the heart beneath a patient's rib cage.
- Figs. 14A and 14B illustrate a method according to the present invention employing the cardiac massage device of Figs. 1, 3, and 4.
- Figs. 15A and 15B illustrate a method according to the present invention employing the device of Figs. 11 and 12.
- Figs. 16 is a perspective view of yet another cardiac massage device constructed in accordance with the principles of the present invention.
- Fig. 17 illustrates the distal end of the cardiac message device of Fig. 16, showing a deployed flared bell structure.
- Fig. 18 is a side view of the cardiac massage device of Fig. 16, shown with the flared bell structure fully retracted.
- Fig. 19 is the side view of the cardiac massage device of Fig. 16, shown with the flared bell structure fully advanced and deployed.
- Figs. 19A and 19B illustrate an alternative, hinged strut structure in a collapsed and deployed configuration, respectively.
- Figs. 20A - 20C illustrate use of the device of Figs. 16-19 in performing a method according the present invention.
- an exemplary device 10 constructed in accordance with the principles of the present invention comprises an outer sheath 12, an inner shaft 14, and an plurality of struts 16 which are shown in a partially deployed configuration extending from a distal end of the sheath 12.
- the struts 16 may be deployed by axially reciprocating the shaft 14, typically by manually grasping and moving a handle 20 at the proximal end of the shaft 14.
- the device 10 will have a plurality of struts 16, typically having at least 3 struts, usually having from 8 to 20 struts, preferably from 10 to 15 struts.
- the struts will usually have atraumatic distal tips, typically having enlarged elements 24 (e.g., epoxy beads) at their distal tips, as shown in Figs. 2A and 2B.
- the distal tip of the elements 16 will be bent so that it will immediately turn radially outward as the strut is axially advanced from the sheath 12, as shown in Fig. 2B.
- a tip As discussed above, it is desirable that advancement of the struts in the axial direction relative to the sheath or other components of the support be limited in order to reduce the risk of damage to the pericardium. Bending the tip, as shown in Fig. 2B, can help achieve that goal.
- the tip may be bent relatively sharply, as shown in Fig. 2B, or alternatively may be formed in a "ski" tip or otherwise deflected in order to permit its outward movement.
- the struts 16 will usually be resilient so that they may spring radially outwardly from the support as they are distally advanced.
- the struts 16 may be formed from a spring-type stainless steel where the struts are formed to have the configuration shown in Fig. 2A, 2B, or other configurations, when they are in their non- constrained state.
- the struts 16 will be formed from a superelastic alloy, such as nickel-titanium alloy, and will similarly have a memorized shape such as that shown in Fig. 2A, 2B, at least when they are being employed in their superelastic form.
- the struts could have a sharply curved configuration as they are extended from the support into the space between the pericardium and the posterior surface of the rib cage. The shape could then at least partially straighten as the struts reach body temperature in order to reduce the profile of the struts in the axial direction, i.e., facilitate movement of the struts into the restricted space between the pericardium and overlying rib cage.
- other shape changes may be induced by the changed body temperature and/or by temperature changes induced by electrical heating, exposure to heated or cooled media, or the like.
- struts 16 may be carry a flexible sheet 26 which is deployed to span between the distal tips of at least some of the struts as the struts are radially expanded, as shown in Fig. 4.
- the flexible sheet may be any of the materials or in any of the forms described above, and will serve as an interface surface for engaging the pericardium as the devices of the present invention are used for direct cardiac massage.
- enlarged distal tips 24 on the struts 16 can increase the profile of the struts since there is more material being accommodated within a limited cross-sectional area. Such an increase in area increases the profile of the device being introduced through the intercostal space. Such increased profile is undesirable.
- the distal tips of the struts 16 may be axially spaced apart, either in a uniformly receding arrangement, as shown in Fig. 5, or in an alternating arrangement as shown in Fig. 6.
- the cardiac massage devices of the present invention may be provided with blunt members at their distal ends to facilitate introduction into the space in between the pericardium and the posterior surface of the ribs.
- a blunt member 30 may be mounted axially within the sheath 12 to define an annular space 32 for reciprocatably receiving the struts 16.
- the struts may then be contained in the retracted configuration, as shown in Fig. 7, and may be axially advanced to deploy radially outwardly, as shown in Fig. 8.
- the blunt member 30 may optionally be used to define guide surfaces 34 which assist the struts in making a rapid turn to a radially outwardly direction, as shown in Fig. 8.
- strut 7 and 8 may comprise a flexible sheet suspended over the distal tips of the struts, as described previously, or may employ an inflatable bladder, as will be described below.
- a mechanically advantaged deployment device such as a screw or gear mechanism, may be used to axially advance the struts and deploy them over the guide surfaces.
- the cardiac massage device as generally described above may be provided with an inflatable bladder 40 which is attached to at least some of the distal tips of individual struts 16.
- the inflatable bladder will have in inflation tube 42 extending proximally outward from the device so that it may be connected to a suitable inflation source, such as a syringe filled with saline, contrast medium, or other suitable inflation medium.
- a suitable inflation source such as a syringe filled with saline, contrast medium, or other suitable inflation medium.
- the inflatable bladder 40 provides two useful features in the present invention. First, inflation of the bladder 40 can assist in the radial deployment of the struts 16 since mechanical force can be imparted to urge the struts in a radially outwardly direction. Second, the inflatable bladder can provide a non-traumatic surface for engaging the heart and protecting the pericardium.
- Fig. 10 illustrates a variation of the inflatable bladder shown in Fig. 9.
- inflatable bladder 50 comprises a torroidal geometiy which can seat against the pericardium to in at least some instances provide a more stable interface.
- the bladder 50 is inflated through an inflation tube 52.
- Figs. 11 and 12 show a blade 60 having a sharpened distal tip 62 which is reciprocatably disposed within the blunt member 30.
- the tip 62 of the blade may be axially advanced, as shown in Fig. 12, in order to facilitate introduction of the device through the skin over the intercostal space.
- the blade should be retracted, as shown in Fig. 11, before the device actually enters the space between the posterior surface of the rib cage and the pericardium.
- the blade will be automatically retracted before the device can enter beyond the posterior surface of the rib cage.
- Fig. 13 the patient's heart H is shown in cross-section between ribs R n where n indicates the rib number.
- the aorta A is also shown extending from the top of the heart.
- sheath 12 of the cardiac massage device of Figs. 1, 3 and 4 is introduced through the intercostal space between F ⁇ and R 5 , as shown in Fig. 14A.
- Shaft 14 is then advanced in a distal direction to radially extend the struts 16, as shown in Fig. 14B.
- the flexible sheet 26 is thus engaged against the pericardium P, and the device as a whole may be reciprocated through the intercostal space to depress the heart, as shown in broken line.
- Such reciprocation will preferably be performed at a rate from 40 cycles/minute to
- Figs. 15A and 15B The use of the device of Figs. 11 and 12 is illustrated in Figs. 15A and 15B.
- the device is introduced by engaging the blunt member 30' against the patient's skin at a region over the heart and between and R 5 .
- Blade 60 is advanced so that tip 62 extends partly through the thickness of the patient's skin overlying the intercostal space.
- the blade is then retracted as the blunt member 30 is advanced inwardly.
- Struts 16 may be deployed radially outwardly to engage the pericardium P, as shown in Fig. 15B, and the device then reciprocated to alternately compress and relieve the heart to induce circulation, as shown in broken line. Relief of the compression allows the ventricle to refill prior to the next compression step.
- cardiac massage device 100 comprises a sleeve 102, a shaft 104 slidably mounted in a central lumen of the sleeve 102, and a handle 106 attached to a proximal end of the shaft.
- the sleeve 102 includes a positioning flange 110 near its distal end, typically spaced proximally of the tip 112 of the device by an optimum distance, generally as set forth above.
- a blunt cap 120 is positioned at the distal -most end of the device 100 and facilitates entry of the device into the chest cavity by blunt dissection, as described in more detail hereinafter.
- a flared bell structure 130 is attached to the distal end of shaft 104 and assumes a trumpeted configuration when fully deployed, as shown in both of those figures.
- the flared bell structure 130 comprises a plurality of outwardly curving struts 132 (the illustrated embodiment has a total of eight struts, but this number could vary).
- the struts are preferably formed from a resilient metal, usually formed from a superelastic alloy, such as nitinol. The use of such resilient materials will not always provide the degree of rigidity desired for the forward surface 136 (Fig. 19) of the flared bell structure.
- re- enforcing beams 138 may be provided. It has been found that the combination of the curved struts with straight beam supports provides a useful combination of stiffness over the proximal portion of the structure and greater flexibility at the tip portions.
- the blunt cap 120 is mounted on a rod 140 (Fig. 19) having a handle 142 at its proximal end.
- a rod 140 Fig. 19
- the forward tip of the sleeve will engage the rear of the end cap 120, as best seen in Fig. 18.
- end cap 120 will be free to move axially. In use, the end cap will typically be withdrawn proximally into the interior of the structure 130.
- the distal tips of the struts 130 are preferably connected by a fabric cover 150 having an edge which is folded over and stitched to hold the cover in place.
- the fabric cover may be a light mesh, composed of polyester or the like, and will help distribute forces quite evenly over the region of the pericardium which is contacted by the flared bell structure.
- the present invention can utilize articulated struts comprising a plurality of hinged segments where the segments can be rigid, flexible, or resilient.
- the hinges can be mechanical hinges using a conventional pivot pin and could also be flexible connectors which permit the desired flexure about the connecting point.
- a link can be joined on the side of the structure to facilitate radial deflection of the strut as it is opened. As illustrated in Figs.
- a strut structure 200 comprises a proximal segment 202, a distal segment 204, and a link 210 which provides a pivoting connection 212 which is retracted relative to the proximal segment 202 as the strut is deployed.
- the strut structure 200 is shown in its collapsed configuration in Fig. 19A and C partially deployed configuration in Fig. 19B. All other aspects of the device design may be as previously described.
- a very particular flared bell structure is illustrated in Figs. 16-19, will be appreciated that a variety of other collapsible and disployable bell or trumpet shaped structures could be provided.
- the structures could rely on mechanical action for opening and closing the structures, rather than on the resilient nature of the structure itself.
- Structures could also have auxiliary balloons and other components as described previously with other embodiments.
- Figs. 20A - 20C use of the device 100 for cardiac massage of a heart H will be described.
- a small Incision is made over the heart, preferably between the forth and fifth ribs (R and R 5 ) as described previously.
- the device 100 is pushed through the incision with the blunt cap 120 bluntly dissecting tissue until the flange 110 engages the outer chest wall, as illustrated if Fig. 20B.
- the flared bell structure is still not deployed.
- the flared bell structure 130 is then deployed by advancing shaft 104 until a first marker 160 approaches the proximal end 162 of the sleeve 102.
- the handle 106 may be manually grasped and the device shaft 104 pumped through the sleeve 102. This will cause the deployed flared bell structure 130 to compress the heart, generally shown in broken line in Fig. 20C.
- the device 100 may be withdrawn by retracting the shaft 104 relative to sleeve 102 to draw the structure 130 back into the sleeve.
- the structure 130 will be sufficiently retracted as soon as the second marker 162 becomes visible out of the proximal end of the sleeve.
- the device may be proximally withdrawn through the incision and the incision closed in the conventional manner.
Abstract
Description
Claims
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/087,665 US6200280B1 (en) | 1998-05-29 | 1998-05-29 | Cardiac massage apparatus and method |
US09/087,665 | 1998-05-29 | ||
US11193498P | 1998-12-11 | 1998-12-11 | |
US60/111,934 | 1998-12-11 |
Publications (2)
Publication Number | Publication Date |
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WO1999062457A1 WO1999062457A1 (en) | 1999-12-09 |
WO1999062457A9 true WO1999062457A9 (en) | 2000-03-09 |
Family
ID=26777256
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1999/009203 WO1999062457A1 (en) | 1998-05-29 | 1999-04-28 | Cardiac massage apparatus and method |
Country Status (2)
Country | Link |
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US (1) | US6287267B1 (en) |
WO (1) | WO1999062457A1 (en) |
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US7734344B2 (en) | 2003-12-02 | 2010-06-08 | Uab Research Foundation | Methods, systems and computer program products to inhibit ventricular fibrillation during cardiopulmonary resuscitation |
US20060063964A1 (en) * | 2004-08-20 | 2006-03-23 | Massen Richard J | Micro electromechanical machine-based ventricular assist apparatus |
TWI360416B (en) | 2006-12-14 | 2012-03-21 | Ind Tech Res Inst | Apparatus of cardiopulmonary resuscitator |
US9872705B2 (en) | 2013-10-07 | 2018-01-23 | Regentis Biomaterials Ltd. | Treatment of cavities in a human body |
EP2874546B1 (en) | 2013-10-07 | 2016-09-07 | Regentis Biomaterials Ltd. | Apparatus for treatment of cavities in a human body |
EP3436105B1 (en) * | 2016-03-30 | 2021-04-28 | Heartware, Inc. | Flanged heart tissue blocker |
CN109045448B (en) * | 2018-08-06 | 2020-07-17 | 四川大学华西医院 | Device for constipation old people |
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Also Published As
Publication number | Publication date |
---|---|
US6287267B1 (en) | 2001-09-11 |
WO1999062457A1 (en) | 1999-12-09 |
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