Wire cutting tools and methods for cardiac wall remodeling devices

Abstract

Several cardiac wall remodeling devices and methods are disclosed. One cardiac wall remodeling apparatus includes a cutting tool for severing a wire within a patient. The cutting tool includes an actuator for manipulation by a user, a movable inner shaft coupled to the actuator, and an outer sleeve coupled to the inner shaft. The outer shaft includes a backstop disposed along an inner wall of the outer sleeve and a channel disposed between a first end and a second end of the outer sleeve. The inner shaft includes an inner shaft, a compressible member, and a cutter.

Description

[Technical field]

[0001] Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 197,296, filed June 4, 2021, which is incorporated by reference herein in its entirety. [Background technology]

[0002] Ischemic heart failure and systolic heart failure are conditions in which the left ventricle expands and dilates. In ischemic heart failure, myocardial infarction occurs and the left ventricle remodels over a period of days or months. In systolic heart failure, the left ventricle expands for other reasons. For example, the initial causes of systolic heart failure include chronic hypertension, mitral regurgitation, and other dilated cardiomyopathies. A dilated heart, especially a dilated left ventricle, can significantly increase the tension and stress of the heart wall during both diastolic filling and systolic contraction, contributing to further dilation or enlargement of the left ventricle.

[0003] Mitral insufficiency or mitral regurgitation is often associated with ischemic and systolic heart failure. As ventricular dilation progresses, valve function may worsen. For example, as the left ventricle dilates, the papillary muscles (attached to the valve leaflets by chordae tendineae) may move radially outward and downward relative to the mitral valve and relative to its normal position. However, during this movement of the papillary muscles, the length of the various chordae remains substantially constant. This impairs the leaflets' ability to fully close by prematurely tensioning them. In addition, left ventricular enlargement may increase the size of the mitral annulus, but the area of ​​the leaflets remains constant. This may result in a narrower coaptation area of ​​the leaflets. Furthermore, in a normal heart, the size of the mitral valve contracts during systole, aiding in valve coaptation. Right ventricular enlargement reduces annular contraction, distorting the size of the annulus, often worsening mitral regurgitation. The combination of changes to the mitral annulus and displacement of the papillary muscles can result in a regurgitant mitral valve. This increased regurgitation can in turn increase ventricular wall stress, which may advance the diastolic process, which can further exacerbate mitral valve insufficiency. Summary of the Invention

[0004] This summary is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any features contained within an example of this summary are not required by the claims unless the claims explicitly recite those features. Also, features, components, steps, concepts, etc. described in the examples of this summary and elsewhere in this disclosure can be combined in various manners. Various features and steps described elsewhere in this disclosure may be included in the examples summarized here.

[0005] An implantable device or implant (e.g., an implantable device, etc.) is configured to be positioned within a native heart valve to remodel one or more walls of the heart to enable the heart to function more efficiently.

[0006] In one exemplary embodiment, a cutting tool for severing a wire within a patient includes an actuator, an outer shaft, a movable inner shaft, a compressible member, and a cutter or blade. The actuator is operable by a user external to the patient. The movable inner shaft is coupled to the actuator. The compressible member is compressible by the actuator from an expanded length to a compressed length. The cutter has a length between the expanded length and the compressed length of the compressible member. An outer sleeve is coupled to the inner shaft such that the inner shaft is movable relative to the outer shaft. A backstop is disposed along an inner wall of the outer sleeve. The outer sleeve includes a cutting channel. The cutting tool is configured to cut a wire received within the cutting channel of the outer sleeve.

[0007] In one exemplary embodiment, a handle for operating a cutting tool includes an outer frame and a two-stage trigger. A cavity extends partially into the outer frame. The cavity houses a first spring and a two-stage trigger. The trigger is coupled to the outer housing and movable within the cavity. The two-stage trigger includes an outer housing, an inner member, and a spring coupled to the outer housing and the inner member.

[0008] In one exemplary embodiment, the assembly includes a cutting tool and a two-stage cutting tool control handle. The cutting tool includes an actuator, an outer shaft, a movable inner shaft, a compressible member, and a cutter or blade. The actuator is operable via the two-stage cutting control handle outside the patient. The movable inner shaft is coupled to the actuator. The compressible member can be compressed from an extended length to a compressed length by a two-stage trigger. The cutter has a length between the extended length and the compressed length of the compressible member. The outer sleeve is coupled to the inner shaft such that the inner shaft is movable relative to the outer shaft. A backstop is disposed along an inner wall of the outer sleeve. The outer sleeve includes a cutting channel. The cutting tool is configured to cut a wire received within the cutting channel of the outer sleeve. The handle includes an outer frame and a two-stage trigger. A cavity extends partially into the outer frame. The cavity houses a first spring and a two-stage trigger. The trigger is coupled to the outer housing and is movable with the cavity. The two-stage trigger includes an outer housing, an inner member, and a spring coupled with the outer housing and the inner member.

[0009] A further understanding of the nature and advantages of the present invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like elements bear like reference characters and in which:

[0010] In order to further clarify various aspects of the embodiments of the present disclosure, a more particular description of certain embodiments will be made by referring to various aspects of the accompanying drawings. It is understood that these drawings depict only typical embodiments of the present disclosure and therefore are not to be considered as limiting the scope of the present disclosure. Moreover, although the drawings may be drawn to scale for some embodiments, the drawings are not necessarily drawn to scale for all embodiments. The embodiments of the present disclosure and other features and advantages will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0011] [Figure 1] 1 shows a cut-away view of a human heart during diastole. [Diagram 2] 1 shows a cut-away view of a human heart during systole. [Diagram 3] A cut-away view of a human heart in diastole is shown with the chordae tendineae attaching the leaflets of the mitral and tricuspid valves to the ventricular wall. [Figure 4] 1 shows a healthy mitral valve with the leaflets closed as viewed from the atrial side of the mitral valve. [Diagram 5] 1 shows a dysfunctional mitral valve with visible gaps between the leaflets when viewed from the atrial side of the mitral valve. [Figure 6] FIG. 1 shows a cut-away view of a human heart showing the papillary muscles. [Figure 7] FIG. 1 shows a cut-away view of a human heart showing the multi-layered heart walls. [Figure 8] FIG. 1 is a close-up cut-away view of the human heart wall. [Figure 9] FIG. 9 is an enlarged cutaway view of the human heart wall of FIG. 8 showing the needle about to penetrate the heart wall. [Figure 10] 9 is an enlarged cutaway view of the human heart wall of FIG. 8 showing a needle inserted into the myocardium of the heart wall. [Figure 11] 9 is an enlarged cutaway view of the human heart wall of FIG. 8 showing a needle inserted into the pericardial parietal tissue of the heart wall. [Figure 12] 9 is an enlarged cutaway view of the human heart wall of FIG. 8 showing the needle inserted into the pericardial cavity of the heart wall. [Figure 13] FIG. 9 is an enlarged cutaway view of the human heart wall of FIG. 8 showing a needle injecting dye into the pericardial cavity of the heart wall. [Figure 14] 9 is an enlarged cutaway view of the human heart wall of FIG. 8 showing a needle inserted into the pericardial cavity of the heart wall and a catheter adjacent to the endocardium of the heart wall. [Figure 15] 9 is an enlarged cutaway view of the human heart wall of FIG. 8 showing a needle and catheter inserted into the pericardial cavity of the heart wall. [Figure 16]9 is an enlarged cutaway view of the human heart wall of FIG. 8 showing an anchor deployed within the pericardial space of the heart wall. [Figure 16A] 17 is a view similar to that of FIG. 16 with the anchor deployed through the introducer or needle. [Figure 16B] FIG. 17 is a view similar to FIG. 16 with the anchor deployed over the introducer or needle. [Figure 16C] FIG. 17 is a view similar to FIG. 16 with the anchor deployed over the introducer or needle. [Figure 17] 17 is an enlarged cutaway view of the human heart wall of FIG. 8 showing the anchor of FIG. 16 seated within the pericardial cavity of the heart wall. [Figure 18] 9 is an enlarged cutaway view of the human heart wall of FIG. 8 showing the screw catheter adjacent to the endocardium of the heart wall. [Figure 19] 9 is an enlarged cutaway view of the human heart wall of FIG. 8 showing a screw catheter secured to the myocardium of the heart wall. [Figure 20] FIG. 20 is an enlarged cutaway view of the human heart wall of FIG. 19 showing a needle delivered through the screw catheter. [Figure 21] 20 is an enlarged cutaway view of the human heart wall of FIG. 19 showing the needle inserted into the myocardium of the heart wall. [Figure 22] FIG. 20 is an enlarged cutaway view of the human heart wall of FIG. 19 showing the needle inserted into the parietal tissue of the heart wall. [Figure 23] 20 is an enlarged cutaway view of the human heart wall of FIG. 19 showing the needle inserted into the pericardial cavity of the heart wall. [Figure 24] FIG. 20 is an enlarged cutaway view of the human heart wall of FIG. 19 showing a needle injecting dye into the pericardial cavity of the heart wall. [Diagram 25] 20 is an enlarged cutaway view of the human heart wall of FIG. 19 showing the needle inserted into the pericardial cavity of the heart wall and the secondary catheter adjacent to the endocardium of the heart wall. [Figure 26] FIG. 20 is an enlarged cutaway view of the human heart wall of FIG. 19, with a needle and secondary catheter inserted into the pericardial cavity of the heart wall. [Figure 26A]FIG. 2 is an enlarged cutaway view of the human heart wall showing a needle and a secondary catheter inserted into the pericardial space of the heart wall. [Figure 27] 20 is an enlarged cutaway view of the human heart wall of FIG. 19 showing an anchor deployed within the pericardial space of the heart wall. [Figure 27A] FIG. 1 is an enlarged cutaway view of a human heart wall showing an anchor deployed within the pericardial space of the heart wall. [Figure 28] 27 is an enlarged cutaway view of the human heart wall of FIG. 19 showing the anchor of FIG. 26 seated within the pericardial cavity of the heart wall. [Figure 28A] FIG. 1 is an enlarged cutaway view of a human heart wall showing anchors seated within the pericardial cavity of the heart wall. [Figure 29] FIG. 1 is a close-up cut-away view of a human heart wall showing a needle about to penetrate the heart wall. [Diagram 30] FIG. 30 is an enlarged cutaway view of the human heart wall of FIG. 29 showing the needle extending through the heart wall. [Diagram 31] 30 is an enlarged cutaway view of the human heart wall of FIG. 29 showing the needle extending through the heart wall and the catheter adjacent to the endocardium of the heart wall. [Diagram 32] FIG. 30 is an enlarged cutaway view of the human heart wall of FIG. 29 showing the needle and the catheter extending through the heart wall. [Diagram 33] FIG. 33 is an enlarged cutaway view of the human heart wall of FIG. 32 showing an anchor deployed through the catheter. [Diagram 34] FIG. 30 is an enlarged cutaway view of the human heart wall of FIG. 29 showing the anchors seated against the parietal tissue of the heart wall. [Diagram 35] FIG. 2 is an enlarged cut-away view of a human heart wall showing a screw catheter secured to the myocardium of the heart wall. [Diagram 36] FIG. 36 is an enlarged cutaway view of the human heart wall of FIG. 35 showing a needle delivered through the screw catheter. [Figure 37] FIG. 36 is an enlarged cutaway view of the human heart wall of FIG. 35 showing the needle inserted through the heart wall. [Figure 38]FIG. 36 is an enlarged cutaway view of the human heart wall of FIG. 35 showing the needle inserted through the heart wall and the secondary catheter adjacent to the endocardium of the heart wall. [Figure 39] FIG. 36 is an enlarged cutaway view of the human heart wall of FIG. 35 showing the needle and secondary catheter inserted through the heart wall. [Diagram 40] FIG. 36 is an enlarged cutaway view of the human heart wall of FIG. 35 showing an anchor deployed through a secondary catheter. [Diagram 41] 41 is an enlarged cutaway view of the human heart wall of FIG. 35 showing the anchor of FIG. 40 seated against the parietal tissue of the heart wall. [Diagram 42] 1 shows a cut-away view of a human heart showing needles inserted through the papillary muscles of the heart and through the heart wall. [Diagram 43] 43 shows a cut-away view of the human heart of FIG. 42 showing a needle inserted through the papillary muscle and a delivery catheter positioned adjacent to the papillary muscle. [Diagram 44] FIG. 2 is an enlarged cutaway view of the human heart wall showing a needle and catheter inserted through the papillary muscles of the heart and into the pericardial space of the heart wall. [Diagram 45] FIG. 45 is an enlarged cutaway view of the human heart wall of FIG. 44 showing an anchor deployed within the pericardial space of the heart wall. [Diagram 46] FIG. 45 is an enlarged cutaway view of the human heart wall of FIG. 44 showing the anchor seated within the pericardial cavity of the heart wall. [Figure 47] 1 illustrates a cut-away view of a human heart showing anchors with wires seated against the exterior of the heart wall and extending through the papillary muscles. [Figure 48] FIG. 1 shows a cut-away view of a human heart showing a first anchor seated against the exterior of the heart wall with a wire extending through a first papillary muscle and a second anchor seated against the exterior of the heart wall with a second wire extending through a second papillary muscle. [Figure 49A] 49 illustrates a cut-away view of the human heart of FIG. 48 showing the first and second wires being pulled through the connectors to pull the papillary muscles toward each other. [Figure 49B]1 shows the first and second wires secured within the connector and cut. [Figure 50] FIG. 49C shows a cut-away view of the human heart of FIG. 49B, showing the third anchor seated against the ventricular septum and the third wire connected to the first and second wires. [Figure 51] FIG. 1 illustrates a cut-away view of a human heart showing a first anchor seated against the exterior of the heart wall with a first wire extending through the papillary muscles and a second anchor seated against the ventricular septum and the second wire connected to the first wire. [Figure 52] A cutaway view of a human heart is shown with a first wire extending through the heart wall, a second anchor seated against the ventricular septum, and a first anchor seated against the exterior of the heart wall with the second wire connected to the first wire. [Diagram 53] FIG. 1 is an exploded view of a wire clamp in accordance with an exemplary embodiment. [Figure 53A] FIG. 1 is an exploded view of a wire clamp in accordance with an exemplary embodiment. [Figure 54] FIG. 1 is an exploded view of a wire clamp in accordance with an exemplary embodiment. [Figure 54A] FIG. 1 is an exploded view of a wire clamp in accordance with an exemplary embodiment. [Figure 55] FIG. 1 is a cross-sectional view of a wire clamp in accordance with an exemplary embodiment. [Figure 55A] FIG. 1 is a cross-sectional view of a wire clamp in accordance with an exemplary embodiment. [Figure 56] FIG. 1 is a cross-sectional view of a wire clamp in accordance with an exemplary embodiment. [Figure 56A] FIG. 1 is a cross-sectional view of a wire clamp in accordance with an exemplary embodiment. [Figure 57A] 1 is a diagram of an anchor, wire, and wire clamp positioned between tissue walls according to an exemplary embodiment. [Figure 57B] 1 is a diagram of an anchor, wire, and wire clamp positioned between tissue walls according to an exemplary embodiment. [Figure 57C] 1 is a diagram of an anchor, wire, and wire clamp positioned between tissue walls according to an exemplary embodiment. [Fig. 57D] 1 is a diagram of an anchor, wire, and wire clamp positioned between tissue walls according to an exemplary embodiment. [Figure 57E] 1 is a diagram of an anchor, wire, and wire clamp positioned between tissue walls according to an exemplary embodiment. [Fig. 57F] 1 is a diagram of an anchor, wire, and wire clamp positioned between tissue walls according to an exemplary embodiment. [Fig. 57G] 1 is a diagram of an anchor, wire, and wire clamp positioned between tissue walls according to an exemplary embodiment. [Fig. 57H] 1 is a diagram of an anchor, wire, and wire clamp positioned between tissue walls according to an exemplary embodiment. [Fig. 57I] 1 is a diagram of an anchor, wire, and wire clamp positioned between tissue walls according to an exemplary embodiment. [Fig. 57J] 1 is a diagram of an anchor, wire, and wire clamp positioned between tissue walls according to an exemplary embodiment. [Figure 58] FIG. 1 is a perspective view of a working end of a wire clamp installation tool in accordance with an exemplary embodiment; [Figure 58A] FIG. 1 is a perspective view of a working end of a wire clamp installation tool in accordance with an exemplary embodiment; [Figure 59] 1 is a cross-sectional view of a working end of a wire clamp installation tool in accordance with an exemplary embodiment; FIG. [Figure 59A] 1 is a cross-sectional view of a working end of a wire clamp installation tool in accordance with an exemplary embodiment; FIG. [Figure 60] FIG. 1 is a perspective view of a wire clamp in accordance with an exemplary embodiment; [Figure 60A] FIG. 1 is a perspective view of a wire clamp in accordance with an exemplary embodiment; [Figure 61] FIG. 1 is a perspective view of an engagement device according to an exemplary embodiment. [Figure 61A] FIG. 1 is a perspective view of an engagement device according to an exemplary embodiment. [Figure 62] 1 is a cross-sectional view of an engagement device secured to a component of a wire clamp in accordance with an exemplary embodiment; FIG. [Figure 62A] 1 illustrates a cross-sectional view of an engagement device secured to a component of a wire clamp in accordance with an exemplary embodiment; [Figure 63] FIG. 63 is an exploded view of FIG. [Figure 63A] FIG. 62B is an exploded view of the components illustrated in FIG. 62A. [Figure 63B] 1 is a schematic diagram of an engagement device used to position an insert within a body of a locking device according to an exemplary embodiment. [Figure 63C] 1 is a schematic diagram of an engagement device used to position an insert within a body of a locking device according to an exemplary embodiment. [Fig. 63D] 1 is a schematic diagram of an engagement device used to position an insert within a body of a locking device according to an exemplary embodiment. [Figure 63E] 1 is a schematic diagram of an engagement device used to position an insert within a body of a locking device according to an exemplary embodiment. [Fig.63F] 1 is a schematic diagram of an engagement device used to position an insert within a body of a locking device according to an exemplary embodiment. [Figure 63G] 1 is a schematic diagram of an engagement device used to position an insert within a body of a locking device according to an exemplary embodiment. [Figure 64] 1 illustrates a socket positioned adjacent to a working end of a wire clamp installation tool according to an exemplary embodiment; [Fig. 64A] 1 illustrates a socket positioned adjacent to a working end of a wire clamp installation tool according to an exemplary embodiment; [Figure 65] FIG. 1 illustrates a perspective cross-sectional view of a wire clamp installation tool in accordance with an exemplary embodiment. [Figure 66] 1 is a perspective cross-sectional view of an operating handle portion of a wire clamp installation tool according to an exemplary embodiment; FIG. [Figure 67] 1 is a cross-sectional view of a portion of an operating handle portion of a wire clamp installation tool according to an exemplary embodiment; [Figure 68]1 is a cross-sectional view of an operative end and operative handle portion of a wire clamp installation tool according to an exemplary embodiment; [Figure 69] FIG. 2 is an enlarged perspective cross-sectional view of an operating handle portion of a wire clamp installation tool according to an exemplary embodiment. [Figure 70A] 1 is a diagram of a wire clamp being installed by a wire clamp installation tool in accordance with an illustrative embodiment; [Figure 70B] 1 is a diagram of a wire clamp being installed by a wire clamp installation tool in accordance with an illustrative embodiment; [Figure 70C] 1 is a diagram of a wire clamp being installed by a wire clamp installation tool in accordance with an illustrative embodiment; [Fig. 70D] 1 is a diagram of a wire clamp being installed by a wire clamp installation tool in accordance with an illustrative embodiment; [Figure 70E] 1 is a diagram of a wire clamp being installed by a wire clamp installation tool in accordance with an illustrative embodiment; [Fig. 70F] 1 is a diagram of a wire clamp being installed by a wire clamp installation tool in accordance with an illustrative embodiment; [Fig. 70G] 1 is a diagram of a wire clamp being installed by a wire clamp installation tool in accordance with an illustrative embodiment; [Figure 71A] 1 illustrates a wire cutting tool in use according to an exemplary embodiment; [Figure 71B] 1 illustrates a wire cutting tool in use according to an exemplary embodiment; [Figure 71C] 1 illustrates a wire cutting tool in use according to an exemplary embodiment; [Fig. 71D] 1 illustrates a wire cutting tool in use according to an exemplary embodiment; [Figure 71E] 1 illustrates a wire cutting tool in use according to an exemplary embodiment; [Figure 72A] 1 illustrates an alternative exemplary embodiment of a wire cutting tool according to an exemplary embodiment; [Fig. 72B]1 illustrates an alternative exemplary embodiment of a wire cutting tool according to an exemplary embodiment; [Figure 73A] FIG. 72C is a diagram of components of the wire cutting tool of FIGS. 72A-B. [Figure 73B] FIG. 72C is a diagram of components of the wire cutting tool of FIGS. 72A-B. [Fig. 74A] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Fig. 74B] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Fig. 74C] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Fig. 75A] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Fig. 75B] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Figure 76A] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Figure 76B] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Figure 77A] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Fig. 77B] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Fig. 78A] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Fig. 78B] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Figure 79A] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Figure 79B] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Figure 80A] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Figure 80B] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Figure 81A] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Fig. 81B] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Figure 82] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Figure 83] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Figure 84] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Fig. 85A] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Fig. 85B] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Figure 86] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Fig. 87A] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Fig. 87B] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Fig. 88A] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Fig. 88B] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Figure 89A] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Figure 89B] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Figure 90A] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Figure 90B] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Figure 91A] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Figure 91B] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Figure 92] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Figure 93A] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Figure 93B] FIG. 1 illustrates a wire clamp in accordance with an exemplary embodiment. [Figure 94] 1 illustrates an exemplary embodiment of an anchor for a papillary muscle access system, shown in an extended configuration. [Figure 95] 95 illustrates the anchor of FIG. 94 in an undeployed, extended configuration. [Figure 95A] 1 illustrates another exemplary embodiment of an anchor in a substantially undeployed configuration. [Figure 95B] FIG. 95B is a plan view of a piece of material cut into a pattern for use in the connector of the anchor shown in FIG. 95A. [Figure 95C] FIG. 95C is a side view of the material illustrated in FIG. 95B. [Fig. 95D] FIG. 95C is a plan view of a connector made by folding the material shown in FIG. 95B. [Figure 95E] FIG. 95D is a side view of the connector shown in FIG. 95D. [Fig. 95F] FIG. 95D is a plan view of a portion of the connector shown in FIG. 95D attached to a portion of the anchor. [Figure 95G] FIG. 95F is a side view of the connector and anchor shown in FIG. 95F. [Fig. 95H] FIG. 95B is a plan view of another exemplary embodiment of a piece of material cut into a pattern for use in the connector of the anchor illustrated in FIG. 95A. [Fig. 95I] 95B shows an exemplary embodiment of an anchor similar to the embodiment shown in FIG. 95A, in which the high strength fibers are oriented to increase tensile strength. [Figure 96] 95 illustrates the anchor of FIG. 94 in a deployed configuration. [Figure 96A] 95B shows the anchor of FIG. 95A in a deployed configuration. [Figure 96B] 96B shows an exemplary embodiment of an anchor similar to that shown in FIG. 96A, in which the high strength fibers are oriented to increase the strength of the anchor. [Figure 96C] 96B shows an exemplary embodiment of an anchor similar to that shown in FIG. 96A, in which the high strength fibers are oriented to increase the strength of the anchor. [Figure 96D] 1 illustrates an exemplary embodiment of a hybrid fabric. [Figure 96E]1 illustrates an exemplary embodiment of a hybrid fabric. [Figure 97] The anchor of FIG. 94 is shown in an undeployed, extended configuration along with a hemostatic plug. [Figure 98] The anchor of FIG. 94 is shown in a deployed configuration with a hemostatic plug. [Figure 99] 95 shows a delivery sheath and steerable catheter for delivering the anchor of FIG. 94. [Figure 100] 99 shows an anchor delivery catheter extending from the delivery sheath and steerable catheter of FIG. [Figure 101] 101 shows a needle extending from the anchor delivery catheter of FIG. 100. [Figure 102] 102 shows an anchor extending along the needle of FIG. 101; [Figure 103] The anchor and hemostatic plug are shown along with the needle and pusher of the delivery system of FIG. [Figure 104] 104 shows the anchor and hemostatic plug of FIG. 103. [Figure 105] 104 shows the anchor and hemostatic plug of FIG. 103 with a wire attached. [Fig. 106] The anchor with attached wire is shown without the hemostatic plug. [Figure 107] A delivery system for deploying an anchor and hemostatic plug is shown without the wire. [Figure 108] The delivery system, anchor, and hemostatic plug of FIG. 107 are shown with a wire. [Fig. 109] 109 shows the delivery system, anchor, and hemostatic plug of FIG. 108 with the anchor in a deployed state. [Figure 110] 1 shows a close-up view of the anchor and hemostatic plug in a deployed state. [Figure 110A] 95B shows an enlarged view of the anchor and hemostatic plug of FIG. 95A in a deployed state. [Figure 111] 13 shows the anchor and hemostatic plug in a deployed state with the needle and delivery catheter of the delivery system withdrawn. [Figure 112]FIG. 1 is an enlarged cutaway view of a human heart wall showing a delivery sheath and steerable catheter positioned adjacent to the heart wall. [Fig. 112A] 1 shows a delivery catheter, a piston, and an anchoring device for delivering the anchor. [Fig. 112B] FIG. 112B is a cross-sectional view of the delivery catheter, piston, and anchor device of FIG. 112A. [Figure 112C] FIG. 112C is a cross-sectional view of the delivery catheter of FIG. 112B. [Fig. 112D] 112D is a cross-sectional view of the delivery catheter of FIG. 112C taken along the plane indicated by line 133-133 of FIG. 112C. [Figure 112E] FIG. 112C is a cross-sectional view of the piston of FIG. 112B. [Fig. 112F] 112E is a cross-sectional view of the piston of FIG. 112E taken along the plane indicated by line 135-135 of FIG. 112E. [Figure 112G] FIG. 112C is a cross-sectional view of the delivery catheter and piston of FIG. 112B. [Figure 113] FIG. 2 is an enlarged cutaway view of a human heart wall showing a delivery catheter secured to the myocardium of the heart wall. [Fig. 113A] FIG. 112C is a cross-sectional view of the piston of FIG. 112B showing the clutch mechanism. [Fig. 113B] 113B is a cross-sectional view of the piston of FIG. 113A taken along the plane indicated by line 138-138 of FIG. 113A. [Figure 113C] FIG. 113C is a view similar to FIG. 113B showing an increase in torque applied between the piston and the anchor. [Fig. 113D] FIG. 113C is a view similar to FIG. 113B showing an increase in torque applied between the piston and the anchor. [Figure 113E] FIG. 113C is a view similar to FIG. 113B showing an increase in torque applied between the piston and the anchor. [Fig. 113F] FIG. 11 is a cross-sectional view of an alternative clutch arrangement between the piston and the clutch. [Figure 113G] FIG. 11 is a cross-sectional view of an alternative clutch arrangement between the piston and the clutch. [Fig. 113H] FIG. 1 is an enlarged cutaway view of a human heart wall showing a delivery catheter, piston, and anchoring device positioned adjacent to the heart wall. [Fig. 113I] FIG. 1 is an enlarged cutaway view of a human heart wall showing a delivery catheter, piston, and anchoring device positioned adjacent the heart wall with the piston in a compressed state. [Fig. 113J] FIG. 2 is an enlarged cutaway view of a human heart wall showing an anchoring device partially secured to the myocardium of the heart wall. [Figure 113K] FIG. 113J is a cross-sectional view showing the position of the piston clutch of FIG. [Fig. 113L] FIG. 2 is an enlarged cut-away view of a human heart wall showing an anchoring device secured to the myocardium of the heart wall. [Figure 113M] FIG. 113C is a cross-sectional view showing the movement of the piston clutch when the anchor reaches the position shown in FIG. 113L. [Fig. 113N] FIG. 113C is a cross-sectional view showing the movement of the piston clutch when the anchor reaches the position shown in FIG. 113L. [Fig. 114] FIG. 2 is an enlarged cutaway view of the human heart wall showing a needle inserted into the pericardial space of the heart wall. [Fig. 114A] FIG. 2 is an enlarged cutaway view of the human heart wall showing a needle inserted into the pericardial space of the heart wall. [Fig. 115] FIG. 1 is an enlarged cutaway view of a human heart wall showing injection of dye into the pericardial space of the heart wall. [Fig. 115A] FIG. 1 is an enlarged cutaway view of a human heart wall showing a needle injecting dye into the pericardial cavity of the heart wall. [Fig. 115B] FIG. 1 is an enlarged cutaway view of a human heart wall showing the injection of a wire into the pericardial space of the heart wall. [Fig. 116] FIG. 1 is a close-up cut-away view of a human heart wall showing anchors being deployed along with needles. [Fig. 116A] FIG. 1 is a close-up cut-away view of a human heart wall showing anchors being deployed along with needles. [Figure 117] FIG. 2 is an enlarged cutaway view of the human heart wall showing the anchors extending into the pericardial space. [Fig. 118] FIG. 1 is an enlarged cutaway view of the human heart wall showing the anchor deployed within the pericardial space. [Fig. 118A] FIG. 1 is an enlarged cutaway view of the human heart wall showing the anchor deployed within the pericardial space. [Figure 119] FIG. 2 is an enlarged cutaway view of the human heart wall showing the anchor seated within the pericardial space. [Fig. 119A] FIG. 2 is an enlarged cutaway view of the human heart wall showing the anchor seated within the pericardial space. [Fig. 119B] FIG. 2 is an enlarged cutaway view of the human heart wall showing the anchor seated within the pericardial space. [Figure 119C] FIG. 2 is an enlarged cutaway view of a human heart wall showing an anchoring device being detached from the myocardium of the heart wall. [Fig. 119D] 159 is a cross-sectional view of the piston of FIG. 158 showing the position of the clutch as the anchor is removed from the heart wall. [Figure 120] FIG. 1 is an enlarged cutaway view of the human heart wall showing the anchor seated within the pericardial space and the delivery system removed. [Fig. 120A] FIG. 1 is an enlarged cutaway view of the human heart wall showing the anchor seated within the pericardial space and the delivery system removed. [Figure 121] FIG. 1 is an enlarged cutaway view of a human heart wall showing a delivery sheath and steerable catheter positioned adjacent to the papillary muscles of the heart. [Fig. 121A] FIG. 1 shows a cut-away view of a human heart in diastole with a steerable catheter and a delivery catheter positioned adjacent to the papillary muscles of the heart. [Figure 122] FIG. 1 is an enlarged cutaway view of a human heart wall showing a delivery catheter secured to a papillary muscle of the heart. [Fig. 122A]FIG. 1 shows a cut-away view of a human heart in diastole with a steerable catheter and a delivery catheter positioned adjacent to the papillary muscles of the heart. [Figure 123] FIG. 2 is an enlarged cutaway view of the human heart wall showing the needle inserted through the papillary muscle and further into the pericardial cavity of the heart wall. [Figure 124] FIG. 1 is a close-up cut-away view of a human heart wall showing a needle injecting dye into the pericardial cavity of the heart wall. [Fig. 125] FIG. 1 is a close-up cut-away view of a human heart wall showing anchors deployed along needles. [Fig. 126] FIG. 1 is an enlarged cutaway view of the human heart wall showing the anchors extending into the pericardial space. [Figure 127] FIG. 1 is an enlarged cutaway view of the human heart wall showing an anchor deployed within the pericardial space. [Figure 128] FIG. 2 is an enlarged cutaway view of the human heart wall showing the anchor seated within the pericardial space. [Figure 129] FIG. 1 is an enlarged cutaway view of the human heart wall showing the anchor seated within the pericardial space and the delivery system removed. [Fig. 130A] 1 illustrates an exemplary embodiment of a helical anchor implanted in tissue. [Fig. 130B] 1 illustrates an exemplary embodiment of a helical anchor implanted in tissue. [Fig. 130C] 1 illustrates an exemplary embodiment of a helical anchor implanted in tissue. [Fig. 130D] 1 illustrates an exemplary embodiment of a helical anchor implanted in tissue. [Fig. 131A] 1 illustrates an exemplary embodiment of a helical anchor implanted in tissue. [Fig. 131B] 1 illustrates an exemplary embodiment of a helical anchor implanted in tissue. [Fig. 131C] 1 illustrates an exemplary embodiment of a helical anchor implanted in tissue. [Fig. 131D] 1 illustrates an exemplary embodiment of a helical anchor implanted in tissue. [Fig. 131E] 1 illustrates an exemplary embodiment of a helical anchor implanted in tissue. [Fig. 132A] 1 illustrates an exemplary embodiment of a helical anchor and a delivery system for the helical anchor. [Fig. 132B] 1 illustrates an exemplary embodiment of a helical anchor and a delivery system for the helical anchor. [Fig. 133A] 132A and 132B are shown implanted in tissue. [Fig. 133B] 132A and 132B are shown implanted in tissue. [Fig. 133C] 132A and 132B are shown implanted in tissue. [Fig. 133D] 132A and 132B are shown implanted in tissue. [Figure 133E] 132A and 132B are shown implanted in tissue. [Fig. 133F] 132A and 132B are shown implanted in tissue. [Fig. 134] 1 shows an exemplary embodiment of a helical anchor implanted in a ventricular heart wall. [Fig. 135] 1 shows an exemplary embodiment of two helical anchors implanted in the ventricular heart wall. [Fig. 136] 1 shows an exemplary embodiment of a helical anchor implanted in a ventricular heart wall. [Fig. 137] 1 shows an exemplary embodiment of two helical anchors implanted in the ventricular heart wall. [Figure 138] 1 shows an exemplary embodiment of a helical anchor implanted in a ventricle of the heart. [Figure 139] 1 shows an exemplary embodiment of a helical anchor implanted in a ventricle of the heart. [Fig. 140] 1 shows an exemplary embodiment of a helical anchor implanted in a ventricular heart wall. [Fig. 141]1 shows an exemplary embodiment of a helical anchor implanted in a ventricular heart wall. [Fig. 142] 1 illustrates an exemplary embodiment of a helical anchor and delivery rail. [Fig. 143] FIG. 1 is a side view of an exemplary embodiment of a helical anchor. [Fig. 144] FIG. 144 is a tip view of the helical anchor shown in FIG. 143. [Fig. 145A] 1 illustrates the delivery of a helical anchor to the endocardial layer of the heart wall. [Fig. 145B] 1 illustrates the delivery of a helical anchor to the endocardial layer of the heart wall. [Fig. 145C] 1 illustrates the delivery of a helical anchor to the endocardial layer of the heart wall. [Fig. 146] FIG. 1 is an enlarged cut-away view of a human heart wall showing a portion of a helical anchor device applying a compressive force to the myocardium of the heart wall. [Fig. 147A] 1 illustrates an exemplary embodiment of a guard for use during implantation of a helical anchor. [Fig. 147B] 1 illustrates an exemplary embodiment of a guard for use during implantation of a helical anchor. [Fig. 148] 1 shows an exemplary embodiment of a guard for use during implantation of a helical anchor. [Figure 149] The use of the guard of FIG. 148 is shown. [Fig. 150] The use of the guard of FIG. 148 is shown. [Fig. 151A] The use of the guard of FIG. 148 is shown. [Fig. 151B] The use of the guard of FIG. 148 is shown. [Fig. 151C] The use of the guard of FIG. 148 is shown. [Fig. 151D] The use of the guard of FIG. 148 is shown. [Fig. 152A] 1 illustrates an exemplary embodiment of a lubricant applied to a fabric cover on the wire of a helical anchor. [Fig. 152B] 1 illustrates an exemplary embodiment of a lubricous fabric cover on the wire of a helical anchor. [Fig. 152C]1 shows an exemplary embodiment of a fabric for covering the wire of a helical anchor. [Fig. 153A] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 153B] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 153C] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 153D] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 153E] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 153F] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 153G] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 153H] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 153I] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 153J] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Figure 153K] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 154A] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 154B] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 154C] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 154D] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 154E] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 154F] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 154G]1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 154H] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 154I] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 154J] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Figure 154K] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 154L] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Figure 154M] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 155A] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 155B] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 155C] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 155D] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 155E] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 155F] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 155G] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 155H] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 155I] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 155J] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Figure 155K] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 156A] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 156B] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 156C] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 156D] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Figure 156E] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 156F] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Figure 156G] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 156H] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 156I] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 156J] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Figure 156K] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 156L] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 157A] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 157B] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 157C] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 157D] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 157E] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 157F] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Figure 157G] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 157H]1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 157I] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 157J] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Figure 157K] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 157L] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Figure 157M] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 157N] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 157O] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Figure 157P] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 158A] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 158B] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 158C] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 158D] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 158E] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 158F] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Figure 158G] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 159] 13 illustrates the use of an exemplary embodiment of a tissue remodeling system to approximate papillary muscles. [Fig. 160] 13 illustrates the use of an exemplary embodiment of a tissue remodeling system to approximate papillary muscles. [Fig. 161]13 illustrates the use of an exemplary embodiment of a tissue remodeling system to approximate papillary muscles. [Fig. 162] 13 illustrates the use of an exemplary embodiment of a tissue remodeling system to approximate papillary muscles. [Fig. 163] 1 illustrates an exemplary embodiment of a tissue remodeling system with anchors implanted in two papillary muscles and the heart wall. [Fig. 164] 1 illustrates an exemplary embodiment of a tissue remodeling system with anchors implanted in one papillary muscle and the heart wall. [Fig. 165] 1 illustrates an exemplary embodiment of a tissue remodeling system having anchors implanted on spaced portions of the heart wall. [Fig. 166] 1 illustrates an exemplary embodiment of the depth of a helical anchor in the endocardial layer of the heart wall. [Fig. 167] 1 illustrates an alternative embodiment of an anchor implanted in the endocardial layer of the heart wall. [Fig. 168A] 1 illustrates the deployment of an exemplary embodiment of a tissue remodeling system. [Fig. 168B] 1 illustrates the deployment of an exemplary embodiment of a tissue remodeling system. [Fig. 168C] 1 illustrates the deployment of an exemplary embodiment of a tissue remodeling system. [Fig. 168D] 1 illustrates the deployment of an exemplary embodiment of a tissue remodeling system. [Figure 168E] 1 illustrates the deployment of an exemplary embodiment of a tissue remodeling system. [Fig. 168F] 1 illustrates the deployment of an exemplary embodiment of a tissue remodeling system. [Figure 168G] 1 illustrates the deployment of an exemplary embodiment of a tissue remodeling system. [Figure 169A] 168A-168H show exemplary embodiments of alternative force application structures in the tissue remodeling system of FIGS. [Fig. 169B] 168A-168H show exemplary embodiments of alternative force application structures in the tissue remodeling system of FIGS. [Fig. 170A]1 illustrates the use of an exemplary embodiment in a tissue remodeling system for remodeling the shape of a cardiac ventricle. [Fig. 170B] 1 illustrates the use of an exemplary embodiment in a tissue remodeling system for remodeling the shape of a cardiac ventricle. [Fig. 170C] 1 illustrates the use of an exemplary embodiment in a tissue remodeling system for remodeling the shape of a cardiac ventricle. [Fig. 170D] 1 illustrates the use of an exemplary embodiment in a tissue remodeling system for remodeling the shape of a cardiac ventricle. [Fig. 170E] 1 illustrates the use of an exemplary embodiment in a tissue remodeling system for remodeling the shape of a cardiac ventricle. [Fig. 170F] 1 illustrates the use of an exemplary embodiment in a tissue remodeling system for remodeling the shape of a cardiac ventricle. [Fig. 170G] 1 illustrates the use of an exemplary embodiment in a tissue remodeling system for remodeling the shape of a cardiac ventricle. [Fig. 171] FIG. 1 shows a cut-away view of a human heart with an anchor delivery device inside the heart. [Fig. 172A] FIG. 1 is a perspective view of an exemplary embodiment of a coiled anchor. [Fig. 172B] FIG. 172B is a top view of the coiled anchor shown in FIG. 172A. [Fig. 172C] 172B is a different side elevational view of the coiled anchor shown in FIG. 172A. [Fig. 172D] 172B is a different side elevational view of the coiled anchor shown in FIG. 172A. [Fig. 172E] 172B is a different side elevational view of the coiled anchor shown in FIG. 172A. [Fig. 172F] FIG. 172B is a bottom view of the coiled anchor shown in FIG. 172A. [Fig. 173A] FIG. 1 is a perspective view of an exemplary embodiment of a coiled anchor. [Fig. 173B] FIG. 173B is a top view of the coiled anchor shown in FIG. 173A. [Fig. 173C] 173B is a different side elevational view of the coiled anchor shown in FIG. 173A. [Fig. 173D] 173B is a different side elevational view of the coiled anchor shown in FIG. 173A. [Fig. 173E] 173B is a different side elevational view of the coiled anchor shown in FIG. 173A. [Fig. 173F] FIG. 173B is a bottom view of the coiled anchor shown in FIG. 173A. [Fig. 174A] FIG. 1 is a perspective view of an exemplary embodiment of a coiled anchor. [Fig. 174B] FIG. 173B is a top view of the coiled anchor shown in FIG. 173A. [Fig. 174C] 174B is a different side elevational view of the coiled anchor shown in FIG. 174A. [Fig. 174D] 174B is a different side elevational view of the coiled anchor shown in FIG. 174A. [Fig. 174E] 174B is a different side elevational view of the coiled anchor shown in FIG. 174A. [Fig. 174F] FIG. 174B is a bottom view of the coiled anchor shown in FIG. 174A. [Fig. 175A] 1 illustrates an exemplary embodiment of a helical anchor implanted in tissue. [Fig. 175B] 1 illustrates an exemplary embodiment of a helical anchor implanted in tissue. [Fig. 175C] 1 illustrates an exemplary embodiment of a helical anchor implanted in tissue. [Fig. 175D] 1 illustrates an exemplary embodiment of a helical anchor implanted in tissue. [Fig. 175E] 1 illustrates an exemplary embodiment of a helical anchor implanted in tissue. [Fig. 175F] 1 illustrates an exemplary embodiment of a helical anchor implanted in tissue. [Fig. 175G] 1 illustrates an exemplary embodiment of a helical anchor implanted in tissue. [Fig. 175H] 1 illustrates an exemplary embodiment of a helical anchor implanted in tissue. [Fig. 176A] FIG. 1 is a schematic diagram showing a coiled anchor penetrating endocardial tissue and embedded within myocardial tissue. [Fig. 176B] FIG. 1 is a schematic diagram showing a coiled anchor penetrating endocardial tissue and embedded within myocardial tissue. [Fig. 176C] FIG. 1 is a schematic diagram showing a coiled anchor penetrating endocardial tissue and embedded within myocardial tissue. [Fig. 176D] FIG. 1 is a schematic diagram showing a coiled anchor penetrating endocardial tissue and embedded within myocardial tissue. [Fig. 176E] FIG. 1 is a schematic diagram showing a coiled anchor penetrating endocardial tissue and embedded within myocardial tissue. [Fig. 176F] FIG. 1 is a schematic diagram showing a coiled anchor penetrating endocardial tissue and embedded within myocardial tissue. [Fig. 176G] FIG. 1 is a schematic diagram showing a coiled anchor penetrating endocardial tissue and embedded within myocardial tissue. [Fig. 176H] FIG. 1 is a schematic diagram showing a coiled anchor penetrating endocardial tissue and embedded within myocardial tissue. [Fig. 177A] 1 shows deployment of a coiled anchor and attached tether. [Fig. 177B] 1 shows deployment of a coiled anchor and attached tether. [Fig. 178A] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 178B] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 178C] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 178D] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 179A] 1 shows deployment of a coiled anchor and attached tether. [Fig. 179B] 1 shows deployment of a coiled anchor and attached tether. [Fig. 180A] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 180B] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 180C] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 180D] 1 illustrates the use of an exemplary embodiment of a tissue remodeling system. [Fig. 181A] 1 shows deployment of a coiled anchor and attached tether. [Fig. 181B] 1 shows deployment of a coiled anchor and attached tether. [Fig. 181C] 1 shows deployment of a coiled anchor and attached tether. [Fig. 182A] 1 shows deployment of a coiled anchor and attached tether into the ventricular wall. [Fig. 182B] 1 shows deployment of a coiled anchor and attached tether into the ventricular wall. [Fig. 182C] 1 shows deployment of a coiled anchor and attached tether into the ventricular wall. [Fig. 182D] 1 shows deployment of a coiled anchor and attached tether into the ventricular wall. [Fig. 182E] 1 shows deployment of a coiled anchor and attached tether into the ventricular wall. [Fig. 182F] 1 shows deployment of a coiled anchor and attached tether into the ventricular wall. [Fig. 182G] 1 shows deployment of a coiled anchor and attached tether into the ventricular wall. [Fig. 182H] 1 shows deployment of a coiled anchor and attached tether into the ventricular wall. [Fig. 183A] 1 shows the deployment of a coiled anchor and attached tether into the ventricular inner wall. [Fig. 183B] 1 shows the deployment of a coiled anchor and attached tether into the ventricular inner wall. [Fig. 183C] 1 shows the deployment of a coiled anchor and attached tether into the ventricular inner wall. [Fig. 183D]1 shows the deployment of a coiled anchor and attached tether into the ventricular inner wall. [Fig. 183E] 1 shows the deployment of a coiled anchor and attached tether into the ventricular inner wall. [Fig. 183F] 1 shows the deployment of a coiled anchor and attached tether into the ventricular inner wall. [Fig. 183G] 1 shows the deployment of a coiled anchor and attached tether into the ventricular inner wall. [Fig. 184A] FIG. 1 shows a cut-away view of a human heart showing a first anchor attached to the ventricular septum and a second anchor attached to the ventricular wall, along with a wire connecting the first and second anchors. [Fig. 184B] FIG. 1 shows a cutaway view of a human heart showing a first anchor attached to the ventricular septum, a second anchor attached to the ventricular wall, and a third anchor attached to the ventricular wall, along with wires connecting the first, second, and third anchors. [Fig. 184C] FIG. 1 shows a cutaway view of a human heart showing a first anchor attached to the ventricular septum, a second anchor attached to the ventricular wall, a third anchor attached to the ventricular wall, and a fourth anchor attached to the ventricular wall, along with wires connecting the first, second, third, and fourth anchors. [Fig. 184D] FIG. 1 shows a cut-away view of a human heart showing a first anchor attached to a papillary muscle and a second anchor attached to the papillary muscle along with a wire connecting the first anchor and the second anchor. [Fig. 184E] FIG. 1 shows a cutaway view of a human heart showing a first anchor attached to the ventricular septum, a second anchor attached to a papillary muscle, and a third anchor attached to a papillary muscle, along with wires connecting the first, second, and third anchors. [Fig. 185A] FIG. 1 is a perspective view of an exemplary embodiment of a coiled anchor. [Fig. 185B] FIG. 185B is a side elevational view of the coiled anchor shown in FIG. 185A. [Fig. 186A]1 illustrates an exemplary embodiment of a coiled anchor having an anti-rotation feature. [Fig. 186B] 1 illustrates an exemplary embodiment of a coiled anchor having an anti-rotation feature. [Fig. 186C] 1 illustrates an exemplary embodiment of a coiled anchor having an anti-rotation feature. [Fig. 187] 1 illustrates an exemplary embodiment of a coiled anchor having a fabric disposed on at least a portion of an outer ring portion. [Fig. 188] 188 illustrates the coiled anchor shown in FIG. 187 implanted in tissue. [Fig. 189] 1 illustrates a wire cutting tool according to an exemplary embodiment; [Fig. 190] 1 illustrates a cross-sectional view of a wire cutting tool and a wire according to an exemplary embodiment; [Fig. 191] 1 illustrates a cross-sectional view of a wire cutting tool and a wire according to an exemplary embodiment; [Fig. 192] 1 illustrates a cross-sectional view of a wire cutting tool and a wire according to an exemplary embodiment; [Fig. 193] 1 illustrates a cross-sectional view of a wire cutting tool and a wire according to an exemplary embodiment; [Fig. 194] 1 illustrates a cross-sectional view of a wire cutting tool and a wire according to an exemplary embodiment; [Fig. 195] 1 illustrates a cross-sectional view of a handle of a wire cutting tool according to an exemplary embodiment. [Fig. 196] 1 illustrates a trigger on a handle according to an exemplary embodiment. [Figure 197] 1 illustrates a trigger on a handle according to an exemplary embodiment. [Figure 198] 1 illustrates a handle of a wire cutting tool according to an exemplary embodiment; [Figure 199] 1 illustrates a handle of a wire cutting tool according to an exemplary embodiment; [Figure 200] 1 illustrates a handle and wire cutting tool according to an exemplary embodiment. [Figure 201] 1 illustrates a handle and wire cutting tool according to an exemplary embodiment. [Fig. 202] 1 illustrates a handle and wire cutting tool according to an exemplary embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] The following description refers to the accompanying drawings which illustrate specific embodiments of the present disclosure. Other embodiments having different structure and operation do not depart from the scope of the present disclosure.

[0013] Exemplary embodiments of the present disclosure are directed to devices and methods for remodeling the geometry 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 may be made unless specifically excluded. In other words, individual components in the disclosed devices and systems may be combined unless they are mutually exclusive or physically impossible.

[0014] As described herein, when one or more components are described as being connected, joined, fastened, coupled, attached, or otherwise interconnected, such interconnection may be direct, such as between the components, or may be indirect, such as through the use of one or more intermediate components. Also, as described herein, references to a "member," "component," or "portion" are not limited to a single structural member, component, or element, but may 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 including) (preferably within 10%, more preferably within 1%, and most preferably within 0.1%) a given value or condition.

[0015] 1 and 2 are cutaway views of a human heart H during diastole and systole, respectively. The right ventricle RV and the left ventricle LV are separated from the right atrium RA and the left atrium LA by the tricuspid valve TV and the mitral valve MV, i.e., the atrioventricular valves, respectively. In addition, 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 that extend inward across their respective orifices, which come together or "coapt" in flow to form a one-way fluid-occluding surface. The remodeling devices, systems, and methods of the present application are described primarily with respect to the left ventricle LV. Thus, the anatomy of the left side of the heart is described in more detail. It should be understood that the devices, systems, and methods described herein may also be used for remodeling the right ventricle.

[0016] The left atrium LA receives oxygenated blood from the lungs. During the diastolic phase or diastole, seen in FIG. 1, blood already collected in the left atrium LA (during systole) moves to the left ventricle LV through the mitral valve MV due to the expansion of the left ventricle LV. During the systolic phase or systole, seen in FIG. 2, the left ventricle LV contracts to pump blood into the body through the aortic valve AV and the ascending aorta AA. During systole, the leaflets of the mitral valve MV close, preventing blood from returning from the left ventricle LV into the left atrium LA, and blood is collected from the pulmonary veins into the left atrium.

[0017] Referring now to Figures 1-5, the mitral valve MV includes two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24, which is a variably dense ring of fibrous tissue that surrounds 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., muscles located at the base of the chordae tendineae and within the wall of the left ventricle) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles 12 serve to limit the movement of the mitral valve MV and prevent mitral valve inversion and prolapse. 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 support the mitral valve MV against the high pressures required to circulate blood throughout the body. Together, the papillary muscles and chordae tendineae are known as the subvalvular tissue, which function to prevent the mitral valve MV from prolapsing into the left atrium LA when the mitral valve is closed.

[0018] FIG. 6 is a cutaway view of a human heart with a cross 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 FIG. 7) extend inward across their respective orifices, coming together or "coapting" in flow to form a one-way fluid-occluding surface. The devices and methods for remodeling the shape of the heart wall W are described primarily with respect to the left ventricle LV. In some embodiments, the devices and methods can be used to approximate the papillary muscles, which are also described primarily with respect to the left ventricle LV. In addition to reducing the size of the ventricle to increase ventricular function, approximating the papillary muscles together can cause the leaflets to coapt and prevent mitral valve regurgitation. It should be understood that the devices described herein can also be used to remodel the right ventricle RV, and to approximate the papillary muscles of the tricuspid valve TV.

[0019] In one exemplary embodiment, the device described by the present application is used to remodel the shape of the ventricle to improve cardiac function. Cardiac function can be improved by reducing the size of the ventricle, approximating the papillary muscles, and / or correcting the function of the mitral valve MV. In one exemplary embodiment, the device is configured to reshape the wall of a human heart H to prevent the mitral valve MV from returning blood from the left ventricle LV to the left ventricle LA.

[0020] When a healthy mitral valve MV is in the closed position, the leaflets 20, 22 are coapted, thereby preventing blood from leaking from the left ventricle LV into the left atrium LA. Regurgitation can occur when one or both of the leaflets 20, 22 of the mitral valve MV protrude into the left atrium LA during systole, or when the leaflets fail to coapt or close with each other. This protrusion or failure to coapt creates a gap between the leaflets 20, 22, which can allow blood to flow back from the left ventricle LV into the left atrium LA during systole.

[0021] The devices and procedures disclosed herein refer to left ventricular remodeling with the attendant potential for better coaptation of the mitral valve leaflets, however, it should be understood that the devices and concepts provided herein may also be used to remodel the right ventricle, thereby potentially resulting in better coaptation of the tricuspid TV valve leaflets.

[0022] 8, there is shown an enlarged cutaway view of the human heart wall W. The heart wall W has multiple layers including endocardium 102, myocardium 104, and epicardium 106. Endocardium 102 is the innermost layer of the heart H. It forms the inner layer of all four ventricles and is directly connected by the papillary muscles 12 to all of the inner cardiac appendages such as the bicuspid valve BV, tricuspid valve TV, pulmonary valve (not shown), vena cava valve AV, and chordae tendineae CT.

[0023] The myocardium 104 is located between the inner endocardium 102 and the outer epicardium 106. The myocardium 104 is the basic muscle that makes up the heart H and functions by providing a scaffold for the ventricles. The myocardium 104 contracts and relaxes the heart walls to allow blood to pass between the chambers.

[0024] The epicardium 106 is the visceral layer of the serous pericardium. The epicardium is the innermost of the two layers of the pericardium. The epicardium covers the outer surface of the heart. It is directly fused internally to the myocardium. It is composed primarily of connective tissue and provides a protective envelope for the heart.

[0025] The pericardium 108 is a double-walled sac that contains the heart and the roots of the great blood vessels that exit or enter the heart. A space is formed between the epicardium 106 and the serous layer of the pericardium 108, known as the pericardial cavity 110, which contains pericardial fluid. A layer of parietal pericardium 112 is disposed around the heart. An outer parietal pericardium 112 and an inner serous pericardial layer are outside the pericardial cavity 110.

[0026] 9-17, an exemplary embodiment of a device 120 for remodeling the shape of the heart wall W, and an exemplary embodiment of a system and method for delivering and deploying the device 120 within the pericardial space 110 are shown. With reference to FIG. 17, the device 120 includes an anchor 122 and a wire 124 engaged or connected to the anchor 122 and extending from the anchor 122. The wire 124 can take a wide variety of different forms. Examples of the wire 124 include, but are not limited to, a suture, a wire, a cable, a string, a bendable rod, any combination thereof, and the like. The wire 124 may be any element or combination of elements configured to extend from the anchor 122, through the heart wall W, and into the interior chamber.

[0027] Anchor 122 is configured to be positioned against an outwardly facing surface 126 relative to an internal chamber of the heart H, such as, for example, the left ventricle LV or right ventricle of the heart H. In the embodiment shown in FIG. 17, outwardly facing surface 126 is a portion of the epicardium 106, and anchor 122 is disposed within the pericardial space 110. In the embodiment shown in FIG. 34, outwardly facing surface 126 is the pericardium 108.

[0028] The anchor 122 can be configured in a variety of ways. Any configuration that can be positioned to engage the outwardly facing surface 126 of the heart wall W can be used to assist in pulling a portion of the heart wall W inwardly (i.e., toward the interior chamber). For example, the anchor 122 can be a fluff, a sufficiently sized knot formed in the wire 124, a stopper, or some other wire anchoring device. The anchor 122 is collapsible / expandable or reconfigurable such that the anchor can be delivered through a catheter or sheath in a delivery state (e.g., collapsed or extended) that fits within the lumen of the catheter, and can reshape or expand to a deployed state once delivered to the appropriate location. In one exemplary embodiment, the anchor 122 includes a shape memory alloy, such as Nitinol, to provide shape setting capabilities.

[0029] 9, in one exemplary embodiment, deployment of device 120 includes delivering puncture device 130 into an internal chamber (e.g., left ventricle LV) of heart H and adjacent to heart wall W. Puncture device 130 may be any suitable device for puncturing or creating a passageway in human heart wall W, such as, for example, a needle, wire, or other similar device. In the illustrated embodiment, puncture device 130 is a needle or hollow wire having an internal passageway (not shown) and an opening 131 proximate a distal end 133 of the puncture device, fluidly connecting the internal passageway (not shown) to the exterior of puncture device 130. However, in other exemplary embodiments, the puncture device is not hollow. In the illustrated embodiment, puncture device 130 has a pointed or sharp tip. However, in other exemplary embodiments, the tip of puncture device 130 is blunt.

[0030] In Figure 10, the puncture device 130 has extended through the endocardium 102 into the heart wall W and into the myocardium 104 to create a passageway 132 through the heart wall W. However, the puncture device 130 has not yet been inserted sufficiently to deploy the anchor 122 into the pericardial space 110. Thus, the puncture device 130 in Figure 10 is shown in a partially inserted position.

[0031] In Figure 11, the puncture device 130 extends through the endocardium 102, the myocardium 104, the epicardium 106, and the pericardium 108 and into the epicardial tissue 112, extending a passageway 132 in the heart wall W. However, the puncture device 130 extends beyond the pericardial cavity 110 in which the anchor 122 is positioned in this exemplary embodiment. Thus, the puncture device 130 in Figure 11 is shown in an over-insertion position for this exemplary embodiment (although this may be the correct position in other embodiments).

[0032] In Figure 12, puncture device 130 extends through endocardium 102, myocardium 104, epicardium 106, and into pericardial cavity 110, with opening 131 and distal end 133 within pericardial cavity 110. Thus, puncture device 130 of Figure 12 is properly positioned to deploy anchor 122 within pericardial cavity 110.

[0033] In one exemplary embodiment, the proper positioning of the puncture device 130 is optionally verified. Proper positioning of the puncture device 130 can be verified in a variety of different ways. For example, the positioning of the puncture device can be determined visually, by providing a marker, e.g., a radiopaque marker, by ejecting material into a cavity, e.g., the pericardial cavity, by sensing the pressure required to eject fluid from the puncture device, by sensing the force required to advance the puncture device, by positioning a small guidewire in the pericardial cavity, and / or by using an electrical signal, e.g., by an electrical signal provided by and / or sensed by the puncture device. In one exemplary embodiment, as shown in FIG. 13, a dye 134, or other detectable fluid, is delivered through the puncture device 130 and injected into the pericardial cavity 110 to verify that the puncture device 130 is properly positioned to deploy the anchor 122 in the pericardial cavity 110. The dye 134 can be detected by any suitable technique, such as x-ray or other imaging technique, to verify that the lancing device 130 is properly positioned.

[0034] In FIG. 14 , the puncture device 130 extends into the pericardial space 110 and the delivery catheter 136 is positioned within a cardiac chamber (e.g., the left ventricle LV) such that a distal end 138 of the delivery catheter 136 is adjacent the endocardium 102. In the illustrated embodiment, the delivery catheter 136 is concentric with the puncture device 130. However, in other embodiments, the delivery catheter 136 may not be concentric with the puncture device 130. In still other embodiments, the delivery catheter 136 may be omitted. For example, the device 120 may be delivered directly through or over the puncture device 130 rather than through a separate catheter (see FIGS. 16A-16C ).

[0035] In Figure 15, the delivery catheter 136 extends through the passageway 132 such that the distal end 138 of the delivery catheter 136 is positioned within the pericardial space 110. With reference to Figure 16, with the distal end 138 of the delivery catheter 136 positioned within the pericardial space 110, a device 120 (see Figure 17) for remodeling the shape of the heart wall W can be delivered through the delivery catheter 136. In particular, an anchor 122 (see Figures 16 and 17) can be extended or pushed out of the distal end 138 of the delivery catheter 136 into the pericardial space 110 while an attached wire 124 (see Figures 16 and 17) extends through the delivery catheter 136 within the passageway 132.

[0036] As discussed above, the anchor 122 can take a wide variety of different forms and can be delivered in a wide variety of different ways. In the example shown in FIGS. 16A-16C, the delivery catheter 136 is omitted. In FIG. 16A, the anchor 122 is delivered through the puncture device 130 and the catheter 136 can be omitted. In any of the embodiments disclosed herein, the anchor 122 can be delivered through the puncture device 130. In FIG. 16B, the anchor 122 is delivered onto the puncture device 130. In this example, a pusher 137 pushes the anchor 122 along the outer surface of the puncture device 130 to deploy the anchor 122, as shown in FIG. 16C. In any of the embodiments disclosed herein, the anchor 122 can be delivered onto the puncture device 130.

[0037] 16 and 17, the delivery catheter 136 and puncture device 130 can be removed by withdrawing them from the passageway 132 and out of the ventricle. The device 120 remains deployed in the heart wall W with the anchor 122 in and the wire 124 extending into the pericardial space 110 and through the epicardium 106, myocardium 104, and endocardium 102 into the ventricle (e.g., the left ventricle LV or right ventricle RV).

[0038] To seat the anchor 122 and remodel the heart wall W, the wire 124 can be tensioned by pulling the wire 124 in an inward direction toward the ventricle, as shown by arrow A1 in FIG. 17. As described in more detail below, by deploying, connecting, and pulling two or more devices against each other, the heart wall can be pulled inward and the shape of the heart wall(s) can be remodeled. The anchor 122 engages and presses against an outward facing surface 126, which in the illustrated embodiment is the epicardium 106. The anchor 122 (see FIG. 17) is too large in its deployed state to fit through the passage 132 (see FIG. 14) formed by the puncture device 130 (see FIG. 14). Thus, by further tensioning the wire 124, the heart wall W can be pulled inward toward the ventricle (e.g., the left ventricle LV).

[0039] In one exemplary embodiment, device 120 is configured to prevent blood leakage through passageway 132 (see FIG. 14 ) into pericardial space 110. Blood leakage can be blocked in a variety of different ways. For example, anchor 122 can cover a hole through the epicardium, a seal separate from anchor 122 can be disposed over the hole in the epicardium, a seal can be disposed over the hole in the endocardium, a portion of anchor 122 can block passageway 132, wire 124 can be configured to block the passageway, and / or a component disposed on the wire can block the passageway. In one exemplary embodiment, puncture device 130 and / or delivery catheter 136 are configured such that passageway 132 closes immediately or substantially upon withdrawal of puncture device 130 and / or delivery catheter 136.

[0040] 18-28, another exemplary embodiment of deployment of device 120 (see FIG. 27) for remodeling the shape of the heart wall W within the pericardial space 110, as well as systems and methods for delivering device 120, are shown. With reference to FIG. 18, deployment of device 120 includes delivering an anchor catheter 200 within an internal chamber (e.g., left ventricle LV) of the heart H and adjacent to the heart wall W. Anchor catheter 200 may be any suitable catheter or catheter-like device capable of being attached or secured to the heart wall W.

[0041] In the exemplary embodiment, anchor catheter 200 includes an anchoring device 202 attached to a distal end 204 of anchor catheter 200. Examples of suitable anchoring devices include, but are not limited to, expandable barbs, suction ends such as suction cones, and / or a cork screw shaped tip as illustrated. Anchoring device 202 may be any device capable of temporarily attaching anchor catheter 200 to the heart wall W. In the illustrated embodiment, anchoring device 202 is a wire formed into a helical shape.

[0042] 19, the fixation catheter 200 is attached to the heart wall W. In the illustrated embodiment, as shown in FIG. 19, the fixation catheter 200 can be attached to the heart wall W by rotating the fixation catheter 200 in the direction of the arrow A2 about the illustrated axis Z. As a result, the helical anchoring device 202 can penetrate the heart wall W through the endocardium 102 and thread into the myocardium 104 to fix the anchoring catheter 200 to the heart wall W. The anchoring device 202 thus fixes the position of the catheter 200 relative to the heart wall W. Because the heart H is beating during the procedures described herein, fixing the catheter 200 relative to the heart wall greatly simplifies and improves the accuracy of the steps of penetrating the wall W with the puncture device 130, positioning the distal end 133 of the puncture device within the pericardial space 110, positioning the delivery catheter 136 within the pericardial cavity 110, and / or deploying the anchor 122 within the pericardial space 110 (see FIG. 27).

[0043] With reference to Figure 20, puncture device 130 has been delivered through anchor catheter 200 into an internal chamber (e.g., left ventricle LV) of heart H such that a distal end of the puncture device is adjacent to the heart wall W. In Figure 21, puncture device 130 has extended through endocardium 102 into the heart wall W and into myocardium 104, forming a passageway 132 in the heart wall W. However, puncture device 130 has not yet been inserted sufficiently to deploy anchor 122 (see Figure 27) into pericardial space 110. Thus, puncture device 130 in Figure 21 is shown in a partially inserted position.

[0044] In Figure 22, the puncture device 130 extends through the endocardium 102, the myocardium 104, the epicardium 106, and the pericardium 108 into the outer parietal pericardial tissue 112. However, in this exemplary embodiment, the puncture device 130 extends beyond the pericardial cavity 110 in which the anchor 122 (see Figure 27) is positioned. Thus, the puncture device 130 in Figure 22 is shown in an over-insertion position in this exemplary embodiment.

[0045] In Figure 23, puncture device 130 extends through endocardium 102, myocardium 104, epicardium 106, and into pericardial cavity 110 such that opening 131 and distal end 133 are located within pericardial cavity 110. Thus, puncture device 130 of Figure 23 is properly positioned to deploy anchor 122 (see Figure 27) within pericardial cavity 110.

[0046] In one exemplary embodiment, the proper positioning of the puncture device 130 is optionally verified. The proper positioning of the puncture device 130 can be verified in a variety of different ways. For example, the positioning of the puncture device can be determined visually, by providing a marker, e.g., a radiopaque marker, to the puncture device, by ejecting material into a cavity, e.g., the pericardial cavity, by sensing the pressure required to eject fluid from the puncture device, by sensing the force required to advance the puncture device, by providing and / or sensing an electrical signal to the puncture device (e.g., the puncture device can be used to sense an ECG signal generated by the heart). In one exemplary embodiment, as shown in FIG. 24, a dye 134, or other detectable fluid, is delivered through the puncture device 130 and injected into the pericardial cavity 110 to verify that the puncture device 130 is properly positioned to deploy the anchor 122 in the pericardial cavity 110. The dye 134 can be detected by any suitable technique, such as an x-ray or other imaging technique, to verify that the puncture device 130 is properly positioned.

[0047] In FIG. 25, the puncture device 130 extends into the pericardial space 110 and the delivery catheter 136 extends through the anchoring catheter 200 so that the distal end 138 of the delivery catheter 136 is adjacent the endocardium 102 .

[0048] In Fig. 26, the delivery catheter 136 extends through the passageway 132 such that a distal end 138 of the delivery catheter 136 is positioned within the pericardial space 110. As shown in Fig. 27, with the distal end 138 of the delivery catheter 136 positioned within the pericardial space 110, the device 120 for remodeling the shape of the heart wall W can be delivered through the delivery catheter 136. In particular, the anchor 122 can extend out the distal end 138 of the delivery catheter 136 and into the pericardial space 110, while the attached wire 124 extends through the delivery catheter 136 within the passageway 132.

[0049] 26-28, the delivery catheter 136 and puncture device 130 can be removed by withdrawing them from the passageway 132 and out of the ventricle. The device 120 remains deployed in the heart wall W with the anchor 122 in the pericardial space 110 and the wire 124 extending through the epicardium 106, myocardium 104, and endocardium 102 into the ventricle (e.g., the left ventricle LV).

[0050] To seat the anchor 122 against the heart wall W, the fixation catheter 200 may optionally remain attached to the heart wall W and the distal end 204 may be pressed against the heart wall W, as shown by arrow A3. At the same time, the wire 124 may be tensioned by pulling the wire 124 in an inward direction toward the ventricle, as shown by arrow A4 in FIG.

[0051] To remodel the heart wall W, the fixation catheter 200 is removed (if not previously removed). The wire 124 can be tensioned by pulling the wire 124 in an inward direction toward the ventricle, as shown by arrow A4 in FIG. 28. As described in more detail below, two or more devices can be deployed, coupled, and pulled toward each other to pull the heart wall inward and remodel the shape of the heart wall(s). The anchor 122 engages and presses against the outward facing surface 126, which in the illustrated embodiment is the epicardium 106. The anchor 122 in the deployed state is too large to fit through the passage 132 formed by the puncture device 130. Thus, once the anchor catheter 200 is removed, the wire 124 can be further tensioned to pull the heart wall W inward toward the ventricle (e.g., the left ventricle LV).

[0052] In one exemplary embodiment, device 120 is configured to prevent blood leakage through passageway 132 into pericardial space 110. Blood leakage can be blocked in a variety of different ways. For example, anchor 122 can cover a hole through the epicardium, a seal separate from anchor 122 can be disposed over the hole in the epicardium, a seal can be disposed over the hole in the endocardium, a portion of anchor 122 can block passageway 132, wire 124 can be configured to block the passageway, and / or a component disposed on the wire can block the passageway. In one exemplary embodiment, puncture device 130 and / or delivery catheter 136 are configured such that passageway 132 closes immediately or substantially immediately after withdrawal of puncture device 130 and / or delivery catheter 136.

[0053] 29-34, there is shown an exemplary embodiment of a device 120 (FIG. 34) for remodeling the shape of the heart wall W, and an exemplary embodiment of a system and method for delivering and deploying the device 120 to an exterior surface of the heart H. With reference to FIG. 29, in one exemplary embodiment, deployment of the device 120 includes delivering a puncture device 130 into an interior chamber of the heart H (e.g., the left ventricle LV) and adjacent to the heart wall W.

[0054] In Figure 30, puncture device 130 extends through endocardium 102, myocardium 104, epicardium 106, pericardium 108, and outer parietal pericardial tissue 112 into the heart wall W, creating a passage 132 through heart wall W such that opening 131 and distal end 133 of puncture device 130 are outside of heart H. Thus, puncture device 130 of Figure 30 is properly positioned to deploy anchor 122 in this exemplary embodiment.

[0055] In FIG. 31 , the puncture device 130 extends through the heart wall W and the delivery catheter 136 is positioned within a cardiac chamber (e.g., the left ventricle LV) such that a distal end 138 of the delivery catheter 136 is adjacent the endocardium 102. In FIG. 32 , the delivery catheter 136 extends through the passageway 132 such that a distal end 138 of the delivery catheter 136 is outside the heart H, such as adjacent the distal end 133 of the puncture device 130. In the illustrated embodiment, the delivery catheter 136 is concentric with the puncture device 130. However, in other embodiments, the delivery catheter 136 may not be concentric with the puncture device 130. In still other embodiments, the delivery catheter 136 may be omitted. For example, the device 120 may be delivered directly through the puncture device 130 rather than through a separate catheter.

[0056] In Figure 33, device 120 (Figure 34) for remodeling the shape of heart wall W can be delivered through a delivery catheter 136. In particular, anchor 122 may extend out a distal end 138 of delivery catheter 136 outside of heart wall H, while attached wire 124 extends through delivery catheter 136 in passageway 132.

[0057] 34, the delivery catheter 136 and puncture device 130 can be removed by withdrawing them from the passageway 132 and out of the ventricle. The device 120 remains deployed through the heart wall W with the anchor 122 exterior to the heart wall W and the wire 124 extending through the parietal pericardial tissue 112, the pericardium 108, the pericardial space 110, the epicardium 106, the myocardium 104, and the endocardium 102 and into the ventricle (e.g., the left ventricle LV).

[0058] To seat the anchor 122 and remodel the heart wall W, the wire 124 can be tensioned by pulling the wire 124 in an inward direction toward the ventricle, as shown by arrow A5 in FIG. 34. As described in more detail below, two or more devices can be deployed, coupled, and pulled toward each other to pull the heart wall inward and remodel the shape of the heart wall(s). The anchor 122 engages with an outwardly facing surface 126, which in the illustrated embodiment is the outer parietal pericardial tissue layer 112. In one exemplary embodiment, the anchor 122 presses a localized region of the pericardium 108 against the epicardium, thus pushing the myocardium 104 inward to remodel the heart wall W. The deployed anchor 122 is too large to fit through the passage 132 formed by the puncture device 130. Thus, by further tensioning the wire 124, the heart wall W can be pulled inward toward the ventricle (e.g., the left ventricle LV).

[0059] In one exemplary embodiment, the device 120 is configured to prevent blood leakage through the passageway 132 into the pericardial space 110. Blood leakage can be blocked in a variety of different ways. For example, the anchor 122 can locally pull the pericardium into contact with the epicardium to block the hole through the pericardium, a seal separate from the anchor 122 can be placed over the hole in the pericardium, a seal can be placed over the hole in the endocardium, a portion of the anchor 122 can block the passageway 132, the wire 124 can be configured to block the passageway, and / or a component disposed on the wire can block the passageway. In one exemplary embodiment, the puncture device 130 and / or delivery catheter 136 are configured such that the pericardial passageway 132 and / or hole closes immediately or substantially immediately after withdrawal of the puncture device 130 and / or delivery catheter 136.

[0060] 35-41 , there is shown another exemplary embodiment of deployment of device 120 for remodeling the shape of the heart wall W, as well as systems and methods for delivering device 120 to an exterior surface of heart H. With reference to FIG 35 , deployment of device 120 includes delivering anchor catheter 200 into an interior chamber of heart H (e.g., left ventricle LV) and attaching the anchor catheter to the heart wall W.

[0061] In the exemplary embodiment, anchor catheter 200 includes an anchoring device 202 attached to a distal end 204 of anchor catheter 200. Examples of suitable anchoring devices include, but are not limited to, expandable barbs, suction ends such as suction cones, and / or a cork screw shaped tip as illustrated. Anchoring device 202 may be any device capable of temporarily attaching anchor catheter 200 to the heart wall W. In the illustrated embodiment, anchoring device 202 is a wire formed into a helical shape.

[0062] In the illustrated embodiment, the anchoring catheter 200 can be attached to the heart wall W by rotating the anchoring catheter 200 in the direction of arrow A5 about axis Y, as shown in Figure 35. As a result, the helical anchoring device 202 can penetrate the heart wall W through the endocardium 102 and thread into the myocardium 104, securing the anchoring catheter 200 to the heart wall W.

[0063] 36, puncture device 130 has been delivered into an internal chamber (e.g., left ventricle LV) of heart H via anchor catheter 200. A distal end 133 of the puncture device is adjacent to the heart wall W. In FIG. 37, puncture device 130 extends through endocardium 102, myocardium 104, epicardium 106, and pericardium 108 into the heart wall W, creating a passageway 132 through the heart wall W. An opening 131 and distal end 133 of puncture device 130 are exterior to heart H. The puncture device 130 of FIG. 37 is properly positioned to deploy anchor 122 in this exemplary embodiment.

[0064] 38, the puncture device 130 extends through the heart wall W, and the delivery catheter 136 is positioned within the temporary anchor catheter 200 such that the distal end 138 of the delivery catheter 136 is adjacent the endocardium 102. In FIG. 39, the delivery catheter 136 extends through the passageway 132 such that the distal end 138 of the delivery catheter 136 is outside of the heart H, such as adjacent the distal end 133 of the puncture device 130.

[0065] 40 , device 120 for remodeling the shape of heart wall W can be delivered through a delivery catheter 136. In particular, anchor 122 may extend out a distal end 138 of delivery catheter 136 outside of heart wall H, while attached wire 124 extends through delivery catheter 136 in passageway 132.

[0066] 41, the delivery catheter 136 and puncture device 130 can be removed by withdrawing them from the passageway 132 and out of the ventricle. The device 120 remains deployed through the heart wall W with the anchor 122 exterior to the heart wall W and the wire 124 extending through the epicardium 106, myocardium 104, and endocardium 102 into the ventricle (e.g., the left ventricle LV).

[0067] To seat anchor 122 firmly against the heart wall W, anchor catheter 200 may optionally remain attached to the heart wall W and distal end 204 may be maintained against the heart wall W, as shown by arrow A6. At the same time, wire 124 may be tensioned by pulling wire 124 in an inward direction toward the ventricle, as shown by arrow A7 in FIG. 41. This seating step is optional and may be omitted.

[0068] Once the anchor 122 is firmly seated, the anchor catheter 200 is removed and the wire 124 is tensioned to remodel the heart wall. As described in more detail below, two or more devices can be deployed, coupled, and pulled toward one another to pull the heart wall inward and remodel the shape of the heart wall(s). The anchor 122 engages with an outwardly facing surface 126, which in the illustrated embodiment is the outer wall tissue layer 112. In one exemplary embodiment, the anchor 122 presses a localized region of the pericardium 108 against the epicardium, thus pushing the myocardium 104 inward to remodel the heart wall W. In its deployed state, the anchor 122 is too large to fit through the passage 132 formed by the puncture device 130. Thus, once the anchor catheter 200 is removed, the wire 124 can be further tensioned to pull the heart wall W inward toward the ventricle (e.g., the left ventricle LV).

[0069] In one exemplary embodiment, the device 120 is configured to prevent blood leakage through the passageway 132 into the pericardial space 110. Blood leakage can be blocked in a variety of different ways. For example, the anchor 122 can locally pull the pericardium into contact with the epicardium to block the hole through the pericardium, a seal separate from the anchor 122 can be placed over the hole in the pericardium, a seal can be placed over the hole in the endocardium, a portion of the anchor 122 can block the passageway 132, the wire 124 can be configured to block the passageway, and / or a component disposed on the wire can block the passageway. In one exemplary embodiment, the puncture device 130 and / or delivery catheter 136 are configured such that the pericardial passageway 132 and / or hole closes immediately or substantially immediately after withdrawal of the puncture device 130 and / or delivery catheter 136.

[0070] 42-47, another exemplary embodiment of the deployment of the device 120 for remodeling the shape of the heart wall W, as well as a system and method for delivering the device 120. The example shown in FIG. 42-47 can be placed in the pericardial cavity 110, as illustrated by FIG. 46, or outside the pericardium (see, e.g., FIG. 34; the location can also be selected to pass the wire 124 through the papillary muscle). With reference to FIG. 42, in one exemplary embodiment, the deployment of the device 120 includes delivering a puncture device 130 into an internal chamber of the heart H (e.g., the left ventricle LV or the right ventricle RV). The puncture device 130 then extends through one of the papillary muscles 12 and through the heart wall W, creating a passageway 132.

[0071] In Fig. 43, a delivery catheter 136 is disposed about the puncture device 130 and positioned within a cardiac ventricle (e.g., the left ventricle LV). A distal end 138 of the delivery catheter 136 is positioned adjacent to the papillary muscles 12. In Figs. 42 and 43, the pericardium 108 is not shown. As mentioned above, in this embodiment, the anchor 122 may be deployed within the pericardial space 110 or on the outside of the pericardium.

[0072] 44, the puncture device 130 is shown in the proper position for deploying the anchor 122 within the pericardial space 110. The delivery catheter 136 is extended through the passageway 132 such that a distal end 138 of the delivery catheter 136 is within the pericardial space 110 adjacent the distal end 133 of the puncture device 130.

[0073] 45 , the device 120 for remodeling the shape of the heart wall W can be delivered through a delivery catheter 136. In particular, the anchor 122 can extend from a distal end 138 of the delivery catheter 136 into the pericardial space 110, while the attached wire 124 extends through the delivery catheter 136 in the passageway 132 through the heart wall and papillary muscles 12.

[0074] 46, the delivery catheter 136 and puncture device 130 can be removed by withdrawing them from the passageway 132 and out of the ventricle. The device 120 remains deployed through the heart wall W, with the anchor 122 in the pericardial space 110 and the wire 124 extending through the epicardium 106, myocardium 104, and endocardium 102 into the ventricle (e.g., the left ventricle LV).

[0075] To seat the anchor 122 and remodel the heart wall W, the wire 124 can be tensioned by pulling the wire 124 in an inward direction toward the ventricle, as shown by arrow A8 in FIG. 46. As described in more detail below, two or more devices can be deployed, coupled, and pulled toward each other to pull the heart wall inward and remodel the shape of the heart wall(s). The anchor 122 engages and presses against the outward facing surface 126, which in the illustrated embodiment is the epicardium 106. The deployed anchor 122 is too large to fit through the passage 132 formed by the puncture device 130. Thus, further tensioning of the wire 124 can pull the heart wall W inward toward the ventricle (e.g., the left ventricle LV).

[0076] In one exemplary embodiment, the device 120 is configured to prevent blood leakage through the passageway 132 into the pericardial space 110. Blood leakage can be blocked in a variety of different ways. For example, the anchor 122 can locally pull the pericardium into contact with the epicardium to block the hole through the pericardium, a seal separate from the anchor 122 can be placed over the hole in the pericardium, a seal can be placed over the hole in the endocardium, a portion of the anchor 122 can block the passageway 132, the wire 124 can be configured to block the passageway, and / or a component disposed on the wire can block the passageway. In one exemplary embodiment, the puncture device 130 and / or delivery catheter 136 are configured such that the pericardial passageway 132 and / or hole closes immediately or substantially immediately after withdrawal of the puncture device 130 and / or delivery catheter 136.

[0077] In one exemplary embodiment, device 120 is configured to prevent blood leakage through passageway 132 into pericardial space 110. Blood leakage can be blocked in a variety of different ways. For example, anchor 122 can cover a hole through the epicardium, a seal separate from anchor 122 can be disposed over the hole in the epicardium, a seal can be disposed over the hole in the endocardium, a portion of anchor 122 can block passageway 132, wire 124 can be configured to block the passageway, and / or a component disposed on the wire can block the passageway. In one exemplary embodiment, puncture device 130 and / or delivery catheter 136 are configured such that passageway 132 closes immediately or substantially immediately after withdrawal of puncture device 130 and / or delivery catheter 136.

[0078] FIG. 47 shows device 120 in a deployed position with anchor 122 engaged with outward facing surface 126 and wire extending through heart wall W and one of papillary muscles 12 into left ventricle LV and through mitral valve MV. The device shown in FIG. 47 can be deployed in any manner described herein. In the example shown in FIGS. 42-47, device 120 is attached without anchoring catheter 200. However, in other embodiments, device 120 can be deployed using and anchoring catheter 200 in any manner described herein.

[0079] 48 shows the second device 220 in a deployed position with the first device 120 attached. The second device 220 includes a second anchor 222 that engages the second outwardly facing surface 126 and a second wire that extends through the heart wall W and through another papillary muscle 12, into the left ventricle LV and through the mitral valve MV. The second device 120 can be deployed in any of the manners described herein. In one exemplary embodiment, the second device 220 is deployed in the same manner as the first device 120.

[0080] 49A, in one exemplary embodiment, the first and second wires are routed through a connector 240. In the example illustrated in Fig. 49A, the papillary muscles 12 are pulled together or approximated by pushing or holding the connector 240 in place, as shown by arrow 241, and pulling the wires 124, 224, as shown by arrows 243, 245, respectively. The distance that the connector 240 is pushed, as shown by arrow 241, and the wires 124, 224 are pulled controls the distance that the papillary muscles 12 are pulled towards each other, which determines the subsequent remodeling of the heart wall.

[0081] 49A, in one exemplary embodiment, the papillary muscles 12 can be pulled toward one another to improve coaptation between the leaflets of the mitral valve MV. That is, the chordae tendineae are attached to the leaflets of the mitral valve MV and the papillary muscles. By approximating the papillary muscles toward one another, the chordae tendineae CT pull the mitral valve leaflets toward one another, enhancing coaptation of the mitral valve leaflets. The enhanced or corrected coaptation of the leaflets can reduce or eliminate mitral valve regurgitation.

[0082] 49B, after the papillary muscles 12 and heart wall W have been pulled by the wires 124, 224 into the desired remodeling position, the connector 240 secures the position of the wires within the connector. Once secured, the wires can be cut as shown. Thus, both the device 120 and the second device 220 are shown in a deployed position with the anchors 122, 222 engaged with the outwardly facing surfaces 126, 226 and the wires 124, 224 extending through the heart wall W, through the papillary muscles 12, and into the left ventricle LV. The wires 124, 224 remain under tension to pull inwardly, drawing the heart wall W inwardly to remodel the shape of the heart wall W.

[0083] The wires 124, 224 can be connected together in a variety of ways. For example, the wires can be tied together or held together by a wire locking device 240. The wire locking device 240 can be any suitable device capable of holding the wires 124, 224 together under tension such that the heart wall W is held in a remodeling position. A variety of different wire locking devices 240 are shown and described below.

[0084] Any number of devices 120 and any number of wire locking devices 240 can be used to tailor cardiac wall remodeling for each different patient. In one exemplary embodiment, two or more wires 124 are locked together with each of the locking devices. FIG. 50 shows an example where three wires are connected together with one locking device. In some embodiments, multiple locking devices are used, with at least two wires connected together with each locking device. In the example shown in FIG. 50, the third device 320 is shown in a deployed position with the third anchor 322 engaged with the third outwardly facing surface 326 and the third wire 324 extending through the cardiac wall into the left ventricle LV, along with the deployed first device 120 and second device 220. In the illustrated embodiment of FIG. 48, the cardiac wall associated with the third device 320 is the ventricular septum IS. Thus, the ventricular septum IS defines the third outwardly facing surface 326, and the third wire 324 extends through the ventricular septum IS.

[0085] 49B, the wires 124, 224, 324 can be pulled inwardly to pull the heart wall W inward and remodel the shape of the heart wall W. To hold the heart wall W in the remodeled position, the wires 124, 224, 324 can be connected in the left ventricle LV while under tension, for example, by a wire locking device 240 or other suitable means for connecting the wires 124, 224, 324.

[0086] 51, both device 120 and second device 220 are shown in a deployed position with anchors 122, 222 engaged with outward facing surfaces 126, 226. Wire 124 extends through the heart wall W, through the papillary muscles 12, and into the left ventricle LV. Second device 220 is deployed such that second anchor 222 engages outward facing surface 226 on the interventricular septum IS, and second wire 224 extends through the interventricular septum IS and into the left ventricle LV.

[0087] 49B, the wires 124, 224 can be pulled inwardly to pull the heart wall W inward and the ventricular septum IS inward to remodel the shape of the heart wall W and the ventricular septum IS. To hold the heart wall W and the ventricular septum IS in the remodeled position, the wires 124, 224 can be connected in the left ventricle LV while under tension, for example, by a wire locking device 240 or other suitable means for connecting the wires 124, 224.

[0088] 52, both device 120 and second device 220 are shown in a deployed position with anchors 122, 222 engaged with outward facing surfaces 126, 226. Wire 124 extends through the heart wall W and into the left ventricle LV, but not through the papillary muscles 12. Second device 220 is deployed such that second anchor 222 engages outward facing surface 226 on the interventricular septum IS and second wire 224 extends through the interventricular septum IS and into the left ventricle LV.

[0089] 49B, the wires 124, 224 can be pulled inwardly to pull the heart wall W inwardly to remodel the shape of the heart wall W and the ventricular septum IS. To hold the heart wall W and the ventricular septum IS in the remodeled position, the wires 124, 224 can be connected within the left ventricle LV while under tension, for example, by a wire locking device 240 or other suitable means for connecting the wires 124, 224.

[0090] The devices 120 can be used in a wide variety of different ways to remodel the heart and / or approximate the papillary muscles. Two or more devices 120 can be deployed with a single locking device 240, or two or more wire locking devices 240 with two or more devices 120 per locking device 240 can be deployed to remodel the heart of a single patient. For example, any of the configurations shown in Figures 50, 51, and 52 can be used in combination on a single patient's heart. For example, a pair of devices 120, 220 can be used to approximate the papillary muscles 12 while also remodeling the shape of the right ventricle using one or more additional pairs (or three, or four, etc.) of devices for the same patient. Or, in one exemplary embodiment, the pair of devices 120, 220 pull one papillary muscle and a portion of the heart wall or ventricular septum IS relatively toward each other, while the other on the pair of devices 120, 220 pulls another papillary muscle and a portion of the heart wall or ventricular septum IS relatively toward each other. In another embodiment, in one exemplary embodiment, the wire is not deployed through the papillary muscles, and a pair of devices 120, 220 relatively pulls two portions of the heart wall or ventricular septum IS toward one another, and another pair of devices 120, 220 relatively pulls two other portions of the heart wall or ventricular septum IS toward one another.

[0091] The wire locking device 240 can take a wide variety of different forms. An exemplary embodiment of the wire locking device 240 is shown in Figures 53 and 54. Figure 53 shows an exploded side view of the wire locking device 240, which consists of a body 302 and a threaded insert 304. The body 302 has an input opening 306 and two exits 308 (the second exit is not visible in each of the views). Figure 54 shows an orthogonal view of Figure 53.

[0092] FIG. 55 shows a cross-sectional view of the wire locking device 240 of FIGS. 53 and 54. As shown, the threaded insert 304 is partially inserted into the body 302. The first wire 124 and the second wire 224 are shown entering the body 302 through an input opening 306 that passes between a conical clamping surface 406 of the body 302 and a conical surface 408 of the insert 304. After passing between the two clamping surfaces, the first wire 124 exits the wire locking device 240 through one outlet 308 and the second wire 224 extends through the other outlet 308. The wires 124, 224 can take a wide variety of different forms. For example, the wires can be sutures, wires, cables, strings, bendable rods, any combination thereof, and the like.

[0093] 56 shows the threaded insert 304 inserted into the body 302 such that the first and second wires (124 and 224) are captured or clamped between the conical clamping surface 406 of the body 302 and the conical surface 408 of the insert 304. This insertion is performed by rotating the threaded insert 304 such that the threaded insert is drawn into the body 302 by the action of threads 502 formed on the insert and mating threads 504 formed in the body chamber.

[0094] Figures 57A-57E show the clamp in use. As shown, a first anchor 122 and a second anchor 222 are positioned on an outer surface 126 of the heart wall W. The first anchor 122 is attached to a first wire 124 and the second anchor 222 is attached to a second wire 224. The first and second anchors 122, 222 and wires 124, 224 can be deployed as described above.

[0095] As shown in FIG. 57B, the first and second wires 124 and 224 are positioned within a wire locking device 240, such as the device shown in FIG. 55. In FIG. 57C, the wire locking device 240 is pushed along the wires 124, 224, as shown by arrow 530, and positioned and held adjacent the first and second anchors 122 and 222. The first and second wires 124 and 224 are pulled through the clamp, as shown by arrow 532, drawing the first and second anchors inward, as shown by arrow 534. This has the effect of drawing the heart wall W together. Once the heart wall W is in the desired position, the threaded insert 304 is rotated at 540, as shown in FIG. 57D. This serves to fix the first and second wires 124 and 224, as shown in FIG. 56. This fixation maintains tension on the wall W, thereby maintaining the heart wall in the remodeled shape. Once the first and second wires 124 and 224 are secured, they may be cut as shown in FIG. 57E.

[0096] 57A-57E, in one exemplary embodiment, the wire locking device 240 is configured to be delivered to the ventricle LV, RV through a catheter (i.e., a transcatheter). Tension is applied to the wire 124, 224 by pulling on the wire 124, 224 from outside the patient's body (i.e., from the patient's groin, clavicle, or chest) while the wire locking device is in the ventricle. The wire locking device 240 is locked by rotating (or otherwise actuating) a wire locking tool or driver 550 from outside the patient's body (i.e., from the patient's groin, clavicle, or even chest) while the wire locking device is in the ventricle. Thus, in one exemplary embodiment, the act of rotating the threaded insert 304 includes a tool or driver 550 that can position the wire locking device 240 and rotate the threaded insert 304 inside the heart.

[0097] The tool or driver 550 can take a wide variety of different forms. In the example shown in Figures 58 and 59, the tool 550 includes a catheter 552, a socket 562, and a drive member 574. The socket 562 and drive member 574 are configured to hold the wire locking device 240 while the catheter 552 moves the wire locking device 240 along the wires 124, 224 through the patient's vasculature (typically through one or more guide catheters) to a ventricle of the patient. The socket 562 includes a recess 563 for receiving the body 302 and is shaped to releasably engage and prevent rotation of the body 302 when the threaded insert 304 is rotated. Referring again to Figure 55, a recess 570 for engaging the drive member 574 is located in the threaded insert 304 opposite the conical surface 408 of the insert 304. A drive member 574 is positionable within the recess 570 and can be latched to and disengaged from the threaded insert 304 .

[0098] FIG. 59 shows the working end of the tool 550 with the wire locking device 240 inserted into the recess 563 of the socket 562. In one exemplary embodiment, the driver 574 is movable between an engaged or expanded state (FIG. 59) and a disengaged or collapsed state (as indicated by the arrow in FIG. 63). The driver 574 can be configured to engage and disengage in a wide variety of different configurations. In the example shown in FIG. 59, the driver 574 is positioned within the recess 570 of the insert 304 before the driver 574 moves from the disengaged state to the engaged state. In the disengaged state, the retaining rod 572 is not disposed at the end of the driver member. Upon entering the recess 570, the retaining rod 572 moves to the position shown in FIG. 59, causing the driver 574 to expand into an engaged state in the recess 570 of the insert 304, thereby coupling the driver 574 to the insert 304 (until the rod 572 is removed). 60 shows a perspective view of the wire locking device 240, showing the recess 570 located in the insert 304. FIG. 61 shows another view of the driver 574 without the retention rod 572.

[0099] 62 shows a view of the insert 304 positioned on a drive member 574 with a retaining rod 572 positioned to secure the insert 304 to the engagement device 574. A shaft 582 is attached to the driver 574, which allows rotation of the driver 574 relative to the catheter 552 and socket 562. The illustrated driver 574 includes fingers 584 that are pushed outwardly by the retaining rod 572, which causes the fingers 584 to expand into the recesses 570 of the insert 304, securing the insert 304 to the engagement device 574. For clarity, this view omits the remaining components of the tool 550.

[0100] As shown in FIG. 63, when the retaining rod 572 is withdrawn from the insert 304, the fingers 584 retract to a disengaged state. When the fingers retract to a disengaged state, the end of the driver 574 is smaller than the recess 570 in the insert 304, thereby releasing the insert 304. For example, the fingers 584 can be made of steel, a shape memory alloy, or other resilient material that springs toward a disengaged state when the retaining rod 572 is removed. FIG. 64 shows the socket 562 adjacent the released wire locking device 240. Also shown is a portion of the catheter 552 attached to the socket 562.

[0101] 53A, 54A, 55A, 56A, 57F-57J, 58A, 59A, 60A, 61A, 62A, 63A-63G, and 64A illustrate another exemplary embodiment of a locking device 240 having a body 302 and a threaded insert 304 for positioning within the body. In this embodiment, as with other exemplary embodiments described herein, the threaded insert may have external threads 502 on a proximal outer portion of the threaded insert 304. The insert 304 may be substantially cylindrical and may have a tapered or conical distal end 408. The insert may be rotated within the body 302 by applying a torque to rotate the insert and thread it into the body. The external insert threads 502 thread into mating threads 504 of the body 302, with the threads aligned or mated in a first direction. This first direction requires that the insert be rotated clockwise to thread it into the body, i.e., the threads are right handed. In another embodiment, the threads can be left handed.

[0102] With reference to FIG. 62A, in an exemplary embodiment, the insert may have an opening 570 with an internal thread 167. A driver 574 (see FIG. 59A) with an external thread 170 may be rotated into the internal thread 167 of the opening 570 to secure the driver to the insert. This attachment of the driver to the insert may occur prior to rotating the insert to attach it to the body. The threads of the driver that mate with the internal threads of the body may be aligned or mated in a second direction. In an exemplary embodiment where the first direction is clockwise (right-handed), the threads in the second direction may require the driver to be rotated counterclockwise to attach it to the insert, i.e., left-handed threads (or vice versa). Once the driver 574 is secured to the insert 304, the insert may be rotated into the body by rotation of the driver, which will be described in more detail below.

[0103] To deploy the implant, the driver 574 is secured to the insert 304. The driver is secured to the insert by rotating in a second direction. Once the driver is secured to the insert, the driver rotates in a first direction to rotate the insert into the body. This rotation in the first direction rotates and advances the insert into the body 302 of the device 240, so that the insert and body become secured together by being threaded together. Once the threads are secured between the insert and the body, the driver can continue to rotate in the first direction. The distal end of the driver then unscrews from the insert so that the driver can be removed. In particular, rotation of the driver in the first direction when secured to the insert rotates the insert into the body. Once the insert is fully rotated into the body, the driver, still rotating in the first direction, increases the torsional load until it reaches a torsional preload value. At that point, the insert stops rotating with the driver. Continued application of a rotational force to the driver increases the torque above a threshold value, which causes the distal end of the driver to begin to unscrew from the internal threads of the insert. The torque then drops as the driver begins to rotate relative to the insert. Continued rotation of the driver in this direction disengages the driver from the insert, thereby allowing removal of the delivery tool (driver, catheter).

[0104] The wire locking device 240 and threaded insert 304 for positioning within the body 302 can take a wide variety of different forms. An exemplary embodiment of the wire locking device 240 is shown in Figures 53A and 54A. Figure 53A shows an exploded side view of the wire locking device 240, which consists of the body 302 and the threaded insert 304. The body 302 has an input opening 306 and two outlets 308 (the second outlet is not visible in each of the views). Figure 54A shows an orthogonal view of Figure 53A. The threaded insert 304 may have a threaded opening 570 at the top (proximal) end 168 of the insert 304. The threaded insert may have external threads 502 that are in a first orientation, e.g., right-handed threads, that align with the body threads 504. The internal threads of this same insert may be left-handed threads. (The reverse may also be true, where the outer threads 502 are left-handed and right-handed inner threads are in the opening 570.) The driver 574 may be a threaded rod having threads that fit into the opening 570 having left-handed threads.

[0105] 55A and 56A show cross-sectional views of the wire locking device 240 of FIGS. 53A and 54A. As shown in FIG. 55A, the threaded insert 304 is partially inserted into the body 302. The threaded distal end 169 of the driver 574 is secured within the threaded opening 570 of the insert 304 (threaded distal end 169 is shown smaller than the threaded opening 570 to illustrate the bit features; however, in most exemplary embodiments, these two features mate and / or are substantially the same size). The first wire 124 and the second wire 224 are shown entering the body 302 via the input opening 306, which passes between the conical clamping surface 406 of the body 302 and the conical surface 408 of the insert 304. After passing between the two clamping surfaces, the first wire 124 exits the wire locking device 240 through one outlet 308 and the second wire 224 extends through the other outlet 308. The wires 124, 224 can take a wide variety of different forms. For example, the wires can be sutures, wires, cables, strings, bendable rods, or any combination thereof.

[0106] 56A shows the threaded insert 304 inserted into the body 302 such that the first and second wires (124 and 224) are captured and / or clamped between the conical clamping surface 406 of the body 302 and the conical surface 408 of the insert 304. This insertion is performed by rotating the threaded insert 304 such that the threaded insert is drawn into the body 302 by the action of the threads 502 formed on the insert and the mating threads 504 formed in the body chamber. In FIG. 56A, a driver 574 having a threaded distal end 169 remains inserted into the opening 570 of the insert 304.

[0107] Figures 57F-57J illustrate the clamp in use. As shown, first anchor 122 and second anchor 222 are positioned on the outer surface 126 of the heart wall W. First anchor 122 is attached to first wire 124 and second anchor 222 is attached to second wire 224. First and second anchors 122, 222 and wires 124, 224 can be deployed as described above.

[0108] As shown in FIG. 57G, the first and second wires 124 and 224 are positioned within a wire locking device 240, such as the device shown in FIG. 55A. In FIG. 57H, the wire locking device 240 is pushed along the wires 124, 224, as shown by arrow 530, to position and hold them adjacent to the first and second anchors 122 and 222. The first and second wires 124 and 224 are pulled through the clamp, as shown by arrow 532, drawing the first and second anchors inward, as shown by arrow 534. This has the effect of drawing the heart wall W inward. Once the heart wall W is in the desired position, the threaded insert 304 is rotated at 540, as shown in FIG. 57I. This serves to fix the first and second wires 124 and 224, as shown in FIG. 56A. This fixation maintains tension on the wall W, thereby maintaining the heart wall in the remodeled shape. Once the first wire 124 and the second wire 224 are secured, they can be cut as shown in FIG. 57J.

[0109] 57F-57J, in one exemplary embodiment, the wire locking device 240 is configured to be delivered to the ventricle LV, RV through a catheter (i.e., a transcatheter). Tension is applied to the wire 124, 224 by pulling the wire from outside the patient's body (i.e., from the patient's groin, clavicle, or chest) while the wire locking device is in the ventricle. The wire locking device 240 is locked by rotating (or otherwise actuating) a wire locking tool or driver 550 from outside the patient's body (i.e., from the patient's groin, clavicle, or even chest) while the wire locking device is in the ventricle. Thus, in one exemplary embodiment, the act of rotating the threaded insert 304 includes a tool or driver 550 that can position the wire locking device 240 and rotate the threaded insert 304 inside the heart.

[0110] The tool or driver 550 can take a wide variety of different forms. In the example shown in Figures 58A and 59A, the tool 550 includes a catheter 552, a socket 562, and a drive member 574. The socket 562 and drive member 574 are configured to hold the wire locking device 240 while the catheter 552 moves the wire locking device 240 along the wires 124, 224 through the patient's vasculature (typically through one or more guide catheters) to the patient's ventricle. The socket 562 includes a recess 563 for receiving the body 302 and is shaped to releasably engage and prevent rotation of the body 302 when the threaded insert 304 is rotated. Referring again to Figure 55A, a recess 570 for engaging the drive member 574 is located in the threaded insert 304 opposite the conical surface 408 of the insert 304. A drive member 574 having a threaded distal end 169 can be engaged and disengaged with the threaded insert 304 by mating threads 170 of the driver with internal threads 167 of the recess 570 of the insert 304 .

[0111] FIG. 59A shows the working end of the tool 550 with the wire locking device 240 inserted into the recess 563 of the socket 562. In one exemplary embodiment, the driver 574 is movable between an engaged state (FIG. 59A) and a disengaged state. The driver 574 can be configured to engage and disengage in a variety of different configurations. In the example shown in FIG. 59A, the driver 574 threads into a threaded opening 570 of the insert 304. FIG. 60A shows a perspective view of the wire locking device 240 showing the threaded insert 304 located within the body 302 of the wire locking device 240. FIG. 61A shows a view of the threaded distal end 169 of the driver 574.

[0112] 62A shows a view of the insert 304 threaded onto the drive member 574, where the shaft 582 is attached to the driver 574, which allows rotation of the driver 574 relative to the catheter 552 and socket 562. The illustrated driver 574 includes a threaded distal end 169. The threads 170 on the distal end 169 mate with the threads 502 in the recess 540 of the insert 304 to secure the driver to the insert, such that continued rotation of the driver 574 can rotate the insert 304 into the body 302. For clarity, this view omits the remaining components of the tool 550.

[0113] As shown in Fig. 63A, after the insert 304 bottoms out within the body, continued rotation of the driver 574 in the same rotational direction used to secure the insert 304 within the body 302 causes the driver to unscrew the internal threads of the cavity 570 of the insert 304. Fig. 64A shows the socket 562 adjacent the released wire locking device 240. Also shown is a portion of the catheter 552 attached to the socket 562.

[0114] 63B and 63C, there is shown a schematic diagram of an insert 304 and a driver 574 engaging one with the other. In FIG. 63B, the insert 304 has an opening 570 with an internal thread 167. The driver 574 has a distal end 169 with threads 170 oriented to mate with the internal threads 167 of the insert. The threads 170 at the distal end of the driver can be left-handed threads. In the same exemplary embodiment, the internal threads 167 of the insert 304 are left-handed threads and the external threads 502 of the insert 304 that mate with the body 302 are right-handed threads. In another exemplary embodiment, all threads are reverse-handed from those just described. In FIG. 63C, the driver has been rotated in a first direction, as indicated by arrow 171, so that the threads are torqued to a preload threshold and the driver engages the insert.

[0115] 63D and 63E, there is shown a schematic of the insert being deployed within the body 302 of the device 240. In FIG. 63D, the insert 304 is deployed within the body 302 by rotation of the insert 304 with the driver 574 to rotate the external threads 502. A torque is applied to the driver 574 with the catheter handle (not shown), which translates a twist through the system to the insert, as shown by arrow 171. As the insert is rotated further into the body and engages the body 302 and / or the wires 124, the torque increases throughout the system. In FIG. 63D, the first wire 124 and the second wire 224 are threaded through the body 302 and can be pulled to remodel the heart wall. In Figure 63E, the insert 304 is fully deployed within the body 302, with the first wire 124 and the second wire 224 each secured between the conical end 408 of the insert 304 and the body 302. Continued rotation from this position will cause the insert 304 to reach or exceed the torsional preload value required to secure the wire 124. The insert will soon stop rotating upon application of additional torque from the driver. Additionally, in this position, the driver will soon begin to rotate relative to the insert once the torsional preload in the insert has been exceeded.

[0116] 63F and 63G, there is shown a schematic diagram of the driver 574 disengaging from the insert 304. In FIG. 63F, torque is applied to the driver in the same direction as that applied to secure the insert 304 to the body 302. Torque can be applied in the same direction as before because the outer insert threads 502 and the inner insert threads 167 are threaded in opposite directions. The driver begins to unscrew, thus disengaging from the insert in FIG. 63F. In FIG. 63G, the driver is completely unscrewed and separated from the insert so that it can be removed from the implanted device 240 by pulling it proximally through the catheter.

[0117] The tool 550 can be manipulated in a variety of different ways to lock the wire 124, 224 with the wire locking device 240. FIG. 65 shows one exemplary embodiment of a handle 602 for manipulating the tool 550 described above. The handle 602 allows for operation of the tool 550 from outside the patient's body while the socket 562 and driver 574 are within the patient's heart chamber. The socket 562 is shown slightly enlarged relative to the handle 602 for clarity. Additionally, for clarity, the portion of the catheter 552 between the handle 602 and the socket 562 is not shown. One skilled in the art will appreciate that the shaft or catheter 552 can be long enough to position the socket 562 within the patient's heart while the surgical handle 602 can be outside the patient's body with the catheter 552 extending through the patient's vasculature.

[0118] As shown, the operating handle 602 includes a grip 604 and an engagement handle 606. FIG. 66 shows a detailed view of the operating handle 602, including the grip 604, the engagement handle 606, and a release lever or control 612. FIG. 67 provides a close-up view of the engagement handle 606. The release lever or control 612 can take a wide variety of different forms. For example, the control 612 may be a lever, a button, a trigger, etc. In the illustrated embodiment, the release control 612 has a wing shape to facilitate operation and is connected to the end of the retention rod 572.

[0119] FIG. 68 shows a cutaway view of the socket 562 and operating handle 602. As shown, the retaining rod 572 passes from the release lever 612 through the catheter 552 and into the socket 562. The shaft can be threaded into the patient's body around a location 622 where it can be threaded into a vein or artery to position the wire locking device 240. As shown, an inner driver shaft 582 passes through the catheter 552 from the engagement handle 606 to an area near the socket 562. As shown, this shaft 582 functions to move the wire locking device 240 further into the socket 562 and rotate the drive member 574. This occurs when a user pushes the engagement handle 606 against the grip 604 and rotates the grip. A spring 626 positioned within the grip 604 resists this pushing and rotating motion, biasing the engagement handle 606 and connected drive member 574 toward a retracted position.

[0120] 69, the second spring 632 positions the release control 612 so that the retaining rod extends from the engagement device 574 (not shown). This position secures the wire lock device 240 to the engagement device 574, which is located at the end of the inner shaft 582 opposite the engagement handle 606. In the exemplary embodiment, the positioning shaft 634 functions to keep the release lever 612 aligned as it moves between the engaged and disengaged positions. The positioning shaft 634 is connected to the release control 612 at end 635 and slides within holes 637, 639.

[0121] Referring to FIG. 70A, in an exemplary embodiment, during use, the first anchor 122 and the second anchor 222 are positioned on the outer surface of the heart wall W with the first wire 124 and the second wire 224 attached to and threaded through the heart wall W. The wires (124 and 224) are threaded through the wire locking device 240, as shown in FIG. 55. This threading through the locking device 240 occurs outside the patient's body. The wire locking device 240 is secured to the driver 574 inside the socket 562, as shown in FIG. 70B. Once the wires (124 and 224) are held in place outside the patient, the socket 562 is inserted into the patient and threaded through the guide catheter into the vein or artery. The wire locking device 240 is positioned adjacent to the first and second anchors (122 and 222) using the socket 562. 70C, once this positioning has been achieved, the first and second wires (124 and 224) are pulled, as shown by arrow 676, while the socket is maintained in place or advanced, as shown by arrow 677. This pulling 676 of the wires 124, 224, and the maintaining or advancing 677 of the wire locking device 240, causes the first anchor 122 and second anchor 222 to be drawn inward 678, as first shown in FIG.

[0122] After the first anchor 122 and the second anchor 222 are retracted inward 678, the wire locking device 240 is secured as shown and described in FIGS. 56 and 57D. This is accomplished by rotating the engagement handle 606 relative to the grip 604, as shown by arrow 679. This rotation causes the shaft 582 to rotate 579 relative to the catheter 552, which in turn rotates the driver 574 relative to the socket 562. The rotation of the driver 574 relative to the socket 562 causes the threaded insert 304 to rotate and advance axially within the body 302. The engagement threaded insert 304 and body 302 thus secure the first and second wires (124 and 224) as shown in FIG.

[0123] 70E, after the first and second wires (124 and 224) have been secured by the wire locking device 240, the engagement device 574 is released from the threaded insert 304 portion of the wire locking device 240 by pulling rearward on the release control 612 to retract the retention rod 572, as shown by arrow 680. This rearward pull pulls the driver shaft or rod 572 out (680) of the end of the driver 574. This allows the driver 574 to spring back to its retracted state (see FIG. 60), which is smaller than the recess 570, and the driver 574 is released from the insert 304.

[0124] 70F, after the driver 574 is released from the wire locking device 240, the tool 550 is withdrawn from the patient as shown by arrow 682. The wire locking device 240 and the first and second wires (124 and 224) remain within the patient as shown in FIG.

[0125] The first and second wires (124 and 224) can be severed with the wire locking device 240 using a cutting tool 700. The cutting tool can take a wide variety of different forms. An exemplary embodiment of such a cutting tool 700 is shown in FIG. 71A. The cutting tool 700 includes a slidably or telescopically coupled outer component or sleeve 701 and an inner component or plunger 703. As shown, the first and second wires 124 and 224 are threaded through an opening 702 in the cutting tool 700. For example, the wires 124, 224 can be threaded through an opening 702 that is external to the patient's body.

[0126] The cutting tool 700 is advanced 705 through the guide catheter to position the cutting end 704 of the tool in the wire locking device 240, as shown in Figure 7 IB. In an exemplary embodiment, the wire 124, 224 is held in a fixed position outside the patient's body while the cutting end 704 is advanced into position.

[0127] Referring to Fig. 71C, in an exemplary embodiment, the plunger 703 is pressed as shown by arrow 709, cutting the first and second wires (124 and 224). Referring to Fig. 71D, after the wires 124, 224 are cut, the cutting tool 700 and the first and second wires 124 and 224 are withdrawn from the patient as shown by arrows 720, 722, respectively, so that the wire locking device 240 remains in place, as shown in Fig. 71E.

[0128] A more specific example of a cutting tool 700 is shown in Figures 72A and 72B. The cutting tool includes an outer sleeve 701 and an inner shaft 703. The outer shaft 701 is shown separately in Figure 73A, and the inner shaft 703 of the cutting tool 700 is shown in Figure 73B. The inner shaft 703 includes a head 710 having a passageway 712 through which the wire 124, 224 can be routed. For example, the wire 124, 224 can be routed through the passageway 712 outside the patient's body. The inner shaft 703 is slidably disposed within the outer sleeve 701 such that the head 710 pulls the wire 124, 224 against the blade 714 of the outer sleeve to sever the wire 124, 224.

[0129] The wire locking device 240 can take a wide variety of different forms. FIGS. 74A-93B show various non-limiting examples of wire locking device 240 that can be used in the cardiac wall remodeling techniques described herein. An exemplary embodiment of the wire locking device 240 is shown in FIGS. 74A and 74B. As shown, the wire locking device 240 is comprised of a housing 802 and a threaded insert 804. FIG. 74B shows a view of the wire locking device 240 looking at the outer end of the threaded insert 804. As shown in FIG. 74A, when the threaded insert 804 is partially inserted into the housing 802, one or more wires 124 can be threaded through a pair of openings 808. With the wires 124 threaded as shown in FIG. 74A, the threaded insert 804 can be rotated to draw the threaded insert into the housing 802, trapping the wires between the threaded insert 804 and the housing 802, as shown in FIG. 74C. As shown in Fig. 74C, the threaded insert 804 may be formed with a concave surface 810 or flat surface located at the inner end of the threaded insert 804. In certain embodiments, this concave surface may provide a more secure clamping action because this configuration avoids the reduced contact area that would occur if the insert 804 had a convex pointed or rounded end.

[0130] 75A, 75B, 76A and 76B illustrate another exemplary embodiment of the wire locking device 240. In this exemplary embodiment, an outer housing 812 has a threaded or serrated opening 814 that passes longitudinally therethrough. The wire 124 is threaded through the threaded opening 814 and a spring 816 is disposed within the threaded opening 814. The spring 816 may be formed from a shape memory metal such as, but not limited to, nickel titanium (nitinol) or another resilient material such as steel. The resilient properties of the spring 816 expand to engage the threads of the threaded opening 814, capturing the wire between the threads of the threaded opening 814 and the spring 816.

[0131] 75A and 75B show one exemplary embodiment of a system for deploying the wire locking device shown in FIG. 76A and 76B. In the illustrated example, a spring 816 is compressed within a catheter 820. The catheter 820 is positioned inside an outer housing 812. The wire 124 is threaded between the catheter 820 and the body 812. By retracting the catheter 820, the spring 816 is released from the catheter 820 while a pusher 818, such as a rod or catheter, holds the axial position of the spring 816. When the spring 816 is released, it expands outward to the position shown in FIG. 75B. In the position shown in FIG. 75B, the wire is captured between the spring 816 and a threaded or serrated opening 814 in the housing 812.

[0132] 77A and 77B show another exemplary embodiment of the wire locking device 240. In this embodiment, the wire passes through a clamping member 832 having an opening 834 that passes longitudinally through the clamping member 832. When it is desired to clamp the wire 124, a sleeve 836 is moved along the clamping member 832 causing jaws 838 formed within the clamping member 832 to close and secure on the wire 124. As shown in FIG. 77B, teeth or serrations 840 can be formed within the clamping member 832 to more firmly engage the wire 124. The sleeve 836 can be maintained in a closed position on the clamping member 832 in a variety of different ways. For example, the sleeve 836 can have an interference fit with the clamping member 832, the sleeve 836 and the clamping member 832 can be threaded together, etc.

[0133] An exemplary embodiment of a wire locking device 240 is shown in Figures 78A and 78B. As shown in Figure 78A, the wire locking device 240 comprises a housing 842 and a threaded insert 844. The threaded insert 844 has a passageway 850 formed therein that extends longitudinally therethrough. In use, the wire 124 passes through the opening 850 as shown. The threaded insert 844 is rotated such that threads formed in the insert engage threads formed in the housing 842. As the threaded insert 844 is pulled into the housing 842, a tapered end 856 of the threaded insert 844 engages a taper 858 formed in the housing. This engagement deforms the tapered end of the insert, as shown by arrow 859, closing a portion of the passageway onto the wire 124, thereby clamping the wire 124 in place relative to the wire locking device 240. 78B illustrates a top view of the wire locking device 240 showing the end of the threaded insert 844 opposite the tapered end 856. As shown, the exemplary embodiment has a hexagonal shaped opening 850 in the threaded insert 844, which facilitates the use of a tool (not shown) to rotate the threaded insert 844 relative to the housing 842, thus tightening the wire 124, as described herein.

[0134] Another exemplary embodiment of the wire locking device 240 is shown in Figures 79A and 79B. In this embodiment, the wire 124 is woven through a spring 862, as shown in Figure 79B. The spring 862 may be formed from, but is not limited to, a resilient material such as steel, or a shape memory metal such as nickel titanium (nitinol). As shown, the spring 862 returns to its tightly coiled state, as shown in Figure 79A. This serves to capture the wire 124 between the coils of the spring 862 and lock the wire 124 in place.

[0135] Another exemplary embodiment of the wire locking device 240 is shown in Figures 80A and 80B. The wire locking device 240 is made up of two pieces, a receiver 872 and a locking insert 874. As shown, the wire 124 is placed between the receiver 872 and the locking insert 874, and the two are brought together as shown in Figure 80B. The receiver 872 and the locking insert can be connected together in a variety of different ways to connect the wires and lock them in place. In the example shown in Figures 80A and 80B, the receiver has a locking hook 876 that engages with a locking groove 878 in the locking insert 874. When the locking hook 876 engages the locking groove 878, the teeth 880 of the locking insert 874 interlock with the teeth 882 of the receiver 872. These two sets of teeth 880 and 882 capture the wire 124 and lock it in place relative to the wire locking device 240 .

[0136] Another exemplary embodiment of a wire locking device 240 is shown in Figures 81A and 81B. As shown, the device has a receiver 892 and a locking insert 894. The wire 124 is placed between the receiver 892 and the locking insert 894 and the two are pulled together as shown in Figure 81B. A spring 896 draws the receiver 892 and the locking insert 894 together and holds them in this position, locking the wire 124, as shown in Figure 81B.

[0137] 82, the exemplary embodiment of the wire locking device 240 includes a pair of toothed jaws 902 and 904 held together by a spring 906. The closing force applied by the spring 906 causes the toothed jaws 902 and 904 to lock a wire (not shown) in place relative to the clamp 240.

[0138] In the exemplary embodiment of the wire locking device 240 illustrated in FIG. 83, a pair of toothed cams 912 are positioned such that movement of a pair of wires 124 rotates the cams 912. Depending on the direction the wire is pulled and the corresponding direction the cams 912 rotate, the locking device 240 allows the wire to move through the locking device or prevents the wire from moving through the locking device. For example, when the wire 124 is pulled against the locking device 240 in the direction shown by the arrow, the cams 912 tighten the wire 124 such that it is locked in place against the wire locking device 240. The tension achieved by the pair of anchors 122 in the above embodiment creates a force shown by the arrow, which causes the locking device 240 to lock the position of the wire 124. In some exemplary embodiments, the cams can be optionally spring loaded such that the cams 912 are biased against the wire 124.

[0139] In another exemplary embodiment, the wire locking device 240 is formed of a movable plate and cleat that are used to secure two or more wires. As shown in FIG. 84, the wire 124 is threaded between a cleat 922 and an adjustable plate 924. The cleat 922 rotates about a pin 926 to secure the wire 124 between the cleat 922 and the plate 924. The plate 924 can be moved closer or farther away from the cleat 922 depending on the thickness and number of wires 124. In the illustrated exemplary embodiment, the plate 924 can be secured in place using one or more fasteners 928 that secure the plate 924 between a backing plate 930 and a clamping plate 932.

[0140] In another exemplary embodiment, the wire locking device 240 illustrated in Figures 85A and 85B secures the wire 124 passing through an inner component 942 of the wire locking device 240. The inner component 942 is inserted into an element 944 which functions to compress the inner component 942 as illustrated in Figure 85B, thereby securing the wire 124 by compression of the inner component 942.

[0141] An exemplary embodiment of a wire locking device 240 is shown in FIG. 86. Such a wire locking device can be made from a resilient material such as steel, or a shape memory metal such as, but not limited to, nickel titanium (nitinol). As shown, the wire 124 passes between an inner locking component 952 and a memory metal outer locking component 954. The inner locking housing 952 has fingers 953 that fit into slots between fingers 956 of the outer locking housing 954. The two parts 952, 954 are brought together to snap onto the wire 124. The fingers 953, 956 interlock with each other to place the wire 124 into the hole in the wire locking device 240.

[0142] Another exemplary embodiment of the wire locking device 240 is shown in FIGS. 87A and 87B and includes a strap of material 962. In FIG. 87A, the strap 962 is held in an elongated state by a holder 963. The wire 124 is woven in and out of the elongated strap 962 and slides easily relative to the strap when it is in the elongated position. The strap can be made of a shape memory material such as, but not limited to, nickel titanium (nitinol) as shown in FIG. 87B and a shape set into a coil shape (or other wire restraining shape). When the locking strap 962 is released from the holder, it returns to its set position, such as a spiral shape. The spiral shape locks the strap in place and wraps the wire as shown in FIG. 87B.

[0143] In another exemplary embodiment of the wire locking device 240, as shown in Figures 88A and 88B, the wire 124 is threaded through an inner clamp barrel 972. The inner clamp barrel 972 is disposed inside an outer clamp barrel 974, which has an inner diameter slightly larger than the outer diameter of the inner clamp barrel 972. As a result, the wire 124 is wedged between the inner barrel 972 and the outer barrel 974, locking the wire 124 in place relative to the wire locking device 240.

[0144] 89A and 89B show an exemplary embodiment of a wire locking device 240 similar to the device of FIGS. 88A and 88B. In the example shown in FIGS. 88A and 88B, the inner clamp barrel 972 includes a pin 976 and the outer clamp barrel 974 includes a slot 978. To lock the wire 124, the pin 976 is placed in the slot 978, the inner clamp barrel 972 advances into the outer clamp barrel 974, and the inner clamp barrel 972 rotates within the outer clamp barrel 974 to move the pin circumferentially along the slot. As a result, after the inner clamp barrel 972 rotates relative to the outer clamp barrel 974, the inner clamp barrel can be withdrawn from the outer clamp barrel. In this manner, the pin 976 and the slot 978 lock the device 240 to prevent the wire 124 from being unintentionally removed.

[0145] 90A and 90B show another exemplary embodiment of the wire locking device 240. As shown, the wire 124 is threaded through an opening in an outer housing 982. A plunger 984 and a spring 986 are disposed inside the outer housing 982. As shown in FIG. 90A, a spacer 988 is positioned to hold the plunger 984 in a contracted state during installation. The spacer 988 may be part of an installation tool (not shown) that guides the wire locking device 240 into place. In the contracted state, the wire 124 is free to move relative to the wire locking device 240. When the spacer 988 is removed, the plunger 984 is forced by the spring 986 against the outer housing 982, capturing the wire 124 in place.

[0146] The properties of shape memory metals, such as, but not limited to, nickel titanium (nitinol), may be used in exemplary embodiments of a wire locking device. One such embodiment of a wire locking device 240 is shown in Figures 91A and 91B. As shown, the wire 124 is threaded into a tube 992 formed from a shape memory metal. When it is desired to clamp the wire 124 in place, the memory metal of the tube 992 can return to a shape-set coiled state 994, as shown in Figure 91B. This forces the wires 124 into a circuitous path and holds them in place.

[0147] In another exemplary embodiment, the wire locking device 240 uses a spool to pull back the wire and lock it in place. Such a wire locking device 240 is shown in FIG. 92. As shown, a spool 1002 is used to pull the wire 124 into an outer housing 1004. The wire locking device 240 includes an engagement hub 1006 that is secured to the spool 1002. The engagement hub 1006 can be rotated by an installation tool 1008. The engagement hub 1006 is formed with teeth 1010 that engage with a pawl 1012 that allows the engagement hub 1006 to rotate in only one direction, thereby causing the spool 1002 to clamp down on the wire 124 and hold it in a clamped state.

[0148] An exemplary embodiment of an integrated wire locking device 240 is shown in Figures 93A and 93B. As shown, the wire 124 is threaded through an opening 1022 formed in the wire locking device 240. A tab portion 1024 is formed in the wire locking device 240. The tab portion 1024 captures the wire 124 between the tab portion 1024 and a base portion 1026. This capture, along with the circuit path of the wire 124 through the opening 1022, serves to lock the wire 124 in place relative to the clamp 240. In certain embodiments, such exemplary embodiment of the wire locking device 240 may be formed from a resilient material, such as, but not limited to, a shape memory metal, such as nickel titanium (nitinol).

[0149] 94-111, there is shown an exemplary embodiment of a device 120 for remodeling the shape of a heart wall, as well as a system 1400 and method for delivering the device 120 to the exterior surface of the heart H. The system 1400 and the device 120 can be configured in a variety of ways.

[0150] In the illustrated embodiment, the system 1400 includes a guide sheath 1402 , a steerable catheter 1404 , a delivery catheter 1406 , a pusher 1408 , a hemostatic plug 1410 , a puncture device 130 , and the device 120 .

[0151] 95, an exemplary embodiment of a device 120 for remodeling the shape of a heart wall is shown. The device 120 includes an anchor 122 and a wire 124. The anchor 122 can be configured in a variety of ways. Any configuration that can be positioned to engage an outwardly facing surface of the heart wall W to assist in pulling a portion of the heart wall W inwardly (i.e., toward the interior chamber of the heart) can be used. In the illustrated embodiment, the anchor 122 is reconfigurable such that the anchor can be delivered through a catheter or sheath in a delivery state (e.g., an elongated state as shown in FIG. 95) that fits within the lumen of the delivery catheter 1406 and can be reconfigured to a deployed state once delivered to the appropriate location.

[0152] In the illustrated embodiment, the anchor 122 has a generally cylindrical elongate body 1426 forming a tube having a central passage 1428. However, in other embodiments, the body 1426 can be shaped other than cylindrical. For example, the elongate body 1426 may have a cross-section that is oval, rectangular, or other shape. The body 1426 has a length L and includes a first end portion 1430 and a second end 1432 opposite the first end.

[0153] In the illustrated embodiment, the body 1426 includes one or more features to facilitate bending of the body 1426. The features can be configured in a variety of ways. In the illustrated embodiment, the features include a series of transverse cuts 1434 along the body 1426. In one embodiment, the series of cuts 1434 is a plurality of cuts, each cut generally perpendicular to the longitudinal axis A8 of the body 1426. In the illustrated embodiment, the cuts in the series of cuts 1434 are evenly spaced along the body 1426 and extend from the first end portion 1430 to the second end portion 1432. For example, the series of cuts 1434 can extend over at least 80% of the length L of the body M. In other embodiments, the series of cuts 1434 can be non-evenly spaced and can extend over less than 80% of the length L of the body 1426.

[0154] Additionally, each of the cuts in the series of cuts 1434 extends partially into the body 1426. In one embodiment, each of the cuts extends 25%-75% through the body.

[0155] The anchors 122 can be made from any suitable material that can be reshaped from an elongated state to a curved deployed state, In one exemplary embodiment, the anchors 122 can include a shape memory alloy, such as Nitinol, to provide the shape setting capability.

[0156] The wire 124 is connected to the anchor 122 such that pulling on the wire 124 can tension the anchor 122. In some embodiments, pulling on the wire 124 can also reshape the anchor from an elongated state (FIG. 95) to a curved deployed state (FIG. 96). In the illustrated embodiment, the wire 124 has a terminal end 1436 formed with a closed shape 1438, such as a circle 1438. The wire 124 is positioned such that the wire 124 passes through the closed terminal end 1436 to form a loop 1440 in the wire 124 that can be pulled out by pulling on the wire 124.

[0157] The wire 124 can be connected to the anchor 122 in a variety of ways. In the illustrated embodiment, the anchor includes a plurality of loops 1442, with the wire 124 passing through each of the loops 1442 to connect the wire 124 to the anchor 122. The number, size, location, and configuration of the loops 1442 may vary in different embodiments. In the illustrated embodiment, the anchor includes three equally sized, evenly spaced loops 1442 along the length L of the anchor 122.

[0158] In the illustrated embodiment, each of the loops 1442 is formed by a wire that is fixedly attached at its end to the body 1426 of the anchor 122. The wire forming the loops 1442 may be fixedly attached in any suitable manner. In some embodiments, the body 1426 may include an opening through which the end of the wire forming the loops 1442 may be inserted into the body 1426 and attached to the body 1426 122 (see, e.g., FIG. 96). In other embodiments, the wire forming the loops 1442 may be tied externally to the body 1426 of the anchor 122 (see, e.g., FIG. 98) or otherwise attached externally, for example, by adhesive or other fastening devices.

[0159] However, in other embodiments, the loops 1442 can be formed from materials other than wire. A loop 1440 of the wire 124 passes through each of the loops 1442 to connect the wire 124 to the anchor 122.

[0160] 95A-95G, another exemplary embodiment of a device 9520 for remodeling the shape of the heart wall is shown. The device 9520 is similar to the illustrated device 120 of FIG. 95 in that the device 9520 includes an anchor 1422 and a wire 1424. However, instead of utilizing a plurality of loops 1442 formed by a wire through which the wire 124 passes, the device 9520 utilizes a fabric, woven material, or similar flexible material configured to readily reform an anchor in a deployed state that can be used to pull a portion of the heart wall inwardly to remodel the shape of the heart wall.

[0161] The anchor 1422 can be configured in a variety of ways. Any configuration that can be positioned to engage an outwardly facing surface of the heart wall W to assist in pulling a portion of the heart wall W inwardly (i.e., toward the interior chamber of the heart) may be used. In the illustrated embodiment, the anchor 1422 is the same as or substantially similar to the anchor 122 of FIG. 95. Thus, the description of anchor 122 applies equally to the anchor 1422.

[0162] The wire 1424 is connected to the anchor 1422 such that pulling on the wire 1424 tensions the anchor 1422. In some embodiments, pulling on the wire 1424 can also reshape the anchor from a substantially elongated state (FIG. 95A) to a circular deployed state (FIG. 96A). In the illustrated embodiment, the wire 1424 has a terminal end 1436 formed with a closed shape 1438, such as a circle. The wire 1424 is positioned such that the wire 1424 passes through the closed terminal end 1436 to form a loop 1440 in the wire 1424 that can be extracted by pulling on the wire 1424.

[0163] The wire 1424 can be connected to the anchor 1422 in a variety of ways. In the illustrated embodiment, a connector 9542 made from a cloth, fabric, or similar flexible material is used to connect the wire 1424 to the anchor 1422. The connector 9542 can be configured in a variety of ways, for example, different shapes and different materials. In one exemplary embodiment, the connector 9542 is made from a low profile cloth. The cloth can take a wide variety of different forms. It can be woven, knitted, braided, or non-woven. When woven, knitted, or braided, the cloth can optionally utilize high strength yarns. The cloth can include any of the cloths, threads, and thread components disclosed in U.S. Patent No. 8,833,402 to Rasmussen et al., issued September 16, 2014, which is incorporated herein by reference in its entirety. In one exemplary embodiment, the permanent implant grade high strength yarns can be made from ultra-high molecular weight polyethylene (UHMwPE), polyethylene terephthalate (PET), and / or other materials and blends of materials. In some exemplary embodiments, the yarn materials are oriented to increase the strength of the yarns. In some exemplary embodiments, the connector 9542 is made from a thin material that has a minimum tensile strength of 60 N or more in combination with the tensile wire 1424 when used with the disclosed anchor 1422. In one exemplary embodiment, the fabric has low profile yarns and high orientation in the molecular chains of the polymer to achieve high strength and low connector profile. The yarns used in the functional direction to achieve high tensile strength can have a strength of at least 40 grams / denier. In one exemplary embodiment, high strength Dyneema® yarns or other UHMwPE yarns with PET yarns may have approximately three times the pull-out strength of the wire 1424 running through the connector compared to an otherwise identical connector made only from high density PET fabric.

[0164] In one exemplary embodiment, the connector fabric 9542 is a high density PET fabric and / or hybrid fabric (described below) having 150-270 warp threads per inch, e.g., 170-250 warp threads per inch, e.g., 190-230 warp threads per inch, e.g., 210 warp threads per inch, or about 210 warp threads per inch, and 110-230 weft threads per inch, e.g., 130-210 weft threads per inch, e.g., 150-190 weft threads per inch, e.g., about 170 weft threads per inch, e.g., 170 weft threads per inch. A wide variety of different yarns can be used for the warp and weft. For example, 40d / 24f PET yarns can be used for the warp and weft. In one exemplary embodiment, the thickness of a fabric made from high strength yarns such as UHMwPE yarns such as Dyneema® yarns with conventional yarns such as PET yarns is also less compared to another identical fabric made only from conventional yarns such as PET. The use of fabric as the connector 9542 provides an even force distribution to the tissue.

[0165] 130 and 131 show two examples of woven fabrics 13100 that can be used to make connectors 9542. In the example shown in FIG. 96D, the woven fabric 13110 includes high-strength yarns 13102 in the weft direction 13104 and conventional yarns 13106 in the warp direction 13108. In the example shown in FIG. 96E, the woven fabric 13110 includes conventional yarns 13106 in the weft direction 13104 and high-strength yarns 13102 in the warp direction. The high-strength yarns 13102 can take a wide variety of different forms. For example, the high-strength yarns 13102 can be UHMwPE yarns, such as Dyneema® yarns. The conventional yarns 13106 can take a wide variety of different forms. For example, the conventional yarns 13106 can be conventional plastics, such as PET. The conventional yarns 13106 and the high-strength yarns 13102 are woven to form a hybrid fiber. In one exemplary embodiment, the high-strength yarn size can be 25 dtex / 10 filaments, the conventional yarn size can be 44 dtex / 24 filaments, and the fabric is constructed using at least 180 weft / inch and 160 warp / inch. For example, the UHMWPE yarn size can be 25 dtex / 10 filaments, the PET yarn can be 44 dtex / 24 filaments, and the fabric is constructed using at least 180 weft / inch and 160 warp / inch. The high-strength yarn and the conventional yarn can be multifilament or monofilament. For example, the UHMWPE yarn and the PET yarn can be multifilament or monofilament. The UHMPWPE yarn can be a size of 11 dtex up to 55 dtex, while the PET yarn can be a size of 11 dtex up to 44 dtex. The UHMPWPE yarn can be a size of 11 dtex up to 55 dtex, while the PET yarn can be a size of 11 dtex up to 44 dtex.

[0166] The connector 9542 can take a variety of different shapes. In some exemplary embodiments, the connector 9542 is configured to reshape the anchor from the elongated state (FIG. 95A) to the circular deployed state (FIG. 96A) even by pulling the wire 1424. In some other exemplary embodiments, the anchor 1422 is shape-set to the deployed state and the connector 9542 is not configured to reshape the anchor by pulling the wire. In the exemplary embodiment shown in FIGS. 95B-95C, the connector 9542 includes a patterned fabric or other material 9544 that is laser cut or otherwise formed. In the illustrated embodiment, the patterned material 9544 has a first end 9546, a second end 9548, a first side 9549, and a second side 9550 opposite the first side 9549.

[0167] The patterned material 9544 includes a series of cutouts 9551 that extend across the length LC of the patterned material 9544 along a central longitudinal axis AC. The cutouts 9551 can be configured in a variety of manners, including the shape, size, and number of cutouts. In the illustrated embodiment, the cutouts 9551 are generally diamond shaped, with the cutouts 9551 adjacent the first end 9546 and adjacent the second end 9548 being half diamond shaped. However, in other embodiments, the cutouts 9551 may take other shapes, such as, for example, circular, elliptical, triangular, hexagonal, octagonal, and / or rectangular. In the illustrated embodiment, the cutouts 9551 are positioned and shaped such that the patterned material 9544 is symmetrical about the longitudinal axis AC. Further, in the illustrated embodiment, the patterned material 9544 includes five complete cutouts adjacent the first end 9546 and two half-open cutouts adjacent the second end 9548. However, in other embodiments, the patterned material 9544 may include more than five complete cutouts or less than five complete cutouts.

[0168] In one exemplary embodiment, the cutout dimensions at the folded portion (i.e., the portion connecting the diamonds in FIG. 95B) are selected to achieve the required tensile strength. Based on the desired minimum tensile strength, the number of cutouts, the width of the portion connecting the diamonds, the fabric fiber parameters, such as the strength, size, and yarn density of the high strength yarns in the fabric, are optimized. In one exemplary embodiment, a hybrid fabric of high strength yarns such as UHMWPE yarns with conventional yarns such as PET yarns utilizes edge melt seals from the filaments of plastic conventional filaments such as PET filaments to avoid yarn fraying and / or premature component failure, i.e., low tensile strength, when the components of the connector 9542 are cut into different shapes. In one exemplary embodiment, the low melt temperature and melt flow properties of high strength yarns such as UHMWPE yarns do not melt evenly at the edges when the fabric is cut into the shape of the connector 9542 using high temperature techniques such as laser cutting. When traditional yarns such as PET yarns are included, the edges are cut using high temperature techniques such as laser cutting, resulting in a uniform edge thickness despite the fabric containing high strength yarns such as UHMWPE yarns.

[0169] The cutout 9551 forms a patterned material 9544 having a first band 9552 forming an upper edge 9554 and a lower band 9556 forming a lower edge 9558. The cutout 9551 is defined by a series of first inwardly tapered portions 9560 and a series of opposing second inwardly tapered portions 9562 aligned with the series of first inwardly tapered portions 9560. Each of the first and second inwardly tapered portions 9560, 9562 is generally triangular, for example forming an equilateral or equilateral triangle. However, the portions 9560 may have a wide variety of different shapes. Each of the first inwardly tapered portions 9560 is connected to a corresponding second inwardly tapered portion 9562 by a bridge 9564.

[0170] 95D-E, to form the connector 9542, the patterned material 9544 is folded lengthwise onto itself along a central longitudinal axis AC, as best shown in FIG. 95E. Thus, the bridge 9564 is folded in half such that the upper edge 9554 is positioned adjacent the lower edge 9558 and the first inwardly tapered portion 9560 is positioned adjacent the second inwardly tapered portion 9562. In this folded configuration, the material 9544 resembles a sawtooth shape.

[0171] The connector can be connected to the anchor in a wide variety of different ways. With reference to Figures 95F-G, the first band 9552 is connected to the second band 9556 at two locations to connect the connector to the anchor and to connect the wire 1424 to the anchor 1422. In the illustrated example, first, the first band 9552 is connected to the second band 9556 adjacent the top edge 9554 and the bottom edge 9558, as shown by wire 9566. Second, the first band 9552 is connected to the second band 9556 adjacent the first inwardly tapered portion 9560 and the second inwardly tapered portion 9562, as shown by wire 9568. The first band 9552 can be connected to the second band 9556 in any suitable manner, such as by stitching, staples, and / or adhesive or other suitable attachment. As a result of the first band 9552 being connected to the second band 9556 as disclosed, the material 9544 forms a first passage (or passages) 9570 through which the anchor 1422 extends and a second passage 9572 through which the wire 1424 extends.

[0172] FIG 95H shows another patterned material 9544 where the first band 9552 is narrower than the second band 9556. To form the connector 9542, from the patterned material 9544 shown in FIG 95H, the material is folded onto itself lengthwise along the center of the bridge 9564. The upper edge 9554 is positioned significantly inward of the lower edge 9558, and the first inwardly tapered portion 9560 is positioned adjacent to the second inwardly tapered portion 9562. The connector can connect to the anchor in a variety of different manners.

[0173] In the embodiment of FIG. 95H, the second band 9556 is folded over the anchors. The folded second band 9556 may be connected to itself (to be folded over itself) and / or to the first band 9552. The second band 9556 can be connected to the first band 9552 and / or to itself in any suitable manner, such as by stitching, staples, and / or adhesive or other suitable attachment. As a result of the second band 9556 being folded, the material 9544 forms a first passageway (or passageways) through which the anchors extend and a second passageway through which the wires extend.

[0174] 95B, 95F, 95H, 95I, 96B, and 96C, in some exemplary embodiments, the fabric 13100 can be oriented and cut in a pattern 9544 (FIG. 95B) that maximizes the tensile strength of the connector 9542. In one exemplary embodiment, the fabric 13100 is oriented and cut such that the high strength fibers 13102 (see FIGS. 96D and 96E) extend in the direction indicated by the arrow 9502 (see FIGS. 95I, 96B, and 96C). In the example shown in FIGS. 95I, 96B, and 96C, the direction 9502 corresponds to a line perpendicular to the edge 9565 (or axis AC) of the connecting portion 9564. This direction can also be characterized as extending in the direction of the shortest line extending from the anchor 1422 to the edge 9565 of the connecting portion. In another exemplary embodiment, the fabric 13100 is oriented and cut such that the high strength fibers 13102 extend in a direction perpendicular to the direction indicated by the arrow 9502 (see FIGS. 95I, 96B, and 96C). In the example illustrated by FIGS. 95I, 96B, and 96C, the direction perpendicular to the direction 9502 corresponds to a line parallel to the edge 9565 and / or edge 9558 of the connecting portion 9564.

[0175] 96, the anchor 122 is shown in a deployed state. The deployed state of the anchor 122 can be in a variety of shapes. Any shape that can be used to pull a portion of the heart wall inward to remodel the shape of the heart wall can be used, such as a curved shape. In the illustrated embodiment, the anchor 122 is ring-shaped in the deployed state such that the first end 1430 is adjacent to the second end 1432 and the body 1426 is curved in a circle. In some embodiments, the first end portion 1430 and the second end portion 1432 can abut. In other embodiments, the first end portion 1430 and the second end portion 1432 can not abut. For example, the first end portion 1430 and the second end portion 1432 can be spaced apart from one another or can overlap,

[0176] The anchor 122 can be reshaped from the elongated state to the deployed state in a variety of ways. For example, the anchor 122 can include a shape memory alloy and be shape set to the deployed shape. Alternatively, or in conjunction with the anchor being shape set, the wire 124 can be used to reshape the anchor 122. In particular, the wire loop 1440 passes through each of the loops 1442, so that pulling the wire 124 pulls the wire loop 1440 through, thereby bending the body 1426 into a loop while pulling the first end 1430 and the second end 1432 together.

[0177] 96A, anchor 1422 is shown in a deployed state. The deployed state of anchor 1422 can be in a variety of shapes. Any shape that can be used to pull a portion of the heart wall inward to remodel the shape of the heart wall can be used, such as a curved shape. In the illustrated embodiment, anchor 1422 is ring-shaped in the deployed state.

[0178] The anchor 1422 may be reshaped from the elongated state to the deployed state in a variety of ways. For example, the anchor 1422 may include a shape memory alloy and be shape set to the deployed shape. Alternatively, or in conjunction with the anchor being shape set, the wire 1424 may be used to reshape the anchor 1422. In particular, by pulling the wire 1424, the wire loop 1440 decreases in size as it passes through the second passage 9572. As the wire loop 1440 decreases in size, the bridges 9564 are pulled towards each other, thereby pulling the anchor 1422 into a ring shape. The bridges 9564 on the connector body converge towards a center point of the ring. The overlapping tapered portions 9560, 9562 are generally triangular in shape, so that as the connector body is pulled into the ring, the overlapping tapered portions 9560, 9562 are pulled together to form a substantially solid disk that can be pulled against tissue, such as heart wall tissue.

[0179] In Fig. 97, the device 120 includes a hemostatic plug 1410. The hemostatic plug 1410 can be configured in a variety of ways. Any device capable of stopping the occurrence of bleeding from the passageway formed by the puncture device 130 in the heart wall can be used. In the illustrated embodiment, the hemostatic plug 1410 is formed as a cylindrical tube having a distal end 1444 and a central passageway 1446 through which the wire 124 extends. However, in other embodiments, the hemostatic plug 1410 can be configured other than cylindrical.

[0180] In the illustrated embodiment, the terminal end 1436 of the wire 124 is attached to the distal end 1444 of the hemostatic plug 1410. The wire 124 forms loops 1440 and is connected to the anchor 122 by passing through each of the loops 1442.

[0181] 98, the anchor 122 is shown in a deployed state. In the illustrated embodiment, the anchor 122 is ring-shaped in the deployed state such that the first end portion 1430 is adjacent the second end portion 1432, the body 1426 is curved in a circular shape, and the distal end 1444 of the hemostatic plug 1410 is generally adjacent the center of the circle.

[0182] 99, an exemplary embodiment of a portion of a guide sheath 1402 and a portion of a steerable catheter 1404 is shown. Both the guide sheath 1402 and the steerable catheter 1404 can be configured in a variety of ways. Any suitable known guide sheath 1402 and steerable catheter 1404 can be used. In the illustrated embodiment, the guide sheath 1402 and the steerable catheter 1404 are concentric, with the guide sheath 1402 including an inner lumen (not shown) through which the steerable catheter extends from a distal end 1450 of the guide sheath 1402. Similarly, the steerable catheter 1404 includes an inner lumen 1452 that opens at a distal end 1454 of the steerable catheter 1404.

[0183] In FIG. 100, a portion of the steerable catheter 1404 and a portion of the delivery catheter 1406 are shown. The delivery catheter 1406 includes an anchoring device 1456 attached to a distal end 1458 of the delivery catheter 1406. The anchoring device 1456 may be any suitable device capable of attaching to the heart wall W. In the illustrated embodiment, the anchoring device 1456 is a wire formed in a helical shape configured to be threaded into the heart wall W to secure the delivery catheter 1406 to the heart wall W. The delivery catheter 1406 includes an inner lumen (not shown) that opens at the distal end 1458.

[0184] 101 shows a portion of the steerable catheter 1404, a portion of the delivery catheter 1406, and the puncture device 130. The puncture device 130 may be any suitable device for penetrating or creating a passageway into the wall of a human heart, such as, for example, a needle, wire, or other similar device. In the illustrated embodiment, the puncture device 130 is a needle or hollow wire having an internal passageway (not shown) and an opening (not shown) proximate a distal end 1460 of the puncture device 130, fluidly connecting the internal passageway (not shown) to the exterior of the puncture device 130.

[0185] In the illustrated embodiment, the puncture device 130 is delivered through an inner lumen (not shown) of the delivery catheter 1406 and extends from a distal end 1458 of the delivery catheter 1406 .

[0186] 102 shows a portion of the steerable catheter 1404, a portion of the delivery catheter 1406, the puncture device 130, and the anchor 122. The anchor 122 is shown in an elongated state, extending from a distal end 1458 of the delivery catheter 1406 and over the puncture device 130 such that the puncture device 130 is received within a central passageway 1428 of the anchor 122, and the anchor 122 and the puncture device 130 are concentric.

[0187] In FIG. 103, an exemplary embodiment of the puncture device 130, anchor 122, hemostatic plug 1410, and pusher 1408 are shown. The pusher 1408 can be configured in a variety of ways. Any configuration capable of pushing the hemostatic plug 1410 and anchor 122 onto the puncture device 130 and beyond the distal end 1460 of the puncture device 130 can be used. In the illustrated embodiment, the pusher 1408 has an elongated cylindrical body 1462 having a distal end 1464 configured to abut the proximal end 1466 of the hemostatic plug 1410. The body 1462 includes an internal passageway (not shown) extending through the pusher body 1462. The puncture device 130 may be received within the passageway (not shown) such that the pusher 1408 is slidable over and concentric with the puncture device 130.

[0188] 104, the anchor 122 and hemostatic plug 1410 are illustrated. The anchor 122 is shown in an elongated state and the hemostatic plug 1410 is shown as a cylindrical tube. Both the anchor 122 and the hemostatic plug 1410 are concentric with the puncture device 130 and are configured to be slidable over the puncture device 130. As shown in FIG. 104, when delivered over the puncture device 130, the anchor 122 and the hemostatic plug 1410 are longitudinally aligned and the distal end 1444 of the hemostatic plug 1410 is adjacent to the first end 1430 of the anchor 122.

[0189] In FIG. 105, the anchor 122 and hemostatic plug 1410 are shown with the wire 124 and loops 1442 on the anchor 122. The terminal end 1436 of the wire 124 is attached to the distal end 1444 of the hemostatic plug 1410. The loops 1440 of the wire 124 pass through each of the loops 1442, connecting the wire 124 to the anchor 122. The wire 124 then extends from the distal end 1444 to the proximal end 1466 through a central passage 1446 (FIG. 97) in the hemostatic plug.

[0190] 106, the anchor 122 without the hemostatic plug 1410 is shown with the wire 124 and loops 1442 on the anchor 122. The terminal end 1436 of the wire 124 is formed with a closed circular shape 1438, and the wire 124 is positioned such that the wire 124 passes through the closed terminal end 1436. The loops 1440 of the wire 124 pass through each of the loops 1442 to connect the wire 124 to the anchor 122.

[0191] In FIG. 107, the system 1400 shows the anchor 122 partially deployed beyond the distal end 1460 of the puncture device 130 (FIG. 101). The delivery catheter 1406 is shown extending partially from the steerable catheter 1404, and the pusher 1408 is shown extending partially from the delivery catheter 1406 and through the anchor device 1456. As the pusher 1408 extends from the delivery catheter 1406, the distal end 1464 of the pusher 1408 engages the proximal end 1466 of the hemostatic plug 1410, pushing both the hemostatic plug 1410 and the anchor 122 onto the puncture device 130. As the distal end 1432 of the anchor 122 moves beyond the distal end 1460 of the puncture device 130 (FIG. 101), the anchor 122 can begin to reform to its curved, deployed state. For example, anchor 122 may include a shape memory alloy that is shape set to a curved, deployed state, such that the portion of anchor 122 that is no longer received on puncture device 130 can return to the curved, deployed state to which the shape memory alloy was set.

[0192] 108, the system 1400 is shown showing the anchor 122 (FIG. 101) partially deployed beyond the distal end 1460 of the puncture device 130, with the wire 124 connected to the anchor 122. In particular, the wire 124 is connected to the hemostatic plug 1410, extends through a loop 1442, and then loops around and extends through a central passage 1446 (FIG. 97) of the hemostatic plug 1410.

[0193] 109-110, the system 1400 is shown with the anchor 122 deployed. In particular, the wire 124 (FIG. 110) is withdrawn by pulling the wire 124 into the delivery catheter 1406 in a direction away from the anchor. Because the loop 1440 (FIG. 97) of the wire 124 passes through a loop 1442 on the anchor 122, pulling the wire 124 closes the loop 1440, drawing the loop 1442 together and helping, in conjunction with any shape-setting properties of the anchor, to reshape the anchor 122 from its elongated state to its curved, deployed state shown in FIGS. 109-110. At the same time, the distal end 1444 of the hemostatic plug 1410 is positioned adjacent the center of the curved anchor 122.

[0194] Similarly, in FIG. 110A, the system is shown with the anchor 1422 deployed. In particular, the wire 1424 is withdrawn by pulling the wire 1424 into the delivery catheter 1406 in a direction away from the anchor 1422. Because the loop 1440 (FIG. 96A) of the wire 1424 passes through a second passage 9572 on the anchor 1422, pulling the wire 1424 closes the loop 1440 and draws the overlapping tapered portions 9560, 9562 together, which in conjunction with any shape-setting features of the anchor, helps to facilitate reshaping the anchor 1422 from an elongated or undeployed state to a curved, deployed state. At the same time, the distal end 1444 of the hemostatic plug 1410 is positioned adjacent the center of the curved anchor 1422.

[0195] In FIG. 111, the system 1400 is shown with the anchor 122 deployed and the delivery catheter 1406 is retracted into the steerable catheter 1404. The wire 124 (see FIG. 110) is withdrawn by pulling the wire 124 into the delivery catheter 1406, away from the anchor. Because the loop 1440 (FIG. 97) of the wire 124 passes through a loop 1442 on the anchor 122, pulling the wire 124 closes the loop 1440, drawing the loop 1442 together and helping, in conjunction with any shape-setting properties of the anchor, to reshape the anchor 122 from its elongated state to its curved, deployed state shown in FIGS. 109-110. At the same time, the distal end 1444 of the hemostatic plug 1410 is pulled into the center of the curved anchor 122 as the loop 1440 is shortened by pulling the wire 124.

[0196] 112-120, deployment of device 120 into pericardial space 110 for remodeling the shape of heart wall W, as well as systems and methods for delivering device 120, are shown. With reference to FIG. 112, deployment of device 120 includes delivering a guide sheath 1402 and a steerable catheter 1404 into an internal chamber (e.g., left ventricle LV) of heart H. Steerable catheter 1404 is deployed such that a distal end 1454 of steerable catheter 1404 is adjacent heart wall W.

[0197] 113, a delivery catheter 1406 extends from a distal end 1454 of the steerable catheter 1404. An anchoring device 1456 of the delivery catheter 1406 is attached to the heart wall W, such as by, for example, rotating the delivery catheter 1406 about axis Z relative to the steerable catheter 1404 to thread the anchoring device 1456 into the heart wall (i.e., through the endocardium 102 and into the myocardium 104). In the illustrated embodiment, a distal end 1458 of the delivery catheter 1406 abuts or is adjacent the endocardium 102.

[0198] 114, the puncture device 130 is delivered into an internal chamber (e.g., the left ventricle LV) of the heart H via a delivery catheter 1406. The puncture device 130 may extend from a distal end 1458 of the delivery catheter 1406 such that a distal end 1460 of the puncture device 130 extends into the heart wall W. In the illustrated embodiment, the distal end 1460 of the puncture device 130 extends through the endocardium 102, the myocardium 104, the epicardium 106, and into the pericardial cavity 110 to form a passageway 132. Because the delivery catheter 1406 is fixed to the heart wall W, the insertion location of the puncture device 130 can be precisely controlled.

[0199] 115, to verify that the puncture device 130 is properly positioned for deploying the anchor 122 within the pericardial space 110, a dye 134 or other detectable fluid can be delivered through the puncture device 130 and injected into the pericardial space 110. The dye 134 can be detected by any suitable technique, such as an x-ray, to verify that the puncture device 130 is properly positioned.

[0200] In Fig. 116, the anchor 122 and hemostatic plug 1410 extend from the delivery catheter 1406, over the puncture device 130 (Fig. 115), and through the passageway 132. As shown in Fig. 116, the anchor 122 remains in an elongate state while sliding along the puncture device 130 into the pericardial space 110.

[0201] In FIG. 117, the anchor 122 is partially deployed beyond the distal end 1460 (FIG. 114) of the puncture device 130 (FIG. 101). The delivery catheter 1406 is shown extending partially from the steerable catheter 1404, and the pusher 1408 is shown extending partially from the delivery catheter 1406 and through the anchor device 1456. As the pusher 1408 extends from the delivery catheter 1406, the distal end 1464 of the pusher 1408 engages the hemostatic plug 1410, pushing both the hemostatic plug 1410 and the anchor 122 onto the puncture device 130 (FIG. 101). As the distal end 1432 of the anchor 122 moves beyond the distal end 1460 of the puncture device 130 (FIG. 101), the anchor 122 can begin to reform to its curved, deployed state. For example, anchor 122 may include a shape memory alloy that is shape set to a curved, deployed state, such that the portion of anchor 122 that is no longer received on puncture device 130 can return to the curved, deployed state to which the shape memory alloy was set.

[0202] In FIG. 118 , the anchor 122 is in a deployed state and a hemostatic plug 1410 is positioned within the passageway 132 to prevent bleeding from the passageway 132. In the illustrated embodiment, a distal end 1444 of the hemostatic plug 1410 is at or near the inner wall of the pericardial space 110. To reform the anchor 122, the wire 124 is withdrawn by pulling the wire 124 away from the anchor and into the hemostatic plug 1410. Because the loop 1440 ( FIG. 97 ) of the wire 124 passes through a loop 1442 on the anchor 122, pulling the wire 124 closes the loop 1440 and draws the hemostatic plug 1410 and anchor 122 together, drawing the loop 1442 together which, in conjunction with any shape-setting properties of the anchor 122, helps to facilitate reforming the anchor 122 from the elongated state to the curved deployed state shown in FIG. 118 .

[0203] 119-120, the pusher 1408 and puncture device can be removed by withdrawing them from the passageway 132 and into the delivery catheter 1406. The anchor 122, hemostatic plug 1410, and wire 124 remain deployed in the heart wall W, with the anchor 122 in the pericardial cavity 110 and the wire 124 extending through the epicardium 106, myocardium 104, and endocardium 102.

[0204] To seat the anchor 122, the delivery catheter 1406 may remain attached to the heart wall W and the distal end 1458 may be pressed against the heart wall W. At the same time, the wire 124 may be tensioned by pulling the wire 124 in an inward direction toward the ventricle, as shown by arrow A9. As a result, the anchor 122 is pulled against the outwardly facing surface 126 that partially defines the pericardial space 110, as shown by arrow A10. As the wire 124 is pulled in the direction of A9, the hemostatic plug 1410 is urged in the opposite direction, as shown by arrow A11, such that the distal end 1444 of the hemostatic plug 1410 is positioned at or adjacent to the center of the anchor 122. The deployed anchor 122 is too large to fit through the passage 132 formed by the puncture device 130. Thus, once the delivery catheter 1406 is removed, further tension on the wire 124 can be applied to pull the heart wall W inward toward the ventricle (eg, the left ventricle LV).

[0205] 112A-G, 113A-N, 114A, 115A, 115B, 116A, 117A, 118A, 119A-D, and 120A, the system 1400 and method for delivering the device 120 to a surface of the heart may include a piston 1500. The piston 1500 may be disposed between and coupled to the delivery catheter 1406 and the anchor device 1456.

[0206] 112A-B, there is shown a portion of the delivery catheter 1406, the piston 1500, and the anchoring device 1456. The piston 1500 includes a piston body 1502 coupled to a piston head 1504. The anchoring device 1456 can be coupled to a distal end 1506 of the piston head 1504.

[0207] 112B, the delivery catheter 1406 may include an inner lumen 1512 extending through the distal end 1458 of the delivery catheter 1406. The piston 1500 may include an inner lumen 1508 extending through the piston body 1502 and the piston head 1504. The inner lumen 1508 opens at the distal end 1506 of the piston head 1504 and at the proximal end 1510 of the piston body 1502.

[0208] The proximal end 1510 of the piston body 1502 is positioned within the inner lumen 1512 of the delivery catheter 1406 between the resistance member 1514 and the distal end 1458 of the delivery catheter 1406. The piston body 1502 can be configured to slide at least partially through the distal end 1458 of the delivery catheter 1406 and into the inner lumen 1512 of the delivery catheter 1406.

[0209] The delivery catheter 1406 may include a stopper 1516 coupled to an inner wall 1518 of the delivery catheter 1406. The stopper 1516 couples and secures the proximal end 1510 of the resistance member 1514.

[0210] The piston 1500 can be configured to slide within the distal end 1458 of the delivery catheter 1406. The resistance member 1514 resists the sliding motion of the piston 1500 and biases the piston 1500 toward the extended position. The resistance member 1514 can include a variety of shapes and materials. The resistance member 1514 can be a spring, a wire formed into a helical shape, or a spring-loaded or force-damping material, as shown in FIG.

[0211] The piston 1500 and delivery catheter 1406 may have one or more recesses 1522 that slidably engage one or more protrusions 1523. The recesses 1522 mate with the protrusions 1523 to couple the piston 1500 and delivery catheter 1406 such that the piston 1500 and delivery catheter 1406 can slide axially relative to one another but cannot rotate relative to one another. The resistance member 1514 biases the piston 1500 distally from the delivery catheter 1406 and may include a slot 1522. That is, the piston 1500 engages the delivery catheter 1406 to prevent rotation of the piston 1500 relative to the delivery catheter 1406. This engagement can be accomplished in a variety of ways other than the illustrated slot and protrusion arrangement.

[0212] FIG. 112D shows a cross section of a portion of the delivery catheter 1406 shown in FIG. 112C. In the example shown in FIG. 112C and FIG. 112D, the recess 1522 is a slot or multiple slots in the inner wall 1518 of the delivery catheter 1406. FIG. 112F shows a cross section of the proximal end 1510 of the piston body 1502 shown in FIG. 112E. In the example shown, the piston body 1502 includes a protrusion 1523 extending from an outer wall 1524 of the piston body 1502. The piston body 1502 may include multiple protrusions 1523. The protrusions 1523 may include various sizes and shapes. The slot 1522 may include a shape complementary to the protrusion 1523.

[0213] 112G, the outer wall 1524 of the proximal end 1510 of the piston body 1502 can engage the inner wall 1518 of the delivery catheter 1406. The connection between the proximal end 1510 of the piston body 1502 and the inner wall 1518 of the delivery catheter 1406 allows the piston 1500 to slide within the delivery catheter 1406. As the delivery catheter 1406 rotates, the engagement of the protrusions 1523 and the slots 1522 causes the piston 1500 to rotate with the delivery catheter 1406.

[0214] Referring again to FIG. 112B, the piston 1500 is shown in a disengaged position, characterized by the proximal end 1510 of the piston body 1502 in contact with the resistance member 1514, the inner wall 1518, and the distal end 1458 of the delivery catheter 1406. A force in the direction A' can be applied to the anchoring device 1456, which in turn applies a force to the piston 1500, moving the piston 1500 proximally in the direction A' relative to the delivery catheter 1406. A force on the anchoring device 1456 can bring the piston head 1504 into contact with the distal end 1458 of the delivery catheter 1406. This position, shown in FIG. 113I, can be referred to as the actuation or engagement position. The force can be applied by pressing the anchor 1456 of the delivery catheter 1406 against the heart wall W or any other material in contact with the anchoring device 1456.

[0215] The relative positions of the piston 1500 and the delivery catheter 1406 can be detected. A minimum or optimal force with which the anchoring device 1456 is pressed against the material before rotation can be detected based on the relative positions of the piston 1500 and the delivery catheter 1406. The engagement of the piston head 1504 with the distal end 1458 of the delivery catheter 1406 (compressed or activated position) can indicate to a user that the anchoring device 1456 is in an engagement suitable for use. For example, the engaged or activated position can indicate that the anchoring device 1456 is pressed against the heart wall W with a pressure suitable for temporary implantation of the anchoring device 1456 into the heart.

[0216] A user can determine whether to apply additional force to the anchoring device 1456 by observing the relative position of the piston head 1504 to the distal end 1458 of the delivery catheter 1406. With reference to FIGS. 112B and 112E, to detect the relative position of the piston head 1504 to the distal end 1458 of the delivery catheter 1406, the piston head 1504 and / or the catheter 1406 may include markers 1526, 1530, respectively. The markers 1526 may be located on the proximal end 1528 of the piston head 1504, as shown, or on any other portion of the piston head. With reference to FIGS. 112B and 112C, the delivery catheter 1406 markers 1530 may be located on the distal end 1458 of the delivery catheter 1406.

[0217] 112B, in the unactivated or extended position, the marker 1526 is at a distance D from the marker 1530. The piston 1500 may move in a direction A' due to the action of force, for example, when the anchoring device is pressed against a material, such as the heart wall, such as the endocardium and / or papillary muscles of the ventricle. As the piston 1500 moves in the direction A', the distance between the marker 1526 and the distal end of the delivery catheter 1406 decreases. The distance between the marker 1526 and the marker 1530 also decreases. The marker 1526 may abut the marker 1530 when the piston 1500 reaches the compressed or activated position. A user may detect the relative position of the piston 1500 and the delivery catheter 1406 by tracking the positions of the markers 1526 and 1530 using a visual scope, an electrical sensor that detects contact between the markers 1526, 1530, or other suitable means.

[0218] The contact, positioning, and / or pressure applied to the anchor device 1456 and piston 1500 can be determined by a variety of other means. For example, the markers 1530 and 1526 can be otherwise positioned or replaced. The delivery catheter 1406 or piston 1500 can be equipped with force measuring or pressure sensing devices and means for communicating the pressure or force to a user, such as, for example, a visual display device, an indicator light, an audible indicator, etc.

[0219] The anchoring device 1456 may rotate into the receiving material, e.g., the heart wall W. As the anchoring device 1456 rotates further into the receiving material, the amount of torque required may increase until a "torque threshold" is reached. The torque threshold for optimal engagement of the anchoring device 1456 into the heart wall W may be predetermined based on a number of factors, including the composition of the receiving material, the size and shape of the anchoring device, and the distance the anchoring device must travel into the receiving material. In one exemplary embodiment, the torque threshold is based on the increase in force that occurs when the anchor 1456 bottoms out on the tissue. For example, during the initial engagement of the anchor 1456 with the tissue, the torque gradually increases as the anchor engages more into the tissue. However, once the anchor 1456 bottoms out, there is a sudden increase in the torque required to continue rotating the catheter 1406. In one exemplary embodiment, the "threshold torque" is set between the gradually increasing torque and the sudden increase in torque that results from the anchor bottoming out.

[0220] 113A-113B, the system 1400 may include an over-torque prevention device 1533 designed to prevent excessive torque of the anchoring device 1456 into the heart wall W. Over-torque may occur when the torque applied to the anchoring device 1456 is greater than a predetermined torque threshold. The over-torque prevention device 1533 may comprise a clutch mechanism configured to decouple the delivery catheter 1406 from the piston 1500 and / or the anchoring device 1456 when the torque applied to the anchoring device 1456 is greater than a predetermined torque threshold. The clutch mechanism automatically allows rotation of the delivery catheter 1406 and the piston 1500 to be decoupled from rotation of the anchoring device 1456 when a threshold torque is reached, thereby preventing over-rotation of the anchoring device 1456 into the receiving material. In another exemplary embodiment, the clutch mechanism may be between the delivery catheter 1406 and the piston 1500, rather than between the piston 1500 and the anchor 1456.

[0221] The overtorque device can take a wide variety of different forms. For example, any clutch mechanism can be used. For example, in the example illustrated in FIGS. 113A-113E, the piston head includes a cap rotatably connected to the piston body. The overtorque device 1533 can include one or more arms 1534 extending from an inner wall 1540 of the rotatable cap piston head 1504. The arms 1534 can be configured to contact a pin 1536 extending distally from a distal end 1538 of the piston body 1502. The distal end 1538 of the piston body 1502 can include one or more pins 1536.

[0222] In the illustrated example, the cap piston head 1504 includes two arms 1534 positioned approximately 180 degrees apart, and the distal end 1538 of the piston body 1502 includes two pins 1536 positioned 180 degrees apart. However, any number of arms and pins can be used. The torque threshold can be altered by various means, including increasing or decreasing the length of the arms 1548 relative to the size of the pins 1550.

[0223] 113B-113C correspond to a situation where the torque applied to the delivery catheter 1406 and anchor 1456 is less than a predetermined torque threshold. Referring to FIG. 113C, as the delivery catheter 1406 rotates, the pin 1536 contacts and pushes the arm 1534. This contact causes the piston head 1504 and anchor device 1456 to rotate at the same speed as the delivery catheter 1406 and piston body 1502. The arm 1534 contacting the pin 1536 can provide resistance experienced by a user applying torque. The resistance can indicate that the applied force has not reached or exceeded the torque threshold.

[0224] 113D and 113E illustrate a situation where the torque applied to the delivery catheter 1406 reaches and exceeds a predetermined torque threshold. In the position shown in FIG. 113D, the arm 1534 can bend relative to the pin 1536 and begin to slide past the pin 1536. The arm 1534 moves past the pin 1536 and the delivery catheter 1406 and the piston body 1502 decouple from the piston head 1504 and the anchoring device 1456. The delivery catheter 1406 and the piston body 1502 rotate relative to the piston head 1504 and the anchoring device 1456. The arm 1534 sliding past the pin 1536 can prevent excessive torque from being applied to the anchoring device 1456, thereby preventing the anchoring device 1456 from being pushed too far into the receiving material. The movement of the arm 1534 past the pin 1536 can rapidly reduce the resistance experienced by the user applying the torque. A decrease in resistance can indicate that a torque threshold has been reached and that rotation of the delivery catheter 1406 should be slowed, stopped, or reversed.

[0225] The arm 1534 and pin 1536 may have numerous variations of shapes, sizes, and other configurations to optimize the setting and control of the torque threshold. For example, with reference to FIGS. 113F-113G, the overtorque prevention device 1533 may include an arm 1534 made of a thin sheet metal material. The arm 1534 may extend along an inner wall 1540 of the cap of the piston head 1504. The arm 1534 may be coupled with a flexible spring member 1542 to form an inclined surface. The size of the arm 1534 and the spring member 1542 may be altered to increase or decrease the desired predetermined threshold torque value.

[0226] 113F corresponds to a situation where the torque applied to the delivery catheter 1406 is less than a predetermined torque threshold. As the delivery catheter 1406 rotates, the pin 1536 contacts the arm 1534. This contact causes the piston head 1504 to rotate at the same speed as the delivery catheter 1406 and the piston body 1502.

[0227] 113G corresponds to when the torque applied to the delivery catheter 1406 reaches or exceeds a predetermined torque threshold. The arm 1534 is allowed to bend by the pin 1536 and the piston body 1502 begins to rotate faster relative to the piston head 1504. The pin 1536 slides past the arm 1534, decoupling the anchor 1546 from the catheter 1406.

[0228] 113H-N, 114A, 115A, 115B, 116A, 117A, 118A, 119A-D, 120A, 121A, and 122A, there is shown a system and method for deploying and delivering device 120 for remodeling the shape of the heart wall W. The methods illustrated by 113H-N, 114A, 115A, 115B, 116A, 117A, 118A, 119A-D, 120A, 121A, and 122A may be adapted to any of the embodiments disclosed herein. For example, the deployments described by Figures 113H-N, 114A, 115A, 115B, 116A, 117A, 118A, 119A-D, 120A, 121A, and 122A may be adapted to any of the anchors, stoppers, delivery devices, and methods described herein.

[0229] 113H, deployment of the device 120 includes delivering a delivery catheter 1406 into an internal chamber (e.g., the left ventricle LV) of the heart H and adjacent to the heart wall W. The delivery catheter 1406 extends from a distal end 1454 of a steerable catheter (not shown). A desired location on the endocardium 102 is selected and the anchoring device 1456 is positioned against or adjacent the endocardium 102. The delivery catheter 1406 is shown in an uncompressed position.

[0230] 113H and 113I, the anchoring device 1456 is pressed against the endocardium 102 with a force that moves the piston 1500 proximally into the delivery catheter 1406. The force with which the anchoring device 1456 is pressed against the endocardium 102 can be selected to optimize delivery of the anchoring device 1456 to the endocardium 102 and myocardium 104. With reference to FIG. 113I, movement of the piston 1500 in the A' direction relative to the delivery catheter 1406 decreases the distance between marker 1526 and marker 1530.

[0231] 113I, the anchoring device 1456 is positioned for a suitable pressure against the heart wall W, and the piston 1500 is shown in an activated position. Marker 1526 is adjacent to marker 1530 and the distal end of the delivery catheter. A user using a scope can observe the activated position by determining that marker 1526 abuts marker 1530. This can indicate to the user that the anchoring device 1456 is ready to be attached to the heart wall W.

[0232] 113J-N, the anchoring device 1456 is attached to the heart wall W. In the illustrated embodiment, the anchoring device 1456 can be attached to the heart wall W by rotating the delivery catheter 1406 about the illustrated axis Z in the direction of arrow A2 (FIG. 113J). As a result, the anchoring device 1456 is screwed through the endocardium 102 into the heart wall W and into the myocardium 104.

[0233] 113A and 113J-K, the anchoring device 1456 rotates partially into the heart wall W. The torque applied to the delivery catheter 1406 is below a predetermined torque threshold. Referring to FIG. 113K, as the delivery catheter 1406 or piston body 1502 rotates, the arm 1534 contacts the pin 1536. This contact causes the piston head 1504 and anchoring device 1456 to rotate at the same speed as the delivery catheter 1406 and piston body 1502. As a result, a progressive increase in torque can be provided to suggest to the user to continue rotating the anchoring device 1456 into the heart wall W.

[0234] 113A and 113L-N, the anchor device 1456 is properly attached to the heart wall W. The torque applied to the delivery catheter 1406 meets and exceeds the predetermined torque threshold. With reference to FIG. 113M, the torque applied to the delivery catheter 1406 reaches the predetermined torque threshold. The arm 1534 is allowed to flex as the pin 1536 moves thereon.

[0235] 113N, the torque applied to the delivery catheter 1406 exceeds a predetermined torque threshold. The pin 1536 moves past the arm 1534, rotating the delivery catheter 1406 and the piston body 1502 relative to the cap of the piston head 1504. The movement of the pin 1536 past the arm 1534 may prevent excessive torque from being applied to the anchoring device 1456, thereby preventing the anchoring device 1456 from being pushed too far into the heart wall W. The sliding of the pin 1536 past the arm 1534 may cause a sudden decrease in the resistance experienced by the user applying the torque. The decrease in resistance may indicate that the threshold torque value has been exceeded and that the rotation of the delivery catheter 1406 should be slowed, stopped, or reversed.

[0236] 114A, the puncture device 130 is delivered into an internal chamber (e.g., the left ventricle LV) of the heart H via a delivery catheter 1406 and a piston 1500. The puncture device 130 can extend from a distal end 1458 of the delivery catheter 1406 through a distal end 1506 of the piston head 1504 such that a distal end 1460 of the puncture device 130 extends into the heart wall W. In the illustrated embodiment, the distal end 1460 of the puncture device 130 extends through the endocardium 102, the myocardium 104, the epicardium 106 into the pericardial cavity 110 to form a passageway 132. Because the delivery catheter 1406 is fixed to the heart wall W, the insertion location of the puncture device 130 can be precisely controlled.

[0237] 115A, to verify that the puncture device 130 is properly positioned for deploying the anchor 122 within the pericardial cavity 110, a dye 134 or other detectable fluid can be delivered through the puncture device 130 and injected into the pericardial cavity 110. The dye 134 can be detected by any suitable technique, such as an x-ray, to verify that the puncture device 130 is properly positioned. With reference to FIG. 115B, in another embodiment, instead of a dye, a wire 300 or other radiopaque marker can be delivered through the puncture device 130 into the pericardial cavity 110 to verify that the puncture device 130 is properly positioned.

[0238] In Fig. 116A, the anchor 122 and hemostatic plug 1410 extend from the delivery catheter 1406, over the puncture device 130 (Fig. 114A) and through the passageway 132. As shown in Fig. 116A, the anchor 122 remains in an elongated state while sliding along the puncture device 130 into the pericardial space 110.

[0239] In FIG. 117A, the anchor 122 is partially deployed beyond the distal end 1460 (FIG. 114A) of the puncture device 130. The pusher 1408 is shown extending partially through the anchor device 1456 from the delivery catheter 1406 and the piston 1500. As the pusher 1408 extends from the piston 1500, the distal end 1464 of the pusher 1408 engages the hemostatic plug 1410 and pushes both the hemostatic plug 1410 and the anchor 122 onto the puncture device 130. As the distal end 1432 of the anchor 122 moves beyond the distal end 1460 of the puncture device 130, the anchor 122 can begin to reform to its curved, deployed state. For example, the anchor 122 may include a shape memory alloy that is shape set to the curved, deployed state. Thus, the portion of the anchor 122 that is no longer received on the puncture device 130 can return to the curved, deployed state to which the shape memory alloy is set.

[0240] In FIG. 118A , the anchor 122 is in a deployed state with a hemostatic plug 1410 positioned within the passageway 132 to prevent bleeding from the passageway 132. In the illustrated embodiment, a distal end 1444 of the hemostatic plug 1410 is at or near the inner wall of the pericardial space 110. To reform the anchor 122, the wire 124 is withdrawn by pulling the wire 124 away from the anchor and into the hemostatic plug 1410. Because the loop 1440 of the wire 124 passes through a loop 1442 on the anchor 122, pulling the wire 124 closes the loop 1440, pulling the hemostatic plug 1410 and anchor 122 together, pulling the loop 1442 together, which in conjunction with any shape-setting features of the anchor 122, helps to facilitate reforming the anchor 122 from the elongated state to the curved deployed state shown in FIG. 119A .

[0241] 119A-B, the pusher 1408 and puncture device 130 can be removed by withdrawing them from the passageway 132 and into the delivery catheter 1406. The anchor 122, hemostatic plug 1410, and wire 124 remain deployed in the heart wall W, with the anchor 122 in the pericardial cavity 110 and the wire 124 extending through the epicardium 106, the myocardium 104, and the endocardium 102.

[0242] 119A, to seat the anchor 122, the wire 124 can be tensioned by pulling the wire 124 in an inward direction toward the ventricle, as shown by arrow A9. As a result, the anchor 122 is pulled against the outwardly facing surface 126 that partially defines the pericardial space 110, as shown by arrow A10. As the wire 124 is pulled in the direction of A9, the hemostatic plug 1410 is urged in the opposite direction, as shown by arrow A11, such that the distal end 1444 of the hemostatic plug 1410 is positioned at or adjacent to the center of the anchor 122. The deployed anchor 122 is too large to fit through the passage 132 formed by the puncture device 130.

[0243] 119C, the anchoring device 1456 can be removed from the heart wall W. In the illustrated embodiment, the anchoring device 1456 can be removed from the heart wall W by rotating the delivery catheter 1406 about the illustrated axis Z in the direction of arrow A13, which is opposite direction A2 (FIG. 113J). As a result, the anchoring device 1456 can be disengaged from the heart wall W. The piston 1500 can be in an activated position or a deactivated position when removing the anchoring device 1456 from the heart wall W.

[0244] 113A and 119D, the anchoring device 1456 is partially rotated out of the heart wall W. As the delivery catheter 1406 rotates about axis Z as shown in the direction of arrow A13 (FIG. 119C), the end of the arm 1534 contacts the pin 1536. This contact causes the piston head 1504 and anchoring device 1456 to rotate at the same speed as the delivery catheter 1406 and piston body 1502. When the anchoring device 1456 is removed, the pin 1536 maintains constant contact with the arm 1534 at all torques. The arm 1534 does not bend to allow the pin 1536 to pass the arm 1534 as the anchoring device rotates out of the heart wall W, even if the torque applied in the A13 direction reaches or exceeds a predetermined torque threshold in the A2 direction. Thus, the torque is not limited to the removal direction of A13, since it is in the anchoring direction of A2. This is due to an abrupt stop between the end of the arm and the pin in the removal direction, rather than a gradual ramp engagement in the arm drilling direction.

[0245] Referring to FIG. 120A, once the delivery catheter 1406 is removed, further tension can be applied to the wire 124 to pull the heart wall W inward toward the ventricle (eg, the left ventricle LV).

[0246] The piston and / or clutch embodiments of Figures 112A-G, 113A-N, 114A, 115A, 115B, 116A, 117A, 118A, 119A-D, 120A can be used in any of the embodiments of the present application. For example, Figures 26A, 27A, and 28A illustrate the use of a piston and / or clutch in the embodiments of Figures 26-28 described above. In Figures 26A and 27A, the device 120 for remodeling the shape of the heart wall W can be delivered through a delivery catheter 136. In particular, the delivery catheter 136 extends through the piston 1500 and through the passageway 132 such that the distal end 138 of the delivery catheter 136 is positioned within the pericardial space 110. 27A , with a distal end 138 of a delivery catheter 136 positioned within the pericardial space 110, a device 120 for remodeling the shape of the heart wall W can be delivered through the delivery catheter 136. In particular, the anchor 122 can extend out the distal end 138 of the delivery catheter 136 and into the pericardial space 110, while the attached wire 124 extends through the delivery catheter 136 within the passageway 132.

[0247] 28A, the delivery catheter 136 and puncture device 130 can be removed by withdrawing them from the passageway 132 and out of the ventricle. The device 120 remains deployed through the heart wall W with the anchors 122 engaging the outwardly facing surface 126 of the heart wall W and the wire 124 extending through the epicardium 106, myocardium 104, and endocardium 102 into the ventricle (e.g., the left ventricle LV). The wire 124 can be tensioned by pulling the wire 124 inwardly towards the ventricle, as shown by arrow A12.

[0248] 121-129, deployment of device 120 into pericardial space 110 and through one of the papillary muscles 12, and systems and methods for delivering device 120, are illustrated to remodel the shape of the heart wall W. With reference to FIG. 121, deployment of device 120 includes delivering a guide sheath 1402 and a steerable catheter 1404 into an internal chamber (e.g., left ventricle LV) of the heart H. The steerable catheter 1404 is positioned such that a distal end 1454 of the steerable catheter 1404 is adjacent one of the papillary muscles 12 of the heart H.

[0249] 122 , a delivery catheter 1406 extends from a distal end 1454 of the steerable catheter 1404. An anchoring device 1456 of the delivery catheter 1406 is attached to the papillary muscle 12, for example, by rotating the delivery catheter 1406 about axis Z relative to the steerable catheter 1404 to thread the anchoring device 1456 into the papillary muscle 12. In the illustrated embodiment, a distal end 1458 of the delivery catheter 1406 abuts or is adjacent to the papillary muscle 12.

[0250] 123, the puncture device 130 is delivered into an internal chamber (e.g., the left ventricle LV) of the heart H via a delivery catheter 1406. The puncture device 130 can extend from a distal end 1458 of the delivery catheter 1406 such that a distal end 1460 of the puncture device 130 extends through the papillary muscles 12 and the heart wall W. In the illustrated embodiment, the distal end 1460 of the puncture device 130 extends through the papillary muscles 12, the endocardium 102, the myocardium 104, the epicardium 106, and into the pericardial cavity 110 to form a passageway 132. Because the delivery catheter 1406 is fixed to the papillary muscles 12, the insertion location of the puncture device 130 can be precisely controlled.

[0251] 124, to verify that the puncture device 130 is properly positioned for placing the anchor 122 within the pericardial space 110, a dye 134 or other detectable fluid can be delivered through the puncture device 130 and injected into the pericardial space 110. The dye 134 can be detected by any suitable technique, such as an x-ray, to verify that the puncture device 130 is properly positioned.

[0252] In Fig. 125, the anchor 122 and hemostatic plug 1410 extend from the delivery catheter 1406, over the puncture device 130 (Fig. 115) and through the passageway 132. As shown in Fig. 116, the anchor 122 remains in an elongate state while sliding along the puncture device 130 into the pericardial space 110.

[0253] In FIG. 126, the anchor 122 is deployed partially beyond the distal end 1460 of the puncture device 130 (FIG. 123). The delivery catheter 1406 is shown extending partially from the steerable catheter 1404, and the pusher 1408 is shown extending partially from the delivery catheter 1406 through the anchor device 1456. As the pusher 1408 extends from the delivery catheter 1406, the distal end 1464 of the pusher 1408 engages the hemostatic plug 1410 and pushes both the hemostatic plug 1410 and the anchor 122 onto the puncture device 130 (FIG. 123). As the distal end 1432 of the anchor 122 moves beyond the distal end 1460 of the puncture device 130 (FIG. 123), the anchor 122 can begin to reform to its curved, deployed state. For example, the anchor 122 may include a shape memory alloy that is shape set to the curved, deployed state. Thus, the portion of the anchor 122 that is no longer received on the puncture device 130 can return to the curved, deployed state to which the shape memory alloy is set.

[0254] In FIG. 127 , the anchor 122 is in a deployed state and a hemostatic plug 1410 is positioned within the passageway 132 to prevent bleeding from the passageway 132. In the illustrated embodiment, a distal end 1444 of the hemostatic plug 1410 is at or near the inner wall of the pericardial cavity 110. To reform the anchor 122, the wire 124 is withdrawn by pulling the wire 124 away from the anchor and into the hemostatic plug 1410. Because the loop 1440 ( FIG. 97 ) of the wire 124 passes through a loop 1442 on the anchor 122, pulling the wire 124 closes the loop 1440, pulling the hemostatic plug towards the anchor and pulling the loop 1442 together, which in conjunction with any shape-setting features of the anchor 122 helps to facilitate reforming the anchor 122 from an elongated state to the curved deployed state shown in FIG. 127 .

[0255] 128-129 , the pusher 1408 and puncture device can be removed by withdrawing them from the passageway 132 and into the delivery catheter 1406. The anchor 122, hemostatic plug 1410, and wire 124 remain deployed in the heart wall W, with the anchor 122 in the pericardial space 110 and the wire 124 extending through the epicardium 106, myocardium 104, endocardium 102, and papillary muscles 12.

[0256] To seat the anchor 122, the delivery catheter 1406 may remain attached to the heart wall W and the distal end 1458 may be pressed against the heart wall W. At the same time, the wire 124 may be tensioned by pulling the wire 124 in an inward direction toward the ventricle, as shown by arrow A9. As a result, the anchor 122 is pulled against the outwardly facing surface 126, which in the illustrated embodiment is the inner pericardial layer (i.e., the visceral plate of the serous pericardium) that partially defines the pericardial cavity 110, as shown by arrow A10. As the wire 124 is pulled in the A9 direction, the hemostatic plug 1410 is urged in the opposite direction, as shown by arrow A11, such that the distal end 1444 of the hemostatic plug 1410 is positioned at or adjacent to the center of the anchor 122. The deployed anchor 122 is too large to fit through the passage 132 formed by the puncture device 130. Thus, when the delivery catheter 1406 is removed, the further tension in the wire 124 can pull the heart wall W inward toward the ventricle (eg, the left ventricle LV).

[0257] The piston and / or clutch embodiments of Figures 112A-112G, 113A-113N, 114A, 115A, 115B, 116A, 117A, 118A, 119A-119D, and 120A can be used to deploy one or more devices 120 to one or more papillary muscles 12 to remodel the shape of the heart wall W. For example, with reference to Figures 121A and 122A, a guide sheath 1402 may puncture and extend through the atrial septum 1560 and optionally be guided through the mitral valve MV. A steerable catheter 1404 may extend from the guide sheath 1402. The steerable catheter 1404 is positioned such that a distal end 1454 of the steerable catheter 1404 may be steered adjacent one of the papillary muscles 12 of the heart H. The delivery catheter 1406, piston 1500, and anchoring device extend from a distal end 1454 of the steerable catheter 1404. The device 120 can be delivered through the papillary muscles 12 according to Figures 112A-G, 113A-N, 114A, 115A, 115B, 116A, 117A, 118A, 119A-D, and 120A.

[0258] In certain embodiments, tissue remodeling can be achieved through the use of one or more helical anchors. These anchors can be deployed in a target region of cardiac tissue via steerable guide rails. An exemplary steerable guide rail 1304 used to deploy a helical anchor 1310 is shown in FIGS. 130A-D. Referring to FIG. 130A, the steerable guide rail 1304 is shown deployed adjacent to tissue 1308. In certain embodiments, the guide rail 1304 can engage the tissue 1308 at one or more points. In other embodiments, the steerable guide rail 1304 is positioned relative to the target region of tissue 1308. Although the steerable guide rail 1304 is shown along a substantially flat surface of the tissue 1308, it will be appreciated that the steerable guide rail 1304 can be positioned in any target region of the tissue 1308, including positioned along curved or uneven regions of the tissue.

[0259] The steerable guide rail 1304 can be deployed with an associated tether 1306 and stopper 1302. As shown, the tether 1306 is located within an inner cavity of the steerable guide rail 1304. The tether 1306 is held in place by the stopper 1302. As shown in FIG. 130B, the helical anchor 1310 is positioned along the steerable guide rail 1304 such that when the helical anchor 1310 is rotated, the anchor engages the tissue 1308 along a path established by the steerable guide rail 1304. The tissue engagement can be used to remodel the tissue and / or provide an anchor or connection to the tissue. The helical anchor 1310 can be deployed along the steerable guide rail 1304 in a fully engaged position coil along the entire length of the anchor 1310 and embedded into the tissue as shown in FIG. 130C. Of course, the stopper 1302 is sized and shaped in such a way that the stopper 1302 is not pulled through the end of the helical anchor. In FIG. 130D, the steerable guide rail 1304 can be removed while the anchor 1310 and stopper 1302 remain fixed in position at the target tissue location in the tissue 1308.

[0260] As shown in FIGS. 131A-131E, after an anchor (e.g., helical anchor 1310) is deployed in a target tissue region, remodeling (or additional remodeling) of the tissue region can be achieved using tether 1306. FIG. 131A shows an exemplary steerable guide rail 1304 (with associated tether 1306 and stopper 1302) deployed adjacent to tissue 1308. In FIG. 131B, the helical anchor 1310 can be positioned along the guide rail and then rotated to engage the tissue 1308 along the path established by the steerable guide rail 1304. FIG. 131C shows the helical anchor 1310 fully deployed within the tissue 1308. In FIG. 131D, the steerable guide rail 1304 is removed and the anchor stopper 1312 is moved along the tether to the proximal end of the helical anchor 1310. The anchor stop 1312 is positioned to contact the helical anchor such that when a pushing force is applied to the tether stop 1312 and a pulling force is applied to the stop 1302 by the tether 1306, the helical anchor is contracted. This contraction of the tissue allows for targeted remodeling of the tissue 1308. Once a desired level of tissue contraction / remodeling is achieved, a locking mechanism 1314 can be attached to the tether 1306 that holds the stop 1312 in place, which maintains the desired compressed position of the anchor 1310 within the tissue 1308.

[0261] The stopper 1302 can take a wide variety of different forms. The stopper is shown diagrammatically in FIG. 130D and FIG. 131D. The stopper 1302 may be completely larger than the inner diameter of the coiled anchor 1310, the stopper may be sized to friction fit inside the inner diameter of the coiled anchor 1310, or the stopper has a portion that is larger than the inner diameter of the coiled anchor 1310 and a portion that fits inside the coiled anchor. In FIG. 132A-B, an exemplary embodiment of the stopper 1302 is shown. In the illustrated example, the stopper 1302 is connected to a tether 1306, which can hold the stopper against a steerable guide rail 1304, as shown in 132A. The stopper 1302 is connected to the end of the tether 1306 by a distal knot 1300. Distal knot 1300 is attached to, or to a portion of, tether 1306 and prevents stopper 1302 from moving past distal knot 1300. In some embodiments, distal knot 1300 is formed from tether 1306 via, for example, one or more surgical knots known in the art. In other embodiments, distal knot 1300 may be attached to a distal end of tether 1306. Additionally, stopper 1302 is sized to prevent steerable guide rail 1304 from moving past stopper 1302.

[0262] In the example shown in FIG. 132A, the stopper 1302 includes a nose cone 1301 and a stem 1303. The depicted nose cone 1301 tapers outward from the distal knot 1300, and the stem tapers inward away from the nose cone 1301. In FIG. 132B, the helical anchor 1310 is shown advanced along the steerable guide rail 1304. In certain embodiments, the helical anchor 1310 can be advanced along the steerable guide rail 1304 by a pusher 1316. The pusher 1316 can be manipulated to both advance the helical anchor 1310 along the steerable guide rail 1304 and rotate the helical anchor 1310 about the steerable guide rail 1304. It is understood that the pusher 1316 may extend outside of the body to facilitate controlled deployment of the helical anchor 1310 into the target tissue region.

[0263] 133A-133F show an exemplary deployment of a helical anchor 1310 into tissue 1308 using a steerable guide rail 1304. In FIG. 133A, the steerable guide rail 1304 is positioned relative to a target tissue region 1308. The steerable guide rail 1304 is associated with a nosecone 1301 and a stopper 1302 including a stem or strain relief portion 1303. A tether 1306 extends through the steerable guide rail 1304 to a distal knot 1300 as shown. In FIG. 133B, a pusher 1316 is used to advance the helical anchor 1310 along the steerable guide rail to an implant location within the target tissue 1308. Once in position, the pusher 1316 rotates the helical anchor 1310 about the guide rail 1304 to implant the helical anchor 1310 into the tissue 1308. In FIG. 133C, the pusher 1316 is shown with the helical anchor 1310 fully deployed within the tissue 1308. Once the helical anchor 1310 is implanted at the target location, the pusher 1316 and steerable guide rail 1304 can be retracted. In FIG. 133D, the pusher 1316 and steerable guide rail 1304 are retracted. The tether 1306 is pulled to pull the distal stopper 1302 against and / or into the distal end of the helical anchor 1310. The proximal anchor stopper 1312 is advanced along the tether 1306 against and / or into the proximal end of the helical anchor 1310. The proximal stopper 1312 may have the same or a different form as the distal stopper 1302. Proximal stopper 1312 may be completely larger than the inner diameter of coiled anchor 1310, the stopper may be sized to friction fit inside the inner diameter of coiled anchor 1310, or the stopper has a portion that is larger than the inner diameter of coiled anchor 1310 and a portion that fits inside the coiled anchor. Locking mechanism 1314 can fix the position of anchor stopper 1312 along tether 1306.As shown in FIG. 133E, the locking mechanism 1314 can be manipulated by a tool 1315, such as a torque driver or other tool, that secures the locking mechanism 1314 in place on the tether 1305. For example, the locking mechanism may have any of the forms of connectors 240 disclosed herein. Pulling the stopper 1302 with the tether and pushing the stopper 1312 compresses the helical anchor and contracts the tissue 1308. Once the desired compression of the helical anchor 1310 is achieved, the locking mechanism 1314 can be secured and the tool 1315 can be removed. As shown in FIG. 133F, the locking mechanism 1314 secures the position of the helical anchor 1310 between the stopper 1302 and the anchor stopper 1312. In certain embodiments, the tool 1315 can be used to tighten or loosen the locking mechanism 1314 to further manipulate the tissue engaged with the helical anchor 1310 to reshape or remodel the tissue 1308.

[0264] 134 illustrates a helical anchor 1310 deployed in left ventricular heart wall tissue at a target tissue location 1340 along the height of the left ventricle, for example parallel to the direction of flow through the mitral valve MV. As shown, the helical anchor 1310 has been contracted by force applied by stopper 1302 and anchor stopper 1312.

[0265] 135 shows multiple helical anchor(s) 1310 deployed at heart wall target tissue locations 1350 and 1352 along the height of the left ventricle, for example parallel to the direction of flow through the mitral valve MV. As shown, helical anchor(s) 1310 are contracted by forces applied by anchor stop(s) 1302 and anchor stop(s) 1312.

[0266] 136 shows a helical anchor 1310 deployed in heart wall tissue at a target tissue location 1360 perpendicular to the height of the left ventricle, e.g., perpendicular to the direction of flow through the mitral valve MV. As shown, the helical anchor 1310 is contracted by a force applied by stopper 1302 and anchor stopper 1312.

[0267] 137 shows multiple helical anchor(s) 1310 deployed at heart wall target tissue locations 1370 and 1372 perpendicular to the height of the left ventricle, e.g., perpendicular to the direction of flow through the mitral valve MV. As shown, helical anchor(s) 1310 are contracted by force applied by stop(s) 1302 and anchor stop(s) 1312.

[0268] 138 illustrates a helical anchor 1310 deployed in heart wall tissue at a target tissue location 1380 located at the base or apex of the left ventricle of the heart. As shown, helical anchor 1310 is contracted by forces applied by anchor stop 1302 and anchor stop 1312.

[0269] In Fig. 139, helical anchor 1310 is deployed in heart wall tissue at a target tissue location 1390 located at the bottom or apex of the left ventricle of the heart. As shown, helical anchor 1310 is contracted by a force applied by tether 1306. In such an embodiment, tether 1306 can manipulate helical anchor 1310 to achieve a desired contraction / remodeling of tissue at target tissue location 1390. Once the desired shape or position is achieved, tether lock 1392 can be used to secure tether 1306 and hold the position of helical anchor 1310.

[0270] FIG 140 illustrates helical anchor 1310 deployed in heart wall tissue at target tissue location 1401 located on the left ventricular side of the ventricular septum. As shown, helical anchor 1310 is contracted by force applied by anchor stopper 1302 and anchor stopper 1312. In another exemplary embodiment, as shown in FIG 141, target tissue location 1401 is located on the right ventricular side of the ventricular septum.

[0271] It will be appreciated that any of the above exemplary deployments of one or more helical anchor(s) 1310 can be used in combination with each other to reshape multiple target tissue locations within a single heart.

[0272] FIG. 142 shows a close-up view of the helical anchor 1310 on the steerable guide rail 1304. The helical anchor 1310 is shown to have an anchor diameter AD. The diameter AD is the diameter of the coil or wire used to form the helical anchor 1310. The steerable guide rail 1304 is shown to have a guide rail diameter GD. The gap between the steerable guide rail 1304 and the helical anchor 1610 on the surface of the target tissue is measured as a stitch depth SD. The stitch depth SD can determine how well the target tissue is engaged by the helical anchor 1310. This is particularly important when targeting a particular tissue and / or a particular tissue depth. For example, the stitch depth SD can be configured to engage the helical anchor 1310 to the target endocardial tissue of the left ventricle while avoiding or substantially avoiding the myocardial tissue. In some exemplary embodiments, the stitch depth SD is between 0.02 mm and 2 mm, such as between 0.5 mm and 1.5 mm, such as between 0.75 mm and 1.25 mm, such as 1 mm or less. The helical anchor 1310 may have a pitch P, measured as the distance between two adjacent coils. It will be appreciated that the pitch P may be determined when the coil is at rest or may change when the helical anchor 1310 is expanded / contracted. The helical anchor 1310 may also have a puncture distance PD, measured from the outside of the wire or coil that forms the helical anchor 1310 and the steerable guide rail 1304.

[0273] FIG. 143 illustrates an exemplary helical anchor 1310 having a lead coil pitch LP and a kick angle KA. The lead coil pitch LP is a measurement of the distance from the apex of the lead coil LC to the apex of the next adjacent trailing coil TC. The geometry of the lead coil (e.g., lead coil pitch LP) can determine the bite angle taken by the helical anchor 1310 when deployed in tissue. The kick angle KA is measured as the angle between the tip of the leading coil LC and the trailing coil TC.

[0274] FIG. 144 shows a front view of an exemplary helical anchor 1310 with a tip bias or kickout T at the tip of the lead coil LC. The tip bias or kickout T is the distance that the tip of the lead coil LC extends outward from the outer diameter of the coiled anchor 1310. This tip bias or kickout causes the guide rail 1304 to hold the helical anchor in tissue and mate the tip of the coil with the tissue 1308 as the helical anchor rotates about the guide rail. As previously discussed, the geometry of the lead coil LC can determine the bite angle at which the helical anchor 1310 engages the target tissue region.

[0275] 145A-C show an exemplary targeted deployment of a helical anchor 1310 into a target tissue region 1307 with limited or no engagement with tissue region 1309. In FIG. 145A, a steerable guide rail 1304 is deployed to rest against a surface of the target tissue region 1307. A stopper 1302 is shown at a distal end of the steerable guide rail 1304. The helical anchor 1310 is deployed along the steerable guide rail 1304 to engage the target tissue region 1307 while restricting the depth of the anchor into the tissue to limit engagement with the tissue region 1309. In some exemplary embodiments, the target tissue region 1307 is endocardial tissue and the tissue region 1309 is myocardial tissue.

[0276] In FIG. 145B, the steerable guide rail 1304 is retracted, exposing the tether 1306. An anchor stopper 1302 is attached to the tether 1306. The tether 1306 is pulled, causing the stopper 1302 to engage with the coiled anchor 1310. In FIG. 145C, an anchor stopper 1312 is slidably disposed on the tether 1306. The tether 1306 is pulled, causing the stopper 1302 to engage with the coiled anchor 1310 while the stopper 1312 is pressed against the coiled anchor, compressing the helical anchor 1310. A locking mechanism 1314 is also attached to the tether 1306 to secure the compressed state of the helical anchor 1310.

[0277] FIG. 146 illustrates an exemplary embodiment of a stopper 1302 in contact with a helical anchor 1310 and in contact with tissue 1308, such as endocardial tissue. As shown, the stopper 1302 includes a nose cone portion 1301 and a stem portion 1303. When a force F is applied to the tether 1306, the stem portion 1303 is drawn into the anchor 1310, compressing the tissue 1308. Due to the optional taper of the stem portion 1303, different amounts of compression are provided to the tissue in coils A, B, C, and D. In the illustrated example, the taper of the stem portion 1303 causes the greatest tissue compression to occur in coil A, with the compression decreasing progressively through coils B, C, and D, providing a distribution of load in coils A, B, C, and D. This compression of the tissue 1308 between the stem portion 1303 and coils A, B, C, D increases the amount of force F that needs to be applied to the tether to pull the coiled anchor 1310 out of the tissue. This increase in force F to pull the coiled anchor 1310 out of the tissue is due to sharing or distributing force F to all of the coils A, B, C, and D compressing the tissue, rather than concentrating the force only on the leading coil A. If the stem portion were omitted and the force was concentrated only on the leading coil A, force F could sequentially pull coils A, B, C, D out of the tissue, one at a time. The stem portion 1303 can take a wide variety of different forms. For example, the stem portion 1303 could be six to compress the tissue between any number of coils of the anchor 1310. If included, the stemmed proximal stopper 1312 increases the pulling force by the same amount as the stemmed distal stopper 1302.

[0278] 147A-B show an exemplary optional shield 1320 for use during deployment of the helical anchor 1310 using the steerable guide rail 1304. In FIG. 147A, the shield 1320 is in its active position that allows the helical anchor 1310 and steerable guide rail 1304 to advance through the patient's anatomy without inadvertently engaging the anchor's lead coil with non-target tissue. For example, the shield 1320 can rotate around the steerable guide rail within the helical anchor 1310 to engage non-target obstructions instead of the tip of the helical anchor 1310. For example, the shield 1320 can engage the atrial wall, the mitral or tricuspid valves, chordae tendineae, etc. instead of the tip of the helical anchor. In certain embodiments, the location of the target tissue may be located in proximity to sensitive non-target tissue or organs. The shield 1320 is operable to push back or hold sensitive non-target tissue so that the helical coil 1310 can be safely deployed.

[0279] In FIG. 147B, the shield 1320 is shown retracted. For example, the shield 1320 may be a shape-setting wire that can be pulled between the steerable guide 1304 and the helical anchor 1310 to straighten and remove the shield 1320. In one exemplary embodiment, the shield 1320, the end of the steerable guide 1304, and the end of the helical anchor 1310 are positioned in the target tissue. The shield 1320 is shown in FIG. 147A in a shield shape. In one use, the helical anchor 1310 can be rotated to implant the helical anchor into the target tissue with the shield in place in the shield shape. After the helical anchor 1310 is embedded in the tissue, both the guide rail 1304 and the shield 1320 can be pulled through the helical anchor 1310, causing the shield to straighten as it is pulled through the helical anchor. In another use, the shield 1320 can be pulled through the helical anchor 1310 before the helical anchor 1310 is rotated to implant the helical anchor into the target tissue, allowing the shield to straighten as it is pulled through the helical anchor. In other embodiments, the shield 1320 can be secured to the steerable guide rail 1304 and retracted therewith.

[0280] FIG. 148 illustrates an exemplary embodiment of a guard 1330. The guard functions similarly to the shield 1320 and is described in more detail with reference to FIGS. 149-151A-151D. The guard allows the helical anchor 1310 and steerable guide rail 1304 to be advanced through the patient's anatomy without inadvertent engagement of the anchor's lead coil with non-target tissue. For example, the guard 1330 engages a non-target obstruction instead of the tip of the helical anchor 1310. For example, the guard 1330 can engage the atrial wall, the mitral or tricuspid valve, chordae tendineae, etc. instead of the tip of the helical anchor.

[0281] In FIG. 149, the helical anchor 1310 and steerable guide rail 1304 are disposed inside a guard 1330. The guard 1330 has an open side 1332 where the helical anchor is free to engage target tissue and a closed side 1334 that prevents non-target tissue or organs from engaging the helical anchor 1310. The tip 1331 of the guard is closed on both sides. Before the tip of the anchor 1310 engages tissue, the tip of the anchor 1310 is positioned inside the tip 1331 to prevent engagement with non-target tissue.

[0282] In the example illustrated in FIG. 149, the stopper 1302 is positioned outside the tip 1331 of the guard 1330. The tether 1306 and / or the steerable guide 1304 extend through an opening 1336 in the tip 1331. The stopper 1302 can be retracted through the opening 1336 by pulling on the tether 1306. For example, the opening 1336 can be larger than the stopper 1302 and / or the stopper can be compressible such that the stopper 1302 can be pulled through the opening 1336. In other exemplary embodiments, the stopper 1302 is positioned inside the tip 1331 of the guard 1330. In these embodiments, the opening 1336 can be omitted.

[0283] 150, the open side 1332 forms a "window" through which the leading coil of the helical anchor 1310 can engage the target tissue. For example, the anchor 1310 can be retracted into the guard 1330 and moved so that the tip of the helical anchor 1310 moves out of the tip 1331 and into the confines of the open side 1332. With the opening 1332 facing the target tissue and the steerable guide 1304 pressing the helical anchor 1310 against the tissue, the helical anchor 1310 can be rotated to engage the tissue with the tip of the anchor and implant the helical anchor into the tissue.

[0284] The guard 1330 can extend the length of the tether 1306 and / or the steerable guide rail 1304 and terminate at a stopper 1302. The tip 1331 of the guard 1330 can be shaped to facilitate traversal of the guard 1330, anchor, and steerable guide rail 1304 through the patient's cardiovascular system.

[0285] 151A-151D illustrate a method of removing an exemplary guard 1330 from an implanted anchor 1310 and withdrawing it from the patient. The steerable rail 1304 can be removed from the anchor and / or patient before, simultaneously with, or after any of the following guard removal steps. In FIG. 151A, a force F is applied to the stopper 1302 to draw the stopper through the opening 1336 and into the distal end of the helical anchor 1310. The guard 1330 is moved so that the stopper 1302 and the helical anchor 1310 are both within the window formed by the open side 1332. With reference to FIG. 151B, once the stopper 1302 and the helical anchor 1310 are within the window formed by the open side 1332, the guard 1330 moves away from the stopper 1302 and the helical anchor 1310, as shown by arrow 1338. The nosecone 1301 of the stopper is optionally tapered and / or the window includes a tapered surface 1339 that allows the guard 1330 to slide off the nosecone 1301, as shown in FIG 151B. With reference to FIGs. 151C and 151D, once the guard 1330 is separated from the stopper 1302 and helical anchor 1310, the guard can be withdrawn from the patient leaving the stopper 1302 and helical anchor 1310 implanted.

[0286] FIG. 152B illustrates an exemplary embodiment of a helical anchor 1310 having a cover 1519 and / or a lubricant 1520 on the outer surface 1521 of the wire forming the helical implant 1310. The cover 1519 and lubricant can take a wide variety of different forms. For example, the cover can be a wrap, a coating, a sleeve, a spunbond fiber, etc. Any type of cover or coating can be used. The lubricant 1520 can be any lubricant that reduces friction between the implant 1310 and the tissue 1308 into which the anchor 1310 is implanted. As a result, the amount of torque required to implant the helical anchor can be reduced by the lubricant. In the example illustrated in FIG. 152A, the cover 1519 is provided on the outer surface 1521 and then the lubricant 1520 is applied to the cover 1519. This forms the anchor 1310 having the cover 1519 wetted with the lubricant 1520 illustrated in FIG. 152B. In another exemplary embodiment, the material forming the cover 1519 is already lubricated when applied to the anchor 1310 or the material forming the cover has lubricating properties such as a coating material including Teflon. Referring to FIG. 152C, in one exemplary embodiment, the implant coating 1520 is made of a nonwoven material such as stapled nonwoven, meltblown, spunbond / spunlaid, or flashspun. In one exemplary embodiment, the nonwoven material is porous and absorbs the lubricant 1520. In one exemplary embodiment, the implant coating 1520 is made of BioSpun polymer, which can improve tissue ingrowth at the deployment site. The implant coating 1520 can also provide the helical anchor 1310 with a roughened surface, which can reduce metallic reflections and enhance ECHO imaging. In one exemplary embodiment, the roughened surface is provided by the nonwoven material. In one exemplary embodiment, the roughened surface is provided by BioSpun polymer. It will be understood that the covered helical anchor 1310 shown in FIG. 152B may be used interchangeably with any of the helical anchors 1310 described herein.

[0287] 153A-K show an exemplary deployment of helical anchors 1310A, 1310B within target tissue regions 1530A, 1530B. The anchors 1310 are then pulled toward each other and secured to remodel the target tissue regions 1530A and / or 1530B. In FIG. 153A, the steerable guide rail 1304 is advanced into position relative to the target tissue region 1530B. In FIG. 153B, the helical anchor 1310B is deployed along the steerable guide rail 1304 to engage the target tissue region 1530B. In FIG. 153C, the helical anchor 1310B is shown fully deployed into the target tissue region 1530B. In FIG. 153D, the steerable guide rail 1304 is removed, exposing the tether 1306. In FIG. 153E, the steerable guide rail 1304 has been advanced into position relative to the target tissue region 1530A. In this exemplary embodiment, the tether 1306 extending through the anchor 1310B continues through the steerable guide rail 1304 opposite the target tissue location 1530A. In FIG. 153F, the second helical anchor 1310A is deployed along the steerable guide rail 1304 into the target tissue region 1530A. In FIG. 153G, the helical anchor 1310A is shown fully deployed into the target tissue region 1530A. In FIG. 153H, the steerable guide rail 1304 has been removed, exposing the tether 1306. In FIG. 153I, the tether lock 1532 is advanced along the tether 1306 as shown by arrow 1537, while the tether 1306 is pulled as shown by arrow 1535. 153J, when tether lock 1532 is adjusted, tether 1306 pulls helical anchors 1310A and 1310B and attached tissue regions 1530A and 1530B toward one another. In FIG. 153K, tether lock 1532 is locked in a fixed position holding target tissue regions 1530A and 1530B in a remodeling position, and the end of tether 1306 is cut. Tether lock 1532 can take a wide variety of different forms. For example, any of connectors 240 can be used as tether lock 1532.

[0288] 154A-154M show exemplary deployment of helical anchors 1310A, 1310B in target tissue region(s) 1540A-1540B. In FIG. 154A, steerable guide rail 1304 is advanced into position relative to target tissue region 1540B. In FIG. 154B, helical anchor 1310B is deployed along steerable guide rail 1304 to engage target tissue region 1540B. In FIG. 154C, helical anchor 1310B is shown fully deployed in target tissue region 1540B. In FIG. 154D, steerable guide rail 1304 is removed, exposing tether 1306 in helical anchor 1310B. In FIG. 154E, stabilizer 1542B is deployed in the space between target tissue region 1540B and helical anchor 1310B. The stabilizer 1542B can be slidably disposed over the tether 1306. The diameter of the stabilizer 1542B can be the same as, larger, or smaller than the diameter of the steerable guide rail 1304. In other embodiments, the stabilizer 1542B is inserted separately from and without the aid of the tether 1306. In FIG. 154F, the steerable guide rail 1304 has been advanced into position relative to the target tissue region 1540A. The tether 1306 extends through the anchor 1310B, which continues through the steerable guide rail 1304 opposite the target tissue location 1540A. In FIG. 154G, the second helical anchor 1310A has been deployed along the steerable guide rail 1304 into the target tissue region 1540A. In Fig. 154H, the helical anchor 1310A is shown fully deployed within the target tissue region 1540A. In Fig. 154I, the steerable guide rail 1304 is removed, exposing the tether 1306 within the anchor 1310A. In Fig. 154J, a second stabilizer 1542A is deployed within the space between the target tissue region 1540A and the helical anchor 1310A. The diameter of the stabilizer 1542A may be the same as, larger, or smaller than the diameter of the steerable guide rail 1304.As shown, stabilizer 1542A, tether 1306 is threaded through stabilizer 1542A. In other embodiments, stabilizer 1542A is inserted into anchor 1310A without the aid of tether 1306. In FIG. 154K, tether lock 1532 is advanced along tether 1306, as shown by arrow 1537, while tether 1306 is pulled, as shown by arrow 1535. Referring to FIG. 154L, as tether lock 1532 is advanced, tether 1306 pulls on stabilizers 1542A and 1542B, thereby pulling anchors 1310A, 1310B and moving target tissue regions 1540A and 1540B closer together. In FIG. 154M, tether lock 1532 is locked in a fixed position holding target tissue areas 1540A and B in a desired position, and the ends of tether 1306 are cut.

[0289] 155A-155K show an exemplary deployment of helical anchors 1310A, 1310B implanted in target tissue regions 1550A and 1550B. In FIG. 154A, the steerable guide rail 1304B is advanced into position relative to the target tissue region 1550B. In FIG. 155B, the helical anchor 1310B is deployed along the steerable guide rail 1304B and engaged with the target tissue region 1550B. In FIG. 155C, the helical anchor 1310B is shown fully deployed in the target tissue region 1550B with the stopper 1302B connected to the tether 1306B at the distal end of the anchor 1310B. In FIG. 155D, the steerable guide rail 1304B is removed, exposing the tether 1306B inside the anchor 1310B. In FIG. 155E, the second steerable guide rail 1304A is advanced into position relative to the target tissue location 1550A. In FIG. 155F, the second helical anchor 1310A is deployed along the steerable guide rail 1304A into the target tissue region 1550A. In FIG. 155G, the helical anchor 1310A is fully deployed into the target tissue region 1550A and the stopper 1302A is attached to the second tether 1306A. In FIG. 155H, the steerable guide rail 1304A is removed, exposing the tether 1306A. In FIG. 155I, the tether lock 1532 is advanced along the tethers 1306A, 1306B as shown by arrow 1537, while the tethers 1306A, 1306B are pulled as shown by arrow 1535. 155J, as tether lock 1532 is adjusted, tethers 1306A, 1306B pull helical anchors 1310A and 1310B and attached tissue regions 1550A and 1550B toward one another. In FIG. 155K, tether lock 1532 is locked in a fixed position holding target tissue regions 1550A and 1550B in a desired position.

[0290] 156A-156L show an exemplary deployment of two helical anchors 1310 deployed in target tissue regions 1560A and 1560B. In FIG. 156A, the steerable guide rail 1304B is advanced to a position proximate the target tissue region 1560B. In FIG. 156B, the helical anchor 1310B is advanced along the steerable guide rail 1304B to engage the target tissue region 1560B. In FIG. 156C, the helical anchor 1310B is shown fully deployed in the target tissue region 1560B with a stopper 1302B disposed at the end of the anchor. In FIG. 156D, the steerable guide rail 1304B is removed and replaced with a stabilizer 1542B. The stabilizer 1542B is deployed in the space between the target tissue region 1560B and the helical anchor 1310B. As shown, the tether is threaded through the stabilizer 1542B. In other embodiments, the stabilizer 1542B is inserted next to the tether 1306B. In FIG. 156E, the second steerable guide rail 1304A is deployed adjacent to the target tissue location 1560A. In FIG. 156F, the helical anchor 1310A is deployed along the steerable guide rail 1304A into the target tissue region 1560A. In FIG. 156G, the helical anchor 1310A is shown fully deployed into the target tissue region 1560A with the stopper 1302A disposed at the end of the anchor. In FIG. 156H, the steerable guide rail 1304A has been removed, exposing the tether 1306A. In FIG. 156I, the stabilizer 1542A is deployed in the space between the target tissue region 1560A and the helical anchor 1310A. In Fig. 156J, tether lock 1532 is advanced along tethers 1306A, 1306B, as shown by arrow 1537, while tethers 1306A, 1306B are pulled, as shown by arrow 1535. Referring to Fig. 156J, as tether lock 1532 is adjusted, tether 1306 is pulling helical anchors 1310A and 1310B and attached tissue regions 1560A and 1560B toward each other.In Fig. 156K, tether lock 1532 has been tightened, further pulling stabilizers 1542A and 1542B and moving target tissue regions 1560A and 1560B closer together. In Fig. 156L, tether lock 1532 has been locked in a fixed position holding target tissue regions 1560A and B in a desired position, and the ends of tethers 1306A, 1306B have been cut.

[0291] 157A-157L show another exemplary deployment of anchors 1310A and 1310B among multiple target tissue regions 1570A and 1570B. In FIG. 157A, steerable guide rail 1304B is advanced to a position proximate target tissue region 1570B. In FIG. 157B, helical anchor 1310B is advanced along steerable guide rail 1304B to engage target tissue region 1570B. In FIG. 157C, helical anchor 1310B is shown fully deployed within target tissue region 1570B with stopper 1302B located at the end of guide rail 1304B. In FIG. 157D, steerable guide rail 1304B is removed, exposing tether 1306B on the inside of anchor 1310B. In Fig. 157E, anchor stopper 1312B is applied to the proximal end of helical anchor 1310B along with tether 1306B. In Fig. 157F, a force F is applied to anchor stopper 1312B while tether 1306B is pulled, contracting helical anchor 1310B and remodeling target tissue region 1570B. Referring to Fig. 157G, once the desired compression of helical anchor 1310B is achieved, locking mechanism 1314B is secured to tether 1306B. Locking mechanism 1314B holds stopper 1312B in place, thereby maintaining the desired compressed position of anchor 1310B within tissue 1570B.

[0292] In FIG. 157H, the second steerable guide rail 1304A is advanced to a position adjacent the target tissue location 1570A. In FIG. 157I, the second helical anchor 1310A is deployed along the steerable guide rail 1304A into the target tissue region 1570A. In FIG. 157J, the helical anchor 1310A is shown fully deployed into the target tissue region 1570A with the stopper 1302A at the end of the guide rail 1304A. In FIG. 157K, the steerable guide rail 1304A is removed, exposing the tether 1306A on the inside of the helical anchor 1310A. In FIG. 157L, the anchor stopper 1312A is applied to the proximal end of the helical anchor 1310A along the tether 1306A. In Fig. 157M, a force F is applied to anchor stopper 1312A while tether 1306A is pulled to contract helical anchor 1310A and alter target tissue region 1570A. Referring to Fig. 157N, once the desired compression of helical anchor 1310A is achieved, locking mechanism 1314A is secured to tether 1306A. Locking mechanism 1314A holds stopper 1312B in place, thereby maintaining the desired compressed position of anchor 1310 within tissue 1308. In Fig. 157N, helical anchors 1310A and 1310B are shown fully deployed and locked in a contracted position for reshaping / remodeling tissue at their respective target tissue regions. In Fig. 157O, tether lock 1532 is attached to tethers 1306A and 1306B and advanced as indicated by arrow 1537 while tethers 1306A, 1306B are pulled as indicated by arrow 1535. As tether lock 1532 is adjusted, tethers 1306A, 1306B pull helical anchors 1310A and 1310B and attached tissue regions 1570A and 1570B toward each other. In Fig. 157P, tether lock 1532 is locked in a fixed position holding target tissue regions 1570A and 1570B in a remodeling position and the ends of tether 1306 are cut.

[0293] 158A-G show an exemplary simultaneous deployment of multiple guide rails 1304A, 1304B (see FIG. 158B) for helical anchors to multiple target tissue regions. In FIG. 158A, a deployment catheter 1580 guides a horseshoe-shaped stabilizer 1582 through the mitral valve MV into the left ventricle LV. In FIG. 158B, the horseshoe-shaped stabilizer 1582 reaches the apex of the left ventricle LV. In some embodiments, a tether 1306 is disposed within or connected to the horseshoe-shaped stabilizer 1582 (see FIG. 158E). With reference to FIG. 158C, the steerable guide rails 1304A and 1304B are deployed from the deployment catheter 1580 and positioned relative to the target tissue regions 1583A and 1583B. In FIG. 158C, the steerable guide rail 1304A is positioned relative to the target tissue location 1583A and the helical anchor 1310A is deployed along the steerable guide rail 1304A. In FIG. 158D, the steerable guide rail 1304B is positioned relative to the target tissue location 1583B and the helical anchor 1310B is deployed along the steerable guide rail 1304B. In FIG. 158E, the steerable guide rails 1304A and 1304B are removed, exposing the tether 1306 that extends through the anchors 1310A, 1310B. In FIG. 158F, the tether 1306 is retracted, causing the horseshoe shaped stabilizer 1582 to contact and / or extend within the helical anchors 1310A and 1310B. Retracting the tether 1306 also pulls the anchors 1310A and 1310B towards each other, remodeling the tissue at the target site. In some embodiments, the horseshoe stabilizer 1582 contacts the helical anchors 1310A and 1310B and / or tissue in the gap between the surface of the target tissue area and the inner diameter of the helical anchors. Referring to FIG. 158G, the tether lock 1532 is attached to the end of the tether 1306 and is advanced while the end of the tether 1306 is pulled.When tether lock 1532 is adjusted, the tether pulls helical anchors 1310A and 1310B and attached tissue regions 1583A and 1583B toward each other. Tether lock 1532 is locked in a fixed position holding target tissue regions 1583AA and 1583B in a remodeling position, and the end of tether 1306 is cut.

[0294] In Fig. 159, an anchor 1310 is implanted in one of the papillary muscles 12 of the left ventricle. A first wire 1306 extends from the first anchor 1310 through the mitral valve MV. The anchor 1310 depicted in Fig. 159 can be attached in any manner described herein.

[0295] In FIG. 160, the second anchor is shown in an implanted position with the first anchor 1310 attached. The second wire extends from the second anchor 1310 through the mitral valve MV. The second device 120 can be installed in any of the manners described herein. In one exemplary embodiment, the second device 220 is installed in the same manner as the first device 120.

[0296] In Fig. 161, in one exemplary embodiment, the first and second wires 1306 are routed through a connector 1532. The papillary muscles 12 are pulled together or approximated by pushing or holding the connector 1532 in place and pulling the wire 1306, as shown by the arrows. The distance the connector 1532 is pushed and the distance the wire 1306 extends from the connector 1532 controls how far the papillary muscles 12 are pulled toward each other, which in turn determines the remodeling of the heart wall.

[0297] 161, in one exemplary embodiment, the papillary muscles 12 can be pulled toward one another to improve coaptation between the mitral valve leaflets. That is, the chordae tendineae are attached to the mitral valve MV leaflets and the papillary muscles. By approximating the papillary muscles toward one another, the chordae tendineae CT pull the mitral valve leaflets toward one another, enhancing coaptation of the mitral valve leaflets. Enhanced or corrected coaptation of the leaflets can reduce or eliminate mitral valve regurgitation.

[0298] 162, after the wire 1306 has pulled the papillary muscles 12 and the heart wall W into the desired remodeling position, the connector 1314 locks the position of the wire within the connector. Once locked, the wire can be cut as shown. Thus, both anchors 1310 are shown in the deployed position. The wire 1306 remains under tension and pulls inward, pulling the heart wall W inward to remodel the shape of the heart wall W.

[0299] Any number of anchors 1310 and any number of wire locking devices 1532 can be used to tailor the heart wall remodeling to each individual patient. In one exemplary embodiment, two or more wires 124 are locked together with each of the locking devices. FIG. 163 shows an example where three wires are connected together with one locking device. In some embodiments, more than one locking device is used, with at least two wires connected together with each locking device. In the example shown in FIG. 163, the three anchors 1310 are shown in a deployed position with the third anchor engaging the heart wall. In the illustrated embodiment of FIG. 163, the heart wall associated with the third anchor 1310 is the ventricular septum IS. The wires 1306 can be pulled inward to remodel the shape of the heart wall W. To hold the heart wall W in a remodeling position, the wire 1306 can be connected within the left ventricle LV while under tension, for example, by a wire locking device 1532 or other suitable means for connecting the wire 1306.

[0300] In Fig. 164, one anchor 1310 is implanted in the papillary muscles 12 and a second anchor 1310 is attached to the ventricular septum IS. The wire 1306 can be pulled inwardly to pull the papillary muscles 12 inward and the ventricular septum IS inward to remodel the shape of the ventricle. To hold the papillary muscles 12 and the ventricular septum IS in the remodeled position, the wire 1306 can be connected into the left ventricle LV while under tension, for example, by a wire locking device 1532 or other suitable means for connecting the wire 1306.

[0301] In Fig. 165, one anchor 1310 is attached to the heart wall W and a second anchor 1310 is implanted on the ventricular septum IS. The wire 1306 can be pulled inward to pull the heart wall W inward to remodel the shape of the heart wall W and the ventricular septum IS. To hold the heart wall W and the ventricular septum IS in the remodeled position, the wire 1306 can be connected into the left ventricle LV while under tension, for example, by a wire locking device 1532 or other suitable means for connecting wires.

[0302] The device can be used in a wide variety of different ways to remodel the heart and / or approximate the papillary muscles. To remodel a patient's heart, a single locking device 1532 and two or more anchors 1310 can be deployed, or two or more wire locking devices 1532 with two or more anchors 1310 per locking device 1532 can be deployed. For example, any of the configurations disclosed herein can be used in combination on a patient's heart.

[0303] FIG. 166 illustrates an exemplary helical anchor 1310 deployed in endocardial tissue 102. While many embodiments described herein include the deployment of one or more helical anchors, it is understood that in some embodiments, different types of anchors may be used in a substantially similar manner. For example, FIG. 167 illustrates various alternative anchors 1310′, 1310″, 1310′″ deployed in a target tissue region, e.g., endocardial tissue 102. The alternative anchors 1310′, 1310″, 1310′″ may be configured with a tissue engagement depth (i.e., a penetration depth into the tissue) that targets endocardial tissue while avoiding or substantially avoiding myocardial tissue. In some exemplary embodiments, the stitch depth penetration depth of the alternative anchors may be between 0.02 mm and 2 mm, e.g., between 0.5 mm and 1.5 mm. 2. The thickness of the anchor 1310 is between 0.75 mm and 1.25 mm, e.g., 1 mm or less. As shown, anchor 1310' is a ring anchor. Anchor 1310" is a hook anchor secured to the outside of endocardial tissue 102, and anchor 1310'" is a hook anchor secured to the inside of endocardial tissue 102. It is understood that anchors 1310', 1310", 1310'" are for illustrative purposes only, and that additional types of anchors may be used in the exemplary embodiments described herein.

[0304] 168A-G show an exemplary embodiment of a device 16800 including multiple guides / stabilizers 16804. Multiple helical anchors 1310 can be deployed on the guides / stabilizers 16804. In FIG. 168A, the steerable guides 16804A-C are connected at an end connector 1680. The end connector 1680 can take a wide variety of different forms. For example, the end connector can comprise multiple connectors as illustrated, or the guides / stabilizers 16804 can be fixedly connected to the end connectors 1680. If the guides / stabilizers 16804 are fixedly connected to the end connectors 1680, the guides / stabilizers 16804 can be made from a spring type material such that the guides / stabilizers expand outward when released from the delivery catheter 16802. Connector 1680 allows guides / stabilizers 16804A-16804C to be deployed together at a target tissue location, and each guide / stabilizer can be manipulated about connector 1680 to target multiple target tissue locations.

[0305] 168B illustrates a steerable guide / stabilizer 16804 connected and released from the delivery catheter 16802 to allow the guide / stabilizer 16804 to expand in different directions. As shown, a tether 1306 is attached to each of the guide / stabilizers 16804, such as at each end of the guide / stabilizer 16804.

[0306] FIG 168C shows an example helical anchor 1310C deployed along guide / stabilizer 16804C. FIG 168D shows an example helical anchor 1310B deployed along guide / stabilizer 16804B. FIG 168E shows an example helical anchor 1310A deployed along guide / stabilizer 16804A. Although each helical anchor is deployed along its respective guide / stabilizer, it will be understood that the deployed anchors may also be used to locally modify tissue at the target tissue region in which they are implanted (see, e.g., FIG 157N).

[0307] In Fig. 168F, the tether 1306 is pulled while the locking mechanism 1532 is advanced to draw the guides / stabilizers 16804A-C and the coiled anchors 1310A-C thereon toward one another. In Fig. 168G, the position of the tether 1306 within the locking mechanism 1532 has been altered such that the excess tether extending proximally has been cut.

[0308] It is understood that helical anchors 1310A-1310C may have the same or different bite angles, coil pitches, etc. In the example shown in FIG. 168G, helical anchor 1310A has anchor pitch AA, helical anchor 1310B has anchor pitch AB, and helical anchor 1310C has anchor pitch AC. In some exemplary embodiments, anchor pitches AA, AB, and AC are the same. In other exemplary embodiments, anchor pitches AA, AB, and AC are different.

[0309] 168F, 169A, and 169B, the wires 1306 may be pulled independently (see FIG. 168F), or a single wire 1306 may be pulled (see FIGS. 169A and 169B) to pull the guides / stabilizers 16804A-16804C together. Pulling the wires 1306 independently allows for different forces or tensions to be applied to each of the guides / stabilizers 16804A-16804C. Pulling a single wire can provide a uniform force or tension applied to the guides / stabilizers 16804A-16804C.

[0310] In FIG. 169A, the wires 1306 connected to the guides / stabilizers 16804A-16804C are connected to a single wire 16900 that extends through the connector 1532. Pulling the single wire 16900 while pushing the connector 1532 pulls all three wires 1306. As a result, all three guides / stabilizers 16804A-16804C are pulled, as shown by the arrows. In one exemplary embodiment, the force exerted by the single wire 16900 is applied uniformly to the guides / stabilizers 16804A-16804C. The locking mechanism 1532 can tighten on the tether 1306 to hold the position of the helical anchors 1310A-1310C.

[0311] FIG. 169B is a schematic view looking toward the apex of the ventricle with three anchors 1310A-C implanted in the ventricle. In this example, a single wire 1306 is connected to all three of the anchors 1310A-C. The wire 1306 can be connected to the multiple anchors in a wide variety of different ways. For example, the wire 1306 can be threaded through loops 16902 attached to the anchors 1310A-C or through guides / stabilizers disposed within the anchors. The single wire 1306t extends through the connector 1532. Pulling the single wire 1306 on the proximal side of the connector 1532 (i.e., away from the anchors 1310A-C) while pushing the connector 1532 will pull all three loops 16902. As a result, all three anchors 1310A-C are pulled toward each other. In one exemplary embodiment, the force applied by the single wire 1306 is applied uniformly to the anchors 1310A-C. The locking mechanism 1532 can tighten on the tether 1306 to hold the position of the helical anchors 1310A-C.

[0312] 170A-170G illustrate an exemplary deployment of the device 16800 described above with reference to FIGS. 168A-168G into a cardiac chamber, such as the left ventricle LV. In FIG. 170A, a delivery catheter 16802 positions the device 16800 within the cardiac chamber. For example, the delivery catheter 16802 can position the device 16800 at the apex of the left ventricle LV, as shown.

[0313] 170B shows a connected steerable guide / stabilizer 16804 that has been released from the delivery catheter 16802, allowing the guide / stabilizer 16804 to expand in different directions. In the example shown, the guide / stabilizer expands to contact the wall of the left ventricle. As shown, a tether 1306 is attached to each of the guide / stabilizers 16804, such as at each end of the guide / stabilizer 16804.

[0314] FIG. 170C illustrates an exemplary helical anchor 1310C deployed in the wall of the ventricle along the guide / stabilizer 16804C. For example, the helical anchor 1310C can be implanted in the ventricular septum or another wall of the left ventricle LV. FIG. 170D illustrates an exemplary helical anchor 1310B deployed in the wall of the ventricle along the guide / stabilizer 16804B. For example, the helical anchor 1310B can be implanted in the wall of the left ventricle LV. FIG. 170E illustrates an exemplary helical anchor 1310A deployed in the wall of the ventricle along the guide / stabilizer 16804A. For example, the helical anchor 1310A can be implanted in the wall of the left ventricle LV. Although each helical anchor is deployed along its respective guide / stabilizer, it will be understood that the deployed anchors can also be used to locally modify tissue at the target tissue region in which they are implanted (see, for example, FIG. 157N).

[0315] In FIG. 170F, the tether 1306 is pulled while the locking mechanism 1532 is advanced to draw the guides / stabilizers 16804A-C and the coiled anchors 1310A-C thereon toward one another. This pulls the ventricular wall inward, remodeling the shape of the ventricle. In FIG. 170G, the position of the tether 1306 within the locking mechanism 1532 is fixed and the excess tether extending proximally is cut, securing the remodeled shape of the ventricle.

[0316]

[00101] Figures 171-188 illustrate various embodiments relating to a coiled anchor device. Figure 171 illustrates a cutaway view of a heart including an exemplary deployment system 17100 for implanting a coiled anchor 17204 (see Figure 172A) in the interior wall of the left ventricle LV. The coiled anchor is disposed inside the deployment system 17100 of Figure 171 and straightened or partially straightened to take the shape of the deployment system.

[0317] The deployment system 17100 can take a wide variety of different forms. In the illustrated example, the deployment system includes a guide sheath or catheter 17500, a first steerable catheter 17501, and a second steerable catheter 17503. The coiled anchor is positioned within and delivered from the second steerable catheter 17503 in the illustrated embodiment. However, the deployment system may include any number of catheters. For example, in one exemplary embodiment, the deployment system may include an optional guide sheath, a steerable catheter disposed within the optional guide sheath, and a steerable implant catheter having an end to which the coiled anchor is attached. As described in more detail below, the coiled anchor 17204 is positioned at its deployment location via the second steerable catheter 17503, e.g., via the heart wall of the left ventricle LV or a papillary muscle of the left ventricle LV.

[0318] 172A-172F show an exemplary embodiment of a coiled anchor 17204. The coiled anchor 17204 can take a wide variety of different forms. In the illustrated example, the coiled anchor 17204 is large, substantially annular or ring-shaped, and includes a substantially planar or planar outer ring portion 17205 and a radially inwardly extending portion 17202. The outer ring portion 17205 and the radially inwardly extending portion 17202 can be made from a variety of different materials. For example, the ring portion 17205 and the radially inwardly extending portion 17202 can be formed from a metal, such as titanium, steel, and / or a shape memory alloy, such as Nitinol. However, it will be appreciated that in alternative embodiments, the ring portion 17205 and the radially inwardly extending portion 17202 of the coiled anchor 17204 can be formed using any number of materials capable of implantation into human tissue.

[0319] In the illustrated embodiment, the ring portion 17205 is relatively large compared to the diameter of the wire used to make the ring portion. For example, the diameter of the ring portion 17205 may be many times larger than the diameter of the wire used to make the ring portion 17205. For example, the diameter of the ring portion 17205 may be 5 to 35 times the diameter of the wire used to make the ring portion, such as 10 to 30 times the diameter of the wire used to make the ring portion, such as 15 to 20 times the diameter of the wire used to make the ring portion, such as about 17 times the diameter of the wire used to make the ring portion. In one exemplary embodiment, the diameter d1 of the wire used to make the ring portion is 0.015 to 0.062 inches, such as 0.025 to 0.050 inches, such as 0.030 to 0.040 inches, such as about 0.035 inches. In one exemplary embodiment, the diameter d2 of the ring portion is between 0.250 and 1.0 inches, such as between 0.375 and 0.75 inches, such as between 0.45 and 0.7 inches, for example about 0.6 inches.

[0320] Ring portion 17205 may include any number of turns. For example, ring portion 17205 may have 1 / 2 to 3 turns, such as 3 / 4 to 2 turns, such as 7 / 8 to 1-1 / 4 turns, such as 15 / 16 to 1-1 / 18 turns, etc. In the illustrated example, ring portion 17205 includes approximately 1 turn.

[0321] As shown in FIG. 172A, the coiled anchor 17204 may be associated with a coupler 17200. The coupler 17200 may take a wide variety of different forms. The coupler may be any structure that facilitates attachment to the coiled anchor 17204, facilitates advancement of the coiled anchor from the catheter 17501 and / or catheter 17503, facilitates rotation of the coiled anchor, and facilitates release of the coiled anchor. The coupler 17200 is illustrated generally in FIGS. 172A-E. The coupler 17200 may be connected to the coiled anchor 17204 in a wide variety of different ways. In certain embodiments, the coupler 17200 is connected to the coiled anchor 17204 via frictional forces. In other embodiments, the coupler 17200 and the coiled anchor 17204 may be connected via an adhesive, glue, bonding agent, adhesive, or the like. The coiled anchor 17204 extending from the coupler 17200 may have a radially inwardly extending portion 17202 that includes a transition portion 17203 having a smaller bend radius than the remainder of the coiled anchor 17204. In some embodiments, the coiled anchor 17204 is a continuous coil. In certain embodiments, the radially inwardly extending portion 17202 is formed from a different material than the coiled anchor 17204 and is joined at a joint. The coiled anchor 17204 terminates at an anchor tip 17206. The anchor tip 17206 is sharpened to facilitate implantation of the coiled anchor into tissue.

[0322] FIG. 172C illustrates the bite angle B of the anchor tip. The bite angle B is the angle that the anchor tip 17206 forms with a horizontal plane when the remainder of the coil 17205 is positioned on the horizontal plane. In certain embodiments, the bite angle of the anchor tip 17206 can be selected to accommodate implantation in different tissue regions. The low profile of the coiled anchor 17204 can be used to target thin tissue remodeling in the left ventricular wall of the heart. For example, the bite angle B can be selected to engage only endocardial tissue or endocardial tissue and a small depth of tissue past the endocardial tissue. In one exemplary embodiment, the bite angle B is less than 3 degrees, such as less than 2 degrees, such as less than 1 degree, such as less than 0.75 degrees, such as less than 0.050 degrees, such as less than 0.250 degrees, such as less than 0.125 degrees, such as less than 0.05 degrees.

[0323] FIG 172C is an overhead view of an exemplary coiled anchor 17204 having a coupler 17200 and a radially inwardly extending portion 17202. FIG 172C is a side view of the coiled anchor 17204. FIG 172D is another side view of the coiled anchor 17204. FIG 172E is an opposite side view of the coiled anchor 17204. FIG 172F is an underside view of the coiled anchor 17204.

[0324] 173A-173F show another exemplary embodiment of the coiled anchor 17204. In the exemplary embodiment shown in FIGS. 173A-173F, the coiled anchor 17204 includes a strain relief. The coiled anchor 17204 may include both a strain relief and a coupler, a strain relief without a coupler, or a coupler without a strain relief. FIG. 173A is an exemplary coiled anchor 17204 having a radially inwardly extending portion 17202 and a strain relief 17201. The strain relief 17201 can take a wide variety of different forms. Any spring, shock absorber, or other structure capable of absorbing, damping, or otherwise reducing the forces applied to the strain relief and transmitted to the outer coil 17205 can be used.

[0325] 173A, the strain relief 17201 is a coiled continuation of the transition section 17202. The additional coils of the strain relief 17201 can limit the load on tissue by stretching when implanted in tissue. By incorporating the strain relief 17201 into the coiled anchor 17204, the maximum load that the coiled anchor 17204 can impart to tissue can be reduced.

[0326] The coiled strain relief 17201 can take a wide variety of different forms: it can be formed of a wire having a constant diameter, it can be formed of a coil having a constant diameter, it can be formed of a wire that tapers as it extends away from the outer portion 17205, and / or it can be a coil that tapers radially inward as it extends away from the outer portion 17205.

[0327] In the example shown in FIG. 173A, the coiled strain relief 17201 is made from wire that tapers as the coiled strain relief extends away from the outer ring portion 17205, with the coil forming the coiled strain relief 17201 tapering radially inward as the coil extends away from the outer ring portion 17205. The illustrated coiled strain relief 17201 can be configured to reduce strain applied to the ring 17205 by a predetermined amount. For example, the wire forming the coiled strain relief can taper from the diameter of the ring portion 17205 (see ring portion wire diameter ranges above) to 0.001-0.015 inches, such as 0.003-0.012 inches, such as 0.005-0.010 inches, such as about 0.008 inches, at the reference 17300. The coil forming the coiled strain relief 17201 may taper from 0.125-0.250 inches to the diameter of the wire at the nominal 17300, for example, from 0.140-0.200 inches to the diameter of the wire at the nominal 17300, for example, from 0.160-0.180 inches to the diameter of the wire at the nominal 17300.

[0328] In some embodiments, the radially inwardly extending portion 17202 tapers towards the strain relief 17201 such that the diameter of the coil at the radially inwardly extending portion 17202 is larger than at the strain relief 17201. In certain embodiments, the coiled anchor 17204 may have a coil diameter or width CW of 0.025 to 0.040 inches or any of the diameters described above. In certain exemplary embodiments, the coiled anchor 17204 has a coil width CW of 0.035.

[0329] FIG. 173B is an overhead view of an exemplary coiled anchor 17204 having a radially inwardly extending portion 17202 and a strain relief 17201. FIG. 173C is a side view of the coiled anchor 17204 having a radially inwardly extending portion 17202 and a strain relief 17201. FIG. 173D is another side view of the coiled anchor 17204 having a radially inwardly extending portion 17202 and a strain relief 17201. FIG. 173E is yet another side view of the coiled anchor 17204 having a radially inwardly extending portion 17202 and a strain relief 17201. FIG. 173C is an underside view of the coiled anchor 17204 having a radially inwardly extending portion 17202 and a strain relief 17201.

[0330] 174A-174F illustrate an exemplary embodiment of a coiled anchor 17204 including both a strain relief 17201 and a coupler 17200a. FIG. 174a shows the coupler 17200a disposed within the strain relief 17201. It will be understood that the coupler 17200a and the strain relief 17201 may be attached via friction or otherwise as described herein. The illustrated coupler 17200a has an opening O that can allow the coupler 17200a to be operably connected and disconnected to the deployment device 17100. In some embodiments, the coupler 17200a is hollow such that the deployment device 17100 can be inserted into the coupler 17200a to operably connect the deployment device 17100 and the coupler 17200a at the opening O. During deployment, the connection between the deployment device 17100 and the coupler 17200a may be used to guide the coiled anchor 17204 to a deployment position, torqueing the coiled anchor 17204 so that the anchor tip 17206 penetrates tissue, until the coiled anchor 17204 is fully deployed in the target tissue region. After deployment, the deployment device 17100 can be detached from the coupler 17200a and removed from the body. For example, the coupler can operate in the same or substantially the same manner as the connections illustrated in FIGS. 54-74F.

[0331] FIG. 174B is an overhead view of an exemplary coiled anchor 17204 with strain relief 17201 and coupler 17200a. FIG. 174C is a side view of coiled anchor 17204 with strain relief 17201 and coupler 17200a. FIG. 174D is a side view of coiled anchor 17204 with strain relief 17201 and coupler 17200a showing opening O. FIG. 174E is a side view of coiled anchor 17204 with strain relief 17201 and coupler 17200a. FIG. 173C is an underside view of coiled anchor 17204 with strain relief 17201 and coupler 17200a (not visible).

[0332] 175A-175H illustrate the deployment of an exemplary coiled anchor 17204 into a target tissue region 17502 with a delivery system 17100. The delivery system 17100 may have any number of catheters, optional pushers, and / or optional couplers as described above. The remaining portion of the coiled anchor 17204 is straightened or substantially straightened inside the delivery system 17100. In FIG. 175A, the deployment system 17100 is shown in a deployed position, with the anchor tip 17206 of the coiled anchor 17204 pushed out and exposed at the end of the deployment system 17100. FIG. 175B illustrates the coiled anchor 17204 and associated coupler 17200 after being fully pushed out of the deployment system (or the deployment system pulled back over the anchor). The anchor 17204 moves to its coiled state due to its shape memory. The deployment system 17100 moves the coiled anchor to a deployed position proximate the target tissue region 17502. FIG. 175C shows the coiled anchor 17204 with a downward force applied by an optional pusher 17570 of the deployment system 17100, such as a rod, coil, or wire, to position the coiled anchor 17204 at the target tissue region 17502. FIG. 175D shows deployment of the coiled anchor 17204 into the target tissue region 17502. As the deployment device 17100 is rotated, the anchor tip 17206 penetrates the tissue and the coiled anchor 17204 is advanced into the tissue.

[0333] 175E-H illustrate further deployment of the coiled anchor 17204 into the target tissue region 17502. Each of FIGS. 175E-H illustrates further rotation of the anchor to advance the anchor further into the tissue. As shown in FIG. 175H, the coiled anchor 17204 is fully deployed into the target tissue region 17502 such that only a portion of the radially inwardly extending portion 17202 and the coupler 17200 remain outside of the tissue. Once the coiled anchor 17204 is fully deployed into the tissue, the deployment device 17100 can be detached from the coupler 17200 and removed from the body.

[0334] 176A-H show how the coiled anchor 17204 penetrates the endocardium 102 and embeds in the myocardium 104. In FIG. 176A, the coiled anchor 17204 is pressed against the target tissue region 17502 and rotates about the coupler 17200 to puncture the endocardium and create an opening 17600 through the endocardium. The coiled anchor 17204 is allowed to slide slightly under the endocardium 102 and engage the myocardium 104.

[0335] 176C-176D, rotation of the coiled anchor 17204 about the coupler 17200 continues. The ring portion 17205 advances through the opening 17600, creating a pathway 17602 through tissue of the myocardium 104. Referring to FIG. 176D, the pathway 17602 and the embedded ring portion 17205 are circular or substantially circular. As a result, the myocardial tissue is trapped within the ring portion 17205.

[0336] The tissue of the endocardium 102 is significantly stronger than the tissue of the myocardium 104. For example, the tissue of the endocardium 102 may be four times stronger than the tissue of the myocardium 104. As a result, the position of the opening 17600 is fixed or substantially fixed. In FIG. 176E, rotation of the coiled anchor 17204 about the coupler 17200 continues. This rotation advances the radially inwardly extending portion 17202 into the opening 17600. Because the position of the opening 17600 is essentially fixed, the movement of the radially inwardly extending portion 17202 through the opening causes the coupler 17200 and ring portion 17205 to translate from position 17610 to position 17612, as shown by arrow 17614. This translational motion pulls on the tissue captured within the ring portion 17205, placing the tissue in tension, as shown in FIGS. 176F and 176G.

[0337] 176H, arrows 17630 represent translation of ring portion 17205 due to movement of radially inwardly extending portion 17202 through opening 17600. Myocardial tissue portion 17650 between radially inwardly extending portion 17202 and ring portion 17205 is placed in tension. Myocardial tissue portion 17652 is compressed between radially inwardly extending portion 17202 and ring portion 17205 while tissue portion 17652 is under tension due to translation of ring portion 17205. Translation of ring portion 17205 shown in FIGS. 176E-176H can strain ring portion 17205 and / or lock the ring portion in tissue (i.e., prevent rotation of ring portion in a direction opposite to that illustrated by FIGS. 176C-176E). The distortion of the ring portions can take a variety of different forms. For example, in FIG. 176H , ​​a portion of the right ring portion 17205 of the radially inwardly extending portion 17202 and a portion of the left ring portion 17205 of the radially inwardly extending portion 17202 can both be compressed toward the radially inwardly extending portion 17202. A portion of the right ring portion 17205 of the radially inwardly extending portion 17202 and a portion of the left ring portion 17205 of the radially inwardly extending portion 17202 can both be stretched away from the radially inwardly extending portion 17202. A portion of the ring portion 17205 to the right of the radially inwardly extending portion 17202 may be compressed toward the radially inwardly extending portion 17202, while a portion of the ring portion 17205 to the left of the radially inwardly extending portion 17202 may extend away from the radially inwardly extending portion 17202. A portion of the ring portion 17205 to the left of the radially inwardly extending portion 17202 may be compressed toward the radially inwardly extending portion 17202, while a portion of the ring portion 17205 to the right of the radially inwardly extending portion 17202 may extend away from the radially inwardly extending portion 17202. Or the ring portions 17205 may not deform.

[0338] In one exemplary embodiment, a desired locking force can be achieved by varying the angle of radially inwardly extending portion 17202. In a particular exemplary embodiment, the locking force is between 10-20 Newtons.

[0339] FIG. 177A shows the coiled anchor 17204 fully deployed within the target tissue region 17502. In some embodiments, a tether 17208 may be connected to the coiled anchor 17204. In some embodiments, the tether 17208 is connected to the coiled anchor 17204 via a surgical knot. In some embodiments, the tether 17208 is disposed within the coiled anchor 17204. In other embodiments, the tether 17208 is attached to the coupler 17200. FIG. 177B shows the coiled anchor 17204 fully deployed with the deployment system 17100 and deployment device 17100 removed, exposing the tether 17208.

[0340] 178A-D illustrate tissue remodeling using a coiled anchor 17204. FIG. 178A illustrates an exemplary coiled anchor 17204a deployed at a target tissue region 17502a. Connected to the coiled anchor 17204a is a coupler 17200a and a tether 17208a. Proximate to the deployment location of the coiled anchor 17204a is a second tissue region, target tissue region 17502b, where the coiled anchor 17204b and associated coupler 17200b and tether 17208b are deployed. FIG. 178B illustrates the tether lock 17210 being advanced along the tethers 17208a and 17208b, as indicated by arrow 17802. As tether 17208a and tether 17208b are pulled in the direction of arrow 17804, coiled anchors 17204a and 17204b are pulled toward each other, thereby manipulating the engaged tissue at target tissue regions 17502a and 17502b. FIG. 178C shows the tether locks advanced further along tethers 17208a and 17208b. Once the desired tissue manipulation is achieved, tether locks 17210 can be locked, holding target tissue regions 17502a and 17502b in a remodeling position, and the ends of tethers 17208a and 17208b are cut, as shown in FIG. 178D. Tether locks 17210 can take a variety of forms. For example, any of connectors 240 can be used as tether locks 17210.

[0341] FIG 179A shows an exemplary coiled anchor 17204 with a strain relief 17201 deployed within a target tissue region 17502. In some embodiments, a tether 17208 may be connected to the strain relief 17201 of the coiled anchor 17204. FIG 179B shows a fully deployed coiled anchor 17204 with the strain relief 17201, deployment system 17100, and pusher 17570 removed, leaving the tether 17208 exposed.

[0342] 180A-180D illustrate tissue remodeling using a coiled anchor 17204 having strain relief 17201. FIG. 180A illustrates an exemplary coiled anchor 17204a having strain relief 17201a deployed in a target tissue region 17502a. A tether 17208a is attached to the coiled anchor 17204a. Proximate to the deployment location of the coiled anchor 17204a is a second tissue region, target tissue region 17502b, where a coiled anchor 17204b having strain relief 17201b and tether 17208b is deployed. FIG. 180B illustrates a tether lock 17210 being advanced along tether 17208a and tether 17208b, as indicated by arrow 18002. As tethers 17208a and 17208b are pulled in the direction of arrow 18004, coiled anchors 17204a and 17204b are pulled toward one another, thereby manipulating the engaged tissue at target tissue regions 17502a and 17502b. FIG. 180C shows the tether locks advanced further along tethers 17208a and 17208b. Once the desired tissue manipulation is achieved, tether locks 17210 are locked in place holding target tissue regions 17502a and 17502b in a remodeling position, and the ends of tethers 17208a and 17208b are cut. FIG. 180D shows the tether anchor 17210 locked in place, creating tension in strain relief 17201a in the direction of arrow 18006a and in strain relief 17201b in the direction of arrow 18006b. The strain reliefs 17201a, 17201b can limit and / or attenuate loads on the coiled anchors 17204a and 17204b. For example, the strain reliefs 17201a, 17201b can expand and contract as the tissue regions 17502a, 17502b move toward and away from one another. For example, the tissue regions 17502a, 17502b can be portions of the heart wall that move toward and away from one another as the heart beats.Thus, the strain reliefs 17201a, 17201b expand and contract to control the load applied to the heart wall by the tethered anchors.

[0343] FIG. 181A illustrates the deployment of a coiled anchor 17204a and associated coupler 17200a into a target tissue region 17502. The coupler 17200a has an opening O that operably connects and disconnects to a pusher 17570 of the deployment device 17100. FIG. 181A illustrates the coupler 17200a connected to the deployment device 17100. FIG. 181B illustrates the coupler 17200b disconnected from the deployment device 17100. FIG. 181B further depicts a tether 17208 disposed within the coupler 17200a. FIG. 181C illustrates the deployment device 17100 fully retracted, exposing the tether 17208.

[0344] 182A-H illustrate an exemplary deployment of the coiled anchor 17204 into the target tissue region 17502. FIG. 182A illustrates a catheter 17503 positioned proximate to the target tissue region 17502. FIG. 182B illustrates the anchor tip 17206 of the coiled anchor 17204 protruding from the catheter 17503. FIG. 182C illustrates the coiled anchor 17204 protruding further from ...

Claims

1. 1. A cutting tool for severing a wire within a patient, comprising: an actuator for manipulation by a user; a movable inner shaft coupled to the actuator; a compressible member coupled to the movable inner shaft; a cutter connected to the movable inner shaft; the compressible member includes an expanded length and a compressed length; the cutter has a length between the expanded length and the compressed length of the compressible member; an outer sleeve coupled to the inner shaft, the outer sleeve comprising a backstop disposed along an inner wall of the outer sleeve and a channel disposed between a first end and a second end of the outer sleeve; The cutting tool is configured to cut the wire received inside the channel of the outer sleeve.

2. The cutting tool of claim 1 , wherein the channel has a circular cross-section.

3. A cutting tool according to any one of claims 1 to 2, wherein the compressible member comprises at least one of a spring, a sponge, or other resilient material.

4. The cutting tool of any one of claims 1 to 3, wherein the compressible member and the cutter are coupled to the inner shaft.

5. The cutting tool of any one of claims 1 to 4, wherein the compressible member is disposed between the inner shaft and an inner wall of the outer sleeve.

6. The cutting tool of any one of claims 1 to 5, wherein the compressible member is coupled to the inner shaft at a distal end of the compressible member.

7. The cutting tool of any one of claims 1 to 6, wherein the cutter comprises a blade, a guillotine, or a knife.

8. A cutting tool according to any preceding claim, wherein the compressible member engages the wire and presses the wire against the backstop before the cutter advances through the wire.

9. The cutting tool of claim 8 , wherein the compressible member shortens to the compressed length when the compressible member presses the wire against the backstop.

10. The cutting tool of claim 9 , wherein the cutter advances through the wire as the compressible member is shortened to the compressed length.

11. 1. An assembly for severing a wire within a patient, comprising:

1. A cutting tool comprising: an actuator for manipulation by a user; a movable inner shaft coupled to the actuator, the movable inner shaft comprising an inner shaft, a compressible member, and a cutter; the compressible member includes an expanded length and a compressed length; the cutter has a length between the expanded length and the compressed length of the compressible member; an outer sleeve coupled to the inner shaft, the outer sleeve including a backstop disposed along an inner wall of the outer sleeve and a channel disposed between a first end and a second end of the outer sleeve; a cutting tool configured to cut the wire received inside the channel of the outer sleeve; and A handle coupled to the cutting tool, The outer frame and a cavity extending partially into the outer frame, the cavity housing a first spring; and an assembly comprising: a handle; and a trigger coupled to the outer frame and movable within the cavity, the trigger comprising an outer housing, an inner member, and a second spring coupled to the outer housing and the inner member.

12. The assembly of claim 11 , wherein the channel has a circular cross-section.

13. An assembly according to any one of claims 11 to 12, wherein the compressible member comprises at least one of a spring, a sponge, or other resilient material.

14. The assembly of any one of claims 11 to 13, wherein the compressible member and the cutter are coupled to the inner shaft.

15. The assembly of any one of claims 11 to 14, wherein the compressible member is disposed between the inner shaft and an inner wall of the outer sleeve.

16. The assembly of any one of claims 11 to 15, wherein the compressible member is coupled to the inner shaft at a distal end of the compressible member.

17. The assembly of any one of claims 11 to 16, wherein the cutter comprises a blade, a guillotine, or a knife.

18. An assembly according to any one of claims 11 to 17, wherein the compressible member engages the wire and presses the wire against the backstop before the cutter advances through the wire.

19. 20. The assembly of claim 18, wherein a compressible member presses the wire against the backstop, the compressible member shortening to the compressed length.

20. 20. The assembly of claim 19, wherein the compressible member is shortened to the compressed length and the cutter advances through the wire.

21. The assembly of any one of claims 11 to 20, wherein the outer housing includes one or more protrusions extending therefrom.

22. The assembly of any one of claims 11 to 21, wherein the trigger is movable in a first direction and a second direction.

23. 23. The assembly of claim 22, wherein the trigger must be moved in the first direction before it can be moved in the second direction.

24. The assembly of claim 22, wherein moving the trigger in the second direction initiates movement of the cutting tool.

Images