US20200205831A1 - Grasping for tissue repair - Google Patents

Abstract

The invention provides improved devices, systems, and methods for tissue approximation and repair at treatment sites. The invention provides devices, systems, and methods that may more successfully approximate and repair tissue by improving the capture of tissue into the devices. The invention may be a one-way mechanism that allows tissue to enter the mechanism but not easily exit, such as a leaf-spring, a protrusion, a pivoting arm and one or more frictional elements.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• The present application is a continuation application of U.S. patent application Ser. No. 16/748,450, filed on Jan. 21, 2020, which is a continuation application of U.S. patent application Ser. No. 16/241,647, filed on Jan. 7, 2019, which is a continuation application of U.S. patent application Ser. No. 14/577,852, filed on Dec. 19, 2014, issued as U.S. Pat. No. 10,188,392, the entire contents of which are incorporated herein by reference.
BACKGROUND
• The present invention relates generally to medical methods, devices, and systems. In particular, the present invention relates to methods, devices, and systems for the endovascular, percutaneous, or minimally invasive surgical treatment of bodily tissues, such as tissue approximation or valve repair. More particularly, the present invention relates to repairing heart valves and venous valves, and devices and methods for removing or disabling mitral valve repair components through minimally invasive procedures.
• Surgical repair of bodily tissues often involves tissue approximation and fastening of such tissues in the approximated arrangement. When repairing valves, tissue approximation includes coapting the leaflets of the valves in a therapeutic arrangement which may then be maintained by fastening or fixing the leaflets. Such coaptation can be used to treat regurgitation which most commonly occurs in the mitral valve.
• Mitral valve regurgitation is characterized by retrograde flow from the left ventricle of a heart through an incompetent mitral valve into the left atrium. During a normal cycle of heart 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 into the aorta through the aortic valve. Mitral valve regurgitation can significantly decrease the pumping efficiency of the heart, placing the patient at risk of severe, progressive heart failure.
• Mitral valve regurgitation can result from a number of different mechanical defects in the mitral valve or the left ventricular wall. The valve leaflets, the valve chordae which connect the leaflets to the papillary muscles, the papillary muscles themselves, or the left ventricular wall may be damaged or otherwise dysfunctional. Commonly, the valve annulus may be damaged, dilated, or weakened, limiting the ability of the mitral valve to close adequately against the high pressures of the left ventricle.
• The most common treatments for mitral valve regurgitation rely on valve replacement or repair including leaflet and annulus remodeling, the latter generally referred to as valve annuloplasty. One technique for mitral valve repair which relies on suturing adjacent segments of the opposed valve leaflets together is referred to as the “bow-tie” or “edge-to-edge” technique. While all these techniques can be effective, they usually rely on open heart surgery where the patient's chest is opened, typically via a sternotomy, and the patient placed on cardiopulmonary bypass.
• The need to both open the chest and place the patient on bypass is traumatic and has associated high mortality and morbidity.
• In some patients, a fixation device can be installed into the heart using minimally invasive techniques. The fixation device can hold the adjacent segments of the opposed valve leaflets together and may reduce mitral valve regurgitation. One such device used to clip the anterior and posterior leaflets of the mitral valve together is the MitraClip® fixation device, sold by Abbott Vascular, Santa Clara, Calif., USA.
DESCRIPTION OF THE BACKGROUND ART
• Many techniques exist for approximating and repairing tissues and organs at treatment sites. For example, minimally invasive and percutaneous techniques for coapting and modifying mitral valve leaflets to treat mitral valve regurgitation are described in PCT Publication Nos. WO 98/35638; WO 99/00059; WO 99/01377; and WO 00/03759; WO 2000/060995; WO 2004/103162. Maisano et al. (1998) Eur. J. Cardiothorac. Surg. 13:240-246; Fucci et al. (1995) Eur. J. Cardiothorac. Surg. 9:621-627; and Umana et al. (1998) Ann. Thorac. Surg. 66:1640-1646, describe open surgical procedures for performing “edge-to-edge” or “bow-tie” mitral valve repair where edges of the opposed valve leaflets are sutured together to lessen regurgitation. Dec and Fuster (1994) N. Engl. J. Med. 331:1564-1575 and Alvarez et al. (1996) J. Thorac. Cardiovasc. Surg. 112:238-247 are review articles discussing the nature of and treatments for dilated cardiomyopathy.
• Mitral valve 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. Linear segmental annuloplasty for mitral valve repair is described in Ricchi et al. (1997) Ann. Thorac. Surg. 63:1805-1806. Tricuspid valve annuloplasty is described in McCarthy and Cosgrove (1997) Ann. Thorac. Surg. 64:267-268; Tager et al. (1998) Am. J. Cardiol. 81:1013-1016; and Abe et al. (1989) Ann. Thorac. Surg. 48:670-676.
• Percutaneous transluminal cardiac repair procedures are described in Park et al. (1978) Circulation 58:600-608; Uchida et al. (1991) Am. Heart J. 121: 1221-1224; and Ali Khan et al. (1991) Cathet. Cardiovasc. Diagn. 23:257-262. Endovascular cardiac valve replacement is described in U.S. Pat. Nos. 5,840,081; 5,411,552; 5,554,185; 5,332,402; 4,994,077; and 4,056,854. U.S. Pat. No. 3,671,979 describes a catheter for temporary placement of an artificial heart valve.
• Other percutaneous and endovascular cardiac repair procedures are described in U.S. Pat. Nos. 4,917,089; 4,484,579; and 3,874,338; and PCT Publication No. WO 91/01689.
• Thoracoscopic and other minimally invasive heart valve repair and replacement procedures are described in U.S. Pat. Nos. 5,855,614; 5,829,447; 5,823,956; 5,797,960; 5,769,812; and 5,718,725.
BRIEF SUMMARY
• The present disclosure describes devices intended for intravascular delivery and for use in treating mitral valve defects in human patients. The mitral valve of a human heart has an atrial side, a ventricular side, an anterior leaflet, a posterior leaflet, and an opening between the leaflets.
• In one embodiment, the device can include a body, a pair of proximal elements, and a pair of distal elements. Each proximal element is coupled at a first end to the body on opposite sides of the body, and has a free second end. Each proximal element has a proximal engagement surface between its first and second ends. Each proximal engagement surface is configured to approximate and engage a portion of the leaflets adjacent the mitral valve on the atrial side.
• Each proximal engagement surface also has a proximal retaining element configured to permit tissue to move toward the first end of the proximal element and to resist movement of the tissue away from the first end of the proximal element.
• Each distal element is pivotally coupled at a first end to the body on opposite sides of the body, and has a free second end. Each distal element has a distal engagement surface between its first and second ends. Each distal engagement surface is configured to approximate and engage a portion of the leaflets adjacent the mitral valve on the ventricular side.
• A first one of the proximal elements cooperates with a first one of the distal elements to form a space for receiving a portion of the anterior leaflet therebetween. A second one of the proximal elements cooperates with a second one of the distal elements to form a space for receiving a portion of the posterior leaflet therebetween. Each such space has an open end and a closed end, and the closed end forms an apex.
• The device includes an actuator for selectively moving the distal elements between a first position in which the distal elements are in a collapsed, low profile configuration for delivery of the device, a second position in which the distal elements are in an expanded configuration for positioning the device relative to the mitral valve, and a third position in which the distal elements are secured in position against a portion of the leaflets adjacent the mitral valve on the ventricular side.
• The device also includes an actuator for selectively moving the proximal elements between a first position in which the proximal elements are in a collapsed, low profile configuration for delivery of the device and a second position in which the proximal elements are in an expanded configuration for engaging a portion of the leaflets adjacent the mitral valve on the atrial side.
• Each distal element can also include a distal retaining element positioned along the distal engagement surface. Each distal retaining element is configured to cooperate with a corresponding proximal retaining element to capture a free edge of the mitral valve leaflet as the device is positioned relative to the mitral valve. Each retaining element can be configured to cooperate with a frictional element to allow a leading free edge of the leaflets to move in a first direction toward the body with little or no resistance or restriction and to resist or prevent movement of the free edge of the leaflets in an opposite direction away from the body.
• These and other objects and features of the present disclosure will become more fully apparent from the following description and appended claims, or may be learned by the practice of the embodiments of the invention as set forth hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS
• To further clarify the above and other advantages and features of the present disclosure, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only illustrated embodiments of the invention and are therefore not to be considered limiting of its scope. Embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
• FIG. 1 illustrates free edges of leaflets of the mitral valve in normal coaptation, andFIG. 2 illustrates the free edges in regurgitative coaptation.
• FIGS. 3A-3C illustrate grasping of the leaflets with a fixation device, inversion of the distal elements of the fixation device and removal of the fixation device, respectively.
• FIG. 4 illustrates the fixation device in a desired orientation relative to the leaflets.
• FIG. 5 illustrates an exemplary fixation device coupled to a shaft.
• FIGS. 6A-6B, 7A-7B, and 8 illustrate a fixation device in various possible positions during introduction and placement of the device within the body to perform a therapeutic procedure.
• FIGS. 9A-9B illustrate a fixation device embodiment with a leaf spring.
• FIG. 10 illustrates a close-up of a portion of another embodiment of a fixation device.
• FIG. 11A illustrates a close-up of a portion of another embodiment of a fixation device.
• FIGS. 11B and 11C each illustrate a close-up cross-sectional side view of a portion of another embodiment of a fixation device.
• FIGS. 11D and 11E each illustrate a close-up cross-sectional transverse view of a portion of another embodiment of a fixation device.
• FIG. 12 illustrates a close-up of a portion of another embodiment of a fixation device.
DETAILED DESCRIPTIONI. Introduction
• A. Cardiac Physiology
• As shown inFIG. 1, the mitral valve (MV) comprises a pair of leaflets (LF) having free edges (FE) which, in patients with normal heart structure and function, meet evenly to close along a line of coaptation (C). The leaflets (LF) attach to the surrounding heart structure along an annular region called the annulus (AN). The free edges (FE) of the leaflets (LF) are secured to the lower portions of the left ventricle LV through chordae tendinae (or “chordae”).
• As the left ventricle of a heart contracts (which is called “systole”), blood flow from the left ventricle to the left atrium through the mitral valve (MV) (called “mitral regurgitation”) is usually prevented by the mitral valve.
• Regurgitation occurs when the valve leaflets do not close properly and allow leakage from the left ventricle into the left atrium. A number of heart structural defects can cause mitral regurgitation.FIG. 2 shows a mitral valve with a defect causing regurgitation through a gap (G).
II. General Overview of Mitral Valve Fixation Technology
• Several methods for repairing or replacing a defective mitral valve exist. Some defects in the mitral valve can be treated through intravascular procedures, where interventional tools and devices are introduced and removed from the heart through the blood vessels. One method of repairing certain mitral valve defects includes intravascular delivery of a fixation device to hold portions of the mitral valve tissues in a certain position. One or more interventional catheters may be used to deliver a fixation device to the mitral valve and install it there as an implant to treat mitral regurgitation.
• FIG. 3A illustrates a schematic of aninterventional tool10 with adelivery shaft12 and afixation device14. Thetool10 has approached the mitral valve MV from the atrial side and grasped the leaflets LF.
• Thefixation device14 is releasably attached to theshaft12 of theinterventional tool10 at the distal end of theshaft12. In this application, when describing devices, “proximal” means the direction toward the end of the device to be manipulated by the user outside the patient's body, and “distal” means the direction toward the working end of the device that is positioned at the treatment site and away from the user. When describing the mitral valve, proximal means the atrial side of the leaflets and distal means the ventricular side of the leaflets.
• Thefixation device14 comprisesproximal elements16 anddistal elements18 which protrude radially outward and are positionable on opposite sides of the leaflets LF as shown so as to capture or retain the leaflets therebetween. Thefixation device14 is coupleable to theshaft12 by acoupling mechanism17.
• FIG. 3B illustrates that thedistal elements18 may be moved in the direction ofarrows40 to an inverted position. Theproximal elements16 may be raised as shown inFIG. 3C. In the inverted position, thedevice14 may be repositioned and then be reverted to a grasping position against the leaflets as inFIG. 3A. Or, thefixation device14 may be withdrawn (indicated by arrow42) from the leaflets as shown inFIG. 3C. Such inversion reduces trauma to the leaflets and minimizes any entanglement of the device with surrounding tissues.
• FIG. 4 illustrates thefixation device14 in a desired orientation in relation to the leaflets LF. The mitral valve MV is viewed from the atrial side, so theproximal elements16 are shown in solid line and thedistal elements18 are shown in dashed line. The proximal anddistal elements16,18 are positioned to be substantially perpendicular to the line of coaptation C. During diastole (when blood is flowing from the left atrium to the left ventricle),fixation device14 holds the leaflets LF in position between theelements16,18 surrounded by openings or orifices O which result from the diastolic pressure gradient, as shown inFIG. 4.
• Once the leaflets are coapted in the desired arrangement, thefixation device14 is detached from theshaft12 and left behind as an implant.
• A. Exemplary Fixation Device
• FIG. 5 illustrates anexemplary fixation device14. Thefixation device14 is shown coupled to ashaft12 to form aninterventional tool10. Thefixation device14 includes acoupling member19, a pair of opposedproximal elements16, and a pair of opposeddistal elements18.
• Thedistal elements18 compriseelongate arms53, each arm having aproximal end52 rotatably connected to thecoupling member19 and afree end54. Preferably, eachfree end54 defines a curvature about two axes,axis66 perpendicular to longitudinal axis ofarms53, andaxis67 perpendicular toaxis66 or the longitudinal axis ofarms53.
• Arms53 have engagement surfaces50.Arms53 andengagement surfaces50 are configured to engage about 4-10 mm of tissue, and preferably about 6-8 mm along the longitudinal axis ofarms53.Arms53 further include a plurality of openings.
• Theproximal elements16 are preferably resiliently biased toward thedistal elements18. When thefixation device14 is in the open position, eachproximal element16 is separated from theengagement surface50 near theproximal end52 ofarm53 and slopes toward theengagement surface50 near thefree end54 with the free end of theproximal element16 contactingengagement surface50, as illustrated inFIG. 5.
• Proximal elements16 include a plurality ofopenings63 and scalloped side edges61 to increase their grip on tissue. Theproximal elements16 optionally include a frictional element or multiple frictional elements to assist in grasping the leaflets. The frictional elements may comprisebarbs60 having tapering pointed tips extending toward engagement surfaces50. Any suitable frictional elements may be used, such as prongs, windings, bands, barbs, grooves, channels, bumps, surface roughening, sintering, high-friction pads, coverings, coatings or a combination of these.
• Theproximal elements16 may be covered with a fabric or other flexible material. Preferably, when fabrics or coverings are used in combination with barbs or other frictional features, such features will protrude through such fabric or other covering so as to contact any tissue engaged byproximal elements16.
• Thefixation device14 also includes an actuator oractuation mechanism58. Theactuation mechanism58 comprises two link members orlegs68, eachleg68 having afirst end70 which is rotatably joined with one of thedistal elements18 at a riveted joint76 and asecond end72 which is rotatably joined with astud74. Theactuation mechanism58 comprises twolegs68 which are each movably coupled to abase69. Or, eachleg68 may be individually attached to thestud74 by a separate rivet or pin. Thestud74 is joinable with an actuator rod which extends through theshaft12 and is axially extendable and retractable to move thestud74 and therefore thelegs68 which rotate thedistal elements18 between closed, open and inverted positions.
• Immobilization of thestud74 holds thelegs68 in place and therefore holds thedistal elements18 in a desired position. Thestud74 may also be locked in place by a locking feature. This actuator rod and stud assembly may be considered a first means for selectively moving the distal elements between a first position in which the distal elements are in a collapsed, low profile configuration for delivery of the device, a second position in which the distal elements are in an expanded configuration for positioning the device relative to the mitral valve, and a third position in which the distal elements are secured in position against a portion of the leaflets adjacent the mitral valve on the ventricular side.
• FIGS. 6A-6B, 7A-7B, and 8 illustrate various possible positions of thefixation device14 ofFIG. 5.FIG. 6A illustrates aninterventional tool10 delivered through acatheter86. Thecatheter86 may take the form of a guide catheter or sheath. Theinterventional tool10 comprises afixation device14 coupled to ashaft12 and thefixation device14 is shown in the closed position.
• FIG. 6B illustrates a device similar to the device ofFIG. 6A in a larger view. In the closed position, the opposed pair ofdistal elements18 are positioned so that the engagement surfaces50 face each other. Eachdistal element18 comprises anelongate arm53 having a cupped or concave shape so that together thearms53 surround theshaft12. This provides a low profile for thefixation device14.
• FIGS. 7A-7B illustrate thefixation device14 in the open position. In the open position, thedistal elements18 are rotated so that the engagement surfaces50 face a first direction. Distal advancement of the actuator rod relative toshaft12, and thus distal advancement of thestud74 relative to couplingmember19, applies force to thedistal elements18 which begin to rotate around joints76. Such rotation and movement of thedistal elements18 radially outward causes rotation of thelegs68 aboutjoints80 so that thelegs68 are directed slightly outwards. Thestud74 may be advanced to any desired distance correlating to a desired separation of thedistal elements18. In the open position, engagement surfaces50 are disposed at an acute angle relative toshaft12, and are preferably at an angle of between 90 and 180 degrees relative to each other. In the open position, the free ends54 ofarms53 may have a span therebetween of about 10-20 mm, usually about 12-18 mm, and preferably about 14-16 mm.
• Proximal elements16 are typically biased outwardly towardarms53. Theproximal elements16 may be moved inwardly toward theshaft12 and held against theshaft12 with the aid ofproximal element lines90 which can be in the form of sutures, wires, nitinol wire, rods, cables, polymeric lines, or other suitable structures. Theproximal element lines90 extend through the shaft302 of the delivery catheter300 and connect with theproximal elements16. Theproximal elements16 are raised and lowered by manipulation of the proximal element lines90. Once the device is properly positioned and deployed, the proximal element lines can be removed by withdrawing them through the catheter and out the proximal end of thedevice10. The proximal element lines90 may be considered a second means for selectively moving the proximal elements between a first position in which the proximal elements are in a collapsed, low profile configuration for delivery of the device and a second position in which the proximal elements are in an expanded configuration for engaging a portion of the leaflets adjacent the mitral valve on the atrial side.
• In the open position, thefixation device14 can engage the tissue which is to be approximated or treated. Theinterventional tool10 is advanced through the mitral valve from the left atrium to the left ventricle. Thedistal elements18 are then deployed by advancing actuator rod relative toshaft12 to thereby reorientdistal elements18 to be perpendicular to the line of coaptation. The entire assembly is then withdrawn proximally and positioned so that the engagement surfaces50 contact the ventricular surface of the valve leaflets, thereby engaging the left ventricle side surfaces of the leaflets. Theproximal elements16 remain on the atrial side of the valve leaflets so that the leaflets lie between the proximal and distal elements. Theinterventional tool10 may be repeatedly manipulated to reposition thefixation device14 so that the leaflets are properly contacted or grasped at a desired location. Repositioning is achieved with the fixation device in the open position. In some instances, regurgitation may also be checked while thedevice14 is in the open position. If regurgitation is not satisfactorily reduced, the device may be repositioned and regurgitation checked again until the desired results are achieved.
• It may also be desired to invertdistal elements18 of thefixation device14 to aid in repositioning or removal of thefixation device14.FIG. 8 illustrates thefixation device14 in the inverted position. By further advancement of actuator rod relative toshaft12, and thusstud74 relative to couplingmember19, thedistal elements18 are further rotated so that the engagement surfaces50 face outwardly and free ends54 point distally, with eacharm53 forming an obtuse angle relative toshaft12.
• The angle betweenarms53 when the device is inverted is preferably in the range of about 270 to 360 degrees. Further advancement of thestud74 further rotates thedistal elements18 around joints76. This rotation and movement of thedistal elements18 radially outward causes rotation of thelegs68 aboutjoints80 so that thelegs68 are returned toward their initial position, generally parallel to each other. Thestud74 may be advanced to any desired distance correlating to a desired inversion of thedistal elements18. Preferably, in the fully inverted position, the span between free ends54 is no more than about 20 mm, usually less than about 16 mm, and preferably about 12-14 mm.Barbs60 are angled slightly in the distal direction (away from the free ends of the proximal elements16), reducing the risk that the barbs will catch on or lacerate tissue as the fixation device is withdrawn.
• Once thedistal elements18 of thefixation device14 have been positioned in a desired location against the left ventricle side surfaces of the valve leaflets, the leaflets may then be captured between theproximal elements16 and thedistal elements18. Theproximal elements16 are lowered toward the engagement surfaces50 by releasing tension from proximal element lines90, thereby releasingproximal elements16 so that they are then free to move, in response to the internal spring bias force formed intoproximal elements16, from a constrained, collapsed position to an expanded, deployed position and so that the leaflets are held between theproximal elements16 and thedistal elements18. If regurgitation is not sufficiently reduced, theproximal elements16 may be raised and thedistal elements18 adjusted or inverted to reposition thefixation device14.
• After the leaflets have been captured between the proximal anddistal elements16,18 in a desired arrangement, thedistal elements18 may be locked to hold the leaflets LF in this position or thefixation device14 may be returned to or toward a closed position. This is achieved by retraction of thestud74 proximally relative to couplingmember19 so that thelegs68 of theactuation mechanism58 apply an upwards force to thedistal elements18 which in turn rotate thedistal elements18 so that the engagement surfaces50 again face one another. The releasedproximal elements16 which are biased outwardly towarddistal elements18 are concurrently urged inwardly by thedistal elements18. Thefixation device14 may then be locked to hold the leaflets in this closed position. Thefixation device14 may then be released from theshaft12. Thefixation device14 optionally includes a locking mechanism for locking thedevice14 in a particular position, such as an open, closed or inverted position or any position therebetween. The locking mechanism may include a release harness. Applying tension to the release harness may unlock the locking mechanism.
• The lock lines92 engage the release harnesses108 of the locking mechanism106 to lock and unlock the locking mechanism106. The lock lines92 extend through the shaft302 of the delivery catheter300. A handle attached to the proximal end of the shaft is used to manipulate and decouple thefixation device14.
• Additional disclosure regardingsuch fixation devices14 may be found in PCT Publication No. WO 2004/103162 and U.S. patent application Ser. No. 14/216,787, the disclosures of both of which are incorporated herein in their entirety.
• B. Improved Grasping Mechanisms
• Sometimes it can be difficult to capture or retain tissue withinfixation device14 so thatfixation device14 approximates or repairs the tissue as desired. Leaflet insertion may be assessed throughout the process of installing afixation device14, but it can be difficult to differentiate good and poor leaflet insertion and retention. For example, whenfixation device14 is used in endovascular or minimally invasive procedures, visualization of the capturing or retention of tissue may be difficult.
• At times during the process of installing afixation device14, the tissue desired to be captured or retained betweenproximal elements16 anddistal elements18 may seem to be securely captured or retained when it is actually only partially captured or insecurely captured. As a result, the free edges FE of leaflet tissue LF may later disassociate from thefixation device14 and thefixation device14 may then not properly coapt, approximate, or repair the tissue. Even if imaging methods make it possible to visualize when tissue is captured in the fixation device, they may not allow for a viewer to distinguish between securely and insecurely captured tissue. For example, color Doppler echo may show that regurgitation has been reduced, but it may not provide precise specifics on where along the leafletsLF fixation device14 has captured the tissue, and whether the capturing is secure.
• If a leaflet is poorly grasped betweenproximal elements16 anddistal elements18, eventually that leaflet LF may separate from thefixation device14. This may result in thefixation device14 being attached to only one of the leaflets LF, or separating from both leaflets LF, and no longer functioning as desired.
• In addition to difficulties arising from the imaging or visualization of thedevice14 as it is installed, difficulty in capturing or retaining tissue withinfixation device14 may also result from the nature of tissue desired to be captured or retained. For example, when usingfixation device14 to fix mitral valve leaflets LF to each other to stop or reduce mitral valve regurgitation, the leaflets LF are constantly moving as the heart beats.
• FIGS. 9-12 illustrate various embodiments that are intended to help afixation device14′ capture and retain the free edges FE of leaflets LF during placement of thefixation device14′. To do so, these embodiments include the addition of a retainingelement400 positioned on the proximal side of eachdistal element18′. The retainingelement400 combines with frictional elements such asbarbs410 at the lower end of theproximal element16′ to capture the free edge FE of the leaflet upon its initial insertion and help retain it there until the proximal and distal elements are fully deployed. The lower end of theproximal element16′ is the end closest to thestud74′.
• The retainingelement400 andbarbs410 are configured to cooperate to allow the free edge FE of the leaflets LF to easily or freely move in a first direction toward the apex430 formed between eachproximal element16′ and the correspondingdistal element18′, but at the same time to resist or prevent movement of the free edge FE of the leaflet tissue LF in the opposite direction away fromapex430. In this way, retainingelement400, in cooperation with thebarbs410, help to retain the leaflets LF in thedevice14′ while the device is being positioned relative to the leaflets LF and before theproximal elements16′ anddistal elements18′ are fully deployed.
• The retainingelement400 may serve as a passive capture mechanism that retains leaflet tissue LF without needing to be activated. For example, the retainingelement400 may retain leaflet tissue LF in thedevice14′ when a length of tissue of about 4-10 mm, and preferably about 6-8 mm, is located along the longitudinal axis of thedistal elements18′. A retainingelement400 may be located on thedistal elements18′, as shown in the illustrated embodiments, or the retainingelement400 may be located on theproximal elements16′, or it may be located on both thedistal elements18′ and theproximal elements16′. A retainingelement400 may hold a leaflet LF in place without closing thefixation element18′ andgripping element16′.
• As shown inFIGS. 9A-9B, in one embodiment, a retainingelement400 may be aspring element402 that retains leaflets LF inserted into thefixation device14′. Thespring element402 may help capture or hold any leaflet LF that inserts past a given point along thedistal elements18′ which is determined to be sufficient insertion depth.
• Referring again toFIGS. 9A-B, thespring element402 is on adistal element18′. Eachdistal element18′ has aspring element402 incorporated into or attached to thedistal element18′. Thespring element402 may be incorporated into or attached to thedistal element18′ at amidpoint414 between afirst end404 of thedistal element18′ that attaches to astud74′ and thefree end406 of thedistal element18′. It may also be incorporated into or attached to thedistal element18′ closer to thefree end406 of eachdistal element18′ or to thefirst end404 of eachdistal element18′. As shown inFIGS. 9A-B, thefixed end412 of thespring element402 is located between themidpoint414 andfree end406 of thedistal element18′. In addition, thespring element402 of the retainingelement400 is elongate and can extend in an elongate fashion along substantially an entire length of thedistal element18′ and associated distal engagement surface. Alternatively, the retainingelement400 can extend in an elongate fashion from a location near or adjacentfirst end404 to a location distal a midpoint of the distal engagement surface of thedistal element18′ or from a location near or adjacentsecond end406 to a location distal a midpoint of the distal engagement surface of thedistal element18′.
• Thespring element402 may comprise a low-force leaf spring408 biased to push thespring element402 towards the leaflet LF and encourage frictional elements orbarbs410 to be deeply inserted into the leaflet LF, so the leaflet LF remains in a fully seated state untildistal elements18′ are further closed. As illustrated,barbs410 are orientated at an angle pointing towardapex430. Withbarbs410 oriented in that direction, the leading edge LE of the leaflet tissue LF is allowed to move in a first direction towardapex430 with little or no restriction or resistance. As the leading edge LE of the leaflet tissue moves towardapex430,spring element402 directs or urges the leaflet tissue LF toward and into contact withbarbs410. Once the leaflet tissue LF comes into contact with and engages thebarbs410, the angled orientation of thebarbs410causes barbs410 to penetrate into the leaflet tissue LF and then restricts or prevents movement of the leaflet tissue LF in the opposite direction away fromapex430. Thus, the combination of the retainingelement400 and thebarbs410 effectively function as a directional trap that permits the leaflet tissue LF to move in a first direction towardapex430 with little or no resistance, while restricting or preventing movement of the leaflet tissue LF in a second or opposite direction away fromapex430.
• Theleaf spring408 may have one or more lobes or a partial lobe. Theleaf spring408 may be biased to allow for little to no resistance to a leaflet LF as it inserts. It may have surface features, a pointed edge, or other elements that create resistance to make it difficult for the leaflet LF to retract out. Such surface features may include, for example, dimples, bumps, ridges, or indents. For example, as shown inFIG. 9A-B, thefree end416 of thespring element402 may be configured to curve toward thedistal elements18′ (as shown inFIG. 9A) when tissue LF is being trapped, and curve away from thedistal element18′ (as shown inFIG. 9B) when tissue LF is being released. When the leaflet is entrapped between thedistal elements18′ and theproximal elements16′, thefree end416 of thespring element402 may be configured to lie flat against thedistal element18′.
• The retainingelement400 helps thefixation device14 capture tissue whenproximal elements16′ are raised anddistal elements18′ are still partially open. The retainingelement400 may be configured to urge the leaflet tissue against thebarbs410 on theproximal elements16. The retainingelement400 may be a one-way mechanism that allows tissue to enter but not exit, such as a ratchet or something similar to a ratchet.
• Because repositioning and regrasping thefixation device14′ is sometimes required, the one-way mechanism should have a way for the leaflet tissue LF to be permitted to escape. The retaining element can be designed to allow tissue to exit under certain circumstances, such as when thedistal elements18′ are opened to approximately 180°, as shown inFIG. 9B, or are opened even further in an inverted position, as shown inFIG. 8. Or, when theproximal elements16′ are raised, the leaflet tissue LF may be released to allow regrasping.
• To ensure that the leaflets LF are properly grasped in afixation device14′, one method of using a device with a retainingelement400 such as aspring element402 located near each set ofdistal elements18′ andproximal elements16′ is to first capture one or both leaflets LF in thespring element402. The spring element urges the leaflets LF against thebarbs410 at the lower end of theproximal element16′ to capture the free edge FE of the leaflet LF upon its initial insertion and help retain it there until the proximal anddistal elements16,18 are fully deployed. It may be possible to confirm that one or more leaflets LF is captured based on imaging methods such as color Doppler echo. When leaflets LF are trapped between thespring element402 and thebarbs410, then theproximal elements16′ may be lowered toward thesurfaces50′ of thedistal elements18′, so that the leaflets LF are held therebetween and thedistal elements18′ may be locked to hold the leaflets LF in this position or thefixation device14′ may be returned to or toward a closed position.
• In another embodiment, as shown inFIG. 10, a retainingelement400 comprises anarm417. Eachdistal element18′ has anarm417 incorporated into or attached to thedistal element18′. Thearm417 may be incorporated into or attached at afixed end415 to thedistal element18′ at amidpoint414 between afirst end404 of thedistal element18′ that attaches to astud74′ and thefree end406 of thedistal element18′. It may also be incorporated into or attached to thedistal element18′ closer to thefree end406 of eachdistal element18′ or to thefirst end404 of eachdistal element18′. As shown inFIG. 10, thefixed end415 of thearm417 is located between themidpoint414 andfree end406 of thedistal element18′.
• Thearm417 has a projection orprojections418 of a suitable shape and size to assist in retaining the leaflets LF in position. Theseprojections418 may have sharp tips located opposite to thearm417, or sharp edges between their tips and thearm417. They may comprise barbs having tapering pointed tips, scalloped edges, prongs, windings, bands, grooves, channels, bumps, surface roughening, sintering, high-friction pads, coverings, coatings or a combination of these. As shown inFIG. 10, these projections may be oriented away from thesurface50′ and angled away from the free ends406 of thedistal element18′. They may also orient toward the free ends406, or be perpendicular to thesurface50′. The projections may flex or collapse toward thedistal element18′ when thefixation device14′ is closed and flex out to a fixed angle when thefixation device14′ is open. For example, theprojections418 may bias toward a fixed angle from the engagement surfaces50′, but may be pushed flat against thedistal element18′ when thedistal elements18′ close around theshaft12.
• The fixation device should be configured with enough space between theproximal elements16′ and thedistal elements18′ for a leaflet LF to be easily inserted past theprojections418 on thedistal elements18′. The chordal tethered leaflets LF may be tensioned lightly upon thefixation device14′ just prior to closing thedistal elements18′ andproximal elements16′. They may also be securely affixed to thedevice14′ prior to closing thedistal elements18′ andproximal elements16′.
• In one embodiment, thearm417 may be a flexible leaf-spring that pivots at afixed end415 and is positioned between theproximal element16′ anddistal elements18′. It may also include a system ofprojections418 angled to allow entry of the tissue between thedistal element18′ andproximal element16′, but to prevent retraction of the tissue LF. As shown, theprojection418 andleaf spring417 may be combined in the same structure. In addition, thearm417 of the retainingelement400 is elongate and can extend in an elongate fashion along substantially an entire length of thedistal element18′ and associated distal engagement surface. Alternatively, the retainingelement400 can extend in an elongate fashion from a location near or adjacentfirst end404 to a location distal a midpoint of the distal engagement surface of thedistal element18′ or from a location near or adjacentsecond end406 to a location distal a midpoint of the distal engagement surface of thedistal element18′.
• As shown inFIG. 11, in another embodiment the retainingelement400 may comprise one ormore protrusions420. One ormore protrusions420 may be positioned close to the hinge point of thedistal elements18′ on theengagement surface50′. When a leaflet LF is inserted past theprotrusion420, theprotrusion420 may reduce leaflet detachment upon deployment of thefixation device14′ by directing or urging the leaflet LF into contact with the gripping surfaces orbarbs410 located on the opposingproximal element16′. Theprotruding feature420 may be located near amidpoint414 between afirst end404 of thedistal element18′ that attaches to astud74′ and thefree end406 of thedistal element18′. It may also be incorporated into or attached to thedistal element18′ closer to thefree end406 of eachdistal element18′ or to thefirst end404 of eachdistal element18′. Aprotruding feature420 may be a rigid piece of material that is affixed to theengagement surface50′ ofdistal elements18′ and may be atraumatic to aid with directing or urging the leaflet LF while causing minimal damage to the leaflet LF, such as not penetrating or puncturing the leaflet LF. The protruding feature may be comprised of any biocompatible material or materials, such as a polymer, nitinol, or other alloys, or bioabsorbable materials.
• Theprotruding feature420 of thedistal elements18′ may passively engage the leaflet tissue LF when leaflet tissue LF is sufficiently inserted into thedevice14′. Or, the protrudingfeature420 may be configured to help engage leaflet tissue and secure it into position when theproximal elements16′ are lowered and also secure the leaflet tissue LF. Theprotruding feature420 may help entrap tissue between theprotruding feature420 and the gripping surfaces of theproximal elements16′. Thefeature420 may urge the tissue LF against thebarbs410.
• While theprotruding feature420 is illustrated as including a generally curved or domed outer surface, it will be understood that various other surface orientations are appropriate while maintaining the atraumatic nature and ability to aid with directing or urging the leaflet LF. For instance, as illustrated inFIGS. 11B-11E, the protrudingfeature420 can have a curved surface that is symmetric or asymmetric in (i) a direction fromfirst end404 towards thesecond end406. (ii) a direction cross-wise, transverse, or oblique to the direction fromfirst end404 towards thesecond end406, or (iii) both. So theprotruding feature420 can be symmetric in at least one axis, at least two axes, or in all three axes. Alternatively, the protrudingfeature420 can be asymmetric in at least one axis, at least two axes, or in all three axes.
• In another embodiment, shown inFIG. 12, the retainingelement400 may comprise ahinge422 that is attached to thesurface50′ of thedistal elements18′. Thehinge422 connects to anarm424 that can swing toward and away from thedistal element18′. As shown inFIG. 12, thearm424 may bias toward thefirst end404 of eachdistal element18′. Thearm424 may be capable of laying parallel to or flat against thesurface50′ while being oriented toward thefirst end404 of thedistal element18′. It also may be capable of laying parallel to or flat against thesurface50′ while being oriented toward thefree end406 of thedistal element18′, and therefore capable of rotating 180°. Thehinge422 may restrict the movement of thearm424 so that it can, for example, only lie parallel to thesurface50′ while being oriented toward thefirst end404 of thedistal element18′ and be rotated about 90°, so that the angle formed between thearm424 and the portion of thedistal element18′ below thehinge422 can be no greater than 90°. Thehinge422 may also be a pivoting element.
• There may also bemultiple arms424 on thedistal element18′. For example, there may be two arms, each located the same distance between theends404 and406, and positioned next to each other on theengagement surface50′. If there are multiple retainingelements400, such asmultiple arms424 ormultiple spring elements402, they may be configured to be positioned on either side of thebarbs410 on the proximal element. Retaining element orelements400 may also be positioned to be located betweenbarbs410 on theproximal element16′, if there aremultiple barbs410 on theproximal element16′. In addition, thearm424 of the retainingelement400 is elongate and can extend in an elongate fashion along substantially an entire length of thedistal element18′ and associated distal engagement surface. Alternatively, the retainingelement400, and associatedarm424, can extend in an elongate fashion from a location near or adjacentfirst end404 to a location distal a midpoint of the distal engagement surface of thedistal element18′ or from a location near or adjacentsecond end406 to a location distal a midpoint of the distal engagement surface of thedistal element18′.
• Thedistal elements18 may be covered with a fabric or other flexible material. Preferably, when fabrics or coverings are used in combination withprojections418, such features will protrude through such fabric or other covering so as to contact the leaflet tissue LF.
• Analogous to a mechanical pawl, the bias, angle, and direction of a retainingelement400 may allow the leaflet to fall or slide deeper towards thestud74′ without much resistance but may restrict the ability of the leaflet LF to move back out. By permitting the leaflet LF to easily enter but not permitting it to easily be removed from thefixation device14′, this may help entrap the leaflet LF in a fully inserted state.
• In the embodiments described above, the retainingelement400 is a passive element. However, retainingelement400 may also include an active element such that, when a piece of leaflet tissue LF proceeds beyond or next to a portion of the retainingelement400, the retainingelement400 may automatically spring or deploy in such a way as to retain tissue LF in place.
• In another embodiment, afixation device14 or14′ may comprise a mechanical or physical sensor or some visual indicator of when a leaflet is properly inserted into the device prior to closing thedistal elements18′ and deployment of thefixation device14 or14′. For example, a tactile sensor may be embedded near thefirst end404 of each distal element. Each tactile sensor may provide a signal or indication when the leaflet LF touches the sensor, and the sensor may be located so that the leaflet LF will be unable or unlikely to touch the sensor unless the leaflet is adequately captured.
• Yet another mechanism for enhancing the placement and retention of the leaflet tissue LF in thefixation device14 or14′ is to facilitate actuation of eachproximal element16 or16′ and eachdistal element18 or18′ independent from one another. When theproximal elements16 or16′ for both leaflets LF are activated simultaneously, and thedistal elements18 or18′ for each leaflet LF are also activated simultaneously, it can be hard to capture both leaflets, because it is necessary to capture both at the same time. In other words, when the activation of bothproximal elements16 or16′ is symmetric, and the activation of bothdistal elements18 or18′ is symmetric, thefixation device14 or14′ is not able to grasp one leaflet first and then the other. If a catheter or thefixation device14 or14′ is not properly positioned, or if either leaflet LF has redundant or loose length, thefixation device14 or14′ may not fully seat the leaflets between eachdistal fixation element18 or18′ and proximalgripping element16 or16′.
• In one embodiment, eachproximal element16 or16′ and/or eachdistal element18 or18′ may be activated independently from each other. For example, there may be a separate proximal element line for eachproximal element16 or16′. Similarly, there may be twoactuator rods64 which extend through theshaft12, each of which may be configured to activate onedistal element18 or18′.
• In addition to being used to repair mitral valves, these devices can be used in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including abdominal, thoracic, cardiovascular, intestinal, digestive, respiratory, and urinary systems, and other systems and tissues. The invention provides devices, systems, and methods that may more successfully approximate and repair tissue by improving the capture of tissue into the devices.
• The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims (15)

What is claimed is:

1. A device for fixation of leaflets of a heart valve comprising:

a delivery catheter having a distal end; and

a fixation implant releasably attached to the distal end, the fixation implant comprising:

first and second distal elements moveable between an open position and a closed position, each distal element extending outwardly from a center of the fixation implant in the open position;

a first retaining element attached to the first distal element;

a second retaining element attached to the second distal element;

a first proximal element movable to capture a first leaflet of the heart valve between the first proximal element and the first retaining element; and

a second proximal element moveable to capture a second leaflet of the heart valve between the second proximal element and the second retaining element,

wherein the first and second distal elements are configured to cover the first and second retaining elements, respectively, in the closed position.

2. The device ofclaim 1, wherein each proximal element includes a plurality of friction elements.

3. The device ofclaim 2, wherein the plurality of friction elements comprises a plurality of barbs.

4. The device ofclaim 2, wherein each of the first and second retaining elements is configured to cooperate with the plurality of friction elements of the respective proximal element to allow a leading free edge of the first leaflet of the heart valve and the second leaflet of the heart valve, respectively, to move freely in a first direction toward the center of the fixation implant and to restrict movement of the free edge of the respective first and second leaflet of the heart valve in a second direction opposite the first direction.

5. The device ofclaim 1, further comprising at least two sutures configured to raise and lower each of the first and second proximal elements relative the first and second retaining elements, respectively.

6. The device ofclaim 1, wherein each of the first and second distal elements includes a fabric covering.

7. The device ofclaim 6, wherein each of the first and second distal elements has at least a portion having a concave surface.

8. The device ofclaim 7, wherein the concave surfaces of the first and second distal elements are configured to surround a central portion of the fixation implant in the closed position.

9. The device ofclaim 8, wherein the central portion has a longitudinal axis defining the center of the fixation implant.

10. The device ofclaim 1, wherein each of the first and second retaining elements is capable of being aligned parallel with the respective first and second distal element in the closed position.

11. The device ofclaim 1, wherein the first retaining element comprises a first spring portion and the second retaining element comprises a second spring portion.

12. The device ofclaim 1, wherein the first retaining element is attached proximate a midpoint of the first distal element in the closed position, and the second retaining element is attached proximate a midpoint of the second distal element in the closed position.

13. The device ofclaim 1, wherein each first and second retaining element is attached to the first and second distal element, respectively, proximate the center of the fixation implant.

14. A fixation implant for fixation of leaflets of a heart valve comprising:

first and second distal elements moveable between an open position and a closed position, each distal element extending outwardly from a center of the fixation implant in the open position;

a first retaining element attached to the first distal element;

a second retaining element attached to the second distal element;

a first proximal element movable to capture a first leaflet of the heart valve between the first proximal element and the first retaining element; and

a second proximal element moveable to capture second leaflet of the heart valve between the second proximal element and the second retaining element,

wherein the first and second distal elements are configured to cover the first and second retaining elements, respectively, in the closed position.

15. A fixation implant for fixation of leaflets of a heart valve comprising:

first and second distal elements moveable between an open position and a closed position, each distal element including a fabric covering and defining a concave shape, each distal element extending outwardly from a center of the fixation implant when in the open position;

a first retaining element attached to the first distal element and disposed within the concave shape of the first distal element when in the closed position;

a second retaining element attached to the second distal element and disposed within the concave shape of the second distal element when in the closed position;

a first proximal element movable to capture a first leaflet of the heart valve between the first proximal element and the first retaining element; and

a second proximal element moveable to capture second leaflet of the heart valve between the second proximal element and the second retaining element.

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