WO2021025882A1

WO2021025882A1 - Heart wall implant and method

Info

Publication number: WO2021025882A1
Application number: PCT/US2020/043598
Authority: WO
Inventors: Mark Simon VREEKE; Ralph Schneider; Gregory Bak-Boychuk; Juan Valencia; Emil Karapetian; Cristobal R. HERNANDEZ
Original assignee: Edwards Lifesciences Corporation
Priority date: 2019-08-05
Filing date: 2020-07-24
Publication date: 2021-02-11
Also published as: EP4009907A1; CN114173715A

Abstract

An anchor device for implantation in heart tissue includes a helical anchor and a helical delivery component. The helical delivery component can be hollow and the helical anchor can be disposed inside the helical delivery component for delivery. The helical anchor can be hollow and the helical delivery component can be disposed inside the hollow helical anchor.

Description

HEART WALL IMPLANT AND METHOD

RELATED APPLICATION

[0001] The present application claims the benefit of U.S. Provisional Patent Application No. 62/882,811, filed on August 5, 2019, which is incorporated herein by reference in its entirety.

BACKGROUND

[0002] Ischemic heart failure and systolic heart failure are conditions whereby the left ventricle of the heart becomes enlarged and dilated. With ischemic heart failure, a cardiac infarction occurs and the left ventricle remodels over a period of time, such as over days or months. With systolic heart failure, the left ventricle undergoes dilation for some other reason. For example, initial causes of heart systolic heart failure include chronic hypertension, mitral valve incompetency, and other dilated cardiomyopathies. A dilated heart, and particularly a dilated left ventricle, can significantly increase the tension and/or stress in the heart wall both during diastolic filling and systolic contraction, which contributes to ongoing dilatation of the left ventricular chamber.

[0003] Mitral valve incompetency or mitral valve regurgitation often accompanies ischemic and systolic heart failure. As the dilation of the ventricle proceeds, valve function may worsen. For example, as the dilation of the left ventricle progresses, the papillary muscles (to which the leaflets are connected via the chordae tendinea) may move radially outward and downward relative to the mitral valve, and relative to their normal positions. During this movement of the papillary muscles, however, the various chordae lengths remain substantially constant. This compromises the full closure ability of the leaflets by exerting tension prematurely on the leaflets. In addition, the enlargement of the left ventricle can cause the size of the mitral valve annulus to increase, while the area of the leaflets of the valve remains constant. This may lead to an area of less coaptation of the valve leaflets. Moreover, in normal hearts, the size of the mitral valve contracts during systole, aiding in valve coaptation. Right ventricular enlargement reduces annular contraction and distorts annulus size, often exacerbating mitral valve regurgitation. The combination of the changes to the mitral valve annulus and the movement of the papillary muscles can result in a regurgitant mitral valve. This increase in regurgitation can, in turn, increase ventricular wall stress thereby advancing the dilation process, which can even further worsen mitral valve dysfunction. SUMMARY

[0004] In one exemplary embodiment, an anchor device for implantation in heart tissue includes a helical anchor and a helical delivery component. The helical delivery component can be hollow and the helical anchor can be disposed inside the helical delivery component for delivery. The helical anchor can be hollow and the helical delivery component can be disposed inside the hollow helical anchor.

[0005] In one exemplary method, a helical anchor is implanted in heart tissue. A helical anchor is provided in a hollow helical delivery component. The hollow helical delivery component and the helical anchor are rotated into the heart tissue. The hollow helical delivery component is counter-rotated to remove the hollow helical delivery component from the heart tissue and leave the helical anchor in the heart tissue.

[0006] In one exemplary method, a helical anchor is implanted in heart tissue. A helical delivery component is provided in a hollow helical anchor. The helical delivery component and the hollow helical anchor are rotated into the heart tissue. The helical delivery component is counter-rotated to remove the helical delivery component from the heart tissue and leave the hollow helical anchor in the heart tissue.

[0007] A system includes an anchor device and a catheter. The anchor device is configured for implantation in heart tissue. The anchor device includes a helical anchor and a hollow helical delivery component. The helical anchor is disposed in the hollow helical delivery component. The helical anchor and the hollow delivery component are disposed in the catheter.

[0008] A system includes an anchor device and a catheter. The anchor device is configured for implantation in heart tissue. The anchor includes a hollow helical anchor and a helical delivery component. The delivery component is disposed in the hollow helical anchor. The helical anchor and the hollow delivery component are disposed in the catheter.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] To further clarify various aspects of embodiments of the present disclosure, a more particular description of the certain embodiments will be made by reference to various aspects of the appended drawings. It is appreciated that these drawings depict only typical embodiments of the present disclosure and are therefore not to be considered limiting of the scope of the disclosure. Moreover, while the figures can be drawn to scale for some embodiments, the figures are not necessarily drawn to scale for all embodiments. Embodiments and other features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0010] Figure 1 illustrates a cutaway view of the human heart in a diastolic phase;

[0011] Figure 2 illustrates a cutaway view of the human heart in a systolic phase;

[0012] Figure 3 illustrates a cutaway view of the human heart in a diastolic phase, in which the chordae tendineae are shown attaching the leaflets of the mitral and tricuspid valves to ventricle walls;

[0013] Figure 4 illustrates a healthy mitral valve with the leaflets closed as viewed from an atrial side of the mitral valve;

[0014] Figure 5 illustrates a dysfunctional mitral valve with a visible gap between the leaflets as viewed from an atrial side of the mitral valve;

[0015] Figure 6 illustrates a cutaway view of the human heart showing the papillary muscles;

[0016] Figure 7 illustrates a cutaway view of the human heart showing the multilayer heart wall;

[0017] Figure 8 is an enlarged cutaway view of the human heart wall;

[0018] Figures 9A-9C illustrate an exemplary tissue reshaping anchor device;

[0019] Figure 10 illustrates an exemplary deployed anchor;

[0020] Figure 11 illustrates an exemplary anchor for axial tissue contraction;

[0021] Figure 11A illustrates an exemplary anchor for radial tissue expansion;

[0022] Figure 12 illustrates an exemplary anchor for axial tissue expansion;

[0023] Figure 12A illustrates an exemplary anchor for radial tissue contraction;

[0024] Figure 13 illustrates an exmplary tissue reshaping anchor device;

[0025] Figure 14 illustrates an exemplary deployment of the exemplary tissue reshaping anchor device of Figure 13;

[0026] Figure 15 illustrates an exemplary deployed anchor;

[0027] Figure 16 illustrates an exemplary anchor for tissue contraction;

[0028] Figure 17 illustrates an exemplary anchor for tissue expansion;

[0029] Figures 18A-18D illustrate an exemplary deployment of an anchor into a target tissue area;

[0030] Figures 19A-19B illustrate an exemplary deployment of an anchor into a target tissue area for tissue contraction;

[0031] Figure 20 illustrates an exemplary anchor with a tether; [0032] Figures 21A-21D illustrate an exemplary deployment of an achor into a target tissue location;

[0033] Figures 22A-22C illustrate another exemplary tissue reshaping anchor device;

[0034] Figure 23 illustrates an exemplary deployed anchor;

[0035] Figure 24 illustrates an exemplary anchor for tissue contraction;

[0036] Figure 25 illustrates and exemplary anchor for tissue expansion;

[0037] Figures 26A-26C illustrate an exemplary deployment of an anchor into a target tissue area;

[0038] Figures 27A-27B illustrate an exemplary deployment of an anchor into a target tissue area for tissue contraction

[0039] Figure 28 illustrates an exemplary anchor with a tether;

[0040] Figures 29A-29C illustrate an exemplary deployment of an achor into a target tissue location;

[0041] Figures 30A-30C illustrate an exemplary method of modification of a deployed anchor;

[0042] Figures 31-38 depict various exemplarly deployment positions of exemplay anchors;

[0043] Figure 39 illustrates an exemplary deployment of an anchor into a human heart wall;

[0044] Figure 40 illustrates an exemlary deployment of an anchor into a human heart wall;

[0045] Figure 41 illustrates an exemplary embodiment of a system that includes a helical anchor, a helical anchor delivery device, and a catheter; and

[0046] Figures 42 and 43 illustrate an exemplary embodiment of a system that includes a helical anchor, a helical anchor delivery device, and a catheter.

DETAILED DESCRIPTION

[0047] The following description refers to the accompanying drawings, which illustrate specific embodiments of the present disclosure. Other embodiments having different structures and operation do not depart from the scope of the present disclosure.

[0048] Some heart conditions can be treated or repaired through reshaping or remodeling of heart tissue, specifically, the heart wall. Heart tissue can be reshaped by implanting one or more anchors to engage the tissue and reshape an area of the heart. Exemplary embodiments of the present disclosure are directed to devices and methods for remodeling the shape of one or more walls of a human heart. It should be noted that various embodiments of devices and systems for delivery are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components of the disclosed devices and systems can be combined unless mutually exclusive or otherwise physically impossible.

[0049] As described herein, when one or more components are described as being connected, joined, affixed, coupled, attached, or otherwise interconnected, such interconnection may be direct as between the components or may be indirect such as through the use of one or more intermediary components. Also, as described herein, reference to a "member," “component,” or “portion” shall not be limited to a single structural member, component, or element but can include an assembly of components, members, or elements. Also, as described herein, the terms “substantially” and “about” are defined as at least close to (and includes) a given value or state (preferably within 10% of, more preferably within 1% of, and most preferably within 0.1% of).

[0050] Figures 1 and 2 are cutaway views of the human heart H in diastolic and systolic phases, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA, respectively, by the tricuspid valve TV and mitral valve MV; i.e., the atrioventricular valves. Additionally, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets extending inward across the respective orifices that come together or "coapt" in the flowstream to form the one-way, fluid-occluding surfaces. The remodeling devices, systems, and methods of the present application are described primarily with respect to the left ventricle LV. Therefore, anatomical structures of the left side of the heart will be explained in greater detail. It should be understood that the devices, systems, and methods described herein may also be used in remodeling the right ventricle.

[0051] The left atrium LA receives oxygenated blood from the lungs. During the diastolic phase, or diastole, seen in Figure 1, the blood that was previously collected in the left atrium LA (during the systolic phase) moves through the mitral valve MV and into the left ventricle LV by expansion of the left ventricle LV. In the systolic phase, or systole, seen in Figure 2, the left ventricle LV contracts to force the blood through the aortic valve AV and ascending aorta AA into the body. During systole, the leaflets of the mitral valve MV close to prevent the blood from regurgitating from the left ventricle LV and back into the left atrium LA, and blood is collected in the left atrium from the pulmonary vein. [0052] Referring now to Figures 1-5, the mitral valve MV includes two leaflets, the anterior leaflet 20 and the posterior leaflet 22. The mitral valve MV also includes an annulus 24, which is a variably dense fibrous ring of tissues that encircles the leaflets 20, 22.

Referring to Figure 3, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae 10. The chordae tendineae 10 are cord-like tendons that connect the papillary muscles 12 (i.e., the muscles located at the base of the chordae tendineae and within the walls of the left ventricle) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles 12 serve to limit the movements of the mitral valve MV and prevent the mitral valve from being inverted or prolapsed. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and the left ventricle LV. The papillary muscles do not open or close the mitral valve MV. Rather, the papillary muscles brace the mitral valve MV against the high pressure needed to circulate blood throughout the body. Together the papillary muscles and the chordae tendineae are known as the subvalvular apparatus, which functions to keep the mitral valve MV from prolapsing into the left atrium LA when the mitral valve closes.

[0053] Figures 6 is a cutaway view of the human heart with the section through the papillary muscles of the left ventricle. The right ventricle RV is separated from the left ventricle LV by the interventricular septum IS. The mitral valve leaflets 20, 22 shown in Figure 7 extend inward across the respective orifices that come together or “coapt” in the flowstream to form the one-way, fluid-occluding surfaces. The devices and methods for remodeling the shape of the heart walls W are described primarily with respect to the left ventricle LV. The devices and methods can be used to approximate the papillary muscles in some embodiments, which are also described primarily with respect to the left ventricle LV. In addition to reducing the size of the ventricle to increase the ventricular function, bringing the papillary muscles closer together can cause the valve leaflets to coapt and prevent mitral valve regurgitation. It should be understood that the devices described herein may also be used in remodeling the right ventricle RV and approximate the papillary muscles of the tricuspid valve TV.

[0054] In one exemplary embodiment, the devices described by the present application are used to remodel the shape of a ventricle to improve heart function. Heart function can be improved by reducing the size of the ventricle, approximating the papillary muscles, and/or correcting the shape and/or function of the mitral valve MV. In one exemplary embodiment, the devices are configured to reshape the wall of a human heart H in a way that causes the mitral valve MV to prevent blood from regurgitating from the left ventricle LV and back into the left atrium LA.

[0055] When a healthy mitral valve MV is in a closed position, the leaflets 20, 22 coapt, which prevents blood from leaking from the left ventricle LV to the left atrium LA. Regurgitation can occur when one or both of the leaflets 20, 22 of the mitral valve MV prolapse into the left atrium LA during systole or the leaflets fail to coapt or close together against one another. This prolapse and/or a failure to coapt causes a gap between the leaflets 20, 22, which allows blood to flow back into the left atrium LA from the left ventricle LV during systole.

[0056] The descriptions of devices and procedures disclosed herein refer to remodeling the left ventricle, with the possible consequence of better coaption of the leaflets of the mitral valve. However, it should be understood that the devices and concepts provided herein can be used to remodel the right ventricle, with the possible consequence of better coaption of the tricuspid valve TV leaflets.

[0057] Referring now to Figure 8, an enlarged cutaway view of the human heart wall W is illustrated. The heart wall W has multiple layers, which include the endocardium 102, the myocardium 104, and the epicardium 106. The endocardium 102 is the most inner layer of the heart H. It forms the inner layer of all four heart chambers and is directly connected to all the inner cardiac appendages, such as the bicuspid valve BV, the tricuspid valve TV, the pulmonary valve (not shown), the aortic valve AV, and the chordae tendineae CT by way of the papillary muscles 12.

[0058] The myocardium 104 sits between the inner endocardium 102 and the outer epicardium 106. The myocardium 104 is the basic muscle that makes up the heart H and it functions by providing a scaffolding for the heart chambers. The myocardium 104 contracts and relaxes the cardiac walls so that blood can pass between the chambers.

[0059] The epicardium 106 is a visceral layer of serous pericardium. The epicardium is the innermost of the two layers of the pericardium. The epicardium covers the external surfaces of the heart. It is directly fused with the myocardium internally. It is comprised mainly of connective tissue and protectively encompasses the heart.

[0060] The pericardium 108 is the double-walled sac that contains the heart and roots of the great vessels that leave from or enter the heart. A space is formed between epicardium 106 and the serous layer of the pericardium 108, which is known as the pericardial cavity 110, which contains pericardial fluid. A layer of parietal pericardium 112 is disposed around the heart. The outer parietal layer 112 and the inner serous pericardium layer are on the outside of the pericardial cavity 110.

[0061] Referring to Figs. 9A-9C, an exemplary tissue reshaping anchor device 900 is shown. Tissue reshaping anchor device 900 comprises at least an anchor 908 associated with an anchor delivery component 902. In some embodiments, an optional anchor stop 904 is used to keep the anchor 908 in tissue while the delivery component 902 is removed from the anchor.

[0062] The anchoring device can take a wide variety of different forms. In the illustrated exemplary embodiments, tissue reshaping anchor device 900 has a corkscrew, coil, spiral, helical or similar shape which can operate as a screw. When the anchor device 900 is rotated clockwise or counterclockwise (depending on the configuration of the helix), the tissue reshaping anchor device 900 screws or bores into heart tissue along a path defined by the shape of the tissue reshaping anchor device.

[0063] The delivery component 902 can take a wide variety of different forms. For example, the delivery component can be configured to be positioned on the outside or inside of the anchor 908. In the example illustrated by Figures 9A-9C, the anchor delivery component 902 comprises a cavity 909 wherein an anchor 908 resides.

[0064] The anchor 908 can take a wide variety of different forms. In the example illustrated by Figures 9A-9C, the anchor 908 has a first end 906 and a second end 910. The first end 906 of anchor 908 can be attached to anchor stop 904. Anchor stop 904 can extend the length of the anchor delivery component 902 and be used to control the position of anchor 908 within the delivery component 902. For example, anchor stop 904 can be used to fix or hold the anchor 908 in place as anchor delivery component 902 is retracted.

[0065] Fig. 9A-9C further illustrates various deployment positions of an exemplary tissue reshaping anchor device 900. In Fig. 9A, tissue reshaping anchor device 900 is in a delivery position. In the delivery position, the tissue reshaping anchor device 900 can be delivered to the target tissue location and rotated or screwed into the tissue at the location.

The target tissue location can be a tissue location where reshaping is desired. For example, the target location can be the wall of the ventricle, the annulus of a native valve, such as the mitral valve or the tricuspid valve, a papillary muscle, etc.

[0066] Once a satisfactory target tissue location has been reached, the tissue reshaping device 900 can be screwed into the target tissue. In some embodiments, the target tissue is endocardial tissue. Once the device 900 is screwed into the tissue, anchor delivery component 902 can be removed or retracted from the anchor 908, as illustrated in Figs. 9B and 9C by arrow 911. During deployment, the anchor 908 remains fixed in the tissue at the target location while anchor delivery component 902 is rotated in the opposite direction of the application of the tissue reshaping anchor device 900 to the target tissue. This rotation retracts the anchor delivery component 902 from the implanted anchor 908 and the target tissue. In Fig. 9C the anchor 908 is fully removed from the anchor delivery component 902 and the anchor delivery component 902 can be removed from the body.

[0067] In some exemplary embodiments, the second end or tip 910 of the anchor 908 can be configured to secure the anchor 908 at the target tissue location while the anchor delivery component 902 is retracted. For example, the tip 910 of the anchor can be positioned inside of the delivery component 902 while the tissue reshaping anchor device 900 is screwed into the tissue. The tip 910 (or other portion) of the anchor can have expanding features or high friction features, such as barbs that sufficiently hold the anchor 908 in the tissue while the delivery component is retracted, without the need for a stop 904.

[0068] In some exemplary embodiments, the tip 910 of the anchor can be positioned outside of the delivery component 902 while the tissue reshaping anchor device 900 is screwed into the tissue. The tip 910 of the anchor can have features that allow the anchor tip to be screwed into the tissue but prevent the anchor from being unscrewed from the tissue.

For example, the tip 910 can have ramped surfaces that can easily advance into the tissue but are more difficult to pull out of the tissue. Such features sufficiently hold the anchor 908 in the tissue while the delivery component is retracted, without the need for a stop 904.

[0069] In some embodiments, anchor stop 904 is configured to provide a force to a proximal end 906 of the anchor 908 that is sufficient to hold in the anchor in the tissue at the target location while the anchor delivery component 902 is retracted. After the delivery component 902 is retracted from the tissue at the delivery site and the anchor 908, the anchor stop 904 can optionally be detached from the first end 906 of anchor 908. In another exemplary embodiment, the anchor stop 904 is left attached to the anchor 908 and is used as connection line. For example, two or more anchors can be connected and pulled toward one another with connection lines.

[0070] In one exemplary embodiment, implanting the anchor 908 in the tissue at the target location reshapes the tissue at the target location. The tissue can be reshaped in a variety of different ways. For example, the tissue can be reshaped based on a change in the shape of the anchor 908 from the delivery condition (i.e. the shape of the anchor 908 in the delivery component 902) to the released condition (i.e. the shape of the anchor 908 released outside the delivery component 902). This shape change can be axial contraction, axial extension, radial contraction and/or radial expansion. For example, the shape change can be axial contraction only, axial extension only, radial contraction only, radial expansion only, axial contraction with radial expansion, or axial extension with radial contraction. Any of these changes in shape cause the anchor 908 to engage the tissue to contract or expand the tissue at the target location.

[0071] While in some embodiments, the shape of the anchor 908 can change between the delivery state and the delivered or implanted state. However, in other embodiments the shape of the anchor 908 can remain the same between the delivery state and the delivered or implanted state. For example, the shape of the anchor delivery component 902 can be the same as anchor 908.

[0072] In embodiments where the shape of the anchor 908 changes between the delivery state and the delivered or implanted state, the anchor delivery component 902 and the anchor can have different shapes. The different shape of anchor delivery component 902 can maintain the anchor 908 in the shape of anchor delivery component 902 (or a shape that is between or a blend of the shapes of the delivery component 902 and the anchor). As the anchor 908 is deployed from the anchor delivery component 902, the anchor 908 will return to or spring back to its unconstrained shape. The anchor 908 can be shape set to a wide variety of different unconstrained shapes.

[0073] As depicted at Fig. 10, anchor 908 has been fully deployed by the anchor delivery component 902 and can modify or reshape the tissue at the target tissue location.

[0074] Fig. 13 shows an exemplary tissue reshaping anchor device 900 wherein anchor 908 is hollow with a cavity formed therein. The anchor 908 can be located within a cavity 909 formed within anchor delivery component 902. Anchor 908 has a first end 906 and a second end 910. The first end 906 can be attached to an anchor stop 904. Fig. 14 shows a hollow anchor 908 is fully deployed at a target tissue location. Similar to Figs. 10, 11, 11A, 12, and 12A, Figs. 15-17 depict examples of deployed shape changes of hollow anchor 908. Figures 16 and 17 illustrate axial expansion and contraction of the anchor 908 respectively. However, the anchor can be configured to radially expand or contract as described above. As depicted at Fig. 15, hollow anchor 908 has been fully deployed by the anchor delivery component 902 and can modify or reshape the tissue at the target tissue location. In an exemplary embodiment shown in Fig. 16, the hollow anchor 908 takes a shape which contracts tissue at the target tissue location. The amount of contraction corresponds to a reduction of the pitch d multiplied by the number of coils that engage tissue. In Fig. 17, the anchor 908 takes a shape which axially expands tissue at the target location. The amount of expansion corresponds to the change in pitch d multiplied by the number of coils that engage tissue.

[0075] Figs. 18A-18D shows an exemplary tissue reshaping anchor device 900 applied to tissue 1800 at a target location. In some embodiments, the tissue 1800 is a heart wall. In the example illustrated by Figure 18A, the tissue reshaping anchor device 900 is screwed into tissue 1800 along the surface 1802 of the tissue. For example, the tissue reshaping anchor device 900 can be delivered to a target location, such that an axis of the device is substantially parallel to the surface 1802 and adjacent to the tissue. Rotating the tissue reshaping anchor device 900 causes the device 900 to screw/advance into the tissue 1800. As a result, a first portion 1804 of the delivery component 902 and a first portion 1814 of the anchor 908 protrude from the surface 1804 of the target tissue 1800 and a second portion 1806 of the delivery component 902 and a second portion 1816 of the anchor 908 are embedded within tissue 1800 at the target location 1800. In other embodiments, the anchor 908 can protrude from both a first surface and a second surface of the target tissue location 1800, when the diameter of the device 900 is greater than the thickness of the tissue.

[0076] Fig. 18B illustrates the anchor 908 partially deployed from the anchor delivery component 902. The anchor 908 remains implanted at the target tissue location while anchor delivery component 902 is rotated in the opposite direction of the application of the anchor delivery component 902 to the tissue 1800. This opposite direction rotation retracts the anchor delivery component 902 from the anchor 908 and the target tissue 1800.

[0077] In some exemplary embodiments, the second end or tip 910 of the anchor 908 can be configured to secure the anchor 908 in the target tissue 1800 while the anchor delivery component 902 is retracted. For example, the tip 910 of the anchor can be positioned inside of the delivery component 902 while the tissue reshaping anchor device 900 is screwed into the tissue 1800. The tip 910 (or other portion) of the anchor can have expanding features or high friction features, such as barbs that sufficiently hold the anchor 908 in the tissue while the delivery component is retracted, without the need for a stop 904.

[0078] In some exemplary embodiments, the tip 910 of the anchor can be positioned outside of the delivery component 902 while the tissue reshaping anchor device 900 is screwed into the tissue 1800. The tip 910 of the anchor can have features that allow the anchor tip to be screwed into the tissue but prevent the anchor from being unscrewed from the tissue. For example, the tip 910 can have ramped surfaces that can easily advance into the tissue but are more difficult to pull out of the tissue. Such features sufficiently hold the anchor 908 in the tissue while the delivery component is retracted, without the need for a stop 904.

[0079] In some embodiments, the illustrated optional anchor stop 904 is configured to provide a force to a proximal end 906 of the anchor 908 that is sufficient to hold in the anchor in the tissue at the target location while the anchor delivery component 902 is retracted. After the delivery component 902 is retracted from the tissue 1800 at the delivery site and the anchor 908, the anchor stop 904 can optionally be detached from the first end 906 of anchor 908 as illustrated by Figure 18D. In another exemplary embodiment, the anchor stop 904 is left attached to the anchor 908 and is used as connection line. For example, two or more anchors can be connected and pulled toward one another with connection lines.

[0080] Fig. 18C illustrates the anchor 908 fully deployed from the anchor delivery component 902. The anchor 908 remains implanted at the target tissue location and the delivery component 902 can be removed. In some embodiments, the anchor stop 904 can be configured to automatically detach from the first end 906 of anchor 908, once anchor 908 has been fully removed from the anchor delivery component 902. Fig. 18D depicts the anchor 908 fully deployed within the tissue 1800 at the target location.

[0081] Fig. 19A-19B show an exemplary embodiment where the tissue reshaping anchor device 900 is deployed along the surface of the tissue 1800 and the anchor 908 compresses the tissue. In Fig. 19A, anchor 908 is deployed from anchor delivery component 902. As shown, the axial length of anchor delivery component 902 is longer the axial length of the anchor 908. As a result, as anchor 908 is deployed within the tissue 1800 at the target location, tissue 1902 between the coils of the anchor is compressed to conform with the axially compressed shape of anchor 908. Anchor 908 is shown protruding from a first surface of target tissue location 1800 and a portion of anchor 908 is embedded within target tissue location 1800 (As described with respect to Figures 18A-18D). In some other exemplary embodiments, anchor 908 can additionally protrude from a second surface of target tissue location 1800 and compress the tissue axially.

[0082] As anchor delivery component 902 is rotated, the anchor delivery component 902 is removed from the tissue 1800 and the anchor 908. A completely deployed anchor 908 is shown in Fig. 19B. Compressed tissue 1902 is axially compressed between first, second, and third contracting deployed coils of anchor 908. The anchor 908 can extend further than the illustrated three coils in order to contract additional tissue 1902. Additionally, in alternative embodiments, anchor 908 can have an unconstrained shape that is axially wider than anchor delivery component 902 and would therefore cause tissue 1902 to expand or stretch to conform to the shape of anchor 908. In yet another alternative embodiment, anchor 908 and anchor delivery component 902 can have the same shape wherein tissue (e.g. tissue 1902) would be held in substantially the same place after anchor 908 has been deployed within target tissue location 1800.

[0083] Fig. 20 shows an exemplary anchor 908 deployed within a target tissue area 1800. In some embodiments, anchor 908 associated with a tether or line 2004. As shown in Fig. 20, the anchor 908 can contract tissue 1902. Tether 2004 can then be used to further manipulate tissue 1902 and/or target tissue location 1800 via a tension associated with tether 2004. For example, the tether or line can be used to remodel heart walls, such as ventricular walls and/or to move or approximate the papillary muscles. In certain embodiments, tether 2004 can be attached or connected to another anchor or tissue reshaping anchor device. For example, the tether or line 2004 can be used in any of the ways that the lines described in US Provisional Patent Application Serial No. 62/836,799 April 22, 2019 are used. US Provisional Patent Application Serial No. 62/836,799 is incorporated herein by reference in its entirety.

[0084] Fig. 21A-21D shows an exemplary tissue reshaping anchor device 900 deployed within tissue 1800 at a target location. In some embodiments, target tissue location 1800 is a heart wall. In the example illustrated by Figures 21A-21D, the tissue reshaping anchor device 900 is screwed into tissue 1800 with the lengthwise axis of the anchoring device 900 perpendicular or substantially perpendicular to the surface 1802 of the tissue 1800.

[0085] At Fig. 21A, tissue reshaping anchor device 900 is applied within the tissue 1800 at the target location. As shown, the entire or substantially the entire anchor 908 is embedded within the tissue 1800 at the target location.

[0086] At Fig. 21B, the delivery component 902 is partially withdrawn from the anchor 908 by rotating the delivery component 902 in a direction that is opposite to the direction used to embed the device 900.

[0087] At Fig. 21C, the delivery component 902 is fully withdrawn from the anchor 908 and the anchor remains implanted in the tissue 1800. In some embodiments, anchor stop 904 can be configured to automatically detach from the first end 906 of anchor 908 once anchor 908 has been fully removed from the anchor delivery component 902. In other embodiments, the anchor stop 904 can be removed by operation of a disengagement mechanism that is situated at the proximal end of a delivery catheter for the device 900. In other embodiments, the anchor stop 904 is not included and the anchor 908 is configured to hold the tissue 1800 and maintain its position in the tissue while the delivery component 902 is removed. For example, as mentioned above, the second end 910 of the anchor can be configured to secure the anchor 908 in the tissue 1800 at the target tissue location 1800 while the anchor delivery component 902 is retracted. For example, the end 910 can optionally have any of the tissue retention features described herein. Figure 21D illustrates the anchor 908 implanted in the tissue 1800 and the delivery component removed. Fig. 21D depicts anchor 908 fully deployed within the tissue 1800 with the optional anchor stop 904 optionally still attached to anchor 908. In some embodiments, the anchor stop 904 can be used as a tether to the anchor 908. For example, the anchor stop 904 can be used as the tether or line 2004 described herein and can be used in any of the ways that the lines described in US Provisional Patent Application Serial No. 62/836,799 April 22, 2019 are used.

[0088] Referring to Fig. 22A-22C, another exemplary tissue reshaping anchor device 900 is shown. This exemplary tissue reshaping anchor device 900 comprises at least an outer anchor 908 and inner anchor delivery component 902. In exemplary embodiments, tissue reshaping anchor device 900 forms a corkscrew, coil, spiral, helical or similar shape which can operate as a screw, such that when rotated clockwise or counterclockwise, the tissue reshaping anchor device 900 can be axially advanced, for example, into heart tissue. In certain embodiments, the anchor 908 comprises a cavity 2209 wherein the anchor delivery component 902 resides. Anchor 908 has a first end 906 and a second end 910. During application into a target tissue location, tissue reshaping anchor device can be screwed into place, and once the anchor has been implanted, the anchor delivery component 902 can be retracted.

[0089] An exemplary application of the anchor 908 into tissue is shown in various stages in Figs. 22A-22C. In Fig. 22A, tissue reshaping anchor device 900 is in a delivery position. In the delivery position, the anchor 908 and anchor delivery component 902 can be rotated or screwed into tissue at a target location. The target tissue location can be a tissue location where reshaping or tissue manipulation is desired and/or where an anchor and/or tether is needed.

[0090] Once a satisfactory target tissue location has been reached, the anchor delivery component 902 can be retracted from inside the anchor 908, as depicted in Fig. 22B. In one exemplary embodiment, the friction between the outside surface of the delivery component 902 and the inside surface of the anchor 908 is configured such that the anchor 908 remains fixed at the target tissue location while anchor delivery component 902 is rotated in the opposite direction of the application of the anchor delivery component 902. As a result, the anchor delivery component 902 is retracted from the tissue at the target location. Optionally, the anchor 908 can have an outer surface that is configured to secure the anchor 908 in the tissue 1800 at the target tissue location. For example, the outside surface of the anchor 908 can have friction increasing features, such as knurling, barbs, etc. In Fig. 22C, the anchor 908 is fully removed from the anchor delivery component 902 and the anchor delivery component 902 can be removed from the body.

[0091] Figs. 23-25 illustrate further embodiments of the exemplary hollow anchor 908 as shown in Figs. 22A-22C. As depicted at Fig. 23, anchor 908 has been fully deployed to a target tissue location with the anchor delivery component 902 fully retracted from the cavity within anchor 908. In one exemplary embodiment, the anchor 908 can reshape the tissue at the target location. Tissue can be reshaped based on the shape of the anchor 908 which can contract or expand tissue at the target tissue location.

[0092] In an exemplary embodiment shown in Fig. 24, the anchor 908 takes a shape which axially (i.e. along the length of the anchor 908) contracts tissue at the target tissue location. The amount of contraction can be the reduction in pitch d multiplied by the number of anchor turns that engage tissue. In one exemplary embodiment, the anchor is configured to axially contract and not radially expand or not substantially radially expand. In another exemplary embodiment, the anchor 908 takes a shape which radially (i.e. the diameter of the anchor 908) expands tissue at the target tissue location. In one exemplary embodiment, the anchor is configured to radially expand and not axially contract or not substantially axially contract. In one exemplary embodiment, the anchor is configured to both radially expand and axially contract.

[0093] In an exemplary embodiment shown in Fig. 25, the anchor 908 takes a shape which axially expands tissue at the target tissue location. The amount of axial expansion can be the increase in pitch d multiplied by the number of anchor turns that engage tissue. In one exemplary embodiment, the anchor is configured axially lengthen and not radially contract or not substantially radially contract. In one exemplary embodiment, the anchor 908 takes a shape which radially contracts tissue at the target tissue location. In one exemplary embodiment, the anchor is configured to radially contract and not axially expand or not substantially axially expand. In one exemplary embodiment, the anchor is configured to both radially contract and axially expand. It will be appreciated that, in certain embodiments, anchor 908 can comprise a combination of contraction and expansion zones such that tissue can be engaged in contraction in one area of the target tissue location and engaged in expansion in another area of the target tissue location. [0094] In an exemplary embodiment shown in Fig. 24, the anchor 908 takes a shape which contracts tissue at the target tissue location when the anchor delivery component 902 is retracted. The amount of contraction can be determined by a distance d. In Fig. 25, the anchor 908 takes a shape with expands tissue at the target tissue location when the anchor delivery component 902 is retracted. The amount of expansion can be determined by a distance d.

[0095] Figs. 26A-26C shows an exemplary tissue reshaping anchor device 900 applied to tissue 1800 at a target location. In some embodiments, the tissue 1800 is a heart wall. In the example illustrated by Figure 26A, the tissue reshaping anchor device 900 is screwed into tissue 1800 along the surface 1802 of the tissue. For example, the tissue reshaping anchor device 900 can be delivered to a target location, such that an axis of the device is substantially parallel to the surface 1802 and adjacent to the tissue. Rotating the tissue reshaping anchor device 900 causes the device 900 to screw/advance into the tissue 1800. As a result, a first portion 1804 of the delivery component 902 and a first portion 1814 of the anchor 908 protrude from the surface 1804 of the target tissue 1800 and a second portion 1806 of the delivery component 902 and a second portion 1816 of the anchor 908 are embedded within tissue 1800 at the target location 1800. In other embodiments, the anchor 908 can protrude from both a first surface and a second surface of the target tissue location 1800, when the diameter of the device 900 is greater than the thickness of the tissue.

[0096] Fig. 26B illustrates the anchor 908 partially deployed from the anchor delivery component 902. The anchor 908 remains implanted at the target tissue location while anchor delivery component 902 is rotated in the opposite direction of the application of the anchor delivery component 902 to the tissue 1800. This opposite direction rotation retracts the anchor delivery component 902 from the anchor 908 and the target tissue 1800. In some exemplary embodiments, the outside surface of the anchor 908 can be configured to secure the anchor 908 in the target tissue 1800. The tip 910 (or other portion) of the anchor can have expanding features or high friction features, such as barbs that hold the anchor 908 in the tissue. Fig. 26C illustrates the anchor 908 fully deployed from the anchor delivery component 902. The anchor 908 remains implanted at the target tissue location and the delivery component 902 can be removed.

[0097] Fig. 27A-27B show an exemplary embodiment where the tissue reshaping anchor device 900 is deployed along the surface of the tissue 1800 and the anchor 908 compresses the tissue. In Fig. 27A, anchor 908 is deployed from the anchor delivery component 902. As shown, the axial length of the anchor delivery component 902 is longer than the axial length of the anchor 908. As a result, as anchor 908 is deployed within the tissue 1800 at the target location, tissue 1902 between the hollow coils of the anchor is compressed to conform with the axially compressed shape of anchor 908. Anchor 908 is shown protruding from a first surface of target tissue location 1800 and a portion of anchor 908 is embedded within target tissue location 1800 (As described with respect to Figures 18A-18D). In some other exemplary embodiments, anchor 908 can additionally protrude from a second surface of target tissue location 1800 and compress the tissue axially.

[0098] As anchor delivery component 902 is rotated, the anchor delivery component 902 is removed from the tissue 1800 and the anchor 908. A completely deployed anchor 908 is shown in Fig. 27B. Compressed tissue 1902 is axially compressed between first, second, and third contracting deployed coils of anchor 908. The anchor 908 can extend further than the illustrated three coils in order to contract additional tissue 1902. Additionally, in alternative embodiments, anchor 908 can have an unconstrained shape that is axially wider than anchor delivery component 902 and would therefore cause tissue 1902 to expand or stretch to conform to the shape of anchor 908. In yet another alternative embodiment, anchor 908 and anchor delivery component 902 can have the same shape wherein tissue (e.g. tissue 1902) would be held in substantially the same place after anchor 908 has been deployed within target tissue location 1800.

[0099] Fig. 28 shows an exemplary anchor 908 deployed within tissue 1800 at a target area. In some embodiments, anchor 908 associated with a tether or line 2004. As shown in Fig. 28, the anchor 908 can contract tissue 1902. The tether 2004 can then be used to further manipulate tissue 1902 and/or target tissue location 1800 via a tension associated with the tether 2004. For example, the tether or line can be used to remodel heart walls, such as ventricular walls and/or to move or approximate the papillary muscles. In certain embodiments, tether 2004 can be attached or connected to another anchor or tissue reshaping anchor device. For example, the tether or line 2004 can be used in any of the ways that the lines described in US Provisional Patent Application Serial No. 62/836,799 April 22, 2019 are used. US Provisional Patent Application Serial No. 62/836,799 is incorporated herein by reference in its entirety.

[00100] At Fig. 29A, tissue reshaping anchor device 900 is applied within the tissue 1800 at the target location. As shown, the entire or substantially the entire anchor 908 is embedded within the tissue 1800 at the target location.

[00101] At Fig. 29B, the delivery component 902 is partially withdrawn from the anchor 908 by rotating the delivery component 902 in a direction that is opposite to the direction used to embed the device 900. [00102] At Fig. 29C, the delivery component 902 is fully withdrawn from the anchor 908 and the anchor remains implanted in the tissue 1800. In some exemplary embodiments, the anchor 908 is configured to hold the tissue 1800 and maintain its position in the tissue while the delivery component 902 is removed. For example, the second end 910 of the anchor and/or the outside surface of the anchor 908 can be configured to secure the anchor 908 in the tissue 1800 at the target tissue location 1800 while the anchor delivery component 902 is retracted. For example, the end 910 and/or the outside surface of the anchor can optionally have any of the tissue retention features described herein. Once the anchor 908 is implanted in the tissue 1800, the delivery component is removed. Fig. 21D depicts anchor 908 fully deployed within the tissue 1800 with the optional anchor stop 904 optionally still attached to anchor 908.

[00103] In the exemplary embodiment illustrated by Figs. 29A-29C, the exemplary tissue reshaping anchor device 900 can be deployed within the heart wall. In some embodiments, anchor 908 and anchor delivery component 902 can be partially embedded within the tissue 1800.

[00104] In some embodiments, an exemplary anchor 908 that has been deployed into a target tissue location can be modified by an anchor modification device 912. An exemplary modification of a deployed anchor 908 is shown in in Figs. 30A-30C. In Fig. 30A, anchor 908 is shown in a deployed position. In some exemplary embodiments, an anchor delivery component 902 can be used to deliver the anchor 908. In other exemplary embodiments, the anchor 908 is directly delivered, such as with a catheter, and a delivery device 902 that surrounds or is surrounded by the anchor 908 is omitted.

[00105] The anchor modification device 912 can be inserted at the first end 906 of the anchor 908. As anchor modification device 912 is rotated it is further inserted into the cavity of anchor 908 as shown in Fig. 30B. At Fig. 30C, the anchor modification device 912 is shown fully inserted into anchor 908. As shown, anchor modification device 912 causes the shape of the anchor 908 to be contracted, which can further contract tissue being modified by anchor 908. It will be appreciated that anchor modification device 912 can be similarly applied in order to cause the shape of anchor 908 to expand, except the modification device 912 is longer than the anchor 908. Application of anchor modification device 912 can allow for modification or additional modification and reshaping of tissue after the anchor 908 has been deployed. The anchor modification device 912 can change the shape of the anchor 908 in a wide variety of different ways. For example, the anchor modification device 912 can be configured to axially expand, axially contract, radially expand, and/or radially contract the anchor.

[00106] Fig. 31-39 depict various deployment positions of an exemplary anchor 908 for modifying, reinforcing, and/or reshaping heart tissue. In the examples illustrated by Figures 31-39, the anchor(s) 908 are deployed along or parallel the tissue surface to remodel the heart tissue. It will be appreciated that anchor(s) 908 as illustrated by Figures 31-39 may comprise any of the exemplary anchor embodiments disclosed herein. In certain embodiments, a combination of alternative anchor embodiments may be used for reshaping heart tissue. As depicted, anchor(s) 908 are deployed such that at least a portion of anchor 908 is embedded within the heart wall tissue to contract tissue at target location. It will be appreciated that anchor(s) 908 can be similarly deployed at the various tissue locations to expand tissue at the target tissue locations. In some embodiments, anchor 908 does not expand or contract and simply retains tissue in a fixed position reinforcing the tissue. In certain embodiments, anchor(s) 908 may be deployed into tissue as a means to prevent further or future dilation of the tissue. In certain preventative embodiments, anchor(s) 908 may be deployed to expand, contract, and/or retain tissue in a fixed position. This can be used to reinforce the ventricle and prevent and/or reduce further or further dilation. It will be appreciated that anchor(s) 908 may be similarly deployed to reinforce tissue at various tissue locations.

[00107] Fig. 31 shows anchor 908 deployed within left ventricular heart wall tissue at target location 3100 which is along the height of left ventricle, such as parallel to the direction of flow through parallel to the mitral valve MV.

[00108] Fig. 32 shows a plurality of anchors 908 deployed within heart wall tissue at target tissue locations 3200, 3202, and 3204 which are along the height of left ventricle, such as parallel to the direction of flow through the mitral valve MV.

[00109] Fig. 33 shows an anchor 908 deployed within heart wall tissue at target tissue location 3300 which is perpendicular to the height of left ventricle, such as perpendicular to the direction of flow through the mitral valve MV.

[00110] Fig. 34 shows a plurality of anchors 908 deployed within heart wall tissue at target tissue locations 3400, 3402, and 3404 which are perpendicular to the height of left ventricle, such as perpendicular to the direction of flow through the mitral valve MV.

[00111] Fig. 35 shows an anchor 908 deployed within heart wall tissue at target tissue location 3500 located at the bottom or apex of the left ventricle of the heart. [00112] Fig. 36 shows a plurality of anchors 908 deployed within heart wall tissue at target tissue locations 3600 and 3602 located perpendicular to the aortic valve AV and mitral valve MV in the left ventricle of the heart as well as at target tissue location 3604 located at the bottom of the left ventricle of the heart.

[00113] Fig. 37 shows an anchor 908 deployed within heart wall tissue at a target location 3700 located on the left ventricular side of the ventricular septal wall. In other exemplary embodiments, the target location 3700 is on the right ventricular side of the ventricular septal wall.

[00114] Fig. 38 shows an anchor 908 deployed within heart wall tissue at target tissue location 3800 located on the side of the left ventricle.

[00115] Referring now to Fig. 39-40, an enlarged cutaway view of the human heart wall W is illustrated. The heart wall W has multiple layers, which include the endocardium 102, the myocardium 104, and the epicardium 106. The endocardium 102 is the most inner layer of the heart H. It forms the inner layer of all four heart chambers and is directly connected to all the inner cardiac appendages, such as the bicuspid valve BV, the tricuspid valve TV, the pulmonary valve (not shown), the aortic valve AV, and the chordae tendineae CT by way of the papillary muscles 12. In Fig. 39 an exemplary anchor 908 is shown deployed within the endocardium 102 and myocardium 104, with a first end 906 and second end 910 of anchor 908 secured within the myocardium 104. In Fig. 40 an exemplary anchor 908 is shown deployed and embedded within the myocardium 104.

[00116] Similar to the exemplary embodiments illustrated in Fig. 31-38, in the examples illustrated by Figures Fig. 39-40, the anchor(s) 908 can be deployed along or parallel the tissue surface to remodel the heart tissue. It will be appreciated that anchor(s) 908 as illustrated by Fig. 39-40 may comprise any of the exemplary anchor embodiments disclosed herein. In certain embodiments, a combination of alternative anchor embodiments may be used for reshaping heart tissue. Anchor(s) 908 can deploy such that at least a portion of anchor 908 is embedded within the heart wall tissue to contract tissue at target location. It will be appreciated that anchor 908 can be similarly deployed at the various tissue locations to expand tissue at the target tissue locations. In some embodiments, anchor 908 does not expand or contract and simply retains tissue in a fixed position reinforcing the tissue. In certain embodiments, anchor(s) 908 may be deployed into tissue as a means to prevent further or future dilation of the tissue. In certain preventative embodiments, anchor(s) 908 may be deployed to expand, contract, and/or retain tissue in a fixed position. In some embodiments, this can be used to reinforce the ventricle and prevent and/or reduce further or further dilation. It will be appreciated that anchor(s) 908 may be similarly deployed to reinforce tissue at various tissue locations.

[00117] The anchors 908 disclosed herein can be delivered in a wide variety of different ways. In some exemplary embodiments, the anchors 908 and anchor delivery component 902 can be delivered with a catheter 4100. The catheter 4100 can take a wide variety of different forms and the anchor 908 can be disposed in the catheter 4100 in a wide variety of different ways.

[00118] Referring to Figure 41, in one exemplary embodiment, the anchor 908 and the delivery component 902 are disposed in the catheter 4100 in a coiled onfiguration. The coiled anchor 908 can be implanted by extending (gradually or all at once) the anchor 908 and/or the delivery component 902 from the catheter and implanting the anchor in any of the ways disclosed herein. The anchor 908 and the delivery component 902 can take any of the forms disclosed herein. In the example illustrated by Figure 41, the anchor 908 is the inner component and the delivery component 902 is the outer component. However, in other exemplary embodiments, the anchor 908 can be the outer component and the delivery component 902 can be the inner component. In other embodiments, the implanted anchor (the parts that stay in the heart tissue) can include both an inner component and an outer component.

[00119] Referring to Figure 42 and 43, in one exemplary embodiment, the coiled anchor 908 and the coiled delivery component 902 are disposed in the catheter 4100 in a straight configuration. The coiled anchor 908 and the coiled delivery component 902 can be placed in the catheter 4100 in the straight configuration in a variety of different ways. For example, the coiled anchor 908 and/or the coiled delivery component 902 can be shape set in the coiled configuration, straightened, and placed in the catheter. When the coiled anchor 908 and/or the coiled delivery component 902 are moved out of the catheter 4100, the coiled anchor 908 and/or the coiled delivery component 902 return to the coiled configuration. The coiled anchor 908 can be implanted by extending (gradually or all at once) the anchor 908 and/or the delivery component 902 from the catheter and implanting the anchor in any of the ways disclosed herein. The anchor 908 and the delivery component 902 can take any of the forms disclosed herein. In the example illustrated by Figures 42 and 43, the anchor 908 is the inner component and the delivery component 902 is the outer component. However, in other exemplary embodiments, the anchor 908 can be the outer component and the delivery component 902 can be the inner component. In other embodiments, the implanted anchor (the parts that stay in the heart tissue) can include both an inner component and an outer component.

[00120] While various inventive aspects, concepts and features of the disclosures can be described and illustrated herein as embodied in combination in the exemplary embodiments, these various aspects, concepts, and features can be used in many alternative embodiments, either individually or in various combinations and sub-combinations thereof. Unless expressly excluded herein all such combinations and sub-combinations are intended to be within the scope of the present application. Still further, while various alternative embodiments as to the various aspects, concepts, and features of the disclosures — such as alternative materials, structures, configurations, methods, devices, and components, alternatives as to form, fit, and function, and so on — can be described herein, such descriptions are not intended to be a complete or exhaustive list of available alternative embodiments, whether presently known or later developed. Those skilled in the art can readily adopt one or more of the inventive aspects, concepts, or features into additional embodiments and uses within the scope of the present application even if such embodiments are not expressly disclosed herein.

[00121] Additionally, even though some features, concepts, or aspects of the disclosures can be described herein as being a preferred arrangement or method, such description is not intended to suggest that such feature is required or necessary unless expressly so stated. Still further, exemplary or representative values and ranges can be included to assist in understanding the present application, however, such values and ranges are not to be construed in a limiting sense and are intended to be critical values or ranges only if so expressly stated.

[00122] Moreover, while various aspects, features and concepts can be expressly identified herein as being inventive or forming part of a disclosure, such identification is not intended to be exclusive, but rather there can be inventive aspects, concepts, and features that are fully described herein without being expressly identified as such or as part of a specific disclosure, the disclosures instead being set forth in the appended claims. Descriptions of exemplary methods or processes are not limited to inclusion of all steps as being required in all cases, nor is the order that the steps are presented to be construed as required or necessary unless expressly so stated. The words used in the claims have their full ordinary meanings and are not limited in any way by the description of the embodiments in the specification.

Claims

1. An anchor device for implantation in heart tissue, comprising: a helical anchor; and a hollow helical delivery component, wherein the helical anchor is disposed in the hollow helical delivery component.

2. The anchor device of claim 1 wherein an unconstrained axial length of the helical anchor is less than an unconstrained axial length of the delivery component.

3. The anchor device of any of claims 1 to 2 wherein an unconstrained axial length of the helical anchor is greater than an unconstrained axial length of the delivery component.

4. The anchor device of any of claims 1 to 3 wherein an unconstrained diameter of the helical anchor is less than an unconstrained diameter of the delivery component.

5. The anchor device of any of claims 1 to 4 wherein an unconstrained diameter of the helical anchor is greater than an unconstrained diameter of the delivery component.

6. An anchor device for implantation in heart tissue, comprising: a hollow helical anchor; and a helical delivery component, wherein the delivery component is disposed in the hollow helical anchor.

7. The anchor device of claim 6 wherein an unconstrained axial length of the helical anchor is less than an unconstrained axial length of the delivery component.

8. The anchor device of any of claims 6 to 7 wherein an unconstrained axial length of the helical anchor is greater than an unconstrained axial length of the delivery component.

9. The anchor device of any of claims 6 to 8 wherein an unconstrained diameter of the helical anchor is less than an unconstrained diameter of the delivery component.

10. The anchor device of any of claims 6 to 9 wherein an unconstrained diameter of the helical anchor is greater than an unconstrained diameter of the delivery component.

11. A method of implanting a helical anchor in heart tissue, the method comprising: providing the helical anchor in a hollow helical delivery component; rotating the hollow helical delivery component and the helical anchor into the heart tissue; and counter-rotating the hollow helical delivery component to remove the hollow helical delivery component from the heart tissue and leave the helical anchor in the heart tissue.

12. The method of claim 11 wherein the helical anchor compresses the heart tissue when the hollow helical delivery component is removed from the heart tissue.

13. The method of any of claims 11 and 12 wherein an unconstrained axial length of the helical anchor is less than an unconstrained axial length of the delivery component.

14. The method of any of claims 11 and 12 wherein an unconstrained diameter of the helical anchor is less than an unconstrained diameter of the delivery component.

15. The method of claim 11 wherein the helical anchor expands the heart tissue when the hollow helical delivery component is removed from the heart tissue.

16. The method of any of claims 11 to 15 wherein an unconstrained axial length of the helical anchor is greater than an unconstrained axial length of the delivery component.

17. The method of any of claims 11 to 16 wherein an unconstrained diameter of the helical anchor is greater than an unconstrained diameter of the delivery component.

18. A method of implanting a helical anchor in heart tissue, the method comprising: providing a helical delivery component in a hollow helical anchor; rotating the helical delivery component and the hollow helical anchor into the heart tissue; and counter-rotating the helical delivery component to remove the helical delivery component from the heart tissue and leave the hollow helical anchor in the heart tissue.

19. The method of claim 18 wherein the hollow helical anchor compresses the heart tissue when the helical delivery component is removed from the heart tissue.

20. The method of any of claims 18 and 19 wherein an unconstrained axial length of the helical anchor is less than an unconstrained axial length of the delivery component.

21. The method of any of claims 18 and 19 wherein an unconstrained diameter of the helical anchor is less than an unconstrained diameter of the delivery component.

22. The method of claim 18 wherein the helical anchor expands the heart tissue when the hollow helical delivery component is removed from the heart tissue.

23. The method of any of claims 18 to 22 wherein an unconstrained axial length of the helical anchor is greater than an unconstrained axial length of the delivery component.

24. The method of any of claims 18 to 23 wherein an unconstrained diameter of the helical anchor is greater than an unconstrained diameter of the delivery component.

25. A system comprising: an anchor device for implantation in heart tissue, comprising: a helical anchor; and a hollow helical delivery component, wherein the helical anchor is disposed in the hollow helical delivery component; and a catheter, wherein the helical anchor and the hollow delivery component are disposed in the catheter.

26. The system of claim 25 wherein an unconstrained axial length of the helical anchor is less than an unconstrained axial length of the delivery component.

27. The system of any of claims 25 to 26 wherein an unconstrained axial length of the helical anchor is greater than an unconstrained axial length of the delivery component.

28. The system of any of claims 25 to 27 wherein an unconstrained diameter of the helical anchor is less than an unconstrained diameter of the delivery component.

29. The system of any of claims 25 to 28 wherein an unconstrained diameter of the helical anchor is greater than an unconstrained diameter of the delivery component.

30. The system of any of claims 25 to 29 wherein the helical anchor and the delivery component are in the catheter in a helical configuration.

31. The system of any of claims 25 to 29 wherein the helical anchor and the delivery component are in the catheter in a straightened configuration.

32. The system of claim 31 the helical anchor and the delivery component become helical upon exiting the catheter.

33. A system comprising: an anchor device for implantation in heart tissue, comprising: a hollow helical anchor; and a helical delivery component, wherein the delivery component is disposed in the hollow helical anchor; and a catheter, wherein the helical anchor and the hollow delivery component are disposed in the catheter.

34. The system of claim 33 wherein an unconstrained axial length of the helical anchor is less than an unconstrained axial length of the delivery component.

35. The system of any of claims 33 to 34 wherein an unconstrained axial length of the helical anchor is greater than an unconstrained axial length of the delivery component.

36. The system of any of claims 33 to 35 wherein an unconstrained diameter of the helical anchor is less than an unconstrained diameter of the delivery component.

37. The system of any of claims 33 to 36 wherein an unconstrained diameter of the helical anchor is greater than an unconstrained diameter of the delivery component.

38. The system of any of claims 33 to 37 wherein the helical anchor and the delivery component are in the catheter in a helical configuration.

39. The system of any of claims 33 to 37 wherein the helical anchor and the delivery component are in the catheter in a straightened configuration.

40. The system of claim 39 the helical anchor and the delivery component become helical upon exiting the catheter.