Patent Application
20220023035
The present invention relates generally to a tether locking assembly for implanted cardiac medical devices, such as an artificial heart valve to replace the native heart valve, and which are secured at the implantation site by anchoring tethers secured to an intracardiac member, such as an intracardiac 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, and pulmonic valves, but replacement of mitral and tricuspid valves remains challenging given the complex and delicate anatomy to which prostheses must attach. Anchoring transcatheter valves, in general, or transcatheter mitral and tricuspid valves, in particular, remains difficult, because doing so, either in the in-situ position of cardiac valves, or in other body lumens, requires interaction with a great variety of shapes and sizes of either cardiac valve annuli or other lumens. In this regard, the ability to tether transcatheter valves with one or more anchors affixed to intracardiac wall(s) provides greater security and flexibility for the transcatheter prosthesis by lessening need for fixation at the exact site of the prosthesis. For example, Applicants' Ser. No. 15/943,971 discloses an exemplary 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.
Presented herein is a detachable tether locking assembly for an endovascularly implanted medical device wherein the tether locking assembly is likewise implanted and locked utilizing endovascular techniques. For the sake of discussion, the tether locking assembly is described and shown used in connection with an atrial sealing skirt for a heart valve which is anchored to an intracardiac wall with tethers which extend from and anchor to the valve. The sealing skirt is positioned so as to be sealed at the atrial floor and secured in place by the detachable tether locking assembly.
The tether locking assembly comprises at least one atrial positioning rod, at least one conduit, and a detachable lock. The positioning rod has a proximal end configured to cooperate with an endovascular delivery system, and a distal end reversibly coupled to the detachable lock. The inner lumen of the positioning rod is configured for receipt of the tether wherein the positioning rod pushes or pulls the atrial skirt, thereby applying differential force and flexion to the associated top brim, allowing apposition to the atrial floor and/or conformation around an intracardiac lead. In another aspect, rotation of the positioning rod and/or pushing or pulling of internal elements of the positioning rod causes the detachable lock to engage the tether, or cord and/or suture connected to the tether, securing the cord, suture or tether to the valve (for example, atrial skirt), maintaining the force and flexion of the atrial skirt to atrial floor and/or intracardiac lead.
As shown and described, the sealing skirt includes a frame having a cylindrical shape, with the bottom of the cylinder at or below the valve annular level, and with the top of the cylinder extending into the atrium. According to one aspect of the present invention, the tether locking assembly is integrated with the valve. The valve, adjacent to the top brim, extends longitudinally along the interior or exterior of skirt body, includes one or more conduits, which take the shape of a cylinder whose cross-section is any portion of a circle, ellipse, parabola, or hyperbola, or take the shape of a polyhedron with a flat base and top which assume the shape of a polygon with three or more sides. These conduits are constructed from the membrane covering the skirt, or may be made of, but not limited to, stainless steel, nitinol or other metal alloys. The one or more conduits are hollow and accommodate at least one tether (or chord connected thereto), and each conduit attaches to a detachable lock near the atrial surface of the skirt.
The tether locking assembly includes a conduit (integrated or non-integrated with the atrial sealing skirt body), a detachable lock comprising a plurality of hypotubes, and a positioning rod for activating the detachable lock. According to one aspect of the invention, the conduit is integrated with the sealing skirt. According to another aspect of the present invention, the tether locking system is not integrated with the valve and the conduit is positioned adjacent the atrial side of the valve or medical device, the ventricular side of the valve or medical device, or remotely connected to the valve by the tether. The conduit shown is generally cylindrical with a cross-section in any portion is a circle, ellipse, parabola or hyperbola, or take the shape of a polygon with three or more sides. The integrated conduits are constructed from the membrane covering the sealing skirt or may be made of, but not limited to, stainless steel, nitinol or other metal alloys. The non-integrated conduits may be made of, but not limited to, stainless steel, nitinol or other metal alloys. The at least one conduit is hollow and accommodates at least one tether and each conduit cooperates with the detachable lock adjacent to or remote from the sealing skirt. The tether locking assembly includes at least one atrial positioning rod with proximal end attached to a delivery system, and a distal end reversibly coupled to the detachable lock, which, if the conduit is integrated with the sealing skirt, is attached to the proximal end of the conduit of the atrial skirt. Through the inner lumen of the positioning rod runs the tether wherein the positioning rod pushes or pulls the atrial skirt, thereby applying differential force and flexion to the associated top brim, allowing apposition to the atrial floor and/or conformation around an intracardiac lead. In another aspect, rotation of the positioning rod and/or pushing or pulling of internal elements of the positioning rod causes the detachable lock to engage the cord and/or suture, securing the cord and/or suture to the atrial skirt, maintaining the force and flexion of the atrial skirt to atrial floor and/or intracardiac lead.
The detachable lock includes a conduit, a first hypotube and a second hypotube and is positioned within the central lumen of the positioning rod. The second hypotube threadingly engages a locking clip positioned within a second hypotube and the first hypotube cooperate with tabs wherein removal of the first and second hypotubes secures the lock assembly position on the tether which, in turn, secures the sealing skirt position.
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. As used herein “fluid” refers to any substance that is free to flow and include liquids, gases, and plasma. “Fluid communication” as used herein refers to any connection or relative positioning permitting substances to freely flow between the relevant components. As used herein “integrated” refers to being contained by or adjacent to the corresponding member. The directional term “proximal” refers to the atrial side of the heart valve, in the direction of the delivery system and “distal” refers to the ventricular side in the direction of the anchor.
For the purposes of describing and defining the present invention it is noted that the use of relative terms, such as “substantially”, “generally”, “approximately”, and the like, are utilized herein to represent an inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. These terms are also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.
The detachable, tether locking assembly 10 as described herein is used in connection with medical devices and systems to be minimally invasively implanted in the heart to replace, to repair, or to support a native heart structure. By way of example only, the present invention as shown and described relates to a tether locking assembly 10 used with devices, methods and systems for endovascularly introducing and anchoring an anchor 75 (
As used herein, “tether” refers generally to a structure which extends from the anchor 75 secured to an atrial wall (interventricular septum or intracardiac wall) to the valve assembly 100 or another medical device employed. As disclosed in Applicant's prior application Ser. No. 15/943,971, “tether” refers generally to the cords of the tethering assembly comprised of the tether docking arm and chord or suture extending proximally therefrom. Alternatively, “tether” does not include a tether docking arm and is merely a tether in the form a tether cord extending directly or indirectly form the anchor 75 to the heart device, such as the valve 100. As used herein, the non-integrated conduit refers to a conduit which is not supported by the atrial skirt body 48. For example, the conduit's open upper end is not defined by the atrial skirt top brim 47 and is not fully supported longitudinally by the skirt body 48.
As shown, the heart valve assembly 100 includes a skirt body 48 and an atrial skirt top brim 47 extending circumferentially along the upper end of the valve 100. The skirt body 48 is generally cylindrical, and the atrial skirt top brim 47 is configured to conform to an atrial floor 4, such as the right atrial floor as shown. The atrial sealing skirt 46 is coupled to the anchor 75 by the tether 21 as described herein.
The transcatheter atrial sealing skirt 46 is sized and configured to sit in the tricuspid valve (in the example shown) between the right atrium 3 and the right ventricle 6 as illustrated in
According to one aspect of the present invention shown in
The at least one tether 21 is coupled, directly or indirectly to the anchor. In one aspect, the tether 21 may be a strong yet flexible cord such as, for example and without limitation, an expanded polytetrafluoroethylene (ePTFE) or ultra-high-molecular-weight polyethylene (UHMWPE, UHMW) cord. In use, described more fully below, a central portion of the cord 21 (between the distal end and the proximal end) extends through and/or be coupled to the atrial sealing skirt 46 to hold the skirt in the desired position relative to the tricuspid annulus or the mitral annulus.
The tether locking assembly 10 includes a positioning rod 44 with a distal end 54, a proximal end 61 and an inner rod lumen 62 extending there between, the inner rod lumen is sized and configured so that a portion of the tether 21 extends therein. At least a portion of the atrial positioning rod 44 is flexible so that the distal end 54 of the atrial positioning rod may be positioned at or adjacent to the deployment site 5. The proximal portion of the positioning rod 44 extends beyond the delivery system, such as the delivery guide 38, as shown in
The at least one positioning rod 44 is configured to couple with the conduit 53, when the conduit 53 is integrated with the valve as shown in
Inside the detachable lock 56 is a locking clip 59 shown in
As shown in
According to one aspect of the present invention, as shown in
As shown in
As the second hypotube 58 is retracted according to
The locking assembly 10 shown not integrated with the sealing skirt 46,
In one aspect, the atrial sealing skirt 46 may be retrieved or repositioned. For example, if it is determined that the atrial sealing skirt is to be removed or repositioned, an atrial positioning rod 44 is positioned over each suture so that a portion of the suture is in the inner rod lumen 62. When the distal end 54 of the positioning rod is adjacent to or in contract with the detachable lock 56, advancing the first gateway hypotube 57 and the retracting hypotube 58 attaches the detachable lock to the distal end of the positioning rod, thereby unlocking the lock from the cord 21. With each cord unlocked, the valve may be removed from and/or repositioned in the deployment site 5.
In another aspect, the atrial sealing skirt 46 may be repositioned and/or removed days to weeks after valve deployment. In this aspect, the sutures are not cut, but wrapped around a spool or other wrapping device. This device is then attached to the valve on the atrial skirt top brim 47. Days after deployment of the valve and completion of the procedure, the spool/wrapping device may be re-captured, allowing un-wrapping and retrieval of the sutures. An atrial positioning rod 44 is then positioned over each suture so that a portion of the suture is in the inner rod lumen 62. When the distal end 54 of the positioning rod is adjacent to or in contract with the detachable lock 56, advancing the gateway hypotube 57 and the retracting hypotube 58 attaches the detachable lock to the distal end of the positioning rod, thereby unlocking the lock from the cord 21. With each cord unlocked, the valve is removed from and/or repositioned in the deployment site 5.
The tether locking assembly 10 is utilized after an atrial sealing skirt 46 (as shown) is implanted utilizing a transcatheter approach by placing a right or left ventricular anchor 75 and securing a tether 21 to the anchor 75. Once the valve is positioned at the implantation site, the tether 21, threaded and extending through the aperture 121 of the at least one conduit 53, is employed to secure the position of the valve. As shown in
According to one aspect, the tether is pre-assembled with the valve 100 or the conduit 53 when it is not integrated with the valve, such that each tether 21 is threaded through the conduit. As such, the atrial sealing skirt 46 is moveable along the length of the at least one tether 21 until the desired deployment site 5 has been reached. That is, the atrial sealing skirt is free floating on the tether 21 until locked in placed by the detachable lock assembly 10.
When the atrial sealing skirt 46 is in the desired deployment site 5, the atrial positioning rod 44 is then be inserted over each tether 21 such that a portion of each tether 21 extends within inner rod lumen 62 and a portion extends beyond the proximal end 61 of the positioning rod 44. With reference to
The atrial sealing skirt 46 position does not require pulling a tether 21 through the ventricular apex heart 2, because the atrial sealing skirt 46 moves freely over the tether 18 until the desired skirt 46 position is achieved. After the desired valve position is achieved, the at least one atrial positioning rod 44 urges the atrial sealing skirt 46 into position and is locked into place via the detachable lock assembly 10 within the conduit 53 and connected to the end of each positioning rod 44. The atrial sealing skirt 46 may be repositioned or retrieved until release of the tethers (or sutures extending therefrom) that extend through each atrial positioning rod 44
As shown in
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.
The application claims priority to U.S. Provisional Patent Application No. 63/056,123 filed Jul. 24, 2020, the disclosure of which is hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63056123 | Jul 2020 | US |
