WO2020096861A1 - Percutaneous anchoring for treatment of heart failure with reduced ejection fraction - Google Patents

Abstract

A cardiac device comprises a first anchoring element having an at least partially hollow interior and a second anchoring element configured to penetrate a proximal side of a first tissue wall. The second anchoring element comprises a head having a pointed tip and a substantially flat base and an elongate body. The second anchoring element is configured to rotate to a perpendicular orientation with respect to the first anchoring element after the second anchoring element exits a distal side of the first tissue wall. The cardiac device further comprises a first suture configured to pass through the first anchoring element and attach to the second anchoring element.

Description

PERCUTANEOUS ANCHORING FOR TREATMENT OF HEART FAILURE WITH

REDUCED EJECTION FRACTION

RELATED APPLICATION

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

62/757,299, filed on November 8 2018, entitled PERCUTANEOUS ANCHORING FOR 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. The cardiac device comprises a first anchoring element having an at least partially hollow interior and a second anchoring element configured to penetrate a first side of a first tissue wall. The second anchoring element comprises a head having a pointed tip and a substantially flat base and an elongate body. The second anchoring element is configured to rotate to a perpendicular orientation with respect to the first anchoring element after the second anchoring element exits a second side of the first tissue wall. The cardiac device further comprises a first suture configured to pass through the first anchoring element and attach to the second anchoring element.

[0005] The first suture may be configured to apply force to the second anchoring element to cause the second anchoring element to rotate. In some embodiments, the cardiac device comprises a third anchoring element configured to penetrate a first side of a second tissue wall. The third anchoring element may comprise a head having a pointed tip and a substantially flat base and an elongate body. The cardiac device may further comprise a fourth anchoring element having an at least partially hollow interior. The third anchoring element may be configured to rotate to a perpendicular orientation with respect to the fourth anchoring element after the third anchoring element exits a second side of the second tissue wall. The first suture may be further configured to pass through the fourth anchoring element and attach to the third anchoring element.

[0006] In some embodiments, the first suture is further configured to apply force to the second anchoring element to move the second anchoring element towards the third anchoring element. The first tissue wall may be a posterior wall and the second tissue wall may be a septum. In some embodiments, the first suture is configured to attach to the head of the second anchoring element at the base. The cardiac device may further comprise a second suture configured to pass through the first anchoring element and attach to the second anchoring element.

[0007] The elongate body may be at least partially hollow and the first suture may pass through the elongate body. In some embodiments, the elongate body comprises one or more cavities situated such that the first suture enters one of the one or more cavities when the second anchoring element rotates. The elongate body may have a cylindrical shape. In some embodiments, the head has a conical shape. The base of the head may be circular in shape and equal in diameter to the elongate body.

[0008] In some embodiments, the first suture is configured to attach to an outer surface of the elongate body. The cardiac device may further comprise a second suture configured to attach to the outer surface of the elongate body.

[0009] In some implementations, the present disclosure relates to a method comprising passing a first end of a first tensioning member through a hollow interior of a first anchoring device, attaching the first end of the first tensioning member to a second anchoring device, and penetrating a first side of a first tissue wall with the second anchoring device. The second anchoring device comprises a head having a pointed tip and a substantially flat base and an elongate body. The method further comprises inserting the second anchoring device through the first tissue wall until the second anchoring device entirely protrudes from a second side of the first tissue wall, inserting the first anchoring device into the first tissue wall, rotating the second anchoring device to a perpendicular orientation with respect to the first anchoring device, and cinching the first tensioning member to apply pressure to the second anchoring device.

[0010] In some embodiments, cinching the first tensioning member causes rotation of the second anchoring device. The method may further comprise passing a second end of the first tensioning member through a hollow interior of a third anchoring device, attaching the second end of the first tensioning member to a fourth anchoring device, and penetrating a first side of a second tissue wall with the fourth anchoring device. In some embodiments, the fourth anchoring device comprises a head having a pointed tip and a substantially flat base and an elongate body. The method may further comprise passing the fourth anchoring device through the second tissue wall until the fourth anchoring device entirely protrudes from a second side of the second tissue wall, inserting the third anchoring device into the second tissue wall, rotating the fourth anchoring device to a perpendicular orientation with respect to the first anchoring device, and cinching the first tensioning member to apply pressure to the fourth anchoring device.

[0011] Cinching the first tensioning member may cause tire fourth anchoring device to move towards the second anchoring device. In some embodiments, the first tissue wall is a posterior wall and the second tissue wall is a septum. The first end of the first tensioning member may be attached to the head of the first anchoring device at the base in some embodiments, the method comprises passing a second tensioning member through the hollow interior of the first anchoring device and attaching the second tensioning member to the second anchoring device.

[0012] In some embodiments, the elongate body is at least partially hollow and the first tensioning member passes through the elongate body. The elongate body may comprise one or more cavities situated such that the first tensioning member enters one of the one or more cavities when the second anchoring device rotates.

[0013] The elongate body may have a cylindrical shape. The head may have a conical shape. In some embodiments, the base of the head is circular in shape and equal in diameter to the elongate body. The method may further comprise attaching the first tensioning member to an outer surface of the elongate body. In some embodiments, the method further comprises attaching a second suture to the outer surface of the elongate body.

[0014] In some implementations, the present disclosure relates to an apparatus. The apparatus comprises a first means for anchoring having an at least partially hollow interior and a second means for anchoring configured to penetrate a first side of a first tissue wall. The second means for anchoring comprises a head having a pointed tip and a substantially flat base and an elongate body. The second means for anchoring is configured to rotate to a perpendicular orientation with respect to the first means for anchoring after the second means for anchoring exits a second side of the first tissue wall. The apparatus further comprises a first means for cinching configured to pass through the first means for anchoring and attach to tire second means for anchoring.

[0015] In some embodiments, the first means for cinching is configured to apply force to tire second means for anchoring to cause the second means for anchoring to rotate.

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 shows a view' of the heart including a remodeling device implanted in the left ventricle in accordance with one or more embodiments.

[0021] 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.

[0022] Figures 6A, 6B, and 6C illustrate portions of a remodeling device including a needle, a screwy and at least one cord in accordance with one or more embodiments.

[0023] Figures 7-1, 7-2, and 7-3 provide a flow diagram representing a process for remodeling a ventricle of the heart in accordance with one or more embodiments.

[0024] Figures 8-1, 8-2, 8-3, 8-4, 8-5A, 8-5B, 8-6A, and 8-6B show examples of various stages of a process for remodeling a ventricle in accordance with one or more embodiments.

DETAILED DESCRIPTION

[0025] The headings provided herein are for convenience only and do not necessarily affect tire 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 biood 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 he 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, tire 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 leafiets/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 rapture.

[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, tire posterior leaflet may comprise a larger surface area in certain anatomies.

[0033] The valve leaflets of the mitral valve 6 may he 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 arc 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 arc 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 show_'s the mitral valve 6, wherein the disposition of the valve 6, papillary muscles 15 and/or chordae tendineae 16 may he 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 wail, 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 he 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 hack 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 fire 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 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 the suture(s), the walls of the ventricle may be repositioned inward.

[0041] The suture(s) may be anchored through use of anchoring elements 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.

[0042] 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 extend at least partially outside of the heart and/or into another chamber of the heart.

[0043] In some embodiments, anchoring elements may comprise threaded screws, corkscrews, needles, barbs, hooks, and/or other devices configured to puncture and/or secure to a ventricle wall. When a suture is cinched, pressure may be applied to multiple anchoring elements in order to reduce strain at any one individual anchor. Multiple types of anchoring elements may be used to anchor a suture to a tissue wall. For example, a penetration element (e.g., a needle) may be used to pass through a ventricle wall and rotate outside the wall and a securing element (e.g., a screw) may be used to screw into the ventricle wall to assist in passing the penetration element through tire ventricle wall and anchoring the penetration element to the ventricle wall after the penetration element passes through the ventricle wall.

[0044] The term“needle” is used herein according to its broad and ordinary meaning and may refer to an anchoring device/element having a pointed end and configured to penetrate a tissue wall with the pointed end. In some embodiments, the needle may have a conical shape. The needle may be at least partially solid and/or at least partially hollow. In optional embodiments, at least a portion of an outer surface of the needle may be threaded to facilitate twisting the needle into a tissue wall. A needle may be configured to rotate after passing through a ventricle wall to securely latch onto an outer surface of the ventricle wall.

In this way, a secure attachment to the ventricle wall may be established with minimal risk of tearing through the ventricle wall and/or of causing unnecessary damage to cardiac tissue.

[0045] As used herein, the term“screw” is used according to its broad and ordinary meaning and may refer to a threaded element (see, e.g.. Figure 6.4), a corkscrew' element (see, e.g., Figure 6B), and/or other element configured to be twisted and/or pressed into a tissue wall. In some embodiments, the screw_' may be at least partially cylindrical in shape. Through use of a screwy one or more sutures may be anchored to ventricle walls with minimal risk of bleeding at the ventricle wall. In optional embodiments, the screw' may be configured to be inserted into a tissue wall without twisting.

[0046] In some embodiments, a remodeling device may comprise a needle and/or screw at multiple sides of a ventricle connected by one or more sutures. For example, a first needle and/or first screw may be inserted into a first ventricle wall (e.g., a posterior wall) and a second needle and/or second screw' may he inserted into a second ventricle wall (e.g., a septum). One or more sutures may connect to the first needle and the second needle and/or may be tightened to reduce a distance between the first ventricle wall and the second ventricle wall.

[0047] 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. Each of the anchoring elements and/or suture(s) may be delivered and adjusted using a transfemoral (artery), transapical, or transseptal procedure. Once in place, the anchoring elements and/or suture(s) may be detached from the delivery system and left in the heart as an implant. The suture(s) may 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.

[0048] Figure 4 shows a view' of the heart 1 including a remodeling device implanted in the left ventricle 3. The remodeling device may comprise one or more anchoring elements and/or one or more sutures 402. Anchoring elements may include needles 404a, 404b and/or screws 406a, 406b. Each of the needles 404a, 404b may be configured to penetrate and pass entirely through a ventricle wall and rotate approximately ninety degrees after passing through the ventricle wall. The screw's 406a, 406b may be configured to anchor into a ventricle wall. In some embodiments, the screws 406a, 406b may be threaded and/or may comprise coils and may be twisted into the ventricle wall to minimize bleeding.

[0049] The one or more sutures 402 may connect multiple anchoring elements or may connect to a single anchoring element. In some embodiments, the one or more sutures 402 may be configured to pass through hollow portions of the screws 406a, 406b and/or connect to the needles 404a, 404b. The one or more sutures 402 may be cinched to apply pressure to the needles 404a, 404b and/or screws 406a, 406b.

[0050] In some embodiments, the remodeling device may be delivered to the heart 1 percutaneously. For example, a catheter may be inserted into the right ventricle 4 and/or 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 (transapical), 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 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.

[0051] 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 remodeling devices to one or more papillary muscles. For example, a first remodeling device may be inserted into a first papillary muscle and a second remodeling device may be inserted into a second papillary muscle and a suture, when tightened, may create pressure at the first and second remodeling devices to move the first and second papillary muscles closer together.

[0052] In some embodiments, each of the one or more sutures 402 may comprise one or more lengths of material and/or may 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 402 may comprise one or more flexible or rigid mechanisms and may be capable of tensioning (e.g., cinching) to decrease a distance between one or more anchoring elements at a first ventricle wall (e.g., the posterior wall 18) and one or more anchoring elements at a second ventricle wall (e.g., the septum 17). The suture(s) 402 may be connected to any of the one or more anchoring elements and/or may pass through the anchoring elements. In some embodiments, the suture(s) 402 may be configured to be tensioned and/or locked into place through use of a locking element, one or more anchoring elements, and/or other suitable elements.

[0053] The one or more sutures 402 and/or one or more anchoring elements may be configured to be passed through a catheter. Each of the one or more anchoring elements may be configured to be passed through a ventricle wall. As shown in Figure 4, a screw 406a may be embedded into the posterior wall 18 of the left ventricle 3 and a needle 404a may be configured to be passed through the posterior wall 18 and/or may be configured to be secured against an exterior side of the posterior wall 18. The needle 404a and/or screw 406a may be at least partially composed of metal, plastic, polymer, Teflon, Nitinol, felt, or other material. Each of the anchoring elements may be at least partially composed of a material that may be sufficiently rigid in structure to maintain a desired level of pressure at the posterior wall 18, septum 17, or other tissue area.

[0054] As shown in Figure 4, a first needle 404a may be embedded into a posterior wall 18 and/or a second needle 404b may he embedded in the septum 17. In some embodiments, the second needle 404b can be configured to be anchored to the septum 17 and/or at least a portion of the suture(s) 402 can be configured to be passed through the septum 17. The suture(s) 402 can be cinched at and/or locked in place by the second needle 404b. For example, an end of a suture 402 may be accessible to a surgeon and when the suture 402 is pulled, the suture 402 may be configured to tighten to pull the first needle 404a and the second needle 404b closer together. After the suture 402 is tightened, the suture 402 may be configured to be locked in place.

[0055] In some embodiments, a delivery mechanism (e.g., a catheter) may be used for attaching the needles 404a, 404b 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 5 is a cross-section view' (viewed from above) of the heart 1 showring an implanted ventricle remodeling device. While the device is illustrated as being implanted for remodeling the left ventricle 3, the device may additionally or alternatively be configured to be implanted for remodeling the right ventricle 4 or other chamber. The remodeling device may comprise one or more sutures 502 and one or more anchoring elements. In the example shown in Figure 5, a suture 502 is anchored at the posterior wall 18 by a first needle 504a and a first screw 506a. The suture 502 is also anchored to the septum 17 by a second needle 504b and a second screw 506b. The suture(s) 502 may pass between a first papillary muscle 15a and a second papillary muscle 15p, however other orientations of the suture(s) 502 and/or anchoring elements may be implemented. In some embodiments, the remodeling device may 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) 502 may he anchored at opposing (i.e., facing) ventricle walls.

[0057] As a suture 502 is tensioned, the suture 502 may be configured to apply force to the first needle 504a and/or the second needle 504b to cause the first needle 504a to move towards the second needle 504b and/or to cause the second needle 504b to move towards the first needle 504a. Accordingly , tightening the suture 502 may cause the posterior wall 18 and septum 17 to move closer together, thereby reducing the volume of the left ventricle 3

[0058] Figures 6A-6C illustrate portions of a remodeling device including a needle 602, a screw' 612, and at least one suture 610. In some embodiments, the needle 602 may include a head 604 portion and a body 606 portion. The head 604 may have a pointed tip 620 which may be configured to puncture a ventricle wall. In some embodiments, the head 604 may have an at least partially conical shape with the pointed tip 620 at a first end and a substantially flat base 614 at a second end. The outer surface of the head 604 may be at least partially smooth and/or threaded to facilitate twisting and/or inserting into a ventricle wall. The diameter of the head 604 may increase gradually from the tip 620 to the base 614. At the base 614, the diameter of the head 604 may be approximately equal to a diameter of the body 606 and/or screw 612. in this way, the head 604 may be configured to create an opening in the ventricle wall that may be large enough to fit the head 604, body 606, and/or screw' 612. The head 604 may be at least partially hollow' in structure or may be at least partially solid. The head 604 may comprise, for example at the base 614 and/or outer surface, one or more connection mechanisms for attaching to one or more sutures 610. For example, a suture 610 may attach at an attachment point 622 at the base 614 or outer surface of the head 604 or body 606. The one or more sutures may be configured to attach to the needle 602 (e.g., at the attachment point 622) through use of a hook or similar mechanism at the needle 602.

[0059] The body 606 may be connected to the head 604 and/or may be an extension of the head 604. In some embodiments, the body 606 may have a substantially cylindrical shape. The diameter of the body 606 may be approximately equal to a diameter of the head 604 at the base 614 (i.e., where the head 604 meets the body 606) and/or to a diameter of the screw 612. The body 606 may comprise, for example at the outer surface, one or more connection mechanisms for attaching to one or more sutures 610. For example, the one or more sutures 610 may attach at an attachment point 622 at the outer surface of the body 606 (see, e.g.. Figure 6B). In some embodiments, the body 606 may be at least partially hollow. The one or more sutures 610 may enter the body 606 at an open side 618 of the body 606 and pass through a hollow area of the body 606 to attach to the needle 602. in some embodiments, the one or more sutures 610 may also pass through a hollow portion 624 of the screw 612.

[0060] After passing through a ventricle wall, the needle 602 may be configured to rotate approximately ninety degrees, though some embodiments may involve less rotation or more rotation. In some embodiments, the one or more sutures 610 may be attached to the needle 602 in a way that promotes rotation of the needle 602. For example, a suture 610 may be attached to the base 614 in an off-center position and/or at an outer surface of the needle 602 such that when the suture 610 is tensioned, the needle 602 may be configured to naturally rotate in such a way that an end of the suture 610 (i.e., the end of the suture 610 attached to the needle 602) may be as close to the ventricle wall as possible. In some embodiments, the needle 602 may include a rotation mechanism (e.g., a pin or spring) that, when activated (e.g., removing a pin), may be configured to cause the needle 602 to rotate.

[0061] In some embodiments, the needle 602 and/or screw 612 may be situated inside a sheath during delivery. A sheath may comprise a covering that may be placed over the needle 602 and/or screw 612 and may be configured to hold the needle and/or screw' 612 in a pre -determined position. After delivery, the sheath may be configured to be removed and/or partially removed from the needle 602 and/or screw 612. For example, after the needle 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 configured to he pulled back to expose the needle 602. In some embodiments, exposing the needle 602 may be configured to cause the needle 602 to rotate. For example, a rotation mechanism (e.g., a spring) may be configured to apply pressure to the needle 602 to promote rotation of the needle 602. While in the sheath, the needle 602 may be prevented from rotating. However, after the sheath is at least partially removed to expose the needle 602, the rotation mechanism may be configured to cause rotation of the needle 602.

[0062] In some embodiments, one or more guidewires and/or locking mechanisms may he configured to hold the needle 602 and/or screw 612 in a pre-determined position. For example, guidewires and/or locking mechanisms may be used to hold the needle 602 and/or screw 612 together.

[0063] In some embodiments, the body 606 may comprise one or more partial cylinders. For example, the body 606 may comprise a solid structure and/or may be a half cylinder in shape. The one or more sutures 610 may be configured to attach to the base 614 of the head 604 at a portion that is not covered and/or surrounded by the body 606. In some embodiments, the body 606 may comprise multiple separate pieces, each connected to and/or extending from the head 604. For example, the body 606 may comprise two quarter-cylinders on opposing sides. In this way, the one or more sutures 610 may attach to the base 614 at one or more points that may not be covered and/or surrounded by the body 606 and the one or more sutures 610 may lay flatly against the base 614 of the head 604 after the needle 602 rotates.

[0064] The body 606 and/or head 604 may be sized and/or shaped to provide maximal surface area to prevent re-insertion of the needle 602 into the ventricle after the needle 602 passes through the ventricle wail and/or rotates. For example, the length of the needle (from tip 620 to open side 618) may exceed the width of the needle 602 at the base 614 and/or open side 618. Moreover, the length of the head 602 (from tip 620 to base 614) may exceed the width of the head 604 at the base 614. Similarly, the length of the body 606 (from open side 618 to base 614) may exceed the width of the body 606. In this way, the needle 602 may be prevented from fitting back through the hole created in the ventricle wall by the needle 602 and may also be prevented from over-rotation. For example, the needle 602 may be configured to rotate approximately ninety degrees, such that the needle 602 is situated substantially in parallel with the ventricle wall and/or substantially perpendicular with respect to the screw' 612.

[0065] The needle 602 may be any length and/or width, but in some embodiments may be less than 24 mi dimeters in length (from the open side 618 to the tip 620). The needle 602 may be sized to avoid contacting and/or damaging the coronary artery outside the heart and, after passing through the ventricle wall, may he positioned inside the pericardial sac and/or may extend out of the pericardial sac.

[0066] In the embodiment shown in Figure 6 A, the screw 612 may have an at least partially cylindrical shape and/or an at least partially threaded outer surface. In some embodiments, the screw' 612 may comprise a helical coil (see, e.g., Figure 6B). The screw'

612 may be at least partially hollow' and/or may comprise a hollow' portion 624 to allow' the one or more sutures 610 to pass through the screw 612. The body 606 may also be at least partially hollow to allow the one or more sutures 610 to pass inside the body 606 and attach to the base 614 of the head 604.

[0067] The needle 602 may comprise (e.g., at the body 606) one or more cavities 616 that may be sized and/or oriented to allow the one or more sutures 610 to enter and/or pass through at least one of the one or more cavities 616, for example after the needle 602 rotates. A cavity 616 may be an opening in the body 606 and/or head 604 configured to fit the one or more sutures 610 and may be minima! in width and/or depth in order to maximize surface area of the body 606 and/or head 604. In some embodiments, a cavity 616 may have a triangular shape with a larger width at an open side 618 of the body 606 to allow tire one or more sutures 610 to more easily enter the slot. The width of the cavity 616 may decrease towards the base 614 to maximize surface area of the body 606. The needle 602 may have multiple cavities 616 to allow the suture 610 to more easily pass into any of the cavities 616.

[0068] Figure 6B shows another embodiment of a remodeling device including a screw 612 that comprises a helical corkscrew. The screw 612 may be composed of a shape- memory alloy (e.g., Nitinol) or other material. In some embodiments, the suture 610 may pass through the screw 612 such that the coils of the screw' 612 surround the suture 610. As shown in Figure 6B, the suture(s) 610 may not pass through the hody 606 and/or may attach at a point 622 that is at an outside surface portion of the body 606 and/or the head 604. While only a single suture 610 is shown, multiple sutures 610 may be used (see, e.g., Figure 6C). After the needle 602 passes through the ventricle wall, tensioning the suture(s) 610 can cause rotation of the needle 602 as the needle 602 can naturally rotate to a position at which the point 622 is closer to the ventricle wall than prior to rotation of the needle 602. In some embodiments, the screw' 612 may comprise a driver head portion 626, which may be shaped and/or dimensioned to be engaged by a driver tool of some kind in order to allow' for exertion of rotational force on the screw' 612.

[0069] Figure 6C show's another embodiment of a remodeling device including multiple sutures 610a, 610b. Each of the sutures 610a, 610b may be configured to be passed through the screw' 612 and/or attached to the needle 602. While Figure 6C shows two sutures 610a, 610b attaching to points 622a, 622b at an outside portion of the body 606, the sutures 610a, 610b may attach to the base 614 of the head 604 and/or one suture (e.g., 610a) may attach to the outside portion and the other suture (e.g., 610b) may attach to the base 614. in some embodiments, more than two sutures may be used. Each of the sutures 610a, 610b may attach to each of multiple needles 602 (e.g., a first needle 602 at a first ventricle wall and a second needle 602 at a second ventricle wall). [0070] By using multiple sutures, force applied by the sutures 610a, 610b may be distributed across an area at the needle 602 between the sutures. In some embodiments, the attachment points 622a, 622b may be separated by less than five millimeters, but in other embodiments the attachment points 622a, 622b may be separated by five millimeters or more. Each of foe sutures 610a, 610b may be configured to be delivered through a common opening created in a ventricle wall. While both sutures 610a, 610b are shown in Figure 6C as attaching to the body 606, one or both of the sutures 610a, 610b may be attached to the head 604.

[0071 ] Figure 7 (7-1, 7-2, and 7-3) 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 foe 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, 8-3, 8-4, 8-5A, 8-5B, 8-6A, and 8-6B) show's examples of various stages of the process 700 for remodeling a ventricle shown in Figure 7. For illustrative purposes, the screw' 812 shown in Figure 8 is a threaded screw' but in other embodiments may comprise a helical coil and/or other device(s).

[0072] 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 foe art. The remodeling device may include one or more cords (i.e., sutures) and/or anchoring elements (e.g., needles, screws).

[0073] 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 be configured to remodel foe right ventricle or may be passed through the septum into foe 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 be configured to 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.

[0074] In some embodiments, foe remodeling device may be fed through a catheter (e.g., a transfemoral catheter) that may he 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 transseptai needle may be configured to 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.

[0075] The remodeling device may be configured to 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 cords and/or anchoring elements may be configured to be positioned to avoid contacting the papillary muscles during delivery and/or after delivery of the remodeling device.

[0076] As shown in Figure 8-1, the remodeling device may comprise one or more connected and/or connectable elements. In some embodiments, the remodeling device may comprise one or more cords 810 (not shown in Figure 8-1 ; see, e.g., Figure 8-4), needles 802, and/or screws 812. The one or more cords 810 may be configured to be pre-attached to the one or more needles 802 and/or screws 812 prior to delivery of the remodeling device or may be configured to he attached after the needles and/or screws 812 are positioned in the ventricle. In some embodiments, the one or more cords 810 may be configured to pass through the one or more screws 812 via a hollow space 824 in the one or more screws 812.

[0077] The remodeling device may include one or more locking mechanisms 830 which may be configured to be engaged by one or more guidewires 832 or similar devices to facilitate a connection between the one or more connected and/or connectable elements. For example, the guidewires 832, when inserted into the locking mechanisms 830, may be configured to prevent the needle 802 and screw 812 from separating. In some embodiments, the locking mechanisms 830 may comprise one or more holes, indentations, and/or grooves, in the body 606 and/or screw' 812.

[0078] The needle 802 may comprise a head 804 and/or a body 806. In some embodiments, the body 806 may be at least partially hollow and/or may comprise a cylindrical shell. The locking mechanisms 830, which may comprise one or more holes, indentations, and/or pins which may each be configured for fitting an end of a guidewire 832, may be situated in the body 806. In optional embodiments, the screw 812 may include additional locking mechanisms 830. When the guidewire 832 is inserted into the locking mechanisms 830, movement of the needle 802 and/or screw 812 may be configured to be controlled by the guidewire 832 and/or the needle 802 and screw 812 may be configured to be pressed together. By holding the screw 812 and the needle 802 together, the screw' 812 may be configured to assist in passing the needle 802 through a ventricle wall and/or the needle 802 may be configured to assist the screw 812 in passing through the ventricle wall. Because the screw' 812 may be at least partially threaded (or, in other embodiments, may have an at least partially helical coil structure), the screw 812 can be configured to be pressed into a ventricle wall using a twisting motion, which may minimize bleeding.

[0079] At step 704, the process 700 involves anchoring the remodeling device to a ventricle wall. Anchoring the remodeling device may involve passing at least a portion of the remodeling device at least partially through the ventricle wall. In some embodiments, the remodeling device may be configured to be twisted during anchoring to reduce the risk of bleeding at the ventricle wall. Anchoring may involve puncturing a proximal side of the ventricle wall, passing the needle 802 and/or screw 812 into the ventricle wall, and/or continuing to press and/or screw the remodeling device into the ventricle wall until the needle 802 surfaces and entirely protrudes from a distal side of the ventricle wall. In some embodiments, the screw 812 may be configured to be removed after the remodeling device is anchored or may remain in the ventricle wall to provide an anchor to the needle 802.

[0080] At step 706, the process 700 involves disengaging the locking

mechanisms. As shown in Figure 8-2, the guidewires 832 may be configured to he released from the locking mechanisms 830 by moving the guidewires 832 inward and/or away from the locking mechanisms 830 and/or walls of the body 806 and/or screw 812. By moving the guidewires 832 away from the locking mechanisms 830, the needle 802 and/or screw' 812 may be allowed to separate and/or move freely, thereby allowing the needle 802 to rotate.

[0081] At step 708, the process 700 involves applying pressure to the needle 802 to separate the needle 802 from the screw' 812. As shown in Figure 8-3, the guidewires 832 may be configured to be pressed against the needle 802 at the base 814. In optional embodiments, the guidewires 832 may be configured to pull the screw 812 away from the needle 802.

[0082] At step 710, the process 700 involves separating the needle 802 from the screw 812. The separation between the needle 802 and screw 812 may be caused by applying pressure to the needle 802. As shown in Figure 8-4, the needle 802 may be configured to be separated from the screw' 812 to create a space 840 between the needle 802 and the screw'

812. The space 840 may be sufficiently large to allow rotation of the needle 802 to a substantially perpendicular position with respect to the screw 812.

[0083] At step 712, the process 700 involves rotating the needle 802. As shown in Figures 8-5A and 8-5B, the needle 802 may be configured to rotate while the screw' 812 remains embedded in the ventricle wall 850 and/or the screw 812 may not rotate. After rotation of the needle 802 is complete, the needle 802 may be configured to be substantially perpendicular with respect to the screw 812. As shown in Figure 8-5 A, the cord 810 may be configured to be attached to the needle 802 at an attachment point 822 that is inside the body 806. Accordingly, the cord 810 may be configured to pass through a cavity 816 in the needle 802 (e.g., at the body 806). In this way, the cord 810 may be configured to lay flatly against the base 814 of the head 804 when the needle 802 rotates.

[0084] As shown in Figure 8-5B, the cord 810 may be configured to be attached to the needle 802 at an attachment point 822 that may be at an outer surface of the needle (e.g., at the body 806 and/or head 804). Accordingly, when cord 810 is cinched, the needle 802 may be configured to naturally rotate such that the attachment point 822 is at or near to the ventricle wall 850.

[0085] in some embodiments, the remodeling device may comprise a rotation mechanism, for example a spring, pin, and/or an indentation which may be configured to be activated by the guidewires 832 and/or otherwise to cause rotation of the needle 802. In optional embodiments, at least one of the guidewires 832 may be configured to be pressed against a side of the body 806 to cause rotation of the needle 802.

[0086] At step 714, the process 700 involves cinching the cord(s) 810. While steps 714 and 712 are shown as separate steps, in some embodiments cinching the cord(s)

810 may be configured to cause rotation of the needle 802. in some embodiments, one or more ends of the cord(s) 810 may be accessible to a surgeon, for example via a catheter. Cinching the cord(s) may involve pulling one or more ends of the cord(s). The eord(s) may be tightened as necessary to cause a desired amount of ventricle remodeling. Cinching the cord(s) may be configured to 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.

[0087] As shown in Figure 8-6.4, a cord 810 may attach to the needle 802 at a point 822 at or near the base 814 of the head 804. While only one cord 810 is shown in Figure 8-6A, multiple cords 810 may be used (see, e.g., Figure 8-6B).

[0088] As shown in Figure 8-6B, a first cord 810a and a second cord 810b may be configured to be attached at points 822a and 822b at an outer surface of the head 804 and/or body 806. While two cords 810a, 810b are shown, a single cord 810 (see, e.g., Figure 8-6A) or more than two cords 810 may be used. [0089] In some embodiments, the eord(s) 810 may be locked in place. In one use case, 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 cord(s) 810 in place. For example, a locking mechanism may be configured to be fitted around the cord(s) 810 and/or may be configured to slide along the cord(s) 810 and/or pinch or otherwise engage the cord at a desired position to prevent movement of the cord or other anchoring elements. After the cord(s) 810 i s/are locked in place, excess length of the cord(s) 810 may he cut off or otherwise removed.

[0090] 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.

Additional Embodiments

[0091] 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.

[0092] 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.

[0093] 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 first anchoring element having an at least partially hollow interior;

a second anchoring element configured to penetrate a first side of a first tissue wall, the second anchoring element comprising a head having a pointed tip and a substantially flat base, and an elongate body,

wherein the second anchoring element is configured to rotate to a perpendicular orientation with respect to the first anchoring element after the second anchoring element exits a second side of the first tissue wall: and

a first suture configured to pass through the first anchoring element and attach to the second anchoring element.

2. The cardiac device of claim 1, wherein the first suture is configured to apply force to the second anchoring element to cause the second anchoring element to rotate.

3. The cardiac device of claim 1 or claim 2, further comprising:

a third anchoring element configured to penetrate a first side of a second tissue wall, the third anchoring element comprising a head having a pointed tip and a substantially flat base, and an elongate body; and

a fourth anchoring element having an at least partially hollow interior, wherein the third anchoring element is configured to rotate to a perpendicular orientation with respect to the fourth anchoring element after the third anchoring element exits a second side of the second tissue wall, wherein the first suture is further configured to pass through the fourth anchoring element and attach to the third anchoring element.

4. The cardiac device of claim 3, wherein the first suture is further configured to apply force to the second anchoring element to move the second anchoring element towards the third anchoring element.

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

6. The cardiac device of any of claims 1-3, wherein the first suture is configured to attach to the head of tire second anchoring element at the base.

7. The cardiac device of any of claims 1-3 or 6, further comprising a second suture configured to pass through the first anchoring element and attach to the second anchoring element.

8. The cardiac device of any of claims 1-3, 6, or 7, wherein the elongate body is at least partially hollow, and tire first suture is further configured to pass through the elongate body.

9. The cardiac device of claim 8, wherein the elongate body comprises one or more cavities and the first suture is further configured to enter one of the one or more cavities when the second anchoring element rotates.

10. The cardiac device of any of claims 1-3 or 6-8, wherein the elongate body has a cylindrical shape.

11. The cardiac device of claim 10, wherein the head has a conical shape.

12. The cardiac device of claim 10 or claim 11, wherein the base of the head is circular in shape and equal in diameter to the elongate body.

13. The cardiac device of any of claims 1-3, 6-8 or 10, wherein the first suture is configured to attach to an outer surface of the elongate body.

14. The cardiac device of claim 13, further comprising a second suture configured to attach to the outer surface of the elongate body.

15. A method comprising:

passing a first end of a first tensioning member through a hollow interior of a first anchoring device;

attaching the first end of the first tensioning member to a second anchoring device; penetrating a first side of a first tissue wall with the second anchoring device, the second anchoring device comprising a head having a pointed tip and a substantially flat base, and an elongate body;

inserting the second anchoring device through the first tissue wall until the second anchoring device entirely protrudes from a second side of the first tissue wall;

inserting the first anchoring device into the first tissue wall;

rotating the second anchoring device to a perpendicular orientation with respect to the first anchoring device; and

cinching the first tensioning member to apply pressure to the second anchoring device.

16. The method of claim 15, wherein cinching the first tensioning member causes rotation of the second anchoring device.

17. The method of claim 15 or claim 16, further comprising:

passing a second end of the first tensioning member through a hollow interior of a third anchoring device; attaching the second end of the first tensioning member to a fourth anchoring device; penetrating a first side of a second tissue wail with the fourth anchoring device, the fourth anchoring device compri ing a head having a pointed tip and a substantially flat base, and an elongate body;

passing the fourth anchoring device through the second tissue wall until the fourth anchoring device entirely protrudes from a second side of the second tissue wall;

inserting the third anchoring device into the second tissue wall;

rotating the fourth anchoring device to a perpendicular orientation with respect to the first anchoring device; and

cinching the first tensioning member to apply pressure to the fourth anchoring device.

18. The method of claim 17, wherein cinching the first tensioning member causes the fourth anchoring device to move towards the second anchoring device.

19. The method of claim 17 or claim 18, wherei the first tissue wall is a posterior wall and the second tissue wall is a septum.

20. The method of any of claims 15-17, wherein the first end of the first tensioning member is attached to the head of the first anchoring device at the base.

21. The method of any of claims 15-17 or 20, further comprising passing a second tensioning member through the hollow interior of the first anchoring device, and attaching the second tensioning member to the second anchoring device.

22. The method of any of claims 15-17, 20, or 21 , wherein the elongate body is at least partially hollow, and the first tensioning member passes through the elongate body.

23. The method of claim 22, wherein the elongate body comprises one or more cavities situated such that the first tensioning member enters one of the one or more cavities when the second anchoring device rotates.

24. The method of any of claims 15-17 or 20-22, wherein the elongate body has a cylindrical shape.

25. The method of claim 24, wherein the head has a conical shape.

26. The method of claim 25, wherein the base of the head is circular in shape and equal in diameter to the elongate body.

27. The method of any of claims 15-17, 20-22, or 24, further comprising attaching the first tensioning member to an outer surface of the elongate body.

28. The method of claim 27, further comprising attaching a second cinching device to the outer surface of the elongate body.

29. An apparatus comprising:

a first means for anchoring having an at least partially hollow interior;

a second means for anchoring configured to penetrate a first side of a first tissue wall, the second means for anchoring comprising a head having a pointed tip and a substantially flat base, and an elongate body, wherein the second means for anchoring is configured to rotate to a perpendicular orientation with respect to the first means for anchoring after the second means for anchoring exits a second side of the first tissue wall; and

a first means for cinching configured to pass through the first means for anchoring and attach to the second means for anchoring.

30. The apparatus of claim 29, wherein the first means for cinching is configured to apply force to the second means for anchoring to cause the second means for anchoring to rotate.