Prosthetic mitral valve device

Abstract

The present invention relates to prosthetic mitral valve devices. More specifically, methods, systems, and devices are disclosed for delivering a self-expanding prosthetic mitral valve device to the left atrium without engaging the left ventricle, the native mitral valve leaflets, or the annular tissue downstream of the superior annulus during delivery, and in some embodiments, the ventricle, mitral valve leaflets, and / or the annular tissue located downstream of the superior annulus are not engaged by the delivered, positioned, and expanded prosthetic mitral valve device.

Description

[0001] This application is a divisional application of the invention application with the application date of January 19, 2018, the application number of 201880007705.2, and the authorized text invention name of "Prosthetic Mitral Valve Device". Technical Field

[0002] The invention described herein relates to delivery systems, devices, and methods for delivering and / or positioning cardiac valves. Background Art

[0003] 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.

[0004] The mitral valve is located between the left atrium and the left ventricle and helps control the flow of blood 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 located between the right atrium and the right ventricle, while the aortic valve and pulmonary valve are semilunar valves located in the arteries through which blood flows out of the heart. The valves are all one-way valves with leaflets that open to allow forward (antegrade) blood flow. Normally functioning valve leaflets close under the pressure exerted by regurgitant blood to prevent blood from flowing back (retrograde) into the chamber from which it just exited.

[0005] Due to various reasons and / or conditions (including but not limited to disease, trauma, congenital malformations, and aging), native heart valves may be or become dysfunctional. These types of conditions may result in the valve structure not opening properly (stenotic failure) and / or not closing properly (regurgitation).

[0006] Mitral valve regurgitation is a specific problem caused by a dysfunctional mitral valve. Mitral valve regurgitation is caused by a mitral valve that allows at least some retrograde blood flow from the left atrium to the left ventricle. This blood reflux places a burden on the left ventricle in a certain volume load, which may lead to a series of left ventricular compensatory adaptations and adjustments, including remodeling the ventricular chamber size and shape, which significantly change during the long-term clinical course of mitral valve regurgitation.

[0007] Therefore, native heart valves (such as the mitral valve) may typically require functional repair and / or assistance, 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), to learn about a surgery that is highly traumatic, full of patient risks, and not only requires long-term hospitalization but also a very painful recovery period.

[0008] Less invasive methods and devices for replacing dysfunctional heart valves are also known and involve percutaneous access and catheter facilitated delivery of the replacement valve. Most of these solutions involve replacement heart valves attached to a structural support such as a stent well known in the art, or other forms of wire mesh designed to expand after 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 within the subject's heart chamber or blood vessel and holding the expanded device in place. This self-expanding form also presents problems when the device is not properly positioned on the first positioning attempt, as is often the case, and must therefore be recaptured and adjusted in position. This recapture process, in the case of a fully or even partially expanded device, requires the device to be recontracted to a point that allows the operator to retract the contracted device into the delivery sheath or catheter, adjust the entry position for the device, and then redeploy the positionally adjusted device distally out of the delivery sheath or catheter to re-expand it to the proper position. Contracting an already expanded device is difficult because the expanded stent or wire mesh is typically designed to achieve an expanded state that also resists collapsing or contracting forces.

[0009] In addition to the open surgical approach discussed above, access to the valve of interest is achieved percutaneously via at least one of the following well-known access routes: transapical, transfemoral, transatrial, and transseptal delivery techniques.

[0010] Typically, the art focuses on systems and methods that use one of the above well-known access routes to allow partial delivery of a contractible valve device, where one end of the device is released from the delivery sheath or catheter and expansion occurs for initial positioning, and then full release and expansion when proper positioning is achieved. See, for example, U.S. Patent No. 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); as well as U.S. Patent Publication No. 2015 / 0272731 (Racchini); and 2016 / 0235531 (Ciobanu).

[0011] However, known delivery systems, devices, and methods still suffer from significant deficiencies in the delivery method, including in particular positioning and recapture capabilities and efficiency.

[0012] In addition, known "replacement" heart valves are designed to completely replace the native heart valve. Thus, these replacement heart valves physically engage the annulus and / or valve leaflets, thereby eliminating all remaining function of the native valve and leaving the patient completely dependent on the replacement valve. In general, maintaining and / or preserving the native function of the heart valve is the preferred solution, and thus repair of the valve is preferred over complete replacement. Obviously, there will be cases where the native valve has almost completely lost its function prior to an interventional implantation procedure, or where the native valve continues to lose function after implantation. The preferred solution is to deliver and implant a valve device that will function both as a supplemental functional valve and completely replace the native function of a valve that has lost most or all of its function. However, the inventive solutions described below will generally apply to all types and forms of heart valve devices unless otherwise noted.

[0013] Finally, known solutions for, e.g., mitral valve replacement systems, devices, and methods require a two-chamber solution, i.e., the implanted replacement valve device is involved and engages in both the left atrium and the left ventricle. Typically, these solutions include a radially expandable stent in the left atrium, where an anchor or tether (configured to pass downward through the annulus) extends downward from the stent device through the annulus to a sub-annular surface, left ventricular chordae tendineae, and even into the left ventricular wall surface within the left ventricle.

[0014] This two-chamber solution is unnecessarily cumbersome and thus more difficult to deliver and position / re-capture / re-position from a strictly structural perspective. In addition, the two-chamber solution has difficulties in performing ventricular anchoring and / or tethering required to maintain position. Additionally, these solutions interfere with native valve function as described above, because the portion of the device disposed within the left ventricle must pass through the annulus, annulus, and native mitral valve, thereby disrupting any remaining coaptation ability of the native leaflets. Additionally, the two-chamber solution typically requires traumatic anchoring of some native tissue, resulting in unnecessary trauma and potential complications.

[0015] It will further be appreciated that the two-chamber mitral valve solution requires precise sub-annular and / or ventricular engagement with anchors, tethers, and the like, because the atrial portion of the device cannot adequately anchor itself to the upper portion of the annulus and / or the atrial chamber. Again, the inventive solutions described herein readily apply to single-chamber or two-chamber solutions unless otherwise noted. SUMMARY OF THE INVENTION

[0016] Various embodiments of the invention disclosed herein are particularly directed to the above problems.

[0017] According to one aspect of the present invention, there is provided a prosthetic mitral valve device adapted to be used in a method of delivering the prosthetic mitral valve device to an implantation site within the left atrium of a patient's heart, comprising:

[0018] a self-expanding prosthetic mitral valve frame; and

[0019] a prosthetic mitral valve, which includes prosthetic mitral valve leaflets;

[0020] wherein the method includes:

[0021] entering the left atrium using a delivery catheter, the delivery catheter having a proximal end, a distal end, and a lumen therethrough;

[0022] loading the self-expanding prosthetic mitral valve frame in a contracted configuration at the proximal end of the delivery catheter into the lumen of the delivery catheter, wherein the contracted configuration of the self-expanding prosthetic mitral valve frame includes the prosthetic mitral valve attached thereto;

[0023] translating a positioning element through the lumen of the catheter;

[0024] engaging an open frame portion of the self-expanding prosthetic mitral valve frame with the positioning element;

[0025] engaging the lumen of the left superior pulmonary vein with the distal end of the positioning element;

[0026] delivering the contracted self-expanding prosthetic mitral valve frame out of the distal end of the delivery catheter and into a position in the left atrium proximate to the implantation site;

[0027] allowing the delivered self-expanding prosthetic mitral valve frame to expand at the implantation site within the left atrium, wherein at least a portion of the expanded self-expanding prosthetic mitral valve frame engages at least a portion of the upper annular surface within the left atrium; and

[0028] ensuring that the left ventricle, the annular tissue below or downstream of the upper annular surface, and the native mitral valve leaflets of the heart are not contacted at any point during the delivery of the self-expanding prosthetic mitral valve frame before the delivered self-expanding prosthetic mitral valve frame is allowed to expand within the left atrium. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 A side cross-sectional view showing an embodiment of the present invention is presented.

[0030] Figure 2A A side view showing an embodiment of the present invention is presented.

[0031] Figure 2B A side cross-sectional view showing an embodiment of the present invention is presented.

[0032] Figure 3A Shows a side cross-sectional view of an embodiment of the present invention.

[0033] Figure 3B Shows a side cross-sectional view of an embodiment of the present invention.

[0034] Figure 4 Shows a side cross-sectional view of an embodiment of the present invention.

[0035] Figure 5A Shows a side cross-sectional view of an embodiment of the present invention.

[0036] Figure 5B Shows a side cross-sectional view of an embodiment of the present invention.

[0037] Figure 6A Shows a side cross-sectional view of an embodiment of the present invention.

[0038] Figure 6B Shows a side cross-sectional view of an embodiment of the present invention.

[0039] Figure 6C Shows a side cross-sectional view of an embodiment of the present invention.

[0040] Figure 7A Shows a side cross-sectional view of an embodiment of the present invention.

[0041] Figure 7B Shows a side cross-sectional view of an embodiment of the present invention.

[0042] Figure 8A Shows a top view of an embodiment of the present invention.

[0043] Figure 8B Shows a side and partial exploded view of an embodiment of the present invention.

[0044] Figure 9A Shows a side cross-sectional view of an embodiment of the present invention.

[0045] Figure 9B Shows a side cross-sectional view of an embodiment of the present invention.

[0046] Figure 9C Shows a side cross-sectional view of an embodiment of the present invention.

[0047] Figure 9D Shows a side cross-sectional view of an embodiment of the present invention.

[0048] Figure 10A Shows a side cross-sectional view of an embodiment of the present invention.

[0049] Figure 10B A side cross-sectional view of an embodiment of the present invention is shown.

[0050] Figure 10C A side cross-sectional view of an embodiment of the present invention is shown.

[0051] Figure 11 A side cross-sectional view of an embodiment of the present invention is shown.

[0052] Figure 12 A side view of an embodiment of the present invention is shown. Detailed Description

[0053] Various embodiments of the present invention are disclosed in the figures for providing percutaneous access to a valve of interest via at least one of the following known access routes: transapical, transfemoral, transatrial, and transseptal delivery techniques. Each of these access routes can be used for the embodiments disclosed herein.

[0054] Thus, Figure 1 An embodiment of a prosthetic valve device 100 having a two-piece frame in a contracted configuration is shown. The distal portion 102 of the contracted device includes a valve having a portion of a support frame with prosthetic leaflets 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 contracted device 100 includes the remaining support frame, which is operatively connected to the distal portion 102 of the contracted device 100 and is longitudinally translatably and rotatably confined within the lumen of an inner sheath 108, the inner sheath 108 being at least longitudinally translatable relative to the outer sheath 104, and wherein the outer sheath 104 is at least longitudinally translatable relative to the inner sheath 108. The inner and / or outer sheaths 108, 104 may also be rotationally translatable 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 less than the outer diameter D of the outer sheath.

[0055] Figure 1The preferred construction of the device includes a constricted device 100, which consists of a single unit having a proximal portion 106 and a distal portion 102, as shown. The outer sheath 104 can be retracted to first expose the distal portion 102 by releasing it from the distal end 110 of the outer sheath 104 for initial dilation and positioning in the target chamber of the heart. Alternatively, the distal portion 102 of the device 100 can be pushed distally, for example, in response to distal translation of the inner sheath 108 or in response to a pusher that presses against the proximal portion 106 of the device 100, to be released from the distal end 110 of the outer sheath 104. In the case of the pusher, the proximal portion 106 will ultimately be pushed distally out of the smaller lumen of the inner sheath 106 and into the larger lumen of the outer sheath 104, where a temporary secondary dilation of the proximal portion 106 occurs, followed by a secondary positioning dilation when the proximal portion 106 is finally released from the distal end 110 of the outer sheath 104.

[0056] If dilated within the left atrium associated with the prosthetic mitral valve, the lower portion of the distal portion 102 can be positioned against the upper surface of the annulus within the left atrium.

[0057] In this construction, if the distal portion 102 is properly positioned and released / dilated, the secondary release and dilation of the proximal portion 106 of the device 100 can be initiated and achieved according to the alternative methods described above in connection with the initial release and dilation of the distal portion 102. Those skilled in the art will recognize that once the initial positioning dilation of the distal portion 102 is completed, the secondary positioning dilation of the proximal portion 106 will also be properly located and positioned.

[0058] Figure 1 The construction allows for the delivery of the device 100 by a two-step frame positioning dilation method in its various embodiments, which includes a frame that can be slightly oversized for the chamber (e.g., atrium) size. Some frames in the constricted form can be up to 2 times the size of any chamber (e.g., atrium) in longitudinal length. Therefore, a staged positioning dilation method is necessary for delivery.

[0059] Now turning to Figure 2A and 2B, a prosthetic valve device 200 is provided, which includes a support stent frame in which a prosthetic valve is attached and / or supported. The design includes two parts (a distal part 202 and a proximal part 206) having an expanded diameter, where the prosthetic valve with leaflets 205 is held / supported within the distal part 202, and the two parts are connected by a central part 203 having a diameter smaller than the expanded diameters of the two parts 202, 206. As shown, the two parts 202, 206 include an undeformed and fully expanded spherical shape, but other shapes can be used, as will be readily understood by those skilled in the art. Some embodiments may include at least one of the proximal part 206 and the distal part 202 having an expanded size that is slightly larger than the size of the target chamber (e.g., the left atrial size) to allow for expanded anchoring. Additionally, the aspect ratio of each of the two parts 206, 202 can vary.

[0060] As shown, the collapsed stent with the valve is held within the lumen of the delivery sheath 204, and the distal part of the device 200, which is held or supported therein, is released from the end 210 of the delivery sheath 204 and then expands and is positioned within the target chamber (e.g., the left atrium). When proper positioning is confirmed, the remaining central part 203 (if not previously released together with the distal part 202) and / or the proximal part 206 can then be released and expanded in position by Figure 1 the methods described, which include using an inner sheath and / or a push rod as described above to translate the device 200 out of the distal end 210 of the outer delivery sheath 204. As Figure 1 , this embodiment includes a two-step or staged delivery mechanism. Figure 1 and Figure 2A Embodiments of groups / 2B may include a coating or covering on the distal part 202, while the proximal part 206 may include an open frame formed, for example, by a stent mesh. In Figure 2A the case of / 2B, the central part 202 may also include an open mesh construction and is not covered. Figure 2B The dashed lines in show an alternative embodiment where the expanded and delivered part 202 includes hinge points 212 to assist in orienting the leaflets and the prosthetic valve within the distal part 202 downward toward the native valve.

[0061] Figure 3A , 3B , 4, 5A, and 5B provide further disclosure of exemplary prosthetic valve devices with support means (e.g., stent-like) and related exemplary delivery methods. Thus, Figure 3A shows the collapsed device 300 within the lumen of the delivery sheath 304, operatively communicating with a push / pull rod 308 actuated by the device operator, and the push / pull rod is capable ofFigure 3A The contracting device 300 therein is translated distally out of the distal end 310 of the delivery sheath 304 for positioning and dilation, and conversely, if necessary, the expanded device 300 as shown is pulled back into the distal end 310 of the delivery sheath 304. The push / pull rod 308 may also, in certain embodiments, allow the contracting device 300 to rotate within the lumen of the delivery sheath 310 to assist in positioning prior to release and dilation. Additionally, the operative connection of the push / pull rod 308 with the contracting device 300 may include a screw or clamp release mechanism 311 connected to the most proximal portion of the contracting device 300. The base or lower portion of the device 300 may be covered with tissue or other biocompatible material, while the upper portion of the device may include an open grid configuration. Figure 3B Generally, the contracting device 300 is loaded and positioned within the delivery sheath 304, and the valve portion 305 is oriented in the downward position as shown. This allows the contracting valve device 305 to be pushed out of the delivery sheath 304 in a laterally oriented manner as shown, and allows the expanded valve device 300 to be properly oriented to the native valve and the target chamber, such as the mitral valve and the left atrium, after release from the delivery sheath.

[0062] In some cases, an alignment line 315 may be translated from the delivery sheath 304 into the pulmonary vein (e.g., the left superior pulmonary vein PV) to assist in the positioning and delivery of the device 300.

[0063] Shown is the lateral delivery of the device 300 during dilation and immediately after delivery from the outer end 310 of the delivery sheath 304, where the delivered device is oriented and aligned generally vertically to be positioned on the native valve.

[0064] Figure 4 Thus, as best shown in and, the prosthetic valve device 500 may be delivered asymmetrically laterally (where the valve portion 505 is oriented on the bottom as shown), and may include a positioning element 515 that is operatively connected to the prosthetic valve device 500 and that extends from the delivery sheath 503, where at least the distal end of the push tube or positioning element 515 is disposed within the pulmonary vein PV (e.g., the left superior pulmonary vein as shown). The system provides a self-centering system that can expand after release / translation of the contracting prosthetic valve device 500 from the distal end 510 of the delivery sheath 504. As shown, once the prosthetic valve device 500 is delivered from the distal end 510 of the delivery sheath 504, the push tube 508 and associated connector 511 may be used to assist in manipulating the orientation of the prosthetic valve device 500.

[0065] Thus, as Figure 5A and 5B Best shown, the prosthetic valve device 500 may be delivered asymmetrically laterally (where the valve portion 505 is oriented on the bottom as shown), and may include a positioning element 515 that is operatively connected to the prosthetic valve device 500 and that extends from the delivery sheath 503, where at least the distal end of the push tube or positioning element 515 is disposed within the pulmonary vein PV (e.g., the left superior pulmonary vein as shown). The system provides a self-centering system that can expand after release / translation of the contracting prosthetic valve device 500 from the distal end 510 of the delivery sheath 504. As shown, once the prosthetic valve device 500 is delivered from the distal end 510 of the delivery sheath 504, the push tube 508 and associated connector 511 may be used to assist in manipulating the orientation of the prosthetic valve device 500.

[0066] Now turning toFigures 6A - 6C For the delivery of the prosthetic valve device 600, a delivery catheter or sheath 604 is used, which includes a pre-curved distal portion 620 or a distal portion 620 adapted to be bendable to provide a generally straight distal segment within the atrium. Figure 6A A pre-curved embodiment is provided, which is curved to allow the prosthetic valve device 600 to be loaded in a configuration that positions the valved base 605 in place after release from the distal end 610 of the pre-curved distal portion 620 of the delivery catheter or sheath (more specifically, from the straightened distal segment distal to the pre-curved distal portion 620). Thus, as shown, the valvular support portion 605 of the collapsed and expandable frame / stent is the most distal within the lumen of the delivery catheter / sheath 604. The pre-curved portion 620 allows for easy orientation of the valved portion 605 with respect to the upper surface of the exemplary mitral valve and / or its annulus.

[0067] Thus, a delivery system having a curved distal portion as in Figure 6A allows the prosthetic valve device 600 to be positioned on the annulus and native valve leaflets. When positioned on the annulus and native valve leaflets, the curved delivery catheter or sheath 604 can be withdrawn proximally either alone or together with a pusher 608 or similar device proximal to the prosthetic valve device 600 to release and deliver the prosthetic valve device 600 into the left atrium and expand the delivered device 600. It is noted that the curved delivery catheter or sheath 604 includes, in some embodiments, a straightened distal end within the left atrium and distal to the curved segment 620, where the collapsed prosthetic valve device 600 is translated and manipulated about the curved portion 620 of the curved delivery catheter or sheath. The collapsed prosthetic valve device 600 can be assisted in translating about the curved portion 620 of the curved delivery catheter or sheath, i.e., by sutures attached to the distal end of the implant, a pull wire attached to the distal end of the implant (extending to the proximal end of the delivery catheter or sheath), or by taking advantage of Figure 1 a natural flex point between the proximal and distal portions of the prosthetic valve device in the configuration of

[0068] Figure 6B and 6CIncluding an alternative way to create a bend section 620 by providing a series of incisions or serrations 609 along the bottom surface of the sheath or catheter, resulting in a weakened area that is prone to bending, to allow bending of the distal portion of the delivery sheath or catheter 604. As shown, the pull wire 625 is attached to the distal end 610 of the catheter 604 along this bottom weakened incision or serrated area and is arranged to pass through the catheter / sheath lumen to the operator, who can achieve the desired curvature by pulling the wire proximally with a force F before releasing the contracted prosthetic valve structure 600, the prosthetic valve structure 600 being oriented in a contracted form as Figure 6A and is released to actually directly position and expand on the target valve or upper annular surface. The incision 609 can extend completely through the catheter / sheath wall, or can be simply a section of the catheter / sheath wall that is thinner than the rest of the catheter / sheath wall. The shown incision 609 is uniform and generally square, but any depth, shape, and uniform or non-uniform spacing can be used to achieve the weakened area.

[0069] Figure 7A and 7B illustrates a delivery system for exemplary prosthetic valve replacement or repair of a heart chamber such as the left atrium, such as a mitral valve, using a delivery catheter or sheath 704 as shown in Figure 7A and adding an additional guiding tool 728, which is used to assist in guiding the expanded valved device (not shown) when the valved device is released from the distal end 710 of the catheter or sheath 704 using the methods or devices described herein. The additional guiding tool 728 can be disposed, for example, within the superior pulmonary vein PV. The guiding tool 728 can be hingedly or rotatably attached to the catheter or sheath 704, allowing the tool 728 to be rotated into place. A pull wire similar to the pull wires shown in FIGS. 6B and 6C can be used to connect to the tool 728 and manipulate the tool 728 into place.

[0070] Figure 7B illustrates two delivery systems, namely a first delivery system 800 for alignment and deployment and a second delivery system 850 for recapture and repositioning if necessary. One of the delivery systems, namely the first delivery system 800 or the second delivery system 850, can enter the target heart chamber via a trans-femoral access method, while the other delivery system can enter the target heart chamber via another trans-venous access method. The first delivery system 800 can thus include a delivery catheter or sheath 804 as described elsewhere herein, while the second delivery system can include a catheter or sheath 854 for recapture and repositioning, which is structurally similar to the delivery catheter / sheath 804.

[0071] Figure 8A and 8BAn embodiment is shown that is designed to facilitate the precise positioning of a prosthetic heart valve within a chamber such as the left atrium, including but not limited to self-centering and fluoroscopic techniques. In this embodiment of the prosthetic stent-based valve device 900, with the prosthetic valve and leaflets 905 supported near the bottom of the valve device, the upper portion 909 of the device 900 can be divided into sub-portions as shown from the top in Figure 8A The situation shown provides 4 sub-portions, but other numbers of sub-portions can of course be useful and within the scope of the present invention. As shown, the opposing sub-portions are either open grid or open wire constructs 907, or are formed of a fabric in the form of a sail 908. After the device 900 is delivered to the heart chamber of the subject, the fabric sail 908 will capture and use the natural forces of blood flow to maneuver the device frame 900 into proper position and then release and expand when the positioning is confirmed.

[0072] Figure 8B is a related concept but also includes an annulus spacer 919, which can be delivered first via a delivery catheter / sheath as previously described herein, and in some embodiments, the spacer can be guided into place using a guide wire positioned within the lumen of the delivery catheter / sheath and further moved out of the distal end of the delivery catheter / sheath and either near the upper annular surface of the chamber (proximally), or can be at least partially disposed within the annular throat. Once released from the lumen and distal end of the delivery catheter / sheath, the annular spacer 919 can expand from its delivered constricted form and be positioned on the upper annular surface, which can space the prosthetic valve and leaflets 905 from the upper annular surface. Next, the prosthetic valve device (as described herein and may or may not include a sail 908 as in Figure 7A is delivered from the delivery catheter / sheath and expanded in position to connect with the previously positioned spacer 919.

[0073] We next describe the Figures 9A - 9D positioning and orientation delivery structure in Figure 9A Thus, it includes a left atrial appendage plug 1006 disposed on the side surface of the constricted device 100 within the lumen of the delivery sheath 1004, and in Figure 9BIn this case, the left atrial appendage plug 1006 is at least partially positioned within the left atrial appendage. Once the left atrial appendage is engaged by the left atrial appendage plug 1006, the operator confirms that the valved prosthesis 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, where an initial positioning dilation will result in the left atrial appendage plug being oriented into the left atrial appendage, and then a secondary positioning dilation of the remainder of the device is initiated by release from the distal end of the delivery sheath.

[0074] Figure 9A and 9B An additional benefit of certain embodiments of and is that the left atrial appendage plug 1006 can be employed as a device to prevent blood clotting within the left atrial appendage, where the left atrial appendage plug 1006 completely fills the left atrial appendage and / or the outer flange 1008 completely covers the left atrial appendage opening to prevent any blood clots from forming and / or migrating out of the heart and potentially causing a stroke.

[0075] Figure 9D A slightly different mechanism is shown, where a guide wire 1020 is disposed through the delivery sheath 1004 and into the left atrial appendage to provide directional guidance for the positioning dilation (one-step or staged) of a contracted prosthetic valved device (not shown) within the lumen of the delivery sheath 1004. The sheath 1004 can be pulled back to deploy / release the valved device (not shown) from the distal end of the sheath 1004 for positioning dilation, or a pusher rod can be used as previously described to push the valved device out of the distal end of the sheath. In these cases, the guide wire 1020 positioned within the left atrial appendage provides key directional guidance parameters such that the operator knows that the positioning will be appropriate upon dilation. The guide wire 1020 can include a non-invasive tip to prevent damage to the tissue of the left atrial appendage.

[0076] Figure 9C Another alignment / orientation system is shown, where the delivery catheter / sheath 1004 is introduced into the left atrium via a pulmonary vein PV (e.g., the superior pulmonary vein), and the guide wire 1020 is disposed to pass through the lumen of the delivery catheter / sheath 1004 and into or near the annulus (i.e., the annular throat) as a guide for the valved device to be delivered (not shown, but in a compressed and self-expanding state as previously described). When the sheath 1004 is pulled back or a pusher rod is used to push the contracted valved device out of the distal end of the delivery catheter or sheath 1004, the expanding valved device can slide down the pre-positioned guide wire 1020 to reach the appropriate position upon full expansion.

[0077] Figure 10AIllustrated is a partially expanded stent-valve device 1100 released from a delivery catheter sheath. At least one capture wire 1030 is shown (shown radially surrounding the device 1100, but other surrounding positions may be employed), and it restricts the fully expansion of the expandable device 1100 until it is properly positioned within a target heart chamber (e.g., the left atrium). When the proper position is confirmed, the capture wire 1030 can be removed, i.e., retrieved distally by cutting and passing through the lumen of the delivery sheath 1004, or by disconnecting the connector pins or latches 1032 or the like, to allow the device 1100 to fully expand at the properly positioned location. Figure 10B is similar and has alignment wires 1130 that assist in position orientation when it exits the distal end of the delivery catheter / sheath 1104 while it is connected to the partially expanded sheath at two or three or more stable points 1034 until the proper position is confirmed. The connection at the stable points 1134 can hold the partially expanded device in that state until the proper position is confirmed, and then the connection can be removed, i.e., by cutting (as in the case of a releasable suture) or by disconnecting the connector pins or latches, to allow full expansion at the properly positioned location, or by providing a secondary wire cutter that is introduced via the delivery catheter / sheath 1104 to cut the alignment wires 1130.

[0078] Figure 10C An alternative prosthetic heart valve device is provided, shown in an expanded position in place after being released from the distal end of the delivery catheter / sheath 1104, and includes at least one attachment point 1032 within the stent heart 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 configuration can operate in several different ways to facilitate recapture, repositioning, and / or redeployment.

[0079] First, an embodiment can include two or more pull / push wires 1130 that are slightly shorter than the chamber (e.g., the left atrium) dimension to ensure proper positioning. Once the position is confirmed to be proper, the pull / push wires 1130 can be released, e.g., by a secondary wire cutter or other device to break the pull / push wire connection between at least one attachment point 1032 and the two or more pull / push wires 1130, thereby allowing the properly positioned frame to fully expand within the chamber. As with other embodiments described herein, the fully expanded frame can be slightly larger than at least one dimension to facilitate anchoring.

[0080] Another embodiment may further include a pusher rod that is translationally disposed within the lumen of the delivery catheter / sheath 1104 and that also provides a distally extending releasable connector that attaches to at least one attachment point 1032 within the stent-based heart valve frame so as to release the attachment between the at least one attachment point 1032 and two or more push / pull wires 1130 after proper positioning has been confirmed. This embodiment provides the further benefit of using a distally extending releasable connector tool to pull proximally on at least one attachment point, where the attachment point and the push / pull wire are connected to points on the stent frame, which causes the stent frame to contract slightly or fully when a proximal force is applied to the attachment point to allow repositioning. Once repositioned, a distal force is applied to the releasable connector tool to fully expand the prosthetic valve frame.

[0081] Yet another embodiment may include that the attachment points 1132, the push / pull wires 1130, and / or the connection of the push / pull wires to the stent frame are formed of a material that dissolves within a short time period.

[0082] Figure 11 A prosthetic valve device 1200 is shown that includes a ball-and-socket relationship between a support frame (socket or partial socket) and a prosthetic valve and leaflets 1253 (ball or partial ball) disposed therein. In this embodiment, the outer frame 1250 is a partial sphere as shown with rounded corners and a center point 1252, and the center point 1252 is generally disposed around the native valve and annulus. The outer frame 1250 may include radially extending flanges 1254 to connect and seal with the upper annular surface and may further include wall elements 1256 that extend upwardly from at least some portions of the radially extending flange 1252 to connect and seal against the wall of a chamber (such as the left atrium). The radially extending flange 1252 may include an expandable stent-like structure to provide a radially expanding force to assist in anchoring the device 1200. Alternative configurations may include any of the prosthetic stent valve frames described herein, such as and without limitation, an upper open-expandable frame and a lower expandable frame covered by tissue.

[0083] The prosthetic valve further includes an internal partial sphere 1253 having rounded corners that match or are complementary to the rounded corners of the partial sphere 1250 of the outer frame, but having a smaller radius than the outer frame 1250 because the internal partial sphere 1253 resides within the partial sphere 1250 of the outer frame. The prosthetic leaflets are supported within the internal partial sphere 1253. The internal partial sphere 1253 may include a friction fit with the partial sphere 1250 of the outer frame such that some movement is feasible in all dimensions (including rotation) without losing the proper valve position relative to the native valve and / or annulus. Alternatives may allow a looser friction fit such that the internal partial sphere substantially floats within the partial sphere of the outer frame, thereby allowing a greater range of motion than a tighter friction fit.

[0084] Figure 12 An implant frame is shown, to which a prosthetic valve device 1300 is attached via a connector element 1302 to a lasso structure 1304, which in turn is operably connected to a manipulation wire 1306. The manipulation wire 1306 may include a single wire or two wires that extend proximally to an operator who can then manipulate the lasso 1304 and the connector element 1302. The lasso structure 1304 may include two distal wires W1, W2 or more than two distal wires operably connected to the connector element 1302. If the manipulation wire 1306 includes two wires W1, W2, the first of the two wires may be connected to wire 1 and the second of the two wires may be connected to wire 1. By the operator pulling one or both of the manipulation wires W1, W2, the wires W1, W2 can be disconnected from the connector element 1302. The lasso structure 1304 may be expandable as shown to a diameter greater than the inner diameter of the lumen of the catheter 1305 and is arranged to pass through the implant frame structure, wherein the connector element 1302 operably connected to the lasso 1304 and the device frame 1300 is generally at the middle of the implant structure. This configuration allows the operator to manipulate the device 1300 with the lasso structure 1304 during deployment and also allows retrieval into the lumen of the catheter 1305 if necessary. The connector element 1302 may be constructed with the frame structure of the device 1300 to allow the frame structure of the device 1300 to contract, thereby allowing the structure of the device 1300 to be pulled back into the lumen of the catheter 1305. The connector element 1302 may also be disconnected from the frame of the device 1300 by the operator, whereby one or both of the wires W1, W2 are disconnected and the lasso structure 1304 is withdrawn proximally through the catheter 1305. In other embodiments, the connector element 1302 may remain attached to the frame structure of the device 1300 when the operator disconnects the wires W1, W2 from the connector element 1302 and pulls the lasso structure 1304 proximally through the catheter sheath 1305.

[0085] The descriptions of the various inventions, their embodiments and applications given herein are illustrative and are not intended to limit the scope of the present invention. The features of the various embodiments can be combined with other embodiments within the concept of these inventions. Variations and modifications of the embodiments disclosed herein are possible, and those skilled in the art will understand the actual alternatives and equivalents of the various elements of the embodiments after studying this patent document. These and other variations and modifications of the embodiments disclosed herein can be made without departing from the scope and spirit of the present invention.

Claims

1. A prosthetic mitral valve device adapted for use in a method of delivering the prosthetic mitral valve device to an implantation site within the left atrium of a patient's heart, comprising: Self-expanding prosthetic mitral valve frame; and a prosthetic mitral valve, which includes prosthetic mitral valve leaflets; wherein the method includes: using a delivery catheter to enter the left atrium, the delivery catheter having a proximal end, a distal end, and a lumen therethrough; loading the self-expanding prosthetic mitral valve frame in a contracted configuration at the proximal end of the delivery catheter into the lumen of the delivery catheter, wherein the contracted configuration of the self-expanding prosthetic mitral valve frame includes the prosthetic mitral valve attached thereto; translating a positioning element through the lumen of the delivery catheter; engaging the self-expanding prosthetic mitral valve frame with the positioning element; engaging the lumen of the left superior pulmonary vein with the distal end of the positioning element; delivering the contracted self-expanding prosthetic mitral valve frame out of the distal end of the delivery catheter and into a position in the left atrium proximate to the implantation site; allowing the delivered self-expanding prosthetic mitral valve frame to expand at the implantation site within the left atrium, wherein at least a portion of the expanded self-expanding prosthetic mitral valve frame engages at least a portion of the upper annular surface within the left atrium; and ensuring that the left ventricle, the annular tissue below or downstream of the upper annular surface, and the native mitral valve leaflets of the heart are not contacted at any point during the delivery of the self-expanding prosthetic mitral valve frame before the delivered self-expanding prosthetic mitral valve frame is allowed to expand within the left atrium, wherein: the contracted self-expanding prosthetic mitral valve frame further includes a proximal portion and a distal portion, wherein the prosthetic mitral valve leaflets are disposed within the distal portion; the method further includes loading an inner sheath into the lumen of the delivery catheter, the inner sheath including a lumen therethrough, a distal end, and a proximal end; when the inner sheath is loaded into the lumen of the delivery catheter, the lumen of the delivery catheter is configured to receive the distal portion of the contracted self-expanding prosthetic mitral valve frame, and the lumen of the inner sheath is configured to receive the proximal portion of the contracted self-expanding prosthetic mitral valve frame; and delivering the contracted self-expanding prosthetic mitral valve frame out of the distal end of the delivery catheter and into a position in the left atrium proximate to the implantation site includes: pushing the contracted self-expanding prosthetic mitral valve frame out of the delivery catheter such that: the distal portion of the contracted self-expanding prosthetic mitral valve frame exits the delivery catheter, and then the proximal portion exits the inner sheath and into the lumen of the delivery catheter to allow initial expansion of the proximal portion, and subsequently the proximal portion exits the lumen of the delivery catheter, whereby the proximal portion has a temporary secondary expansion upon exiting the delivery catheter.

2. The prosthetic mitral valve device according to claim 1, wherein, The positioning element extends through an open frame segment of the prosthetic mitral valve frame.

3. The prosthetic mitral valve device according to claim 1, wherein, Delivering a collapsed self-expanding prosthetic mitral valve frame and allowing the delivered self-expanding prosthetic mitral valve frame to expand further comprises: delivering a distal portion of the self-expanding prosthetic mitral valve frame, positioning the distal portion of the self-expanding prosthetic mitral valve frame near the implantation site, and allowing the delivered distal portion of the self-expanding prosthetic mitral valve frame to expand before delivering a proximal portion of the collapsed self-expanding prosthetic mitral valve frame, and allowing the proximal portion of the self-expanding prosthetic mitral valve frame to expand.

4. The prosthetic mitral valve device according to claim 1, wherein, The method further comprises: providing a pusher rod connected to the collapsed prosthetic mitral valve frame; and using the pusher rod to push the collapsed prosthetic mitral valve frame through the lumen of the delivery catheter for delivery and expansion within the left atrium.

5. The prosthetic mitral valve device according to claim 4, wherein, The method further comprises: at least partially collapsing the expanded prosthetic mitral valve frame within the lumen of the delivery catheter by pulling proximally on the pusher rod.

6. The prosthetic mitral valve device according to claim 1, wherein, The self-expanding prosthetic mitral valve frame further comprises a central portion disposed between the proximal portion and the distal portion, the central portion having a maximum diameter less than the maximum diameter of the proximal portion and the maximum diameter of the distal portion.

7. The prosthetic mitral valve device according to claim 6, wherein, The method further comprises: providing a hinge on the central portion of the self-expanding prosthetic mitral valve frame; delivering the central portion out of the distal end of the delivery catheter lumen such that the hinge is exposed to the left atrium; rotating the distal portion toward the upper circumferential surface of the left atrium; and delivering the proximal portion out of the distal end of the delivery catheter lumen and into the left atrium.

8. The prosthetic mitral valve apparatus according to claim 1, wherein, The method further comprises: translating an alignment wire disposed through the lumen of the delivery catheter; engaging an open frame portion of the self-expanding prosthetic mitral valve frame with the alignment wire; and engaging the left superior pulmonary vein with the alignment wire before delivering the prosthetic mitral valve device along the alignment wire into the left atrium.

9. The prosthetic mitral valve apparatus according to claim 1, further comprising at least one capture wire that extends through the lumen of the delivery catheter and engages the self-expanding prosthetic mitral valve frame, and is adapted to limit the expansion of the frame to a partially expanded configuration.

10. The prosthetic mitral valve apparatus according to claim 9, wherein, The at least one capture wire is adapted to orient the partially expanded prosthetic mitral valve frame in position by manipulating the at least one capture wire at the proximal end of the delivery catheter.

11. The prosthetic mitral valve apparatus according to claim 10, wherein, The method further comprises: orienting the partially expanded prosthetic mitral valve frame in position within the left atrium; confirming proper orientation of the partially expanded prosthetic mitral valve frame; removing the at least one capture wire; and allowing the partially expanded prosthetic mitral valve frame to fully expand.

12. The prosthetic mitral valve apparatus according to claim 11, wherein, The method further comprises: providing a push / pull rod disposed through the lumen of the delivery catheter, the push / pull rod being adapted to assist in orienting the partially expanded prosthetic mitral valve frame in position.

13. The prosthetic mitral valve apparatus according to claim 1, further comprising a snare element attached to the prosthetic mitral valve frame and adapted to be manipulated at the proximal end of the delivery catheter; the method further comprising manipulating the snare element to orient in position, prevent full expansion of the prosthetic mitral valve frame, and / or allow full expansion of the prosthetic mitral valve frame within the left atrium.

14. The prosthetic mitral valve apparatus according to claim 1, wherein, The self-expanding prosthetic mitral valve frame further comprises an upper portion formed by a stent, the upper portion including at least two sets of opposing sub-portions, at least one of the opposing sub-portions including a fabric covering.

15. The prosthetic mitral valve apparatus according to claim 14, wherein, The method further comprises using the fabric covering to capture blood flow to position the self-expanding prosthetic mitral valve frame and expand the positioned self-expanding prosthetic mitral valve frame.

16. The prosthetic mitral valve apparatus according to claim 1, wherein, Translation: The translation of the inner sheath through the lumen of the delivery catheter causes the contracted self-expanding prosthetic mitral valve frame to translate through the lumen of the delivery catheter, and the inner sheath surrounds the proximal portion but does not surround the distal portion of the contracted self-expanding prosthetic mitral valve frame.

17. The prosthetic mitral valve apparatus according to claim 16, wherein, Translation: The first outer diameter of the inner sheath is smaller than the second outer diameter of the lumen of the delivery catheter.

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