Devices, systems and methods for treating cardiac conditions

Abstract

Disclosed herein is a device for treating a native valve annulus. In some examples, the technology includes a device comprising a plurality of arms configured to move independently of one another and a coupler coupled to the arms and configured to move relative to the arms. The device can further include a plurality of anchors, each of which is carried by a distal portion of one of the arms and configured to engage tissue at or adjacent to the annulus. When the device is in a deployed configuration such that the arms extend axially and radially away from the coupler, movement of the coupler relative to the arms can reduce a circumferential distance between at least some of the anchors.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of priority to U.S. Provisional Application No. 63 / 263,354, filed November 1, 2021, U.S. Provisional Application No. 63 / 223,965, filed July 20, 2021, U.S. Provisional Application No. 63 / 200,455, filed March 8, 2021, and U.S. Provisional Application No. 63 / 150,014, filed February 16, 2021, each of which is incorporated by reference in its entirety herein.

[0002] The present technology relates to devices, systems, and methods for treating cardiac conditions. [Background technology]

[0003] Valvular regurgitation (VR) is a common valvular heart disease (VHD) in which one of the heart's valves fails to close tightly, allowing blood to flow backwards through the valve. Patients suffer from shortness of breath, fatigue, chest pain, cardiac flutter, and sometimes death. Approximately 15% of people over the age of 75 have valvular heart disease, affecting at least 2.5% of the U.S. population and more than 100 million people worldwide. Today, surgical mitral valve repair is a robust and effective procedure for correcting mitral regurgitation, with many years of clinical experience and validated evidence. However, surgical mitral valve intervention in high-risk patients remains a challenging procedure, with 30-day mortality rates approaching 3.1%. Mortality rates are even higher in patients with functional mitral regurgitation, and concomitant impairment of left ventricular ejection fraction is often observed. Treatment of tricuspid regurgitation also faces serious obstacles. Current products have issues with visual imaging, pacemaker lead interactions, and are unable to treat patients with larger valves. For these reasons, new low-risk percutaneous strategies are needed to treat VHD in both degenerative and functional anatomy and minimize the potential complications associated with open-heart surgery. Summary of the Invention [Means for solving the problem]

[0004] The subject technology is illustrated in accordance with various aspects, as described below, including, for example, with reference to Figures 1-39. Various embodiments of aspects of the subject technology are described as numbered annotations (1, 2, 3, etc.) for convenience. These are provided as examples and are not intended to be limitations of the subject technology. (Appendix 1) 1. A device for treating a native valve annulus, the device comprising: a plurality of arms, each having a proximal portion and a distal portion, the arms being configured to move independently of one another; a coupler coupled to the arm and configured to move relative to the arm; a plurality of anchors, each of the anchors being carried by a distal portion of one of the arms and configured to engage tissue at or adjacent to the annulus; Equipped with A device, wherein when the device is in a deployed configuration such that the arms extend axially and radially away from the coupler, movement of the coupler relative to the arms reduces the circumferential distance between at least some of the anchors. (Appendix 2) 2. The device of claim 1, wherein the valve annulus is a cardiac valve annulus, and the device is configured to be delivered adjacent to and above the valve annulus so that the anchor is embedded within the valve annulus cardiac tissue just above the plane of the valve orifice. (Appendix 3) 3. The device of claim 1 or claim 2, wherein the coupler is configured to translate and / or rotate relative to the arm. (Appendix 4) 4. The device of any one of claims 1-3, wherein the arms are configured to translate and / or rotate independently of each other. (Appendix 5) 5. The device of any one of claims 1-4, wherein each of the arms includes one or more locking elements, and movement of the coupler relative to the arms causes the coupler to engage at least some of the locking elements on at least some of the arms, thereby fixing the axial position of each of the arms relative to the other arms and / or the coupler. (Appendix 6) 6. The device of any one of clauses 1-5, wherein when the arms are in the deployed configuration, movement of the coupler relative to the arms reduces the angle between adjacent arms. (Appendix 7) 7. The device of any one of claims 1-6, wherein each of the anchors is removably coupled to one of the arms such that upon completion of treatment, the coupler and arms are removed from the patient while the anchor remains embedded in the valve annulus. (Appendix 8) 8. The device of any one of claims 1-7, wherein each of the anchors is attached to a single arm. (Appendix 9) 9. The device of any one of claims 1-8, further comprising a suture coupled to the anchor. (Appendix 10) 10. The device of any one of claims 1-9, wherein some or all of the arms comprise at least one of a tube, a solid rod, or a ribbon. (Appendix 11) 11. The device of any one of claims 1-10, wherein the device is configured to be delivered percutaneously to the valve annulus. (Appendix 12) 1. A device for treating a native valve annulus, the device comprising: A plurality of arms; a coupler coupled to the arm, the coupler configured to move relative to the arm; and a plurality of anchors, each of the plurality of anchors being carried by a distal portion of one of the arms and configured to be implanted at or adjacent to the valve annulus; Equipped with A device, wherein when the device is in a deployed configuration, movement of the couplers relative to the arms reduces the circumferential distance between at least some of the anchors. (Appendix 13) 1. A system for treating a native valve annulus, the system comprising: a plurality of elongate members, each of the plurality of elongate members having a proximal region and a distal region; a plurality of arms configured to be positioned at or adjacent to the valve annulus, each of the arms having a proximal portion and a distal portion, each of the distal portions coupled to a distal region of a corresponding elongate member; a coupler coupled to the arm and configured to move relative to the arm; a plurality of anchors, each of the anchors coupled to a distal portion of one of the arms and configured to engage tissue at or adjacent to the annulus; Equipped with A system in which, when the arms are in a deployed configuration, movement of the coupler relative to the arms reduces the area enclosed by the anchor. (Appendix 14) 14. The system of claim 13, wherein the elongate member is a first elongate member, and the system further includes a second elongate member having a proximal region and a distal region, the distal region of the second elongate member coupled to the coupler such that movement of the second elongate member causes movement of the coupler relative to the arm. (Appendix 15) 15. The system of claim 14, wherein the second elongate member is a solid rod. (Appendix 16) 15. The system of claim 14, wherein the second elongate member is a flexible tube. (Appendix 17) 15. The system of claim 14, wherein the second elongate member is an elongate shaft that surrounds the first elongate member. (Appendix 18) 18. The system of any one of claims 13-17, wherein rotation and / or translation of one of the extension members causes rotation and / or translation of a corresponding arm. (Appendix 19) 19. The system of any one of claims 13-18, wherein the coupler is configured to translate and / or rotate relative to the arm. (Appendix 20) 20. The system of any one of claims 13-19, wherein each of the anchors is removably coupled to one of the arms. (Appendix 21) 21. The system of claim 20, wherein actuation of one of the extension members causes a corresponding anchor to detach from a corresponding arm. (Appendix 22) 22. The system of any one of claims 13-21, further comprising a suture coupled to the anchor and extending proximally along the elongate member. (Appendix 23) 23. The system of any one of claims 13-22, further comprising an imaging element configured to be advanced to a location at or adjacent to the annulus while the arm is positioned at or adjacent to the annulus. (Appendix 24) 24. The system of any one of claims 13-23, wherein each of the arms includes one or more locking elements, and movement of the coupler relative to the arms causes the coupler to engage at least some of the locking elements on at least some of the arms, thereby fixing the axial position of each of the arms relative to the other arms and / or the coupler. (Appendix 25) 1. A method for treating a native valve annulus in a patient, the method comprising: positioning a device in a low-profile delivery configuration at or proximate to the valve annulus, the device comprising a plurality of arms, a coupler coupled to the arms, and a plurality of anchors, each of the plurality of anchors coupled to one of the arms; Expanding the device to a deployed configuration in which the arms extend radially away from the coupler; engaging tissue at or adjacent to the annulus with at least some of the anchors; Changing the shape of the valve orifice by moving the coupler relative to the arm. A method comprising: (Appendix 26) 26. The method of claim 25, wherein varying the shape of the valve orifice comprises reducing an area of ​​the valve orifice. (Appendix 27) 27. The method of claim 25 or 26, further comprising, after changing the shape of the valve orifice, substantially fixing a length of suture coupled to the anchor and extending therebetween. (Appendix 28) detaching the anchor from the arm, thereby leaving the anchor embedded in the annulus; and Removing the arm and coupler from the patient. 28. The method of any one of claims 25-27, further comprising: (Appendix 29) 29. The method of any one of claims 25-28, wherein the valve annulus is a cardiac valve annulus and the device is deployed adjacent to and above the valve annulus such that the anchor is embedded in the annulus cardiac tissue just above the plane of the valve orifice. (Appendix 30) 30. The method of any one of clauses 25-29, wherein moving the coupler relative to the arms reduces the angular and / or circumferential distance between a) adjacent arms and / or b) adjacent anchors. (Appendix 31) 31. The method of any one of clauses 25-30, wherein moving the coupler relative to the arm comprises translating the coupler distally along the arm. (Appendix 32) 32. The method of any one of clauses 25-31, further comprising rotating and / or translating one or more of the arms independently from the other one or more of the arms. (Appendix 33) 33. The method of any one of clauses 25-32, further comprising rotating the device and engaging tissue with an anchor. (Appendix 34) 34. The method of any one of clauses 25-33, wherein moving the coupler includes using the coupler to engage one or more locking elements on one or more of the arms, thereby longitudinally securing the arms relative to each other and / or the coupler. (Appendix 35) 35. The method of any one of claims 25-34, wherein the device is positioned percutaneously at the valve annulus. [Brief description of the drawings]

[0005] Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on clearly illustrating the principles of the present disclosure.

[0006] [Figure 1] FIG. 1 shows a treatment device configured in accordance with some embodiments of the present technology.

[0007] [Figure 2A] 2A and 2B show a distal assembly of a treatment device in a first and second position, respectively, in accordance with some embodiments of the present technology. [Figure 2B] 2A and 2B show a distal assembly of a treatment device in a first and second position, respectively, in accordance with some embodiments of the present technology.

[0008] [Diagram 3]3A and 3B are isolated views of the arms of the distal assembly shown in FIGS. 2A and 2B, configured in accordance with some embodiments of the present technology.

[0009] [Figure 4] 4A and 4B are isolated views of another arm configured for use with the distal assembly shown in FIGS. 2A and 2B and configured in accordance with some embodiments of the present technology.

[0010] [Diagram 5] 5A and 5B are top and perspective views, respectively, of a coupler configured for use with a treatment device of the present technology.

[0011] [Figure 6A] FIG. 6A is a side view of an operating member configured in accordance with some embodiments of the present technology.

[0012] [Figure 6B] FIG. 6B is an isolated view of the distal portion of the manipulation member shown in FIG. 6A.

[0013] [Figure 7] 7 and 8 are perspective and cross-sectional views, respectively, of an anchor assembly configured for use with a treatment device of the present technology. [Figure 8] 7 and 8 are perspective and cross-sectional views, respectively, of an anchor assembly configured for use with a treatment device of the present technology.

[0014] [Figure 9] FIG. 9 is an isolated close-up view of an anchor constructed in accordance with the present technology.

[0015] [Figure 10] FIG. 10 is an enlarged isolated view of a prior art anchor.

[0016] [Figure 11]11A-11C are schematic illustrations of sutures coupled to a valve annulus shown in open and closed configurations, in accordance with some embodiments of the present technology.

[0017] [Figure 12] FIG. 12 diagrammatically depicts a suture coupled to a valve annulus shown in a closed configuration, in accordance with some embodiments of the present technology.

[0018] [Figure 13] 13A and 13B are schematic depictions of a prior art suture in an open and closed configuration.

[0019] [Figure 14] 14-22, 23A-23C, and 24A-24C show different coupler configurations in accordance with some embodiments of the present technology. [Figure 15] 14-22, 23A-23C, and 24A-24C show different coupler configurations in accordance with some embodiments of the present technology. [Figure 16] 14-22, 23A-23C, and 24A-24C show different coupler configurations in accordance with some embodiments of the present technology. [Figure 17] 14-22, 23A-23C, and 24A-24C show different coupler configurations in accordance with some embodiments of the present technology. [Figure 18] 14-22, 23A-23C, and 24A-24C show different coupler configurations in accordance with some embodiments of the present technology. [Figure 19] 14-22, 23A-23C, and 24A-24C show different coupler configurations in accordance with some embodiments of the present technology. [Figure 20] 14-22, 23A-23C, and 24A-24C show different coupler configurations in accordance with some embodiments of the present technology. [Figure 21] 14-22, 23A-23C, and 24A-24C show different coupler configurations in accordance with some embodiments of the present technology. [Figure 22]14-22, 23A-23C, and 24A-24C show different coupler configurations in accordance with some embodiments of the present technology. [Figure 23] 14-22, 23A-23C, and 24A-24C show different coupler configurations in accordance with some embodiments of the present technology. [Figure 24] 14-22, 23A-23C, and 24A-24C show different coupler configurations in accordance with some embodiments of the present technology.

[0020] [Figure 25A] 25A and 25B show a distal assembly configured for use with a treatment device of the present technology, shown in a first and second position, respectively. [Figure 25B] 25A and 25B show a distal assembly configured for use with a treatment device of the present technology, shown in a first and second position, respectively.

[0021] [Figure 25C] FIG. 25C is an enlarged view of the anchor of the distal assembly shown in FIGS. 25A and 25B.

[0022] [Figure 26] FIG. 26 illustrates a distal assembly configured in accordance with some embodiments of the present technology.

[0023] [Figure 27] FIG. 27 illustrates a distal assembly configured in accordance with some embodiments of the present technology.

[0024] [Figure 28A] FIG. 28A illustrates a distal assembly configured in accordance with some embodiments of the present technology.

[0025] [Figure 28B] FIG. 28B is an enlarged view of the anchor of the distal assembly shown in FIG. 28A.

[0026] [Figure 29] 29 and 30 are perspective and cross-sectional views, respectively, of an anchor assembly configured for use with a treatment device of the present technology. [Diagram 30] 29 and 30 are perspective and cross-sectional views, respectively, of an anchor assembly configured for use with a treatment device of the present technology.

[0027] [Figure 31-1] 31A-31G show different anchors configured in accordance with certain embodiments of the present technology. [Figure 31-2] 31A-31G show different anchors configured in accordance with certain embodiments of the present technology.

[0028] [Diagram 32] 32A and 32B are different views of an anchor configured in accordance with some embodiments of the present technology.

[0029] [Diagram 33] 33-35 show different anchors configured in accordance with certain embodiments of the present technology. [Diagram 34] 33-35 show different anchors configured in accordance with certain embodiments of the present technology. [Diagram 35] 33-35 show different anchors configured in accordance with certain embodiments of the present technology.

[0030] [Diagram 36] FIG. 36 shows a finishing device configured in accordance with an embodiment of the present technology.

[0031] [Figure 37] 37A-37D show the distal portion of the finishing device of FIG. 36 in different positions in accordance with an embodiment of the present technology.

[0032] [Figure 38]38 and 39 show a distal portion of a finishing device, configured in accordance with certain embodiments of the present technology, in different states of use. [Figure 39] 38 and 39 show a distal portion of a finishing device, configured in accordance with certain embodiments of the present technology, in different states of use. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] Detailed Description The present technology relates to devices, systems, and methods for treating cardiac structures, such as native heart valves. Some embodiments of the present technology are directed to devices, systems, and methods for reshaping native valve annuli, such as native heart valve annuli. Specific details of some embodiments of the present technology are described below with reference to Figures 1-39.

[0034] FIG. 1 shows a device 100 for treating a heart valve annulus configured in accordance with some embodiments of the present technology. The device 100 has a proximal portion 100a with a handle 101 configured to be positioned outside the body during treatment, and a distal portion 100b configured to be positioned percutaneously adjacent to, above, and / or within the heart valve annulus. The distal portion 100b of the device 100 includes a distal assembly 103 configured to be operated by one or more actuators (e.g., buttons, sliders, knobs, etc.) on the handle 101 to implant multiple anchors into the annulus cardiac tissue just above and / or within the plane of the valve orifice. The device 100 may further include an elongated shaft 120 extending distally from the handle 101 to the distal portion 100b of the device, and a coupler 129 for receiving one or more other devices (such as finishing devices as disclosed herein) and / or sutures 114 therethrough.

[0035] 2A and 2B are close-up views of a distal assembly 103 in a first and second position, respectively, according to some embodiments of the present technology. As shown, the distal assembly 103 can include a coupler 106, a plurality of arms 102 extending through the coupler 106, and a plurality of anchor assemblies 122 carried by distal end portions of the arms 102. Each of the anchor assemblies 122 houses a corresponding anchor 130 in a low-profile configuration. The distal assembly 103 further includes a suture 114 extending between the anchor assemblies 122. Only some of each of the aforementioned components are labeled in the drawings for ease of viewing the underlying structures.

[0036] The distal assembly 103 is configured to be disposed in a low-profile configuration within the elongated shaft 120 for intravascular delivery to a treatment site (e.g., proximate to a native valve annulus). In this low-profile configuration, the arms 102 can be generally linear and extend generally parallel to one another. Upon release from the elongated shaft 120, the arms 102 can be biased to assume a curved configuration such that each of the arms 102 extends radially away from the longitudinal axis L of the device 100. In this deployed configuration, the anchor assemblies 122 encompass a shape that can be modified by adjusting the position of the arms 102. As discussed herein, each of the arms 102 is configured to rotate and / or translate independently of the other arms 102. Additionally or alternatively, axial advancement of the coupler 106 over the arms 102 can reduce the angle between each of the arms 102 and the longitudinal axis L, thereby drawing the anchor assemblies 122 closer together. In Fig. 2A, the distal assembly 103 is shown in a first deployed configuration in which the arms 102 extend away from the longitudinal axis L of the device 100 at a first angle and the anchor assembly 122 encompasses a first area. In Fig. 2B, the device 100 is shown in a second deployed configuration in which the coupler 106 has been advanced distally relative to its position in Fig. 2A. The arms 102 extend away from the longitudinal axis L at a second angle that is less than the first angle and the distal portion 102b of the arms 102 encompasses a second area that is less than the first area.

[0037] The suture 114 can be coupled to the anchor assembly 122 and / or anchor 130 prior to delivery of the device 100 to a treatment site. For example, the suture 114 can have a looped portion 114a that extends between the anchor 130 and / or anchor assembly 122 about the longitudinal axis L of the device 100, and first and second tails 114a, 114b that extend proximally from ends 115a, 115b of the looped portion 114a back to the handle 101 (or another extracorporeal location). The proximal end of the suture 114 can exit the handle 101 at a coupler 129. In some embodiments, the handle 101 optionally includes an anchoring member 127 that temporarily fixes the length of the suture 114 within the device 100. The fastening members 127 can be tabs, hooks, pins, clamps, and / or any suitable means for fastening to the ends of the sutures 114 .

[0038] The arms 102 are configured to facilitate placement of the anchor assembly 122 and / or anchor 130 within the annulus tissue to reshape and / or size the annulus. Each of the arms 102 includes a proximal portion 102a and a distal portion 102b. The proximal portion 102a of the arm 102 can be coupled to a corresponding elongated member 110 (shown only in FIG. 2A ) that extends proximally to the handle 101, and the distal portion 102b of the arm 102 can be coupled to a corresponding anchor assembly 122. Translation and / or rotation of a given elongated member 110 causes translation and / or rotation of a corresponding arm 102. The handle 101 can include multiple actuators (e.g., buttons, sliders, knobs, etc.), each coupled to a proximal end portion of one of the elongated members 110. Movement of a given actuator causes movement of a corresponding elongated member 110 (and thus movement of a corresponding arm 102). 1, the actuator comprises a knob 122 coupled to a proximal end portion of the elongated member 110. The knob 122 can have a linear extension in the handle 101 that couples to a corresponding elongated member 110. Rotation of a given knob 122 causes translation and rotation of the corresponding elongated member 110 (and thus translation of the corresponding arm 102). In some embodiments, the actuator for controlling the translation and / or rotation of the elongated member 110 and / or arm 102 is a slider, and translation of the slider causes translation of the corresponding elongated member 110 and / or arm 102. According to an embodiment, a single one of the actuators may control the translation and / or rotation of two or more arms simultaneously.

[0039] The individual elongated members 110 can comprise, for example, wires, tubes (as shown in FIG. 2A), twisted wires (as shown in FIG. 25A), braided wires, braided tubes, coils, and / or other suitable configurations. The elongated members 110 can comprise metal or polymeric materials. In some embodiments, the proximal end portion 102a of each of the arms 102 is substantially secured to a distal end portion of one of the elongated members 110 via a band 108 that extends around both the elongated member 110 and the arm 102. The band 108 may be crimped over and along the ends of the elongated member 110 and the arm 102. The elongated members 110 can be coupled to the arms 102 via other fastening means. For example, in those embodiments in which the elongate member 110 comprises a braided or twisted wire, the elongate member 110 can be braided or twisted over the end of the arm 102 (or into the lumen of the arm 102 if the arm 102 is a tube) and secured with adhesive and / or a crimp band. In some embodiments, the device 100 does not include any elongate member 110, and instead the arm 102 has a sufficient length to extend proximally back into the handle.

[0040] 2A and 2B includes eight arms evenly spaced about the longitudinal axis L of the device 100. In some embodiments, the distal assembly 103 may include more or less than eight arms (e.g., two arms, three arms, four arms, five arms, six arms, seven arms, nine arms, ten arms, etc.) and / or the arms 102 may be non-uniformly distributed.

[0041] One, some, or all of the arms 102 can comprise elongated elements such as flexible tubes (e.g., metal tubes, polymer tubes, laser-cut tubes, etc.), solid rods, ribbons, or other suitable structures. FIGS. 3A and 3B illustrate the arms 102 isolated from the distal assembly 103 shown in FIGS. 2A and 2B. The arms 102 are shown in a low-profile delivery state in FIG. 3A and in a relaxed, unconstrained state in FIG. 3B. As shown, at least in the relaxed, unconstrained state, the arms 102 can each have a pre-set curve and / or bend along the longitudinal axis of the individual arm 102. For example, in some embodiments, some or all of the arms 102 can comprise a superelastic and / or resilient material (such as Nitinol or a similar metal alloy) that has been heat treated such that the arms 102 each are configured to assume a pre-set curved and / or bent configuration upon release from a delivery sheath (such as the elongated shaft 120). The arm 102 can have a continuous radius of curvature along its length, or may have a varying radius of curvature. In some embodiments, the radius of curvature of the arm 102 decreases toward the distal end portion 102b of the arm 102.

[0042] Some or all of the arms 102 can have the same curvature, or some or all of the arms 102 can have different curvatures. Similarly, some or all of the arms 102 can have the same radius of curvature, or some or all of the arms 102 can have different radii of curvature. Some or all of the arms 102 can have the same length, and some or all of the arms 102 can have different lengths. Some or all of the arms 102 can have the same cross-sectional shape, and some or all of the arms 102 can have different cross-sectional shapes. Some or all of the arms 102 can have the same cross-sectional dimensions, and some or all of the arms 102 can have different cross-sectional dimensions. The curvature, length, cross-sectional shape, and cross-sectional dimensions of each of the arms 102 can be selected based on the shape and / or size of the annulus to be treated.

[0043] At least some of the arms 102 include a first, relatively smooth side and a second side having a plurality of coupler engagement elements configured to engage arm engagement elements 117 on the coupler 106 (FIG. 5A) and fix the axial position of one, some, or all of the arms relative to the coupler 106 and / or relative to each other. In some embodiments, the corresponding engagement members of the arms 102 and coupler 106 are configured to allow movement in a single direction, similar to a ratchet. In these and other embodiments, the engagement members of the arms 102 and coupler 106 have an integrated release mechanism that allows bidirectional movement when an operator desires to adjust one of the arms, as discussed in further detail below.

[0044] In some embodiments, the coupler engaging elements comprise a plurality of protrusions 112 (individually labeled 112a-112f, proximal to distal) spaced apart by notches 111 along the length of the arm 102, as shown, for example, in FIGS. 3A and 3B. For example, in some embodiments, the arm 102 is made from a solid rod where selected portions (notches 111) are removed along only one circumferential side of the rod, thereby leaving the protrusions 112. Because the protrusions 112 are formed from the remaining material of the solid rod, the diameter of the arm 102 at the protrusions 112 is the same as any other portion of the rod where no material has been removed. Some or all of the arms 102 can have the same number of coupler engaging elements 112, and some or all of the arms 102 can have different numbers of coupler engaging elements 112. In some embodiments, the engaging elements may comprise anchoring structures other than the coupler engaging elements.

[0045] 3A and 3B, the proximal-most notch 121 can be longer than the more distal notch 111. This provides the physician with more freedom (relative to a notch having a shorter length) in translating the arm 102 proximally or distally before engaging the coupler 106 with the first (proximal-most) projection 112a. Similarly, the length of the proximal notch 121 dictates the distance the extension structure 105 and coupler 106 can travel from a proximal-most starting position without also moving the arm 102, as discussed below.

[0046] The protrusion 112 can have a beveled proximal surface 113 and a distally facing step 115. The beveled proximal surface 113 allows distal advancement of the coupler 106 over (or proximal movement of) the arm 102, while the step 115 prevents proximal movement of the coupler 106 beyond the step 115, at least when the arm 102 is in certain rotational orientations. The arm 102 is configured to be positioned through one of the first openings 116 in the coupler 106 (see FIG. 5A ) such that a first side of the arm 102 is radially closer to a center of the coupler 106 and a second side of the arm 102 is radially closer to an edge of the coupler 106. In such an orientation, the second side of the arm 102 , i.e., the side having the protrusion 112 , is circumferentially aligned with the arm engaging element 117 on the coupler 106 .

[0047] In some embodiments, for example as shown in FIGS. 4A and 4B, one, some, or all of the arms 102 have a preset bend 103a that effectively divides the individual arm 102 into a generally linear proximal region positioned at a first angle relative to the longitudinal axis L of the device 100 and a generally linear distal region positioned at a second angle relative to the longitudinal axis L of the device 100 (and angled relative to the proximal region). The second region can be distal to the first region along the longitudinal axis of the individual arm 102, and the second angle can be greater than the first angle. The distal portion can advantageously be linear to allow the anchor 130 to extend inside the tube of the arm to which it is to be connected. Having a larger curvature in the bend 103a allows the arm 102 to extend a greater distance from the coupler 106, if desired. In some embodiments, both the proximal and distal regions are curved, both the proximal and distal regions are linear, or the proximal region is linear and the distal region is curved, hi some embodiments, the arm 102 is preset to assume a continuous or near continuous curve.

[0048] In some embodiments, one, some, or all of the arms 102 have multiple pre-set bends along their respective longitudinal axes, for example as shown in Figures 4A and 4B. For example, in some embodiments, one, some, or all of the arms 102 can have a first pre-set bend 103b at or near the connection to the extension member 110 and a second pre-set bend 103a along an intermediate portion of the arm 102. The first pre-set bend 103b can be located, for example, at a location along the longitudinal axis of the respective arm 102 that is between the proximal-most locking element and the joint between the articulated arm 102 and the respective extension member 110. In any of the embodiments having one or more pre-set bends along one or more of the arms 102, the portion of the arm 102 on either side of the bend can be approximately linear or curved.

[0049] 5A and 5B are isolated top and perspective views, respectively, of the coupler 106. The coupler 106 may be configured to hold the arms 102 in a desired spatial arrangement and prevent axial movement of the arms 102 relative to one another once the coupler 106 engages one or more coupler engagement elements on the arms 102 (as detailed herein). As best shown in FIG. 2B, the device 100 may include an extension structure 105 configured to extend between the coupler 106 and the handle 101 and provide the operator with translational and / or rotational control of the coupler 106. For example, the extension structure 105 may have a proximal end portion coupled to a slider 126 (or any other actuator) on the handle 101 (FIG. 1) and a distal end portion secured to the coupler 106. The extension structure 105 may extend through the extension shaft 120 generally parallel to the extension member 110. Translation of the slider 126 causes translation of the extension structure 105, thereby causing translation of the coupler 106. In some embodiments, the actuator for controlling the translation of the extension structure 105 and / or the coupler 106 is a knob, and rotation of the knob causes translation of the extension structure 105. Distal translation of the extension structure 105 and the coupler 106 from a starting proximal-most position does not also cause the arm 102 to move distally. However, once the coupler 106 reaches a first notch on the arm 102, continued distal translation of the coupler 106 pushes the arm 102 forward, thereby ejecting the arm 102 (and the distal assembly 103) from the extension shaft 120. To move the coupler 106 distally over the arms 102 (to engage the coupler engagement element 112), one or more actuators 124 on the handle 101 can be actuated to releasably fix the axial and / or rotational position of the arms 102 relative to the handle 101. The handle 101 can include an actuator 124 for each arm 102 such that the axial position of each arm 102 relative to the coupler 106 can be independent of the axial position of the other arms 102.In some embodiments, a single actuator 124 can axially and / or rotationally simultaneously secure two or more arms 102. The actuator 124 can be a screw, knob, clamp, button, and / or other releasable securing means.

[0050] The elongated structure 105 can be a solid rod or a hollow tube. In those embodiments in which the elongated structure 105 is a hollow tube, the sutures 114 (and / or other components) can extend through the lumen of the elongated structure 105 from the handle 101 to the distal assembly 103. In some embodiments, for example as shown in FIGS. 6A and 6B, the elongated structure 105 comprises a laser cut tube. A distal end portion of the tube can be secured to the coupler 106 (e.g., via welding, adhesive, snap fit, friction fit, crimp, or other suitable attachment means) and a proximal end portion can be coupled to the handle 101. The tube can have a first, more proximal portion 105a that does not include any cuts and a second, more distal portion 105b that includes a series of circumferentially extending cuts that increase the flexibility of the tube along that portion. This increased flexibility allows the elongated structure to track near the heart and around sharp turns therein. In some embodiments, the angle of the laser cuts is between about 0.1 degrees and about 20 degrees. The uncut sections are also designed to alternate at about 90 degrees to one another, which allows the tube to bend in multiple directions.

[0051] In some embodiments, the elongation structure 105 comprises an elongation shaft having a lumen configured to slidably receive the elongation member 110 such that the elongation shaft surrounds the elongation member 110. In such embodiments, the elongation shaft can have a diameter that substantially corresponds to the diameter of the coupler 106 such that a distal end of the elongation shaft is coupled to the coupler 106 around the circumference of the coupler 106.

[0052] As shown in FIGS. 5A and 5B, the coupler 106 can comprise a disk having a plurality of openings extending therethrough. The plurality of openings can include one or more first openings 116 and one or more second openings 118. Each of the first openings 116 can be configured to partially or completely receive one of the arms 102 therethrough. The second openings 118 can be configured to receive a distal end portion of the elongated structure 105 as detailed herein. Additionally or alternatively, the second openings 118 can be configured to receive one or more other components of the system therethrough, such as an imaging element for better visualization during the procedure, a locking catheter configured to lock the suture in place before the device is removed, a suture 114, a cutting catheter, a locking and cutting catheter, etc. In some embodiments, the coupler 106 can include additional openings. 5A and 5B, the first openings 116 are evenly spaced around the circumference of the coupler 106, and the single second opening 118 is positioned in a more central portion of the coupler 106. In some embodiments, the first and second openings 116, 118 can have other arrangements, for example, as described herein with reference to FIGS.

[0053] It should be understood that the elongated structure 105 can engage and / or couple to the coupler 106 at other non-central locations. For example, in some embodiments, the coupler 106 includes a third opening (not shown) configured to receive and / or be coupled to a distal portion of the elongated structure 105, and the second opening 118 (whether centrally or otherwise located) can be configured to receive a suture locking device therethrough. In some embodiments, the elongated structure 105 can include one or more coupler engaging elements configured to engage the coupler 106 and fix the axial position of the elongated structure 105 relative to the coupler 106. The coupler engaging elements can be similar to any of the coupler engaging elements described herein with reference to the arm 102.

[0054] In some embodiments, the coupler 106 can include one or more recesses 119 extending radially inward from an outer edge of the coupler 106. The recesses 119 can be configured to receive wires, shafts, or other components passing therethrough from the handle 101 to the distal portion 100b of the device 100. The recesses 119 can be positioned between adjacent first openings 116 such that the coupler 106 includes alternating recesses 119 and first openings 116 in a circumferential direction. In some embodiments, the coupler 106 does not include any recesses 119, for example, as shown in FIGS. 2A and 14.

[0055] As best shown in FIG. 5A, the coupler 106 can include one or more engagement elements configured to engage one or more coupler engagement elements of the arm 102 and / or the extension structure 105. For example, the coupler 106 can include one or more arm engagement elements 117 disposed within one, some, or all of the first openings 116. The arm engagement elements 117 can be configured to engage one or more coupler engagement elements 112 and / or other portions of the arm 102, thereby creating a reversible ratchet means for axial movement of the coupler 106 relative to the arm 102. Each arm engagement element 117 is configured to allow rotation and translation of the arm 102, as desired, while also allowing selective engagement of the arm 102 and preventing proximal movement of the arm 102. As described above, one, some, or all of the coupler engaging elements 112 of a particular arm 102 can be disposed on only one side of the arm 102, and the arm engaging element 117 of the coupler 106 can comprise a ridge disposed along only a portion of the inner surface that defines the corresponding first opening 116. Thus, the coupler engaging element 112 of the arm 102 only engages (and locks into place with) the arm engaging element 130 in the first opening 116 when the coupler engaging element 112 of the arm 102 is circumferentially aligned with the arm engaging element 117 in the first opening 116. One, some, or all of the arms 102 can be shaped to include one or more bends (e.g., as described herein) that facilitate and / or further secure engagement with the arm engaging element 117. For example, one, some, or all of the arms 102 may be biased radially outward such that when the arms 102 are positioned in the correct orientation, the arms 102 are urged toward the arm engaging element 117 (or any other engaging element). If the arm 102 is rotated such that the coupler engaging element 112 is out of alignment with the arm engaging element 117, the arm 102 becomes uncoupled from the arm engaging element 117 and can move axially relative to the first opening 116.The ability to decouple the arm 102 from the coupler 106 allows for repositioning of one or more arms 102 of the device 100, which can be beneficial, for example, when an operator desires to retract and reposition an arm 102 as needed.

[0056] Once the arms 102 are positioned at a desired location relative to the annular tissue (such as supraannular tissue), the anchor assembly 122 is proximate and / or contacts the tissue, the axial and / or rotational position of the arms 102 can be fixed (e.g., via actuator 124) and the coupler 106 is advanced distally over the arms 102, thereby drawing the arms 102 toward each other as the arm engaging element 117 of the coupler 106 engages the coupler engaging element 112 of the arms 102, thereby locking the arms 102 in place (at least temporarily).

[0057] The arm engaging elements 117 can have any number of shapes and may be positioned at any circumferential and / or axial location within the first openings 116. For example, as shown in FIG. 5A, one, some, or all of the arm engaging elements 117 can have a radial inner surface that extends along a generally curved path. In some embodiments, the arm engaging elements 117 can have a radial inner surface that extends along a generally linear path. In some embodiments, one, some, or all of the arm engaging elements 117 have a radial inner surface that has one or more portions that extend along a generally curved path and one or more portions that extend along a generally linear path. In some embodiments, the arm engaging elements 117 comprise a single protrusion within a corresponding first opening 116. In some embodiments, the arm engaging elements 117 comprise multiple protrusions within a particular first opening 116. One, some, or all of the first openings 116 can have the same number of arm engaging elements 117. One, some, or all of the first openings 116 can have different numbers of arm engaging elements 117. The arm engaging elements 117 in one, some, or all of the first openings 116 can have the same shape. The arm engaging elements 117 in one, some, or all of the first openings 116 can have different shapes. The arm engaging elements 117 in one, some, or all of the first openings 116 can generally be positioned at and / or span the same circumferential location and / or have the same arc length. The arm engaging elements 117 in one, some, or all of the first openings 116 can be positioned at and / or span different circumferential locations and / or have different arc lengths. The arm engaging element 117 may extend along 180 degrees or less, or 160 degrees or less, 140 degrees or less, 120 degrees or less, 100 degrees or less, 90 degrees or less, 80 degrees or less, 60 degrees or less, 45 degrees or less, 30 degrees or less, 20 degrees or less, 10 degrees or less, 5 degrees or less, 4 degrees or less, 3 degrees or less, 2 degrees or less, or 1 degree or less of the first opening 116.In some embodiments, one, some, or all of the arm engaging elements 117 may span 360 degrees or more. In some embodiments, one, some, or all of the first openings 116 do not include an arm engaging element 117.

[0058] In accordance with some aspects of the present technology, the coupler 106 additionally or alternatively includes one or more elongated structure engaging elements in the second opening 118. For example, in some embodiments, the coupler 106 has one or more ridges in the second opening 118 and / or one or more of the other openings in the coupler 106. The elongated structure engaging elements can interface with coupler engaging elements on the elongated structure 105 in a manner similar to that described above with respect to the arm engaging elements and coupler engaging elements on the arms.

[0059] Coupler 106 is configured to hold portions of arms 102 together radially, with arms 102 each having a length proximal to coupler 106 and a length distal to (and cantilevered from) coupler 106. In some embodiments, arms 102 are configured to slide axially through the openings, for example, in response to axial movement of a corresponding elongated member 110. Additionally or alternatively, arms 102 can rotate within their respective openings, for example, in response to rotation of a corresponding elongated member 110.

[0060] One, some, or all of the arms 102 can be configured to move independently of one another, thereby allowing independent adjustment of each anchor assembly 122 and / or anchor 130 of the device 100. This provides the operator with localized geometric control to customize the size and site of anchoring. In some embodiments, one, some, or all of the arms 102 are configured to rotate about their own longitudinal axis, independent of one another. Additionally or alternatively, one, some, or all of the arms 102 may be configured to move axially relative to one another.

[0061] In some embodiments, the elongated shaft 120 is steerable. The device 100 can include an elongated member (not visible) extending between a distal end portion of the elongated shaft 120 and an actuator 128 in the handle 101. The elongated member can be a wire, suture, tubular member, or the like. Rotation of the actuator 128 in a first direction retracts the elongated member, thereby causing deflection and / or bending of the elongated shaft 120. Rotation of the actuator 128 in a second direction releases tension on the elongated member, thereby straightening the elongated shaft 120. In some embodiments, the actuator 128 actuates the elongated member via translation (rather than rotation). In some embodiments, the actuator 128 actuates the elongated member via translation and rotation. In some embodiments, the device 100 includes a second elongated member extending between a distal end portion of the elongated shaft 120 and a second actuator (not shown) in the handle 101. Tension on the second elongate member can cause deflection and / or bending of the elongate shaft 120 in a direction different than the direction of deflection and / or bending caused by the elongate member coupled to the actuator 128 .

[0062] As described above, each of the anchors 130 and / or anchor assemblies 122 can be carried by a different one of the arms 102. In some embodiments, each of the anchors 130 may be removably coupled to a corresponding one of the arms 102 such that, upon completion of treatment, the arms 102 may be removed from the patient (along with the remainder of the device 100) with only the anchors 130 and sutures 114 remaining embedded in the valve annulus. For example, the anchors 130 can be mechanically or electrically detachable from the distal portion 102b of the arms 102. In some embodiments, the handle 101 includes an actuator that, when triggered by an operator, causes one, some, or all of the anchors 130 to be released from the corresponding arms 102.

[0063] 7 and 8 are perspective and cross-sectional views of anchor assembly 122. Anchor assembly 122 can include a cylindrical housing 182 coupled to a distal end portion 102b of a corresponding arm 102 and an anchor 130 disposed partially or completely within housing 182. Generally, anchor assembly 122 is configured to deliver anchor 130 to a treatment site and facilitate insertion of anchor 130 into tissue at a desired location. In some embodiments, anchor assembly 122 is configured to contain anchor 130 within a lumen of housing 182 until arm 102 exerts sufficient axial force on anchor 130 to eject anchor 130 from housing 182.

[0064] As shown in FIGS. 7 and 8 , the housing 182 has a proximal end portion 182a and a distal end portion 182b. The proximal end portion 182a of the housing 182 defines an opening through which the distal end portion 102b of the arm 102 extends. The distal end portion 182b defines an opening 186 through which the anchor 130 is configured to pass in a low-profile state as the anchor 130 is ejected from the housing 102. In some embodiments, the housing 182 optionally includes diametrically opposed notches 184 extending proximally from the distal end surface. The notches 184 can be configured to receive retraction and delivery lengths of the suture 114 (shown only in FIG. 8 ) and help guide the path of the suture 114 between adjacent anchor assemblies 122. The housing 182 can include a cylindrical sidewall defining a lumen configured to receive the anchor 130 in a generally linear low-profile delivery state. The lumen can be sized such that the anchor 130 remains within the lumen based on frictional forces between the anchor 130 and an inner surface of the housing 182. In some embodiments, the anchor 130 is biased to assume a curved configuration upon release from the housing 182, and thus, when contained therein, continuously presses outward against the inner surface of the housing 182. The housing 182 can include a slot 180 extending along at least a portion of its length configured to receive a guide 188 coupled to a distal end of the arm 102. The guide 188 can be configured to slide along and within the slot 180, thereby preventing rotation of the arm 102 relative to the housing 182. In some embodiments, the arm 102 is configured to rotate relative to the housing 182 (or vice versa). For example, in some embodiments, the housing 182 does not include the slot 180 and / or the arm 102 does not include the guide 188.

[0065] In use, the operator pushes the distal end surface of the housing 182 into contact with the annulus tissue (e.g., by distal advancement of the corresponding arm 102) at the desired anchor insertion site. The tissue resists distal movement of the housing 182, but the operator continues to push the corresponding arm 102 distally, thereby urging distal movement of the arm 102 relative to the housing 182. As the arm 102 moves distally within the housing 182, the arm 102 pushes the anchor 130 through the distal opening of the housing 182 and into the tissue.

[0066] In some embodiments, device 100 includes an elongate member (e.g., a wire, tube, etc.) (not shown) having a distal end portion coupled to anchor 130 and a proximal end portion coupled to handle 101. For example, the distal portion of the elongate member can extend through an opening 138 in anchor 130 and / or otherwise be coupled to proximal portion 130a of anchor 130 and then extend proximally through or along a lumen of arm 102 (if arm 102 includes a lumen) back to handle 101. If the operator is not satisfied with the deployment of anchor 130, the physician can retract the elongate member rearward to retract anchor 130 proximally, out of the tissue, and back into housing 182. With respect to any of the anchors discussed with reference to Figures 9 and 31A-35, removal of anchor 130 into housing 182 straightens the bend in anchor 130 and forces anchor 130 into a radially collapsed and / or generally linear configuration that fits within the lumen of housing 182.

[0067] Upon completion of treatment, the arms 102 may be removed from the patient (along with the remainder of the device 100) leaving only the anchors 130 and sutures 114 embedded in the valve annulus. The releasability of the anchors 130 is advantageous because it allows treatment with little or no mechanical equipment remaining in the patient, especially compared to conventional devices such as the IRIS Transcatheter Valvuloplasty Ring System (Boston Scientific, Marlborough, Massachusetts). The releasability of the anchors 130 also allows the physician to perform a valve replacement procedure or limbal repair in the future. FMR (MitraClip TM Typical limbal repair therapies (such as for Abbott Cardiovascular, MN, USA) do not allow for room for future intervention to secure the valve. In some embodiments, one or more of the anchors 130 can be fixed to the corresponding arm 102 (i.e., non-detachable).

[0068] FIG. 9 is an isolated view of an anchor 130 configured in accordance with the present technology. The anchor 130 comprises a proximal portion 130a configured to be coupled to the suture 114 and a distal portion 130b configured to penetrate and be embedded in the annulus tissue. The proximal portion 130a comprises an opening 138 configured to receive the suture 114 therethrough. In some embodiments, the proximal portion 130a and / or the opening 138 can be configured to be removably coupled to a component of the device 100 (e.g., a distal end portion of the arm 102, a portion of the anchor assembly 122, a portion of the anchor assembly housing 182, etc.). As shown in FIG. 9, the anchor 130 can comprise at least two arms 132, all or a portion of which are configured to be embedded in tissue. Each of the at least two arms 132 has a distal tip 136 configured to penetrate the annulus tissue. In some embodiments, the distal tip 136 is beveled to provide a sharp surface. In other embodiments, the distal tip 136 is blunt.

[0069] In some embodiments, including those depicted by FIG. 9, the anchor 130 can be formed from an elongated member, such as a wire, that is bent back on itself to form an opening 138. The wire can have a circular, rectangular, square shape, or other cross-sectional shape. The proximal end of the arm 132 is continuous in the bend and the distal end corresponds to the distal end portion 130b of the anchor 130. The elongated member can be formed from a superelastic and / or resilient material, such as Nitinol, cobalt chrome, and / or alloys thereof. The wire can have a diameter of about 0.30 mm to about 0.50 mm, about 0.35 mm to about 0.45 mm, about 0.40 mm to about 0.45 mm, about 0.40 mm, about 0.43 mm, or about 0.45 mm. While using a larger diameter wire increases the overall surface area and strength of the wire, such stiffness also increases friction between the anchor 130 and the anchor assembly housing 182, making it more difficult to push the anchor 130 out of the housing 182. For example, all else being equal, the inventors have found that anchors formed using 0.43 mm or larger wire are significantly more difficult to deploy than anchors formed from 0.40 mm wire. As discussed below with reference to FIGS. 33-35, in some embodiments, the anchor 130 is cut from a sheet of material (including superelastic and / or resilient materials). In either case, the elongate member can be shaped (e.g., via heat treatment) such that the elongate member is biased to assume a desired curved shape upon release from the housing 182 of the anchor assembly 122. In some embodiments, the elongate member can be shaped such that the plane of the opening 138 is approximately 90 degrees from the direction along which the distal tip 136 extends.

[0070] 9, in some embodiments, the arms 132 may cross over one another between the proximal and distal portions 130a, 130b of the anchor 130 while still generally extending along the same path. The intersections 134 between the arms 132 can provide additional structural support to the tissue engaging portion of the anchor 130, thereby improving fixation with tissue. In some embodiments, the arms 1302 do not cross over one another between the proximal and distal portions 130a, 130b of the anchor 130, as shown, for example, with reference to FIGS. 32C and 32F.

[0071] To demonstrate the superior performance of the anchor 130 of the present technology over existing anchors, the inventors conducted tensile tests on ten samples of the anchor design shown in FIG. 9 ("Test Anchors") and two sample groups of prior art anchor designs shown in FIG. 10. Unlike the test anchors, the legs of the prior art anchors diverge laterally after crossing. One of the prior art groups consisted of eight samples made using 0.40 mm Nitinol wire ("Group I") and the other prior art group consisted of seven samples made using 0.45 mm Nitinol wire ("Group II"). The test anchors were made from 0.40 mm Nitinol wire. Testing was performed using an AMETEK DFE II force gauge. The anchors were inserted into the sheep's hearts using a single arm and anchor assembly. The ends of the anchors were pre-attached with sutures. Once the anchor was embedded in the tissue, the free end of the suture was attached to a force gauge and pulled, measuring the force. The maximum force required to pull the anchor out of the tissue was then recorded, and the results are seen in Table 1 below.

[0072] As demonstrated, the anchor design of the present technology is capable of supporting 1.75 times the maximum load of the prior art anchor, even at the increased wire sizes of Group II. [Table 1]

[0073] In use, the device 100 can be positioned within a blood vessel at or near a native annulus, such as a heart valve annulus, with the arms 102 contained within a delivery sheath in a low-profile delivery configuration. In some embodiments, the arms 102 can be released from the constraint of the delivery sheath by pushing the arms 102 through an opening at the distal end of the elongated shaft 120. For example, as described above, the coupler 106 can be advanced distally until it engages a proximal portion of the arms 102, at which point continued axial advancement of the coupler 106 also advances the arms 102 (unless the arms are axially fixed by one or more actuators, as discussed above). In some embodiments, the elongated shaft 120 can be retracted proximally to expose the arms 102, thereby allowing the arms 102 to extend radially away from the longitudinal axis L of the device 100 into a deployed configuration. In either case, device 100 can be deployed adjacent to and above the valve annulus such that anchor assembly 122 is positioned adjacent to the annulus tissue just above the plane of the valve orifice.

[0074] The arms 102 can be independently adjusted to precisely position each anchor 130 according to a particular valve geometry. Thus, the device 100 of the present technology is configured to treat a wide variety of annulus shapes and sizes. Once the anchor assembly 122 and / or anchor 130 are in a desired position relative to the annulus tissue, the arms 102 can be advanced distally to urge the anchor 130 out of the anchor assembly 122 and into the annulus tissue. Each of the arms 102 can be advanced separately to deploy the anchor 130, or some or all of the arms 102 can be advanced simultaneously to simultaneously deploy the anchors 130. For example, in some embodiments, axial translation and / or rotation of the coupler 106 rotates all of the arms 102 simultaneously such that the anchors 130 engage and / or embed in the tissue substantially simultaneously, thereby saving procedure time. In some embodiments, an operator may deploy anchor 130 for a first one of arms 102 and then adjust the position of a second one of arms 102 before deploying anchor 130 associated with the second one of arms 102. In some embodiments, one or more of arms 102 can be translated and / or rotated to partially or completely remove anchor 130 from tissue.

[0075] Once the anchors 130 are sufficiently secured to the annulus tissue, the coupler 106 can be moved relative to the arms 102 (or vice versa) to draw the arms 102 together to reshape and / or size the annulus. Generally, advancing the coupler 106 distally relative to the arms 102 reduces the angle and / or circumferential distance between a) adjacent arms and / or b) adjacent anchors. Similarly, advancing the coupler 106 distally relative to the arms 102 reduces the angle between the individual arms 102 and the longitudinal axis L. In some embodiments, the coupler 106 can be advanced distally over the arms 102 until it engages at least a first (or most proximal) level of coupler engagement element 112 along the arms 102. The stepped surface of the coupler engagement element 112 prevents the coupler 106 from moving proximally beyond the groove 112, thus limiting axial movement between the coupler 106 and the arms 102. Regardless of the engagement of the coupler 106 with the coupler engaging element 112, the arm 102 maintains the ability to rotate within its respective opening in the coupler 106. Additionally, as discussed above, in some embodiments, the arm 102 can rotate within its respective opening to unlock its axial position. If the operator desires to reduce the area of ​​the annulus even further, the coupler 106 can be advanced distally over the arms 102 until it engages at least a second level coupler engaging element 112 distal to the first level coupler engaging element 112 along the arms 102. In some embodiments, the coupler 106 and at least one of the arms 102 can be held in place while one or more of the other arms 102 are pulled proximally to engage the next level coupler engaging element 112. Thus, depending on the needs of a particular modification, the coupler 106 is configured to engage different levels of grooves on different arms 102. For example, the coupler 106 can simultaneously engage with a first coupler engagement element level 112 on one of the arms 102 and a second coupler engagement element level 112 on another of the arms 102.

[0076] 11A diagrammatically depicts looped portion 114a of suture 114 extending around the annulus prior to arms 102 and / or anchors 130 modifying the size and / or shape of the annulus. The location of anchor 130 is indicated by an X, and suture tail 114b is not shown. Once anchor 130 has penetrated and secured to tissue and the shape and / or size of the annulus has been modified (e.g., by coupler 106 pulling arms 102 inward), the circumference of the annulus will be less than it was prior to the modification, and thus some slack 123 will be present in looped portion 114a of suture 114. In some embodiments, slack in the suture 114 can be removed as the arms 102 draw the annulus together, for example, by an operator pulling on exposed ends of the suture 114 that extend from coupler 129 on handle 101 (FIG. 1). In either case, the suture 114 only passively participates in modifying the annulus shape and / or size, as it is the arms 102 of the device that provide the inward force that modifies the shape and / or size of the annulus. This is in contrast to some prior art devices, which fasten the sutures and draw the annulus tissue together, as diagrammatically demonstrated in FIGS. 13A and 13B.

[0077] Once the annulus has been modified to a desired shape and / or size by the arms 102 and / or anchors 130, the length of the suture 114 extending between the anchors 130 can be adjusted to approximate the new, shorter length of the circumference of the annulus (as shown in FIG. 11B). The suture 114 can then be fixed at that length such that upon removal of the arms 102 and the remainder of the device, the suture 114 will hold the anchors 130 in the modified shape. For example, the device 100 can include an extension shaft (not shown) configured to be advanced distally over the tails 114b of the sutures 114, thereby coalescing the more distal portions of the tails 114b. One example of an extension shaft is the finishing device disclosed herein. Other devices are also possible. The extension shaft can be advanced until a distal end portion of the extension shaft is positioned where the tails branch into the looped portion of the suture 114. The device 100 may further include a locking means (either incorporated into the elongate shaft or separate from the elongate shaft) that effectively ties, fastens, or otherwise secures the length of the suture 114, as shown, for example, by locking element 125 in FIG. 11C. With reference to FIG. 12, in some embodiments, the device 100 may include locking elements 127a, 127b (shown diagrammatically) that are delivered (e.g., via the elongate shaft) at the ends 115a, 115b of the looped portion 114a proximate to an opening 138 in the anchor 130. The locking elements 127a, 127b are secured to the suture 114 and may have a cross-sectional dimension that exceeds the cross-sectional dimension of the opening 138 in the anchor 130. Thus, once in position, the locking elements 127a, 127b prevent migration of the suture 114 through the opening 138. In some embodiments, locking elements can be incorporated into arms 102, anchor assemblies 122, anchors 130, and / or sutures 114 and manipulated into a locked position by a tool advanced to the treatment site.In either case, the suture 114 may then be cut with an extension shaft (or another tool, such as one of the finishing devices disclosed herein) to remove the remaining suture 114 from the treatment site. I. Additional Embodiments

[0078] 14 is a top view of a coupler 106 for use with the treatment device 100 of the present technology. The coupler 106 can be substantially the same as the coupler 106 described with respect to FIGS. 5A and 5B, except that the coupler 106 does not include a recess cut into its circumferential edge.

[0079] 15 is a top view of a coupler 106 for use with a treatment device 100 of the present technology. The coupler 106 can be substantially similar to the coupler 106 described with respect to FIG. 14, except that the coupler 106 does not include an arm engagement element within the first opening 116.

[0080] FIG. 16 is a top view of a coupler 106 for use with a treatment device 100 of the present technology. The coupler 106 can be similar to the coupler 106 of FIG. 15, except that the coupler 106 has a cutout 1500 through which two or more arms 102 are configured to extend. Similarly, the coupler 106 shown in FIG. 17 has an opening 1600 configured to receive two or more arms 102 therethrough. The couplers shown in FIGS. 16 and 17 can be beneficial because they allow movement of the coupler 106 without engaging at least some of the arms (i.e., arms that extend through the cutout 1500 or opening 1600). In some embodiments, one or more of the arms do not include any coupler engagement elements such that movement of the arm is decoupled from movement of the coupler 106.

[0081] FIG. 18 is a top view of a coupler 406 for use with a treatment device of the present technology. Similar to coupler 106, coupler 406 can comprise a disk having multiple openings extending therethrough. The multiple openings can include one or more first openings 416 and one or more second openings 418. Each of the first openings 416 can be configured to receive one of the arms 102 therethrough. The second openings 418 can be configured to receive an end of an elongated structure to couple coupler 406 to a proximal portion of the system. In some embodiments, coupler 406 can include additional openings. In contrast to coupler 106 shown in FIGS. 5A and 5B, the second opening 418 of coupler 406 is positioned on one side of the disk and the first opening 416 is disposed on a second side of the disk. In such an embodiment, one or more of the arms 102 may be longer and / or have a greater curvature to compensate for the offset positioning at the coupler 106. Additionally or alternatively, the first openings 416 may be arranged in a D-shape, thereby orienting the arms 102 in a similar shape to mimic the natural contour of the mitral valve annulus. In some embodiments, the first openings 416 may be arranged in other shapes or have other configurations. The second openings 418 may be positioned anywhere along the area of ​​the coupler. For example, the second openings 418 may be offset from the first openings 416 (as shown in FIG. 18) or may be positioned between the first openings 416 (e.g., as shown in FIGS. 5A and 19). In either case, the second openings may be sized to receive an imaging element (as described herein), a suture, a tool for locking and / or cutting the suture, and / or another component.

[0082] FIG. 19 illustrates an exemplary coupler 506 configured in accordance with some embodiments of the present technology. The coupler 506 can be used with any of the devices disclosed herein. As illustrated in FIG. 19, in some embodiments, the coupler 506 includes a plurality of first openings 516 arranged in a D-shape around the coupler 506 and a second opening 518 between and surrounded by the first openings 516. In these couplers and any of the embodiments disclosed herein, the coupler 506 can have a non-circular shape. For example, in some embodiments, the coupler 506 can have a D-shape, as illustrated in FIG. 20. In these and other embodiments, the shape of the coupler can be square, rectangular, elliptical, oval, triangular, polygonal, etc., and / or can have curved and / or linear edges. In the embodiment depicted by FIG. 20, the D-shaped coupler 506 has a D-shape and first openings arranged in a D-shape. In some embodiments, the D-shaped coupler 506, or any shape coupler described herein, has openings in other arrangements, such as circular, rectangular, elliptical, oval, triangular, polygonal, etc.

[0083] 21 illustrates an example coupler 506 configured in accordance with some embodiments of the present technology. The coupler 506 can be used with any of the devices disclosed herein. As shown in FIG. 21, in some embodiments, the coupler 506 includes a plurality of first openings 516 arranged in a D-shape around the coupler 506, and a second opening 518 between and surrounded by the first openings 516.

[0084] As shown in FIG. 22, in some embodiments, the device 600 can include first and second couplers 606a, 606b configured to be arranged side-by-side within the delivery sheath 603. The first and second couplers 606a, 606b can each include one or more first openings 616 configured to receive the arm 102 therethrough. The remaining space 617 within the lumen of the delivery sheath can be configured to receive a suture, an elongated structure, an imaging element, and / or other components therethrough. In some embodiments, one or both of the first and second couplers 606a, 606b have one or more second openings. The first and second couplers 606a, 606b can have the same or different number of openings and / or the same or different shapes. In some embodiments, the first and second couplers can have other arrangements.

[0085] 23A-23C depict a configuration in which the device includes first and second couplers 706a, 706b arranged co-linearly within a delivery sheath 703. In FIG. 23A, a portion of the sidewall of the delivery sheath 703 has been removed to show the first and second couplers. FIG. 23B is a top view of the first coupler 706a and FIG. 23C is a top view of the second coupler 706b. The first and second couplers 706a, 706b can have one or more first openings and one or more second openings, as shown diagrammatically in FIG. 23A-23C.

[0086] In some embodiments, the function of the coupler may be split into two separate components. FIG. 24A, for example, shows a portion of the device having a locating coupler 805 and a locking coupler 807, both of which are disposed within the lumen of the delivery sheath 803. In FIG. 24A, a portion of the sidewall of the delivery sheath 803 has been removed to show the couplers. FIG. 24B is a top view of the locating coupler 805, and FIG. 24C is a top view of the locking coupler 807. Referring together to FIGS. 24A-24C, the locating coupler 805 can have multiple openings (such as a first opening 816 and one or more second openings 818 configured to receive the arms therethrough) and can be configured to hold the arms and / or extension members spaced apart in a desired arrangement. The locking coupler 807 can be fixed to the inner surface 805 of the delivery sheath and can be axially rotated or translated to engage the locking elements along the arms. For example, the locking coupler 807 can be moved to align with one or more grooves 112 on the arm and lock the arm in place. In some embodiments, instead of a notch, the arm can have a thread and the locking coupler 807 would then function like a nut and bolt arrangement, i.e., the locking coupler can be rotated relative to the arm (or vice versa), causing the locking coupler 807 to move distally relative to the arm, thereby drawing the arms together.

[0087] 25A and 25B show a distal assembly 2503 configured in accordance with some embodiments of the present technology. The distal assembly 2503 can be generally similar to the distal assembly 103 of FIGS. 2A and 2B. For example, the distal assembly 103 includes an arm 102 having a coupler engagement element 112, a coupler 106, an extension member 110, an extension structure 105, a band 108, and a suture 114. The arm 102 can comprise a hollow tube such that a notch formed in the arm 102 exposes the lumen of the arm 102.

[0088] The distal end portion 102b of each arm 102 can be removably coupled to an anchor 200. In some embodiments, each anchor 200 may be removably coupled to a corresponding one of the arms 102 such that, upon completion of treatment, the arm 102 may be removed from the patient (along with the remainder of the device 100) with only the anchor 200 and the suture 114 remaining embedded in the valve annulus. For example, the anchor 200 can be mechanically or electrically detachable from the distal portion 102b of the arm 102. In some embodiments, the handle includes an actuator that, when triggered by an operator, causes one, some, or all of the anchors 200 to be released from the corresponding arm 102. For example, actuation of the release mechanism can disengage a coupling element at the distal portion 102b of the arm 102 from a coupling element at the coupling portion 202 of the anchor 200. In some embodiments, a distal portion of the arm 102 has a slot 107 and a proximal portion of the anchor 200 has a protrusion 203 that rides within the slot. To release an anchor, the corresponding arm 102 can be rotated relative to the anchor such that the protrusion 203 on the anchor 200 becomes aligned with the exit path of the slot on the arm 102 (or vice versa). By pivoting the arm 102 (clockwise or counterclockwise) to release the anchor 200, the operator can urge the arm 102 distally toward the tissue so that the anchor 200 is pushed further into the tissue and / or more surface area of ​​the anchor contacts the tissue. Thus, as the arm 102 is subsequently rotated, the tissue resists and / or prevents the anchor from rotating with the arm 102. More simply stated, the device may be configured such that a pushing and rotating motion (clockwise or counterclockwise) unlocks one, some, or all of the anchors 200 from the arms 102. In these and other embodiments, the arms 102 and anchors 200 may be coupled via a snap-fit ​​assembly such that the anchors 200 snap into the distal ends of the arms 102. To disengage, another component can slide over the arms and serve to push and release a tab on the anchor 200 back into the tube.Additionally or alternatively, the device may include one or more sutures or wires to hold the anchors to the corresponding arms. When the sutures or wires are pulled out of the handle, the anchors 200 are released as well.

[0089] Each anchor 200 can have a coupling portion 202 for removably coupling to a corresponding arm 102, an intermediate portion 204 extending distally from the coupling portion 202, and a tissue-engaging portion 206 extending laterally away from the intermediate portion 204 (portions 202, 204, and 206 are labeled on only one of the anchors 200 in each of FIGS. 25A and 25B for ease of viewing of the other components). A close-up of the tissue-engaging portion 206 of one of the anchors 200 is shown in FIG. 25C. The tissue-engaging portion 206 can be configured to engage annulus tissue atraumatically or traumatically at a specific location and secure the anchor 200 to the tissue. For example, the tissue-engaging portion 206 can include one or more hooks, tines, barbs, or other fixation components. In some embodiments, the tissue engaging portion 206 includes a first region 208 extending laterally away from the intermediate portion 204 and a second region 210 extending laterally away from the first region 208. The longitudinal axis L3 of the intermediate region 204 can be positioned at a 90 degree angle relative to the longitudinal axis L1 of the first region 208 (as shown in FIG. 25C), or the longitudinal axis L3 can be positioned at a non-90 degree angle relative to the longitudinal axis L1 of the first region 208. The angle between the intermediate region 204 and the second region 208 can be adjusted based on the desired tissue engaging properties. For example, the closer the angle between the intermediate region 204 and the second region 208 is to 90 degrees, the more difficult it will be to remove the anchor from the tissue. The longitudinal axis L2 of the second region 210 can be positioned at a non-90 degree angle relative to the longitudinal axis L1 of the first region 208. The angle between the first region 208 and the second region 210 can be adjusted based on the desired tissue engagement properties. In some embodiments, one, some, or all of the anchors 200 can be retractable by advancing and / or rotating the corresponding arm 102.

[0090] In use, the device 100 can be positioned within a blood vessel at or near a native annulus, such as a heart valve annulus, with the arms 102 contained within a delivery sheath in a low-profile delivery configuration. In some embodiments, the arms 102 can be released from the constraint of the delivery sheath by pushing the arms 102 through an opening at the distal end of the elongated shaft 120. For example, as described above, the coupler 106 can be advanced distally until it engages a proximal portion of the arms 102, at which point continued axial advancement of the coupler 106 also advances the arms 102 (unless the arms are axially fixed by one or more actuators, as discussed above). In some embodiments, the elongated shaft 120 can be retracted proximally to expose the arms 102, thereby allowing the arms 102 to extend radially away from the longitudinal axis L of the device 100 into a deployed configuration. In either case, device 100 can be deployed adjacent to and above the valve annulus such that anchor assembly 122 is positioned adjacent to the annulus tissue just above the plane of the valve orifice.

[0091] As the arms 102 extend away from the longitudinal axis L of the device 100, the anchors 200 also move radially away from the longitudinal axis L of the device 100 toward the annulus tissue in the plane of orifice or directly above it. An expansion force associated with the initial deployment of the arms 102 can bring the anchors 200 into contact with the annulus tissue. In some embodiments, the entire device 100 can be rotated about the longitudinal axis L such that the tissue engaging portions 206 of the anchors 200 penetrate or further into the annulus tissue. Each one of the arms 102 can be independently rotated and / or translated as needed to position each anchor 200 at a desired anchor point along the native annulus. The independent movement of the arms 102 allows for independent movement of the anchors 200, thereby allowing the device 100 to treat a wide variety of annulus shapes and sizes. Once anchor 200 is in a desired position relative to the annulus tissue, one or more components of device 100 can be actuated and moved to bring anchor 200 into contact with the annulus tissue. For example, in some embodiments, axial translation and / or rotation of coupler 106 rotates all of arms 102 simultaneously to substantially simultaneously engage and / or embed anchor 200 in tissue, thereby saving procedure time. In some embodiments, one or more of arms 102 are translated and / or rotated to partially or completely remove anchor 200 from tissue.

[0092] The operator can then actuate the detachment mechanism from the handle to detach the anchor 200 from the corresponding arm 102, thereby leaving the anchor 102 embedded in the valve annulus. The arms 102, couplers 106, elongated members 110, and remainder of the device 100 are then removed from the patient.

[0093] FIG. 26 shows a distal portion of a distal assembly 2603 for treating a native heart valve configured in accordance with some embodiments of the present technology. The distal assembly 2603 of FIG. 26 can have some components substantially similar to those of the distal assembly 2503 of FIG. 25A and 25B. However, in contrast to the distal assembly 2503, the distal assembly 2603 includes an anchor 904 that is non-detachable from the arm 902. For example, the anchor 904 can be part of the same monolithic piece of material as the arm 902. In the embodiment shown in FIG. 26, the arm 902 and the anchor 904 are cut from a single metal tube (e.g., a Nitinol tube or other superelastic and / or resilient material). In some embodiments, the anchor 904 and the arm 902 may be formed separately and permanently attached together, such as by welding.

[0094] In those embodiments in which the arms and anchors are permanently fixed to one another, the arms may be removably coupled to the elongated member and remain embedded in the annulus with the anchor. For example, the proximal end portions 902a of the arms 902 can each be releasably coupled to a distal end portion of an elongated member (not shown in FIG. 26) via a coupling member 909. In some embodiments, for example as shown in FIG. 26, the proximal ends of the arms are L-shaped pieces that fit into another component that is also L-shaped. That component can be crimped onto the braided wire, thus acting as one piece. The device may include a separate tube that extends across the two L-shaped ends and keeps the two pieces together. When the tube is pulled back, the two L-shaped ends separate, thus allowing the arms and coupler to remain in the patient. Snap-fit ​​assemblies, locking arrangements, and other configurations and coupling elements are also possible. For example, the components can be glued together or even fabricated from one piece of metal tubing (laser cut on the rear and front ends of the tube to form an L-shaped connection). In these and other embodiments, the proximal end portions 902a of the arms 902 can each be removably coupled to the distal end portions of the elongate member via mechanical or electrical melt removal means.

[0095] FIG. 27 shows a distal portion of a distal assembly 2703 for treating a native heart valve configured in accordance with some embodiments of the present technology. The distal assembly 2703 of FIG. 27 can have some components substantially similar to those of the distal assembly 2503 of FIG. 25A. However, in contrast to the distal assembly 2503, the distal assembly 2703 includes an anchor 1004 that is non-detachable from the arm 1002. For example, the anchor 1004 can be part of the same monolithic piece of material as the arm 1002. In the embodiment shown in FIG. 27, the arm 1002 and the anchor 1004 are cut from a flat metal ribbon (e.g., a Nitinol tube or other superelastic and / or resilient material). In some embodiments, the anchor 1004 and the arm 1002 may be formed separately and permanently attached together, such as by welding. The proximal end portion 1002a of each of the arms 1002 can be releasably coupled to a distal end portion of the elongated member 1010 via a coupler 1009. For example, the coupler 1009 can be a clip and the proximal end portion 1002a of each of the arms 1002 can include an opening configured to receive a portion of the clip. The device may further include an anchoring member (such as a tube or other component) configured to be positioned over the clip and hold the clip in a locked position (not shown). Once the anchoring member is retracted away from the clip, the clip is free to open and release the corresponding arm. In these and other embodiments, the proximal end portion 1002a of each of the arms 1002 can be releasably coupled to a distal end portion of the elongated member 1010 via mechanical or electrolytic detachment means.

[0096] FIG 28A shows a distal assembly 2803 in a first position according to some embodiments of the technology. FIG 28B is a close-up view of the anchor of the device shown in FIG 28A. The distal assembly 2803 of FIG 28A can be generally similar to the distal assembly 2503 of FIG 25A and 25B, except that the anchor 1200 shown in FIG 28A and 28B includes a curved tissue-engaging portion, as described below. The anchor 1200 can be formed (e.g., via laser drilling, CNC, EDM, etc.) from the same tube as the arms, or may be a separate component that is removably coupled to the arms.

[0097] The anchor 1200 can have a proximal portion 1200a, a distal portion 1200b, and a longitudinal axis L extending therebetween. The proximal portion 1200a can include a coupling portion for releasably coupling to a corresponding arm 102, and the anchor 1200 can further include an intermediate portion 1205 coinciding with or extending distally therefrom the coupling portion 1200a. The intermediate portion 1205 can include one or more openings 1205 configured to receive a suture therethrough.

[0098] The anchor 1200 can further include a tissue engaging portion 1206 extending away from the intermediate portion 1205. The tissue engaging portion 1206 can be configured to atraumatically or traumatically engage annulus tissue and anchor the anchor 1200 to the tissue at a specific location. For example, the tissue engaging portion 1206 can comprise one or more hooks, tines, barbs, or other fixation components. In some embodiments, the tissue engaging portion 1206 extends longitudinally away from the intermediate portion 1205 at an angle while simultaneously curving around the longitudinal axis L of the anchor 1200. The tissue engaging portion 1206 can be curved around more than about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% of the circumference of the anchor 1200, for example. The tissue engaging portion 1206 can have a radius of curvature that is greater than or less than the radius of curvature of the intermediate portion 1205. Similarly, the tissue engaging portion 1206 can extend radially beyond the radially outermost portion of the intermediate portion 1205. The tissue engaging portion 1206 includes a curved distally facing side 1208, a leading edge 1244 (which can be atraumatic or atraumatic) that extends distally from the remainder of the tissue engaging portion 1206, a proximally facing side 1242, and a proximally extending protrusion 1240. To lock the anchor into tissue, the arms can be rotated less than a full 360 degree revolution. For example, to lock the anchor into tissue, the arm can be rotated less than 270 degrees, less than 180 degrees, less than 135 degrees, less than 90 degrees, less than 45 degrees, less than 30 degrees, less than 20 degrees, less than 15 degrees, less than 10 degrees, less than 5 degrees, between 10 and 90 degrees, between 20 and 180 degrees, between 45 and 180 degrees, etc. In some embodiments, the arm can be rotated a full turn or more (1.25 turns, 1.5 turns, 1.75 turns, 2 turns, etc.).

[0099] The anchors 1200 can be detached from the corresponding arms via any of the release mechanisms disclosed herein.

[0100] 29 and 30 are perspective and cross-sectional views of an anchor assembly 2922. The anchor assembly 2922 can be configured to deploy a corresponding anchor 130 into tissue in response to an axial force above a predetermined threshold, thereby preventing accidental deployment of the anchor from the delivery system. As shown in the enlarged view of FIG. 18, the anchor assembly 122 can include a housing 1802 and a spring-loaded pusher 1804 carried by the housing 1802. The housing 1802 can be configured to contain the anchor until deployment is desired. In use, the physician pushes the corresponding arm 102 distally to place a distal end surface 1806 of the housing 1802 in contact with tissue at the desired fixation site. The physician can continue to press the distal end of the housing 1802 against the tissue, which eventually triggers the spring-loaded pusher, which forcibly ejects the anchor from the housing 1802 into the tissue.

[0101] In some embodiments, the device includes one or more elongate members (wires, tubes, etc.) having a distal end coupled to the anchor and a proximal end coupled to the handle. If the physician is not satisfied with the deployment, the physician can retract the wire back and retract the anchor proximally out of the tissue and back into the housing 1802. With respect to any of the anchors discussed herein with reference to Figures 9 and 31A-35, removal of the anchor into the housing 1802 straightens the bend in the anchor and forces the anchor into a radially collapsed configuration that fits within the lumen of the housing 1802.

[0102] 31A-35 illustrate various anchors of the present technology that include multiple insertion arms. The use of multiple insertion arms can provide improved penetration and gripping of the annular tissue versus a single insertion arm.

[0103] 31A-31G show various anchor designs 1300, 1310, 1320, 1330, 1350, 1360, 1370 (collectively referred to as "anchors 1340"), each comprising a proximal end portion 1300a configured to be removably coupled to a component of a delivery system and a distal end portion 1300b configured to penetrate and be embedded in annulus tissue. The anchor 1340 can be formed from an elongate member, such as a wire, that is bent back onto itself to form two arms 1302. The proximal ends of the arms 1302 are thus joined at the bend, and the distal ends correspond to the distal end portion 1300b of the anchor 1300. In some embodiments, the distal ends are beveled to provide a sharp surface for penetrating the annulus tissue. In other embodiments, the distal ends are blunt. The suture can be threaded through an opening formed by a bend in the elongate member at the proximal end portion 1300a of the individual anchor.

[0104] The elongate member of anchor 1340 shown in FIGS. 31A-31G comprises a wire having a rounded cross-sectional shape. In other embodiments, the elongate member and / or wire forming anchor 1340 can have any suitable cross-sectional shape. For example, in some embodiments, the elongate member comprises a wire having a rectangular cross-sectional shape. The elongate member can be formed from a superelastic and / or resilient material, such as Nitinol, Cobalt Chromium, and / or alloys thereof. In such embodiments, the elongate member can be so shaped (e.g., via heat treatment) in a desired shape.

[0105] In some embodiments, the arms 1302 do not cross over each other between the proximal and distal end portions 1300a, 1300b of the anchor, as depicted, for example, by anchors 1300 and 1320. In other embodiments, the arms 1302 cross over each other between the proximal and distal end portions 1300a, 1300b, as depicted, for example, by anchors 1310 and 1330. The intersections 1304 between the arms 1302 can provide additional structural support to the tissue engaging portion of the anchor, thereby improving fixation with tissue.

[0106] 32A and 32B are different views of another example of an anchor 1500, in accordance with an embodiment of the present technology. Features of anchor 1500 can generally be similar to corresponding features of anchor 1340 of FIGS. 31A-31G. Thus, like numbers are used to identify similar or identical components in FIGS. 32A and 32B. In any of the anchor embodiments herein, the location of the intersection of the arms can affect the gripping strength of the anchor.

[0107] 33, 34, and 35 illustrate additional examples of anchors 1600, 1600', and 1600'' in accordance with embodiments of the present technology. Features of anchors 1600, 1600', and 1600'' may generally be similar to corresponding features of the anchors of FIGS. 31A-31G. Thus, like numbers will be used to identify similar or identical components in FIGS. 33-35, and discussion of anchors 1600, 1600', and 1600'' of FIGS. 33-35 will be limited to those features that differ from the anchors of FIGS. 31A-31G.

[0108] In contrast to the bent elongate members of FIGS. 9 and 31A-32B, anchors 1600, 1600', and 1600'', shown in FIGS. 33-35, are formed from a sheet of material that is laser cut and then bent (via shape setting, cold working, or other suitable methods) into the desired shape. Anchors 1600, 1600', and 1600'' further include openings 1608 extending through the thickness of the material, through which sutures may be threaded. All or a portion of the outer surface of arms 1602 can be flat, which may provide improved engagement with tissue (versus a rounded surface).

[0109] Any of the anchors 1600 , 1600 ′, and 1600 ″ can be used with any of the distal assemblies disclosed herein, including anchor assemblies 122 and 2922 and distal assembly 103 .

[0110] For any of the anchor embodiments described herein, including those shown in Figures 31A-35, the anchor can have a single arm or more than two arms (e.g., three arms, four arms, five arms, etc.). In those embodiments in which the anchor comprises a single arm, the arm may be thicker than each arm of a two arm embodiment. For example, for the anchors shown in Figures 31A-35, the elongate member can have a larger cross-sectional dimension. In the embodiment illustrated by Figures 33-35, a single-arm anchor can have an arm with a thickness that is greater than the thickness of either of the arms 1602.

[0111] 36 illustrates a finishing device 3600 configured in accordance with some embodiments of the present technology. The finishing device 3600 is configured for use with a treatment device 100 of the present technology to cut and / or lock the sutures 114 once the annulus has been reshaped to a desired geometry. The finishing device 3600 can include a proximal portion 3600a and a distal portion 3600b. The finishing device 3600 can include a handle 3602 at the proximal portion 3600a, a finishing element 2021 at the distal portion 3600b, and an elongated shaft 2022 extending therebetween. The elongated shaft 2022 can be configured to be slidably positioned over the proximal tail of the sutures 114, through a coupler 129 (FIG. 1) on the handle 101 of the treatment device 100, and through the elongated shaft 120 to the distal assembly 103. In some embodiments, the elongate shaft 2022 is configured to extend through a lumen of the elongate structure 105. In certain embodiments, the elongate shaft 202 extends through a separate lumen within the elongate shaft 120.

[0112] The finishing element 2021 can be configured to lock a desired length of the suture 114 to the valve annulus and / or can be configured to cut the suture 114. FIGS. 37A and 37B are close-up perspective and cross-sectional views, respectively, of the finishing element 2021 of the finishing device 3600. The finishing element 2021 can include a locking assembly 2001 configured to be coupled to a proximal portion of an anchor (such as any of the anchors of the present technology) and configured to secure the suture 114 in place relative to the corresponding anchor. The locking assembly 2001 is movable between an unlocked configuration (FIGS. 37A and 37B) and a locked configuration (shown in FIG. 37C). In some embodiments, the locking assembly 2001 is indirectly coupled to the anchor, for example, via a separate component.

[0113] The locking assembly 2001 can include a base 2002 and a plug 2004 extending through a lumen of the base 2002. The base 2002 can include a tubular body portion 2002b and a locking portion 2002a extending distally from the body portion 2002b. The locking portion 2002a can include a beveled surface that increases in height in the distal direction (away from the body portion 2002b). The body portion 2002b can have an opening 2008 in its sidewall configured to receive the suture 114 therethrough. The body portion 2002b can also be threaded along all or a portion of its exterior surface.

[0114] The plug 2004 can comprise an elongate member having a distal portion 2010 configured to engage the locking portion 2002a of the base 2002 and a proximal portion (not labeled) configured to be coupled to an elongate member 2020 extending proximally of the handle 3602. The distal portion 2010 can have a proximally facing edge 2006. As the operator pushes the plug 2004 distally (via the elongate member 2020), the distal portion 2010 slides distally up the beveled surface of the locking portion 2002a of the base 2002. As the edge 2006 moves distally beyond the distal edge of the beveled surface, the edge 2006 abuts against the distally facing end surface of the beveled surface, thereby preventing proximal movement of the plug 2004 relative to the base 2002, as shown in FIG. With plug 2004 in this forward position, a suture (not shown) is pinched between mid-portion 2004b of plug 2004 and the inner surface of body portion 2002b. The mid-portion of plug 2004 can be rounded (or of other cross-sectional shape) and have a cross-sectional dimension that is sized such that it cannot advance up the slope of locking portion 2002a of base 2002 and thus prevents plug 2004 from continuing to move distally.

[0115] 37C, to cut the suture 114 (not shown), a cutter 2100 with a sharp distal edge 2102 can be advanced over the base 2002 and wedged into a portion of the suture extending through an opening 2008 in the base 2002 between the base 2002 and the distal edge 2102 of the cutter 2100. In some embodiments, the cutter 2100 is advanced distally by rotating the cutter 2100 over the base 2000, which can sever the suture via shear forces. In such embodiments, an outer surface of at least a proximal portion of the base 2002 of the locking member 2000 can be threaded (such as threads 2024) and an inner surface of the cutter 2100 can have complementary threads. In some embodiments, the cutter 2100 can be advanced distally without rotating the cutter 2100. For example, the cutter 2100 can be advanced and cut the suture at the portion extending out of the opening 2008. In either case, the proximal end of the cutter 2100 can be coupled to an elongated shaft 2022 that extends back to the handle 3602 for rotational and / or axial control of the cutter 2100. Movement of an actuator 2032 (e.g., knob, slider, etc.) on the handle 3602 can translate and rotate the elongated shaft 2022, thereby rotating and advancing the cutter 2100. The elongated shaft 2022 can be a polymeric tube, a metal tube (e.g., Nitinol, stainless steel, etc.), and may or may not be laser cut. After the suture is cut, the cutter 2100 can be retracted proximally to expose the connection between the elongated member 2020 and the plug 2004 / locking element 2001. This allows the elongate member 2020 and plug 2004 to decouple, thereby allowing the device 3600 to be removed, leaving the locking element 2001 at the treatment site.

[0116] 38 depicts a locking member 2000 for use with the treatment system of the present technology. The locking member 2000 can be coupled to a proximal portion of an anchor (such as any of the anchors of the present technology) and configured to secure a suture in place relative to the corresponding anchor. The locking member 2000 is movable between an unlocked configuration (not shown) and a locked configuration (shown in FIG. 38). In some embodiments, the locking member 2000 is indirectly coupled to the anchor, for example, via a separate component.

[0117] The locking member 2000 can comprise a tubular base 2002 and a plug 2004 extending through a lumen of the base 2002. The base 2002 can comprise a body portion 2002b and a locking portion 2002a extending distally from the body portion 2002b. The locking portion 2002a can comprise a bevel that increases in height in the distal direction (away from the body portion 2002b). The body portion 2002b can have an opening 2008 in its sidewall. A suture can extend distally through the opening 2008 into the lumen of the body portion and then out through the distal opening of the body portion 2002b.

[0118] The plug 2004 can comprise an elongate member having a distal portion 2004a, an intermediate portion 2004b, and a proximal portion 2004c. The distal portion 2004a comprises an engagement portion 2010 at its distal end having a proximally facing edge 2006. As the physician pushes the plug 2004 distally, the engagement portion 2010 slides distally up the beveled surface of the locking portion 2002a of the base 2002. As the edge 2006 moves distally beyond the distal edge of the beveled surface, the edge 2006 abuts against the distally facing end surface of the beveled surface, thereby preventing proximal movement of the plug 2004 relative to the base 2002. When the plug 2004 is in this forward position, the suture is pinched between the intermediate portion 2004b of the plug 2004 and the inner surface of the base 2002. Intermediate portion 2004b of plug 2004 can be rounded (or of other cross-sectional shape) and have a cross-sectional dimension that is sized such that intermediate portion 2004 cannot advance up the slope of locking portion 2002a of base 2002, thus also preventing plug 2004 from continuing to move distally. Proximal portion 2004c of plug 2004 is configured to be removably coupled to a portion of a delivery system (such as a distal portion of an arm).

[0119] As shown in FIG. 39, to cut the suture, a cutter 2100 with a sharp distal edge 2102 can be advanced over the base 2002 and wedged onto a portion of the suture extending through an opening 2008 in the base 2002 between the base 2002 and the distal edge 2102 of the cutter 2100. In some embodiments, the cutter 2100 can be advanced distally by rotating the cutter 2100 (as shown in FIG. 39), which can cut the suture via shear forces. In such embodiments, an outer surface of at least a proximal portion of the base 2002 of the locking member 2000 can be threaded and an inner surface of the cutter 2100 can have complementary threads. In some embodiments, the cutter 2100 can be advanced distally without rotating the cutter 2100. For example, the cutter 2100 can be advanced and cut the suture at the portion extending out of the opening 2008. In either case, the proximal end of the cutter can be coupled to an extension tube that extends back into the handle, which may be attached to a tube that extends into the handle and into a knob, for rotational and / or axial control of the cutter 2100. The extension tube can be a polymer tube, a metal tube (e.g., Nitinol, stainless steel, etc.), and may or may not be laser cut.

[0120] In any of the embodiments disclosed herein, the cutter can be a separate catheter that is configured to be tracked over the locking catheter to a location along the suture for severing.

[0121] Many pacemaker leads typically seat around the tricuspid valve annulus. Existing annulus repair devices often interfere with the pacemaker lead when attempting to place the ring around the valve annulus. The design of the present technology advantageously includes a break in the suture loop, with two suture portions 114b extending proximally through the center of the elongated shaft 120. These portions can be placed between the pacemaker leads without causing any disturbance to the leads.

[0122] In some embodiments, the device includes one or more radiopaque markers disposed on the distal end portion of the elongated shaft 120, the ends of each anchor assembly, and / or the arms, so that the operator can see the location of the elongated shaft 120 as it is tracked through the patient and the location of each arm prior to implantation of the anchor into the tissue. Additionally, using the radiopaque markers on the ends of the anchor assemblies, the physician can see the location of each arm relative to the heart wall. The two arms on the ends where the sutures return to the center of the shaft can have different markers (e.g., two marker bands, thicker bands, etc.), so that the physician can carefully rotate the elongated shaft 120 by rotating the handle 101 so that these two ends can be placed around the existing pacemaker lead.

[0123] In some embodiments, the physician can pre-measure the valve diameter of the patient (using conventional imaging techniques). Since the spacing of the coupler engagement elements on the arms is known, the handle 101 can have markings that correspond to the diameter of the area encompassed by the arms 102 when the coupler 106 is at a given level of the coupler engagement elements. The physician can then advance the slider on the handle 101 to a point on the handle 101 that is pre-marked. Each pre-marked spot on the handle 101 will correlate with the coupler 106 that extends to the next coupler engagement element in the arm. Once the arms have been pulled together to the preferred size, the procedure can continue and the physician can control each arm and deploy the corresponding anchor into the tissue. Once all of the anchors are deployed, the physician can then advance the coupler 106 further, bringing the arms to their final diameter and / or area.

[0124] Another advantage of having multiple arms is that in situations where the valve is tilted (i.e., in a plane that is angled relative to the entry path of the device) and the extension shaft 120 follows it in a straight line toward the valve, the physician can shorten one or more arms (by rotating the arm so that the coupler engaging element on the arm is not aligned with the arm engaging element in the coupler and is pulled back) and extend other arms (push the arm forward) to create a tilted implant and treat the tilted valve.

[0125] Some devices need to be perpendicular to the valve to be used. The distal assembly of the present technology approaches the valve perpendicular to the plane of the valve, yet is still able to treat tilted valves. With the added ability to deflect or steer the distal end of the shaft, the devices of the present technology can treat more valves (sizes, positions, and shapes) than any other device, both commercially available and in development.

[0126] Any of the embodiments disclosed herein may further include an imaging element. The imaging element may comprise an elongated member having a distal portion configured to extend proximate to the heart valve annulus. The distal portion may have one or more sensors (one or more ultrasound transducers, optical elements, etc.) that may be operated to provide visual assistance to the physician during delivery and implantation of the device and acquire data at the treatment site. For example, the sensor may capture one or more images of the position of the device relative to the heart valve annulus. The devices and systems of the present technology may further be configured to center the imaging catheter to the implant.

[0127] In some embodiments, the imaging element comprises one or more ultrasound transducers. For example, a distal portion of the imaging element may comprise a longitudinally disposed ultrasound transducer and a circumferentially disposed ultrasound transducer. The imaging element may be an intravascular ultrasound catheter (IVUS) or an intravascular echocardiography (ICE) catheter. In either case, the imaging element may be contained within and advanced along the central lumen of a delivery catheter. In some embodiments, by rotating the imaging element around the inside of the annulus, the relative positions of the device and any leaflets will be ascertained for precise positioning of the anchor around and above the annulus.

[0128] In some embodiments, the imaging element is contained within and advanced along an offset non-central lumen of the elongated shaft 120. In this way, the imaging element will not interfere with the device, its mounting or other features, and the drive components. In some embodiments, the imaging element may be steered to position and image the side of the annulus with little rotation, allowing for quicker visualization of the anchor points of the device. The offset lumen may exit more proximally relative to the distal end of the elongated shaft 120. This more proximal exit would reduce the overall profile or diameter of the distal end of the delivery catheter. In addition, this more proximal exit port would allow for visualization of the annulus from above. The offset lumen may also be compressible, allowing for an even smaller profile until the imaging element is advanced through the offset lumen.

[0129] The imaging element may be integrated into the same delivery system as the device, or alternatively may be introduced secondarily through another entry site, such as through the aortic valve, and placed near or within the implant for imaging and anchor placement.

[0130] In some embodiments, software or electronic control can be effective to cycle through radial cross-sectional images around the annulus circumference, alleviating the need to physically move the imaging element via rotation, translation, or deflection. A larger circumferential transducer array can also be placed distal to the annulus, not interfering with the spatial limitations of the delivery catheter, further reducing the profile of the delivery catheter. In some embodiments, the transducers of the imaging element can generate a three-dimensional image of the annulus. The operator can then more easily verify the relative alignment of the annulus, leaflets, and implant.

[0131] In some use examples, the device 100 can be advanced across the septum, which separates the upper chambers of the heart. An imaging element is advanced to a location above a valve annulus of the heart, e.g., the mitral annulus, tricuspid annulus, aortic annulus, etc. The device can be ejected from the distal end of the elongated shaft above and proximate to the valve annulus. A series of radial images can be taken to properly position the anchors for insertion into the annular tissue. For example, an ICE catheter can be advanced through the lumen of the elongated shaft 120 and / or elongated structure 105 and positioned to capture circumferential images to confirm that all anchors are properly placed and anchored above the leaflets and within the annular tissue. If one or more anchors are not properly positioned or anchored, they can be rotatably retracted, repositioned, and re-anchored prior to removal of the arms and the remainder of the device. It should also be appreciated that treatment of the tricuspid valve involves insertion of the device for access through the jugular vein, whereby the device can then be advanced up the superior vena cava into the right atrium adjacent and above the tricuspid annulus. In some embodiments, device 100 can be advanced through the femoral artery, into the inferior vena cava, and into the right atrium to treat the tricuspid valve. conclusion

[0132] Although many of the embodiments are described above with respect to systems, devices, and methods for reshaping the mitral annulus, the technology is also applicable to other applications and / or other approaches, such as reshaping the aortic annulus, the tricuspid annulus, or any modification of any valve located in or at the heart or anywhere therein. Depending on the valve for treatment, the device can have any number of arms. For example, a device for treating the mitral valve may utilize six arms, while a device for treating the larger tricuspid valve may require eight arms. Furthermore, other embodiments in addition to those described herein are also within the scope of the technology. In addition, some other embodiments of the technology can have different configurations, components, or techniques than those described herein. Those skilled in the art will therefore understand that the technology can have other embodiments with additional elements, or without some of the features shown and described above with reference to FIGS. 1-39.

[0133] The description of the embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the precise form disclosed above. Where the context permits, singular or plural terms may also include the plural or singular terms, respectively. Specific embodiments of the present technology and examples therefor are described above for illustrative purposes, but various equivalent modifications are also possible within the scope of the present technology, as one skilled in the relevant art would recognize. For example, while steps are presented in a given order, alternative embodiments may perform the steps in a different order. Various embodiments described herein may also be combined to provide further embodiments.

[0134] Further, unless the word "or" is expressly limited to mean only a single item, exclusively from the other items, with reference to a list of two or more items, the use of "or" in such a list should be interpreted to include (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. In addition, the term "comprising" is used throughout to mean including at least the recited features, but not to the exclusion of any more of the same features and / or other features of additional types. Also, while specific embodiments are described herein for illustrative purposes, it should be understood that various modifications may be made without departing from the technology. Furthermore, although advantages associated with certain embodiments of the technology are described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments necessarily exhibit such advantages to fall within the scope of the technology. Thus, the present disclosure and associated technology can encompass other embodiments not expressly shown or described herein.

[0135] As used herein, the terms "generally," "substantially," "about," and similar terms are used as terms of approximation, not degree, and are intended to take into account inherent variations in measured or calculated values ​​that will be recognized by one of ordinary skill in the art.

Claims

1. 1. A device for treating a native valve annulus, the device comprising: a plurality of arms, each having a proximal portion and a distal portion, the arms configured to move independently of one another; a coupler coupled to the arm and configured to move relative to the arm; a plurality of anchors, each of the plurality of anchors carried by a distal portion of one of the arms and configured to engage tissue at or adjacent to the valve annulus; Equipped with When the device is in a deployed configuration such that the arms extend axially and radially away from the coupler, movement of the coupler relative to the arms reduces the circumferential distance between at least some of the anchors.

2. 2. The device of claim 1, wherein the valve annulus is a heart valve annulus and the device is configured to be delivered adjacent to and above the valve annulus such that the anchor is embedded in the annulus heart tissue just above the plane of a valve orifice.

3. The device of claim 1 or claim 2, wherein the coupler is configured to translate and / or rotate relative to the arm.

4. A device according to any one of claims 1 to 3, wherein the arms are configured to translate and / or rotate independently of each other.

5. 5. A device as claimed in any one of claims 1-4, wherein each of the arms includes one or more locking elements, and movement of the coupler relative to the arms causes the coupler to engage at least some of the locking elements on at least some of the arms, thereby fixing the axial position of each of the arms relative to other arms and / or the coupler.

6. A device according to any preceding claim, wherein when the arms are in a deployed configuration, movement of the coupler relative to the arms reduces the angle between adjacent arms.

7. 7. The device of claim 1, wherein each of the anchors is releasably coupled to one of the arms such that upon completion of treatment, the coupler and arms are removed from the patient while the anchors remain embedded in the valve annulus.

8. A device according to any preceding claim, wherein each of the anchors is attached to a single arm.

9. The device of any one of claims 1-8, further comprising a suture coupled to the anchor.

10. The device of any one of claims 1-9, wherein some or all of the arms comprise at least one of a tube, a solid rod, or a ribbon.

11. The device of any one of claims 1-10, wherein the device is configured to be delivered percutaneously to the valve annulus.

12. 1. A device for treating a native valve annulus, the device comprising: A plurality of arms; a coupler coupled to the arm, the coupler configured to move relative to the arm; and a plurality of anchors, each of the plurality of anchors being carried by a distal portion of one of the arms and configured to be implanted at or adjacent to the valve annulus; Equipped with A device, wherein when the device is in a deployed configuration, movement of the couplers relative to the arms reduces the circumferential distance between at least some of the anchors.

13. 1. A system for treating a native valve annulus, the system comprising: a plurality of elongate members, each of the plurality of elongate members having a proximal region and a distal region; a plurality of arms configured to be positioned at or adjacent to the valve annulus, each of the arms having a proximal portion and a distal portion, each of the distal portions coupled to a distal region of a corresponding elongate member; a coupler coupled to the arm and configured to move relative to the arm; a plurality of anchors, each of the plurality of anchors coupled to a distal portion of one of the arms and configured to engage tissue at or adjacent the valve annulus; Equipped with A system wherein when the arms are in a deployed configuration, movement of the coupler relative to the arms reduces an area enclosed by the anchor.

14. 14. The system of claim 13, wherein the elongate member is a first elongate member, the system further comprising a second elongate member having a proximal region and a distal region, the distal region of the second elongate member coupled to the coupler such that movement of the second elongate member causes movement of the coupler relative to the arm.

15. The system of claim 14 , wherein the second elongate member is a solid rod.

16. The system of claim 14 , wherein the second elongate member is a flexible tube.

17. The system of claim 14 , wherein the second elongate member is an elongate shaft that surrounds the first elongate member.

18. A system according to any one of claims 13 to 17, wherein rotation and / or translation of one of the extension members causes rotation and / or translation of a corresponding arm.

19. A system according to any one of claims 13 to 18, wherein the coupler is configured to translate and / or rotate relative to the arm.

20. The system of any one of claims 13-19, wherein each of the anchors is removably coupled to one of the arms.

21. The system of claim 20 , wherein actuation of one of the extension members causes a corresponding anchor to detach from a corresponding arm.

22. The system of any one of claims 13-21, further comprising a suture coupled to the anchor and extending proximally along the elongate member.

23. 23. The system of any one of claims 13-22, further comprising an imaging element configured to be advanced to a location at or adjacent to the annulus while the arm is positioned at or adjacent to the annulus.

24. 24. The system of any one of claims 13-23, wherein each of the arms includes one or more locking elements, and movement of the coupler relative to the arms causes the coupler to engage at least some of the locking elements on at least some of the arms, thereby fixing the axial position of each of the arms relative to other arms and / or the coupler.

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