Implantable Devices

Abstract

To provide a durable solution to mitral valve disease. [Solution] The implantable device of the present invention comprises a frame having at least a first pair of adjacent struts, the frame having a proximal end and a distal end, the frame having an anti-retraction feature configured to resist movement of the frame within the valve annulus, a plurality of distally directed anchors movably supported by the frame and configured to be at least partially embedded in tissue surrounding the native valve and extendable distally relative to the frame, and a movable restraint connected to the frame and configured to restrain the frame in a desired configuration.

Description

[Technical field]

[0001] [Incorporation by reference to priority application] This application claims priority to U.S. Provisional Application No. 62 / 116,248, filed February 13, 2015, the entirety of which is incorporated herein by reference.

[0002] TECHNICAL FIELD The present invention relates generally to heart valves, and more particularly to devices, systems, and methods for heart valve replacement. [Background technology]

[0003] [Description of Related Art] Mitral valve disease is usually repaired through invasive surgical procedures or by mitral valve replacement, which involves creating two small openings and complicated pinching of the leaflets or removing the native valve. Surgical procedures involve risky bypass surgery, including opening the patient's chest and ventricles to expose the mitral valve for direct visualization and repair. Resection or partial removal of the patient's leaflets, along with implantation of a surgical ring, such as the Carpenter Edwards Physio, manufactured by Edwards Life Science, is a traditional but complex technique used by surgeons to reduce the patient's mitral annular diameter, allowing the leaflets to properly coapt and reduce mitral regurgitation. The E-valve catheter device, described in US Patent No. 5,399,991 and recently approved in the United States, attempts to replicate a surgical technique developed by Dr. Ottavio Alfieri, in which a connection is made across the mitral valve to create two openings with a smaller combined cross-sectional area for blood to flow through. This technique often reduces regurgitation slightly, but is not as durable a solution as surgical ring implantation. Thus, there is a need for a solution to mitral valve disease that does not have these drawbacks. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent No. 7,736,388B2 Summary of the Invention

[0005] The device may be used as a heart valve replacement. The device includes an implantable frame coupled to a valve that includes one or more leaflets. The device may replace the native mitral valve. The device may be delivered by catheterization, for example, via a venous access in the groin or a transseptal puncture of the heart to access the left atrium. The device is delivered in a collapsed configuration and exposed in the left atrium for expansion.

[0006] The device may include a frame of closed configuration defining an axis having a first side generally axially and a second side opposite the first side, with a skirt, such as a flared end, connected to an end of the frame. The skirt may be a flared end or end portion of the frame. The frame may be expandable. The implantable frame may be coupled to one or more leaflets, e.g., attached to one or more leaflets. The leaflets may be tissue, polymer, or other suitable material. In some embodiments, the leaflets may be coupled to the frame utilizing suturing techniques.

[0007] The device may include one or more anchors coupled to the frame. The anchors may be long rods with pierces at the ends of one or more of the anchors. The anchors may be positioned around the periphery of the frame, for example from the distal or proximal end of the frame. The frame may be well secured within the mitral valve with anchors that engage native tissue, such as the native annulus. The anchors may take a straight path, a curved path, or a combination thereof, as they engage or engage the tissue. The anchors may take a skirt path, such as a flared end, as they engage or engage the tissue.

[0008] The device may include one or more seals. Seals such as barriers, rings, cuffs, or toroids may be included, for example, to prevent leakage around the valve and / or to aid in fixation of the implanted frame.

[0009] In one aspect, an implantable heart valve device is disclosed. The device includes a tubular frame having a proximal end, a distal end, and a central lumen extending therethrough, the frame including at least a first pair of adjacent struts joined at proximal apexes and at least a second pair of adjacent struts joined at distal apexes. The device further includes a plurality of distal anchors coupled to the frame and configured to be implanted in tissue surrounding a native mitral valve, a valve coupled to the frame to regulate blood flow through the central lumen, a movable restraint coupled to the frame and configured to restrain the frame at a desired width, and an annular seal carried by the frame to prevent perivalvular leakage.

[0010] In some embodiments, the annular seal includes a barrier. The barrier may be located on the interior of the frame. The barrier may be located on the exterior of the frame.

[0011] In some embodiments, the annular seal includes a cuff. The cuff may be inflatable.

[0012] In some embodiments, the annular seal includes an axially extending barrier and an outwardly and radially extending ring.

[0013] In some embodiments, the leaflets include pericardial tissue.

[0014] In some embodiments, the device further comprises a plurality of connectors for connecting the valve to the tubular body.

[0015] In some embodiments, the restraint includes an opening that receives the first pair of adjacent struts. The restraint can include a collar. The collar can include a threaded surface. The first pair of adjacent struts can include a threaded surface.

[0016] In some embodiments, the constraint comprises a loop carried by the tubular body and surrounding a central lumen. The constraint may be configured to reversibly adjust the implant body radially within a predetermined range.

[0017] In some embodiments, axial advancement of the collar reduces the angle between the first pair of struts to reshape the implant body.

[0018] In some embodiments, each anchor is rotatably held by the implant body.

[0019] In some embodiments, the anchor is configured to be retractable.

[0020] In some embodiments, the implant body is configured to be reshaped so that the diameter at the proximal end is different than the diameter at the distal end.

[0021] In some embodiments, the restraint is axially slidable along the first pair of struts.

[0022] In some embodiments, at least one of the plurality of anchors has a helical shape, and rotating the anchor causes the anchor to extend into the tissue.

[0023] In some embodiments, the device includes at least four pairs of adjacent struts and at least four apexes.The device may include at least four restraints.The device may include at least four anchors.

[0024] In some embodiments, rotation of the anchor axially displaces the anchor relative to the implant body.

[0025] In some embodiments, each strut in an adjacent pair of struts includes a thread surface.

[0026] In some embodiments, the valve includes at least a first leaflet and a second leaflet. The first and second leaflets may be different sizes to selectively direct blood flow direction exiting the valve. The valve may further include a third leaflet, the first leaflet being larger than both the second and third leaflets. The first leaflet may be disposed on an anterior side of the valve.

[0027] In some embodiments, the distal end of the implant body includes a skirt that flares outwardly from the lumen. The skirt may be flared outwardly and distally.

[0028] In some embodiments, the distal end of the implant body includes an outwardly and proximally flared skirt.

[0029] Components in the figures are not necessarily drawn to scale to enhance clarity and improve understanding of the various components and embodiments described herein. Additionally, components that are known to be common and well understood by those skilled in the art have not been depicted to provide a clear view of the various embodiments described herein, and thus the drawings are in simplified form for clarity and conciseness. [Brief description of the drawings]

[0030] [Figure 1A] FIG. 1A is a partial cross-sectional view of the anatomy and peripheral features of the native mitral valve in a human heart. [Figure 1B] FIG. 1B is a detailed view of the native mitral valve of FIG. 1A. [Figure 1C] FIG. 1C is a perspective view of a prior art tricuspid valve. [Diagram 2] FIG. 2 is a partial side view of an embodiment of a heart valve device including an embodiment of a frame and distally extending anchors. [Figure 3A] FIG. 3A is a perspective view of an embodiment of a heart valve device having an embodiment of a frame with a sloped skirt at a distal end and a distally and outwardly extending anchor disposed at the distal end of the frame. [Figure 3B] FIG. 3B is a perspective view of an embodiment of a heart valve device having an embodiment of a frame with a sloped skirt at the proximal end and distally and outwardly extending anchors disposed at the proximal end of the frame. [Figure 4A] FIG. 4A is a perspective view of different embodiments of anchors that may be used with the various heart valve devices described herein. [Figure 4B] FIG. 4B is a perspective view of a different embodiment of an anchor that may be used with the various heart valve devices described herein. [Diagram 5] FIG. 5 is a perspective view of an embodiment of a heart valve device having a frame with a skirt, an angled anchor, a mitral valve, and an internal annular seal shown as a barrier. [Figure 6A] FIG. 6A is a partial perspective view of an embodiment of a delivery system for delivering and deploying the various heart valve devices described herein using a balloon. [Figure 6B] FIG. 6B is a partial perspective view of the system of FIG. 6A with the balloon expanded. [Figure 7A] FIG. 7A is a partial perspective view of an embodiment of a heart valve device illustrating an embodiment of a frame-anchor interface. [Figure 7B] FIG. 7B is a partial perspective view of an embodiment of a heart valve device illustrating an embodiment of a frame-anchor interface. [Figure 7C] FIG. 7C is a partial cross-sectional view of a heart valve device illustrating an embodiment of a curved interface between the frame and anchors. [Figure 8A] FIG. 8A shows various views of an embodiment of a heart valve device with valves having leaflets of different sizes and shapes configured for redirecting blood flow exiting the device. [Figure 8B] FIG. 8B shows various views of an embodiment of a heart valve device with valves having leaflets of different sizes and shapes configured for redirecting blood flow exiting the device. [Figure 8C] FIG. 8C is a side view of the device of FIG. 8A showing an embodiment of the redirected flow exiting the device. [Figure 8D] FIG. 8D is a side view of the device of FIG. 8B showing an embodiment of the redirected flow exiting the device. [Figure 8E] FIG. 8E is a partial cross-sectional view of a mitral heart valve with an embodiment of a heart valve device implanted for redirecting blood flow into the left ventricle. [Figure 8F] FIG. 8F is a partial cross-sectional view of a mitral heart valve with an embodiment of a heart valve device implanted for redirecting blood flow into the left ventricle. [Figure 9] FIG. 9 is a partial side view of an embodiment of a heart valve device showing a frame and anchor interface including a coil surrounding a central spike. [Figure 10] FIG. 10 is a side view of an embodiment of a heart valve device with an extension frame to extend into the left ventricle and eliminate the native mitral valve when the device is implanted in the mitral annulus. [Figure 11] FIG. 11 is a perspective view of an embodiment of a heart valve device with a seal shown as a woven barrier. [Figure 12] FIG. 12 is a perspective view of an embodiment of a heart valve device with an expandable frame having an angled portion and a seal shown as a barrier. [Figure 13A] FIG. 13A is a partial cross-sectional view of a human heart showing an embodiment of a delivery system for delivering a heart valve device with a seal shown as a ring or cuff, such as a toroid. [Figure 13B] FIG. 13B is a partial cross-sectional view of a human heart showing an embodiment of a delivery system for delivering a heart valve device with a seal shown as a ring or cuff, such as a toroid. [Figure 13C] FIG. 13C is a partial cross-sectional view of a human heart showing an embodiment of a delivery system for delivering a heart valve device with a seal shown as a ring or cuff, such as a toroid. [Figure 14A] FIG. 14A is a partial side view of an embodiment of a heart valve device showing a frame with a sealing system including threads and a corresponding movable restraint shown as a collar. [Figure 14B] FIG. 14B is a partial side view of an embodiment of a heart valve device showing a frame with a sealing system including threads and corresponding moveable restraints shown as collars. [Figure 15] FIG. 15 is a perspective view of an embodiment of a heart valve device showing a frame with a sealing system including threads and a select arrangement of corresponding movable restraints shown as collars. [Figure 16] FIG. 16 is a perspective view of an instrument for holding the various heart valve devices described herein for surgical placement or catheter delivery of the device. [Figure 17] FIG. 17 is a perspective view of an embodiment of an instrument head that may be used with the instrument of FIG. [Figure 18] FIG. 18 is a perspective view of an embodiment of a heart valve device with an internal annular seal shown as a barrier and angled anchors for delivering and securing the device from within the left ventricle, showing a delivery system driver coupled with one of the anchors. [Figure 19A] FIG. 19A is a top view of an embodiment of a heart valve device with a frame shown as a circular ring. [Figure 19B] FIG. 19B is a perspective view of an embodiment of a heart valve device with a frame shown as a circular ring. [Figure 19C] FIG. 19C is a perspective view of the device of FIGS. 19A-B with a valve. [Figure 20A] FIG. 20A is a top view of an embodiment of a heart valve device with a frame shown as a "D" shaped ring. [Figure 20B] FIG. 20B is a perspective view of an embodiment of a heart valve device with a frame shown as a "D" shaped ring. [Figure 20C] FIG. 20C is a perspective view of the device of FIGS. 20A-B with a valve. [Figure 21A] FIG. 21A is a top view of an embodiment of a heart valve device with a frame shown as an elliptical ring. [Figure 21B]FIG. 21B is a perspective view of an embodiment of a heart valve device with a frame shown as an elliptical ring. [Figure 21C] FIG. 21C is a perspective view of the device of FIGS. 21A-B with a valve. [Figure 22A] FIG. 22A is a partial top view of an embodiment of a delivery and shaping system for delivering and shaping, eg, ovalizing, the various heart valve devices described herein. [Figure 22B] FIG. 22B is a partial perspective view of an embodiment of a delivery and shaping system for delivery and shaping, eg, ovalizing, of the various heart valve devices described herein. [Figure 22C] FIG. 22C is a perspective view of the system and device of FIGS. 22A-B with a valve connected to the device. [Diagram 23] FIG. 23 is a partial perspective view of an embodiment of a piston-based delivery and shaping system for delivery and shaping, eg, ovalizing, of the various heart valve devices described herein. [Figure 24A] FIG. 24A is a partial perspective view of an embodiment of a balloon-based delivery and shaping system for delivery and shaping, eg, ovalizing, of the various heart valve devices described herein. [Figure 24B] FIG. 24B is a partial perspective view of an embodiment of a balloon-based delivery and shaping system for delivery and shaping, eg, ovalizing, of the various heart valve devices described herein. [Figure 25A] FIG. 25A is a partial perspective view of an embodiment of a rotating shaft-based delivery and shaping system for delivery and shaping, eg, ovalizing, of the various heart valve devices described herein. [Figure 25B] FIG. 25B is a partial perspective view of an embodiment of a rotating shaft-based delivery and shaping system for delivery and shaping, eg, ovalizing, of the various heart valve devices described herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] In the following description, which illustrates many embodiments and applications, reference is made to the accompanying drawings, which form a part hereof, and which show, by way of illustration, specific embodiments in which the embodiments described herein may be practiced. It is understood that other embodiments may be utilized and changes may be made without departing from the scope of the disclosure.

[0032] Various inventive features are described below, each of which can be used independently of one another or in combination with other features. However, any one inventive feature does not address all of the problems described above, but only one of the problems described above. Furthermore, one or more of the problems described above may not be fully addressed by the features of each embodiment described below.

[0033] Various embodiments of heart valve devices are described. Related delivery and / or deployment systems are also described. The device may include an expandable frame with anchors that secure the device to native heart tissue. The anchors may be aligned to an axis defined by the frame and / or angled relative to such axis. The frame may be expanded and / or shaped for fixed placement within a native heart valve annulus, such as the native mitral annulus. For example, the frame may have flared ends or skirts that allow for secure placement of the device in the heart when expanded. The device may also include a barrier to direct blood flow. The device may include a seal to prevent blood leakage around the device. These are some of the features of the devices and systems described herein.

[0034] FIG. 1A is a partial cross-sectional view of the native mitral valve MV and left ventricle LV of a human heart. FIG. 1B is a detailed view of the native mitral valve MV of FIG. 1A. The mitral valve MV connects the left ventricle LV to the left atrium (top of mitral valve MV). The mitral valve annulus MVA surrounds the mitral valve MV. The chordae tendineae CT extend from the papillary muscles of the left ventricular LV wall to the leaflets of the mitral valve MV. The aortic valve AV is downstream of the mitral valve MV. During diastole of the left ventricle LV, the mitral valve MV opens to allow blood flow from the left atrium (top of mitral valve MV) through the mitral valve MV to the left ventricle. The aortic valve AV closes to prevent blood flow from leaving the left ventricle during ventricular diastole. During ventricular systole, the mitral valve MV closes and the aortic valve AV opens to allow blood flow from the left ventricle through the aortic valve AV to the aorta (top of aortic valve AV).

[0035] As shown in Figure IB, the mitral valve MV includes an anterior leaflet and a posterior leaflet that surround an orifice. The orifice is surrounded by a fibrous ring, the mitral valve annulus MVA. The two leaflets are joined at the anterior commissure at one end of the orifice and the posterior commissure at the opposite end of the orifice.

[0036] 1C is a perspective view of a prior art tricuspid valve, similar to one that may be inserted into a collapsible frame.

[0037] FIG. 2 is a partial side view of an embodiment of a heart valve replacement device 10 having a distally extending anchor 300. The device 10 may include an expandable frame 100. In some embodiments, the device 10 may include a valve 200 (see, e.g., FIG. 5). The valve 200 may be comprised of tissue leaflets coupled to the frame 100. The device 10 may include one or more distally extending anchors 300 coupled to the distal end 102 of the frame 100 for anchoring the frame 100 and / or the valve 200 within the natural annulus. The device 10 may include an anti-retraction feature for anchoring the device, such as a skirt 150 formed from a flared frame 100 end. Alternatively or additionally, the device 10 may include various other anchoring features, such as anti-counter rotation anchors 300, curvilinear path anchors, or outwardly extending anchors / angled anchors 300, as described herein.

[0038] The frame 100 may include a proximal end 101 and a distal end 102 opposite the proximal end 101. When implanted, the device 10 may be oriented such that the proximal end 101 is closer to the left atrium and the distal end 102 is closer to the left ventricle.

[0039] In some embodiments, the frame 100 can be tubular between the proximal end 101 and the distal end 102. A tube includes any generally circular closed shape. By way of example, the frame 100 can be annular or non-annular, as described herein. The frame 100 can have a variety of shapes, such as, for example, a "D" shape, an oval shape, an elliptical shape, etc., as described herein. The shape can be selected to match the patient's anatomy.

[0040] The frame 100 may include a body 110. The body 110 may be a tubular structure. The body 110 may define a central lumen that extends therethrough between a proximal end 101 and a distal end 102. In some embodiments, the body 110 may be formed primarily from one or more wires or segments. The wires or segments may have a variety of cross-sectional configurations, such as round, flat, polygonal, segmented, smooth, sharp, areas of increase, areas of decrease, other suitable configurations, or combinations thereof. The wires or segments may form a set of struts of the frame 100.

[0041] The body 110 may include struts 110A, 110B, 110C, as shown in FIG. 2. For clarity, the other struts in FIG. 2 are not labeled. The frame 100 may include one or more vertices formed by pairs of adjacent struts. Each strut of the pair of adjacent struts may include a thread surface, as described herein. As shown, there may be one or more proximal vertices 103 disposed at the proximal end 101 of the frame 100, for example, formed by the proximal vertices of struts 110A, 110B, 110C. There may be one or more distal vertices 104 disposed at the distal end 102 of the frame 100, for example, formed by struts 110A and 110B, 110B and 110C, etc. For clarity, not all vertices 103, 104 are labeled. There may be at least four pairs of adjacent struts and at least four vertices.

[0042] The body 110 may be separate parts connected together. By way of example, the frame 100 may be comprised of multiple body 100 parts, such as one or more struts 110A, 110B, 110C, connected together. As shown in FIG. 2, adjacent struts may be connected together by one of the anchors 300. By way of example, strut 110A may be connected to strut 110B via anchor 300. Similarly, strut 110B may be connected to strut 110C via the other anchor 300. The remaining struts of the frame 100 may be similarly connected together.

[0043] In some embodiments, frame 100 may include openings for connecting portions of the frame together. As shown, strut 110A and strut 110B include openings for common anchor 300 to extend through the opening in the rotation path. Other struts may be similarly connected. Body 110 may be formed by connecting separate portions together via welding, fusing, pins, or screws to construct frame 100.

[0044] In some embodiments, the body 110 may be integral. For example, the body 110 may be formed from the same monolithic piece of material. In some embodiments, the body 110 is partially integral. By way of example, the body 110 may be formed from a number of connected strut groups, each strut group including a number of integral struts. The anchor 300 may be connected to the integral or partially integral body 110 as described above for the frame 100 made of separate pieces connected together.

[0045] The anchor 300 may include a body 320 and a head 310. The body 320 may extend along the length of the anchor 300. The body 320 may include a piercing end, such as a sharp tip, for penetrating and engaging tissue. The body 320 may be in a coiled configuration as shown. The head 310 may be disposed at an opposite end of the anchor 300 as the piercing tip. The head 310 may include a mechanism for engaging an instrument with the anchor 300, for example, for movement of the anchor 300 into tissue to secure the device 10 in place, as further described herein. The anchor 300 may be coupled to and extend distally from the distal end 102 of the frame 100, as shown in FIG. 2.

[0046] 2, frame 100 may be generally cylindrical in an expanded and / or contracted configuration. Proximal and distal ends 101, 102 may be generally aligned with the struts and / or generally along an axis defined by frame 100. As such, anchor 300 may generally extend axially and / or in the same plane as frame 100. Anchor 300 may thus extend generally axially through frame 100 as shown. Frame 100 and anchor 300 may thus generally define a cylindrical, or elongated tubular, three-dimensional volume.

[0047] In some embodiments, a percutaneous aortic valve frame configuration may be included, for example, as described in U.S. Patent Application No. 12 / 986,780 by Rowe, filed Jan. 7, 2011, the entire contents of which are incorporated herein by reference. In some embodiments, an adjustable intraluminal mitral valve 200 annulus configuration may be included, for example, as described in U.S. Patent Application No. 14 / 562,554 by Lashinski, filed Dec. 5, 2014, the entire contents of which are incorporated herein by reference.

[0048] The frame 100 may be formed from a variety of materials, including, but not limited to, stainless steel, cobalt chrome, nitinol, nitinol alloys, other suitable implantable or implant grade materials, or combinations thereof. The frame 100 may be constructed from a malleable material. The device may be radiolucent, allowing device expansion to be monitored via x-ray or fluoroscopy. Additional markers may be added for better visualization across the frame 100.

[0049] Frame 100 may have a uniform thickness. In some embodiments, struts 110A, 110B, 110C may have different thicknesses and / or widths, for example, to increase stability and flexibility in stressed areas. The approximate wall thickness of tubular frame 100 may be about 0.20 to about 1.00 millimeters thick. Struts 110A, 110B, 110C widths may be about 0.20 to about 1.00 millimeters thick. In some embodiments, struts 110A, 110B, 110C widths may be about 0.50 millimeters thick. In some embodiments, struts 110A, 110B, 110C widths may be about 0.75 millimeters wide. In some embodiments, variable thicknesses may be employed radially and / or longitudinally, for example, to obtain different stiffnesses across frame 100. The thickness of frame 100 may be achieved by machining, such as by grinding, selected areas of the material of frame 100, such as body 110 or struts 110A, 110B, 110C.

[0050] Frame 100 may have a variable surface topography, including, but not limited to, surface contours, surface finishes, surface coatings, etc. The desired topography may be obtained by surface grinding selected areas of frame 100. Frame 100 may be electropolished, for example, after assembly of frame 100, to obtain a smooth, passivated surface that reduces adverse tissue effects or reactions to the alloying elements. These and other methods may be used to adopt the desired thicknesses as described above.

[0051] In some embodiments, fabrication of the frame 100 may include laser cutting a pattern of small tubes to define a predictable expansion geometry. The tubular elements of the frame 100 may be removed by a cutting laser, such as a Nd:YAG or CO2 laser. For example, a diamond or sinusoidal pattern may be applied to allow expansion and contraction, for example for implantation and delivery. Holes may be drilled in the frame 100 to attach attachment features, such as for attaching tissue and / or anchors 300 through sutures, as described further herein.

[0052] The frame 100 can be configured to expand. In some embodiments, the frame 100 can be configured to expand by shape memory. For example, the frame 100 can be constructed from a Nitinol alloy and heat set to a desired diameter or shape, reducing or eliminating the need for mechanical means for expansion within the deployment site.

[0053] In some embodiments, the frame 100 may be configured to expand mechanically. By way of example, the expansion of the frame 100 may involve actuation. In some embodiments, the frame 100 may be configured to expand fluidly. By way of example, the expansion of the frame 100 may involve hydraulic means. In some embodiments, the frame 100 may expand via a combination of mechanical, fluid, and / or other means. By way of example, the expansion of the frame 100 may be via balloons or linkages to provide an internal radial force that moves the frame 100 from a collapsed state to an expanded state. Further details of frame expansion characteristics are provided herein, for example with respect to FIGS. 22A-25B.

[0054] The frame 100 may have a non-uniform expansion. The non-uniform expansion of the frame 100 may be designed into the cut pattern. In some embodiments, the non-uniform geometry of the frame 100 may provide a better fit for each patient, for example. For example, an elliptical pattern may better fit the mitral valve anatomy, such as the annulus shape, of a particular patient. An elliptical final shape may allow for a preferred final shape that is more similar to a GeoForm annuloplasty ring, for example, with an anterior-posterior dimension narrower than the septal-lateral dimensions. In some embodiments, vertical geometric relief in the device, for example, the leaflets of the valve 200, may be included to help move the leaflets to a normally coapted state, for example by lifting the anterior leaflets from their shed and dilated pathological position.

[0055] The frame 100 may include various drug eluting features, such as coatings applied to the frame 100. The drugs may prevent or inhibit the tissue healing response. Such features may include heparin, thin film polymer, drug eluting, hydrophilic type or other suitable coatings, or combinations thereof. Many drugs and anti-inflammatory agents may be added to the coating for proper healing. Pockets, holes, or wells may be included, for example cut into the frame 100, to create spaces to load drugs or coatings for elution into the surrounding area of ​​the body.

[0056] The device 10 may include one or more anchors 300. There may be at least four anchors 300. There may be fewer or more than four anchors 300. The anchors 300 may rotate. Each of the anchors 300 may be rotatably retained in the frame 100. Rotation of the anchors 300 may axially displace the anchors 300 relative to the frame body 110. The anchors 300 may be configured to penetrate tissue, resist bending and / or axial movement, and perform other necessary functions. The anchors 300 may be configured to be retractable. The device 10 may be positioned within the mitral valve 200 annulus and attached to native tissue via multiple anchors 300. The anchors 300 may be positioned around the frame 100 as described herein. The anchors 300 may prevent the device 10 from moving relative to adjacent tissue and / or prevent leakage around the device 10. A variety of anchors 300 may be used to secure the device, including, for example, multiple barbed spikes as described herein.

[0057] In some embodiments, the anchor 300 may include clockwise or counterclockwise rotation threads. The anchor 300 may be comprised of a wire body 320, such as a round, oval, rectangular, other suitable wire, or combinations thereof. The anchor 300 may be polished smooth, may have surface irregularities, such as to limit rotation in one or both directions, other suitable properties, or combinations thereof. The rotation anchor 300 may be comprised of stainless steel, cobalt chrome, a polymer, other suitable implantable or implant grade material, or combinations thereof.

[0058] The anchor 300 may be coiled, helical, or the like. The helical anchor 300 may be comprised of a wire body 320 having a cross-sectional diameter of about 0.2 millimeters to about 1.0 millimeters. In the coiled configuration, the anchor may have a "coil diameter" of about 1.0 millimeters to about 3.0 millimeters. The coil diameter refers to a length approximately equal to the diameter of the final coiled shape formed by the coiled wire as measured perpendicular to the axis defined by the coil. The pitch of the coil may be about 10 threads per inch to about 36 threads per inch. The pitch may be constant along the length of the anchor. In some embodiments, the pitch is not constant along the length of the anchor. The axial length of the anchor, as measured along the axis, may be of various lengths. In some embodiments, the axial length may be about 2 millimeters to about 10 millimeters. An alternative configuration may be to cut a helical pattern into the coiled anchor 300 having a similar configuration as described above.

[0059] The anchors 300 can be threaded through the frame 100 via openings 130, such as holes, for passing the anchors, as described in further detail herein, for example with respect to Figures 7A-7B. In some embodiments, the frame 100 can have a single through-hole connection that allows the anchors 300 to freely rotate and move laterally within the holes. In embodiments having anchors 300 and frame 100 with through-holes, for example as shown in Figures 3B and 5, the device 10 can draw the frame 100 closer to the tissue when rotated to engage the tissue.

[0060] Connection and driving of the anchor 300 may be via slotted elements, hex wrenches, or similar means. The connection and detachment means can be a pure slot and receiver, collapsible joint, or magnetic connection to hold the anchor 300 against a driving means, such as a rotating shaft, located outside the patient's body. The connections can be pre-attached and mounted for delivery or attached to the body with larger elements staggered lengthwise along the delivery catheter to reduce cross-sectional diameter. See, for example, Figures 4A-4B.

[0061] In some embodiments, anchor 300 may be a threaded rod with raised or cut threads on the periphery. Anchor 300 acts as a more stable element in tissue to resist bending moments at the connecting shaft. Adding stiffness or material in the central shaft may result in stronger point fixation, at the expense of more rotational force being required to drive anchor 300 into tissue. When constructed from similar materials as coiled anchor 300, the shape and form may be tapered to reduce penetration force during insertion.

[0062] Surface modifications on anchor 300 can increase retention by resisting counter-rotation. Small barbs or surface notches on anchor 300 can resist counter-rotation and loosening of anchor 300 after implantation. These surface modifications can be done through chemical treatments or mechanical forces that notch or swage anchor 300.

[0063] The anchors 300 that attach the frame 100 to the surrounding tissue can be parallel to the central axis of the frame 100, or can be angled outward to orient the anchors 300 further into the solid tissue. An angle of about 5 degrees to 90 degrees from the central axis can orient the anchors 300 into the fibrous myocardial tissue for added strength and fixation. The angle can vary circumferentially depending on the annular tissue surrounding the anchors 300. In particular, between the triangular regions near the aortic valve AV, the tissue is fibrous but thin, so a more acute angle is appropriate so as not to penetrate the aortic valve AV sinus that would lead to undesirable leakage. On the other hand, opposite the triangular region, a more obtuse angle can be advantageous since there is thicker, more vascularized tissue in this region. Also, a deeper anchor 300 allows for further penetration into the soft tissue. These angle variations can be incorporated into the proximally or distally placed anchors 300 in the frame 100.

[0064] The position of the anchors 300 may vary along the height of the frame 100 to orient the angle of the device 10 and / or to accommodate and accommodate the saddle shape of the three-dimensional shape of the native mitral valve.

[0065] Delivery of device 10 may be via the femoral vein in the groin for transseptal entry into the left atrium and into the mitral annulus MVA. Anchor 300 may be inserted from the left atrium (above the mitral valve) into the annulus MVA. In some embodiments, delivery may be from a transapical entry, e.g., anchor 300 may not be placed in the left ventricle LV.

[0066] Figure 3A is a perspective view of an embodiment of a heart valve replacement device 10 including an embodiment of a frame 100 having an angled distal end 102. The device 10 of Figure 3A may have the same or similar configuration and / or function as the device 10 described with respect to Figure 2, and vice versa. As shown in Figure 3A, the device 10 may include a distally and outwardly extending anchor 300 disposed at the distal end of the frame. That is, the anchor 300 is disposed at an angle relative to an axis defined by the frame 100 and / or relative to a plane defined by the generally tubular portion of the frame 100.

[0067] The frame 100 may have an anti-retraction feature, such as a skirt 150. Such features may include a beveled or flared distal end 102 of the frame 100 to capture the frame 100 in the valve 200 annulus from the left ventricle LV. This feature may be a bend in the lower laser cut pattern in the frame 100, which may be actuated at or during the deployment phase, for example as shown in FIG. 12. This lower portion of the frame 100 may be angled in an upward direction toward the left atrium to resist movement as the valve 200 closes. Blood pressure acts on the closed valve 200, for example during systole, exerting a force in the direction of the left atrium. The flared lower frame 100 portion and / or anchors 300 may resist this force that would move the frame 100 from its intended deployment.

[0068] 3B is a perspective view of an embodiment of a heart valve device 10 having an embodiment of a frame 100 with an angled skirt at the proximal end 101, and distally and outwardly extending anchors 300 disposed at the proximal end 101 of the frame. The device 10 of FIG. 3B may have the same or similar configuration and / or function as other devices 10 described herein, such as the devices 10 described with respect to FIG. 2 and FIG. 3A, and vice versa. However, as noted, in FIG. 3B the proximal end 101 is flared to form a skirt 150. Additionally, the anchors 300 each pass through an opening at the apex of the frame 100 at the proximal end 101. Such an arrangement may allow for implantation of the device 10 from within the left ventricle LV, as further described herein, for example, with respect to FIG. 18.

[0069] 4A and 4B are perspective views of various embodiments of an anchor 300 that may be used with the various heart valve devices 10 described herein. The anchor 300 may be rotated to draw the device 10 into intimate contact with the surrounding tissue to prevent migration. As shown in FIG. 4A, the anchor 300 includes a head 310 that may have a recess 310A defined therein. A complementary shaped tool, such as a square head or hex head tool, may be received in the recess 310A to transmit a rotational force from the tool to the anchor 300. As shown in FIG. 4B, the head 310 may be a generally flat or otherwise non-coiled portion of the anchor body 320 that may be grasped or secured by a corresponding tool for similar rotation of the anchor 300.

[0070] 5 is a perspective view of an embodiment of a heart valve device 10 having a frame with a flared skirt 150, an angled anchor 300, an implant mitral valve 200, and an internal annular seal 400 shown as a barrier. The device 10 has a valve 200 attached to the frame 100 with an integral anchor 300 at the proximal end 101 of the device 10 and an annular seal 400 to prevent leakage around the device 10. The valve 200 includes leaflets 210A, 210B, and 210C. The leaflets 210A, 210B, and 210C are attached with an annular seal 400 to prevent leakage around the device 10. The seal 400 may include a seal body 410. The seal body 410 may be a thin walled structure that generally forms the sidewall of the seal 400. The seal 400 is shown attached to the internal side of the frame 100. Seal 400 is shown with dashed lines for clarity. In some embodiments, seal 400 may be attached to the exterior side of frame 100. In some embodiments, there may be an interior seal 400 and an exterior seal 400. The exterior seal 400 may have other configurations and embodiments, such as those shown and described for the woven barrier seal 400 in FIG. 11, or the expansion valve surrounding seal 500 in FIG. 12 and FIG. 13A-C.

[0071] The device 10 may include an expandable, implantable frame 100 with tissue leaflets, such as leaflets 210A, 210B, and 210C, coupled to the frame 100, e.g., attached directly to the frame 100. There may be only two leaflets. The device 10 may include multiple connectors to connect the valve 200 to the frame body 100. The mitral valve 200 may be shaped and defined, e.g., by expanding the lateral dimension of the septum with an instrument to provide a predictable space for placement of the device 10. This shaping may be defined by the frame 100 and allow for intimate contact for placement of the anchor 300 into the surrounding tissue. Although an instrument such as a Cogan cervical clamp is used to spread the tissue in an open chest placement, a spreading device needs to accompany the device 10 delivery and thus may be delivered via a catheter using similar means.

[0072] In some embodiments, the valve 200 may be tissue. The tissue valve 200 composition may include bovine or porcine tissue that is cross-linked around the heart to fix the material. Examples of chemical fixatives that may be used to cross-link collagenous biological tissue may include, for example, aldehydes (e.g., formaldehyde, glutaraldehyde, dialdehyde starch, paraformaldehyde, glyceraldehyde, glyoxalacetaldehyde, acrolein), diisocyanates (e.g., hexamethylene diisocyanate), carbodiimides, photo-oxidation, and certain polyepoxy compounds (e.g., Denacol-810, -512, or related compounds). Of the chemical fixatives, glutaraldehyde may be used. Glutaraldehyde may be used as a fixative for commercially available bioprosthetic products such as porcine bioprosthetic heart valves (i.e., Carpentier-Edwards® stented porcine bioprosthesis; Baxter Healthcare Corporation; Edwards CVS Division, Irvine, Calif. 92714-5686), bovine pericardial heart valve prostheses (e.g., Carpentier-Edwards® pericardial bioprosthesis; Baxter Healthcare Corporation; Edwards CVS Division, Irvine, Calif. 92714-5686), and stentless porcine aortic prostheses (e.g., Edwards Plymouth stentless aortic bioprosthesis; Baxter Edwards AG, Spierstrasse 5, GH6048, Horn, Switzerland).

[0073] A number of different techniques and methods are used to incorporate the tissue valve 200 into a stent or other type of frame 100, such as clamping, tying, gluing, or stitching. However, many of the techniques used for this purpose typically create a stented valve 200 with concentrated stresses at the points where the leaflets are attached to the stent frame 100. That is, because the stent is relatively stiff compared to the flexible material from which the leaflets of the tissue valve 200 are made, the repeated bending action of the leaflets can create stress concentrations at the points where the tissue valve 200 is attached to the stent. These stress concentrations can ultimately lead to tissue tears, leakage of the valve 200, and / or failure of the heart valve 200. The attachment points can also be sites of tissue ablation that can lead to tissue tears. Thus, to distribute stress from the attachment and suture areas and provide a non-ablative contact surface for the bioprosthetic heart valve leaflets, the features described herein provide methods and devices for durable attachment of the tissue valve 200 to the frame 100.

[0074] Polymeric leaflets may be used to construct the valve 200 leaflets 210A, 210B, 210C from polymers such as polyester, Teflon, urethane, etc., and may be reinforced with stronger material elements to strengthen and improve fatigue resistance. Decellularized tissue anti-calcium treatment may be added.

[0075] FIG. 6A is a partial perspective view of an embodiment of a delivery system 600 for delivering and positioning various heart valve devices 10 described herein using a balloon 640. FIG. 6B is a partial perspective view of the system of FIG. 6A with the balloon 640 expanded. To achieve large radial expansion of the device 10 to the appropriate size and location, the device 10 may be attached to an actuatable delivery system 600 and a central balloon 640. The system 600 may include a delivery device 610, which may include a catheter. By way of example, the system 600 may include a delivery catheter with a centrally located balloon 640 for frame 100 expansion and frame 100 connection to hold the device 10 during delivery and fixation at or around the annulus. The balloon 640 may be expanded to include a first portion 642 located near the device 610 and a second portion 644 located on the opposite side of the device 10. The system 600 may include one or more guides 620 for guidance of one or more delivery wires 630. Wire 630 may be attached to frame 100 at the apexes of struts of frame 100, such as struts 110A, 110B, 110C. Wire 630 may be attached to a proximal end 101 of frame 100. Proximal end 101 may form a skirt 150, such as a flared end, of frame 100. Guide 620 includes and / or guides a driver to rotate or move anchor 300. The driver couples to a head of anchor 300 to drive the anchor into tissue.

[0076] 7A and 7B are partial perspective views of an embodiment of a heart valve device 10 illustrating an embodiment of an interface between a frame 100 and an anchor 300. The body 110 of the frame 100 may include an opening 130 through which a coiled anchor body 310 passes in a threaded manner through the anchor 300. The frame 100 may be formed from separate sections, such as struts, as described. Thus, the coiled anchor 300 may pass through the opening 130 of an adjacent frame 100 portion to join the two frame 100 portions together. In some embodiments, the frame 100 may be unitary as noted.

[0077] One or more of the anchors 300 may include one or more stops 330. Each anchor 300 may be incorporated into the frame 100 and a stop 330 at a distal end may be provided to resist movement of the anchor 300 away from the frame 100. The proximal portion may be limited in movement by a drive head. The stops 330 may be located at the proximal and / or distal ends of the anchors 300. The stops 330 may limit rotational movement by a raised portion or a change in the helical cross-sectional shape.

[0078] FIG. 7C is a partial cross-sectional view of the heart valve device 10, showing an embodiment of a curved interface between the frame 100 and the anchor 300. This interface may be used with various devices 10 described herein, such as the skirt 150 of the device 10 described with respect to FIG. 3A. As shown in FIG. 7C, the frame 100 portion with the opening 130 is shown in cross-section for clarity. As shown, the curved or canted coil body 320 of the anchor 300 follows a curved path. This may allow, for example, for the rotational drive axis to be oriented in a different direction or plane than the insertion axis. The rotational or delivery drive axis refers to the direction of the instrument used to drive the anchor 300. The insertion axis refers to the direction in which the anchor 300 is inserted into the tissue. This may be utilized, for example, to drive the same axis as the delivery instrument, but force the anchor along a different, second axis or direction. Thus, to facilitate delivery of the anchor 300, the portion of the frame 100 that holds the coiled anchor 300, such as the skirt 150, may be curved or angled to change the direction of impact relative to the tissue insertion direction. Thus, the anchor 300 may be a flexible portion that is directed through a series of openings 130 in the frame 100. Alternatively, a tubular portion may redirect or angle the anchor 300 in various directions. The rotation, delivery and insertion axes may vary from about 5 to about 90 degrees from the axis of the native mitral valve annulus and / or device 10. In some embodiments, the rotation, delivery and insertion axes may vary from about 40 degrees from the axis of the native mitral valve annulus and / or device 10.

[0079] 8A-8F show various views of an embodiment of a heart valve device 10 with a valve 200, e.g., leaflets, configured, e.g., sized and / or shaped, for redirecting blood flow out of the device 10. The native mitral valve directs blood flow toward the posterior wall of the left ventricle LV to preserve blood momentum and aid in the efficiency of the heart. Conventional surgical valves used in the mitral annulus do not have this efficiency because blood flow is directed toward the middle of the left ventricle LV. Thus, in some embodiments, the device 10 described herein directs blood flow through the implant device 200 to replicate the blood flow path of the native mitral valve.

[0080] Figure 8A is a top view of an embodiment of device 10. In Figure 8B, the right side view is a top view of an embodiment of device 10 and the left side view is a side view of device 10. Figures 8C and 8D are side views of device 10 of Figures 8A and 8B showing an embodiment of redirected flow exiting device 10. Figures 8E-8F are partial cross-sectional views of a mitral heart valve with an embodiment of device 10 implanted for redirecting blood flow into the left ventricle.

[0081] As shown in Figures 8A-8B, the valve 200 may include three leaflets 210A, 210B, 210C. In some embodiments, there may be only two leaflets. The device 10 may include a valve 200 with leaflets configured, for example, sized and / or positioned, to direct blood flow to the rear of the heart. To redirect blood flow, the leaflets 210A, 210B, and / or 210C may be different sizes. As shown, the leaflet 210B may be larger than the leaflets 210A and 210B. The leaflet 210B may be located in front of the mitral valve MV when implanted. The larger leaflet does not open as much as the other two smaller leaflets and directs flow towards the smaller leaflet located behind. The same can be done with two larger leaflets and only one smaller leaflet, by orienting the commissures of the two larger leaflets to the front of the native mitral valve. Alternatively or additionally, blood flow may be redirected by bonding portions of the leaflets 210A, 210B, 210C at a common commissure. Bonding the commissures may prevent the leaflets from fully opening and redirect the exiting flow. These or other configurations of leaflets, such as leaflets 210A, 210B, and / or 210C, may redirect blood flow exiting the device 10.

[0082] The leaflets of the valve 200 may be attached in a variety of ways to achieve the various configurations and functions described herein. Attachment of adjacent leaflets of the valve 200 may be by traditional stitching, such as in open surgery, or by application of suture loops or clips or other tissue anchors in percutaneous or transapical procedures. The attachment zone is preferably adjacent to the commissures and extends for about 25% or less, usually about 15% or 10% or less, of the length of the coaptation ends of the leaflets of the valve 200. The opposing leaflets remain unconnected to each other within the central coaptation zone, allowing the opposing leaflets to continue to function as a single valve 200. The attachment zone may be at a single end of the leaflet or at both opposing ends.

[0083] In some embodiments, the device 10 may redirect blood flow by orienting the device 10 when implanted such that blood is directed in a particular direction by the leaflets, such as leaflets 210A, 210B, 210C. In some embodiments, the valve 200 may have a predetermined arrangement of leaflets, such as leaflets 210A, 210B, and / or 210C, as described, and a predetermined orientation when implanted. By way of example, the valve 200 may have an arrangement of leaflets 210A, 210B, 210C as shown in FIGS. 8A-8B. The device 10 may have an orientation when implanted that is generally along an axis defined by the native mitral valve. In some embodiments, the device 10 may have an orientation when implanted that is generally off this axis. Thus, a way to direct flow to the posterior wall is to tilt the mounting plane of the device 10, for example with a cylindrical device 10. The flow can be directed appropriately by adding features to the structure supporting the device 10 , such as the frame 100 , that modify the mounting plane of the implant device 10 .

[0084] As shown in Figures 8D and 8F, the expansion frame 100 may define a central longitudinal axis around which the frame 100 is concentrically disposed. By way of example, the unconstrained expanded configuration of the frame 100 may be cylindrical, frusto-conical, or other shaped to define a central longitudinal axis. The device 10 may redirect flow as mentioned. The flow direction may be generally as shown in Figures 8C and 8E. Furthermore, the flow direction may be along a major flow axis as shown in Figures 8D and 8F, with or without redirection. In some applications of the device 10, it is desirable to configure the major flow axis to be tilted back at an angle "B" relative to the central longitudinal axis defined by the frame 100. The major flow axis is the normal direction that flow travels into the left ventricle LV after exiting and / or traveling through the device 10. The angle "B" between the central longitudinal axis and the primary flow axis is at least about 5 degrees, and in some applications at least about 10 degrees, but typically is less than about 45 degrees, and in some applications may be less than about 20 degrees. An exemplary embodiment of this angle is shown as angle "B" in Figures 8D and 8F.

[0085] The deflection of the main axis of flow from the central longitudinal axis can be achieved in a three leaflet valve, such as valve 200 including leaflets 210A, 210B, 210C, by increasing the size of the anterior leaflets, such as anterior leaflet 201B. An exemplary embodiment of such a device 10 is shown in Figures 8A and 8B. Enlarging the anterior leaflets, such as anterior leaflet 210B, displaces the main axis of flow posteriorly. The size of the anterior leaflet may be increased such that the anterior leaflet 210B occupies an angle "A" of the circumference of the valve 200, where a valve, annular or otherwise, has a full circumference of 360 degrees. This is shown, for example, in Figures 8A and 8B (right view in Figure 8B). In some embodiments, the size of the anterior leaflet 210B may be increased such that the anterior leaflet 210B occupies an angle "A" of at least about 125 degrees of the circumference of the valve 200. In some embodiments, the anterior leaflet 210B occupies at least about 135 degrees, or 145 degrees, or 160 degrees, or more, of the circumference of the valve 200.

[0086] 9 is a partial side view of an embodiment of a heart valve device 10 showing the interface of the frame 100 and anchor 300, including a coil 320 surrounding a central spike 340. The distal spike 340 may be centered about the axis of the coil 320 of the anchor 300, which rotates about the spike 340 to increase the moment, strength, and fatigue resistance of the anchor 300. The spike 340 may be coupled to the frame 100, such as a distal apex 104, described in further detail herein, for example with respect to FIGS. 2 and 3A.

[0087] 10 is a side view of an embodiment of a heart valve device 10 with an extension frame 100. The taller frame 100 extends the device 10 down into the left ventricle LV. The device 10 with the extension frame 100 extends into the left ventricle LV and may displace the native mitral valve when the device 10 is implanted in the mitral valve annulus MVA. The proximal end 101 of the frame 100 may be attached to the annulus and the distal end 102 may displace the native valve.

[0088] FIG. 11 is a perspective view of an embodiment of a heart valve device 10 having a woven seal 400. The woven seal 400 includes a woven seal body 410 formed from a woven material that surrounds the device 10 to prevent peripheral leakage. The woven material may be constructed of a polymer fabric or metal wire to provide more structural integrity. Both measures are of expandable nature to accommodate varying patient anatomy. The woven seal 400 may be a substitute for the frame 100. That is, the woven seal 400 may take the place of the frame 100 and provide structure and sealing properties to the device 10. The anchor 300 may be coupled to the woven seal 400 as shown. The woven seal 400 may have the same or similar properties and / or functionality as the frame 100, such as the flared end or skirt 150, the external seal 500, etc.

[0089] 12 is a perspective view of an embodiment of a heart valve device 10 having an expandable frame 100. The device 10 has an expandable frame 100 and an anchor 300 disposed at a proximal end 101. An additional feature may be at a distal end 102 of the frame 100 that anchors the frame 100 inward and proximal to the native annulus. The frame 100 may include one or more skirts 150. As shown, a first skirt 150 may be disposed at the proximal end 101 and may include one or more frame tabs 112 with an opening therethrough to receive the anchor 300. A second skirt 150 may be disposed at the distal end 102 and may include one or more angled frame portions 114. The frame portions 114 may be disposed at the distal end 102 of the frame 100 and extend outward and proximally. The frame portions 114 may expand upon delivery of the device 10 to secure the device 10 within the mitral annulus.

[0090] Depending on the desired function of the valve 200, one or both of two different types of seals may be preferably carried by the valve. As described in FIG. 12, the device 10 may have a seal 400. As described herein, the valve replacement with the device 10 may include a tubular support frame 100. The anchors 300 may be carried by the proximal end 101 (e.g., atrium) or the distal end 102 (e.g., ventricle) of the frame 100, depending on whether the implant-last portion of the frame 100 extends primarily into the left atrium or, alternatively, in the ventricular direction, such as to exclude the native valve leaflets. As a result, the annulus of the prosthetic valve 200 may be axially displaced along the flow path relative to the native annulus. To prevent blood flow in the annular space between the annulus of the prosthetic valve 200 and the native annulus, the frame 100 is preferably provided with an annular seal 400, such as a thin sleeve or membrane, which prevents blood flow through the frame wall between the prosthetic annulus and the natural annulus.

[0091] It may also be desirable to include structures to inhibit paravalvular leakage, for example, blood leaking around the valve 200 and / or device 10. Paravalvular leakage may occur between the device 10 and the natural annulus due to a possible geometric mismatch between the orifices of the native valve and the outer diameter of the device 10. For seals 400 that are concerned with possible leakage through the wall of the frame 100, a water-tight membrane may be carried on the inside of the frame 100 (as shown in FIG. 12), on the outside of the frame 100, or both. For seals 500 that are concerned with inhibiting paravalvular leakage, a barrier or membrane is preferably carried on the outer surface of the frame 100, as will be apparent to those skilled in the art. Thus, the seals 400 or 500 on the outside of the frame 100 may be configured to provide both functions, with axially extending parts that cover at least a portion of the length of the frame 100, including the base of the valve leaflets, and parts that extend or are extendable radially outward to fill the space between the frame 100 and the adjacent anatomy.

[0092] An embodiment of a radially outwardly extending component that fills the space between the frame 100 and the adjacent anatomy is the annular seal 500 shown in Figures 13A-13C. The seal 500, such as a sealing ring, may be located on the outside of the frame 100, for example along a central portion of the frame 100, to reduce leakage around the frame 100 as described above. Additionally or alternatively, the seal 500 may be located on the inside of the frame 100. The seal 500 may be activated when an expansion means, such as an inflation mechanism, increases the physical size of the seal 500. In this manner, the seal 500 may have a smaller contracted configuration upon delivery and a larger expanded configuration when implanted. Alternatively, the seal 500 may be passive. For example, the seal 500 may self-expand upon expansion of the device 10 within the heart. The seal 500 may include a radially outwardly extending ring component as shown, but may also include an axially extending component that acts as a barrier, as described above.

[0093] 13A-13C are partial cross-sectional views of a human heart illustrating an embodiment of a delivery system 600 for delivering a heart valve device 10. As illustrated, the device 10 may include a seal 500. FIG. 13A illustrates the device 10 being delivered venously from the groin via a transseptal puncture to access the left ventricle LV. FIG. 13B illustrates the system 600 and device 10 including the anchor 300 inserted into the valve annulus. FIG. 13C illustrates the system 600 and device 10 including the anchor 300 inserted and the rotating anchor 300 removed from the delivery catheter 610 and the sealing cuff inflated. Attached to the device 10 of FIGS. 13A and 13B is a rotating connection 630 that drives the coiled anchor 300, and an inflation tube 650 that changes the size of the seal 500 to reduce or stop paravalvular leakage via hydraulic pressure.

[0094] The seal 500 may be a sealing ring or cuff. The seal 500 may have a general shape such as a toroid. The seal 500 may be added between the proximal portion at the left atrium (above the mitral valve) and the left ventricle LV to prevent leakage around the frame 100. The seal 500 may be of passive nature and may be constructed from a woven fabric or velour. Alternatively, a more active seal 500 may be used that is inflated or expanded to contact the surrounding tissue. For construction of an active seal 500, a fluid solution may be used to hydraulically expand and fill with saline or a polymer solution that hardens to a predetermined durometer. The seal 500 may be constructed from a polymer balloon material such as nylon or Pebax and may be filled from the handle of the delivery catheter 610. In some embodiments, the seal 500 includes an annular skirt, such as a flange, similar to the skirt 150 described with respect to the frame 100. The skirt of seal 500 is attached to device 10 at one end and angles radially outward in either the proximal or distal direction. The skirt of seal 500 is held by a support structure, such as a plurality of struts. Preferably, the skirt of seal 500 angles radially outward in the distal direction so that ventricular pressure improves sealing between the skirt of seal 500 and the adjacent anatomy.

[0095] In some embodiments, the seal 500 includes a ring-shaped tube that is held against a radially outwardly facing surface of the device 10, such as the surface of the frame 100. The tube of the seal 500 may include a fill port with a valve. The fill tube may extend from a deployment catheter, e.g., the instrument 610, to the fill port of the seal 500, in order to place the tube of the seal 500 in communication with a source of inflation medium, with an inflation lumen extending the length of the catheter. The ring-shaped tube of the seal 500 may be at least partially filled after deployment of the device 10, e.g., an implant, but before the release of the device 10 from the deployment catheter. The presence of a paravalvular leak is examined by injection of a contrast agent and viewing the atrium with fluoroscopy. The tube of the seal 500 may be further inflated, or other reactive actions may be taken, such as repositioning the device 10, depending on the functionality observed. Once the functionality of the device 10 and the level of paravalvular leakage (if any) are deemed adequate, the fill tube is removed from the fill port of the tube of the seal 500, the valve of the fill port is closed to retain the inflation medium therein, and the device 10 is released from the deployment catheter.

[0096] 14A-14B are partial side views of an embodiment of a heart valve device 10 showing a frame 100 with a sealing system 140 including threads 142 and corresponding movable restraints 144, such as collars, at the proximal end 101. There may be at least four movable restraints 144. The movable restraints 144 may have openings to receive adjacent struts of the pair of frame 100. FIG. 14A shows an initial unlocked position of the pair of struts 110A, 110B in the body 110 of the frame 100. FIG. 14B shows a final locked position of the struts 110A, 110B. The restraints 144 may be axially slidable along the struts of the pair. Axial advancement of the movable restraints 144, such as collars, reduces the angle between the struts of the pair and reshapes the frame 100. As further shown, the pair of struts 110A, 110B have cables 160 connecting the vertices of the struts 110A, 110B at the distal end 102, such that tension on the cables 160 can pull the two vertices and the anchors 300 together with the corresponding tissue in which the anchors 300 are embedded. The cables 160 can be connected to openings 116A, 116B in the struts 110A, 110B. Additionally, a movable constraint 144, such as a collar having an opening, an internally threaded collar, a nut, or the like, can lock the position and / or angle of the struts 110A, 110B and release tension on the cables 160. The sealing system 140 can be a notch feature held as a nut or a thread for a notch to hold the movable constraint 144 in a desired position against opposing movement of the struts 110A, 110B. In some embodiments, the frame 100 may be configured to be reshaped such that the width, e.g., diameter, at the proximal end 101 is different than the width, e.g., diameter, at the distal end 102 .

[0097] Cables 160 or other tension elements connecting adjacent struts may extend through the deployment catheter and be releasably grasped by a retraction element, such as a pull wire with a distal hook, or by a suture loop wrapped around the cables 160. Proximal retraction of the retraction element displaces the cables 160 proximally, as described in FIG. 14B. Proximal retraction elements and cables 160 may be provided between each pair of adjacent struts, or every second or third pair of struts, depending on the desired functionality. Alternatively, the cables 160 may include a lasso configuration that encircles the entire frame 100 or is connected to adjacent struts of every other pair. Proximal retraction of at least one end of the cables 160 reduces the circumference of the frame 100, as one or both ends of the cables 160 that form a lasso loop extend proximally through the deployment catheter. In an alternative configuration, cables 160 surround at least a portion of frame 100, but are configured to be an integral part of frame 100 and remain attached to frame 100 after deployment. Reduction in the perimeter of frame 100 is accomplished by proximal retraction of a retraction element that is releasably coupled to cables 160, such as that described above with respect to FIG.

[0098] 15 is a perspective view of an embodiment of the heart valve device 10 showing a frame 100 with multiple sealing systems 140 including a select arrangement of threads 142 and corresponding collars 144. Some or all of the anchors 300 and collars 144 may be used depending on the needs of the patient. Not all of the apices of the frame 100 include a collar 144.

[0099] 16-17 are perspective views of an instrument 700 for holding a heart valve device 10 described herein for surgical placement or catheter delivery of the device 10. The instrument 700 may include a handle 710, body portions 720A, 720B, and corresponding instrument heads 730A, 730B. The instrument 700 may be used for surgical placement of the frame 100 by opening and / or closing the instrument 700 depending on the position and / or angle of the handle 710 and / or body portions 720A, 720B. Similar instruments may be configured for transapical or transfemoral catheter delivery. As shown in FIG. 17B, the instrument heads 730A, 730B may include receiving portions 731A, 731B, 732A, 732B. For example, receiving portion 731B may receive and hold strut 110A of frame body 110, and receiving portion 732B may receive and hold strut 110B.

[0100] 18 shows a perspective view of an embodiment of a heart valve device 10 with an angled anchor 300 for delivery and fixation from the left ventricle LV. The device 10 may be delivered and fixed from the left ventricle LV, with the anchor 300 driven from underneath the device 10 in the left ventricle LV. By way of example, a driver 620 may rotate the anchor 300 from the left ventricle LV. The device 10 may include a seal 400 as shown, such as an internal annular barrier, as described in more detail herein.

[0101] Defining the frame 100 diameter to match the patient's anatomy can be accomplished by predefining a shape set size using a shape memory material such as Nitinol, or by expanding a malleable frame 100 material to a defined diameter. Another means can be to reduce the size of the frame 100 using synchronizing wires that encircle the diameter and reduce the length of the wires to provide a force to change the frame 100 shape and size, causing the frame 100 to collapse. Further means can include forces that change the shape of the struts 110A, 110B in the sinusoidal frame 100, including bending forces or collar forces on the struts 110A, 110B that bring the base of the frame 100 together and hold the associated surrounding tissue together. Further means may include cutting threads into the frame struts 110A, 110B to engage a movable constraint 144, such as a nut that advances or rotates on the struts 110A, 110B, drawing the struts together and providing a gathering force on the surrounding tissue. Other means may include a cable 160, string, or other connection between the lower segments of the struts where tension draws the two struts 110A, 110B together. This force may be tension in any direction and may include a proximal or distal force that pushes or pulls the cable 160, drawing the surrounding struts and associated tissue together. The connection between the struts may be by thread means, or by a push-pull mechanism through the exterior of the body and catheter of the device 10.

[0102] As the struts 110A, 110B are drawn together, the apexes of the struts 110A, 110B can be locked or secured with a movable restraint 144, such as a collar or nut disposed on the struts 110A, 110B as described herein. The locking of the struts 110A, 110B can be accomplished with a sealing system 140 to prevent the movable restraint 144 from moving proximally or from loosening against the struts 110A, 110B and moving the struts 110A, 110B away from each other. Alternatively, a small tab can engage with a ratchet surface that prevents the movable restraint 144 from moving proximally but allows the movable restraint 144 to advance further if necessary. Alternatively, the movable restraint 144 can be a nut that is threaded from the apex, which holds the two struts 110A, 110B in close proximity to each other.

[0103] The device 10 may be formed using these and other methods to obtain a variety of different shapes and sizes. The movable restraints 144 may be coupled to the frame 100 and configured to restrain the frame 100 in a desired width, diameter, orientation, shape, etc. Other embodiments of movable restraints may be applied, such as loops that tighten around the frame 100, as described below. Some of these shapes, sizes, configurations, etc. are described with respect to Figures 19A-25B.

[0104] 19A-19B are top and perspective views, respectively, of an embodiment of a heart valve device 10 with a frame 100 shown as a circular ring. The device 10 may include a frame 100 having a ring-shaped body 110. The body 110 may be circular, e.g., annular. The circular shaped device 10 may be placed and secured to or around the annulus and tightened to reduce the natural annulus diameter, after which the device retains its initial circular shape.

[0105] FIG 19C is a perspective view of the device 10 of FIGS. 19A-19B with a valve 200. The device 10 may include a frame 100, shown as a ring-shaped body 110, coupled to or configured to be coupled to the valve 200. The frame 100 may have the valve 200 fabricated therein or secondarily attached. The device 10 may be placed in the annulus, secured thereto, and tightened to reduce the natural annulus diameter. The device 10 retains its circular shape with the valve 200.

[0106] 20A-20B are top and perspective views, respectively, of an embodiment of a heart valve device 10 with a frame shown as a "D" shaped ring. Device 10 may include a frame 100 having a "D" shaped body 110. Device 10 may be configured, for example, shaped to have a "D" shape. The "D" shaped device 10 may be placed and secured in the naturally "D" shaped annulus and tightened to reduce the natural annulus width. The straight portion of the "D" in the device better matches the natural shape and contour of the annulus along the posterior wall.

[0107] FIG 20C is a perspective view of the device 10 of FIGS. 20A-20B with a valve 200. The device 10 may include a frame 100 having a D-shaped body 110 coupled to or configured to be coupled to the valve 200. The frame 100 may have the valve 200 fabricated therein or secondarily attached. The device 10 may be placed in the annulus, secured thereto, and tightened to reduce the natural annulus diameter. The device 10 retains its D-shape with the valve 200.

[0108] 21A-21B are top and perspective views, respectively, of an embodiment of a heart valve device 10 with a frame 100 shown as an oval ring. The device 10 may include a frame 100 having an oval-like shaped body 110. The body 110 may be oval in shape or circular, such as oval, and the oval-like shaped device 10 may be placed and secured to or around the annulus and tightened to reduce the natural annulus diameter, after which the device retains its initial circular shape. The device 10 may be controlled by tightening to maintain its oval shape, or further tightened to an annular configuration. Maintaining the oval shape may minimize the amount of tightening required when the apex of the long axis is aligned with the commissure. Stretching the annulus in this direction may naturally shorten the anterior-posterior (AP) distance and reduce any regurgitation. Such tightening according to this and other embodiments may be achieved with a movable restraint 144, which may be a collar and / or loop. The constraint 144 may include a loop that is coupled to and / or retained by the frame 100 and surrounds a central lumen of the frame 100. The constraint 144 may be configured to reversibly adjust the size and shape of the frame 100 radially within an operating range.

[0109] 21C is a perspective view of the device of FIGS. 21A-21B with a valve. Device 10 may include a frame 100 having an oval shaped body 110 coupled to or configured to be coupled to a valve 200. Frame 100 may have valve 200 fabricated therein or secondarily attached. Device 10 may be placed in the annulus, secured thereto, and tightened to reduce the natural annulus diameter. Device 10 may maintain an oval or other circular shape based on the amount of tightening.

[0110] 22A-22B are top and perspective views, respectively, of an embodiment of a delivery and shaping system for delivering and shaping, e.g., ovalizing, the various heart valve devices described herein. The device 10 may include an oval form and frame configured to be shaped in an oval manner. One way to ovalize the circular ring and annulus is to use a catheter-based device to stretch both simultaneously along the same axis as the commissures. The device may be made from a looped flat ribbon with a preset bend. As the ribbon exits the catheter, the distal end of the loop is pulled proximally while the proximal end of the ribbon remains stationary. This causes the ribbon to make a wide loop, pushing the annulus of the device outward at the commissures to create the desired oval shape. The oval ring, with a valve 200 made or attached therein, can be placed in the annulus, secured, and tightened to reduce the natural annulus diameter. The device can maintain an oval or circular shape based on the amount of tightening. This can be achieved with a novel functional valve 200.

[0111] 22C is a perspective view of the system and device of FIGS. 22A-22B with a valve coupled to the device. An oval ring, with a prosthetic valve 200 created or attached therein, can be placed in the annulus, secured, and tightened to reduce the native annulus diameter. The device can maintain an oval or circular shape based on the amount of tightening. This can be accomplished with a novel functional valve 200.

[0112] The device 10 may include an oval feature and a frame 100 configured to be shaped like an oval, with the frame 100 coupled to or configured to be coupled to a valve 200. The frame 100 may include a valve 200 and / or an oval feature fabricated therein or secondarily attached thereto. The device 10 may be placed in the annulus, secured thereto, and tightened to reduce the natural annulus diameter. The device may maintain an oval or other circular shape based on the amount of tightening.

[0113] Some methods for ovalizing the ring are described below, each of which may be used in conjunction with a delivery catheter.

[0114] 23 is a partial perspective view of an embodiment of a piston-based delivery and shaping system for delivery and shaping, e.g., ovalizing, of the various heart valve devices described herein. A pair of opposing shafts with nested sections can be used to expand the annulus in opposite directions to create the oval.

[0115] 24A-B are partial perspective views of an embodiment of a balloon-based delivery and shaping system for delivery and shaping, e.g., ovalizing, of the various heart valve devices described herein. A liquid-filled balloon with anvil ends and a central shaft connecting them can be used to form an oval annulus. The balloon can also be shaped like an oblong cylinder with rounded ends and have a fill port going in the middle of its length. This type of balloon can also generate sufficient fluid pressure to expand the annulus.

[0116] 25A-B are partial perspective views of an embodiment of a rotating shaft-based delivery and shaping system for delivery and shaping, e.g., ovalizing, of the various heart valve devices described herein. The device exiting the delivery catheter may hold a proximal exterior connection that can apply torque to two opposing shafts. When rotated in opposite directions, the shafts extend outward, pushing the annulus to create the oval.

[0117] While what are presently considered to be exemplary embodiments have been shown and described, those skilled in the art will recognize that various other modifications may be made and equivalents substituted without departing from the invention. Additionally, numerous modifications may be made to adapt a particular situation to the teachings of the invention without departing from the central concepts described herein. Thus, it is intended that the invention not be limited to the particular embodiments disclosed, but that such invention may include all embodiments that fall within the scope of the appended claims and equivalents thereof.

[0118] It is contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments disclosed above may be made and still fall within one or more of the present inventions. Furthermore, any specific features, forms, methods, characteristics, features, properties, attributes, or elements disclosed herein with respect to the embodiments may be used in all other embodiments disclosed herein. Thus, various features and forms of the disclosed embodiments may be combined or substituted for one another to produce various modes of the disclosed invention. Thus, it is intended that the scope of the invention disclosed herein should not be limited by the specific disclosed embodiments described above. Moreover, the invention is susceptible to various modifications and alternative forms, specific examples of which are shown in the drawings and described in detail herein. However, the invention should not be limited to the specific forms or methods disclosed, but on the contrary, includes all modifications, equivalents, and alternatives falling within the spirit and scope of the various embodiments described and the scope of the appended claims. Any method disclosed herein need not be performed in the order described.

[0119] Ranges described herein also include any and all overlaps, subranges, and combinations thereof. Words such as "up to," "at least," "greater than," "less than," and "between" are inclusive of the recited numbers. Numbers preceded by terms such as "approximately," "about," "up to about," and "substantially," as used herein, are inclusive of the recited numbers and also correspond to amounts or characteristics that approximate the recited amount or characteristic that still perform the desired function or obtain the desired result. For example, the terms "approximately," "about," and "substantially" can refer to amounts that are less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the recited amount or characteristic. A characteristic of an embodiment disclosed herein that is preceded by a term such as "approximately," "about," and "substantially," as used herein, corresponds to a characteristic with some variability for that characteristic that still performs the desired function or obtains the desired result.

[0120] With respect to the use of substantially any plural and / or singular terminology herein, those of skill in the art can convert from plural to singular and / or from singular to plural as appropriate to the context and / or application. The various singular-plural permutations are expressly set forth herein for clarity.

[0121] Generally, those skilled in the art will understand that the terms used herein are generally intended to be "non-limiting" terms (e.g., the term "including" should be understood as "including but not limited to," the term "having" should be understood as "having at least," the term "including" should be understood as "including but not limited to," etc.). When a specific number is intended in the introduction of the description of an embodiment, such an intention is clearly stated in the embodiment, and in the absence of such a statement, it will be further understood by those skilled in the art that such an intention does not exist. For example, as an aid to understanding, the present disclosure may include the use of the introductory phrases "at least one" and "one or more" to introduce the description of an embodiment. However, the use of such phrases should not be understood to suggest that the introduction of an embodiment description by the indefinite article "a" or "an" limits any particular embodiment that includes the introduction of such an embodiment description to an embodiment that includes only such a description, even when the same embodiment includes the introductory phrases "one or more" or "at least one" and an indefinite article such as "a" or "an." (For example, "a" and / or "an" should be generally understood to mean "at least one" or "one or more.") The same applies to the use of definite articles used to introduce the description of the embodiments. Furthermore, even if a specific number is explicitly described in the introduction of the description of the embodiments, those skilled in the art will understand that such a description should generally be understood to mean at least the number described (for example, the mere description of "two items" without other modifications generally means at least two items or two or more items). Furthermore, when a definition similar to "at least one of A, B, and C, etc." is used, such a configuration is generally intended in the sense that a person skilled in the art would understand the definition. (For example, "a system having at least one of A, B, and C" may include, but is not limited to, a system having only A, only B, only C, both A and B, both A and C, both B and C, and / or both A, B, and C, etc.) When a definition similar to "at least one of A, B, or C, etc." is used, such a configuration is generally intended in the sense that a person skilled in the art would understand the definition.(For example, "a system having at least one of A, B, or C" can include, but is not limited to, systems having only A, only B, only C, both A and B, both A and C, both B and C, and / or both A, B and C, etc.) Those skilled in the art will further appreciate that substantially any disjunctive language and / or expression in the descriptions, embodiments, or drawings presenting two or more alternative terms should be understood to contemplate the possibility of including one of the terms, either term, or both terms. For example, the phrase "A or B" is understood to include the possibilities of "A" or "B" or "A and B."

[0122] While the invention has been described herein with respect to certain embodiments, and with respect to certain exemplary methods, it is understood that the scope of the invention is not limited thereto, and applicants intend that variations of the methods and materials described herein that are apparent to those skilled in the art are within the scope of the disclosed invention.

Claims

1. In an implantable device, a frame having a proximal end and a distal end, the frame comprising at least a first pair of adjacent struts that meet at a distal apex located at the distal end of the frame, the frame comprising an anti-retraction feature configured to resist movement of the frame within the valve annulus; at least one anchor disposed in the anti-retraction configuration, at least partially embedded in tissue surrounding the native valve, extendable distally away from the frame and retractable relative to the frame; a movable constraint coupled to the frame and configured to constrain the frame in a desired configuration.

2. a frame having a proximal end and a distal end and comprised of a plurality of adjacent struts, the adjacent struts meeting at a distal apex located at the distal end of the frame, the frame having an anti-retraction feature configured to resist movement of the frame within the valve annulus; a plurality of anchors disposed on and coupled to the anti-retraction configuration, the anchors being extendable and retractable relative to the frame and having distal ends configured to engage tissue.

3. 3. The implantable device of claim 1 or 2, wherein the anti-retraction feature is located at a distal end, a proximal end, or both of the frame.

4. 4. The implantable device of claim 3, wherein said anti-retraction feature is a skirt formed from one of the proximal or distal ends of said frame.

5. The implantable device of claim 4 , wherein the frame is disposed about a central axis and the skirt is disposed at an angle relative to the central axis of the frame.

6. 5. The implantable device of claim 4, wherein said skirt is formed from a distal end of said frame and tapers upwardly toward a proximal end of said frame.

7. 6. The implantable device of claim 5, wherein said skirt is formed from a proximal end of said frame and tapers toward a distal end of said frame.

8. 6. The implantable device of claim 5, wherein the skirt supports the distally directed anchors and orients the distally directed anchors at an angle relative to a central axis of the frame.

9. 9. The implantable device of claim 8, wherein the anchor is disposed at a distal end of the frame and extends distally and outwardly and is disposed at an angle relative to a central axis of the frame.

10. 5. The implantable device of claim 4, wherein said frame is comprised of a plurality of struts joined in pairs to form a plurality of apexes, and said skirt is formed from a plurality of apexes.

11. The implantable device of claim 1 , wherein said at least one anchor is rotatably supported by said frame.

12. 3. The implantable device of claim 1 or 2, wherein the frame including the anti-retraction feature is expandable relative to a central axis defined by the frame.

13. The implantable device of claim 1, wherein the frame is formed of a plurality of struts joined in pairs to form a plurality of vertices, and the movable constraint portion is connected to at least one of the vertices and adjusts the configuration of the frame by adjusting the position of the pair of joined struts.

14. 9. The implantable device of claim 8, wherein the skirt is angled around the circumference of the proximal end of the frame and the distally directed anchor is disposed on the skirt.

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