WO2020096862A1

WO2020096862A1 - Percutaneous treatment of heart failure with reduced ejection fraction

Info

Publication number: WO2020096862A1
Application number: PCT/US2019/059249
Authority: WO
Inventors: Nima V. NIA; Hengchu Cao
Original assignee: Edwards Lifesciences Corporation
Priority date: 2018-11-08
Filing date: 2019-10-31
Publication date: 2020-05-14

Abstract

A cardiac device comprises a cloth configured to extend from a first ventricle wall to a second ventricle wall, a first plurality of anchoring elements configured to secure the cloth to a first area of tissue at the first ventricle wall, a second anchoring element configured to secure the cloth to a second area of tissue at a second ventricle wall, and a cinching device. The cinching device is configured to attach to the first portion of the cloth and apply force to the first portion of the cloth to move the first plurality of anchoring elements towards the second anchoring element and at least partially compress the ventricle. The first plurality of anchoring elements are positioned around a first portion of the cloth.

Description

PERCUTANEOUS TREATMENT OF HEART FAIUURE WITH REDUCED

EJECTION FRACTION

RELATED APPLICATION

[0001] This application claims priority to U.S. Provisional Application No.

62/757,295, filed on November 8, 2018, entitled PERCUTANEOUS TREATMENT OF HEART FAILURE WITH REDUCED EJECTION FRACTION, the disclosure of which is hereby incorporated by reference in its entirety.

BACKGROUND

[0002] The present disclosure generally relates to the field of improving heart performance.

[0003] Heart Failure with reduced Ejection Fraction (HFrEF), also known as systolic heart failure, is characterized by an inability of the heart to contract adequately, resulting in less oxygen-rich blood being expelled into the body. Functional mitral valve regurgitation (FMR) is a disease that occurs when the left ventricle of the heart is distorted or dilated, displacing the papillary muscles that support the two valve leaflets. When the valve leaflets can no longer come together to close the annulus, blood may flow back into the atrium.

SUMMARY

[0004] In some implementations, the present disclosure relates to a cardiac device comprising a cloth configured to extend from a first ventricle wall to a second ventricle wall, a first plurality of anchoring elements configured to secure the cloth to a first area of tissue at the first ventricle wall, a second anchoring element configured to secure the cloth to a second area of tissue at a second ventricle wall, and a cinching device. The cinching device is configured to attach to the first portion of the cloth and apply force to the first portion of the cloth to move the first plurality of anchoring elements towards the second anchoring element and at least partially compress the ventricle. The first plurality of anchoring elements are positioned around a first portion of the cloth.

[0005] In some embodiments, the first area of tissue is at a posterior wall and the second area of tissue is at a septum. The cinching device may be attached to the first portion of the cloth at a point that is approximately equidistant from each anchoring element of the first plurality of anchoring elements. In some embodiments, the first plurality of anchoring elements comprises five or more anchoring elements. The cinching device may not contact the first plurality of anchoring elements. In some embodiments, each of the cloth and the cinching device passes between two papillary muscles of the ventricle.

[0006] The cardiac device may further comprise a second plurality of anchoring elements configured to secure the cloth to the second area of tissue at the second ventricle wall. The second plurality of anchoring elements may comprise the second anchoring element. In some embodiments, the cardiac device further comprises a third plurality of anchoring elements configured to secure the cloth to a third area of tissue between the first area of tissue and the second area of tissue. The third plurality of anchoring elements may be positioned around a second portion of the cloth. In some embodiments, the cinching device is further configured to attach to the second portion of the cloth at a point that is approximately equidistant from each anchoring element of the third plurality of anchoring elements. The third area of tissue may be at an apex region of the ventricle. In some embodiments, the cardiac device further comprises a fourth plurality of anchoring elements configured to secure the cloth to a fourth area of tissue between the first area of tissue and the third area of tissue. The cardiac device may further comprise a fifth plurality of anchoring elements configured to secure the cloth to a fifth area of tissue between the second area of tissue and the third area of tissue.

[0007] In some implementations, the present disclosure relates to a method comprising inserting a catheter into a ventricle of a heart and passing a cardiac device through the catheter. The cardiac device comprises a cloth configured to extend from a first ventricle wall to a second ventricle wall, a first plurality of anchoring elements, a second anchoring element, and a cinching device. The method further comprises attaching the cinching device to a first portion of the cloth, passing the first plurality of anchoring elements through the cloth to secure the cloth to a first area of tissue at the first ventricle wall, passing the second plurality of anchoring elements through the cloth to secure the cloth to a second area of tissue at a second ventricle wall, tightening the cinching device to apply force to the first portion of cloth to move the first plurality of anchoring elements towards the second anchoring element and at least partially compress the ventricle, and locking the cinching device in place. The first plurality of anchoring elements are positioned around the first portion of the cloth;

[0008] In some embodiments, the first area of tissue is at a posterior wall and the second area of tissue is at a septum. The cinching device may be attached to the first portion of the cloth at a point that is approximately equidistant from each anchoring element of the first plurality of anchoring elements. In some embodiments, the first plurality of anchoring elements comprises five or more anchoring elements.

[0009] The cardiac device may further comprise a second plurality of anchoring elements. The second plurality of anchoring elements may comprise the second anchoring element. In some embodiments, the method further comprises passing the second plurality of anchoring elements through the cloth to secure the cloth to the second area of tissue at the second ventricle wall.

[0010] In some embodiments, the cinching device does not contact the first plurality of anchoring elements. Each of the cloth and the cinching device may pass between two papillary muscles of the ventricle.

[0011] The cardiac device may further comprise a third plurality of anchoring elements. In some embodiments, the method further comprises passing the third plurality of anchoring elements through the cloth to secure the cloth to a third area of tissue between the first area of tissue and the second area of tissue. The third plurality of anchoring elements may be positioned around a second portion of the cloth.

[0012] In some implementations, the present disclosure relates to an apparatus for remodeling a ventricle, the apparatus comprising a means for distributing force configured to extend from a first ventricle wall to a second ventricle wall and a first plurality of means for anchoring configured to secure the means for distributing force to a first area of tissue at the first ventricle wall. The first plurality of means for anchoring are positioned around a first portion of the means for distributing force. The apparatus further comprises a second means for anchoring configured to secure the means for distributing force to a second area of tissue at a second ventricle wall and a means for cinching configured to attach to the first portion of the means for distributing force and apply force to the first portion of the means for distributing force to move the first plurality of means for anchoring towards the second means for anchoring and at least partially compress the ventricle.

[0013] In some embodiments, the first area of tissue is at a posterior wall and the second area of tissue is at a septum. The means for cinching may be attached to the first portion of the means for distributing force at a point that is approximately equidistant from each means for anchoring of the first plurality of means for anchoring. In some embodiments, the first plurality of means for anchoring may comprise five or more means for anchoring.

[0014] The apparatus may further comprise a second plurality of means for anchoring configured to secure the means for distributing force to the second area of tissue at the second ventricle wall. The second plurality of means for anchoring may comprise the second means for anchoring. In some embodiments, the means for cinching does not contact the first plurality of means for anchoring. Each of the means for distributing force and the means for cinching may pass between two papillary muscles of the ventricle.

[0015] In some embodiments, the apparatus further comprises a third plurality of means for anchoring configured to secure the means for distributing force to a third area of tissue between the first area of tissue and the second area of tissue. The third plurality of means for anchoring may be positioned around a second portion of the means for distributing force. In some embodiments, the means for cinching is further configured to attach to the second portion of the means for distributing force at a point that is approximately equidistant from each means for anchoring of the third plurality of means for anchoring.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Various embodiments are depicted in the accompanying drawings for illustrative purposes, and should in no way be interpreted as limiting the scope of the inventions. In addition, various features of different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondence between reference elements.

[0017] Figure 1 provides a cross-sectional view of a human heart.

[0018] Figure 2 provides a cross-sectional view of the left ventricle and left atrium of an example heart.

[0019] Figure 3 provides a cross-sectional view of a heart experiencing mitral regurgitation.

[0020] Figure 4 illustrates a delivery process for a device for reducing ventricle volume in accordance with one or more embodiments.

[0021] Figure 5 shows a ventricle remodeling device implanted in the left ventricle in accordance with one or more embodiments.

[0022] Figure 6 is a cross-section view (viewed from above) of the heart showing an implanted ventricle remodeling device having two anchoring points in accordance with one or more embodiments.

[0023] Figure 7 is a cross-section view of the heart (viewed from above) with an implanted ventricle remodeling device having more than two anchoring points along the ventricle walls in accordance with one or more embodiments.

[0024] Figure 8 is a flow diagram representing a process for remodeling a ventricle of the heart in accordance with one or more embodiments. DETAILED DESCRIPTION

[0025] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0026] Although certain preferred embodiments and examples are disclosed below, inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and to modifications and equivalents thereof. Thus, the scope of the claims that may arise herefrom is not limited by any of the particular

embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain embodiments; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

[0027] In humans and other vertebrate animals, the heart generally comprises a muscular organ having four pumping chambers, wherein the flow thereof is at least partially controlled by various heart valves, namely, the aortic, mitral (or bicuspid), tricuspid, and pulmonary valves. The valves may be configured to open and close in response to a pressure gradient present during various stages of the cardiac cycle (e.g., relaxation and contraction) to at least partially control the flow of blood to a respective region of the heart and/or to blood vessels (e.g., pulmonary, aorta, etc.).

[0028] Figure 1 illustrates an example representation of a heart 1 having various features relevant to certain embodiments of the present inventive disclosure. The heart 1 includes four chambers, namely the left atrium 2, the left ventricle 3, the right ventricle 4, and the right atrium 5. A wall of muscle 17, referred to as the septum, separates the left 2 and right 5 atria and the left 3 and right 4 ventricles. The heart 1 further includes four valves for aiding the circulation of blood therein, including the tricuspid valve 8, which separates the right atrium 5 from the right ventricle 4. The tricuspid valve 8 may generally have three cusps or leaflets and may generally close during ventricular contraction (i.e., systole) and open during ventricular expansion (i.e., diastole). The valves of the heart 1 further include the pulmonary valve 9, which separates the right ventricle 4 from the pulmonary artery 11, and may be configured to open during systole so that blood may be pumped toward the lungs, and close during diastole to prevent blood from leaking back into the heart from the pulmonary artery. The pulmonary valve 9 generally has three cusps/leaflets, wherein each one may have a crescent-type shape. The heart 1 further includes the mitral valve 6, which generally has two cusps/leaflets and separates the left atrium 2 from the left ventricle 3. The mitral valve 6 may generally be configured to open during diastole so that blood in the left atrium 2 can flow into the left ventricle 3, and advantageously close during diastole to prevent blood from leaking back into the left atrium 2. The aortic valve 7 separates the left ventricle 3 from the aorta 12. The aortic valve 7 is configured to open during systole to allow blood leaving the left ventricle 3 to enter the aorta 12, and close during diastole to prevent blood from leaking back into the left ventricle 3.

[0029] Heart valves may generally comprise a relatively dense fibrous ring, referred to herein as the annulus, as well as a plurality of leaflets or cusps attached to the annulus. Generally, the size of the leaflets or cusps may be such that when the heart contracts the resulting increased blood pressure produced within the corresponding heart chamber forces the leaflets at least partially open to allow flow from the heart chamber. As the pressure in the heart chamber subsides, the pressure in the subsequent chamber or blood vessel may become dominant, and press back against the leaflets. As a result, the leaflets/cusps come in apposition to each other, thereby closing the flow passage.

[0030] The atrioventricular (i.e., mitral and tricuspid) heart valves may further comprise a collection of chordae tendineae and papillary muscles for securing the leaflets of the respective valves to promote and/or facilitate proper coaptation of the valve leaflets and prevent prolapse thereof. The papillary muscles, for example, may generally comprise finger like projections from the ventricle wall. With respect to the tricuspid valve 8, the normal tricuspid valve may comprise three leaflets (two shown in Figure 1) and three corresponding papillary muscles 10 (two shown in Figure 1). The leaflets of the tricuspid valve may be referred to as the anterior, posterior and septal leaflets, respectively. The valve leaflets are connected to the papillary muscles 10 by the chordae tendineae 13, which are disposed in the right ventricle 4 along with the papillary muscles 10. Although tricuspid valves are described herein as comprising three leaflets, it should be understood that tricuspid valves may occur with two or four leaflets in certain patients and/or conditions; the principles relating to papillary muscle repositioning disclosed herein are applicable to atrioventricular valves having any number of leaflets and/or papillary muscles associated therewith.

[0031] The right ventricular papillary muscles 10 originate in the right ventricle wall, and attach to the anterior, posterior and septal leaflets of the tricuspid valve, respectively, via the chordae tendineae 13. The papillary muscles 10 of the right ventricle 4 may have variable anatomy; the anterior papillary may generally be the most prominent of the papillary muscles. The papillary muscles 10 may serve to secure the leaflets of the tricuspid valve 8 to prevent prolapsing of the leaflets into the right atrium 5 during ventricular systole. Tricuspid regurgitation can be the result of papillary dysfunction or chordae rupture.

[0032] With respect to the mitral valve 6, a normal mitral valve may comprise two leaflets (anterior and posterior) and two corresponding papillary muscles 15. The papillary muscles 15 originate in the left ventricle wall and project into the left ventricle 3. Generally, the anterior leaflet may cover approximately two-thirds of the valve annulus. Although the anterior leaflet covers a greater portion of the annulus, the posterior leaflet may comprise a larger surface area in certain anatomies.

[0033] The valve leaflets of the mitral valve 6 may be prevented from prolapsing into the left atrium 2 by the action of the chordae tendineae 16 tendons connecting the valve leaflets to the papillary muscles 15. The relatively inelastic chordae tendineae 16 are attached at one end to the papillary muscles 15 and at the other to the valve leaflets; chordae tendineae from each of the papillary muscles 15 are attached to a respective leaflet of the mitral valve 6. Thus, when the left ventricle 3 contracts, the intraventricular pressure forces the valve to close, while the chordae tendineae 16 keep the leaflets coapting together and prevent the valve from opening in the wrong direction, thereby preventing blood to flow back to the left atrium 2. The various chords of the chordae tendineae may have different thicknesses, wherein relatively thinner chords are attached to the free leaflet margin, while relatively thicker chords (e.g., strut chords) are attached farther away from the free margin.

[0034] Figure 2 provides a cross-sectional view of the left ventricle 3 and left atrium 2 of an example heart 1. The diagram of Figure 2 shows the mitral valve 6, wherein the disposition of the valve 6, papillary muscles 15 and/or chordae tendineae 16 may be illustrative as providing for proper coapting of the valve leaflets to advantageously at least partially prevent regurgitation and/or undesirable flow into the left atrium from the left ventricle 3 and vice versa. Although a mitral valve 6 is shown in Figure 2 and various other figures provided herewith and described herein in the context of certain embodiments of the present disclosure, it should be understood that papillary muscle repositioning principles disclosed herein may be applicable with respect to any atrioventricular valve and associated anatomy (e.g., papillary muscles, chordae tendineae, ventricle wall, etc.), such as the tricuspid valve.

[0035] As described above, with respect to a healthy heart valve as shown in Figure 2, the valve leaflets 61 may extend inward from the valve annulus and come together in the flow orifice to permit flow in the outflow direction (e.g., the downward direction in Figure 2) and prevent backflow or regurgitation toward the inflow direction (e.g., the upward direction in Figure 2). For example, during atrial systole, blood flows from the atria 2 to the ventricle 3 down the pressure gradient, resulting in the chordae tendineae 16 being relaxed due to the atrioventricular valve 6 being forced open. When the ventricle 3 contracts during ventricular systole, the increased blood pressures in both chambers may push the valve 6 closed, preventing backflow of blood into the atria 2. Due to the lower blood pressure in the atria compared to the ventricles, the valve leaflets may tend to be drawn toward the atria. The chordae tendineae 16 can serve to tether the leaflets and hold them in a closed position when they become tense during ventricular systole. The papillary muscles 15 provide structures in the ventricles for securing the chordae tendineae 16 and therefore allowing the chordae tendineae 16 to hold the leaflets in a closed position. The papillary muscles 15 may include a first papillary muscle 15a (e.g., an anterolateral papillary muscle, which may be primarily tethered to the anterior leaflet, for example) and a second papillary muscle 15p (e.g., the posteromedial papillary muscle, which may be primarily tethered to the posterior leaflet, for example). Each of the first papillary muscle 15a and second papillary muscle 15p may provide chordae tendineae 16 to each valve leaflet (e.g., the anterior and posterior leaflets). With respect to the state of the heart 1 shown in Figure 2, the proper coaptation of the valve leaflets, which may be due in part to proper position of the papillary muscles 15, may advantageously result in mitral valve operation substantially free of leakage.

[0036] Heart valve disease represents a condition in which one or more of the valves of the heart fails to function properly. Diseased heart valves may be categorized as stenotic, wherein the valve does not open sufficiently to allow adequate forward flow of blood through the valve, and/or incompetent, wherein the valve does not close completely, causing excessive backward flow of blood through the valve when the valve is closed. In certain conditions, valve disease can be severely debilitating and even fatal if left untreated. With regard to incompetent heart valves, over time and/or due to various physiological conditions, the position of papillary muscles may become altered, thereby potentially contributing to valve regurgitation. For example, as shown in Figure 3, which illustrates a cross-sectional view of a heart 1 experiencing mitral regurgitation flow 21, dilation of the left ventricle may cause changes in the position of the papillary muscles 15 that allow flow 21 back from the ventricle 3 to the atrium 2. Dilation of the left ventricle can be caused by any number of conditions, such as focal myocardial infarction, global ischemia of the myocardial tissue, or idiopathic dilated cardiomyopathy, resulting in alterations in the geometric relationship between papillary muscles and other components associated with the valve(s) that can cause valve regurgitation. Functional regurgitation may further be present even where the valve components may be normal pathologically, yet may be unable to function properly due to changes in the surrounding environment. Examples of such changes include geometric alterations of one or more heart chambers and/or decreases in myocardial contractility. In any case, the resultant volume overload that exists as a result of an insufficient valve may increase chamber wall stress, which may eventually result in a dilatory effect that causes papillary muscle alteration resulting in valve dysfunction and degraded cardiac efficiency.

[0037] With further reference to Figure 3, the heart 1 is shown in a state where functional mitral valve regurgitation (FMR) is present. FMR may be considered a disease of the left ventricle 3, rather than of the mitral valve 6. For example, mitral valve regurgitation may occur when the left ventricle 3 of the heart 1 is distorted or dilated, displacing the papillary muscles 15 that support the two valve leaflets 61. The valve leaflets 61 therefore may no longer come together sufficiently to close the annulus and prevent blood flow back into the atrium 2. If left untreated, the FMR experienced in the state shown in Figure 3 may overload the heart 1 and can possibly lead to or accelerate heart failure. Solutions presented herein provide devices and methods for moving the papillary muscles 15 closer to their previous position, which may advantageously reduce the occurrence of mitral regurgitation.

[0038] As shown in Figure 3, the leaflets 61 of the mitral valve (or tricuspid valve) are not in a state of coaptation, resulting in an opening between the mitral valve leaflets 61 during the systolic phase of the cardiac cycle, which allows the leakage flow 21 of fluid back up into the atrium 2. The papillary muscles 15 may be displaced due to dilation of the left ventricle 3, or due to one or more other conditions, as described above, which may contribute to the failure of the valve 6 to close properly. The failure of the valve leaflets 61 to coapt properly may result in unwanted flow in the outflow direction (e.g., the upward direction in Figure 3) and/or unwanted backflow or regurgitation toward the inflow direction (e.g., the downward direction in Figure 2).

[0039] Some embodiments disclosed herein provide solutions for treating FMR and/or heart failure with reduced ejection fraction (HFrEF) without the need for surgical procedures or destroying cardiac tissue. In particular, passive techniques to improve valve performance are disclosed for improving cardiac function. Further, various embodiments disclosed herein provide for the treatment of FMR and/or HFrEF that can be executed on a beating heart, thereby allowing for the ability to assess the efficacy of the treatment and potentially implement modification thereto without the need for bypass support.

[0040] Some embodiments involve remodeling one or more ventricles (e.g., reducing ventricular volume) to restore valve function and/or improve ejection fraction. Ventricular remodeling (e.g., reducing left ventricle volume) can potentially treat FMR and/or HFrEF by, for example, repositioning the papillary muscles to improve coaptation of valve leaflets. Some embodiments described herein involve reducing ventricle volume by inserting a means for cinching, which may include a cord, band, suture, string, tube, or other length of material (referred to herein collectively as a“cord,”“cinching device,”“tensioning member,” or “means for cinching”) into a ventricle and anchoring the cord to multiple walls of the ventricle. By tightening the cord, the walls of the ventricle may be repositioned inward.

[0041] In some embodiments, a mechanical device for treating FMR, HFrEF, and/or other diseases may be delivered to an affected area of tissue via a transcatheter procedure. The device may comprise a plurality of means for anchoring (also referred to herein as “anchoring elements”), including corkscrews, hooks, barbs, etc., which may be delivered to one or more ventricle walls. As used herein, the term“ventricle wall” is used according to its broad and ordinary meaning and may refer to any area of tissue separating a ventricle from another chamber of the heart or an area outside the heart and may include, for example, the septum, posterior walls, and the region of the ventricle near the apex of the heart, among others.

[0042] The plurality of anchoring elements may be configured to anchor a means for distributing force, which may include a cloth or similar device, to one or more ventricle walls. As used herein, the term“cloth” is used according to its broad and ordinary meaning and may refer to any piece of material (e.g., polyethylene terephthalate (PET)) suitable for implanting in a human heart and distributing force across the anchoring elements and/or portions of the ventricle walls. For example, the cloth may be a flat sheet of material or may be a sheet of shaped material having, for example, a tube-like shape. The cloth may be flexible and/or may be configured to stretch when force is applied to it.

[0043] In some embodiments, a cloth may be attached to one or more cords. As used herein, the term“cord” is used according to its broad and ordinary meaning and may refer to a suture, band, tube, string, or similar device. A cord may be sized and/or shaped to attach to and/or fit into one or more cloths. In some embodiments, a cord may comprise one or more attachment mechanisms for attaching to the cloth and/or may be pre-attached to the cloth. Each of the anchoring element(s), cloth(s), and/or cord(s) may be delivered and adjusted using a transfemoral (artery), transapical, or transseptal procedure. Once in place, the anchoring element(s), cloth(s), and/or cord(s) may be detached from the delivery system and left in the heart an implant. In some embodiments, a cloth may be pre-attached to at least one end of a cord (i.e., the cloth may be attached to the cord before the cloth is introduced into the ventricle). The cord may be tightened to apply pulling force to one or more anchoring elements, cloths, and/or cords and/or to press the anchoring elements and/or ends of the cloth together, thereby reducing a distance between a plurality of ventricle walls to reduce ventricle volume and treat FMR and/or HFrEF. For example, a cloth may be anchored to a first ventricle wall by one or more anchoring elements. One or more cords may extend from at or near a second ventricle and may attach to the cloth. The one or more cords may be tightened and/or cinched to cause the cloth and/or anchoring elements to move towards the second ventricle wall. As a result, the first ventricle wall may be pulled towards the second ventricle wall and/or the second ventricle wall may be pulled towards the first ventricle wall.

[0044] One or more anchoring elements may directly contact and/or anchor one or more cords and/or may contact and/or anchor a cloth or tube (referred to herein collectively as a“cloth”) that may be attached to the cord. For example, a cord may be situated at least partially inside a cloth (e.g., passing through the cloth) and/or may be attached to a portion of the cloth (e.g., a central portion of the cloth). The cloth may be anchored to at least one ventricle wall by one or more anchoring elements. In some embodiments, the cord may be anchored (directly and/or indirectly) to multiple ventricle walls. For example, the cloth may be anchored to a posterior wall of the heart by one or more anchoring elements and the cord may be anchored to the posterior wall by virtue of the cord being attached to the cloth.

Moreover, the cord may extend from the cloth to the septum and/or other ventricle wall and may be anchored at the septum and/or other anchoring wall by one or more anchoring elements, cloths, and/or other devices. In some embodiments, the cord may be tightened and/or cinched to reduce a distance between multiple ventricle walls, thereby causing reduction of ventricle volume. For example, a length of the cord within a ventricle (e.g., the left ventricle) may be reduced when the cord is tightened and/or cinched. Accordingly, the cord may be configured to apply pulling force to one or more ventricle walls when the cord is tightened and/or cinched. [0045] In some embodiments, one or more anchoring elements may comprise threaded devices (e.g., corkscrews), barbs, hooks, and/or other devices configured to puncture and secure to a ventricle wall. Multiple anchoring elements may be used to attach one or more cloths to one or more ventricle walls in order to provide greater surface area for applying pressure to the ventricle wall(s). Accordingly, when a cord is attached to the one or more cloths, force applied by the cord may be configured to apply pressure at each of the anchoring elements anchoring the one or more cloths. For example, a cord may be attached to a cloth at a central position between multiple anchoring elements configured to anchor the cloth to ventricle wall (e.g., a posterior wall of the left ventricle). By tightening and/or cinching the cord, pressure may be applied at the central position of the cloth and may be correspondingly applied to each of the anchoring elements. In this way, strain at any one individual anchor may be limited, which may reduce risk and/or extent of damage to the tissue the anchoring elements are anchored to.

[0046] Figure 4 illustrates a delivery process for a device for reducing ventricle volume. In some embodiments, a catheter 401 may be inserted into the heart 1. In the example shown in Figure 4, the catheter 401 is inserted into the right ventricle 4. The catheter 401 is then passed through the septum 17 into the left ventricle 3. However, the catheter 401 may alternatively be inserted into the left ventricle 3. The catheter 401 may be inserted through the tricuspid valve, aortic valve, mitral valve, apex region (transapical), or through any other valve and/or ventricle wall. In the example shown in Figure 4, the device may be configured to reduce volume of the left ventricle 3, however some embodiments may involve reducing volume of the right ventricle 4 and/or other heart chamber. By passing the device through the septum 17, there may be a reduced risk of bleeding and open-heart surgery may not be required for implanting the device.

[0047] A cord 402 and/or one or more anchoring elements 404 may be passed through the catheter 401 for delivery into the heart 1. Each of the one or more anchoring elements 404 may be embedded and/or anchored into a ventricle wall. While only a single anchoring element 404 is shown in Figure 4, multiple anchoring elements 404 may be passed through the catheter 401 and/or anchored into the ventricle wall (see, e.g., Figure 5). As shown in Figure 4, one or more anchoring elements 404 may be anchored and/or embedded into the posterior wall 18 of the left ventricle 3. In some embodiments, the one or more anchoring elements 404 may be configured to penetrate one or more ventricle walls and/or may be configured to attach to an outer surface of the one or more ventricle walls. The anchoring elements 404 may be composed of metal, plastic, polymer, Teflon, Nitinol, felt, or other material. In some embodiments, the anchoring elements 404 may be composed of a rigid material in order to maintain a desired level of pressure at the posterior wall 18, septum 17, or other tissue area and/or ventricle wall.

[0048] In some embodiments, the cord 402 may comprise one or more lengths of material and/or may be attached to a cloth. Each of the one or more lengths of material may comprise a suture, string, cord, wire, band, tube, or other similar device. In some

embodiments, the cord 402 may comprise one or more flexible or rigid mechanisms and may be capable of tightening (e.g., cinching) to reduce a length of the cord 402 situated within one or more ventricles (e.g., the left ventricle 3 in Figure 4). Moreover, the cord 402 may be configured to attach to one or more ventricle walls and/or attach to devices anchored to one or more ventricle walls. For example, the cord 402 may be attached to one or more anchoring elements 404 and/or one or more cloths attached to the one or more anchoring elements 404 anchored to a first ventricle wall (e.g., the posterior wall 18) and/or a second ventricle wall (e.g., the septum 17). Accordingly, tightening the cord 402 may be configured to decrease a distance between one or more anchoring elements at the first ventricle wall and one or more anchoring elements at the second ventricle wall. The cord 402 may be connected to any of the one or more anchoring elements, may pass between two or more anchoring elements (e.g., may be pinched between the two or more anchoring elements), and/or may be connected to a cloth anchored to a ventricle wall by one or more anchoring elements. In some embodiments, the cord 402 may be configured to be tightened and locked into place through use of a locking element or otherwise.

[0049] While only one anchoring element 404 is shown in Figure 4, any number of anchoring elements 404 may be anchored to a ventricle wall. In some embodiments, the anchoring elements 404 may engage one or more ventricle walls (e.g., the posterior wall 18) after a cloth is situated between the anchoring elements 404 and the ventricle wall and/or after delivery of the cloth. For example, the cloth may be passed through the catheter 401 and situated against or near the posterior wall 18. One or more anchoring elements 404 may then be used to anchor the cloth to the posterior wall 18. In some embodiments, the cord 402 may be attached to the cloth, and in some cases an end of the cord 402 may be attached to a point of the cloth that is approximately equidistant from each of two or more anchoring elements 404.

[0050] While the process shown in Figure 4 involve passing the catheter 401 first into the right ventricle 4 and through the septum 401 into the left ventricle 3, catheters 401 may be delivered in other ways. For example, a catheter 401 may be delivered into the left ventricle 3 via the aortic valve or other entry point. In some embodiments, anchoring elements 404 may be delivered to multiple ventricle walls. For example, a catheter delivered to the left ventricle 3 via the aortic valve may be positioned to deliver one or more anchoring elements 404 to the posterior wall 18 and to the septum 17, apex region of the left ventricle 3, one or more papillary muscles, and/or other area(s) of tissue within the left ventricle 3.

[0051] Figure 5 shows a ventricle remodeling device implanted in the left ventricle 3 via the process shown in Figure 4 or otherwise. As shown in Figure 5, a first set of anchoring elements 504a may be embedded into a posterior wall 18 and/or a second set of anchoring elements 504b may be embedded in the septum 17. In some embodiments, the first set of anchoring elements 504a and/or the second set of anchoring elements 504b may be configured to fix a portion of a cloth 506 to a ventricle wall and/or to at least partially secure a cord 502 which may be attached to at least one portion of the cloth. For illustrative purposes, Figure 5 shows a pentagonal portion 506 of a cloth that may extend further than is shown in Figure 5. For example, the first portion 506 of the cloth shown in Figure 5 may represent only a portion of the cloth that may be anchored between the first set of anchoring elements 504a. In some embodiments, the cloth may comprise a generally tubular (see, e.g., Figures 6 and 7) or other form. However, only the first portion 506 is shown in Figure 5 to illustrate how the first set of anchoring elements 506a may be configured to anchor the first portion 506 of the cloth to a ventricle wall.

[0052] As shown in Figure 5, the first set of anchoring elements 504a may anchor a first portion 506 of a cloth to the posterior wall 18 or other ventricle wall. In some embodiments, the cloth may span a length of a ventricle and may, for example, be affixed to each of the posterior wall 18 and the septum 17. For illustrative purposes, only a first portion 506 of the cloth is shown in Figure 5. While five anchoring elements 504a are shown at the posterior wall 18 and three anchoring elements 504b are shown at the septum 17, any number of anchoring elements may be anchored at each ventricle wall. In some embodiments, the anchoring elements (e.g., 504a) may be spaced apart in such a way that a center point 508 of the first portion 506 of the cloth is approximately equidistant from each anchor. A first end of the cord 502 may attach to the first portion 506 at or near the center point 508. The cord 502 may be tightened to apply pressure to the first portion 506 and a second portion of the cloth anchored to a second ventricle wall (e.g., the septum 17), which may in turn apply pressure to each of the first anchoring elements 504a and the second anchoring elements 504b, thereby causing the ventricle walls to reposition inwards and reducing a distance between the ventricle walls (e.g., the posterior wall 18 and the septum 17). In optional embodiments, the cloth may be anchored to only a first ventricle wall.

[0053] In some embodiments, the cloth may be composed of PET or other suitable material. The cloth may have some elasticity and may be stretched to increase the surface area of the cloth. Similarly, the cord 502 may be composed of an elastic material to allow the cord 502 to stretch as necessary. In some embodiments, the cloth and/or cord 502 may be inelastic and/or may not be stretched.

[0054] In some embodiments, the second set of anchoring elements 504b can be anchored to the septum 17 and at least a portion of the cord 502 can pass through the septum 17. The cord 502 can be cinched at and/or locked in place by the second set of anchoring elements 504b. For example, the second set of anchoring elements 504b may be configured to pinch and/or otherwise hold the cord 502 in a cinched position. In some embodiments, an end of the cord 502 may be accessible to a surgeon and when the cord 502 is pulled, the cord 502 may tighten and/or cinch to pull the first set of anchoring elements 504a and the second set of anchoring elements 504b closer together. After the cord 502 is tightened, the cord 502 may be locked in place (e.g., restricted from loosening) by the second set of anchoring elements 504b and/or a locking mechanism at the septum 17 or elsewhere.

[0055] In some embodiments, a delivery mechanism (e.g., a catheter) may be used for attaching the anchoring elements 504a, 504b to the ventricle walls. For example, the mechanism may be suitable for twisting an anchoring element to screw the anchoring element into a ventricle wall. In some embodiments, the mechanism may be used to detect infarctions in the tissue and/or to avoid portions of tissue that are more fibrous than other portions.

[0056] Figure 6 is a cross-section view (viewed from above) of the heart showing an implanted ventricle remodeling device having two anchoring points. While the device is illustrated as being implanted in the left ventricle 3, the device may alternatively be implanted in the right ventricle 4 or other chamber. The device comprises a cloth 606 and a cord 602 passing through the cloth 606. One or more ends of the cord 602 may be attached to the cloth 606. For example, an end of the cord 602 may be attached to the cloth 606 at a portion of the cloth 606 that is anchored to a first ventricle wall (e.g., the posterior wall 18).

In some embodiments, the cord 602 may be pre-attached to the cloth 606 when the cloth 606 is delivered to the ventricle, while in some embodiments the cord 602 may be attached to the cloth 606 after the cloth 606 is delivered to the ventricle.

[0057] The cloth 606 may be anchored to one or more ventricle walls using anchoring elements. In the example shown in Figure 6, the cloth 606 is anchored to a first anchoring point at the posterior wall 18 by a first set of anchoring elements 604a and to a second anchoring point at the septum 17 by a second set of anchoring elements 604b. The cloth 606 and/or cord 602 may pass between a first papillary muscle l5a and a second papillary muscle 15r. In some embodiments, the device may be positioned to avoid contact with the papillary muscles and chordae tendineae in the ventricle. In some embodiments, the endpoints of the cloth 606 may be anchored at opposing (i.e., facing) ventricle walls. While the cloth 606 and/or cord 602 are shown in Figure 6 passing between the papillary muscles, the cloth and/or cord 602 may be situated at any position within a ventricle.

[0058] As the cord 602 is tightened, the cord 602 may apply force to the first set of anchoring elements 604a and the second set of anchoring elements 604b to cause the first set of anchoring elements 604a to move towards the second set of anchoring elements 604b and/or to cause the second set of anchoring elements 604b to move towards the first set of anchoring elements 604a. Accordingly, tightening the cord 602 may cause the posterior wall 18 and septum 17 to move closer together, thereby reducing the volume of the left ventricle 3. While three anchoring elements are shown in the first set of anchoring elements 604a and the second set of anchoring elements 604b, this is only for illustrative purposes and different numbers of anchoring elements may be used at each anchoring point. Moreover, a number of anchoring elements of the first set of anchoring elements 604a may be different than a number of anchoring elements of the second set of anchoring elements 604b.

[0059] In some embodiments, the cloth 606 may have a generally elastic form and/or may be configured to stretch and/or compress. As shown in Figure 6 (and Figure 7), the cloth 606 may be configured to form folds, creases, and/or other features in a compressed form. As the cloth 606 is stretched and/or expanded, the cloth 606 may be configured to flatten out. In this way, the cloth 606 and/or cord 602 may be configured to accommodate different chamber sizes and/or may be configured to adjust to changing distances between the ventricle walls that the cloth 606 and/or cord 602 may be anchored to. In some embodiments, the cloth 606 may be composed of an elastic material that does not form ridges and/or creases when the cloth 606 is compressed.

[0060] Figure 7 is a cross-section view of the heart (viewed from above) with an implanted ventricle remodeling device having more than two anchoring points along the ventricle walls. As shown in Figure 7, the cloth 706 may be anchored at a plurality of points (e.g., five points in Figure 7) along the ventricle walls such that the cord 702, at least partially, follows the natural curvature of the ventricle. The cloth 706 may be anchored such that the cloth 706 and cord 702 do not contact and/or damage the papillary muscles and/or chordae tendineae in the ventricle. In some embodiments, the endpoints of the cloth 706 may be at opposing (i.e., facing) ventricle walls. In the example shown in Figure 7, a first end/portion of the cloth 706 is anchored at the posterior wall 18 by a first set of anchoring elements 704a and a second portion of the cloth 706 is anchored at the septum 17 by a second set of anchoring elements 704b. Additional anchor sets 704c, 704d, 704e may anchor the cloth 706 at various points on the ventricle walls. In the example shown in Figure 7, the additional anchor sets 704c, 704d, 704e are anchored radially in a horizontal orientation with respect to the left ventricle 3. However, the additional anchor sets 704c, 704d, 704e may be anchored along different orientations, for example along the apex region of the heart (e.g., into the page of the cross-section view shown in Figure 7) or at any other points on the ventricle walls. While the anchor sets 704a-704e may be positioned at various points in the ventricle, the positions of each of the anchor sets 704a-704e may form a continuous line (e.g., a direct route) along the ventricle such that the cord 702 generally follows the natural curvature of the ventricle.

[0061] When the cord 702 is tightened, the cord 702 may apply force to each of the anchor sets 704a-704e. The amount of force applied to each anchor set may be different. For example, because the cord 702 may be attached to a cloth portion anchored by the first set of anchoring elements 704a, the cord 702 may apply a greater force to the first set of anchoring elements 704a than to anchor sets 704c-704e, at which the cord 702 may not be attached.

[0062] In optional embodiments, the cord 702 may attach to the cloth at portions of the cloth anchored to the ventricle by intermediary anchor sets (e.g., anchor sets 704c-704e). For example, the cord 702 may attach to the cloth 706 at a portion of the cloth 706 surrounded by the third set of anchoring elements 704c, the fourth set of anchoring elements 704d, and/or the fifth set of anchoring elements 704e. The cord 702 may be pre-attached to a plurality of points on the cloth 706 and/or may attach to points on the cloth after the cloth is anchored to the ventricle.

[0063] In some embodiments, the cloth 706 may have a generally tubular resting form. However, the cloth 706 may be configured to stretch as necessary to be anchored to multiple points along the ventricle. For example, as shown in Figure 7, the cloth 706 may be configured to form five ends at each of the anchoring points (i.e., at 704a-704e).

[0064] Figure 8 is a flow diagram representing a process 800 for remodeling a ventricle of the heart according to one or more embodiments disclosed herein. While some steps of the process 800 may be directed to the left ventricle, such steps may also be applied to the right ventricle. [0065] At step 802, the process 800 involves inserting a remodeling device comprising a cloth, cord, and one or more anchoring elements into a ventricle of the heart using a transcatheter procedure. For example, the remodeling device may be delivered using a transfemoral, transendocardial, transcoronary, transseptal, transapical, or other approach. In optional embodiments, the remodeling device may be introduced into the desired location during an open-chest surgical procedure, or using other surgical or non-surgical techniques known in the art.

[0066] In some embodiments, the remodeling device may be inserted into the right ventricle (e.g., through the pulmonary valve or tricuspid valve) where it can remodel the right ventricle or may be passed through the septum into the left ventricle. Alternatively, the remodeling device may be inserted into the left ventricle (e.g., through the aortic valve or mitral valve) where it can remodel the left ventricle or may be passed through the septum into the right ventricle. For a transapical procedure, the remodeling device may be inserted through the apex via a catheter.

[0067] The remodeling device may comprise one or more connected and/or connectable elements. In some embodiments, the remodeling device comprises a cloth and one or more anchoring elements for anchoring the cloth to one or more tissue walls. The remodeling device may further comprise a cord for pulling portions of the cloth closer together. In some embodiments, the cord may be attached to the cloth and/or the anchoring elements. In some embodiments, a guidewire may be inserted into the ventricle to facilitate delivery of the cloth, anchoring elements, and/or cord.

[0068] In some embodiments, the remodeling device may be fed through a catheter (e.g., a transfemoral catheter) that may be inserted into the left ventricle or right ventricle. Needles and/or other devices may be passed through the catheter to penetrate the septum and/or other ventricle walls. For example, a transseptal needle may be introduced to pass through the septum from the right ventricle to the left ventricle. The catheter may be sized to accommodate the various elements of the remodeling device. For example, the catheter may have a diameter of at least 12 French to fit anchoring elements having a diameter equal to or less than 12 French.

[0069] In certain embodiments, the one or more connected elements may be inserted at different stages. In one use case, the cloth and/or cord may be inserted before the anchoring elements. For example, a first end of the cloth may be inserted through a catheter into the ventricle. Anchoring elements may then be inserted through the cloth and may puncture one or more ends of the cloth. A first end of each anchoring element may remain within the cloth while a second end of each anchoring element may pass through the cloth and penetrate a tissue wall to secure the cloth against the tissue wall.

[0070] In some use cases, the cord may be pre-attached to the cloth while in other use cases, the cord may comprise an attachment device for attaching to the cloth. The attachment device may comprise one or more of a barb, hook, loop, clasp, magnet, peg, or other mechanism. In some embodiments, the attachment device may be a barb configured to puncture the cloth from inside the cloth and secure against the outside of the cloth. The cord may be attached to the cloth at a point that is approximately equidistant from each anchoring element of a set of anchoring elements. For example, a set of five anchoring elements may be positioned to form a pentagonal pattern around a portion of cloth. The cord may be attached at a center point of the portion of cloth.

[0071] The anchoring element may be any kind of mechanical device configured to attach or otherwise connect to a tissue wall. For example, the anchoring element may comprise a Nitinol wire and/or mesh that may be shape-set in a pre-defined shape (e.g., a corkscrew). The anchoring element may be compressed to pass through a catheter and, after passing through the catheter, may reshape to the pre-defined shape. In some embodiments, the anchoring element may be configured to be twisted, pressed, or otherwise engaged via a catheter or other mechanism to force the anchoring element into a tissue wall.

[0072] The remodeling device may be positioned to cause remodeling of a ventricle while avoiding damage to the papillary muscles, chordae tendineae, and/or other heart anatomy. For example, the cloth, cord, and anchoring elements may be positioned to avoid contacting the papillary muscles during delivery and after delivery of the remodeling device.

[0073] At step 804, the process 800 involves anchoring the cloth to a first ventricle wall. In some embodiments, a plurality of anchoring elements may be used to anchor the cloth to the first ventricle wall. Each of the plurality of anchoring elements may be evenly spaced from a point at which the cloth connects to a first end of the cord.

[0074] In some embodiments, one or more anchoring elements may have a compressed (e.g., lower profile) form during delivery in order to fit through a catheter or similar device and may expand after delivery. For example, the first anchoring elements may be composed of Nitinol or another material with shape-memory characteristics.

[0075] At step 806, the process 800 involves anchoring the cloth to a second ventricle wall (e.g., the septum). In some embodiments, a plurality of anchoring elements may be used to anchor the cloth to the second ventricle wall. Each of the plurality of anchoring elements may be evenly spaced from the cord. In some embodiments, the cord may contact or otherwise engage the plurality of anchoring elements at the second ventricle wall. For example, the anchoring elements may be configured to pinch the cord to hold the cord in place.

[0076] In some embodiments, the cloth may be anchored to various intermediary points of the ventricle between the first ventricle wall and second ventricle wall. For example, the cloth may be anchored to the septum, the posterior wall, and at the apex region.

Moreover, there may be multiple sets of anchoring elements at each ventricle wall. For example, a first set of anchoring elements may anchor a first portion of the cloth to the posterior wall and a second set of anchoring elements may anchor a second portion of the cloth to the posterior wall, where the second portion of the cloth is closer to the apex region than the first portion. A third set of anchoring elements may anchor a third portion of the cloth to the apex region of the ventricle. A fourth set of anchoring elements may anchor a fourth portion of the cloth to the septum.

[0077] At step 808, the process 800 involves tightening the cord. In some

embodiments, the cord may pass through the cloth (e.g., through an opening or gap in the cloth). One or more ends of the cord may be accessible to a surgeon, for example via a catheter. In some embodiments, tightening the cord may involve pulling one or more ends of the cord. The cord may be tightened as necessary to cause a desired amount of ventricle remodeling. Tightening the cord may reduce a distance between the anchoring elements at the first ventricle wall and the anchoring elements at the second ventricle wall, thereby applying force to move the ventricle walls closer together.

[0078] At step 810, the process 800 involves locking the cord, cloth, and/or anchoring elements in place. In some embodiments, one or more locking mechanisms may be delivered (e.g., via the catheter) for use in locking one or more ends of the cord in place. For example, a locking mechanism may be fitted around the cord and may be configured to slide along the cord and/or pinch or otherwise engage the cord at a desired position to prevent movement of the cord, cloth, and or anchoring elements. After the cord is locked in place, excess length of the cord may be cut off or otherwise removed.

[0079] The process 800 and/or other processes, devices, and systems disclosed herein may advantageously provide mechanisms for implementing ventricular remodeling using a fully transcatheter procedure on a beating heart. In certain embodiments, valve leaflets may not be substantially touched or damaged during the process 800. Furthermore, in certain embodiments, the remodeling device may be designed to be retrievable. [0080] Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein can be performed in a different sequence, may be added, merged, or left out altogether. Thus, in certain embodiments, not all described acts or events are necessary for the practice of the processes.

[0081] Conditional language used herein, such as, among others,“can,”“could,” “might,”“may,”“e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is intended in its ordinary sense and is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular embodiment. The terms “comprising,”“including,”“having,” and the like are synonymous, are used in their ordinary sense, and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term“or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term“or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase“at least one of X, Y and Z,” unless specifically stated otherwise, is understood with the context as used in general to convey that an item, term, element, etc. may be either X, Y or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y and at least one of Z to each be present.

[0082] It should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than are expressly recited in that claim. Moreover, any components, features, or steps illustrated and/or described in a particular embodiment herein can be applied to or used with any other embodiment(s). Further, no component, feature, step, or group of components, features, or steps are necessary or indispensable for each embodiment. Thus, it is intended that the scope of the inventions herein disclosed and claimed below should not be limited by the particular embodiments described above, but should be determined only by a fair reading of the claims that follow.

Claims

WHAT IS CLAIMED IS:

1. A cardiac device comprising:

a cloth configured to extend from a first ventricle wall to a second ventricle wall; a first plurality of anchoring elements configured to secure the cloth to a first area of tissue at the first ventricle wall, wherein the first plurality of anchoring elements are positioned around a first portion of the cloth;

a second anchoring element configured to secure the cloth to a second area of tissue at the second ventricle wall; and

a cinching device configured to attach to the first portion of the cloth and apply force to the first portion of the cloth to move the first plurality of anchoring elements towards the second anchoring element and at least partially compress the ventricle.

2. The cardiac device of claim 1, wherein the first area of tissue is at a posterior wall and the second area of tissue is at a septum.

3. The cardiac device of claim 1 or claim 2, wherein the cinching device is attached to the first portion of the cloth at a point that is approximately equidistant from each anchoring element of the first plurality of anchoring elements.

4. The cardiac device of any of claims 1-3, wherein the first plurality of anchoring elements comprises five or more anchoring elements.

5. The cardiac device of any of claims 1-4, further comprising a second plurality of anchoring elements configured to secure the cloth to the second area of tissue at the second ventricle wall, wherein the second plurality of anchoring elements comprises the second anchoring element.

6. The cardiac device of any of claims 1-5, wherein the cinching device does not contact the first plurality of anchoring elements.

7. The cardiac device of any of claims 1-6, wherein each of the cloth and the cinching device passes between two papillary muscles of the ventricle.

8. The cardiac device of any of claims 1-7, further comprising a third plurality of anchoring elements configured to secure the cloth to a third area of tissue between the first area of tissue and the second area of tissue, wherein the third plurality of anchoring elements are positioned around a second portion of the cloth.

9. The cardiac device of claim 8, wherein the cinching device is further configured to attach to the second portion of the cloth at a point that is approximately equidistant from each anchoring element of the third plurality of anchoring elements.

10. The cardiac device of claim 8 or claim 9, wherein the third area of tissue is at an apex region of the ventricle.

11. The cardiac device of any of claims 8-10, further comprising a fourth plurality of anchoring elements configured to secure the cloth to a fourth area of tissue between the first area of tissue and the third area of tissue.

12. The cardiac device of any of claims 8-11, further comprising a fifth plurality of anchoring elements configured to secure the cloth to a fifth area of tissue between the second area of tissue and the third area of tissue.

13. A method comprising:

inserting a catheter into a ventricle of a heart;

passing a cardiac device through the catheter, the cardiac device comprising:

a cloth configured to extend from a first ventricle wall to a second ventricle wall;

a first plurality of anchoring elements;

a second anchoring element; and

a tensioning member;

attaching the tensioning member to the cloth at a first point of the cloth;

passing the first plurality of anchoring elements through the cloth to secure the cloth to a first area of tissue at the first ventricle wall, wherein each anchoring element of the first plurality of anchoring elements is positioned approximately equidistant from the first point; passing the second plurality of anchoring elements through the cloth to secure the cloth to a second area of tissue at a second ventricle wall;

tightening the tensioning member to apply force at the first point of the cloth to move the first plurality of anchoring elements towards the second anchoring element and at least partially compress the ventricle; and

locking the tensioning member in place.

14. The method of claim 13, wherein the first area of tissue is at a posterior wall and the second area of tissue is at a septum.

15. The method of claims 13 or claim 14, wherein the first plurality of anchoring elements comprises five or more anchoring elements.

16. The method of any of claims 13-15, wherein the cardiac device further comprises a second plurality of anchoring elements, the second plurality of anchoring elements comprises the second anchoring element, and the method further comprises passing the second plurality of anchoring elements through the cloth to secure the cloth to the second area of tissue at the second ventricle wall.

17. The method of any of claims 13-16, wherein the tensioning member does not contact the first plurality of anchoring elements.

18. The method of any of claims 13-17, wherein each of the cloth and the tensioning member passes between two papillary muscles of the ventricle.

19. The method of any of claims 13-18, wherein:

the cardiac device further comprises a third plurality of anchoring elements;

the method further comprises passing the third plurality of anchoring elements through the cloth to secure the cloth to a third area of tissue between the first area of tissue and the second area of tissue; and

the third plurality of anchoring elements is positioned around a second portion of the cloth.

20. An apparatus for remodeling a ventricle, the apparatus comprising:

a means for distributing force configured to extend from a first ventricle wall to a second ventricle wall;

a first plurality of means for anchoring configured to secure the means for distributing force to a first area of tissue at the first ventricle wall, wherein the first plurality of means for anchoring are positioned around a first portion of the means for distributing force;

a second means for anchoring configured to secure the means for distributing force to a second area of tissue at a second ventricle wall; and

a means for cinching configured to:

attach to the first portion of the means for distributing force, and to apply force to the first portion of the means for distributing force to move the first plurality of means for anchoring towards the second means for anchoring and at least partially compress the ventricle.

21. The apparatus of claim 20, wherein the first area of tissue is at a posterior wall and the second area of tissue is at a septum.

22. The apparatus of claim 20 or claim 21, wherein the means for cinching is attached to the first portion of the means for distributing force at a point that is approximately equidistant from each means for anchoring of the first plurality of means for anchoring.

23. The apparatus of any of claims 20-22, wherein the first plurality of means for anchoring comprises five or more means for anchoring.

24. The apparatus of any of claims 20-23, further comprising a second plurality of means for anchoring configured to secure the means for distributing force to the second area of tissue at the second ventricle wall, wherein the second plurality of means for anchoring comprises the second means for anchoring.

25. The apparatus of any of claims 20-24, wherein the means for cinching does not contact the first plurality of means for anchoring.

26. The apparatus of any of claims 20-25, wherein each of the means for distributing force and the means for cinching passes between two papillary muscles of the ventricle.

27. The apparatus of any of claims 20-26, further comprising a third plurality of means for anchoring configured to secure the means for distributing force to a third area of tissue between the first area of tissue and the second area of tissue, wherein the third plurality of means for anchoring are positioned around a second portion of the means for distributing force.

28. The apparatus of claim 27, wherein the means for cinching is further configured to attach to the second portion of the means for distributing force at a point that is

approximately equidistant from each means for anchoring of the third plurality of means for anchoring.