US20210000595A1 - Transcatheter valve devices and systems - Google Patents

Abstract

A medical assembly for endovascularly implanting a valve in the heart having a valve and a valve delivery systems for implanting and securing the valve. The valve delivery system introduces and seals the valve at the deployment site.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• The application is divisional of U.S. patent application Ser. No. 15/943,792 (filed Apr. 3, 2018) which claims priority to Provisional Patent Application 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.
FIELD OF THE INVENTION
• The present invention relates generally to a medical assembly for minimally invasively implanting a valve in the heart, a novel valve for replacing the native heart valve, and an anchor system for positioning and restraining the valve. The present invention also relates to methods of implantation of components of the medical assembly and the valve. More specifically, the invention pertains to a novel transcatheter valve, transcatheter valve skirt, tether and anchor, anchor delivery system, and a valve delivery device as well as methods related to such assembly for endovascularly implanting the valve across the tricuspid valve, for replacing the function of the native tricuspid valve.
BACKGROUND OF THE INVENTION
• Transcatheter valves have proven safe and effective for the replacement of native cardiac valves. Although tested extensively for replacement of aortic, mitral, and pulmonic valves, less experience exists for replacement of tricuspid valves given the complex and delicate anatomy to which prostheses must anchor. Also, anchoring either in the in-situ position of cardiac valves or in other body lumens remains challenging given great heterogeneity in shapes and sizes of either cardiac valve annuli or other lumens. In this regard, treatment of tricuspid valve regurgitation remains the most challenging, and fewer transcatheter treatments have been developed.
• Tricuspid valve disease, primarily tricuspid regurgitation (TR), results from either a primary degeneration of the valve (e.g. endocarditis, rheumatic disease, carcinoid, congenital disease, drugs, perforation from intracardiac leads, or other causes), or more commonly from tricuspid annular dilation, secondary to either right atrial and/or right ventricular dilation. TR causes right atrial volume overload, which congests the superior vena cava (SVC) and inferior vena cava (IVC). Congestion of SVC causes plethora of the upper body, and congestion of the IVC causes hepatic/renal congestion, leading to signs and symptoms of congestive heart failure, namely peripheral edema, ascites, dyspnea on exertion and other symptoms. Additionally, persistent right heart volume overload from TR leads to progressive right ventricular dilation and failure, increasing mortality. Because patients suffering TR typically have high surgical risk, developing minimally invasive transcatheter methods to treat TR can be important.
• In 2005, Boudjemline et al developed a novel stent valve, and placed it in the tricuspid annulus of eight sheep. In one animal the valve was trapped in tricuspid cordae, and in another animal the valve had significant paravalvular regurgitation, raising concerns about this approach. No further development of the valve occurred. In 2008, Bai et al. tested a similar type of stent valve, implanting it into the tricuspid annulus of ten sheep. Two animals died during the procedure; despite sustained function of the valve in surviving sheep up to six months, no further development of this valve has continued.
• Because of these challenges of anchoring a valve in the tricuspid annulus, Lauten et al in 2010 designed and implanted stent valves in the IVC and SVC of a sheep model of severe TR, thereby minimizing the transmission of tricuspid regurgitant volume through the vena cava to organs. They demonstrated decreased pressure in the IVC and increased cardiac output.
• Lauten and Laule in 2011 and 2013, respectively, implanted similar custom-made self-expanding stents in the vena cava of patients suffering from severe TR, and both patients had sustained reductions in vena caval pressures and clinical improvement at 12 months.
• U.S. Pat. No. 7,530,995 describes a device, analogous to above method, that reduces pressure effects of TR by placing a stented tissue valve in the SVC, secured via at least one elongate connecting member, to a second stented tissue valve in the IVC. U.S. Pat. Pub. No. US 2012/0136430 A1 details a similar device, consisting of two caval stents, connected by a bridge, with two conical valves movable along the bridge to adjust the distance between the valves.
• Laule et al. further simplified the implantation of valves in the vena cava by using a commercially available transcatheter valve, the Sapien XT (Edwards LifeSciences, Irvine, Calif.), in the cava of three patients, using self-expanding stents as landing zones.
• The methods detailed in sections [0006-0009] suffer several limitations. Lauten's and Laule's techniques, along with the devices described in [0008] require customization to each patient, leading to biological valves with a broad range in size. Inherently, such as broad range in size results in uncertain durability and function, and limits widespread application given need for individual customization. Laule's technique of using a commercially available transcatheter valve, the Sapien valve (with its known performance and durability in thousands of patients), partially solves this, but is limited by seating difficulties and paravalvular regurgitation that would result from implantation in SVCs or IVCs bigger than the largest Sapien valve-29 mm, which occurs commonly in patients with TR. Similarly, other currently available valves cannot work in SVC/IVC diameters bigger than 30-31 mm.
• To solve this, Lauten and colleagues have developed an SVC and IVC self-expanding prosthesis, the Tric Valve (Vertriebs GmbH, Germany), which solves some of the sizing and customization problems outlined in section [0007].
• Nonetheless, the caval valve solutions outlined in [0006-0009 and 0011] suffer this same limitation; specifically, IVC and/or SVC stent valves do not completely restore the function of the tricuspid valve because they are not placed in the anatomically correct position—across the tricuspid annulus. Hence, they palliate symptoms but do not fundamentally address right ventricle (RV) volume overload caused by TR. To address volume overload, intra-annular anchoring of a valve across the native tricuspid valve is required; the above techniques are not suitable for intra-annular anchoring of transcatheter valves given the fragile and complex paraboloid annular anatomy of the tricuspid annulus, along with large and flared anchoring zones in the atria and ventricles connected to the annuli.
• Although investigators have developed docking systems to aid in intra-annular anchoring of transcatheter valves, these techniques are less likely to work for the tricuspid valve for several reasons. For example, Barbanti and colleagues have tested the Helio transcatheter aortic dock (Edwards LifeSciences, Irvine, Calif.), a self-expanding stent covered with expanded polytetrafluoroethylene (ePTFE), to serve as a platform across a severely regurgitant aortic valve to anchor a Sapien transcatheter aortic valve. Although effective in this location, this platform would not remain anchored in a tricuspid annulus; unlike the aortic annulus, the tricuspid annulus has a complex paraboloid shape, easy distensibility, and lack of calcium, which could preclude the Helio dock, a simple tubular structure, from remaining in place.
• Buchbinder and colleagues developed a docking system to anchor transcatheter aortic valves in the mitral position. They describe a docking system consisting of one or two self-expandable or balloon expandable rings, composed of rigid and semi-rigid materials, for intra-atrial and/or intra-ventricular stabilization, with bridging members that connect the rings and lock the transcatheter valve into place. The mitral valve annulus, flanked by thick fibrous trigones and in continuity with the thick left ventricular myocardium, has the external support to accommodate expandable rigid and semi-rigid materials.
• Conversely, approximately three-quarters of the tricuspid valve annulus has minimal external support and is connected to the thin-walled and distensible right atrium and right ventricle. Given the fragility of this annulus, any metal docking system, even while using a compliant metal such as Nitinol, has a higher risk of erosion around the tricuspid annulus than any other valvular annulus. Moreover, any rigid or semi-rigid anchoring device is likely to have malposition over time given that any tricuspid annulus can dilate over the course of weeks.
• To address tricuspid annular dilatation, several transcatheter approaches have been performed to reduce annular dimensions, allowing better tricuspid valve coaptation with reduction in TR. Investigators in the SCOUT I trial describe using the Mitralign system (Mitralign Inc., Tewksbury, Mass., USA) to place pledgeted sutures via a trans-jugular transvenous approach into the tricuspid annulus, thereby shrinking the annular dimensions. Similarly, the TriCinch device (4Tech, Galway, Ireland) reduces the annular dimensions by a screw in the annulus that is tensioned to a stent in the IVC. Mimicking a surgical ring, the Cardioband device (Valtech, Edwards LifeScience, Irving, Calif.) is a semi-complete annuloplasty ring that can be delivered and fixed to the tricuspid annulus minimally invasively. In the same way, the Millipede device (Boston Scientific, Marlborough, Mass.) mimics a complete surgical annuloplasty ring and can be delivered minimally invasively.
• Nonetheless, these approaches have limitations. The Mitralign system has a steep learning curve, often leaving residual moderate to severe TR, does not fix leaflet abnormalities, and is less effective in presence of intracardiac leads. Moreover, any further RV remodeling with leaflet tethering would cause recurrent TR despite annular reduction. The same limitations apply to the TriCinch device, which also has the downside of requiring a stent in the IVC. Although the Cardioband device provides more complete annular reduction, it also leaves moderate to severe TR, and is less effective in the presence of leaflet abnormalities or intracardiac leads. Finally, the Millipede device, with its complete ring, provides the greatest annular reduction, but once again does not address leaflet abnormalities or intracardiac leads.
• Other transcatheter approaches address TR by facilitating leaflet coaptation through direct device interaction with the leaflets. Parada-Campello and colleagues described their initial experience with the Forma Repair System (Edwards Lifesciences, Irvine, Calif.). This device consists of a foam-filled polymer balloon that is positioned over an RV anchor, allowing the tricuspid leaflets to coapt against the spacer, given the leaflets functional competency, thereby reducing TR. Another device, the MitraClip (Abbott Vascular, Abbott Park, Ill., USA), is used to plicate leaflets together.
• Both devices, however, suffer significant limitations. The Forma Repair system has a fixed size balloon, and any further annular dilatation and/or leaflet tethering after implantation leads to recurrent TR. Furthermore, initial human experience has demonstrated a high major adverse event rate, including anchor dislodgement, pericardial tamponade, and emergent cardiac surgery. Tricuspid clipping with the MitraClip system is technically demanding with uncertain reproducibility, and moderate to severe residual TR is common. Like annuloplasty techniques, the Forma Repair system and the MitraClip cannot treat TR effectively in the presence of significant leaflet abnormalities or pacemaker leads.
• In this regard, a transcatheter valve could solve the above problems, while minimizing risk of injury, if it could anchor without requiring leaflet or annulus fixation given the fragile tricuspid and right ventricular issue.
• U.S. Patent Pub. No. US 2013/0172978 A1 describes a valve placed in the mitral position with an atrial skirt, intra-annular valve, and ventricular tether; this system does not require the annular or leaflet fixation that other transcatheter valves without tethers require. This valve, however, requires trans-apical access to the ventricle, which would be a very high-risk approach to the right ventricle. Also, the tether is fixed to the end of the valve. Thus, valve position is adjusted by pulling the tether through the trans-apical incision and securing it with an epicardial anchor, necessitating thoracotomy and access to the apex.
• In contrast, the Lux valve (Ningbo Jenscare Biotechnology Co., LTD, Ningbo, China) is secured by a triangular paddle, fixed to the end of the valve, which anchors to the interventricular septum. Although the Lux valve showed stable anchoring in a goat, these animals had small, nonglobular hearts (average tricuspid annular size ˜2.5 cm, compared to ≥4 cm in humans). It is unclear how a fixed ventricular anchor will function in humans with severe TR, given the tremendous heterogeneity in basal/longitudinal remodeling of the right ventricle in these patients. Additionally, many TR patients suffer right ventricular dysfunction, and a fixed tether to the right ventricular myocardium could, via physical restraint or induction of scarring, further compromise right ventricular function.
• The NaviGate valve (NaviGate Cardiac Structures, Inc., Lake Forest, Calif.) does not require a tether because it anchors directly to the native tricuspid valve using leaflet and annulus fixation. Although initial human experience has not demonstrated right atrial or ventricular injury, its anchoring mechanism to the leaflets and annulus prevents it from being repositionable or retrievable during the procedure, which are important safety features. Furthermore, NaviGate's annular anchoring mechanism requires a large valve, necessitating a very large delivery system, which limits truly percutaneous delivery to select patients. The large size of NaviGate also precludes it from being used as a docking system for commercially available transcatheter valves in the event of its structural deterioration. Finally, given that it requires full expansion against the annulus, it is unlikely this valve can be implanted in the presence of prior tricuspid leaflet clipping with the MitraClip, and is it likely this valve would damage any pre-existing intracardiac leads going across the tricuspid valve.
• Accordingly, it remains desirable in the pertinent art to provide a transcatheter valve for placement across the tricuspid annulus that does not require annular anchoring, can be delivered without trans-apical access, is repositionable and retrievable, can function in the presence of any prior tricuspid repair, including tricuspid clips, can serve as a docking system for other transcatheter valves, and does not damage intracardiac leads.
SUMMARY
• Presented herein is a medical assembly that is implanted minimally invasively across the tricuspid valve, for replacing the function of the native tricuspid valve. The method disclosed herein implants the tricuspid valve through a vein or vein-like anatomical structure including, but not limited to, either internal jugular, either subclavian vein or either femoral vein. Accordingly, and beneficially, no portion of the system requires surgical thoracotomy and trans-apical access for implantation.
• In one aspect, the system comprises a transcatheter valve having an atrial sealing skirt configured to couple to and/or secure the valve to the atrial floor and at least one tether, with each tether attached to one anchor, configured to couple and/or secure the valve to an intracardiac wall, including but not limited to, the ventricular free wall, the ventricular apex, or the interventricular septum.
• The valve is a self-expanding valve composed of nitinol and bovine, equine, or porcine pericardial leaflets, according to one aspect. In another aspect, the atrial sealing skirt is covered with a membrane having a diameter greater than the annulus at the site of deployment so that in use the membrane substantially covers the tricuspid annulus.
• The medical assembly includes an anchor delivery system and a valve delivery system. The anchor delivery system introduces the anchor and attached tether, comprised of one or more cords, and secures the anchor. The valve delivery system provides for positioning of the valve and the sealing skirt thereon.
• The at least one tether comprises at least one cord, with each cord fused to a suture, and the tether is connected to one anchor, comprised of an anchor cap and anchor screw, which is configured to be screwed into or otherwise securely attached to a portion of an intracardiac wall, such as the ventricular apex or interventricular septum. In one aspect, an anchor cap is coupled to the anchor screw, and at least one cord of the tether can extend from the anchor cap through the tricuspid annulus. The valve and the sealing skirt are threaded onto the cord so that the valve and the sealing skirt slidingly engage the cord. In another aspect, a suture is coupled to a proximal end of the cord and can extend outside of the heart to be accessible by a user.
• The valve delivery system further comprises at least one atrial positioning rod having a distal end, an opposed proximal end and an inner rod lumen extending therebetween. A detachable lock is releasably coupled to the distal end of each positioning rod. A portion of the suture is inserted through the inner rod lumen and the positioning rod is advanced over the suture until the distal end of the rod is adjacent to the atrial sealing skirt. In one aspect, the positioning rod is used to position the skirt in a desired position. In another aspect, rotation of the positioning rod can cause the detachable lock to engage the cord to secure the cord to the sealing skirt in the desired position. Continued rotation of the positioning rod can detach the lock from the positioning rod and the rod is retracted from the heart.
• Thus, the at least one cord of the tether couples the valve, via the anchor, to an intracardiac wall such as the ventricular apex or interventricular septum while the at least one detachable lock in the locked position prevents the proximal end of the cord from moving relative to the sealing skirt thereby securely fixing the valve in place in the tricuspid annulus.
• Related methods of implantation are also provided. 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 assembly that is implanted minimally invasively in the heart, and be protected by the accompanying claims.
DESCRIPTION OF THE FIGURES
• FIG. 1 is a cut-away perspective view of a heart showing the transcatheter valve system of the present application positioned in the heart, according to one aspect;
• FIG. 2 is a side elevational view of a tether, with its cords fused to sutures, connected to an anchor of the transcatheter valve ofFIG. 1, according to one aspect;
• FIG. 3A is a side elevational view of an anchor delivery system of the transcatheter valve system ofFIG. 1, according to one aspect;
• FIG. 3B is a magnified side elevational view of the anchor delivery system ofFIG. 3A;
• FIG. 3C is an end view of the anchor delivery system ofFIG. 3A;
• FIG. 4A is a perspective view of the anchor delivery system ofFIG. 3, in which a portion of the device is positioned in the right ventricle;
• FIG. 4B is a perspective view of the anchor delivery system ofFIG. 3, in which the anchor delivery system is delivering a portion of the tether, connected to the anchor, ofFIG. 2 into the right ventricle;
• FIG. 5A is a perspective view of the anchor delivery system ofFIG. 3, in which the anchor delivery system is delivering a portion of the tether, connected to the anchor, ofFIG. 2 into the right ventricle;
• FIG. 5B is a perspective view of the tether, connected to the anchor, ofFIG. 2 positioned in the right ventricle;
• FIG. 6A is a perspective view of two tethers, each connected to an anchor ofFIG. 2 positioned in a heart, according to one aspect;
• FIG. 6B is a magnified view of the two tethers each connected to an anchor ofFIG. 6A;
• FIG. 7A is a perspective view of a valve delivery system of the transcatheter valve system ofFIG. 1 according to one aspect, in which a portion of the valve delivery system is positioned in the right ventricle;
• FIG. 7B is a perspective view of a valve of the transcatheter valve system ofFIG. 1 according to one aspect, in which the valve is being positioned in a tricuspid annulus by the valve delivery system ofFIG. 7A;
• FIG. 7C is an end view of the valve ofFIG. 7B;
• FIG. 8A is a perspective view of a valve of the transcatheter valve system ofFIG. 1, in which the valve is being positioned in the tricuspid annulus by the valve delivery system ofFIG. 7A;
• FIG. 8B is a perspective view of a valve of the transcatheter valve system ofFIG. 1, in which the valve has been positioned in the tricuspid annulus by the valve delivery system ofFIG. 7A;
• FIG. 9A is a perspective view of a valve of the transcatheter valve system ofFIG. 1, in which the valve is being locked into position in the tricuspid annulus by atrial locks;
• FIG. 9B is a perspective view of a valve of the transcatheter valve system ofFIG. 1, in which the valve is locked into position in the tricuspid annulus by atrial locks;
• FIG. 10A is an elevational view of an atrial lock of the transcatheter valve system ofFIG. 1, according to one aspect;
• FIG. 10B is a magnified elevational view of the atrial lock ofFIG. 10A;
• FIGS. 11A-11D are progressive, elevational views illustrating the operation of the atrial lock ofFIG. 10A;
• FIG. 12A is an elevational view of an atrial lock of the transcatheter valve system ofFIG. 1, according to one aspect;
• FIG. 12B is a magnified elevational view of the atrial lock ofFIG. 12A;
• FIG. 13A is an elevational view of the atrial lock ofFIG. 12;
• FIG. 13B is a cross-sectional view of the atrial lock ofFIG. 13A.
• FIGS. 14A-14D are progressive, elevational views illustrating the operation of the atrial lock ofFIG. 12;
• FIG. 14E is a perspective view of an atrial lock of the transcatheter valve system ofFIG. 1, according to one aspect;
• FIG. 15A is a perspective view of the transcatheter valve system ofFIG. 1 positioned in the heart and with sutures remaining;
• FIG. 15B is a perspective view of the transcatheter valve system ofFIG. 1 positioned in the heart with all delivery devices retracted;
• FIG. 16 is a perspective view of an epicardial tether system for positioning an anchor in the pericardial space, according to one aspect;
• FIG. 17 is a perspective view of the epicardial tether system ofFIG. 16, in which a portion of a catheter of the system has entered the pericardial space.
• FIG. 18 is a perspective view of the epicardial tether system ofFIG. 16, in which the pericardial space has been insufflated.
• FIG. 19 is a perspective view of the epicardial tether system ofFIG. 16, in which a J-wire has been inserted into the insufflated pericardial space.
• FIG. 20 is a perspective view of the epicardial tether system ofFIG. 16, in which an anchor delivery guide of the system approaches the insufflated pericardial space.
• FIG. 21 is a perspective view of the epicardial tether system ofFIG. 16, in which an anchor of the system is being positioned in the insufflated pericardial space.
• FIG. 22 is a perspective view of the epicardial tether system ofFIG. 16, in which an anchor of the system has been deployed in the insufflated pericardial space.
• FIG. 23 is a perspective view of the epicardial tether system ofFIG. 16, 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. 24 is a perspective view of an interventricular tether system for positioning an anchor in the left ventricle, according to one aspect;
• FIG. 25 is a perspective view of the interventricular tether system ofFIG. 24, in which an RF wire of the system has crossed the septum and entered the left ventricle;
• FIG. 26 is a perspective view of the interventricular tether system ofFIG. 24, in which a catheter of the system has crossed the septum and entered the left ventricle;
• FIG. 27 is a perspective view of the interventricular tether system ofFIG. 24, in which a J-wire of the system has been advanced through the catheter and into the left ventricle;
• FIG. 28 is a perspective view of the interventricular tether system ofFIG. 24, in which a delivery guide of the system approaches the left ventricle;
• FIG. 29 is a perspective view of the interventricular tether system ofFIG. 24, in which the delivery guide of the system has crossed the septum and entered the left ventricle;
• FIG. 30 is a perspective view of the interventricular tether system ofFIG. 24, in which an anchor of the system is being positioned in the left ventricle;
• FIG. 31 is a perspective view of the interventricular tether system ofFIG. 24, in which an anchor of the system has been deployed in the left ventricle; and
• FIG. 32 is a perspective view of the interventricular tether system ofFIG. 24, in which an anchor of the system has been deployed in the left ventricle and delivery devices of the system have been retracted.
DESCRIPTION OF THE INVENTION
• The present invention is 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 are 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 is 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 may 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 is 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.
• The disclosure herein relates to amedical assembly10 for implanting a valve minimally invasively in theheart1 and methods of implantation of portions of theassembly10 to achieve replacement of the native heart valve.FIG. 1 illustrates thetranscatheter valve12 which has been implanted so as to replace the native tricuspid valve (for example) according to the method disclosed herein and with themedical assembly10 disclosed herein. The assembly comprises atranscatheter valve12 having anatrial sealing skirt14 configured to couple to theatrial floor16, and at least onetether18 configured to connect the valve to at least one anchor19 (FIG. 2), which affixes to an intracardiac wall such as theventricular apex20 as shown. Thetether18 may be anchored byanchor19 to any intracardiac wall, including, but limited to, the interventricular septum, right ventricular apex, or right ventricular free wall. For the sake of discussion only, theventricular apex20 is shown but it is within the spirit and scope of the present invention to anchor thetether18 to any intracardiac wall. Themedical assembly10 includes an anchor delivery system50 (illustrated inFIGS. 3A and 3B) and a valve delivery assembly100 (illustrated inFIG. 7A). The method for implanting the transcatheter tricuspid valve as herein shown and described includes, generally, the method of steps of: utilizing theanchor delivery system50 to deliver the anchor and the tether to secure the anchor to an intracardiac wall such as the ventricular apex; removing theanchor delivery system50; utilizing thevalve delivery assembly100 to position the valve and skirt; locking the atrial skirt; and removing thevalve delivery assembly100, thereby leaving the valve in place of the native tricuspid valve.
The Valve
• Thetranscatheter valve12 is sized and configured to replace the tricuspid valve between theright atrium2 andright ventricle3 as illustrated inFIG. 1. Optionally, however, with slight variations, the valve is sized and configured to be positioned in the mitral annulus between theleft atrium4 and theleft ventricle5. Accordingly, then, while referring primarily to tricuspid valve replacement devices, systems and methods, it is understood that with slight variations, these devices, systems and methods may be used to replace other valves, such as the mitral valve, the aortic valve, the pulmonary valve and the like. For the sake of discussion, only, the following description and attended drawings pertain to a tricuspid valve. With respect to the delivery assemblies and methods, these may be used and practiced with any appropriate valve replacement device. The disclosure herein is not limited to the valve shown and described.
• As shown, thevalve12 is a self-expanding valve (that is, the valve is compressible so that it fits through a catheter of the assembly10). In one aspect, thevalve12 is composed of nitinol and bovine, equine, or porcinepericardial leaflets19, shown inFIG. 7C. In another aspect, thevalve12 has a valve diameter that is smaller than or approximately equal to the annulus at the site ofdeployment13, such as the tricuspid annulus, thereby preventing or reducing apposition to the fragile tricuspid annulus. Thevalve12 is operatively connected to at least onetether18 including at least onecord32 for securing thevalve12 within the heart as described below. At least one bore15 is defined in the outer wall17 of thevalve12, according to another aspect and as illustrated inFIG. 7C. Each bore15 is sized and shaped so that a portion of cord of the tether passes through thebore15. Thus, eachcord32 of thetether18 is coupled to the valve without interfering with anyleaflet19 of the valve. In a further aspect, (not shown) thevalve12 may have anchoring elements positioned along its outer diameter. These anchoring elements allow additional fixation to tricuspid leaflets, but are not necessarily used as a primary fixation mechanism. Referring again toFIG. 1, anatrial sealing skirt14 extends substantially circumferentially around the upper end of thetranscatheter valve12. Theskirt14 is covered with a membrane and has a diameter greater than the annulus at the site ofdeployment13. For example, the sealingskirt22 may have a skirt diameter greater than the diameter of the tricuspid annulus. In another aspect, the atrial skirt is formed by, but not limited to, synthetic materials from the classes consisting of polycarbonate, polyurethane, polyester, expanded polytetrafluoroethylene (ePTFE), polyethylene terephthalate (PET), silicone, natural or synthetic rubbers, or a combination thereof. The atrial skirt may also be covered with adult or juvenile bovine, ovine, equine, or porcine pericardium. Optionally, at least a portion of theatrial skirt14 is formed from alternative materials, such as, for example and without limitation, polyurethane foam or saline-inflatable ring with the ability for polymer exchange for solidification of the ring.
• In one aspect, theatrial sealing skirt14 further comprises at least oneatrial anchor238 such as member protruding through ananchor exit port242 allows stability in the atrium. Stability in the atrium thereby prevents retrograde migration of thevalve12, such as in the event of ventricular anchor dysfunction and the like.
• In another aspect, at least a portion of theatrial sealing skirt14 has one ormore fixation members24, illustrated inFIG. 15B, positioned along its inferior edge, allowing further anchoring to the rightatrial floor16 and/or other portions on the atrial side of the tricuspid annulus, preventing migration of thevalve12 into the proximalright atrium2, thereby preventing instability (e.g. rocking) and paravalvular regurgitation of prosthesis. Also, theatrial skirt14 conforms to the atrial floor topography, including the ability to cover and seal intracardiac leads, such as permanent pacemaker leads. The ability of theatrial skirt14 to seal over leads and prevent regurgitation around them distinguishes this transcatheter valve system from other transcatheter tricuspid repair systems.
The Tether and Anchor
• Referring now toFIG. 2, the at least onetether18 is operatively connected to thereplacement valve12 and connects thevalve12 to theanchor19. Thetether18 includes at least onecord32, and eachcord32 is connected to asuture34. Theanchor19 includes ananchor screw28 and ananchor cap30. In one aspect, the anchor screw is coupled to and extends from adistal end36 of the anchor cap, and the at least onecord32 of thetether18 is coupled to and extends from aproximal end38 of theanchor cap30. That is, theanchor cap30 is positioned between theanchor screw28 and thecord32. Theanchor screw28, ofanchor19, is configured to securely attach thetether18 to an intracardiac wall such as theventricular apex20 of theheart1. For example, theanchor screw28 is an active fixation screw comprising threads or a coil that is securely rotated into the ventricular apex. The anchor via the anchor screw is configured to securely attach the tether to an intracardiac wall such as theventricular apex20 of the heart without extending through the apex and outside of the heart. Thus, in this aspect, substantially no portion of theassembly10 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 screw28, 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 end36 of theanchor cap30 to securely attach thetether18 to theventricular apex20 of theheart1 without extending through the apex and outside of the heart.
• The at least onecord32 has adistal end40 coupled to a portion of theanchor cap30 and aproximal end42 coupled to thesuture34. 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 cord32 (between the distal end and the proximal end) extends through and/or is coupled to thevalve12 to hold the valve in the desired position relative to the tricuspid annulus.
The Anchor Delivery System
• Referring now toFIGS. 3A-3C, 4A and 4B, theanchor delivery system50 for positioning and deploying theanchor cap30 ofanchor19 at the desired position is illustrated. Thedelivery system50 comprises ananchor delivery guide52 and ananchor delivery rod54. In this aspect, theanchor delivery guide52 has adistal end56, an opposedproximal end58 and aninner guide lumen57 extending between the anchordelivery guide tip60 and the opposedproximal end58, and is configured so that at least a portion of theanchor delivery rod54 extends therethrough. In another aspect, at least a portion of theanchor delivery guide52 is flexible so that atip60 at the distal end of theanchor delivery guide52 is positioned at or adjacent to an intracardiacwall anchoring site62 such as theventricular apex20.
• Theanchor delivery rod54 is configured to securely attach theanchor screw28 to theanchoring site62. Theanchor delivery rod54 has adistal end64, an opposedproximal end66 and aninner rod lumen59 extending therebetween, theinner rod lumen59 is sized and configured so that at least a portion of the at least onetether18 is inserted therethrough. In another aspect, at least a portion of theanchor delivery rod54 is flexible so that arod tip68 at the distal end of theanchor delivery rod54 is positioned at or adjacent the intracardiacwall anchoring site62 such as theventricular apex20.
• As shown inFIG. 3B, a bore orsocket70 is defined in therod tip68 of theanchor delivery rod54. The socket is sized and configured to matingly engage theanchor cap30. That is, at least a portion of the anchor cap is positioned in thesocket70 so thatwalls72 of the socket engage the anchor cap. Thus, for example, when theanchor cap30 is positioned in and engages thesocket70, rotation of theanchor delivery rod54 rotates theanchor cap30. Accordingly, the socket engages theanchor cap30 and theanchor screw28 extends distally from theanchor delivery rod54 as illustrated inFIG. 3B. In a further aspect, when thesocket70 engages theanchor cap30, the at least onecord32 and at least a portion of the at least onesuture34 extends through the inner rod lumen of theanchor delivery rod54.
• Theanchor delivery system50 further comprises aguide handle74 with adeflection knob76 coupled to theanchor delivery guide52. The guide handle and the deflection knob are configured and used to help guide thetip60 of the anchor delivery guide to the intracardiacwall anchoring site62 such as theventricular apex20. As shown inFIG. 3A, theanchor delivery system50 includes arod handle78 coupled to theanchor delivery rod54. In use, described more fully below, rotation of the rod handle78 correspondingly rotates therod tip68 and theanchor cap30 when theanchor cap30 is received within thesocket70.
• Theanchor delivery system50 includes asheath80 removably coupled to theanchor delivery guide52. Thesheath80 is in fluid communication with theanchor delivery guide52 so that fluids, such as carbon dioxide and the like surround the anchor delivery guide through the sheath. Acentral sheath channel84 is defined by thesheath80 that is in communication with theanchor delivery guide52 so that theanchor delivery rod54 and other system components extends through thecentral sheath channel84.
• Theanchor delivery system50 optionally includes a J-wire82, as shown inFIGS. 7A, 7B, 8A and 8B that is guidable by the user to theanchoring site62. 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 viasheath80 into theright atrium3, across the site ofdeployment13, into theright ventricle3, to theanchoring site62. By providing a pathway for theanchor delivery guide52 to track over to its final target, a J-wire increases the efficiency and safety of this step.
The Anchor Delivery Method
• To install thevalve12 in the tricuspid annulus, as shown inFIG. 4A, the J-wire82, serving as a guidewire, is inserted into the right internal jugular vein, enters the right atrium and approaches theanchor implantation site62. Theanchor delivery system50 is guided by the user, along the length of the previously implanted J-wire82, to the intracardiacwall anchoring site62 such as theventricular apex20. The anchordelivery guide tip60 at thedistal end56 of theanchor delivery guide52 is positioned at or adjacent the anchoring site such as the ventricular apex. As shown inFIG. 3A the,anchor delivery rod54 and thetether18, connected to theanchor cap30 and anchor screw28 of theanchor19, are positioned within theinner guide lumen57 of theanchor delivery guide52. Theanchor cap30 is coupled to thedistal end64 of theanchor delivery rod54 with thecord32 of thetether18 positioned in thelumen59 of theanchor delivery rod54. Theanchor delivery rod54 is advanced distally through the inner guide lumen of theanchor delivery guide52 until theanchor cap30 coupled to the distal end of theanchor delivery rod54 is positioned at or adjacent the intracardiacwall anchoring site62 such as theventricular apex20.
• With theanchor screw28 of theanchor19, connected to tether18 viaanchor cap30, positioned adjacent to theanchoring site62, theproximal end66 of theanchor delivery rod54 is rotated to cause corresponding rotation of theanchor cap30 as illustrated inFIG. 4B. For example, therotating handle78 is rotated in a first direction to cause corresponding rotation of the anchor cap. The anchor screw coupled to theanchor cap30 also rotates and screws into a portion of the intracardiacwall anchoring site62 such as theventricular apex20 until thedistal end36 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 screw28 does not extend completely through any portion of the heart wall, and trans-apical access is not necessary. Upon placement of theanchor cap30 in the desired position, theanchor delivery rod54 and theanchor delivery guide52 of theanchor delivery system50 are retracted from theheart1 as illustrated inFIG. 5A. As such, inFIG. 5B, thecords32 oftether18, coupled to theanchor cap30, are secured by theanchor screw28 ofanchor19, and remain within the right ventricle and thevalve delivery system100 is employed.
• As shown inFIG. 5B, after placement of theanchor cap30 ofanchor19, the at least onecord32 of thetether18 extends from the anchor cap through the tricuspid annulus and into theright atrium2. Asuture34 is coupled to the proximal end of each cord and extends through the superior (or inferior) vena cava and out of theheart1.
• If more than onetether18, connected to ananchor19, is delivered, eachanchor19 is secured by itsanchor screw28, 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. 6A and 6B, theassembly10 utilizes two anchors and tethers, three anchors and tethers, four anchors and tethers, or more anchors and tethers are also contemplated.
• With theanchor screw28 secured to the ventricular apex and thetether18 in place, thevalve delivery assembly100 may now be utilized to introduce and position thevalve12.
The Valve Delivery System
• Referring now toFIGS. 7A and 7B, thevalve delivery assembly100 for positioning and deploying thevalve12 at the desireddeployment site13 is illustrated. As shown, thevalve delivery assembly100 comprises avalve delivery guide102, anosecone104, avalve deployment knob106 and at least oneatrial positioning rod108. In this aspect, the valve delivery guide has adistal end110, an opposedproximal end112 and aninner guide lumen114 extending therebetween, the inner guide lumen sized and configured so that thevalve12 and other system components is extended therethrough. In another aspect, at least a portion of thevalve delivery guide102 is flexible so that atip116 at the distal end of the valve delivery guide is positioned past thedeployment site13 and into theright ventricle3.
• Thevalve deployment knob106 is coupled to theproximal end112 of thevalve delivery guide102. Acentral channel118 is defined by thevalve deployment knob106 and is in fluid communication with theinner guide lumen114 so that theatrial positioning rod108, the J-wire82 and/or the at least onesuture34 extend through thecentral channel118 and into theinner guide lumen114. In another aspect, thevalve deployment knob106 is rotatable and configured such that rotation of theknob106 in a first direction causes thesheath102 around thevalve12 to be removed. Thenosecone104 may be a conventional nosecone coupled to thevalve delivery guide102 and configured to guide thevalve12 to thedeployment site13.
• With reference toFIGS. 8A and 8B, the at least oneatrial positioning rod108 has adistal end120, an opposedproximal end122 and aninner rod lumen124 extending there between, the inner rod lumen being sized and configured so that a portion of asuture34 and/or acord32 is inserted therethrough. In another aspect, at least a portion of theatrial positioning rod108 is flexible so that thedistal end120 of the atrial positioning rod is positioned at or adjacent to thedeployment site13.
The Atrial Skirt Lock
• The at least oneatrial positioning rod108 comprises adetachable lock126 positioned on or adjacent thedistal end120 of the rod, as illustrated inFIGS. 9-14. In one aspect, the detachable lock is configured to securely attach the at least onecord32 to a portion of theright atrium2. Thus, thedistal end40 of the cord is securely attached to theanchor cap30 in theright ventricle3, and thedetachable lock126 securely attaches thecord32 in the right atrium.
• FIGS. 10A, 10B and 11A-11D illustrate one embodiment of thedetachable lock126. In one aspect, the lock has afirst end128, an opposedsecond end130 and asidewall132 that cooperate to define acentral cavity134. In another aspect, the first end is threaded and configured to matingly engage complementary threads on thedistal end120 of theatrial positioning rod108. Anopening136 is defined in each of the first and second ends of thelock126 so that a portion of thecord32 extends through both openings and through the central cavity. In use, described more fully below, the detachable lock is selectively attached to the atrial positioning rod by rotating therod108 in a first direction, and thedetachable lock126 is selectively detached from the atrial positioning rod by rotating therod108 in a second direction that is opposed to the first direction.
• In one aspect, thedetachable lock126 further comprises aclamp138 movable about and between a first locked position, in which a portion of the clamp secures thecord32 in the desired position, and a second unlocked position, in which the clamp does not secure the cord in the desired position. A biasingmember140 such as a spring and the like is configured to urge theclamp138 to the first locked position. Atab135 or other protrusion extending away from thedistal end120 of theatrial positioning rod108 is configured to maintain the clamp in the second, unlocked position when the detachable lock is attached to therod108.
• FIGS. 12A-14D illustrate another embodiment of adetachable lock226. In one aspect, the lock has afirst end228, an opposedsecond end230 and asidewall232 that cooperate to define acentral cavity234. In another aspect, the first end is threaded and configured to matingly engage complementary threads on thedistal end120 of theatrial positioning rod108. Anopening236 is defined in each of the first and second ends of thelock226 so that a portion of thecord32 extends through both openings and through the central cavity. In use, described more fully below, the detachable lock is selectively attached to the atrial positioning rod by rotating therod108 in a first direction, and thedetachable lock226 is selectively detached from the atrial positioning rod by rotating therod108 in a second direction that is opposed to the first direction.
• In one aspect, thedetachable lock226 further comprises anatrial anchor238 movable about and between a first locked position, in which a portion of the atrial anchor secures thecord32 in the desired position, and a second unlocked position, in which the atrial anchor does not secure the cord in the desired position. A biasingmember240 such as a spring and the like is configured to urge theatrial anchor238 to the first locked position. Atab135 or other protrusion extending away from thedistal end120 of theatrial positioning rod108 is configured to maintain the atrial anchor in the second, unlocked position when the detachable lock is attached to therod108.
• In one aspect, ananchor exit port242 is defined in a portion of thesidewall232 of thedetachable lock226. In this aspect, the anchor exit port is sized and shaped so that, in the first locked position, ahook244 or other grasping element positioned on a tip of246 of the atrial anchor extends through theport242 and outside of thecentral cavity234. In use, in the first locked position, the hook securely anchors the detachable lock (and thus, the cord32) to a portion of theatrium2. With reference now toFIG. 15, theassembly10 further comprises asuture cutter148 sized and configured to pass over the at least onesuture34 through thevalve delivery sheath80 to cut the at least onesuture34.
• In use, theassembly10 implants thevalve12 with a transcatheter approach by placing a right ventricular anchor first. The valve position would not require pulling atether18 through an intracardiac wall such as theventricular apex20 of theheart1, because thevalve12 moves freely over the tether until the desired valve position is achieved. After the desired valve position is achieved, the at least oneatrial positioning rod108 urges theatrial sealing skirt14 into position and is locked into place via adetachable lock126,226 at the end of each positioning rod. The valve is repositioned or retrieved until release of thesutures34 that extend through eachatrial positioning rod108.
• FIG. 14E illustrates another embodiment of adetachable lock526. In one aspect, the lock has afirst end528, an opposedsecond end530 and asidewall532 that cooperate to define acentral cavity534. In another aspect, the first end is threaded and configured to matingly engage complementary threads on thedistal end120 of theatrial positioning rod108. Anopening536 is defined in each of the first and second ends of thelock526 so that a portion of thecord32 extends through both openings and through the central cavity. In use, described more fully below, the detachable lock is selectively attached to the atrial positioning rod by rotating therod108 in a first direction, and thedetachable lock526 is selectively detached from the atrial positioning rod by rotating therod108 in a second direction that is opposed to the first direction.
• In one aspect, thedetachable lock526 further comprises at least one atrial anchor538 movable about and between a first locked position, in which a portion of the atrial anchor secures thecord32 in the desired position, and a second unlocked position, in which the atrial anchor does not secure the cord in the desired position. Optionally, the atrial anchor comprises a first atrial anchor542 and a second atrial anchor544. In another aspect, the atrial anchor comprises a cam lever arm. A biasingmember540 such as a spring and the like is configured to urge the atrial anchor538 to the first locked position. In a further aspect, the biasing member is a compressible polymer. Atab135 or other protrusion extending away from thedistal end120 of theatrial positioning rod108 is configured to maintain the atrial anchor in the second, unlocked position when the detachable lock is attached to therod108.
• In one aspect, ananchor exit port546 is defined in a portion of thesidewall532 of thedetachable lock526. In this aspect, the anchor exit port is sized and shaped so that, in the first locked position, aportion548 of the atrial anchor538 extends through theport546 and outside of thecentral cavity534. In use, in the first locked position, the atrial anchor securely anchors the detachable lock (and thus, the cord32) to a portion of theatrium2.
• With reference now toFIG. 15, theassembly10 optionally further comprises asuture cutter148 sized and configured to pass through thevalve delivery sheath80 to cut the at least onesuture34.
The Valve Delivery and Positioning Method
• In use, theassembly10 implants thevalve12 with a transcatheter approach by placing a right ventricular anchor first. The valve position would not require pulling atether18 through an intracardiac wall such as theventricular apex20 of theheart1, because thevalve12 moves freely over the tether until the desired valve position is achieved. After the desired valve position is achieved, the at least oneatrial positioning rod108 urges theatrial sealing skirt14 into position and is locked into place via adetachable lock126,226 at the end of each positioning rod. The valve is repositioned or retrieved until release of thesutures34 that extend through eachatrial positioning rod108.
• Referring now toFIG. 7A, thevalve delivery assembly100 can then be inserted over the J-wire82 and into a portion of theheart1. Before thevalve delivery guide102 is inserted intosheath80 en route to the heart, thevalve12 is preloaded into thedistal end110 of thevalve delivery guide102. At least a portion of thesuture34 is threaded through the at least one bore15 defined in the outer wall17 of thevalve12, illustrated inFIGS. 7B and 7C, tracking into theinner guide lumen114 of thevalve delivery guide102. As thevalve12, insidedistal end110, and thevalve delivery guide102 move as a unit over J-wire82, a portion of the at least one cord can extend through and away from thedistal end110 of the valve delivery guide, and a portion of the at least one suture can extend through and away from theproximal end112 of thevalve delivery guide102. The valve delivery guide is positioned so that thetip116 at the distal end of thevalve delivery guide102 is passed through thedeployment site13 and into theright ventricle3.
• Thevalve12, which has been preloaded into thedistal end110 of thevalve delivery guide102, is positioned atdeployment site13. In one aspect, and prior to insertion into the valve delivery guide, eachsuture34 is threaded through the at least one bore15 defined in the outer wall17 of thevalve12, illustrated inFIGS. 7B and 7C. In another aspect, similar bores (not shown) is defined in theatrial sealing skirt14 so that each suture is threaded through the bore defined in the sealing skirt. As thevalve12 andvalve delivery guide102 are moved as a unit toward the deployment site, thevalve12 will reach the end of the suture and a portion of thecord32 will become threaded through thebore15 defined in the valve. In one aspect, thevalve12 andvalve delivery guide102 can slide up and down the at least one cord until the desireddeployment site13 has been reached. That is, the valve is free floating on thecord32 until locked in placed by thedetachable lock126,226.
• As is appreciated, with thevalve12 in the desireddeployment site13, thevalve deployment knob106 retracts thedistal end110 of thevalve delivery guide102 while thevalve12 remains fixed in position, thereby “unsheathing” thevalve12 so that the valve and/or theatrial sealing skirt14 will expand to its full, uncompressed size. Optionally, in one aspect, because the valve position is adjusted, thevalve deployment knob106 is used to retract thedistal end110 of thevalve delivery guide102, thereby “unsheathing” thevalve12 so that the valve and/or skirt will expand to its full, uncompressed size with the valve near the desired deployment site.
• Anatrial positioning rod108 is then be inserted over eachsuture34 such that a portion of each suture is in theinner rod lumen124 and a portion of each suture extends from theproximal end122 of the positioning rod. With reference toFIGS. 8A and 8B, thepositioning rod108 is inserted through thevalve delivery guide102 until a portion of thecord32 is in the inner rod lumen and thedistal end120 of the positioning rod (with thedetachable lock126,226 attached thereto) is adjacent to theatrial sealing skirt14. Thepositioning rods108 are pushed down by the user until the sealing skirt is in a desired position relative to the tricuspid annulus. With the sealingskirt14 and thevalve12 in a desired position at thedeployment site13, eachsuture34 is pulled taut by the user, which will in turn pull slack through theinner rod lumen124 until eachcord32 is taut. For example, the end of a suture that extends from theproximal end122 of the atrial positioning rod is pulled by a user to adjust tension in the corresponding cord. In one aspect, differential tension is applied to thecord32 by adjusting the force applied to thesuture34. For example, if the user pulls a first suture harder than asecond suture34, the tension in thecord32 corresponding to the first suture is higher than the tension in the cord coupled to thesecond suture34.
• Referring now toFIGS. 9A and 9B, eachatrial positioning rod108 is then rotated in a first direction to lock eachdetachable lock126,226 against theatrial sealing skirt14 and to thecord32. Thus, thevalve12 is locked by the detachable lock on the atrial side of the tricuspid annulus. Continued rotation in the first direction detaches thelock126,226 from the positioning rod. When the lock has been detached from thepositioning rod108, the rod is retracted from theheart1 through thevalve delivery guide102. With thepositioning rods108 retracted, thecord32 of the at least onetether18 couples the valve to the intracardiac anchor wall such as theventricular apex20. Thedetachable lock126,226 in the locked position prevents theproximal end42 of the cord from moving relative to the sealingskirt14, thereby securely fixing thevalve12 in place in thedeployment site13.
• As illustrated inFIGS. 15A and 15B, with thevalve12 securely fixed in thedeployment site13, thesuture cutter148 is advanced over thesutures34 and to thedetachable lock126,226. The suture cutter then cuts the distal end of each suture just above the detachable lock. The sutures and the suture cutter are then removed from theheart1.
• In one aspect, prior to cutting of thesutures34, thevalve12 is retrieved or repositioned. For example, if it is determined that the valve is to be removed or repositioned, anatrial positioning rod108 is positioned over each suture so that a portion of the suture is in theinner rod lumen124. When thedistal end120 of the positioning rod is adjacent to or in contract with thedetachable lock126,226, rotation of thepositioning rod108 in a second direction that is opposed to the first direction attaches the detachable lock to the distal end of the positioning rod. Continued rotation in the second direction unlocks the lock from thecord32. With each cord unlocked, the valve is removed from and/or repositioned in thedeployment site13.
• In another aspect, thevalve12 could 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 could then be attached to theatrial skirt14 of thevalve12. Days after deployment of the valve and completion of the procedure, the spool/wrapping device could be re-captured, allowing un-wrapping and retrieval of the sutures. Anatrial positioning rod108 could be positioned over each suture so that a portion of the suture is in theinner rod lumen124. When thedistal end120 of the positioning rod is adjacent to or in contract with thedetachable lock126,226, rotation of thepositioning rod108 in the second direction that is opposed to the first direction attaches the detachable lock to the distal end of the positioning rod. Continued rotation in the second direction unlocks the lock from thecord32. With each cord unlocked, the valve is removed from and/or repositioned in thedeployment site13.
The Epicardial Tether System
• In one embodiment, illustrated inFIGS. 16-23, theassembly10 comprises anepicardial tether system300 for positioning ananchor302 in thepericardial space304. In one aspect, the epicardial tether comprises acatheter306, a CO₂gas line308 and amanifold310. In another aspect, the catheter is a micro-catheter having adistal end312 configured to be screwed and/or otherwise urged through at least a portion of the wall of theheart1. For example, and as illustrated inFIG. 16, the distal end of the micro-catheter engages theendocardium314 of the heart. The micro-catheter306 also has aproximal end316 opposed to the distal end and aninner catheter lumen318. The proximal end of the micro-catheter is coupled to the CO₂gas line308 and the manifold310 so that the CO₂gas line and the manifold are in sealed fluid communication with the inner catheter lumen.
• Referring now toFIG. 17, thedistal end312 of the micro-catheter306 is urged through the heart wall until the distal end of the micro-catheter is positioned in thepericardial space304 by thepericardium320. In one aspect, acontrasting agent322 is injected from the manifold310 through theinner catheter lumen318 and into the pericardial space to verify that thedistal end312 of the micro-catheter306 is in thepericardial space304.
• Once thedistal end312 of the micro-catheter306 has been positioned in thepericardial space304, carbon dioxide is injected from the CO₂gas line308 through theinner catheter lumen318 and into thepericardial space304 to insufflate the space, illustrated inFIG. 18.
• In one aspect, the J-wire82 is then advanced through theinner catheter lumen318 and into thepericardial space304 as illustrated inFIG. 19. With the J-wire in place, thecatheter306 is removed from theheart1.
• In another aspect, illustrated inFIGS. 20 and 21, theanchor delivery guide52 is inserted over the J-wire82 until thetip60 at thedistal end56 of the anchor delivery guide is positioned at or adjacent ananchoring site324 in thepericardial space304. Theanchor delivery rod54 is inserted through the inner guide lumen of theanchor delivery guide52 until thedistal end64 of the anchor delivery rod is positioned in thepericardial space304.
• Theanchor302 of theepicardial tether system300 is coupled to thedistal end64 of theanchor delivery rod54. 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 guide52). As illustrated inFIGS. 21 and 22, when theanchor302 positioned on the distal end of the anchor delivery rod reaches thepericardial space304, the anchor expands to its full size, thereby locking theanchor302 in place. Aleft ventricle portion326 of the anchor extends through the endocardium and into the left ventricle.
• In one aspect, the at least onecord32 is coupled to theanchor302 prior to deployment in thepericardial space304. For example, the cord is coupled to the anchor such that the cord is positioned in the inner rod lumen of theanchor delivery rod54. Thus, when the anchor delivery rod is removed from the heart, as illustrated inFIG. 23, the cord extends from theanchor302 in the pericardial space through the tricuspid annulus and superior (or inferior) vena cava to outside of the heart. In this aspect, then, thevalve12,detachable locks126,226,suture34 and the like is coupled to thecord32 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. As is appreciated, the carbon dioxide in thepericardial space304 is resorbed and the pericardium returns to its normal position.
The Interventricular Tether System
• In another embodiment, illustrated inFIGS. 24-32, theassembly10 comprises aninterventricular tether system400 for positioning ananchor402 in theleft ventricle5. In one aspect, the interventricular tether system tether comprises acatheter406, a radiofrequency (“RF”)generator408 and aRF wire410 electrically coupled to the RF generator. In another aspect, the catheter is a wire delivery catheter having adistal end412 configured to be positioned adjacent to or near theseptum7 of theheart1. In use, RF generated by theRF generator408 urges adistal end414 of the RF wire to penetrate the septum, moving from theright ventricle3 into theleft ventricle5 as shown inFIGS. 24 and 25.
• Referring now toFIG. 26, thecatheter406 is then urged into theleft ventricle5. For example, if a portion of thedistal end412 of the catheter is threaded, rotation of thecatheter406 urges the distal end across theseptum7 and into the left ventricle. With a portion of the catheter in the left ventricle, the RF wire is retracted and the J-wire82 is inserted through thecatheter406 until a portion of the J-wire is in theleft ventricle5, illustrated inFIG. 27.
• In another aspect, illustrated inFIGS. 28 and 29, theanchor delivery guide52 is inserted over the J-wire82 until thetip60 at thedistal end56 of the anchor delivery guide is positioned at or adjacent ananchoring site416 in theleft ventricle5. Theanchor delivery rod54 is inserted through the inner guide lumen of theanchor delivery guide52 until thedistal end64 of the anchor delivery rod is positioned in the left ventricle, illustrated inFIG. 30.
• Theanchor402 of theinterventricular tether system400 is coupled to thedistal end64 of theanchor delivery rod54. 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 guide52). As illustrated inFIGS. 31 and 32, when theanchor402 positioned on the distal end of the anchor delivery rod reaches theleft ventricle5, the anchor exits the inner guide lumen of the anchor delivery guide and expand to its full size, thereby locking theanchor402 in place. As illustrated inFIG. 32, aright ventricle portion418 of the anchor extends through theseptum7 and into theright ventricle3.
• In one aspect, the at least onecord32 is coupled to theright ventricle portion418 of theanchor402 prior to deployment in theleft ventricle3. For example, the cord is coupled to the anchor such that the cord is positioned in the inner lumen of theanchor delivery rod54. Thus, when the anchor delivery rod is removed from theheart1, as illustrated inFIG. 32, the cord extends from the right ventricle portion of theanchor402 through the tricuspid annulus. In this aspect then, thevalve12,detachable locks126,226 and the like is coupled to thecord32 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, theinterventricular anchor402 is a screw, similar toanchor screw28, 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 rod54 via ananchor delivery guide52.
• 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 (12)

What is claimed is:

1. A medical assembly for minimally invasively implanting a valve in the heart at a valve deployment site comprising:

a valve configured for endovascular introduction and configured and sized to replace a native heart valve and defining at least one aperture;

a removable valve delivery system for positioning and sealing the valve comprising a valve delivery guide defining an inner guide lumen and having a proximal and distal end, said valve delivery guide lumen configured for receipt of said valve;

at least one cord extending through said valve aperture and extending within inner guide lumen; and

said valve delivery system comprises at least one positioning rod defining a central lumen for selectively receiving said cord wherein said positioning rod is positioned proximal to said valve, along said cord and cooperates with an upper surface of said valve to position said valve.

2. A medical assembly according toclaim 1 further comprising at least one suture extending from a proximal end of said at least one cord wherein said at least one cord and said at least one suture selectively extends within said positioning rod central lumen.

3. A medical assembly according toclaim 2 further comprises at least two of said at least one cord and at least two of said sutures extending from the proximal end of a respective one of said at least two cords, and said valve delivery system comprises at least two positioning rods for selectively receiving a respective one of said at least two cords and one of said at least two sutures.

4. A medical assembly according toclaim 1 further comprising a detachable valve lock to secure said cord in said valve aperture.

5. A medical assembly according toclaim 1 further comprising a tether assembly including at least one cord connected to said valve for operatively anchoring said valve to an intracardiac wall.

6. The medical assembly according toclaim 5 wherein said tether assembly further comprises at least one suture extending from a proximal end of said at least one cord and wherein said at least one of said suture and said at least one cord selectively extend through said inner guide lumen and cooperate with said valve, and said at least one suture extends beyond the inner guide lumen proximal end.

7. The medical assembly according toclaim 1 wherein said removable valve delivery system comprises a valve deployment knob defining a central channel in fluid communication with said inner guide lumen wherein said valve deployment knob is operatively connected to said valve delivery guide wherein rotation of said deployment knob selectively extends and retracts said valve delivery guide within said delivery knob.

8. The medical assembly according toclaim 1 wherein a distal portion of said valve delivery guide is flexible.

9. The medical assembly according toclaim 1 wherein said valve delivery system further comprises a nosecone positioned on a distal end of said valve delivery guide and configured to guide the valve through the valve delivery guide to the valve deployment site.

10. The medical assembly according toclaim 6 wherein said valve defines an aperture and said at least one suture, selectively, extends through said valve aperture and said valve delivery guide further comprises at least one positioning rod defining a central lumen for selectively receiving said at least one suture wherein said positioning rod is positioned proximal to said valve, along said at least one suture and said at least one cord and cooperates with an upper surface of said valve to position said valve.

11. The medical assembly according toclaim 1 wherein said removable valve delivery system comprises a valve deployment knob defining a central channel in fluid communication with said inner guide lumen and said positioning rod extends through said valve deployment knob central channel.

12. The medical assembly according toclaim 5 wherein said tether assembly comprising said at least one cord comprises at least two of said cords and said at least one suture comprises at least two of said at least one sutures, each extending from the proximal end of a respective one of said at least two cords, and said valve delivery system comprising said at least one positioning rod comprises two of said at least one positioning rods, each for selectively receiving a respective one of said at least two cords and one of said at least two sutures.

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