Fixation devices and systems with tissue capture indication features

Abstract

A fixation device includes a center assembly and first and second clamps extending outwardly from the center assembly. Each clamp includes an anchor member and a gripper disposed opposite the anchor member. The gripper includes an indicator arm and a retention arm. The indicator arm and retention arm are independently moveable between a raised position and an engagement position. The retention arm has a length greater than a length of the indicator arm.

Description

Atty Docket No. ABTEVA-0072PCTFIXATION DEVICES AND SYSTEMS WITH TISSUE CAPTURE INDICATION FEATURESCROSS-REFERENCE TO REEATED APPETCATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 654,239, filed May 31, 2024, the disclosure of which is hereby incorporated by reference herein in its entirety.BACKGROUND

[0002] The cardiac cycle is divided into two phases — diastole and systole. Diastole is generally characterized by the muscular relaxation of the heart and the filling of its chambers with blood. On the other hand, systole is generally characterized by the muscular contraction of the ventricles which pumps blood from the ventricles to the arteries. During ventricular systole, ventricular pressure increases relative to atrial pressure resulting in the closure of the mitral valve and the tricuspid valve. The mitral valve separates the left atrium from the left ventricle, and the tricuspid valve separates the right atrium from the right ventricle. These valves operate as check valves preventing blood from flowing back into the atria during ventricular contraction. However, valvular insufficiency may appear in one or both of these valves which may result in a regurgitative flow back into the atrium across the effected valve. Such regurgitative flow can be in the form of mitral valve regurgitation (“MVR”) and / or tricuspid valve regurgitation (“TVR”). Left untreated, MVR and TVR can lead to severe health consequences, such as progressive heart failure, cardiac arrythmias, pulmonary hypertension, stroke, and endocarditis, to name a few.

[0003] MVR and TVR can have a variety of etiologies which typically fall into the categories of degenerative (primary) and functional (secondary) regurgitation. Degenerative valve regurgitation principally occurs due to abnormalities or degeneration of the valve apparatus, such as the valve leaflets, valve annulus, chordae tendineae, and / or papillary muscles. One example of a degenerative valve condition is mitral valve prolapse. Functional valve regurgitation is often a secondary condition that arises from underlying heart conditions or diseases that affect the structure or function of the heart. Examples of conditions that can result in functional regurgitation include dilated cardiomyopathy, ischemic heart disease, pulmonary hypertension, and heart failure. Regardless of the underlying condition precipitating the regurgitative flow, the primary mechanism by which regurgitation occurs is the failure ofAtty Docket No. ABTEVA-0072PCT the valve leaflets to properly and completely seal or coapt during systole which allows a jet of blood to flow back into the atrium between the effected leaflets.

[0004] Treatment options for MVR and TVR generally include Guideline-Directed Medical Therapy (“GDMT”), valve replacement, and valve repair. GDMT usually involves the administration of a combination of drugs that treat an underlying heart condition. Valve replacement and repair may include open-heart surgical options and catheter-based options. Catheter-based repair procedures are sometimes referred to as transcatheter edge-to-edge repair (“TEER”).BRIEF SUMMARY OF THE DISCLOSURE

[0005] In one aspect of the present disclosure, a fixation device for securing tissue includes a center assembly and first and second clamps extending outwardly from the center assembly. Each clamp includes an craddle member moveable between an open position and a closed position, and a gripper member disposed opposite the craddle member. The gripper member includes an indicator arm and a retention arm. The indicator arm and retention arm are each independently moveable between a raised position and an engagement position. The retention arm has a length greater than a length of the indicator arm.

[0006] In one example, the length of the indicator arm is about 50% the length of the retention arm. In another example, the length of the indicator arm is between 25% and 50% the length of the retention arm. In a further example, the length of the indicator arm is between 50% and 75% the length of the retention arm. The indicator arm and retention arm may each include a plurality of frictional elements extending therefrom. Also, in some examples, the indicator arm is configured to move from the raised position to the engagement position thereof while the retention arm is in the raised position thereof.

[0007] Additionally, the retention arm may include a recess, and the indicator arm may be moveably disposed within the recess of the retention arm. Further, the indicator arm may have a first width, and the retention arm may have a second width different from the first width. In one example, the second width is greater than the first width. In another example, the first width is greater than the second width.

[0008] Furthermore, the fixation device may include a base section, and the indicator arm and retention arm may be coupled to the base section. In one example, the base section is coupled to the center assembly. In another example, the base section is coupled to the craddle member. In each of these examples, the retention arm may be coupled to the base section via aAtty Docket No. ABTEVA-0072PCT first hinge feature and a second hinge feature, and the indicator arm may be coupled to the base section via a third hinge feature. In some examples, the base section includes a first segment, a second segment, and a third segment intersecting one another to form a U-shape. The second segment of the base section may include an opening configured to receive a portion of the center assembly.

[0009] In another aspect of the present disclosure, a fixation device for securing tissue includes a center assembly and first and second clamps. The first and second clamps extend outwardly from the center assembly and each include an craddle member moveable between an open position and a closed position, and a gripper member disposed opposite the craddle member. The gripper member of the first clamp includes a first ultrasonic sensor coupled thereto. The first ultrasonic sensor is configured to emit ultrasonic waves toward the craddle member of the first clamp and to generate a first waveform when tissue is absent from a space between the craddle member and the gripper member and to generate a second waveform when tissue is present in the space.

[0010] Additionally, the first ultrasonic sensor may be disposed within a sensor window of the gripper member. In one example, the first ultrasonic sensor is located at a position about 50% of a length of the gripper member. In another example, the gripper member includes a fixed end and a free end, and the first ultrasonic sensor is located at a position between 25% to 50% a length of the gripper member as measured from the fixed end. In further examples, the gripper member of the second clamp may include a second ultrasonic sensor with the same configuration as that of the first ultrasonic sensor described above.

[0011] In a further aspect of the present disclosure, a fixation device for securing tissue includes a center assembly and first and second clamps. The first and second clamps extend outwardly from the center assembly and each include an craddle member moveable between an open position and a closed position, the craddle member including an engagement surface, and a gripper member disposed opposite the craddle member for capturing tissue therebetween. A first indicator is coupled to the craddle member of the first clamp and is configured to translate in a first direction transverse to a longitudinal axis of the craddle member in the presence of tissue between the craddle member and the gripper member of the first clamp. A second indicator is coupled to the craddle member of the second clamp and is configured to translate in a second direction transverse to a longitudinal axis of the craddle member in theAtty Docket No. ABTEVA-0072PCT presence of tissue between the craddle member and the gripper member of the second clamp. The first direction is opposite the second direction.

[0012] In one example, the first and second indicators are electromagnetically actuated. Further, the craddle members may each include an engagement surface, and the first and second directions may be parallel to the engagement surface of the respective craddle members.

[0013] In an even further aspect of the present disclosure, an interventional device for percutaneously securing tissue includes a fixation device, a catheter releasably coupled to the fixation device, and a delivery handle coupled to the catheter. The fixation device includes a center assembly and first and second clamps extending outwardly from the center assembly. Each clamp includes an craddle member moveable between an open position and a closed position, and a gripper member disposed opposite the craddle member. The gripper member includes an indicator arm and a retention arm. The indicator arm is moveable between a raised position and an engagement position thereof and has a first length. The retention arm is independently moveable relative to the indicator arm between a raised position and an engagement position thereof and has a second length greater than the first length.

[0014] In a first example of the interventional device, the interventional device includes a actuation line extending from the catheter and engaging the indicator arm and retention arm of each of the first and second clamps for actuation thereof.

[0015] In a second example of the interventional device, the interventional device includes a first actuation line extending from the catheter and engaging the indicator arm of each of the first and second clamps for actuation thereof, and a second actuation line extending from the catheter and engaging the retention arm of each of the first and second clamps for actuation thereof.

[0016] In a third example of the interventional device, the interventional device includes a first actuation line, a second actuation line, and a third actuation line. The first actuation line engages the indicator arm of the first clamp for actuation thereof, the second actuation line engages the indicator arm of the second clamp for actuation thereof, and the third actuation line engages the retention arm of each of the first and second clamps for actuation thereof.

[0017] In the second and third examples, the delivery handle may include a first actuator handle coupled to the first actuation line for actuation thereof, and a second actuator handle coupled to the second actuation line for actuation thereof. The delivery handle may alsoAtty Docket No. ABTEVA-0072PCT include an interlock coupled to the second actuator handle for selective coupling to first actuator handle.

[0018] In another aspect of the present disclosure, a method for securing tissue includes positioning a fixation device between a first tissue and a second tissue, inserting the first tissue between an craddle member and a gripper member of a first clamp of the fixation device, moving an indicator arm of the gripper member into engagement with the first tissue, and after the indicator arm engages the first tissue, moving a retention arm of the gripper member into engagement with the first tissue.

[0019] The indicator arm may be shorter than the retention arm. Additionally, the method may include inserting the second tissue between the craddle member and gripper member of a second clamp of the fixation device, moving the indicator arm of the second clamp into engagement with the second tissue, and after the indicator arm engages the second tissue, moving the retention arm into engagement with the second tissue.

[0020] Further, in one example, the step of moving the indicator arm of the first clamp into engagement with the first tissue is performed concurrently with the step of moving the indicator arm of the second clamp into engagement with the second tissue. Also, in this example, the method may include moving a first and second actuator concurrently from a first position to a second position. The first and second actuators may be coupled to the indicator arms of the first and second clamps via respective first and second actuation lines extending from the first and second actuators through a catheter.

[0021] In another implementation of the exemplary method, the step of moving the indicator arm of the first clamp into engagement with the first tissue is performed sequentially with the step of moving the indicator arm of the second clamp into engagement with the second tissue. Additionally, the exemplary method may include disengaging an interlock from a first actuator and moving the first actuator and a second actuator sequentially from a first position to a second position thereof. The first and second actuators may be coupled to the indicator arms of the first and second clamps via respective first and second actuation lines extending from the first and second actuators through a catheter.BRIEF DESCRIPTION OF THE DRAWINGS

[0022] FIG. 1 A is a cross-sectional representation of a heart illustrating its four valves.

[0023] FIG. IB is a cross-sectional representation of a heart illustrating the left ventricle and left atrium during systole.Atty Docket No. ABTEVA-0072PCT

[0024] FIG. 2A is a schematic view of a mitral valve during normal coaptation.

[0025] FIG. 2B is a schematic view of a mitral valve during regurgitate coaptation.

[0026] FIGS. 3A and 3B are schematic views of a fixation device according to an embodiment of the present disclosure grasping leaflets of a mitral valve.

[0027] FIG. 4A is a perspective view of a fixation device according to another embodiment of the present disclosure.

[0028] FIG. 4B is a perspective view of the fixation device of FIG. 4A including a covering.

[0029] FIG. 5A is a perspective view of a gripping device of the of the fixation device of FIG. 4A according to an embodiment of the present disclosure.

[0030] FIG. 5B is an elevational view of the gripping device of FIG. 5A.

[0031] FIG. 6A is a perspective view of a gripping device according to another embodiment of the present disclosure.

[0032] FIG. 6B is a partial schematic view of the gripping device of FIG. 6A coupled to an craddle member of the fixation device of FIG. 4A.

[0033] FIG. 6C is a partial schematic view of a gripping device according to an alternative embodiment of the present disclosure coupled to an craddle member according to an alternative embodiment of the present disclosure.

[0034] FIG. 7A is an elevational view of a coupling system according to an embodiment of the present disclosure for coupling the fixation device of FIG. 4A and a delivery system.

[0035] FIGS. 7B and 7C are schematic views of the coupling system of FIG. 7A in respective first and second configurations.

[0036] FIGS. 8A and 8B are schematic cross-sectional views of a coupling system according to another embodiment of the present disclosure for coupling a fixation device, such as the fixation device of FIG. 4A, and a delivery system.

[0037] FIGS. 9A-9B, 10A-10B, 11A-11B, 12A-12B and 13A-13C illustrate the fixation device of FIG. 4A in various possible positions during introduction and placement of the device within a mammalian body to perform a therapeutic procedure.

[0038] FIG. 14 is a perspective view of the fixation device of FIG. 4A including a locking mechanism according to an embodiment of the present disclosure and illustrating a plurality of gripper member lines and a lock line coupled to the fixation device.Atty Docket No. ABTEVA-0072PCT

[0039] FIG. 15 is an elevational view of the locking mechanism and gripper members of the fixation device of FIG. 14 and illustrating a lock line and single gripper member line respectively coupled thereto.

[0040] FIG. 16 is a schematic view of the fixation device of FIG. 4A coupled to a delivery system and illustrating a plurality of gripper member lines coupled to a shaft of the delivery system.

[0041] FIGS. 17A and 17B are partial enlarged views of a distal end portion of the delivery system shaft of FIG. 16 according to an embodiment of the present disclosure.

[0042] FIG. 17C is a cross-sectional view of the delivery system shaft taken along line C-C of FIG. 17B.

[0043] FIG. 17D is a partial perspective view of a distal end portion of one of the gripper member lines of FIG. 16 including a catch element according to an embodiment of the present disclosure.

[0044] FIG. 17E is a partial elevational view of the delivery system shaft of FIG. 17A having holes configured to receive the catch element of FIG. 17D.

[0045] FIG. 17F is a partial elevational view of the delivery system shaft of FIG. 17A and an actuator rod disposed therein intersecting the holes of the delivery system shaft.

[0046] FIG. 17G is a partial elevational view of a distal end portion of one of the gripper member lines of FIG. 16 including a catch element according to another embodiment of the present disclosure.

[0047] FIG. 18A is an enlarged cross-sectional view of the locking mechanism of FIG. 14 taken along a midline thereof and in an unlocked configuration.

[0048] FIG. 18B is an enlarged elevational view of the locking mechanism of FIG. 14 and in a locked configuration.

[0049] FIG. 18C is a perspective view of a release harness of the locking mechanism of FIG. 14.

[0050] FIG. 19A is an elevational view of a locking mechanism of the fixation device of FIG. 4A according to another embodiment of the present disclosure.

[0051] FIG. 19B is a transparent perspective view of a binding plate of the locking mechanism of FIG. 19 A.

[0052] FIG. 19C is an enlarged elevational view of the locking mechanism of FIG. 19A.Atty Docket No. ABTEVA-0072PCT

[0053] FIGS. 20 A and 20B are schematic pinch force diagrams along gripper members and craddle members of different lengths.

[0054] FIG. 21 is a partial schematic view of an interventional tool according to another embodiment of the present disclosure.

[0055] FIGS. 22A-22D are partial schematic views of the interventional tool of FIG.21 grasping tissue.

[0056] FIG. 23A is a partial perspective view of an example proximal end of an interventional tool according to an embodiment of the present disclosure.

[0057] FIG. 23B is a cross-sectional view of an example delivery catheter of the interventional tool of FIG. 23 A according to one example.

[0058] FIG. 24 of schematic view of a distal end of the interventional tool of FIG. 23A according to one example.

[0059] FIG. 25A is a partial perspective view of an example proximal end of an interventional tool according to another embodiment of the present disclosure.

[0060] FIG. 25B is an enhanced transparent view of actuator handles of the interventional tool of FIG. 25 A according to one example.

[0061] FIG. 26 is a schematic view of a distal end of the interventional tool of FIG. 25A according to one example.

[0062] FIG. 27 is a schematic view of a distal end of the interventional tool of FIG.25A according to another example.

[0063] FIG. 28 is a schematic view of a distal end of the interventional tool of FIG. 25A according to a further example.

[0064] FIG. 29 is a partial perspective view of an example proximal end of an interventional tool according to a further embodiment of the present disclosure.

[0065] FIG. 30 is a schematic view of a distal end of the interventional tool of FIG. 29 according to one example.

[0066] FIG. 31 is a schematic view of a distal end of the interventional tool of FIG. 29 according to another example.

[0067] FIG. 32 is a schematic view of a distal end of the interventional tool of FIG. 29 according to a further example.

[0068] FIG. 33 is a partial perspective view of an example proximal end of an interventional tool according to a yet further embodiment of the present disclosure.Atty Docket No. ABTEVA-0072PCT

[0069] FIG. 34 is a schematic view of a distal end of the interventional tool of FIG. 33 according to one example.

[0070] FIG. 35 is a schematic view of a distal end of the interventional tool of FIG. 33 according to another example.

[0071] FIG. 36A is an elevational view of a gripping device according to an embodiment of the present disclosure.

[0072] FIG. 36B is a top view of the gripping device of FIG. 36A.

[0073] FIG. 37 A is an elevational view of a gripping device according to another embodiment of the present disclosure.

[0074] FIG. 37B is a top view of the gripping device of FIG. 37A.

[0075] FIG. 38 is a top view of a gripping device according to a further embodiment of the present disclosure.

[0076] FIG. 39 is a top view of a gripping device according to another embodiment of the present disclosure.

[0077] FIG. 40A is a top view of a gripping device according to a further embodiment of the present disclosure.

[0078] FIG. 40B is a schematic view of exemplary signals generated by the gripping device of FIG. 40A during a tissue grasping procedure.

[0079] FIG. 41A is a perspective view of a fixation device according to another embodiment of the present disclosure.

[0080] FIG. 41B is an elevational view of the fixation device of FIG. 41 A.

[0081] FIG. 42 is a perspective view an indicator assembly of the fixation device of FIG. 41 A and according to one example.

[0082] FIG. 43A is a cutaway view of an indicator assembly of the fixation device of FIG. 41 A and according to another example.

[0083] FIG. 43B is an elevational view of the indicator assembly of FIG. 43A.

[0084] FIG. 44A is a front view of a gripping device according to a further embodiment of the present disclosure.

[0085] FIG. 44B is a front view of a gripping device according to another embodiment of the present disclosure.

[0086] FIG. 44C is a front view of a gripping device according to a further embodiment of the present disclosure.Atty Docket No. ABTEVA-0072PCT

[0087] FIG. 45A is a top view of an indicator arm and a retention arm according to an embodiment of the present disclosure.

[0088] FIG. 45B is a schematic cross-sectional view taken along section line A-A of FIG. 45A illustrating an indicator arm and a retention arm according to another embodiment of the present disclosure.

[0089] FIG. 45C is a schematic cross-sectional view taken along section line A-A of FIG. 45A illustrating an indicator arm and a retention arm according to a further embodiment of the present disclosure.

[0090] FIG. 46 is a top view of a modular indicator arm and retention arm having differing materials in accordance with a further embodiment of the present disclosure.

[0091] FIG. 47A is a front view of a gripper member according to another embodiment of the present disclosure.

[0092] FIG. 47B is a front view of a gripper member according to a further embodiment of the present disclosure.

[0093] FIG. 48A is a partial front view of a gripping device according to another embodiment of the present disclosure.

[0094] FIG. 48B is a partial top view of a gripping device according to a further embodiment of the present disclosure.DETAILED DESCRIPTION

[0095] The valves of a normal heart H are illustrated in FIGS. 1 A and IB. These valves include the mitral valve MV, the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV. The mitral valve MV separates the left atrium LA and the left ventricle LV, and the tricuspid valve TV separates the right atrium RA and the right ventricle RV. The mitral valve MV and the tricuspid valve TV are sometimes referred to as the atrioventricular valves. The mitral valve MV is a bicuspid valve in that it has two leaflets referred to as the posterior leaflet PL and the anterior leaflet AL. The tricuspid valve TV typically has three leaflets referred to as the anterior leaflet AL, the posterior leaflet PL, and the septal leaflet SL. However, studies have shown that, although the TV is typically composed of three leaflets of unequal size, in many cases, two or more than three leaflets may be present as anatomic variants in healthy subjects. Thus, reference herein to the tricuspid valve TV should be understood to refer to the atrioventricular valve located between the right atrium RA and right ventricle RV regardless of the number of leaflets be it two, three, or more than three leaflets. However, exemplaryAtty Docket No. ABTEVA-0072PCT embodiments discussed herein refer to the usual anatomic structure of the tricuspid valve TV that includes three leaflets.

[0096] As illustrated in FIG. IB, the anterior leaflet AL and posterior leaflet PL of the mitral valve MV extend from a valve annulus AN to respective free edges FE. The free edges FE are secured to the lower portions of the left ventricle LV through chordae tendineae CT (referred to hereinafter as the chordae). The chordae CT include a plurality of branching tendons that are attached to papillary muscles PM at the lower portions of the left ventricle LV and extend upwardly to the lower surfaces of each of the valve leaflets where they are attached. The three leaflets of the tricuspid valve TV similarly extend from a valve annulus AN to respective free edges FE which are secured via chordae to the papillary muscles of the right ventricle RV.

[0097] The mitral valve MV depicted in FIGS. IB and 2A illustrate the proper functioning of an atrioventricular valve during ventricular systole. As the ventricles contract, the free edges FE of adjacent leaflets LF meet along a line of coaptation LOG. The joinder of the leaflets LF at this line of coaptation LOC seals off the ventricle from the atrium and prevents the back flow of blood or “regurgitation” from entering into the atrium. Thus, with the right atrium RA and left atrium LA respectively sealed off by the mitral valve MV and tricuspid valve TV, blood in the left ventricle LV can only flow through the aortic valve AV to the body, and blood in the right ventricle RV can only flow through the pulmonary valve PV to the lungs.

[0098] A number of structural defects in the heart H can cause mitral valve regurgitation (“MVR”) and / or tricuspid valve regurgitation (“TVR”). MVR and TVR occur when their respective leaflets LF do not close properly allowing leakage from the ventricle into the atrium. The mitral valve MV depicted in FIG. 2B illustrates valvular insufficiency of an atrioventricular valve resulting in regurgitation. In the depicted example, an enlargement of the heart H may cause the valve annulus AN to become enlarged, making it impossible for the free edges FE of the valve leaflets LF to meet during systole. This may result in a gap G between the leaflets LF which allows blood to leak through the valve. In another example, ruptured or elongated chordae CT can cause a valve leaflet LF to prolapse at least due to inadequate tension transmitted to the leaflet via the chordae CT. While an adjacent leaflet LF may maintain a normal profile, the prolapsing leaflets LF may flail about preventing the proper joinder between the leaflets LF resulting in leakage into the atrium. In a further example, regurgitation can occurAtty Docket No. ABTEVA-0072PCT in patients who have suffered ischemic heart disease which may result in weak ventricular contractions insufficient to effect proper closure.

[0099] The present disclosure describes exemplary systems, devices, and methods for percutaneously repairing a valve to treat cardiac valve regurgitation, particularly MVR and TVR. When referring to such disclosed systems, devices, and methods, the term "proximal" (P) shall mean closer to the user or in a direction toward a device to be manipulated by the user outside the patient’s body, and the term "distal" (D) shall mean more distant from the user or in a direction toward a device that is positioned at the treatment site within the patient’s body (e.g., fixation device 112). With respect to the mitral valve and tricuspid valve, “proximal” shall refer to the atrial or upstream side of the valve leaflets, and “distal” shall refer to the ventricular or downstream side of the valve leaflets.

[0100] FIGS. 3A and 3B depict a fixation device 12, according to an embodiment of the present disclosure, grasping leaflets LF of an atrioventricular valve, which is illustrated as a mitral valve MV. Fixation device 12 may be releasably coupled to a distal end of a shaft 11 of a delivery system to form an interventional tool 10. Fixation device 12 may include craddle members 20 (also referred to herein as first members, lower members, distal elements, or fixation elements) and gripper members 40 (also referred to herein as second members, upper members, proximal elements, gripping elements or gripper members). Craddle members 20 and gripper members 40 may be moveable relative to each other and may protrude radially outward relative to a longitudinal axis Al of fixation device 12. As shown in FIG. 3A, fixation device 12 may be positionable on opposite sides of adjacent leaflets LF of the valve so as to capture or retain the leaflets LF therebetween. In this regard, gripper members 40 may be positioned at a proximal side of the valve leaflets LF, and craddle members 20 may be positioned on a distal side of the valve leaflets LF. Gripper members 40 may be made from cobalt chromium, nitinol, or stainless steel, for example, and craddle members 20 may be made from cobalt chromium or stainless steel, for example.

[0101] Fixation device 12 may be releasably coupled to shaft 11 such that it can be detached and left behind as an implant to hold the leaflets LF together in the coapted position. In this regard, fixation device 12 may be delivered to a target valve percutaneously using any one of a number of different approaches, such as via a transfemoral, a transapical, or a transjugular approach, for example. Thus, in one example of treating MVR, fixation device 12 may be delivered to the deficient mitral valve MV using a transfemoral approach in whichAtty Docket No. ABTEVA-0072PCT fixation device 12 is guided through the inferior vena cava IVC {see FIG. 1A), across the interatrial septum S, and into left atrium LA where fixation device 12 is advanced into the mitral valve MV. Also, in one example of treating TVR, fixation device 12 may be guided transfemorally through the inferior vena cava IVC to the right atrium RA where fixation device 12 is advanced to a desired position within the tricuspid valve TV.

[0102] FIG. 3B is an atrial-side view of fixation device 12 in one example of a desired orientation in relation to adjacent leaflets LF of an atrioventricular valve, such as the depicted mitral valve MV. The craddle members and gripper members 20, 40 are positioned to be substantially perpendicular to the line of coaptation LOC. Thus, in the case of a mitral valve MV, fixation device 12 may be oriented perpendicular (+ / - 5 degrees) to a line of coaptation LOC between the posterior leaflet PL and anterior leaflet AL, and in the case of a tricuspid valve TV, fixation device 12 may be positioned perpendicular (+ / - 5 degrees) to a line of coaptation between the septal leaflet SL and the anterior leaflet AL, the septal leaflet SL and the posterior leaflet PL, or the anterior leaflet AL and the posterior leaflet PL, for example. Device 12 may be moved roughly along the line of coaptation LOC to the location of regurgitation. The leaflets LF may be held in place so that, during diastole, the leaflets LF remain in position between members 20, 40 surrounded by openings O (also referred to herein as orifices) which result from the diastolic pressure gradient. Advantageously, leaflets LF are coapted such that their proximal or upstream surfaces face each other in a vertical orientation, parallel to the direction of blood flow through the valve. The upstream surfaces may be brought together so as to be in contact with one another or may be held slightly apart but will preferably be maintained in the vertical orientation in which the upstream surfaces face each other at the point of coaptation. This simulates the double orifice geometry of a standard surgical bow-tie repair. Color Doppler echo will show if the regurgitation of the valve has been reduced. If the resulting flow pattern is satisfactory, the leaflets LF may be fixed together in this orientation. If the resulting color Doppler image shows insufficient improvement in valve regurgitation, fixation device 112 may be repositioned. This may be repeated until an optimal result is produced wherein the leaflets LF are held in place.

[0103] FIGS. 4A-19C depict a fixation device 112 according to another embodiment of the present disclosure. Fixation device 112 may generally include a pair of craddle members 120, a pair of gripper members 140, a coupling member 160, an actuation mechanism 113, and a stud 131. Craddle members 120 may each include an elongate body 121 in which each bodyAtty Docket No. ABTEVA-0072PCT has a proximal end portion 121a, which may be rotatably connected to the coupling member 160, and a free end 121b, as best shown in FIG. 4A. Free ends 121b may each have a rounded shape to minimize interference with and trauma to surrounding tissue structures according to one example. In one example, each free end 121b defines a curvature extending about two axes 126, 127. The first axis 126 may be a longitudinal axis of each respective body 121. Additionally, bodies 121 may each include an engagement surface 125 that may also be curved about first axis 126 and may extend at least partially along a length of body 121 to the free end 121b. Thus, in some examples, engagement surfaces 125 may each have a cupped or concave shape which may maximize contact area engagement with tissue and may assist in grasping and holding valve leaflets. Such cupped or concave shape may further allow bodies 121 to nest around shaft 111 of interventional tool 110 while in the closed position to minimize the profile of device 112. Thus, bodies 121 may be at least partially cupped or curved inwardly about their longitudinal axes 126 which may form a concavity extending along axis 126 which may nest gripper members 140 when in a lowered position thereof. The second axis 127 about which each free end 121b may be curved may extend perpendicular to first axis 126, as is also shown in FIG. 4A. The curvature about this second axis 127 may be a reverse curvature located at the most distal portion of free ends 121b. In addition to the dual curvature, free ends 121b may flare outwardly at their respective longitudinal edges. It is believed that both the reverse curvature and flare help create an atraumatic configuration that minimizes trauma to the tissue engaged therewith.

[0104] In the nonlimiting embodiment depicted, a transverse width across engagement surfaces 125 (which is in the direction of second axis 127 and determines the width of tissue engaged) may be at least about 2 mm, 3-10 mm in some examples, and about 4-6 mm in some examples. In some embodiments, a wider engagement may be desired wherein the engagement surfaces 125 are larger, for example about 2 cm, or multiple fixation devices 112 may be used adjacent to each other. Bodies 121 may also have a length of about 6-12 mm (defined along first axis 126), and engagement surfaces 125 may be configured to engage a length of tissue of about 4-10 mm along the longitudinal axis 126 of bodies 121 according to some examples. Also, as shown in the illustrated example, each body 121 may include a plurality of openings 128 to enhance grip and to promote tissue ingrowth following implantation.

[0105] In one example, actuation mechanism 113 may include two link members or legs 130. Legs 130 may be comprised of a rigid or semi-rigid metal or polymer such asAtty Docket No. ABTEVA-0072PCTElgiloy®, cobalt chromium or stainless steel, however any suitable material may be used. Each leg 130 may have a first end 132, which may be rotatably joined with one of the craddle members 120 at a riveted joint 135, and a second end 134, which may be rotatably joined with stud 1 1 , as shown in FIG. 4A. Although the depicted embodiment shows both legs 130 pinned to stud 131 by a single rivet 135, it is also contemplated that each leg 130 may be individually attached to the stud 131 by a separate rivet, pin or the like. In other embodiments of actuation mechanism 113, actuation mechanism 113 may include a base 139, and second ends 134 of legs 130 may be rotatably joined with base 169, such as by one or more riveted joints 135, as best shown in FIG. 10B. An actuator rod 170 of delivery system 600 may be joinable with actuation mechanism 113 directly, such as via direct connection with base 139, or indirectly, such as via connection with stud 131, which itself may extend from base 139. In either of these embodiments, actuator rod 170 may be axially extendable and retractable in a proximal-distal direction to actuate actuation mechanism 113 and consequently rotate craddle members 120 between open, closed, and inverted positions, which are described further below. Additionally, coupling member 160, stud 131, and / or base 139 may comprise a center assembly (also referred to herein as a center portion or center body) of fixation device 112, for example.

[0106] Gripper members 140 may, in some examples, be flexible, resilient, and cantilevered from a center of fixation device 112. For example, FIGS. 5 A and 5B depict a gripping device 114 according to an embodiment of the present disclosure that may generally include a pair of gripper members 140, a base section 150, and a pair of hinge features 153 partitioning gripper members 140 from base section 150.

[0107] Gripper members 140 may be in the form of elongate bodies 141 that each extend along a longitudinal axis A2 from a first end portion or fixed end 141a to a second end portion or free end 141b, as shown in FIG. 5 A. Each gripper member 140 may also have opposed side edges 142 that define a width transverse to the longitudinal axis A2. Such width may be less than the width of a corresponding craddle member 120 such that gripper member 140 may be recessed within the concavity formed by engagement surface 125 of craddle member 120 when gripper member 140 is moved into a lowered position, as described in more detail below.

[0108] Gripper members 140 may also each have a first side or proximal side 143 and a second side or distal side 144. In one example, gripper members 140 may include a plurality of openings 146 that may extend from proximal side 143 to distal side 144, as shown in FIG.Atty Docket No. ABTEVA-0072PCT5A. Such openings 146 may be used to couple a gripper member line, which is discussed further below, to a gripper member 140 for raising and lowering gripper member 140. Each gripper member 140 may also include one or more frictional elements 145 extending from distal side 144. For example, each gripper member 140 may include one or more rows of frictional elements 145 where frictional elements 145 in each row may be aligned in a direction transverse to longitudinal axis A2. Frictional elements 145 in such rows may also be aligned with frictional elements 145 in other rows in a lengthwise direction thereby forming columns of frictional elements 145. For example, in the embodiment depicted in FIGS. 5 A and 5B, each gripper member 145 may include four rows of two frictional elements 145. In other words, two columns of four frictional elements 145. In other embodiments, gripper members 140 may include one to six rows of two to six frictional elements 145 per row, for example. However, in other embodiments, frictional elements 145 may be arranged in an offset relationship in a lengthwise and / or transverse direction such that at least some frictional elements 145 are not aligned with another frictional element 145 in such directions.

[0109] Frictional elements 145 may comprise frictional protrusions or tines having tapering pointed tips extending from distal side 144 of gripper members 140. Frictional elements 145 may also be angled toward fixed end 141 a of gripper member 140 which may help prevent frictional elements 145 from inadvertently snaring tissue during repositioning of fixation device 112. In one example, frictional elements 145 may be integral with or connected to a distal surface 144 of a gripper member 140 and protrude therefrom. In another example, as shown in FIG. 5A, frictional elements 145 may be formed from side edges 142, such as by cutting and bending the base material forming gripper members 140, for example. It may be appreciated that any suitable frictional elements may be used, such as prongs, windings, bands, barbs, grooves, channels, bumps, surface roughening, sintering, high-friction pads, coverings, coatings, or a combination of these. However, it should be noted that some types of frictional elements that can be utilized may permanently alter or cause some trauma to the tissue engaged. Thus, it is preferable that frictional elements 145 be atraumatic and generally frictional rather than penetrative so as to not injure or otherwise affect the tissue in a clinically significant way.

[0110] Base section 150 may be connected to a center assembly or center body of fixation device 112 such that gripper members 140 extend outwardly therefrom. For example, base section 150 may be coupled to coupling member 160. In the embodiment depicted, base section 150 may include a first segment 152, a second segment 154, and a third segment 156.Atty Docket No. ABTEVA-0072PCTFirst and third segments 152, 156 may be connected to second segment 154 to form a generally U-shaped or box-shaped structure which may allow a locking mechanism (discussed below) to be positioned between first and third segments 152, 156. However, other shapes may be formed, such as a V-shape, a crescent shape, or semicircular, for example. In some embodiments, first and third segments 152, 156 may be connected to second segment 154 via hinge features 157, for example. Also, second segment 154 may include an opening 158 extending therethrough for receipt of stud 131 and / or actuator rod 170, as shown in FIG. 5 A.

[0111] Hinge features 153 may couple a respective gripper member 140 and base section 150. For example, an hinge feature 153 can couple a gripper member 140 to first segment 152 of base section 150, and another hinge feature 153 can coupled the other gripper member 140 to third segment 156 of base section 150. As shown, hinge features 153 may form a living hinge about which gripper members 140 may bend relative to base section 150. In this regard, hinge features 153 may be integral with gripper members 140 and base section 150 and may bias gripper members 140 to a relaxed position. As illustrated in FIG. 5B, gripper members 140 may form a relaxed angle 149 formed between proximal sides 143 of each gripper member 140. Such relaxed angle 149 is formed when gripper members 140 are in the relaxed position and may form an angle of about 85 degrees to 200 degrees (+ / - 5 degrees). For example, gripper members 140 may form a relaxed angle of 180 degrees in the relaxed position. In another example, gripper members 140 may form a relaxed angle of 185 degrees in the relaxed position. Although the embodiment depicted illustrates bend features 153 as living hinges, in other embodiments bend features 153 may comprise a biased hinge that modularly connects gripper members 140 to base section 150. For example, gripper members 140 may be separately formed from base section 150 and modularly connected to base section 150 via hinge features 153 which may each comprise a spring biased hinge biasing a respective gripper member 140 to the relaxed position, for example.

[0112] Hinge features 153 may also each include an elongate opening extending 151 along the longitudinal axis A2 which may furcate each hinge feature 153, as illustrated in FIG. 5A. Such an elongated opening 151 may have a uniform width extending along axis A2. However, in some embodiments, such as the embodiment depicted, elongate opening 151 may form a bowling -pin shape such that a width of opening 151 is narrower at one end (e.g., the end closest to free end 141b) than the other end (e.g., the end furthers from free end 141b) and is wider somewhere in between. Elongate opening 151 may also not be relegated to just hingeAtty Docket No. ABTEVA-0072PCT feature 153 but may also extend from hinge feature 153 to gripper member 140 and / or base body 150. The elongate opening 151 and corresponding furcation of hinge features 153 may be configured {e.g., in size, shape, spacing, position, etc.) so as to provide the desired resiliency, fatigue resistance, and / or flexibility at the coinciding hinge features 153.

[0113] Hinge features 110 and hinge features 112 may be configured to give gripping device 116 a bent configuration when gripping device is in a relaxed state (z.e., when gripper members are in the relaxed position), such that when gripping device 114 is forced into a stressed state {e.g., by bending gripper members at one or more of the base and / or arm In the exemplary embodiment depicted, gripping device 114 may be formed from a metallic sheet of a spring-like material, such as a shape- memory metal e.g., Nitinol) which may provide the bias of gripper members 140 toward the relaxed position. Alternatively, gripping device 114 could be molded from a biocompatible polymer. Each gripper member 112 may, in one example, be configured to be at least partially recessed within the concavity of the craddle member 120 when no tissue is present. When fixation device 112 is in the open position, each gripper member 140 may be separated from the engagement surface 125 near free end 121b of body 121 and may slope toward engagement surface 125 near free end 121b with the free end 141b of gripper member 140 contacting engagement surface 125, as illustrated in FIGS. 4A and 11B. This arrangement may be facilitated by the dimensions of base section 150. For example, increasing or decreasing the respective lengths of first, second, and third segments 152, 154, 156 of base section 150 may increase or decrease the separation distance between a gripper member 140 and corresponding craddle member 120 which may help accommodate a valve leaflet or other tissues of varying thicknesses. Further examples of gripping devices that may be utilized in fixation device 112 are described in more detail in U.S. Patent No. 11,096,691, the disclosure of which is incorporated by reference herein in its entirety.

[0114] In other embodiments gripper members may be connected to or otherwise extend from craddle members rather than from a center assembly of fixation device, like that of fixation device 112. For example, FIGS. 6 A and 6B depict a gripping device 214 according to another embodiment of the present disclosure that may generally include a first limb 240, a second limb 250, and an hinge feature 260 partitioning first limb 240 from second limb 250. Gripping device 214 may be made from a shape-memory-metal material, such as Nitinol, for example.Atty Docket No. ABTEVA-0072PCT

[0115] First limb 240 may constitute a gripper member of fixation device 112, like that of and as an alternative to gripper member 140 and may include one or more frictional elements 245 which may be similar to frictional elements 145 discussed above. Thus, a plurality of frictional elements 245 may extend from a distal side of first limb 240 such as in one or more rows and / or columns. In the embodiment depicted, a single row of three frictional elements 245 may be provided near a free end 241b of first limb 240. But, as mentioned above, first limb 240 may have any number of frictional elements 245, such as two, four, or six, for example. First limb 240 may also include a pair of elongate beams 247 offset from each other to form a space 248 therebetween. Such space 248 may be configured to receive second limb 250, for example. Additionally, first limb 240 may include one or more openings 246, such as near free end 241b, as shown in FIG. 6A. Such opening 246 may be configured to receive a gripper member line for raising and lowering first limb 240.

[0116] Second limb 250 may be in the form of a beam or other elongate structure. Second limb 250 (also referred to herein as base section) may be configured to couple to an craddle member 120. For example, in the embodiment depicted in FIGS. 6A and 6B, second limb 250 may be curved in a plane transverse to its longitudinal axis. For example, second limb 250 may be semi -cylindrical such that it may have a semi-circular profile. Thus, second limb 250 may have a convex surface 255 configured to conform to the cupped curvature of engagement surface 125 of a corresponding craddle member 120. FIG. 6B illustrates second limb 250 coupled to proximal engagement surface 125 of craddle member 120 such that it is generally recessed within craddle member 120 and free ends 241b, 251b of first and second limbs 240, 250 point in the general direction toward free end 121b of craddle member 120. Thus, in some embodiments, second limb 250 may have a width configured to be positioned within the concavity of craddle member 120 and secure to proximal engagement surface 125. In other embodiments, a second limb 250’ of an alternative gripping device 214’ may not be concave and may instead have a planar surface corresponding to a planar engagement surface 125’ of an alternative craddle member 120’ and secured thereto, as illustrated in FIG. 6C. In further embodiments, craddle member 120 may include a recess or pocket for receipt and securement of second limb 250, such as in a press-fit manner, for example. Second limb 250 may be secured to craddle member 120 in any number of ways, such as via one or more sutures, welding, press-fit, fastener (e.g., rivet or screw) or the like. For example, a rivet, screw, or suture may pass through one or more openings 257 in second limb 250 and into craddle memberAtty Docket No. ABTEVA-0072PCT120. A tissue fixation device, such tissue fixation device 112, may include a pair of gripping devices 214 with one coupled to each craddle member 120 as mentioned above.

[0117] Hinge feature 260 may be coupled to a fixed end 241 of first limb 240 and a fixed end 251 a of second limb 250 such that first and second limbs 240, 250 extend in the same general direction and may form a V-shape when first limb 240 is in an exemplary open or raised position, as illustrated in FIGS. 6B and 6C. As shown, hinge feature 260 may form a living hinge about which first limb 240 may bend relative to second limb 250. In this regard, hinge feature 260 may be integral with first limb 240 and second limb 250 so as to form a monolithic structure and may bias first limb 240 to a relaxed position. Such relaxed position may include second limb 250 extending through space 248 between elongate beams 247 of first limb 240 to form an X-shape. However, it should be noted that such position can generally only be achieved when gripping device 214 is not coupled to craddle member 120 as the presence of craddle member 120 would prevent second limb 250 from passing into space 248. It should also be appreciated that in some embodiments of gripping device 214, hinge feature 260 may be a spring loaded or otherwise biased hinge coupling separately formed first and second limbs 240, 250.

[0118] Fixation device 114 may also have a covering 1 17, as shown in FIG. 4B. As depicted, covering 117 may encapsulate craddle members 120 and actuation mechanism 113. Thus, engagement surfaces 125 may be covered by covering 117 which may help minimize trauma on tissues and enhance primary fixation via additional friction to assist in grasping. Additionally, covering 117 on engagement surfaces 125 may facilitate tissue ingrowth to provide for secondary fixation to ensure long-term security. Covering 117 may be loosely fitted and / or may be flexible such that device 112 can freely move to various positions all the while covering 117 conforms to the contours of the device 112 and remains securely attached thereto. It may be appreciated that the covering 117 may cover specific parts of fixation device 1 12 while leaving other parts exposed. For example, gripper members 140 may be exposed, while craddle members 120 and actuation mechanism 113 may be covered. However, in some embodiments, gripper members 140 may be covered with covering 117 to enhance grip and tissue ingrowth following implantation. Preferably, when a covering 117 is used in combination with frictional elements 145 or other frictional features, such as those extending from gripper members 140, such features may protrude through such covering 117 so as to contact any tissue engaged by gripper members 140.Atty Docket No. ABTEVA-0072PCT

[0119] Covering 117 may be comprised of any biocompatible material, such as polyethylene terepthalate, polyester, cotton, polyurethane, expanded polytetrafluoroethylene (ePTFE), silicon, or various polymers or fibers and have any suitable form, such as a fabric (woven or unwoven), mesh, textured weave, felt, looped or porous structure. Generally, covering 117 has a low profile so as not to interfere with delivery through an introducer sheath or with grasping and coapting of leaflets or tissue. Covering 117 may alternatively be comprised of a polymer or other suitable materials dipped, sprayed, coated, or otherwise adhered to the surfaces of the fixation device 112. Optionally, a polymer coating may include pores or contours to assist in grasping the tissue and / or to promote tissue ingrowth. Any of the coverings 117 may optionally include drugs, antibiotics, anti -thrombosis agents, or anti-platelet agents such as heparin, COUMADIN® (Warfarin Sodium), to name a few. These agents may, for example, be impregnated in or coated on the coverings 117. These agents may then be delivered to the grasped tissues surrounding tissues and / or bloodstream for therapeutic effects.

[0120] FIGS. 7A-7C depict an exemplary coupling system 115 between fixation device 112 and delivery system shaft 111. As mentioned above, once the leaflets of a target valve are coapted in the desired arrangement, fixation device 112 may then be detached from delivery system 600 and left behind as an implant to hold the leaflets together in the coapted position. Such detachment may occur between coupling member 160 of fixation device 112 and a distal end of delivery shaft 111. Thus, coupling member 160 may be configured to be releasably coupled to shaft 111. Coupling member 160 may be disposed at a center of fixation device 112 and may extend proximally along it’s the longitudinal axis of fixation device 1 12. In the coupling system 115 depicted, shaft 111 may form a tubular upper shaft with a first mating surface 163 formed at a distal end thereof, and coupling member 160 may form a detachable lower tubular shaft with a second mating surface 162 formed at a proximal end thereof. Mating surfaces 162, 163 may be correspondingly shaped so that they interlock and form a joining line 165 when merged together, as shown in FIG. 7B. In this regard, mating surfaces 162, 163 may have any shape or curvature which allows or facilitates interlocking and later detachment. For example, in the depicted embodiment, mating surfaces 162, 163 define a joining line 165 with an S-shaped curvature.

[0121] Coupling system 115 may also include actuator rod 170 and stud 131 (or alternatively base 139) such that fixation device 112 may also be releasably coupled to delivery system 600 via connection between actuator rod 170 and stud 131. When shaft 111 is coupledAtty Docket No. ABTEVA-0072PCT to coupling member 160, they may collectively form an axial channel. Actuator rod 170 may pass through this channel to bridge the joining line 165, as shown in FIG. 7B. Actuator rod 170 may comprise a proximal extremity 171, a distal extremity 172, and a joiner 174. Distal extremity 172 may be smaller in diameter than proximal extremity 171 and may be optionally surrounded by a coil 173 which may serve to bias joiner 174 in a proximal direction. However, in some embodiments, actuator rod 170 may not have coil 173 or proximal and distal extremities 171, 172 of differing diameters. Joiner 174 may be removably coupled with stud 131 of fixation device 112 via any one of various possible release mechanisms. For example, in the embodiment depicted, joiner 174 may be threadedly connected to stud 131 of fixation device 112. In this regard, joiner 174 may have internal threads 175 which mate with external threads 133 on stud 131. Alternatively, joiner 174 may have external threads which mate with internal threads of stud 131. As described previously, stud 131 may be connected with craddle members 120 so that advancement and retraction of stud 131, by means of actuator rod 170, manipulates craddle members 120. It is also contemplated that joiner 174 may be directly threadedly engaged with base 139 where no stud 131 is provided. Once detachment of fixation device 112 is desired, actuator rod 170 may be rotated until threads 175 of joiner 174 disengage threads 133 of stud 131. Actuator rod 170 may then be retracted to a position above mating surfaces 162, 163 which in turn allows coupling member 160 to separate from shaft 111 along joining line 165, as illustrated in FIG. 7C.

[0122] FIGS. 8 A and 8B illustrate an alternative example of a coupling system. In this exemplary coupling system 315, shaft 311 of the delivery system (e.g., delivery system 600) may be releasably coupled with coupling member 360 via a detent mechanism, for example. In this regard, shaft 311 may form an upper tubular shaft with detent mechanism features and coupling member 360 may form a lower tubular shaft with detent mechanism features configured to releasably connect with the detent mechanism features of shaft 311. In the embodiment depicted, the detent mechanism may include one or more spring arms 361 integrally formed on shaft 311 and one or more receptacles 362 sized to receive spring arms 361 within coupling member 360. However, shaft 311 may include receptacles 362, while coupling member 360 may include spring arms 361, for example. As shown, spring arms 361 may have a flange-like engagement element 363 at a distal end thereof and are preferably biased inwardly, i.e., toward an interior shaft 311, as shown in FIG. 8B. Receptacles or apertures 362 may be configured to receive and mate with respective engagement elementsAtty Docket No. ABTEVA-0072PCT363 of spring arms 361, as shown in FIG. 8A. Receptacles 362 may extend all the way through the wall of coupling member 360 and may be sized to snuggly fit both engagement elements 362. A snuggly fitting rod (such as actuator rod 370) may extend through shaft 311 and coupling member 360 and may outwardly deflecting the inwardly biased spring arm(s) 361 such that the engagement elements 363 are pushed into respective engagement with a corresponding receptacle 362 thereby coupling the shaft 311 to coupling member 360, as shown in the example of FIG. 8 A. When desirable to detach fixation device 112 from delivery system 600, actuator rod 370 may be retracted to a position above spring arm(s) 361 and engagement features 363 thereof. This allows the inwardly biased spring arms 361 and corresponding engagement elements 363 to disengage from receptacles 362 thereby detaching shaft 311 and coupling member 360. As mentioned above, actuator rod 370 may be threadedly engaged to stud 131. Thus, actuator rod 370 may first be rotated to unthread its threads 375 from stud 131 and then retracted to release coupling member 360 according to an example of the disclosure.

[0123] As mentioned above, fixation device 112 may, in one example, be actuated through multiple positions within a mammalian body during a transcatheter procedure such as by extending and retracting actuator rod 170 when coupled to stud 131 and / or base 139. FIGS. 9A-9B, 10A-10B, 11A-1 IB, 12A-12B, and FIGS. 13A-13B illustrate several of these possible positions and in a sequence that may be utilized during a transcatheter, therapeutic procedure (e.g., tissue approximation).

[0124] FIGS. 9A and 9B depict fixation device 1 12 in an example of a closed position or delivery position. Fixation device 112 may assume the closed position when being delivered through a guide catheter or sheath 3300 of steerable guide system 5, as shown in FIG. 9A. In the closed position, the opposed pair of craddle members 120 may be positioned so that engagement surfaces 125 thereof face each other. The cupped or concave shape of each body 121 in this example allows bodies 121 to surround shaft 111 and optionally contact each other on opposite sides of shaft 111. This provides a low profile for fixation device 112 so that it is readily passable through a delivery catheter 3300 and through any anatomical structures, such as those within the cardiovascular system.

[0125] FIGS. 10A-10B depict fixation device 112 in an example of an open position. Fixation device 112 may assume the open position for capturing and grasping leaflets of a heart valve. In an open position, craddle members 120 may be rotated so that engagement surfacesAtty Docket No. ABTEVA-0072PCT125 thereof face a first direction such that engagement surfaces 125 are disposed at an acute angle relative to shaft 111. For example, the acute angle formed between each engagement surface 125 and shaft may be 45 degrees to 90 degrees. Stated differently, in the open position, engagement surfaces 125 of craddle members 120 may be oriented 90 degrees to 180 degrees relative to each other. However, it is generally preferable for arms to be positioned 120 degrees relative to each other (and 60 degrees relative to shaft 111) for capturing leaflets. Movement of fixation device 112 from the closed position to the open position may be achieved by advancing stud 131 distally relative to coupling member 160 by distally advancing actuator rod 170. Conversely, fixation device 112 may be moved from the open position to the closed position by retracting actuator rod 170 and retracting stud 131 proximally, according to one example of the disclosure.

[0126] As shown in FIG. 10B, gripper members 140 (or gripper members 240) may be in a raised or insertion position when fixation device 112 is in the open position to facilitate insertion of leaflets between craddle members and gripper members 120, 140 for their capture. A loop 148 may be provided on one or both gripper members 140 for receipt of a gripper member line that can raise and lower gripper members 140. Gripper members 140 are, in one example, biased toward craddle members 120. In this regard, gripper members 140 may be moved inwardly toward shaft 111 and held against shaft 111 with the aid of gripper member lines 101 which can be in the form of sutures, wires, nitinol wire, rods, cables, polymeric lines, or other suitable structures, as shown in FIG. 10A. Thus, FIGS. 10A and 10B depict fixation device 1 12 in an insertion configuration in which gripper members 140 are in a raised position and craddle members 120 are in an open position.

[0127] Once fixation device 112 has been positioned in a desired location against the valve leaflets, the leaflets may then be captured between gripper members 140 and craddle members 120. FIGS. 11A and 11B illustrate fixation device 112 in an example of such a position. Here, gripper members 140 are lowered toward engagement surfaces 125 so that gripper members 140 are in a lowered or capture position, and the leaflets are held between distal and gripper members 120, 140. Gripper members 140 are, in one example, lowered into the lowered position while craddle members 120 remain in the open position. Thus, fixation device 112, as shown in FIGS. 11 A and 1 IB is in an example of a capture configuration which may be similar to the insertion configuration of FIGS. 10A and 10B, but with the difference being that gripper members 140 are now lowered toward craddle members 120 by releasingAtty Docket No. ABTEVA-0072PCT tension on gripper member lines 101 to compress the leaflet tissue therebetween. At any time, the gripper members 140 may be raised and the craddle members 120 adjusted or inverted to reposition fixation device 112 if regurgitation is not sufficiently reduced according to one example of the disclosure.

[0128] FIGS. 12A-12B depict an example of an inverted position of fixation device 112. Fixation device 112 may assume the inverted position to aid in repositioning or removal of fixation device 112. In one example of the inverted position, craddle members 120 may be further rotated from the open position, which may be achieved by advancing stud 131 further relative to the open position, so that the engagement surfaces 125 of craddle members 120 face outwardly, and free ends 121b point distally. Additionally, in some examples, engagement surfaces 125 of each body 121 may form an obtuse angle relative to shaft 111. For example, the obtuse angle formed between each engagement surface 125 and shaft 111 may be 135 degrees to 180 degrees. Stated differently, in the inverted position, engagement surfaces 125 of craddle members 120 may be oriented 270 degrees to 360 degrees relative to each other.

[0129] Also, as shown in FIG. 12B, in one example gripper members 140 are in their raised position against shaft 111 while craddle members 120 are in the inverted position by exerting tension on the gripper member lines 101. Thus, a relatively large space may be created between proximal and craddle members 140, 18 for repositioning. In addition, the inverted position allows withdrawal of the fixation device 112 through the valve while minimizing trauma to the leaflets. Engagement surfaces 125 provide an atraumatic surface for deflecting tissue as the fixation device is retracted proximally. It should be further noted that tines 145 of gripper members 140 may, in some examples, be angled slightly in the distal direction (away from the free ends of the gripper members 140), reducing the risk that tines 145 will catch on or lacerate tissue as fixation device 112 is withdrawn and while gripper members 140 are in the raised position.

[0130] After the leaflets have been captured between distal and gripper members 120, 140, craddle members 120 may be returned to or toward the closed position where they may be locked in place. An example of such locking is described further below. FIG. 13 A illustrates fixation device 112 in the closed position wherein the leaflets (not shown) are captured and coapted. In one example, this is achieved by retraction of the stud 131 proximally relative to coupling member 160 so that the legs 130 of the actuation mechanism 113 apply an upwards force to craddle members 120 which in turn rotate craddle members 120 so that engagementAtty Docket No. ABTEVA-0072PCT surfaces 125 again face one another, similar to that of FIGS. 9A and 9B, and so that craddle members 120 rotate gripper members 140 in a direction toward shaft 111. However, because the leaflets are captured between craddle members and gripper members 120, 140, it may be desirable to keep craddle members 120 at about 20 degrees to 60 degrees relative to each other so as to limit the amount of tension and stress on the native tissue. Thus, while fixation device 112 may be returned to the closed position, such closed position may not be as closed as in the initial delivery position.

[0131] As shown in FIG. 13B, fixation device 112 may then be released from shaft 1 11 of delivery system 600 while in the closed position. As mentioned, fixation device 112 may be releasably coupled to delivery system 600 via a coupling system (e.g., coupling system 115 or 315). When the coupling structures of such coupling system are released, gripper member lines 101 may remain attached to gripper members 140 following detachment to function as a tether to keep the fixation device 112 connected with the delivery catheter 610 (see FIG. 16) for reconnection and repositioning. However, in other embodiments, gripper members lines 101 may be released prior to release of fixation device 112 or concurrently with the release of fixation device 112, as described in more detail below.

[0132] FIG. 13C illustrates a released fixation device 1 12 in an example of a closed position. As shown, coupling member 160 remains separated from shaft 111 of delivery system 600, and gripper members 140 are deployed so that tissue (not shown) may reside between gripper members 140 and craddle members 120.

[0133] As mentioned above, gripper member lines or actuators 101 may be releasably coupled to gripper members 140. In some examples, gripper member lines 101 may pass through an opening in gripper members 140, such as openings 146 and 246 in the case of gripper member 240. In other examples, eyelets, which may be formed from one or more lengths of suture, may be coupled to gripper members 140 and gripper member lines 101 may pass through such eyelets. Thus, gripper member lines 101 may be released from gripper members 140 prior to, concurrent with, or after release of fixation device 112 from delivery system 600 according to various examples.

[0134] In an exemplary embodiment of interventional tool 110, as shown in FIG. 14, a plurality of gripper member lines 101a, 101b may extend through corresponding lumens 614a, 614b of shaft 111 of delivery system 600 (see FIG. 16) and may be coupled to gripper members 140 of fixation device 112. Each of gripper member lines 101a and 101b may be elongatedAtty Docket No. ABTEVA-0072PCT flexible threads, wire, cable, sutures, or lines extending through shaft 111, looped through gripper members 140, and extending back through shaft 111 to a delivery device handle of delivery system 600. When detachment is desired, one end of each gripper member line 101a, 101b may be released from delivery system 600, and the other end pulled to draw the free end distally through shaft 111 and through gripper member 140 thereby releasing it. Also, in this arrangement, gripper member lines 101a and 101b may be independently or concurrently manipulated so as to independently or concurrently raise and lower gripper members 140, respectively.

[0135] In another example, interventional tool 110’ may be configured, as shown inFIG. 15 with respect to certain components thereof, such that gripper members 140 may alternatively be supported by a single gripper member line 101 which may extend through both of the gripper members 140. In this arrangement both gripper members 140 may be raised and lowered concurrently by action of a single gripper member line 101. Whether gripper members 140 are manipulated individually by separate gripper member lines 101 or jointly by a single gripper member line 101, the gripper member lines 101 may extend directly through openings (e.g., openings 146, 246) of the gripper members 140 and / or through a layer or portion of a covering 117 on gripper members 140, or through a suture loop / eyelet above or below a covering 117, for example.

[0136] In a further example, interventional tool 110” may be configured, as shown in FIG. 16, such that each gripper member line 101a, 101b may be releasably engaged with structures that are activated by removal of the actuator rod 170 that passes through coupling member 160 and shaft 111 such that release of gripper member lines 101a, 101b occurs concurrently with the release of fixation device 112 from delivery system 600. Thus, in one example, which is depicted in FIG. 16, each gripper member line 101a, 101b may have a first end portion 103a (e.g. , proximal end portion), which may be coupled to an actuator of a delivery system handle, a second end portion 103b e.g., distal end portion) which may be releasably engages to shaft 111 via actuator rod 170, and an intermediate portion 103c which may be coupled to a gripper member 140. As described above and as illustrated in FIG. 7A, stud 131 may be releasably attached to actuator rod 170 which passes through coupling member 160 and shaft 11 1 of delivery system 600. In this way, actuator rod 170 is connectable with fixation device 112 and acts to manipulate fixation device 112 so as to move it through its various positions, which are described above. After the leaflets have been coapted, actuator rod 170Atty Docket No. ABTEVA-0072PCT may be removed proximally from stud 131 which may thereby also release coupling member 160 from shaft 111, as described with respect to FIGS. 7A-7C and also FIGS. 8A and 8B with respect to coupling system 315. This action of actuator rod 170 may be utilized to release distal end portion 103b of each of gripper member lines 101 a, 101b.

[0137] Exemplary features which may be implemented in interventional tool 110” to facilitate release of gripper member lines 101a, 101b in this manner are shown in FIGS. 17A- 17G. As depicted, an actuator rod 470 may be used as an anchor to restrict proximal movement of one or more gripper member lines 401. Gripper member line 401 has a distal end portion 403b which may include a catch element 405, for example a trumpet 405 having a cone shape (see FIG. 17D) or other shapes, such as a ball 405’ having a spherical shape (see FIG. 17G), which can be sized to be received within shaft 411. As shown in the example of FIGS. 17B, shaft 411 may have spring arms 461 like that of the coupling system 315 of FIGS. 8A and 8B for releasing device 1 12 from shaft 411. However, shaft 411 may also have mating surfaces of FIGS. 7A and 7C. In any event, a portion of shaft 411 proximal of spring arms 461 (or mating elements 463), may have two slots 412a and 412b defined therein. Slot 412a can define holes 414a and 414b and slot 412b can define holes 414c and 414d. Holes 414a and 414c can be sized to receive catch element 405 of a pair of gripper member lines 401 , respectively, therethrough and into slots 412a and 412b, respectively. Holes 414b and 414d can be sized to prevent catch element 405 of gripper member lines 401, respectively, from extending beyond slots 412a and 412b, respectively. The configuration of slots 412a and 412b and holes 414a- 414d can allow for easier manufacture of the features in shaft 411. Slots 412a and 412b can be drilled to ensure that slots 412a and 412b do not pass the entire way through shaft 411. In this example configuration, catch elements 405 of gripper member lines 401 can be maintained within shaft 411 to manage the slack of gripper member lines 401.

[0138] In one example, catch element 405 of gripper member line 401 can be inserted into slot 412a through hole 414a beyond a longitudinal axis of shaft 41 1 and toward hole 414b, and catch element 405 of gripper member line 401 can be inserted into slot 412b through hole 414c beyond the longitudinal axis of shaft 411 and toward hole 414d prior to the insertion and coupling of the actuator rod 470 (which passes through shaft 411) with stud 131 of fixation device 112. With actuator rod 470 extending through shaft 411, actuator rod 470 may directly engage catch elements 405 of lines a plurality of gripper member lines 401 thereby preventing their movement back out along the path through which they were inserted. For example,Atty Docket No. ABTEVA-0072PCT trumpets 405 can be inhibited from being advanced through holes 414b and 414d, respectively, and can be prevented from being pulled past actuator rod 470 and through holes 414a and 414c, respectively. Accordingly, the second end portions 403b of gripper member lines 401 can be held in place relative to shaft 414. Once the actuator rod 470 is decoupled from stud 1 1 and subsequently retracted, movement of catch elements 405 at the distal end portions of gripper member lines 401 is no longer restricted and gripper member lines 401 are free to move. Upon proximal retraction, gripper member lines 401 can thread through holes 414a and 414c, respectively, and decouple from the gripper members 140.

[0139] In accordance with one example of the disclosed subject matter, slots 412a and 412b can be drilled at an angle towards the distal end of shaft 411 (see FIGS. 17E and 17F), e.g., with hole 414b formed distal to hole 414a on one side, and hole 414d formed distal to hole 141c on the other side. This example configuration of slots 412a and 412b can provide easier deployment of a plurality of gripper member lines 401 and can reduce friction.

[0140] Prior to securing second end portion 403b of each gripper member line 401 with the shaft 411, each gripper member line 401 can be coupled with a respective gripper member 140, such as in the manner described above with respect to FIG. 16. Thus, when gripper member lines 401 are actuated proximally, gripper member lines 401 can move gripper members 140 relative to craddle members 120, thereby moving gripper members 140 between their respective raised and lowered positions.

[0141] As mentioned above, fixation device 112 optionally includes a locking mechanism (e. g. , locking mechanism 116) for locking device 112 in a particular position, such as in any one of the aforementioned open, closed, and inverted positions or any position therebetween. It may be appreciated that according to various examples, locking mechanism 116 may be configured for both locking and unlocking which correspondingly allows device 112 to be both locked and unlocked. As described in more detail below with respect to various locking mechanism examples, such locking mechanisms may have components disposed between coupling member 160 and base 139 which may be configured to selectively arrest proximal-distal movement of stud 131 / base 139 which consequently arrests movement of craddle members 120. Such locking mechanisms may help provide end user control of the final arm angle of fixation device 112 for tailored and optimal results for each patient. Additionally, such locking mechanisms may bring the leaflets and annulus together which mayAtty Docket No. ABTEVA-0072PCT result in beneficial dimensional changes of the target valve which can prevent adverse remodeling of the heart, particularly for patients with heart failure.

[0142] FIGS. 14, 15, and 16A-16C illustrate an embodiment of the locking mechanism 116. Locking mechanism 1 16 generally includes a housing 181 , one or more wedging elements 180, a release harness 190, and a biasing member 189. Housing 181may be positioned distal to coupling member 160 and may be free-floating, coupled to, or integral with coupling member 160, such as at a distal end thereof. Housing 181 may form a window 183 which may be defined at opposite sides with sloping or tapered surfaces 185 which slope inwardly toward stud 131 in a proximal to distal direction. Wedging elements 180 may be in the form of rolling elements, such as a pair of barbells, disposed on opposite sides of stud 131 and between sloping surfaces 185, as shown in FIGS. 18A and 18B. Each barbell 180 may have a pair of generally cylindrical caps 182 and a shaft 184 therebetween, as illustrated in the barbell cross-section of FIG. 16A. Barbells 180 and stud 131 are preferably comprised of cobalt chromium or stainless steel, however any suitable material may be used. Biasing member 189 may be a spring, such as a leaf spring, for example, and may be positioned at a proximal end of housing 181 between sloping surfaces 185 and proximal to barbells 180 such that spring 189 bears on barbells 180 and biases them in a distal direction. Thus, when barbells 180 are pushed distally by spring 189, they are correspondingly pushed inwardly and wedged against stud 131 by sloping surfaces 185, as illustrated by FIG. 18 A, which depicts barbells 180 in a proximal and unlocked position, and FIG. 18B, which depicts barbells 180 in a distal and locked position.

[0143] As shown in FIGS. 14, 15, and 18C, release harness 190 may be in the form of a ridged wire or rod that may extend proximally from stud 131 toward a proximal end of fixation device 112 and at opposite sides thereof. In this regard, release harness 190 may form a first portion or front portion 192a and a second portion or rear portion 192b. Each of first and second portions 192a, 192b may include a crest or closed proximal end 194 through which a lock line 102 may be threaded and engaged, as described below. Release harness 190 may also form hooked distal ends 196a, 196b which may extend between first and second portions 192a, 192b and between sloping surfaces 185 and stud 131, as shown in FIGS. 18A and 18B. Thus, hooked ends 196a and 196b may be moveable proximally-distally within window 183 formed between sloped surfaces 185 and stud 131. Additionally, hooked ends 196a and 196b may be positioned distal of barbells 180 such that pulling up on harness 190 moves hooked ends 196a,Atty Docket No. ABTEVA-0072PCT196b proximally so as to push the respective barbells 180 against the bias of spring 189 and move them to their unlocked position.

[0144] Movement of harness 190 may be performed by one or more lock line 102 which may be coupled to harness 190 by such as by threading lock line 102 through and engaging one or more of proximal ends 194 of first and second portions 192a, 192b thereof, as shown in FIGS. 14 and 15. Such lock line 102 may have a first end 102a fixedly secured to a delivery system handle of delivery system 600 and a second end 102b releasably secured to a delivery system handle, as described in more detail below. In this regard, tension can be selectively applied to lock line 102 to unlock and lock locking mechanism 116. Also, lock line 102 can be released from release harness 190 prior to, concurrently with, or after release of fixation device 112 from delivery system 600 which may be achieved by releasing the second end 102b from delivery system handle and pulling lock line 102 and its second end through shaft 111. Lock line 102 may be comprised of any suitable material, typically wire, nitinol wire, cable, suture, or thread, to name a few. In addition, lock line 102 may include a coating, such as parylene. Parylene is a vapor deposited pinhole free protective film which is conformal and biocompatible. It is inert and protects against moisture, chemicals, and electrical charge.

[0145] When an upwards force is applied to harness 190 by the lock line 102, hooked ends 196a, 196b may raise barbells 180 against spring 189, as shown in FIG. 18A. This may draw barbells 180 up along sloping surface 185 which unwedges barbells 180 from against stud 131. In this position, stud 131 is free to move. Thus, when lock line 102 is tensioned to raise or lift harness 190, locking mechanism 116 is in an unlocked position wherein stud 131 is free to move actuation mechanism 113 and therefore craddle members 120 to any desired position. Releasing tension in lock line 102 may, on the other hand, transition the locking mechanism 116 to a locked position, as shown in FIG. 18B. Thus, by releasing the upwards force on barbells 180 by hooked ends 192a, 192b, spring 189 forces barbells 180 downwards and wedges barbells 180 between a sloping surface 185 and stud 131. This restricts motion of stud 131, which in turn locks actuation mechanism 113 and therefore craddle members 120 in place. In addition, stud 131 may include one or more grooves or indentations 137 which may receive shaft 184 of each barbell 180. This may provide more rapid and positive locking by causing barbells 180 to settle in a definite position, increase the stability of locking mechanism 116 by further preventing movement of barbells 180, as well as tangible indication to the user that each barbell 180 has reached a locking position. In addition, grooves 137 may be used to indicateAtty Docket No. ABTEVA-0072PCT the relative position of craddle members 120, particularly the distance between craddle members 120. For example, each groove 137 may be positioned to correspond with a 0.5- or 1.0-mm decrease in distance between craddle members 120. As stud 131 is moved, barbells 180 may contact grooves 1 7, and by counting the number of grooves 137 that are felt as stud 131 is moved, the user can determine the distance between craddle members 120 and can provide the desired degree of coaptation based upon leaflet thickness, geometry, spacing, blood flow dynamics and other factors. Thus, grooves 137 may provide tactile feedback to the user.

[0146] Locking mechanism 116 allows fixation device 112 to remain in an unlocked position when attached to delivery system 600 during grasping and repositioning and then maintain a locked position when left behind as an implant. It may be appreciated, however, that locking mechanism 116 may be repeatedly locked and unlocked throughout the placement of the fixation device 112 if desired. Once the final placement is determined, lock line 102 may be removed and fixation device 112 may be left behind.

[0147] FIGS. 19A-19C depict a locking mechanism 516 according to another embodiment of the present disclosure that may be incorporated into a fixation device 112 of the disclosure. In this embodiment, locking mechanism 516 also includes a housing 581, a spring 589, a release harness 590, and a wedging element 500. However, instead of sloping surfaces 185 as present in the example of locking element 116, housing 185 may include generally parallel sidewalls 585 and may include a finger or protrusion 587 extending from one of sidewalls 585 toward stud 131, as best shown in FIG. 19C. Such finger 587 may slope in a distal direction and may define a proximal notch 588. Also, as shown in FIG. 19C, first hooked end 596a of release harness 590 may be positioned distal of finger 587.

[0148] Furthermore, wedging element may comprise a binding lever or binding plate 500. As shown in FIG. 19B, binding plate 500 may have an oblong shape that may extend lengthwise between a first end 501 and a second end 502 thereof. An aperture 504 may be formed between first and second ends 501, 502 and may extend from a top planar surface 508 through a bottom planar surface 506 of binding plate 500. Binding plate 500 may be positioned between sidewalls 406 so that stud 131 passes through aperture 504 and so that first end 501 of binding plate 500 is positioned within notch 588 proximal of finger 587, as best shown in FIG. 19C. Thus, finger 587 may be positioned between first end 501 of binding plate 500 and first hooked end 596a of released harness 590. Also, spring 589 may be positioned proximal to binding plate 500 and provide downward or distal bias thereto. Binding plate 500 and stud 131Atty Docket No. ABTEVA-0072PCT may be comprised of any suitable material. In some embodiments, binding plate 500 may have a higher hardness than stud 131. In other embodiments, binding plate 500 may be comprised of a flexible or semi-flexible material. Such flexibility may allow slight movement of stud 131 in the proximal and distal directions, therefore allowing slight movement of craddle members 120 when locking mechanism 516 is in the locked position. This may allow fixation device 112 to adjust in response to dynamic cardiac forces.

[0149] FIGS. 19A and 19C illustrate binding plate 500 in a locked position or configuration. In this regard, spring 589 pushes binding plate 500 in a distal direction. However, because first end 501 of binding plate 501 is positioned within notch 588, axial movement of first end 501 toward a distal end of housing 581 is prohibited while axial movement of second end 502 of binding plate 500 is permitted. Thus, finger 587 obstructs first end 501 from axial movement and creates a lever type movement of binding plate 500. Moreover, finger 587 obstructs first hooked end 596a of release harness 590 from axial movement resulting in a side-to-side pivoting of release harness 590 upon tension of lock line 102. This pivoting movement correspondingly results in second hooked end 596b of release harness moving proximally and controlling movement of second end 502 of binding plate 500. As such, when an upwards force is applied to harness 590 by lock line 102, second hooked end 596b of release harness 590 raises second end 502 of plate 500 against spring 589 so that planar surfaces 506, 508 of binding plate 500 become oriented substantially perpendicular to stud 131. This aligns aperture 504 with stud 131 allowing free movement of stud 131 in the proximal- distal direction. Thus, in this state, locking mechanism 516 is unlocked wherein stud 131 is free to move actuation mechanism 113 and therefore craddle members 120 to any desired position.

[0150] Release of harness 590 by lock line 102 transitions locking mechanism 516 back to the locked position. By releasing the upwards force on second end 502 of binding plate 500, spring 589 forces second end 502 of biding plate 500 downwards, which misaligns aperture 504 relative to stud 531, and correspondingly wedges binding plate 500 against stud 131, as best shown in FIG. 19C. This arrests movement of stud 131, which in turn locks actuation mechanism 113 and therefore craddle members 120 in place. It may be appreciated that binding plate 500 may have any suitable form to function as described above. For example, plate 500 may have a variety of shapes with or without planar surfaces 506, 508 and / or the aperture 504 may be of a variety of shapes and positioned in a variety of locations, to name a few. ForAtty Docket No. ABTEVA-0072PCT example, binding plate 500 may not have a through-hole, like that of aperture 504, but may rather have a notch such that binding plate 500 does not encircle stud 131 but rather partially surrounds it. Further, it may be appreciated that any number of binding plates 500 may be present. Each binding plate 500, in this regard, may provide an additional binding location which may enhance lock performance.

[0151] While the above-described nonlimiting examples of fixation device 112 may utilize a push-to-open, pull-to-close mechanism for opening and closing craddle members 120, it should be understood that a pull-to-open, push-to-close mechanism may alternatively be provided. For example, craddle members 120 may be coupled at their proximal ends to stud 131 rather than to coupling member 160, and legs 130 may be coupled at their proximal ends to coupling member 160 rather than to stud 131. In this example, when stud 131 is pushed distally relative to coupling member 160, craddle members 120 may close, while pulling on stud 131 proximally toward coupling member 160 may open craddle members 120. Regardless, the aforementioned locking mechanism examples may be configured to arrest stud to lock craddle members 120 in the desired position, as described.

[0152] It is to be understood that the fixation devices and components thereof described above are provided as examples are not to be considered as limiting to fixation devices suitable for use with other aspects of the disclosure.

[0153] The above-described examples of fixation device 112 may be utilized in a TEER procedure or any other tissue approximation procedures (e.g., procedures involving cardiac and non-cardiac tissues). A TEER procedure is a minimally invasive interventional procedure that aims to approximate cardiac valvular leaflets to reduce valvular regurgitation particularly in the mitral and triscupid valves. One of the challenges of this type of procedure is ensuring that the valve leaflets are adequately inserted into the fixation device, such as fixation device 112, for example, so that when the fixation device is deployed, it remains secured to the tissue and sufficiently reduces regurgitation. Current TEER techniques typically rely on echocardiography and fluoroscopy for visualization which typically capture fixed views of the target valve. Such visualization modalities, however, have inherent limitations that present challenges making leaflet capture and grasping one of, if not the most, challenging aspects of a TEER procedure. In particular, technique and technological limitations make it difficult to visually observe the leaflets within the fixation device during and after deployment so that the surgeon cannot directly observe how much leaflet is inserted into the fixation device or whetherAtty Docket No. ABTEVA-0072PCT a leaflet has been captured at all. Thus, surgeons typically assess leaflet capture through circumstantial observations that are heavily reliant on surgeon experience. For example, an operator may observe changes in movements of the leaflets and reductions in backflow via color doppler to estimate the adequacy of leaflet capture.

[0154] Difficulties in visualizing leaflet capture can potentially lead to poor leaflet securement and ultimately single leaflet device attachment (“SLDA”), in which only a single leaflet is captured by the fixation device, or complete detachment (i.e., implant embolization). For example, if a leaflet is not inserted far enough between a gripper member and an craddle member (i.e., shallow leaflet insertion), the proximal and craddle members may not be able to grasp the tissue with enough force to retain the tissue potentially resulting in leaflet slippage and ultimately SLDA or implant embolization. Thus, it generally is not sufficient to just capture valve tissue between proximal and craddle members. Rather, the capture should be of such quality to ensure the fixation device remains attached to the leaflet. The quality of tissue capture can be influenced by a number of factors, one of which being the magnitude of the pinch force applied to the tissue.

[0155] Finite element analysis has been performed to quantify the pinch force within corresponding proximal and craddle members to help determine how deep a leaflet may be inserted to achieve an adequately high probability that a leaflet will be permanently captured with limited or otherwise acceptable risk of SLDA or embolization. The force distribution resulting from this analysis for a first clamp 104 comprised of craddle member 120 and gripper member 140 is shown in FIG. 20A and for a second, longer clamp 104’ comprised of craddle member 120’ and gripper member 140’ is shown in FIG. 20B. As shown, the majority of the generated pinch force is applied to the tissue when approximately more than 50% of a maximum leaflet insertion depth is achieved. Thus, leaflet security is ensured, and leaflet capture is sufficient when a leaflet LF is inserted between proximal and craddle members to a depth of more than 50% of a maximum insertion depth. The maximum insertion depth Lgrip, as depicted in FIGS. 20A and 20B, is the maximum length along which a leaflet LF can be captured between the proximal and craddle members, such as gripper members 120, 120' and craddle members 140, 140’. The maximum insertion depth Lgrip may be measured between a crotch 105 (taking into account any fabric covering on the fixation device) formed between fixed ends 121a, 141a and free ends 121b, 141b of the respective craddle members 120, 120’ and gripper members 140, 140’. Crotch 105 defines a closed end of clamps 104 and 104'. FreeAtty Docket No. ABTEVA-0072PCT ends 121b, 141b define an open end of clamps 104 and 104’. Although distal and gripper members 120, 120’, 140, 140’ typically capture tissue when each craddle member 120, 120' is at about 60 degrees relative to a longitudinal axis defined by shaft 111 (see FIG. 1 IB) (120 degrees relative each other) and are then moved to a final, closed position of 5 to 15 degrees (10 to 30 degrees relative each other), it should be noted that the pinch force generally does not change with the angle of the clamp 104, 104’ up to about the initial capture angle of 60 degrees. Thus, the pinch force will be approximately the same throughout the range of motion from initial capture to the final, closed position.

[0156] Referring now in addition to FIG. 21, which depicts a distal portion of an interventional device 1000 according to an embodiment of the present disclosure. Interventional device 1000 generally includes a delivery catheter 1010 and a fixation device 1012 releasably coupled to delivery catheter 1010.

[0157] In various examples, the distal portion of an interventional device 1000 can be incorporated into the interventional devices previously disclosed to have one more features and elements disclosed herein as will be understood in the context of the present disclosure.

[0158] In one example, delivery catheter 1010 includes a shaft 1011 which is configured to releasably couple to fixation device 1012. In a further example, delivery catheter 1010 includes one or more lumens 1112 extending therethrough for receipt of one or more fixation device control elements. One of such control elements may be an actuator rod (e.g., actuator rod 170 or 470), which may extend through delivery catheter 1010, such as through shaft 1011. Such actuator rod may be configured to couple to fixation device 1012 and to actuate one or more components thereof. In another example, the fixation device control elements may include one or more actuation lines (e.g., gripper member lines 101 or 401) and / or one or more lock lines (e.g., lock line 102 or 502).

[0159] Fixation device 1012 includes a first clamp 1004a and a second clamp 1004b. Fixation device 1012 may also include a center assembly 1005. In examples in which fixation device includes a center assembly 1005, first clamp 1004a extends outwardly relative to center assembly 1005 for capturing a first tissue (e.g., first valve leaflet), and second clamp 1004b extends outwardly relative to center assembly 1005 for capturing a second tissue (e.g., second valve leaflet). In such examples, first and second clamps 1004a, 1004b may be coupled to center assembly 1005 or may be coupled to center assembly 1005 and to each other. InAtty Docket No. ABTEVA-0072PCT examples in which fixation device 1012 does not include center assembly 1005, first and second clamps 1004a, 1004b may be coupled to each other.

[0160] First and second clamps 1004a, 1004b each include a craddle member 1020 (also referred to herein as a first member, lower member, fixation element, or distal element) and a gripper member comprising an indicator arm 1030 and a retention arm 1040. The indicator arm 1030 (also referred to herein as a first arm or alpha arm) has a length shorter than the retention arm 1040 (also referred to herein as a second arm or beta arm). In this regard, first and second clamps 1004a, 1004b may be configured for multi-phase grasping of tissue, as described below. In one example, as shown in FIG. 21, each of first and second clamps 1004a, 1004b includes an craddle member 1020, an indictor arm 1030, and a retention arm 1040. Indicator arms 1030 and retention arms 1040 may be configured with an angle difference, a cross-section difference, a curvature difference, and / or a material difference to optimize differential control and grip security on the tissue. They can also be made with same angle, same cross section, same curvature, and / or same material for ease of manufacture and to reduce overall complexity.

[0161] Each craddle member 1020 includes a first end 1021a (or fixed end) and a second end 1021b (or free end). Craddle members 1020 are each moveable between an open position and a closed position, one example of each position is as described above with respect to FIGS. 9A-13C. For example, first end 1021a of each craddle member 1020 may be rotatably coupled to center portion 1005 and / or to each other such that rotating craddle members 1020 about first ends 1021a causes second ends 1021b to move closer to or further away from each other. In such example, second ends 1021b are positioned closer together in the closed position than the open position.

[0162] Each indicator arm 1030 is disposed opposite a respective craddle member 1020 and includes a first end 1031a (or fixed end) and a second end 1031b (or free end). Indicator arms 1031a are each moveable between a first position and a second position, which may be similar to that described with respect to gripper members 140 and relative to FIGS. 9A-13C. In one example, first end 1031a of each indicator arm 1030 is coupled to center portion 1005, and second end 1031b of each indicator arm 1030 is moveable about first end 1031a such that, in the first position, second ends 1031b are closer together than in the second position. In another example, first end 1031a of each indicator arm 1030 is coupled to a respective craddle member 1040, and second end 1031b of each indicator arm 1030 is moveable about first endAtty Docket No. ABTEVA-0072PCT1031a such that, in the first position, second ends 1031b are closer together than in the second position. Additionally, or alternatively, first ends 1031 a of indicator arms 1030 may be coupled to each other, such as via a base section (e.g., base section 150). In examples in which each indicator arm 1030 is coupled to each other via a base section, such base section may be coupled to center portion 1005.

[0163] Each indicator arm 1030 defines a first gripper member length extending between the first end 1031a and second end 1031b thereof. Additionally, each indicator arm 1030 includes one or more frictional elements 1035 which may be like frictional elements 145 or 245, for example. Where more than one frictional element 1035 is included, such frictional elements 1035 may be arranged in one or more rows and / or staggered along the first length of indicator arm 1030.

[0164] Each retention arm 1040 is disposed opposite a respective craddle member 1020 and includes a first end 1041a (or fixed end) and a second end 1041b (or free end). Retention arms 1040 are moveable between a first position and a second position, which may be similar to that described with respect to gripper members 140 and relative to FIGS. 9A-13C. In one example, first end 1041a of each retention arm 1040 is coupled to center portion 1005, and second end 1041b of each retention arm 1040 is moveable about first end 1041a such that, in the first position, second ends 1041b are closer together than in the second position. In another example, first end 1041a of each retention arm 1040 is coupled to a respective craddle member 1020, and second end 1041b of each retention arm 1040 is moveable about first end 1041a such that, in the first position, second ends 1041b are closer together than in the second position. Additionally, or alternatively, first ends 1041a of retention arms 1040 may be coupled to each other, such as via a base section (e.g., base section 150). In examples in which each retention arm 1040 is coupled to each other via a base section, such base section may be coupled to center portion 1005. Furthermore, such base section may be the same base section that connects indicator arms 1030 to each other, or a separate base section.

[0165] Each retention arm 1040 defines a second gripper member length extending between first end 1041a and second end 1041b thereof. Additionally, each retention arm 1040 includes one or more frictional elements 1045 which may be like frictional elements 145 or 245, for example. Where more than one frictional element 1045 is included, such frictional elements 1045 may be arranged in one or more rows and / or staggered along the length of retention arm 1040.Atty Docket No. ABTEVA-0072PCT

[0166] As best depicted in FIG. 21, indicator arms and retention arms 1030, 1040 of each clamp 1004a, 1004b are disposed opposite a respective craddle member 1020 and are independently moveable relative thereto. Additionally, each retention arm 1040 extends outwardly further than indicator arm 1030 such that second end 1041b of retention arm 1040 can be positioned closer to second end 1021b of craddle member 1020 than indicator am 1030. In other words, the first length of each indicator am 1030 is shorter than the second length of each respective retention arm 1040. Thus, first and second clamps 1004a, 1004b include a craddle member 1020, an indicator arm 1030 extending along craddle member 1020 a first length, and an retention arm 1040 extending along craddle member 1020 a second length greater than the first length. The first length of indicator arm 1030 overlaps with the second length of retention arm 1040 such that both indicator arms and retention arms 1030, 1040 can capture tissue provided the tissue extends within the first or second clamp 1004a, 1004b a sufficient depth to reach indicator arm 1030. In other words, tissue inserts into each clamp 1004a, 1004b in a direction towards center portion 1005. Since indicator am 1030 is shorter than retention arm 1040, tissue may be partially inserted such that only retention ami 1040 may grasp the tissue. Such circumstance may risk SLDA. On the other hand, inserting the tissue within clamps 1004a, 1004b a depth sufficient to reach indicator arm 1030, even if such insertion is not a full-depth insertion, allows indicator am 1030 and retention am 1040 to grasp the tissue. In this circumstance, indicator arm 1030 not only provides added gripping force helping mitigate SLDA, but at such depth, retention am 1040 alone may provide sufficient grasping force to fixate the tissue, as described above with respect to FIGS. 20A and 20B. Thus, each indicator am 1030 may provide an indication to a surgeon that tissue has reached a certain depth within each clamp 1004a, 1004b and that depth may be indicative of a quality grasp such that regrasping may not be needed. As such, in one example method, indicator arms 1030 may be deployed in a first phase to grasp tissue, and retention ams 1040 may be later deployed in a second phase to grasp the tissue. As such, tissue grasped during the first -phase grasping indicates tissue has reached indicator am 1030 and a depth that is the difference between first and second lengths of indicator ams and retention arms 1030, 1040, respectively.

[0167] In one example of first and second clamps 1004a, 1004b, the length of indicator arm 1030 is 50% (+ / - 5%) the length of retention arm 1040. Tissue captured in such example by indicator arms 1030 indicates that tissue has reached a depth of at least 50% of a total gripAtty Docket No. ABTEVA-0072PCT length of first and second clamps 1004a, 1004b. In another example, the length of indicator arm 1030 is between 25% and 50% the length of retention ami 1040. Tissue captured in such example by indicator arms 1030 indicates that tissue has reached a depth of beyond 50% a total grip length. In a further example, the length of indicator arm 1030 is between 50% and 75% the length of retention arm 1040. As mentioned, indicator arms 1030 may indicate a depth of insertion and, therefore, may also indicate the quality of tissue capture of retention arms 1040 as a function of tissue insertion depth, as described above with respect to FIGS. 20A and 20B.

[0168] Indicator arm 1030 may be made from a radiopaque material or include radiopaque markers such that indicator arms 1030 are visible under fluoroscopy. Retention arms 1040 may also be made from a radiopaque material or include radiopaque markers. In one example, the radiopaque signature of the indicator arms 1030 may be different than radiopaque signature of retention arms 10040 such that indicator arms 1030 are easily distinguishable from retention arms 1040 under fluoroscopic imaging.

[0169] Center portion 1005 may include one more components. For example, center portion 1005 may include a coupling member (e.g., coupling member 160 or 360) which is configured to releasably coupled to catheter 1010. In another example, center portion 1005 may include a base (e.g., base 1 9) and / or a stud (e.g., 131) which are coupled to craddle members 1020 and are configured to releasably couple to the actuator rod for actuation of craddle members 1020. In a further example, center portion 1005 may include a locking mechanism (e.g., locking mechanism 116 or 516) configured to secure craddle members 1020 in a selected position.

[0170] Furthermore, it should be understood that fixation device 1012 may have any of the components described with respect to fixation device 112. For example, craddle members 1020 may include any of the features described above with respect to craddle members 120 and may be operable via an actuation mechanism like that of actuation mechanism 113. Additionally, fixation device 1012 may have any of the locking mechanisms described herein (e.g., locking mechanism 116 or 516). Furthermore, interventional device 1000 may have any of the coupling mechanisms described herein (e.g., coupling mechanism 115 or 315).

[0171] Referring now in addition to FIGS. 22A-22D, which depict an exemplary multiphase grasping procedure using first clamp 1004a of fixation device 1012. For ease of illustration, only first clamp 1004a of fixation device 1012 is shown. Nonetheless, it should beAtty Docket No. ABTEVA-0072PCT that the same procedure may be performed by second clamp 1004b concurrently or sequentially with first clamp 1004a, as discussed below.

[0172] As shown in FIG. 22A, fixation device 1012 is positioned between opposing tissues, such as leaflets of a heart valve. Such positioning may be performed percutaneously via catheter 1010. Craddle member 1020 may be moved to an open position, while indicator arms and retention arms 1030, 1040 are located in a first position (or raised position). A leaflet LF is then inserted into the space between craddle member 1020 and indicator arms and retention arms 1030, 1040.

[0173] With the leaflet LF positioned between craddle member 1020 and indicator arms and retention arms 1030, 1040, a first-phase grasping is performed, as shown in FIG. 22C. In this regard, indicator arm 1030 is lowered from the first position to a second position. Engagement of leaflet LF between indicator arm 1030 and craddle member 1020 indicates to the surgeon that leaflet LF has reached a certain depth within first clamp 1004a, as described above. Should indicator arm 1030 be lowered and not engage leaflet LF, then that may indicate to the surgeon that the leaflet LF has not reached a depth sufficient to reach indicator arm 1030 and that indicator arm 1030 should be moved back to the first position and first-phase grasping be retried. Engagement of indicator arm 1030 with leaflet LF may be verified by viewing the lowered indicator arm 1030 via medical imaging (e.g., fluoroscopy and / or echocardiography), viewing leaflet movement patterns using medical imaging (e.g., fluoroscopy and / or echocardiography), and / or assessing regurgitative flow using color Doppler, for example.

[0174] Once indicator arm 1030 grasps leaflet LF, then the second-phase grasping may be performed, as shown in FIG. 22C. In this regard, with indicator arm 1030 engaging the leaflet LF, retention arm 1040 is then lowered into engagement with leaflet LF. Indicator arm 1030 and retention arm 1040 may be complementary to each other. In this regard, indicator arm 1030 ensures leaflet insertion depth relative to second gripper member 1040 is sufficient to ensure a quality grasp of leaflet LF with retention arm 1040. Additionally, indicator arm 1030, at least due to its short moment arm, may be more rigid and may apply more force on leaflet LF than retention arm 1040 to thereby help grasp the tissue and prevent SLDA.

[0175] As shown in FIG. 22D, with leaflet LF captured between indicator arms and retention arms 1030, 1040 and craddle member 1020, craddle member 1020 is moved to a closed position. In this closed position, the additional grip engagement of retention arm 1040 enhances leaflet retention / security as compared to indicator arm 1030 alone.Atty Docket No. ABTEVA-0072PCT

[0176] As mentioned above, this multi-phase grasping procedure may be performed concurrently or sequentially with second clamp 1004b. Additionally, operation of indicator arms 1030 of first and second clamps 1004a, 1004b may be performed concurrently or sequentially. In one example, indicator arms 1030 of first and second clamps 1004a, 1004b may be lowered simultaneously to engage respective tissues. In another example, indicator arm 1030 of first clamp 1004a may be independently lowered to engage a first tissue, and thereafter indicator arm 1030 of second clamp 1004b may be lowered to engage a second tissue.

[0177] Similarly, retention arms 1040 of first and second clamps 1004a, 1004b may be operated simultaneously or currently to engage respective tissues. In one example, retention arms 1040 of first and second clamps 1004a, 1004b may be lowered simultaneously to engage respective tissues. In another example, retention arm 1040 of first clamp 1004a may be independently lowered to engage a first tissue, and thereafter retention arm 1040 of second clamp 1004b may be lowered to engage a second tissue. In a further example, each retention arm 1040 may not be deliberately or manually lowered into engagement with tissue, but rather engagement may be activated automatically as craddle members 1020 are moved to the open position while tissue remains engaged with indicator arms 1030.

[0178] Thus, an exemplary method for a therapeutic procedure, such as securing tissue, approximating tissue, TEER, and the like, includes positioning a fixation device between a first tissue and a second tissue, inserting the first tissue between a first craddle member and a first indicator arm and a first retention arm of the fixation device, moving the first indicator arm into engagement with the first tissue, and after the first indicator arm engages the first tissue, moving the first retention arm into engagement with the first tissue. In some examples, the first indicator arm is shorter than the first retention arm.

[0179] The exemplary method may also include inserting the second tissue between a second craddle member and a second indicator arm and a second retention arm of the fixation device, moving the second indicator arm into engagement with the second tissue, and after the second indicator arm engages the second tissue, moving the second retention arm into engagement with the second tissue. In some examples, the second indicator arm is shorter than the second retention arm.

[0180] In a further implementation of the exemplary method, the step of moving the first indicator arm into engagement with the first tissue is performed concurrently with the step of moving the second indicator arm into engagement with the second tissue. Additionally, theAtty Docket No. ABTEVA-0072PCT exemplary method may include moving a first and second actuator concurrently from a first position to a second position. The first and second actuators may be coupled to the first and second indicator arms via respective first and second actuation lines extending from the first and second actuators through a catheter.

[0181] In another implementation of the exemplary method, the step of moving the first indicator arm into engagement with the first tissue is performed sequentially with the step of moving the second indicator arm into engagement with the second tissue. Additionally, the exemplary method may include disengaging an interlock from a first actuator and moving the first actuator and a second actuator sequentially from a first position to a second position thereof. The first and second actuators may be coupled to the first and second indicator arms via respective first and second actuation lines extending from the first and second actuators through a catheter.

[0182] Referring now in addition to FIGS. 23A-24, which depict an interventional device 1100 according to another embodiment of the present disclosure. Interventional device 1100 is similar to interventional device 1000 in that it includes a catheter 1110 and a fixation device 1 112 releasably coupled to a distal end of catheter 1110. Fixation device 1112, as shown, includes first and second clamps 1 104a, 1104b each including an indicator arm 1 130and a retention arm 1140 like that of fixation device 1012. Interventional device 1100 also includes a delivery handle 1160 coupled to a proximal end of delivery catheter 1110. Thus, interventional device 1100 includes all features of interventional device 1000 described above and further includes the features described below.

[0183] Delivery handle 1110 is configured to control components of fixation device 1112. In one example, delivery handle 1110 includes a housing 1162 and a actuator handle 1170 moveably coupled to housing 1162. An actuation line 1101 of interventional device 1100 is coupled to actuator handle 1 170 and extends from handle 1160, through catheter 1110, to fixation device 1112 where it is coupled to indicator arm and retention arm 1130, 1140 of first and second clamps 1104a, 1104b. Moving actuator handle 1170 relative to housing 1162 moves indicator and retention armss 1130, 1140 between their respective first and second positions to achieve a first and second-phase grasping procedure.

[0184] In the example arrangement shown in FIG. 24, first and second ends of actuation line 1101 are coupled to actuator handle 1170. An intermediate portion of actuation line 1101 extends from delivery catheter 1110 where it is releasably coupled to indicator and retentionAtty Docket No. ABTEVA-0072PCT arms 1130, 1140 of each of first and second clamps 1104a, 1104b. For example, indicator and retention arms 1130, 1140 may each include an eyelet 1136, 1146, and actuation line 1101 may extend through each eyelet 1136, 1146 of the respective indicator and retention arms 1130, 1140 of first and second clamps 1104a, 1 104b.

[0185] In operation, actuator handle 1170 may move between two or more positions relative to housing 1162. For example, in a first position of actuator handle 1170, actuation line 1101 is fully tensioned such that each of indicator and retention arms 1130, 1140 are in their first position (or raised position). In a second position of actuator handle 1170, such as when actuator handle 1170 is moved in a distal direction, some tension on actuation line 1101 may be removed such that indicator arms 1130 of first and second clamps 1104a, 1104b move to their second position (or engagement position) for a first-phase grasp. The bias of indicator arms 1130 may be greater than that of retention arms 1 140 at least due to their shorter moment arm which may cause them to move to the engagement position when some slack is introduced to actuation line 1101. Further, in some examples, indicator arms 1130 may be made from a stiffer material to further increase their bias relative to retention amis 1140. In a third position of actuator handle 1170, the maximum amount of slack is introduced to actuation line 1101 which allows retention arms 1 140 to then move to their respective engagement positions for a second-phase grasp. In such example of actuator handle 1170 and actuation line 1101, indicator arms 1130 are actuated simultaneously with each other, and retention arms 1140 are actuated simultaneously with each other all with the operation of a single actuator line 1101. After tissue has been grasped by fixation device 1112, actuation line 1101 may be removed by releasing the second end of actuation line 1101 from handle 1160 and pulling the released second end through each of indicator and retention arms 1130, 1140.

[0186] Further, in some examples, indicator and retention arms 1130, 1140 of first clamp 1104a may be made with greater stiffness than indicator and retention arms 1130, 1140 of second clamp 1104b. In this regard, when actuation line 1101 is engaged to each indicator and retention arm 1130, 1140 of each clamp 1104a, 1104b, indicator and retention arms 1130, 1140 of second clamp 1104b would be lowered before those of first clamp 1104a. This could provide a four phase grasp in which indicator arm 1130 of second clamp 1104b is lowered, followed by indicator arm 1 130 of first clamp 1104a, followed by retention arm 1140 of second clamp 1104b, and then followed by retention arm 1140 of first clamp 1104a.Atty Docket No. ABTEVA-0072PCT

[0187] Additionally, or alternatively, delivery device handle 1160 includes one or more knobs 1180a, 1180b moveably coupled to housing 1162. An actuator rod (e.g., actuator rod 170 or 370) of interventional device 1100 is coupled to the one or more knobs 1180a, 1180b and extends from handle 1160, through catheter 1 110 to fixation device 11 12 where it is coupled to craddle members 1120. Rotating the one or more knobs 1180a, 1180b moves craddle members 1120 between the open and closed positions and / or releases the actuator rod from fixation device 1112.

[0188] As shown in FIG. 23B, delivery catheter 1110 may have a plurality of lumens extending from a proximal end to a distal end thereof. In one example, the plurality of lumens includes a primary lumen 1113a and a plurality of peripheral lumens 1113b arranged about primary lumen 1113a. In examples in which interventional device 1100 that includes an actuator rod, the actuator rod may extend through primary lumen 1113a. In examples of interventional device 1100 that includes actuation line 1101, such actuation line 1101 may extend through one or more peripheral lumens 1113b. For example, actuation line 1101 may extend from a first peripheral lumen 1113b to fixation device 1112 and extend into a second peripheral lumen 1113b to delivery handle 1160. In another example, actuation line 1101 may extend from a peripheral lumen 1 113b to fixation device 112 and then extend through the same peripheral lumen 1113b back to delivery handle 1160.

[0189] Referring now in addition to FIGS. 25A-26, which depict an interventional device 1200 according to a further embodiment of the present disclosure. Interventional device 1200 is similar to interventional device 1100 in that it includes delivery handle 1260, a catheter 1210, and a fixation device 1212 releasably coupled to a distal end of catheter 1210. Fixation device 1212, as shown, includes first and second clamps 1204a, 1204b each including indicator and retention arms 1230, 1240 like that of fixation device 1012 and 1112. However, delivery handle 1260 is alternatively configured and provides for alternative actuation line arrangements as described below.

[0190] In one example of interventional device 1200, delivery handle 1260 includes first and second actuator handles 1270a, 1270b moveably coupled to housing 1262, as shown in FIGS. 25A and 25B. Interventional device 1200 also includes a first actuation line 1201a and a second actuation line 1201b. First actuation line 1201a is coupled to first actuator handle 1270a, and second actuation line 1201b is coupled to second actuator handle 1270b. Actuation lines 1201a, 1201b extend from handle 1260, through catheter 1210, to fixation device 1212Atty Docket No. ABTEVA-0072PCT where they are coupled to indicator and retention arms 1230, 1240. Moving actuator handles 1270a, 1270b relative to housing 1262 moves indicator and retention amis 1230, 1240 between their respective first and second positions to achieve a first and second-phase grasping procedure with respect to tissue.

[0191] As shown in FIG. 25B, delivery handle 1260 may optionally include an interlock 1271 which may couple first and second actuator handles 1270a, 1270b together. For example, as shown, interlock 1271 may be coupled to second actuator handle 1270b and may be moveable between a first position and a second position. In the first position, as shown in FIG. 25B, interlock 1271 extends from second actuator handle 1270b and into engagement with first actuator handle 1270a thereby coupling first and second actuator handles 1270a, 1270b together facilitating concurrent movement thereof and concurrent actuation of first and second actuation lines 1201a, 1201b. In a second position of interlock 1271, interlock 1271 remains coupled to second actuator handle 1270b but is disengaged from first actuator handle 1270a allowing first and second actuator handles 1270a, 1270b to move independently relative to each other. Although in this example, interlock 1271 is shown as being moveably coupled to second actuator 1270b, it should be understood that interlock 1271 may instead be coupled to first actuator handle 1270a and moveable into engagement with second actuator handle 1270b.

[0192] Additionally, first and second actuator handles 1270a, 1270b can have multiple preset positions which can be facilitated by the use of ball-detents to define each position, for example. Such multiple preset positions can facilitate the application of incremental amounts of tension to actuation lines 1201a, 1201b to raise indicator and retention arms 1130, 1140 in sequence. Thus, for example, actuator handles 1270a, 1270b may each include two preset positions with a first position aligned with an amount of tension needed to raise indicator arm 1130, and a second position aligned with an amount of tension needed to raise retention arm 1140.

[0193] Additionally, or alternatively, delivery device handle 1260 includes one or more knobs 1280a, 1280b moveably coupled to housing 1262. An actuator rod 1215 (see FIG. 26) of interventional device 1200 is coupled to the one or more knobs 1280a, 1280b and extends from handle 1260, through catheter 1210 to fixation device 1212 where it is coupled to craddle members 1220. Rotating the one or more knobs 1280a, 1280b moves craddle members 1220Atty Docket No. ABTEVA-0072PCT between the open and closed positions and / or releases actuator rod 1215 from fixation device 1212.

[0194] In the example arrangement of interventional device 1200 shown in FIG. 26, first actuation line 1201a extends from delivery catheter 1210 and is coupled to indicator and retention arms 1230, 1240 of first clamp 1204a, and second actuation line 1201b extends from delivery catheter 1210 and is coupled to indicator and retention arms 1230, 1240 of second clamp 1204b. Additionally, as illustrated, first and second actuation lines 1201a, 1201b are releasably coupled to shaft 1211. For example, actuation lines 1201a, 1201b may each include catch elements (e.g., catch element 405 or 405’) that may extend into shaft 1211 and releasably engage actuator rod 1215 in a manner similar to that described above with respect to FIGS. 17A-17G. In this regard, releasing actuator rod 1215 from fixation device 1212 and moving it toward delivery handle 1260 disengages first and second actuation lines 1201a, 1201b and allows first and second actuation lines 1201a, 1201b to be released from shaft 1211 and respective indicator and retention arms 1230, 1240 of first and second clamps 1204a, 1204b. Although first and second actuation lines 1201a, 1201b are illustrated as being releasably coupled to catheter shaft 1211 via actuator rod 1215, it is also contemplated that first and second actuation lines 1201 a, 1201b may be releasably coupled to center portion 1205 of fixation device 1212 in the same manner.

[0195] In one illustrative operation of the arrangement of FIG. 26, indicator arms and retention arms 1230, 1240 of first and second clamps 1204a, 1204b may be actuated concurrently, such as when interlock 1271 engages both actuator handles 1270a, 1270b, or actuated independently, such as when interlock 1271 is disengaged from one of actuator handles 1270a, 1270b. However, first and second-phase grasping may be similar to that described above with respect to FIG. 24 in that each actuator handle 1270a, 1270b may move between a plurality of positions to incrementally release tension on actuation lines 1201a, 1201b allowing indicator arms 1230 to first engage tissue, and then retention arms 1240 to engage tissue.

[0196] Referring now in addition to FIG. 27, which depicts interventional device 1200’ according to another example. In this exemplary arrangement, first and second actuation lines 1201a, 1201b are each coupled to indicator and retention arms 1230, 1240 of first and second clamps 1204a, 1204b. However, instead of being releasably coupled to shaft 1211, actuationAtty Docket No. ABTEVA-0072PCT lines 1201a, 1201b extend back up through delivery catheter 1210 to first and second actuator handles 1270a, 1270b, respectively.

[0197] Referring now in addition to FIG. 28, which depicts interventional device 1200” according to another example. Tn this exemplary arrangement, first actuation line 1201 a is coupled indicator arms 1230 of both first and second clamps 1204a, 1204b, and second actuation line 1201b is coupled to retention arms 1240 of both first and second clamps 1204a, 1204b. This allows indicator arms 1230 to be actuated independently of retention arms 1240, such as when interlock 1271 is not engaged to both actuator handles 1270a, 1270b. However, in this arrangement, indicator arms 1230 would be actuated concurrently with each other, and retention arms 1240 would be actuated concurrently with each other.

[0198] Referring now also to FIGS. 29 and 30, which depict an interventional device 1300 according to a further embodiment of the present disclosure. Interventional device 1300 is similar to interventional device 1200 in that it includes delivery handle 1360, a catheter 1310, and a fixation device 1312 releasably coupled to a distal end of catheter 1310. However, delivery handle 1360 is alternatively configured and provides for alternative actuation line arrangements as described below.

[0199] In the depicted example, delivery handle 1360 includes first and second actuator handles 1370a, 1370b that are optionally couplable via an interlock 1371 like that of handle 1260. However, interventional device 1300 differs from device 1200 in that handle 1360 includes a third actuator handle 1370c, and interventional device 1300 includes a third actuation line 1301c coupled to third actuator handle 1370c. Providing third actuator line 1301c allows indicator arms 1330 to be operated independently of retention anus 1340, while also allowing either indicator arms 1330 or retention arms 1340 to be operated independently of each other.

[0200] In the example arrangement of interventional device 1300 shown in FIG. 30, first actuation line 1301a extends from delivery catheter 1310 and is coupled to indicator arm 1330 of first clamp 1304a, and second actuation line 1301b extends from delivery catheter 1310 and is coupled to indicator arm 1330 of second clamp 1304b. Additionally, as illustrated, first and second actuation lines 1301a, 1301b are releasably coupled to shaft 1311. For example, actuation lines 1301a, 1301b may each include catch elements (e.g., catch element 405 or 405’) that may extend into shaft 1311 and releasably engage actuator rod 1315 in a manner similar to that described above with respect to FIGS. 17A-17G. In this regard, releasing actuator rod 1315 from fixation device 1312 and moving it toward delivery handle 1360 disengages firstAtty Docket No. ABTEVA-0072PCT and second actuation lines 1301a, 1301b and allows first and second actuation lines 1301a, 1301b to be released from shaft 1311 and indicator amis 1330 of respective first and second clamps 1304a, 1304b. Although first and second actuation lines 1301a, 1301b are illustrated as being releasably coupled to catheter shaft 131 1 via actuator rod 1315, it is also contemplated that first and second actuation lines 1301a, 1301b may be releasably coupled to center portion 1305 of fixation device 1312 in the same manner.

[0201] Also, as shown in the example of FIG. 30, third actuation line 1301c is coupled to retention arms 1340 of both first and second clamps 1304a, 1304b. In this regard, third actuation line 1301c may extend from catheter 1310, into engagement with retention arms 1340, and back up through catheter 1310 to third actuator handle 1370c.

[0202] In one illustrative operation of the arrangement of FIG. 30, indicator arms 1330 of first and second clamps 1304a, 1304b may be actuated concurrently, such as when interlock 1371 engages both actuator handles 1370a, 1370b, or actuated independently, such as when interlock 1371 is disengaged from one of actuator handles 1370a, 1370b. Additionally, retention anus 1340 are separately actuated by third actuator handle 1370c, such as after first- phase grasping with indicator arms 1330. In this regard, moving third actuator handle 1370c in a distal direction releases tension on third actuation line 1301c allowing retention arms 1340 to concurrently engage tissue previously engaged by indicator arms 1330.

[0203] Referring now in addition to FIG. 31, which depicts interventional device 1300’ according to another example. This exemplary configuration is similar to that of FIG. 30 in that first and second actuation lines are separately coupled to indicator amis of first and second clamps, and third actuation line is coupled to retention arms of both first and second clamps. However, unlike interventional device 1300, first and second actuation lines do not couple to shaft, and instead pass back up through catheter to the respective first and second actuator handles.

[0204] Referring now also to FIG. 32, which depicts interventional device 1300” according to a further example. In this exemplary arrangement, first actuation line 1301a is coupled retention arm 1340 of first clamp 1304a, second actuation line 1301b is coupled to retention arm 1340 of second clamp 1304b, and third actuation line 1301c is coupled to indicator arms 1330 of first and second clamps 1304a, 1304b. This allows retention arms 1340 to be actuated independently of indicator arms 1330 and independently of each other, such as when interlock 1371 is not engaged to both first and second actuator handles 1370a, 1370b.Atty Docket No. ABTEVA-0072PCTHowever, in this arrangement, indicator arms 1330 would be actuated concurrently with each other, and retention arms 1340 could be actuated concurrently with each other when interlock 1371 is engaged to first and second actuator handles 1370a, 1370b.

[0205] Referring now in addition to FIGS. 33 and 34, which depict an interventional device 1400 according to a further embodiment of the present disclosure. Interventional device 1400 is similar to interventional device 1200 in that it includes delivery handle 1460, a catheter 1410, and a fixation device 1412 releasably coupled to a distal end of catheter 1410. However, delivery handle 1460 is alternatively configured and provides for alternative actuation line arrangements as described below.

[0206] In the example depicted, delivery handle 1460 includes first and second actuator handles 1470a, 1470b that are optionally couplable via a first interlock 1471a, like that of gripper member handle 1260. However, interventional device 1400 differs from device 1200 in that delivery handle 1460 includes third and fourth actuator handles 1470c, 1470d optionally couplable by a second interlock 1471b, and interventional device 1400 includes third and fourth actuation lines 1401c, 1401d coupled to third and fourth actuator handles 1470c, 1470d, respectively. Providing third and fourth actuator lines 1401c, 140 Id allows indicator and retention arms 1430, 1440 to be operated independently of one another, while also allowing indicator arms 1430 to be concurrently actuated and retention arms 1440 to be concurrently actuated.

[0207] In the example arrangement of interventional device 1400 shown in FIG. 34, first actuation line 1401a is coupled to indicator arm 1430 of first clamp 1404a, second actuation line 1401b is coupled to indicator arm 1430 of second clamp 1404b, third actuation line 1401c is coupled to retention am 1440 of first clamp 1404a, and fourth actuation line 1401d is coupled to retention arm 1440 of second clamp 1404b. Additionally, as illustrated, each actuation line 140 la- 104 Id are releasably coupled to shaft 1411. For example, actuation lines 1401a-1401d may each include catch elements (e.g., catch element 405 or 405’) that may extend into shaft 1411 and releasably engage actuator rod 1415 in a manner similar to that described above with respect to FIGS. 17A-17G. In this regard, releasing actuator rod 1415 from fixation device 1412 and moving it toward delivery handle 1460 disengages actuation lines 140 la- 140 Id and allows actuation lines 140 la- 140 Id to be released from shaft 1411 and gripper members 1430, 1440 of first and second clamps 1404a, 1404b. Although actuation lines 1401a-1401d are illustrated as being releasably coupled to catheter shaft 1411 via actuator rodAtty Docket No. ABTEVA-0072PCT1415, it is also contemplated that actuation lines 140 la- 140 Id may be releasably coupled to center portion 1405 of fixation device 1412 in the same manner.

[0208] In an illustrative operation of the arrangement of FIG. 34, indicator arms 1430 of first and second clamps 1404a, 1404b may be actuated concurrently, such as when first interlock 1471a engages both first and second actuator handles 1470a, 1470b, or actuated independently, such as when interlock 1471 a is disengaged from one of actuator handles 1470a and 1470b. Similarly, retention arms 1440 of first and second clamps 1404a, 1404b may be actuated concurrently, such as when second interlock 1471b engages both third and fourth actuator handles 1470c, 1470d, or actuated independently, such as when interlock 1471b is disengaged from one of actuator handles 1470c and 1470d.

[0209] Referring now in addition to FIG. 35, which depicts interventional device 1400’ according to another example. This exemplary configuration is similar to that of FIG. 34 in that first, second, third, and fourth actuation lines 140 la- 140 Id are separately coupled to indicator arms 1430 and retention arms 1440 of first and second clamps 1404a, 1404b. However, unlike interventional device 1400, actuation lines 1404a-1404d do not couple to shaft 1411, and instead pass back up through catheter 1410 to the respective actuator handles 1470a-1470d. In such arrangement, actuation lines 1404a-1404d may occupy upwards of eight lumens of delivery catheter 1411. On the other hand, actuation lines 1404a-1404d of the arrangement of FIG. 34 may occupy only four lumens which may free up other catheter lumens for other control elements, such as a lock line (e.g., lock line 102), for example.

[0210] It should be noted that other examples arrangements are possible, such as a combination of the arrangements of FIGS. 34 and 35. For example, first and second actuation lines 1401a, 1401b may couple to catheter shaft 1411, while third and fourth actuation lines 1401c, 140 Id may extend back through catheter 1410, and vice versa. Based on different curvatures and lift forces between indicator and retention arms 1430, 1440, different diameter actuation lines 1401 or different material actuation lines 1401 may be used for indicator and retention arms 1430, 1440.

[0211] Referring now also to FIGS. 36 A and 36B, which depict a gripping device 1502 according to another embodiment of the present disclosure. Gripping device 1502 may be utilized in any of the aforementioned fixation devices 1012, 1112, 1212, 1312, and 1412. As shown, gripping device 1502 is similar to gripping device 114 with the exception that it includes indicator and retention arms 1530, 1540 for a multi-phase gripping operation. In thisAtty Docket No. ABTEVA-0072PCT regard, gripping device 1502 includes a pair of indicator arms 1530, a pair of retention arms 1540, and a base section 1550 coupled to indicator and retention amis 1530, 1540.

[0212] In the example depicted, base section 1550 may have a first segment 1551a, a second segment 1551b, and a third segment 1551c intersecting one another to form a U-shaped structure. An opening 1558 may extend through second segment 1551b for receipt of a center assembly of a fixation device, such as any one of center assemblies 1005, 1105, 1205, 1305, and 1405, for example.

[0213] Gripping device 1502 also includes a plurality of hinge features coupling indicator and retention arms 1530, 1540 with base section 1550. For example, as shown in FIGS. 36A and 36B, a first, second, and third hinge feature 1553a, 1553b feature may couple an indicator arm 1530 and an retention arm 1540 to base section 1550. In this regard, first and second hinge feature 1553a, 1553b may couple retention arm 1540 to base section 1550, and third hinge feature 1553c may couple indicator arm 1530 to base section 1550. As shown, first and second hinge features 1553a, 1553b and retention arm 1540 may define a recess 1547 therebetween within which third hinge feature 1553c and indicator arm 1530 are disposed, which allows indicator arm 1530 to move relative to retention arm 1540. In other words, each indicator arm 1530 may be nested within a respective retention arm 1540.

[0214] As depicted in FIG. 36B, each retention arm 1540 has a length L, and each indicator arm 1530 has a length shorter than length L. In one example, each indicator arm 1530 may have a length between 25% and 50% of length L. In another example, each indicator arm 1530 may have a length 50% (+ / - 5%) of length L. In a further example, each indicator arm 1530 has a length between 50% and 75% of length L. Additionally, each retention arm 1540 has a width Wl, and each indicator arm 1530 has a width W2. Width W1 is greater than width W2.

[0215] Each indicator arm 1530 and retention arm 1540 may include a plurality of frictional elements 1535, 1545 extending therefrom. Such frictional elements 1535, 1545 may be formed from respective side edges 1532, 1542 of the indicator and retention arms 1530, 1540. Furthermore, each indicator arm 1530 and retention arm 1540 may optionally include an eyelet 1536, 1546 for receipt of a actuation line, as shown in FIG. 36A.

[0216] Referring now in addition to FIGS. 37A and 37B, which depict a gripping device 1602 according to another embodiment of the present disclosure. Gripping device 1602 may be utilized in any of the aforementioned fixation devices 1012, 1112, 1212, 1312, andAtty Docket No. ABTEVA-0072PCT1412. As shown, gripping device 1602 is similar to gripping device 214 with the exception that it includes indicator amis and retention amis 1630, 1640 for a multi-phase gripping operation. In this regard, gripping device 1602 includes a base section 1650 configured to couple to an craddle member (e.g., craddle member 1020, 1 120, 1220, 1320, 1420), a bend feature 1653, and an indicator arm 1630 and an retention arm 1640. As shown in FIG. 37B, indicator arm 1630 includes a window 1648 (or recess). Indicator arm 1630 is disposed and moveable within window 1648. Indicator arm 1630 and retention arm 1640 may each be biased toward base section 1650.

[0217] As depicted in FIG. 37B, retention arm 1640 has a length L, and indicator arm 1630 has a length shorter than length L. In one example, indicator arm 1630 may have a length between 25% and 50% of length L. In another example, indicator ami 1630 may have a length 50% (+ / - 5%) of length L. In a further example, indicator arm 1630 has a length between 50% and 75 % of length L. Additionally, each retention arm 1640 has a width W 1 , and each indicator arm 1630 has a width W2. Width W1 is greater than width W2.

[0218] Each indicator arm 1630 and retention arm 1640 may include one or more frictional elements 1635, 1645 extending therefrom. Such frictional elements 1635, 1645 may each form one or more rows of frictional elements. For example, in the embodiment depicted, indicator and retention arms 1630, 1640 each have a single row of frictional elements.

[0219] Referring now in addition to FIG. 38, which depicts a gripping device 1702 according to a further embodiment of the present disclosure. Gripping device 1702 is similar to gripping device 1502 in that gripping device 1602 includes a pair of indicator arms 1730 and a pair of retention arms 1740 each coupled to a base section 1750. However, unlike gripping device 1502, retention arms 1740 have a width W1 that is less than a width W2 of retention arms 1730. In this regard, indicator arms 1730 may each be disposed at an underside of a respective retention arm 1740. In other words, each indicator arm 1730 may be disposed between an retention arms 1740 and an craddle member (e.g., craddle member 1020, 1120, 1220, 1320, or 1420) when gripping device 1702 is included in a fixation device. Each indicator arm 1730 may include a recess 1749 that is configured to receive a portion of retention arm 1740 which allows indicator arms 1730 to engage tissue first in a first-phase gripping operation, and retention arms 1740 to then engage tissue in a second-phase gripping operation.

[0220] Referring now also to FIG. 39, which depicts a gripping device 1802 according to another embodiment of the present disclosure. Gripping device 1802 is configured for aAtty Docket No. ABTEVA-0072PCT three-phase gripping operation. In this regard, gripping device 1802 includes a pair of first- phase gripper members 1830a, a pair of second-phase gripper members 1830b, and a pair of third-phase gripper members 1830c. During operation, first-phase gripper members 1830a may be lowered into engagement with tissue first, followed by second-phase gripper members 1830b, and finally with third-phase gripper members 1830c. The use of a third-phase gripping operation can help verify tissue engagement and reduce the likelihood of a false indication of tissue engagement. Like gripping device 1502, gripper members 1830a- 1830c are coupled to a base section 1850 and are moveable relative thereto.

[0221] As depicted, each third-phase gripper member 1830c has a length L which is longer than second-phase gripper member 1830b, which is longer than first-phase gripper member 1830a. In one example, first-phase gripper member 1830a is between 25% and 50% of the length L, and second-phase gripper member 1830b is between 50% and 75% of the length L. In another example, first-phase gripper member 1830a is between 25% and 50% of the length L, and second-phase gripper member 1830b is 50% (+ / -5%) of the length L.

[0222] In a method for securing tissue, a fixation device may be guided percutaneously to a target location within a patient. Such fixation device can be any of the aforementioned fixation devices (e.g., fixation device 1012, 11 12, 1212, 1312, or 1412). The fixation device may be positioned between a first tissue and a second tissue (e.g., first and second leaflets of a mitral valve or tricuspid valve). The first tissue may then be inserted between a first craddle member and a first indicator arm and a first retention arm of the fixation device. The second tissue may concurrently or sequentially inserted between a second craddle member and a second indicator arm and a second retention arm of the fixation device. Thereafter, the first indicator arm may be moved into engagement with the first tissue, and the second indicator arm may be moved into engagement with the second tissue. The first and second indicator arms may be moved into respective engagement with the first and second tissues concurrently or sequentially. Once the first indicator arm engages the first tissue, the first retention arm may be moved into engagement with the first tissue. Also, once the second indicator arm engages the second tissue, the second retention arm may be moved into engagement with the second tissue. The first and second retention arms may be moved into respective engagement with the first and second tissues concurrently or sequentially.

[0223] The movement of the first and second indicator arms may be performed by the actuation of one or more actuators (e.g., actuators 1170, 1270a, 1270b, 1370a, 1370b, 1370b,Atty Docket No. ABTEVA-0072PCT1470a, 1470b) which are coupled to a delivery handle. The delivery handle may be coupled to a delivery catheter, and one or more actuation lines (e.g., actuation lines 1101, 1201a, 1201b, 1301a, 1301b, 1301c, 1401a, 1401b) may extend from the respective first and second indicator arms to the one or more actuators. In one example, the one or more actuators are driven axially from a first position to a second position which releases tension on the one or more actuation lines allowing the first and second indicator arms to move toward their respective craddle members under their own bias.

[0224] Similarly, the movement of the first and second retention arms may be performed by the actuation of one or more actuators which are coupled to a delivery handle. The one or more actuators may be the same as those that actuate the first and second indicator arms (e.g., actuators 1170, 1270a, 1270b) or they may be separate actuators (e.g., actuators 1370a, 1370b, 1370c, 1470c, 1470d). In one example, the one or more actuators are driven axially from a first position to a second position which releases tension on the one or more actuation lines allowing the first and second retention arms to move toward their respective craddle members under their own bias.

[0225] Additionally, the actuation lines may be coupled to the fixation device or to a shaft of the delivery catheter and may be released therefrom via movement of an actuator rod in a proximal direction. In another example, the actuation lines may be released by releasing at least one end of each actuation line from the actuator and pulling the actuation line through the delivery catheter.

[0226] Referring now in addition to FIG. 40A, which depicts a gripping device 1902 according to a further embodiment of the present disclosure. Gripping device 1902 is configured similar to gripping device 114 in that it includes a pair of gripper members 1940 coupled to a base section 1950. However, unlike gripping device 114, each gripper member 1940 includes one or more ultrasonic sensors 1990. As shown, each gripper member 1940 has one or more sensor windows 1947, and an ultrasonic sensor 1990 disposed at least partially within each of such windows 1947.

[0227] Each ultrasonic sensor 1990 may be configured to utilize a pulse-echo method to indicate the presence or absence of tissue between gripper member 1940 and a craddle member 1920, as shown in FIG. 40B. The pulse-echo method involves emitting a short burst of ultrasonic waves (pulse) into a medium (e.g., blood), which travels until an object (e.g., craddle member 1920 or leaflet LF) is encountered. When the object is encountered, the wavesAtty Docket No. ABTEVA-0072PCT reflect back (echo) to the sensor 1990 which generates a waveform indicative of the distance to the object. As shown in FIG. 40B, when no tissue (e.g., leaflet LF) is present, a first waveform 1903a indicates the distance between gripper member 1940 and craddle member 1920. When leaflet I I is introduced, a second waveform 1903b is generated representing a shorter distance between gripper member 1940 and the leaflet LF. As shown, when the distance is shortened by the presence of leaflet LF, the waveform 1903b produced has a shorter time delay, higher amplitude, and a sharper profile relative the first waveform 1903a due to reduced energy loss and dispersion. In contrast, when the leaflet LF is absent creating a greater distance to the object (i.e., craddle member 1920), the resulting waveform 1903a has longer time delay and lower amplitude due to increased attenuation and wave spreading.

[0228] In one example of gripping device 1902, each gripper member 1940 may include a single ultrasonic sensor 1990 positioned at 50% (+ / -5%) a length L of gripper member or between 25% and 50% the length L as measured from a first end 1941a of gripper member 1940. This may help indicate to the surgeon that tissue has reached a depth sufficient to limit the risk of SLDA. In another example, a first ultrasonic sensor 1990a may be positioned between 25% and 50% the length L, and a second ultrasonic sensor 1990b may be positioned at 50% (+7-5%) the length L as measured from the first end 1941 a of gripper member 1940. This may help provide greater resolution as to the positioning of tissue relative to gripper member 1940 based on the waveforms generated by each sensor 1990a, 1990b. In a further example, as shown in FIG. 40A, a first ultrasonic sensor 1990a is positioned between 25% and 50% the length L as measured from the first end 1941a of gripper member 1940, a second ultrasonic sensor 1990b is positioned at 50% (+ / -5%) the length L, and a third ultrasonic sensor 1947c is positioned between 50% and 75% the length L. This configuration may provide the highest resolution of these examples.

[0229] Referring now also to FIGS. 41 A and 41B, which depict a fixation device 2012 according to another embodiment of the present disclosure. Fixation device 2012 can optionally be configured similar to fixation device 112 in construction, features, and use except as explicitly stated. In one example, fixation device 2012 includes a first indicator 2090a and a second indicator 2090b. First indicator 2090a is coupled to a first craddle member 2020a, and second indicator 2090b is coupled to a second craddle member 2090b. First indicator 2090a is configured to translate outwardly in a first direction transverse or substantially transverse (e.g., within + / -5 degrees, + / -10 degrees, or + / -15 degrees of perpendicular) to a longitudinal axis ofAtty Docket No. ABTEVA-0072PCT first craddle member 2020a, and second indicator 2090b is configured to translate outwardly in a second direction transverse or substantially transverse to the longitudinal axis A3 of second craddle member 2020b opposite the first direction, as illustrated in FIG. 4 IB. Each indicator 2090a, 2090b may be made from a radiopaque material which is visible under fluoroscopic imaging. This may be beneficial in a TEER procedure as fluoroscopic imaging is generally oriented perpendicular to echocardiographic imaging and is in the plane shown in FIG. 41B. Such plane may be oriented substantially parallel (+ / - 5 degrees) to respective engagement surfaces 2025 of craddle members 2020a, 202b. Thus, indicators 2090a, 2090b may be particularly visible via fluoroscopy. Indicators 2090a, 2090b may be in the form of slidable pins that are configured to project outwardly in the presence of a tissue between the respective craddle member 2020a, 2020b and gripper member 2040. In use, a method of indicating tissue capture may include: positioning fixation device 2012 adjacent target tissue; grasping the tissue between craddle member 2020a or 2020b and gripper member 2040; and detecting outward translation of indicator 2090a or 2090b, respectively, wherein the outward translation indicates successful tissue capture. The method may further include observing the indicator 2090a, 2090b under fluoroscopic imaging to confirm tissue presence. In one example, the pins 2090a, 2090b are cylindrical and positioned within correspondingly shaped apertures 2092 in the respective anchor 2020a, 2020b.

[0230] Referring now in addition to FIG. 42, which schematically depicts an indicator 2190 according to an embodiment of the present disclosure and may be coupled each of first and second craddle members 2020a, 2020b. Indicator 2190 is an electromagnetic indicator that includes a pin 2191, a housing 2192, a magnet 2194, a coil 2196, and a circuit 2193. Pin 2191 is slideable disposed within housing 2192. Magnet 2194 may be coupled to pin 2191, and coil 2196 may be disposed about magnet 2194 within housing 2192. Coil 2196 may be an electromagnetic coil, such as a solenoid coil, configured to generate a magnetic field when electrical current flows therethrough. The magnetic field interacts with magnet 2194 to cause translation of pin 2191. Circuit 2193 may be electrically coupled to coil 2196 and may include a power source 2197 and a switch 2195. Switch 2195 may be disposed at a location along engagement surface 2025 of first craddle member 2020a or second craddle member 202b. For example, switch 2195 may be located at 50% (+ / -5%) a length of the respective craddle member 2020a, 2020b, or 25% to 50% (+ / -5%) a length of the respective craddle member 2020a, 2020b as measured from a fixed end 2021 a thereof. Switch 2195 may be configured to be closed whenAtty Docket No. ABTEVA-0072PCT tissue is pressed into contact with engagement surface 2025 via gripper member 2040. When switch 2195 is closed, current flows to coil 2196 which drives magnet 2194 and translates pin 2191 outwardly from the respective craddle member 2020a, 2020b thereby indicating the presence of tissue at the location of the switch 2195. In another example, instead of switch 2195, a pair of electrodes may be utilized such that contact with the electrodes with the tissue closes the circuit 2193 driving the pin 2191 to an indication position. In other words, when circuit 2193 is open, pin 2191 is in a first position recessed within its respective craddle member 2020a, 2020b, and when circuit 2193 is closed, pin 2191 projects outwardly to a second position from craddle member 2020a or 2020b. One or more of pin 2191, housing 2192, and magnet 2194 may be cylindrically shaped in various examples.

[0231] Referring now in addition to FIGS. 43A and 43B, which depict an indicator 2290 according to another embodiment of the present disclosure and may be coupled each of first and second craddle members 2020a, 2020b. Indicator 2290 generally includes a housing 2292, a pin 2291 translatable within housing 2292, and biasing member 2294. Biasing member 2294 may be a helical spring biasing pin 2291 toward an extended position which would be indicative of the presence of tissue between a respective craddle member 2020a, 2020b and gripper member 2040. As shown in FIG. 43B, a lever 2296 may be coupled to pin 2291 . Lever 2296 may be disposed within a slot 2298, such as an L-shaped slot. When lever 2296 is in a first position, lever 2296 is constrained from axial movement within slot 2298 and pin 2296 is recessed within housing 2292, and when lever 2296 is rotated to a second position within slot 2298, lever 2296 is unobstructed by slot 2298 in the axial direction such that pin 2296 may slide axially to its extended position Thus, when coupled to a craddle member 2020a, 2020b, lever 2296 may extend along engagement surface 2025 of the respective craddle member 2020a, 2020b. When tissue is pressed into contact against lever 2296, lever 2296 may rotate relative to a longitudinal axis of housing 2292 until lever 2296 reaches its second position allowing pin 2291 to slide outwardly.

[0232] Referring now to FIGS. 44A-44C, which depict gripping devices according to further embodiments of the present disclosure. In these embodiments, an indicator arm (or alpha arm) and a retention arm (or beta arm) of a gripping device may define relaxed angles therebetween, which may be the same or different, as described below. Such relaxed angles may be selected such that the indicator arm and retention arm interfere with craddle members of a fixation device (e.g., craddle members 120) when the craddle members are in a tissueAtty Docket No. ABTEVA-0072PCT capture position (e.g., open to about 120 degrees to about 180 degrees), thereby providing positive clamping of tissue between the gripping device and the craddle members. It should be appreciated that any of the features described with respect to FIGS. 41A-48B may also be incorporated into a gripping device having more than one gripping devices, such as gripping devices 214 described above.

[0233] Referring now to FIG. 44A, which depicts a gripping device 2302 according to an embodiment of the present disclosure. Gripping device 2302 includes a pair of gripper members each having an indicator arm 2330, a retention arm 2340, and a base section 2350 coupled to indicator arm 2330 and retention arm 2340. Each retention arm 2340 may include a recess, such as recess 1547 described above, within which a respective indicator arm 2330 is disposed. As shown, each indicator arm 2330 and retention arm 2340 may be biased toward a relaxed position and may define a relaxed angle therebetween when in the relaxed position. In the embodiment depicted, indicator arm 2330 has a first relaxed angle a that is substantially equal to a second relaxed angle P of retention arm 2340 such that indicator arm 2330 and retention arm 2340 are substantially coplanar in the relaxed position. In such coplanar arrangement, indicator arm 2330 is nested within and obscured by retention arm 2340 in the front plan view of FIG. 44A. First relaxed angle a and second relaxed angle may each be about 90 degrees to about 200 degrees, such as about 180 degrees. Such coplanar arrangement may provide balanced bias forces between indicator arm 2330 and retention arm 2340, which may result in more uniform clamping pressure on tissue during engagement.

[0234] Referring now to FIG. 44B, which depicts a gripping device 2402 according to another embodiment of the present disclosure. Gripping device 2402 includes a pair of gripper members each having an indicator arm 2430, a retention arm 2440, and a base section 2450 coupled to indicator arm 2430 and retention arm 2440. Each retention arm 2440 may include a recess, such as recess 1547 described above, through which a respective indicator arm 2430 may articulate. As shown, each indicator arm 2430 may be biased toward a first relaxed position and may define a first relaxed angle a, and each retention arm 2440 may be biased toward a second relaxed position and may define a second relaxed angle p, wherein the first relaxed angle a and the second relaxed angle P are each measured between respective indicator arms 2430 and retention arms 2440. In the embodiment depicted, the first relaxed angle a is less than the second relaxed angle P such that each indicator arm 2430 is more upright relative to a respective retention arm 2440. For example, the first relaxed angle a may be about 90Atty Docket No. ABTEVA-0072PCT degrees to about 150 degrees, and the second relaxed angle P may be about 120 degrees to about 200 degrees. In some examples, a difference between the first relaxed angle a and the second relaxed angle may be about 10 degrees to about 40 degrees. In such arrangement, indicator arm 2430 may have a reduced bias force relative to retention arm 2440, which may allow indicator arm 2430 to provide gentler initial contact with tissue during a tissue grasping procedure.

[0235] Referring now to FIG. 44C, which depicts a gripping device 2502 according to a further embodiment of the present disclosure. Gripping device 2502 includes a pair of gripper members each having an indicator arm 2530, a retention arm 2540, and a base section 2550 coupled to indicator arm 2530 and retention arm 2540. Each retention arm 2540 may include a recess, such as recess 1547 described above, through which a respective indicator arm 2530 articulates. As shown, each indicator arm 2530 may be biased toward a first relaxed position and may define a first relaxed angle a, and each retention arm 2540 may be biased toward a second relaxed position and may define a second relaxed angle P, wherein the first relaxed angle a and the second relaxed angle are each measured between respective indicator amis 2530 and retention arms 2540. In the embodiment depicted, the first relaxed angle a is greater than the second relaxed angle P such that each indicator arm 2530 extends from the recess of a respective retention arm 2540 to a greater degree in the relaxed position. For example, the first relaxed angle a may be about 120 degrees to about 200 degrees, and the second relaxed angle P may be about 90 degrees to about 150 degrees. In some examples, a difference between the first relaxed angle a and the second relaxed angle P may be about 10 degrees to about 40 degrees. In such arrangement, indicator am 2530 may have a greater bias force relative to retention am 2540, which may help retain tissue until retention am 2540 can engage to more securely grasp the tissue against an craddle member.

[0236] Referring now to FIGS. 45 A-45C, which depict an indicator ami and a retention arm according to further embodiments of the present disclosure. In these embodiments, an indicator arm and a retention arm may have different bending stiffnesses achieved through different thicknesses, different widths, different effective cross-sections, different material stiffnesses, or combinations thereof, as described below.

[0237] Referring now to FIG. 45 A, which depicts a top plan view of an indicator am 2630 and a retention am 2640 according to an embodiment of the present disclosure. FIG. 45B depicts a schematic cross-sectional view taken along section line A-A of FIG. 45A. As shownAtty Docket No. ABTEVA-0072PCT in FIG. 45B, indicator arm 2630' has a first thickness T1 and retention arm 2640' has a second thickness T2. In the embodiment depicted, the first thickness T1 is less than the second thickness T2. For example, the first thickness T 1 may be about 50% to about 90% of the second thickness T2. In such arrangement, retention arm 2640' may have a greater bending stiffness than indicator arm 2630', which may allow retention arm 2640' to apply a greater clamping force to tissue while indicator arm 2630' provides gentler initial contact with the tissue. It should be appreciated that similar bending stiffness relationships may be achieved by varying the width, effective cross-section, or material stiffness of indicator arm 2630' and retention arm 2640' in addition to or instead of thickness.

[0238] Referring now to FIG. 45C, which depicts a schematic cross-sectional view taken along section line A-A of FIG. 45A according to another embodiment of the present disclosure. As shown in FIG. 45C, indicator arm 2630" has a first thickness T1 and retention arm 2640" has a second thickness T2. In the embodiment depicted, the first thickness T1 is greater than the second thickness T2. For example, the first thickness T1 may be about 110% to about 200% of the second thickness T2. In such arrangement, indicator arm 2630” may have improved durability for repeated deployment during positioning.

[0239] In further embodiments, one or both of indicator arm 2630 and retention arm 2640 may have a variable thickness along its length. For example, indicator arm 2630 or retention arm 2640 may be thicker at a fixed end coupled to a base section and thinner at a free end. Such tapered thickness profile may provide structural support and fatigue resistance at the fixed end while allowing flexibility at the free end for tissue conformance. In other examples, a profile of indicator arm 2630 may be different from a profile of retention arm 2640. It should be appreciated that thickness, width, effective cross-section, and material stiffness may each be varied along the length of indicator arm 2630 and / or retention arm 2640 to achieve desired bending stiffness characteristics.

[0240] Referring now to FIG. 46, which depicts an indicator arm 2730 and a retention arm 2740 according to a further embodiment of the present disclosure. In this embodiment, indicator arm 2730 and retention arm 2740 may comprise different materials, as described below.

[0241] In one example, indicator arm 2730 and retention arm 2740 may be constructed of different materials having differing stiffness. In one example, indicator arm 2730 may comprise a nickel-titanium alloy (e.g., Nitinol) and retention am 2740 may comprise a cobalt-Atty Docket No. ABTEVA-0072PCT chromium alloy (e.g., Elgiloy). In such configuration, indicator arm 2730 may exhibit superelastic properties and a wider range of achievable relaxed angles, while retention arm 2740 may have a higher stiffness for applying greater gripping force to tissue. In another example, indicator arm 2730 may comprise a cobalt-chromium alloy and retention arm 2740 may comprise a nickel-titanium alloy. In such arrangement, indicator arm 2730 may have a higher stiffness for improved durability during repeated deployment, while retention arm 2740 may exhibit superelastic properties for an increased range of motion.

[0242] When indicator arm 2730 and retention arm 2740 comprise different materials, indicator arm 2730 and retention arm 2740 may be joined by various techniques. For example, indicator arm 2730 and retention arm 2740 may be joined by welding (e.g., laser welding or resistance welding) at or near a hinge feature region. In another example, as shown in the top plan view of FIG. 46, indicator arm 2730 may include a plate 2732 at a fixed end thereof. Plate 2732 may include one or more openings 2734 configured to receive one or more rivets or pins. Indicator arm 2730 may be coupled to retention arm 2740 and / or a base section 2750 by passing rivets or pins through openings 2734 and through openings 2744 in retention ami 2740 and / or base section 2750. Alternatively, plate 2732 may be welded or otherwise connected to retention arm 2740 and / or base section 2750. Such mechanical attachment may allow independent material selection for indicator arm 2730 and retention arm 2740. In further examples, indicator arm 2730 and retention arm 2740 may be joined by adhesive bonding, suture or wire lashing through aligned openings 2734, 2744.

[0243] In further embodiments, indicator arm 2730 and retention arm 2740 may be formed from the same base material but have different mechanical properties achieved through localized processing. For example, both indicator arm 2730 and retention arm 2740 may be formed from a nickel-titanium alloy sheet, and localized heat treatment (e.g., laser annealing) may be applied to create different austenite finish temperatures in different regions. In such arrangement, a region corresponding to indicator arm 2730 may have a different stiffness or superelastic behavior than a region corresponding to retention arm 2740. Such differential processing may avoid the need for joining dissimilar materials while still achieving different mechanical properties between indicator arm 2730 and retention arm 2740.

[0244] Referring now to FIGS. 47 A and 47B, which depict an indicator arm and a retention arm according to further embodiments of the present disclosure. In theseAtty Docket No. ABTEVA-0072PCT embodiments, an indicator arm and a retention arm may have different frictional element configurations, as described below.

[0245] Referring now to FIG. 47 A, which depicts an indicator arm 2830 and a retention arm 2840 according to an embodiment of the present disclosure. Indicator arm 2830 may include a single row of frictional elements 2835, and retention arm 2840 may include a plurality of rows of frictional elements 2845 distributed axially along its length, such as two to six rows of frictional elements 2845. Each row may include one or more frictional elements 2835, 2845, such as two frictional elements 2835, 2845 for example. In such configuration, indicator arm 2830 may provide gentler initial contact with tissue, while retention arm 2840 may provide secure long-term tissue retention.

[0246] Referring now to FIG. 47B, which depicts an indicator arm 2930 and a retention arm 2940 according to another embodiment of the present disclosure. Indicator arm 2930 may be free of frictional elements. Retention arm 2940 may include a plurality of frictional elements 2945 for secure tissue retention. In such configuration, indicator arm 2930 may provide gentler contact with tissue and may be repositioned more easily, while retention arm 2940 may provide greater retention of tissue against an craddle member for long-term fixation.

[0247] Referring now to FIGS. 48A and 48B, which depict an indicator arm and a retention arm according to further embodiments of the present disclosure. In these embodiments, an indicator arm and a retention arm may have different actuation line engagement features, as described below.

[0248] Referring now to FIG. 48A, which depicts a front view of an indicator arm 3030 and a retention arm 3040 according to an embodiment of the present disclosure. Indicator arm 3030 may include a single eyelet 3036 for receipt of a first actuation line 3001a. Retention arm 3040 may include a plurality of eyelets 3046a, 3046b distributed along its length for receipt of a second actuation line 3001b. For example, retention arm 3040 may include two eyelets 3046a, 3046b spaced apart along its length through which second actuation line 3001b may extend sequentially. In such configuration, the plurality of eyelets 3046a, 3046b may distribute tension along retention arm 3040, which may prevent or reduce curl or twist of retention arm 3040 during raising and lowering which may occur due to the longer length of retention arm 3040 as compared to indicator arm 3030. Additionally, separate actuation lines 3001a, 3001b may allow independent control of indicator arm 3030 and retention arm 3040.Atty Docket No. ABTEVA-0072PCT

[0249] Referring now to FIG. 48B, which depicts a top plan view of an indicator arm 3130 and a retention arm 3140 according to another embodiment of the present disclosure. Retention arm 3140 may include a first opening 3148a and a second opening 3148b offset axially along its length. An actuation line 3101 may enter first opening 3148a, extend along an underside of retention arm 3140, and exit through second opening 3148b. In such configuration, actuation line 3101 may be captured against the underside of retention arm 3140 between first opening 3148a and second opening 3148b, which may prevent or reduce curl or twist of retention arm 3140 during raising and lowering operations. In other examples, actuation line 3101 may be routed through or along a covering disposed over retention arm 3140.

[0250] It should be appreciated that any of the features described above with respect to FIGS. 44A-48B may be combined in various arrangements. For example, a gripper member may include an indicator am having a smaller relaxed angle (FIG. 44B), a thinner thickness (FIG. 45B), and a single row of frictional elements (FIG. 47 A). In another example, a gripper member may include an indicator arm and a retention ami comprising different materials (FIG. 46) and have different actuation line engagement features (FIG. 48 A or 48B). Other combinations of the features described herein are also contemplated.

[0251] Although the subject matter disclosed herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications set forth in this disclosure. It is therefore to be understood that numerous modifications may be made to the exemplary embodiments and that other arrangements may be devised, such as combining one or more features of one embodiment with another embodiment or features from a plurality of embodiments, as an example. Thus, the exemplary embodiments herein are not intended to be exhaustive or to limit the disclosed subject matter to such embodiments.

Claims

Atty Docket No. ABTEVA-0072PCTCLAIMS1. A fixation device for securing tissue comprising: a center assembly: first and second clamps extending outwardly from the center assembly, each clamp including: an craddle member moveable between an open position and a closed position, the craddlc member including an engagement surface; and a gripper member disposed opposite the craddle member for capturing tissue therebetween; a first indicator coupled to the craddle member of the first clamp and oriented substantially transverse to a longitudinal axis of the craddle member, wherein the first indicator is configured to translate between a first and second position dependent on the presence of tissue between the craddle member and the gripper member of the first clamp.

2. The fixation device of claim 1, further comprising a second indicator coupled to the craddle member of the second clamp and oriented substantially transverse to a longitudinal axis of the craddle member of the second clamp, wherein the second indicator is configured to translate between a first and second position dependent on the presence of tissue between the craddle member and the gripper member of the second clamp, wherein a direction of translation of the first indicator is opposite a direction of translation of the second indicator.

3. The fixation device of claim 1 or 2, wherein the first and second indicators are electromagnetically actuated.

4. The fixation device as in any one of claims 1-3, wherein a direction of translation of the first indicator is substantially parallel to the engagement surface of the craddle member of the first clamp.

5. A fixation device for securing tissue comprising: a center assembly: and first and second clamps extending outwardly from the center assembly, each clamp including: an craddle member moveable between an open position and a closed position; and a gripper member disposed opposite the craddle member, the gripper member including an indicator arm and a retention arm, the retention arm having a length greater than a length ofAtty Docket No. ABTEVA-0072PCT the indicator arm, wherein the indicator arm and the retention arm are each independently moveable between a raised position and an engagement position.

6. The fixation device of claim 5, wherein the length of the indicator arm is about 50% the length of the retention arm.

7. The fixation device of claim 5, wherein the length of the indicator arm is between 25% and 50% the length of the retention arm.

8. The fixation device of claim 5, wherein the length of the indicator arm is between 50% and 75% the length of the retention arm.

9. The fixation device as in any one of claims 5-8, wherein the indicator arm and retention arm each include a plurality of frictional elements extending therefrom.

10. The fixation device as in any one of claims 5-9, wherein the indicator arm is configured to move from the raised position to the engagement position while the retention arm is in the raised position.

11. The fixation device as in any one of claims 5-10, wherein the indicator arm has a greater stiffness than the retention ami such that the indicator ami is biased to move to the engagement position before the retention arm moves to the engagement position.

12. The fixation device as in any one of claims 5-11 , wherein the retention arm includes a recess, and the indicator arm is moveably disposed within the recess of the retention arm.

13. The fixation device of claim 12, further comprising a base section coupled to the indicator arm and the retention arm.

14. The fixation device of claim 13, wherein the base section is coupled to the center assembly.

15. The fixation device of claim 13, wherein the base section is coupled to the craddle member.

16. The fixation device of claim 13, wherein the retention arm is coupled to the base section via a first hinge feature and a second hinge feature.

17. The fixation device of claim 16, wherein the indicator arm is coupled to the base section via a third hinge feature.

18. The fixation device of claim 17, wherein the base section includes a first segment, a second segment, and a third segment intersecting one another to form a U-shape.Atty Docket No. ABTEVA-0072PCT19. The fixation device of claim 18, wherein the second segment of the base section includes an opening configured to receive a portion of the center assembly.

20. The fixation device as in any one of claims 5-19, wherein the indicator arm has a first width, and the retention arm has a second width different from the first width.

21. The fixation device of claim 20, wherein the second width is greater than the first width.

22. The fixation device of claim 20, wherein the first width is greater than the second width.

23. The fixation device as in any one of claims 5-22, wherein the indicator arm has a first relaxed angle and the retention arm has a second relaxed angle different from the first relaxed angle.

24. The fixation device of claim 23, wherein the first relaxed angle is less than the second relaxed angle.

25. The fixation device of claim 24, wherein a difference between the first relaxed angle and the second relaxed angle is about 10 degrees to about 40 degrees.

26. The fixation device of claim 23, wherein the first relaxed angle is greater than the second relaxed angle.

27. The fixation device as in any one of claims 5-26, wherein the indicator arm has a first thickness and the retention am has a second thickness different from the first thickness.

28. The fixation device of claim 27, wherein the first thickness is less than the second thickness.

29. The fixation device of claim 28, wherein the first thickness is about 50% to about 90% of the second thickness.

30. The fixation device of claim 27, wherein the first thickness is greater than the second thickness.

31. The fixation device of claim 30, wherein the first thickness is about 110% to about 200% of the second thickness.

32. The fixation device as in any one of claims 5-31, wherein at least one of the indicator am and the retention arm has a variable thickness along its length.

33. The fixation device as in any one of claims 5-32, wherein the indicator arm comprises a first material and the retention am comprises a second material different from the first material.Atty Docket No. ABTEVA-0072PCT34. The fixation device of claim 33, wherein the first material comprises a nickeltitanium alloy and the second material comprises a cobalt-chromium alloy.

35. The fixation device of claim 33, wherein the first material comprises a cobaltchromium alloy and the second material comprises a nickel-titanium alloy.

36. The fixation device of claim 33, wherein the indicator arm includes a plate at a fixed end thereof, and the plate includes one or more openings configured to receive one or more rivets or pins for coupling the indicator arm to the retention arm.

37. The fixation device as in any one of claims 5-36, wherein the indicator arm and the retention am are formed from a same base material and have different mechanical properties achieved through localized heat treatment.

38. The fixation device as in any one of claims 5-37, wherein the indicator am includes a first number of rows of frictional elements and the retention arm includes a second number of rows of frictional elements, wherein the first number is less than the second number.

39. The fixation device of claim 38, wherein the indicator arm includes a single row of frictional elements and the retention ami includes a plurality of rows of frictional elements distributed axially along a length of the retention am.

40. The fixation device of claim 39, wherein the retention arm includes two to six rows of frictional elements.

41. The fixation device of claim 38, wherein each row includes one or more frictional elements.

42. The fixation device as in any one of claims 5-41, wherein the indicator arm is free of frictional elements and the retention am includes a plurality of frictional elements.

43. The fixation device as in any one of claims 5-42, wherein the indicator am includes a single eyelet for receipt of a first actuation line, and the retention ami includes a plurality of eyelets for receipt of a second actuation line.

44. The fixation device of claim 43, wherein the plurality of eyelets of the retention arm are distributed along a length of the retention am.

45. The fixation device as in any one of claims 5-44, wherein the retention am includes a first opening and a second opening offset axially along a length of the retention arm, and an actuation line extends through the first opening, along an underside of the retention am, and through the second opening.

46. A fixation device for securing tissue comprising:Atty Docket No. ABTEVA-0072PCT a center assembly; first and second clamps extending outwardly from the center assembly, each clamp including: an craddle member moveable between an open position and a closed position; and a gripper member disposed opposite the craddle member; and a first ultrasonic sensor coupled to the gripper member of the first clamp, the first ultrasonic sensor being configured to emit ultrasonic waves toward the craddle member of the first clamp and to generate a first waveform when tissue is absent from a space between the craddle member and the gripper member and to generate a second waveform when tissue is present in the space.

47. The fixation device of claim 46, wherein the first ultrasonic sensor is disposed within a sensor window of the gripper member.

48. The fixation device of claim 46, wherein the first ultrasonic sensor is located at a position about 50% of a length of the gripper member.

49. The fixation device of claim 46, wherein the gripper member includes a fixed end and a free end, and the first ultrasonic sensor is located at a position between 25% to 50% a length of the gripper member as measured from the fixed end.

50. The fixation device as in any one of claims 46-49, wherein a second ultrasonic sensor is coupled to the gripper member of the second clamp, the second ultrasonic sensor being configured to emit ultrasonic waves toward the craddle member of the second clamp and to generate a first waveform when tissue is absent from a space between the craddle member and the gripper member of the second clamp and to generate a second waveform when tissue is present in the space.

51. An interventional device for percutaneously securing tissue comprising: a fixation device including: a center assembly, first and second clamps extending outwardly from the center assembly, each clamp including: an craddle member moveable between an open position and a closed position, and a gripper member disposed opposite the craddle member, the gripper member including an indicator arm and a retention aim, the retention arm having a length greaterAtty Docket No. ABTEVA-0072PCT than a length of the indicator arm, wherein the indicator arm and the retention arm are each independently moveable between a raised position and an engagement position; a catheter releasably coupled to the fixation device; and a delivery handle coupled to the catheter.

52. The interventional device of claim 51, further comprising an actuation line extending from the catheter and engaging the indicator arm and the retention arm of each of the first and second clamps for actuation thereof.

53. The interventional device of claim 51, further comprising a first actuation line extending from the catheter and engaging the indicator arm of each of the first and second clamps for actuation thereof, and a second actuation line extending from the catheter and engaging the retention arm of each of the first and second clamps for actuation thereof.

54. The interventional device of claim 51, further comprising a first actuation line, a second actuation line, and a third actuation line, the first actuation line engaging the indicator arm of the first clamp for actuation thereof, the second actuation line engaging the indicator arm of the second clamp for actuation thereof, and the third actuation line engaging the retention arm of each of the first and second clamps for actuation thereof.

55. The interventional device of claim 54, wherein the delivery handle includes a first actuator handle coupled to the first actuation line for actuation thereof, and a second actuator handle coupled to the second actuation line for actuation thereof.

56. The interventional device of claim 55, wherein each of the first and second actuator handles includes at least two preset positions, wherein a first preset position corresponds to actuation of the indicator arms and a second preset position corresponds to actuation of the retention arms.

57. The interventional device as in any one of claims 55 and 56, further comprising an interlock coupled to the second actuator handle for selective coupling to first actuator handle.

58. The interventional device of claim 51, wherein the indicator arm has a first relaxed angle and the retention arm has a second relaxed angle different from the first relaxed angle.

59. The interventional device of claim 51, wherein the indicator arm has a first thickness and the retention arm has a second thickness different from the first thickness.Atty Docket No. ABTEVA-0072PCT60. The interventional device of claim 51, wherein the indicator arm comprises a first material and the retention ami comprises a second material different from the first material.

61. The interventional device of claim 51, wherein the indicator ami includes a single row of frictional elements and the retention arm includes a plurality of rows of frictional elements distributed axially along a length of the retention arm.

62. The interventional device of claim 51, wherein the indicator arm is free of frictional elements and the retention arm includes a plurality of frictional elements.

63. The interventional device of claim 51, wherein the indicator ami includes a single eyelet for receipt of a first actuation line and the retention arm includes a plurality of eyelets for receipt of a second actuation line.

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