Direct cardiac compression device with improved durability

Abstract

The present invention provides a direct cardiac compression device comprising one or more passive chambers tapering from an opening to an apex; one or more individually and independently inflatable active pockets, each of the one or more inflatable active pockets connected at least partially from the opening to the apex to the one or more passive chambers, and each of the one or more inflatable active pockets, upon inflation, does not pull on adjacent one or more inflatable active pockets; and a frame in contact with the one or more active chambers and at least partially enclosing the one or more active pockets.

Description

Technical Field

[0001] The present invention generally relates to the field of cardiac assist devices, and more particularly, to methods and devices for assisting the heart by using a direct cardiac compression device both in the short term and the long term.

Background Art

[0002] Without limiting the scope of the present invention, its background will be described in relation to a direct cardiac compression device (DCCD). The DCCD can be used for any required length of time, from short periods of several hours to several days, and even for several weeks or months. Previous DCCDs were characterized by a single active chamber in the form of a circle arranged to surround the heart, and in some cases, the DCCD can be partially divided into individual parts around it.

[0003] FIG. 1 is a cross-sectional view of a prior art direct cardiac compression device. Only the active chamber 10 is shown in the figure. The active chamber 10 is divided into a plurality of individual expandable active pockets 12. Each pocket 12 is in contact with the adjacent pocket 12 at the connection point 18. By simultaneously expanding all the pockets 12 from the same source of compressed air, each pocket expands in the central part and at the same time pulls the connection point 18 to bring them closer to each other. FIG. 2 is a side view of a direct cardiac compression device known in the prior art showing the connection point 18.

[0004] Adjacent pockets 12 apply the same force to each connection point 18, but since they are directed in opposite directions and are tangential to the circular contour of the active chamber 12, the tensile stress at each connection point 18 caused by such an arrangement is very high. Repeated application of such tensile stress will cause early failure of the device.

[0005] A second cause of early failure is excessive stress on the outer wall of the active chamber 10. Upon initial inflation with air, the outer wall portion 14 stretches while the inner wall portion 16 is moved inwardly to compress the heart disposed inside the active chamber 10. Since the radius of curvature of the device is close to that of the cross-sectional shape of the heart, the tensile stress at the outer portion 14 is high. As a result, the flexible thin polymer material of the active chamber 10 must withstand two mechanical loads simultaneously, e.g., repeated bending and tensile stress. The combination of these two stresses leads to early failure and interruption of the continuity of the active chamber.

[0006] Another problem with DCCD designs in the prior art is that they cannot follow the natural twisting motion of the heart. As seen in FIG. 1, upon inflation of the prior art device, a radially inward movement of the inner wall portion 16 is caused while the natural motion of the myocardium during heart contraction proceeds with a certain amount of twist, particularly at the apex portion of the myocardium. In a healthy heart, the apex may rotate as much as 15 degrees while progressing from the end-diastolic shape to the end-systolic shape during heart contraction. The twisting motion of the heart may cause tangential friction and displacement of the myocardium relative to the inner wall of the device. During later use, when the epicardial surface of the heart is presumably attached to the inner surface of the device, the twisting motion of the heart may cause excessive wrinkling of the device as the heart may drag the inner surface of the device along with it with each heart contraction, thereby further increasing the level of bending stress in the device and potentially causing its early failure.

[0007] Furthermore, some prior art DCCDs may feature an internal passive chamber (not shown) disposed concentrically inside and within the active chamber 10. Such a passive chamber is used to fill the gap between the non-uniform and not exactly circular shape in the cross-section of the heart and the perfectly round shape of the active chamber. In this case, if the pocket 12 of the active chamber 10 expands, cardiac compression will be indirectly but rather caused via the passive chamber disposed between the heart and the active chamber 10. There is a need for the active chamber 10 to compress the heart more directly to avoid the additional resistance of the active chamber 10 first compressing its inner passive chamber. SUMMARY OF THE INVENTION PROBLEMS TO BE SOLVED BY THE INVENTION

[0008] An object of the present invention is to extend the period of use of a direct cardiac compression device beyond several days, preferably for up to one month or more. The DCCD can be used for any required length of time, from short periods of a few hours to several days, and even weeks or months. This enables the application of the device for an additional group of patients who require more than one or two days of cardiac support. MEANS FOR SOLVING THE PROBLEMS

[0009] The present invention provides a direct cardiac compression device comprising: one or more passive chambers that taper from an opening to a vertex; one or more inflatable active pockets that are individually and independently inflatable, wherein each of the one or more inflatable active pockets is connected at least partially from the opening to the vertex to one or more passive chambers, and each of the one or more inflatable active pockets, when inflated, does not pull adjacent one or more inflatable active pockets; one or more inflatable active pockets; and a frame that contacts one or more active chambers and at least partially surrounds the one or more active chambers. In some embodiments, the one or more inflatable active pockets are in contact with the one or more passive chambers through a direct connection. In some embodiments, the one or more inflatable active pockets are in contact with the one or more passive chambers through fixed tabs connected to the one or more inflatable active pockets and the one or more passive chambers.

[0010] The present invention provides a direct cardiac compression device comprising one or more passive chambers that taper from an opening to a vertex, and one or more inflatable active pockets that can be individually and independently inflated, wherein each of the one or more inflatable active pockets is at least partially connected to the one or more passive chambers from the opening to the vertex, and each of the one or more inflatable active pockets, when inflated, does not stretch adjacent one or more inflatable active pockets, one or more inflatable active pockets, and a frame that contacts one or more active chambers and at least partially surrounds the one or more active chambers. This device further includes a confinement layer disposed at least partially around the direct cardiac compression device. The confinement layer extends partially around the device and extends from the hub to one or more passive chambers, one or more fixed tabs, one or more inflatable active pockets, or can even cover one or more passive chambers and extend across the entire device and back to the hub. The confinement layer can be formed from different materials over different regions, for example, making one region anti-adhesive and the other anti-microbial / anti-bacterial. In some embodiments, each of the plurality of inflatable active pockets is connected to a support cone at the opening. In some embodiments, each of the plurality of inflatable active pockets is connected to a support cone at the opening and at the vertex. In some embodiments, each of the plurality of inflatable active pockets at least partially overlaps. In some embodiments, each of the plurality of inflatable active pockets is connected to a support cone by spot welding, seam welding, a weld line, or a combination thereof. In some embodiments, each of the plurality of inflatable active pockets is connected to one or more fixed tabs by spot welding, seam welding, a weld line, or a combination thereof. In some embodiments, each of the plurality of inflatable active pockets is connected to one or more fixed tabs by spot welding, seam welding, a weld line, or a combination thereof. In some embodiments, the plurality of inflatable active pockets includes 3 to 15 individual inflatable active pockets.In some embodiments, the plurality of inflatable active pockets comprises from 5 to 10 individual inflatable active pockets. In some embodiments, the plurality of inflatable active pockets has a heart-shaped contour. In some embodiments, the device further comprises one or more fibers inserted into the frame to provide support. In some embodiments, the device further comprises a fiber-reinforced mesh in communication with the frame to provide support. In some embodiments, the confinement layer is connected to one or more passive chambers. In some embodiments, the confinement layer surrounds one or more passive chambers. In some embodiments, the device further comprises a hub disposed at the apex and operably communicating with one or more ports. In some embodiments, the frame comprises a wire, polymer, shape memory material, metal, alloy, composite, or combinations thereof. In some embodiments, the frame comprises an elastic energy storage element. In some embodiments, the frame is embedded in a support cone, a plurality of inflatable active pockets, or combinations thereof. In some embodiments, the device further comprises one or more drug therapies, stem cells, or other cardiac assist technologies that improve the function of a damaged or diseased heart. In some embodiments, the device further comprises sensors embedded within the device that can monitor one or more of the following, namely, temperature, pressure, EKG signal, conductivity. In some embodiments, the device further comprises a confinement layer disposed between the inner cone and the heart to assist in the removal of the direct cardiac compression device. In some embodiments, the device further comprises a hub disposed at the apex in communication with the active pocket port, the passive pocket port, or both. In some embodiments, the confinement layer contacts the hub and the plurality of passive pockets. In some embodiments, the confinement layer is not attached to the DCCD device, which is removably attachable without moving the confinement layer. In some embodiments, each of the plurality of inflatable active pockets is connected to the plurality of passive pockets by a fixed tab. In some embodiments, each of the one or more fixed tabs extends at least partially from the opening to the apex.In some embodiments, the device further includes a second support structure disposed between one or more passive chambers and one or more inflatable active pockets.

[0011] The present invention provides a direct cardiac compression device adapted to be implanted in patients suffering from cardiac arrest and related cardiac conditions, the direct cardiac compression device comprising one or more passive chambers that taper from an opening to a vertex, and a plurality of inflatable active pockets connected to the one or more passive chambers and tapering from the opening to a vertex to at least partially surround the one or more passive chambers, each of the plurality of inflatable active pockets being independently inflatable, and each of the one or more inflatable active pockets, when inflated, not stretching adjacent one or more inflatable active pockets; a plurality of inflatable active pockets; a support structure in contact with each of the plurality of inflatable active pockets and extending at least partially from the opening to the vertex, each of the plurality of inflatable active pockets being connected to the support structure at one or more points; a frame in contact with the support structure and at least partially surrounding the support structure; and one or more ports operably communicating with each of the plurality of inflatable active pockets to independently inflate and deflate the plurality of inflatable active pockets and operably communicating with each of the one or more passive chambers to independently inflate and deflate each of the one or more passive chambers. The device further includes a confinement layer disposed at least partially around the direct cardiac compression device. The confinement layer extends partially around the device, extending from the hub to one or more passive chambers, one or more fixed tabs, one or more inflatable active pockets, or even covering one or more passive chambers and extending across the device back to the hub. The confinement layer can be formed from different materials over different regions, for example, forming one region anti-adhesive and the other anti-microbial / anti-bacterial. In some embodiments, each of the plurality of inflatable active pockets is connected to a support cone at the opening. In some embodiments, each of the plurality of inflatable active pockets is connected to a support cone at the opening and at the vertex. In some embodiments, each of the inflatable active pockets of the plurality of inflatable active pockets at least partially overlaps.In some embodiments, each of the plurality of inflatable active pockets is connected to the support cone by spot welding, seam welding, a weld line, or a combination thereof. In some embodiments, each of the plurality of inflatable active pockets is connected to one or more fixed tabs by spot welding, seam welding, a weld line, or a combination thereof. In some embodiments, each of the plurality of inflatable active pockets is connected to one or more fixed tabs by spot welding, seam welding, a weld line, or a combination thereof. In some embodiments, the plurality of inflatable active pockets comprises 5 to 15 individual inflatable active pockets. In some embodiments, the plurality of inflatable active pockets comprises 6 to 10 individual inflatable active pockets. In some embodiments, the plurality of inflatable active pockets has a heart-shaped contour. In some embodiments, the device further comprises one or more fibers inserted into the frame to provide support. In some embodiments, the device further comprises a fiber-reinforced mesh in communication with the frame to provide support. In some embodiments, the confinement layer is connected to one or more passive chambers. In some embodiments, the confinement layer surrounds one or more passive chambers. In some embodiments, the device further comprises a hub disposed at a vertex and operably communicating with one or more ports. In some embodiments, the frame comprises a wire, a polymer, a shape memory material, a metal, an alloy, a composite, or a combination thereof. In some embodiments, the frame comprises an elastic energy storage element. In some embodiments, the frame is embedded in a support cone, a plurality of inflatable active pockets, or a combination thereof. In some embodiments, the device further comprises one or more drug therapies, stem cells, or other cardiac assist technologies that improve the function of a damaged or diseased heart. In some embodiments, the device further comprises a sensor embedded within the device that can monitor one or more of the following, namely, temperature, pressure, EKG signal, conductivity.In some embodiments, the device further includes a confinement layer disposed between the inner cone and the heart to assist in the removal of the direct cardiac compression device. In some embodiments, the device further includes a hub disposed at the apex in communication with the active pocket port, the passive pocket port, or both. In some embodiments, the confinement layer contacts the hub and a plurality of passive pockets. In some embodiments, the confinement layer is removable. In some embodiments, each of the plurality of inflatable active pockets is connected to the plurality of passive pockets by a fixed tab. In some embodiments, each of the one or more fixed tabs extends at least partially from the opening to the apex. In some embodiments, the device further includes a second support structure disposed between the one or more passive chambers and the one or more inflatable active pockets.

[0012] The present invention provides a direct cardiac compression device that provides torsion, the direct cardiac compression device including one or more passive pockets that taper from an opening to a vertex, a passive pocket port operably communicating with the one or more passive pockets to inflate and deflate the one or more passive pockets, a plurality of inflatable active pockets connected to the one or more passive pockets at a first attachment point, each of the plurality of inflatable active pockets at least partially overlapping adjacent one or more inflatable active pockets without causing tension, an active pocket port operably communicating with the plurality of inflatable active pockets to individually inflate and deflate each of the one or more passive pockets to provide cardiac compression, a support structure disposed to at least surround the plurality of inflatable active pockets and connected to each of the plurality of inflatable active pockets at a second attachment point, the first attachment point and the second attachment point causing a torsional movement of the plurality of inflatable active pockets during inflation and deflation, and a confinement layer covering at least a portion of the direct cardiac compression device. The device further includes a confinement layer disposed at least partially around the direct cardiac compression device. The confinement layer extends partially around the device, extending from a hub to one or more passive chambers, one or more fixed tabs, one or more inflatable active pockets, or covering one or more passive chambers and extending across the entire device and back to the hub. The confinement layer can be formed from different materials over different regions, for example, making one region anti-adhesive and the other anti-microbial / anti-bacterial. In some embodiments, each of the plurality of inflatable active pockets is connected to a support cone at an opening. In some embodiments, each of the plurality of inflatable active pockets is connected to a support cone at an opening and a vertex. In some embodiments, each of the plurality of inflatable active pockets at least partially overlaps. In some embodiments, each of the plurality of inflatable active pockets is connected to a support cone by spot welding, seam welding, a weld line, or a combination thereof.In some embodiments, each of the plurality of inflatable active pockets is connected to one or more fixed tabs by spot welding, seam welding, weld lines, or combinations thereof. In some embodiments, each of the plurality of inflatable active pockets is connected to one or more fixed tabs by spot welding, seam welding, weld lines, or combinations thereof. In some embodiments, the plurality of inflatable active pockets comprises from 3 to 15 individual inflatable active pockets. In some embodiments, the plurality of inflatable active pockets comprises from 5 to 10 individual inflatable active pockets. In some embodiments, the plurality of inflatable active pockets has a heart-shaped contour. In some embodiments, the device further comprises one or more fibers inserted into the frame to provide support. In some embodiments, the device further comprises a fiber-reinforced mesh in communication with the frame to provide support. In some embodiments, the confinement layer is connected to one or more passive chambers. In some embodiments, the confinement layer surrounds one or more passive chambers. In some embodiments, the device further comprises a hub disposed at a vertex and operably communicating with one or more ports. In some embodiments, the frame comprises wire, polymer, shape memory material, metal, alloy, composite, or combinations thereof. In some embodiments, the frame comprises an elastic energy storage element. In some embodiments, the frame is embedded in a support cone, a plurality of inflatable active pockets, or combinations thereof. In some embodiments, the device further comprises one or more drug therapies, stem cells, or other cardiac assist technologies that improve the function of a damaged or diseased heart. In some embodiments, the device further comprises a sensor embedded within the device capable of monitoring one or more of the following: temperature, pressure, EKG signal, dielectric constant. In some embodiments, the device further comprises a confinement layer disposed between the inner cone and the heart to assist in the removal of the direct cardiac compression device. In some embodiments, the device further comprises a hub disposed at a vertex in communication with the active pocket port, the passive pocket port, or both.In some embodiments, the confinement layer is in contact with the hub and the plurality of passive pockets. In some embodiments, the confinement layer is removable. In some embodiments, each of the plurality of inflatable active pockets is connected to the plurality of passive pockets by a fixed tab. In some embodiments, each of the one or more fixed tabs extends at least partially from the opening to the apex. In some embodiments, the device further includes a second support structure disposed between the one or more passive chambers and the one or more inflatable active pockets.

[0013] The present invention relates to one or more passive chambers that taper from an opening to a vertex, and a plurality of inflatable active pockets that are connected to the one or more passive chambers and taper from the opening to the vertex and at least partially surround the one or more passive chambers, wherein each of the plurality of inflatable active pockets is independently inflatable, and each of the one or more inflatable active pockets, when inflated, does not stretch adjacent one or more inflatable active pockets; a plurality of inflatable active pockets; a support structure that contacts each of the plurality of inflatable active pockets and extends at least partially from the opening to the vertex, wherein each of the plurality of inflatable active pockets is connected to the support structure at one or more points; a frame that contacts the support structure and at least partially surrounds the support structure; and one or more ports that are operatively communicated with each of the plurality of inflatable active pockets to independently inflate and deflate the plurality of inflatable active pockets and are operatively communicated with each of the one or more passive chambers to independently inflate and deflate the one or more passive chambers, and provides a direct cardiac compression device. A method of treating a patient suffering from one or more symptoms of cardiac arrest is provided, comprising transplanting a direct cardiac compression device to a patient suffering from one or more symptoms of cardiac arrest or related cardiac conditions. The device further includes a confinement layer disposed at least partially around the direct cardiac compression device. The confinement layer extends partially around the device and extends from the hub to one or more passive chambers, one or more fixed tabs, one or more inflatable active pockets, or can even cover one or more passive chambers and extend across the device and back to the hub. The confinement layer can be formed from different materials over different regions, for example, making one region anti-adhesive and the other anti-microbial / anti-bacterial. In some embodiments, each of the plurality of inflatable active pockets is connected to a support cone at the opening. In some embodiments, each of the plurality of inflatable active pockets is connected to a support cone at the opening and at the vertex. In some embodiments, the inflatable active pockets of the plurality of inflatable active pockets at least partially overlap each other.In some embodiments, each of the plurality of inflatable active pockets is connected to the support cone by spot welding, seam welding, a weld line, or a combination thereof. In some embodiments, each of the plurality of inflatable active pockets is connected to one or more fixed tabs by spot welding, seam welding, a weld line, or a combination thereof. In some embodiments, each of the plurality of inflatable active pockets is connected to one or more fixed tabs by spot welding, seam welding, a weld line, or a combination thereof. In some embodiments, the plurality of inflatable active pockets comprises 5 to 15 individual inflatable active pockets. In some embodiments, the plurality of inflatable active pockets comprises 6 to 10 individual inflatable active pockets. In some embodiments, the plurality of inflatable active pockets has a heart-shaped contour. In some embodiments, the device further comprises one or more fibers inserted into the frame to provide support. In some embodiments, the device further comprises a fiber-reinforced mesh in communication with the frame to provide support. In some embodiments, the confinement layer is connected to one or more passive chambers. In some embodiments, the confinement layer surrounds one or more passive chambers. In some embodiments, the device further comprises a hub disposed at a vertex and operably communicating with one or more ports. In some embodiments, the frame comprises a wire, a polymer, a shape memory material, a metal, an alloy, a composite, or a combination thereof. In some embodiments, the frame comprises an elastic energy storage element. In some embodiments, the frame is embedded in a support cone, a plurality of inflatable active pockets, or a combination thereof. In some embodiments, the device further comprises one or more drug therapies, stem cells, or other cardiac assist technologies that improve the function of a damaged or diseased heart. In some embodiments, the device further comprises a sensor embedded within the device that can monitor one or more of the following, namely, temperature, pressure, EKG signal, conductivity.In some embodiments, the device further includes a confinement layer disposed between the inner cone and the heart to assist in the removal of the direct cardiac compression device. In some embodiments, the device further includes a hub disposed at the apex that communicates with an active pocket port, a passive pocket port, or both. In some embodiments, the confinement layer contacts the hub and a plurality of passive pockets. In some embodiments, the confinement layer is removable. In some embodiments, each of the plurality of inflatable active pockets is connected to the plurality of passive pockets by a fixed tab. In some embodiments, each of one or more fixed tabs extends at least partially from the opening to the apex.

[0014] The present invention provides a direct cardiac compression device comprising: one or more passive chambers that taper from an opening to an apex; a second support structure in contact with the one or more passive chambers; a plurality of inflatable active pockets that contact the second support structure and, optionally, the one or more passive chambers, taper from the opening to the apex, and at least partially surround the second support structure, each of the plurality of inflatable active pockets being independently inflatable and each of one or more of the inflatable active pockets, when inflated, not stretching adjacent one or more of the inflatable active pockets; a support structure in contact with each of the plurality of inflatable active pockets and extending at least partially from the opening to the apex, each of the plurality of inflatable active pockets being connected to the support structure at one or more points; a frame in contact with the support structure and at least partially surrounding the support structure; and one or more ports operably communicating with each of the plurality of inflatable active pockets to independently inflate and deflate the plurality of inflatable active pockets and operably communicating with each of the one or more passive chambers to independently inflate and deflate the one or more passive chambers.

Brief Description of the Drawings

[0015] For a more complete understanding of the features and advantages of the present invention, reference is made to the detailed description of the invention in conjunction with the accompanying drawings.

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Best Mode for Carrying Out the Invention

[0016] The fabrication and use of various embodiments of the present invention will be discussed in detail below, but it should be understood that the present invention provides many applicable inventive concepts that can be embodied in a wide variety of specific contexts. The specific embodiments discussed herein are merely illustrative of specific ways of making and using the invention and do not limit the scope of the invention.

[0017] To facilitate understanding of the present invention, some terms are defined below. The terms defined herein have meanings as commonly understood by those skilled in the art related to the present invention.

[0018] As used herein, "biomedical material" refers to a material that is physiologically inert so as to avoid rejection or other negative inflammatory reactions.

[0019] As used herein, the term "joining line" refers to any method of joining two materials, including but not limited to heating, welding, gluing, bonding, adhering, melting, temporary fixing, etc.

[0020] As used herein, "thin polymer film", "polymer film", "polymer", and "film" refer to materials that are substantially biocompatible, liquid-impermeable, and substantially non-elastic. For example, at least a portion of the device can be made from elastic polyurethane, latex, polyether urethane, polycarbonate urethane, silicone, polysiloxane urethane, hydrogenated polystyrene butadiene copolymer, ethylene propylene and dicyclopentadiene terpolymer, hydrogenated poly(styrene butadiene) copolymer, poly(tetramethylene ether glycol) urethane, poly(hexamethylene carbonate ethylene carbonate glycol) urethane, and combinations thereof.

[0021] As used herein, "fiber-reinforced mesh" or "fiber-reinforced layer" refers to any fiber and any configuration. For example, the fiber configuration can be a mesh or weave of fibers of any number of thicknesses or orientations. Additionally, the fiber-reinforced layer can include individual fibers or bundles of fibers or a thicker non-mesh layer. The fiber-reinforced layer can be one or more layers and can include layers of similar and dissimilar designs, such as a woven mesh layer having a layer of individual fibers oriented in a first direction and another layer of individual fibers oriented in a second direction.

[0022] As used herein, "cone", "outer cone", "inner cone", "support cone", and "support structure" are used interchangeably to refer to a support structure.

[0023] The present invention provides a direct cardiac compression device designed for use for both short-term and long-term periods, from several days to one or two months or more. The present invention enables the treatment of an additional group of patients who require cardiac support for more than one or two days using DCCD. The present invention allows for the use of DCCD for short-term to longer periods, ranging from several hours to several days, and even up to several weeks or months, for any length of required time.

[0024] The present invention provides a direct cardiac compression device having an active chamber that includes a plurality of independently assembled inflatable active pockets that, when inflated, do not cause tensile stress in adjacent active pockets.

[0025] FIG. 3 is a side view of the direct cardiac compression device of the present invention. FIG. 4 is a top view of the direct cardiac compression device of the present invention. The direct cardiac compression device 10 includes a novel active chamber that, in this case, extends from a common hub 40 and is pneumatically connected to a source of compressed air and vacuum (not shown) that is operably attached to each other and to the hub 40 and includes a plurality of individual inflatable active pockets 20-38 (the number of pockets can vary from about 3 to about 15). Additionally, the hub 40 can be a bundle of individual tubes. Each inflatable pocket 20-38 extends along a protruding cone that represents the shape of the heart toward the base of the heart at the top of FIG. 3. To ensure proper placement of the inflatable active pockets 20-38 and prevent them from changing position during use, an external cone 42 is placed around the outside of the inflatable active pockets 20-38 and can be made from the same thin polymer film as the inflatable active pockets 20-38 or from another polymeric material. Individually, each pocket can be attached to the external cone 42 at a single point 44 or in the form of a bonding line that extends downward from the point 44 toward the hub 80 along part or all of its length. In FIG. 3, each inflatable active pocket 20-38 is only attached to the external cone 42 and is not attached to each adjacent inflatable pocket 20-38. The individual inflatable active pockets 20-38 can be arranged to overlap each adjacent inflatable pocket 20-38 as shown in FIG. 4, but this is an optional feature of the device design. During use, since the outer external cone 42 resists the tensile load applied by all of the inflatable active pockets 20-38, inflation of each pocket 20-38 causes individual compression of the heart at each location of each pocket. Importantly, the tangential tensile stress at each pocket is removed, thereby promoting a longer life of the polymer film.

[0026] The present invention provides a direct cardiac compression device 10 having a novel active chamber and an external cone 42 that provides a uniform distribution of tensile stress to avoid forming one or more stress concentration points. The present invention also provides a fiber-reinforced layer outside the inflatable active pocket configured to absorb and resist the outward expansion of the device when the active chamber expands. Additionally, the fiber-reinforced layer can be incorporated on the outside of or into the outer wall of the inflatable active pocket. The external cone 42 is designed and configured to absorb a plurality of external forces applied by the inflatable active pockets 20-38 without forming one or more stress concentration points. In contrast to prior art devices, the present invention provides an external cone 42 that receives the applied force and limits the forces seen by the inflatable active pocket itself as in the case of prior art devices.

[0027] The present invention provides a direct cardiac compression device 10 having the ability to separate the wireframe from the active chamber. In at least some prior art devices, the wireframe was constructed within the inflatable portion of the active chamber. In the direct cardiac compression device 10 of the present invention, the wireframe can be disposed outside the active chamber, allowing for greater flexibility in the design of both the active chamber and the wireframe itself. Some further useful improvements are considered to be part of the direct cardiac compression device 10 of the present invention.

[0028] FIG. 5 is a cross-sectional view of another embodiment of the direct cardiac compression device 10 of the present invention. The direct cardiac compression device 10 includes a plurality of inflatable active pockets 20-38 (eight in this case) disposed between an outer cone 42 and an inner cone 56. Each inflatable pocket is attached to the inner cone 56 at a point 60 in this cross-sectional view on the one hand. The other side of the inflatable pocket 20 is attached to the outer cone 42 at a point 62. FIG. 6 is a cutaway view of a direct cardiac compression device showing attachment using a seam weld. The point 62 represents a chamber weld line as seen in FIG. 6. Similarly, the point 60 represents a set of corresponding chamber weld lines on the inner cone 56 (not shown). By using this arrangement, the direct cardiac compression device can hold a plurality of inflatable active pockets 20-38 between two continuous layers of a thin polymer film forming the inner cone 56 and the outer cone 52. By filling the space 58 with saline, a passive fluid-filled space is formed between the inner cone 56 and the outer cone 52, making it possible to provide both passive and active chambers. However, in this case, the passive chamber is not separately disposed inside the active chamber. Rather, the fluid freely fills the space between the inflatable active pockets 20-38 to make close contact between the heart and the outer cone 42. The space 58 between the inner cone 56 and the outer cone 52 forms a passive chamber that can be configured as needed by adjusting the pressure within the space 58. As an alternative, one or more passive chambers can be disposed inside the inflatable active pockets or inside the inner cone. Fluid can be added to the space 58 to adjust the degree of close contact around the heart. The fluid can be a gas, a liquid, or a combination thereof.

[0029] Another embodiment of the direct cardiac compression device provides torsion during inflation. As the inflatable pocket expands during inflation, a pair of attachment points 62 and 60 move closer to each other. Due to the vertically oriented direction of the inflatable pocket 20 as seen in, for example, FIG. 3, this movement of the attachment point 62 towards the attachment point 60 causes a relative torsion of the inner cone 56 inside the outer cone 42. By, for example, obliquely orienting at least a portion of the inflatable pocket 20 as seen in FIG. 6, it leads to a relative torsional movement of the inner cone 56 in a manner similar to the movement of the heart. By adjusting the range of the angular orientation of the weld lines of the inflatable pocket on both sides of each inflatable pocket 20 - 38, a more natural torsional movement of the inner cone 56 that matches the torsional movement of the epicardial surface of the native heart can be achieved. In addition, at least a portion of the inflatable pocket 20 can be oriented obliquely, horizontally, vertically, or a combination thereof.

[0030] A further advantage of the angular orientation of the inflatable active pocket is that it allows for easier compression when the device is retracted into the delivery tube. In addition, by not attaching the inflatable active pocket adjacent to the hub, greater flexibility and the ability to compress to a smaller size prior to deploying the device can also be facilitated.

[0031] FIG. 7 shows an exemplary cross-sectional side view of the device assembly. Shown as position 74 is a sub-assembly of the active and passive chambers as described above, featuring a plurality of inflatable active pockets operably connected to a source of compressed air (not shown). The wireframe 76 can be disposed outside the active chamber 74 and can be made using conventional NiTi wire. Those skilled in the art will recognize that other metals, alloys, polymers, and combinations thereof can be used. Since the present invention is not limited in this regard, the wireframe 76 can be disposed inside the inner cone, between the inner cone and the outer cone, and outside the outer cone.

[0032] The fiber-reinforced layer 78 can be further disposed outside the wire frame 76 or inside the wire frame 76 adjacent to the active chamber 74. This fiber-reinforced layer 78 can be made using individual bundles of fibers such as polyester or nylon ribbons, or a polymer mesh configured to accommodate the outward expansion of the active chamber during inflation of the pockets 20-38. In an embodiment, the mesh 78 can expand fully or partially from the hub 40 to the top of the device. FIG. 7 shows an example of partially covering the device with the mesh layer 78 at the central portion of the device.

[0033] The fiber-reinforced layer 78 can be incorporated into the outer cone 42, for example, by embedding it in the polymer film of the outer cone 42 or by other attachment means fixed to its outer surface. In a further embodiment, the fiber-reinforced layer 78 can be attached to the inner surface or the outer surface, or both, or in a further embodiment, it can be woven therein. In yet another embodiment, the fiber-reinforced layer 78 can be incorporated into the inner surface or the outer surface, or both. Yet other embodiments can be a combination of attachment to the inner surface or the outer surface and incorporation into the inner surface or the outer surface, allowing for numerous combinations.

[0034] One advantage of disposing the fiber-reinforced layer 78 outside the wire frame 76 or integrally therewith is to limit the outward movement of the wire frame during expansion of the inflatable active pocket, thereby reducing the bending load on the NiTi wire and improving its lifespan. In other embodiments, the fiber-reinforced layer 78 can be formed integrally with the exterior 80 of the containment layer 70.

[0035] The individual fibers or bundles that together form the mesh 108 need to be strong enough to withstand together the tensile stresses that expand the inflatable active pocket, thereby guiding these expansions inwardly towards the heart. On the other hand, the fibers need to be made as thin and flexible as possible so as not to increase the size of the delivery sheath and to maximize the flexibility of the device during insertion and removal procedures.

[0036] The confinement layer 70 can comprise an interior 72 designed to separate the device from the heart and an exterior 80 disposed outside the device to separate it from the pericardium. A source of continuous low-level vacuum suction can be operably connected to the inner space of the confinement layer 70 so that any air leakage can be quickly aspirated to reduce the risk of cardiac tamponade.

[0037] A further purpose of the confinement layer 70 is to enable replacement of the device in case of leakage. If the original device is held inside the patient for several days, the surface of the confinement layer may adhere to the patient's tissue, either the heart inside or the pericardium outside, or both. In this case, since the device is not attached to the confinement layer 70, it can still be removed from within the inner space of the confinement layer 70 and replaced with another device, which can be deployed directly inside the confinement layer 70 in this case. Additionally, an appropriate lubricant or other anti-adhesive substance is used to separate the active chamber from the confinement layer to minimize tissue adhesion and allow free movement of the active chamber film relative to the thin film of the confinement layer. Specific suitable lubricants can be liquids, fluids, powders, etc., and specific examples include silicone and Teflon powder. Additionally, some embodiments of the present invention can have leads, electrodes or electrical connections incorporated into the device. When present, these can be made from noble metals (e.g., gold, platinum, rhodium and their alloys) or stainless steel. Additionally, conventional pacemaker leads and defibrillation leads can be incorporated into the present invention to provide cardiac pacing or defibrillation. The confinement layer can remain in place in the body after removal of the active chamber and wire frame to maintain access to the outer surface of the heart during tissue scarring and healing for possible future device implantation.

[0038] 1. Two or three or more electrodes 82 can be arranged inside or outside the device, arranged on the tissue contact surface of the confinement layer 70, and configured to sense an ECG signal from either the external surface of the heart directly or the internal surface of the pericardium (as seen in FIG. 7). The ECG signal can be recorded, stored, or transmitted to assist in the timing of device inflation, diagnosis, treatment, or used as an input for other devices.

[0039] FIG. 8 is a cross-sectional view of another embodiment of the direct cardiac compression device 10 of the present invention, and FIG. 9 is a top view. The direct cardiac compression device 10 includes a frame 70 in contact with a first fixed cone 72a that extends at least partially downward from the frame 70. An active chamber layer 74 is in contact with the first fixed cone 72a and a second fixed cone 72b that extends at least partially downward from the active chamber layer 74. A passive layer 76 is in contact with the second fixed cone 72b that extends at least partially over the passive layer 76. The passive layer 76 and the active chamber 74 can be connected through a circumferential basic weld. A confinement layer 78 extends from the passive layer 76 to enclose the frame 70 and accommodate the direct cardiac compression device 10.

[0040] FIG. 10 is a cross-sectional view of another embodiment of the direct cardiac compression device 10 of the present invention. The direct cardiac compression device 10 includes a frame 70 in contact with a first fixed cone 72a that extends at least partially downward from the frame 70. An active chamber layer 74 is in contact with an active fixed tab 80 that extends to and is connected to the passive layer 70. The active chamber layer 74 can include a number of active chambers in the range of two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, sixteen, seventeen, eighteen or more. A confinement layer 78 extends from the passive layer 76 to enclose the frame 70 and accommodate the direct cardiac compression device 10.

[0041] FIG. 11 is a top view of another embodiment of the direct cardiac compression device 10 of the present invention. The direct cardiac compression device 10 includes a frame 70 in contact with a first fixed cone 72a that extends at least partially downward of the frame 70. An active chamber layer 74 is in contact with an active fixing tab 80 that extends to and is connected to a passive layer 76. In this embodiment, the active chamber layer 74 includes eight active chambers. Each of the eight active chambers is individually connected to the passive layer through an individual active fixing tab 80. The active fixing tab 80 can extend the entire length of the active chamber layer 74 and the passive layer 76, or can extend only partially along the length. The passive layer 76 can include individual passive chambers. In some embodiments, the individual passive chambers are formed by connecting both sides of adjacent individual passive chambers. In some embodiments, the active fixing tabs 80 are disposed between adjacent individual passive chambers and are then connected together. A confinement layer 78 extends from the passive layer 70 to enclose the frame 70 and house the direct cardiac compression device 10. In an alternative embodiment, the active chamber layer 74 is in direct contact with the passive layer 76. Each of the eight active chambers is individually connected to the passive layer and can extend the entire length of the active chamber layer 74 and the passive layer 76, or can extend only partially along the length.

[0042] FIG. 12 is a top view of another embodiment of a portion of the direct cardiac compression device 10 of the present invention. The direct cardiac compression device 10 includes an active chamber layer 74 having eight active chambers 82, each of which is connected to an active fixing tab 80 that extends to and is connected to a passive layer 76. In this embodiment, the passive layer 76 is divided into eight individual passive chambers.

[0043] FIG. 13 is a top view of another embodiment of a part of the direct cardiac compression device 10 of the present invention. The direct cardiac compression device 10 includes an active chamber layer 74 having eight active chambers 82, each of which is connected to an active fixed tab 80 that extends to and is connected to the passive layer 76. In this embodiment, the active fixed tab 80 enables each of the active chambers 82 to be folded as shown in FIG. 14. In this embodiment, the passive layer 76 is divided into eight individual passive chambers. FIG. 15 shows that the individual active fixed tabs 80 can also be connected to adjacent active fixed tabs 80 as shown. The connection part is shown as 84. FIG. 16 shows a top view of another embodiment of the direct cardiac compression device 10 having a frame disposed on the active chamber 82. FIG. 17 shows a top view of another embodiment of the direct cardiac compression device 10 having a confinement layer disposed on the frame 70.

[0044] FIG. 18 is a top view of the frame 70. FIG. 19 is a top view of the frame 70 having a support for connecting the frames 70. FIG. 20 is a side view of the frame 70 having a support for connecting the frames 70. FIG. 21 is a side view of the direct cardiac compression device.

[0045] Generally, when a substance is implanted into the body, the body recognizes the presence of the foreign object and induces an immune defense system to expel and destroy the foreign object. As a result, edema, inflammation of the surrounding tissue, and biodegradation of the implanted substance occur. As a result, the present invention is composed of at least partially implantable substances. Examples of suitable, biocompatible, bio-stable, implantable materials used to make the present invention include, but are not limited to, polyether urethane, polycarbonate urethane, silicone, polysiloxane urethane, hydrogenated polystyrene butadiene copolymer, ethylene propylene and dicyclopentadiene terpolymer, and / or hydrogenated poly(styrene-butadiene) copolymer, poly(tetramethylene ether glycol) urethane, poly(hexamethylene carbonate ethylene carbonate glycol) urethane, and combinations thereof. In addition, the present invention can be reinforced with filaments made of biocompatible, bio-stable, implantable polyamide, polyimide, polyester, polypropylene, and / or polyurethane.

[0046] The substances used in the structure of the present invention minimize the occurrence of infections associated with the implantation of medical devices such as Enterococcus, Pseudomonas aeruginosa, staphylococcus, and staphylococcus epidermidis infections. Embodiments of the present invention include a bioactive layer or coating that prevents or reduces infections. For example, a bioactive agent can be implanted, coated, or dispersed in the present invention and includes antibacterial agents, antibiotics, antimitotic agents, antiproliferative agents, antisecretory agents, non-steroidal anti-inflammatory drugs, immunosuppressive agents, anti-polymerases, antiviral agents, antibody-targeted therapeutic agents, prodrugs, free radical scavengers, antioxidants, biological agents, or combinations thereof. Antibacterial agents include, but are not limited to, benzalkonium chloride, chlorhexidine dihydrochloride, dodecylcarbonylium chloride, and silver sulfadiazine. Generally, the amount of antibacterial agent required depends on the agent, but the concentration ranges from 0.0001% to 5.0%.

[0047] Some embodiments of the present invention can be used in conjunction with stem cell therapy of the heart. Stem cells used for cardiac regenerative therapy include, but are not limited to, stem cells derived from embryonic stem cells, somatic stem cells taken from bone marrow, primordial cells from heart tissue, autologous skeletal myoblasts from muscle tissue, hematopoietic stem cells, mesenchymal stem cells, and vascular endothelial progenitor cells. The present invention can also be used in combination with naturally occurring cardiac stem cells. The transplanted stem cells can be directly injected into the heart tissue including the infarcted area, cardiac scar tissue, border area, or healthy heart tissue. The transplanted stem cells can be injected into the systemic supply area of the heart tissue and can migrate to and engraft in the damaged or diseased area of the heart. The transplanted stem cells can also provide a diffusible product to the damaged or diseased area of the heart.

[0048] The direct cardiac compression device of the present invention includes an inflatable compartment connected to a fluid pressure source through an inlet port and an outlet port. This device expands with positive pressure during cardiac systole and contracts (through suction) during cardiac diastole. Depending on the specific use and configuration of the direct cardiac compression device, other configurations and multiple connections are also possible.

[0049] It will be understood that the specific embodiments described herein are presented by way of example and not as limitations of the present invention. The main features of the present invention can be used in various embodiments without departing from the scope of the present invention. Those skilled in the art will be able to recognize or confirm numerous equivalents to the specific procedures described herein using only routine experimentation. Such equivalents are considered to be within the scope of the present invention and are covered by the claims.

[0050] As used in this specification and the claims, "comprising" (and any form of comprising such as "comprise" and "comprises"), "having" (and any form of having such as "have" and "has"), "including" (and any form of including such as "includes" and "include") or "containing" (and any form of containing such as "contains" and "contain") are inclusive or open-ended and do not exclude additional, unrecited elements or method steps.

[0051] The term "or combinations thereof" as used herein refers to all permutations and combinations of the listed items preceding that term. For example, "A, B, C, or combinations thereof" is intended to include at least one of A, B, C, AB, AC, BC, or ABC, and, if order is important in a particular context, also BA, CA, CB, CBA, BCA, ACB, BAC, or CAB. Continuing with this example, combinations including repetitions of one or more of the items or terms such as BB, AAA, MB, BBC, AAABCCCC, CBBAAA, CABABB, etc. are explicitly included. One of ordinary skill in the art will understand that, unless otherwise apparent from the context, there is usually no limit on the number of items or terms in any combination.

[0052] All of the compositions and / or methods disclosed and claimed in this specification can be made and executed without undue experimentation in light of the present disclosure. Although the compositions and methods of the present invention have been described in terms of preferred embodiments, it will be apparent to those skilled in the art that variations can be applied to the compositions and / or methods described herein and to the steps or sequence of steps of the method without departing from the concept, spirit, and scope of the present invention. All such similar alternatives and modifications apparent to those skilled in the art are considered to be within the spirit, scope, and concept of the present invention as defined by the appended claims.

Claims

1. one or more passive chambers that taper from an opening to a vertex, a plurality of inflatable active pockets that are surrounded by the one or more passive chambers and are individually and independently inflatable, each of the plurality of inflatable active pockets being at least partially connected to the one or more passive chambers from the opening to the vertex, and each of the plurality of inflatable active pockets not pulling adjacent ones of the plurality of inflatable active pockets when inflated, the plurality of inflatable active pockets; a frame that contacts the plurality of inflatable active pockets and at least partially surrounds the plurality of inflatable active pockets; A direct cardiac compression device comprising:

2. one or more passive chambers that taper from an opening to a vertex, a plurality of inflatable active pockets that are connected to the one or more passive chambers, taper from the opening to the vertex, and at least partially surround the one or more passive chambers, each of the plurality of inflatable active pockets being independently inflatable, and each of the plurality of inflatable active pockets not pulling adjacent ones of the plurality of inflatable active pockets when inflated, the plurality of inflatable active pockets; a support structure that contacts each of the plurality of inflatable active pockets and extends at least partially from the opening to the vertex, each of the plurality of inflatable active pockets being connected to the support structure at one or more points, the support structure; a frame that contacts the support structure and at least partially surrounds the support structure; one or more ports that are operably in communication with each of the plurality of inflatable active pockets to independently inflate and deflate the plurality of inflatable active pockets and are operably in communication with each of the one or more passive chambers to independently inflate and deflate the one or more passive chambers; A direct cardiac compression device comprising:

3. The device according to claim 1 or 2, wherein each of the plurality of inflatable active pockets is connected to the plurality of passive chambers by a fixed tab.

4. The device according to claim 3, wherein the fixed tab extends at least partially from the opening to the vertex.

5. The device according to any one of claims 1 to 4, further comprising a confinement layer disposed at least partially directly around the cardiac compression device.

6. The device according to any one of claims 1 to 5, wherein each of the plurality of inflatable active pockets is connected to the support structure at an opening or at an opening and a vertex.

7. The device according to any one of claims 1 to 6, wherein each of the inflatable active pockets of the plurality of inflatable active pockets at least partially overlaps.

8. The device according to any one of claims 1 to 7, wherein each of the plurality of inflatable active pockets is connected by spot welding, seam welding, a welding line or a combination thereof.

9. The device according to any one of claims 1 to 8, wherein the plurality of inflatable active pockets comprises 3 to 15 separate inflatable active pockets.

10. The device according to any one of claims 1 to 8, wherein the plurality of inflatable active pockets comprises 5 to 10 separate inflatable active pockets.

11. The device according to any one of claims 1 to 8, wherein the plurality of inflatable active pockets comprises 7 to 9 separate inflatable active pockets.

12. The device according to any one of claims 1 to 11, further comprising one or more fibers inserted into the frame to provide support.

13. The device according to any one of claims 1 to 12, further comprising a hub disposed at the vertex and operably communicating with one or more ports.

14. The device according to any one of claims 1 to 13, wherein the frame comprises a wire, a polymer, a shape memory material, a metal, an alloy, a composite or a combination thereof.

15. The device according to any one of claims 1 to 14, further comprising a second support structure disposed between one or more passive chambers and the plurality of inflatable active pockets.

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