Tissue grasping devices and related methods

Abstract

A clip for immobilizing leaflets of a cardiac or venous valve includes a hub having a pair of tangle resistant spring-biased outer arms coupled to an inferior end of the hub and a pair of tangle resistant spring-biased inner arms adjacent to the outer arms and coupled to a superior end of the hub. A delivery catheter may be used to position the valve clip adjacent a target valve while the outer and inner arms are biased in an opened position relative to each other. After the valve leaflets are located between the opened outer and inner arms, the biasing forces may be released to allow the clip to self-close the clip over the valve leaflets.

Claims

1. An endovascular heart valve repair system comprising: a delivery catheter having a distal end configured to be introduced into a heart chamber adjacent to a pair of coapting heart valve leaflets, said delivery catheter including a release bar having a pair of inverters; a valve repair leaflet grasping device comprising a hub configured to be removably attached to the release bar of the delivery catheter, a first pair of leaflet capture arms comprising a first inner arm and a first outer arm coupled to the hub, and a second pair of leaflet capture arms comprising a second inner arm and a second outer arm coupled to the hub; and a first set of control tethers positioned on or through the delivery catheter and having distal portions coupled to the outer arms and configured to selectively bias the outer arms into a valve leaflet capture position; and a second set of control tethers positioned on or through the delivery catheter and coupled to the inner arms and configured to selectively bias the inner arms into a valve leaflet capture position; wherein the first set of control tethers are threaded through laterally spaced-apart locations on the inverters so that drawing each of the proximal portions of the of the first set of control tethers in a proximal direction causes the distal portions of each of the first set of control tethers to move in a distal direction to pull outer segments of each of the outer arms in a distal direction into the valve leaflet capture position.

2. An endovascular heart valve repair device as in claim 1, wherein drawing proximal portions of the of the second set of control tethers in a proximal direction causes distal portions of second set of control tethers to pull outer segments of the inner arms in a proximal direction into the valve leaflet capture position.

3. An endovascular heart valve repair device as in claim 1, wherein the pair of inverters comprises a first inverter extending laterally in a first direction from a distal tip of the delivery catheter and a second inverter extending laterally in a second direction from a distal tip of the delivery catheter.

4. An endovascular heart valve repair device as in claim 3, wherein the first and second directions are opposite to each other.

5. An endovascular heart valve repair device as in claim 4, wherein each of the first and second inverters is pivotally attached to the distal tip of the delivery catheter.

6. An endovascular heart valve repair device as in claim 5, wherein the pivotal attachment is configured so that the inverters laterally deploy when the first tethers are pulled proximally to apply an opening force to the inverters but are able to axially collapse in alignment with the delivery catheter in the absence of the opening force.

7. An endovascular heart valve repair device as in claim 6, wherein the first set of tethers pass from a distal end of the release bar, are slidably coupled to each of the inverters and the outer arms, and are fixedly attached to the release bar.

8. An endovascular heart valve repair device as in claim 7, wherein the second set of tethers pass from a distal end of the delivery catheter, are slidably coupled to each of the inner arms, and are fixedly attached to the release bar.

9. An endovascular heart valve repair device as in claim 6, wherein the first set of tethers pass from a distal end of the release bar, are slidably coupled to each of the inverters and the outer arms, and are removably attached to the release bar.

10. An endovascular heart valve repair device as in claim 1, wherein the inner and outer arms comprise inner and outer leaf springs.

11. An endovascular heart valve repair device as in claim 1, wherein the inner leaf springs are biased to open laterally outwardly away from the release bar and the outer leaf springs are biased to close laterally inwardly toward the release bar so that the leaflets may be captures therebetween when the leaf springs are unbiased.

12. An endovascular heart valve repair device as in claim 11, wherein the outward opening bias of the inner leaf springs is less than inward closing bias of the outer leaf springs.

13. An endovascular heart valve repair device as in claim 11, wherein the outer leaf springs are generally straight and lie closely over the release bar when unbiased so that the outer leaf springs will laterally close the inner leaf springs when all leaf springs are free from bias.

14. An endovascular heart valve repair device as in claim 1, wherein the distal portions of the first set of control tethers are attached to the free ends of the outer arms by suture loops.

15. An endovascular heart valve repair system comprising: a delivery catheter having a distal tip configured to be introduced into a heart chamber adjacent to a pair of coapting heart valve leaflets, said delivery catheter including a release bar having a pair of inverters, wherein the pair of inverters comprises a first inverter extending laterally in a first direction from the distal end of the delivery catheter and a second inverter extending laterally in a second direction from the distal end of the delivery catheter, wherein the first and second directions are opposite to each other; a valve repair leaflet grasping device comprising a hub configured to be removably attached to the release bar of the delivery catheter, a first pair of leaflet capture arms comprising a first inner arm and a first outer arm coupled to the hub, and a second pair of leaflet capture arms comprising a second inner arm and a second outer arm coupled to the hub; and a first set of control tethers positioned on or through the delivery catheter and coupled to the outer arms and configured to selectively bias the outer arms into a valve leaflet capture position; and a second set of control tethers positioned on or through the delivery catheter and coupled to the inner arms and configured to selectively bias the inner arms into a valve leaflet capture position; wherein the first set of control tethers are threaded through laterally spaced-apart locations on the inverters so that drawing proximal portions of the of the first set of control tethers in a proximal direction causes distal portions of first set of control tethers to move in a distal direction to pull outer segments of the outer arms in a distal direction into the valve leaflet capture position.

16. An endovascular heart valve repair device as in claim 15, wherein each of the first and second inverters is pivotally attached to the distal tip of the delivery catheter.

17. An endovascular heart valve repair device as in claim 16, wherein the pivotal attachment is configured so that the inverters laterally deploy when the first tethers are pulled proximally to apply an opening force to the inverters but are able to axially collapse in alignment with the delivery catheter in the absence of the opening force.

18. An endovascular heart valve repair device as in claim 17, wherein the first set of tethers pass from a distal end of the release bar, are slidably coupled to each of the inverters and the outer arms, and are fixedly attached to the release bar.

19. An endovascular heart valve repair device as in claim 18, wherein the second set of tethers pass from a distal end of the delivery catheter, are slidably coupled to each of the inner arms, and are fixedly attached to the release bar.

20. An endovascular heart valve repair device as in claim 17, wherein the first set of tethers pass from a distal end of the release bar, are slidably coupled to each of the inverters and the outer arms, and are removably attached to the release bar.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

(2) FIG. 1 illustrates the left ventricle and left atrium of the human heart during systole.

(3) FIG. 2 illustrates the free edges of mitral valve leaflets in normal coaptation.

(4) FIG. 3 illustrates the free edges of mitral valve leaflets in regurgitative coaptation.

(5) FIGS. 4-9 show photographic images of various exemplary combinations and configurations of some exemplary prototypes of this invention.

(6) FIG. 10 shows a photographic image of an exemplary configuration of the prototype that is a combination of straight and curved devices.

(7) FIG. 11 shows a photographic image of an exemplary configuration of a curved prototype with only one side.

(8) FIGS. 12-13 are photographic images of a prototype covered with polyester fabric.

(9) FIG. 14 shows laser-cut flat pattern of an exemplary embodiment of an inner arm of a straight fixation device.

(10) FIG. 15 shows relaxed 3D configuration of an exemplary embodiment of an inner arm of a straight fixation device.

(11) FIG. 16 shows relaxed 3D configuration of an exemplary embodiment of an outer arm of a straight fixation device.

(12) FIG. 17 shows laser-cut flat pattern of an exemplary embodiment of an outer arm of a straight fixation device.

(13) FIGS. 18-20 show 3D views of an exemplary base bracket 5.

(14) FIG. 21 shows photographic images of two different exemplary sizes of the straight prototype (front view) next to a dime as scale.

(15) FIG. 22 shows a photographic image of a straight prototype (side view) next to a dime as scale.

(16) FIG. 23 shows an exemplary embodiment of a release bar 70 with invertors 102, 101.

(17) FIGS. 24-29 show a schematic representation of the inner arm of the fixation device with various exemplary suture attachment and actuation configurations, including deployable inverter arms in accordance with the principles of the present invention.

(18) FIGS. 30-33 show alternative exemplary embodiments and/or configurations to lower and/or invert the laterally extending inverter arms.

(19) FIGS. 34-38 show photographic images of an exemplary embodiment with various arm manipulations and configurations.

(20) FIG. 35 shows the exemplary embodiment of the inverter with a stop feature to prevent overlapping of inverters during the loaded and/or deployed state.

(21) FIG. 36 illustrates the exemplary embodiment of the straight fixation device with one outer arm lowered.

(22) FIG. 37 illustrates the exemplary embodiment of the fixation device with both outer arms lowered.

(23) FIG. 38 shows an alternative exemplary embodiments, schematics and/or configurations to lower and/or invert the inner arms.

(24) FIGS. 39-41 illustrate an exemplary embodiment of a release bar 70 with inverters 101, 102 in various views and collapsed configurations (FIGS. 39 and 40) and deployed a configuration (FIG. 41).

(25) FIG. 42 shows and exemplary actuation pull-wire comprising of a distal suture loop segment crimped/coupled to a metal rod/wire/mandrel.

(26) FIG. 43 shows and exemplary actuation pull-wire comprising of a distal suture loop segment paired with a tubing.

(27) FIG. 44 illustrates the schematic of the sutures 174, 175 looped around an exemplary release rod 160 utilizing key features of the release bar 72.

(28) FIG. 45 shows a magnified view of FIG. 43, wherein the sutures are looped around the Release Rod 160.

(29) FIG. 46 illustrates the schematic of the sutures after the release rod is partially retracted.

(30) FIG. 47 shows a magnified view of FIG. 45, wherein some of the sutures are released from the release bar after the release rod is partially retracted.

(31) FIG. 48 shows an exemplary embodiment of an inverter with a stop feature.

(32) FIGS. 49-50 show various configurations of the embodiment of the inverter

(33) FIG. 51 shows an alternative schematic of the inner arm in a raised position.

(34) FIG. 52 shows an alternative schematic of the inner arm in a lowered position.

(35) FIG. 53 shows an alternative schematic of the curved outer arm in a tissue grasping position.

(36) FIG. 54 shows an alternative schematic of the outer arm in an inverted position.

(37) FIGS. 55-57 show photographic images of a prototype depicting an exemplary embodiment of a short delivery system.

(38) FIG. 58 shows a photographic image of a straight prototype, wherein the fixation device (back view) is in a loaded configuration and covered with fabric.

(39) FIG. 59 shows a side view photographic image of a straight prototype shown in FIG. 58.

(40) FIG. 60 shows a front view photographic image of a straight prototype shown in FIG. 58.

(41) FIGS. 61-64 show photographic images of a straight prototype in different configurations of relaxed and biased positions.

(42) FIG. 65, Panels A-L, show photographic images of a straight prototype during a bench testing.

(43) FIG. 66, Panels A-J, show alternative photographic images of a curved prototype during bench testing.

(44) FIG. 67 shows an exemplary embodiment of the fixation device (front view).

(45) FIG. 68 shows 3D view of the embodiment of the fixation device shown in FIG. 67.

(46) FIG. 69A shows an embodiment of the fixation device formed using wire loops.

(47) FIG. 69B show an exemplary configuration of nested wire loop assembly for inner or outer arms.

(48) FIG. 70 shows a schematic of the fixation device shown in FIG. 68, loaded in a delivery device.

(49) FIGS. 71A and 71B show alternative embodiments of the catheter handle.

(50) FIG. 72 shows a 3D view of the catheter handle shown in FIG. 71.

(51) FIGS. 73-75 illustrate various views of catheter handle 350.

(52) FIGS. 76A-76D illustrates the section views of handle 350 in various configurations for manipulating the release rod 160, using release knob 372.

(53) FIG. 77 shows the release rod in a loaded configuration.

(54) FIG. 78 shows the schematic of a curved device attached to a release bar 72 in a loaded configuration, showing bailout sutures only.

(55) FIG. 79 illustrates the schematic of a release rod that is partially removed from the release bar.

(56) FIG. 80 shows the schematic of a curved device in an inverted orientation and distal from the release bar 72 with the release rod 160 partially retracted.

(57) FIG. 81 shows an inverted curved device retracted inside a catheter with a partially retracted release rod.

(58) FIG. 82 illustrates the schematic of a release rod 160 that is completely removed from the release bar 72.

(59) FIG. 83 shows a fully deployed curved device with the release rod 160 completely retracted from the release bar 72.

(60) FIGS. 84A-84D show photographic images of the prototype, wherein the fixation device is partially deployed and inverted external to the catheter and then retracted completely inside the catheter.

(61) FIG. 85 shows a photographic image of the delivery system prototype sub-assembly showing release bar with tubes 734 attached to pass through actuating sutures.

(62) FIG. 86 shows a single lumen braided shaft with free-floating release rod 160 and freely floating shaft 732 encapsulating the tubes 734.

(63) FIGS. 87-93 illustrate alternative configurations of multi-lumen braided shafts.

(64) FIGS. 94A-94C illustrate exemplary schematic configurations of a two-nested catheter system.

(65) FIGS. 95-99 are photographic images of a preferred embodiment of an exemplary 12 Fr catheter-based delivery system used to deploy the fixation device within the heart.

(66) FIG. 100 is a photographic image of a delivery system prototype with a balloon-like feature on the guide catheter.

(67) FIG. 101 illustrates the curvatures of a preferred two-nested catheter system as it is advanced past the mitral valve.

(68) FIG. 102 shows the curvatures of the two-nested catheter system as in FIG. 101, with an addition of a balloon-like feature on the distal end of the guide catheter.

(69) FIG. 103 illustrates the curvatures of a three-nested catheter system with a balloon-like feature at the tip of a guide catheter.

(70) FIG. 104A illustrates an exemplary bailout guide catheter.

(71) FIG. 104B shows the curvatures of the two-nested catheter system as in FIG. 101 with an addition of a bailout guide catheter.

(72) FIGS. 105-107 illustrate various embodiments of features that may be attached to the guide catheter and/or delivery catheter.

(73) FIGS. 108-109 illustrate features that may be configured at the distal tip section of guide catheter and/or delivery catheter for shielding and/or retracting the fixation device.

(74) FIGS. 110 and 111 show two exemplary variations of a fixation device with claws at the tip of the arms.

(75) FIG. 112 shows an alternate embodiment of the fixation device shown in FIG. 111 with barbs on the interior of the arms.

(76) FIGS. 113A-113F shows alternative views including a flat-pattern of an exemplary fixation arm shown of the type shown FIG. 112.

(77) FIG. 114 illustrates the dimensions of a preferred embodiment of the fixation device.

(78) FIG. 115 illustrates tethered tissue grasping devices on the atrial side of the heart and on the mitral annulus.

(79) FIG. 116 illustrates tethered tissue grasping devices on the atrial side of the heart, mitral annulus, on the cusps of the leaflets and at the edges of the mitral valve.

(80) FIG. 117 illustrates tethered tissue grasping devices on a leaflet of the mitral valve and a papillary muscle of the left ventricle.

(81) FIGS. 118A-118D show an actuation rod in a modular fashion that can be attached and/or detached within a catheter.

(82) FIGS. 119A-119C show alternative embodiments of a modular catheter system.

(83) FIGS. 120A-120E show images of a retrieval system prototype using sutures.

(84) FIG. 120F show an alternative embodiment of the fixation device comprising of sutures utilized during retrieval.

DETAILED DESCRIPTION OF THE INVENTION

(85) I. Cardiac Physiology

(86) The left ventricle LV of a normal heart H in systole is illustrated in FIG. 1. The left ventricle LV is contracting and blood flows outwardly through the tricuspid (aortic) valve AV in the direction of the arrows. Backflow of blood or “regurgitation” through the mitral valve MV is prevented since the mitral valve is configured as a “check valve” which prevents back flow when pressure in the left ventricle is higher than that in the left atrium LA. The mitral valve MV comprises a pair of leaflets having free edges FE which meet evenly to close, as illustrated in FIG. 1. The opposite ends of the leaflets LF are attached to the surrounding heart structure along an annular region referred to as the annulus AN. The free edges FE of the leaflets LF are secured to the lower portions of the left ventricle LV through chordae tendineae CT (referred to hereinafter as the chordae) which include plurality of branching tendons secured over the lower surfaces of each of the valve leaflets LF. The chordae CT in turn, are attached to the papillary muscles PM which extend upwardly from the lower portions of the left ventricle and interventricular septum IVS.

(87) A number of structural defects in the heart can cause mitral valve regurgitation. Regurgitation occurs when the valve leaflets do not close properly allowing leakage from the ventricle into the atrium. As shown in FIG. 2, the free edges of the anterior and posterior leaflets normally meet along a line of coaptation C. An example of a defect causing regurgitation is shown in FIG. 3. Here an enlargement of the heart causes the mitral annulus to become enlarged, making it impossible for the free edges FE to meet during systole. This results in a gap G which allows blood to leak through the valve during ventricular systole. Ruptured or elongated chordae can also cause a valve leaflet to prolapse since inadequate tension is transmitted to the leaflet via the chordae. While the other leaflet maintains a normal profile, the two valve leaflets do not properly meet and leakage from the left ventricle into the left atrium will occur. Such regurgitation can also occur in patients who have suffered ischemic heart disease where the left ventricle does not contract sufficiently to effect proper closure.

(88) II. General Overview

(89) The present invention provides methods and devices for grasping, approximating and fixating tissues such as valve leaflets to treat cardiac valve regurgitation, particularly mitral valve regurgitation. The present invention also provides features that allow repositioning and removal of the device if so desired, particularly in areas where removal may be hindered by anatomical features such as chordae CT. Such removal would allow the surgeon to re-approach the valve in a new manner if so desired.

(90) Grasping will preferably be atraumatic providing a number of benefits. By atraumatic, it is meant that the devices and methods of the invention may be applied to the valve leaflets and then removed without causing any significant clinical impairment of leaflet structure or function. The leaflets and valve continue to function substantially the same as before the invention was applied. Thus, some minor penetration or denting of the leaflets may occur using the invention while still meeting the definition of “atraumatic”. This enables the devices of the invention to be applied to a diseased valve and, if desired, removed or repositioned without having negatively affected valve function. In addition, it will be understood that in some cases it may be necessary or desirable to pierce or otherwise permanently affect the leaflets during either grasping, fixing or both. In some of these cases, grasping and fixation may be accomplished by a single device. Although a number of embodiments are provided to achieve these results, a general overview of the basic features will be presented herein. Such features are not intended to limit the scope of the invention and are presented with the aim of providing a basis for descriptions of individual embodiments presented later in the application.

(91) The devices and methods of the invention rely upon the use of an interventional tool that is positioned near a desired treatment site and used to grasp the target tissue. In endovascular applications, the interventional tool is typically an interventional catheter. In surgical applications, the interventional tool is typically an interventional instrument. In preferred embodiments, fixation of the grasped tissue is accomplished by maintaining grasping with a portion of the interventional tool which is left behind as an implant. While the invention may have a variety of applications for tissue approximation and fixation throughout the body, it is particularly well adapted for the repair of valves, especially cardiac valves such as the mitral valve and tricuspid valve.

(92) As explained in co-owned and reference application (PCT/US2017/042003), the fixation device is adaptable to both retrograde and antegrade configurations for deployment. The fixation device is attached to the Release bar, which is part of the distal delivery catheter as referenced in the previous PCT. In both methods, the placement and position of the device remains unchanged. This may allow the fixation device to be deployed using various entry points that best suit the user need. For illustration purposes, an antegrade approach will be primarily described going forward.

(93) FIGS. 4-9 show images of a few exemplary combinations and configurations of the preferred implant device.

(94) FIGS. 4 and 5 show images of the exemplary standard sizes of straight and curved configuration of the implant device.

(95) FIGS. 6 and 7 show images of the exemplary larger sizes of straight and curved configuration of the implant device.

(96) FIGS. 8 and 9 show images of the exemplary asymmetric configurations of straight and curved implant devices using standard and larger sizes.

(97) FIG. 10 shows an image an exemplary configuration of device that is a combination of straight and curved device. Note, each arm can also be of different thickness, width, length and profile to configure/vary the grasp or coaptation length, grasp force, anulus cinching force.

(98) FIG. 11 shows an image of an exemplary configuration of a curved device with only one side. This allows for a configuration optimized for single leaflet grasping. This concept may be used for other competition devices too. For example, an exemplary embodiment of this invention can be seen in FIG. 12, wherein the Arms of the MitraClip® is cut and removed from one side, while keeping all other aspects of the design intact.

(99) In one preferred method, two such single leaflet devices (FIGS. 10-12) may be deployed on the same leaflet at different sites or on different leaflets and configured to be pulled together and constrained in place. This can be done by techniques and designs common to those skilled in the art. For example, the devices can be configured with attached sutures or tethers with or without keyed or mating features. Once each of these devices have been deployed on the leaflets, the sutures or tethers may then be used pull the two devices together. Once sufficiently approximated to eliminate or reduce regurgitation (as determined via ultrasound or fluoroscopic imaging feedback), the sutures may be secured/fixed/crimped together, and excess strands cut and removed. Thus, constraining the devices in a configuration that prevents regurgitation. Alternatively, the action of pulling the two devices together can be used to mechanically lock them in place.

(100) FIG. 13 shows an image of the MitraClip® device with asymmetric arm lengths, similar to the exemplary device shown in FIG. 8.

(101) FIG. 14 shows flat-pattern of a preferred exemplary embodiment of an inner arm 12 of the straight fixation device. The inner arm consists of atraumatic dual-barb or v-shaped protrusions 18 that allow the inner arm 12 to grip the LF of the MV. Features 24-25 allow the passage of sutures and/or attachment of suture loops to manipulate the inner arms. Features 20-21 couple base bracket 5 to the inner arms. Openings 26 allow the polyester fabric to adhere to one another and prevent movement of the polyester fabric during advancement and/or retraction of the fixation device through the catheter system.

(102) FIG. 15 shows an 3D view of the exemplary embodiment of an inner arm 14 of the fixation device shown in FIG. 14.

(103) FIG. 16 shows 3D view of an exemplary embodiment of an outer arm 15 of the straight fixation device.

(104) FIG. 17 shows flat-pattern of the outer arm 13 shown in FIG. 16. Features 32 and 34 couple base bracket 5 to the outer arms. Features 37-40 allow the passage of sutures and/or attachment of suture loops to manipulate outer arms 13. Opening 37 allows the polyester fabric to adhere to one another and prevents movement of the polyester fabric during advancement and/or retraction of the fixation device through the catheter system.

(105) FIG. 18 shows a component 50 of the base bracket 5. It consists of hinge joint 56 and threaded openings 60 and 62 to allow for miniature screws to fasten arms between the components 50 and 52.

(106) FIG. 19 shows right component 52 of the base bracket 5. It consists of openings 61 and 63, which allow for miniature screws to fasten arms between the components 50 and 52.

(107) FIG. 20 shows an alternative view of the base bracket 5 depicting the hinge joint 56. Opening 65 allows passage of Release Rod 160 for detachable attachment of the base bracket 5 to the Release bar 70, 72.

(108) FIG. 21 shows the image of the front view of a short and long straight design prototypes next to a dime for a side-by-side comparison of its dimensions.

(109) FIG. 22 shows the image of the side view of the long straight design prototype next to a dime as scale.

(110) FIG. 23 shows and alternate exemplary embodiment of Release bar 70, wherein, a) instead of single attachment feature 80, now there are multiple such features 81-84 and b) instead of posts (see FIG. 13G-2, PCT/US2017/042003), Inverters 101, 102 are being used. These inverters provide increased lever arm to flex the outer arms, as compared to the posts.

(111) The Inverters 101, 102 are hinged at 95 and hence, can swivel to allow easy passage through the catheter and provide a combination of configurations that may be used to manipulate the arms (for example, outer arms 13, 15, 195, 197).

(112) The Inverters 101, 102 maybe a simple single component or can be of complex shape with multiple sub-components. Further, they can be a hinged, flexible, rigid and may be joined together immovably or movably. They can be arranged in any configuration to allow for optimal manipulation of the Arms. Furthermore, their surface may be suitably configured to improve functionality and/or to reduce friction.

(113) FIG. 24 shows an exemplary schematic wherein the inner arm 12 elastically lowers upon removal of biasing forces (as shown by arrow direction 120 and indicated by initial dotted-line position to final solid-line position).

(114) FIG. 25 shows the relatively equal increase in lengths of suture segments 126 and 128, as well as their angles. This configuration may cause a) increased frictional resistance hindering the elastic recoil of the arms, and b) decreased force needed to raise (straighten or bias) the inner arms.

(115) FIG. 26 shows schematic of inner arm 12 in raised position. This, as previously described in the PCT, is achieved by pulling 136 on the suture 130. That is, pulling 136 of the suture segment 130 causes progressive shortening of suture segments 128 and 126 leading to raising of the inner arm 12.

(116) Similarly, releasing (or pushing) the suture allows for the inner arm to elastically recoil and return to its relaxed shape-set configuration. However, to those skilled in art can appreciate that this elastic recoil force is relatively low. Thus, lowering friction within the suture segments is paramount. Some of the characteristics that affect friction are a) coefficient of friction, b) angle between the segments 126 and 128, c) incremental length of the suture travel, d) number of bends and curves the suture is exposed to, e) flexibility of the suture, f) pushability of the suture within the catheter lumen and so on.

(117) FIGS. 27-28 show an exemplary alternate embodiment as shown in FIG. 25, wherein the suture segment 126 is along the length of the inner arm 12 and terminates around release bar 76 at features 84 (instead of 88). Note the increase in angle between suture segments 126 and 128.

(118) As can be inferred from FIGS. 27-28, the length of the segment 126 essentially remains the same over the movement of the inner arm, therefore, there is minimal travel of the suture at the tip of the inner arm 12. Further, the Inner arm needs to overcome and pull only segment 128. Hence, in a given condition with all other variable characteristics being same, the alternate configuration of terminating the suture loop at feature 84 (when compared to feature 88) provides lower resistance to the elastic lowering of Inner arm 12.

(119) Similarly, FIGS. 29-33 show alternative exemplary embodiments and/or configurations to lower (and or invert) outer arms. In this configuration, manipulation of outer arms 13, 15, 195, 197 is accomplished by threading suture 180 through feature 84, suture segment 178 through suture loop 281, suture segment 176 through suture loop 282, and coupling suture segment 174 to feature 83 of release bar 70. Inversion of outer arms 13, 15, 195, 197 can further aid during bailout.

(120) FIG. 34 shows an image of an exemplary embodiment of release bar 76 with inverters 101, 102 and an exemplary implant device embodiment like the one depicted in FIG. 13D of the referenced PCT application.

(121) FIG. 35 shows a back-view image of the prototype in FIG. 34, wherein all arms are in raised configuration.

(122) FIG. 36 shows an image of the exemplary ability to manipulate each arm independently—for example, only the Outer arm 13 is lowered.

(123) FIG. 37 shows an image of both Outer arms 13, 15 lowered/inverted.

(124) FIG. 38 shows an image of both Outer arms 13, 15 lowered to grasping angle and both Inner arms 12, 14 lowered over the Outer arms.

(125) This invention, as previously described in the PCT provides the means and method of independent arm manipulations. This improves ease of use in the procedure and adopt according to the disease and anatomical conditions. Additionally, it allows the user to correct the grasp alignment if needed. For example, if on grasping the user determines that one side of the grasp is suboptimal, he can release just that side and grasp it again. Thus, saving significant amount of time when compared to redoing the entire grasping procedure again by releasing both leaflets.

(126) FIGS. 39-41 show a few possible configuration combinations of inverters 101, 102. The Inverters 101, 102 maybe a simple single component or can be of complex shape with multiple sub-components. Further, they can be a hinged, flexible, rigid and may be joined together immovably or movably. They can be arranged in any configuration to allow for optimal manipulation of the Arms. Furthermore, their surface may be suitably configured to improve functionality and or reduce friction.

(127) FIG. 42 shows suture 126 coupled or crimped to a metal wire 138, mitigating friction inside the catheter lumen as it is pulled or pushed. While pulling is not an issue with any suture or rope (high tensile strength, low column/compressive strength), having a metal wire or rod (with sufficient column/compressive strength when inside a catheter lumen) over most of the proximal length of the catheter provides, provides the required push force to overcome and frictional resistance hindering elastic recoil of the arms. In come embodiments, the pushability may be used to augment the recoil of the arms.

(128) Further, FIG. 43 illustrates exemplary embodiment of a suture 126 coupled to rigid tube 139, which can be stainless steel wire, plastic tube and/or metal tube. Rigid tube 139 can be pulled or pushed, thereby reducing the internal friction of the catheter and/or augment strain recovery of the arms.

(129) FIG. 44 illustrates the schematic of sutures looped around release rod 160 utilizing key features of exemplary release bar 72. As can be seen, release rod 160 is completely inserted through release bar 72, anchoring sutures 125 to feature 84 and sutures 174 and 175 to feature 82. Further, the sutures are inserted through features 82 and 84 from the front of release bar 72; however, due to the versatility of release bar 72, the sutures can be inserted from the back or any combinations of front and/or back insertion.

(130) FIG. 45 shows a magnified view of sutures 125, 174 and 175 around release rod 160 of FIG. 43. As can be seen, features 82 and 84 have sufficient room for sutures 125, 174 and 175 to freely move without additional tension to the sutures.

(131) FIG. 46 illustrates the schematic of sutures 125, 174 and 175 after release rod 160 has been partially retracted past feature 82, thus decoupling sutures 174 and 175 from release bar 72.

(132) FIG. 47 shows a magnified view of FIG. 45, wherein sutures 174 and 175 are decoupled from release bar 72 after the release rod 160 has been partially retracted. As can be seen, sutures 174 and 175 are decoupled without tangling. This is the case regardless of the point of entry of the suture (i.e. from behind and/or in front of release bar 72).

(133) FIG. 48 shows an exemplary embodiment of inverters 116 and 117 comprised of stop feature 142 utilized to prevent the inverters from overlapping or moving in the opposite direction when loading the fixation device into a catheter and/or during deployment of the fixation device.

(134) FIG. 49 shows an exemplary embodiment of release bar 72 with inverter 117 in a deployed state. Release bar 72 is shown with a plurality of features 80-88 to allow passages of sutures to loop through and manipulate the arms of the fixation device. In addition, any of these features maybe used to couple the device, with the base towards the distal end (towards 80) or proximal end (towards 88) of the release bar. Thus, allowing device configuration flexibility, for example, allowing antegrade or retrograde approach to the mitral valve.

(135) FIG. 50 shows an exemplary embodiment of release bar 72 with inverter 117 in a catheter loaded configuration. Stop feature 142 of inverter 117 is shown to limit rotation of inverter 117, for example, limit past 10 or 20 or 120 degrees beyond the center axis of release bar 72 in a catheter loaded configuration.

(136) FIGS. 51-52 show the schematics of inner arm 14 in various positions. In contrast to previous configurations, suture segment 128 is now looped through a suture loop 283 of inner arm 14 instead of inner arm 12 such that suture segment 128 manipulates the opposite arm. This crisscrossed configuration allows for more aggressive raising of the inner arms. As can be further seen in this configuration, suture segment 126 is looped through feature 84 of release bar 72. This configuration reduces friction on the sutures when manipulating the inner arms. Further, the suture segment is away from the tissue interfacing/gripping side of the inner arm, to further mitigate the risk of suture entanglement.

(137) FIGS. 53-54 show the schematic of outer arm 15 in various positions. As can be seen, the suture is positioned such that the manipulation of outer arm 15 utilizes feature 82 of release bar 72, thereby reducing tension placed on the sutures when manipulating the outer arms. In this configuration, outer arm 15 is manipulated by threading suture 181 through suture loop 280 at feature 80, suture segment 175 through suture loop 281 and suture segment 177 through suture loop 282.

(138) FIG. 55 shows an image (front view) of the prototype depicting an exemplary embodiment of short delivery system for trans-thoracic approaches. As can be seen in this image, actuation-rods 330, 331, 332, and 333 are inserted in handle 350 to allow manipulations of outer arm 13, inner arm 14, inner arm 12 and outer arm 15, respectively. The stainless steel tube 360 is easily deformable, so the user can bend it as required to gain better access to the valve.

(139) FIG. 56 shows an image (back view) of the prototype described in FIG. 55.

(140) FIG. 57 shows an image of the prototype depicting an alternative embodiment of the delivery system, wherein handle 350 is largely cylindrical and/or conical in shape.

(141) FIG. 58 shows an image of a preferred straight prototype, wherein the fixation device (back view) covered in fabric. As can be seen in this image, sutures controlling the outer arms are inserted through the back of the release bar. This reduces contact between sutures controlling the inner arms, thereby reducing friction between the sutures.

(142) FIG. 59 shows an image of the prototype shown in FIG. 58, wherein the fixation device (side view) is covered in polyester fabric.

(143) FIG. 60 shows an image of the prototype shown in FIG. 58, wherein the fixation device (front view) is covered in polyester fabric.

(144) FIG. 61 shows an image of the prototype shown in FIG. 60, with inverters deployed.

(145) FIG. 62 shows an image of the prototype with the outer arms in a preferred leaflet grasping angle/position, while the inner arms remain raised.

(146) FIG. 63 shows an image of the straight prototype with the outer arms in preferred grasping angle, while the left inner arm is lowered. If a leaflet were to be in between the inner and outer arm, the leaflet would be captured by the inner arm in this configuration.

(147) FIG. 64 shows an image of the prototype with both outer arms and inner arms in grasping position, such that any tissue or leaflets in between the arms would be grasped.

(148) FIGS. 65A-65C show images of a preferred method of deployment of a straight device prototype, as it is advanced through a clear shaft representing a 12 Fr guide catheter. FIG. 65A) Device inside a 12 Fr shaft. FIG. 65B) Device being advanced out of the 12 Fr shaft. FIG. 65C) Device exposed. FIG. 65D) Device Outer Arms are lowered to grasping angle. FIG. 65E) Leaflets stabilized by Outer Arms. FIG. 65F) One side leaflet is grasped by dropping one of Gripper Arms. FIG. 65G) Second leaflet grasped by lowering the other gripper. FIG. 65H) Both Outer Arms are raised. FIG. 65I) The device is fully deployed. FIG. 65J) View of device from ventricular side. FIG. 65K and FIG. 65L) Bailout position showing raised Grippers and inverted Outer Arms.

(149) FIGS. 66A-66J show images of a preferred curved prototype during bench testing. FIG. 66A) Device inside a 12 Fr shaft. FIG. 66B) Device being advanced out of the 12 Fr shaft. FIG. 66C) Device exposed. FIG. 66D) Device Outer Arms are lowered to grasping angle. FIG. 66E) Leaflets stabilized by Outer Arms. FIG. 66F) One side leaflet is grasped by dropping one of Gripper Arms. FIG. 66G) Second leaflet grasped by lowering the other gripper. FIG. 66H) the device is fully deployed. FIG. 66I) View of device from ventricular side. FIG. 66J) Bailout position showing raised Grippers and inverted Outer Arms.

(150) FIG. 67 shows an exemplary embodiment of a curved fixation device. Inner arms 12 and 14 comprise of a plurality of barb-like protrusions 18. As can be seen in the 3D view of the device in FIG. 68, the inner arms 12, 14 are made of sheet metal while the outer arms 191, 193 are made of wire loops.

(151) FIG. 69A shows an exemplary embodiment of the fixation device, wherein inner arms 192, 194 and outer arms 195, 197 are comprised of single primary loop of metal wire, such as Nitinol. Inner arm 192 further comprises of band 250, which is used to affix the metal wires together and small wire loops 252 to pass actuating sutures through. These small suture loops 252 provide a localized attachment point at the arm.

(152) FIG. 69B illustrates a method of assembling nested wire loops to form either inner or outer arms that are optionally held together by bands 250. The nested loops may be of a single wire or multiple wires.

(153) FIG. 70 shows an exemplary schematic of the curved fixation device as in FIG. 68. Further, it demonstrates the configuration in which the fixation device is affixed onto release bar 72. As can be seen, suture 130 controls inner arm 14 instead of inner arm 12 in previous configurations. Similarly, suture 131 controls inner arm 12. This configuration allows for improved raising angle of the inner arms. Suture segments 125, 126 are looped around release rod 160 through feature 85, which is well spaced and away from the tissue interfacing gap of the arms. Additionally, sutures 180, 181 control outer arms 191, 193, respectively. Suture segments 175, 175 of sutures 180, 181 are looped around release rod 160 through feature 82, which is well below and away from the tissue interfacing gap between the two arms. A advantage of this invention is reduced contact between sutures 125, 126 and sutures 174, 175, thereby reducing friction and tangling between the sutures. Moreover, this separation improves manufacturability.

(154) FIGS. 71A and 71B show alternative embodiments of catheter handle 350. Release knob 372 controls release rods 160. Feature 400 allows screws to be placed in order to affix actuation-rods 330, 331, 332, 333 to catheter handle 350 to reduce the possibility of unintentional movement during surgical procedures. This, in addition to the friction provided by the O-rings of the handle.

(155) FIG. 72 shows an alternative view of catheter handle 350. Feature 422 allows set screws to fasten the stainless-steel tube 360 to the nozzle 382.

(156) FIG. 73 illustrates the front view of catheter handle 350, depicting nozzle 382 and features 422.

(157) FIG. 74 illustrates the back view of catheter handle 350. Features 462, 463, 464, 465, 466 allow the insertion of actuation-rods 333, 332, 331, 330, respectively. Alternatively, the actuation-rods can be inserted through features 467 and 468, or any combination of features 462, 463, 464, 465, 466, 467, 468 to actuation-rods 330, 331, 332, 333. Moreover, features 467 and 466 may be used as flush ports to flush saline, insert sensors and actuators and/or insert actuation rod for bailout suture 602.

(158) FIG. 75 illustrates a cross-sectional drawing of the exemplary catheter handle 350. Features 462, 463, 464, 465 allow the smooth insertion of actuation-rods 333, 332, 331, 330, respectively. Further, the acute angles in which channels 462, 463, 464 and 465 may taper to allow guidewires, sutures plastic tubes and/or metal tubes from kinking and/or tangling.

(159) FIG. 76 illustrates an exemplary method of manipulating release rod 160 to decouple the fixation device from the release bar. Release rod 160 is controlled by release knob 372 via threaded features 500 and 502. Threaded features 500 and 502 prevents unintentional removal of release rod 160 as the release knob 372 needs to be unscrewed prior to retraction. To improve speed of unscrewing and to limit amount of retraction, there is a designed gap/slot between the threads 502 and 500. In an exemplary and preferred embodiment, unscrewing release knob 372 from threaded feature 502 and retracting the knob until threaded feature 500 decouples straight fixation devices, from release bars 70 and 72. In an alternate and preferred embodiment for curved devices, unscrewing release knob 372 from threaded features 502 and retracting it up to feature 500 only partially decouples the device from release bar 70 and 72, wherein, the bailout sutures will still remain attached at feature 88. This allows for the device to be retracted back into the guide catheter. However, if complete deployment is desired (as in case of successful grasping of tissue) the release knob 372 must be removed all the way out of both distal 502 and proximal 500 threads.

(160) As seen in FIG. 76A, the release rod 372 is completely inserted, representing a loaded device. To deploy the device, the user first unscrews the release knob 372 as shown in FIG. 76B and retracts it partially through the non-threaded slot between the two threads 502 and 500 as shown in FIG. 76C. Based on the suture attachment points (for example, between 80-85), preferably straight devices can be configured to be released and deployed. To further retract the release rod 160 (for example, through 86-88), the user may optionally unscrew the release knob out of the proximal threads 500. For example, curved devices may be configured to have a bailout suture in the feature 88. Hence, to deploy a curved device in leaflets, the user will need to fully remove the release knob 372 out of the handle body, as shown in FIG. 76D.

(161) FIG. 77 shows release rod 160 completely inserted in release bar 72. As can be seen, release rod 160 is inserted through features 80-88. Further, it is exposed at the distal end of release bar 72.

(162) FIG. 78 shows the schematic of curved device 650 attached to release bar 72 in a loaded configuration, wherein release rod 160 is completely inserted through the release bar. As can be seen, curved device 650 has suture loop 622 which allows suture 600 to affix the device to release bar 72 through feature 88. Note, for simplicity, other sutures to actuate the arms are not shown.

(163) FIG. 79 illustrates the schematic of release rod 160 that is partially retracted (corresponding to FIG. 76C), as indicated by arrow 675, from release bar 72 such that features 80-85 are free. Subsequently, FIG. 80 shows the schematic of curved device 650 partially detached from release bar 72 as release rod 160 is partially retracted. Consequently, curved device 650 is in an inverted position with the bailout suture at feature 88 still coupled to suture loop 622 of curved device 650. Thus, allowing for retraction and removal of the device 650 through the guide catheter 700, as shown in FIG. 81.

(164) FIG. 82 illustrates the schematic of release rod 160 completely removed from release bar 72, freeing features 80-88 of sutures and fixation device.

(165) FIG. 83 shows the complete deployment of curved device 650 with release rod 160 completely removed from release bar 72 (corresponding to FIG. 76D). As such, suture 602 is freed from suture loop 622 and feature 88, thereby decoupling curved device 650 from release bar 72.

(166) FIGS. 84A-84D shows images of an exemplary curved device prototype demonstrating the bailout method as described in FIGS. 76-83, wherein the fixation device is partially deployed but still attached to the deployment suture 600-609 (FIG. 84A). FIGS. 84B-84D show sequential steps of retraction of the device inside of an exemplary 12 F shaft.

(167) FIG. 85 shows an image of the distal end of an exemplary delivery system sub-assembly of a short catheter (as shown in FIGS. 55-57).

(168) FIG. 86 shows a single-lumen braided shaft 700, wherein the release rod 160 is free-floating within the shaft. Optionally, shafts 734 are enclosed inside another free-floating single lumen shaft 732.

(169) FIGS. 87-93 illustrate alternative configurations of multi-lumen braided shafts that may be used for a catheter. Metal wires, metal tubes, plastic tubes, pullwires and/or sutures can be inserted through the lumens 730, 734, 736, 737, 738, 739. Further, Nitinol wires may be inserted to strengthen or maintain stiffness of the catheter. In FIG. 87, in a preferred embodiment, actuating sutures are passed through the inner ring of lumens 737 and nitinol mandrels are optionally inserted in the larger lumens 730, 736, especially in the distal unsupported segment of delivery catheter shaft to maintain straightness of the shaft, as it extends out of the guide curves. The release rod is be passed through any of the larger loops 730, 736.

(170) FIG. 88 shows an alternate embodiment of the shaft in FIG. 87, wherein a torque cable or peek tubing is bonded to the lumen 736 to improve the torque, tension, flexibility and compression characteristics of the catheter shaft.

(171) FIG. 89 shows an alternate embodiment of the shaft with torque cable and/or peek tubing.

(172) FIG. 90 shows the embodiment in FIG. 88, with sutures. As can be seen, each pair of suture strands can be passed through diametrically opposite lumens, as shown for example for suture 180. Such a configuration is preferred, as it balances the suture pull forces across the center of the catheter, to mitigate the pull force induced curving of the catheter.

(173) FIG. 91 shows the embodiment in FIG. 89, with sutures. As can be seen, each pair of sutures strands can be passed through same lumens.

(174) FIGS. 92 and 93 show alternate embodiments of the deliver shaft.

(175) FIGS. 94A-94C show schematic illustrations of an exemplary and preferred two-nested catheter system, as per this invention, respectively.

(176) FIG. 95 shows an image of the distal segments of a preferred two-nested catheter system prototype. As can be seen, the exemplary 9 Fr outer diameter delivery catheter shaft 1020 passes through the lumen of the exemplary 12 Fr steerable guide catheter shaft 1000.

(177) FIG. 96 shows an image of a preferred steerable guide and delivery catheter handles prototypes in a side-by-side view. The exemplary stainless-steel tube 950 provides a means to support and attach the steerable guide catheter handle on to a suitable stand (not shown). And the exemplary stainless-steel tube 940 provides a means to support and translate the delivery catheter, when nested inside the steerable guide handle.

(178) FIG. 97 shows an image of a guide catheter prototype with transseptal curve 980 at segment 901. Transseptal curve 520 can range from −5 degrees to 180 degrees. This degree of curvature allows easy access past the septum to deliver the fixation device. In an alternate embodiment, the catheter in this invention is designed to be fully two-way steerable −180 to 180 or −270 to 270 or −359 to 359 degrees, for added functionality.

(179) FIG. 98 shows an image of a catheter prototype, wherein the guide catheter has a two-way transseptal curve 980 at segment 901 and at segment 1010 has a 4-way mitral curves 985, 986, 987, 988. Mitral curves range from −90 to 90 or −180 to 180 or −270 to 270 or −359 to 359 degrees 983. Further, it has high strength to resist torsion and can be rotated 981 along it's longitudinal axis 983. The 4-way mitral curve with rotation allows easy access to the MV. The guide catheter and delivery catheter may optionally have preset curves.

(180) FIG. 99 shows an image of an exemplary guide catheter prototype in an anatomical heart model.

(181) FIG. 100 shows an image of an exemplary delivery system prototype with an inflatable balloon-like feature 1050 on guide catheter. The balloon feature 1050 can function as a bumper to prevent trauma to the surrounding tissues as the delivery system is advanced or retracted in a vessel. Further, balloon feature 1050 can be inflated to stabilize the guide catheter to prevent unintentional movement (i.e. retraction, progression) of the delivery system. Balloon feature 1050 can be positioned any place along the guide and/or delivery catheter. In a preferred embodiment, the balloon is mounted distally at the tip and when inflated post septal crossing, helps prevent unintended retraction of the guide into the right atrium.

(182) FIG. 101 illustrates the curvature of a preferred two-nested catheter system, as the delivery catheter 1020 is advanced past the MV. The mitral curve of distal guide shaft 1010 and septal curves proximal guide shaft 901 allows easier access to LF, as well as, advantageously positioning fixation device 1040 below MV. It also shows the straight unsupported segment of the delivery catheter 1020.

(183) FIG. 102 illustrates the curvature of a preferred two-nested catheter system with addition of a balloon-like feature 1050 on the distal end of the guide catheter 1010, as the delivery catheter 1020 is advanced past the MV. Potential advantages of two-nested catheter system over three-nested catheter system are lower cost and lower profile.

(184) FIG. 103 shows the curvature of three-nested guide catheter 1020 with an addition of a balloon-like feature 1050 on the distal end of guide catheter 1052, as the delivery catheter 1020 is advanced past the MV. In this configuration, balloon 1050 stabilizes the distal end of the guide catheter 1052 and prevents accidental retraction across the septa S.

(185) FIG. 104A shows bailout catheter guide 1055 with a long pull/push feature 1057. Feature 1057 controls bailout guide catheter 1055 to enclose/cover/shield the fixation device during retraction/bailout. In a preferred embodiment and method, the bailout catheter is situated external to the patient and not advanced inside the patient unless a bailout is desired. This is an advantage of this invention which mitigates the need and risk of insertion of large diameter bailout catheters in most cases. This advantage can be easily applied to typically large French sized three-nested catheter systems such as MitraClip® delivery system, by using a bailout catheter design as per this invention and adding steerability at trans-septal curves to steerable sleeve, and by using a distal balloon as a bumper or shield.

(186) FIG. 104B shows an exemplary two-nested catheter system as in FIG. 101, with addition of a bailout catheter guide 1055, optionally inserted close to septa S. Bailout catheter guide 1055 can be used to enclose/cover/shield the fixation device 1040 during retrieval in order to prevent trauma to the surrounding tissues as the delivery system is retracted from the patient after bailout. The bailout catheter 1055 may optionally comprise of balloon 1050.

(187) FIGS. 105-106 show umbrella-like feature 1110 at the tip of a guide catheter 1010, 1052 or delivery catheter 1020 or bailout catheter 1055. Umbrella feature 1110 functions as an enclosure device to surround fixation device 1040 as the delivery system is advanced and/or retracted during the procedure. Umbrella feature 1110 can be expanded/inflated to stabilize the delivery system during mitral valve repair surgery, thereby increasing efficiency.

(188) FIG. 107 shows inflatable bumper-like balloon feature 1115 that can optionally be part of a standalone attachment feature 1060 that can be mounted on to a catheter 1010, 1020, 1052, 1055. Bumper feature 1115 prevents fixation device 1040 or the delivery system from causing trauma to the lumen walls and/or blood vessels.

(189) FIGS. 108-109 illustrate cross-section of a self-expanding bell/funnel shaped nested flat features 1120 (like flower petals) that may be attached to the guide catheter and/or delivery catheter to enclose/funnel the fixation device 1040 during the progression and/or retraction of the delivery system. The feature 1120 can be actuated using pullwires and/or sutures 1130, 1131, as indicated by the arrows, to collapse or expand.

(190) FIGS. 110 and 111 shows alternative embodiments of a tissue fixation device 1140, 1141 with a claw 210 on the proximal ends of each of the two outer arms 204. Claw 210 is used to increase surface area of the outer arms 204 in order to grasp more target tissue. The base 5 is not shown for simplicity.

(191) Further, FIG. 112 shows an alternative embodiment of the same tissue fixation device 1140, 1141 with the addition of barbs 212. The base 5 is not shown for simplicity.

(192) FIGS. 113A-113F shows alternative views including a flat pattern illustration of the outer arms 204, detailing the preferred angles and positions of barbs 212 and claws 210.

(193) FIG. 114 illustrates the functional length 225 of outer arms 204 and the functional width 227 of a tissue fixation device embodiment 1140, 1141. The thickness of the fixation device is modeled by length of device base 222 and width of device base 224. In a preferred embodiment, the functional length of arms 225 is manufactured to be >1.5× longer than functional width 227. As such, changing the functional length 225 and functional width 227 of the fixation device will vary the amount of tissue to grasp and/or force exerted and/or area of tissue engagement. Additionally, varying base length 222 and thickness of the arms 204 will improve and/or increase the amount of tissue grasping force.

(194) Alternate embodiments/prototypes of the two-arm based tissue fixation devices 1140, 1141 can be seen in FIGS. 10-12.

(195) In another exemplary and preferred embodiment, the two-arm fixation device 1140, 1141 may optionally comprise of an adjustable tether, as described in the ‘SUMMARY OF THE INVENTION’ section.

(196) FIG. 115 illustrates embodiments of the tethered tissue fixation devices used to coapt and/or cinch the target tissue closer. For example, tissue grasping device 1140 is coupled to tether 1146 while tissue grasping device 1141 is coupled to tether 1147. The tethers are cinched and affixed with connector 1144. Tethers 1146 and 1147 can be of metal wires and/or polymeric sutures. The tissue grasping devices can be positioned at locations 2000 or 2002. Location 2000 refers to the atrial wall of the heart and location 2002 refers to the mitral annulus. Structural and functional integrity of the heart is reinforced by cinching and/or coapting the valve annulus and/or strategic locations in the heart such as leaflet edges are some of the obvious advantages of this invention.

(197) FIG. 116 illustrates embodiments of the tethered tissue fixation devices at an exemplary and preferred location 2004, which is at the leaflet edge. Positioning the fixation device at location 2004 and coapting creates edge-to-edge Alfieri repair in a mitral valve to mitigate regurgitation. FIG. 116 additionally show other exemplary locations such as 2006, which is at the cusp of the leaflet.

(198) FIG. 117 illustrates an embodiment of a tethered tissue fixation devices 1150, 1151, wherein connector 1144 is not used. In this embodiment, fixation devices 1150 is coupled to fixation device 1151 via an adjustable tether 1155. Like tether 1146 and 1147, tether 1155 may be a metal wire or a suture. As can be seen in this figure, the fixation device embodiment 1150 is grasped on to the papillary muscle PM and embodiment 1151 is grasped on to the edge of a leaflet, thereby mimicking the functions of the chordae.

(199) FIGS. 118A-118D show modular designs of the distal and proximal ends of actuation rod 138 in various unlocked (FIGS. 118A-118B) and locked (FIGS. 118C-118D) positions. This configuration allows easy removal and/or addition of actuation rod 138 within catheter 737 regarding surgical needs. Further, this modular design allows assembly and disassembly of the catheter system for easy and compact storage as cartridges.

(200) FIG. 119A shows an alternative embodiment of a catheter with a modular configuration, wherein distal shaft of delivery catheter 1020 comprises of male connector 1072 at the proximal end. Male connector 1072 may be inserted into female connector 1070 configured at the distal end of distal shaft of delivery catheter 1020 or proximal shaft of delivery catheter 1021 to assemble or disassemble the catheter system for easy use and storage as cartridges. Further, the connectors may be positioned anywhere along a catheter system such that alternative configurations of catheter shafts or catheter system may be produced, as shown in FIG. 119B-119C

(201) FIGS. 120A-120E show images of the prototype during bench testing of a retrieval system, wherein the fixation device comprises of retrieval sutures 1170, 1172 for the retrieval system to grasp and raise and/or lower the inner and outer arms.

(202) FIG. 120F shows the schematic of an alternative embodiment of the fixation system comprising of inner arms 12 and 14 and outer arms 191 and 193. Retrieval sutures 1170, 1172 are connected to the inner and outer arms for the retrieval system of FIGS. 120A-120E to grasp in order to raise and/or lower the arms.

(203) Anchoring of Release Rod:

(204) The referenced application PCT/US2017/042003 describes Release rod. One or more distal portions of Release rod may comprise one or more anchoring portions that reduces the risk of inadvertent release of release rod from a delivery system. Examples of anchoring portions include, but are not limited to: bends, curves, expanded regions, wider regions, deployable elements, etc.

(205) Guide and Delivery Catheter:

(206) The referenced PCT describes two-catheter system to perform transcatheter percutaneous deployment. In a preferred embodiment, all the curves achieved using three-catheter system (for example as described in U.S. Pat. No. 7,226,467B2) is configured to be achieved using two catheter system. That is, the individual curves of Guide and Sleeve as described in U.S. Pat. No. 7,226,467B2, will be incorporated into a single steerable guide using common catheter manufacturing techniques.

(207) The catheter is typically steered using pull wires or pull-push lumens while advancing or retracting. Hence, using common and typical electromechanical interface such as linear rollers, linear actuators, electro-pneumatic pistons, motors, a robotic interface can be created to duplicate human manipulations. Similarly, delivery catheter can be controlled. Current technology such as those used in robotic surgery is much more advanced and intricate than the movements and manipulations used in a percutaneous transcatheter based structural heart devices. Thus, remote or robotic control of catheter can be performed.

(208) Additionally, in a preferred embodiment, the catheter can be configured to incorporate pressure sensing and dye infusing features. This can be done via: a) main lumen of the catheter shaft, b) a port or grove and or tubular lumen along the ID, OD, or in the wall of the steerable guide (and or delivery) catheter shaft and c) using thin film or spot pressure sensors at various strategic locations of the catheter shaft.

(209) One or more guide catheters and delivery catheters disclosed herein may comprise one or more lumens that can act to accommodate one or more additional elements including, but not limited to: sensors (e.g. pressure sensors, flow sensors, optical sensors, ultrasound sensors, vibration sensors, doppler sensors, force sensors, etc.), one or more elements of Swan Ganz type catheters, OCT elements, gyroscopes, accelerometers, etc. In another embodiment, one or more sensors or elements disclosed herein may be inbuilt or embedded into one or more portions of the devices disclosed herein.

(210) Sensors and actuators that may be used in relation to this invention, to improve the safety, ease of use, and efficacy of the delivery system and fixation device. Sensors and actuators may be used to assist and evaluate device delivery (acute) and efficacy (acute or chronic). Sensors and actuators maybe active or passive, removable or implantable and may provide acute or chronic physiological or non-physiological data to assess or evaluate patient health. Sensors and actuators maybe active or passive, removable or implantable and provide acute or chronic physiological or non-physiological data to access or evaluate implant integrity and or function. Sensors may be used for visualization: thermal, optical, ultrasonic (including ICE), OCT, fluoroscopic Sensors and actuators maybe electrical, mechanical, magnetic, RF, chemical or combination. Sensors and actuators may be wired or wireless and may communicate with mobile or fixed external interface. The catheters of the present invention may be used as a conduit for external sensors, for example pressure sensor replacing Swan-Ganz catheter. The term sensor, electrode, transducer, IC, circuit, chip and actuator may be used interchangeably. Sensors and actuators listed are for examples only. Any suitable metal or polymer or ceramic, organic or inorganic, flexible or rigid, matrix or material and their combinations may be used to produce the desired sensors and actuators. Further, motors may be used to steer the catheters and deploy the device. For example, motors may be used instead of manual knobs or levers to pull or push on the actuation sutures or steerable catheter pullwires or other common mechanisms.

(211) All implant embodiments described in this invention may be optionally covered, wrapped, coated, or the like to improve biocompatibility and tissue interface. Suitable coverings can be fabric, web, fibrous, braid, woven or non-woven. The coatings can be metallic, ceramic, polymeric, or combinations thereof. Suitable metallic coatings include titanium, TiN, tantalum, gold, platinum, and alloys thereof. Suitable ceramic and inorganic coatings include titanium dioxide, hydroxyapatite, CaP, and the like. Suitable polymeric coatings include fluoropolymers, e.g. PTFE, PFA, FEP, ECTFE, ETFE; parylene, polyester, PET, polypropylene, polyurethane, PEEK, PVDF, HDPE, LDPE, UHMWPE, phosphorylcholine, THV, and the like. Suitable biodegradable include poly(lactic acid), poly(glycolic acid), polydioxanone, poly(ε-caprolactone), polyanhydride, poly(ortho ester), copoly(ether-ester), polyamide, polylactone, poly(propylene fumarate), and their combinations. Such metallic, ceramic and/or polymeric coatings are listed as examples only. Any suitable metal, ceramic, polymer, and combination thereof may be used to produce a desirable coating.

(212) In one particular exemplary embodiment of a medical method, a user assesses the regurgitation of valve leaflets through one or more medical imaging methods including, but not limited to fluoroscopy and ultrasound. Based on the assessment of coaptation depth, profile, disease and or size of the leaflets, one or more sizes of straight or curved or a combination shape device is implanted. The advantage of deploying a selected shape and size of implant is to improve efficacy, safety and minimize the number of device implants.

(213) Any of the implant arms disclosed herein may comprise one or more telescoping elements.

(214) For purposes of this description, certain aspects, advantages, and novel features of the embodiments of this disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with one another. The methods, apparatuses, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require that any one or more specific advantages be present, or problems be solved.

(215) Although the operations of some of the disclosed methods are described in a particular order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. As used herein, the terms “a”, “an” and “at least one” encompass one or more of the specified elements. That is, if two of a particular elements are present, one of these elements is also present and thus “an” element is present. The terms “a plurality of” and “plural” mean two or more of the specified elements.

(216) As used herein, the term “and/or” used between the last two of a list of elements means any one or more of the listed elements. For example, the phrase “A, B, and/or C” means “A,” “B,” “C,” “A and B,” “A and C,” “B and C” or “A, B and C.”

(217) As used herein, the term “coupled” generally means physically coupled or linked and does not exclude the presence of intermediate elements between the coupled items absent specific contrary language.

(218) The following is a listing of the reference numbers used in this application: 1 Exemplary embodiment of the fixation device 5 Base bracket 12 Flat-pattern of Inner arm, exemplary embodiment of a straight fixation device used to capture leaflet. 13 Flat pattern of Outer arm, exemplary embodiment of a straight fixation device used to capture leaflet. 14 Inner arm, exemplary embodiment of a fixation device used to capture leaflet. 15 Outer arm, exemplary embodiment of a fixation device used to capture leaflet. 18 Atraumatic barb-like frictional element of inner arm 20 Feature of inner arm 12 allowing the coupling to the base 5 21 Feature of inner arm 12 allowing the coupling to the base 5 24 Feature of inner arm 12 allowing sutures to loop through and manipulate the arms of the fixation device 25 Feature of inner arm 12 allowing sutures to loop through and manipulate the arms of the fixation device 26 Slot feature of inner arm 12 under barb 18 32 Feature of outer arm 14 allowing the coupling to the base 5 34 Feature of outer arm 14 allowing the coupling to the base 5 37 Slot feature of outer arm 14 38 Feature of outer arm 14 allowing sutures to loop through and manipulate the arms of the fixation device 39 Feature of outer arm 14 allowing sutures to loop through and manipulate the arms of the fixation device 40 Feature of outer arm 14 allowing sutures to loop through and manipulate the arms of the fixation device 46 Feature of outer arm 14 allowing sutures to loop through and manipulate the arms of the fixation device 50 Left bracket of base bracket 5 52 Right bracket of base bracket 5 56 Coupling feature of base bracket 5 60 Feature of bracket 50 allowing passage of screw 61 Feature of bracket 52 allowing passage of screw 62 Feature of bracket 50 allowing passage of screw 63 Feature of bracket 52 allowing passage of screw 65 Hole to pass release rod. 70 Release bar, the distal most component of the delivery catheter that interfaces with the fixation device. 72 Release bar, the distal most component of the delivery catheter that interfaces with the fixation device. 80 Feature of release bars 70, 72 allowing sutures to loop through and manipulate the arms of the fixation device. 81 Feature of release bars 70, 72 allowing for passage of sutures 82 Feature of release bars 70, 72 allowing for passage of sutures 83 Feature of release bars 70, 72 allowing for passage of sutures 84 Feature of release bars 70, 72 allowing for passage of sutures 85 Feature of release bars 70, 72 allowing for passage of sutures 86 Feature of release bars 70, 72 allowing for passage of sutures 87 Feature of release bars 70, 72 allowing for passage of sutures 88 Feature of release bars 70, 72 allowing for passage of sutures 95 Hinge component coupled to inverters 101 and 102 101 Right inverter 102 Left inverter 110 Feature of inverter 117 anchoring the inverter to release bars 70, 72 111 Feature of inverter 101 allowing suture to loop through and allow manipulation of the arms 112 Feature of inverter 102 allowing suture to loop through and allow manipulation of the arms 116 Embodiment of left inverter with stopper 142 117 Embodiment of right inverter with stopper 142 120 Manipulation of inner arms 121 Manipulation of inner arms 125 Segment of suture 131 126 Segment of suture 130 127 Segment of suture 131 128 Segment of suture 130 130 Suture allowing control of inner arm 12 or 14 131 Suture allowing control of inner arm 12 or 14 136 Manipulation of suture 130; straightens inner arm 12 138 Actuation rod with distal suture loop 139 Structural actuation tube with distal suture loop and proximal suture ends 142 Stop feature of inverters 116 and 117 to prevent the inverters from flipping to wrong side 150 Feature of release bars 70, 72 allowing passage of sutures, wires, plastic tube and/or metal tube 152 Feature of release bars 70, 72 allowing passage of release rod 160 160 Release rod that anchors fixation device to release bars 70, 72 174 Segment of suture 180 175 Segment of suture 181 176 Segment of suture 180 177 Segment of suture 181 178 Segment of suture 180 179 Segment of suture 181 180 Suture allowing control of outer arm 13 or 15 181 Suture allowing control of outer arm 13 or 15 191 Outer arm, exemplary embodiment of a fixation device used to capture leaflet 193 Outer arm, exemplary embodiment of a fixation device used to capture leaflet 192 Inner arm, exemplary embodiment of a fixation device used to capture leaflet 194 Inner arm, exemplary embodiment of a fixation device used to capture leaflet 195 Outer arm, exemplary embodiment of a fixation device used to capture leaflet 197 Outer arm, exemplary embodiment of a fixation device used to capture leaflet 204 Tissue grasping arm 210 Claw feature of tissue grasping arm 204 212 Barb feature of tissue grasping arm 204 222 Length of base of fixation device embodiment 224 Width of base of fixation device embodiment 225 Functional length of tissue grasping arm 204 227 Functional width of tissue grasping device 250 Band-like feature of inner arm 192 affixing wire loops together 252 Small wire loops within an arm made of wires, to pass actuating sutures through. 280 Suture loop allowing the passage of sutures to control the outer arms 281 Suture loop allowing the passage of sutures to control the outer arms 282 Suture loop allowing the passage of sutures to control the outer arms 283 Suture loop allowing the passage of sutures to control the inner arms 330 Actuation-rod of a handle, allowing manipulation of the outer arm 331 Actuation-rod of a handle, allowing manipulation of the inner arm 332 Actuation-rod of a handle, allowing manipulation of the inner arm 333 Actuation-rod of a handle, allowing manipulation of the outer arm 350 Exemplary embodiment of a custom handle for outer and inner arms manipulation 360 Short delivery shaft 372 Release knob of handle 350 allowing control of release rod 160 382 Opening of handle 350 for delivery shaft 400 Feature of handle for tightening screws to control 350 422 Set screw feature of handle 350 for fastening deliver shaft 462 Feature of handle 350 to manipulate arms 463 Feature of handle 350 to manipulate arms 464 Feature of handle 350 to manipulate arms 465 Feature of handle 350 to manipulate arms 466 Feature of handle 350 to flush line or sensor line or to manipulate arms 467 Feature of handle 350 to flush line or sensor line or to manipulate arms 468 Feature of handle 350 allowing coupling of release knob 372 500 Proximal threaded feature of handle 350 allowing control and manipulation of release knob 372 502 Distal threaded feature of handle 350 allowing control and manipulation of release knob 372 600 Bailout suture segment of curved fixation device 602 Bailout suture segment of curved fixation device 609 Bailout suture segment of curved fixation device 622 Suture loop allowing passage of suture 600 650 Embodiment of a curved fixation device 675 Manipulation of release rod 160 677 Manipulation of suture 602 681 Manipulation of release bar 72 700 Single lumen braided shaft 705 Multilumen braided shaft 725 Braid 727 Inner lumen of braided shaft 730 Peripheral lumen for guidewire, release rod and/or sutures 732 Single lumen shaft 734 Floating lumen to pass through guidewires, sutures, plastic tubes and/or metal tubes 736 Lumen of multi-lumen catheter allowing the passage of wires, sutures, plastic tubes and/or metal tubes 737 Lumen of multi-lumen catheter allowing the passage of wires, sutures, plastic tubes and/or metal tubes 739 Lumen of multi-lumen catheter allowing the passage of wires, sutures, plastic tubes and/or metal tubes 740 PEEK tubing/torque cable 800 Feature of catheter handle 850 Distal tip of guide catheter 900 Radiopaque marker(s) of steerable guide catheter 901 Intermediate steerable guide shaft section allowing stiffness transition for two-way and/or 4-way steering 905 Proximal shaft of steerable guide catheter 940 Stainless steel sheath to support delivery catheter 950 Stainless steel sheath to support steerable guide handle 975 Exemplary embodiment of a custom steerable guide catheter handle 977 Exemplary embodiment of a custom delivery catheter handle 980 Manipulation of the guide catheter 981 Manipulation of the guide catheter 982 Manipulation of the guide catheter 985 Manipulation of the delivery catheter 986 Manipulation of the delivery catheter 987 Manipulation of the delivery catheter 988 Manipulation of the delivery catheter 1000 Shaft of guide catheter 1010 Distal steerable guide shaft section allowing stiffness transition for two-way and/or 4-way steering 1020 Distal shaft of the delivery catheter that is potentially unsupported as it extends out of the guide catheter 1021 Proximal shaft of delivery catheter 1040 Exemplary embodiment of fixation device 1050 Balloon-like feature of feature 1060 stabilizing delivery catheter 1020 during procedure 1052 Third steerable guide catheter 1055 Bailout guide catheter 1057 Push-pull feature of bailout guide catheter 1055 1060 Feature that may be attached to guide catheter 1000 or delivery catheter 1020 1082 Suture loop 1100 Umbrella-like feature of feature 1060 1110 Umbrella-like feature of feature 1060 1115 Bumper-like feature of feature 1060 1120 Bell shaped nested flats 1130 Suture allowing manipulation of feature 1120 1131 Suture allowing manipulation of feature 1120 1140 Tissue grasping device 1141 Tissue grasping device 1144 Connector base 1146 Tether connecting tissue grasping arm 1040 to base 1044 1147 Tether connecting tissue grasping arm 1041 to base 1044 1150 Tissue grasping device with a tether 1151 Tissue grasping device with a tether 1155 Tether connecting tissue grasping arm 1150 to tissue grasping arm 1151 2000 Location of tissue grasping device at atrial wall 2002 Location of tissue grasping device at mitral annulus 2004 Location of tissue grasping device at leaflet edge of mitral valve 2006 Location of tissue grasping device at the cusp of the mitral valve leaflet LF Leaflet of mitral valve PM Papillary muscle of the left ventricle

(219) Although many embodiments of the disclosure have been described in detail, certain variations and modifications will be apparent to those skilled in the art, including embodiments that do not provide all the features and benefits described herein. It will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed embodiments to other alternative or additional embodiments and/or uses and obvious modifications and equivalents thereof. In addition, while a number of variations have been shown and described in varying detail, other modifications, which are within the scope of the present disclosure, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the present disclosure. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the present disclosure. Thus, it is intended that the scope of the present disclosure herein disclosed should not be limited by the particular disclosed embodiments described above. For all of the embodiments described above, the steps of any methods need not be performed sequentially.