WO1999062457A1

WO1999062457A1 - Cardiac massage apparatus and method

Info

Publication number: WO1999062457A1
Application number: PCT/US1999/009203
Authority: WO
Inventors: Rodney A. Brenneman; Jay A. Lenker; Donald Kolehmalnen; Minh Tran
Original assignee: Theracardia, Inc.
Priority date: 1998-05-29
Filing date: 1999-04-28
Publication date: 1999-12-09
Also published as: WO1999062457A9; US6287267B1

Abstract

This invention is a device (10) for performing minimally invasive closed chest heart massage comprising a support (12) having a plurality of curved, deploying struts (16), optionally carrying a sheet (26) or inflatable bladder (40) for engaging the pericardium. The struts (16) are delivered to the space between the pericardium, and the posterior rib cage in a radially collapsed configuration that are deployed radially outwardly with minimum advancement in the axial direction.

Description

CARDIAC MASSAGE APPARATUS AND METHOD

BACKGROUND OF THE INVENTION

1. Field of the Invention

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 in many cases it is theoretically possible to re-establish cardiac function, irreversible damage to vital organs, particularly the brain and the heart itself, will usually occur prior to restoration of normal cardiac activity.

A number of techniques have been developed to provide artificial circulation of blood to oxygenate the heart and brain during the period between cardiac arrest and restoration of normal cardiac activity. Prior to the 1960's, open chest cardiac massage (OCM) was a standard treatment for sudden cardiac arrest. Open chest cardiac massage, as its name implies, involved opening a patient's chest and manually squeezing the heart to pump blood to the body. In the 1960's, closed chest cardiac massage (CCM) where the heart is externally compressed through the chest wall became the standard of treatment. When CCM is combined with airway support, it is known as cardiopulmonary resuscitation (CPR). CPR has the advantage that it is much less invasive than OCM and can be performed by less skilled individuals. It has the disadvantage, however, that it is not generally effective. In particular, the medical literature shows that CCM provides significantly less cardiac output, neuroperfusion, and cardiac perfiision than achieved with OCM.

Methods and devices for performing minimally invasive direct cardiac massage have been described by Buckman et al. and by Drs. Filiberto and Giorgio Zadini in the patent and literature publications listed in the Description of the Background Art below. While the methods of Buckman et al. and the Zadinis differ in a number of respects, they generally rely on introducing a balloon, shoe, or other deployable member to engage the heart through a small incision through an intercostal space above the pericardium. The heart may then be pumped by directly engaging and compressing the pericardium, either by inflating and deflating the member or by reciprocating a shaft attached to the member. Although these approaches have been shown to be effective in animal models, the particular devices described in the patents are awkward for emergency use on human patients. In particular, 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. For example, inflatable balloon members may lack sufficient rigidity to impart the necessary compressive force, rigid shoe-like members risk damage to the pericardium, and cup-shaped compressive members may compress so much of the heart volume that the end diastolic volume is compromised.

For these reasons, it would be desirable to provide improved methods and devices for performing minimally invasive direct cardiac massage. In particular, it would be desirable to provide apparatus and methods which are simple to deploy and carry out and in particular which do not require intervention by a physician. 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.

2. Description of the Background Art

U.S. Patent Nos. 5,582,580; 5,571,074 and 5,484,391 to Buckman, Jr. et al. and 5,683,364 and 5,466,221 to Zadini et al., licensed to the assignee of the present application, describe devices and methods for minimally invasive direct cardiac massage through an intercostal space. 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. 5,256,132; 5,169,381 ; 4,731,076; 4,690,134; 4,536,893; 4,192,293; 4,048,990; 3,613,672; 3,455,298; and 2,826,193. Dissectors employing inflatable components are described in U.S. Patent Nos. 5,730,756; 5,730,748; 5,716,325; 5,707,390; 5,702,417; 5,702,416; 5,694,951; 5,690,668; 5,685,826; 5,667,520; 5,667,479; 5,653,726; 5,624,381; 5,618,287; 5,607,443; 5,601,590; 5,601,589; 5,601,581; 5,593,418; 5,573,517; 5,540,711; 5,514,153; and 5,496,345. Use of a direct cardiac massage device of the type shown in the Buckman, Jr. et al. patents is described in Buckman et al. (1997) Resuscitation 34:247-253 and (1995) Resuscitation 29:237-248.

SUMMARY OF THE INVENTION 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. Most simply, 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. In the exemplary embodiment described hereinafter, 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 hereinbelow. A wide variety of other supports will also be possible, including supports which comprise powered drivers, such as electric, pneumatic, or other motors. Such drivers 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. In some instances, it will be desirable to provide at least some of the struts with a temperature-responsive memory so that the shape of the struts will change in response to a transition from room temperature to body temperature and/or in response to an induced temperature change after they have been deployed, e.g., by electrically heating or cooling the struts and/or infusing a heated or cooled medium into the space surrounding the struts.

Alternatively, the struts may be articulated structures comprising two or more hinged elements, where the elements may be flexible or rigid. For example, each strut may comprise at least a proximal segment and a distal segment attached to each other by a mechanical hinge or flexible connector. Optionally, 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. Preferably, the struts will be contracted within a space having a maximum width of 2 cm, preferably a maximum width of 1.2 cm. After deployment by advancing the struts along the arcuate, diverging paths, the heart-engaging surface which is defined will have a surface area of at least 5 cm², preferably being in the range from about 10 cm² to 100 cm², usually in the range from 20 cm² to 75 cm². Usually, 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.

An important advantage of the present invention is that 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.

In another preferred aspect of the present invention, 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. Alternatively or additionally, 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 impermeable sheet, or the like. Optionally, 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. Alternatively or additionally, 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.

In a still further preferred aspect of the apparatus of the present invention, 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. For example, 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.

In a particularly preferred embodiment of the device of the present invention, 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. Usually, 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. By providing the blade and blunt member on the cardiac massage apparatus, the device can be introduced in a single step with minimum preparation of the patient prior to such introduction. The user need only properly locate the cardiac massage device over the intercostal space and then advance the device through the skin prior to radially deploying the struts to engage the pericardium.

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. Preferably, 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. Optionally, 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. Still further optionally, a flexible sheath may be unfurled as the struts are open. Alternatively, 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.

In another aspect of the method of the present invention, 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. Usually, either a flexible sheet or an inflatable bladder will be suspended between at least some of the struts as the struts are reciprocated.

In a still further aspect of the methods of the present invention, 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. In particular, 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. Preferably, the blade is automatically retracted back into the blunt member before the blunt member can pass completely through the tissue in the intercostal space. The present invention still further provides 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. Usually, 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. 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. In order to enhance the stiffness at the outer peripheral edge or lip of the flared bell structure, 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. Usually, 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. In a preferred aspect of this embodiment, 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. For example, 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. Usually, 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. To facilitate retraction of the flared bell structure back into the sleeve, a distal portion of the sleeve may be formed of a compliant material, such as an elastomeric material. For example, a relatively soft cowling may be attached to the distal end of the sleeve to provide the desired compliance. Advantageously, 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. Usually, 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.

In a further preferred aspect of this embodiment of the present invention, 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. Usually, 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. In this embodiment, 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. Usually, 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 carries 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.

BRIEF DESCRIPTION OF THE DRAWINGS

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.^'

DESCRIPTION OF THE SPECIFIC EMBODIMENTS Referring now to Fig. 1, 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. In some instances, 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. 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. For example, the struts 16 may be formed from a spring-type stainless steel where the struts are formed to have the configuration shown in Fig. 2 A, 2B, or other configurations, when they are in their non- constrained state. Preferably, 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. In some instances, it will be desirable to employ a temperature-induced shape change in the struts as part of their radial deployment. For example, 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. Alternatively, 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. Referring now to Figs. 3 and 4, 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.

Referring now to Figs. 5 and 6, provision of 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. To reduce the profile, 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.

Referring now to Figs. 7 and 8, 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. For example, 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. The embodiment of Figs. 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. Optionally, 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.

Referring to Fig. 9, 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. 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. In particular, inflatable bladder 50 comprises a torroidal geometry 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.

Referring now to Figs. 11 and 12, a further optional aspect of the present invention will be described. The cardiac massage device having a blunt member 30 at its distal end is constructed generally the same as that shown in Figs. 7 and 8. In addition to the structure of Figs. 7 and 8, however, 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. Preferably, the blade will be automatically retracted before the device can enter beyond the posterior surface of the rib cage. Referring now to 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.

In a first exemplary method according to the present invention, sheath 12 of the cardiac massage device of Figs. 1 , 3 and 4 is introduced through the intercostal space between R₄ and R , 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

150 cycles/minute, preferably between 40 cycles/minute and 130 cycles/minute either manually or employing a powered drive (not shown).

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 R and R₅. 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.

Referring now to Figs. 16-19, 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, as best seen in Figs. 17 and 19, 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. To enhance the rigidity and pushability of the 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. When the sleeve is advanced distally over the flared bell structure 130, the forward tip of the sleeve will engage the rear of the end cap 120, as best seen in Fig. 18. When the sleeve is retracted and the flared bell structure deployed, as best seen in Fig. 19, 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.

In addition to the resilient strut structures described previously, 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. There may be two, three, four, or more hinged segments joined end-to-end to form a primary structure. Optionally, 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. 19A and 19B, 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.

Although 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. For example, 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.

Turning now to Figs. 20A - 20C, use of the device 100 for cardiac massage of a heart H will be described. Initially, a small Incision is made over the heart, preferably between the forth and fifth ribs (R and R₅) as described previously. After the incision is made, 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. At that point, 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. Once the structure 130 is fully deployed, 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. Once resuscitation has been completed, 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. Once the structure 130 is retracted, the device may be proximally withdrawn through the incision and the incision closed in the conventional manner. While the above is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used. Therefore, the above description should not be taken as limiting the scope of the invention which is defined by the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A cardiac massage device comprising:

a support; and

a plurality of struts reciprocatably attached to the support, said struts being 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.

2. A device as in claim 1, wherein the contracted configuration has a maximum width of 2 cm.

3. A device as in claim 2, wherein the surface spans an area of at least 5 cm2 when the struts are fully advanced.

4. A device as in claim 3, wherein the struts have distal tips and wherein said distal tips are advanced over an axial distance of 5 cm or less as the struts are fully advanced.

5. A device as in claim 1, wherein the surface comprises a flexible sheet attached to at least some of the struts.

6. A device as in claim 1, wherein the surface comprising an inflatable bladder attached to at least some of the struts.

7. A device as in claim 1, wherein the surface comprises a non-elastic filament around the periphery thereof.

8. A device as in claim 1, wherein the support comprises a sheath having a lumen and a shaft reciprocatably received in the sheath lumen, wherein the struts are attached to the shaft.

9. A device as in claim 8, wherein the support further comprises a blunt member.

10. A device as in claim 9, wherein the blunt member is disposed distal to end of the sheath.

11. A device as in claim 9, wherein the blunt member is reciprocatably received in the sheath lumen.

12. A device as in claim 1 , wherein at least some of the struts have enlarged atraumatic tips.

13. A device as in claim 12, wherein at least some of the enlarged atraumatic tips are axially offset from others to reduce their collective periphery when the struts are retracted.

14. A device as in claim 1, wherein at least some of the struts have bent tips.

15. A device as in claim 1, wherein at least some of the struts are composed of a shape memory alloy.

16. A device as in claim 15, wherein the struts have a first shape at or below room temperature and a second shape at a temperature above room temperature.

17. A device as in claim 16, wherein the first shape is a less arcuate shape and the second shape is the arcuate shape.

18. A method for performing cardiac massage, said method comprising:

advancing a plurality of struts through an intercostal space to a region over a pericardium;

opening the struts along arcuate radially diverging paths between a posterior rib surface and the pericardium; and

engaging the opened struts against the pericardium to periodically compress the heart.

19. A method as in claim 18, further comprising bluntly dissecting a space between the posterior rib surface and the pericardium prior to advancing the plurality of struts.

20. A method as in claim 19, wherein bluntly dissecting comprises advancing a blunt member disposed between said struts.

21. A method as in claim 20, further comprising advancing a blade from the blunt member to partially cut through intercostal tissue in the chest wall and retracting the blade prior to advancing the blunt member.

22. A method as in claim 18, further comprising unfurling a flexible sheet attached to at least some of the struts as the struts are opened.

23. A method as in claim 19, further comprising inflating a bladder attached to at least some of the struts.

24. A method as in claim 23, wherein the bladder is inflated while the struts are being opened.

25. A method as in claim 23, wherein the bladder is inflated after the struts are opened.

26. A method for performing cardiac massage, said method comprising:

engaging a plurality of struts arranged in radially diverging, arcuate paths against a pericardium;

reciprocating the struts against the pericardium to induce circulation.

27. A method as in claim 26, wherein a flexible sheet is suspended between at least some of the struts as the struts are reciprocated.

28. A method as in claim 26, wherein an inflated bladder is suspended between at least some of the struts as the struts are reciprocated.

29. An improved method for bluntly dissecting a region between a posterior rib surface and a pericardium, said method being of the type wherein a blunt member is advanced through an intercostal space, said improvement comprising advancing a blade from the blunt member to partially cut through intercostal skin prior to advancing the blunt member.

30. An improved method as in claim 29, wherein the blade is automatically retracted back into the blunt member prior to advancing the blunt member through the intercostal tissue in the chest wall.

31. A cardiac massage device comprising: a sleeve; a shaft having a proximal end and a distal end slidably mounted in the sleeve; and a flared bell structure attached to the distal end of the shaft, wherein the bell structure is collapsible so that it can be drawn into the sleeve by proximally retracting the shaft and expanded by distally, advancing the shaft.

32. A cardiac massage device as in claim 31, wherein the flared bell structure comprises a plurality of flexible struts, wherein each strut has an unconstrained configuration characterized by an arcuate geometry with a proximal end attached to the shaft and a distal region curved outwardly at an angle in the range from 45┬░ to 135┬░ relative to the shaft axis.

33. A cardiac massage device as in claim 32, wherein at least some of the struts 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.

34. A cardiac massage device as in claim 33, wherein the other end of the beam is attached at a point located from 15% to 50% of the strut length from the distal end of the strut.

35. A cardiac massage device as in claim 31, further comprising a blunt cap which is removably disposed over a distal end of the sleeve when the flared bell structure is retracted into the sleeve.

36. A cardiac massage device as in claim 35, further comprising a rod slidably mounted within the shaft, wherein the blunt cap is attached to a distal end of the rod.

36A. A cardiac massage device as in claim 31 , wherein the flared bell structure comprises a plurality of hinged struts with a distal and proximal segment.

36B. A cardiac massage device as in claim 36 A, wherein at least some of the struts have a third linkage attached at one end to the distal hinged segment, such that retraction of said third linkage relative to the proximal hinged segment, causes radial separation of the distal hinged segment ends.

37. A cardiac massage device as in claim 31 , wherein the shaft has indicia on its outer surface indicating the relative position of the shaft and the sleeve.

38. A cardiac massage device as in claim 37, wherein the indicia include at least one visible band showing when the shaft has advanced sufficiently to fully deploy the flared bell structure.

39. A cardiac massage device as in claim 37, wherein the indicia include at least one visible band showing when the shaft has been retracted sufficient to close the flared bell structure an adequate amount to permit withdrawal of the device from the patient.

40 . A cardiac massage device as in claim 31 , wherein a distal portion of the sleeve is compliant to facilitate retraction of the flared bell structure back into the sleeve.

41. A cardiac massage device as in claim 40, wherein a soft cowling attached to the distal end of the sleeve provides the compliance.

42. A cardiac massage device as in claim 31 , further comprising a lock structure which selectively locks the shaft to the sleeve to prevent premature advancement of the flared bell structure.

43. A cardiac massage device as in claim 42, wherein the lock structure comprises an anchor on the shaft and a latch on the sleeve.

44. A cardiac massage device as in claim 31, further comprising a flange on the sleeve, wherein the flange is positioned a distance from the distal end of the sleeve which permits optimum deployment of the flared bell structure from said distal end when said flange engages the chest wall of the patient.

45. A cardiac massage device as in claim 44, wherein the distance is in the range from 1 cm to 3 cm.

46. A method for performing cardiac massage, said method comprising: advancing a sleeve through an intercostal space in a patient's chest wall to a region adjacent to the pericardium; distally advancing a flared bell structure from a distal end of the sleeve; and engaging the flared bell structure against the pericardium to periodically compress the heart.

47. A method as in claim 46, wherein the flared bell structure is locked relative to the sleeve while the sleeve is being advanced, further comprising releasing the lock after the sleeve has been advanced to its intended location.

48. A method as in claim 47, wherein a flange on the sleeve engages the chest wall to indicate that the sleeve has been advanced to its intended configuration.

49. A method as in claim 47, wherein the lock is manually released.

50. A method as in claim 46, wherein advancing the flared bell structure comprises advancing a shaft which carries said flared bell structure of its distal end through the sleeve which remains stationary relative to the chest wall.

51. A method as in claim 50, further comprising observing a mark on the shaft to determine when the flared bell structure has been completely deployed from the sleeve.

52. A method as in claim 50, further comprising retracting the shaft to draw the flared bell structure back into the sleeve prior to withdrawing the sleeve from the patient.

53. A method as in claim 52, further comprising observing a mark on the shaft to determine when the flared bell structure has been sufficiently drawn back into the sleeve to permit withdrawal of the sleeve from the patient.