WO2020167456A1

WO2020167456A1 - Tissue anchor for treatment of heart failure

Info

Publication number: WO2020167456A1
Application number: PCT/US2020/015419
Authority: WO
Inventors: Nima V. NIA; Hengchu Cao
Original assignee: Edwards Lifesciences Corporation
Priority date: 2019-02-13
Filing date: 2020-01-28
Publication date: 2020-08-20

Abstract

A remodeling device comprises a first anchoring element configured to penetrate a first side of a first tissue wall. The first anchoring element comprises an elongate body and a rotating head rotatably connected to the elongate body and having a pointed tip. The remodeling device further comprises a suture configured to attach to the first anchoring element. The rotating head is configured to rotate to a perpendicular orientation with respect to the elongate body after the rotating head exits a second side of the first tissue wall.

Description

TISSUE ANCHOR FOR TREATMENT OF HEART FAILURE

BACKGROUND

[0001] The present disclosure generally relates to the field of improving heart performance.

[0002] 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

[0003] In some implementations, the present disclosure relates to a remodeling device comprising a first anchoring element configured to penetrate a first side of a first tissue wall. The first anchoring element comprises an elongate body and a rotating head rotatably connected to the elongate body and having a pointed tip. The remodeling device further comprises a suture configured to attach to the first anchoring element. The rotating head is configured to rotate to a perpendicular orientation with respect to the elongate body after the rotating head exits a second side of the first tissue wall.

[0004] In some embodiments, the remodeling device further comprises a second anchoring element configured to anchor to a second tissue wall. The second anchoring element may comprise one or more of a corkscrew, a rotating portion, a non-rotating portion, a threaded screw, and a needle. In some embodiments, the suture is further configured to attach to the second anchoring element.

[0005] The suture may be configured to apply force to the first anchoring element to move the first anchoring element towards the second anchoring element and apply force to the second anchoring element to move the second anchoring element towards the first anchoring element. In some embodiments, the first tissue wall is a posterior wall and the second tissue wall is a septum.

[0006] In some embodiments, the rotating head comprises a first overlapping portion and the elongate body comprises a second overlapping portion that at least partially overlaps with the first overlapping portion. Each of the first overlapping portion and the second overlapping portion may have a half-cylinder shape. In some embodiments, each of the first overlapping portion and the second overlapping portion comprises one or more rotation mechanisms including pegs, cavities, grooves, notches, screws, and pins.

[0007] The suture may be configured to attach to the elongate body of the first anchoring element. In some embodiments, at least a portion of the elongate body has a cylindrical shape. At least a portion of the rotating head may have a conical shape. In some embodiments, the remodeling device further comprises a sheath configured to at least partially cover the rotating head during delivery to prevent rotation of the rotating head and be at least partially removed from the rotating head to allow rotation of the rotating head.

[0008] In some implementations, the present disclosure relates to a method comprising penetrating a first side of a first tissue wall using a first anchoring element that is attached to a suture. The first anchoring element comprises an elongate body and a rotating head rotatably connected to the elongate body and having a pointed tip. The method further comprises passing the first anchoring element through the first tissue wall until the rotating head exits a second side of the first tissue wall, after the rotating head exits the second side of the first tissue wall, rotating the rotating head to a perpendicular orientation with respect to the elongate body, and cinching the suture to apply pressure to the first tissue wall.

[0009] The method may further comprise anchoring a second anchoring element to a second tissue wall. The second anchoring element may comprise one or more of a corkscrew, a rotating portion, a non-rotating portion, a threaded screw, and a needle. In some

embodiments, the suture is also attached to the second anchoring element. Cinching the suture may apply force to the first anchoring element to move the first anchoring element towards the second anchoring element and apply force to the second anchoring element to move the second anchoring element towards the first anchoring element. In some

embodiments, the first tissue wall is a posterior wall and the second tissue wall is a septum.

[0010] In some embodiments, the rotating head comprises a first overlapping portion and the elongate body comprises a second overlapping portion that at least partially overlaps with the first overlapping portion. Each of the first overlapping portion and the second overlapping portion may have a half-cylinder shape. Moreover, each of the first overlapping portion and the second overlapping portion may comprise one or more rotation mechanisms including pegs, cavities, grooves, notches, screws, and pins.

[0011] The suture may be attached to the elongate body of the first anchoring element. In some embodiments, at least a portion of the elongate body has a cylindrical shape. At least a portion of the rotating head may have a conical shape. In some

embodiments, the first anchoring element is at least partially covered by a sheath configured to prevent rotation of the rotating head. The method may further comprise at least partially removing the sheath from the rotating head to allow rotation of the rotating head.

[0012] In some implementations, the present disclosure relates to an apparatus comprising a first means for anchoring configured to penetrate a first side of a first tissue wall. The first means for anchoring comprises an elongate body and a means for rotating that is rotatably connected to the elongate body and has a pointed tip. The apparatus further comprises a means for cinching configured to attach to the first means for anchoring. The means for rotating is configured to rotate to a perpendicular orientation with respect to the elongate body after the means for rotating exits a second side of the first tissue wall.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] 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.

[0014] Figure 1 provides a cross-sectional view of a human heart.

[0015] Figure 2 provides a cross-sectional view of the left ventricle and left atrium of an example heart.

[0016] Figure 3 provides a cross-sectional view of a heart experiencing mitral regurgitation.

[0017] Figure 4 shows a view of the heart including a remodeling device implanted in the left ventricle in accordance with one or more embodiments.

[0018] Figure 5 is a cross-section view (viewed from above) of the heart showing an implanted ventricle remodeling device in accordance with one or more embodiments.

[0019] Figure 6A illustrates an anchoring element prior to rotation of a rotating head and Figure 6B illustrates the anchoring element after rotation of the rotating head in accordance with one or more embodiments.

[0020] Figures 7-1 and 7-2 provide a flow diagram representing a process for remodeling a ventricle of the heart in accordance with one or more embodiments.

[0021] Figures 8-1, 8-2, and 8-3 show examples of various stages of a process for remodeling a ventricle in accordance with one or more embodiments.

DETAIFED DESCRIPTION

[0022] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention. [0023] 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.

[0024] 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.).

[0025] 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.

[0026] 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.

[0027] 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. [0028] 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.

[0029] 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.

[0030] 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., stmt chords) are attached farther away from the free margin.

[0031] 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.

[0032] 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.

[0033] 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.

[0034] 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.

[0035] 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).

[0036] 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.

[0037] 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 one or more sutures, which may include bands, cords, strings, tubes, or other lengths of material (referred to herein collectively as“sutures,”“cords,”“cinching devices,”“tensioning members,” or“means for cinching”) into a ventricle and anchoring the suture(s) to multiple walls of the ventricle. By tightening/tensioning the suture(s), the walls of the ventricle may be repositioned inward.

[0038] The suture(s) may be anchored through use of various means for anchoring, which may include the anchoring elements described herein, that may directly contact and/or anchor the suture(s) to one or more ventricle walls and/or papillary muscles. In some embodiments, the suture(s) may be tightened to reduce a distance between anchoring elements at the multiple walls, thereby reducing ventricle volume.

[0039] 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 of the heart 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. In some embodiments, one or more anchoring elements and/or sutures may pass through a ventricle wall and/or papillary muscle and extend at least partially outside of the heart and/or into another chamber of the heart.

[0040] In some embodiments, anchoring elements may comprise one or more connected/connectable components and/or may be configured to puncture and/or otherwise secure to a ventricle wall. One or more components of an anchoring element may have a threaded exterior and/or may include corkscrews, needles, barbs, hooks, and/or other devices to facilitate puncturing and/or passing through the ventricle wall. When a suture is cinched, pressure may be applied to multiple anchoring elements in order to reduce strain at any one individual anchoring element. Different components of anchoring elements may perform different functions in anchoring one or more sutures to a tissue wall. For example, a rotating/rotatable component may be configured to puncture and/or pass through a ventricle wall and rotate outside the wall and a tensioning component (e.g., an elongate body) may be configured to attach to one or more sutures to apply pressure from the one or more sutures to the rotating component after the rotating component has rotated.

[0041] A sheath may be used to at least partially cover an anchoring element during delivery into the heart. As used herein, the term“sheath” is used according to its broad and ordinary meaning and may refer to any covering, sleeve, shell, and/or casing configured to at least partially cover an outer portion of an anchoring element and/or suture. Sheaths may be composed of any material, including various metals and/or plastics. In some embodiments, a sheath may be configured to entirely surround at least a portion of an anchoring element. For example, for an anchoring element having a cylindrical shape, a sheath may also be cylindrical in shape with a hollow interior configured to fit over the anchoring element. In some embodiments, a sheath may be configured to prevent rotation of an anchoring element. For example, a sheath may at least partially cover a portion of an anchoring element (e.g., a rotating head) that is configured to rotate. To allow rotation of the anchoring element, the sheath may be pulled away from the rotating components of the anchoring element. The sheath may be configured to be removed without applying any force and/or applying minimal force to the anchoring element. In this way, delivery and/or activation (e.g., rotation) of an anchoring element may be simplified by implanting the anchoring element with the sheath and removing the sheath from the anchoring element while the anchoring element is anchored to a ventricle wall and/or papillary muscle. Some embodiments may not include a sheath.

[0042] In some embodiments, a remodeling device may comprise anchoring elements configured to be anchored at each side and/or opposing sides of a ventricle connected by one or more sutures. For example, a first anchoring element may be inserted into a first ventricle wall (e.g., a posterior wall) and a second anchoring element may be inserted into a second ventricle wall (e.g., a septum) with at least some ventricle space between the first ventricle wall and the second ventricle wall. One or more sutures may be configured to connect to the first anchoring element and the second anchoring element and/or may be configured to be tightened to reduce a distance between the first ventricle wall and the second ventricle wall.

[0043] In some embodiments, a mechanical device (e.g., a remodeling device) for treating FMR, HFrEF, and/or other diseases may be configured to be delivered to an affected area of tissue via a transcatheter procedure. Each of the anchoring elements and/or suture(s) may be configured to be delivered and/or adjusted using a transfemoral (artery), transapical, or transseptal procedure. Once in place, the anchoring elements and/or suture(s) may be configured to be detached from the delivery system and/or left in the heart as an implant. The suture(s) may be configured to be tightened to apply pressure to the anchoring elements, thereby reducing a distance between a plurality of ventricle walls to reduce ventricle volume and treat FMR and/or HFrEF.

[0044] Figure 4 shows a view of the heart 1 including a remodeling device implanted in the left ventricle 3. While Figure 4 shows the remodeling device anchored to ventricle walls, the remodeling device may also and/or alternatively be anchored to papillary muscles and/or other areas of tissue. The remodeling device may comprise one or more anchoring elements (e.g., a first anchoring element 402a and a second anchoring element 402b) and/or one or more sutures 401. One or both of the anchoring elements may comprise a rotating head 404a, 404b and/or an elongate body 406a, 406b. While Figure 4 shows each anchoring element 402a, 402b having a rotating head 404a, 404b and an elongate body 406a, 406b, in some embodiments either of the anchoring elements 402a, 402b may comprise alternative and/or different components. For example, an anchoring element 402a, 402b may comprise a corkscrew, hook, threaded screw, and/or a barb or similar device and/or may not comprise a rotating head and/or other rotating components. Each of the rotating heads 404a, 404b may be configured to penetrate and/or pass entirely through a ventricle wall and rotate approximately ninety degrees to a perpendicular orientation with respect to the elongate bodies 406a, 406b after passing through the ventricle wall. The elongate bodies 406a, 406b may be configured to at least partially enter the ventricle wall and may remain in the ventricle wall and/or extend out of the proximal side and/or distal side of the ventricle wall. In some embodiments, the rotating heads 404a, 404b and/or elongate bodies 406a, 406b may be at least partially threaded and/or may comprise coils and may be configured to be twisted into the ventricle wall to minimize bleeding. While each of the anchoring elements 402a, 402b is illustrated as having a rotating head and elongate body, either of the anchoring elements 402a, 402b may comprise different components and/or structure. For example, the second anchoring element 402b may be replaced by an anchor comprising a corkscrew, a button, and/or other components configured to be implanted at the septum 17 or other tissue wall and/or connected to one or more sutures 401.

[0045] The one or more sutures 401 may configured to connect to multiple anchoring elements 402a, 402b or may configured to connect to a single anchoring element. In some embodiments, the one or more sutures 401 may configured to attach at the elongate body 406a, 406b. The one or more sutures 401 may be configured to be cinched to apply pressure to the anchoring elements 402a, 402b and reposition the ventricle walls inward (i.e., closer together).

[0046] In some embodiments, the remodeling device may be configured to be delivered to the heart 1 percutaneously. For example, a catheter may be inserted into the right ventricle 4 and may be passed through the septum 17 into the left ventricle 3. Additionally or alternatively, a catheter may be inserted into the left ventricle 3. In some embodiments, a catheter may be inserted through the tricuspid valve, aortic valve, mitral valve, apex region (e.g., via a transapical procedure), or through any other valve and/or ventricle wall. In the example shown in Figure 4, the remodeling device may be configured to reduce volume of the left ventricle 3, however some embodiments may involve reducing volume of the right ventricle 4 or other heart chamber, or may be configured to be implanted outside the heart.

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] While figures herein may be described with reference to the heart and ventricle remodeling, some embodiments may be configured for delivery to parts of the body other than the heart and may be used for purposes other than ventricle remodeling. Moreover, while remodeling devices are shown as being implanted at ventricle walls, some

embodiments may involve delivering one or more anchoring elements 402a, 402b to one or more papillary muscles. For example, a first anchoring element (e.g., 402a) may be inserted into a first papillary muscle and a second remodeling device (e.g., 402b) may be inserted into a second papillary muscle or a ventricle wall and the suture 401, when tightened, may create pressure at the first anchoring element 402a and/or second anchoring element 402b to move the first and second papillary muscles closer together.

[0048] In some embodiments, each of the one or more sutures 401 may comprise one or more lengths of material and may be configured to be attached to the anchoring elements. Each of the one or more lengths of material may comprise a cord, string, wire, band, tube, and/or other similar device. In some embodiments, the one or more sutures 401 may comprise one or more flexible or rigid mechanisms and/or may be capable of tensioning (e.g., cinching) to decrease a distance between one or more anchoring elements (e.g., 402a) at a first ventricle wall (e.g., the posterior wall 18) and one or more anchoring elements (e.g., 402b) at a second ventricle wall (e.g., the septum 17). The suture(s) 401 may be configured to be connected to any of the one or more anchoring elements 402a, 402b and/or may configured to pass through the anchoring elements 402a, 402b (e.g., through the elongate body 406a, 406b). In some embodiments, the suture(s) 401 may be configured to be tensioned and/or locked into place through use of a locking element or otherwise.

[0049] The one or more sutures 401 and/or one or more anchoring elements 402a, 402b may be configured to be passed through a catheter. Moreover, each of the one or more anchoring elements 402a, 402b may be configured to be passed through a ventricle wall. As shown in Figure 4, a first anchoring element 402a may be configured to be embedded into the posterior wall 18 of the left ventricle 3 and a rotating head 404a may be configured to be passed through the posterior wall 18 and may be configured to be secured against an exterior side of the posterior wall 18. The rotating head 404a and/or elongate body 406a may be composed of metal, plastic, polymer, Teflon, Nitinol, felt, or other material. Each of the anchoring elements 402a, 402b may be composed of a material that is sufficiently rigid in structure to maintain a desired level of pressure at the posterior wall 18, septum 17, or other tissue area.

[0050] As shown in Figure 4, a first anchoring element 402a may be configured to be embedded into a posterior wall 18 and/or a second anchoring element 402b may be configured to be embedded in the septum 17. In some embodiments, the second anchoring element 402b can be configured to be anchored to the septum 17 and at least a portion of the suture(s) 401 can configured to pass through the septum 17. The suture(s) 401 can be configured to be cinched at and/or locked in place at and/or by the second anchoring element 404b. For example, an end of a suture 401 may be accessible to a surgeon and, when the suture 401 is pulled, the suture 401 may be tensioned to apply pulling force to move the first anchoring element 402a and the second anchoring element 402b closer together. After the suture 401 is sufficiently tightened, the suture 401 may be locked in place.

[0051] In some embodiments, a delivery mechanism (e.g., a catheter) may be configured for attaching the anchoring elements 402a, 402b to the ventricle walls. For example, the mechanism may be suitable for pressing against and/or twisting an anchoring element 402a, 402b to insert and/or screw the anchoring element 402a, 402b into a ventricle wall. In some embodiments, the mechanism may be configured to detect infarctions in the tissue and/or to avoid portions of tissue that are more fibrous than other portions.

[0052] Figure 5 provides a cross-sectional view (viewed from above) of the heart 1 showing an implanted ventricle remodeling device. While the device is illustrated as being implanted for remodeling the left ventricle 3, the device may alternatively be implanted for remodeling the right ventricle 4 or other chamber. The remodeling device may comprise one or more sutures 501 and one or more anchoring elements 502a, 502b. In the example shown in Figure 5, a suture 501 is anchored at the posterior wall 18 by a first anchoring element 502a. The first anchoring element 502a comprises a rotating head 504a and an elongate body 506a. The suture 501 is also anchored to the septum 17 by a second anchoring element 502b. The second anchoring element 502b also comprises a rotating head 504b and an elongate body 506b. In some embodiments, the first anchoring element 502a and/or second anchoring element 502b may comprise alternative and/or additional components other than a rotating head 504a, 504b and elongate body 506a, 506b. For example, the first anchoring element 502a and/or second anchoring element 502b may comprise a corkscrew, a button, a stent, and/or other component(s). The suture(s) 501 may be configured to pass between a first papillary muscle 15a and a second papillary muscle 15p. In some embodiments, the remodeling device may be configured to be positioned to avoid contact with the papillary muscles and/or chordae tendineae in the ventricle. In some embodiments, the endpoints of the suture(s) 501 may be configured to be anchored at opposing (i.e., facing) ventricle walls.

[0053] As a suture 501 is tensioned, the suture 501 may be configured to apply force to the first anchoring element 502a and/or the second anchoring element 502b to cause the first anchoring element 502a to move towards the second anchoring element 502b and/or to cause the second anchoring element 502b to move towards the first anchoring element 502a. Accordingly, tightening the suture 501 may cause the posterior wall 18 and septum 17 to move closer together, thereby reducing the volume of the left ventricle 3.

[0054] Figures 6A and 6B illustrate an example anchoring element comprising a rotating head 602 and an elongate body 604. Figure 6A illustrates the anchoring element prior to rotation of the rotating head 602 and Figure 6B illustrates the anchoring element after rotation of the rotating head 602. The rotating head 602 may comprise a tip 606 portion and/or a neck 608 portion. In some embodiments, the tip 606 and the neck 608 may be distinct portions while in other embodiments, the tip 606 may be an extension of the neck 608. The tip 606 may comprise a pointed end 610 which may be configured to puncture a ventricle wall. In some embodiments, the tip 606 may have a conical shape, wherein the pointed end 610 is the point of the tip 606 that is furthest from the neck 608 and the tip 606 gradually increases in diameter from the pointed end 610 until the diameter of the tip 606 is approximately equal to the neck at 608 at the side of the tip 606 that is in contact with the neck 608. In this way, the tip 606 may be configured to create an opening in the ventricle wall that is large enough to fit the tip 606, neck 608, and/or elongate body 604.

[0055] In some embodiments, the rotating head 602 may comprise a first overlapping portion 612 and the elongate body 604 may comprise a second overlapping portion 614. In addition to the second overlapping portion 614, the elongate body may comprise a base 616 portion. The base 616 of the elongate body 604 and/or the neck 608 of the rotating head 602 may by at least partially cylindrical in shape. In optional embodiments, the base 616 and/or neck 608 may be ovular and/or have any other shape. The diameter of the base 616 may be approximately equal to the diameter of the neck 608. Each of the first overlapping portion 612 and the second overlapping portion 614 may comprise a half-cylinder and/or other portion of a cylinder, bisected vertically. As shown in Figure 6 A, prior to rotation of the rotating head 602, the first overlapping portion 612 and the second overlapping portion 614 may together form a full cylinder that is approximately equal in diameter to the base 616 and/or neck 608.

[0056] In some embodiments, the first overlapping portion 612 and/or the second overlapping portion 614 may comprise one or more connection mechanisms for connecting the rotating head 602 to the elongate body 604. A connection mechanism may comprise any device and/or feature configured for establishing a pivoting/rotatable connection between the rotating head 602 and the elongate body 604, and may include a cavity, peg, screw, groove, latch, hook, barb, notch, and/or other mechanism. The connection mechanisms may be configured to provide frictionless or low-friction rotation of the rotating head 602. Multiple connection mechanisms may be used to connect the rotating body 602 to the elongate body 604. As shown in Figures 6A and 6B, the first overlapping portion 612 may comprise a cavity 618 and the second overlapping portion 614 may comprise a peg 620 or similar mechanism that fits into the cavity 618. The cavity 618 may further comprise one or more notches and/or grooves configured to fit the peg 620 to establish a rotatable connection between the first overlapping portion 612 and the second overlapping portion 614. When the rotating head 602 rotates, the established connection between the first overlapping portion 612 and the second overlapping portion 614 may be maintained.

[0057] The elongate body 604 may comprise, for example an end portion 622 and/or outer surface of the elongate body 604, one or more connection mechanisms for attaching to one or more sutures. For example, the elongate body 604 may comprise a hoop, hook, slot, notch, and/or other connection mechanism. In some embodiments, one or more sutures may be pre-attached (e.g., prior to insertion into the heart) to the elongate body 604 while in other embodiments, the one or more sutures may be attached to the elongate body 604 after the anchoring element is delivered to the heart.

[0058] In some embodiments, the outer surface of the rotating head 602 and/or the elongate body 604 may be threaded to facilitate twisting and/or otherwise inserting into a ventricle wall. After passing through a ventricle wall, the rotating head 602 may be configured to rotate approximately ninety degrees, though some embodiments may involve less rotation or more rotation. In some embodiments, the rotating head 602 may include one or more rotation mechanisms (e.g., a pin and/or spring) that, when activated (e.g., removing a pin), causes the rotating head 602 to rotate.

[0059] In some embodiments, the rotating head 602 and/or elongate body 604 may be situated inside a sheath during delivery. A sheath may comprise a covering that may be placed over the rotating head 602 and/or elongate body 604 and may be configured to hold the rotating head and/or elongate body 604 in a pre-determined (e.g., non-rotated) position. After delivery, the sheath may be removed and/or partially removed from the rotating head 602 and/or elongate body 604. For example, after the rotating head 602 enters a proximal side of a ventricle wall, passes through the ventricle wall, and exits a distal side of the ventricle wall, the sheath may be pulled back to expose the rotating head 602. In some embodiments, exposing the rotating head 602 may be configured to cause the rotating head 602 to rotate.

For example, a rotation mechanism (e.g., a spring) may be configured to apply pressure to the rotating head 602 to promote rotation of the rotating head 602. While in the sheath, the rotating head 602 may be prevented from rotating. However, after the sheath is at least partially removed to expose the rotating head 602, the rotation mechanism may cause rotation of the rotating head 602.

[0060] The rotating head 602 may be sized and/or shaped to provide a maximal surface area to prevent re-insertion of the rotating head 602 into the ventricle after the rotating head 602 passes through the ventricle wall and/or rotates. For example, the length of the rotating head 602 may exceed the width of the rotating head 602 at the neck 608.

Moreover, the length of the tip 606 may exceed the width of the rotating head 602 at the neck 608. Similarly, the length of the neck 608 and/or first overlapping portion 612 may each exceed the width of the rotating head 602 at the neck 608. In this way, the rotating head 602 may be prevented from fitting back through a hole created in the ventricle wall by the rotating head 602 and may also be prevented from over-rotation. For example, the rotating head 602 may be configured to rotate approximately ninety degrees, such that the rotating head 602 is situated substantially in parallel with the ventricle wall and/or substantially perpendicular with respect to the elongate body 604.

[0061] The rotating head 602 may be any length and/or width, but in some embodiments may be less than 24 millimeters in length. The rotating head 602 may be sized to avoid contacting and/or damaging the coronary artery outside the heart and, after passing through the ventricle wall, may be positioned inside the pericardial sac and/or may extend out of the pericardial sac.

[0062] In the embodiment shown in Figure 6 A and Figure 6B, the elongate body 604 has a cylindrical shape. In optional embodiments, the elongate body 604 may comprise a helical coil.

[0063] Figure 7 (7-1 and 7-2) provides a flow diagram representing a process 700 for remodeling a ventricle of the heart according to one or more embodiments disclosed herein. While some steps of the process 700 may be directed to the left ventricle, such steps may also be applied to the right ventricle. Figure 8 (8-1, 8-2, and 8-3) shows examples of various stages of the process 700 for remodeling a ventricle shown in Figure 7.

[0064] At step 702, the process 700 involves inserting a remodeling device into a heart using a transcatheter procedure. For example, the remodeling device may be delivered using a transfemoral, transendocardial, transcoronary, transseptal, and/or transapical procedure, 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. The remodeling device may include one or more sutures and/or anchoring elements.

[0065] 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. In optional embodiments, the remodeling device may be delivered to a location outside of the heart for purposes other than remodeling ventricles.

[0066] In some embodiments, the remodeling device may be configured to 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 configured to 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. [0067] 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 sutures and anchoring elements may be positioned to avoid contacting the papillary muscles during delivery and after delivery of the remodeling device. In some embodiments, the remodeling device may comprise multiple anchoring elements which may each be anchored to different areas of tissue in a ventricle of the heart.

[0068] As shown in Figure 8-1, the remodeling device may comprise at least one anchoring element (including a rotating head 802) attached to one or more sutures 801. The one or more sutures 801 may be pre-attached to the anchoring element prior to delivery into the heart or may be attached after the anchoring element is positioned in the ventricle. In some embodiments, at least a portion of an anchoring element may be housed inside a sheath 824 during delivery into the heart. The sheath 824 may be sized and/or shaped to fit around at least a portion of an anchoring element. For anchoring elements having a cylindrical shape, a sheath 824 may similarly have a cylindrical shape and/or an at least partially hollow interior to allow the anchoring element to fit into the sheath 824. In some embodiments, the sheath 824 may cover at least a rotatable connection between a rotating head 802 and an elongate body 804 of the anchoring element to prevent rotation of the rotating head 802 during delivery of the anchoring element. In some embodiments, the remodeling device may not include the sheath 824 and/or the remodeling device may be implemented independently of a sheath 824.

[0069] The anchoring element may comprise a rotating head 802 that may include a pointed tip 806 and/or a neck 808. In some embodiments, the sheath 824 may be configured to not cover the pointed tip 806 and/or neck 808 such that the pointed tip 806 may be configured to contact and/or penetrate a ventricle wall and/or papillary muscle. In

embodiments in which the anchoring element is threaded or has a helical coil structure, the anchoring element may be configured to be pressed into a ventricle wall using a twisting motion, which may minimize bleeding.

[0070] At step 704, the process 700 involves passing at least a portion of an anchoring element through a ventricle wall 830 and/or papillary muscle of the heart. As shown in Figure 8-2, the anchoring element and/or sheath 824 may be inserted at a proximal side 832 of the ventricle wall 830 and at least a portion of the anchoring element (e.g., the rotating head 802) may be configured to pass entirely through the ventricle wall 830 and/or protrude from a distal side 834 of the ventricle wall 830. The anchoring element may be configured to penetrate the ventricle wall 830 through use of the pointed tip 806 of the rotating head 802.

[0071] At step 706, the process 700 involves at least partially removing the sheath 824 to expose at least the rotating head 802 of the anchoring element. The sheath may be configured to be removed from the rotating head 802 when the rotating head 802 is protruding from the distal side 834 of the ventricle wall 830. By exposing the rotating head 802, the rotating head 802 may be allowed to rotate. The sheath 824 may remain covering at least a portion of the elongate body 804 of the anchoring element or may be removed from the body entirely.

[0072] The sheath 824 may be configured to be removed by pulling on the sheath 824 through use of a catheter and/or other tool. Applying force to the anchoring element may not be required in order to remove the sheath 824. Because the sheath 824 can be removed without applying force to the anchoring element, delivery and/or activation (e.g., rotation) of the anchoring element can be advantageously simplified for surgeons and may provide reduced risk of damaging the tissue around the anchoring element.

[0073] At step 708, the process 700 involves rotating the rotating head 802 of the anchoring element. As shown in Figure 8-3, the sheath may be configured to be removed to uncover the elongate body 804 as well as the rotating head 802 when the rotating head 802 rotates. In some embodiments, the rotating head 802 may be capable of rotating at least ninety degrees and/or may rotate in either direction. The rotating head 802 may rotate independently and/or the anchoring element may comprise a rotation mechanism configured to cause rotation of the rotating head 802. For example, the anchoring element may comprise a spring or similar device configured to apply pressure to the rotating head 802 to cause rotation of the rotating head 802. The rotating head 802 may be configured to rotate while the elongate body 804 remains embedded in the ventricle wall 830. The elongate body 804 may not rotate. After rotation of the rotating head 802 is complete, the rotating head 802 may be substantially perpendicular with respect to the elongate body 804. As shown in Figure 8-3, the rotating head 802 may be configured to rotate after exiting the ventricle wall (e.g., at the distal side 834 of the ventricle wall). The one or more sutures 801 may be configured to be attached to the elongate body 804 as shown in Figure 8-3.

[0074] At step 710, the process 700 involves cinching the suture(s) 801 to apply pressure to the rotating portion 802 and/or elongate body 804. In some embodiments, one or more ends of the suture(s) 801 may be accessible to a surgeon, for example via a catheter. Cinching the suture(s) 801 may involve pulling one or more ends of the suture(s) 801. The suture(s) 801 may be tightened as necessary to cause a desired amount of ventricle remodeling. Cinching the suture(s) 801 may be configured to reduce a distance between an anchoring element at a first ventricle wall and an anchoring element at a second ventricle wall, thereby applying force to move the ventricle walls closer together.

[0075] At step 712, the process 700 involves locking the suture(s) 801 to maintain pressure on the rotating portion 802. In some embodiments, one or more locking mechanisms may be configured to be delivered (e.g., via a catheter) for use in locking one or more ends of the suture(s) 801 in place. For example, a locking mechanism may be fitted around the suture(s) 801 and may be configured to slide along the suture(s) 801 and/or pinch or otherwise engage the suture(s) 801 at a desired position to prevent movement of the suture(s) 801 or other anchoring elements. After the suture(s) 801 is/are locked in place, excess length of the suture(s) 801 may be cut off or otherwise removed.

[0076] The process 700 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 700. Furthermore, in certain embodiments, the remodeling device may be designed to be retrievable.

[0077] 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.

[0078] 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.

[0079] 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 remodeling device comprising:

a first anchoring element configured to penetrate a first side of a first tissue wall, the first anchoring element comprising:

an elongate body; and

a rotating head rotatably connected to the elongate body and having a pointed tip; and

a suture configured to attach to the first anchoring element;

wherein the rotating head is configured to rotate to a perpendicular orientation with respect to the elongate body after the rotating head exits a second side of the first tissue wall.

2. The remodeling device of claim 1, further comprising a second anchoring element configured to anchor to a second tissue wall, the second anchoring element comprising one or more of a corkscrew, a rotating portion, a non-rotating portion, a threaded screw, and a needle, wherein the suture is further configured to attach to the second anchoring element.

3. The remodeling device of claim 2, wherein the suture is configured to apply force to the first anchoring element to move the first anchoring element towards the second anchoring element, and to apply force to the second anchoring element to move the second anchoring element towards the first anchoring element.

4. The remodeling device of claim 2 or claim 3, wherein the first tissue wall is a posterior wall and the second tissue wall is a septum.

5. The remodeling device of any of claims 1-4, wherein the rotating head comprises a first overlapping portion and the elongate body comprises a second overlapping portion that at least partially overlaps with the first overlapping portion, each of the first overlapping portion and the second overlapping portion having a half-cylinder shape.

6. The remodeling device of claim 5, wherein each of the first overlapping portion and the second overlapping portion comprises one or more rotation mechanisms including pegs, cavities, grooves, notches, screws, and pins.

7. The remodeling device of any of claims 1-6, wherein the suture is configured to attach to the elongate body of the first anchoring element.

8. The remodeling device of any of claims 1-7, wherein at least a portion of the elongate body has a cylindrical shape.

9. The remodeling device of any of claims 1-8, wherein at least a portion of the rotating head has a conical shape.

10. The remodeling device of any of claims 1-9, further comprising a sheath configured to at least partially cover the rotating head during delivery to prevent rotation of the rotating head, and to be at least partially removed from the rotating head to allow rotation of the rotating head.

11. A method comprising:

penetrating a first side of a first tissue wall using a first anchoring element that is attached to a suture, the first anchoring element comprising:

an elongate body; and

a rotating head rotatably connected to the elongate body and having a pointed tip;

passing the first anchoring element through the first tissue wall until the rotating head exits a second side of the first tissue wall;

after the rotating head exits the second side of the first tissue wall, rotating the rotating head to a perpendicular orientation with respect to the elongate body; and

cinching the suture to apply pressure to the first tissue wall.

12. The method of claim 11, further comprising anchoring a second anchoring element to a second tissue wall, the second anchoring element comprising one or more of a corkscrew, a rotating portion, a non-rotating portion, a threaded screw, and a needle, wherein the suture is also attached to the second anchoring element.

13. The method of claim 12, wherein cinching the suture applies force to the first anchoring element to move the first anchoring element towards the second anchoring element, and applies force to the second anchoring element to move the second anchoring element towards the first anchoring element.

14. The method of claim 12 or claim 13, wherein the first tissue wall is a posterior wall and the second tissue wall is a septum.

15. The method of any of claims 11-14, wherein the rotating head comprises a first overlapping portion and the elongate body comprises a second overlapping portion that at least partially overlaps with the first overlapping portion, each of the first overlapping portion and the second overlapping portion having a half-cylinder shape.

16. The method of claim 15, wherein each of the first overlapping portion and the second overlapping portion comprises one or more rotation mechanisms including pegs, cavities, grooves, notches, screws, and pins.

17. The method of any of claims 11-16, wherein the suture is attached to the elongate body of the first anchoring element.

18. The method of any of claims 11-17, wherein at least a portion of the elongate body has a cylindrical shape.

19. The method of any of claims 11-18, wherein at least a portion of the rotating head has a conical shape.

20. The method of any of claims 11-19, wherein the first anchoring element is at least partially covered by a sheath configured to prevent rotation of the rotating head, the method further comprising at least partially removing the sheath from the rotating head to allow rotation of the rotating head.

21. An apparatus comprising:

a first means for anchoring configured to penetrate a first side of a first tissue wall, the first means for anchoring comprising:

an elongate body; and a means for rotating that is rotatably connected to the elongate body and has a pointed tip; and

a means for cinching configured to attach to the first means for anchoring;

wherein the means for rotating is configured to rotate to a perpendicular orientation with respect to the elongate body after the means for rotating exits a second side of the first tissue wall.