US20220000616A1 - Transcatheter atrial anchors and methods of implantation - Google Patents
Transcatheter atrial anchors and methods of implantation Download PDFInfo
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- US20220000616A1 US20220000616A1 US17/410,123 US202117410123A US2022000616A1 US 20220000616 A1 US20220000616 A1 US 20220000616A1 US 202117410123 A US202117410123 A US 202117410123A US 2022000616 A1 US2022000616 A1 US 2022000616A1
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Definitions
- the present invention relates generally to medical devices and systems that are implanted minimally invasively in the heart and methods of implantation of these devices and systems. More specifically, the invention pertains to intracardiac anchors for anchoring medical devices, such as cardiac valves, to a cardiac wall, including for interventricular or epicardial implantation of a replacement valve into an intracardial wall.
- Transcatheter valves have proven safe and effective for the replacement of native cardiac valves. These valves have been tested extensively for replacement of aortic, mitral, and pulmonic valves, but replacement of tricuspid valves remains challenging given the complex and delicate anatomy to which prostheses must attach. Limiting paravalvular regurgitation of transcatheter mitral and tricuspid valves is challenging because the mitral and tricuspid annuli are complex saddle-shaped structures that are highly dynamic during the cardiac cycle. Compounding this difficulty for the tricuspid valve is the frequent presence of intracardiac leads in patients with significant tricuspid regurgitation (TR). Because ventricular leads traverse the annulus from the right atrium to the right ventricle, a transcatheter tricuspid valve must seal around both the annulus and the lead to limit regurgitation in these patients.
- TR tricuspid regurgitation
- Applicant's Ser. No. 15/943,792 discloses a Transcatheter Anchor and Tether Devices, Systems and Methods of Implantation including an anchor delivery system for introducing a tether coupled to the anchor and a valve delivery system for delivering, positioning and sealing the valve.
- Applicant's Ser. No. 15/943,792 is directed to a Transcatheter Anchor and Tether Devices, Systems and Methods of Implantation wherein, the anchor delivery system comprises an anchor which is implanted and not initially coupled to a tether.
- the disclosure presented herein may be used in connection with either of these delivery or anchoring systems, or any delivery or anchoring systems and may be used for anchoring any valve, including that disclosed in Applicant's Ser. No. 15/974,696.
- the application relates to anchors for tethering a replacement heart valve for replacing a native heart valve.
- the anchor is implanted into a cardiac wall utilizing an anchor delivery system.
- the anchor may be either implanted with a tether connected thereto or implanted and then connected to a tether. If the latter, a tether assembly is mounted to the implanted anchor to connect the anchor to the valve.
- the anchors may be implanted into any cardiac wall including the interventricular septum or the epicardial space and the valve may replace the mitral or tricuspid valve.
- the anchor includes an anchor cap and an anchor screw for implanting into the cardiac wall.
- the tether is coupled to the anchor cap either directly or with a tether assembly.
- the anchor extends through to an opposing side of a cardiac wall, such as the pericardial space or the interventricular septum.
- the anchor screw penetrates the cardiac wall a sufficient depth without penetrating the wall to the opposing side.
- the anchor includes an anchor shaft formed or more than one shaft members which expand within the cardiac wall
- FIG. 1 is a cut-away perspective view of a heart showing the transcatheter atrial sealing skirt system positioned across the tricuspid valve in the heart;
- FIG. 2 is a cut-away perspective view of a heart showing the transcatheter atrial sealing skirt system positioned across the mitral valve in the heart;
- FIG. 3 is a side elevational view of a tether, with its cords fused to sutures, connected to an anchor, according to one aspect;
- FIG. 4A is a side elevational view of an anchor delivery system, according to one aspect
- FIG. 4B is a magnified side elevational view of the anchor delivery system of FIG. 4A ;
- FIG. 4C is an end view of the anchor delivery system of FIG. 4A ;
- FIG. 5A is a perspective view of the anchor delivery system in which a portion of the device is positioned in the right ventricle;
- FIG. 5B is a perspective view of the anchor delivery in which the anchor delivery system is delivering a portion of the tether, connected to the anchor, into the right ventricle;
- FIG. 6A is a perspective view of the anchor delivery system in which the anchor delivery system is delivering a portion of the tether, connected to the anchor into the right ventricle;
- FIG. 6B is a perspective view of the tether, connected to the anchor, positioned in the right ventricle;
- FIG. 7A is a perspective view of two tethers, each connected to an anchor positioned in a heart, according to one aspect
- FIG. 7B is a magnified view of the two tethers each connected to an anchor of FIG. 7A ;
- FIG. 8 is a perspective view of an epicardial tether system for positioning an anchor in the pericardial space, according to one aspect
- FIG. 9 is a perspective view of the epicardial tether system of FIG. 8 , in which a portion of a catheter of the system has entered the pericardial space;
- FIG. 10 is a perspective view of the epicardial tether system of FIG. 8 , in which the pericardial space has been insufflated;
- FIG. 11 is a perspective view of the epicardial tether system of FIG. 8 , in which a J-wire has been inserted into the insufflated pericardial space;
- FIG. 12 is a perspective view of the epicardial tether system of FIG. 8 , in which an anchor delivery guide of the system approaches the insufflated pericardial space;
- FIG. 13 is a perspective view of the epicardial tether system of FIG. 8 , in which an anchor of the system is being positioned in the insufflated pericardial space;
- FIG. 14 is a perspective view of the epicardial tether system of FIG. 8 , in which an anchor of the system has been deployed in the insufflated pericardial space;
- FIG. 15 is a perspective view of the epicardial tether system of FIG. 8 , in which an anchor of the system has been deployed in the insufflated pericardial space and delivery devices of the system have been retracted;
- FIG. 16 is a perspective view of an interventricular tether system for positioning an anchor in the left ventricle, according to one aspect
- FIG. 17 is a perspective view of the interventricular tether system of FIG. 16 , in which an RF wire of the system has crossed the septum and entered the left ventricle;
- FIG. 18 is a perspective view of the interventricular tether system of FIG. 16 , in which a catheter of the system has crossed the septum and entered the left ventricle;
- FIG. 19 is a perspective view of the interventricular tether system of FIG. 16 , in which a J-wire of the system has been advanced through the catheter and into the left ventricle;
- FIG. 20 is a perspective view of the interventricular tether system of FIG. 16 , in which a delivery guide of the system approaches the left ventricle;
- FIG. 21 is a perspective view of the interventricular tether system of FIG. 16 , in which the delivery guide of the system has crossed the septum and entered the left ventricle;
- FIG. 22 is a perspective view of the interventricular tether system of FIG. 16 , in which an anchor of the system is being positioned in the left ventricle;
- FIG. 23 is a perspective view of the interventricular tether system of FIG. 16 , in which an anchor of the system has been deployed in the left ventricle;
- FIG. 24 is a perspective view of the interventricular tether system of FIG. 16 , in which an anchor of the system has been deployed in the left ventricle and delivery devices of the system have been retracted;
- FIG. 25 is a perspective view of the delivery cable of an anchor delivery device for anchoring a tether to a cardiac wall according to another aspect
- FIG. 26 is a perspective view of an anchor according to another aspect for anchoring a tether to a cardiac wall
- FIG. 27 is a perspective view of a tether assembly for anchoring a valve to the anchor;
- FIG. 28 is a perspective view of the anchor assembly, comprised of the tether, coupled to the anchor, for anchoring the tether to a cardiac wall;
- FIG. 29A-29C are perspective views of an anchor according to an alternative aspect with a splitting or expanding anchor screw
- FIG. 30A is a side elevational view of the anchor delivery device
- FIG. 30B is a side view of the anchor delivery device shown within the delivery sheath;
- FIG. 30C is an end view of the anchor delivery device
- FIG. 31A is a perspective view of the anchor delivery device being positioned in the right ventricle
- FIG. 31B is a perspective view of the anchor being implanted into the intracardiac wall.
- FIGS. 32A-32F are perspective views of an anchor according to another aspect having an anchor screw and anchor cap configured for receipt of connecting ring and a tethering system illustrated in sequential steps.
- Ranges can be expressed herein as from “about” one particular value, and/or to “about” another particular value. When such a range is expressed, another aspect includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.
- the terms “optional” or “optionally” mean that the subsequently described event or circumstance may or may not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not.
- the application relates to medical devices and systems to be minimally invasively implanted in the heart and methods of implantation of these devices and systems. More specifically, the application relates to intracardiac anchors 75 and methods and systems for endovascularly introducing and implanting the anchor 75 to a cardiac wall such as for implanting a valve 100 in the heart which is tethered to the anchor 75 to replace the native valve.
- FIG. 1 illustrates the transcatheter valve 100 which has been implanted to replace the native tricuspid valve (for example) according the medical assembly disclosed herein.
- FIG. 2 illustrates the valve 100 implanted to replace the native mitral valve.
- the heart includes the right atrium 3 , right atrial floor 4 , right ventricle 6 , intracardiac wall 7 , left atrium 8 and left ventricle 11 .
- the replacement valve 100 is positioned at the deployment site 5 .
- the anchoring systems are used to anchor a transcatheter valve 100 which may, include an atrial sealing skirt 46 configured to couple to the atrial floor.
- At least one tether 21 composed of one or more cords, connects the valve 100 to the anchor 75 as shown.
- the tether 21 may be implanted by anchor 75 to any intracardiac wall, including, but not limited to, the interventricular septum, ventricular apex, or ventricular free wall.
- the ventricular apex is shown but it is within the spirit and scope of the present invention to anchor the tether 75 to any intracardiac wall.
- a tethering assembly cooperates with the anchor 75 connecting the valve 100 to the anchor 75 .
- the anchors disclosed herein may be used in connection with a valve 100 which includes a sealing skirt 46 for cooperating with the valve 100 to conform to the respective atrial floor to prevent paravalvular regurgitation of prosthesis as disclosed in Applicant's Ser. No. 15/974,696.
- Various aspects of the anchors 75 disclosed herein may be implanted with a tether pre-assembled to the anchor or independent of the tether wherein the tether is applied to the anchor after implantation.
- the anchors described herein may be employed to anchor a tricuspid valve or mitral valve as shown in FIGS. 1 and 2 , respectively.
- the tether 21 includes at least one cord 32 , and each cord 32 is connected to a suture 34 .
- the anchor 75 includes an anchor screw 28 and an anchor cap 30 .
- the anchor screw is coupled to and extends from a distal end 36 of the anchor cap
- the at least one cord 32 of the tether 21 is coupled to and extends from a proximal end 38 of the anchor cap 30 . That is, the anchor cap 30 is positioned between the anchor screw 28 and the cord 32 .
- the anchor screw 28 of anchor 75 , is configured to securely attach the tether 21 to an intracardiac wall such as the ventricular apex 7 of the heart 1 .
- the anchor screw 28 is an active fixation screw comprising threads or a coil that is securely rotated into the ventricular apex.
- the anchor 75 and the anchor screw 28 are configured to securely attach the tether 21 to an intracardiac wall such as the ventricular apex 7 of the heart without extending through the apex and outside of the heart.
- substantially no portion of the assembly completely penetrates and/or extends completely through any portion of the heart wall, and trans-apical access is not necessary.
- a fixation mechanism composed of, but not limited to, nitinol, stainless steel, cobalt-chromium, or titanium alloys, in the shape of barbs, hooks, prongs and the like is positioned at the distal end 36 of the anchor cap 30 to securely attach the tether 21 to the ventricular apex 7 of the heart 1 without extending through the apex and outside of the heart.
- the at least one cord 32 has a distal end 40 coupled to a portion of the anchor cap 30 and a proximal end 42 coupled to the suture 34 .
- the cord is a strong yet flexible cord such as, for example and without limitation, an expanded polytetrafluoroethylene (ePTFE) or ultra-high-molecular-weight polyethylene (UHMWPE or UHMW) cord.
- ePTFE expanded polytetrafluoroethylene
- UHMWPE ultra-high-molecular-weight polyethylene
- the delivery system 50 for positioning and deploying the anchor cap 30 of anchor 75 at the desired implantation site is illustrated.
- the delivery system 50 comprises an anchor delivery guide 52 and an anchor delivery rod 54 .
- the anchor delivery guide 52 has a distal end 56 , an opposed proximal end 58 and an inner guide lumen 57 extending between the anchor delivery guide tip 60 and the opposed proximal end 58 , and is configured so that at least a portion of the anchor delivery rod 54 extends therethrough.
- At least a portion of the anchor delivery guide 52 is flexible so that a tip 60 at the distal end of the anchor delivery guide 52 is positioned at or adjacent to an intracardiac wall anchoring site 62 such as the ventricular apex 7 .
- the anchor delivery rod 54 is configured to securely attach the anchor screw 28 to the anchoring site 62 .
- the anchor delivery rod 54 has a distal end 64 , an opposed proximal end 66 and an inner rod lumen 59 extending therebetween, the inner rod lumen 59 is sized and configured so that at least a portion of the at least one tether 21 is inserted therethrough.
- at least a portion of the anchor delivery rod 54 is flexible so that a rod tip 68 at the distal end of the anchor delivery rod 54 is positioned at or adjacent the intracardiac wall anchoring site 62 such as the ventricular apex 7 .
- a bore or socket 70 is defined in the rod tip 68 of the anchor delivery rod 54 .
- the socket is sized and configured to matingly engage the anchor cap 30 which includes a mating member such as an outer surface configuration which, as shown, in a hexagon. Other mating members or outer surface configurations may be employed. That is, at least a portion of the anchor cap is positioned in the socket 70 so that walls 72 of the socket engage the anchor cap.
- the socket engages the anchor cap 30 and the anchor screw 28 extends distally from the anchor delivery rod 54 as illustrated in FIG. 4B .
- the at least one cord 32 and at least a portion of the at least one suture 34 extends through the inner rod lumen of the anchor delivery rod 54 .
- the anchor delivery system 50 further comprises a guide handle 74 with a deflection knob 76 coupled to the anchor delivery guide 52 .
- the guide handle and the deflection knob are configured and used to help guide the tip 60 of the anchor delivery guide to the intracardiac wall anchoring site 62 such as the ventricular apex 7 .
- the anchor delivery system 50 includes a rod handle 78 coupled to the anchor delivery rod 54 . In use, described more fully below, rotation of the rod handle 78 correspondingly rotates the rod tip 68 and the anchor cap 30 when the anchor cap 30 is received within the socket 70 .
- the anchor delivery system 50 includes a sheath 80 removably coupled to the anchor delivery guide 52 .
- the sheath 80 is in fluid communication with the anchor delivery guide 52 so that fluids, such as carbon dioxide and the like surround the anchor delivery guide through the sheath.
- a central sheath channel 84 is defined by the sheath 80 that is in communication with the anchor delivery guide 52 so that the anchor delivery rod 54 and other system components extends through the central sheath channel 84 .
- the anchor delivery system 50 optionally includes a J-wire 82 , as shown in FIGS. 5A and 5B that is guidable by the user to the anchoring site 62 .
- the J-wire is, for example and without limitation, a 0.025′′ or 0.035′′ J-wire. Of course, J-wires having other diameters are contemplated.
- the J-wire is introduced first via sheath 80 into the right atrium 3 , across the site of deployment 5 , into the right ventricle 6 , to the anchoring site 62 .
- a J-wire increases the efficiency and safety of this step.
- the J-wire 82 serving as a guidewire, is inserted into the right internal jugular vein, enters the right atrium and approaches the anchor implantation site 62 .
- the anchor delivery system 50 is guided by the user, along the length of the previously implanted J-wire 82 , to the intracardiac wall anchoring site 62 such as the ventricular apex 7 .
- the anchor delivery guide tip 60 at the distal end 56 of the anchor delivery guide 52 is positioned at or adjacent the anchoring site such as the ventricular apex. As shown in FIG.
- the, anchor delivery rod 54 and the tether 21 connected to the anchor cap 30 and anchor screw 28 of the anchor 75 , are positioned within the inner guide lumen 57 of the anchor delivery guide 52 .
- the anchor cap 30 is coupled to the distal end 64 of the anchor delivery rod 54 with the cord 32 of the tether 21 positioned in the lumen 59 of the anchor delivery rod 54 .
- the anchor delivery rod 54 is advanced distally through the inner guide lumen of the anchor delivery guide 52 until the anchor cap 30 coupled to the distal end of the anchor delivery rod 54 is positioned at or adjacent the intracardiac wall anchoring site 62 such as the ventricular apex 7 .
- the proximal end 66 of the anchor delivery rod 54 is rotated to cause corresponding rotation of the anchor cap 30 as illustrated in FIG. 5B .
- the rotating handle 78 is rotated in a first direction to cause corresponding rotation of the anchor cap.
- the anchor screw coupled to the anchor cap 30 also rotates and screws into a portion of the intracardiac wall anchoring site 62 such as the ventricular apex 7 until the distal end 36 of the anchor cap is adjacent to the intracardiac wall and/or the tether is securely attached thereto the wall.
- the anchor screw 28 does not extend completely through any portion of the heart wall, and trans-apical access is not necessary.
- the anchor delivery rod 54 and the anchor delivery guide 52 of the anchor delivery system 50 are retracted from the heart 1 as illustrated in FIG. 6A .
- the cords 32 of tether 21 coupled to the anchor cap 30 , are secured by the anchor screw 28 of anchor 75 , and remain within the right ventricle and the valve delivery system 100 is employed.
- the at least one cord 32 of the tether 21 extends from the anchor cap through the tricuspid annulus and into the right atrium 2 .
- a suture 34 is coupled to the proximal end of each cord and extends through the superior (or inferior) vena cava and out of the heart 1 .
- each anchor 75 is secured by its anchor screw 28 , and this process is repeated until all tethers, connected to anchors, have been securely attached to the heart wall.
- the assembly 10 utilizes two anchors and tethers, three anchors and tethers, four anchors and tethers, or more anchors and tethers are also contemplated.
- the assembly comprises an epicardial tether system 300 for positioning an anchor 302 in the pericardial space 304 .
- the epicardial tether comprises a catheter 306 , a CO 2 gas line 308 and a manifold 310 .
- the catheter is a micro-catheter having a distal end 312 configured to be screwed and/or otherwise urged through at least a portion of the wall of the heart 1 .
- the distal end of the micro-catheter engages the endocardium 314 of the heart.
- the micro-catheter 306 also has a proximal end 316 opposed to the distal end and an inner catheter lumen 318 .
- the proximal end of the micro-catheter is coupled to the CO 2 gas line 308 and the manifold 310 so that the CO 2 gas line and the manifold are in sealed fluid communication with the inner catheter lumen.
- the distal end 312 of the micro-catheter 306 is urged through the heart wall until the distal end of the micro-catheter is positioned in the pericardial space 304 by the pericardium 320 .
- a contrasting agent 322 is injected from the manifold 310 through the inner catheter lumen 318 and into the pericardial space to verify that the distal end 312 of the micro-catheter 306 is in the pericardial space 304 .
- carbon dioxide is injected from the CO 2 gas line 308 through the inner catheter lumen 318 and into the pericardial space 304 to insufflate the space, illustrated in FIG. 10 .
- the J-wire 82 is then advanced through the inner catheter lumen 318 and into the pericardial space 304 as illustrated in FIG. 11 . With the J-wire in place, the catheter 306 is removed from the heart 1 .
- the anchor delivery guide 52 is inserted over the J-wire 82 until the tip 60 at the distal end 56 of the anchor delivery guide is positioned at or adjacent an anchoring site 324 in the pericardial space 304 .
- the anchor delivery rod 54 is inserted through the inner guide lumen of the anchor delivery guide 52 until the distal end 64 of the anchor delivery rod is positioned in the pericardial space 304 .
- the anchor 302 of the epicardial tether system 300 is coupled to the distal end 64 of the anchor delivery rod 54 .
- the anchor is a self-expanding anchor (that is, the anchor is compressible so that it fits through the inner guide lumen of the anchor delivery guide 52 ).
- the anchor expands to its full size, thereby locking the anchor 302 in place.
- a left ventricle portion 326 of the anchor extends through the endocardium and into the left ventricle.
- the at least one cord 32 is coupled to the anchor 302 prior to deployment in the pericardial space 304 .
- the cord is coupled to the anchor such that the cord is positioned in the inner rod lumen of the anchor delivery rod 54 .
- the cord extends from the anchor 302 in the pericardial space through the tricuspid annulus and superior (or inferior) vena cava to outside of the heart.
- at least the valve 100 and suture 34 are coupled to the cord 32 . It is within the scope of the present invention, however, for the anchor to be untethered or uncoupled from the valve upon insertion.
- the carbon dioxide in the pericardial space 304 is resorbed and the pericardium returns to its normal position.
- the assembly comprises an interventricular tether system 400 for positioning an anchor 402 in the left ventricle 11 .
- the interventricular tether system tether comprises a catheter 406 , a radiofrequency (“RF”) generator 408 and a RF wire 410 electrically coupled to the RF generator.
- the catheter is a wire delivery catheter having a distal end 412 configured to be positioned adjacent to or near the septum 7 of the heart 1 .
- RF generated by the RF generator 408 urges a distal end 414 of the RF wire to penetrate the septum, moving from the right ventricle 6 into the left ventricle 11 as shown in FIGS. 16 and 17 .
- the catheter 406 is then urged into the left ventricle 11 .
- rotation of the catheter 406 urges the distal end across the septum 7 and into the left ventricle.
- the RF wire is retracted, and the J-wire 82 is inserted through the catheter 406 until a portion of the J-wire is in the left ventricle 11 , illustrated in FIG. 19 .
- the anchor delivery guide 52 is inserted over the J-wire 82 until the tip 60 at the distal end 56 of the anchor delivery guide is positioned at or adjacent an anchoring site 416 in the left ventricle 5 .
- the anchor delivery rod 54 is inserted through the inner guide lumen of the anchor delivery guide 52 until the distal end 64 of the anchor delivery rod is positioned in the left ventricle, illustrated in FIG. 22 .
- the anchor 402 of the interventricular tether system 400 is coupled to the distal end 64 of the anchor delivery rod 54 .
- the anchor is a self-expanding anchor (that is, the anchor is compressible so that it fits through the inner guide lumen of the anchor delivery guide 52 ).
- the anchor exits the inner guide lumen of the anchor delivery guide and expand to its full size, thereby locking the anchor 402 in place.
- a right ventricle portion 418 of the anchor extends through the septum 7 and into the right ventricle 6 .
- the at least one cord 32 is coupled to the right ventricle portion 418 of the anchor 402 prior to deployment in the left ventricle 11 .
- the cord is coupled to the anchor such that the cord is positioned in the inner lumen of the anchor delivery rod 54 .
- the anchor delivery rod is removed from the heart 1 , as illustrated in FIG. 24 , the cord extends from the right ventricle portion of the anchor 402 through the tricuspid annulus.
- the valve 12 , detachable locks 126 , 226 and the like is coupled to the cord 32 as previously described. It is within the scope of the present invention, however, for the anchor to be untethered or uncoupled from the valve upon insertion.
- the interventricular anchor 402 is a screw, similar to anchor screw 28 , or a fixation mechanism composed of, but not limited to, nitinol, stainless steel, cobalt-chromium, or titanium alloys, in the shape of barbs, hooks, prongs.
- This type of interventricular anchor could be delivered by the anchor delivery rod 54 via an anchor delivery guide 52 .
- the anchor 575 is implanted untethered, that is, it is implanted and then a tether assembly 518 is connected to the anchor 575 and the valve 100 .
- components of an anchor assembly shown in FIGS. 25-28 include an anchor 575 having an, an anchor cap 30 and a delivery cable 512 allowing delivery of a tether 518 .
- the anchor cap 30 is coupled to the anchor screw 28 .
- the delivery cable 512 is removably connected to the anchor cap 30 .
- the anchor screw 28 as shown, is sized and configured as a helical screw to affix to an intracardiac wall.
- the anchor screw 28 may be differentially sized (longer or shorter depending on the cardiac wall to which it attaches) and configured as an inclined plane, nail-like head, or as any other type of screw that would be known to those skilled in the art.
- the screw is composed of any known metal alloy, including, but not limited to, nitinol, titanium, or cobalt-chromium.
- the metal alloy of the screw 28 may be coated with biological tissue, such as bovine, ovine, porcine, or equine pericardium, or with any combination of anti-inflammatory drugs that might promote healing and limit inflammation.
- a tip 576 of the anchor screw 28 optionally is constructed of and/or coated with the same or different materials as the anchor screw 28 and may be fashioned as a blunt or sharp tip.
- the anchor 575 is secured to the cardiac wall by rotating the anchor screw 28 until the tip 576 is at a desired depth in the cardiac wall.
- the depth to which anchor screw 28 is screwed in is adjustable according to the location within the heart. For example, the anchor screw 28 may be implanted more deeply into the interventricular septum, for greater fixation, as opposed to the ventricular free wall, i.e. epicardial wall, where a shallower implantation is safer.
- the anchor 575 is removed safely from the cardiac wall, either to be repositioned, or to be removed entirely.
- the anchor cap 30 comprises at least one locking arm 578 extending radially outwardly from the anchor cap 30 .
- the locking arm 578 is sized and configured for releasably securing a portion of the tether 21 (described below) to the anchor cap 30 .
- the at least one locking arm 578 moves between a first locked position, in which the locking member 578 extends a first distance away from the body of the anchor cap 30 , and a second unlocked position in which the locking member 578 extends a second distance away from the anchor cap 30 that is less than the first distance.
- the anchor cap 30 comprises at least one biasing member (not shown), such as a spring, configured to urge each locking arm 578 to the first locked position.
- a plurality of locking arms 578 are provided and are spaced equally around the circumference of the anchor cap 30 , though it is contemplated that the locking arms 578 need not be spaced equally.
- the delivery cable 512 includes a flexible delivery wire 513 having a distal threaded end portion 514 positioned on or formed in the distal end of the delivery wire 513 .
- the delivery wire 513 is constructed of, but not limited to, stainless steel, nitinol or other metal alloys, with or without hydrophilic coatings, or with or without a polymer coating such as polytetrafluoroethylene (PTFE).
- the distal threaded end portion 514 is sized and configured to selectively engage complementary threads formed in a cavity defined in a proximal end 577 of the anchor cap 30 .
- the distal threaded end portion 514 advances, e.g., screws, into via the proximal end 577 of the anchor cap 30 to couple the anchor cap 30 to the distal end of the flexible wire 513 .
- the distal threaded end portion 514 is unscrewed from the proximal end of the anchor 575 , detaching the flexible wire 513 from the anchor 575 .
- an expanding anchor assembly 102 is shown in FIGS. 29A-29C .
- the anchor assembly 102 is an interventricular anchor such as across the interventricular septum.
- the anchor assembly 102 includes an anchor cap 516 and locking arm 578 as described above for cooperating with the tether 518 .
- the anchor assembly 102 also includes an anchor shaft 105 having a distal tip 107 configured for penetrating an intracardiac wall.
- the anchor shaft 105 and anchor screw are comprised of at least two, and as shown three, shaft and anchor sectors 108 .
- the sectors 108 are secured during implantation and intracardiac wall penetration by an internal tensioning means such as tensioning line 109 which splits into at least two or, as shown, three lines 109 terminating at the distal tip 107 of each section 108 .
- an internal tensioning means such as tensioning line 109 which splits into at least two or, as shown, three lines 109 terminating at the distal tip 107 of each section 108 .
- FIGS. 32A-F Anchor with Tether Ring
- an anchor assembly 103 is illustrated.
- the anchor 103 includes an anchor shaft 112 and an anchor screw 114 .
- the anchor screw 114 has a helical configuration and extends distally from an anchor screw base 115 .
- the anchor screw base 115 defines at least one, or a plurality as shown, of anchor flanges 116 and recessed areas 117 therebetween.
- the anchor shaft 112 includes at least one or, as shown, a plurality of locking members 118 shown in FIG. 25 B. Locking members 118 are biased, such as by a spring (not shown), radially outwardly from the anchor shaft 112 .
- a delivery cable in the form of an anchor connector 120 and connector rod 121 cooperate with the anchor shaft 112 to rotate the anchor screw 114 .
- the anchor connector 120 defines at least one or, as shown, a plurality of apertures 122 configured for receipt of the anchor flanges 116 . Accordingly, the anchor connector 120 and connector rod 121 are matingly connected to the anchor shaft 112 , thereby urging the locking members 118 inward.
- the cooperating of the apertures 122 and the flanges 116 integrate the anchor connector 120 and the anchor screw base 115 . Rotation of the connector rod 121 thereby rotates the anchor screw 114 for interventricular or epicardial implantation into an intracardial wall.
- a tether ring 125 is applied over the connector rod 121 and anchor connecter 120 and abuts the proximal end of the anchor screw 114 .
- the docking or tether ring 125 includes a generally cylindrical first distal portion 126 and a second proximal portion 127 having a diameter greater than the first portion 126 .
- the second portion 127 defines at least one or, as shown, a plurality of apertures 129 configured for receipt of tether rods 130 as shown in FIGS. 32E and 32F .
- FIG. 32D the anchor connector 120 and connector rod 121 are removed.
- Tether rods 130 are operative as described above for cooperating with an atrial sealing skirt 46 .
- a tether assembly is provided to enable the anchor 75 / 575 to tether to the valve 100 .
- the flexible wire 513 when the flexible wire 513 is coupled to the anchor 75 / 575 , the flexible wire serves as a guide rail for the advancement of the tether assembly 518 to the anchor 75 / 575 .
- the tether assembly 518 includes one or more tether rods 519 rotatably connected to a docking ring 520 .
- the tether rods 519 are connected to an eyelet 570 defined by docking ring arms 571 as shown in FIG. 27 .
- the tether assembly 518 is advanced over the flexible wire 513 of the delivery cable 512 , and the docking ring 520 of the tether assembly depresses the at least one locking arm 578 of the anchor cap 30 / 516 to the second unlocked position. With the locking arm 578 in the second position, the docking ring 520 advances over the locking arm 578 on the anchor cap 30 or 516 until the docking ring 520 abuts and/or is adjacent to a distal end 579 of the anchor cap 30 or 516 .
- the biasing member of the anchor cap 30 / 516 urges the at least one locking arm 578 to the first locked position, thereby releasably coupling the docking ring 520 , and thus the rest of the tether assembly 518 , to the anchor 75 / 575 .
- the tether assembly 518 when coupled to the anchor 75 or 575 , rotates about a longitudinal axis of the anchor a full 360 degrees.
- the tether assembly 518 may be constrained to lesser degrees of rotation by interaction of a portion of the tether assembly 518 with the at least one locking arm 578 .
- the tether assembly 518 comprises at least one docking ring arm 571 coupled to the docking ring 520 , and at least one tether rod 519 coupled a docking ring arm 571 .
- a distal end of the docking ring arm 571 is securely coupled to or formed monolithically with the docking ring 520 .
- the at least one docking ring arm comprises a plurality of docking ring arms 571 .
- the plurality of docking ring arms 578 are spaced equally around the circumference of the docking ring, though it is contemplated that the docking ring arms 571 need not need spaced equally.
- An eyelet 570 is defined by the docking ring arm 571 .
- the tether rod 519 includes a tether rod hook 572 configured for cooperating with the eyelet 570 .
- a proximal end of each docking ring arm 571 is rotatably coupled to a distal end of a respective tether rod 519 .
- a tether rod hook 572 is defined by the tether rod 519 as shown and is either coupled to or formed monolithically with the distal end of each tether rod 519 .
- the eyelet 570 and the tether rod hook 572 are sized and configured so that the tether rod hook 572 is inserted into the eyelet 570 to securely, rotatably couple the tether rod 519 to the docking ring 520 .
- each tether rod hook 572 rotates about the circumference of the eyelet 570 .
- the proximal end of each tether rod is coupled to a cord 21 .
- the tether rod 519 and the tether rod hook 572 may be composed of any metal alloy.
- the tether assembly 518 is configured to cooperate with any intracardiac anchor including, but not limited to, the interventricular and epicardial anchors disclosed herein and the interventricular and epicardial anchors of Applicants' prior disclosure incorporated herein by reference.
- the anchor delivery device 523 for positioning and deploying the anchor cap 516 (or 30 ) at the desired position is illustrated and pertains to the components of anchor assembly utilizing the tether assembly with an anchor 75 implanted without a tether.
- the delivery device 523 comprises an anchor delivery guide 525 and an anchor delivery rod 529 .
- the anchor delivery guide has a distal end 528 and an inner guide lumen sized and configured so that at least one portion of the anchor delivery rod 529 extends there through.
- At least a portion of anchor delivery guide 525 is flexible so that the distal end 528 of the anchor delivery guide 525 is positioned at or adjacent to an intracardiac wall.
- the anchor delivery rod 529 is configured to securely attach the anchor screw 517 to the intracardiac wall 7 .
- the anchor delivery rod 529 has a distal end 531 , an opposed proximal rotating handle 530 , and an inner rod lumen extending there between.
- the inner rod lumen is sized and configured so that at least a portion of the delivery cable 512 extends there through.
- At least a portion of the anchor delivery rod 529 is flexible so that a rod tip 531 at the distal end of the anchor delivery rod 529 may be positioned at or adjacent the intracardiac wall 7 .
- a portion of the anchor cap 516 / 30 (as shown, the portion proximal to the anchor cap distal end 579 ) is received by and extends within the anchor rod tip 531 .
- the outer configuration of the anchor cap 516 proximal portion includes a firsts surface configuration and the inner wall configuration of said anchor rod 529 distal portion has a second configuration wherein the first and second configuration mate.
- the anchor delivery device 523 also includes a guide handle 526 having a deflection knob 527 coupled to the anchor delivery guide 525 .
- the guide handle 526 and the deflection knob 527 are configured and used to help guide the distal end 528 of the anchor delivery guide 525 to the intracardiac wall 7 .
- a rod handle 530 is coupled to the anchor delivery rod 529 wherein rotation of the rod handle rotates the rod tip 531 and the anchor cap 516 when the anchor cap is positioned in the anchor rod tip 531 .
- a sheath 524 is configured to receive the anchor delivery guide 525 .
- the sheath 524 is in fluid communication with the anchor delivery guide so that fluids, such as heparinized saline and the like surrounds the anchor delivery guide through the sheath 524 .
- a central sheath channel 533 ( FIG. 31B ) is defined in the sheath 524 to provide communication with the inner guide lumen of the anchor delivery guide 525 for the anchor delivery rod 529 and other system components to extend through the central sheath channel 533 .
- FIG. 31A in the tricuspid annulus, for example, a J-wire 82 is endovascularly guided by the user to the intracardiac wall 7 .
- the anchor delivery device or system 523 is then guided over the J-wire until the distal end 528 of the anchor delivery guide 525 is positioned at or adjacent the intracardiac wall 7 .
- FIGS. 31A-B illustrate the anchor assembly implanted into an intracardiac wall that is an endocardial wall.
- Anchor assembly 101 may also be implanted into an interventricular wall.
- the J-wire is, for example and without limitation, a 0.025′′ or 0.035′′ J-wire. Of course, J-wires having other diameters are contemplated.
- the anchor cap 516 / 30 is coupled to the distal end 531 of the anchor delivery rod 529 .
- the anchor delivery rod 529 is then be inserted through the inner guide lumen of the anchor delivery guide 525 until the anchor cap 516 / 30 and the distally extending anchor screw 28 (or sectors 108 ) are positioned at or adjacent the intracardiac wall 7 .
- the anchor assembly 102 of FIGS. 29A-29C may also be implanted and guided by the J-wire 82 such as into the interventricular wall as the intracardiac wall 7 shown.
- the anchor assembly 103 of FIGS. 32A-F may also be implanted and guided by the J-wire 82 into an intracardiac wall 7 , such as an interventricular wall or an epicardial wall.
- the rotating handle 530 of the anchor delivery rod 529 or 121 is rotated to cause corresponding rotation of the anchor cap 516 / 30 as illustrated in FIG. 31B .
- the rotating handle 530 is rotated in a first direction to cause corresponding rotation of the anchor cap 516 .
- the anchor screw 28 (or 108 ) coupled to the anchor cap 516 / 30 also rotates and screws into a portion of the intracardiac wall until the anchor cap 516 / 30 is adjacent to the apex wall Note that in this position, the anchor screw 28 (or 108 ) may or may not extend completely through any intracardiac wall, but trans-apical access is not necessary.
- the anchor delivery rod 529 and the anchor delivery guide 525 are retracted from the heart 2 .
- the flexible wire 513 of the delivery cable 512 extends from the anchor cap 516 , through the tricuspid annulus, and through the right atrium 3 .
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Abstract
Anchor assemblies for endovascular introduction and implantation for tethering a replacement heart valve to a cardiac wall. An anchor delivery system introduces the assembly. The anchor may be either implanted with a tether connected thereto or implanted and then connected to a tether. If the latter, a tether assembly is mounted to the implanted anchor to connect the anchor to the valve. The anchors may be implanted into any cardiac wall including the interventricular septum or the epicardial space and the valve may replace the mitral or tricuspid valve.
Description
- The application is a divisional of U.S. patent application Ser. No. 16/136,506 (filed Sep. 20, 2018) which is a continuation-in-part of U.S. patent application Ser. No. 15/943,971 (filed Apr. 3, 2018) and a continuation-in-part of U.S. patent application Ser. No. 15/943,792 (filed Apr. 3, 2018), both of which claim the benefit of and priority to Provisional Patent Applications Ser. Nos. 62/481,846 (filed Apr. 5, 2017), 62/509,587 (filed May 22, 2017), and 62/558,315 (filed Sep. 13, 2017), the disclosures of all are herein incorporated by reference.
- The present invention relates generally to medical devices and systems that are implanted minimally invasively in the heart and methods of implantation of these devices and systems. More specifically, the invention pertains to intracardiac anchors for anchoring medical devices, such as cardiac valves, to a cardiac wall, including for interventricular or epicardial implantation of a replacement valve into an intracardial wall.
- Transcatheter valves have proven safe and effective for the replacement of native cardiac valves. These valves have been tested extensively for replacement of aortic, mitral, and pulmonic valves, but replacement of tricuspid valves remains challenging given the complex and delicate anatomy to which prostheses must attach. Limiting paravalvular regurgitation of transcatheter mitral and tricuspid valves is challenging because the mitral and tricuspid annuli are complex saddle-shaped structures that are highly dynamic during the cardiac cycle. Compounding this difficulty for the tricuspid valve is the frequent presence of intracardiac leads in patients with significant tricuspid regurgitation (TR). Because ventricular leads traverse the annulus from the right atrium to the right ventricle, a transcatheter tricuspid valve must seal around both the annulus and the lead to limit regurgitation in these patients.
- Applicant's Ser. No. 15/943,792 discloses a Transcatheter Anchor and Tether Devices, Systems and Methods of Implantation including an anchor delivery system for introducing a tether coupled to the anchor and a valve delivery system for delivering, positioning and sealing the valve. Applicant's Ser. No. 15/943,792 is directed to a Transcatheter Anchor and Tether Devices, Systems and Methods of Implantation wherein, the anchor delivery system comprises an anchor which is implanted and not initially coupled to a tether. The disclosure presented herein may be used in connection with either of these delivery or anchoring systems, or any delivery or anchoring systems and may be used for anchoring any valve, including that disclosed in Applicant's Ser. No. 15/974,696.
- The application relates to anchors for tethering a replacement heart valve for replacing a native heart valve. According to various aspects, the anchor is implanted into a cardiac wall utilizing an anchor delivery system. The anchor may be either implanted with a tether connected thereto or implanted and then connected to a tether. If the latter, a tether assembly is mounted to the implanted anchor to connect the anchor to the valve. According to various aspects, the anchors may be implanted into any cardiac wall including the interventricular septum or the epicardial space and the valve may replace the mitral or tricuspid valve.
- The anchor includes an anchor cap and an anchor screw for implanting into the cardiac wall. The tether is coupled to the anchor cap either directly or with a tether assembly. According to one aspect, the anchor extends through to an opposing side of a cardiac wall, such as the pericardial space or the interventricular septum. According to other aspects, the anchor screw penetrates the cardiac wall a sufficient depth without penetrating the wall to the opposing side. According to another aspect, the anchor includes an anchor shaft formed or more than one shaft members which expand within the cardiac wall
- . Other apparatuses, methods, systems, features, and advantages of the medical devices and systems that are implanted minimally invasively in the heart will be or become apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional apparatuses, methods, systems, features, and advantages be included within this description, be within the scope of the medical devices and systems that are implanted minimally invasively in the heart and be protected by the accompanying claims.
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FIG. 1 is a cut-away perspective view of a heart showing the transcatheter atrial sealing skirt system positioned across the tricuspid valve in the heart; -
FIG. 2 is a cut-away perspective view of a heart showing the transcatheter atrial sealing skirt system positioned across the mitral valve in the heart; -
FIG. 3 is a side elevational view of a tether, with its cords fused to sutures, connected to an anchor, according to one aspect; -
FIG. 4A is a side elevational view of an anchor delivery system, according to one aspect; -
FIG. 4B is a magnified side elevational view of the anchor delivery system ofFIG. 4A ; -
FIG. 4C is an end view of the anchor delivery system ofFIG. 4A ; -
FIG. 5A is a perspective view of the anchor delivery system in which a portion of the device is positioned in the right ventricle; -
FIG. 5B is a perspective view of the anchor delivery in which the anchor delivery system is delivering a portion of the tether, connected to the anchor, into the right ventricle; -
FIG. 6A is a perspective view of the anchor delivery system in which the anchor delivery system is delivering a portion of the tether, connected to the anchor into the right ventricle; -
FIG. 6B is a perspective view of the tether, connected to the anchor, positioned in the right ventricle; -
FIG. 7A is a perspective view of two tethers, each connected to an anchor positioned in a heart, according to one aspect; -
FIG. 7B is a magnified view of the two tethers each connected to an anchor ofFIG. 7A ; -
FIG. 8 is a perspective view of an epicardial tether system for positioning an anchor in the pericardial space, according to one aspect; -
FIG. 9 is a perspective view of the epicardial tether system ofFIG. 8 , in which a portion of a catheter of the system has entered the pericardial space; -
FIG. 10 is a perspective view of the epicardial tether system ofFIG. 8 , in which the pericardial space has been insufflated; -
FIG. 11 is a perspective view of the epicardial tether system ofFIG. 8 , in which a J-wire has been inserted into the insufflated pericardial space; -
FIG. 12 is a perspective view of the epicardial tether system ofFIG. 8 , in which an anchor delivery guide of the system approaches the insufflated pericardial space; -
FIG. 13 is a perspective view of the epicardial tether system ofFIG. 8 , in which an anchor of the system is being positioned in the insufflated pericardial space; -
FIG. 14 is a perspective view of the epicardial tether system ofFIG. 8 , in which an anchor of the system has been deployed in the insufflated pericardial space; -
FIG. 15 is a perspective view of the epicardial tether system ofFIG. 8 , in which an anchor of the system has been deployed in the insufflated pericardial space and delivery devices of the system have been retracted; -
FIG. 16 is a perspective view of an interventricular tether system for positioning an anchor in the left ventricle, according to one aspect; -
FIG. 17 is a perspective view of the interventricular tether system ofFIG. 16 , in which an RF wire of the system has crossed the septum and entered the left ventricle; -
FIG. 18 is a perspective view of the interventricular tether system ofFIG. 16 , in which a catheter of the system has crossed the septum and entered the left ventricle; -
FIG. 19 is a perspective view of the interventricular tether system ofFIG. 16 , in which a J-wire of the system has been advanced through the catheter and into the left ventricle; -
FIG. 20 is a perspective view of the interventricular tether system ofFIG. 16 , in which a delivery guide of the system approaches the left ventricle; -
FIG. 21 is a perspective view of the interventricular tether system ofFIG. 16 , in which the delivery guide of the system has crossed the septum and entered the left ventricle; -
FIG. 22 is a perspective view of the interventricular tether system ofFIG. 16 , in which an anchor of the system is being positioned in the left ventricle; -
FIG. 23 is a perspective view of the interventricular tether system ofFIG. 16 , in which an anchor of the system has been deployed in the left ventricle; -
FIG. 24 is a perspective view of the interventricular tether system ofFIG. 16 , in which an anchor of the system has been deployed in the left ventricle and delivery devices of the system have been retracted; -
FIG. 25 is a perspective view of the delivery cable of an anchor delivery device for anchoring a tether to a cardiac wall according to another aspect; -
FIG. 26 is a perspective view of an anchor according to another aspect for anchoring a tether to a cardiac wall; -
FIG. 27 is a perspective view of a tether assembly for anchoring a valve to the anchor; -
FIG. 28 is a perspective view of the anchor assembly, comprised of the tether, coupled to the anchor, for anchoring the tether to a cardiac wall; -
FIG. 29A-29C are perspective views of an anchor according to an alternative aspect with a splitting or expanding anchor screw; -
FIG. 30A is a side elevational view of the anchor delivery device; -
FIG. 30B is a side view of the anchor delivery device shown within the delivery sheath; -
FIG. 30C is an end view of the anchor delivery device; -
FIG. 31A is a perspective view of the anchor delivery device being positioned in the right ventricle; -
FIG. 31B is a perspective view of the anchor being implanted into the intracardiac wall; and -
FIGS. 32A-32F are perspective views of an anchor according to another aspect having an anchor screw and anchor cap configured for receipt of connecting ring and a tethering system illustrated in sequential steps. - The present invention can be understood more readily by reference to the following detailed description, examples, and claims, and their previous and following description. Before the present system, devices, and/or methods are disclosed and described, it is to be understood that this invention is not limited to the specific systems, devices, and/or methods disclosed unless otherwise specified, as such can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting.
- The following description of the invention is provided as an enabling teaching of the invention in its best, currently known aspect. Those skilled in the relevant art will recognize that many changes can be made to the aspects described, while still obtaining the beneficial results of the present invention. It will also be apparent that some of the desired benefits of the present invention can be obtained by selecting some of the features of the present invention without utilizing other features. Accordingly, those who work in the art will recognize that many modifications and adaptations to the present invention are possible and can even be desirable in certain circumstances and are a part of the present invention. Thus, the following description is provided as illustrative of the principles of the present invention and not in limitation thereof.
- As used herein, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to a “tether” includes aspects having two or more tethers unless the context clearly indicates otherwise.
- Ranges can be expressed herein as from “about” one particular value, and/or to “about” another particular value. When such a range is expressed, another aspect includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.
- As used herein, the terms “optional” or “optionally” mean that the subsequently described event or circumstance may or may not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not.
- The application relates to medical devices and systems to be minimally invasively implanted in the heart and methods of implantation of these devices and systems. More specifically, the application relates to
intracardiac anchors 75 and methods and systems for endovascularly introducing and implanting theanchor 75 to a cardiac wall such as for implanting avalve 100 in the heart which is tethered to theanchor 75 to replace the native valve. - The disclosure herein relates
anchors 75 and anchor delivery assemblies for implanting minimally invasively in theheart 1 and methods of implantation.FIG. 1 illustrates thetranscatheter valve 100 which has been implanted to replace the native tricuspid valve (for example) according the medical assembly disclosed herein.FIG. 2 illustrates thevalve 100 implanted to replace the native mitral valve. The heart, of course, includes theright atrium 3, rightatrial floor 4,right ventricle 6,intracardiac wall 7, leftatrium 8 andleft ventricle 11. Thereplacement valve 100 is positioned at thedeployment site 5. As shown and described, by way of example, the anchoring systems are used to anchor atranscatheter valve 100 which may, include anatrial sealing skirt 46 configured to couple to the atrial floor. At least onetether 21, composed of one or more cords, connects thevalve 100 to theanchor 75 as shown. Thetether 21 may be implanted byanchor 75 to any intracardiac wall, including, but not limited to, the interventricular septum, ventricular apex, or ventricular free wall. For the sake of discussion only, the ventricular apex is shown but it is within the spirit and scope of the present invention to anchor thetether 75 to any intracardiac wall. - Also, a tethering assembly cooperates with the
anchor 75 connecting thevalve 100 to theanchor 75. For example, the anchors disclosed herein may be used in connection with avalve 100 which includes a sealingskirt 46 for cooperating with thevalve 100 to conform to the respective atrial floor to prevent paravalvular regurgitation of prosthesis as disclosed in Applicant's Ser. No. 15/974,696. Various aspects of theanchors 75 disclosed herein may be implanted with a tether pre-assembled to the anchor or independent of the tether wherein the tether is applied to the anchor after implantation. The anchors described herein may be employed to anchor a tricuspid valve or mitral valve as shown inFIGS. 1 and 2 , respectively. - Referring now to
FIG. 3 , at least onetether 21 and, as shown, composed of a plurality ofcords 32, is/are operatively connected to thereplacement valve 100 and connects thevalve 100 to theanchor 75. Thetether 21 includes at least onecord 32, and eachcord 32 is connected to asuture 34. Theanchor 75 includes ananchor screw 28 and ananchor cap 30. In one aspect, the anchor screw is coupled to and extends from adistal end 36 of the anchor cap, and the at least onecord 32 of thetether 21 is coupled to and extends from aproximal end 38 of theanchor cap 30. That is, theanchor cap 30 is positioned between theanchor screw 28 and thecord 32. Theanchor screw 28, ofanchor 75, is configured to securely attach thetether 21 to an intracardiac wall such as theventricular apex 7 of theheart 1. For example, theanchor screw 28 is an active fixation screw comprising threads or a coil that is securely rotated into the ventricular apex. Theanchor 75 and theanchor screw 28 are configured to securely attach thetether 21 to an intracardiac wall such as theventricular apex 7 of the heart without extending through the apex and outside of the heart. Thus, in this aspect, substantially no portion of the assembly completely penetrates and/or extends completely through any portion of the heart wall, and trans-apical access is not necessary. In a further aspect (not shown), rather than theanchor screw 28, a fixation mechanism composed of, but not limited to, nitinol, stainless steel, cobalt-chromium, or titanium alloys, in the shape of barbs, hooks, prongs and the like is positioned at thedistal end 36 of theanchor cap 30 to securely attach thetether 21 to theventricular apex 7 of theheart 1 without extending through the apex and outside of the heart. - The at least one
cord 32 has adistal end 40 coupled to a portion of theanchor cap 30 and aproximal end 42 coupled to thesuture 34. In one aspect, the cord is a strong yet flexible cord such as, for example and without limitation, an expanded polytetrafluoroethylene (ePTFE) or ultra-high-molecular-weight polyethylene (UHMWPE or UHMW) cord. In use, described more fully below, a central portion of the cord 32 (between the distal end and the proximal end) extends through and/or is coupled to thevalve 100 to hold the valve in the desired position relative to the tricuspid annulus. - Referring now to
FIGS. 4A-C , 5A and 5B, theanchor delivery system 50 for positioning and deploying theanchor cap 30 ofanchor 75 at the desired implantation site is illustrated. Thedelivery system 50 comprises ananchor delivery guide 52 and ananchor delivery rod 54. In this aspect, theanchor delivery guide 52 has adistal end 56, an opposedproximal end 58 and aninner guide lumen 57 extending between the anchordelivery guide tip 60 and the opposedproximal end 58, and is configured so that at least a portion of theanchor delivery rod 54 extends therethrough. In another aspect, at least a portion of theanchor delivery guide 52 is flexible so that atip 60 at the distal end of theanchor delivery guide 52 is positioned at or adjacent to an intracardiacwall anchoring site 62 such as theventricular apex 7. - The
anchor delivery rod 54 is configured to securely attach theanchor screw 28 to theanchoring site 62. Theanchor delivery rod 54 has adistal end 64, an opposedproximal end 66 and aninner rod lumen 59 extending therebetween, theinner rod lumen 59 is sized and configured so that at least a portion of the at least onetether 21 is inserted therethrough. In another aspect, at least a portion of theanchor delivery rod 54 is flexible so that arod tip 68 at the distal end of theanchor delivery rod 54 is positioned at or adjacent the intracardiacwall anchoring site 62 such as theventricular apex 7. - As shown in
FIG. 4B , a bore orsocket 70 is defined in therod tip 68 of theanchor delivery rod 54. The socket is sized and configured to matingly engage theanchor cap 30 which includes a mating member such as an outer surface configuration which, as shown, in a hexagon. Other mating members or outer surface configurations may be employed. That is, at least a portion of the anchor cap is positioned in thesocket 70 so thatwalls 72 of the socket engage the anchor cap. Thus, for example, when theanchor cap 30 is positioned in and engages thesocket 70, rotation of theanchor delivery rod 54 rotates theanchor cap 30. Accordingly, the socket engages theanchor cap 30 and theanchor screw 28 extends distally from theanchor delivery rod 54 as illustrated inFIG. 4B . In a further aspect, when thesocket 70 engages theanchor cap 30, the at least onecord 32 and at least a portion of the at least onesuture 34 extends through the inner rod lumen of theanchor delivery rod 54. - The
anchor delivery system 50 further comprises aguide handle 74 with adeflection knob 76 coupled to theanchor delivery guide 52. The guide handle and the deflection knob are configured and used to help guide thetip 60 of the anchor delivery guide to the intracardiacwall anchoring site 62 such as theventricular apex 7. As shown inFIG. 4A , theanchor delivery system 50 includes arod handle 78 coupled to theanchor delivery rod 54. In use, described more fully below, rotation of the rod handle 78 correspondingly rotates therod tip 68 and theanchor cap 30 when theanchor cap 30 is received within thesocket 70. - The
anchor delivery system 50 includes asheath 80 removably coupled to theanchor delivery guide 52. Thesheath 80 is in fluid communication with theanchor delivery guide 52 so that fluids, such as carbon dioxide and the like surround the anchor delivery guide through the sheath. Acentral sheath channel 84 is defined by thesheath 80 that is in communication with theanchor delivery guide 52 so that theanchor delivery rod 54 and other system components extends through thecentral sheath channel 84. - The
anchor delivery system 50 optionally includes a J-wire 82, as shown inFIGS. 5A and 5B that is guidable by the user to theanchoring site 62. The J-wire is, for example and without limitation, a 0.025″ or 0.035″ J-wire. Of course, J-wires having other diameters are contemplated. As in any over-the-wire system, the J-wire is introduced first viasheath 80 into theright atrium 3, across the site ofdeployment 5, into theright ventricle 6, to theanchoring site 62. By providing a pathway for theanchor delivery guide 52 to track over to its final target, a J-wire increases the efficiency and safety of this step. - To install the
valve 100 in the tricuspid annulus, as shown inFIG. 5A , the J-wire 82, serving as a guidewire, is inserted into the right internal jugular vein, enters the right atrium and approaches theanchor implantation site 62. Theanchor delivery system 50 is guided by the user, along the length of the previously implanted J-wire 82, to the intracardiacwall anchoring site 62 such as theventricular apex 7. The anchordelivery guide tip 60 at thedistal end 56 of theanchor delivery guide 52 is positioned at or adjacent the anchoring site such as the ventricular apex. As shown inFIG. 5B the,anchor delivery rod 54 and thetether 21, connected to theanchor cap 30 and anchor screw 28 of theanchor 75, are positioned within theinner guide lumen 57 of theanchor delivery guide 52. Theanchor cap 30 is coupled to thedistal end 64 of theanchor delivery rod 54 with thecord 32 of thetether 21 positioned in thelumen 59 of theanchor delivery rod 54. Theanchor delivery rod 54 is advanced distally through the inner guide lumen of theanchor delivery guide 52 until theanchor cap 30 coupled to the distal end of theanchor delivery rod 54 is positioned at or adjacent the intracardiacwall anchoring site 62 such as theventricular apex 7. - With the
anchor screw 28 of theanchor 75, connected to tether 21 viaanchor cap 30, positioned adjacent to theanchoring site 62, theproximal end 66 of theanchor delivery rod 54 is rotated to cause corresponding rotation of theanchor cap 30 as illustrated inFIG. 5B . For example, therotating handle 78 is rotated in a first direction to cause corresponding rotation of the anchor cap. The anchor screw coupled to theanchor cap 30 also rotates and screws into a portion of the intracardiacwall anchoring site 62 such as theventricular apex 7 until thedistal end 36 of the anchor cap is adjacent to the intracardiac wall and/or the tether is securely attached thereto the wall. Note that in this position, theanchor screw 28 does not extend completely through any portion of the heart wall, and trans-apical access is not necessary. Upon placement of theanchor cap 30 in the desired position, theanchor delivery rod 54 and theanchor delivery guide 52 of theanchor delivery system 50 are retracted from theheart 1 as illustrated inFIG. 6A . As such, inFIG. 6B , thecords 32 oftether 21, coupled to theanchor cap 30, are secured by theanchor screw 28 ofanchor 75, and remain within the right ventricle and thevalve delivery system 100 is employed. - As shown in
FIG. 6B , after placement of theanchor cap 30 ofanchor 75, the at least onecord 32 of thetether 21 extends from the anchor cap through the tricuspid annulus and into the right atrium 2. Asuture 34 is coupled to the proximal end of each cord and extends through the superior (or inferior) vena cava and out of theheart 1. - If more than one
tether 21, connected to ananchor 75, is delivered, eachanchor 75 is secured by itsanchor screw 28, and this process is repeated until all tethers, connected to anchors, have been securely attached to the heart wall. In one aspect and as illustrated inFIGS. 7A and 7B , theassembly 10 utilizes two anchors and tethers, three anchors and tethers, four anchors and tethers, or more anchors and tethers are also contemplated. - In another aspect, illustrated in
FIGS. 8-15 , the assembly comprises anepicardial tether system 300 for positioning ananchor 302 in thepericardial space 304. In one aspect, the epicardial tether comprises acatheter 306, a CO2 gas line 308 and amanifold 310. In another aspect, the catheter is a micro-catheter having adistal end 312 configured to be screwed and/or otherwise urged through at least a portion of the wall of theheart 1. For example, and as illustrated inFIG. 8 , the distal end of the micro-catheter engages theendocardium 314 of the heart. The micro-catheter 306 also has aproximal end 316 opposed to the distal end and aninner catheter lumen 318. The proximal end of the micro-catheter is coupled to the CO2 gas line 308 and the manifold 310 so that the CO2 gas line and the manifold are in sealed fluid communication with the inner catheter lumen. - Referring now to
FIG. 9 , thedistal end 312 of the micro-catheter 306 is urged through the heart wall until the distal end of the micro-catheter is positioned in thepericardial space 304 by thepericardium 320. In one aspect, acontrasting agent 322 is injected from the manifold 310 through theinner catheter lumen 318 and into the pericardial space to verify that thedistal end 312 of the micro-catheter 306 is in thepericardial space 304. - Once the
distal end 312 of the micro-catheter 306 has been positioned in thepericardial space 304, carbon dioxide is injected from the CO2 gas line 308 through theinner catheter lumen 318 and into thepericardial space 304 to insufflate the space, illustrated inFIG. 10 . - In one aspect, the J-
wire 82 is then advanced through theinner catheter lumen 318 and into thepericardial space 304 as illustrated inFIG. 11 . With the J-wire in place, thecatheter 306 is removed from theheart 1. - In another aspect, illustrated in
FIGS. 12 and 13 , theanchor delivery guide 52 is inserted over the J-wire 82 until thetip 60 at thedistal end 56 of the anchor delivery guide is positioned at or adjacent ananchoring site 324 in thepericardial space 304. Theanchor delivery rod 54 is inserted through the inner guide lumen of theanchor delivery guide 52 until thedistal end 64 of the anchor delivery rod is positioned in thepericardial space 304. - The
anchor 302 of theepicardial tether system 300 is coupled to thedistal end 64 of theanchor delivery rod 54. In one aspect, the anchor is a self-expanding anchor (that is, the anchor is compressible so that it fits through the inner guide lumen of the anchor delivery guide 52). As illustrated inFIGS. 13 and 14 , when theanchor 302 positioned on the distal end of the anchor delivery rod reaches thepericardial space 304, the anchor expands to its full size, thereby locking theanchor 302 in place. Aleft ventricle portion 326 of the anchor extends through the endocardium and into the left ventricle. - In one aspect, the at least one
cord 32 is coupled to theanchor 302 prior to deployment in thepericardial space 304. For example, the cord is coupled to the anchor such that the cord is positioned in the inner rod lumen of theanchor delivery rod 54. Thus, when the anchor delivery rod is removed from the heart, as illustrated inFIG. 15 , the cord extends from theanchor 302 in the pericardial space through the tricuspid annulus and superior (or inferior) vena cava to outside of the heart. In this aspect, at least thevalve 100 andsuture 34 are coupled to thecord 32. It is within the scope of the present invention, however, for the anchor to be untethered or uncoupled from the valve upon insertion. As is appreciated, the carbon dioxide in thepericardial space 304 is resorbed and the pericardium returns to its normal position. - In another embodiment, illustrated in
FIGS. 16-24 , the assembly comprises aninterventricular tether system 400 for positioning ananchor 402 in theleft ventricle 11. In one aspect, the interventricular tether system tether comprises acatheter 406, a radiofrequency (“RF”)generator 408 and aRF wire 410 electrically coupled to the RF generator. In another aspect, the catheter is a wire delivery catheter having adistal end 412 configured to be positioned adjacent to or near theseptum 7 of theheart 1. In use, RF generated by theRF generator 408 urges adistal end 414 of the RF wire to penetrate the septum, moving from theright ventricle 6 into theleft ventricle 11 as shown inFIGS. 16 and 17 . - Referring now to
FIG. 18 , thecatheter 406 is then urged into theleft ventricle 11. For example, if a portion of thedistal end 412 of the catheter is threaded, rotation of thecatheter 406 urges the distal end across theseptum 7 and into the left ventricle. With a portion of the catheter in the left ventricle, the RF wire is retracted, and the J-wire 82 is inserted through thecatheter 406 until a portion of the J-wire is in theleft ventricle 11, illustrated inFIG. 19 . - In another aspect, illustrated in
FIGS. 20 and 21 , theanchor delivery guide 52 is inserted over the J-wire 82 until thetip 60 at thedistal end 56 of the anchor delivery guide is positioned at or adjacent ananchoring site 416 in theleft ventricle 5. Theanchor delivery rod 54 is inserted through the inner guide lumen of theanchor delivery guide 52 until thedistal end 64 of the anchor delivery rod is positioned in the left ventricle, illustrated inFIG. 22 . - The
anchor 402 of theinterventricular tether system 400 is coupled to thedistal end 64 of theanchor delivery rod 54. In one aspect, the anchor is a self-expanding anchor (that is, the anchor is compressible so that it fits through the inner guide lumen of the anchor delivery guide 52). As illustrated inFIGS. 23 and 24 , when theanchor 402 positioned on the distal end of the anchor delivery rod reaches theleft ventricle 11, the anchor exits the inner guide lumen of the anchor delivery guide and expand to its full size, thereby locking theanchor 402 in place. As illustrated inFIG. 24 , aright ventricle portion 418 of the anchor extends through theseptum 7 and into theright ventricle 6. - In one aspect, the at least one
cord 32 is coupled to theright ventricle portion 418 of theanchor 402 prior to deployment in theleft ventricle 11. For example, the cord is coupled to the anchor such that the cord is positioned in the inner lumen of theanchor delivery rod 54. Thus, when the anchor delivery rod is removed from theheart 1, as illustrated inFIG. 24 , the cord extends from the right ventricle portion of theanchor 402 through the tricuspid annulus. In this aspect then, the valve 12,detachable locks 126, 226 and the like is coupled to thecord 32 as previously described. It is within the scope of the present invention, however, for the anchor to be untethered or uncoupled from the valve upon insertion. - In another aspect, the
interventricular anchor 402 is a screw, similar toanchor screw 28, or a fixation mechanism composed of, but not limited to, nitinol, stainless steel, cobalt-chromium, or titanium alloys, in the shape of barbs, hooks, prongs. This type of interventricular anchor could be delivered by theanchor delivery rod 54 via ananchor delivery guide 52. - According to another aspect of the present invention, the
anchor 575 is implanted untethered, that is, it is implanted and then atether assembly 518 is connected to theanchor 575 and thevalve 100. According to this aspect, components of an anchor assembly shown inFIGS. 25-28 include ananchor 575 having an, ananchor cap 30 and adelivery cable 512 allowing delivery of atether 518. Theanchor cap 30 is coupled to theanchor screw 28. Thedelivery cable 512 is removably connected to theanchor cap 30. Theanchor screw 28, as shown, is sized and configured as a helical screw to affix to an intracardiac wall. Optionally, however, theanchor screw 28 may be differentially sized (longer or shorter depending on the cardiac wall to which it attaches) and configured as an inclined plane, nail-like head, or as any other type of screw that would be known to those skilled in the art. In one aspect, the screw is composed of any known metal alloy, including, but not limited to, nitinol, titanium, or cobalt-chromium. In another aspect, the metal alloy of thescrew 28 may be coated with biological tissue, such as bovine, ovine, porcine, or equine pericardium, or with any combination of anti-inflammatory drugs that might promote healing and limit inflammation. Atip 576 of theanchor screw 28 optionally is constructed of and/or coated with the same or different materials as theanchor screw 28 and may be fashioned as a blunt or sharp tip. - In use, the
anchor 575 is secured to the cardiac wall by rotating theanchor screw 28 until thetip 576 is at a desired depth in the cardiac wall. The depth to which anchor screw 28 is screwed in is adjustable according to the location within the heart. For example, theanchor screw 28 may be implanted more deeply into the interventricular septum, for greater fixation, as opposed to the ventricular free wall, i.e. epicardial wall, where a shallower implantation is safer. By reversing the rotation of theanchor screw 28, theanchor 575 is removed safely from the cardiac wall, either to be repositioned, or to be removed entirely. - The
anchor cap 30 comprises at least onelocking arm 578 extending radially outwardly from theanchor cap 30. The lockingarm 578 is sized and configured for releasably securing a portion of the tether 21 (described below) to theanchor cap 30. The at least onelocking arm 578 moves between a first locked position, in which the lockingmember 578 extends a first distance away from the body of theanchor cap 30, and a second unlocked position in which the lockingmember 578 extends a second distance away from theanchor cap 30 that is less than the first distance. Theanchor cap 30 comprises at least one biasing member (not shown), such as a spring, configured to urge each lockingarm 578 to the first locked position. As shown, a plurality of lockingarms 578 are provided and are spaced equally around the circumference of theanchor cap 30, though it is contemplated that the lockingarms 578 need not be spaced equally. - Now referring to
FIG. 25 , thedelivery cable 512 includes aflexible delivery wire 513 having a distal threadedend portion 514 positioned on or formed in the distal end of thedelivery wire 513. Thedelivery wire 513 is constructed of, but not limited to, stainless steel, nitinol or other metal alloys, with or without hydrophilic coatings, or with or without a polymer coating such as polytetrafluoroethylene (PTFE). The distal threadedend portion 514 is sized and configured to selectively engage complementary threads formed in a cavity defined in aproximal end 577 of theanchor cap 30. In use, the distal threadedend portion 514 advances, e.g., screws, into via theproximal end 577 of theanchor cap 30 to couple theanchor cap 30 to the distal end of theflexible wire 513. As described more fully below, the distal threadedend portion 514 is unscrewed from the proximal end of theanchor 575, detaching theflexible wire 513 from theanchor 575. - According to another aspect of the present invention, an expanding
anchor assembly 102 is shown inFIGS. 29A-29C . As shown, theanchor assembly 102 is an interventricular anchor such as across the interventricular septum. Theanchor assembly 102 includes ananchor cap 516 and lockingarm 578 as described above for cooperating with thetether 518. Theanchor assembly 102 also includes ananchor shaft 105 having adistal tip 107 configured for penetrating an intracardiac wall. Theanchor shaft 105 and anchor screw are comprised of at least two, and as shown three, shaft andanchor sectors 108. Thesectors 108 are secured during implantation and intracardiac wall penetration by an internal tensioning means such astensioning line 109 which splits into at least two or, as shown, threelines 109 terminating at thedistal tip 107 of eachsection 108. Once thedistal tip 107 of theanchor shaft 105 enters an intracardiac wall, such as the interventricular septum, theinternal tensioning line 109 is released and relaxed, allowing theshaft sectors 108 to separate by the action of internal biasing members (not shown), such as, but not limited to, one or more springs located along one or more inner walls of theshaft sectors 108. - Anchor with Tether Ring (
FIGS. 32A-F ) - According to another aspect of the disclosure, as shown in
FIGS. 32A-F , ananchor assembly 103 is illustrated. Theanchor 103 includes ananchor shaft 112 and ananchor screw 114. As shown, theanchor screw 114 has a helical configuration and extends distally from ananchor screw base 115. Theanchor screw base 115 defines at least one, or a plurality as shown, ofanchor flanges 116 and recessedareas 117 therebetween. Theanchor shaft 112 includes at least one or, as shown, a plurality of lockingmembers 118 shown inFIG. 25 B. Locking members 118 are biased, such as by a spring (not shown), radially outwardly from theanchor shaft 112. A delivery cable in the form of ananchor connector 120 andconnector rod 121 cooperate with theanchor shaft 112 to rotate theanchor screw 114. Theanchor connector 120 defines at least one or, as shown, a plurality ofapertures 122 configured for receipt of theanchor flanges 116. Accordingly, theanchor connector 120 andconnector rod 121 are matingly connected to theanchor shaft 112, thereby urging the lockingmembers 118 inward. The cooperating of theapertures 122 and theflanges 116 integrate theanchor connector 120 and theanchor screw base 115. Rotation of theconnector rod 121 thereby rotates theanchor screw 114 for interventricular or epicardial implantation into an intracardial wall. - After the
anchor screw 114 has been implanted, atether ring 125 is applied over theconnector rod 121 andanchor connecter 120 and abuts the proximal end of theanchor screw 114. The docking ortether ring 125 includes a generally cylindrical firstdistal portion 126 and a secondproximal portion 127 having a diameter greater than thefirst portion 126. Thesecond portion 127 defines at least one or, as shown, a plurality ofapertures 129 configured for receipt oftether rods 130 as shown inFIGS. 32E and 32F . As shown inFIG. 32D , theanchor connector 120 andconnector rod 121 are removed. The lockingmembers 118 are urged radially outward so as to engage thesecond portion 127 of thetether ring 125 to lock thetether ring 125 on theanchor screw base 115. Tetherrods 130 are operative as described above for cooperating with anatrial sealing skirt 46. - With any of the aforementioned anchors which are implanted without a tether (that is, not pre-connected), a tether assembly is provided to enable the
anchor 75/575 to tether to thevalve 100. For example, as shown inFIGS. 27 and 28 , when theflexible wire 513 is coupled to theanchor 75/575, the flexible wire serves as a guide rail for the advancement of thetether assembly 518 to theanchor 75/575. Thetether assembly 518 includes one ormore tether rods 519 rotatably connected to adocking ring 520. Thetether rods 519 are connected to aneyelet 570 defined by dockingring arms 571 as shown inFIG. 27 . Thetether assembly 518 is advanced over theflexible wire 513 of thedelivery cable 512, and thedocking ring 520 of the tether assembly depresses the at least onelocking arm 578 of theanchor cap 30/516 to the second unlocked position. With thelocking arm 578 in the second position, thedocking ring 520 advances over the lockingarm 578 on theanchor cap docking ring 520 abuts and/or is adjacent to adistal end 579 of theanchor cap anchor cap 30/516 urges the at least onelocking arm 578 to the first locked position, thereby releasably coupling thedocking ring 520, and thus the rest of thetether assembly 518, to theanchor 75/575. - In one aspect, when coupled to the
anchor tether assembly 518 rotates about a longitudinal axis of the anchor a full 360 degrees. Optionally, in another aspect, thetether assembly 518 may be constrained to lesser degrees of rotation by interaction of a portion of thetether assembly 518 with the at least onelocking arm 578. - As shown in
FIG. 28 , in one aspect, thetether assembly 518 comprises at least onedocking ring arm 571 coupled to thedocking ring 520, and at least onetether rod 519 coupled adocking ring arm 571. As shown, a distal end of thedocking ring arm 571 is securely coupled to or formed monolithically with thedocking ring 520. As shown, the at least one docking ring arm comprises a plurality ofdocking ring arms 571. As shown, the plurality ofdocking ring arms 578 are spaced equally around the circumference of the docking ring, though it is contemplated that thedocking ring arms 571 need not need spaced equally. Aneyelet 570 is defined by thedocking ring arm 571. Thetether rod 519 includes atether rod hook 572 configured for cooperating with theeyelet 570. - A proximal end of each
docking ring arm 571 is rotatably coupled to a distal end of arespective tether rod 519. Atether rod hook 572 is defined by thetether rod 519 as shown and is either coupled to or formed monolithically with the distal end of eachtether rod 519. In another aspect, theeyelet 570 and thetether rod hook 572 are sized and configured so that thetether rod hook 572 is inserted into theeyelet 570 to securely, rotatably couple thetether rod 519 to thedocking ring 520. In use, eachtether rod hook 572 rotates about the circumference of theeyelet 570. As shown inFIG. 27 , the proximal end of each tether rod is coupled to acord 21. Thetether rod 519 and thetether rod hook 572 may be composed of any metal alloy. - The
tether assembly 518 is configured to cooperate with any intracardiac anchor including, but not limited to, the interventricular and epicardial anchors disclosed herein and the interventricular and epicardial anchors of Applicants' prior disclosure incorporated herein by reference. - Referring now to
FIGS. 30A-30 C and 31A-31B, the anchor delivery device 523 for positioning and deploying the anchor cap 516 (or 30) at the desired position is illustrated and pertains to the components of anchor assembly utilizing the tether assembly with ananchor 75 implanted without a tether. The delivery device 523 comprises ananchor delivery guide 525 and ananchor delivery rod 529. The anchor delivery guide has adistal end 528 and an inner guide lumen sized and configured so that at least one portion of theanchor delivery rod 529 extends there through. At least a portion ofanchor delivery guide 525 is flexible so that thedistal end 528 of theanchor delivery guide 525 is positioned at or adjacent to an intracardiac wall. - The
anchor delivery rod 529 is configured to securely attach theanchor screw 517 to theintracardiac wall 7. Theanchor delivery rod 529 has adistal end 531, an opposed proximalrotating handle 530, and an inner rod lumen extending there between. The inner rod lumen is sized and configured so that at least a portion of thedelivery cable 512 extends there through. At least a portion of theanchor delivery rod 529 is flexible so that arod tip 531 at the distal end of theanchor delivery rod 529 may be positioned at or adjacent theintracardiac wall 7. - A portion of the
anchor cap 516/30 (as shown, the portion proximal to the anchor cap distal end 579) is received by and extends within theanchor rod tip 531. The outer configuration of theanchor cap 516 proximal portion includes a firsts surface configuration and the inner wall configuration of saidanchor rod 529 distal portion has a second configuration wherein the first and second configuration mate. Thus, when theanchor cap 516/30 is positioned in and engaged with theanchor rod tip 531, rotation of theanchor delivery rod 529 rotates theanchor cap 516/30. In this position, theanchor screw 28 extends distally from theanchor delivery rod 529 as illustrated inFIG. 30B and thedelivery cable 512 extends through the inner rod lumen of theanchor delivery rod 529. - The anchor delivery device 523 also includes a
guide handle 526 having adeflection knob 527 coupled to theanchor delivery guide 525. The guide handle 526 and thedeflection knob 527 are configured and used to help guide thedistal end 528 of theanchor delivery guide 525 to theintracardiac wall 7. Arod handle 530 is coupled to theanchor delivery rod 529 wherein rotation of the rod handle rotates therod tip 531 and theanchor cap 516 when the anchor cap is positioned in theanchor rod tip 531. - As shown, in
FIG. 30A asheath 524 is configured to receive theanchor delivery guide 525. Thesheath 524 is in fluid communication with the anchor delivery guide so that fluids, such as heparinized saline and the like surrounds the anchor delivery guide through thesheath 524. A central sheath channel 533 (FIG. 31B ) is defined in thesheath 524 to provide communication with the inner guide lumen of theanchor delivery guide 525 for theanchor delivery rod 529 and other system components to extend through thecentral sheath channel 533. - As shown in
FIG. 31A , in the tricuspid annulus, for example, a J-wire 82 is endovascularly guided by the user to theintracardiac wall 7. The anchor delivery device or system 523 is then guided over the J-wire until thedistal end 528 of theanchor delivery guide 525 is positioned at or adjacent theintracardiac wall 7.FIGS. 31A-B illustrate the anchor assembly implanted into an intracardiac wall that is an endocardial wall.Anchor assembly 101 may also be implanted into an interventricular wall. The J-wire is, for example and without limitation, a 0.025″ or 0.035″ J-wire. Of course, J-wires having other diameters are contemplated. Theanchor cap 516/30 is coupled to thedistal end 531 of theanchor delivery rod 529. Theanchor delivery rod 529 is then be inserted through the inner guide lumen of theanchor delivery guide 525 until theanchor cap 516/30 and the distally extending anchor screw 28 (or sectors 108) are positioned at or adjacent theintracardiac wall 7. - The
anchor assembly 102 ofFIGS. 29A-29C may also be implanted and guided by the J-wire 82 such as into the interventricular wall as theintracardiac wall 7 shown. Theanchor assembly 103 ofFIGS. 32A-F may also be implanted and guided by the J-wire 82 into anintracardiac wall 7, such as an interventricular wall or an epicardial wall. - With the anchor screw 28 (or sectors 108) of
anchors systems intracardiac wall 7, therotating handle 530 of theanchor delivery rod anchor cap 516/30 as illustrated inFIG. 31B . For example, therotating handle 530 is rotated in a first direction to cause corresponding rotation of theanchor cap 516. The anchor screw 28 (or 108) coupled to theanchor cap 516/30 also rotates and screws into a portion of the intracardiac wall until theanchor cap 516/30 is adjacent to the apex wall Note that in this position, the anchor screw 28 (or 108) may or may not extend completely through any intracardiac wall, but trans-apical access is not necessary. Upon placement of theanchor cap 516 in the desired position, theanchor delivery rod 529 and theanchor delivery guide 525 are retracted from the heart 2. After placement of theanchor cap 516/30, theflexible wire 513 of thedelivery cable 512 extends from theanchor cap 516, through the tricuspid annulus, and through theright atrium 3. - Although several aspects of the invention have been disclosed in the foregoing specification, it is understood by those skilled in the art that many modifications and other aspects of the invention will come to mind to which the invention pertains, having the benefit of the teaching presented in the foregoing description and associated drawings. It is thus understood that the invention is not limited to the specific aspects disclosed hereinabove, and that many modifications and other aspects are intended to be included within the scope of the appended claims. Moreover, although specific terms are employed herein, as well as in the claims that follow, they are used only in a generic and descriptive sense, and not for the purposes of limiting the described invention.
Claims (28)
1. An intracardiac anchor assembly for minimally invasively anchoring a cardiac device to a cardiac wall at an anchor implantation site by endovascular insertion and implantation and for tethering the cardiac device to the anchor, said anchor assembly comprising:
an anchor comprising an anchor cap having a distal end facing an implantation site and a proximal end and a mating member;
an anchor screw extending from said anchor cap distal end configured for implantation into the cardiac wall;
at least one tether extending from said anchor cap proximal end configured for tethering the cardiac device and having a length sufficient to extend from the anchor cap and to the cardiac device to be implanted; and
an anchor delivery system comprising and anchor delivery rod defining a longitudinally extending lumen and having a distal end for cooperating with said anchor cap wherein forces applied to said anchor delivery rod actively fixate the anchor screw into the implantation site and being sized and configured for receipt of said at least one tether extending proximally from said anchor cap distal end.
2. The intracardiac anchor assembly according to claim 1 wherein said anchor screw is an active fixation screw having a substantially helical configuration wherein said forces applied to said anchor cap by said anchor delivery rod are rotational forces.
3. The intracardiac anchor assembly according to claim 1 wherein said anchor cap mating member is defined by a proximal end thereof.
4. The intracardiac anchor assembly according to claim 3 wherein said anchor delivery rod has a distal end having a first configuration and said anchor cap proximal end has a second configuration wherein said first and second configurations are mating configurations wherein rotational forces applied to said anchor delivery rod applies rotational forces to said anchor cap.
5. The intracardiac anchor assembly according to claim 1 further comprising an anchor delivery guide configured for endovascular implementation and having a proximal and distal end and defining a longitudinally extending lumen extending between said ends and said anchor is removably received within said delivery guide lumen and said anchor delivery rod is removably positioned within said delivery guide lumen for cooperation with said anchor.
6. The medical assembly according to claim 1 wherein a distal portion of said delivery rod is substantially flexible.
7. The intracardiac anchor assembly according to claim 5 further comprising a sheath removably coupled to said anchor delivery guide and being in fluid communication with said anchor delivery guide.
8. The intracardiac anchor assembly according to claim 5 further comprising a J-wire inserted within said anchor delivery system for placing said anchor delivery guide.
9. The intracardiac anchor assembly according to claim 1 wherein said anchor screw is sized and configured to penetrate the cardiac wall but not to exit the cardiac wall on an opposing side thereof.
10. A method of endovascularly implanting an anchor assembly for minimally invasively implanting a medical device in the heart and anchoring the medical device to an intracardiac wall at an implantation site with an anchor and at least one tether connecting the anchor and the medical device, said anchor assembly comprising an anchor delivery system having an anchor delivery guide defining a longitudinally extending lumen and having an anchor delivery rod defining an inner rod lumen, said anchor delivery rod being removably positioned within the anchor delivery guide lumen, the method comprising the steps of:
endovascularly introducing the anchor delivery system into the heart wherein the anchor delivery system includes at least a portion of the anchor and tether positioned within the anchor delivery rod lumen and at least a portion of the anchor delivery rod positioned within the anchor delivery guide lumen;
advancing a distal end of the anchor delivery guide into the heart, through a deployment site and to the implantation site;
advancing the anchor delivery rod and contacting the anchor screw against the implantation site;
manipulating the anchor delivery rod and implanting the anchor into the implantation site to anchor the anchor and tether to the intracardiac wall; and
retracting the anchor delivery guide and anchor delivery rod leaving the anchor implanted at the implantation site.
11. The method according to claim 10 further comprising the step of endovascularly introducing a J-wire into the heart, through the deployment site and to the implantation site prior to said step of advancing the anchor delivery guide into the heart and said step of advancing the anchor delivery guide into the heart includes advancing the anchor guide over the inserted J-wire for guidance.
12. The method according to claim 10 wherein said step of manipulating the anchor delivery rod to implant the anchor includes the step of advancing a distal end of the anchor delivery rod to contact a proximal surface of the anchor and mating the surfaces to engage the delivery rod and the anchor.
13. The method according to claim 10 further comprising the step of rotating the anchor delivery rod and the anchor to implant the anchor screw at the implantation site.
14. The method according to claim 12 wherein said step of implanting the anchor includes an interventricular implantation.
15. The method according to claim 10 wherein said step of implanting the anchor includes an epicardial implantation.
16. An interventricular anchor assembly for endovascularly delivering and implanting an anchor in the septum comprising:
a removable catheter having a proximal and distal end and defining a central lumen between said proximal and distal ends wherein said catheter distal end is configured to be endovascularly introduced into the heart and through the septum;
a removeable radio frequency wire extending through said central lumen and operatively connected to a radio frequency source for guiding said wire into the heart and through the septum;
a removeable J-wire extending within said catheter central lumen;
a removeable anchor delivery guide defining a central lumen, said delivery guide selectively positioned along said J-wire wherein said J-wire extend within said delivery guide lumen;
an anchor delivery rod defining a central lumen, said anchor delivery rod positioned within said anchor delivery guide lumen;
an anchor connected to a distal end of said delivery rod wherein the anchor is expandable so as to expand after piercing said septum upon exiting an opposing side of the septum; and
at least one cord connected to a proximal end of said anchor and extending along said delivery rod lumen.
17. The interventricular anchor assembly according to claim 16 wherein a distal end of said catheter is a screw for penetrating the septum with rotational forces applied to said delivery rod.
18. A method of endovascularly implanting an interventricular anchor assembly for minimally invasively implanting a medical device into the septum of the heart and anchoring the medical device to the septum at an implantation site with an anchor and at least one tether connecting the anchor and the medical device, said anchor assembly comprising a catheter and an anchor delivery system, said catheter having a central lumen for receiving a removeable radio frequency wire extending through said catheter lumen and operatively connected to a radio frequency source, the anchor delivery system having an anchor delivery guide defining a longitudinally extending lumen and having an anchor delivery rod defining an inner rod lumen, wherein said anchor delivery rod is removably positioned within the anchor delivery guide lumen, the method comprising the steps of:
endovascularly introducing and advancing the catheter and radio frequency wire into the heart wherein the radio frequency wire is positioned adjacent the septum;
advancing the radio frequency wire and then the catheter through the septum;
retracting the radio frequency wire from the catheter and heart;
inserting a J-wire through the catheter lumen so as to penetrate the septum and exit an opposing side of the septum;
inserting and advancing the anchor delivery guide over the J-wire reaching the implantation site;
inserting the anchor delivery rod within the delivery guide lumen and through the septum, reaching the implantation site;
advancing the anchor delivery rod to release the anchor which self-expands on the opposing side of the septum; and
removing the anchor delivery system and catheter.
19. The method according to claim 18 wherein said step of advancing the catheter includes applying rotational forces to the catheter to achieve penetration of the septum.
20. An epicardial anchor assembly for endovascularly delivering and implanting an anchor in the pericardial space comprising:
a removable catheter having a proximal and distal end and defining a central lumen between said proximal and distal ends wherein said catheter distal end is configured to be endovascularly introduced into the heart, penetrate the endocardium and into the pericardial space and wherein the catheter proximal end and central lumen are in fluid communication with a fluid source;
a removeable anchor delivery guide defining a central lumen;
an anchor delivery rod positioned within said anchor delivery guide lumen;
an anchor connected to a distal end of said delivery rod and said anchor delivery rod is advanced along said delivery guide lumen to as to position said anchor in the pericardial space wherein the anchor is expandable so as to expand within the pericardial space; and
at least one cord connected to a proximal end of said anchor and extending along said delivery rod lumen and extending proximally from said delivery rod and said catheter.
21. The epicardial anchor assembly according to claim 20 wherein said removable catheter distal end includes an outer surface including helical threads for penetrating the endocardium when the catheter is rotated.
22. The epicardial anchor assembly according to claim 20 wherein said fluid source comprises a fluid for insufflating the pericardial space.
23. The epicardial anchor assembly according to claim 20 further comprising a J-wire extending within said catheter central lumen wherein said delivery guide is configured to move along said J-wire.
24. A method of endovascularly implanting an epicardial anchor assembly for minimally invasively implanting a medical device in the pericardial space of the heart and anchoring the medical device to the pericardium at an implantation site with an anchor and at least one tether connecting the anchor and the medical device, said anchor assembly comprising a catheter and an anchor delivery system, said catheter having proximal and distal ends and defining a central lumen between said proximal and distal ends wherein said catheter distal end is configured to be endovascularly introduced into the heart, penetrate the endocardium and into the pericardial space and wherein the catheter central lumen is in fluid communication with a fluid source, the anchor delivery system having an anchor delivery guide defining a longitudinally extending lumen and having an anchor delivery rod defining an inner rod lumen, and a said anchor delivery rod being removably positioned within the anchor delivery guide lumen, the method comprising the steps of:
endovascularly introducing and advancing the catheter into the heart towards the implantation site adjacent the implantation site;
advancing the catheter to penetrate and exit the epicardial surface and entering the pericardial space;
injecting the fluid from the fluid source along the catheter lumen and insufflating the pericardial space;
inserting a J-wire through the catheter lumen until it reaches the pericardial space;
removing the catheter from the heart;
inserting and advancing the anchor delivery guide over the J-wire reaching the implantation site;
inserting the anchor delivery rod within the delivery guide lumen and to the implantation site;
advancing the anchor delivery rod to release the anchor in the pericardial space and expanding the anchor within the pericardial space; and
removing the anchor delivery system.
25. The method according to claim 24 further comprising the step of injecting a contrasting agent into the pericardial space after said step of advancing the catheter into the pericardial space.
26. A method of endovascularly implanting an anchor assembly for minimally invasively implanting a medical device in the heart and anchoring the medical device to an intracardiac wall at an implantation site with an anchor, anchor assembly comprising an anchor including an anchor cap, an anchor screw and a removable anchor delivery cable sized and configured for endovascular introduction and having a distal end configured to mate with the anchor cap proximal end to removably couple the delivery cable to the anchor cap; said anchor assembly also including a tether assembly comprising a docking ring configured to cooperate with the anchor cap to selectively secure the docking ring to the anchor cap and at least one tether rod extending from the docking ring and said anchor assembly comprising an anchor delivery system having an anchor delivery guide defining a longitudinally extending lumen and having an anchor delivery rod defining an inner rod lumen, said anchor delivery rod being removably positioned within the anchor delivery guide lumen, the method comprising the steps of:
endovascularly introducing the anchor delivery system into the heart wherein the anchor delivery system includes at least a portion of the anchor positioned within the anchor delivery rod lumen and at least a portion of the anchor delivery rod positioned within the anchor delivery guide lumen;
advancing a distal end of the anchor delivery guide into the heart, through a deployment site and to the implantation site;
advancing the anchor delivery rod and contacting the anchor screw against the implantation site;
manipulating the anchor delivery rod and implanting the anchor into the implantation site to anchor the anchor and tether to the intracardiac wall;
retracting the anchor delivery guide and anchor delivery rod leaving the anchor implanted at the implantation site;
endovascularly introducing the delivery cable and connecting it to the anchor cap of the implanted anchor;
endovascularly introducing the docking ring over the delivery cable to cooperate with the anchor cap; and
removing the delivery rod.
27. The method according to claim 26 wherein said step of manipulating the anchor delivery rod and implanting the anchor includes rotating the delivery rod so as to rotate the anchor screw to penetrate the intracardiac wall at the implantation site.
28. The method according to claim 26 wherein after said step of manipulating the anchor delivery rod and implanting the anchor includes the step of implanting the anchor screw so as to exit the opposing side of the intracardiac wall and the method includes the step of expanding a distal portion of the anchor screw.
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20210169645A1 (en) * | 2019-12-05 | 2021-06-10 | Tendyne Holdings, Inc. | Braided Anchor For Mitral Valve |
Families Citing this family (25)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20090276040A1 (en) * | 2008-05-01 | 2009-11-05 | Edwards Lifesciences Corporation | Device and method for replacing mitral valve |
GB2536538B (en) | 2014-09-17 | 2018-07-18 | Cardiomech As | Anchor for implantation in body tissue |
US11833034B2 (en) | 2016-01-13 | 2023-12-05 | Shifamed Holdings, Llc | Prosthetic cardiac valve devices, systems, and methods |
US9877833B1 (en) | 2016-12-30 | 2018-01-30 | Pipeline Medical Technologies, Inc. | Method and apparatus for transvascular implantation of neo chordae tendinae |
US10925731B2 (en) | 2016-12-30 | 2021-02-23 | Pipeline Medical Technologies, Inc. | Method and apparatus for transvascular implantation of neo chordae tendinae |
US11083580B2 (en) | 2016-12-30 | 2021-08-10 | Pipeline Medical Technologies, Inc. | Method of securing a leaflet anchor to a mitral valve leaflet |
US11696828B2 (en) | 2016-12-30 | 2023-07-11 | Pipeline Medical Technologies, Inc. | Method and apparatus for mitral valve chord repair |
US11123187B2 (en) * | 2017-04-05 | 2021-09-21 | Opus Medical Therapies, LLC | Transcatheter atrial anchors and methods of implantation |
US11103351B2 (en) * | 2017-04-05 | 2021-08-31 | Opus Medical Therapies, LLC | Transcatheter atrial sealing skirt and related method |
US10820991B2 (en) | 2017-04-05 | 2020-11-03 | Opus Medical Therapies, LLC | Transcatheter atrial sealing skirt, anchor, and tether and methods of implantation |
US11337685B2 (en) * | 2017-04-05 | 2022-05-24 | Opus Medical Therapies, LLC | Transcatheter anchoring assembly for a mitral valve, a mitral valve, and related methods |
US10820992B2 (en) | 2017-04-05 | 2020-11-03 | Opus Medical Therapies, LLC | Transcatheter atrial sealing skirt, anchor, and tether and methods of implantation |
US12121775B2 (en) | 2018-06-27 | 2024-10-22 | Dhiren Rajagopal | Brace for preventing finger injuries |
EP3860519A4 (en) | 2018-10-05 | 2022-07-06 | Shifamed Holdings, LLC | Prosthetic cardiac valve devices, systems, and methods |
GB2579420B (en) * | 2018-11-29 | 2023-02-01 | Cardiomech As | Device for heart repair |
WO2020176209A1 (en) * | 2019-02-25 | 2020-09-03 | Edwards Lifesciences Corporation | Adjustment mechanism and method for a guide wire |
WO2020191216A1 (en) | 2019-03-19 | 2020-09-24 | Shifamed Holdings, Llc | Prosthetic cardiac valve devices, systems, and methods |
CN114786593B (en) | 2019-10-11 | 2023-12-12 | 欧普斯医疗疗法有限公司 | Transcatheter chordae implantation device and implantation method |
US10980523B1 (en) * | 2019-11-01 | 2021-04-20 | Stephanie Toy | Medical device to access pericardial space with control |
AU2021209921A1 (en) | 2020-01-22 | 2022-08-18 | Opus Medical Therapies, LLC | Transcatheter anchor support, systems and methods of implantation |
JP2023515809A (en) * | 2020-02-20 | 2023-04-14 | エンリケス-サラノ、モーリス | Transcatheter valve leads and valve elements |
US12053371B2 (en) | 2020-08-31 | 2024-08-06 | Shifamed Holdings, Llc | Prosthetic valve delivery system |
US11877928B2 (en) * | 2020-10-01 | 2024-01-23 | Opus Medical Therapies, LLC | Transcatheter anchor support and methods of implantation |
US20230346545A1 (en) * | 2022-04-29 | 2023-11-02 | Tangent Biotech Inc. | Percutaneous tricuspid valve repair devices and methods |
WO2024092059A1 (en) * | 2022-10-26 | 2024-05-02 | Pipeline Medical Technologies, Inc. | Mitral valve leaflet repair system |
Family Cites Families (118)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4242715A (en) | 1978-08-10 | 1980-12-30 | Ultradyne, Inc. | Self-defense apparatus |
US4337496A (en) | 1978-08-10 | 1982-06-29 | Ultradyne, Inc. | Self-defense apparatus |
US4746057A (en) | 1986-03-25 | 1988-05-24 | Wagner Otto W | Finger-stabilized eating plate |
US4830360A (en) | 1987-07-24 | 1989-05-16 | Carr Jr Earnest F | Orthopedic exercise glove |
US5079776A (en) | 1989-12-07 | 1992-01-14 | Crawford David H | Glove for rock climbing |
WO1994020049A1 (en) | 1993-03-08 | 1994-09-15 | Fingease Pty. Ltd. | Dynamic traction splint |
US5312438A (en) * | 1993-05-03 | 1994-05-17 | Lanny L. Johnson | Suture anchor and method of use |
US5683451A (en) * | 1994-06-08 | 1997-11-04 | Cardiovascular Concepts, Inc. | Apparatus and methods for deployment release of intraluminal prostheses |
US5569306A (en) * | 1995-06-06 | 1996-10-29 | Thal; Raymond | Knotless suture anchor assembly |
US6042583A (en) * | 1995-06-14 | 2000-03-28 | Medworks Corporation | Bone anchor-insertion tool and surgical method employing same |
US5706520A (en) | 1995-08-15 | 1998-01-13 | The United States Of America As Represented By The Department Of Health And Human Services | Hand puncture protector |
US5662704A (en) * | 1995-12-01 | 1997-09-02 | Medtronic, Inc. | Physiologic mitral valve bioprosthesis |
US5849004A (en) * | 1996-07-17 | 1998-12-15 | Bramlet; Dale G. | Surgical anchor |
US6093162A (en) | 1998-11-16 | 2000-07-25 | Fairleigh; Angela | Dynamic splint for post-operative treatment of flexible implant arthroplasty of the fingers |
GB0125925D0 (en) * | 2001-10-29 | 2001-12-19 | Univ Glasgow | Mitral valve prosthesis |
US20060241656A1 (en) | 2002-06-13 | 2006-10-26 | Starksen Niel F | Delivery devices and methods for heart valve repair |
US7404824B1 (en) | 2002-11-15 | 2008-07-29 | Advanced Cardiovascular Systems, Inc. | Valve aptation assist device |
US20040138707A1 (en) * | 2003-01-14 | 2004-07-15 | Greenhalgh E. Skott | Anchor removable from a substrate |
US20040190383A1 (en) | 2003-03-24 | 2004-09-30 | Fila Luxembourg S.A.R.L. | Housing for electronic device wearable on user's finger |
EP1462880A3 (en) | 2003-03-24 | 2005-04-06 | Fila Luxembourg S.a.r.l. | Housing for electronic device wearable on user's finger |
US7530995B2 (en) | 2003-04-17 | 2009-05-12 | 3F Therapeutics, Inc. | Device for reduction of pressure effects of cardiac tricuspid valve regurgitation |
US8343213B2 (en) * | 2003-12-23 | 2013-01-01 | Sadra Medical, Inc. | Leaflet engagement elements and methods for use thereof |
US7780725B2 (en) | 2004-06-16 | 2010-08-24 | Sadra Medical, Inc. | Everting heart valve |
WO2005094711A2 (en) | 2004-03-30 | 2005-10-13 | Green Alan J | Flowable agent dispenser |
AU2006212750B2 (en) | 2005-02-07 | 2011-11-17 | Evalve, Inc. | Methods, systems and devices for cardiac valve repair |
US7722666B2 (en) * | 2005-04-15 | 2010-05-25 | Boston Scientific Scimed, Inc. | Valve apparatus, system and method |
SE531468C2 (en) | 2005-04-21 | 2009-04-14 | Edwards Lifesciences Ag | An apparatus for controlling blood flow |
US20070118151A1 (en) * | 2005-11-21 | 2007-05-24 | The Brigham And Women's Hospital, Inc. | Percutaneous cardiac valve repair with adjustable artificial chordae |
US20070142838A1 (en) * | 2005-12-19 | 2007-06-21 | Christopher Jordan | Surgical suture staple and attachment device for securing a soft tissue to a bone |
US8932348B2 (en) | 2006-05-18 | 2015-01-13 | Edwards Lifesciences Corporation | Device and method for improving heart valve function |
US20070277279A1 (en) | 2006-05-19 | 2007-12-06 | David Battat | Finger mounted rock climbing implement |
US8333155B2 (en) | 2006-11-28 | 2012-12-18 | Zipholdings, Llc. | Trim controlled, dynamically controllable, trolley brake |
DE102007043830A1 (en) | 2007-09-13 | 2009-04-02 | Lozonschi, Lucian, Madison | Heart valve stent |
US8273973B2 (en) | 2008-04-29 | 2012-09-25 | Things 4 Strings, Llc | Bow hold training device |
US20090276040A1 (en) * | 2008-05-01 | 2009-11-05 | Edwards Lifesciences Corporation | Device and method for replacing mitral valve |
US8323335B2 (en) | 2008-06-20 | 2012-12-04 | Edwards Lifesciences Corporation | Retaining mechanisms for prosthetic valves and methods for using |
EP2313152B1 (en) * | 2008-07-21 | 2022-08-31 | Bioventrix | Cardiac anchor structures |
EP2367505B1 (en) | 2008-09-29 | 2020-08-12 | Edwards Lifesciences CardiAQ LLC | Heart valve |
US8489165B2 (en) | 2008-10-29 | 2013-07-16 | Cnoga Medical Ltd. | Finger deployed device for measuring blood and physiological characteristics |
US8808368B2 (en) * | 2008-12-22 | 2014-08-19 | Valtech Cardio, Ltd. | Implantation of repair chords in the heart |
US8147542B2 (en) * | 2008-12-22 | 2012-04-03 | Valtech Cardio, Ltd. | Adjustable repair chords and spool mechanism therefor |
US8545553B2 (en) * | 2009-05-04 | 2013-10-01 | Valtech Cardio, Ltd. | Over-wire rotation tool |
US20110011917A1 (en) * | 2008-12-31 | 2011-01-20 | Hansen Medical, Inc. | Methods, devices, and kits for treating valve prolapse |
US8549175B2 (en) | 2009-06-09 | 2013-10-01 | Qualcomm Incorporated | Methods and apparatus for adaptively scheduling a finger stabilization algorithm |
US8940042B2 (en) | 2009-10-29 | 2015-01-27 | Valtech Cardio, Ltd. | Apparatus for guide-wire based advancement of a rotation assembly |
US20130190861A1 (en) | 2012-01-23 | 2013-07-25 | Tendyne Holdings, Inc. | Prosthetic Valve for Replacing Mitral Valve |
US8449599B2 (en) | 2009-12-04 | 2013-05-28 | Edwards Lifesciences Corporation | Prosthetic valve for replacing mitral valve |
EP2509538B1 (en) * | 2009-12-08 | 2017-09-20 | Avalon Medical Ltd. | Device and system for transcatheter mitral valve replacement |
US9441832B2 (en) | 2010-03-02 | 2016-09-13 | Glenn Bushee | Compact lighting system with infrared indicator |
WO2011111047A2 (en) | 2010-03-10 | 2011-09-15 | Mitraltech Ltd. | Prosthetic mitral valve with tissue anchors |
US8790394B2 (en) * | 2010-05-24 | 2014-07-29 | Valtech Cardio, Ltd. | Adjustable artificial chordeae tendineae with suture loops |
DE112011102305T5 (en) | 2010-07-09 | 2013-05-16 | Highlife Sas | Transcatheter atrioventricular valve prosthesis |
WO2012018599A1 (en) | 2010-08-03 | 2012-02-09 | Cook Medical Technologies Llc | Two valve caval stent for functional replacement of incompetent tricuspid valve |
US10105224B2 (en) | 2010-09-01 | 2018-10-23 | Mvalve Technologies Ltd. | Cardiac valve support structure |
US10321998B2 (en) | 2010-09-23 | 2019-06-18 | Transmural Systems Llc | Methods and systems for delivering prostheses using rail techniques |
US20120078360A1 (en) | 2010-09-23 | 2012-03-29 | Nasser Rafiee | Prosthetic devices, systems and methods for replacing heart valves |
EP2478868A1 (en) * | 2011-01-25 | 2012-07-25 | The Provost, Fellows, Foundation Scholars, and the other Members of Board, of the College of the Holy and Undivided Trinity of Queen Elizabeth | Implant device |
US8888843B2 (en) * | 2011-01-28 | 2014-11-18 | Middle Peak Medical, Inc. | Device, system, and method for transcatheter treatment of valve regurgitation |
EP2688516B1 (en) | 2011-03-21 | 2022-08-17 | Cephea Valve Technologies, Inc. | Disk-based valve apparatus |
US9308087B2 (en) | 2011-04-28 | 2016-04-12 | Neovasc Tiara Inc. | Sequentially deployed transcatheter mitral valve prosthesis |
WO2013009975A1 (en) | 2011-07-12 | 2013-01-17 | Boston Scientific Scimed, Inc. | Coupling system for medical devices |
CN108375676B (en) | 2011-07-21 | 2022-01-07 | 詹森诊断器材有限责任公司 | Assay for capturing and detecting circulating multiple myeloma from blood |
CA2957442C (en) * | 2011-08-11 | 2019-06-04 | Tendyne Holdings, Inc. | Improvements for prosthetic valves and related inventions |
US20130331929A1 (en) | 2011-09-09 | 2013-12-12 | Endoluminal Sciences Pty Ltd. | Means for Controlled Sealing of Endovascular Devices |
US8900295B2 (en) * | 2011-09-26 | 2014-12-02 | Edwards Lifesciences Corporation | Prosthetic valve with ventricular tethers |
US9039757B2 (en) * | 2011-10-19 | 2015-05-26 | Twelve, Inc. | Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods |
US8858623B2 (en) * | 2011-11-04 | 2014-10-14 | Valtech Cardio, Ltd. | Implant having multiple rotational assemblies |
US9827092B2 (en) * | 2011-12-16 | 2017-11-28 | Tendyne Holdings, Inc. | Tethers for prosthetic mitral valve |
WO2013103612A1 (en) | 2012-01-04 | 2013-07-11 | Tendyne Holdings, Inc. | Improved multi-component cuff designs for transcatheter mitral valve replacement, subvalvular sealing apparatus for transcatheter mitral valves and wire framed leaflet assembly |
US20130184811A1 (en) * | 2012-01-13 | 2013-07-18 | Tendyne Holdings, Inc. | Device and Method for Replacing Mitral Valve |
US9005084B2 (en) | 2012-01-26 | 2015-04-14 | Cognatus Innovations Llc | Apparatus and systems for finger exercise |
DE102012002785B4 (en) | 2012-02-15 | 2017-06-01 | Festo Ag & Co. Kg | orthosis |
US20130304197A1 (en) | 2012-02-28 | 2013-11-14 | Mvalve Technologies Ltd. | Cardiac valve modification device |
US9427315B2 (en) | 2012-04-19 | 2016-08-30 | Caisson Interventional, LLC | Valve replacement systems and methods |
US9474605B2 (en) | 2012-05-16 | 2016-10-25 | Edwards Lifesciences Corporation | Devices and methods for reducing cardiac valve regurgitation |
US9578982B2 (en) | 2012-07-11 | 2017-02-28 | Kenrick Rampersad | Disposable finger tongs for handling a food product |
US9033383B2 (en) | 2012-07-11 | 2015-05-19 | Kenrick Rampersad | Disposable finger tongs for handling a food product |
WO2016179427A1 (en) | 2015-05-07 | 2016-11-10 | Kenrick Rampersad | Disposable finger tongs for handling food product |
WO2014022124A1 (en) | 2012-07-28 | 2014-02-06 | Tendyne Holdings, Inc. | Improved multi-component designs for heart valve retrieval device, sealing structures and stent assembly |
WO2014021905A1 (en) | 2012-07-30 | 2014-02-06 | Tendyne Holdings, Inc. | Improved delivery systems and methods for transcatheter prosthetic valves |
US9439763B2 (en) | 2013-02-04 | 2016-09-13 | Edwards Lifesciences Corporation | Prosthetic valve for replacing mitral valve |
DE102013102609A1 (en) | 2013-03-14 | 2014-09-18 | Technische Universität Dresden | Fingerling |
US9486306B2 (en) | 2013-04-02 | 2016-11-08 | Tendyne Holdings, Inc. | Inflatable annular sealing device for prosthetic mitral valve |
US20140296972A1 (en) | 2013-04-02 | 2014-10-02 | Tendyne Holdings | Deployment Compensator for Transcatheter Valve Delivery |
CN105658178B (en) | 2013-06-25 | 2018-05-08 | 坦迪尼控股股份有限公司 | Feature is complied with thrombus management and structure for prosthetic heart valve |
US20140379076A1 (en) | 2013-06-25 | 2014-12-25 | Tendyne Holdings, Inc. | Halo Wire Fluid Seal Device for Prosthetic Mitral Valves |
EP2896387A1 (en) | 2014-01-20 | 2015-07-22 | Mitricares | Heart valve anchoring device |
WO2015120122A2 (en) | 2014-02-05 | 2015-08-13 | Robert Vidlund | Apparatus and methods for transfemoral delivery of prosthetic mitral valve |
US9986993B2 (en) * | 2014-02-11 | 2018-06-05 | Tendyne Holdings, Inc. | Adjustable tether and epicardial pad system for prosthetic heart valve |
US20150250590A1 (en) | 2014-03-10 | 2015-09-10 | St. Jude Medical, Cardiology Division, Inc. | Transapical mitral chordae replacement |
EP3157469B2 (en) | 2014-06-18 | 2024-10-02 | Polares Medical Inc. | Mitral valve implants for the treatment of valvular regurgitation |
EP3160396B1 (en) * | 2014-06-24 | 2022-03-23 | Polares Medical Inc. | Systems for anchoring an implant |
US10383729B2 (en) | 2014-09-29 | 2019-08-20 | The Provost, Fellows Foundation Scholars, and The Other Members of the Board, of the College of The Holy and Undivided Trinity of Queen Elizabeth Near Dublin (TCD) | Heart valve treatment device and method |
US10213307B2 (en) | 2014-11-05 | 2019-02-26 | Medtronic Vascular, Inc. | Transcatheter valve prosthesis having an external skirt for sealing and preventing paravalvular leakage |
ES2968133T3 (en) | 2014-12-14 | 2024-05-08 | Trisol Medical Ltd | Prosthetic valve and deployment system |
US9861477B2 (en) | 2015-01-26 | 2018-01-09 | Boston Scientific Scimed Inc. | Prosthetic heart valve square leaflet-leaflet stitch |
WO2016126739A1 (en) | 2015-02-03 | 2016-08-11 | RCM Enterprise, LLC | Biomechanical finger brace assembly |
US20160245616A1 (en) | 2015-02-23 | 2016-08-25 | Damon William Derousse | Vertical forward grip |
US10080652B2 (en) | 2015-03-13 | 2018-09-25 | Boston Scientific Scimed, Inc. | Prosthetic heart valve having an improved tubular seal |
EP3283010B1 (en) | 2015-04-16 | 2020-06-17 | Tendyne Holdings, Inc. | Apparatus for delivery and repositioning of transcatheter prosthetic valves |
US10441416B2 (en) * | 2015-04-21 | 2019-10-15 | Edwards Lifesciences Corporation | Percutaneous mitral valve replacement device |
AU2016202264B2 (en) | 2015-04-23 | 2017-12-07 | T.J Preston & D.L Taylor | Climbing tool |
US10232564B2 (en) | 2015-04-29 | 2019-03-19 | Edwards Lifesciences Corporation | Laminated sealing member for prosthetic heart valve |
WO2016186909A1 (en) | 2015-05-18 | 2016-11-24 | Mayo Foundation For Medical Education And Research | Percutaneously-deployable prosthetic tricuspid valve |
WO2016209970A1 (en) | 2015-06-22 | 2016-12-29 | Edwards Lifescience Cardiaq Llc | Actively controllable heart valve implant and methods of controlling same |
US20170143478A1 (en) | 2015-11-02 | 2017-05-25 | Robert S. Schwartz | Devices and methods for reducing cardiac valve regurgitation |
ES2875921T3 (en) | 2015-12-22 | 2021-11-11 | Medira Ag | Mitral valve coaptation improvement prosthetic device |
WO2017117560A1 (en) | 2015-12-30 | 2017-07-06 | Pipeline Medical Technologies, Inc. | Mitral leaflet tethering |
US10188541B2 (en) | 2016-01-21 | 2019-01-29 | William Miles Combs | Immobilizing splints |
WO2017189276A1 (en) | 2016-04-29 | 2017-11-02 | Medtronic Vascular Inc. | Prosthetic heart valve devices with tethered anchors and associated systems and methods |
EP3311774B1 (en) | 2016-10-19 | 2022-05-11 | P+F Products + Features Vertriebs GmbH | Self-expandable atrioventricular valve and system of cardiac valves |
CN106618798B (en) | 2016-10-24 | 2019-10-11 | 宁波健世生物科技有限公司 | A kind of heart valve prosthesis and its conveying and method for releasing fixed by interventricular septum |
US11123187B2 (en) * | 2017-04-05 | 2021-09-21 | Opus Medical Therapies, LLC | Transcatheter atrial anchors and methods of implantation |
US11103351B2 (en) * | 2017-04-05 | 2021-08-31 | Opus Medical Therapies, LLC | Transcatheter atrial sealing skirt and related method |
US10820992B2 (en) * | 2017-04-05 | 2020-11-03 | Opus Medical Therapies, LLC | Transcatheter atrial sealing skirt, anchor, and tether and methods of implantation |
US10820991B2 (en) | 2017-04-05 | 2020-11-03 | Opus Medical Therapies, LLC | Transcatheter atrial sealing skirt, anchor, and tether and methods of implantation |
US10327895B2 (en) | 2017-05-05 | 2019-06-25 | Vdyne, Llc | Pressure differential actuated prosthetic medical device |
US12121775B2 (en) | 2018-06-27 | 2024-10-22 | Dhiren Rajagopal | Brace for preventing finger injuries |
-
2018
- 2018-09-20 US US16/136,506 patent/US11123187B2/en active Active
-
2021
- 2021-08-24 US US17/410,123 patent/US20220000616A1/en active Pending
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20210169645A1 (en) * | 2019-12-05 | 2021-06-10 | Tendyne Holdings, Inc. | Braided Anchor For Mitral Valve |
US11648110B2 (en) * | 2019-12-05 | 2023-05-16 | Tendyne Holdings, Inc. | Braided anchor for mitral valve |
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