Independent proximal element actuation method

Abstract

A fixation system for securing leaflets of a heart valve includes an implantable fixation device having a first arm and a second arm, a first proximal element movable between a first position and a second position relative to the first arm, and a second proximal element movable between a first position and a second position relative to the second arm. The fixation system includes a delivery device having a catheter, first and second proximal element wires, and a handle having first and second proximal element wire handles coupled to the first and second proximal element wires, respectively. The handle may include an interlock movable between an unlocked position and a locked position.

Description

Background Art

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 62 / 874,327, filed on July 15, 2019, and U.S. Provisional Application No. 62 / 930,948, filed on November 5, 2019, the entire disclosure of each of which is incorporated herein by reference. 1. Technical Field

[0004] The presently disclosed subject matter generally relates to medical methods, devices, and systems. Specifically, the presently disclosed subject matter relates to methods, devices, and systems for performing endovascular, percutaneous, or minimally invasive surgical treatments of body tissue, such as tissue approximation or valve repair. More specifically, the presently disclosed subject matter relates to the repair of heart valves and venous valves.

[0005] Surgical repair of body tissues typically involves approximating the tissues and securing them in an approximated arrangement. When repairing a valve, tissue approximation involves coapting the valve leaflets in a therapeutic arrangement, which can then be maintained by securing or fixing the leaflets. This coaptation can be used to treat regurgitation, which most commonly occurs in the mitral valve.

[0006] Mitral regurgitation is characterized by backward flow from the heart's left ventricle through a dysfunctional mitral valve into the left atrium. During the heart's normal cycle of contraction (systole), the mitral valve acts as a check valve to prevent oxygenated blood from flowing back into the left atrium. In this way, oxygenated blood is pumped through the aortic valve into the aorta. Valvular regurgitation can significantly reduce the heart's pumping efficiency, putting the patient at risk for severe, persistent heart failure.

[0007] Mitral regurgitation can be caused by a variety of different mechanical defects in the mitral valve or left ventricular wall. The valve leaflets, the chordae tendineae connecting the leaflets to the papillary muscles, the papillary muscles, or the left ventricular wall may be damaged or otherwise dysfunctional. Often, the annulus may be damaged, dilated, or weakened, limiting the mitral valve's ability to close adequately against the high pressures in the left ventricle.

[0008] The most common treatment for mitral regurgitation relies on valve replacement or repair involving leaflet and annular reshaping, commonly referred to as annuloplasty. A more recent mitral valve repair technique relies on suturing together adjacent segments of opposing valve leaflets, known as the "bowtie" or "edge-to-edge" technique. While all of these techniques can be highly effective, they typically rely on open-heart surgery, during which the patient's chest is opened, typically via a sternotomy, and cardiopulmonary bypass is placed. The need to open the chest and place the patient on bypass is invasive and associated with high mortality and morbidity rates. Recently, minimally invasive catheter-based procedures have been developed to deliver implantable clips to incompetent valves. These clips are used to secure portions of the valve leaflets together, thereby reducing regurgitation. Although clips appear promising, their delivery and deployment can be challenging. In some cases, visualizing the clips and valve leaflets using techniques such as fluoroscopy and echocardiography can be challenging. Therefore, improved attachment mechanisms and attachment assessment methods are desired.

[0009] For these reasons, it would be desirable to provide improved methods, devices, and systems for performing mitral and other heart valve repairs. Such methods, devices, and systems should preferably not require open chest access and be capable of being performed intravascularly, i.e., using a device advanced to the heart from a point in the patient's vasculature distal to the heart, or by minimally invasive methods. In addition, such devices and systems should provide features that allow for easier delivery of the fixation device, as well as repositioning and optionally removal of the fixation device prior to fixation to ensure optimal placement. More preferably, these methods, devices, and systems are useful for repairing tissues other than heart valves within the body. At least some of these objectives will be achieved by the subject matter of the present disclosure as described hereinafter. 2. Background Art

[0011] Minimally invasive and percutaneous techniques for approximating and modifying mitral valve leaflets to treat mitral regurgitation are described in PCT Publication Nos. WO 98 / 35638, WO 99 / 00059, WO 99 / 01377, and WO 00 / 03759.

[0012] Maisano et al. (1998) in Eur. J. Cardiothorac. Surg. 13:240-246, Fucci et al. (1995) in Eur. J. Cardiothorac. Surg. 9:621-627, and Umana et al. (1998) in Ann. Thorac. Surg. 66:1640-1646 describe open surgical procedures for performing "edge-to-edge" or "bow-tie" mitral valve repair, in which the edges of opposing valve leaflets are sutured together to reduce regurgitation. Dec and Fuster (1994) in N. Engl. J. Med. 331:1564-1575 and Alvarez et al. (1996) in J. Thorac. Cardiovasc. Surg. 112:238-247 are review articles discussing the nature and treatment of dilated cardiomyopathy.

[0013] Mitral annuloplasty is described in the following publications: Bach and Bolling (1996), Am. J. Cardiol. 78:966-969; Kameda et al. (1996), Ann. Thorac. Surg. 61:1829-1832; Bach and Bolling (1995), Am. Heart J. 129:1165-1170; and Bolling et al. (1995), 109:676-683. Ricchi et al. (1997), Ann. Thorac. Surg. 63:1805-1806, describe a linear segmental annuloplasty for mitral valve repair. Tricuspid annuloplasty is described by McCarthy and Cosgrove (1997) in Ann. Thorac. Surg. 64:267-268, by Tager et al. (1998) in Am. J. Cardiol. 81:1013-1016, and by Abe et al. (1989) in Ann. Thorac. Surg. 48:670-676.

[0014] Percutaneous endovascular cardiac repair procedures are described by Park et al. (1978) in Circulation 58:600-608, Uchida et al. (1991) in Am. Heart J. 121:1221-1224, and Ali Khan et al. (1991) in Cathet. Cardiovasc. Diagn. 23:257-262.

[0015] Endovascular heart valve replacement is described in U.S. Patent Nos. 5,840,081, 5,411,552, 5,554,185, 5,332,402, 4,994,077, and 4,056,854. See also U.S. Patent No. 3,671,979, which describes a catheter for temporary placement of an artificial heart valve.

[0016] Other percutaneous and endovascular cardiac repair procedures are described in U.S. Patent Nos. 4,917,089, 4,484,579, and 3,874,338, and PCT Publication No. WO 91 / 01689.

[0017] Thoracoscopic and other minimally invasive heart valve repair and replacement procedures are described in U.S. Patent Nos. 5,855,614, 5,829,447, 5,823,956, 5,797,960, 5,769,812, and 5,718,725. Summary of the Invention

[0018] According to the disclosed subject matter, a system for securing leaflets of a heart valve is provided. The system includes an implantable fixation device having a first arm and a second arm, a first proximal element movable between a first position and a second position relative to the first arm, and a second proximal element movable between the first position and the second position relative to the second arm. The system also includes a delivery device comprising: a catheter having a proximal end portion and a distal end portion, the catheter defining at least one lumen extending therebetween; a first proximal element wire extending through the at least one lumen, wherein the first proximal element wire is releasably coupled to the first proximal element and is actuatable to move the first proximal element between the first position and the second position; and a second proximal element wire extending through the at least one lumen, wherein the second proximal element wire is releasably coupled to the second proximal element and is actuatable to move the second proximal element between the first position and the second position. The delivery device may further include a handle having a first proximal element wire handle coupled to the first proximal element wire and actuatable to deploy the first proximal element wire to move the first proximal element between a first position and a second position, and a second proximal element wire handle coupled to the second proximal element wire and actuatable to deploy the second proximal element wire to move the second proximal element between the first position and the second position. The handle may include an interlock movable between an unlocked position in which the first and second proximal element wire handles are independently actuatable and a locked position in which the first and second proximal element wire handles are coupled together so as to be actuatable together.

[0019] As embodied herein, the first proximal element line handle and the second proximal element line handle can be aligned in parallel. The first proximal element line handle and the second proximal element line handle can be aligned coaxially. The first proximal element line handle and the second proximal element line handle can each include a rotatable switch.

[0020] The handle may include a first stop to limit the distance each of the first proximal element line handle and the second proximal element line handle can move in the first direction. The handle may include a second stop to limit the distance each of the first proximal element line handle and the second proximal element line handle can move in the second direction.

[0021] The interlock may include a sliding locking mechanism. Additionally or alternatively, the interlock may include a rotational locking mechanism. The interlock may include a latch movably coupled to the first proximal element wire handle and a recess disposed in the second proximal element wire handle. The latch and recess may include complementary dovetail shapes. The dovetail shape may be asymmetrical. The latch may include a catch that is receivable in a first stop in the first proximal element wire handle to hold the latch in an unlocked position, and the latch that is receivable in a second stop in the first proximal element wire handle to hold the latch in a locked position. The catch may be disposed on a cantilever. Additionally or alternatively, the interlock may include a removable clasp.

[0022] Furthermore, the system of the disclosed subject matter may include various features to enhance performance. For example, at least one of the first proximal element wire handle and the second proximal element wire handle may include a tactile indicator. The first arm and the first proximal element may be disposed on a first side of the implantable fixation device, and the second arm and the second proximal element may be disposed on a second side of the implantable fixation device, and the first side may have an echogenicity different from that of the second side. At least one of the first side and the second side may have an echogenic marker. At least one of the first side and the second side may include an echogenic coating on at least a portion thereof. The echogenicity of at least one of the first side and the second side may be altered by an electrical current. At least one of the first proximal element wire and the second proximal element wire may include an echogenic coating on at least a portion thereof. The first side may have a fluoroscopic appearance different from that of the second side. At least one of the first side and the second side may have a fluoroscopic marker.

[0023] Additionally or alternatively, the catheter may define a flow conduit extending between a proximal end portion and a distal end portion of the catheter, wherein the distal end portion of the flow conduit is positioned adjacent to a first side of the implantable fixation device. The first proximal element wire handle may include a flow port configured to allow fluid to flow through the flow conduit and flush toward the first side of the implantable fixation device. The catheter may define a second flow conduit extending between the proximal end portion and the distal end portion of the catheter. The distal end portion of the second flow conduit may be positioned adjacent to a second side of the implantable fixation device, and the second proximal element wire handle may include a second flow port configured to allow fluid to flow through the second flow conduit and flush toward the second side of the implantable fixation device.

[0024] The disclosed system can include a first proximal element wire and a second proximal element wire coupled to the system in various ways to enhance performance. For example, the first proximal element wire can include a first end portion, a second end portion, and a midsection between the first and second end portions. The first proximal element wire can be coupled to the first proximal element at its midsection. The second proximal element wire can include a first end portion, a second end portion, and a midsection between the first and second end portions. The second proximal element wire can be coupled to the second proximal element at its midsection. The first end portion of the first proximal element wire can be secured to the first proximal element wire handle, and the first end portion of the second proximal element wire can be secured to the second proximal element wire handle. The first proximal element wire can be secured to the first proximal element wire handle by a first clamp, and the second proximal element wire can be secured to the second proximal element wire handle by a second clamp. The first proximal element wire can be secured to the first proximal element wire handle by a first clamp and a first set screw, and the second proximal element wire can be secured to the second proximal element wire handle by a second clamp and a second set screw. The first proximal element wire may be secured to the first proximal element wire handle by a first ratchet spool, and the second proximal element wire may be secured to the second proximal element wire handle by a second ratchet spool. The first ratchet spool may further include a first cone for guiding the first proximal element wire, and the second ratchet spool may further include a second cone for guiding the second proximal element wire. The second end portion of the first proximal element wire may be secured to the first proximal element wire handle, and the second end portion of the second proximal element wire may be secured to the second proximal element wire handle.

[0025] Various catheter configurations can be provided in accordance with the disclosed subject matter. For example, the at least one lumen can include at least a first proximal element wire lumen and a second proximal element wire lumen. The at least one lumen can include at least a third proximal element wire lumen and a fourth proximal element wire lumen. The delivery device can also include a shaft extending through the at least one lumen, the shaft releasably coupled to a coupling member of an implantable fixation device. The second end portion of the first proximal element wire can be secured to one of the shaft and the coupling member, and the second end portion of the second proximal element wire can be secured to one of the shaft and the coupling member.

[0026] The first proximal element line may be one of a suture, a wire, a nitinol wire, a rod, a cable, and a polymer wire; and the second proximal element line may be one of a suture, a wire, a nitinol wire, a rod, a cable, and a polymer wire.

[0027]

[0011] Other aspects of the nature and advantages of the disclosed subject matter are set forth in the detailed description that follows, taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 The left ventricle and left atrium of the heart are shown during systole.

[0029] Figure 2A The free edges of the leaflets are shown in normal apposition, and Figure 2B The free edge is shown during regurgitant apposition.

[0030] Figures 3A to 3C Grasping a leaflet with a fixation device, inverting the distal element of the fixation device, and removing the fixation device are illustrated, respectively.

[0031] Figure 4 The fixation device is shown positioned in a desired orientation relative to the leaflets.

[0032] Figures 5A to 5B as well as Figures 6A to 6B An exemplary embodiment of the coupling mechanism of the present application is illustrated.

[0033] Figure 7 An embodiment of the fixing device of the disclosed subject matter is illustrated.

[0034] Figures 8A to 8B 、 Figures 9A to 9B 、 FIG. 10A to FIG. 10B 、 Figures 11A to 11B as well as Figures 12 to 14 Pictured Figure 7 The fixation device of FIG. 1 is in various possible positions during the introduction and placement of the device in the body to perform a therapeutic procedure.

[0035] Figures 15A to 15H Pictured Figure 7 A fixing device having a clamp pusher.

[0036] Figures 15I to 15V Pictured Figure 7 A fixation device having independently actuatable proximal elements.

[0037] Figures 15W1 to 15AB7 The diagram shows the near-end component wires connected to Figure 7 Various embodiments of the proximal element of the fixation device.

[0038] Figures 15AC1 to 15AC4 Pictured Figures 15I to 15V Various control mechanisms for independently actuatable proximal elements of the fixation device.

[0039] 16A to 16C The illustrations show a covering on a fixture with the fixture in various positions.

[0040] Figure 17An embodiment of a fixation device comprising a proximal element and a locking mechanism is illustrated.

[0041] Figure 18 Provided Figure 17 Cross-sectional view of the locking mechanism.

[0042] Figures 19 to 20 Cross-sectional views of the locking mechanism are provided in the unlocked and locked positions, respectively.

[0043] Figure 21 and FIG. 22A to FIG. 22B Another embodiment of a locking mechanism is shown.

[0044] Figure 23 and FIG. 24A to FIG. 24B Yet another embodiment of a locking mechanism is shown.

[0045] Figure 25 is a perspective view of an embodiment of a delivery catheter for a fixation device.

[0046] Figure 26 An embodiment of a fixation device coupled to the distal end of a delivery catheter is illustrated.

[0047] Figure 27 A portion of the shaft of a delivery catheter and a fixation device that can be coupled to the catheter are shown.

[0048] FIG. 28A to FIG. 28B An exemplary embodiment of an actuator rod assembly is illustrated.

[0049] Figures 29A to 28B 、 FIG. 30A to FIG. 30B 、 Figures 31A to 31B as well as FIG. 32A to FIG. 32B The diagram shows FIG. 28A to FIG. 28B Layers of an exemplary cable used in an actuator rod.

[0050] Figures 33A to 33B 、 Figures 34A to 34B 、 Figures 35A to 35B 、 Figures 36A to 36B as well as Figures 37A to 37B The diagram shows FIG. 28A to FIG. 28B Another exemplary cable layer for use in an actuator rod.

[0051] Figures 38A to 38B 、 Figure 39 and Figure 40 is a cross-sectional view of an embodiment of a shaft of a delivery catheter.

[0052] FIG. 40A to FIG. 40B An embodiment of the nose of the shaft of the delivery catheter is illustrated.

[0053] Figures 41A to 41C Various arrangements of locking wires engaging the release harness of the locking mechanism are illustrated.

[0054] Figures 42A to 42B Various arrangements of proximal element lines engaging the proximal elements of the fixation device are illustrated.

[0055] Figure 43 An embodiment of a handle of a delivery catheter is illustrated.

[0056] Figure 44 is a cross-sectional view of the main body of the handle.

[0057] Figure 45 An embodiment of a locking wire handle is illustrated.

[0058] Figure 45A Pictured Figure 45 A locking wire handle is positioned within a half-tube disposed within a sealed chamber.

[0059] Figures 46A to 46B The mechanism for applying tension to the locking wire is illustrated.

[0060] Figure 47 and Figures 47A to 47B Features of the actuator stem control and handle are illustrated.

[0061] Figure 48 A perspective view of an embodiment of the multi-catheter guiding system and an interventional catheter positioned therethrough that is the subject of the present disclosure.

[0062] Figure 49A The main curve in the outer guide catheter is shown.

[0063] Figure 49B Illustration of the secondary curve in the inner guide catheter.

[0064] Figures 49C to 49D Example movement of the inner guide catheter through an angle θ is illustrated.

[0065] Figure 50A is a perspective side view of a multi-catheter guiding system with an additional curve in the outer guiding catheter.

[0066] Figure 50B The diagram shows the external guide catheter due to Figure 49A The improvement caused by the additional curve.

[0067] Figures 51A to 51D Illustration of an approach to accessing the mitral valve using a multi-catheter introduction system.

[0068] Figures 52A to 52D The curvature of a guide catheter of the presently disclosed subject matter is illustrated by actuation of one or more pull wires.

[0069] Figure 52E The diagram shows the attachment of the pull wire to the tip ring.

[0070] Figures 53A to 53I Embodiments of the disclosed subject matter are illustrated that include segments comprised of braided inclusions or coils.

[0071] Figures 54A to 54C The keying features of the disclosed subject matter are illustrated.

[0072] Figures 55A to 55B is a perspective view of a guide catheter comprising a series of articulated members.

[0073] Figure 56 Various embodiments of the handle are illustrated.

[0074] Figure 57 Pictured Figure 56 A handle wherein a portion of the housing is removed.

[0075] Figure 58 Illustration of the steering mechanism within the handle.

[0076] Figure 59 The attachment of the pull wire to the disc is shown.

[0077] Figures 60A to 60B A hard stop pin is shown limiting the rotation of the disc.

[0078] Figures 61A to 61C A portion of a hard stop gear assembly is shown.

[0079] Figures 62A to 62F A ball is shown that limits the rotation of the disk.

[0080] Figure 63 An embodiment of a friction assembly is illustrated.

[0081] Figure 64 An embodiment of an interventional system of the presently disclosed subject matter is illustrated.

[0082] Figure 64A An embodiment of a hemostatic valve for use with the presently disclosed subject matter is illustrated.

[0083] Figure 64B An embodiment of a fixation device introducer is illustrated.

[0084] Figure 65 Another embodiment of the interventional system of the presently disclosed subject matter is illustrated.

[0085] Figures 66 to 68 An embodiment of a stabilizer base for use with the presently disclosed subject matter is illustrated.

[0086] Figure 69 A kit constructed according to the principles of the disclosed subject matter is illustrated.

[0087] Figure 70 A handle according to an exemplary embodiment is illustrated.

[0088] Figures 71A to 71C 、 Figure 72 、 Figure 73 as well as Figures 74A to 74B Illustrated are perspective views of various proximal element wire handle embodiments in parallel alignment according to the disclosed subject matter.

[0089] Figures 75A to 75B 、 Figures 76A to 76B Illustrated are perspective views of various proximal element wire handle embodiments aligned in parallel and having interlocking embodiments in accordance with the disclosed subject matter.

[0090] Figures 76C to 76F Illustrated are side and perspective views of a proximal element wire handle embodiment in parallel alignment and having an interlock including a latch having a dovetail shape in accordance with the disclosed subject matter.

[0091] Figures 76G to 76H Pictured Figure 76C A top sectional view of an embodiment of the present invention.

[0092] Figures 77A to 77B Illustrated is a perspective view of a proximal element wire handle embodiment in parallel alignment and with an interlock embodiment in accordance with the disclosed subject matter.

[0093] Figures 78A to 78C and Figure 79 Illustrated are perspective views of various proximal element wire handle embodiments in accordance with the disclosed subject matter.

[0094] Figure 80 and Figure 81 Illustrated are perspective views of various proximal element wire handle embodiments coaxially aligned and having various interlock embodiments in accordance with the disclosed subject matter.

[0095] Figures 82A to 82B as well as Figures 83A to 83B Illustrated are perspective views of various proximal element wire handle embodiments configured as rotatable switches in accordance with the disclosed subject matter.

[0096] Figures 84 to 85 is a radiographic image of an implantable fixation device including a radiopaque marker in accordance with the disclosed subject matter.

[0097] Figures 86 to 87 Illustrated is a schematic diagram of a catheter having flow conduits in accordance with the disclosed subject matter.

[0098] Figures 88A to 88B Various cross-sectional views of a clamp for securing a proximal element wire to a proximal element wire handle in accordance with the disclosed subject matter are illustrated.

[0099] Figure 89 Illustrated is a cross-sectional view of a collet for securing a proximal element wire to a proximal element handle in accordance with the disclosed subject matter.

[0100] Figure 90 Illustrated is a cross-sectional view of a ratchet for securing a proximal element wire to a proximal element wire handle in accordance with the disclosed subject matter. DETAILED DESCRIPTION

[0101] 3. 1. Cardiac physiology

[0102] Figure 1 FIG shows the left ventricle LV of a normal heart H during systole. The left ventricle LV contracts and blood flows outward in the direction of the arrow through the tricuspid valve (aortic valve) AV. Backflow or "regurgitation" of blood through the mitral valve MV is prevented because the mitral valve is constructed as a "check valve" that prevents backflow when the pressure in the left ventricle is higher than the pressure in the left atrium LA. Figure 1 As illustrated in Figure 1 , the mitral valve MV comprises a pair of leaflets having free edges FE that meet evenly to close. The opposite ends of the leaflets LF are attached to the surrounding heart structures along an annular region called the annulus AN. The free edges FE of the leaflets LF are fixed to the lower part of the left ventricle LV by chordae tendineae CT (hereinafter referred to as chordae tendineae), which comprise a plurality of branching tendons fixed to the lower surface of each of the valve leaflets LF. The chordae tendineae CT are in turn attached to the papillary muscles PM and the interventricular septum IVS that extend upward from the lower part of the left ventricle.

[0103] Many structural defects in the heart can cause mitral regurgitation. Regurgitation occurs when the valve leaflets do not close properly, allowing leakage from the ventricles to the atria. Figure 2A As shown in , the free edges of the anterior and posterior leaflets usually meet along the line of apposition C. Examples of defects that cause regurgitation are shown in Figure 2B . Here the enlargement of the heart causes the mitral annulus to become larger so that the free edges FE do not meet during systole. This results in a gap G that allows blood to leak through the valve during ventricular contraction. A ruptured or stretched tendon can also cause a valve leaflet to prolapse because insufficient tension is transmitted to the leaflet via the tendon. The two valve leaflets do not meet properly while the other leaflet maintains its normal contour, and leakage from the left ventricle into the left atrium will occur. This regurgitation can also occur in patients with ischemic heart disease, where the left ventricle does not contract sufficiently to achieve proper closure.

[0104] 4. 2. General Overview

[0105] The presently disclosed subject matter provides methods and devices for grasping, approximating, and securing tissue, such as valve leaflets, to treat heart valve regurgitation, particularly mitral regurgitation. The presently disclosed subject matter also provides features that allow the device to be repositioned and removed when desired, particularly in areas where removal may be hindered by anatomical features, such as chordae tendineae. Such removal will allow the surgeon to reapproach the valve in a new manner, if necessary.

[0106] The gripping will preferably be non-invasive, thus providing a number of benefits. Non-invasive means that the devices and methods of the disclosed subject matter can be applied to the valve leaflets and then removed without causing any clinically apparent damage to the leaflet structure or function. The leaflets and valve continue to function essentially the same as before the application of the disclosed subject matter. Therefore, some minor penetration or indentation of the leaflets may occur using the disclosed subject matter while still meeting the definition of "non-invasive". This enables the devices of the disclosed subject matter to be applied to diseased valves and, if necessary, removed or repositioned without negatively impacting valve function. In addition, it should be understood that in some cases, it may be necessary or desirable to puncture or otherwise permanently affect the leaflets during gripping, fixation, or both gripping and fixation. In some of these cases, gripping and fixation can be accomplished by a single device. Although many embodiments are provided to achieve these results, a general overview of the basic features will be presented herein. These features are not intended to limit the scope of the disclosed subject matter, and the purpose of presenting these features is to provide a basis for the description of the various embodiments presented later in this application.

[0107] The apparatus and methods of the disclosed subject matter rely on the use of an interventional tool that is positioned proximate the desired treatment site and used to grasp the target tissue. In intravascular applications, the interventional tool is typically an interventional catheter. In surgical applications, the interventional tool is typically an interventional instrument. In a preferred embodiment, fixation of the grasped tissue is achieved by maintaining the grasp using a portion of the interventional tool that remains as an implant. Although the disclosed subject matter may have various applications for tissue approximation and fixation throughout the body, the disclosed subject matter is particularly suitable for repair of valves, and particularly heart valves such as the mitral valve. Reference Figure 3A , illustrates an interventional tool 10 having a delivery device, such as a shaft 12, and a fixation device 14, which has approached the mitral valve MV from the atrial side and grasped the leaflets LF. As described above, the mitral valve can be accessed surgically or by using endovascular techniques, either by a transventricular retrograde approach or a transatrial antegrade approach. For illustrative purposes, an antegrade approach is described.

[0108] The fixation device 14 is releasably attached to the shaft 12 of the interventional tool 10 at the distal end of the shaft 12. When describing the devices of the subject matter disclosed herein, "proximal" means the direction toward the end of the device to be manipulated by a user outside the patient's body, and "distal" means the direction toward the working end of the device positioned at the treatment site and away from the user. With respect to the mitral valve, proximal refers to the atrial or upstream side of the valve leaflets, and distal refers to the ventricular or downstream side of the valve leaflets.

[0109] The fixation device 14 generally includes a proximal element 16 (or clamping element; wherein "proximal element" and "clamping element" are used interchangeably herein) and a distal element 18 (or fixation element; wherein "distal element" and "fixation element" are used interchangeably herein) that project radially outward and are positionable on opposite sides of the leaflet LF as shown so as to capture or retain the leaflet therebetween. The proximal element 16 preferably comprises cobalt chromium, nitinol, or stainless steel, and the distal element 18 preferably comprises cobalt chromium or stainless steel, although any suitable material may be used. The fixation device 14 is capable of being coupled to the shaft 12 by a coupling mechanism 17. The coupling mechanism 17 allows the fixation device 14 to be detached and left as an implant to hold the leaflets together in an apposed position.

[0110] In some cases, it may be necessary to reposition or remove the fixation device 14 after the proximal element 16, the distal element 18, or both have been deployed to capture the leaflet LF. Such repositioning or removal may be necessary for a variety of reasons, such as to reapproximate the valve in an attempt to achieve better valve function, to more optimally position the device 14 on the leaflet, to obtain a better grip on the leaflet, to detangle the device 14 from surrounding tissue such as tendons, to replace the device 14 with a device having a different design, or to abort the fixation process, to name a few. To facilitate repositioning or removal of the fixation device 14, the distal element 18 is releasable and optionally capable of being flipped into a configuration suitable for withdrawing the device 14 from the valve without tangling or interfering with or damaging tendons, leaflets, or other tissue. Figure 3B The inverted position is shown, wherein the distal element 18 can be moved in the direction of arrow 40 to the inverted position. Likewise, the proximal element 16 can be raised if desired. In the inverted position, the device 14 can be repositioned to a desired orientation, wherein the distal element can then be restored to its original position. Figure 3A Alternatively, the fixing device 14 may be positioned as shown in FIG. Figure 3C4. The device 14 is shown withdrawn from the leaflets (indicated by arrow 42). This inversion reduces damage to the leaflets and minimizes any entanglement of the device with surrounding tissue. Once the device 14 has been withdrawn through the valve leaflets, the proximal and distal elements can be moved to a closed position or configuration suitable for removal from the body or reinsertion through the mitral valve.

[0111] Figure 4 The diagram shows the position of the fixation device 14 in a desired orientation relative to the leaflets LF. This is a short-axis view of the mitral valve MV from the atrial side, and therefore, the proximal element 16 is shown in solid lines and the distal element 18 is shown in dashed lines. The proximal element 16 and the distal element 18 are positioned approximately perpendicular to the line of apposition C. The device 14 can be moved generally along the line of apposition to a regurgitant position. The leaflets LF are held in place so that during diastole, as shown Figure 4 As shown in , the leaflets LF are maintained in a position between the elements 16, 18 surrounded by the opening O created by the diastolic pressure gradient. Advantageously, the leaflets LF are aligned so that the proximal or upstream surfaces of the leaflets LF face each other in a vertical orientation parallel to the direction of blood flow through the mitral valve MV. The upstream surfaces can be brought together so as to touch each other or can be kept slightly apart, but will preferably be maintained in a vertical orientation in which the upstream surfaces face each other at the point of apposition. This simulates the double orifice geometry of a standard surgical bow tie repair. Color Doppler echo will show whether the regurgitation of the valve has been reduced. If the resulting mitral flow pattern is satisfactory, the leaflets can be fixed together in this orientation. If the resulting color Doppler image shows insufficient improvement in mitral regurgitation, the interventional tool 10 can be repositioned. This can be repeated until the optimal result is produced, wherein the leaflets LF are held in place.

[0112] Once the leaflets are in apposition in the desired arrangement, the fixation device 14 is then detached from the shaft 12 and left as an implant to hold the leaflets together in the apposed position. As previously mentioned, the fixation device 14 is coupled to the shaft 12 by a coupling mechanism 17 . Figures 5A to 5B 、 Figures 6A to 6B An exemplary embodiment of such a coupling mechanism is illustrated. Figure 5A The upper shaft 20 and the removable lower shaft 22 are shown interlocked at a line of engagement or mating surface 24. The mating surface 24 can have any shape or curvature that will allow or facilitate interlocking and subsequent separation. As shown, a close-fitting outer sheath 26 is positioned over the shafts 20, 22 to cover the mating surface 24. Figure 5B The lower shaft 22 is shown separated from the upper shaft 20. This is achieved by retracting the outer sheath 26, exposing the mating surfaces 24, thereby allowing the shafts 20, 22 to separate.

[0113] Similarly, Figure 6AThe upper tubular shaft 28 and the removable lower tubular shaft 30 are shown interlocked at a mating surface 32. Again, the mating surface 32 can have any shape or curvature that will allow or facilitate interlocking and subsequent separation. The upper tubular shaft 28 and the lower tubular shaft 30 form an outer member having an axial passage. As shown, a closely fitting rod 34 or inner member is inserted through the tubular shafts 28, 30 to bridge the mating surfaces 32. The rod 34 can also be used to actuate a fixing device described below, such as Figure 26 The actuator rod 64 or FIG. 28A to FIG. 28B The actuator rod 64a is shown in FIG. Figure 6B The lower shaft 30 is shown separated from the upper shaft 28. This is achieved by retracting the rod 34 to a position above the mating surface 32, which in turn allows the shafts 28, 30 to separate. Other examples of coupling mechanisms are described and illustrated in U.S. Patent No. 6,752,813 and U.S. Patent Publication No. 2009 / 0163934, the entire contents of each of which are incorporated herein by reference for all purposes.

[0114] In a preferred embodiment, the mating surface 24 (or mating surface 32) is an S-shaped curve that defines male and female elements on the upper shaft 20 (or upper shaft 28), which interlock with corresponding female and male elements on the lower shaft 22 (or lower shaft 30), respectively. Typically, the lower shaft is the coupling mechanism 17 of the fixture 14. Therefore, the shape of the mating surface selected will preferably provide at least some mating surface that is transverse to the axial axis of the mechanism 19 to facilitate the application of compressive and tensile forces to the fixture 14 through the coupling mechanism 17, while causing minimal interference when the fixture 14 is to be released from the upper shaft.

[0115] 5. 3. Fixtures

[0116] A. Introduction and Placement of Fixation Devices

[0117] The fixation device 14 is delivered to the valve or desired tissue using a delivery device. Depending on the application, the delivery device can be rigid or flexible. For intravascular applications, the delivery device comprises a flexible delivery catheter, which will be described in a later section. Typically, however, such a catheter comprises a shaft having a proximal end and a distal end and a fixation device releasably attached to the distal end of the shaft. The shaft is generally elongated and flexible, suitable for intravascular introduction. Alternatively, the delivery device may comprise a shorter and less flexible interventional instrument that can be used for transthoracic surgical introduction through the wall of the heart, although a certain degree of flexibility and minimal profile are generally desired. As Figure 3AAs illustrated in , the fixation device can be releasably coupled to the delivery device. The fixation device can have a variety of forms, some of which will be described herein.

[0118] Figure 7 Another embodiment of a fixation device 14 is illustrated. Here, the fixation device 14 is shown coupled to the shaft 12 to form the interventional tool 10. The fixation device 14 comprises a coupling member 19 and a pair of opposed distal elements 18. The distal elements 18 comprise elongated arms 53, each having a proximal end 52 rotatably connected to the coupling member 19 and a free end 54. The free ends 54 have a rounded shape to minimize interference with and trauma to surrounding tissue structures. Preferably, each free end 54 defines a curvature about two axes, one of which is an axis 66 perpendicular to the longitudinal axis of the arm 53. Thus, the engagement surface 50 has a cupped or concave shape for the surface area in contact with tissue and facilitates gripping and retaining the valve leaflets. This further allows the arms 53 to nest around the shaft 12 in the closed position, minimizing the device's profile. Preferably, the arms 53 are at least partially cupped or curved inward about their longitudinal axis 66. Similarly, each free end 54 preferably defines a curvature about an axis 67 perpendicular to the axis 66 or the longitudinal axis of the arm 53. This curvature is a reverse curvature along the distal-most portion of the free end 54. Likewise, the longitudinal edges of the free end 54 may flare outwardly. Both the reverse curvature and the flaring minimize trauma to tissue engaged by the free end.

[0119] In a preferred embodiment suitable for mitral valve repair, the lateral width across the engagement surface 50 (which determines the width of the tissue being engaged) is at least about 2 mm, typically 3 mm to 10 mm, and preferably about 4 mm to 6 mm. In some cases, a wider engagement is desired, wherein the engagement surface 50 is larger, for example, about 2 cm, or multiple fixation devices are used adjacent to each other. The arm 53 and the engagement surface 50 are configured to engage a length of tissue along the longitudinal axis of the arm 53 of about 4 mm to 10 mm, and preferably about 6 mm to 8 mm. The arm 53 also includes a plurality of openings to enhance grip and promote tissue ingrowth after implantation.

[0120] The valve leaflets are captured between the distal element 18 and the proximal element 16. In some embodiments, the proximal element 16 is flexible, resilient, and suspended from the coupling member 19. The proximal element is preferably resiliently biased toward the distal element. Each proximal element 16 is shaped and positioned to be at least partially recessed within a concave portion of the distal element 18 when no tissue is present. When the fixation device 14 is in the open position, the proximal elements 16 are shaped such that each proximal element 16 is separated from the engagement surface 50 near the proximal end 52 of the arm 53 and is inclined toward the engagement surface 50 near the free end 54, wherein the free end of the proximal element contacts the engagement surface 50, as shown in FIG. Figure 7 This shape of the proximal element 16 accommodates valve leaflets or other tissues of varying thicknesses.

[0121] The proximal element 16 includes a plurality of openings 63 and scalloped side edges 61 to enhance tissue grip. The proximal element 16 may optionally include frictional attachments, frictional features, or grip-enhancing elements to assist in grasping and / or retaining the leaflets. In a preferred embodiment, the frictional attachments include barbs 60 having tapered tips extending toward the engagement surface 50. It will be appreciated that any suitable frictional attachment may be used, such as prongs, coils, strips, barbs, grooves, channels, bumps, surface roughness, sintered portions, high-friction pads, coverings, coatings, or combinations thereof. Optionally, magnets may be present in the proximal and / or distal elements. It will be appreciated that the mating surfaces may be made of or include materials of opposite magnetic charge to generate an attractive force through magnetic forces. For example, the proximal and distal elements may each include oppositely charged magnetic materials, such that tissue is held under constant compression between the proximal and distal elements to promote faster tissue healing and ingrowth. Furthermore, in addition to or as an alternative to biasing the proximal elements toward the distal elements, magnetic forces can be used to pull the proximal elements 16 toward the distal elements 18. This can facilitate deployment of the proximal elements 16. In another example, the distal elements 18 each include oppositely charged magnetic materials such that tissue positioned between the distal elements 18 is held between the distal elements 18 by magnetic forces. Actuation of the proximal elements can also be accomplished using one or more proximal element wires or actuators such as those described below.

[0122] The proximal element 16 may be covered with a fabric or other flexible material as described below to enhance grip and tissue ingrowth after implantation. Preferably, when a fabric or covering is used in combination with barbs or other friction features, these features will protrude through such fabric or other covering to contact any tissue engaged by the proximal element 16.

[0123] In an exemplary embodiment, the proximal element 16 is formed from a sheet of metal of a spring-like material using a stamping operation that creates the opening 63, the scalloped edge 61, and the barbs 60. Alternatively, the proximal element 16 may comprise a spring-like material or be molded from a biocompatible polymer. It should be noted that while some types of friction attachments that may be used in the presently disclosed subject matter may permanently alter or cause some trauma to the tissue engaged thereby, in preferred embodiments, the friction attachments will be atraumatic and will not injure or otherwise affect the tissue in a clinically significant manner. For example, in the case of the barbs 60, it has been demonstrated that after engaging the mitral valve leaflets by the fixation device 14, if the device is later removed during surgery, the barbs 60 do not leave significant permanent scarring or other damage to the leaflet tissue, and thus the barbs 60 are considered atraumatic.

[0124] The fixation device 14 also includes an actuation mechanism 58. In this embodiment, the actuation mechanism 58 includes two linkage members or legs 68, each leg 68 having a first end 70 rotatably coupled to one of the distal elements 18 at a riveted joint 76 and a second end 72 rotatably coupled to a stud 74. The legs 68 preferably comprise a rigid or semi-rigid metal or polymer such as 7. Cobalt chromium or stainless steel, however any suitable material may be used. Although in the illustrated embodiment, both legs 68 are pinned to stud 74 by single rivet 78, it will be appreciated that each leg 68 may be individually attached to stud 74 by separate rivets or pins. Stud 74 can be coupled to actuator rod 64 (not shown), which extends through shaft 12 and can be extended and retracted axially to move stud 74 and therefore move legs 68, thereby rotating distal element 18 between closed position, open position and inverted position. Similarly, the fixing of stud 74 holds legs 68 in place and therefore holds distal element 18 in the desired position. Stud 74 can also be locked in place by a locking feature, which will be further described in the following section.

[0125] In any of the various embodiments of the fixation device 14 disclosed herein, it may be desirable to provide some mobility or flexibility in the distal element 18 and / or the proximal element 16 when in the closed position, so that these elements can move or flex as the valve leaflets open or close. This provides shock absorption, thereby reducing forces on the leaflets and minimizing the possibility of leaflet tears or other trauma. This mobility or flexibility can be provided by constructing the distal element 18 from a flexible, resilient metal or polymer of appropriate thickness. Furthermore, the locking mechanism of the fixation device (described below) can be constructed of a flexible material to allow some slight movement of the proximal and distal elements even when locked. Furthermore, the distal element 18 can be connected to the coupling mechanism 19 or the actuation mechanism 58 by a mechanism that biases the distal element into the closed position (inward) but allows the arms to open slightly in response to forces applied by the leaflets. For example, rather than being pinned at a single point, these components can be pinned together via a slot that allows the pin to translate slightly in response to forces against the arm. A spring is used to bias the pinned components toward one end of the slot.

[0126] Figures 8A to 8B 、 Figures 9A to 9B 、 FIG. 10A to FIG. 10B 、 Figures 11A to 11B and Figures 12 to 14 The device 14 is shown in various possible positions during its introduction and placement into the body to perform a treatment procedure. Figure 7 Implementation of the fixing device 14. Figure 8A An embodiment of an interventional tool 10 is illustrated being delivered through a catheter 86. It will be appreciated that the interventional tool 10 can take the form of a catheter, and similarly, the catheter 86 can take the form of a guide catheter or sheath. However, in this example, the terms interventional tool 10 and catheter 86 will be used. The interventional tool 10 includes a fixation device 14 coupled to a shaft 12, and the fixation device 14 is shown in a closed position. Figure 8B Shown in a larger view Figure 8A . In the closed position, the pair of opposed distal elements 18 are positioned so that the engagement surfaces 50 face each other. Each distal element 18 includes an elongated arm 53 having a cup-shaped or concave shape so that the arms 53 together surround the shaft 12 and optionally contact each other on opposite sides of the shaft. This provides a low profile for the fixation device 14 that can be easily passed through the catheter 86 and any anatomical structure such as the mitral valve. In addition, Figure 8BAlso included is an actuation mechanism 58. In this embodiment, the actuation mechanism 58 includes two legs 68, each movably coupled to a base 69. The base 69 is coupled to an actuator rod 64 that extends through the shaft 12 and is used to manipulate the fixture 14. In some embodiments, the actuator rod 64 is directly attached to the actuation mechanism 58, specifically to the base 69. However, the actuator rod 64 may alternatively be attached to a stud 74, which in turn is attached to the base 69. In some embodiments, the stud 74 is threaded, such that the actuator rod 64 is attached to the stud 74 via a screw-like action. However, the rod 64 and stud 74 may be coupled by any releasable mechanism to allow the fixture 14 to be separated from the shaft 12. Additional aspects of the actuator rod and its coupling to the fixture are disclosed below.

[0127] Figures 9A to 9B The fixture 14 is shown in an open position. In the open position, the distal element 18 is rotated so that the engagement surface 50 faces a first direction. Through the action of the actuator rod 64, the stud 74 is pushed forward relative to the distal end of the coupling member 19 to apply a force to the distal element 18, causing the distal element 18 to begin rotating around the joint 76 due to the freedom of movement along this direction. This radially outward rotation and movement of the distal element 18 causes the legs 68 to rotate around the joint 80, causing the legs 68 to be slightly oriented outward. The stud 74 can be pushed to any desired distance related to the desired spacing of the distal element 18. In the open position, the engagement surface 50 is arranged at an acute angle relative to the shaft 12, and preferably at an angle between 90 and 180 degrees relative to each other. In one embodiment, in the open position, the free ends 54 of the arms 53 have a span of approximately 10 to 20 mm, typically approximately 12 to 18 mm, and preferably approximately 14 to 16 mm.

[0128] The proximal element 16 is generally biased outwardly toward the arm 53. The proximal element 16 can be moved inwardly toward the shaft 12 and held against the shaft 12 by a proximal element wire 90 in the form of a suture, wire, nitinol wire, rod, cable, polymer wire, or other suitable structure. The proximal element wire 90 can be connected to the proximal element 16 by passing the wire 90 in a variety of ways. Figure 9A As shown in FIG, when the proximal element 16 has a ring shape, the wire 90 can pass through the ring and fold back. Figure 9B As shown in FIG, when the proximal element 16 has an elongated solid shape, the wire 90 can pass through one or more openings 63 in the element 16. Figure 9BAs shown in FIG, a wire loop 48 may be present on proximal element 16, through which proximal element wire 90 may be threaded and folded back. Such a wire loop 48 may be used to reduce friction on proximal element wire 90, or, when proximal element 16 is solid or lacks other loops or openings, proximal element wire 90 may be attached through the wire loop 48. Proximal element wire 90 may be attached to proximal element 16 via a detachable device that allows a single wire 90 to be attached to proximal element 16 without folding back and allows the single wire 90 to be directly detached from proximal element 16 when desired. Examples of such detachable devices include hooks, shackles, clips, or frangible connectors, to name a few. By applying sufficient tension to proximal element wire 90, the detachable device can be detached from proximal element 16, such as by breaking the connector. Other mechanisms for detachment may also be used. Similarly, locking wire 92 may be attached to and detached from the locking mechanism via similar detachable devices.

[0129] In the open position, the fixation device 14 can engage tissue to be accessed or treated. Figures 7 to 9B The embodiment illustrated in FIG is suitable for repairing the mitral valve using an antegrade approach from the left atrium. The interventional tool 10 is advanced from the left atrium through the mitral valve to the left ventricle. The distal element 18 is oriented perpendicular to the line of apposition and is then positioned so that the engagement surface 50 contacts the ventricular surface of the valve leaflet, thereby grasping the leaflet. The proximal element 16 remains on the atrial side of the valve leaflet so that the leaflet is located between the proximal element and the distal element. In this embodiment, the proximal element 16 has friction attachments such as barbs 60 that are directed toward the distal element 18. However, at this time, neither the proximal element 16 nor the barbs 60 contact the leaflet.

[0130] The interventional tool 10 can be repeatedly manipulated to reposition the fixation device 14 so that the leaflet is properly contacted or gripped at the desired location. Repositioning is achieved with the fixation device in the open position. In some cases, reflux can also be checked with the device 14 in the open position. If reflux is not satisfactorily reduced, the device can be repositioned and reflux checked again until the desired result is achieved.

[0131] It may also be desirable to invert the fixation device 14 to assist in repositioning or removal of the fixation device 14 . FIG. 10A to FIG. 10BThe fixture 14 is shown in an inverted position. Further advancement of the stud 74 relative to the coupling member 19 further rotates the distal element 18 so that the engagement surface 50 faces outward and the free end 54 points distally, with each arm 53 forming an obtuse angle relative to the shaft 12. The angle between the arms 53 is preferably in the range of approximately 270 to 360 degrees. Further advancement of the stud 74 causes the distal element 18 to further rotate about the joint 76. This radially outward rotation and movement of the distal element 18 causes the legs 68 to rotate about the joint 80, returning the legs 68 to their initial position, in which they are substantially parallel to one another. The stud 74 can be advanced to any desired distance associated with the desired inversion of the distal element 18. Preferably, in the fully inverted position, the span between the free ends 54 does not exceed approximately 20 mm, typically less than approximately 16 mm, and preferably is approximately 12 to 14 mm. In this illustration, the proximal element 16 is held in place against the shaft 12 by applying tension to the proximal element line 90. Thus, a relatively large space can be created between elements 16, 18 for repositioning. In addition, the inverted position allows the fixation device 14 to be withdrawn through the valve while minimizing trauma to the leaflets. When the fixation device is retracted proximally, the engagement surface 50 provides an atraumatic surface for deflecting tissue. It should also be noted that the barbs 60 are slightly angled in the distal direction (away from the free end of the proximal element 16), thereby reducing the risk that the barbs will snag or tear tissue as the fixation device is withdrawn.

[0132] Once the fixation device 14 has been positioned in the desired position against the valve leaflets, the leaflets may then be captured between the proximal and distal elements 16 , 18 . Figures 11A to 11B The fixation device 14 is shown in this position. Here, the proximal element 16 is lowered towards the engagement surface 50 so that the leaflet is held between the proximal element 16 and the engagement surface 50. Figure 11B In FIG, the proximal element 16 is shown as including barbs 60 that can be used to provide atraumatic gripping of the leaflet. Alternatively, a larger, sharper barb or other penetrating structure can be used to pierce the leaflet to more actively assist in holding the leaflet in place. This position is similar to Figures 9A to 9B To the open position, however, the proximal element 16 is now lowered toward the arm 53 by releasing the tension on the proximal element wire 90 to compress the leaflet tissue between the proximal element 16 and the arm 53. At any time, if regurgitation is not sufficiently reduced, the proximal element 16 can be raised and the distal element 18 can be adjusted or inverted to reposition the fixation device 14.

[0133] After the leaflets have been captured between the proximal and distal elements 16, 18 in the desired arrangement, the distal element 18 can be locked to hold the leaflets in that position, or the fixation device 14 can be returned to or toward the closed position. Such locking will be described in a later section. Figure 12 The fixture 14 is shown in a closed position, wherein the leaflets (not shown) are captured and engaged. This is achieved by retracting the stud 74 proximally relative to the coupling member 19, causing the legs 68 of the actuating mechanism 58 to apply an upward force to the distal element 18, which in turn rotates the distal element 18 so that the engagement surfaces 50 once again face each other. The released proximal element 16, which is biased outwardly toward the distal element 18, is simultaneously pushed inwardly by the distal element 18. The fixture 14 can then be locked to hold the leaflets in this closed position, as described below.

[0134] like Figure 13 As shown in , the fixing device 14 can then be released from the shaft 12. As mentioned, the fixing device 14 can be released by the coupling member 19 (in Figure 17 ) is releasably coupled to shaft 12. Figure 13 The coupling structure is illustrated, with the coupling member 19 of the fixture 14 attached to a portion of the shaft 12. As shown, the proximal element wire 90 can remain attached to the proximal element 16 after being separated from the shaft 12 to serve as a tether to maintain the connection between the fixture 14 and the catheter 86. Alternatively, when the proximal element wire 90 is removed, a separate tether connected between the shaft 12 and the fixture 14 can be used specifically for this purpose. In any case, the repair of the leaflet or tissue can be observed by non-invasive visualization techniques such as echocardiography to ensure the desired results. If repair is not required, the fixture 14 can be retracted using the tether or proximal element wire 90 so that the coupling member 19 can be reconnected to the shaft 12.

[0135] In an exemplary embodiment, the proximal element wires 90 are elongated flexible threads, wires, cables, sutures, or threads that extend through the shaft 12, are looped through the proximal element 16, and extend through the shaft 12 back to the proximal end of the shaft 12. When detachment is desired, one end of each wire can be released at the proximal end of the shaft 12, and the other end pulled to pull the free end of the wire distally through the shaft 12 and the proximal element 16, thereby releasing the fixation device. It should be understood that detachment can be achieved in other ways, for example, by releasing the distal end of the proximal element wire to free it from the anchor and retracting the delivery catheter handle, for example, as described herein with reference to Figure 15I described.

[0136] Figure 14As shown, the coupling member 19 remains separated from the shaft 12 of the interventional tool 10 and the proximal element 16 is deployed so that tissue (not shown) can be located between the proximal element 16 and the distal element 18.

[0137] Although the above-described embodiments of the disclosed subject matter utilize a push-to-open, pull-to-close mechanism to open and close the distal element 18, it should be understood that a pull-to-open, push-to-close mechanism is equally possible. For example, the distal element 18 can be coupled at its proximal end to the stud 74 rather than to the coupling member 19, and the legs 68 can be coupled at their proximal ends to the coupling member 19 rather than to the stud 74. In this example, when the stud 74 is pushed distally relative to the coupling member 19, the distal element 18 will close, while pulling the stud 74 proximally toward the coupling member 19 will open the distal element 18.

[0138] In some cases, the valve leaflets may become completely or partially dislodged from the fixture due to poor leaflet insertion between the proximal and distal elements. Therefore, standard imaging techniques such as echocardiography and fluoroscopy are used to assess the insertion of the valve leaflets into the fixture. However, depending on the angle and / or position of the proximal and distal elements relative to the delivery catheter, assessing the depth of valve leaflet insertion into the fixture or distinguishing the leaflets from the proximal and distal elements of the fixture can be challenging. Therefore, visualization is preferably performed with the distal elements in a more open configuration—in which the distal elements are displaced relative to each other. However, because many current embodiments of the fixture only allow the proximal elements to open to an angle of approximately 85°, the distal elements must be closed to an angle of between approximately 45° and preferably 60° to securely grasp the valve leaflets between the proximal and distal elements. While this configuration helps the operator visualize and distinguish the valve leaflets from the fixture, it is preferable to open the distal elements further to an angle greater than 90°, and more preferably to 120° or greater. Therefore, modifications to the proximal elements are required to open further.

[0139] Figures 15A to 15H The diagram shows Figure 7 A to Figure 14 The device is similar to an embodiment of the fixing device, wherein the main difference is that this embodiment includes a clamp pusher. Figure 15AA fixture 14 is illustrated which generally takes the same form as the fixture 14 previously described. In addition to the features previously described, the fixture 14 also includes a clamp pusher 81. The clamp pusher 81 deflects radially outward to create an arcuate region 83 which expands outward until the arcuate region 83 engages the upper surface of the proximal element 16. As the arcuate region 83 continues to deflect radially outward, the arcuate region 83 further pushes the proximal element 16, causing the proximal element to deflect outward and rotate toward the engagement surface of the distal element 18. Thus, the proximal elements 16 can be deflected further outward than they would normally be, and therefore, the valve leaflets can be captured between the proximal and distal elements when the distal elements are positioned in a more open position with a larger angle therebetween. In a preferred embodiment, the angle between the distal elements is greater than about 90°, preferably greater than about 110°, and more preferably greater than about 120°. In Figure 15A In an embodiment, the clamp pusher 81 includes two arms formed from a metal, polymer, or other linear material. Exemplary materials include cobalt chromium, stainless steel, nitinol, and the like. Polymers may also be used to manufacture the clamp pusher. The clamp pusher 81 can be actuated to bend outward when an axially oriented compressive force is applied that is generally parallel to the longitudinal axis of the clamp pusher arms. During compression, the clamp pusher bends outward, thereby forming an arcuate region 83. In other embodiments, the clamp pusher can be a spring that is resiliently biased to bend outward, thereby forming the arcuate region 83. However, when the proximal element wire (not shown here) is tensioned to lift the proximal element 16, the clamp pusher spring will contract to a reduced profile.

[0140] Figure 15B The illustration shows a fixation device 14 having a covering for tissue ingrowth that is aligned with the underlying 16A to 16C The cover is substantially the same as that discussed in , and wherein the clamp pusher 81 is expanded to engage the proximal element 16 (also referred to as the clamping element) with the distal element 18 (also referred to as the fixation element). The valve leaflets (not shown for convenience) are clamped between the proximal element 16 and the distal element 18. Figure 15C The clip pusher 81 is shown in a collapsed configuration. The arcuate region 83 collapses, allowing the proximal element 16 to be retracted toward the shaft 12, thereby allowing the valve leaflets (not shown) to be released from the fixation device 14. The clip pusher 83 is offset relative to the proximal element 16 so that the proximal element can be retracted without interfering with the clip pusher 81.

[0141] Figure 15DThe clamp pusher 83, which preferably includes two spring arms 99, is highlighted. Each arm 99 is formed from wire or machined from sheet or other stock material, and in this embodiment, has a rectangular cross-section, although other cross-sections are also contemplated. The distal portion 91 of each arm 99 has a notched region 93 forming a pair of fingers that can engage with bosses or other attachment mechanisms on the fixture 14. The notches can be released from the bosses when the fixture 14 is separated from the delivery catheter shaft 12. In addition, each arm includes two arcuate regions or peaks, including a larger distal arcuate region 83 and a smaller proximal arcuate region 95. The larger arcuate region 83 flares outward a greater distance to engage the proximal element 16 and urge it into engagement with the distal element 18. When the distal arcuate region 83 relaxes and contracts away from the proximal element 16, or when contracted by retraction of the proximal element, the smaller proximal arcuate region 95 expands radially outward. An attachment ring or coupling collar 97 is adjacent the nose 318 (described in greater detail below) and is slidably disposed on the shaft 12 and allows the clamp arm 99 to be coupled to the shaft 12 . Figure 15E The distal arcuate region 83 is illustrated engaging the proximal element 16 and the engagement of the notch 93 on the distal portion of each arm 99 with the boss 94 on the fixture 14 is also illustrated.

[0142] Additional features may be provided to help maintain alignment of the clip pusher 83 relative to the delivery catheter shaft 12 . Figure 15E1 shows a cross-sectional view of the delivery catheter shaft 12 with the clamp pusher 83, and Figure 15E2 A side view of the delivery catheter shaft 12 with a clamp pusher 83 is shown. Figure 15E1 and 15E2 , each arm 99 can have a slot 8112, and the delivery catheter shaft 12 can have one or more protrusions 1281, with the slot 8112 riding on the protrusions 1281 to maintain alignment of the clip pusher 83 relative to the delivery catheter shaft 12. The area of the arm 99 having the slot 8112 is wider than the rest of the arm 99 to accommodate the slot 8112. The greater width can also allow the arm 99 to be pushed to the side without becoming misaligned relative to the delivery catheter shaft 12. Figure 15E3 A cross-sectional view of the delivery catheter shaft 12 is shown, and Figure 15E4 A side view of the delivery catheter shaft 12 is shown. Figure 15E3 and 15E4 As shown in , each arm 99 can have one or more inwardly curved regions 8212, and the delivery catheter shaft 12 can have one or more valleys 1282 that accommodate the inwardly curved regions 8212 to maintain alignment of the clamp pusher 83 relative to the delivery catheter shaft 12.

[0143] Figure 15F A top view of a clamp pusher 81 having two arms 99 is shown. Figure 15F The two arms 99 are shown offset from each other so that in this exemplary embodiment, angle α is about 160° and angle θ is about 200°, as opposed to positioning the arms 180° apart from each other. Positioning the arms asymmetrically about the axis creates a larger gap on one side and allows the proximal element 16 to avoid collision with the clamp pusher arm 99 when the proximal element is retracted against the shaft 12. Figure 15G is a top view of the collar 97, and Figure 15H 8 is a side view of the gripper pusher arms 99. The cutouts 98 on one side of the arms 99 create additional space between the arms 99, which also helps prevent the proximal element 16 from interfering with the gripper pusher 83 when the proximal element 16 is retracted. The cutouts are located on both arms 99 and face the larger gap indicated by the angle θ to maximize the space for the proximal element 16.

[0144] As mentioned above, for example, with reference to Figure 9A and Figure 9B , actuation of the proximal element 16 can be achieved by using one or more proximal element wires or actuators 90. Such actuation can be achieved in various ways. For example, Figure 15I As shown in FIG, proximal element actuators 90A and 90B can pass through wire loops 48A and 48B disposed radially outwardly and proximally of proximal elements 16A and 16B, respectively. The distal ends of proximal element actuators 90A and 90B can include closed loops 95A and 95B that surround the proximal elements 16A and 16B. Figure 15I , the shaft 12 and the coupling member 19 are shown coupled together. As described above, the shaft 12 and the coupling member 19 can be coupled together in a releasable manner. In order to surround the shaft 12 and the coupling member 19 with closed loops 95A and 95B, the closed loops 95A and 95B are placed on the shaft 12 and / or the coupling member 19 before the shaft 12 and the coupling member 19 are coupled together. When the closed loops 95A and 95B surround the shaft 12 and the coupling member 19, the closed loops 95A and 95B hold the distal ends of the proximal element actuators 90A and 90B in place relative to the shaft 12 and the coupling member 19 and limit the extent to which the proximal element actuators 90A and 90B can be retracted. The proximal element actuators 90A and 90B are mechanically connected to the proximal elements 16A and 16B, respectively, by passing through the wire loops 48A and 48B. Thus, as Figure 15J, when proximal element actuators 90A and 90B are proximally retracted in direction 96, proximal element actuators 90A and 90B move proximal elements 16A and 16B, respectively, away from distal elements 18A and 18B. Similarly, pushing proximal element actuators 90A and 90B distally moves proximal elements 16A and 16B toward distal elements 18A and 18B.

[0145] Proximal element actuators 90A and 90B can be moved to move proximal elements 16A and 16B at various angles and distances relative to distal elements 18A and 18B. Furthermore, the degree to which proximal element actuators 90A and 90B are pushed or pulled can be maintained to maintain the position of proximal elements 16A and 16B relative to distal element 18. For example, Figure 15K As shown in FIG, proximal element actuators 90A and 90B are pulled proximally and held in the position shown so as to maintain proximal elements 16A and 16B in an intermediate position relative to distal element 18. The intermediate position is between the position toward which proximal elements 16A and 16B are biased and the position toward which proximal elements 16A and 16B are biased. Figure 15J between the fully retracted positions shown in . Figure 15N As shown in , once proximal elements 16A and 16B are in the desired position, shaft 12 and coupling member 19 can be decoupled such that proximal retraction of proximal element actuators 90A and / or 90B decouples the proximal element wires from proximal element 16. Thus, fixation device 14 can remain in place while shaft 12, proximal element actuators 90A and 90B, and other components can be removed from the surgical site. Figure 15O to Figure 15O As shown in FIG, the fixing device 14 generally includes the following 16A to 16C Cover 100 is substantially the same as the cover discussed in .

[0146] It may be desirable to provide independent actuation of proximal elements 16A and 16B. Figure 15L As shown in , proximal element actuator 90A is proximally retracted and rotates proximal element 16A away from distal element 18A, while proximal element actuator 90B is distally pushed and rotates proximal element 16B toward distal element 18B. Figure 15MAs shown in FIG, proximal element actuator 90A is left alone, allowing proximal element 16A to maintain its biased position while proximal element actuator 90B is proximally retracted, thereby moving proximal element 16B away from distal element 18B. Providing independent actuation of proximal elements 16A and 16B allows the leaflets to be grasped independently by proximal elements 16A and 16B and distal elements 18A and 18B. Consequently, fixture 14 can more easily and in a more optimal position for apposition of the leaflets. For example, rather than grasping both leaflets simultaneously, the first leaflet can be grasped in a desired position, and then fixture 14 can be repositioned so that the second leaflet can be grasped in a more optimal position. Alternatively, if desired, the leaflets can still be grasped simultaneously because the independently actuatable proximal element actuators can still be moved simultaneously. Furthermore, after the leaflets are grasped, they can be released and, for example, re-grasped if the leaflets were not properly apposed during the first grasp. Various embodiments configured for independent or simultaneous movement of proximal elements are described herein.

[0147] An embodiment of a fixation device similar to the one described above may include both a clamp pusher 81 and independently actuatable proximal elements 16A and 16B, such as Figure 15O Having both the clamp pusher 81 and independently actuatable proximal elements 16A and 16B can allow the fixation device to have many of the advantages described above, such as a more precise and secure grasp of the leaflets.

[0148] Figure 15P The distal end of the proximal element actuator 90 is shown. The proximal element actuator 90 includes a circular section 90R and a flat section 90F distal to the circular section 90R. When the proximal element actuator 90 is passed through the proximal element 16 and coupled to the fixture 14, the flatter portion of the flat section can be positioned so that it faces the proximal element 16. When the proximal element actuator 90 is advanced proximally, the proximal element actuator 90 will therefore tend to deflect and push the proximal element in a direction toward the proximal element 16 rather than in other directions. The proximal element actuator 90 also includes a ring-shaped end 95. As shown Figure 15P As shown in , the ring end 95 may comprise a separate wire loop attached at its distal end to the distal end of the flat section 90F, such as with solder 94 .

[0149] The proximal element actuator 90 may also be releasably coupled to the fixture 14 in other ways. For example, Figure 15Q and Figure 15R, proximal element actuator 90 includes a helical distal end segment 95L that is releasably coupled to fixture 14. Helical distal end segment 95L is wrapped around shaft 12 and / or coupling mechanism 19. Retracting proximal element actuator 90 with sufficient force can deform helical distal end segment 95L such that helical distal end segment 95L is released from fixture 14. Alternatively, or in combination, helical distal end segment 95L can include a shape memory material such that helical distal end segment 95L straightens upon application of a sufficient amount of heat, thereby facilitating proximal retraction of proximal element actuator 90 away from fixture 14.

[0150] The proximal element actuator 90 may be releasably coupled to the fixation device 14 via sutures. Figure 15S and Figure 15T As shown in FIG, the proximal element actuator 90 is releasably coupled to the fixation device 14 via a suture knot 95S. Each proximal actuator 90 can be coupled to the fixation device 14 by a separate suture knot 95S. Alternatively, a pair of proximal actuators 90 can be coupled to the fixation device 14 by a single suture knot.

[0151] The proximal element actuator 90 may be as follows Figure 15U and Figure 15V 48. The proximal element 16 is shown as including an enlarged section 90T. The diameter of the enlarged section 90T exceeds the diameter of the opening of the loop 48. When the proximal element actuator 90 is retracted, the loop 48 limits the proximal movement of the enlarged section 90T. Thus, a tensile force is exerted on the loop 48 and the proximal element 16, which facilitates actuation of the proximal element 16. The enlarged section 90T may be a sleeve attached to the proximal element actuator 90.

[0152] The proximal element actuator 90 may be releasably coupled to the proximal element 16 at the radially outward end of the proximal element 16 by attachment means, such as Figures 15W1 to 15W2 The attachment means may include Figure 15W1 The ring 90CR shown in the perspective view, Figure 15W2 The short clip 90CC shown in the three-dimensional diagram, or Figures 15W3 to 15W5 The long clip shown in 90cl. Figure 15W3 A perspective view of an elongated clip 90CL attaching the proximal element actuator 90 to the proximal element 16 is shown. Figure 15W4 and Figure 15W5 1 and 2 show a front view and a side view, respectively, of an elongated clip 90CL attaching the proximal element actuator 90 to the proximal element 16. The elongated clip 90CL may include a pair of legs 90CLL that traverse the length of the proximal element 16. Figure 15W5 As shown in FIG, the leg 90CLL is disposed between the two rows of barbs 60.

[0153] The attachment device can be spring-loaded to latch onto the radially outward end of the proximal element 16 or sized to slide into the radially outward end of the proximal element 16. When the proximal element actuator 90 is retracted, the attachment device remains attached to the proximal element 16. However, when the proximal element 16 is rotated to be approximately parallel to the axis 19, further proximal retraction of the proximal element actuator 90 can release the attachment device from the outer end of the proximal element 16. A mechanical mechanism can be provided to limit the extent to which the proximal element actuator 90 can be retracted proximally so that the attachment device is not inadvertently detached. Instead, detachment occurs only when the entire delivery device, including the proximal element actuator 90, is retracted from the fixture 14.

[0154] The proximal element actuator 90 may include two wires: an actuation wire 90AA and a release wire 90RR, for example Figures 15X1 to 15X3 As shown in . Figure 15X1 A perspective view of the radially outward end of the proximal element 16 having the aperture 48A is shown. Figure 15X2 A cross-sectional view of the radially outward end of the proximal element 16 having the aperture 48A is shown. The actuation wire 90AA has an annular end 90AAL that passes through the aperture 48A to pass through the proximal element 16. The release wire 90RR passes through a portion of the annular end 90AAL. Figure 15X3 In FIG. 1 , the actuation wire 90AA and the release wire 90RR are similarly positioned to pass through the loop 48 of the proximal element 16. Figures 15X1 to 15X3 When positioned in the arrangement shown in , similar to the above-described embodiments, retracting the actuation wire 90AA rotates the proximal element 16 relative to the distal element 18. Retracting the release wire 90RR so that it no longer passes through the annular end 90AAL allows the actuation wire to be retracted away from the proximal element 16.

[0155] In many embodiments, the shaft 12 and the coupling member 19 are releasably coupled together via an L-shaped locking mechanism. Figure 15Y1 As shown in , the proximal element actuator 90 may include a rounded T-shaped end 90T distal to the flat section 90F, and the shaft 12 may include an L-shaped end 12L. Figure 15Y2 As shown in the perspective view of FIG, when the proximal element actuator 90 and the shaft 12 are placed into the channel 19C of the coupling member 19, the proximal element actuator 90 is releasably coupled to the coupling member 19. When the shaft 12 is placed through the channel 19C, the L-shaped end 12L is pushed inward until the L-shaped end 12L reaches the orifice 19A. At this time, as shown in FIG. Figure 15Y3As shown in the cross-sectional view of FIG, the L-shaped end 12L is expanded outward to fit into the aperture 19A, thereby locking the shaft 12 in place relative to the coupling member 19. The rounded T-shaped distal end 90T will generally be placed in the passage 19C before the shaft 12. Figure 15Y3 As shown in FIG, when the shaft is placed in channel 19C, the rounded T-shaped distal end 90T is then captured in the space 19CA between channel 19C and the wider portion of the shaft 12. Other L-shaped locking mechanisms or other locking mechanisms are described in commonly assigned U.S. patent application Ser. No. 12 / 393,452, filed on February 26, 2009, entitled “Detachment Mechanism for Implantable Fixation Devices,” which is incorporated herein by reference in its entirety.

[0156] The rounded T-shaped end 90T of the proximal element actuator 90 can also be used to facilitate releasable coupling of the proximal element wire 90 to the shaft 12 and coupling member 19 in many other ways. For example, Figure 15Z1 As shown in FIG, the L-shaped end portion 12L of the shaft 12 may include at least one proximal element line slot 12S. Figure 15Z3 and Figure 15Z4 As shown in FIG, the T-shaped end 90T of the proximal element actuator 90 is slid into the proximal element wire slot 12L. The shaft 12 is then placed into the coupling member 19, thereby also locking the proximal element wire 90 in place. Figure 15Z5 As shown in , removing shaft 12 from coupling member 19 allows proximal element wire 90 to slide out of proximal element wire slot 12S of L-shaped end 12L, thereby decoupling proximal element actuator 90 from both shaft 12 and coupling device 19 .

[0157] like Figure 15AA1 As shown in , the proximal element actuator 90 can include a flat T-shaped end 90TF. The shaft 12 can also include an inner distal cover 1511 surrounding the distal portion of the shaft 12 and an outer distal cover 1521 surrounding the inner distal cover. The inner distal cover 1511 will generally be in a fixed position relative to the shaft 12, while the outer distal cover will be movable relative to the shaft 12 within a range determined by a protrusion 1515 of the inner distal cover 1511 positioned through a side channel 1525 of the outer distal cover 1521. To releasably couple the proximal element actuator 90 to the shaft 12 and the coupling wire 19, the T-shaped end portion 90TF fits into the T-shaped cutout 1513 of the inner distal cover 1511, and when the shaft 12 is placed into the coupling device 19, the coupling device 19 pushes the outer distal cover 1521 onto the inner distal cover 1511 to cover the T-shaped cutout 1513 and the T-shaped end portion 90TF, as shown. Figure 15AA2In some embodiments, the outer distal cover 1521 can be spring loaded against the inner distal cover 1523 so as to tend to keep them in Figure 15AA1 The relative positions shown in .

[0158] The proximal element actuator 90 may be releasably coupled to the fixture 14 in various ways using variations of inner and outer distal collars on the distal portion of the shaft 12, such as, for example, Figures 15AB1 to 15AB7 As shown in . Figure 15AB1 An inner distal collar 1511A is shown having a pair of T-shaped cutouts 1513 and a protrusion 1514 . Figure 15AB3 An outer distal collar 1521A is shown having a channel 1524. When the inner distal collar 1511A is slid into the outer distal collar 1521A, the channel 1524 guides the inner distal collar 1511A via the protrusion 1514 of the inner distal collar 1511A, e.g. Figures 15AB3 to 15AB5 As shown in Figure 15AA1 and Figure 15AA2 In the embodiment shown in FIG, in order to releasably couple the proximal element actuator 90 to the shaft 12 and the coupling member 19, the T-shaped end portion 90TF fits into the T-shaped cutout 1513 of the inner distal collar 1511S. When the shaft 12 is placed into the coupling device 19, the coupling member 19 pushes the outer distal collar 1521S onto the inner distal collar 1511S to cover the T-shaped cutout 1513 and the T-shaped end portion 90TF, as shown in FIG. Figure 15AB6 and Figure 15AB7 As shown in .

[0159] As described below, a delivery device or delivery catheter 300 can be used to introduce and position a fixation device as described above. In embodiments of the disclosed subject matter having independently actuatable proximal element wires, the handle 304 of the delivery catheter will typically include a control mechanism for the independently actuatable proximal element wires. For example, the control mechanism may include a pair of independently actuatable proximal element wire handles 393A and 393B that are configured to control the proximal element wires. Figure 15AC1 and further described herein, or as shown in FIG. Figure 15AC2 The proximal element wire handles 393A and 393B are coupled to the proximal element wires 90A and 90B and may share a common or interconnected lumen in a delivery device, such as, for example, Figure 71C As shown in . Stops can be provided to limit the extent to which the proximal element wire handles 393A and 393B can be retracted or advanced, thereby limiting the extent to which the proximal element actuators 90A and 90B can be retracted or advanced. In some embodiments, for example, Figure 15AC3 and Figure 15AC4As shown in FIG and further described herein, the proximal element wire handle 393 can be actuated by a rotatable switch 395 attached thereto.

[0160] B. Covering on fixtures

[0161] Fixing device 14 can optionally include a covering. The covering can assist in grasping tissue and can subsequently provide a surface for tissue ingrowth. The ingrowth of surrounding tissue such as valve leaflets provides stability for device 14 because device 14 is further anchored in place and can cover the device with natural tissue, thereby reducing the possibility of immune response. The covering can include any biocompatible material, such as polyethylene terephthalate, polyester, cotton, polyurethane, expanded polytetrafluoroethylene (ePTFE), silicon or various polymers or fibers, and the covering can have any suitable form, such as fabric, mesh, textured braid, felt, annular or porous structure. Typically, the covering has a small profile so as not to interfere with the delivery carried out by the introducer sheath or the grasping and apposition of the leaflets or tissue.

[0162] 16A to 16C The cover 100 is illustrated on the fixture 14 with the fixture 14 in various positions. Figure 16A Shown is a cover 100 enclosing the distal element 18 and the actuation mechanism 58 when the device 14 is in the open position. Thus, the engagement surface 50 is covered by the cover 100, which helps minimize trauma to the tissue and provides additional friction to assist in grasping and holding the tissue. Figure 16B Shown in an inverted position Figure 16A The cover 100 is loose-fitting and / or flexible or elastic so that the device 14 can be freely moved to various positions and the cover 100 conforms to the contours of the device 14 and remains securely attached in all positions. Figure 16C The device 14 is shown in a closed position. Thus, when the fixation device 14 is left in the closed position as an implant, the exposed surface of the device 14 is substantially covered by the covering 100. It will be appreciated that the covering 100 can cover specific portions of the fixation device 14 while leaving other portions exposed. For example, the covering 100 can include a sleeve that fits on the distal element 18 instead of the actuation mechanism 58, a cap that fits on the distal end 54 of the distal element 18, or a pad that covers the engagement surface 50, to name a few. It will be appreciated that the covering 100 can allow any friction attachments, such as barbs, to be exposed. In addition, the covering 100 can cover any other surface of the proximal element 16 and / or the fixation device 14. In any case, the covering 100 should be durable to withstand multiple introduction cycles and, when implanted in the heart, a lifetime of cardiac cycles.

[0163] The covering 100 may alternatively comprise a polymer or other suitable material that is impregnated, sprayed, coated, or otherwise adhered to the surface of the fixation device 14. Optionally, the polymer coating may include pores or contours to assist in gripping tissue and / or promoting tissue ingrowth.

[0164] Any of the coverings 100 may optionally include a drug, antibiotic, antithrombotic agent, or antiplatelet agent such as heparin, (warfarin sodium), to name a few. These agents can, for example, be impregnated in or coated on the covering 100. These agents can then be delivered to the tissue and / or grasped tissue surrounding the bloodstream to achieve a therapeutic effect.

[0165] C. Fixture locking mechanism

[0166] As previously mentioned, the fixing device 14 optionally includes a locking mechanism for locking the device 14 in a specific position, such as an open position, a closed position, or an inverted position, or any position therebetween. It will be appreciated that the locking mechanism includes an unlocking mechanism that allows the device to be locked and unlocked. Figures 17 to 20 An embodiment of the locking mechanism 106 is shown. Figure 17 In this embodiment, the locking mechanism 106 is disposed between the coupling member 19 and the base 69 of the actuation mechanism 58. The base 69 is fixedly attached to a stud 74 that extends through the locking mechanism 106. The stud 74 is releasably attached to the actuator rod 64 that passes through the coupling member 19 and the shaft 12 of the interventional tool 10. The base 69 is also connected to the leg 68 of the actuation mechanism 58, which is in turn connected to the distal element 18.

[0167] Figure 17 Also illustrated is a proximal element 16, which in this embodiment straddles the locking mechanism and is attached below the locking mechanism 106. The proximal element 16 is shown as being supported by a proximal element wire 90. The proximal element 16 is raised and lowered by manipulation of the proximal element wire 90. In addition, a locking wire 92 is shown connected to a release harness 108 of the locking mechanism 106. The locking wire 92 is used to lock and unlock the locking mechanism 106, as will be described below. The proximal element wire 90 and the locking wire 92 can comprise any suitable material, typically a wire, a nitinol wire, a cable, a suture, or a thread, to name a few. In addition, the proximal element wire 90 and / or the locking wire 92 can comprise a coating, such as parylene. Parylene is a vapor-deposited, pinhole-free protective film that is conformal and biocompatible. Parylene is inert and resistant to moisture, chemicals, and electrical charges.

[0168] Figure 18 Provided Figure 17 106 . However, here the proximal elements 16 are supported by a single proximal element wire 90 that passes through both proximal elements 16. In this arrangement, both elements are raised and lowered simultaneously by the action of the single proximal element wire 90. Whether the proximal elements 16 are manipulated individually or collectively by the separate proximal element wires 90, the proximal element wires 90 can extend directly through openings in the proximal elements and / or through layers or portions of the covering 100 over the proximal elements, or through suture loops above or below the covering 100.

[0169] Figures 19 to 20 The locking mechanism 106 is illustrated in the figures, which show the locking mechanism 106 in an unlocked position and a locked position, respectively. Figure 19 , the locking mechanism 106 includes one or more wedging elements, such as rolling elements. In this embodiment, the rolling elements include a pair of barbells 110 disposed on opposite sides of the stud 74, each barbell having a pair of generally cylindrical caps and an axle located between the pair of generally cylindrical caps. The barbells 110 and the stud 74 preferably comprise cobalt chrome or stainless steel, however any suitable material may be used. The barbells 110 are manipulated by the hooked end 112 of the release harness 108. As Figure 19 As shown in FIG, when the locking line 92 (as Figure 17 108, the hooked end 112 causes the barbell 110 to rise against the spring 114. This pulls the barbell 110 upward along the sidewall or inclined surface 116, thereby removing the barbell 110 from the stud 74. In this position, the stud 74 is free to move. Thus, when the locking wire 92 raises or lifts the harness 108, the locking mechanism 106 is in the unlocked position, wherein the stud 74 frees the actuating mechanism 58 and, therefore, the distal element 18 to move to any desired position. Figure 20As shown in FIG, releasing the wire harness 108 by the locking wire 92 shifts the locking mechanism 106 into the locked position. By releasing the upward force on the barbell 110 via the hooked end 112, the spring 114 forces the barbell 110 downward, wedging it between the inclined surface 116 and the stud 74. This restricts the movement of the stud 74, which in turn locks the actuation mechanism 58 and, consequently, the distal elements 18 in place. Additionally, the stud 74 may include one or more grooves 82 or recessed portions that receive the barbell 110. This can provide a faster and more positive locking by securing the barbell 110 in a defined position, increase the stability of the locking feature by further preventing movement of the barbell 110, and provide a tangible indication to the user that the barbell has reached the locked position. Furthermore, the grooves 82 can be used to indicate the relative position of the distal elements 18, particularly the distance between them. For example, each groove 82 can be positioned to correspond to a 0.5 mm or 1.0 mm decrease in the distance between the distal elements 18. As the stud 74 moves, the barbell 110 will contact the grooves 82; by counting the number of grooves 82 felt as the stud 74 moves, the user can determine the distance between the distal elements 18 and provide a desired degree of coaptation based on leaflet thickness, geometry, spacing, hemodynamics, and other factors. Thus, the grooves 82 can provide tactile feedback to the user.

[0170] The locking mechanism 106 allows the fixation device 14 to remain in an unlocked position when attached to the interventional tool 10 during grasping and repositioning, and then to remain in a locked position when left as an implant. However, it will be appreciated that the locking mechanism 106 can be repeatedly locked and unlocked throughout the placement of the fixation device 14, if desired. Once the final placement position is determined, the locking wire 92 and the proximal element wire 90 are removed and the fixation device is left behind.

[0171] Figure 21 、 FIG. 22A to FIG. 22B Another embodiment of the locking mechanism 106 is shown. Figure 21 In this embodiment, the locking mechanism 106 is again disposed between the coupling member 19 and the base 69 of the actuation mechanism 58. The base 69 is connected to a stud 74 that extends through the locking mechanism 106 and to an actuator rod that extends through the coupling member 19 and the shaft 12 of the interventional tool 10. The base 69 is also connected to the leg 68 of the actuation mechanism 58, which in turn is connected to the distal element 18. Figure 21 Also illustrated is the proximal member 16 that operates the locking mechanism 106 in this embodiment. The locking mechanism 106 includes a folding leaf structure 124 having overlapping portions 124a, 124b, each folding structure 124 being attached to the proximal member 16. Figure 21 and Figure 22A, for clarity, the folding structure 124 is shown without the rest of the locking mechanism 106. The proximal element 16 is flexible and resilient and is biased outward. The folding leaf structure 124 includes an aperture 125 ( Figure 22B ) so that the stud 74 passes through the hole 125 of the parts 124a, 124b as shown. The locking mechanism includes a slot in which the end 123 of the folding leaf structure 124 is fixed. When the proximal element 16 is in the unfolded position, as shown Figure 21 As shown in FIG, the folding leaf structure 124 is substantially perpendicular to the stud 74 so that the holes 125 in each overlapping portion are vertically aligned. This allows the stud 74 to pass freely through the hole, and the locking mechanism 106 is considered to be in the unlocked position.

[0172] like Figure 22A As shown in , the expansion of the proximal element 16 tilts the folding leaf structure 124 to be arranged in a non-vertical orientation relative to the stud 74, and the holes 125 are no longer vertically aligned with each other. In this arrangement, the stud 74 cannot move freely due to friction with the holes of the folding leaf structure 124. Figure 22B A larger perspective view of the folded structure 124 in this position is provided. Thus, the locking mechanism 106 is considered to be in the locked position. This arrangement allows the fixation device 14 to remain in the unlocked position during grasping and repositioning, and then to remain in the locked position when the proximal element 16 is deployed and the fixation device 14 is left as an implant. However, it will be appreciated that the locking mechanism 106 can be repeatedly locked and unlocked throughout the placement of the fixation device 14, if desired.

[0173] Figure 23 、 FIG. 24A to FIG. 24B Another embodiment of the locking mechanism 106 is illustrated. Referring to FIG. 22 , in this embodiment, the locking mechanism 106 is again disposed between the coupling member 19 and the base 69 of the actuating mechanism 58. Furthermore, the base 69 is connected to a stud 74 that extends through the locking mechanism 106 and is connected to an actuator rod that extends through the coupling member 19 and the shaft of the interventional tool 10. FIG. 22 illustrates the proximal element 16 manipulating the locking mechanism 106 in this embodiment. The locking mechanism 106 includes C-shaped structures 128, each of which is attached to the proximal element 16. FIG. 24A to FIG. 24B As shown in FIG, C-shaped structures 128 are hooked around studs 74 so that studs 74 pass through the "C" of each structure 128. As shown, the structures 128 cross each other and the "C" of each structure 128 face each other. Springs 130 bias the C-shaped structures into engagement with each other. When the proximal element is in the undeployed position, as shown Figure 24A, the C-shaped structures 128 are urged to an orientation that is more orthogonal to the axial direction defined by the studs 74, thereby bringing the "C" of each structure 128 into closer axial alignment. This allows the stud 74 to freely pass through the "C" of each structure 128. The outward expansion of the proximal element 16 urges the C-shaped structures to a more angled, non-orthogonal orientation relative to the studs 74, thereby causing the sidewalls of the "C" of each structure 128 to more forcefully engage the studs 74. In this arrangement, the studs 74 are unable to move freely due to friction with the "C"-shaped structures 128.

[0174] D. Additional Embodiments of Fixing Devices

[0175] In other embodiments, the proximal elements can be manipulated to enhance grip. For example, the proximal elements can be lowered to grasp a leaflet or tissue between the proximal and distal elements, and then the proximal elements can be moved to drag the leaflet or tissue into the fixture. In another example, the proximal elements can be lowered independently to grasp the leaflet or tissue. This may be useful for sequential grasping. In sequential grasping, one proximal element is lowered to capture a leaflet or tissue portion between the proximal and distal elements. The fixture is then moved, adjusted, or manipulated to a position for grasping another leaflet or tissue portion between another set of proximal and distal elements. In this position, a second proximal element is then lowered to grasp the other leaflet or tissue portion.

[0176] Other exemplary embodiments of the fastening device are disclosed in U.S. Patent No. 7,563,267 and U.S. Patent No. 7,226,467, each of which is incorporated herein by reference in its entirety. Those skilled in the art will appreciate that the various features of the disclosed fastening devices may be substituted for one another or used in combination with other disclosed features.

[0177] 6. 4. Delivery device

[0178] A. Overview of Delivery Devices

[0179] Figure 25A perspective view of an embodiment of a delivery device or delivery catheter 300 is provided that can be used to introduce and position a fixation device as described above. The delivery catheter 300 includes a shaft 302 having a proximal end 322 and a distal end 324, and a handle 304 attached to the proximal end 322. A fixation device (not shown) is removably coupled to the distal end 324 for delivery to a site within the body, typically for intravascular delivery to the mitral valve. Thus, extending from the distal end 324 is a coupling structure 320 for coupling with the fixation device. An actuator rod 64 also extends from the distal end 324. The actuator rod 64 is connectable to the fixation device and used to manipulate the fixation device, typically to open and close the distal elements. This coupling to the fixation device is Figure 26 is shown in the figure.

[0180] Figure 26 An embodiment of the fixture 14 is illustrated coupled to the distal end 324 of a delivery catheter 300. The shaft 302 is shown having a nose 318 near its distal end 324. In this embodiment, the nose 318 has a flange shape. This flange shape prevents the nose 318 from retracting into the guide catheter or introducer, as will be discussed in later sections. However, it will be appreciated that the nose 318 can have any shape, including bullet-shaped, rounded, blunt, or pointed, to name a few. Extending from the nose 318 is a compression coil 326 through which the coupling structure 320 and the actuator rod 64 pass. As shown, the actuator rod 64 is capable of coupling with the stud 74 of the fixture 14. This coupling is Figure 27 is shown in the figure.

[0181] Figure 27 A portion of a shaft 302 of a delivery catheter 300 and a fixture 14 that can be coupled to the catheter 300 are shown. An actuator rod 64 passes through the shaft 302. In this embodiment, the actuator rod 64 includes a proximal end 303 and a distal end 328, with the distal end 328 of the actuator rod 64 being surrounded by a coil 330. The proximal end 303 typically comprises stainless steel, nitinol, or To name a few, the proximal end 303 may have a diameter in the range of 0.010 inches to 0.040 inches, preferably 0.020 inches to 0.030 inches, more preferably 0.025 inches, and a length in the range of 48 inches to 72 inches. The distal end 328 may be tapered, typically comprising stainless steel, nitinol, or To name a few, the distal end 328 can have a diameter in the range of 0.011 inches to 0.025 inches and a length in the range of 4 inches to 12 inches. This narrowing increases the flexibility of the distal end 324 of the actuator rod 64. The actuator rod 64 also includes an adapter 332 attached to the distal end 328. The adapter 332 is capable of being removably attached to the stud 74 of the fixture 14. In this embodiment, the adapter 332 has internal threads that mate with external threads on the stud 74 of the fixture 14. As previously described, the stud 74 is connected to the distal element 18 so that advancement and retraction of the stud 74 by means of the actuator rod 64 manipulates the distal element. Likewise, the coupling member 19 of the fixture 14 mates with the coupling structure 320 of the catheter 300. Therefore, the coupling member 19 and the coupling structure 320 are as previously described with respect to Figures 6A to 6B Works as described.

[0182] Return to reference Figure 26 The fixture 14 may also include a locking mechanism including a release harness 108, as previously described with respect to Figures 17 to 20 302 of the delivery catheter 300 and is connected to the proximal element 16. The proximal element 16 is raised and lowered by manipulation of the proximal element wire 90, as previously described. The proximal element wire 90 can be connected to the proximal element 16 in various arrangements, as will be described in later sections.

[0183] Return to reference Figure 25A handle 304 attached to the proximal end 322 of the shaft 302 is used to manipulate the coupled fixture 14 and, optionally, disconnect the fixture 14 for permanent implantation. As described, the fixture 14 is primarily manipulated by the actuator rod 64, the proximal element wire 90, and the locking wire 92. The actuator rod 64 manipulates the distal element 18, the proximal element wire 90 manipulates the proximal element 16, and the locking wire 92 manipulates the locking mechanism. In this embodiment, the actuator rod 64 can translate (extend or retract) to manipulate the distal element 18. This is accomplished using an actuator rod controller 314, which will be described later. The actuator rod 64 can also be rotated to engage or disengage the threaded adapter with the threaded stud 74. This is accomplished using an actuator rod handle 316, which will also be described later. Furthermore, the proximal element wire 90 can be extended, retracted, loaded with various amounts of tension, or removed using the proximal element wire handle 312. 302. The locking wire 92 can be extended, retracted, loaded with various amounts of tension, or removed using a locking wire handle 310. These two handles 310, 312 will be described in more detail in a later section. The actuator rod handle 316, the actuator rod controller 314, the proximal element wire handle 312, and the locking wire handle 310 are all engaged with the body 308, within which the actuator rod 64, the proximal element wire 90, and the locking wire 92 are guided into the shaft 302. The handle 304 also includes a support base 306 connected to the body 308. The body 308 can slide along the support base 306 to provide translation of the shaft 302. In addition, the body 308 can rotate about the support base 306 to rotate the shaft.

[0184] although Figure 27 While the embodiment of the invention is promising, in some cases, the actuator rod 64 may deform during delivery of the fixation device 14, particularly along the thinner distal end region 328, thereby making it more challenging to properly deliver and attach the fixation device to the valve leaflets. For example, when tracing a tortuous vessel or when steering the distal portion of the delivery device through a large angle, such as 90° or greater, the tapered distal end 328 of the actuator rod 64 may become permanently deformed and, therefore, may not be able to return to a generally straight configuration after deflection. FIG. 28A to FIG. 28B Pictured Figure 27 An alternative embodiment of the actuator rod shown in FIG. In this embodiment, the tapered distal end 328 has been replaced by a flexible cable. The actuator rod 64a is an elongated shaft or mandrel that is typically constructed in the same manner as the Figure 2764a and the like. A flexible cable 2702 is provided between the distal end of the actuator rod 64a and the proximal end of a coupling or adapter 2708. The flexible cable 2702 allows torque, tension, and compression to be transmitted to the coupling 2708 while allowing bending and flexing without causing deformation of the flexible cable. In this exemplary embodiment, the distal portion of the actuator rod 64a is joined to the proximal end of the flexible cable 2702 by a sleeve 2704. The sleeve 2704 has a central channel 2718 extending through the sleeve 2704 for receiving the flexible cable and the actuator rod. The sleeve 2704 can then be crimped, swaged, or otherwise reduced in diameter so that the two ends are fixedly attached together. In alternative embodiments, adhesives, welds, welded joints, etc. can also be used to join the two ends together. Similarly, the proximal end of the coupler 2708 may include a central channel 2718 sized to receive the distal portion of the flexible cable 2702. In this exemplary embodiment, the coupler is cylindrical in shape, wherein the proximal portion 2716 has a larger diameter than the diameter of the distal portion 2710. After the proximal portion 2716 has been crimped or swaged onto the flexible cable, the diameters of the proximal and distal portions of the coupler may be the same, as shown in FIG. Figure 28B The distal portion of the coupler may include a threaded channel 2712 that may be threadably attached to a connector such as that previously described. Figure 7 and Figure 27 The fixing device 14 described in . Figure 28B The actuator rod 64a is illustrated after having been coupled with the flexible cable and coupler by swaging.

[0185] Even after bending or deflecting 90° or more, the flexible cable is preferably resiliently biased to return to a generally straight or linear configuration. In a preferred embodiment, the flexible cable is 25 cm or less, preferably 10 cm to 20 cm long, and more preferably 15 cm to 20 cm long. The flexible cable also has an outer diameter that is preferably 0.015" to 0.035" and more preferably 0.020" to 0.030", and nominally 0.025", although those skilled in the art will appreciate that other sizes may be used. The actuator rod 64a is typically of the same Figure 27The actuator rod 64a and the flexible cable 2702 are of the same form as the actuator rod 64 in FIG. The actuator rod 64a and the flexible cable 2702 are configured to transmit at least 0.74 inch-ounces of torque from the proximal end of the actuator spindle to the distal end of the flexible cable at a torque transmission ratio of approximately 1:1. This torque is required to threadably disconnect the connector 2708 from the fixture after the valve has been satisfactorily repaired. In addition, the actuator rod 64a and the flexible cable 2702 are also designed to transmit at least 2.5 pounds of compressive force distally to the fixture to actuate the distal element of the fixture. In addition, the actuator rod and the flexible cable can withstand a tensile force of at least 14.7 pounds without significant stretching or elongation. This force is experienced when the fixture is actuated to close the distal element. Various metals, polymers, and other materials can be used for the actuator rod, the flexible cable, the sleeve, and the connector. However, in a preferred embodiment, the coupler is made of 17-4H1150 stainless steel, while the cable comprises 304V stainless steel, and the mandrel is 304 stainless steel with an ultra-spring wire temper.

[0186] Flexible cables of various configurations can be used, such as Figures 29A to 32B The cables shown in . Figures 29A to 32B The flexible cable is a twisted cable with reverse winding, which is designed to have a high torque transmission ratio in the counterclockwise direction. The cable consists of four layers of wire. The innermost layer 2802 is Figure 29A , and includes three wires 2802a, 2802b, 2802c that are spirally wound together. Figure 29B A cross section of the cable 2802 taken along line AA is shown. Figure 30A As shown in , the next layer 2902 includes nine additional wire bundles 2904 wrapped around the innermost layer 2802. Figure 30B is a cross section taken along line BB. The next layer 3002 is Figure 31A and includes ten additional wire bundles 3006 wrapped around layer 2902, and Figure 31B A cross section taken along line DD is shown in FIG. Figure 32A As seen in FIG, the outermost layer 3102 includes an additional ten wires 3108 wound around layer 3002, and Figure 32B A cross section taken along line DD is shown in . Those skilled in the art will appreciate that various wire material properties (eg, diameter, tensile strength, etc.) and winding patterns may be used.

[0187] Figures 33A to 37B An alternative embodiment is illustrated in . This embodiment is similar to the previously described embodiment, with the main difference being that the cable is stretched after winding, thereby changing the surface finish and some mechanical properties. Figure 33AThe innermost layer 3202 is shown, and the innermost layer 3202 includes three wires 3204 wound together, such as Figure 33B As shown in a cross section taken along line AA. Figure 34A The next layer 3302 is shown and includes nine wires 3304 wrapped around the innermost layer 3202. Figure 34B A cross section along line BB is shown. Figure 35A The next layer 3402 of wires is shown in FIG. 3 , and the next layer 3402 has ten wires 3404 wound around the previous layer 3302, as shown in FIG. Figure 35B The outermost layer 3502 is shown in a cross section taken along line CC. Figure 36A and includes ten additional wires 3504 wrapped around the previous layer 3402, and Figure 36B A cross section taken along line DD is shown in . The assembly formed from the four layers of wire is then pulled to change the surface finish of the cable and to modify the material properties of the finished cable assembly to desired values. Figure 37A The completed cable assembly 3602 is shown, and Figure 37B A cross section taken along line EE is shown in . Those skilled in the art will appreciate that other cable configurations may be used and that these are merely exemplary embodiments.

[0188] B. Delivery Catheter Shaft

[0189] Figure 38A Pictured Figure 25 348 and 350. In this embodiment, the shaft 302 has a tubular shape with an internal lumen 348 and includes a material such as a braided laminate material that provides hoop strength while maintaining flexibility and kink resistance. Such a material may include a stainless steel braid or coiled wire embedded in a polymer such as polyurethane, polyester, Pebax, Grilamid TR55, and AESNO, to name a few. To provide further support and hoop strength, a support coil 346 is provided within the lumen 348 of the shaft 302, such as Figure 38A As shown in .

[0190] Threaded through the support coil 346 are various elongated bodies, including tubular guides and cylindrical rods. For example, one type of tubular guide is a compression coil 326 that extends from the proximal end 322 of the shaft 302 through the lumen 348 to the distal end 324, and the actuator rod 64 extends through the compression coil 326. Thus, the compression coil typically has a length in the range of 48 inches to 60 inches and an inner diameter in the range of 0.020 inches to 0.035 inches to allow the actuator rod 64 to pass therethrough. The actuator rod 64 can be manipulated to rotate and translate within and relative to the compression coil 326. The compression coil 326 allows lateral flexibility of the actuator rod 64 and therefore lateral flexibility of the shaft 302, while resisting buckling and providing column strength under compression. The compression coil can include 304V stainless steel to provide these properties.

[0191] To provide additional tensile strength to the shaft 302 and minimize elongation, a tensioning cable 344 may also be threaded through the support coil 346. The tensioning cable 344 extends from the proximal end 322 of the shaft 302 through the lumen 348 to the distal end 324. Thus, the tensioning cable 344 typically has a diameter in the range of 0.005 inches to 0.010 inches and a length in the range of 48 inches to 60 inches. In a preferred embodiment, the tensioning cable 344 comprises 304V stainless steel.

[0192] In addition, there can be at least one locking wire spool 341 having a tubular shape having a locking wire lumen 340 through which the locking wire 92 passes between the locking wire handle 310 and the locking mechanism 106. The locking wire spool 341 extends from the proximal end 322 of the shaft 302 through the lumen 348 to the distal end 324. Thus, the locking wire spool 341 typically has a length in the range of 48 inches to 60 inches, an inner diameter in the range of 0.016 inches to 0.030 inches, and an outer diameter in the range of 0.018 inches to 0.034 inches. In a preferred embodiment, the locking wire spool 341 comprises a 304V stainless steel coil, however, other structures or materials that provide kink resistance and compressive strength may also be used.

[0193] Similarly, there can be at least one proximal element spool 343 having a tubular shape, the proximal element spool 343 having a proximal element wire lumen 342. The proximal element wire 90 passes through the lumen 342 between the proximal element wire handle 312 and the proximal element 16. Thus, the proximal element spool 343 extends from the proximal end 322 of the shaft 302 through the lumen 348 to the distal end 324. Thus, the proximal element spool 343 typically has a length in the range of 48 inches to 60 inches, an inner diameter in the range of 0.016 inches to 0.030 inches, and an outer diameter in the range of 0.018 inches to 0.034 inches. In a preferred embodiment, the proximal element spool 343 comprises a 304V stainless steel coil, however, other structures or materials that provide kink resistance and compressive strength may also be used.

[0194] In this embodiment, the elongated body (the actuator rod 64 enclosed by the compression coil 326, the tensioning cable 344, the locking spool 341, and the proximal element spool 343) each "floats" freely in an internal lumen 348 within the support coil 346 and is fixed only to the proximal end 322 and distal end 324 of the shaft 302. The lumen 348 is typically filled with heparinized saline and flushed with heparinized saline during use. Alternatively or in addition, the lumen 348 can be filled with one or more fillers, such as flexible rods, protrusions, extruded segments, gels or other fluids. Preferably, the filler allows some lateral movement or deflection of the elongated body within the lumen 348, but in some cases may restrict such movement. Alternatively, part or all of the length can be formed as an extruded multi-lumen shaft to enhance pushability. Typically, the elongated body is fixed at the proximal and distal ends of the shaft and is free to move laterally and rotationally between the proximal and distal ends of the shaft. This freedom of movement of the elongated body provides increased flexibility for the shaft 302 because the elongated body self-adjusts and repositions during bending and / or twisting of the shaft 302. It will be appreciated that the elongated body may not be fixed at the proximal and distal ends. The elongated body is simply unconstrained in at least one position relative to the shaft 302 so as to be able to move laterally within the lumen 348. Preferably, the elongated body is unconstrained in at least one distal portion of the catheter that is, for example, 5 cm to 15 cm from the distal end 324 so as to provide maximum flexibility in the distal portion.

[0195] Furthermore, additional or alternative elongated bodies may be provided. For example, if needed or desired, such as Figure 38BAs shown in , additional proximal element wire shafts 343 can be provided defining additional proximal element wire lumens 342. For example, and as further embodied herein, four proximal element wire shafts 343 can be provided defining four proximal element wire lumens 342, and two locking wire element shafts 341 can be provided defining two locking wire lumens 340. The size or diameter of the plurality of elongated bodies can be adjusted (e.g., reduced) to accommodate or fit within a shaft of a predetermined cross-sectional profile. Additional accessory lumens can be provided, for example, two additional accessory lumens can be provided.

[0196] However, it will be appreciated that alternative shaft 302 designs may be used. For example, referring to Figure 39 In this embodiment, the shaft 302 again has a tubular shape with an internal lumen 348 and a support coil 346 disposed within the lumen 348 of the shaft 302. Filling the internal lumen 348 within the support coil 346 is an extrusion 334 having lumens through which pass the various elongated bodies including the actuator rod 64 enclosed by the compression coil 326, the tensioning cable 344, the locking spool 341, and the proximal element spool 343, as shown. The support coil 346 and the elongated bodies can have the same geometry and include the same configurations as described above with respect to FIG. Figure 38A The materials are the same as those described above.

[0197] Alternatively, as Figure 40 As shown in FIG, the shaft 302 may include an internal divider 350 to create multiple lumens within the shaft 302. For example, the divider 350 may have a central lumen 352 for passing the actuator rod 64, optionally surrounded by the compression coil 326. Additionally, the divider 350 may also form at least one locking wire lumen 340 for passing the locking wire 92 and at least one proximal element wire lumen 341 for passing the proximal element wire 90. Optionally, each of the lumens defined by the divider 350 may be lined with an anti-kink element, such as the coils of the previous embodiments.

[0198] FIG. 40A to FIG. 40B An embodiment of the nose 318 of the shaft 302 is shown. Figure 40A , nose 318 includes tip ring 280 and locking ring 282. In a preferred embodiment, epoxy and PEBAX are deposited between tip ring 280 and locking ring 282 to bond tip ring 280 and locking ring 282 together. Locking ring 282 has a geometry that cooperates with tip ring 280 to maintain relative alignment between locking ring 282 and tip ring 280. Figure 40B Illustrated is another embodiment of the nose 318 of the shaft 302. Here, the tip ring 280 is covered by a soft tip 284 to provide a more atraumatic tip and a smoother transition to the shaft.

[0199] C. Locking line arrangement

[0200] As previously mentioned, when the lock wire 92 is present, the wire 92 passes through at least one lock wire lumen 340 between the lock wire handle 310 and the locking mechanism 106. The lock wire 92 engages the release wire harness 108 of the locking mechanism 106 to lock and unlock the locking mechanism 106 as previously described. The lock wire 92 can engage the release wire harness 108 in various arrangements, examples of which are described in Figures 41A to 41C In each embodiment, there are two locking wire lumens 340 within the shaft 302 of the delivery catheter 300 that terminates at the nose 318. The lumens 340 are disposed on alternating sides of the actuator rod 64 such that each lumen 340 leads toward the release harness 108.

[0201] Figure 41A The following embodiment is illustrated in which two locking wires 92, 92' are threaded through a single locking wire lumen 340 and through the release wire harness 108 on one side of the actuator rod 64 (for clarity, the actuator rod 64 is shown without a surrounding housing such as a coupling structure). The locking wires 92, 92' are then separated so that each is threaded on an opposite side of the actuator rod 64. The locking wires 92, 92' are then threaded through the release wire harness 108' on the opposite side of the actuator rod 64 and continue together through another single locking wire lumen 340'. This locking wire arrangement is similar to Figure 26 The arrangement is the same as shown in FIG.

[0202] Figure 41B The illustration shows an embodiment in which one lock wire 92 is threaded through a single lock wire lumen 340, through a release wire bundle 108 on one side of the actuator rod 64, and back into the lock wire lumen 340. Similarly, another lock wire 92′ is threaded through another single lock wire lumen 340′, through a different release wire bundle 108′ on the opposite side of the actuator rod 64, and back into another single lock wire lumen 340′.

[0203] Figure 41C The illustration shows an embodiment in which both locking wires 92, 92' are threaded through a single locking wire lumen 340. One locking wire 92 is threaded through the release wire bundle 108 on one side of the actuator rod 64 and then through the other locking wire lumen 340' on the opposite side of the actuator rod 64. The other locking wire 92' is threaded through the other release wire bundle 108' on the other side of the actuator rod 64' and then threaded through the other locking wire lumen 340' along with the previous locking wire 92.

[0204] It will be appreciated that various locking wire arrangements can be used and are not limited to the arrangements illustrated and described above. Various arrangements allow the wire harnesses 108 to be manipulated independently or collectively, allowing for various amounts of tension to be applied, and varying the force required to remove the locking wire when the fixation device is to be left in place. For example, a single locking wire passing through one or two lumens can be connected to two release wire harnesses for simultaneous application of tension.

[0205] D. Proximal component line layout

[0206] As previously mentioned, when the proximal element wire 90 is present, the wire 90 passes through the at least one proximal element wire lumen 342 between the proximal element wire handle 312 and the at least one proximal element 16. As previously mentioned, the proximal element wire 90 engages the proximal element 16 to raise or lower the element 16. The proximal element wire 90 can engage the proximal element 16 in various arrangements, examples of which are described in Figures 42A to 42B In each embodiment, there are two proximal element line lumens 342 within the shaft 302 of the delivery catheter 300 that terminates at the nose 318. The lumens 342 are disposed on alternating sides of the actuator rod 64 (which is shown without a surrounding housing, such as a coupling structure, for clarity) such that each lumen 342 leads toward the proximal element 16.

[0207] Figure 42A The following embodiment is shown: in which one proximal element wire 90 passes through a single proximal element wire lumen 342. The proximal element wire 90 passes through the eyelet 360 of the proximal element 16 on one side of the actuator rod 64, passes over the actuator rod 64 and passes through the eyelet 360' of the other proximal element 16' on the other side of the actuator rod 64. The proximal element wire 90 then passes through another single proximal element wire lumen 342'. The proximal element wire arrangement is similar to Figure 26 The arrangement is the same as shown in FIG.

[0208] Figure 42B The illustration shows an embodiment in which one proximal element wire 90 passes through a single proximal element wire lumen 342, through an eyelet 360 of the proximal element 16 on one side of the actuator rod 64, and returns to the proximal element wire lumen 342. Similarly, another proximal element wire 90' passes through another single proximal element wire lumen 342' on the opposite side of the actuator rod 64 and returns to the other single proximal element wire lumen 342'.

[0209] It will be appreciated that various proximal element wire arrangements may be used and are not limited to the arrangements illustrated and described above. Various arrangements allow for manipulation of the proximal elements independently or collectively, allow for application of various amounts of tension, and vary the force required to remove the proximal element wires when the fixation device is to be left in place. For example, a single proximal element wire passing through one or both lumens in shaft 302 may be used to simultaneously actuate both proximal elements. As another example, two proximal element wires passing through one or more respective lumens in shaft 302 may be used to independently actuate each proximal element.

[0210] E. Main body of the handle

[0211] Figure 43 An embodiment of a handle 304 of a delivery catheter 300 is illustrated. As previously mentioned, the actuator rod handle 316, the actuator rod controller 314, the proximal element wire handle 312, and the locking wire handle 310 are all engaged with the body 318. The handle 304 also includes a support base 306 connected to the body 308. The body 308 can slide along the support base 306 to provide translation of the shaft 302, and the body 308 can rotate about the support base 306 to rotate the shaft.

[0212] Figure 44 Provided Figure 43 , a partial cross-sectional view of the body 308 of the handle 304 depicted in . As shown, the body 308 includes a sealed chamber 370 within which the actuator rod 64, the proximal element wire 90, and the locking wire 92 are guided into the shaft 302. The sealed chamber 370 is in fluid communication with the interior lumen 348 of the shaft 302 and is typically filled with saline and flushed with heparin or heparinized saline. The sealed chamber 370 has a seal 372 along its periphery to prevent leakage and the introduction of air into the chamber 370. Any air in the chamber 370 can be exhausted from the chamber 370 by one or more luer pieces 374 that pass through the body 308 and into the chamber 370, as shown. Figure 43 In this embodiment, the handle 304 includes two such Luer pieces 374, one on each side of the body 308 (the second Luer piece is symmetrically positioned on the Figure 43 308 is hidden from view). Now refer to Figure 44 The seal chamber 370 also has various additional seals, such as an actuator rod seal 376 surrounding the actuator rod 64 at the location where the actuator rod 64 enters the seal chamber 370 and a shaft seal 378 surrounding the shaft 302 at the location where the shaft 302 enters the seal chamber 370.

[0213] F. Locking wire handle and proximal element wire handle

[0214] As previously mentioned, the locking wire 92 can be extended, retracted, loaded with various amounts of tension, or removed using the locking wire handle 310. Likewise, the proximal element wire 90 can be extended, retracted, loaded with various amounts of tension, or removed using the proximal element wire handle 312. Both handles 310, 312 can be similarly designed to manipulate the appropriate wire 90, 92 passing therethrough.

[0215] Figure 45 An embodiment of a locking wire handle 310 having a locking wire 92 passing therethrough is illustrated. The locking wire handle 310 has a distal end 384, a proximal end 382, and an elongated shaft 383 located between the distal end 384 and the proximal end 382. The distal end 384 is positionable within the sealed chamber 370 such that the proximal end 382 extends from the chamber 370 beyond the body 308. The free end of the locking wire 92 is positioned near the proximal end 382 to pass through a wall of the handle 310 near the threaded protrusion 390. The handle 310 also includes a cap 388 positionable on the protrusion 390. The internal threads of the cap 388 mate with the threads on the threaded protrusion 390 such that the cap 388 retains the free end of the locking wire 92 between the cap 388 and the protrusion 390 and / or other portions of the handle 310 by friction. The locking wire 92 passes through a central lumen (not shown) of the elongated shaft 383, extends through the sealed chamber 370 (e.g., Figure 44 ) and extends through the shaft 302 to the locking mechanism 106.

[0216] Disposed near the distal end 384 of the handle 310 is at least one wing 392. Figure 45 In the embodiment shown, two wings 392 are present, each wing 392 disposed on opposite sides of the elongated shaft 383. As shown, the wings 392 extend radially outward and curve proximally, with a portion oriented parallel to the elongated shaft 383. It will be appreciated that the wings 392 may alternatively have the form of a radially extending solid or continuous protrusion and have a portion oriented parallel to the elongated shaft 383. The wings 392 serve to maintain the lock wire handle 310 in a desired position, which in turn maintains the lock under a desired tension load, as will be described further below. The handle 310 also includes a finger grip 386 located near the proximal end 382. The finger grip 386 extends radially outward to align with the radial extension of the at least one wing 392. Thus, a user can determine the orientation of the wings 392 within the sealed chamber 370 by aligning the finger grip 386 on the exterior of the body 308. The finger grip 386 may also serve to aid in the ergonomic manipulation of the handle 310.

[0217] The portion of the wing 392 parallel to the elongated axis 383 has grooves or serrations 394. The serrations 394 are used to apply tension to the locking wire 92. Figure 45A As shown in FIG, the locking wire handle 310 is positioned within a half tube 400 disposed within the sealed chamber 370. The half tube 400 includes an upper half 402 and a lower half 404, each half 402, 404 having grooves or serrations 406 that mate with the serrations 394 of the wings 392. Thus, as shown in FIG. Figure 46A As shown in FIG, when the wings 392 are rotated to engage the serrations 394, 406, the elongated shaft 383 is held in place. Figure 46B As shown in FIG, wings 392 can be rotated so that wings 392 are positioned between halves 402, 404 and serrations 394, 406 are disengaged. In this position, shaft 383 can translate to apply or release tension in locking wire 92. Thus, tension in wire 92 can be adjusted by rotating shaft 383 to disengage serrations 394, 406, translating shaft 383, and then rotating shaft 383 back to reengage serrations 394, 406. Alternatively, finger grip 386 can be pulled to apply tension to locking wire 92. Pulling finger grip 386 causes locking wire handle 310 to translate within half-tube 400. This translation is possible due to the angle of serrations 394, 406 and the flexibility of wings 382. However, the angle of serrations 394, 406 prevents translation in the opposite direction, i.e., by pushing finger grip 386. Thus, to release tension from locking wire 92, shaft 383 is rotated to disengage serrations 394, 406, thereby allowing shaft 383 to translate, and then shaft 383 is rotated back to reengage serrations 394, 406.

[0218] To remove the locking wire 92, the cap 388 is removed from the threaded protrusion 390, exposing the free end of the locking wire 92. If there is a locking wire 92 with two free ends, successively pulling on one of the free ends pulls the entire length of the locking wire 92 out of the catheter 300. If there is more than one locking wire 92, each locking wire 92 will have two free ends. Continuously pulling on one of the free ends of each locking wire 92 pulls the entire length of each locking wire 92 out of the catheter 300.

[0219] It will be appreciated that the proximal element wire handle 312 has features corresponding to the locking wire handle 310 and is configured in a manner similar to that of FIG. Figure 45A 、 Figures 46A to 46B It will also be appreciated that other mechanisms may be used to manipulate the locking wire 92 and the proximal element wire 90, including buttons, springs, levers, and knobs.

[0220] As previously described, such proximal element wire handles can be configured to manipulate the proximal elements independently or collectively. For example, a first proximal element wire handle can be configured to couple to a first proximal element wire and be actuated to deploy the first proximal element wire to move the first proximal element between a first position and a second position, and a second proximal element wire handle can be configured to couple to a second proximal element wire and be actuated to deploy the second proximal element wire to move the second proximal element between a first position and a second position. The first proximal element wire handle and the second proximal element wire handle can be independently movable.

[0221] For example, and as previously referred to Figure 15AC1 As described, the first proximal element line handle and the second proximal element line handle can be aligned in parallel. In this regard, and with reference to Figure 71A , the proximal element wire handles 393A and 393B of the proximal element wire control mechanism 1600 can be configured to allow simultaneous actuation, such that the proximal elements 16A and 16B are actuated simultaneously, and / or configured to allow independent actuation, such that the proximal elements 16A and 16B can be moved independently. Each of the first and second proximal element wire handles can have some or all of the features of the proximal element wire handle 312 described above, including, for example, a finger grip 386 near the proximal end 382 that can extend radially outwardly to align with the at least one wing 392.

[0222] Additionally, the proximal element wire control mechanism 1600 can include independently actuatable proximal element wire handles 393A and 393B, each connected to a collar 1602. The collar 1602 can be configured to attach to the handle 304 of the delivery catheter, which can allow the proximal element wire control mechanism 1600 to be attached without having to modify the remaining handle components of a handle having a single proximal element wire handle. Thus, the handle 304 can be used with a proximal element wire control mechanism that uses a single proximal element wire handle, and as embodied herein, the handle 304 can be used with a proximal element wire control mechanism that uses two proximal element wire handles, such as the proximal element wire control mechanism 1600.

[0223] Reference Figures 71A to 71C and Figure 72, the proximal element line handles 393A and 393B can include end caps 1604A and 1604B. Each of the end caps 1604A and 1604B can include a finger grip portion, such as one or more side recessed portions 1606A and 1606B and / or one or more top recessed portions 1608A and 1608B. The side recessed portions 1606A and 1606B can be configured to align when the end caps 1604A and 1604B are aligned. Similarly, the top recessed portions 1608A and 1608B can be configured to align when the end caps 1604A and 1604B are aligned. In this manner, the placement of the side recessed portions 1606A and 1606B can form a combined side recessed recess 1606. For example, when an operator uses a pinching and pulling motion, the combined side concave recesses 1606 can facilitate simultaneous actuation of the proximal element wire handles 393A and 393B. The concave recesses can be formed on opposite sides of the end caps 1604A and 1604B. Similarly, the placement of the top concave portions 1608A and 1608B can form a combined top concave recess 1608 on the tops of the end caps 1604A and 1604B that can facilitate simultaneous actuation of the proximal element wire handles 393A and 393B using a single finger pushing motion (e.g., a pushing motion).

[0224] The end caps 1604A and 1604B can have various shapes to facilitate simultaneous and independent movement of the first proximal element wire handle 393A and the second proximal element wire handle 393B. Figure 73 As shown in FIG, end caps 1604A and 1604B can be formed as protrusions extending in opposite directions. The protrusions can be grasped by an operator simultaneously or independently and thus can be actuated simultaneously or independently. Figures 74A to 74B As shown in , end caps 1604A and 1604B can be formed as rings, for example, each sized to receive one or more corresponding fingers of an operator. The distal end of the proximal element wire handle can include a ratchet feature such as wings 392, which can be used to lock the handle in a desired position, as described herein. As embodied herein, control mechanism 1600 can include a thumb press to stabilize the operator's hand when pulling one or both proximal element wire handles 393A and 393B.

[0225] In further accordance with the disclosed subject matter, the proximal element wire handles 393A and 393B can be operatively coupled or connected to further facilitate simultaneous actuation of the proximal elements 16A and 16B, as discussed herein. For example, and with reference to Figures 75A to 75B 、 Figures 76A to 76H and Figures 77A to 77BFor purposes of illustration and not limitation, the proximal element wire handles 393A and 393B may include an interlock 1610 that is movable between an unlocked position in which the first proximal element wire handle 393A and the second proximal element wire handle 393B are independently actuable and a locked position in which the first proximal element wire handle 393A and the second proximal element wire handle 393B are coupled together so as to be actuable together. The interlock 1610 may be fixedly or movably coupled to the first proximal element wire handle 393A and removably coupled to the second proximal element wire handle 393B. The interlock 1610 may include, for example, a latch 1611 and a recess 1612. As Figure 75A 、 Figure 76A 、 Figure 76C and Figure 76E As shown in FIG, in the locked position, the latch recess 1612 can receive the latch 1611 so that the proximal element wire handles 393A and 393B are operably connected for simultaneous actuation. Figure 75B 、 Figure 76B 、 Figure 76D and Figure 76F As shown in FIG, in the unlocked position, the latch 1611 can be removed from the recess 1612 so that the proximal element wire handles 393A and 393B are not operatively connected and can be actuated independently. The latch 1611 can be configured to move linearly (e.g., as shown in FIG. Figures 75A to 75B ), rotational movement (e.g., as Figures 76A to 76D ), or move with any suitable motion to lock and unlock the interlocking portion. Figures 76C to 76H As shown in FIG, for purposes of illustration and not limitation, the latch 1611 and the recess 1612 can have complementary dovetail shapes 1613. When the latch 1611 is engaged with the recess 1612, the dovetail shape 1613 can limit the proximal element wire handles 393A and 393B from being pulled apart from each other. The dovetail shape 1613 can also prevent the interlock from switching between a locked position and an unlocked position. The dovetail shape 1613 can be symmetrical or asymmetrical. For example, the dovetail shape 1613 can be an asymmetrical taper. For example, as Figure 76G As shown in , for purposes of illustration and not limitation, at least the dovetail shape 1613 of the latch 1611 can have a first height or thickness at a first side 1611A of the latch 1611 and increase to a second height or thickness at a second side 1611B of the latch 1611, wherein the second height or thickness is greater than the first height or thickness. Because the first side 1611A of the latch 1611 is directed toward the recess when in the unlocked state, the asymmetrical shape can allow the latch to more easily engage the recess when the proximal element line handles 393A and 393B are not perfectly aligned. The recess 1612 can be provided with a complementary asymmetrical taper 1613. As shown in FIG. Figures 76G to 76H As shown in FIG, for purposes of illustration and not limitation, the latch 1611 may include a catch 1611C that may be received in stops 1617A and 1617B provided in the end cap 1604B of the proximal element wire handle 393B to retain the latch 1611. For example, the stop 1617B may retain the latch 1611 in the locked position ( Figure 76G ), and the stopper 1617A can hold the latch 1611 in the unlocked position ( Figure 76H ). The latch 1611C can be provided on the cantilever 1611D. The latch 1611C and the stops 1617A, 1617B can provide a form-fitting snap at each position to let the user know that he or she has changed positions and to prevent accidental movement of the latch. A locking bar 1614 can be provided to facilitate movement of the latch 1611. Actuation of the interlock 1610 between the locked position and the unlocked position can be performed with a single hand or a single finger. Either the latch 1611 and the recess 1612 can be provided in either the first proximal element line handle 393A or the second proximal element line handle 393B.

[0226] According to the disclosed subject matter, the interlock can be configured such that rotational movement can move the interlock 1610 into a locked position (e.g., Figure 77A ) and the unlocked position (as shown in Figure 77B For example, and as Figures 77A to 77B As shown in , rotation of end cap 1604A can cause interlock 1610 to move between a locked position and an unlocked position. Thus, rather than providing a movable latch, the interlock can be fixedly coupled to end cap 1604A or integrally formed with end cap 1604 such that the interlock can be moved between a locked position and an unlocked position by rotation of one of end caps 1604A or 1604B or by rotation of the entire proximal element wire handle 393A or 393B. Recess 1620 can facilitate rotation of interlock 1610, and as embodied herein, ribs 1622 and grooves 1623 can be provided to limit overall rotational movement.

[0227] According to the disclosed subject matter, the proximal element wire handles can be coaxially aligned as described herein with reference to Figure 15AC2 This configuration may allow for simultaneous actuation or independent actuation of the first and second proximal element wire handles, and thus simultaneous actuation or independent movement of the proximal elements, respectively.

[0228] The various configurations and features mentioned herein can be similarly provided with a first proximal element line handle and a second proximal element line handle coaxially aligned. For example, and with reference to Figures 78A to 78CFor purposes of illustration and not limitation, the proximal element wire handles are shown as being coaxially aligned. Each proximal element wire handle 393A and 393B can include a finger grip 386A and 386B. The proximal element wire handles 393A and 393B can be rotated to cause the finger grips 386A and 386B to align or misalign. Figure 78A Two coaxially aligned proximal element wire handles 393A and 393B are shown in a raised position. Figure 78B The proximal element line handle 393A is shown in a lowered position and the proximal element line handle 393B is shown in a raised position. Figure 78C Two coaxially aligned proximal element line handles 393A and 393B are shown in a lowered position. Thus, the proximal element line handles can be actuated simultaneously or independently from a raised position to a lowered position.

[0229] In addition, and as referred to herein Figure 45 The locking wire handle embodiment described, Figure 79 The proximal element wire handles include, for example, a first proximal element wire handle 393A and / or a second proximal element wire handle 393B having a finger grip 386A disposed near the proximal end 382, the finger grip 386A being extendable radially outwardly to engage with at least one wing 392 (e.g., see Figure 45 ) alignment. The second proximal element wire handle 393B can be threaded into the first proximal element wire handle 393A and can be operated by rotating the finger grip 386B. A cap 388, such as described herein, can also be provided.

[0230] In further accordance with the disclosed subject matter, interlock 1610 can be locked and unlocked by button 1615, as shown. Figure 80 As previously described, the interlock can be configured to move between an unlocked position in which the first and second proximal element wire handles are independently actuable and a locked position in which the first and second proximal element wire handles are coupled together so as to be actuable together. For example, the interlock can include any of the various latch and recess configurations described herein. Additionally or alternatively, and as Figure 81 , for purposes of illustration and not limitation, interlock 1610 can be a removable element, such as removable buckle 1616. Interlock 1610 can be in a locked position when removable buckle 1616 is coupled to the handle, and interlock 1610 can be in an unlocked position when removable buckle 1616 is removed from the handle. The removable element is not limited to a buckle and can be any practical design, such as a pin or the like.

[0231] As previously mentioned Figure 15AC3 and Figure 15AC4As described, the first proximal element line handle and the second proximal element line handle can be actuated by a rotatable switch. Figures 82A to 82B and Figures 83A to 83B For purposes of illustration and not limitation, the proximal element line handles 393A and 393B of the control mechanism 1600 may include a first rotatable switch 1624A and a second rotatable switch 1624B configured to rotate and move about a central axis 1626. The rotatable switch 1624A may be connected to the proximal element line 90A such that actuation of the rotatable switch 1624A about the central axis 1626 causes the proximal element 16A to move between a first position and a second position. Similarly, the rotatable switch 1624B may be connected to the proximal element line 90B such that actuation of the rotatable switch 1624B about the central axis 1626 causes the proximal element 16B to move. In this manner, a visual cue as to the position of the proximal elements 16A and 16B may be provided. For example, as the switches are raised together (e.g., as Figure 82A ), the rotatable switches 1624A and 1624B may be similar to the proximal elements 16A and 16B in the raised portion. As the switch is depressed (e.g., as shown in FIG. Figure 82B ), rotatable switches 1624A and 1624B may be similar to proximal elements 16A and 16B in a lowered position. If desired, rotatable switches 1624A and 1624B may be coupled with a planetary gear and / or clutch system (not shown) to allow simultaneous actuation of the proximal element line switches, and thus simultaneous movement of proximal elements 90A and 90B.

[0232] To actuate the proximal element wires using the rotatable switches, the proximal element wires 90A and 90B may be wound around a spool (not shown) coupled to the rotatable switches 1624A and 1624B. Figures 83A to 83B As shown in FIG, rotatable switches 1624A and 1624B may include a gear and rack arrangement. For example, rotating switch 1624A may engage gear 1618A and move rack 1619A axially, and rotating switch 1624B may engage gear 1618B and move rack 1619B axially. Switches 1624A and 1624B may be disposed on the same side of the proximal element line (e.g., as shown in FIG. Figure 83A ) or on the opposite side of the proximal element line (e.g., as shown in Figure 83B ).

[0233] According to the disclosed subject matter, and with reference to Figure 72 、 Figures 76A to 76B and Figures 82A to 82BFor purposes of illustration and not limitation, one or both of the proximal element wire handles 393A, 393B can include a marking, such as a tactile marking 1628, such as a single dimple. The operator can use the tactile marking to determine and identify which of the proximal element wire handles 393A, 393B, for example, by actuating the corresponding proximal element 16A. Additionally, the corresponding proximal element 16A can be provided with a corresponding radiopaque or echogenic marking. If desired, the other proximal element wire handle 393B and the corresponding proximal element 16B can each be provided with corresponding markings, such as two dimples and two radiopaque or echogenic markings. The markings 1628 can allow the operator to know which proximal element wire handle 393A, 393B to actuate to control the corresponding proximal element 16A, 16B on the anterior side of the mitral valve and which proximal element wire handle 393A, 393B to actuate to control the corresponding proximal element 16A, 16B on the posterior side of the mitral valve, when needed, which can ensure capture or alternatively release of the correct leaflet. In addition to or as an alternative to the tactile markings, the markings can be visual markings, for example, but not limited to, the proximal element wire handles 393A and 393B can be different colors or have different color markings provided on the proximal element wire handles 393A and 393B.

[0234] In this manner, and in accordance with the disclosed subject matter, various methods are provided for mapping proximal element wire handles 393A, 393B to proximal elements 16A, 16B. For example, the first arm 53A and the first proximal element 16A can be positioned on a first side of the implant, and the second arm 53A and the second proximal element 16B can be positioned on a second side of the implant. In this manner, it is possible to determine which proximal element wire handle 393A, 393B controls each side of the implant. For purposes of illustration and not limitation, the echogenicity of the implantable fixation device 14 can be used. For example, one or more components of the fixation device 14 can be made more or less echogenic, such that one side of the fixation device 14 is more or less echogenic than another side. For example, the proximal element 16A, a covering on the proximal element 16A, and / or the proximal element wire 90A can be coated or provided with an echogenic material. Additionally or alternatively, a ring with echogenic material can be placed on one side of the implant, while a ring with more or less echogenic material can be placed on the other side of the implant. For example, the ring can be made of half stainless steel and half plastic. As implemented herein, for example, a small electrical current delivered by an operator through one of the proximal element wires 90A, 90B can make the proximal element wire 90A or 90B more echogenic than the other when an electrical signal passes through it. The operator can perform a test actuation to confirm that the proximal element wire handles 393A, 393B correspond to the respective proximal elements 16A, 16B.

[0235] Reference Figure 84 and Figure 85 , for purposes of illustration and not limitation, variable fluoroscopy can be used to map the proximal element wire handles 393A, 393B to the proximal elements 16A, 16B. As an example, a first side of the fixture 14 can have a different fluoroscopy than a second side. For example, a radiopaque marker 1629 can be placed on one side of the fixture 14, such as on one of the arms 53 or the proximal elements 16. For example, placement of the radiopaque marker can include crimping a metal band (Au, Ptlr, Ta, etc.) to one of the arms 53 or the proximal elements 16. The marker can be placed on the arm (1629A), at the tip of the arm (1629B), or around the arm (1629C). As Figure 84 As shown in , a marker is placed on one of the two device arms or proximal elements to provide an asymmetric reference feature on the clip device. This feature is useful because it helps the user understand which proximal element is responding (moving) when one of the proximal element wire handles is actuated. When treating the mitral valve, the radiopaque marker provides a visual cue (under X-ray imaging) that helps the user identify or remember which proximal element wire handle corresponds to grasping the anterior leaflet or the posterior leaflet. Additionally or alternatively, the radiopaque material (Au, Ptlr, Ta, etc.) can be woven into one end of the covering 100 as a strand, for example, as Figure 85 The operator may perform a test actuation to confirm that the proximal element wire handles 393A, 393B have tactile markings 1628 that correspond to the sides of the fixation device that include radiopaque markings.

[0236] Furthermore, once the fixation device 14 has been aligned with the mitral valve in the left atrium, the operator can repeatedly actuate the proximal element wire handle 393A having the tactile marker 1628. Such repeated actuation of the proximal element wire handle 393 can result in a "swinging" motion of the corresponding proximal element 16 being raised and lowered by actuation of the proximal element wire handle 393 having the tactile marker 1628. Thus, the operator can confirm which side of the mitral valve (anterior or posterior) the "swinging" proximal element is positioned on and which proximal element wire handle 393 is associated with that side during the procedure.

[0237] As further disclosed herein, and with reference to Figure 86 and Figure 87For purposes of illustration and not limitation, the delivery catheter shaft 302 can include one or more flow conduits 1660 extending from a proximal end portion to a distal end portion. The distal end portion of the flow conduit can be positioned adjacent a first side of the implantable fixation device 14. The proximal end portion of the flow conduit 1660 can be associated with a proximal element wire handle 393. The proximal element wire handle 393 can have a flow port, such as a Luer connector or the like, to attach a reservoir (e.g., a syringe or plunger) to flush a radiopaque fluid 1664 through the flow conduit 1660. For example, and as Figure 86 As shown in , both proximal element wire handles 393A and 393B can be provided with syringes or plungers 1662A and 1662B to flush radiopaque fluid through flow conduits 1660A and 1660B, respectively. Alternatively, each proximal element wire handle itself can be provided with a reservoir of radiopaque fluid and a plunger or syringe to push the radiopaque fluid through the corresponding flow port and flow conduit. Figure 87 As shown in , for example, when the radiopaque fluid 1664 is flushed through the flow conduit 1660A, the fluid 1664 will be directed toward the first side of the implant, and the operator can confirm which side of the mitral valve (anterior or posterior) the first proximal element wire handle 393A is associated with, for example, based on the location where the visible fluid 1664 is ejected.

[0238] As described herein, a single proximal element line may be provided, or a first proximal element line and a second proximal element line may be provided. As described herein, the proximal element line may extend through the shaft 12, through the proximal elements 16A, 16B, and may extend back through the shaft 12 (e.g., as described herein). Figure 42A Alternatively, each proximal element line 90A, 90B may extend through the shaft 12, through the respective proximal element 16A, 16B, and each proximal element line 90A, 90B may extend back through the shaft (e.g., as shown in FIG. Figure 42B , which depicts proximal element wires 90, 90' received through lumens 342, 342', respectively). Alternatively, each proximal element wire 90A, 90B can extend through the shaft 12, through the respective proximal element 16A, 16B, and each proximal element wire 90A, 90B can be coupled to the shaft 12 and / or coupling member 19 (e.g., as shown in FIG. Figure 15I ).

[0239] In accordance with the disclosed subject matter, a first proximal element wire can include a first end portion, a second end portion, and an intermediate portion located between the first end portion and the second end portion. Similarly, a second proximal element wire can include a first end portion, a second end portion, and an intermediate portion located between the first end portion and the second end portion. The first end portion of proximal element wire 90A can be coupled to a proximal element wire handle 393A, and the first end portion of proximal element wire 90B can be coupled to a proximal element wire handle 393B. As discussed herein, various configurations can be provided to couple one or both ends of each proximal element wire to a corresponding proximal element wire handle. For example, and with reference to Figures 88A to 88B , the proximal element wire handle 393A can have a lumen through which the pin 1630 passes. The pin can have a first half 1632 and a second half 1634, each half having teeth 1636 and complementary tooth recesses 1638, the tooth recesses 1638 being configured to receive the opposing teeth 1636 of the opposing half. The first half 1632 and the second half 1634 of the pin 1630 can be press-fit into the lumen of the proximal element wire handle 393A, and the proximal element wire 90A (not shown) can extend between the two halves 1632, 1634 of the pin 1610. The teeth 1636 can improve the grip or "bite" of the two halves 1632, 1634 on the proximal element wire 90A. As Figure 88B As shown in , for purposes of example and not limitation, the lumen of the proximal element wire handle 393A can be hexagonal in cross-section and the pin 1610 can be circular in cross-section and sized to be compressed when inserted into the lumen.

[0240] As an alternative, and with reference to Figure 89 For purposes of illustration and not limitation, the proximal element wire handle 393A can have a lumen with a central axis and a screw 1650 positioned therein. The screw 1650A can have a lumen with a collet 1652A therein, the collet 1652A having fingers 1654A. The proximal element wire 90A can be disposed within a recess formed within the fingers 1654A. When the screw 1650A is tightened, the collet fingers 1654A can tighten downward and grip the proximal element wire 90A. In this regard, the proximal element wire 90A can be secured in a tensioned or untensioned state. Setting the proximal element wire 90A in a tensioned state can facilitate the manufacturing process. The proximal element wire 90B can be coupled to the proximal element wire handle 393B using a similar collet system.

[0241] As another alternative, and with reference to Figure 90For purposes of illustration and not limitation, each of the first and second proximal element wire handles 393A can include a lumen with a central axis and a ratchet 1640 positioned therein. The ratchet 1640 can include one or more ratchet prongs 1644 that can engage one or more ratchet recesses 1646 within the lumen of the proximal element wire handle 393A. As embodied herein, the ratchet can be rotated in one direction by turning a knob or using a screwdriver, hex wrench, or the like. Each proximal element wire 90A can be wound around the ratchet 1640, which couples the proximal element wire 90A to the proximal element wire handle 393A. The ratchet prongs 1646 and ratchet recesses 1646 inhibit or prevent rotational movement of the ratchet 1640 in the opposite direction. The lumen of each proximal element wire handle 393A, 393B can also include a tapered portion 1648. The tapered portion 1648 of the proximal element wire handle 393A can guide the corresponding proximal element wire 90A radially outward from the central axis of the proximal element wire handle lumen, which can facilitate the winding of the proximal element wire 90A around the ratchet 1640 when the knob is rotated. If desired, a release mechanism can be provided for each proximal element wire handle to release the ratchet.

[0242] G. Actuator rod controller and handle

[0243] The actuator rod 64 may be manipulated using an actuator rod controller 314 and an actuator rod handle 316 . Figure 47 A cross-sectional view of a portion of the handle 304 including the actuator rod control 314 and the actuator rod handle 316 is provided. The actuator rod handle 316 is located at the proximal end of the handle 314. The actuator rod handle 316 is fixedly attached to the proximal end of the actuator rod 64. The actuator rod 64 is inserted through a collet 426, which is disposed within a retainer 428 as shown. The retainer 428 has external threads 434 that mate with the internal threads 432 of the actuator rod control 314. Thus, rotation of the actuator rod control 314 causes the retainer 428 to translate along the actuator rod control 314 via the action of the threads, as will be described in more detail below. The actuator rod control 314 is rotatably coupled to the body 308 of the handle 304 and is held in place by a lip 430.

[0244] Reference Figure 47A, the actuator rod controller 314 can be manually rotated in a clockwise or counterclockwise direction, as indicated by arrow 436. Rotation of the actuator rod controller 314 causes the actuator rod 64 to translate (extend or retract) to manipulate the distal element 18 of the fixture 14. Specifically, rotation of the actuator rod controller 314 causes the external threads 434 of the adjacent retainer 428 to translate along the mating internal threads 432 of the actuator rod controller 314. Rotation of the retainer 428 itself is prevented by retaining pins 424 that protrude from the retainer 428 and are embedded in recesses 438 in the body 308 of the handle 304. As the retainer 428 translates, each retaining pin 424 translates along its corresponding recess 438. Because the collet 426 is attached to the retainer 428, the collet 426 translates along with the retainer 428. To simultaneously translate the actuator rod 64, the actuator rod 64 is removably attached to the collet 426 by a pin 422. The pin 422 may have any suitable form, including, for example, Figure 47 The portion shown in FIG4 is a clip shape wrapped around the collet 426. Thus, rotation of the actuator rod controller 314 provides fine control over the translation of the actuator rod 64 and, therefore, the positioning of the distal element 18.

[0245] Reference Figure 47B As shown, removal of pin 422 allows the actuator rod handle 316 and the fixedly attached actuator rod 64 to be disengaged from the collet 426. Once disengaged, the actuator rod 64 can be rotated by manually rotating the actuator rod handle 316, as indicated by arrow 440. As previously described, rotation of the actuator rod 64 engages or disengages the threaded adapter 332 of the delivery catheter 300 with the threaded stud 74 of the fixture 14. This serves to attach or detach the fixture 14 from the delivery catheter 300. Additionally, when the actuator rod 64 is in the disengaged state, the actuator rod 64 can be optionally retracted and optionally removed from the catheter 300 by pulling the actuator rod handle 316 and withdrawing the actuator rod 64 from the handle 304.

[0246] Depending on the application, the location of the target site and the selected method, the device of the disclosed subject matter can be modified or used in combination with other devices known in the art in a manner well known to those skilled in the art. For example, the delivery catheter can be modified in length, rigidity, shape and maneuverability for the desired application. Similarly, the orientation of the fixture relative to the delivery catheter can be inverted or otherwise changed. The actuating mechanism can be changed to be driven in alternating directions (push to open, pull to close, or pull to open, push to close). The material and design can be changed to, for example, more flexible or more rigid. And the fixture components can be changed to components of different sizes or shapes. In addition, the delivery catheter of the disclosed subject matter can be used to deliver other types of devices, particularly intravascular and minimally invasive surgical devices for angioplasty, plaque resection, stent delivery, embolic filtration and removal, septal defect repair, tissue approach and repair, vascular clamping and ligation, suturing, aneurysm repair, vascular occlusion, electrophysiological mapping and ablation, etc. Therefore, the delivery catheter of the disclosed subject matter can be used in applications where a highly flexible, kink-resistant device with high compressive, tensile and torsional strength is required.

[0247] H. Pusher handle design

[0248] After successfully engaging and grasping the leaflet, typically at an angle between 120 and 180 degrees, the distal element of the fixation device is manipulated by manually rotating the actuator rod 64. This causes the distal element to move proximally, for example, by an angle of 60 degrees. Figure 11B However, referring to Figure 15B As the angle between the distal elements 18 decreases, the clamp pusher 81 and the proximal element actuator 90 also need to be retracted. Figure 70 An embodiment of a handle that coordinates these movements is shown. As shown in the figure, Figure 44 The proximal element wire handle 312 is fitted with a spring loaded pusher attachment 414 which is connected to a clamp pusher actuator 411 which extends to the clamp pusher 81 of the fixture. The spring loaded pusher attachment 414 surrounds the proximal element wire 90 but moves independently of the proximal element wire 90. The spring 413 is used to provide tension on the proximal element wire 90 by applying a small force on the clamp pusher 81 relative to the clamp pusher actuator. In addition, the clamp pusher actuator wire 412 is coupled to the actuator rod 64 so that when the actuator rod 64 is actuated to close the distal element 18, the clamp pusher 81 is retracted. As Figure 70As shown in FIG, pusher actuator wire 412 interacts with spring-loaded pusher attachment 414 to retract spring-loaded pusher attachment 414 when distal element 18 is closed. On the other hand, the distal end of pusher actuator wire 412 is configured to slide distally relative to spring-loaded pusher attachment 414, such that distal movement of gripper pusher 81 is independent of movement of distal element 18. This allows for separation between proximal element 16 and distal element 18 to assist in grasping the leaflets. Finally, due to the spring coupling between spring-loaded pusher attachment 414 and proximal element wire handle 312, proximal element actuator 90 also retracts as gripper pusher actuator 411 retracts. Notably, due to the spring coupling via spring 413, proximal element actuator 90 is allowed to travel further than gripper pusher actuator 411. This additional travel is allowed via expansion of spring 413 and serves to remove slack in the proximal element actuator as the angle between proximal element 16 and distal element 18 decreases.

[0249] 7. 5.Multi-catheter guidance system

[0250] A. Overview of the Guidance System

[0251] Reference Figure 48 , illustrates an embodiment of a multi-catheter guiding system 1 of the presently disclosed subject matter. System 1 includes an outer guiding catheter 1000 having a proximal end 1014, a distal end 1016, and a central lumen 1018 extending therethrough, and an inner guiding catheter 1020 having a proximal end 1024, a distal end 1026, and a central lumen 1028 extending therethrough, wherein, as shown, the inner guiding catheter 1020 is coaxially positioned within the central lumen 1018 of the outer guiding catheter 1000. The distal ends 1016, 1026 of the catheters 1000, 1020, respectively, are sized to be capable of passing through a body lumen, typically a body lumen such as a blood vessel. Thus, distal end 1016 preferably has an outer diameter in the range of approximately 0.040 inches to 0.500 inches, more preferably in the range of 0.130 inches to 0.320 inches. Central lumen 1018 is sized for passage of inner guide catheter 1020; distal end 1026 preferably has an outer diameter in the range of approximately 0.035 inches to 0.280 inches, more preferably in the range of 0.120 inches to 0.200 inches. Central lumen 1028 is sized for passage of various devices. Thus, central lumen 1028 preferably has an inner diameter in the range of approximately 0.026 inches to 0.450 inches, more preferably in the range of 0.100 inches to 0.180 inches.

[0252] Figure 48 The diagram illustrates an interventional catheter 1030 positioned within the inner guide catheter 1020, which may optionally be included in the system 1, although other interventional devices may be used. The interventional catheter 1030 has a proximal end 1034 and a distal end 1036, wherein an interventional tool 1040 is positioned at the distal end 1036. In this embodiment, the interventional tool 1040 comprises a detachable fixing device or clip. Optionally, as shown, the interventional catheter 1030 may further comprise a nose piece 1042 having a stopper 1043. The stopper 1043 prevents the interventional tool 1040 from entering the central lumen 1028 of the inner guide catheter 1020. Thus, the interventional catheter 1030 can be advanced and retracted until the stopper 1043 contacts the distal end 1026 of the inner guide catheter 1020, thereby preventing further retraction. This may provide certain advantages in some procedures. It will be appreciated that in embodiments including such a stopper 1043, the interventional catheter 1030 will be preloaded within the inner guide catheter 1020 for advancement through the outer guide catheter 1000, or both the interventional catheter 1030 and the inner guide catheter 1020 will be preloaded into the outer guide catheter 1000 for advancement to the target tissue. This is because the stopper 1043 prevents the interventional catheter 1030 from being advanced through the inner guide catheter 1020.

[0253] The outer guide catheter 1000 and / or the inner guide catheter 1020 are pre-bent and / or have a steering mechanism to position the distal ends 1016, 1026 in a desired direction, the embodiment of the steering mechanism being described in detail below. The pre-bending or steering of the outer guide catheter 1000 directs the distal end 1016 in a first direction to produce a primary curve, while the pre-bending and / or steering of the inner guide catheter 1020 directs the distal end 1026 in a second direction different from the first direction to produce a secondary curve. The primary curve and the secondary curve together form a compound curve. Advancement of the interventional catheter 1030 through the coaxial guide catheters 1000, 1020 directs the interventional catheter 1030 through the compound curve in a desired direction, typically in a direction that will allow the interventional catheter 1030 to reach its target.

[0254] The steering of the outer guide catheter 1000 and the inner guide catheter 1020 can be achieved by actuation of one or more steering mechanisms. The actuation of the steering mechanisms is achieved by using the following actuators: the actuators are usually located on the handles connected to each of the catheters 1000, 1020. Figure 48, handle 1056 is connected to the proximal end 1014 of the outer guide catheter 1000 and remains outside the patient's body during use. Handle 1056 includes a steering actuator 1050 that can be used to bend, arc, or reshape the outer guide catheter 1000, such as to form a primary curve. As shown, handle 1057 is connected to the proximal end (not shown) of the inner guide catheter 1020 and can optionally be connected to handle 1056 to form a larger handle. Handle 1057 includes a steering actuator 1052 that can be used to bend, arc, or reshape the inner guide catheter 1020, such as to form a secondary curve, and to move the distal end 1026 of the inner guide catheter 1020 by an angle θ, as will be described in a later section.

[0255] In addition, locking actuators 1058, 1060 can be used to actuate a locking mechanism to lock the catheters 1000, 1020 in a particular position. Actuators 1050, 1052, 1058, 1060 are illustrated as buttons, however, it will be appreciated that these and any additional actuators located on handles 1056, 1057 can have any suitable form, including knobs, thumbwheels, levers, switches, latches, sensors, or other devices. Other embodiments of the handles will be described in detail in later sections.

[0256] Additionally, the handle 1056 may include a digital or graphical display 1061 of information, such as data indicating the position of the catheters 1000, 1020 or the forces on the actuators. It will also be appreciated that the actuators 1050, 1052, 1058, 1060 and any other buttons or screens may be provided on a single handle connected to both catheters 1000, 1020.

[0257] B. Sample Location

[0258] Figures 49A to 49D Examples of positions in which the catheters 1000, 1020 may be maintained are shown. Figure 49A , the outer guide catheter 1000 can be pre-bent and / or steered into a position that includes a main curve 1100. The main curve 1100 typically has a radius of curvature 1102 in the range of about 0.125 inches to 1.000 inches, preferably in the range of about 0.250 inches to 0.500 inches, or forms a curve in the range of about 0° to 120°. As shown, when this position includes only the main curve 1100, the distal end 16 lies in a single plane X. The axis x that passes transversely through the center of the central lumen 18 at the distal end 16 lies in plane X.

[0259] Reference Figure 49B, inner guide catheter 1020 extends through central lumen 1018 of outer guide catheter 1000. Inner guide catheter 1020 can be pre-bent and / or steered into a position that includes secondary curve 1104. Secondary curve 1104 typically has a radius of curvature 10600 in the range of approximately 0.050 inches to 0.750 inches, preferably in the range of approximately 0.125 inches to 0.250 inches, or forms a curve in the range of approximately 0° to 180°. Secondary curve 1104 can lie in the same plane as primary curve 1100, namely plane X, or it can lie in a different plane, such as plane Z as shown. In this example, plane Z is substantially orthogonal to plane X. An axis z, which passes transversely through the center of central lumen 1028 of inner guide catheter 1020 at distal end 1026, lies in plane Z. In this example, the x-axis and the z-axis are at an angle of approximately 90 degrees relative to each other; however, it will be appreciated that the x-axis and the z-axis may be at any angle relative to each other. Furthermore, while in this example the primary curve 1100 and the secondary curve 1104 lie in different planes, particularly substantially orthogonal planes, the curves 1100 and 1104 may alternatively lie in the same plane.

[0260] Now refer to Figure 49C , the inner guide catheter 1020 can be further manipulated to allow the distal end 1026 to move an angle θ1070. Angle θ1070 is in the range of approximately -180° to +180°, typically in the range of -90° to +90°, and may be in the range of -60° to +60°, -45° to +45°, -30° to +30°, or less. As shown, angle θ1070 lies in plane Y. In particular, axis y extending through the center of the central lumen 1028 at the distal end 1026 forms an angle θ1070 with axis z. In this example, plane Y is orthogonal to both plane X and plane Z. Axes x, y, and z all intersect at a point within the central lumen 1028 that also coincides with the intersection of planes X, Y, and Z.

[0261] Similarly, Figure 49DThe diagram illustrates movement of the distal end 1026 through an angle θ1070 on opposite sides of the axis z. Again, the angle θ1070 is measured from the axis z to the axis y, which extends through the center of the central lumen 1016 at the distal end 1026. As shown, the angle θ1070 lies in plane Y. Thus, the primary curve 1100, the secondary curve 1104, and the angle θ1070 can all lie in different planes, and optionally in orthogonal planes. However, it will be appreciated that the planes in which the primary curve 1100, the secondary curve 1104, and the angle θ1070 lie can be interdependent, and thus allow for the possibility that some of the primary curve 1100, the secondary curve 1104, and the angle θ1070 lie in the same plane.

[0262] Additionally, the outer guide catheter 1000 may be pre-shaped and / or steerable to provide additional curves or shapes. Figure 50A As shown in FIG, an additional curve 1110 can be formed by the outer guide catheter 1000 adjacent to the main curve 1100. In this example, the curve 1110 elevates or raises the distal end 1016 of the outer guide catheter 1000, which in turn raises the distal end 1026 of the inner guide catheter 1020. This elevation Figure 50B . Here, system 1 is shown in dashed lines before being raised, with axis y' passing through the intersection of axis z and axis x'. After applying curve 1110, the distal portion of system 1 is raised in the direction of axis z, so that axis x' is raised to axis x" and axis y' is raised to axis y". This raises distal end 1026 to the desired height.

[0263] Figures 49A to 49D and Figures 50A to 50B The hinged position of the multi-catheter introducing system 1 shown in FIG. 1 is particularly useful for accessing the mitral valve. Figures 51A to 51D A method of accessing the mitral valve MV using the system 1 is illustrated. To access the mitral valve, an external guide catheter 1000 may be tracked over a dilator and guidewire from a puncture in the femoral vein, through the inferior vena cava and into the right atrium. Figure 51AAs shown in , the outer guide catheter 1000 can be punctured through the fossa F in the atrial septum S. The outer guide catheter 1000 is then advanced through the fossa F and bent by the main curve 1100 so that the distal end 1016 is guided across the mitral valve MV. Again, it will be understood that this approach is merely exemplary and that other approaches may be used, such as through the jugular vein, femoral artery, port access, or direct access, to name a few. Positioning of the distal end 1016 on the mitral valve MV can be achieved by pre-bending the outer guide catheter 1000 and / or by steering the outer guide catheter 1000 to a desired position, wherein the catheter 1000 is in this position when the dilator and guidewire are retracted. In this example, the formation of the main curve 1100 causes the distal end 1016 to move in a main plane corresponding to the previous plane X, which is generally parallel to the valve surface. This moves the distal end 1016 laterally along the short axis of the mitral valve MV and allows the distal end 1016 to be centered over the opening O between the leaflets LF.

[0264] Reference Figure 51B , the inner guide catheter 1020 is advanced through the central lumen 1018 of the outer guide catheter 1000, and the distal end 1026 is positioned so that the central lumen 1028 is directed toward the target tissue, namely the mitral valve MV. In particular, the central lumen 1028 will be directed toward a specific area of the mitral valve MV, such as toward the opening O between the valve leaflets LF, so that a specific interventional procedure can be performed. Figure 51B , the inner guide catheter 1020 is shown in a position that includes a secondary curve 1104 in a secondary plane corresponding to the previous plane Z. The formation of the secondary curve 1104 causes the distal end 1026 to move vertically and angularly between the commissures C, thereby directing the central lumen 1028 toward the mitral valve MV. In this position, an interventional device or catheter 1030 passing through the central lumen 1028 will be directed toward and / or through the opening O. Although the main curve 1100 and the secondary curve 1104 can be varied to accommodate different anatomical variations of the valve MV and different surgical procedures, further adjustments beyond these two curvatures may be required for proper positioning of the system 1.

[0265] Reference Figure 51C , the distal end 1026 of the inner guide catheter 1020 can be positioned through an angle θ 1070. This allows the distal end 1026 to move vertically and angularly through a plane θ corresponding to the previous plane Y. Movement of the distal end 1026 through the angle θ 1070 in either direction is Figure 51C1016. This movement can be achieved by pre-bending and / or steering the catheter 1020. Thus, the central lumen 1028 can be guided toward the mitral valve MV in a plane different from the para-plane. After such movement, the inner guide catheter 1020 will be in a position such that the opening of the central lumen 1028 at the end 1016 faces in the desired direction. In this case, the desired direction is toward the center of the mitral valve and orthogonal to the mitral valve.

[0266] In some cases, it is desirable to raise or lower the distal end 1026 so that the distal end 1026 is at a desired height relative to the mitral valve MV. This can be achieved by pre-bending and / or turning the outer guide catheter 1000 to form an additional curve 1110. Typically, this is used to elevate the distal end 1026 above the mitral valve MV, wherein such elevation is Figure 50B is shown in the figure.

[0267] When the curvature in the catheter 1000, 1020 is formed by a steering mechanism, the steering mechanism can be locked in place by a locking feature. The locking can provide additional rigidity and stability in the guide system 1 for passing an interventional device or catheter 1030 through the guide system 1, such as Figure 48 As shown in . The interventional catheter 1030 can be passed through the central lumen 1028 toward the target tissue, in this case the mitral valve MV. As described above, positioning the distal end 1026 above the opening O allows the catheter 1030 to be passed through the opening O between the leaflets LF when desired, such as Figure 51D At this point, any desired procedure may be applied to the mitral valve for correction of regurgitation or any other condition.

[0268] C. Steering mechanism

[0269] As previously mentioned, curvature can be formed in the catheter 1000, 1020 by pre-bending, steering, or any suitable means. Pre-bending refers to setting a specific curvature in the catheter before use, such as by heating a polymer or by utilizing a shape memory alloy. Since the catheter is generally flexible, the catheter is loaded onto a guidewire, dilator obturator, or other introduction device to straighten the catheter over the entire arched region. Once the catheter is positioned in the anatomical structure, the introduction device is removed and the catheter is allowed to relax back to the pre-bend setting.

[0270] To provide a higher degree of control and a variety of possible curvatures, a steering mechanism can be used to create the curvature and position the catheter. In some embodiments, the steering mechanism comprises a cable or pull wire within the wall of the catheter. Figure 52AAs shown in FIG, the outer guide catheter 1000 may include a pull wire 1120 that is slidably disposed in a lumen within the wall of the catheter 1000 extending to the distal end 1016. By applying tension to the pull wire 1120 in the proximal direction, the distal end 1016 bends in the direction of the pull wire 1120, as indicated by arrow 1122. Similarly, as shown in FIG. Figure 52B As shown in FIG, the placement of the pull wires 1120 along opposite sides of the catheter 1000 will allow the distal end 1016 to bend in opposite directions, as indicated by arrows 1124, when tension is applied to the pull wires 1120. Figure 52C , the diametrically opposed placement of the pull wires 1120 within the wall of the catheter 1000 allows the distal ends 1016 to be turned in opposite directions. This provides a method of correcting or adjusting for curvature. For example, if tension is applied to one pull wire to create curvature, that curvature can be reduced by applying tension to the diametrically opposed pull wire. Referring now to Figure 52D As shown, another set of opposing pull wires 1120' can extend within the wall of the catheter 1000. This combination of pull wires 1120, 1120' allows the distal end to bend in at least four directions indicated by arrows 1122, 1124, 1126, 1128. In this example, the pull wires 1120 create the main curve 1100 of the outer guide catheter 1000, and the pull wires 1120' create the lift. It will be appreciated that Figures 52A to 52D This also applies to the inner guide catheter 1020. For example, Figure 52D In FIG. 1 , pull wire 1120 can create a secondary curve 1104 of inner guide catheter 1020 , and pull wire 1120 ′ creates angle θ 1070 .

[0271] Such pull wires 1120 and / or pull wires 1120' and associated lumens may be placed in any arrangement, singly or in pairs, symmetrically or asymmetrically, and there may be any number of pull wires. This may allow for curvature in any direction and about various axes. The pull wires 1120, 1120' may be secured at any location along the length of the catheter by any suitable method such as gluing, tying, soldering or potting. When tension is applied to the pull wire, a curvature is formed from the point of attachment of the pull wire in a proximal direction. Thus, depending on the location of the attachment point of the pull wire, a curvature may be formed over the entire length of the catheter. However, typically, the pull wire will be attached near the distal end of the catheter, optionally to an embedded tip ring 280, such as Figure 52E As shown, the pull wire 1120 passes through the orifice 286 in the tip ring 280, forms an annular shape and then returns through the orifice 286 and returns upward through the catheter wall (not shown). Alternatively, the lumen housing the pull wire may be straight, such as Figures 52A to 52D As shown in , or it can be curved.

[0272] D. Catheter structure

[0273] The outer guide catheter 1000 and the inner guide catheter 1020 can have the same or different constructions and can include any suitable material or combination of materials to produce the curvature described above. For clarity, the examples provided will refer to the outer guide catheter 1000, however, it will be understood that these examples can also apply to the inner guide catheter 1020.

[0274] In embodiments where the catheter is pre-curved rather than or in addition to being steerable, the catheter 1000 may comprise a polymer or copolymer that can be set at a desired curvature, such as by heat setting. Likewise, the catheter 1000 may comprise a shape memory alloy.

[0275] In embodiments where the catheter is steerable, the catheter 1000 can be comprised of one or more of a variety of materials, either along the length of the catheter 1000 or in various segments. Example materials include polyurethane, Pebax, nylon, polyester, polyethylene, polyimide, polyethylene terephthalate (PET), polyetheretherketone (PEEK). Additionally, the walls of the catheter 1000 can be reinforced with various structures such as metal braid or coils. Such reinforcements can be located along the length of the catheter 1000 or in various segments.

[0276] For example, refer to Figure 53A , the catheter 1000 can have a proximal braided segment 1150, a coiled segment 1152, and a distal braided segment 1154. The proximal braided segment 1150 provides increased column strength and torque transfer. The coiled segment 1152 provides increased steerability. The distal braided segment 1154 provides a mix of steerability and torque / column strength. In another example, referring to Figure 53B , the outer guide catheter 1000 has a proximal double-layer braided segment 1151 and a distal braided segment 1154. Therefore, the proximal double-layer segment 1151 includes a multi-lumen tube 1160 (having a steering lumen 1162 for pulling the wire and a central lumen 1163, the distal end of the steering lumen 1162 optionally being embedded with a stainless steel coil for reinforcement), an inner braided layer 1164 and an outer braided layer 1166, as shown Figure 53C Similarly, Figure 53D A cross-sectional view of a distal braided segment 1154 including a multi-lumen tube 1160 and a single braided layer 1168 is provided. Figure 53E , the inner guide catheter 1020 includes a multi-lumen tube 1160 without a reinforcement at its proximal end, a single-braided intermediate section 1170, and a single-braided distal section 1171. Each of the single-braided sections 1170, 1171 has a multi-lumen tube 1160 and a single-braided layer 1168, as shown in FIG. Figure 53F However, segments 1170, 1171 comprise polymers of varying durometers that generally decrease toward the distal end.

[0277] Figure 53G Another example of a cross-section of the distal end section of outer guide catheter 1000 is illustrated. Here, layer 1130 comprises 55D Pebax and has a thickness of approximately 0.0125 inches. Layer 1131 comprises a 30 ppi braid and has a thickness of approximately 0.002 inches by 0.0065 inches. Layer 1132 comprises 55D Pebax and has a thickness of approximately 0.006 inches. Layer 1133 comprises a 30 ppi braid and has a thickness of approximately 0.002 inches by 0.0065 inches. And finally, layer 1134 comprises nylon 11 and includes a steering lumen for pull wire 1120 having a diameter of approximately 0.0105 inches. Central lumen 1163 is of sufficient size for passage of devices.

[0278] Figures 53H to 53I Additional examples of cross-sections of inner guide catheter 1020 are illustrated. Figure 53I A cross section of a portion of the distal end is shown, and Figure 53I A cross section of a more distal portion of the distal end is shown. Figure 53H , layer 1135 comprises a 40D polymer and has a thickness of approximately 0.0125 inches. Layer 1136 comprises a 30 ppi braid and has a thickness of approximately 0.002 inches by 0.0065 inches. Layer 1137 comprises a 40D polymer and has a thickness of approximately 0.006 inches. Layer 1138 comprises a 40D polymer layer and has a thickness of approximately 0.0035 inches. And finally, layer 1139 comprises a 55D liner. Additionally, a coiled steering lumen is included for a pull wire 1120 having a diameter of approximately 0.0105 inches. Also, a central lumen 1163 is of sufficient size for passage of a device. Reference Figure 53I Layer 1140 comprises a 40D polymer, layer 1141 comprises a 35D polymer, layer 1142 comprises a braid, and layer 1143 comprises a pad. Additionally, a coiled steering lumen 1144 is included for a pull wire. Furthermore, a central lumen 1163 is of sufficient size for passage of a device.

[0279] Figures 54A to 54C An embodiment of a keying feature that can be incorporated into a catheter shaft is illustrated. The keying feature is used to maintain the relationship between the inner and outer guide catheters to assist in steering capability. Figure 54A, the inner guide catheter 1020 includes one or more protrusions 1400 extending radially outward. In this example, there are four protrusions 1400 spaced equidistantly around the exterior of the catheter 1020. Likewise, the outer guide catheter 1000 includes corresponding notches 1402 that align with the protrusions 1400. Thus, in this example, the catheter 1000 includes four notches spaced equidistantly around its central lumen 1018. Thus, the inner guide catheter 1020 is able to translate within the outer guide catheter 1000, however, rotation of the inner guide catheter 1020 within the outer guide catheter 1000 is prevented by keying features, i.e., interlocking protrusions 1400 and notches 1402. This keying helps maintain a known positional relationship between the inner guide catheter 1020 and the outer guide catheter 1000. Because the inner and outer guide catheters 1020 and 1000 form curvatures in different directions, such keying helps ensure that the compound curvature formed by the individual curvatures in the inner and outer guide catheters 1020 and 1000 is the intended compound curvature. Keying can also increase stability, where the curvatures remain in place, reducing the possibility of compensating for each other.

[0280] Figure 54B Pictured Figure 54A FIG1 is a cross-sectional view of an outer guide catheter 1000. Here, the catheter 1000 includes a notched layer 1404 along the inner surface of the central lumen 1018. The notched layer 1404 includes notches 1402 of any size, shape, arrangement, and number. Optionally, the notched layer 1404 may include a lumen 1406, typically for passing the pull wire 1120. However, the lumen 1406 may alternatively or additionally be used for other purposes. It will also be appreciated that the notched layer 1404 may be incorporated into the wall of the catheter 1000, such as by extrusion, or the notched layer 1404 may be a separate layer positioned within the catheter 1000. Furthermore, it will be appreciated that the notched layer 1404 may extend the entire length of the catheter 1000 or only include one or more portions of the length of the catheter 1000, including small strips at designated locations along the length of the catheter 1000.

[0281] Figure 54C Pictured Figure 54AFIG1 is a cross-sectional view of an inner guide catheter 1020 of FIG1. Here, the catheter 1020 includes protrusions 1400 along the outer surface of the catheter 1020. The protrusions 1400 can have any size, shape, arrangement, and number. It will be appreciated that the protrusions 1400 can be incorporated into the wall of the catheter 1020, such as by extrusion, can be included in a separate cylindrical layer on the outer surface of the catheter 1020, or the protrusions 1400 can be separately adhered to the outer surface of the catheter 1020. Furthermore, it will be appreciated that the protrusions 1400 can extend the entire length of the catheter 1000 or only one or more portions of the length of the catheter 1020, including small strips at designated locations along the length of the catheter 1020.

[0282] Thus, the keying feature may be present along one or more specific portions of the catheters 1000, 1020, or may extend along the entire length of the catheters 1000, 1020. Likewise, the recesses 1402 may extend along the entire length of the outer guide catheter 1020 while the protrusions 1400 extend along discrete portions of the inner guide catheter 1000, and the recesses 1402 may extend along discrete portions of the outer guide catheter 1020 while the protrusions 1400 extend along the entire length of the inner guide catheter 1000. It will also be appreciated that the protrusions 1400 may be present on the inner surface of the outer guide catheter 1000 while the recesses 1402 are present along the outer surface of the inner guide catheter 1020.

[0283] Alternatively or additionally, one or more steerable portions of the catheter 1000 may include a series of articulating members 1180, such as Figure 55A An exemplary embodiment of a steerable portion of a catheter including such an articulating member 1180 is described in U.S. Patent No. 7,682,319, which is incorporated herein by reference for all purposes. Figure 55B An outer guide catheter 1000 is illustrated having a steerable portion including an articulation member 1180 at a distal end 1016 thereof.

[0284] In short, refer to Figure 55A , each articulated member 1180 can have any shape, particularly a shape that allows for interfitting or nesting as shown. In addition, it is desirable that each member 1180 has the ability to resist independent rotation of adjacent articulated members 1180. In this embodiment, the articulated members 1180 include dome-shaped rings 1184 that fit together. The dome-shaped rings 1184 each include a base 1188 and a dome 1186. The base 1188 and the dome 1186 have a hollow interior that forms a central lumen 1190 when the dome-shaped rings 1184 fit together in series. In addition, the dome 1186 allows each articulated member 1180 to fit with the inner surface of an adjacent dome-shaped ring 1184.

[0285] The interfitting dome-shaped rings 1184 are connected by at least one pull wire 1120. Such a pull wire generally extends through the length of the catheter 1000 and at least one of the interfitting dome-shaped rings 1184 to a fixed point where the pull wire 1120 is fixedly attached. By applying tension to the pull wire 1120, the pull wire 1120 causes the series of interfitting dome-shaped rings 1184 adjacent to the attachment point to be curved. Thus, pulling on or applying tension to at least one pull wire causes the catheter 1000 to turn or deflect in the direction of that pull wire 1120. By positioning the various pull wires 1120 throughout the circumference of the dome-shaped rings 1184, the catheter 1000 can be directed in any number of directions.

[0286] Likewise Figure 55A As shown in , each cooperating dome-shaped ring 1184 may include one or more pull wire lumens 1182, through which the pull wire 1120 passes. Alternatively, the pull wire 1120 may pass through the central lumen 1190. In any case, the pull wire is attached to the catheter 1000 at the position where the desired bend is to be formed. The pull wire 1120 can be fixed in place by any suitable method such as soldering, gluing, tying, welding or potting. This fixing method generally depends on the material used. The hinge member 1180 may include any suitable material, including stainless steel, various metals, various polymers or copolymers. Similarly, the pull wire 1120 may include any suitable material such as fiber, suture, metal wire, metal braid or polymer braid.

[0287] E.Handle

[0288] As previously mentioned, manipulation of the guide catheters 1000 , 1020 is accomplished through the use of handles 1056 , 1057 attached to the proximal ends of the catheters 1000 , 1020 . Figure 56 A preferred embodiment of handles 1056, 1057 is shown. As shown, handle 1056 is attached to the proximal end 1014 of outer guide catheter 1000, and handle 1057 is attached to the proximal end 1024 of inner guide catheter 1020. Inner guide catheter 1020 is inserted through handle 1056 and coaxially positioned within outer guide catheter 1000. In this embodiment, handles 1056, 1057 are not attached as shown. Figure 48 It will be appreciated that such handles 1056, 1057 may alternatively be connected by external connecting rods, bars or plates or by additional external stabilizing bases. The embodiments of the stabilizing bases will be described in the following sections. Return to reference Figure 56, the interventional catheter is inserted through the handle 1057 and is coaxially positioned within the inner guide catheter 1020 and the outer guide catheter 1000.

[0289] Each handle 1056, 1057 includes two steering knobs 1300a, 1300b that emerge from the handle housing 1302 for user manipulation. The steering knob 1300a is disposed on one side of the housing 1302, and the steering knob 1300b is disposed on the face of the housing 1302. However, it will be appreciated that this placement may vary based on various factors, including the type of steering mechanism, the size and shape of the handle, the type and arrangement of components within the handle, and ergonomics, to name a few.

[0290] Figure 57 Pictured Figure 56 13. The present invention also provides a schematic diagram of a handle 1056, 1057 of a catheter, wherein a portion of the housing 1302 is removed to expose the components of the handle. Each knob 1300a, 1300b controls a steering mechanism for forming a curvature in the attached catheter. Each steering mechanism includes a hard stop gear assembly 1304 and a friction assembly 1306. Tension is applied to one or more pull wires by the action of the hard stop gear assembly to form a curve in the catheter. The tension is maintained by the friction assembly. When the tension is released from the one or more pull wires, the catheter returns to a straightened position.

[0291] Figure 58 The steering mechanism within the handle is illustrated with housing 1302 removed for clarity. Here, steering knob 1300a is attached to hard stop gear assembly 1304 and friction assembly (not visible in the view), and steering knob 1300b is attached to a separate hard stop gear assembly 1304 and friction assembly 1306. Steering knob 1300a is attached to knob post 1318, which passes through base 1308 and terminates in knob gear 1310. Knob gear 1310 actuates hard stop gear assembly 1304, thereby applying tension to one or more pull wires 1120.

[0292] Knob gear 1310 is a toothed wheel that meshes with disc gear 1312. Rotation of steering knob 1300a rotates knob post 1318 and knob gear 1310, which in turn rotates disc gear 1312. Rotation of disc gear 1312 applies tension to one or more pull wires extending through an attached catheter, which in this example is outer guide catheter 1000. As shown, outer guide catheter 1000 passes through base 1308, wherein one or more pull wires 1120 extending through catheter 1000 are attached to disc 1314. This attachment is Figure 5913. The catheter 1000 is shown passing through the base 1308. A pull wire 1120 passing through the steering lumen 1162 in the catheter 1000 emerges from the wall of the catheter 1000, passes through an aperture 1320 in the disk 1314, and is attached to an anchor pin 1316 on the disk 1314. Rotation of the disk 1314 about the disk post 1315 by the action of the disk gear 1312 (indicated by arrow 1328) applies tension to the pull wire 1120 by pulling it through the aperture 1320 and wrapping it around the disk 1314 as the disk 1314 rotates. Additional rotations of the disk 1314 apply increasing tension to the pull wire 1120. In order to limit the amount of tension applied to the pull wire 1120, to limit the curvature of the catheter and / or to avoid possible breakage of the pull wire 1120, the rotation of the disk 1314 can be limited by a hard stop pin 1322 that is attached to the disk 1314 and extends into the base 1308.

[0293] Figures 60A to 60B Illustrated is how hard stop pin 1322 may be used to limit the rotation of disk 1314 . Figures 60A to 59 B provides a top view in which the disc 1314 is disposed on the base 1308. Anchor pin 1316 is shown with the pull wire 1120 attached thereto. A groove 1326 is formed in the base 1308 below the disc 1314 and forms an arcuate shape. A hard stop pin 1322 extends from the disc 1314 into the groove 1326 in the base 1308. Now referring to Figure 60B , rotation of disk 1314 about knob post 1318, indicated by arrow 1330, pulls pull wire 1120 through aperture 1320 as previously described, thereby wrapping pull wire 1120 around disk 1314. As shown, as disk 1314 rotates, hard stop pin 1322 follows groove 1326. Disk 1314 continues to rotate until hard stop pin 1322 reaches hard stop 1324. Hard stop 1324 locates in groove 1326 and prevents further passage of hard stop pin 1322. Thus, by positioning hard stop 1324, rotation of disk 1314 can be limited to any rotation angle less than or equal to 360 degrees.

[0294] In some cases, it is desirable to limit the rotation of the disk 1314 to a rotation angle greater than 360 degrees. This can be achieved by another embodiment of the hard stop gear assembly 1304. Figures 61A to 61B , a portion of such a hard stop gear assembly 1304 is shown. Figure 61AThe base 1308 is shown with a disc-shaped post 1315 positioned therethrough. Also shown in the base 1308 is an aperture 1334 through which the knob post 1318, knob gear 1310, and friction assembly 1306 pass, and a passage 1336 through which the conduit 1000 passes. In this embodiment of the hard stop gear assembly 1304, the groove 1326 also exists in an arcuate shape around the disc-shaped post 1315, however, the ball 1332 is positioned in the groove 1326 rather than in the hard stop pin 1322. Figure 61B As shown in , the disc 1314 is positioned above the groove 1326 and the ball 1332. Figure 61C The disk 1314 shown in FIG has a groove 1356 in its surface located adjacent to the base 1308, the groove 1356 having an arcuate shape similar to the groove 1326 in the base 1308. The ball 1332 is not fixedly attached to the base 1308 or the disk 1314 and is therefore free to move along the channel formed by the groove 1326 in the base 1308 and the groove in the disk 1314.

[0295] Figures 62A to 62F It illustrates how the rotation of disk 1314 may be limited by ball 1332 to rotation angles greater than 360 degrees. Figures 62A to 62F The groove 1326 in the base 1308 is shown, wherein the groove 1326 has an arcuate shape surrounding the disc-shaped post 1315. The groove 1326 does not form a complete circle; the first groove end 1350a and the second groove end 1350b form a wall that prevents the ball 1332 from passing through. It will be understood that the groove ends 1350a, 1350b can be separated by any distance, thereby shortening the length of the groove 1326 by any amount and allowing the ball 1332 to move, and thus adjust the catheter deflection to any desired amount. First, referring to Figure 62A , ball 1332 is positioned within groove 1326 near first groove end 1350a. Disk 1314 has a matching groove 1352 (shown in phantom) including a first groove end 1354a and a second groove end 1354b. Disk 1314 is positioned over ball 1332 such that ball 1332 is located near second groove end 1354b.

[0296] Now refer to Figure 62B , the disk 1314 can be rotated while the ball 1332 remains in place. Here, the disk 1314 has been rotated 90 degrees, as indicated by the arrow 36000 and the position of the groove ends 1354a, 1354b. Now referring to Figure 62C , the disk 1314 can be rotated further while the ball 1332 remains in place. Here, the disk 1314 has been rotated 270 degrees, as indicated by the arrow 36000 and the position of the groove ends 1354a, 1354b. Figure 62D As shown in FIG, the disk 1314 can continue to rotate to 360 degrees, as indicated by arrow 36000. Here, the first groove end 1354a in the disk 1314 has contacted the ball 1332 and pushed the ball 1332 along the groove 1326 in the base. Figure 62E , the disk 1314 can rotate further, and the ball 1332 is pushed by the first groove end 1354a in the disk 1314 along the groove 1326 in the base 1308. Here, the disk 1314 is shown to have rotated 540 degrees. Figure 62F , the disk 1314 rotates until the ball 1332 reaches the second groove end 1350b of the base 1308, thereby providing a hard stop. In this position, the ball 1332 is retained between the first groove end 1354a of the disk 1314 and the second groove end 1350b of the base 1308, and further rotation of the disk 1314 is prevented. Thus, in this example, the disk 1314 rotates approximately 660 degrees. By positioning the groove ends 1350a, 1350b and / or the groove ends 1354a, 1354b, any maximum rotation angle can be set. In addition, in some embodiments, rotation can be limited by adding more than one ball 1332 to the groove 1326. For example, two, three, four, five, six, seven, eight, nine, ten, or more balls can be used to limit travel and therefore curvature.

[0297] It is understood that one or more pull lines 1120 may be arranged in a manner similar to Figure 59 13. The guide wire 1120 is attached to the disk 1314 in the manner shown in FIG. 13. Thus, as the disk 1314 rotates about the disk post 1315 via the action of the disk gear 1312, tension is applied to the pull wire 1120 by pulling it through the aperture 1320 and wrapping it around the disk 1314 as the disk 1314 rotates. Additional rotations of the disk 1314 apply increasing tension to the pull wire 1120. The rotational restriction described above limits the amount of tension applied to the pull wire 1120 to limit the curvature of the catheter and / or avoid possible breakage of the pull wire 1120.

[0298] As mentioned, each steering mechanism includes at least a hard stop gear assembly 1304 and a friction assembly 1306. As described above, tension is applied to one or more pull wires by the action of the hard stop gear assembly to form a curve in the catheter. The tension is maintained by the friction assembly. Figure 63An embodiment of a friction assembly 1306 is illustrated. Friction assembly 1306 essentially holds a steering knob, in this example, steering knob 1300b, and its associated knob post 1318 in a rotational position. Here, rotation of knob 1300b and post 1318 rotates an attached knob gear 1310. Knob gear 1310 actuates hard stop gear assembly 1304, thereby applying tension to one or more puller wires 1120. Knob gear 1310 is a toothed wheel that meshes with a disc gear 1312. Rotation of steering knob 1300b rotates knob post 1318 and knob gear 1310, which in turn rotates disc gear 1312. Rotation of disc gear 1312 applies tension to one or more puller wires extending through an attached catheter, in this example, outer guide catheter 1000.

[0299] Steering knob 1300b and knob post 1318 are held in a rotated position by friction provided by friction pad 1370. Friction pad 1370 is positioned between a ring 1372 attached to knob post 1318 and a plate 1374 attached to base 1308. Knob post 1318 extends from knob 1300b through ring 1372, friction pad 1370, and then through plate 1374. Plate 1374 has internal threads that mate with threads on knob post 1318. When knob post 1318 is rotated, the threads on post 1318 advance through threads on plate 1374. This pulls ring 1372 closer to plate 1374, compressing friction pad 1370 between ring 1372 and plate 1374. Friction pad 1370 can comprise any O-ring or sheet material having the desired friction and compression properties, such as silicone rubber, natural rubber, or synthetic rubber. In a preferred embodiment, an EPDM rubber O-ring is used. Friction of friction pad 1370 against ring 1372 prevents reverse rotation of knob post 1318. The greater the compression of friction pad 1370, the stronger the frictional hold. Thus, as steering knob 1300b is rotated and more and more tension is applied to pull wire 1120, more and more friction is applied to ring 1372, holding knob 1300b in place.

[0300] Manual reverse rotation of the steering knob 1300b releases the tension on the pull wire 1120 and pulls the ring 1372 away from the plate 1374, thereby reducing the friction load. When the tension is released from the pull wire 1120, the catheter 1000 returns toward the straightened position.

[0301] It will be appreciated that each handle 1056, 1057 includes a steering mechanism for each curve to be formed in the attached catheter. Figure 57As shown in FIG, handle 1056 includes a steering mechanism for forming a primary curve 1100 in outer guide catheter 1000 and a steering mechanism for forming an additional curve 1110. Similarly, handle 1057 includes a steering mechanism for forming a secondary curve 1104 in inner guide catheter 1020 and a steering mechanism for forming angle θ 1070.

[0302] Some curves, such as primary curve 1100, secondary curve 1104, and additional curve 1110, each typically vary in curvature between a straight configuration and a curved configuration in a single direction. This motion can be achieved with a single set of hard stop gear assembly 1304 and friction assembly 1306. However, other curves, such as angle θ 1070, can be formed in two directions, such as Figures 49C to 49D This motion is achieved by two sets of hard stop gear assemblies 1304 and friction assemblies 1306, each set controlling the curvature in a single direction.

[0303] Figure 63 The figure shows the presence of another set of friction components 1306'. One or more pull wires 1120' extending within the wall of the catheter 1000, such as Figure 52D 13. The opposing set shown in FIG is attached to disk 1314' in the same manner as cable 1120 is attached to disk 1314. Disks 1314, 1314' are arranged so that rotation of steering knob 1300b in one direction applies tension to cable 1120 via disk 1314, and rotation of steering knob 1300b in the opposite direction applies tension to cable 1120' via disk 1314'. Similarly, additional friction assembly 1306' is shown having ring 1372' attached to knob post 1318 and friction pads 1370' disposed between ring 1372' and opposite sides of plate 1374. Thus, when rotation of steering knob 1300b in the opposite direction applies tension to cable 1120' via disk 1314', friction pads 1370' apply tension to ring 1372', thereby holding knob post 1318' in place.

[0304] It will be appreciated that various other mechanisms may be used to tension and hold the pull wire 1120 in place. Example mechanisms that may alternatively be used include clutches, ratchets, levers, knobs, rack and pinion gears, and deformable handles, to name a few.

[0305] F.Interventional System

[0306] Figure 64An embodiment of an interventional system 3 of the presently disclosed subject matter is illustrated. An embodiment of a multi-catheter introducing system 1 of the presently disclosed subject matter is shown, the multi-catheter introducing system 1 comprising an outer guide catheter 1000 having a proximal end 1014 and a distal end 1016 and an inner guide catheter 1020 having a proximal end 1024 and a distal end 1026, wherein the inner guide catheter 1020 is coaxially positioned within the outer guide catheter 1000 as shown. Additionally, a hemostasis valve 1090 is provided within or external to the handle 1056 as shown to provide a leak-free seal with or without the inner guide catheter 1020 in place. The valve 1090 also prevents backflow and reduces the likelihood of air introduction when the inner guide catheter 1020 is inserted through the outer guide catheter 1000. An example of a hemostasis valve 1090 is shown in FIG. Figure 64A , however any suitable valve or hemostatic valve may be used to provide similar functionality. Figure 64A , the valve 1090 has a first end 1091, a second end 1092, and a lumen 1093 passing through the first and second ends 1091, 1092. The inner wall of the lumen 1093 preferably tapers toward the end 1091 and may further include a plurality of tapered axial channels configured to receive the protrusions 1400 on the inner guide catheter 1020. The first end 1091 is attached to the outer guide catheter 1000, and the second end 1092 is free. Now return to reference Figure 64 , the distal ends 1016 , 1026 of the catheters 1000 , 1020 , respectively, are sized to be able to pass through a body lumen, typically through a body lumen such as a blood vessel lumen.

[0307] To assist in inserting the fixation device 14 through the hemostatic valve 1090, a fixation device introducer may be used. For example, when the fixation device 14 is loaded onto the delivery catheter 300 and the inner guide catheter 1020, insertion of the fixation device 14, the delivery catheter 300, and the inner guide catheter 1020 through the outer guide catheter 1000 includes passing the fixation device 14 through the hemostatic valve 1090 on the outer guide catheter 1000. To reduce any trauma to the fixation device 14 by the hemostatic valve 1090, a fixation device introducer may be used. Figure 64B, an embodiment of a fixation device introducer 1420 is illustrated in FIG. The introducer 1420 includes a loading body 1422 and an insertion end piece 1424. The fixation device 14 is loaded into the loading body 1422 and the insertion end piece 1424 to approximately dashed line 1428. The insertion end piece 1424 has a separating end that creates individual separating segments 1430, in this embodiment, four separating segments 1430. By compressing the separating segments 1430, the end piece 1424 forms a tapered portion. This tapered portion is then inserted through the hemostatic valve 1090, allowing the insertion end piece 1424 to create a smooth passage for the fixation device 14 through the valve. Once the insertion end piece 1424 is inserted through the valve 1090, the fixation device 14 and the attached delivery catheter 300 and inner guide catheter 1020 can then be advanced through the fixation device introducer 1420. The fixation device introducer 1420 also includes a hemostatic valve within the loading body 1422 to prevent any backflow or leakage through the introducer 1420.

[0308] Manipulation of the guide catheters 1000, 1020 is accomplished using handles 1056, 1057 attached to the proximal ends of the catheters 1000, 1020. As shown, handle 1056 is attached to the proximal end 1014 of the outer guide catheter 1000, and handle 1057 is attached to the proximal end 1024 of the inner guide catheter 1020. The inner guide catheter 1020 is inserted through handle 1056 and coaxially positioned within the outer guide catheter 1000.

[0309] An embodiment of the delivery catheter 300 of the presently disclosed subject matter is inserted through the handle 1057 and coaxially positioned within the inner guide catheter 1020 and the outer guide catheter 1000. Accordingly, a hemostatic valve 1090 is provided within the handle 1057 as shown, or externally thereto, to provide a leak-proof seal with or without the delivery catheter 300 in place. The valve 1090 functions as described above. The delivery catheter 300 includes a shaft 302 having a proximal end 322 and a distal end 324, and a handle 304 attached to the proximal end 322. The fixation device 14 is removably coupled to the distal end 324 for delivery to a site within the body.

[0310] The outer guide catheter 1000 and / or the inner guide catheter 1020 are pre-bent and / or have a steering mechanism to position the distal ends 1016, 1026 in a desired direction. The pre-bend or steering of the outer guide catheter 1000 directs the distal end 1016 in a first direction to create a primary curve, while the pre-bend and / or steering of the inner guide catheter 1020 directs the distal end 1026 in a second direction different from the first direction to create a secondary curve. The primary and secondary curves together form a compound curve. Advancement of the delivery catheter 300 through the coaxial guide catheters 1000, 1020 directs the delivery catheter 300 through the compound curve in a desired direction, typically in a direction to position the fixation device 14 at a desired location within the body.

[0311] Figure 65 Portions of another embodiment of the interventional system 3 of the presently disclosed subject matter are illustrated. Handles 1056, 1057 of the multi-catheter guide system 1 of the presently disclosed subject matter are shown. As shown, each handle 1056, 1057 includes a set of steering knobs 1300a, 1300b. Manipulation of the guide catheters 1000, 1020 is achieved using steering knobs 1300a, 1300b attached to the proximal ends of the catheters 1000, 1020. Also shown is a handle 304 of the delivery catheter 300, which includes a proximal element wire handle 312, a locking wire handle 310, an actuator rod controller 314, and an actuator rod handle 316, among other features. The handle 304 is supported by a support base 306 connected to the handle 1057.

[0312] It will be appreciated that the system 3 described above is not intended to limit the scope of the disclosed subject matter. The system 3 may include any or all of the components of the disclosed subject matter described. Additionally, the multi-catheter guide system 1 of the disclosed subject matter may be used to introduce other delivery catheters, interventional catheters, or other devices. Similarly, the delivery catheter 300 may be introduced via other introducers or guide systems. Furthermore, the delivery catheter 300 may be used to deliver other types of devices to a target location within the body, including endoscopic staplers, devices for electrophysiological mapping or ablation, septal defect repair devices, heart valves, annuloplasty rings, and the like.

[0313] In addition, many components of the system 3 may include one or more hydrophilic coatings. Hydrophilic coatings become slippery when wetted, eliminating the need for a separate lubricant. Thus, such coatings may be present on multi-catheter guide systems, delivery catheters, and fixation devices, including proximal and distal elements, to name a few.

[0314] Additionally, the system 3 may be supported by an external stabilizer base 1440, the embodiment of which is shown in FIG. Figure 66. The stabilizer base 1440 maintains the relative positions of the outer guide, inner guide, and delivery catheter during surgery. In this embodiment, the base 1440 includes a platform 1442 having a planar shape for positioning on or against a flat surface such as a table or workbench. The base 1440 also includes a pair of handle holders 1444, 1448, each of which is attached to the platform 1442 and extends upwardly at an angle or vertically therefrom. Figure 67 As shown in , handle holder 1444 includes a recess 1446 for holding outer guide catheter 1000 , thereby supporting handle 1056 . Figure 67 The handle 1056 is shown attached to the outer guide catheter 1000, with the handle 1056 positioned so that the proximal end 1014 of the outer guide catheter 1000 rests in the recess 1446. Return to Reference Figure 66 , the handle holder 1448 includes an elongated portion 1452 having a slot 1450 and a hooked end 1454. Figure 68 As shown in FIG, handle 1057 rests on elongated portion 1452, and handle 304 rests on hooked end 1454, so that inner guide catheter 1020 extends from handle 1057 to handle 1056 and continues within outer guide catheter 1000. Handle 304 is additionally supported by support base 306 as shown.

[0315] It will be appreciated that the stabilizer base 1440 may take a variety of forms and may include differences in structural design to accommodate various types, shapes, arrangements, and numbers of handles.

[0316] G.Kit

[0317] Now refer to Figure 69 , a kit 1500 according to the presently disclosed subject matter includes any of the components described with respect to the presently disclosed subject matter. Kit 1500 can include any of the components described above, such as an outer guide catheter 1000 including a handle 1056, an inner guide catheter 1020 including a handle 1057, a delivery catheter 300, and a fixation device 14, as well as instructions for use ("IFU"). Optionally, any of the kits in the kit can also include any of the other system components described above, such as various interventional tools 1040 or components associated with positioning the device within a body lumen, such as a guidewire 1202, a dilator 1206, or a needle 1204. The instructions for use IFU will describe any of the methods described above, and all kit components will typically be packaged together in a bag 1505 or other conventional medical device packaging. Typically, those kit components that will be used to perform surgery on a patient will be sterilized and stored within the kit. Alternatively, separate bags, bags, trays, or other packaging can be provided within a larger package, wherein the smaller packages can be opened individually to separately hold these components in a sterile manner.

[0318] Although the foregoing is a complete description of preferred embodiments of the disclosed subject matter, various alternatives, substitutions, additions, modifications, and equivalents are possible without departing from the scope of the disclosed subject matter. For example, in many of the above-described embodiments, the disclosed subject matter is described in the context of approaching the valve structure from the upstream side, that is, the atrial side in the case of the mitral valve. It should be understood that any of the foregoing embodiments can also be used for other approaches, including from the downstream side of the ventricle or valve and using surgical approaches through the heart wall. In addition, the disclosed subject matter can be used for the treatment of various other tissue structures besides heart valves and will find use in various tissue approximation, attachment, closure, clamping and ligation applications, some endovascular procedures, some endoscopic procedures, and some open procedures.

[0319] Again, although the foregoing disclosed subject matter has been described in some detail by way of illustration and example for purposes of clarity of understanding, it will be apparent that various alternatives, modifications and equivalents may be used, and the foregoing description should not be taken as limiting the scope of the disclosed subject matter as defined by the appended claims.

Claims

1. A fixation system for fixing a leaflet of a heart valve, the fixation system comprising: An implantable fixation device, comprising: First and second arms, a first proximal element movable relative to the first arm between a first position and a second position, and a second proximal element movable relative to the second arm between a first position and a second position; and A delivery device, comprising: a catheter having a proximal end portion and a distal end portion, the catheter defining at least one lumen extending between the proximal end portion and the distal end portion, a first proximal element wire extending through the at least one lumen, the first proximal element wire being releasably coupled to the first proximal element and actuatable to move the first proximal element between the first position and the second position, a second proximal element wire extending through the at least one lumen, the second proximal element wire being releasably coupled to the second proximal element and actuatable to move the second proximal element between the first position and the second position, and A handle having: a first proximal element wire handle coupled to the first proximal element wire and actuatable to deploy the first proximal element wire to move the first proximal element between the first position and the second position, a second proximal element wire handle coupled to the second proximal element wire and actuatable to deploy the second proximal element wire to move the second proximal element between the first position and the second position; and an interlock portion movable between an unlocked position in which the first and second proximal element line handles are independently actuable and a locked position in which the first and second proximal element line handles are coupled together so as to be actuable together, Wherein, the interlocking portion includes a latch movably coupled to the first proximal element wire handle and a recess provided in the second proximal element wire handle.

2. The fixing system according to claim 1, wherein: The first proximal element line handle and the second proximal element line handle are aligned in parallel.

3. The fixing system according to claim 1, wherein: The first proximal element line handle and the second proximal element line handle each include a rotatable switch.

4. The fixing system according to claim 1, wherein: The handle further includes a first stop to limit a distance that each of the first proximal element line handle and the second proximal element line handle can move in a first direction.

5. The fixing system according to claim 1, wherein: The handle further includes a second stop to limit a distance that each of the first proximal element line handle and the second proximal element line handle can move in a second direction.

6. The fixing system according to claim 1, wherein: The interlock includes a slide lock mechanism.

7. The fixing system according to claim 1, wherein: The interlock includes a rotational locking mechanism.

8. The fixing system according to claim 1, wherein: The latch and the recess include complementary dovetail shapes.

9. The fixing system according to claim 8, wherein: The dovetail shape is asymmetrical.

10. The fixing system according to claim 1, wherein: The latch includes a catch that is receivable in a first stop in the first proximal element line handle to hold the latch in the unlocked position, and the catch is receivable in a second stop in the first proximal element line handle to hold the latch in the locked position.

11. The fixing system according to claim 10, wherein: The lock buckle is arranged on the cantilever.

12. The fixing system according to claim 1, wherein: The interlocking portion includes a removable buckle.

13. The fixing system according to claim 1, wherein: At least one of the first proximal element line handle and the second proximal element line handle includes a tactile indicator.

14. The fixing system of claim 1, wherein: The first arm and the first proximal element are disposed on a first side of the implantable fixation device, and the second arm and the second proximal element are disposed on a second side of the implantable fixation device, The first side portion has an echogenicity different from an echogenicity of the second side portion.

15. The fixing system according to claim 14, wherein: At least one of the first side and the second side has an echogenic marker.

16. The fixing system of claim 14, wherein: At least one of the first side and the second side includes an echogenic coating on at least a portion thereof.

17. The fixing system of claim 14, wherein: The echogenicity of at least one of the first side and the second side is alterable by an electric current.

18. The fastening system of claim 1, wherein: At least one of the first proximal element wire and the second proximal element wire includes an echogenic coating on at least a portion thereof.

19. The fastening system of claim 1, wherein: The first arm and the first proximal element are disposed on a first side of the implantable fixation device, and the second arm and the second proximal element are disposed on a second side of the implantable fixation device, wherein the first side has a different fluoroscopic view than the second side.

20. The fastening system of claim 19, wherein: At least one of the first side and the second side has fluoroscopic markings.

21. The fastening system of claim 1, wherein: The first arm and the first proximal element are disposed on a first side of the implantable fixation device, and the second arm and the second proximal element are disposed on a second side of the implantable fixation device, wherein the catheter defines a flow conduit extending between the proximal end portion and the distal end portion of the catheter, wherein the distal end portion of the flow conduit is positioned adjacent the first side of the implantable fixation device, and The first proximal element wire handle includes a flow port configured to allow fluid to pass through the flow conduit and flush toward the first side of the implantable fixation device.

22. The fixing system of claim 21, wherein: The catheter defines a second flow conduit extending between the proximal and distal end portions of the catheter, wherein the distal end portion of the second flow conduit is positioned adjacent the second side of the implantable fixation device, and The second proximal element wire handle includes a second flow port configured to allow fluid to pass through the second flow conduit and flush toward the second side of the implantable fixation device.

23. The fastening system of claim 1, wherein: the first proximal element wire comprising a first end portion, a second end portion, and an intermediate portion between the first end portion and the second end portion, the first proximal element wire being coupled to the first proximal element at the intermediate portion of the first proximal element wire; and The second proximal element line includes a first end portion, a second end portion, and a middle portion located between the first end portion and the second end portion, and the second proximal element line is coupled to the second proximal element at the middle portion of the second proximal element line.

24. The fixing system of claim 23, wherein: A first end portion of the first proximal element wire is secured to the first proximal element wire handle, and a first end portion of the second proximal element wire is secured to the second proximal element wire handle.

25. The fastening system of claim 24, wherein: The first proximal element wire is secured to the first proximal element wire handle by a first clamp, and the second proximal element wire is secured to the second proximal element wire handle by a second clamp.

26. The fastening system of claim 24, wherein: The first proximal element wire is secured to the first proximal element wire handle by a first collet and a first set screw, and the second proximal element wire is secured to the second proximal element wire handle by a second collet and a second set screw.

27. The fastening system of claim 24, wherein: The first proximal element wire is secured to the first proximal element wire handle by a first ratchet spool, and the second proximal element wire is secured to the second proximal element wire handle by a second ratchet spool.

28. The fastening system of claim 27, wherein: The first ratchet spool further includes a first cone for guiding the first proximal element wire, and the second ratchet spool further includes a second cone for guiding the second proximal element wire.

29. The fastening system of claim 24, wherein: The second end portion of the first proximal element wire is secured to the first proximal element wire handle, and the second end portion of the second proximal element wire is secured to the second proximal element wire handle.

30. The fastening system of claim 1, wherein: The at least one lumen includes at least a first proximal element wire lumen and a second proximal element wire lumen.

31. The fastening system of claim 30, wherein: The at least one lumen includes at least a third proximal element wire lumen and a fourth proximal element wire lumen.

32. The fastening system of claim 1, wherein: The delivery device further includes a shaft extending through the at least one lumen, the shaft being releasably coupled to a coupling member of the implantable fixation device, wherein a second end portion of the first proximal element wire is fixed to one of the shaft and the coupling member, and a second end portion of the second proximal element wire is fixed to one of the shaft and the coupling member.

33. The fastening system of claim 1, wherein: The first proximal element line includes one of a wire and a rod; and the second proximal element line includes one of a wire and a rod.

34. The fastening system of claim 33, wherein: The wires include nitinol wires and polymer wires.

35. The fastening system of claim 33, wherein: The wire material includes a suture.

36. The fastening system of claim 1, wherein: The first proximal element line comprises a cable; and the second proximal element line comprises a cable.

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