Systems, methods, and devices for a delivery system, method, and device for implanting an artificial heart valve

Abstract

Disclosed are embodiments of delivery systems, devices, and methods for delivering a prosthetic heart valve device to a heart chamber for expanded implementation. More specifically, disclosed are methods, systems, and devices for delivering a self-expanding prosthetic mitral valve device to the left atrium without engagement of the left ventricle, the native mitral valve leaflets, or the annular tissue downstream of the upper annular surface during delivery, and in some embodiments without engagement of the ventricle, the mitral valve leaflets, and / or the annular tissue downstream of the upper annular surface by the delivered, positioned, and expanded prosthetic mitral valve device. [Selected Figure] Figure 5A

Description

Technical Field

[0001] [Inventors] Jeffrey W. Chambers, a citizen of the United States of America, of Maple Grove, Minnesota; Gregory G. Brucker, a citizen of the United States of America, of Minneapolis, Minnesota; Joseph P. Higgins, a citizen of the United States of America, of Minnetonka, Minnesota; Saravana B. Kumar, a citizen of India, of Minnetonka, Minnesota; Jason S. Diedering, a citizen of the United States of America, of Minneapolis, Minnesota; Karl A. Kabarowski, a citizen of the United States of America, of Maple Grove, Minnesota; Robert J. Thatcher, a citizen of the United States of America, of Blaine, Minnesota; James E. Flaherty, a citizen of the United States of America, of Minnetonka, Minnesota; Jeffrey R. Stone, a citizen of the United States of America, of Minnetonka, Minnesota.

[0002] [Cross - Reference to Related Applications] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 448,036, filed on January 19, 2017, entitled "Systems, Methods, and Apparatus for Delivery Systems, Methods, and Apparatus for Implanting an Artificial Heart Valve", which is hereby incorporated by reference in its entirety.

[0003] [Description of Research and Development Sponsored by the Federal Government] Not applicable

[0004] [Incorporation by Reference] All references, including but not limited to publications, patent applications, and patents mentioned herein, are hereby incorporated by reference into this specification to the same extent and with the same effect as if each reference were specifically and individually indicated to be incorporated by reference.

[0005] [Technical Field] The invention described herein relates to delivery systems, devices, and methods for delivering and / or positioning heart valves.

Background Art

[0006] The human heart includes four chambers and four heart valves that assist in the forward (antegrade) flow of blood through the heart. The chambers include the left atrium, left ventricle, right atrium, and left ventricle. The four heart valves include the mitral valve, tricuspid valve, aortic valve, and pulmonary valve.

[0007] The mitral valve is positioned between the left atrium and the left ventricle and helps control blood flow from the left atrium to the left ventricle by acting as a one-way valve to prevent backflow into the left atrium. Similarly, the tricuspid valve is positioned between the right atrium and the right ventricle, while the aortic valve and pulmonary valve are semilunar valves positioned within the arteries that carry blood out of the heart. All of the valves are one-way valves and have valve leaflets that open to allow forward (antegrade) blood flow. Properly functioning valve leaflets close under the pressure exerted by the backflow of blood to prevent blood from flowing back (regurgitating) into the chamber from which the blood has just flowed out.

[0008] Congenital heart valves can be or become dysfunctional for various reasons and / or conditions including, but not limited to, disease, trauma, congenital malformations, and aging. These types of conditions can cause the valve structure to not be able to open properly (stenotic disorder) and / or not be able to close properly (regurgitation).

[0009] Mitral regurgitation is a specific problem resulting from a malfunctioning mitral valve. Mitral regurgitation results from the mitral valve and permits at least some retrograde blood flow from the right atrium into the left atrium. This backflow of blood can impose a volume load on the left ventricle that can lead to a series of left ventricular compensatory adaptations and adjustments, including remodeling of the ventricular cavity size and shape that varies considerably over the long-term clinical course of mitral regurgitation.

[0010] Thus, generally, native heart valves, such as the mitral valve, may require functional repair and / or augmentation, including partial or complete replacement. Such interventions can take several forms, including open-heart surgery and open-heart implantation of replacement heart valves. See, for example, U.S. Patent No. 4,106,129 (Carpentier) for procedures that are highly invasive, carry patient risks, require long hospital stays, and also a recovery period that is very painful.

[0011] Less invasive methods and devices for replacing a dysfunctional heart valve are also known and include percutaneous access and catheter-mediated delivery of the replacement valve. Most of these solutions include a replacement heart valve attached to a structural support such as a stent commonly known in the art, or other forms of wire networks designed to expand upon release from a delivery catheter. See, for example, U.S. Patent No. 3,657,744 (Ersek), U.S. Patent No. 5,411,552 (Andersen). Self-expanding variants of the support stent assist in positioning the valve and holding the expanded device in a predetermined position within the target heart chamber or blood vessel. This self-expanding configuration also presents problems when, as often happens, the device is not properly positioned on the first positioning attempt and thus must be recaptured and repositioned. This recapture process in the case of a fully or partially expanded device requires the operator to pull the folded device back into the delivery sheath or catheter, adjust the arrival position of the device, and then refold the device to a point where it can be re-expanded to the appropriate position by redeploying the positionally adjusted device distally from the delivery sheath or catheter. Since an expanded stent or wire network is generally designed to achieve an expanded state that also resists compressive or folding forces, it is difficult to fold an already expanded device.

[0012] In addition to the open-heart techniques described above, access to the target valve is achieved percutaneously via at least one of the known access routes of at least transapical, transfemoral, transatrial, and transseptal delivery techniques.

[0013] Generally, the art has focused on systems and methods that allow for the partial delivery of a folded valve device using one of the aforementioned known access paths, where one end of the device is released from a delivery sheath or catheter, extended for initial positioning, and then fully released and extended once appropriate positioning is achieved. See, for example, U.S. Patent Nos. 8,852,271 (Murray, III), 8,747,459 (Nguyen), 8,814,931 (Wang), 9,402,720 (Richter), 8,986,372 (Murray, III), and 9,277,991 (Salahieh), and U.S. Patent Publications 2015 / 0272731 (Racchini), and 2016 / 0235531 (Ciobanu).

Prior Art Documents

Patent Documents

[0014]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

Patent Document 7

Patent Document 8

Patent Document 9

Patent Document 10

Patent Document 11

SUMMARY OF THE INVENTION

PROBLEMS TO BE SOLVED BY THE INVENTION

[0015] However, known delivery systems, devices, and methods still have significant deficiencies in delivery methodologies, including, among other things, positioning and recapture capabilities and efficiency.

[0016] Furthermore, known "replacement" heart valves are intended to completely replace the native heart valve. Thus, these replacement heart valves physically engage the annulus throat portion and / or the valve leaflets, thereby eliminating all remaining functions of the native valve and causing the patient to rely entirely on the replacement valve. Generally speaking, it is a preferred solution to maintain and / or preserve the native function of the heart valve, and thus valve augmentation is preferred over complete replacement. Clearly, there will be cases where the native valve has substantially completely lost functionality prior to an interventional implantation procedure, or where the native valve continues to lose functionality after the implantation procedure. The preferred solution is the delivery and implantation of a valve device that can not only function as an assistive functional valve but also completely replace the native function of a valve that has lost most or all of its function. However, the solution of the present invention described below applies generally to all types and forms of heart valve devices unless otherwise specified.

[0017] Finally, known solutions for mitral valve replacement systems, devices, and methods require a two-chamber solution, i.e., an implanted replacement valve device is involved and engaged with the left atrium and the left ventricle. Generally, these solutions include a radially expandable stent within the left atrium and use the left ventricle, the left ventricular chordae tendineae, and even the subannular plane within the left ventricular wall to have a fixation or anchoring that is connected downward from the stent device through the annulus throat (disposed downward through the annular penetration).

[0018] Such two-chamber solutions are unduly bulky and are thus more difficult to deliver and position / re-capture / re-position from a strictly structural point of view. Further, two-chamber solutions present difficulties in that they require ventricular fixation and / or tethering connections to maintain position. Further, the device portion disposed within the left ventricle must be routed through the valve annulus, the circumferential sleeve, and the native mitral valve, thereby disturbing the remaining joining ability of the native valve leaflets, and thus these solutions interfere with the functionality of the native valve as described above. Additionally, two-chamber solutions generally require invasive fixation of some native tissue, resulting in unnecessary trauma and potential complications.

[0019] Furthermore, it will be appreciated that two-chamber mitral valve solutions require sub-annular and / or ventricular engagement with anchors, tethers, etc., as the atrial portion of the device cannot adequately secure itself to the upper portion of the heart chamber and / or valve annulus. It should be noted that the solutions of the present invention described herein are readily applicable to single or two-chamber solutions unless otherwise indicated.

Means for Solving the Problems

[0020] Various embodiments of several inventions disclosed herein address these problems, among others.

Brief Description of the Drawings

[0021]

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Embodiments for Carrying Out the Invention

[0022] Various embodiments of the present invention are disclosed in the drawings for providing percutaneous access to a target valve via at least one of the known access routes of the transapical, transfemoral, transatrial, and transseptal delivery techniques. Each of these access routes can be used in the embodiments disclosed herein.

[0023] Accordingly, FIG. 1 shows one embodiment of an artificial valve device 100 having a two-part frame in a folded configuration. The distal portion 102 of the folded device includes a valve having an artificial valve leaflet with a portion of a support frame, and is longitudinally translatably and rotatably confined within the lumen of an outer sheath 104 having a first outer diameter D. The proximal portion 106 of the folded device 100 includes the remaining support frame, which is operatively connected to the distal portion 102 of the folded device 100 and is longitudinally translatably and rotatably confined within the lumen of an inner sheath 108 that is at least longitudinally translatable relative to the outer sheath 104, and the outer sheath 104 is at least longitudinally translatable relative to the inner sheath 108. The inner sheath 108 and / or the outer sheath 104 can also be translationally movable in a rotational direction relative to the other sheath. The inner sheath 108 is disposed within the lumen of the outer sheath 104, and thus, the inner sheath 108 includes a second outer diameter D' that is smaller than the outer diameter D of the outer sheath.

[0024] The preferred configuration of the apparatus of FIG. 1 includes a folded apparatus 100 that is comprised of one unit having a proximal portion 106 and a distal portion 102 as shown. The outer sheath 104 may be retracted to first expose and release the distal portion 102 from the distal end 110 of the outer sheath 104 and perform an initial expansion and positioning into the target cavity of the heart. Alternatively, the distal portion 102 of the apparatus 100 may be pushed distally and released from the distal end 110 of the outer sheath 104 in response to, for example, a distal translation of the inner sheath 108 or in response to a push rod that pushes the proximal portion 106 of the apparatus 100. In the case of a push rod, the proximal portion 106 is ultimately pushed distally from the small lumen of the inner sheath 106 into the large lumen of the outer sheath 104 where a provisional secondary expansion of the proximal portion 106 occurs, followed by a secondary positioning expansion when the proximal portion 106 is finally released from the distal end 110 of the outer sheath 104.

[0025] When expanded within the left atrium in relation to an artificial mitral valve, the lower portion of the distal portion 102 may be positioned relative to the upper surface of the valve annulus within the left atrium.

[0026] In this configuration, when the distal portion 102 is properly positioned and released / expanded, the secondary release and expansion of the proximal portion 106 of the apparatus 100 may be initiated and achieved according to the alternative methods described above with respect to the initial release and expansion of the distal portion 102. One of ordinary skill in the art will recognize that once the initial positioning expansion of the distal portion 102 is complete, the secondary positioning expansion of the proximal portion 106 will then also be properly placed and positioned.

[0027] The configuration of FIG. 1 enables, in its various embodiments, the delivery of an apparatus 100 that includes a frame that may be slightly too large in dimension for a cavity, such as an atrium, by a two - stage frame positioning expansion method. Some frames in the folded form may be twice as long longitudinally as the dimension of any cavity, such as an atrium. Therefore, a step - by - step positioning expansion method is required for delivery.

[0028] Referring now to FIGS. 2A and 2B, there is provided an artificial valve device 200 comprising a support stent frame with an artificial valve attached therein and / or supported therein, the design including two portions (distal 202 and proximal 206) having an expanded diameter connected by a central portion 203, where the artificial valve with valve tip 205 is held / supported within the distal portion 202, and the central portion 203 has a diameter smaller than the expanded diameters of the two portions 202, 206. As shown, the two portions 202, 206 comprise a non-deformed fully expanded sphere, although other shapes can be used as will be readily understood by those skilled in the art. Certain embodiments may include at least one of the proximal portion 206 and the distal portion 202 having an expanded size slightly larger than the dimensions of the target cavity, e.g., the left atrial dimension, to allow for expansion fixation. Further, the aspect ratio of each of the two portions 206, 202 can vary.

[0029] As shown, the folded stent with the valve is held within the lumen of the delivery sheath 204, and the distal portion that holds or supports the device 200 therein is released from the end 210 of the delivery sheath 204 and then positioned and expanded within the target cavity, e.g., the left atrium. Once proper positioning is confirmed, the remaining central portion 203 (if not previously released together with the distal portion 202) and / or the proximal portion 206 can be released and positioned and expanded by the methods described in connection with FIG. 1, including the use of the inner sheath and / or a push rod for translating the device 200 from the distal end 210 of the outer delivery sheath 204. Similar to FIG. 1, this embodiment includes a two-stage or staged delivery mechanism. Both sets of the embodiments of FIGS. 1 and 2A / 2B can include a coating or cover on the distal portion 202, while the proximal portion 206 can include, for example, an open frame formed from stent cells. In the case of FIGS. 2A / 2B, the central portion 202 can also include an open cell structure and need not be covered. The dashed lines in FIG. 2B show an alternative embodiment where the expanded delivery portion 202 includes a hinge point 212 to assist in directing the artificial valve and valve tip within the distal portion 202 downwardly toward the native valve.

[0030] Figures 3A, 3B, 3C, 5A, and 5B provide exemplary delivery methods related to further disclosure of an exemplary prosthetic valve device having support means such as, for example, with a stent. Thus, FIG. 3A shows a folded device 300 within the lumen of a delivery sheath 304 operably communicating with a push / pull rod 308 actuated by a device operator. This device can translate the folded device 300 distally from the distal end 310 of the delivery sheath 304 as shown in FIG. 3A, and conversely, if necessary, retract the expanded device 300 into the distal end 310 of the delivery sheath 304 as shown in FIG. 3B. Also, in certain embodiments, the push / pull rod 308 can rotate the folded device 300 within the lumen of the delivery sheath 310 to assist in positioning prior to release and expansion. Further, the operable communication between the push / pull rod 308 and the folded device 300 can include a screw or clip release mechanism 311 connected to the most proximal portion of the folded device 300. The base or bottom of the device 300 may be covered with tissue or other biocompatible material, and the top of the device may include an open cell structure.

[0031] Generally, the folded device 300 is loaded and positioned within the delivery sheath 304 with the valve portion 305 oriented downward as shown. This allows the folded valve device 305 to be pushed laterally out of the delivery sheath 304 as shown, and correctly orient the valve device 300, which expands upon release from the delivery sheath, towards the native valve and the target chamber, such as the mitral valve and the left atrium.

[0032] In some cases, an alignment wire 315 can be translated from the delivery sheath 304 into a pulmonary vein, such as the left superior pulmonary vein PV, for example, to assist in positioning and delivering the device 300.

[0033] Figure 4 shows the lateral delivery of the device 300 during expansion and immediately after delivery from the outer end 310 of the delivery sheath 304, with the delivered device being substantially vertically oriented and aligned for positioning on the native valve.

[0034] Accordingly, as best shown in FIGS. 5A and 5B, the prosthetic valve device 500 can be delivered asymmetrically in the lateral direction (with the valve portion 505 oriented at the bottom as shown), and can include a locating element 515 operably connected to the prosthetic valve device 500, where the locating element 515 or at least the distal end of the push tube extends from the delivery sheath 503 with the locating element 515 disposed within the pulmonary vein PV, e.g., the left upper pulmonary vein as shown. This system provides an auto - centering system that can expand when the folded prosthetic valve device 500 is released / translated from the distal end 510 of the delivery sheath 504. As shown, the push tube 508 and associated connection 511 can be used to assist in manipulating the orientation of the prosthetic valve device 500 when the prosthetic valve device 500 is delivered from the distal end 510 of the delivery sheath 504.

[0035]

[0036] Referring now to FIGS. 6A - 6C, the prosthetic valve device 600 is delivered using a delivery catheter or sheath 604 that includes a distal portion 620 that is pre - curved within the atrium or that can be adapted to be curved to present a substantially straight distal end section 620. FIG. 6A provides a pre - curved embodiment that is curved to enable loading of the prosthetic valve device 600 in a configuration that positions the valved bottom 605 in the proper location when released from the distal end 610 of the pre - curved distal portion 620 of the delivery catheter or sheath, and more specifically from the straight distal section that is distal to the pre - curved distal portion 620. Thus, as shown, the folded and expandable frame / stent valve support portion 605 is the most distal within the lumen of the delivery catheter / sheath 604. The pre - curved portion 620 enables easy orientation of the valved portion 605 having an exemplary mitral valve and / or the upper surface of its annulus.Accordingly, a delivery system having a curved distal portion as shown in FIG. 6A enables positioning of the prosthetic valve device 600 over the valve annulus and native valve leaflets. Once positioned over the valve annulus and native valve leaflets, the curved delivery catheter or sheath 604 is withdrawn proximally, either alone or in combination with a push rod 608 or similar device proximal to the prosthetic valve device 600, to deploy and deliver the prosthetic valve device 600 into the left atrium and to expand the delivered device 600. The curved delivery catheter or sheath 604, in some embodiments, includes a straight distal end that is within the left atrium and distal to the curve 620, and it is notable that the compressed prosthetic valve device 600 is translated and manipulated around the curved portion 620 of the curved delivery catheter or sheath 604. The compressed prosthetic valve device 600 can be assisted in translating around the curved portion 620 of the curved delivery catheter or sheath by including suture attachment to the distal end of the implant, a pull wire attached to the distal end of the implant that extends to the proximal end of the delivery catheter or sheath, or by taking advantage of the natural flexion point in the arrangement of FIG. 1 between the proximal and distal portions of the prosthetic valve device and / or by hinge points such as those shown in FIG. 2.

[0037] Figures 6B and 6C include an alternative approach for creating a curved portion 620 by enabling the curvature of the distal portion of the delivery sheath or catheter 604 by providing a series of incisions or serrations 609 that become weak regions prone to bending along the bottom surface of the sheath or catheter. As shown, the pull wire 625 is attached to the distal end 610 of the catheter 604 along this bottom weak incision or serrated region, routed through the catheter / sheath lumen for the operator, and the operator can pull the wire in the proximal direction with a force F to obtain a desired curvature before releasing the folded artificial valve structure 600, and the folded artificial valve structure 600 is oriented in a folded configuration as in Figure 6A and is released to expand and position substantially directly onto the target valve or upper annulus. The incision 609 may extend completely through the catheter / sheath wall or may be only a section having a catheter / sheath wall that is thinner than the remaining portion of the catheter / sheath wall. The illustrated incision 609 is uniform and generally square, but any depth, shape, and its uniform or non-uniform spacing may be used to achieve a weakened region.

[0038] Figures 7A and 7B show a system for delivering an exemplary artificial valve, such as mitral valve replacement or augmentation, to a heart chamber, such as the left atrium, in combination with an additional guiding instrument 728 used to assist in guiding the device (not shown) with a valve being expanded using a transseptal access through a delivery catheter or sheath 704 as shown in Figure 7A and using the methods or devices described herein when the device is released from the distal end 710 of the catheter or sheath 704. The additional guiding instrument 728 can be disposed, for example, within the superior pulmonary vein PV. The guiding instrument 728 may be hingedly or rotatably attached to the catheter or sheath 704 so as to allow the instrument 728 to rotate in a fixed position. A pull wire similar to that shown in Figures 6B and 6C can be used to connect to the instrument 728 and operate the instrument 728 to a predetermined position.

[0039] FIG. 7B shows two delivery systems, a first delivery system 800 for alignment and placement and a second delivery system 850 for recapture and repositioning as needed. One of the first delivery system 800 or the second delivery system 850 can access the target heart chamber via a trans-femoral access method, and the other delivery system can access the target heart chamber via another trans-venous access method. Thus, the first delivery system 800 may include a delivery catheter or sheath 804 as described elsewhere herein, and the second delivery system may include a recapture and repositioning catheter or sheath 854 having a structure similar to the delivery catheter / sheath 804.

[0040] FIGS. 8A and 8B show embodiments designed to facilitate the accurate positioning of an artificial heart valve within a chamber, such as the left atrium, and include, but are not limited to, auto-centering and fluoroscopy techniques. In this embodiment of the prosthetic stent-valve device 900, since the artificial valve and valve leaflets 905 are supported near the bottom of the valve device, the upper portion 909 of the device 900 can be divided into small segments as shown from above in FIG. 8A. In the illustrated case, four small segments are provided, but other numbers of small segments may certainly be useful and are within the scope of the present invention. As shown, the opposing small segments are either of an open cell structure or an open wire structure 907, or are composed of a fabric in the form of a kind of sail 908. When this device 900 is delivered to the target heart chamber, the fabric sail 908 captures and uses the force of the natural blood flow to manipulate the device frame 900 into the appropriate position and then releases and expands when the positioning is confirmed.

[0041] Figure 8B is a related concept and also includes an annular spacer 919 that can be initially delivered via a delivery catheter / sheath as described above in this specification. In certain embodiments, the spacer may be directed to a predetermined position with a guidewire positioned within the lumen of the delivery catheter / sheath. Further, it may exit from the distal end of the delivery catheter / sheath and be disposed proximate (proximally) to the upper annular surface of the chamber or at least midway within the annular throat. When released from the lumen and distal end of the delivery catheter / sheath, the annular spacer 919 may expand from its delivered folded configuration and be positioned on the upper annular surface, separating the artificial valve and valve tip 905 from the upper annular surface. Subsequently, an artificial valve device, which may or may not include a sail 908 as described herein and shown in FIG. 7A, is delivered from the delivery catheter / sheath, positionally expanded, and connected to the previously positioned spacer 919.

[0042] Next, the positional orientation delivery structures are described in FIGS. 9A - 9D. Generally, each of these valve - equipped devices is designed for use in the left atrium and utilizes the left atrial appendage (LAA) as an orientation mechanism. Thus, FIG. 9A includes an LAA plug 1006 disposed on the side of the folded device 100 within the lumen of the delivery sheath 1004. In FIG. 9B, the LAA plug 1006 is at least partially positioned within the LAA. When the LAA is engaged by the LAA plug 1006, the operator confirms that the valve - equipped artificial device 1000 is in the correct position. This device can be used in combination with any of the previously described devices and methods, including but not limited to staged two - step delivery devices and methods, whereby the initial positioning expansion aligns the LAA plug within the LAA, and then the secondary positioning expansion of the remainder of the device is initiated by release from the distal end of the delivery sheath.

[0043] A further advantage of the particular embodiments of FIGS. 9A and 9B is the use of the LAA plug 1006 as a device for preventing coagulation within the LAA, the LAA plug 1006 completely filling the LAA and / or the outer flange 1008 completely covering the LAA opening to prevent any thrombus from forming and / or exiting the heart and potentially causing a stroke.

[0044] FIG. 9D shows a slightly different mechanism by which the guide wire 1020 is disposed within the LAA through the delivery sheath 1004 to provide an orientation guide for (one-step or stepwise) positioning and expanding a folded device with an artificial valve (not shown) within the lumen of the delivery sheath 1004. The sheath 1004 can be withdrawn to position the expansion, and the valve-equipped device (not shown) can be deployed / liberated from the distal end of the sheath 1004, or a push rod can be used to extrude the valve-equipped device from the distal end of the sheath as described above. In these cases, the guide wire 1020 positioned within the LAA provides important orientation guide parameters so that the operator knows that the positioning will be appropriate upon expansion. The guide wire 1020 may include a non-traumatic tip to avoid damaging the tissue of the LAA.

[0045] FIG. 9C shows another alignment / orientation system where the delivery catheter / sheath 1004 is introduced into the left atrium via a pulmonary vein PV, such as the superior pulmonary vein, and the guide wire 1020 is passed through the lumen of the delivery catheter / sheath 1004 and disposed within or adjacent to the annulus, i.e., the annular throat, as a guide for the valve-equipped device (not shown, but compressed and self-expanding as described above) to be delivered. When the sheath 1004 is withdrawn or a push rod is used to extrude the folded valve-equipped device from the distal end of the delivery catheter or sheath 1004, the expanding valve-equipped device slides down over the pre-positioned guide wire 1020 and assumes an appropriate position when fully expanded.

[0046] Figure 10A shows a partially expanded stent-valve device 1100 released from a delivery catheter sheath. At least one capture wire 1030 (shown radially wound around device 1100, although it may take other winding positions) is shown, which prevents the expandable device 1100 from fully expanding until it is properly positioned within the target heart chamber, such as the left atrium. Once the proper position is confirmed, the capture wire 1030 can be removed by cutting and pulling distally through the lumen of the delivery sheath 1004, or by disconnecting the connecting pin or latch 1032 or the like so that the device 1100 can be fully expanded at the appropriate location. Figure 10B similarly has alignment wires 1130, which assist in the positional orientation when fed out from the distal end of the delivery catheter / sheath 1104 while connected to a sheath that partially expands at two or more stabilization points 1034 until the proper position is confirmed. The connection of the stabilization points 1134 holds the partially expanded device in that state until the proper position is confirmed, and then can be removed by cutting (as in the case of releasable sutures), or by disconnecting the connecting pin or latch to allow full expansion at the appropriate location, or by providing a secondary means over a wire cutter introduced through the delivery catheter / sheath 1104 to clip the alignment wire 1130.

[0047] Figure 10C provides an alternative artificial heart valve device shown in a positionally expanded position after being released from the distal end of the delivery catheter / sheath 1104, and includes at least one attachment point 1032 disposed within the stent-valve device, and two or more pull / push wires 1130 having a first end connected to at least one attachment point 1032 and a second end attached to a point 1033 around the stent frame. This arrangement can function in several different ways to facilitate recapture, repositioning, and / or redeployment.

[0048] First, one embodiment can include two or more pull / push wires 1130 that are slightly shorter in length than the dimensions of the cavity (e.g., the left atrium) to ensure proper positioning. Once the position is confirmed to be appropriate, the pull / push wires 1130 can be released, for example, by secondary means over a wire cutter or other means, to break the connection of the pull / push wire between at least one attachment point 1032 and the two or more pull / push wires 1130, thereby enabling full expansion of the frame properly positioned within the cavity. Similar to other embodiments described herein, the fully expanded frame may be slightly larger than at least one dimension to facilitate fixation.

[0049] Another embodiment further includes a push rod disposed translationally within the lumen of the delivery catheter / sheath 1104, and further provides a distally extending releasable connection attached to at least one attachment point 1032 within the stent-valve frame for disconnecting the attachment between at least one attachment point 1032 and the two or more push / pull wires 1130 after proper positioning is confirmed. This embodiment provides the additional advantage of pulling at least one attachment point proximally using a distally extending releasable connecting device, where the attachment point and the push / pull wire are connected to points on the stent frame, and when a proximal force is applied to the attachment point, the stent frame is slightly or fully folded to allow repositioning. Once repositioned, a distal force is applied to the releasable connecting device to fully expand the artificial valve frame.

[0050] Yet another embodiment can include attachment points 1132 to the stent frame formed of a material that dissolves in a short time, the push / pull wires 1130, and / or the connection of the push / pull wires.

[0051] FIG. 11 shows an artificial valve device 1200 including a ball and socket relationship between a support frame (socket or partial socket) having an artificial valve and a valve tip 1253 (ball or partial ball) disposed therein. In this embodiment, as shown, the outer frame 1250 is a partial sphere having a rounded center point 1252, and the center point 1252 is generally disposed around the native valve and valve annulus. The outer frame 1250 may include a radially extending flange 1254 for connecting and sealing with an upper annular surface, and may further include a wall element 1256 extending upward from at least a portion of the radially extending flange 1252 for connecting and sealing with the wall of a cavity (e.g., the left atrium). The radially extending flange 1252 may include an expandable stent-like structure for providing a radial expansion force to assist in fixing the device 1200. Alternative structures may include any of the artificial stent-valve frames described herein, such as, but not limited to, an upper open-expandable frame with a lower expandable frame covered with tissue.

[0052] The artificial valve further includes an inner partial sphere 1253, which has a radius that matches or is complementary to the radius of the partial sphere 1250 of the outer frame, but since the inner partial sphere 1253 is located inside the partial sphere 1250 of the outer frame, it has a radius smaller than that of the outer frame 1250. The artificial valve tip is supported within the inner partial sphere 1253. The inner partial sphere 1253 may include a friction fit with the partial sphere 1250 of the outer frame such that any movement, including rotation, is possible in all dimensions without losing an appropriate valve position relative to the native valve and / or valve annulus. Alternatively, a looser friction fit may be allowed, permitting a wider range of motion than a tighter friction fit by essentially floating the inner partial sphere within the partial sphere of the outer frame.

[0053] FIG. 12 shows an implant frame to which an artificial valve device 1300 is attached that is connected to a lasso structure 1304 via a connecting element 1302. The lasso structure 1304 is then operably connected to an operating wire 1306, which may comprise a single wire or two wires, extends in the proximal direction of the operator, and the operator can then manipulate the lasso 1304 and the connecting element 1302. The lasso structure 1304 may comprise two distal wires W1, W2, or more than three distal wires, operably connected to the connecting element 1302. If the operating wire 1306 includes two wires W1, W2, the first of the two wires can be connected to wire 1 and the second of the two wires can be connected to wire 1. By the operator pulling one or both of the operating wires W1, W2, the wires W1, W2 can be disconnected from the connecting element 1302. The lasso structure 1304 can be expandable to a diameter larger than the inner diameter of the lumen of the catheter 1305, as shown, and is disposed through the implant frame structure together with the lasso 1304 and the connecting element 1302 operably connected to the device frame 1300 generally at the center of the implant structure. This configuration allows the operator to maneuver the device 1300 with the lasso structure 1304 during deployment and also to retrieve it into the lumen of the catheter 1305 if necessary. The connecting element 1302 may be configured with the frame structure of the device 1300 to allow folding of the frame structure of the device 1300 and to be able to pull the structure of the device 1300 back into the lumen of the catheter 1305. The connecting element 1302 may also be detached from the frame of the device 1300 by the operator, whereby one or both of the wires W1, W2 are detached and the lasso structure 1304 retracts proximally through the catheter 1305. In other embodiments, the connecting element 1302 may remain attached to the frame structure of the device 1300 when the operator disconnects the wires W1, W2 from the connecting element 1302 and pulls the lasso structure 1304 proximally through the catheter sheath 1305.

[0054] The descriptions of the various inventions, embodiments, and uses described in this specification are illustrative and are not intended to limit the scope of the invention. The features of the various embodiments can be combined with other embodiments within the contemplation of these inventions. Modifications and alterations to the disclosed embodiments are possible, and practical alternatives and equivalents to the various elements of the embodiments will be apparent to those skilled in the art upon review of this patent document. These and other modifications and alterations to the disclosed embodiments can be made without departing from the scope and spirit of the invention.

Claims

1. A delivery system for performing a method of delivering a self-expanding mitral valve apparatus to a implantation site within the left atrium of a patient's heart, wherein the delivery system comprises: a delivery catheter having a proximal end, a distal end, and a lumen therethrough; an inner sheath loaded within the lumen of the delivery catheter, the inner sheath having a distal end that engages the self-expanding mitral valve apparatus when folded; the self-expanding mitral valve apparatus; a plug disposed on a side surface of the self-expanding mitral valve apparatus, the plug having a flange; and the self-expanding mitral valve apparatus comprises: a proximal portion provided at one end of the self-expanding mitral valve apparatus, a distal portion provided at the other end of the self-expanding mitral valve apparatus, and a central portion disposed between the proximal portion and the distal portion and connecting the proximal portion and the distal portion; a mitral valve having mitral valve leaflets disposed within the distal portion; and a hinge disposed within the central portion; and the proximal portion, the distal portion, and the central portion are each configured to be expandable; the maximum diameter of the central portion during expansion is configured to be smaller than the maximum diameter of the proximal portion during expansion and the maximum diameter of the distal portion during expansion; the delivery system further comprises: accessing the left atrium using the delivery catheter; loading the self-expanding mitral valve apparatus in a folded configuration into the lumen of the delivery catheter at its proximal end; delivering the self-expanding mitral valve apparatus from the distal end of the delivery catheter into the left atrium at a location proximate to the implantation site; allowing the delivered self-expanding mitral valve apparatus to expand within the left atrium at the implantation site, wherein at least a portion of the expanded apparatus engages at least a portion of an upper annular surface within the left atrium; ensuring that the left ventricle, annular tissue below or downstream of the upper annular surface, and native mitral valve leaflets are not contacted at any point during delivery of the self-expanding mitral valve apparatus prior to the delivered self-expanding mitral valve apparatus being able to expand within the left atrium; aligning the plug with the left atrial appendage; Engaging the left atrial appendage with the plug such that when the self-expanding mitral valve apparatus expands, the plug is positioned within the left atrial appendage and the flange engages the atrial wall around the left atrial appendage and seals the atrial wall. Delivering the central portion from the distal end of the lumen of the delivery catheter to expose the hinge to the left atrium. Rotating the distal portion toward the upper annular surface of the left atrium. Delivering the proximal portion from the distal end of the lumen of the delivery catheter into the left atrium. configured to perform the method including: The translation of the inner sheath through the lumen of the delivery catheter results in the translation of the self-expanding mitral valve apparatus through the lumen of the delivery catheter. Delivery system. **Claim 2** The delivery system according to claim 1, wherein the inner sheath comprises a lumen therethrough sized to receive the proximal portion of the self-expanding mitral valve apparatus when folded. **Claim 3** The delivery system according to claim 2, wherein the distal end of the inner sheath engages the distal portion of the self-expanding mitral valve apparatus when folded, and the distal portion is not received within the lumen of the inner sheath. **Claim 4** The delivery system according to claim 1, wherein the distal portion of the folded self-expanding valve apparatus is delivered and positioned proximate the implantation site and is expanded before the proximal portion of the folded self-expanding mitral valve apparatus is delivered and expanded. **Claim 5** The delivery system further comprises a push rod connected to the folded self-expanding mitral valve apparatus. The method according to claim 1, further comprising pushing the folded self-expanding mitral valve apparatus using the push rod through the lumen of the delivery catheter for delivery and expansion within the left atrium. **Claim 6** The delivery system according to claim 5, further configured to perform the method including at least partially folding the self-expanding mitral valve apparatus expanded within the lumen of the delivery catheter by pulling the push rod in a proximal direction. **Claim 7** Further comprising a placement element having a distal end. The delivery system translating the placement element through the lumen of the delivery catheter. engaging the open frame portion of the self-expanding prosthetic mitral valve device with the placement element; engaging the lumen of the left superior pulmonary vein with the distal end of the placement element prior to delivering the self-expanding prosthetic mitral valve device to the left atrium The delivery system according to claim 5, further configured to perform the method comprising the above.

8. The delivery system according to claim 7, wherein the placement element extends through the open frame portion of the self-expanding prosthetic mitral valve device.

9. further comprising an alignment wire, The delivery system, translating the alignment wire through the lumen of the delivery catheter; engaging the open frame portion of the self-expanding prosthetic mitral valve device with the alignment wire; engaging the left superior pulmonary vein with the alignment wire prior to delivering the self-expanding prosthetic mitral valve device into the left atrium along the alignment wire The delivery system according to claim 1, further configured to perform the method comprising the above.

10. further comprising at least one capture wire extending through the lumen of the delivery catheter, The delivery system, engaging the self-expanding prosthetic mitral valve device with the at least one capture wire so as to constrain the expansion of the self-expanding prosthetic mitral valve device to a partially expanded configuration The delivery system according to claim 1, further configured to perform the method comprising the above.

11. The delivery system according to claim 10, further comprising the at least one capture wire further adapted to positionally orient the partially expanded device by operating the at least one capture wire at the proximal end of the delivery catheter.

12. The delivery system, positionally orienting the partially expanded device within the left atrium; confirming the correct orientation of the partially expanded device; removing the at least one capture wire; allowing the partially expanded device to fully expand The delivery system according to claim 11, further configured to perform the method comprising the above.

13. The delivery system according to claim 12, further comprising a push / pull rod passing through the lumen of the delivery catheter adapted to assist in positionally orienting the partially expanded device.

14. further comprising a lanyard element attached to the self-expanding prosthetic mitral valve device adapted to be manipulated at the proximal end of the delivery catheter, the delivery system, positionally oriented to prevent full expansion of the self-expanding prosthetic mitral valve device and / or to allow full expansion of the self-expanding prosthetic mitral valve device within the left atrium by manipulating the lanyard element, The delivery system according to claim 1, further configured to perform the method comprising.

15. The delivery system according to claim 1, wherein the self-expanding prosthetic mitral valve device further comprises an upper portion formed from a stent including at least two sets of opposing subsections, at least one set of the opposing subsections including a fabric cover.

16. the delivery system, using the fabric cover to capture blood flow to position the self-expanding prosthetic mitral valve device and expanding the positioned self-expanding prosthetic mitral valve device, The delivery system according to claim 15, further configured to perform the method comprising.

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