Transcatheter anchor support, systems and methods of implantation

A minimally invasively implanted anchor support for securing a medical device to a heart wall including an anchoring member and an expandable distal anchor retraint which is implanted through the anchoring member, through the heart wall, and expands on the opposing heart wall side to anchor a medical device. A single-stage anchor system includes the distal flange and a two-stage anchor system includes the distal flange and a proximal flange which cooperates with the distal flange to secure a medical device to the heart wall and methods of a single-stage anchor system and a two-stage anchor system.

FIELD OF INVENTION

The present invention relates generally to medical devices and systems for minimally invasively being implanted into the heart and methods of implantation of these devices and systems. More specifically, the invention pertains to medical devices and systems which are implanted minimally invasively into any wall of the heart, using one or more anchor supports.

SUMMARY OF INVENTION

Presented herein are medical devices and systems which are implanted minimally invasively into any wall of the heart, using one or more anchor supports. The valve anchoring system presented herein includes a single-stage anchor support or a two-stage anchor support, each consisting of a distal flange, and an anchor. The two-stage anchor support additionally includes a proximal flange. The anchor cooperates with an appropriate heart wall to implant the anchor support to the heart wall. The distal flange is introduced with a distal flange sheath through the anchoring member, such as the anchor coil, and through to the opposing side of the heart wall and expands within the cardiac space to secure the anchor support. Regarding the two-stage anchor support, a proximal flange delivery catheter delivers the proximal flange, to the proximal end of the distal flange and cooperates therewith to conform to the heart wall opposing the distal flange.

The anchor support including the anchor is configured to cooperate with an anchor support delivery cable, which can be used for delivery of a tether assembly; this system may connect to any type of intracardiac prosthesis including, but not limited to, a transcatheter valve replacement (complete of hemi-valve replacement), valve repair system (chordal replacement, coaptation element, leaflet augmentation device, or annuloplasty ring), myocardial remodeling device, or ventricular assist device, securely anchoring any of these devices to a respective intracardiac wall. In one aspect, the anchoring system is delivered completely endovascularly, using a support delivery system, without the need for chest or cardiac incisions.

With regard to the two-stage anchor support, the distance between the distal and proximal flanges is not fixed and is variable depending on the heart wall thickness or application. Additionally, the physical properties of the distal and proximal flanges may selectively differ. The flexible compression element of the proximal flange allows it to be positioned securely at a variable distance from the distal flange depending on the thickness of the intracardiac wall. Additionally, as the flex connector of the distal flange is pulled in tension by the tethering system, the flexible compression element pushes the proximal flange away from flex connector base towards the intracardiac tissue. This system of forces increases mechanical stability of the anchor support and replicates the effect of a cantilevered beam, enabling redirection of the tensile force as displaced from the intracardiac wall anchoring site.

The system including the anchor support comprises a trans-septal guide catheter, anchor delivery guide, and an anchor support delivery system. The anchor support delivery system comprises an anchor, anchor torque driver, microcatheter with screw tip dilator, support delivery control handle, and anchor support.

According to the single-stage anchor support, the anchor support is composed of a distal flange and according to the two-stage anchor support, the anchor support is composed of a distal and proximal flange. According to both aspects, the distal flange may take various geometric forms, including, but not limited to, a generally disc-like form or a three-dimensional form. The distal flange includes an anchor restraint (shown as a disk and other configurations), support rod, flex connector (in the form of a wire or flexible coil), and flex connector base. In the single-stage anchor support, the distal flange connects, via the support rod, to the flex connector, which connects to the flex connector cap, which serves as a docking element for the tether assembly. The two-stage anchor support incorporates all the elements of the distal flange, but also has a proximal flange, which is composed of an anchor restraint (for example, disk) flexible compression element, and docking element to secure the proximal portion of the flexible compression element to the flex connector of the distal flange, just under the flex connector cap The distal flange has a cap at its terminal end, and the cap may take the shape of a portion of a sphere or of any polyhedron. Each face of the disk comprises a variable thickness or diameter, and may be shaped like a circle, ellipse, any polygon. In either the one or two-stage anchor support, attached to the distal flange is a rod, which can be of variable thickness and length, taking the shape of a circular or elliptical cylinder, or taking the shape of a prism with any polygonal cross-sectional shape. The distal flange selectively includes additional metal or plastic fixation elements that lock the position of the anchor support relative to the anchor. The proximal end of the rod connects to the flex connector.

The flex connector is selectively composed of any metal alloy such as a flexible nitinol wire or a variably pitched nitinol spring with variable thickness and length has variable flexibility along its length. The flex connector optionally is also covered by any biological or synthetic membrane as described above. The flex connector base is composed of a preselected material including any metal alloy and be of any shape. Further, the proximal end of the tether cap may define an internal “female” thread, which can accept “male” threads of a distal end of an anchor support delivery cable, although other means of attaching the anchor support delivery cable to the flex connector base are not excluded. Finally, the flex connector base can serve as a docking member for a tether assembly to connect the tether swivel to an intracardiac prosthesis such as a valve replacement.

The proximal flange is distal to the flex connector base and extends around the flex connector and the connector rod of the distal flange. The proximal flange has a restraint, abutting the anchor base of the anchor and around the proximal portion of support rod and distal portion of the flex connector of the distal flange, has a restraint face that may be of variable thickness or diameter, and may be shaped like a circle, ellipse, or any polygon. Also, the proximal flange restraint may take the same or different shape and may bend in a concave or convex fashion towards the intracardiac wall. The proximal flange restraint has a central lumen of any shape or diameter such that the it can be advanced over the flex connector and support rod. Extending from this lumen on the proximal side of the proximal flange restraint is a flexible compression element, which may be a helical coil or conical coil of any thickness, radius, pitch, helix angle, or cone angle. Alternatively, the flexible compression element may take the shape of any spring with an alternative cross-sectional shape, such as a square, rectangle, or any polygon, or take the form of any compression element designed to handle an axial load. Attached to the proximal portion of the compression element is a docking element in the shape of a circular or elliptical cylinder or taking the shape of a prism with any polygonal cross-sectional shape. The docking element may have, anywhere along its length or radius, one or more extension members of any shape, and the element has a lumen of any diameter or shape that allows the element to go over the flex connecter base. Once the element has advanced over the flex connector base, either the shape of the element or extension members external or internal to the element's lumen prevent the element from moving proximal to the base of the flex connector base.

The anchor support or portions thereof may be formed of an appropriate material including any metal alloy, such as, but no limited to, nitinol, stainless steel, titanium, or cobalt chromium, and any portion of the anchor support is optionally covered with biological tissue, such as bovine, ovine, porcine, or equine pericardium, or synthetic membranes such as, but not limited to, polytetrafluoroethylene (PTFE) or polyethylene terephthalate (PET).

According to various aspects, the anchor comprises an anchor coil and an anchor base. The anchor coil may comprise any appropriate helical device, or the anchor coil may be an inclined plane wrapped around a nail-like head, or a type of Archimedes-type screw, and be “right-handed” or “left-handed”. The anchor coil is composed of any appropriate material including a metal alloy, such as, but not limited to, nitinol, stainless steel, titanium, or cobalt-chromium, and is optionally covered by any biological or synthetic membranes as is possible for anchor support described above. To facilitate penetration of the tissue, the tip of the anchor coil has, according to one aspect, a different diameter or cross-sectional shape as the rest of the coil; for example, the tip is, but is not limited to, the shape of a barb, hook, prong, or the like.

According to various aspects, the tether assembly consists of a tether swivel, composed of any metal or metallic alloy, and tethers, composed of, but without limitation, expanded polytetrafluoroethylene (ePTFE), ultra-high molecular-weight polyethylene (UHNWPE or UHNW), nitinol wire, or any known surgical suture. The tether swivel further consists of a tether ring, one or more locking arms, with or without one or more tether arms. The locking arms and tether arms have a variable length and thickness and are spaced equally or at variable distances along the circumference of the tether ring. The tether arms have distal coupling members, in the shape of eyelets, but without limitation in shape, that attach to tethers.

In one aspect, prior to docking of the tether system, the anchor torque driver remains attached to the anchor coil during fixation of the anchor coil to the cardiac wall. Fixation occurs by rotation of the anchor coil knob of the anchor support delivery control handle, thereby rotating the torque driver, which rotates the anchor coil via engagement with the anchor base. In another aspect, after fixation of the anchor coil to the wall, rotation of the microcatheter delivery knob of the anchor support delivery control handle rotates the microcatheter with screw tip dilator, driving the screw tip dilator and associated microcatheter across the interventricular septum (or another cardiac wall). Once microcatheter has traversed the septum (or other cardiac wall), the screw tip dilator is removed. In a further aspect, the distal flange of either the single or two-stage anchor support is pushed by the support delivery cable through the microcatheter until the anchor restraint exits the end of the microcatheter and is deployed. After deployment, the microcatheter is removed, allowing the anchor torque driver to be disengaged from the anchor base of the anchor coil, which remains fixed into the cardiac wall.

In another aspect, the anchor support delivery cable is used as a guidewire for delivery of the proximal flange. Over the guidewire, the proximal flange delivery sheath, attached to the docking element of the proximal flange, pushes the proximal flange to the end of anchor delivery guide. Once the proximal flange exits the distal end of the anchor delivery guide, the proximal flange restraint expands, and is pushed by the proximal flange delivery sheath (attached to disk via the flex coil and docking element) until the proximal flange restraint abuts the intracardiac wall near the anchor base. Continued pushing of the proximal flange advances the docking element and flexible compression element over the flex connector until the docking element goes past the flex connector base, at which point the element cannot be retracted past the flex connector base. The proximal flange delivery sheath is disengaged from the docking element, leaving the proximal flange and anchor support delivery cable in place.

In another aspect, the anchor support delivery cable is used as a guidewire for the docking of the tether assembly onto the flex connector base of the flex connector. After docking of the tether assembly and associated intracardiac device, the anchor support delivery cable is unscrewed or otherwise disengaged from the flex connector base, thereby fully deploying anchor support system.

In another aspect, before deployment of distal flange according to one aspect of the invention, the anchor is retrieved and redeployed if an alternative anchoring site is desired. Specifically, the anchor torque driver is rotated in opposite direction, thereby turning the anchor base and attached anchor coil so that the anchor coil disengages from the tissue. After anchor and anchor support delivery, the anchor support is capable of being retrieved and redeployed if it is interfering with intracardiac structures such as papillary muscles, chordal or valvular apparatus. Alternatively, the anchor support may be removed, leaving the anchor in position, and another anchor and support may be deployed at an alternative site.

Presented herein are anchor supports for supporting medical devices and systems which are implanted minimally invasively into any wall of the heart, such as a heart valve to replace a native heart valve. The anchoring devices includes an anchor support, with or without an anchor, and a tether assembly. According to one aspect, the distal end of the anchor support cooperates with an anchor and the proximal end of the anchor support cooperates with a tether assembly. According to another aspect, the distal end of the anchor support connects to a cardiac wall directly and connects to the tether assembly. The anchor support thus connects to a tether assembly that connects to the intracardiac device or implant, such as a transcatheter valves, and securely anchors the to a respective intracardiac wall. In one aspect, the anchor support is delivered completely endovascularly, using a support delivery system, followed by delivery of the tether assembly without the need for chest or cardiac incisions. In one aspect, the system comprises a trans-septal guide catheter, anchor delivery sheath, and an anchor support delivery system. The anchor support delivery system comprises an anchor, anchor torque driver, microcatheter with screw tip dilator, support delivery control handle, and anchor support. In another aspect, the system comprises a trans-septal guide catheter, anchor delivery sheath, and anchor support delivery system without an anchor. In this aspect, instead of being secured to the wall with an anchor, the anchor delivery sheath is secured to the cardiac wall by protrusions, spikes, barbs, claws, microneedles, or suction mechanisms. In another aspect, the anchor support delivery system comprises a microcatheter that functions without a screw tip dilator, but with an alternative dilator. In this aspect, the microcatheter is coupled with either a radiofrequency tip dilator, helical coil tip dilator, needle tip dilator, rotating tip drill dilator, oscillating tip dilator, or laser tip dilator.

Related methods of operation 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 devices and systems that are implanted minimally invasively in the heart and be protected by the accompanying claims.

DETAILED 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.

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.

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. 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 is 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.

As used herein, “distal” refers generally to the operative end of a member or facing the direction of implantation and “proximal” refers generally to the end of a member facing direction of introduction or facing the user performing the implantation. As used herein, a “restraint” in terms of the anchor restraint43of the distal flange41and the anchor restraint of the proximal flange210may be of various geometric configurations, planar or multi-dimensional, without departing from the scope of the application. Particularly with regard to the distal flange41, for the sake of discussion, a distal anchor restraint in the form of a disk is often shown and described.

The anchor support40, and medical systems and methods including the anchor support40, comprises either a single-stage anchor support45or a two-stage anchor support245. The anchor support40, either a single-stage45or two-stage245, includes a distal flange41which is implanted with a single-stage flange delivery step. The anchor support40having a two-stage anchor support245, also includes a proximal flange210and a second-stage delivery step for its implantation. The anchor support40thus includes at least a distal flange41and an anchor securing member20such as coil21extending distally from an anchor cap23. The distal flange41is implanted into the heart wall through the center lumen of the anchor coil21as explained below. Extending proximally from the distal flange41is a flex connector47which may be either a wire47or a coil48. With regards to the two-stage anchor support245, the flex connector47extends between the distal41and proximal210flanges and a flexible compression element204extends proximally from the proximal flange210and a docking element206/211is positioned on its proximal end. The proximal flange is introduced over the flexible connector47and the flex connector base49wherein the docking element206/211is pushed over the flex connector base49and the docking arms208/213spring inward to secure the proximal flange210. In all aspects, the system including the anchor support40is minimally invasively endovascularly implanted in the heart1. The distal flange41and proximal flange210possesses different configurations as represented in the various Figures and discussed below. The anchor support40may also be secured with means of a any distal flange shown inFIGS.60-80as explained below, with or without an anchor coil21.

Tethering systems110and locking systems300are provided for use with the anchor supports40. Additionally, methods and systems for endovascularly introducing and implanting anchors20and anchor support40to a cardiac wall using anchor delivery sheath130, anchor support delivery system140, and proximal flange delivery catheter220are described. The anchor support45or245is connected to a tethering system110and may be secured by locking system300, to anchor an intracardiac implant, such as a valve100in the heart. The intracardiac implant may be connected to another intracardiac implant with or without an extension member in between. This application also relates to use of this system for the implantation of other intracardiac implants, such as valve repair devices (e.g. chordal repair systems400, valve coaptation devices500, leaflet augmentation systems600, or annuloplasty rings), ventricular remodeling devices800, or other cardiac implants such as transcatheter ventricular assist devices700.FIGS.1A and1Billustrates the transcatheter valve100which has been implanted to the replace the native mitral valve (for example) according the medical assembly disclosed herein.FIGS.2A and2Billustrate the valve100implanted to replace the native tricuspid valve.FIG.3illustrates the transcatheter chordal system400implanted to provide chordal support to the native mitral valve.FIG.4illustrates the coaptation element500implanted to facilitate coaptation of the native tricuspid leaflets.FIG.5illustrates the hemi-valve or leaflet augmentation device600implanted to improve function of the native mitral valve.FIG.6illustrates the transcatheter left ventricular assist device700implanted to improve function of the left ventricle.FIG.7illustrates the transcatheter left ventricular remodeling system800. The heart, of course, includes the left atrium5, mitral valve6, left ventricle7, interventricular septum8, right ventricle9, tricuspid valve10, and right atrium11. The replacement valve100is positioned either to replace the mitral valve6or the tricuspid valve10, or other intracardiac implants are positioned as shown in the various Figures. As shown and described inFIGS.1A,1B,2A,2B, by way of example, the anchor support40is used to secure a transcatheter valve to a tethering system110and locking system300.

The Anchor

Referring now toFIG.8, the anchor support40includes an anchoring member, which as shown in numerous figures, is an anchor coil21and anchor cap23. The description which immediately follows refers to the an anchor coil21but it is to be appreciated that other anchoring members such as shown in other figures may replace the coil21without departing from the scope of the present invention. In one aspect, the anchor coil21is coupled to and extends from the distal end27of anchor cap23. The anchor cap23has coupling recesses24configured to attach to an anchor torque driver143. The anchor coil21of anchor20is configured to securely attach to an intracardiac wall such as the interventricular septum8of the heart1. The anchor coil21, as shown, is sized and configured as a helix to fix to an intracardiac wall and has an open central lumen. Optionally, however, the anchor coil21may be differentially sized (longer or shorter depending on patient-specific anatomy of the cardiac wall to which it attaches) and configured as an inclined plane, nail-like head, or as any other type of screw that would be known to those skilled in the art. In one aspect, the coil is composed of any known metal alloy, including, but not limited to, nitinol, titanium, or cobalt-chromium. In another aspect, the coil21may be covered in synthetic membranes such as polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE) or polyethylene terephthalate (PET). In another aspect, the coil21may be covered in biological tissue, such as bovine, ovine, porcine, or equine pericardium, or with any combination of anti-inflammatory drugs or other natural or synthetic compounds that might promote healing and limit inflammation. A tip(s)22of the anchor coil21optionally is constructed and/or coated with the same or different materials as the anchor screw21and may be fashioned as a blunt or sharp tip.

In use, the anchor20is secured to the cardiac wall by rotating anchor coil21until tip(s)22is at a desired depth in the cardiac wall. The depth to which anchor coil21is screwed in an adjustable manner according to not only the location within the heart but also the specific anatomy of a patient. For example, the anchor coil22may be implanted more deeply into the thicker portion of the interventricular septum, or more deeply into a patient with a thicker interventricular septum. By reversing the rotation of the anchor coil21, the anchor20is removed safely from the cardiac wall, either to be repositioned, or to be removed entirely.

Rotation of anchor coil21occurs when the anchor torque driver143, shown inFIGS.9-13B, rotates the anchor cap23via the coupling of the anchor cap to the anchor torque driver distal end146. The distal end146the anchor torque driver143comprises coupling arms147, which have coupling tabs148that connect to the anchor cap23via the coupling recesses24. The coupling tabs148remain outwardly expanded and attached to the coupling recesses24as long as the microcatheter161remains within this junction. Once the microcatheter161is retracted, the coupling tabs148may move inwards and away from the coupling recesses24, allowing the anchor torque driver143to disengage from the anchor cap23of the anchor20. The recesses24possesses any length, width, or polygonal shape to be complementary to coupling tabs148.

The Distal Flange of the Anchor Support

Referring toFIGS.14A-C, the distal flange41consists of a cap42, anchor restraint43, proximal portion44of anchor restraint43, rod46ending in flex connector47, attached to flex connector base49. The cap42may take the shape of a portion of a sphere or any polyhedron. The-anchor restraint43may be of any thickness or diameter, and may be circular, ellipsoid, polygonal, or be composed of one or more interconnecting polygonal shapes. In one aspect, the anchor restraint43or rod46are preferably composed of nitinol, but may composed of any known metal alloy, including, but not limited to titanium, or cobalt-chromium. In another aspect, the anchor restraint43or rod46can have additional fixation members (not shown) extending from any portion of surface to provide further engagement with tissue. Distal flange41includes a rod46attached to a flex connector47composed of a nitinol wire inFIGS.14A and14Band a flex connector48composed of a nitinol spring inFIG.14C.

Flex connector47/48may have variable diameter, length, coil pitch and be composed of additional metallic alloys or polymeric plastics. In another aspect, any portion of the distal flange41may be covered in synthetic membranes such as polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE) or polyethylene terephthalate (PET), or covered in biological tissue, tissue, such as bovine, ovine, porcine, or equine pericardium, or with any combination of anti-inflammatory drugs or other natural or synthetic compounds that might promote healing and limit inflammation.

Referring toFIG.15, the distal flange delivery cable60includes a flexible delivery wire62having a distal threaded end portion61positioned on or formed in the distal end of the delivery wire62. The delivery wire62is constructed of, but not limited to, stainless steel, nitinol or other metal alloys, with or without hydrophilic coatings, or with or without a polymer coating such as polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE) or polyethylene terephthalate (PET). The distal threaded end portion61is sized and configured to selective engage complementary threads formed in a cavity defined in the end50of the flex connector base49. In use, before distal flange delivery, the distal threaded end portion61has been screwed into the end50of the flex connector base49of the flex connector47of distal flange41, forming the distal flange delivery cable assembly which has been loaded in the distal flange support loader80(FIG.17) and the distal flange support holder/loaded flange90is used to introduce the anchor support into microcatheter161. As described more fully below, at the end of procedure after distal flange41delivery, with or without proximal flange docking, the distal threaded end portion61is unscrewed from the end50of the flex connector base49, thereby detaching the flexible delivery wire62of the distal flange delivery cable60from the distal flange41.

The Proximal Flange of the Anchor Support

Referring toFIGS.21A-B, the proximal flange210consists of disk201, lumen202, proximal connector203, and flexible compression element204. Proximal flange210has docking element206(FIG.21A) or211(FIG.21B).FIG.21Ashows a docking element206comprising distal end207, at least one docking arms208, and at least one external arm209.FIG.21Bdepicts a proximal flange210has docking element211comprised of distal end212, and docking arms213. The disk201may take the shape of like a circle, ellipse, or any polygon, be of variable thickness or diameter, and may take the same or different shape as the distal flange disk. Also, the disk and may bend in a concave or convex fashion towards the intracardiac wall, or take a frustoconical or any polyhedral shape towards the intracardiac wall. Connected to the proximal side of the disk201is the proximal connector, which may take the shape of a column, cylinder, or prism with any polygonal cross-section, and is connected to a flexible compression element204, which may be a helical coil or conical coil of any thickness, radius, pitch, helix angle, or cone angle. Alternatively, the flexible compression element may take the shape of any spring with an alternative cross-sectional shape, such as a square, rectangle, or any polygon, or take the form of any compression element designed to handle an axial load. Attached to the proximal portion of the compression element204in proximal flange210is a docking element206in the shape of a circular or elliptical cylinder, or taking the shape of a prism with any polygonal cross-sectional shape. Docking element206has one or more docking arms208of any shape, thickness, width, height, that bend towards the center at same or different angles, and may be found anywhere around the perimeter of the docking element. The docking element206has one or more external arms209, and an end207. Docking element211may have any of the shape properties of docking element206, without the external arms209, and has docking arms213. The lumen202starts at the end of disk201and continues through the proximal connector203, is in continuity with the internal channel of the flexible compression element204, which is continuity with the internal channels and ends207and212of docking elements206or211, respectively. Any of the components of proximal flange210are preferably composed of nitinol, but may composed of any known metal alloy, including, but not limited to titanium, or cobalt-chromium. In another aspect, any portion of the proximal flange210may be covered in synthetic membranes such as polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE) or polyethylene terephthalate (PET), or covered in biological tissue, tissue, such as bovine, ovine, porcine, or equine pericardium, or with any combination of anti-inflammatory drugs or other natural or synthetic compounds that might promote healing and limit inflammation.

The Proximal Portion of the Anchor Support and Tethering System

As shown inFIGS.16A-B, a tether swivel base112having at least one tether swivel locking arm113and at least one tether swivel chord arm114is provided. As shown, a distal end of the swivel locking arm113and tether swivel chord arm114are securely coupled to or formed monolithically with the tether swivel base112. A shown, the plurality of tether swivel locking arms113and tether swivel chord arms114are spaced equally around the circumference of the tether swivel base112, though it is contemplated that the locking arms113and chord arm114need not be spaced equally. An eyelet116is defined by the tether swivel chord arm114. The eyelet116is coupled to one or more chords117.

In one aspect, when tether assembly110is coupled to anchor support45and anchor21, the tether assembly110has freedom to rotate about a longitudinal axis of the anchor support45a full 360 degrees. Optionally, in another aspect, the tether assembly110may be constrained to lesser degrees of rotation by interaction of a portion of the tether assembly110with the flex connector base49.

As shown, in another aspect, coupling occurs when the tether assembly110is advanced over the flexible delivery wire62of the anchor support delivery cable60. As the tether swivel base112advances over the proximal end50of flex connector base49, the proximal end50pushes the tether swivel locking arms113outward, until the arms advance underneath the proximal end50, when they spring back into original position thereby locking the tether assembly110to the flex connector base49and therefore to the rest of the anchor support45and associated anchor support45. Any portion of the tether assembly may be composed of any metal or metal alloy, and the chords may be composed of any combination of nitinol wire, any surgical suture, expanded polytetrafluoroethylene (ePTFE) or ultra-high-molecular-weight polyethylene (UHMPWE or UHMW).

The Anchor Support Assemblies

As shown inFIG.28, after anchor support40delivery to the interventricular wall, distal flange delivery cable assembly is delivered through the anchor coil21. Once fully deployed, the anchor support disk43is past the tip of22of anchor coil21, with the anchor support rod46extending through the center of the anchor coil21and anchor cap23, and the flex connector47extending proximally from the anchor cap23, and remains connected to the distal flange delivery cable60via the attachment of the distal threaded end61to the end50of the flex connector base49. The anchor support delivery cable60serves as a guide wire for the proximal flange210. In anchor support245, as shown inFIGS.29-34, the proximal flange210has been advanced over the flex connector47of distal flange delivery cable assembly with the flex connector47extending through lumen202, through flexible compression element204, and through docking element211. The end212of docking element211is below end50of flex connector base49, and the locking arms213are flexed toward the segment of flex connector47just below the flex connector base49so that the docking element211prevents the proximal flange210from moving proximally relative to the flex connector47. Because the docking element211or206is fixed relative to the flex connector base49, the flexible compression element204, connected via the proximal connector203, urges the disk201forward. The disks of the distal and proximal flanges can be at variable distances depending on the thickness of the intracardiac wall between the flanges as illustrated inFIGS.31-34. After docking of the proximal flange, then anchor support delivery cable60serves as a guide wire for delivery of tethering system and locking system.

The Anchor Delivery Sheath

Referring now toFIG.35, the anchor delivery sheath130is illustrated. The sheath130has a shaft131, and a distal end132. In another aspect, at least a portion of the shaft131is flexible so that the distal end132is flexed and positioned at or adjacent to an intracardiac wall such as the interventricular septum8. Flexion occurs when the deflection knob134of the anchor delivery sheath handle133is rotated. The anchor support delivery system140is inserted into the lumen136, extending from the proximal portion of anchor delivery sheath handle133to the distal end132.

The Proximal Flange Delivery Catheter

Referring now toFIGS.23-24, shown is the proximal flange delivery catheter220with distal end221, lumen222, and shaft223. In one aspect, the distal end221reversibly mates with the proximal flange210because the docking element206or211is reversibly coupled inside the lumen222of the distal end221. In another aspect, at least a portion of the shaft223is flexible so that it can track the curve of the anchor support delivery system140and the anchor delivery sheath130.

The Anchor and Distal Flange Delivery System

Referring now toFIGS.35-38B, the anchor support delivery system140for delivering the anchor21and deploying the distal flange delivery cable assembly65across the interventricular septum is illustrated. The delivery system140comprises the anchor21, anchor torque driver143, microcatheter161and screw dilator162, access valve151, and anchor support delivery handle150. As illustrated inFIGS.9-10, the anchor torque driver143consists of a shaft144with inner lumen149, ending in distal end146, with one or more coupling arms147ending in coupling tabs148which mate with the coupling recesses24of anchor cap23of anchor20. In another aspect, the anchor driver143is coupled to the delivery handle150by entering the valve151. Rotation of the anchor driver is controlled by the anchor coil knob152at distal end of the delivery handle150.

As illustrated inFIG.13A, the microcatheter161has a distal shaft164integrated with a proximal control hub166. In another aspect, the microcatheter screw dilator162with tip163resides inside the microcatheter161, as illustrated inFIGS.13B and38B, the microcatheter screw dilator tip163, like the anchor coil, may be differentially sized (longer or shorter depending on patient-specific anatomy of the cardiac wall to which it attaches) and configured as an inclined plane, nail-like head, or as any other type of screw that would be known to those skilled in the art. Alternatively the dilator tip163may be a cone, sphere, cylinder, or any polyhedral shape for the purpose of penetrating tissue. In one aspect, the coil is composed of any known metal alloy, including, but not limited to, nitinol, titanium, or cobalt-chromium. The microcatheter may be of any diameter or length with lumen to accommodate the microcatheter dilator, and the microcatheter may be composed of any metallic alloy or polymeric plastic.

As illustrated inFIG.38B, the dilator tip163of microcatheter screw dilator162and associated microcatheter161reside within the anchor cap23of the anchor20, and the proximal portion of each extend through the lumen of the anchor torque driver143. Inside the anchor torque driver143, the microcatheter extends into the anchor support delivery handle150via the access valve151, and the proximal control hub166of the microcatheter161couples inside the microcatheter holder160within the ground153of the anchor support delivery handle150.

The Method of Implanting the Anchor

To install anchor20to interventricular septum8, as shown inFIG.39, access is obtained to the femoral vein (not shown) using standard techniques, and a trans-septal crossing system (not shown) is used to traverse the interatrial septum into the left atrium5. Over a wire in the left atrium5, the trans-septal sheath180is advanced into the left atrium5; the trans-septal sheath deflector knob181is rotated until the trans-septal sheath tip182is pointing to the mitral valve6. As shown inFIGS.40-41, a j-wire190is advanced over into the left ventricle7, and the anchor delivery sheath130is advanced over the wire into the left ventricle7, followed by removal of the j-wire190and the anchor delivery sheath dilator136Next, rotation of the deflector knob134bends the distal tip132of the anchor delivery sheath130toward the interventricular septum8.

As shown inFIGS.42A-B, the delivery system140is inserted into the anchor delivery sheath130, until the anchor coil21of the anchor20extends outside the distal tip132of the anchor delivery sheath130and abuts the interventricular septum8. As shown inFIGS.43A-B, rotation of the anchor coil knob152rotates the anchor driver143, which rotates the coupled anchor cap23, thereby driving the anchor coil21across the interventricular septum.

The Method of Advancing the Microcatheter

As illustrated byFIGS.44-46once the anchor20is secured in the septum, the microcatheter with screw dilator traverses the septum according to the following steps: 1) the dilator knob158is pushed forward until the magnets159of the head155of the threaded rod154secure the dilator knob158, so that the dilator tip163extends outside the end of the microcatheter 2) rotation of the microcatheter control knob156rotates the threaded rod154, which rotates the microcatheter holder160, thereby rotating the proximal control hub166of the microcatheter161. This rotation causes the microcatheter161and screw tip dilator162to rotate in unison, and both advance across tissue as the dilator tip163of the dilator162screws through the tissue 3) Once the microcatheter and screw tip dilator have traversed the tissue, the dilator knob158is pulled out, thereby pulling out screw tip dilator162, leaving microcatheter161across the tissue for anchor support delivery.

The Method of Implanting the Distal Flange

As shown inFIGS.47A-B, the distal flange41collapsed within the distal flange loader80is inserted into the proximal end of the anchor support delivery system140via the head155of the threaded rod154. As shown inFIGS.48A-B, the distal flange41is pushed inside the microcatheter161until the anchor restraint43exits the microcatheter and expands on the other side of the septum.FIGS.48C and48Dshow the same procedure with the flange41according to another aspect of the invention.

As shown inFIGS.49A-B, reverse rotation of the head155of the threaded rod154turns the microcatheter holder160(FIG.37), thereby turning the proximal control hub166of the microcatheter161(FIG.13A), so that the microcatheter161retracts back out of the junction of the anchor torque driver143and the anchor cap23of the anchor20. When this occurs, as shown inFIGS.50-51, the coupling tabs148of the coupling arms147of the anchor torque driver143are released from the coupling recesses24of the anchor cap23, thereby allowing the anchor torque driver143to be retracted from the anchor20as shown inFIG.52. After the anchor torque driver143is disengaged the anchor support delivery system140is removed, leaving the distal flange delivery cable60in place. The same procedure is shown inFIGS.53A and53Bin connection with the alternative distal flange41.

The Method of Implanting the Proximal Flange

As shown inFIGS.54A-D, representing a two-stage anchor support245having a proximal flange210, the proximal flange210, attached to the proximal flange delivery catheter220and collapsed within the proximal flange loader280having lumen28inFIG.26, is threaded over the delivery cable60and is inserted into the proximal end of anchor delivery guide130inFIGS.54C and54D. Proximal flange delivery catheter220pushes the proximal flange210into the anchor delivery guide130when the proximal flange loader280is removed. As shown inFIGS.55A-B, the proximal flange is pushed out of the anchor delivery guide130by the proximal flange delivery catheter220, allowing the disk201to advance over the flex connector47and rod46via lumen202of proximal flange210; once outside the tip of the anchor delivery guide130, the disk201expands. Continued pushing of the proximal flange delivery catheter220advances the disk201until it approaches the interventricular septum8(or other intracardiac wall) as shown inFIGS.56A-56B. Once the disk201contacts tissue, the proximal flange delivery catheter pushes the docking element211or206, compressing the flexible compression element204until the docking element211or206goes over the end50flex connector base49of the flex connector47. At this point the docking arms208or213bend inwards towards the flex connector base49, locking the docking element below the end50of the flex connector base49, preventing the docking element and associated proximal flange from moving proximally and the proximal flange is secured in its position. As tension is applied to the flex connector backwards via the tethering/locking systems associated with an intracardiac device, the flexible compression element, expanding against the secured docking element, urges the disk201forwards, providing a cantilever force to the anchor and distal flange.

The Method of Implanting the Tether System

As shown inFIG.53C-D, the tether delivery system170is advanced over delivery cable60into trans-septal sheath180, until the tether delivery system170exits the distal tip182. As shown inFIGS.53E-F, the single stage anchor support45is shown. It is to be understood that this is by way of example and the same tether delivery system170may be employed with the two-stage anchor support245. Tracking over the delivery cable60, the distal end172of the tether delivery system170docks onto the flex connector base49of the flex connector47or48. After coupling of the tether assembly110to the flex connector base49occurs, the distal end172of the tether delivery system170may be retracted, leaving the tether assembly110connected to the anchor/anchor support assembly, as shown inFIG.53E-F. The tether assembly110may be pre-connected to a transcatheter valve100or other intracardiac device, and the delivery cable60may be detached from the end50of the flex connector base49, leaving behind, for example, a transcatheter valve connected via the tether assembly to the anchor/anchor support assembly.

The Tapered Anchor

Referring now toFIG.59, at least one tapered anchor900includes a penetrating coil902, stacked coil903, funneled coil904, and docking coil906. In one aspect, the penetrating coil902is continuous with the stacked coil903, which is continuous with the funneled coil904, which is continuous with the docking coil206. The docking coil906with distal end907is configured to reversibly attach to the anchor torque driver143. The penetrating coil902of anchor900is configured to securely attach to an intracardiac wall such as the interventricular septum8of the heart1. The tapered anchor900, as shown, is sized and configured as a helix to fix to an intracardiac wall. Optionally, each section of tapered anchor900may be differentially sized by radius, length, or pitch of coil (e.g. wider/narrower radius and/or longer or shorter and/or coil density depending on patient-specific anatomy of the cardiac wall to which it attaches). In one aspect, any section of the tapered anchor900is composed of any known metal alloy, including, but not limited to, nitinol, titanium, or cobalt-chromium. In another aspect, any section of the tapered anchor200may be covered in synthetic membranes such as polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE) or polyethylene terephthalate (PET). In another aspect, any section of the tapered anchor200may be covered in biological tissue, such as bovine, ovine, porcine, or equine pericardium, or with any combination of anti-inflammatory drugs or other natural or synthetic compounds that might promote healing and limit inflammation. A tip(s)901at the end of the penetrating coil902of the tapered anchor200optionally is constructed and/or coated with the same or different materials as the rest of the tapered anchor200and may be fashioned as a blunt or sharp tip.

In use, the tapered anchor900is secured to the cardiac wall by rotating tapered anchor900until tip(s)901is at a desired depth in the cardiac wall. The depth to which the tapered anchor900is screwed in an adjustable manner according to not only the location within the heart but also the specific anatomy of a patient. For example, the tapered anchor900may be implanted more deeply into the thicker portion of the interventricular septum, or more deeply into a patient with a thicker interventricular septum. In another aspect, the stacked coil903of the tapered anchor900has a smaller coil angle, creating a denser coil that prevents the tapered anchor900from advancing further once the stacked coil903has contacted the cardiac wall. By reversing the rotation of the tapered anchor900, it is removed safely from the cardiac wall, either to be repositioned, or to be removed entirely.

Rotation of the tapered anchor900occurs when the anchor torque driver143rotates the docking coil906, which has coupled to the anchor torque driver distal end146(coupling mechanism not shown). The anchor torque driver distal end146remains coupled to the docking coil906, while the microcatheter161is advanced and the anchor support40is implanted. After anchor support40has been implanted, similar to anchor/anchor support assembly illustrated in46A-B, the anchor restraint43abuts the end of the penetrating coil202of the tapered anchor900, with the funneled coil904extending over the proximal portion44of the anchor restraint43and over the rod46of anchor support45. In another aspect, the docking coil906is configured to couple around the flex connector47or48of anchor support45, respectively. The flex connector base49abuts the end207of the docking coil906of the tapered coil900, ready to accept the tether110as described above.

FIGS.60-120generally illustrate alternative configurations of the distal flange anchor restraint and alternative anchoring members other than a coil as shown in the preceding figures. It is to be understood that the distal flanges depicted therein may be employed with a single-stage anchor support or a two-stage anchor support having a proximal flange. The proximal flange anchor restraint may also assume any configurations shown with regard to the distal flange anchor restraint.

The Anchor Support with Inflatable Elements

Referring toFIGS.60-61, the anchor support40may include the anchor support shown inFIG.60or anchor support301shown inFIG.61. Anchor support, both consist of a distal inflatable element302, proximal portion303of inflatable element302, rod304ending in flex connector306, attached to flex connector base307. The distal inflatable element302may take any shape, including a any portion of a (or complete) sphere, cylinder, polyhedron, or torus. The distal inflatable element302may contain one or more metallic components, including, but not limited to, nitinol, stainless steel, titanium, or cobalt-chromium, stainless steel, and any portion of the one or more inflatable elements is composed of biological tissue, such as bovine, ovine, porcine, or equine pericardium, or synthetic membranes such as, but not limited to, polytetrafluoroethylene (PTFE) or polyethylene terephthalate (PET). In practice the distal inflatable element302is in a collapsed form with low profile until anchor support is in position, at which time any gaseous or liquid element is infused via the distal end308of flex connector base307such that the gaseous or liquid element goes through a channel (not illustrated) in inner lumen311, until it exits proximal portion303, thereby inflating distal element302until desired shape and size is obtained. In another aspect, proximal portion303and rod304are preferably composed of nitinol, but may composed of any known metal alloy, including, but not limited to titanium, or cobalt-chromium. In another aspect, the distal inflatable element302or rod304have additional fixation members (not shown) extending from any portion of surface to provide further engagement with tissue. Flex connector306is a nitinol wire like flex connector47or maybe a nitinol spring like flex connector48. As either a nitinol wire or nitinol spring, flex connector306is of variable diameter, length, coil pitch and be composed of additional metallic alloys or polymeric plastics.FIG.61illustrates anchor support with all the characteristics of anchor support, but with a proximal inflatable element309, that may take any shape and contain any material that distal inflatable element302takes, but the shape and/or material of proximal inflatable element309may differ from distal inflatable element302. Like distal inflatable element302, proximal inflatable element309begins as a deflated low-profile element and is inflated, at the same or at a different time, via infusion of a gaseous or liquid element via the distal end308of flex connector base307through a channel (not illustrated) in lumen311. According to another aspect, the gaseous or liquid element infused into either inflatable element is exchanged for any type of polymeric resin. Like distal inflatable element302, proximal inflatable element309can have additional fixation members (not shown) extending from any portion of surface to provide further engagement with tissue. In another aspect, any portion of the anchor support is covered in synthetic membranes such as polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE) or polyethylene terephthalate (PET), or covered in biological tissue, tissue, such as bovine, ovine, porcine, or equine pericardium, or with any combination of anti-inflammatory drugs or other natural or synthetic compounds that might promote healing and limit inflammation.

The Anchor Support with Radially Extending Elements

Referring toFIGS.62-63, the anchor support40may include anchor support320which may convert from its undeployed form321to its deployed form322. Anchor support320has a distal securing element323in a collapsed form shown inFIG.52or in an expanded form shown inFIG.53. Distal securing element323is composed of one or more extension elements324generally bending backwards (concave). These extension elements324are connected via element base325, which connects to the proximal section326of anchor support320. The extension elements324are preferentially composed of nitinol metal, but any portion of them is composed of any metallic or plastic alloy and is covered anywhere along their length with biological or synthetic membranes. The extension elements324is spaced evenly or variably around the long axis of element base325. The extension elements324is the same or different in diameter and length, and the cross section of each is the cross section of any polygon, circle, or ellipse, and each extension element may generally bend backwards (concave) in the shape of a circle, ellipse, parabola, any sinusoidal curve, or is shaped as the edge of any polygon; it is also understood that one of more extension elements324of distal securing element323may bend forwards (convex). The tip of each element is the same as each element, or is, but is not limited to, the shape of a barb, hook, prong, or the like. The components of proximal section326have the same structure and function as components303,304,306-308, inFIGS.60-61except proximal section326does not have an inner lumen and does not serve to inflate any element.

Referring toFIGS.64-65, the anchor support40includes anchor support327which converts from its undeployed form328to its deployed form329. Anchor support327has distal securing element331in its undeployed form inFIG.64, or in its deployed form inFIG.65, with extension elements. These extension elements connect via element base333to proximal section334. Like extension elements324, extension elements332may have variability in location along the long axis of333, may have any variability in material or shape properties. Also, although these extension elements332are general bending forwards (convex), one or more of these elements may bend forwards (convex). Proximal section334has the same characteristics as proximal section326.

The Anchor Support with Helical Coil

Referring toFIGS.66-67, the anchor support40includes anchor support340, which converts from its undeployed form341to its deployed form342. Anchor support340has support coil343, shown in its undeployed form inFIG.66, and in its deployed form inFIG.67. Support coil343is formed by wire344, whose proximal end347, is fixed to the distal end349of proximal element348, and wire344is preferentially constructed of nitinol although either one may have any metallic alloy or plastic element, and any portion of either support coil is covered by either synthetic or biological membranes. Support coil343, along its length, is differentially sized by radius, length, or pitch of coil (e.g. wider/narrower radius and/or longer or shorter and/or coil density depending on patient-specific anatomy of the cardiac wall to which it attaches). The tip346of support coil343is the same as rest of the coil, or is, but is not limited to, the shape of a barb, hook, prong, or even a straight rod; for purpose of example,FIGS.68-69illustrate an anchor coil which ends in a trowel element351, composed of a trowel bar352and trowel head353. Finally, proximal element348has the same material and shape properties as proximal section326inFIG.63.

The Anchor Support with Helical Coil in Conical Shape

Referring toFIGS.70-71, anchor support45includes anchor support355and converts from its undeployed form356to its deployed form357. Anchor support355has anchor coil358, shown in its undeployed form inFIG.70, and shown in its deployed form inFIG.71. Except for the shape of the anchor coil358, anchor support355has all the subcomponents, and material/shape possibilities as anchor support340.

The Anchor Support with Helical Coil in Two-Stage Process

Referring toFIGS.72A-C, anchor support45many include anchor support360, where the anchor coil361, is similar to anchor support340inFIGS.66-67, but is not directly attached to the tip367of proximal section366. Instead anchor coil361is in an elongated form as shown inFIG.72A, and the proximal end363of anchor coil361is attached to delivery cable364. Once proximal section366is in position, delivery cable364is pushed so that anchor coil361moves from the proximal tip368of proximal section366, through channel369, until the distal tip362of anchor coil361, exits the distal tip367of proximal section366. As the distal tip362of anchor coil exits361, as shown inFIG.62B, the anchor coil takes its preformed shape; as it exits fully, anchor coil361forms its fully preformed shape as shown inFIG.72C. At this point, delivery cable364is disengaged from the proximal end363of anchor coil361. Otherwise, the material and shape properties of anchor support360mirror those of anchor support340inFIGS.66-67.

The Anchor Support with Covered Helix

Referring toFIGS.73-74, the anchor support45includes anchor support380, which may convert from its undeployed form381to its deployed form382. Anchor support380as a distal covered helix383, in its undeployed form inFIG.73, and in its deployed form inFIG.74. The distal covered helix383is formed by a support wire384, which is preferentially constructed of nitinol although it may have any metallic alloy or plastic element, and along its length is differentially sized by radius, length, or pitch of coil. The support wire384is covered by synthetic and/or biological membrane386across the diameter of each loop, so that helical coil formed by support wire384is a covered helix much like a compressed Archimedes screw.

The Anchor Support with Umbrella/Parachute-Like Element(s)

Now referring toFIGS.75-76, the anchor support40includes anchor support390shown inFIG.75, or anchor support391shown inFIG.76. Anchor support390has distal umbrella element392. Umbrella element392has one or more umbrella petals393. Each umbrella petal393has a wire frame394, preferentially composed of nitinol, although any portion of the frame is any metallic or plastic element and is covered by any synthetic or biological membrane. Spanning the wire frame394is a membrane396, which may be any synthetic or biological membrane. Each umbrella petal393may be the same or different from the other petal, and may take the shape of polygon, circle, ellipse, or sinusoidal curve in the X-Y plane, and any portion may curve in a convex/concave or sinusoidal fashion in the Z-plane toward the cardiac wall. Anchor support391has distal parachute element398. Parachute element398is formed by a wire frame399, also preferentially nitinol, although any portion of the frame may contain any metallic or plastic element and is covered by any synthetic or biological membrane. The parachute element398may take the shape of any parachute or sail-like shape, may have any number or shape of struts (not shown) spanning the element398, and is covered by any type of synthetic or biological membrane. Finally, proximal elements397and402have the same material and shape properties as proximal section326inFIG.63.

The Anchor Support with Star-Like Element(s)

Now referring toFIGS.77-78, the anchor support40includes anchor support410, which converts from its undeployed form411to its deployed form412. Anchor support410has a star element413that traverses the septum as a slotted hypotube with a distal end414, proximal end416and one or more deformable members417between the ends. The star element413is preferably composed of cobalt-chromium and nitinol, although any portion of it is constructed of any metallic alloy or plastic polymer and covered with either synthetic or biological membranes. The distal414and proximal416ends have the cross-sectional area of a circle, ellipse, or any polygon, and the deformable members417also have any cross-section shape and deform along one or more junctions to form any polygonal shape. As a matter of example, the deployed form412shows the deformable members417taking the shape of triangles. Also, any deformable member417may take the same or different shape as any other deformable member. The proximal element418have the same material and shape properties as proximal section326inFIG.62.

The Anchor Support with Pivoting Bar Element(s)

Now referring toFIGS.79-80, the anchor support40includes anchor support430, which convert from its undeployed form431to its deployed form432. Anchor support430has a bar element433, which has a distal end434, pivot element436, and proximal end437. The bar element433have any diameter or length and have any straight or curved shape along its long axis, with its cross-sectional areal is any circle, ellipse, or polygon. The pivot element436is any shape and located anywhere along the long axis of bar element433. Both the bar and pivot elements are constructed of any metallic allow or plastic polymer, is covered by any synthetic or biological membrane and may or may not have additional fixation members on its surface (not shown). Deployment wire438, also constructed of any metallic alloy or plastic polymer, is attached to pivot element436and extends through lumen (not shown) of proximal element439, until wire438exits the proximal end441of proximal element439. Thus, deployment wire, through pushing or pulling can assist in deploying the bar element433. Alternatively, deployment wire438is a spring or coil and connects to distal end442of proximal element439such that when bar element433exits microcatheter and is in free space, the bar element433pivots and then is pulled taut against the distal end442of the proximal element439.

The Anchor Support Delivery System without Anchor Coil

When the anchor support delivery system140is be used to deliver an anchor support without using anchor20, the anchor support delivery system140is combined with an alternative embodiment of the anchor torque driver143, which does not have one or more coupling arms147and tabs148. Instead the end146of this alternative embodiment of anchor torque driver143is connected directly and irreversibly to fixation elements450,460, or470. Also, these fixation elements attached to anchor torque driver143are be used to stabilize the anchor delivery130, so that microcatheter161has a stable platform to traverse the cardiac wall.FIG.81-82shows a fixation element450that has one or more protrusions451attached to fixation element base452, which is attached to the distal end of anchor torque driver143. The one or more protrusions451are shaped as a needle, barb, hook, spear, circle, ellipse, or as any polyhedron. Any portion of the fixation element450, including the one or more protrusions451, is composed of any metallic alloy or plastic polymer and may be coated with any synthetic or biological membrane.

As shown inFIGS.83-84, is an alternative fixation element460attached to anchor torque driver143. Fixation element460, has one or more extension members461, with tip462and base463. The one or more extension members461may be of any length or diameter, have the cross-section of a circle, ellipse, or any polygon. Along the long axis, the extension member is straight, be any type of curve, or any portion of the perimeter of a polygon. The tip462may or be the same shape as rest of the extension member461, or is shaped as needle, barb, hook, spear, circle, ellipse, or as any polyhedron. Base463of each extension member461is attached to fixation element base464, and each base463may or may not have a pivot element, joint, or spring to allow the extension member461to bend inwards or outwards to any degree. Any portion of fixation element460is composed of any metallic alloy or plastic polymer and may be coated with any synthetic or biological membrane.

As shown inFIGS.85-86, fixation element470is attached to anchor torque driver143via element base474. Fixation element470is in the shape of a suction cup with a frame471, inlet472, and covering surface473. Fixation element470may be frusto-conical in structure, or its base might be any type of circle, ellipse, or polygon, and the rest of the suction cup could also be in the shape of any part of a polygon. The frame471is constructed of any metallic alloy or plastic polymer, and the covering surface473may be any synthetic or biological membrane. Around the perimeter of the inlet472, additional fixation elements such as microneedles (not shown) may be provided. Finally, a lumen (not shown) within base474extending through anchor torque driver all the way to beginning of the anchor support delivery system is used to create negative pressure so that the fixation element470further adheres to the cardiac wall.

The Method of Stabilizing the Anchor Delivery Sheath without Anchor

As shown inFIGS.87A-B, the delivery system140attached to fixation element450is inserted into the anchor delivery sheath130until the fixation element450extends outside the distal tip132of the anchor delivery sheath130and engages the interventricular septum8. After microcatheter delivery and anchor support delivery, the fixation element450is disengaged from the intraventricular septum8with retraction of the delivery system140.

As shown inFIGS.88A-B, the delivery system140attached to fixation element460is inserted into the anchor delivery sheath130. While within the anchor delivery sheath130, fixation element460is constrained. Namely, extension members461may be closer together when the extension members pivot close together by the freedom of movement given by a pivot element at base463of each extension member461. Alternatively, the extension members461are constructed of nitinol so that the members are constrained with the sheath before exiting the tip of anchor delivery sheath130. Once the fixation element460exits distal tip132of anchor delivery sheath130, the extension members461, either through action of a pivot element at each base463or through the members forming pre-formed shape of nitinol, extend radially outward as they affix to the interventricular septum8. Additionally, the tip462of each extension member461is shaped (as a barb, spear, hook, needle, etc.) so as to engage tissue of the interventricular septum. After microcatheter delivery and anchor support delivery, the fixation element460is disengaged from the intraventricular septum8with retraction of the delivery system140. As the delivery system140retracts, the extension members461move inwards so that they are pulled inside the distal tip132of anchor delivery sheath130.

As shown inFIGS.89A-B, the delivery system140attached to fixation element470is inserted into anchor delivery sheath130. While in the sheath, element470is constrained by the diameter of the anchor delivery sheath130, but upon exit of distal tip132, element470expands to its pre-formed size. The suction cup adheres to the interventricular septum8through passive action, additional active fixation elements (not shown) and/or negative pressure exerted to element470through the delivery system140. After microcatheter delivery and anchor support delivery, the fixation element470is disengaged and retracted back into anchor delivery sheath130by retraction of the delivery system140.

The Method of Advancing Microcatheter without Anchor Coil

As illustrated inFIGS.90-92, the microcatheter with screw tip dilator traverses the septum without the anchor coil, using an alternative fixation element. For purposes of illustration, the fixation element450is being shown, although the same process can be used with fixation elements460or470. All the same steps described above are used as well.

Method of Advancing Microcatheters with Alternative Mechanisms

The methods of advancing the microcatheter also apply to microcatheters with alternative tip dilators. For example,FIG.93shows a microcatheter, but instead of screw tip dilator162, as needle tip dilator480penetrates tissue. Needle tip dilator480may be of any known shape in the art and may be composed of any metallic alloy or plastic polymer and covered with any biological or synthetic membrane. Also, needle tip dilator480may rotate as screw tip dilator does or may have a swivel mechanism to stay in same position as the body of the needle tip dilator advances forward.

FIG.94shows a radiofrequency tip dilator490. Radiofrequency tip dilator490is connected via a radiofrequency cable491, which connects to radiofrequency generator492. Radiofrequency tip dilator490delivers radiofrequency energy to the tissue while being advanced. It is also contemplated that the radiofrequency generator492and cable491could also connect to other tip dilators.

FIG.95shows a laser tip dilator500. Laser tip dilator might be any type of laser that administers laser light impulses as the laser tip dilator and microcatheter are being advanced through the tissue.

FIG.96shows a rotating burr tip dilator510. The rotating burr has any spherical, ellipsoid, or polyhedral shape, and is made of any metallic alloy and be covered by any cutting elements that may also be made of any metallic allow or gem, such as diamonds. The rotating burr tip dilator510is connecting to rotating cable511, which is connected to power source512. The rotating burr tip dilator510, rotates clockwise or counterclockwise at any revolutions per minute. The rotating burr tip dilator510, like other tip dilators, is advanced as by rotation of the microcatheter control knob156.

FIG.97shows a helical tip dilator520. The helical tip dilator520may take any of the shape or material properties as described for the anchor coil described above. In practice, the helical tip dilator520traverses the interventricular septum in exactly the same way as the screw tip dilator as described above.

FIG.98shows an oscillating tip dilator530. The oscillating tip dilator530may take any shape and is composed of any metallic alloy or plastic polymer. Oscillating tip dilator530is connected to oscillator rod531which is connected to oscillator motor532. Oscillator motor532, when activated, pushes the oscillator rod531to and fro, thereby moving the oscillator tip dilator530back and forth, at any hertz, along the long axis of the microcatheter.

Examples of Other Anchor Supports Connected Via the Tether Assembly

As illustrated inFIGS.99-120, any of the other anchor supports is connected to the tether assembly with or without the anchor, just as anchor support40is connected to the tether assembly with or without the anchor.