WO2019204194A1

WO2019204194A1 - Cardiac treatment system and method

Info

Publication number: WO2019204194A1
Application number: PCT/US2019/027459
Authority: WO
Inventors: Aaron J. Hjelle; Mark Christopher KRAUS; James F. BUCK
Original assignee: Mardil, Inc.
Priority date: 2018-04-16
Filing date: 2019-04-15
Publication date: 2019-10-24

Abstract

Devices and methods provide localized pressure to a patient's heart to improve heart functioning. The devices include a cardiac band with pressure-exerting member(s) coupled thereto. In addition (or alternatively), the cardiac implant devices can include one or more elements for applying localized support or pressure to epicardial surface tissue adjacent to papillary muscles associated with the mitral and/or tricuspid heart valves. The localized pressure/support can modify the position of papillary muscles relative to the associated heart valve, and thereby improve adaptation of the native valve leaflets. The combined components of the implant can apply supporting or deformation forces to multiple targeted regions of the heart, such as the ventricle walls, particular valve structures, and the papillary muscles. Such supporting or deformation forces applied to multiple targeted regions of the heart can treat heart valve regurgitation effectively.

Description

CARDIAC TREATMENT SYSTEM AND METHOD

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application Serial No.

62/658,258, filed April 16, 2018, the content of which Application is incorporated herein by reference in its entirety.

TECHNICAL FIELD

[0001] The present disclosure relates to medical devices for treating heart diseases and valvular dysfunction, including valvular regurgitation.

BACKGROUND OF THE INVENTION

[0002] Various compression-style systems currently exist for treating heart diseases and conditions such as congestive heart disease and valvular dysfunction. These systems typically involve either: (a) jackets that are placed around the heart to limit heart expansion to treat congestive heart disease, including Tillable chambers to exert localized pressure to alter valve shape, or (b) bands that are placed around the base portion of the heart with fillable chambers to exert localized pressure adjacent the annulus level of the heart to re-form the shape of heart valves, for example to minimize valve leakage.

[0003] An example of the former is an early version of the present assignee’s Ventouch^® device, described for example in U.S. Patent 9,421,102. This device comprises a jacket made of a mesh material that surrounds the entirety of the lower half of the heart, from the atrial -ventricular groove to the apex of the heart, and includes one or more fillable chambers to provide localized pressure to alter valve shape and hence address valvular regurgitation issues. The mesh material provides for device in-growth with the cardiac tissue, which offers the advantage of

reinforcement of the ventricular wall to relieve cardiac wall stress, which can create ventricular dilation in many heart failure patients. The mesh ingrowth also provides a robust and safe environment to support the fillable chambers. An example of the second type of system is a device referred to as basal annuloplasty of the cardia externally, or“BACE,” also developed by the assignee of the present application and described in Hote et al .,“Report of an external basal annuloplasty device for mitral regurgitation (basal annuloplasty of the cardia externally device implantation),” Journal of the Practice of Cardiovascular Sciences. Vol. 1, Issue 2, pp. 200-02 (May-August 2015), as well as U.S. Patent 8,092,363 entitled "Heart Band With Fillable Chambers To Modify Heart Valve Function." This BACE device includes a silicone band or strip that encompasses the circumference of the heart at the level of the annulus (the upper base region of the heart, including the A-V groove), and includes several fillable chambers disposed within inner and outer layers of the silicone band such that the chambers are provided around the entire periphery of the device. The fillable chambers exert inward radial forces at the annulus level of the heart to alter valve shape. The use of silicone or similar material in the manufacture of the band or strip type implant device prevents tissue in-growth of the device, and as such facilitate removal of the device if desired.

SUMMARY

[0004] Some embodiments described herein provide a system including a cardiac implant structure configured to be positioned around the exterior of an epicardial surface of a heart. Such a system can be used, for example, to treat various heart conditions, including but not limited to functional mitral regurgitation (“FMR”), tricuspid valve regurgitation, congestive heart failure, or a combination thereof. In some cases, the cardiac implant structures described herein modify heart valve function by applying localized support or pressure to various regions of the heart.

For example, in some embodiments the cardiac implant structures described herein apply pressure to epicardial surface tissue adjacent to the mitral and/or tricuspid heart valves. This treatment can have the effect of beneficially modifying the shape of the heart valve(s) to mitigate heart valve regurgitation, which is a condition whereby blood leaks from the ventricle back through the valve into the atrium. Over time, on the left side of the heart, the back flow of blood through the mitral valve creates a damming of blood in the lungs causing symptoms of shortness of breath. This specific left heart condition causes the left ventricle to pump a greater volume of blood, which results in greater strain on this chamber of the heart.

[0005] In addition (or alternatively) to applying pressure to tissue adjacent to the mitral and/or tricuspid heart valves, in some embodiments the cardiac implant structures described herein include one or more elements for applying localized support or pressure to the epicardial surface tissue adjacent to the location(s) of papillary muscles associated with the mitral and/or tricuspid heart valves. The localized pressure/support can modify the position of papillary muscles relative to the associated heart valve, and thereby improve coaptation of the native valve leaflets in some cases. Accordingly, the combined components of the implant structure can be configured to apply supporting or deformation forces to multiple targeted regions of the heart, such as the ventricle walls of the heart, particular valve structures of the heart, and the papillary muscles of the heart. Such supporting or deformation forces to multiple targeted regions of the heart has been found to treat heart valve (mitral and/or tricuspid) regurgitation effectively.

[0006] In one aspect, this disclosure is directed to a cardiac implant for implantation around an exterior of a heart. The implant includes a band dimensioned to be circumferentially received around ventricles of the heart; one or more first pressure-exerting members coupled to or defined by the band and positioned to exert pressure on the exterior of the heart adjacent to an annulus of a targeted heart valve while the band is circumferentially positioned around the ventricles of the heart; and one or more second pressure-exerting members coupled to the band and positioned to exert pressure on the exterior of the heart adjacent to papillary muscles associated with the targeted heart valve while the band is circumferentially positioned around the ventricles of the heart.

[0007] Such a cardiac implant may optionally include a strap including a first end portion and a second end portion. The first and second end portions of the strap may be each attached to respective locations of the band such that, while the band is circumferentially positioned around the ventricles of the heart, the strap extends around the exterior of the heart passing over a location adjacent to papillary muscles associated with the targeted heart valve. The one or more second pressure-exerting members may be coupled to or defined by the strap.

[0008] In another aspect, this disclosure is directed to a cardiac implant for implantation around an exterior of a heart. The implant includes a band dimensioned to be circumferentially received around ventricles of the heart, and one or more pressure-exerting members coupled to or defined by the band and positionable, while the band is circumferentially positioned around the ventricles of the heart, to exert pressure on: (i) the exterior of the heart adjacent to an annulus of a targeted heart valve, and (ii) the exterior of the heart adjacent to papillary muscles associated with the targeted heart valve. [0009] Such a cardiac implant may optionally include one or more of the following features. Each pressure-exerting member may be or include an inflatable chamber. Each pressure- exerting member may include a rigid member and a pressure-exerting member. The rigid member may be configured to exert the pressure.

[0010] In another aspect, this disclosure is directed to a cardiac implant for implantation around an exterior of a heart. The implant includes a band dimensioned to be circumferentially received around ventricles of the heart; a first pressure-exerting member coupled to or defined by the band; and a first member coupled to the band and oriented such that, while the band is circumferentially positioned around the ventricles of the heart, the member can transfer pressure from the first pressure-exerting member to: (i) the exterior of the heart adjacent to an annulus of a targeted heart valve, and (ii) the exterior of the heart adjacent to papillary muscles associated with the targeted heart valve.

[0011] In another aspect, this disclosure is directed to a cardiac implant for implantation around an exterior of a heart. The implant includes: a band dimensioned to be circumferentially received around ventricles of the heart; one or more pressure-exerting members coupled to or defined by the band and positioned to exert pressure on the exterior of the heart adjacent to an annulus of a targeted heart valve while the band is circumferentially positioned around the ventricles of the heart; and a first strap including a first end portion and a second end portion.

The first and second end portions of the first strap are each attached to respective locations of the band such that, while the band is circumferentially positioned around the ventricles of the heart, the first strap extends around the exterior of the heart passing over a first location adjacent to papillary muscles associated with the targeted heart valve.

[0012] Such a cardiac implant may optionally include one or more of the following features. In some embodiments, the implant also includes a second strap including a first end portion and a second end portion. The first and second end portions of the second strap can be each attached to respective locations of the band such that, while the band is circumferentially positioned around the ventricles of the heart, the second strap extends around the exterior of the heart passing over a second location adjacent to papillary muscles associated with the targeted heart valve. [0013] In another aspect, this disclosure is directed to a method of treating a heart valve. The method includes implanting any of the cardiac implants described herein on an exterior surface of a heart such that the implant exerts localized pressure at: (i) the exterior of the heart adjacent to an annulus of the heart valve, and (ii) the exterior of the heart adjacent to one or more papillary muscles associated with the heart valve.

[0014] These and other embodiments described herein may provide one or more of the following benefits. First, some embodiments include an implant structure having a combination of components that operate to contemporaneously apply forces for supporting or deformation of different targeted regions of the heart. For example, the implant structure of particular embodiments of the system described can be configured to contemporaneously apply localized pressure to a defined area of the posterior lateral surface of the heart while also applying a restraining force of to the ventricle walls of the heart and a compressive supporting force to the papillary muscle region(s) of the heart.

[0015] Second, some embodiments of the system or method described herein can be used to treat various heart conditions, including but not limited to functional mitral valve regurgitation (“FMR”), tricuspid valve regurgitation, congestive heart failure, or a combination thereof. Upon implantation, implantation structure can apply forces for supporting or deformation regions of the heart in a manner that eliminates or reduces the symptoms of these conditions and that improves blood flow from the heart.

[0016] Third, some embodiments of the system or method described herein can include a delivery device configured to advantageously advanced the implant structure to the heart through a relatively small opening of a selected intercostal space proximate to the apex of the heart in a minimally-invasive manner.

[0017] The details of one or more embodiments of the invention are set forth in the

accompanying drawings and the description below. Other features, objects, and advantages of such embodiments will be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS [0018] FIG. 1 illustrates a posterior view of a human heart.

[0019] FIG. 2 illustrates the structure of a mitral valve including chordae tendineae and papillary muscles.

[0020] FIG. 3 is a cross-sectional view of the heart taken transversely through the atria and looking inferiorly.

[0021] FIG. 4 is a schematic longitudinal cross-section of a heart depicting FMR.

[0022] FIG. 5 shows the heart of FIG. 4 being treated with pressure exerted on epicardial surface tissue adjacent to the mitral valve.

[0023] FIG. 6 shows the heart of FIG. 4 being treated with pressure exerted on epicardial surface tissue adjacent to the mitral valve and also adjacent to the papillary muscles.

[0024] FIG. 7 shows an example implant that is treating a heart by exerting pressure on multiple localized epicardial surface tissue areas including adjacent to the mitral and/or tricuspid valve(s) and also adjacent to the papillary muscles.

[0025] FIG. 8 shows another example implant that is treating a heart by exerting pressure on multiple localized epicardial surface tissue areas including adjacent to the mitral and/or tricuspid valve(s) and also adjacent to the papillary muscles.

[0026] FIG. 9 shows another example implant that is treating a heart by exerting pressure on multiple localized epicardial surface tissue areas including adjacent to the mitral and/or tricuspid valve(s) and also adjacent to the papillary muscles.

[0027] FIG. 10 shows a schematic longitudinal cross-section of the heart and implant of FIG. 9.

[0028] FIG. 11 shows another example implant that is treating a heart by exerting pressure on multiple localized epicardial surface tissue areas including adjacent to the mitral and/or tricuspid valve(s) and also adjacent to the papillary muscles.

[0029] FIG. 12 shows another example implant that is treating a heart by exerting pressure on multiple localized epicardial surface tissue areas including adjacent to the mitral and/or tricuspid valve(s) and also adjacent to the papillary muscles. D TATF D DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[0030] This disclosure relates to U.S. Provisional Patent Application No. 62/558,027, entitled “Cardiac Treatment System and Method” (the“Ό27 patent application”) commonly assigned with the present application and incorporated by reference herein. The Ό27 patent application describes embodiments of a mesh type device similar to the early version of the Ventouch^® device described above, including a configuration of fillable chambers that may be filled to exert inward pressure not only at the level of the heart annulus but also adjacent the papillary muscles. This combined treatment, along with the overall constraining force applied to the ventricles of the heart, has been found to provide a very effective treatment for functional mitral valve regurgitation.

[0031] Referring to FIG. 1, a heart 100 is shown in a posterior view. Accordingly, the following vessels of the heart 100 are visible: the aortic arch 110, the superior vena cava 120, the pulmonary arteries 130, the pulmonary veins 140, and the inferior vena cava 150. Inferior to the vessels, an annular area 160 is delineated by broken lines extending around the outer periphery of the heart 100.

[0032] The annular area 160 defines, in a general manner, the epicardial surface adjacent to the mitral and/or tricuspid valves of the heart 100, in other words, it can be said that the annular area 160 is generally at the annulus level of the heart. The annular area 160 is bounded superiorly by the“atrio-ventricular” or A-V groove (the junction between the atrial and ventricular chambers of the heart 100) and extends inferiorly to slightly below the mitral and tricuspid valves of the heart 100. Application of localized pressure on the epicardial surface tissue in the annular area 160 can have the effect of beneficially modifying the shape of the mitral and/or tricuspid valves to reduce heart valve regurgitation. For example, localized pressure on the epicardial surface tissue in the annular area 160 can modify the shape of the annulus of the mitral and/or tricuspid valves to reduce heart valve regurgitation.

[0033] Inferior to the annular area 160 are regions 170 and 180 that are adjacent to papillary muscles of the mitral valve. More specifically, region 170 is referred to as the posterior medial papillary muscle (PMPM) region 170, and region 180 is referred to as the anterior lateral papillary muscle (ALPM) region 180. Application of localized pressure on the epicardial surface tissue in the PMPM region 170 and/or ALPM region 180 can have the effect of beneficially modifying the position of the papillary muscles of the mitral valve in relation to the annulus of the mitral to reduce mitral valve regurgitation. The tricuspid valve has analogous regions on the other side of the heart 100, and localized pressure can be similarly applied to reduce tricuspid valve regurgitation.

[0034] The heart 100 is enclosed within a double walled sac known as the pericardium (not shown). The inner layer of the pericardial sac is the visceral pericardium or epicardium. The outer layer of the pericardial sac is the parietal pericardium. The term“endocardial surface” refers to the inner walls of the heart. The term“epicardial surface” refers to the outer walls of the heart.

[0035] Referring also to FIG. 2, a mitral valve 200 includes an annulus 210, an anterior leaflet 220, and a posterior leaflet 230. During systole, the free edges of the anterior leaflet 220 and the posterior leaflet 230 are intended to close and seal against each other along a line of coaptation 240 (as shown). In such a case, blood being pumped out of the ventricle is occluded from flowing through the mitral valve 200 and instead flows through the aortic arch. During diastole, the free edges of the anterior leaflet 220 and the posterior leaflet 230 separate from each other to allow blood to flow through the mitral valve 200, from the left atrium and into the left ventricle.

[0036] Chordae tendineae 250 are attached on their superior ends to the leaflets 220 and 230, and on their inferior ends to papillary muscles 260. The papillary muscles 260 extend from the endocardium of the left ventricle. In effect, the chordae tendineae 250 act as tethers for the leaflets 220 and 230. Accordingly, the position(s) of the papillary muscles 260 relative to the annulus 210 affect the positions of the leaflets 220 and 230 during systole, when the free edges of the anterior leaflet 220 and the posterior leaflet 230 are intended to close and seal against each other.

[0037] Referring also to FIG. 3, a transverse cross-sectional view of the heart 100 taken through the atria and looking inferiorly reveals locations of the mitral valve 200, the tricuspid valve 300, the aortic valve 190, and the pulmonary valve 192. The approximate locations of the mitral valve papillary muscles 260 are indicated by broken-line circles. The locations of the PMPM region 170 and the ALPM region 180 are also indicated. As described further herein, application of localized pressure at one or more locations such as, but not limited to, one or more locations in the annular area 160, the PMPM region 170, and the ALPM region 180 can be effective for reducing regurgitation of the mitral valve 200 in some patients. Analogously, application of localized pressure at one or more locations such as, but not limited to, one or more locations in the annular area 160 and locations effecting the papillary muscles associated with the tricuspid valve 300 can be effective for reducing regurgitation of the tricuspid valve 300 in some patients. Multiple embodiments of implants that are configured to apply such localized pressure at one or more locations on the heart 100 to treat valve regurgitation are described herein.

[0038] Referring also to FIG. 4, an enlarged heart 100 is shown in longitudinal cross-section. For comparison, a healthy heart is shown in broken lines. The enlarged left ventricle LV of the enlarged heart 100 is causing FMR in this example. Such FMR is occurring because the left ventricle LV is distorted or dilated (enlarged), displacing the papillary muscles 260 and chordae 250 that support the two leaflets of the mitral valve 200, thereby stretching the annulus of the mitral valve 200.

[0039] Referring also to FIG. 5, a first pressure-exerting member 400 (e.g., a fillable chamber, inflatable chamber, expandable member, fillable bladder, and the like, coupled to a band device or a jacket at a specific location) can be used to exert a localized pressure on the posterior lateral surface (in the annular area 160) of the enlarged heart 100 to thereby deflect the“P2” portion of the posterior leaflet of the mitral valve 200 in an attempt to treat the FMR. While such a treatment may serve to reduce or eliminate FMR in some cases, in other cases (such as the depicted example) the effects of the distended left ventricle LV on the papillary muscles 260 and chordae 250 are not fully overcome by use of the single pressure-exerting member 400.

[0040] Referring also to FIG. 6, in some cases the effects of displaced papillary muscles 260 and chordae 250 that result from the distorted or dilated left ventricle LV can be counteracted by the use of one or more additional pressure-exerting member(s) 500 (e.g., coupled to a band device or a jacket such that when implanted the member(s) are positioned at a specific location such as the PMPM region 170 and/or the ALPM region 180). The pressure-exerting member(s) 500 can exert localized pressure on the wall of the heart 100 adjacent to the effected papillary muscles 260. Accordingly, the pressure-exerting member(s) 500 can exert localized pressure or support to gently correct the position(s) of the papillary muscles 260, and to thereby relieve tension on the chordae 250 (which otherwise prohibits normal functioning of the mitral valve 200). Such a concerted local pressurization on the heart 100 at: (i) the annulus of the mitral valve in the annular area 160 and (ii) the left ventricular wall at the location(s) of effected papillary muscles in the PMPM region 170 and/or the ALPM region 180, can be used to effectively reduce or eliminate FMR of an enlarged heart 100 in many cases.

[0041] Referring to FIG. 7, an example cardiac implant 700 can be positioned on or around the exterior of the heart 100 (e.g., positioned within the pericardial sac and directly external to the epicardial surface) to treat various heart conditions. Such heart conditions can include, but are not limited to, FMR, tricuspid valve regurgitation, and congestive heart failure. In some implementations, a superior edge portion of the implant 700 can be positioned approximately at the A-V groove. The inferior-most portions of the ventricles of the heart 100, including the apex of the heart 100, are not covered or contacted by the implant 700.

[0042] The implant 700 includes a band 710. The band 710 is dimensioned to be peripherally- received around the superior portions of the ventricles of the heart 100. The band 710 can be elastic, or inelastic, or a combination of both elastic and inelastic. The band 710 includes a first portion 720 and a second portion 740. The first portion 720 is positioned superiorly to the second portion 740 while the band 710 is circumferentially positioned around the ventricles of the heart 100. In some embodiments, the width of the first portion 720 is between about 2 cm to about 5 cm, or about 3 cm to about 6 cm, or about 4 cm to about 7 cm, or about 2 cm to about 8 cm, or about 2 cm to about 10 cm, or about 4 cm to about 10 cm, without limitation.

[0043] The first portion 720 of the band 710 includes one or more first pressure-exerting members 712 that are coupled to or defined by the band 710. It should be understood that the depicted quantity, size, shape, and locations of the first pressure-exerting members 712 relative to the first portion 720 of the band 710 are merely illustrative. Any and all other possible variations of factors such as, but not limited to, quantity, size, shape, and locations of the first pressure-exerting members 712 relative to the first portion 720 of the band 710 are also envisioned within the scope of this disclosure. [0044] The one or more first pressure-exerting members 712 are positioned to exert pressure on the exterior of the heart 100 adjacent to an annulus of a targeted heart valve while the band 710 is circumferentially positioned around the ventricles of the heart 100. For example, in some cases the one or more first pressure-exerting members 712 are positioned to exert pressure on the exterior of the heart 100 in the annular area 160 (as shown in FIG. 1). Accordingly, the one or more first pressure-exerting members 712 can modify the shape of an annulus of a targeted heart valve (e.g., mitral valve, tricuspid valve, or pulmonary valve) to treat valvular regurgitation. In some embodiments, multiple first pressure-exerting members 712 are included that are respectively positioned to exert pressure on the exterior of the heart 100 adjacent to the annuli of multiple targeted heart valves while the band 710 is circumferentially positioned around the ventricles of the heart 100. In some embodiments, two or more of the first pressure-exerting members 712 are spaced apart from each other along the band 710. Accordingly, two or more respective“localized” areas of pressure can be applied to the exterior of the heart 100 in the annular area 160 by such spaced-apart first pressure-exerting members 712. While the first pressure-exerting members 712 are depicted as generally rectangular in shape, other shapes of first pressure-exerting members 712 are also envisioned. For example, first pressure-exerting members 712 can be circular, elliptical, semi -toroidal, triangular, linear, pyramidal, irregularly shaped, and any other like shape, or combinations of shapes.

[0045] The second portion 740 of the band 710 includes one or more second pressure-exerting members 742 that are coupled to or defined by the band 710. It should be understood that the depicted quantity, size, shape, and locations of the second pressure-exerting members 742 relative to the second portion 740 and the first portion 720 of the band 710 are merely illustrative. Any and all other possible variations of factors such as, but not limited to, quantity, size, shape, and locations of the second pressure-exerting members 742 relative to the first portion 720 and the first portion 720 of the band 710 are also envisioned within the scope of this disclosure.

[0046] The one or more second pressure-exerting members 742 are positioned to exert pressure on the exterior of the heart 100 adjacent to papillary muscles of a targeted heart valve while the band 710 is circumferentially positioned around the ventricles of the heart 100. For example, in some cases the one or more second pressure-exerting members 742 are positioned to exert pressure on the exterior of the heart 100 at the PMPM region 170 and/or the ALPM region 180 (as shown in FIG. 1). Accordingly, the one or more second pressure-exerting members 742 can modify the orientation of one or more native leaflets of a targeted heart valve (e.g., mitral valve, or tricuspid valve) relative to an annulus of the targeted heart valve to treat valvular

regurgitation. In some embodiments, multiple second pressure-exerting members 742 are included that are respectively positioned to exert pressure on the exterior of the heart 100 adjacent to multiple papillary muscles of one or more targeted heart valves while the band 710 is circumferentially positioned around the ventricles of the heart 100. While the second pressure- exerting members 742 are depicted as generally trapezoidal in shape, other shapes of second pressure-exerting members 742 are also envisioned. For example, second pressure-exerting members 742 can be circular, elliptical, rectangular, semi -toroidal, triangular, linear, pyramidal, irregularly shaped, and any other like shape, or combinations of shapes.

[0047] The band 710 can be made of various materials and/or combinations of materials. For example, the band 710 can be made of materials such as, but not limited to, silicone, polyester, PTFE (polytetrafluoroethylene), expanded PTFE (ePTFE), Denier polyester, polypropylene, stainless steel, nitinol, and/or other suitable biocompatible materials and combinations thereof. Portions of the band 710, or the entirety of the band 710, can be made of a continuous sheet material in some embodiments. For example, in some embodiments, the band 710 can be made partially or entirely of a sheet of silicone rubber (which may comprise multiple laminated sheets). Portions of the band 710, or the entirety of the band 710, can be made of a mesh material (e.g., woven or knitted polyester fibers, such as an“Atlas knit” having knitted fibers with directional expansion properties) in some embodiments. In some embodiments, the band 710 can be made of a combination of materials, such as silicone rubber sheet material and polyester mesh material. In some embodiments, portions or an entirety of the band 710 can include textured surfaces to increase friction between the band 710 and the exterior of the heart 100. For example, in some embodiments, the band 710 may be mostly made of silicone sheet material, but patches of mesh material may be included to increase the friction between the band 710 and the exterior of the heart 100. Such patches of mesh material may be located at the positions of some or all of the pressure-exerting members 712 and/or 742, for example. [0048] The pressure-exerting members 712 and 742 can be various types of constructs. For example, in some embodiments, the pressure-exerting members 712 and 742 are inflatable chambers that can be selectively filled to a desired level, and subsequently adjusted if/as desired. Various types of inflation media can be used such as, but not limited to, saline, a hardening polymer, a gel, a gas, inert gasses (such as fluorocarbons), a contrast agent, or other suitable materials, and combinations thereof. As another example, in some embodiments, the pressure- exerting members 712 and 742 comprise open-cell foam members. In some such cases, the open-cell foam members are contained in an airtight cell that can be vacuum-evacuated to control the size of the open-cell foam member. In other words, a vacuum can be drawn in the airtight cell to cause the open-cell foam member to contract (in comparison to the“natural” size of the open-cell foam member when it is exposed to atmospheric pressure). Conversely, such a vacuum can be selectively partially or fully released from within the airtight cell to allow the open-cell foam member to expand toward its natural size. As a further example, the pressure- exerting members 712 and 742 can be spring members that may be compressed during implantation, and released thereafter so the spring members then exert pressure. In some embodiments, one or more of the pressure-exerting members 712 and 742 of the cardiac implant 700 can be constructed in one manner, and one or more other pressure-exerting members 712 and 742 of the same cardiac implant 700 can be constructed in one or more different manners. In some embodiments, all the pressure-exerting members 712 and 742 of the cardiac implant 700 are all the same type of construct.

[0049] In some embodiments that include inflatable chambers as one or more of the pressure- exerting members 712 and 742, the inflatable chambers are created in areas where an inner layer material of the band 710 and an outer layer material of the band 710 are not bound to one another (whereas the inner and outer layer materials at other portions of the band 710 are bound together). In some such embodiments, the inner and outer layers of the band 710 can be two different materials so that the inflatable chamber, when inflated, expands more interiorly (that is, toward the heart wall when implanted) than exteriorly. In such a case, the inflatable chamber is configured to provide a differential compliance in which the inner layer material of the inflatable chamber is significantly more compliant than the opposing (less compliant) outer layer material of the inflatable chamber. [0050] In some embodiments that include inflatable chambers as one or more of the pressure- exerting members 712 and 742, the inflatable chambers are inserted into pockets or internal spaces defined by the band 710. In some such embodiments, an inflatable chamber can be installed in particular pockets or internal spaces defined by the band 710, whereas other pockets or internal spaces defined by the band 710 can remain unfilled by an inflatable chamber. The configuration of inflatable chambers (e.g., positions and size) in a particular implant 700 can be determined on a patient-specific basis. In some cases, inflatable chambers can be added to a band 710 of an already implanted implant 700 in situ.

[0051] In particular embodiments that include inflatable chambers as one or more of the pressure-exerting members 712 and 742, the inflatable chambers are attached to a surface of the band 710, such as by heat-staking, adhering, ultrasonic welding, suturing, and the like. In certain embodiments, the inflatable chambers include peripheral sidewalls having one or more undulations (e.g., one, two, three, four, five, six, or more than six undulations). The undulations can act like the folds of a bellows (or an accordion) to allow such inflatable chambers to transition between a low profile to a substantially expanded profile for exerting localized pressure onto the exterior of the heart 100. Moreover, undulations of the peripheral sidewalls allow the transition between a low profile to a substantially expanded profile to be accomplished without material stretching, if so desired.

[0052] In some embodiments that include inflatable chambers as one or more of the pressure- exerting members 712 and 742, the inflatable chambers are inflatable/deflatable via a filling tube (such as filling tube 744 shown in FIG. 7). In some such embodiments, a single filling tube is dedicated as being in fluid communication with a single inflatable chamber. In other such embodiments, a single filling tube is in fluid communication with two or more inflatable chambers. In particular embodiments of the implant 700, one or more of the inflatable chambers is/are singularly in fluid communication with a dedicated filling tube, while two or more other inflatable chambers are in fluid communication with a shared filling tube. While no filling tubes are illustrated as connected to the inflatable chambers of the first portion 720, it should be understood that each inflatable chamber by definition has a filling tube associated therewith.

[0053] The filling tubes 744 may optionally be made of silicone and/or other types of suitable bio-implantable materials. Depending upon the method of manufacturing the implant 700, the individual filling tubes 744 may be integrally formed as the inflatable chambers of the implant 700 are formed, or they may be inserted after the inflatable chambers have been formed.

[0054] The filling tubes 744 (and inflatable chambers connected thereto) may optionally be inflated/deflated through a port-type device such as, but not limited to, a blunt needle port, a sharp needle port, a Luer port fitting, a subcutaneous port, etc. In some embodiments, a port- type device may not be used, and instead, the filling tubes 744 may be clamped in a closed position, as described previously. In some cases, the filling tubes 744 may be used for inflating and/or deflating the inflatable chambers post-implementation of the implant 700. For example, in one approach the implant 700 is first received onto the heart 100. After a period of time (e.g.: about 30 days, or 20-30 days, or 10-30 days, or 20-40 days, or 30-60 days, without limitation) fibrotic encapsulation of at least some portions of the implant 700 will have occurred. At this time, the inflatable chambers can then be inflated (e.g., through filling tubes 744 using a needle to percutaneously access a subcutaneous port attached to the filling tube(s) 744). Thus, subcutaneous ports may be employed for percutaneous inflation and deflation for therapy optimization or abandonment. Alternatively, and because in some cases implanted subcutaneous port-type devices may have potential drawbacks, clamping or plugging of the filling tubes 744 may be done, with the fluid path staying in the intercostal space and being accessible by a small "cut-down" procedure to access the filling tubes 744.

[0055] The open superior end of the cardiac implant 700 enables the implant 700 to be implanted by advancing it around the heart 100 from an inferior (apex) end of the heart 100 to become, for example, approximately aligned on the superior end with an atrial -ventricular groove of the heart 100. In some embodiments, the superior edge portion of the implant 700 can include an elastic band that can engage with the atrial -ventricular groove of the heart 100. In some implementations, the process of implanting the cardiac implant 700 can be performed in a minimally-invasive fashion, and while the heart 100 is beating. For example, in some implementations a left intercostal mini-thoracotomy using contrast pericardiography and fluoroscopic visualization can be used with a specialized implantation system to install the implant 700 onto the heart 100. After opening the parietal pericardium, the lower portion of the heart 100 is free for applying the implant 700 over the apex of the heart 100. In some implementations, the implant 700 can be secured to the heart 100 using attachment assistance from adhesives, self-firing clips, sutures, etc. In some implementations, no such attachment assistance is used to secure the implant 700 to the heart 100. For example, in some

implementations friction between the implant 700 and the heart 100 is all that is necessary to secure the implant 700 on the heart 100. Some small amount of compressive hoop-like pressure from the implant 700 onto the heart 100 may be beneficial in some cases. However, the implant 700 should not be so tight on the heart 100 as to cause a significant increase in left ventricular pressure during diastole, obstructions to the coronary arteries or other vessels such as the coronary sinus, and/or other detrimental hemodynamic effects. In other implementations, the process of implanting the cardiac implant 700 may involve a surgeon putting the cardiac implant 700 in place by hand without the use of special tools, using for example a sternotomy or thoracotomy approach.

[0056] Multiple sizes of implants 700 are envisioned that are suitable for treating multiple sizes of hearts 100. For example, the diameters of the band 710 can be available in incremental sizes. In some embodiments, the width of the band 710 can also be available in incremental sizes. Accordingly, in some implementations an implant 700 of a particular size can be selected for a patient based on a pre-operative measurement of the patient’s heart 100. For example, in some instances a measurement is taken of the patient’s largest ventricular perimeter, and that measurement is used to select the size of implant 700 to be used for that patient. In some embodiments, a particular size of implant 700 can be used for a range of heart measurement values. For example, a particular size of implant 700 may be used for a range of maximum ventricular perimeters of 36.9 cm to 40.0 cm. Another size of implant 700 may be used for a range of maximum ventricular perimeters of 40.1 cm to 43.4 cm. Still another size of implant 700 may be used for a range of maximum ventricular perimeters of 34.0 cm to 36.8 cm, and so on. It should be understood that these ranges of maximum ventricular perimeters provided are merely illustrative, and are non-limiting examples. In addition, factors such as the band 710 material compliance and size, the compliance of an optional elastic band on the superior end portion of the band 710, and fillable chamber construction may be selected in accordance with the teachings herein to achieve implant design configurations that enable a fewer number of sizes for a wide range of heart sizes, thereby achieving inventory cost benefits. [0057] One or more types of imaging modalities can be used to facilitate the implantation process. For example, such imaging modalities can include, but are not limited to

transesophageal echocardiography (TEE), fluoroscopy, MRI, computed tomography, and the like, and combinations thereof. In some embodiments, the cardiac implant 700 can include one or more radiopaque markers (e.g., tantalum, platinum, tungsten, palladium alloys, and the like) to denote particular landmarks on the implant 700 and/or to define the orientation of the implant 700. For example, in some embodiments one or more radiopaque markers can be used to define the position(s) of the pressure-exerting members 712 and/or 742 (e.g., around the periphery of the pressure-exerting members 712 and/or 742), the edge(s) of the implant 700 (e.g., the superior edge), and the like. In some implant procedures, contrast agent solutions are injected into the heart 100, or within the pericardial space, to enhance the radiographical visualization of anatomical features of the heart 100 on which an implant 700 is to be installed and is to be oriented relative to.

[0058] Referring to FIG. 8, another example cardiac implant 800 can be positioned on or around the exterior of the heart 100 (e.g., positioned within the pericardial sac and directly external to the epicardial surface) to treat various heart conditions. Such heart conditions can include, but are not limited to, FMR, tricuspid valve regurgitation, and congestive heart failure. In some implementations, a superior edge portion of the implant 800 can be positioned approximately at the A-V groove of the heart.

[0059] The implant 800 includes a band 810. The band 810 is dimensioned to be peripherally- received around the superior portions of the ventricles of the heart 100. The band 810 can be elastic, or inelastic, or a combination of both elastic and inelastic. The band 810 includes a first portion 820 and a second portion 840. The first portion 820 is positioned superiorly to the second portion 840 while the band 810 is circumferentially positioned around the ventricles of the heart 100.

[0060] The cardiac implant 800 can include any of the features and variations of features that are described above in reference to the cardiac implant 700 (FIG. 7). That is, the above descriptions of the elements, portions, materials, constructs, configurations, implantation techniques, and so on, pertaining to cardiac implant 700 generally also apply to implant 800.

One particular distinction pertaining to the implant 800 in comparison to the implant 700 is the inclusion of one or more pressure-exerting members 842 that extend over both portions 820 and 840. Accordingly, it can be envisioned that the one or more pressure-exerting members 842 that extend over both portions 820 and 840 are configured to exert pressure on: (i) the exterior of the heart 100 adjacent to an annulus of a targeted heart valve (in the annular area 160 as shown in FIG. 1), and (ii) the exterior of the heart 100 adjacent to papillary muscles associated with the targeted heart valve (at the PMPM region 170 and/or the ALPM region 180 as shown in FIG. 1). While the cardiac implant 800 is depicted here as treating a mitral valve of the heart 100, it should be understood that the implant 800 can alternatively or additionally be configured to treat a tricuspid valve of the heart 100 and/or a pulmonary valve of the heart 100 in an analogous manner.

[0061] Referring to FIGS. 9 and 10, another example cardiac implant 900 can be positioned on or around the exterior of the heart 100 (e.g., positioned within the pericardial sac and directly external to the epicardial surface) to treat various heart conditions. Such heart conditions can include, but are not limited to, FMR, tricuspid valve regurgitation, and congestive heart failure.

In some implementations, a superior edge portion of the implant 900 can be positioned approximately at the A-V groove of the heart 100.

[0062] The implant 900 includes a band 910. The band 910 is dimensioned to be peripherally- received around the superior portions of the ventricles of the heart 100. The band 910 can be elastic, or inelastic, or a combination of both elastic and inelastic.

[0063] The cardiac implant 900 can include any of the features and variations of features that are described above in reference to the cardiac implant 700 (FIG. 7). That is, the above descriptions of the elements, portions, materials, constructs, configurations, implantation techniques, and so on, pertaining to cardiac implant 700 generally also apply to implant 900. For example, one or more pressure-exerting members 912 can be coupled to the band 910. While the implant 900 is depicted here as having a single pressure-exerting member 912, two or more pressure-exerting members 912 can be included along the band 910.

[0064] The cardiac implant 900 also includes one or more members 942. In some embodiments, the member 942 is a thin elongate element that stiffly resists bending (has high flexural rigidity). The member 942 can be made of any suitable material including, but not limited to, thermoplastics, polycarbonate, fluoropolymers, ABS, polyesters, nylon, sulfone, polypropylene, polyurethane, stainless steel, titanium, and the like, and combinations thereof. In some embodiments, the member 942 can be adjustable, such as malleable, trim-able, shapeable, expandable, and the like. In some embodiments, the entire surface of the member 942 that abuts the heart 100 is planar. In particular embodiments, the entire surface of the member 942 that abuts the heart 100 is not planar, but is contoured, multi-planar, and the like. The member 942 can have any suitable shape. In some embodiments, portions or the entirety of the surface of the member 942 can be textured to increase friction with the exterior of the heart 100. In some embodiments, portions or the entirety of the member 942 can include radiopaque markers that identify the orientation of the member 942 under x-ray fluoroscopy.

[0065] The member 942 is coupled to the band 910 and oriented such that, while the band 910 is circumferentially positioned around the superior portions of the ventricles of the heart 100 as shown, the member 942 can transfer pressure from the pressure-exerting member 912 to: (i) the exterior of the heart 100 adjacent to an annulus of a targeted heart valve, and (ii) the exterior of the heart 100 adjacent to papillary muscles associated with the targeted heart valve. In other words, the pressure-exerting member 912 presses against the member 942, and the member 942, in turn, simultaneously presses against the exterior surface of the heart 100 in both the annular area 160 (FIG. 1) and an area adjacent to a papillary muscle (e.g., the PMPM region 170, the ALPM region 180, or an analogous region for papillary muscles of the tricuspid valve). While in the depicted embodiment of implant 900, a single combination of a pressure-exerting member 912 and a member 942 is shown, it should be understood that in some embodiments two or more combinations of a pressure-exerting member 912 and an associated member 942 can be included. Moreover, in some embodiments one or more additional pressure-exerting member 912 (without an associated member 942) can be included that exerts pressure directly on the annular area 160 alone.

[0066] In a variation of the embodiment shown in FIGS. 9 and 10, the device 900 may be configured such that the rigid member 942 is positioned vis-a-vis the pressure-exerting member 912 such that a superior portion of the rigid member 942 is on the outside of the pressure- exerting member 912, as opposed to be on the inside of the pressure-exerting member 912 as shown in FIGS. 9 and 10. In this variation, when the pressure-exerting member 912 is expanded, it may cause the rigid member 942 to pivot such that the inferior portion of the rigid member 942 may in some cases provide a greater force at a location adjacent the papillary muscle.

[0067] Referring to FIG. 11, another example cardiac implant 1100 can be positioned on or around the exterior of the heart 100 (e.g., positioned within the pericardial sac and directly external to the epicardial surface) to treat various heart conditions. Such heart conditions can include, but are not limited to, FMR, tricuspid valve regurgitation, and congestive heart failure.

In some implementations, a superior edge portion of the implant 1100 can be positioned approximately at the A-V groove of the heart 100.

[0068] The cardiac implant 1100 can include any of the features and variations of features that are described above in reference to the cardiac implant 700 (FIG. 7). That is, the above descriptions of the elements, portions, materials, constructs, configurations, implantation techniques, and so on, pertaining to cardiac implant 700 generally also apply to implant 1100.

[0069] The implant 1100 includes a band 1110. The band 1110 is dimensioned to be peripherally-received around the superior portions of the ventricles of the heart 100. The band 1110 can be elastic, or inelastic, or a combination of both elastic and inelastic. The band 1110 includes a first portion 1120 and a second portion 1140. The first portion 1120 is positioned superiorly to the second portion 1140 while the band 1110 is circumferentially positioned around the ventricles of the heart 100.

[0070] The first portion 1120 of the band 1110 includes one or more first pressure-exerting members 1112 that are coupled to or defined by the band 1110. It should be understood that the depicted quantity, size, shape, and locations of the first pressure-exerting members 1112 relative to the first portion 1120 of the band 1110 are merely illustrative. Any and all other possible variations of factors such as, but not limited to, quantity, size, shape, and locations of the first pressure-exerting members 1112 relative to the first portion 1120 of the band 1110 are also envisioned within the scope of this disclosure (e.g., as described above in the context of first pressure-exerting members 712 and band 710).

[0071] A strap 1141 extends from the band 1110, looping around the inferior ventricle regions of the heart 100, including at or near the apex of the heart 100 in some implementations. A first end portion of the strap 1141 is attached to a portion of the band 1110 (e.g., as visible), and a second end portion of the strap 1141 (the opposite end in comparison to the first end) is also attached to another portion of the band 1110 (not visible, on the opposite side of the heart 100). The strap 1141 is oriented to extend over an exterior surface of the heart 100 adjacent to papillary muscles of a mitral valve and/or tricuspid valve (e.g., at the PMPM region 170, the ALPM region 180, and/or an analogous region for papillary muscles of the tricuspid valve).

[0072] The strap 1141 can be made of any of the materials described above in reference to the strap 710. In some embodiments, the strap 1141 and the band 1110 are made of the same material. In some embodiments, the strap 1141 and the band 1110 are made of differing materials. The strap 1141 can be made of an elastic material or an inelastic material, or a combination of both. In particular embodiments, the strap 1141 is length adjustable.

[0073] In some embodiments, such as the depicted embodiment, one or more second pressure- exerting members 1142 are coupled to or defined by the strap 1141. In some embodiments, the strap 1141 does not include any second pressure-exerting members 1142 coupled thereto. The second pressure-exerting member(s) 1142 is/are oriented to exert localized pressure against an exterior surface of the heart 100 adjacent to papillary muscles of a mitral valve and/or tricuspid valve (e.g., at the PMPM region 170, the ALPM region 180, and/or an analogous region for papillary muscles of the tricuspid valve). Accordingly, one or more first pressure-exerting members 1112 can exert pressure against the exterior of the heart 100 in the annular area 160 to reshape an annulus of a targeted heart valve, and simultaneously one or more second pressure- exerting members 1142 can exert pressure against the exterior of the heart 100 adjacent to papillary muscles of the targeted heart valve. In some embodiments, multiple valves of the heart 100 can be treated concurrently by the same implant 1100.

[0074] Referring to FIG. 12, another example cardiac implant 1200 can be positioned on or around the exterior of the heart 100 (e.g., positioned within the pericardial sac and directly external to the epicardial surface) to treat various heart conditions. Such heart conditions can include, but are not limited to, FMR, tricuspid valve regurgitation, and congestive heart failure. In some implementations, a superior edge portion of the implant 1200 can be positioned approximately at the A-V groove of the heart 100. [0075] The cardiac implant 1200 can include any of the features and variations of features that are described above in reference to the cardiac implant 700 (FIG. 7). That is, the above descriptions of the elements, portions, materials, constructs, configurations, implantation techniques, and so on, pertaining to cardiac implant 700 generally also apply to implant 1200.

[0076] The implant 1200 includes a band 1210. The band 1210 is dimensioned to be peripherally-received around superior portions of the ventricles of the heart 100. The band 1210 includes one or more first pressure-exerting members 1212 that are coupled to or defined by the band 1210. It should be understood that the depicted quantity, size, shape, and locations of the first pressure-exerting members 1212 relative to the band 1210 are merely illustrative. Any and all other possible variations of factors such as, but not limited to, quantity, size, shape, and locations of the first pressure-exerting members 1212 relative to the band 1210 are also envisioned within the scope of this disclosure (e.g., as described above in the context of first pressure-exerting members 712 and band 710).

[0077] A first strap l24la extends from the band 1210, looping around the inferior ventricle regions of the heart 100. Additionally, a second strap l24lb extends from the band 1210, looping around the inferior ventricle regions of the heart 100. As depicted, the straps l24la and l24lb can loop around opposite sides of the inferior ventricle regions of the heart 100. First end portions of the straps l24la-b are attached to a portion of the band 1210 (e.g., as visible), and second end portions of the straps l24la-b (the opposite ends in comparison to the first ends) are also attached to another portion of the band 1210 (not visible, on the opposite side of the heart 100). In some embodiments, one or both of the straps l24la-b are oriented to extend over exterior surfaces of the heart 100 adjacent to papillary muscles of a mitral valve and/or tricuspid valve (e.g., at the PMPM region 170, the ALPM region 180, and/or an analogous region for papillary muscles of the tricuspid valve). Accordingly, one or more first pressure-exerting members 1212 can exert pressure against the exterior of the heart 100 in the annular area 160 to reshape an annulus of a targeted heart valve, and simultaneously one or both straps l24la-b can exert pressure against the exterior of the heart 100 adjacent to papillary muscles of the targeted heart valve. In some embodiments, multiple valves of the heart 100 can be treated concurrently by the same implant 1200. [0078] The straps l24la-b can be made of any of the materials described above in reference to the strap 710. In some embodiments, the straps l24la-b and the band 1210 are made of the same material. In some embodiments, the straps l24la-b and the band 1210 are made of differing materials. The straps l24la-b can be made of an elastic material, or an inelastic material, or a combination of both. In particular embodiments, one or both of the straps l24la-b are length adjustable.

[0079] A number of embodiments of the invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the scope of the invention. Accordingly, other embodiments are within the scope of the following claims.

Claims

CLAIMS What is claimed is:

1. A cardiac implant for implantation around an exterior of a heart, the implant comprising: a band dimensioned to be circumferentially received around ventricles of the heart;

one or more first pressure-exerting members coupled to or defined by the band and positioned to exert pressure on the exterior of the heart adjacent to an annulus of a targeted heart valve while the band is circumferentially positioned around the ventricles of the heart; and

one or more second pressure-exerting members coupled to the band and positioned to exert pressure on the exterior of the heart adjacent to papillary muscles associated with the targeted heart valve while the band is circumferentially positioned around the ventricles of the heart.

2. The implant of claim 1, further comprising a strap including a first end portion and a second end portion, wherein the first and second end portions of the strap each attached to respective locations of the band such that, while the band is circumferentially positioned around the ventricles of the heart, the strap extends around the exterior of the heart passing over a location adjacent to papillary muscles associated with the targeted heart valve, and

wherein the one or more second pressure-exerting members coupled to or defined by the strap.

3. A cardiac implant for implantation around an exterior of a heart, the implant comprising:

a band dimensioned to be circumferentially received around ventricles of the heart; and one or more pressure-exerting members coupled to or defined by the band and

positionable, while the band is circumferentially positioned around the ventricles of the heart, to exert pressure on: (i) the exterior of the heart adjacent to an annulus of a targeted heart valve, and (ii) the exterior of the heart adjacent to papillary muscles associated with the targeted heart valve.

4. The implant of claim 3, wherein each pressure-exerting member comprises an inflatable chamber.

5. The implant of claim 3, wherein each pressure-exerting member comprises a rigid member and a pressure-exerting member, and wherein the rigid member is configured to exert the pressure.

6. A cardiac implant for implantation around an exterior of a heart, the implant comprising: a band dimensioned to be circumferentially received around ventricles of the heart; a first pressure-exerting member coupled to or defined by the band; and

a first member coupled to the band and oriented such that, while the band is

circumferentially positioned around the ventricles of the heart, the member can transfer pressure from the first pressure-exerting member to: (i) the exterior of the heart adjacent to an annulus of a targeted heart valve, and (ii) the exterior of the heart adjacent to papillary muscles associated with the targeted heart valve.

7. A cardiac implant for implantation around an exterior of a heart, the implant comprising: a band dimensioned to be circumferentially received around ventricles of the heart; one or more pressure-exerting members coupled to or defined by the band and positioned to exert pressure on the exterior of the heart adjacent to an annulus of a targeted heart valve while the band is circumferentially positioned around the ventricles of the heart; and

a first strap including a first end portion and a second end portion, wherein the first and second end portions of the first strap are each attached to respective locations of the band such that, while the band is circumferentially positioned around the ventricles of the heart, the first strap extends around the exterior of the heart passing over a first location adjacent to papillary muscles associated with the targeted heart valve.

8. The cardiac implant of claim 7, further comprising a second strap including a first end portion and a second end portion, wherein the first and second end portions of the second strap are each attached to respective locations of the band such that, while the band is circumferentially positioned around the ventricles of the heart, the second strap extends around the exterior of the heart passing over a second location adjacent to papillary muscles associated with the targeted heart valve.

9. A method of treating a heart valve, the method comprising:

implanting the implant of any one of claims 1-8 on an exterior surface of a heart such that the implant exerts localized pressure at: (i) the exterior of the heart adjacent to an annulus of the heart valve, and (ii) the exterior of the heart adjacent to one or more papillary muscles associated with the heart valve.