Artificial valve to prevent outflow obstruction

Abstract

Provision of an artificial valve to avoid outflow obstruction. A prosthetic mitral valve (510) can be anchored within a native mitral valve. The prosthetic mitral valve preferably has a large prosthetic anterior leaflet that spans the entire width of the native anterior leaflet, and the prosthetic leaflet moves away from the left ventricular outflow tract during systole to create a clear, unobstructed outflow tract. In one embodiment, a prosthetic heart valve for implantation into a patient's native mitral valve includes a radially expandable anchor frame (525) having an expanded configuration and a collapsed configuration, and a prosthetic valve coupled to the anchor frame.

Description

Background Art

[0001] (Related Application) This application claims priority to U.S. Provisional Patent Application No. 62 / 288,987, filed on January 29, 2016.

[0002] This application is related to U.S. Patent No. 8,579,964, filed on April 28, 2011, U.S. Patent No. 8,579,964, filed on April 28, 2011, U.S. Patent Application Publication No. 2015 / 0216655, filed on April 13, 2015, U.S. Patent Application Publication No. 2015 / 0257878, filed on April 21, 2015, U.S. Patent Application Publication No. 2014 / 0039611, filed on April 19, 2013, U.S. Patent Application Publication No. 2013 / 0211508, filed on November 16, 2012, U.S. Patent Application Publication No. 2014 / 0052237, filed on February 8, 2013, U.S. Patent Application Publication No. 2014 / 0155990, filed on May 5, 2013, U.S. Patent Application Publication No. 2014 / 0257467, filed on March 3, 2014, and U.S. Patent Application Publication No. 2014 / 0343669, filed on April 1, 2014. The entire contents of the above applications are hereby incorporated by reference in their entirety for all purposes.

[0003] Mitral regurgitation, also known as mitral insufficiency or mitral incompetence, is a cardiac condition in which the mitral valve does not close properly. This results in an abnormal leakage of blood, which is retrograde, from the left ventricle through the mitral valve into the atria. Persistent mitral regurgitation can lead to congestive heart failure. Conventional surgical repair of the valve generally yields good clinical outcomes but requires open-heart surgery and a long, expensive hospital stay with a prolonged recovery period. More recently, minimally invasive techniques have been developed to deliver artificial heart valves percutaneously to the heart via a catheter through the patient's vascular system. As an alternative, transapical techniques are used to introduce prostheses through the chest wall and through the apex. Exemplary prostheses include those described in U.S. Patent No. 8,579,964 (Patent Document 1), whose entire contents are incorporated herein by reference for all purposes. While these prosthetic devices and delivery techniques are considered promising, in certain situations they may obstruct blood flow, disrupt blood flow through the prosthesis, or interfere with natural pathways, thereby potentially leading to hemodynamic problems. Therefore, it would be desirable to provide improved devices, systems, and methods that avoid obstructing blood outflow and maintain natural pathways and natural hemodynamics. At least some of these objectives can be satisfied by the exemplary embodiments described herein. [Prior art documents] [Patent Documents]

[0004] [Patent Document 1] U.S. Patent No. 8,579,964 [Overview of the project] [Problems that the invention aims to solve]

[0005] The present invention relates in general to medical systems, devices, and methods, and more specifically to artificial heart valves that can be used to repair valves such as mitral valves, heart valves, or any other valves. [Means for solving the problem]

[0006] In the first aspect, the artificial heart valve for implantation in the patient's natural mitral valve comprises a radially expandable anchor frame having an expanded configuration and a folded configuration. The heart valve also comprises an artificial valve coupled to the anchor frame. The artificial valve comprises a plurality of artificial leaflets, each having a free end and a fixed end, the fixed end being coupled to the anchor frame, and the free ends of the plurality of artificial leaflets having an open configuration and a closed configuration. In the open configuration, the free ends are positioned apart from each other to allow antegrade blood flow through them, and in the closed configuration, the free ends are positioned adjacent to each other to substantially prevent retrograde blood flow through them. The artificial mitral valve is configured to direct blood flow through the artificial valve in a non-turbulent manner, circularly, toward the apex along the posterior wall of the patient's left ventricle and upward along the septum until it is released from the left ventricular outflow tract during systole.

[0007] As blood flow exits the left ventricular outflow tract through the artificial mitral valve and left ventricle, it substantially maintains momentum and conserves energy. Blood flow is indirectly directed to the apex or septum.

[0008] Multiple prosthetic leaflets may include an anterior leaflet sized to extend across the entire width of the natural anterior leaflet. During systole, the prosthetic anterior leaflet may displace away from the left ventricular outflow tract, providing an unobstructed and unblocked outflow tract for blood flow.

[0009] In another aspect, the prosthetic heart valve for implantation in the patient's natural mitral valve features a radially expandable anchor frame having an expanded configuration and a folded configuration. The prosthetic heart valve also features a prosthetic valve coupled to the anchor frame, comprising multiple prosthetic leaflets, each having a free end and a fixed end. The fixed end is coupled to the anchor frame, and the free ends of the multiple prosthetic leaflets have an open configuration and a closed configuration. In the open configuration, the free ends are positioned apart from each other to allow antegrade blood flow through them, and in the closed configuration, the free ends are positioned adjacent to each other to substantially prevent retrograde blood flow through them. The multiple prosthetic leaflets include a prosthetic anterior leaflet sized to extend across the entire width of the natural anterior leaflet. During systole, the prosthetic anterior leaflet displaces away from the left ventricular outflow tract, providing an unobstructed and unblocked outflow tract.

[0010] The artificial heart valve is configured to direct blood flow through the valve in a non-turbulent manner, preferably directed in a circular upward direction along the septum, following the posterior wall of the patient's left ventricle toward the apex, and then being discharged from the left ventricular outflow tract. The blood flow preferably substantially maintains momentum and conserves energy as it passes through the artificial mitral valve and left ventricle and out of the left ventricular outflow tract.

[0011] In any aspect, the anchor frame may include an anterior fixation tab configured to fix on the fibrous triangle of the natural mitral valve or anterior to the natural anterior leaflet and adjacent to any tissue. The anchor frame may also include a second anterior fixation tab configured to fix on the second fibrous triangle of the natural mitral valve or anterior to the natural anterior leaflet and adjacent to any tissue. The anchor frame may have a D-shaped cross-section having a substantially flat anterior portion and a cylindrical posterior portion. The flat anterior portion prevents the prosthetic valve from impacting the left ventricular outflow tract, and the cylindrical portion engages with the posterior portion of the natural mitral valve. The anchor frame may comprise one or more commissures and an anterior fixation tab. One or more commissures may have a free end and an opposite end coupled to the anchor frame. Multiple commissures may be coupled to multiple prosthetic leaflets, and the anterior fixation tabs may be configured to fix on the fibrous triangle of the natural mitral valve or anterior to the natural anterior leaflet and adjacent to any tissue. The front anchoring tab and one or more commissar columns can be nested within each other when the anchor frame is in a folded configuration. The front anchoring tab may originate from a circumferential position on the anchor frame, and one or more commissar columns may also originate from the same circumferential position on the anchor frame as the front anchoring tab. The front anchoring tab may originate from one or more commissar columns, or one or more commissar columns may originate from an anchoring tab.

[0012] In another aspect, a method of treating the natural mitral valve in a patient's heart involves providing a prosthetic mitral valve, immobilizing the prosthetic mitral valve within the natural mitral valve, and directing blood flow in a non-turbulent manner. The blood flow is directed through the prosthetic mitral valve in a circular direction upward along the septum, along the posterior wall of the patient's left ventricle toward the apex, and then released through the left ventricular outflow tract.

[0013] The method may further include substantially maintaining the momentum of blood flow and conserving energy as blood flows out of the left ventricular outflow tract through the artificial mitral valve and left ventricle. Directing blood flow may include indirectly directing blood flow to the apex or septum. The artificial mitral valve may have an artificial anterior leaflet extending to the width of the natural anterior leaflet, and the method may further include displacing the artificial anterior leaflet away from the left ventricular outflow tract to provide an unobstructed and unblocked outflow tract during systole. Fixing the prosthesis may include fixing an anterior fixation tab positioned on the anterior portion of the artificial valve to the fibrous triangle of the natural mitral valve, or to tissue anterior to and adjacent to the natural anterior leaflet.

[0014] In yet another aspect, a method for treating a natural mitral valve in a patient's heart includes providing a prosthetic mitral valve having an artificial anterior leaflet that extends to the width of the natural anterior leaflet, immobilizing the prosthetic mitral valve within the natural mitral valve, and displacing the prosthetic anterior leaflet during systole so as to move away from the left ventricular outflow tract during systole, thereby creating an unoccluded outflow tract.

[0015] The method may further involve directing blood flow through the artificial mitral valve in a non-turbulent manner, along the posterior wall of the patient's left ventricle toward the apex, and upward in a circular direction along the septum until it is released from the left ventricular outflow tract. Fixing the prosthesis may involve fixing an anterior fixation tab, positioned on the anterior portion of the artificial valve, to the fibrous triangle of the natural mitral valve, or to tissue anterior to and adjacent to the natural anterior leaflet.

[0016] In another aspect, the prosthetic valve for implantation in a patient's natural mitral valve comprises a radially expandable anchor frame having an expanded configuration and a folded configuration, and a prosthetic valve coupled to the anchor frame. The prosthetic valve comprises multiple prosthetic leaflets, each having a free end and a fixed end. The fixed end is coupled to the anchor frame, and the free ends of the multiple prosthetic leaflets have an open configuration and a closed configuration. In the open configuration, the free ends are positioned apart from each other to allow antegrade blood flow through them, and in the closed configuration, the free ends are positioned adjacent to each other to substantially prevent retrograde blood flow through them. The multiple prosthetic leaflets comprise a prosthetic anterior leaflet sized to extend across the entire width of the natural anterior leaflet. During systole, the prosthetic anterior leaflet displaces away from the left ventricular outflow tract, providing an unobstructed and unblocked outflow tract.

[0017] The anchor frame may include a pre-fixation tab configured to anchor to the anterior portion of the natural mitral valve, the anterior portion of the natural mitral valve may include a fibrous triangle. The anchor frame may also include a second pre-fixation tab configured to anchor to a second anterior portion of the natural mitral valve. In some embodiments, the anchor frame may have a D-shaped cross-section having a substantially flat anterior portion and a cylindrical posterior portion, the flat anterior portion preventing the prosthetic valve from colliding with the left ventricular outflow tract, and the cylindrical posterior portion engaging with the posterior portion of the natural mitral valve. In some examples, the anchor frame may comprise one or more commissures and pre-fixation tabs, the one or more commissures having a free end and an opposite end coupled to the anchor frame, and the one or more commissures being coupled to a plurality of prosthetic valve leaflets.

[0018] The pre-fixation tab can be configured to fix to the anterior portion of the natural mitral valve. In some embodiments, the pre-fixation tab and one or more commissure columns can be nested together when the anchor frame is in a folded configuration. The pre-fixation tab arises from a circumferential position on the circumference of the anchor frame, and one or more commissure columns also arise from the same circumferential position on the circumference of the anchor frame as the pre-fixation tab. The pre-fixation tab may arise from one or more commissure columns, or one or more commissure columns may arise from the pre-fixation tab.

[0019] In some examples, the anchor frame may further comprise multiple chordal bumper struts arising from one or more commissure struts. These chordal bumper struts may be configured to position the sub-biological structure away from the LVOT. In some embodiments, the commissure struts may comprise anchoring elements adjacent to the free end of the commissure struts, configured to engage with the delivery system. The anchor frame may further comprise multiple furcicular struts arising from one or more commissure struts. These furcicular struts may be configured to arch over the distance between adjacent commissure struts. Each furcicular strut may consist of an anchoring element positioned at the apex of the furcicular strut or adjacent to the free end of the furcicular strut. The anchoring element may be configured to engage with the delivery catheter. The furcicular struts may be deformable members, allowing for radial contraction of the anchor frame when retracted into the delivery catheter. The anchoring elements may comprise a single threaded connector, multiple threaded connectors, a buckle connector, or a prong connector.

[0020] In another aspect, an artificial heart valve for implantation into a patient's natural mitral valve comprises a radially expandable anchor frame, a pre-fixation tab coupled to the anchor frame, and an artificial valve coupled to the anchor frame. The radially expandable anchor frame has an expanded configuration and a folded configuration, and an upstream end and a downstream end. The radially expandable anchor frame comprises one or more commissures having a free end and a downstream end, with opposite ends coupled to the anchor frame adjacent to the downstream end, and a pre-fixation tab coupled to the anchor frame adjacent to the downstream end. The pre-fixation tab is configured to fix to the anterior portion of the natural mitral valve. The pre-fixation tab and one or more commissures are nested together when the anchor frame is in the folded configuration. The artificial valve comprises one or more artificial valve leaflets, each having a free end and a fixed end, the fixed end being coupled to the anchor frame. One or more commissures are coupled to one or more artificial valve leaflets.

[0021] In some embodiments, the free ends of one or more artificial valve leaflets may have both open and closed configurations. In an open configuration, the free ends may be positioned apart from each other to allow antegrade blood flow through them, while in a closed configuration, the free ends may be positioned adjacent to each other to substantially prevent retrograde blood flow through them. One or more artificial valve leaflets may comprise an artificial anterior leaflet sized to extend across the width of the natural anterior leaflet between two natural fibrous triangles. During systole, the artificial anterior leaflet can displace away from the left ventricular outflow tract to provide an unobstructed and unblocked outflow tract. The anterior portion of the natural mitral valve may comprise a fibrous triangle.

[0022] In some examples, the anchor frame may have a second anterior anchoring tab configured to anchor to a second anterior portion of the natural mitral valve. In addition, or alternatively, the anchor frame may have a D-shaped cross-section having a substantially flat anterior portion and a cylindrical posterior portion. The flat anterior portion can prevent the artificial heart valve from colliding with the left ventricular outflow tract, and the cylindrical portion can engage with the posterior portion of the natural mitral valve.

[0023] The pre-anchoring tab can originate from a circumferential position on the circumference of the anchor frame, and one or more commissar columns can also originate from the same circumferential position on the circumference of the anchor frame as the pre-anchoring tab. In some examples, the pre-anchoring tab can originate from one or more commissar columns, or one or more commissar columns can originate from the pre-anchoring tab.

[0024] In another aspect, a method for treating a natural mitral valve in a patient's heart includes providing a mitral valve prosthesis having an artificial anterior leaflet extending to the width of the natural anterior leaflet, immobilizing the mitral valve prosthesis within the natural mitral valve, and displacing the artificial anterior leaflet in systole so as to move away from the left ventricular outflow tract during systole, thereby creating an unoccluded outflow tract. Immobilizing the mitral valve prosthesis within the natural mitral valve may include immobilizing a pre-fixation tab positioned on the anterior portion of the prosthesis valve onto the anterior portion of the natural mitral valve. In some examples, the anterior portion of the natural mitral valve may have a fibrous triangle.

[0025] The method can include radially expanding the prosthetic mitral valve from a folded configuration to an expanded configuration, and radially expanding the prosthetic mitral valve can include expanding one or more pre - anchoring tabs away from a nested position within one or more commissural struts. The method can include radially expanding the prosthetic mitral valve from a folded configuration to an expanded configuration, and radially expanding can include expanding one or more post - anchoring tabs away from a nested position within one or more commissural struts. In some examples, anchoring the prosthetic mitral valve can include actuating an actuator mechanism on a delivery system in a first direction that can include moving a sheath catheter away from the prosthetic mitral valve, removing a restraint, thereby enabling the prosthetic mitral valve to expand. The method can further include actuating the actuator mechanism in a second direction opposite the first direction that can include moving the sheath catheter toward the prosthetic mitral valve, providing a restraint, thereby causing the prosthetic mitral valve to be forcibly compressed. In some examples, actuating the actuator mechanism in the first direction can include moving a bell catheter away from a fixation catheter, removing a restraint, thereby enabling commissural anchors to be released. The commissural anchors can include fixation elements that engage the frame of the prosthetic mitral valve to the delivery system. Actuating the actuator mechanism in the second direction can include moving the bell catheter toward the fixation catheter, providing a restraint that captures or limits the commissural anchors. Providing a restraint that captures or limits the commissural anchors can include slidably releasing a limiting element over the commissural anchors. Also, actuating the actuator mechanism can include moving the sheath catheter over the fixation catheter, thereby applying a restraint, that can include enabling the commissural anchors to be compressed. The commissural anchors can include flexible fixation elements that can engage the frame of the prosthetic mitral valve to the delivery system.

[0026] In another aspect, a method of treating a native mitral valve within a patient's heart includes providing an artificial mitral valve coupled to a radially expandable anchor frame having an upstream end and a downstream end, expanding the radially expandable anchor frame from a folded configuration to an expanded configuration, securing the artificial mitral valve within the native mitral valve, wherein the pre - securing tab secures to the anterior portion of the native mitral valve, and radially expanding the pre - securing tab away from a nested position within one or more commissural struts. The radially expandable anchor frame includes one or more commissural struts having free ends and opposite ends coupled to the anchor frame adjacent the downstream end, and a pre - securing tab coupled to the anchor frame adjacent the downstream end. The anterior portion of the native mitral valve can include a fibrous triangle. In some examples, expanding the anchor frame radially can include expanding one or more commissural struts away from a nested position within the pre - securing tab.

[0027] The artificial mitral valve can include an artificial anterior leaflet, and the method can include spanning the width of the native anterior valve leaflet between two native fibrous triangles, displacing the artificial anterior leaflet away from the left ventricular outflow tract, and creating an outflow tract that is not occluded by the displacement of the artificial anterior leaflet.

[0028] In another aspect, the delivery system for delivering a prosthesis to a target therapeutic area comprises an internal guidewire catheter having a proximal end, a distal end, and a lumen extending between them, the lumen being sized to slidably receive a guidewire; a flexible dilator tip coupled to the guidewire catheter, having a tapered and flexible self-expanding edge; a sheath catheter slidably positioned over the internal guidewire catheter, having a proximal end and a distal end; and an actuator mechanism operably coupled to the proximal end of the sheath catheter. Actuation of the actuator mechanism in a first direction moves the sheath catheter away from the dilator tip, thereby removing the constraint from the prosthesis and allowing the prosthesis to expand. Actuation of the actuator mechanism in a second direction opposite to the first direction moves the sheath catheter to engage with the dilator tip, thereby encapsulating the prosthesis within it.

[0029] The system may include a stationary anchoring catheter positioned to cover and secure a guidewire catheter, having an anchor element adjacent to the distal end of the anchor catheter and configured to engage with a prosthesis. In some examples, a bell catheter may be slidably positioned covering the anchoring catheter. The bell catheter may have a bell element positioned adjacent to the distal end of the bell catheter, and the bell element can restrain a prosthesis to engage with the anchor catheter. The anchoring catheter may have a flexible prong-type anchor element adjacent to the distal end of the anchor catheter, configured to engage with a prosthesis. A sheath catheter may be slidably positioned covering the anchoring catheter. Specifically, advancement of the distal end of the sheath catheter may fold the flexible prong-type anchor element to engage with a prosthesis.

[0030] In some embodiments, a stationary bell catheter can be positioned to cover and secure an anchor catheter. The bell catheter may have a bell element positioned adjacent to the distal end of the bell catheter, which can release the prosthesis from the anchor catheter. In some embodiments, the system may include a bell catheter rotatably positioned to cover a guidewire catheter. The bell catheter may have an internally threaded bell element positioned adjacent to the distal end of the bell catheter, which can restrain the prosthesis to engage. A second actuator mechanism may be operably coupled to the proximal end of the bell catheter. Actuation of the second actuator mechanism in a first direction can couple the prosthesis to the bell catheter and provide restraint for the prosthesis, while actuation of the second actuator mechanism in a second direction opposite to the first direction can detach the prosthesis from the bell catheter and remove restraint from the prosthesis. The system may include a rotary torque catheter rotatably positioned to cover a guidewire catheter. The torque catheter may have a drive gear element positioned adjacent to the distal end of the torque catheter and configured to transmit torque. Multiple rotatable threaded connector catheters can be rotatably positioned adjacent to a torque catheter. Each threaded connector catheter may have a driven gear element adjacent to the distal end of each threaded connector catheter and a threaded socket adjacent to the distal end of each threaded connector catheter. The driven gear element can be sized to entangle with the driven gear element and receive torque, and the threaded socket can be configured to restrain and engage a prosthesis. A second actuator mechanism can be operably coupled to the proximal end of the torque catheter. Actuation of the second actuator mechanism in a first direction can couple a prosthesis to the threaded connector catheter, and actuation of the second actuator mechanism in a second direction opposite to the first direction can detach the prosthesis from the threaded connector catheter.

[0031] On either side, the method may further include radially expanding the artificial mitral valve from a folded configuration to an expanded configuration. Radially expanding the prosthesis may include expanding the pre-fixed tab so as to move away from the nested configuration with commissure posts.

[0032] These and other embodiments are described in further detail in the following description relating to the attached drawings. This specification also provides, for example, the following items: (Item 1) An artificial heart valve for implantation into a patient's natural mitral valve, wherein the heart valve is A radially expandable anchor frame having an extended configuration and a folded configuration, The artificial valve connected to the anchor frame and Equipped with, The artificial valve comprises a plurality of artificial valve leaflets, each of which has a free end and a fixed end, the fixed end being coupled to the anchor frame, and the free ends of the plurality of artificial valve leaflets having an open configuration and a closed configuration, in the open configuration the free ends are arranged apart from each other to allow antegrade blood flow through them, and in the closed configuration the free ends are arranged adjacent to each other to substantially prevent retrograde blood flow through them. The plurality of artificial valve leaflets each have an artificial anterior leaflet whose size is determined to extend across the entire width of the natural anterior leaflet. A heart valve in which, during systole, the artificial anterior leaflet is displaced away from the left ventricular outflow tract, providing an unobstructed and unblocked outflow tract. (Item 2) The valve according to item 1, wherein the anchor frame comprises a pre-fixing tab configured to be fixed to the anterior portion of the natural mitral valve. (Item 3) The valve according to item 2, wherein the anterior portion of the natural mitral valve comprises a fibrous triangle. (Item 4) The valve according to item 2, wherein the anchor frame comprises a second pre-fixing tab configured to fix to the second anterior portion of the natural mitral valve. (Item 5) The valve according to item 1, wherein the anchor frame has a D-shaped cross-section having a substantially flat front portion and a cylindrical rear portion, the flat front portion preventing the artificial heart valve from colliding with the left ventricular outflow tract, and the cylindrical rear portion engaging with the rear portion of the natural mitral valve. (Item 6) The anchor frame comprises one or more commissure posts and a pre-fixing tab, each of the one or more commissure posts having a free end and an opposite end connected to the anchor frame, and each of the one or more commissure posts is connected to the plurality of artificial valve leaflets. The valve according to item 1, wherein the aforementioned pre-fixation tab is configured to be fixed to the anterior portion of the natural mitral valve. (Item 7) The valve described in item 6, wherein the pre-fixing tab and the one or more crossing columns are nested together when the anchor frame is in the folded configuration. (Item 8) The valve according to item 6, wherein the pre-anchoring tab originates from a circumferential position on the circumference of the anchor frame, and the one or more connecting columns also originate from the same circumferential position on the circumference of the anchor frame as the pre-anchoring tab. (Item 9) The valve according to item 6, wherein the pre-fixing tab originates from one or more commissure columns, or the one or more commissure columns originate from the pre-fixing tab. (Item 10) The valve according to item 9, wherein the anchor frame further comprises a plurality of chordal bumper supports arising from one or more commissar columns, the plurality of chordal bumper supports configured to position the natural subvalve biostructure away from the LVOT. (Item 11) The valve according to item 9, wherein the commutating column further comprises a fixing element adjacent to the free end of the commutating column, the fixing element being configured to engage with a delivery system. (Item 12) The valve according to item 9, wherein the anchor frame further comprises a plurality of furculate struts arising from one or more commissure struts, the plurality of furculate struts configured to span the distance between adjacent commissure struts, and each furculate strut comprises an anchoring element adjacent to the free end of the furculate strut, the anchoring element configured to engage with a delivery catheter. (Item 13) The valve according to item 12, wherein the plurality of furculate-shaped supports are deformable members, allowing the anchor frame to contract radially when retracted into the delivery catheter. (Item 14) The valve according to item 12, wherein the anchoring element comprises a single threaded connector, a buckle connector, or a prong connector. (Item 15) An artificial heart valve for implantation into a patient's natural mitral valve, wherein the heart valve is A radially expandable anchor frame having an extended configuration and a folded configuration, and an upstream end and a downstream end, wherein the radially expandable anchor frame comprises one or more commissar columns having a free end and an opposite end coupled to the anchor frame adjacent to the downstream end, and a pre-fixing tab coupled to the anchor frame adjacent to the downstream end, wherein the pre-fixing tab is configured to be fixed to the anterior portion of the natural mitral valve, and the pre-fixing tab and the one or more commissar columns are nested together when the anchor frame is in the folded configuration, The artificial valve connected to the anchor frame and Equipped with, The artificial valve comprises one or more artificial valve leaflets, each of which has a free end and a fixed end, the fixed end being coupled to the anchor frame. A heart valve in which one or more commissures are connected to one or more artificial valve leaflets. (Item 16) The valve according to item 15, wherein the free ends of one or more artificial valve leaflets have an open configuration and a closed configuration, in the open configuration, the free ends are positioned apart from each other to allow antegrade blood flow through them, and in the closed configuration, the free ends are positioned adjacent to each other to substantially prevent retrograde blood flow through them, and the one or more artificial valve leaflets include an artificial anterior leaflet sized to extend to the width of the natural anterior leaflet between two natural fibrous triangles, and in systole, the artificial anterior leaflet displaces away from the left ventricular outflow tract to provide an unobstructed and unblocked outflow tract. (Item 17) The valve according to item 15, wherein the anterior portion of the natural mitral valve comprises a fibrous triangle. (Item 18) The valve according to item 15, wherein the anchor frame comprises a second pre-fixing tab configured to fix to the second anterior portion of the natural mitral valve. (Item 19) The valve according to item 15, wherein the anchor frame has a D-shaped cross-section having a substantially flat front portion and a cylindrical rear portion, the flat front portion preventing the artificial heart valve from colliding with the left ventricular outflow tract, and the cylindrical portion engaging with the rear portion of the natural mitral valve. (Item 20) The valve according to item 15, wherein the pre-anchoring tab originates from a circumferential position on the circumference of the anchor frame, and the one or more connecting columns also originate from the same circumferential position on the circumference of the anchor frame as the pre-anchoring tab. (Item 21) The valve according to item 15, wherein the pre-fixing tab originates from one or more commissure columns, or the one or more commissure columns originate from the pre-fixing tab. (Item 22) A method for treating a natural mitral valve in a patient's heart, wherein the method is To provide an artificial mitral valve having an artificial anterior leaflet that extends to the width of the natural anterior leaflet, To fix the artificial mitral valve within the natural mitral valve, During systole, the prosthetic anterior leaflet is displaced in a way that it moves away from the left ventricular outflow tract, thereby creating an unoccluded outflow tract. Methods that include... (Item 23) Fixation is the method of item 22, which includes fixing a pre-fixation tab positioned on the anterior portion of the artificial valve to the anterior portion of the natural mitral valve. (Item 24) The method according to item 23, wherein the anterior portion of the natural mitral valve is provided with a fibrous triangle. (Item 25) The method according to item 22, comprising radially expanding the artificial mitral valve from a folded configuration to an expanded configuration, wherein the radial expansion of the artificial mitral valve comprises expanding one or more pre-fixed tabs away from nested positions within one or more commissures. (Item 26) The method according to item 22, comprising radially expanding the artificial mitral valve from a folded configuration to an expanded configuration, wherein the radial expansion includes expanding one or more post-fixation tabs away from their nested positions within one or more commissure columns. (Item 27) Fixing the artificial mitral valve involves activating an actuator mechanism on the delivery system in a first direction, wherein activating the actuator mechanism in the first direction includes moving the sheath catheter away from the artificial mitral valve, removing the constraint, and thereby allowing the artificial mitral valve to expand; and activating the actuator mechanism in a second direction opposite to the first direction. Includes, The method according to item 22, wherein acting the actuator mechanism in the second direction includes moving the sheath catheter toward the artificial mitral valve, providing restraint, and thereby causing the artificial mitral valve to be forcibly compressed. (Item 28) The method according to item 27, further comprising acting the actuator mechanism in the first direction to move the bell catheter away from the anchoring catheter, thereby removing the restraint and allowing the commissure anchor to be released, the commissure anchor comprising an anchoring element that engages the frame of the artificial mitral valve with the delivery system, and acting the actuator mechanism in the second direction to move the bell catheter toward the anchoring catheter and provide restraint that captures or restricts the commissure anchor. (Item 29) The method of item 28, wherein providing the constraint includes sliding a restricting element on the commutating anchor in a releaseable manner. (Item 30) The method according to item 27, wherein activating the actuator mechanism includes moving the sheath catheter over the anchoring catheter, thereby applying restraint, and applying restraint includes allowing the commissure anchor to be compressed, the commissure anchor comprising a flexible anchoring element that engages the frame of the artificial mitral valve with the delivery system. (Item 31) A method for treating a natural mitral valve in a patient's heart, wherein the method is To provide an artificial mitral valve coupled to a radially expandable anchor frame having an upstream end and a downstream end, wherein the radially expandable anchor frame comprises one or more commissar columns having a free end and an opposite end coupled to the anchor frame adjacent to the downstream end, and a pre-fixing tab coupled to the anchor frame adjacent to the downstream end, Extending the radially expandable anchor frame from a folded configuration to an extended configuration, The artificial mitral valve is to be fixed into the natural mitral valve, wherein the pre-fixation tab is fixed to the anterior portion of the natural mitral valve. Extending the pre-fixing tab radially so as to move away from its nested position within one or more of the aforementioned cross-columns. Methods that include... (Item 32) The method according to item 31, wherein the anterior portion of the natural mitral valve is provided with a fibrous triangle. (Item 33) The method according to item 31, wherein extending the anchor frame radially includes extending one or more of the one or more cross columns away from their nested positions within the pre-anchored tab. (Item 34) The artificial mitral valve comprises an artificial anterior leaflet, and the method is It extends to the width of the natural anterior valve leaflet between the two natural fibrous triangles, Displacing the artificial anterior leaflet so that it is away from the left ventricular outflow tract, To create an outflow tract that is not blocked by the displacement of the artificial anterior leaflet. The method described in item 31, including the method described in item 31. (Item 35) A delivery system for delivering a prosthesis to a target treatment area, wherein the system is An internal guidewire catheter having a proximal end, a distal end, and a lumen extending between them, wherein the lumen is sized to slidably receive a guidewire, A flexible dilation tip coupled to the guidewire catheter, wherein the dilation tip has a tapered and flexible self-expanding edge, A sheath catheter slidably positioned to cover the aforementioned internal guidewire catheter, wherein the sheath catheter has a proximal end and a distal end, An actuator mechanism operably coupled to the proximal end of the sheath catheter and Equipped with, The operation of the actuator mechanism in the first direction moves the sheath catheter away from the tip of the expander, thereby removing the constraint from the prosthesis and allowing the prosthesis to expand. The system wherein the operation of the actuator mechanism in a second direction opposite to the first direction moves the sheath catheter so as to engage with the tip of the expander, thereby enclosing the prosthesis therein. (Item 36) The system according to item 35, further comprising a stationary anchoring catheter positioned to cover and secure the guidewire catheter, wherein the anchoring catheter has an anchoring element adjacent to the distal end of the anchoring catheter and configured to engage with the prosthesis. (Item 37) The system according to item 36, further comprising a bell catheter slidably positioned over the anchoring catheter, wherein the bell catheter has a bell element positioned adjacent to the distal end of the bell catheter, the bell element restraining the prosthesis to engage with the anchor catheter. (Item 38) The system according to item 36, wherein the anchoring catheter has a flexible prong-type anchoring element adjacent to the distal end of the anchoring catheter, and the anchoring element is configured to engage with the prosthesis. (Item 39) The system according to item 38, wherein the sheath catheter is slidably positioned to cover the anchoring catheter, and the advance of the distal end of the sheath catheter causes the flexible prong-type anchor element to fold to engage with the prosthesis. (Item 40) The system according to item 36, further comprising a stationary bell catheter positioned to cover and fix the anchoring catheter, wherein the bell catheter has a bell element positioned adjacent to the distal end of the bell catheter, the bell element releasing the prosthesis from the anchor catheter. (Item 41) The system according to item 35, further comprising a bell catheter rotatably positioned over the guidewire catheter, wherein the bell catheter has an internally threaded bell element positioned adjacent to the distal end of the bell catheter, the threaded bell element restraining the prosthesis to engage. (Item 42) The system according to item 41, further comprising a second actuator mechanism operably coupled to the proximal end of the bell catheter, wherein the operation of the second actuator mechanism in a first direction couples the prosthesis to the bell catheter and provides a restraint for the prosthesis, and the operation of the second actuator mechanism in a second direction opposite to the first direction couples the prosthesis to the bell catheter and removes the restraint from the prosthesis. (Item 43) The system according to item 35, further comprising a rotary torque catheter rotatably positioned over the guidewire catheter, wherein the torque catheter has a drive gear element adjacent to the distal end of the torque catheter and configured to transmit torque. (Item 44) The system according to item 43, further comprising a plurality of rotating threaded connector catheters rotatably arranged adjacent to the torque catheter, each of the threaded connector catheters having a driven gear element adjacent to the distal end of each threaded connector catheter and a threaded socket adjacent to the distal end of each threaded connector catheter, wherein the driven gear element is sized to interlock with the driving gear element and receive torque, and the threaded socket is configured to restrain and engage the prosthesis. (Item 45) The system according to item 44, further comprising a second actuator mechanism operably coupled to the proximal end of the torque catheter, wherein the operation of the second actuator mechanism in a first direction connects the prosthesis to the threaded connector catheter, and the operation of the second actuator mechanism in a second direction opposite to the first direction disconnects the prosthesis from the threaded connector catheter.

[0033] (Citation by reference) All publications, patents, and patent applications described herein are incorporated herein by reference to the same extent as each individual publication, patent, or patent application is specifically and individually indicated to be incorporated by reference.

[0034] Novel features of the present invention are described in detail in the appended claims. A further understanding of the features and advantages of the present invention will be obtained by referring to the following embodiments for carrying out the invention, which describe illustrative embodiments in which the principles of the present invention are utilized, and to the accompanying drawings. [Brief explanation of the drawing]

[0035] [Figure 1] Figure 1 depicts the anatomical heart in a frontal view. [Figure 2] Figure 2 shows a cross-section of Figure 1 and the internal biological structure of the heart, including the left ventricular outflow tract (LVOT) and the artificial mitral valve. [Figure 3] Figure 3 depicts the anatomical heart in a posterior view. [Figure 4] Figure 4 shows the cross-section of Figure 3 and the internal biological structure of the heart, specifically the mitral and the space below the aortic valve. [Figure 5] Figure 5 illustrates an embodiment of an artificial mitral valve configured to avoid LVOT occlusion. [Figure 6] Figure 6 illustrates the inflow diagram of a three-lobed mitral valve prosthesis configured to avoid LVOT occlusion. [Figure 7] Figure 7 illustrates the outflow diagram of a three-lobed mitral valve prosthesis configured to avoid LVOT occlusion. [Figure 8A] Figure 8A shows the outflow diagram of a single-lobe artificial mitral valve of the duckbill valve type. [Figure 8B] Figure 8B shows the outflow diagram of a bifurcated artificial mitral valve. [Figure 8C] Figure 8C depicts the outflow of an anterior single-leaflet artificial mitral valve in the open position. [Figure 8D] Figure 8D depicts the outflow of an anterior single-leaflet artificial mitral valve in the closed position. [Figure 8E] Figure 8E shows the outflow diagram of a three-lobed artificial mitral valve with a large anterior leaflet. [Figure 8F] Figure 8F shows the outflow diagram of a quadruple-lobed artificial mitral valve. [Figure 9]Figure 9 shows the frame flattening pattern of the artificial mitral valve frame. [Figure 10] Figure 10 shows the frame flattening pattern of an artificial mitral valve frame with a chordal bumper support. [Figure 11] Figure 11 shows the frame flattening pattern of an artificial mitral valve frame with chordal bumper struts and furcicular struts. [Figure 12] Figure 12 shows the frame flattening pattern of an artificial mitral valve frame with a furcicular strut. [Figure 13] Figure 13 illustrates an embodiment of an artificial mitral valve with a furcicular strut shaped to avoid LVOT occlusion. [Figure 14] Figure 14 illustrates an embodiment of an artificial mitral valve with a bone-shaped support fixed to the delivery system. [Figure 15] Figure 15A shows an embodiment of a modified delivery system and furcula-shaped support anchorage with multiple threaded connectors connected. Figure 15B shows an embodiment of a modified delivery system and furcula-shaped support anchorage with multiple threaded connectors disconnected. [Figure 16] Figure 16A shows an embodiment of a modified delivery system and furcula-shaped support anchorage with a split threaded connector connected. Figure 16B shows an embodiment of a modified delivery system and furcula-shaped support anchorage with the split threaded connector disconnected. [Figure 17] Figure 17A shows an embodiment of the delivery system and furcicular support anchoring method with a flexible pin connector connected. Figure 17B shows an embodiment of the delivery system and furcicular support anchoring method with the flexible pin connector disconnected. [Figure 18] Figure 18A shows an embodiment of the delivery system and furcicular post anchoring method with a flexible buckle connector connected. Figure 18B shows an embodiment of the delivery system and furcicular post anchoring method along with an internal view of the connected flexible buckle connector. Figure 18C shows an embodiment of the delivery system and furcicular post anchoring method along with an internal view of the disconnected flexible buckle connector. [Figure 19]Figure 19A shows an embodiment of the delivery system and furcicular support anchoring method, along with an internal view of the connected anchor-shaped connector. Figure 19B shows an embodiment of the delivery system and furcicular support anchoring method in which the anchor-shaped connector is not constrained to allow for disconnection. [Figure 20-1] Figure 20A depicts an embodiment of the delivery system in a closed configuration with an artificial mitral valve internally loaded. Figure 20B depicts an embodiment of the delivery system in a partially open configuration with an artificial mitral valve internally loaded and deployed. Figure 20C depicts an embodiment of the delivery system in a substantially open configuration with an artificial mitral valve internally loaded and partially deployed. [Figure 20-2] Figure 20D depicts an embodiment of the delivery system in a substantially open configuration with the artificial mitral valve loaded and nearly released. Figure 20E depicts an embodiment of the delivery system in a fully open configuration with the artificial mitral valve loaded internally just before final deployment. Figure 20F depicts an embodiment of the artificial mitral valve after release. [Figure 21] Figures 21A-C show an embodiment of a delivery system having a slotted anchoring mechanism that can be adapted to an anchored furcular post. [Figure 22] Figure 22 shows an enlarged view of an embodiment of a delivery system having a slotted anchoring mechanism that can be adapted to an anchored furcular post. [Figure 23] Figure 23 shows an exploded view of a delivery system with a slotted anchoring mechanism that can be adapted to an anchored furcicular post. [Figure 24] Figures 24A-C show an embodiment of a delivery system having a flexible connector anchor mechanism that can be adapted to a pinned furcular post. [Figure 25] Figure 25 depicts an exploded view of an embodiment of a delivery system having a flexible connector anchor mechanism that can be adapted to a pinned furcular support. [Figure 26A] Figure 26A depicts an exploded view of an operational delivery system having a slide connector anchor mechanism that can be adapted to a flexible buckle furculate support. [Figure 26B]Figure 26B depicts an enlarged view of an implementation of a delivery system having a slide connector anchor mechanism that can be adapted to a flexible buckle furculate support. [Figure 27] Figure 27 shows an exploded view of an operational delivery system with a single screw connector anchor mechanism, which can be adapted to a split-threaded furculate support. [Figure 28] Figure 28 shows an enlarged view of an implementation of a delivery system with a single screw connector anchor mechanism, which can be adapted to a furculate support with split threads. [Figure 29] Figure 29 shows an exploded view of an operational delivery system with multiple screw connector anchoring mechanisms that can be adapted to a threaded furculate post. [Figure 30] Figure 30 shows an exploded view of a working concentric catheter with a delivery system featuring multiple screw connector anchoring mechanisms, which can be adapted to a threaded furculate support. [Figure 31] Figure 31 shows an enlarged view of the end of a delivery system embodiment, which may be adapted to a threaded furculate support, and a sun gear and multiple threaded connector anchor mechanism. [Figure 32] Figure 32 shows turbulent blood flow within the heart. [Figure 33] Figure 33 shows the undisturbed blood flow within the heart. [Figure 34] Figure 34 illustrates an artificial mitral valve that directs blood within the heart in a non-turbulent manner. [Figure 35] Figure 35 shows a perspective view of the artificial valve. [Figure 36] Figure 36A illustrates the atrial skirt of the prosthetic valve. Figure 36B illustrates a top view of the prosthetic valve. [Figure 37] Figure 37 illustrates the flattening pattern of the artificial valve. [Figure 38] Figure 38 shows a perspective view of the artificial valve. [Figure 39] Figure 39A shows a front view of the artificial valve. Figure 39B shows a top view of the artificial valve. [Figure 40] Figure 40 illustrates the deployment of the artificial valve. [Figure 41]Figure 41 shows a side view of the artificial valve. [Figure 42] Figure 42 illustrates the composite cross column and anchor tab. [Figure 43] Figures 43A and 43B illustrate the unextended and extended anchor tabs. Figure 43C illustrates the flat pattern of the extended anchor tab. [Figure 44] Figure 44 shows a D-shaped prosthesis. [Figure 45] Figure 45 shows a side view of the artificial valve. [Figure 46] Figure 46 shows a top view of the artificial valve with four leaflets and four anchors. [Figure 47] Figure 47 shows a top view of the prosthetic valve with three leaflets and three anchors. [Figure 48] Figure 48 shows the flattening pattern of the artificial valve. [Figure 49] Figure 49 shows the natural valve leaflets covering and overlapping the anchor tab. [Figure 50] Figure 50 shows an inverted anchor tab with the cross-columns nested inside. [Figure 51] Figure 51 shows an embodiment with two anchors located adjacent to the natural anterior tip and an extended region lacking similar anchors in the posterior portion. [Figure 52] Figure 52 shows the flattening pattern of the artificial valve. [Figure 53] Figure 53 shows another flattening pattern of the artificial valve. [Figure 54] Figure 54 shows a perspective view of the artificial valve. [Figure 55] Figure 55 shows the mitral valve adjacent to the aortic valve. [Figure 56] Figure 56 shows another anchor tab nested within the cross-column in the extended configuration. [Figure 57] Figure 57 shows an anchor tab nested within a cross-column in an extended configuration. [Figure 58] Figure 58 shows an anchor tab nested inside a cross-column in a folded configuration. [Figure 59] Figure 59 shows the variable column thickness. [Modes for carrying out the invention]

[0036] Specific embodiments of the disclosed devices, delivery systems, and methods will be described herein with reference to the drawings. No embodiment of the invention is intended to imply that any particular component, feature, or step is essential to the invention.

[0037] As used herein, similar numbers refer to similar elements.

[0038] Figure 1 provides an explanatory diagram of the anatomical heart, represented herein by its anterior surface 10. Anterior views of various structures of the anatomical heart are also presented. The superior vena cava 50, right atrium 40, and right ventricle 20 are shown on the left side (of the viewer) of the anterior surface 10, with the superior and inferior structures separated by the right coronary artery 120. Sectional line AA divides the cardiac biostructure into lateral sections, which are further discussed in Figure 2. Moving to the right side (of the viewer) of the heart, an anterior view of the aorta 60 can be seen in a position superior to the pulmonary trunk 90. ​​Below the pulmonary trunk 90 are the left atrium 70 and left atrial appendage 80. Below the left atrial appendage 80, located on its left and right lateral sides (of the viewer), are the left anterior descending coronary artery 100 and the intermediate coronary artery 110, respectively. Finally, below all the aforementioned elements is the left ventricle 30.

[0039] Figure 2 shows the internal structure of the heart after dissection of the anterior surface 10 of the heart (as shown in Figure 1) along section AA. Section AA is demarcated by a diagonal zone 130 representing the incision surface. Starting from the uppermost element, the aorta 140 is depicted posteriorly. Below and behind the aorta 140 is the right atrium 180. An internal view of the left atrium 150 is shown, revealing the possible location of the artificial mitral valve 210 after implantation. The inflow region 220 and outflow region 230 of the artificial mitral valve 210 can also be seen. The anterior surface 170 of the artificial mitral valve 210 may be adjacent to zone 190 of the left ventricular outflow tract 200 (LVOT). The pre-fixation tab 240 may be positioned to avoid obstruction of the LVOT 200. When systole occurs and blood flows from below the artificial mitral valve 210 toward the LVOT 200, a large-volume channel leading directly to the aorta 140 may be present due to the large area of ​​zone 190. This configuration allows the LVOT 200 to be free from obstruction by external prosthesis expandable material or projections.

[0040] An artificial mitral valve may have one or more tabs. An artificial mitral valve may have one, two, three, four, five, six, seven, eight, nine, ten, or more than ten tabs. The posterior fixation tab 250 may be located opposite the anterior fixation tab 240 of the artificial mitral valve 210. The posterior fixation tab 250 may abut against the native biostructure and rest against the posterior ventricular shelf region 160, which is formed within the ventricle at the junction of the ventricle and the posterior mitral annulus (see Figure 4 for a clearer depiction). A third fixation tab is obscured in the depiction in Figure 2. Typically constructed from chemically preserved pericardial tissue taken from various species such as cattle, pigs, or sheep, the leaflets 260 may be located between the anterior fixation tab 240 and the posterior fixation tab 250. Further details relating to the artificial mitral valve 210 are provided beginning with Figure 5.

[0041] Figure 3 provides an explanatory diagram of the anatomical heart, represented herein by the posterior view 265 of the heart. Posterior views of various structures of the anatomical heart are also presented. Starting from the uppermost element, the posterior view of the superior vena cava 380 is adjacent to the posterior view of the aorta 370 and superior to the posterior view of the pulmonary trunk 390. Further posterior, the right atrium 270, left atrial appendage 280 (appearing to the left of the viewer), left atrium 340, right pulmonary vein 350, and left pulmonary vein 360 (appearing to the right of the viewer) are depicted. Sectional line BB divides the presented cardiac biostructure into superior and inferior sections, which are further discussed in Figure 4. The coronary arteries and associated branches include the left marginal branch 290, the circumflex branch 300, the posterior left ventricular branch of the left coronary artery 310, and the posterior interventricular branch 320 of the right coronary artery. Finally, at the lowest position of the elements is the apex 330.

[0042] Figure 4 shows the internal structure of the heart after incision of the posterior surface 265 of the heart (as shown in Figure 3) along section BB. Section BB is demarcated by a shaded zone 400 representing the incision surface. Starting from the top of the figure, the posterior ventricular shelf 470 is adjacent to the fixed end of the posterior mitral valve leaflet 450 and connected to it by tissue. This shelf may provide a location for the posterior fixation tab of a prosthetic mitral valve as described herein. The arcade-shaped posterior chordae tendineae 455 are located adjacent to the posterior mitral valve leaflet 450 and connected to it by tissue, finding their insertion points along the free edge of the leaflet. The fixed ends of the chordae tendineae 455 find insertion points in both the anterolateral papillary muscle 430 and the posteromedial papillary muscle 440. The papillary muscles 430 and 440 serve as muscular support bases for tethering effect, provided by the chordae tendineae that span the distance between the free edge insertion of the leaflet and the papillary muscle insertion while under dynamic tension. Opposite the posterior mitral leaflet 450 is the anterior mitral leaflet 460. During systole, the posterior and anterior mitral leaflets 450 and 460 communicate with each other when their free edges close to prevent retrograde blood flow into the left atrium. The free edge of the anterior leaflet 460 closely resembles the chordal structure of the posterior leaflet, and is adjacent to and connected by the arcade-like anterior chordae tendineae 465, which similarly finds fixed end insertion points in both the anterolateral 430 and posteromedial 440 papillary muscles.

[0043] The fixed end of the anterior leaflet 460 is directly adjacent to the inflow of the aortic valve 500 and connected to it by tissue. This adjacency is commonly known as aortic-mitral valve continuity. In this region, there is a risk of outflow tract obstruction, and the present invention aims to minimize LVOT obstruction. On the lateral side of the fixed end of the anterior leaflet 460 is a region of high-density cartilage tissue known as a fibrous triangle, which plays a role as a skeletal structure of the heart as a whole. The anterior septal fibrous triangle 480 and the anterolateral fibrous triangle 490 are represented by triangles that define the boundaries of the landing zone to which the anterior fixed tab of a prosthetic mitral valve (not shown) can abut during valve deployment. For reference, the tricuspid valve 410 and the aorta 420 are shown at the bottom of the figure.

[0044] Figure 5 illustrates the present invention in a perspective view showing an artificial mitral valve 510 (210 as shown in Figure 2) with a large anterior leaflet. The prosthesis may comprise an atrial region, an annular region, a valvular region, and an anchorage region. A frame 525 may provide a structural means on which the entire artificial valve can be built, as indicated by the dashed line in Figure 5. The frame may be a nitinol frame. The frame 525 may be layered in various biocompatible fabrics that provide excellent sealing properties. The biocompatible fabric may be polyester, nylon, or any other biocompatible material known to those skilled in the art. Medical-grade sutures may be used to sew the various fabrics onto the frame 525 and construct the prosthesis. The atrial region of the prosthesis may comprise an atrial skirt 520 that acts as a flange, allowing the valve inflow region (220 as shown in Figure 2) to align and seal with respect to the natural mitral annulus on the bottom surface of the left atrium. The atrial skirt 520 may traverse the entire circumference of the inflow region of the prosthetic valve (220 as shown in Figure 2) and may communicate with and connect to an annular region 530 that traverses the circumference of the prosthetic valve. In this representation, the anterior surface of the prosthetic valve is shown facing outward to the right from the viewer. Therefore, the anterior leaflet 580 is shown facing outward to the right. One or more leaflets may form the valve region of the prosthesis. The leaflets may comprise an anterior leaflet 580, a posterior septal leaflet 570, and a posterolateral leaflet 590. The anterior leaflet 580 may comprise an anterior leaflet inflow surface as described herein. The posterior septal leaflet 570 may comprise a posterior septal leaflet inflow surface as described herein. The posterolateral leaflet 590 may comprise a posterolateral leaflet inflow surface as described herein.

[0045] One or more of the multiple leaflets may comprise chemically preserved pericardial tissue. Chemically preserved pericardial tissue may be treated with chemical preservatives that promote polymer crosslinking, make the tissue inert and biocompatible for humans, and / or prepare the tissue for further sterilization. Leaflet tissue may originate from, but is not limited to, bovine, porcine, or sheep sources. In a closed configuration, the free ends of the anterior leaflet 580, posterior septal leaflet 570, and posterolateral leaflet 590 may intersect at the triple point of the leaflet junction 600. Conversely, the fixed end of each leaflet may be sutured to both the annular region of the valve and the next adjacent leaflet at specific locations that provide increased structural elasticity, as described herein. Figure 5 shows three leaflets, but an artificial mitral valve may comprise any number of leaflets. For example, an artificial mitral valve may comprise one, two, three, four, five, six, seven, eight, nine, ten, or more than ten leaflets.

[0046] Each leaflet can be joined to the next adjacent leaflet at a commissure attachment point through a commissure suture pad. Thus, an artificial mitral valve may have one or more commissure attachment points and one or more commissure suture pads. Specifically, the posterior septal 570 and anterior 580 leaflets can be joined together and attached to the anterior septal commissure attachment point 550 through the anterior septal commissure suture pad 560; the anterior 580 and posterolateral 590 leaflets can be joined together and attached to the anterolateral commissure attachment point 625 through the anterolateral commissure suture pad 615; and the posterolateral 590 and posterior septal 570 leaflets can be joined together and attached to the posterior commissure attachment point 645 through the posterior commissure suture pad 640. Figure 5 shows three commissure attachment points and three commissure suture pads, but an artificial mitral valve may have any number of commissure attachment points. For example, an artificial mitral valve may have 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 commissure attachment points and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 commissure suture pads.

[0047] One or more commissure anchors may extend into free space from each of the commissure attachment points so as to be detached from the valve. For example, the anterior septal commissure anchor 555 may extend from the anterior septal commissure attachment point 560, the anterior lateral commissure anchor 620 may extend from the anterior lateral commissure attachment point 625, and the posterior commissure anchor 650 may extend from the posterior commissure attachment point 645. Each of the commissure anchors may comprise means through which a prosthesis can be anchored and connected to a suitable delivery system, as described herein. The shape of each of the multiple commissure anchors may generally resemble the shape of an anchor or crescent, but those skilled in the art will recognize that any shape that allows the multiple commissure anchors to be effectively anchored to a potential delivery system may be implied by this element. Figure 5 shows three commissure anchors, but an artificial mitral valve may comprise any number of commissure anchors. For example, an artificial mitral valve may have 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 commissure anchors.

[0048] In this case, one or more of the anchoring tabs extend toward the valve, away from each of the commissure attachment points. Each anchoring tab may comprise a fixed end communicating with a commissure attachment point and a free end extending toward the atrial skirt, through which the prosthesis can attach itself to the natural biostructure. The anterior anchoring tab can generally be positioned relative to the natural fibrous triangle of the mitral valve, while the posterior anchoring tab can generally be positioned relative to the posterior ventricular shelf of the mitral valve. An anterior septal triangle anchoring tab 540 (240 as shown in Figure 2) may have a fixed end connected to an anterior septal commissure anchor point 560 and a free end 545 that can be positioned relative to the anterior septal fibrous triangle (480 as shown in Figure 4). An anterolateral triangular anchoring tab 610 (260 as shown in Figure 2) may be connected at its fixed end to an anterolateral commissure anchor point 625 and may have a free end (not shown in this figure) that is resting against the anterolateral fibrous triangle (490 as shown in Figure 4). Finally, a posterior anchoring tab 630 (250 as shown in Figure 2) may be connected at its fixed end to a posterior commissure anchor point 645 and may have a free end 635 that is resting against the posterior shelf (470 as shown in Figure 4). Figure 5 shows three anchoring tabs, but a prosthetic mitral valve may have any number of anchoring tabs. For example, a prosthetic mitral valve may have 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 anchoring tabs.

[0049] Figure 6 illustrates the inlet diagram 660 of an artificial mitral valve (510 as shown in Figure 5). The approximate "D" shape of the artificial mitral valve can be fully understood by following a path clockwise from the front surface 690 (the flat side of the D) of the valve inlet until it reaches the rear surface 700 (the curved portion of the D) and then returns to the front surface 690 of the valve inlet. The front surface 690 of the valve inlet is adjacent to the anterior portion 670 of the atrial skirt (520 as shown in Figure 5). The rear surface 700 of the valve inlet is adjacent to the posterior portion 680 of the atrial skirt. Multiple frame struts 740 may surround the valve inlet in a circumferential direction. The frame struts 740 may provide structural support and mounting means for both the anterior 670 and posterior 680 portions of the atrial skirt to the annular region (530 as shown in Figure 5) of the artificial mitral valve. The posterolateral cusp inflow surface 710 (corresponding to the posterolateral cusp 590 as shown in Figure 5), the anterior cusp inflow surface 720 (corresponding to the anterior cusp 580 as shown in Figure 5), and the posterior septal cusp inflow surface 730 (corresponding to the posterior septal cusp 570 as shown in Figure 5) are also depicted. The posterior anchorage tab free end 635, the anterolateral triangular anchorage tab free end 610, and the anterior septal triangular anchorage tab free end 545 are also shown.

[0050] Figure 7 illustrates the outflow diagram 750 of an artificial mitral valve (510 as shown in Figure 5). The triple junction of the valve leaflets (600 as shown in Figure 5) described above can be formed during systole when the junctional surface 775 of the posterior septal leaflet 770 (570 as shown in Figure 5), the junctional surface 765 of the posterolateral leaflet 760 (590 as shown in Figure 5), and the junctional surface 785 of the anterior leaflet 780 (580 as shown in Figure 5) are brought into contact with each other through valve closure. The previously described commissures and anchoring tabs are also depicted in this outflow figure 750 and are identified by the posterior anchoring tab 800 (630 as shown in Figure 5) and its associated posterior commissure anchor 805 (650 as shown in Figure 5), the anterior septal triangular anchoring tab 810 (540 as shown in Figure 5) and its associated anterior septal commissure anchor 815 (555 as shown in Figure 5), and the anterolateral triangular anchoring tab 790 (610 as shown in Figure 5) and its associated anterolateral commissure anchor 795 (620 as shown in Figure 5).

[0051] Figure 8A illustrates an embodiment of an artificial mitral valve (as shown in Figure 5, 510) having a single leaflet 830 in the form of a duckbill valve, and is presented in outflow figure 820. The duckbill valve can be made by making an incision 840 near the center of the single leaflet 830, on which a leaflet junction can be created on which the resulting valve can function. The artificial mitral valve may further comprise one or more of the following: an anterior surface 690 of the valve inlet, a posterior surface 700 of the valve inlet, an anterolateral triangular anchoring tab 790 and associated anterolateral commissure anchor 795, a posterior anchoring tab 800 and associated posterior commissure anchor 805, or an anterior septal triangular anchoring tab 810 and associated anterior septal commissure anchor 815.

[0052] Figure 8B illustrates an embodiment of an artificial mitral valve (as shown in Figure 510) having a double or two-leaflet configuration, again shown in outflow figure 850. The two-leaflet configuration can be realized via a pair of leaflets comprising anterior leaflet 870 and posterior leaflet 860, which can be made integral at the leaflet junction 880 during systole. The artificial mitral valve may further comprise one or more of the following: an inlet front 690, an inlet rear 700, an anterolateral triangular anchoring tab 790 and associated anterolateral commissure anchor 795, a posterior anchoring tab 800 and associated posterior commissure anchor 805, and / or an anterior septal triangular anchoring tab 810 and associated anterior septal commissure anchor 815.

[0053] Figures 8C and 8D show an embodiment of a single-leaflet mitral valve prosthesis (as shown in Figure 5, 510) as seen from outflow Figure 890, which has a single large anterior leaflet 900 that can straddle the entire valve orifice during systole and seal against the posterior surface 700 of the valve inlet. In the open configuration, the posterior outflow region 910 can allow antegrade blood flow from the left atrium through the valve into the left ventricle. The prosthesis prosthesis may further comprise one or more of the following: an anterior surface 690 of the valve inlet, a posterior surface 700 of the valve inlet, an anterolateral triangular anchoring tab 790 and associated anterolateral commissure anchor 795, a posterior anchoring tab 800 and associated posterior commissure anchor 805, or an anterior septal triangular anchoring tab 810 and associated anterior septal commissure anchor 815.

[0054] Figure 8D shows that in the closed configuration 920, the large anterior leaflet 900 is closed, and the posterior covering region 925 of the anterior leaflet 900 seals against the leaflet joint edge 930 that appears on the posterior surface 700 of the valve inlet. The artificial mitral valve may further comprise one or more of the following: a front surface 690 of the valve inlet, a posterior surface 700 of the valve inlet, an anterolateral triangular anchoring tab 790 and associated anterolateral commissure anchor 795, a posterior anchoring tab 800 and associated posterior commissure anchor 805, or an anterior septal triangular anchoring tab 810 and associated anterior septal commissure anchor 815.

[0055] Figure 8E illustrates an embodiment of an artificial mitral valve (as shown in Figure 510) comprising a tri-leaflet configuration 940, formed from multiple leaflets, which are represented herein as a large anterior leaflet 960, a small posterolateral leaflet 970, and a small posterior septal leaflet 950. During systole, the leaflets are forced to close along the leaflet junction 980 and to contact each other. The artificial mitral valve may further comprise one or more of the following: an inlet front 690, an inlet rear 700, an anterolateral triangular anchoring tab 790 and associated anterolateral commissure anchor 795, a posterior anchoring tab 800 and associated posterior commissure anchor 805, or an anterior septal triangular anchoring tab 810 and associated anterior septal commissure anchor 815.

[0056] Figure 8F depicts an embodiment of an artificial mitral valve (as shown in Figure 5, 510) as seen from the outflow view, having a four-leaflet configuration 990. The valve may be formed from a plurality of leaflets, described herein as a posterior leaflet 1000, a septal leaflet 1010, anterior leaflet 1020, and a lateral leaflet 1030. During systole, the leaflets may be forced to close along the leaflet junctional edge 1040 and come into contact with each other. The artificial mitral valve may have one or more anchoring tabs and commissure anchors. There may be an anterior septum 810 and an anterolateral triangular anchoring tab and corresponding commissure anchors (815 anterior septum and 795 anterolateral), as well as a posterior septum 1060 and posterolateral 1050 anchoring tab, and corresponding posterior septum 1065 and posterolateral 1055 commissure anchors. The artificial mitral valve may further comprise one or more of the following: an anterior surface 690 of the valve inlet, a posterior surface 700 of the valve inlet, an anterolateral triangular anchoring tab 790 and associated anterolateral commissure anchor 795, a posterior anchoring tab 800 and associated posterior commissure anchor 805, or an anterior septal triangular anchoring tab 810 and associated anterior septal commissure anchor 815.

[0057] Figure 9 depicts a frame planar pattern 1070, which is a representation of the tool path that a machine tool (such as a focused laser, a punching machine, an end mill, or any other machine tool known to those skilled in the art) may follow during the fabrication of an artificial valve (510 as shown in Figure 5). The frame may be cut from tubular raw material. For example, the frame may be cut from tubular nitinol raw material. The device may include several features previously discussed (introduced in Figure 5), such as an anterior-lateral commissure anchor 795 (element 620 in Figure 5), an anterior-septal commissure anchor 815 (element 555 in Figure 5), and a posterior commissure anchor 805 (element 650 in Figure 5). The term “column type” refers to the elements illustrated in the frame planar pattern, so the elements of the frame may be undeformed (i.e., sharpest through metallurgical heat treatment known to those skilled in the art) and generally analogous to rectangular members or “columns.” Additional details regarding the spatial relationship between the commissure structure and the anchoring tab are depicted in Figure 9. This flat pattern represents the embodiment of the artificial mitral valve depicted in Figure 5.

[0058] An artificial mitral valve may comprise one or more mounting rails, one or more commisses, one or more commissure mounting holes, one or more commissure slots, and one or more commissure connection points. An artificial mitral valve may comprise one, two, three, four, five, six, seven, eight, nine, ten, or more than ten mounting rails, one, two, three, four, five, six, seven, eight, nine, ten, or more than ten commisses, one, two, three, four, five, six, seven, eight, nine, ten, or more than ten commissure mounting holes, one, two, three, four, five, six, seven, eight, nine, ten, or more than ten commissure slots, and one, two, three, four, five, six, seven, eight, nine, ten, or more than ten commissure connection points.

[0059] The anterolateral commissure anchor 795 may protrude directly from the anterolateral commissure 1085. The anterolateral commissure may be the origin and insertion point for the anterolateral anchoring tab 1110 (610 as shown in Figure 5) via the anterolateral commissure junction 1100. One or more rows of anterolateral commissure mounting holes 1090 may be located adjacent to the anterolateral commissure mounting slot 1095 within the structure of the anterolateral commissure 1085. The mounting holes 1090 may provide a place for suturing, which can be used to suture an anterolateral commissure suture pad (615 as shown in Figure 5) into position. The anterolateral commissure suture pad may work in conjunction with the anterolateral commissure mounting holes to help fasten the leaflets of the artificial mitral valve to the frame. The free end 1111 of the anterolateral anchoring tab 1110 is also shown, as is the free end 1116 of the anterior septal anchoring tab 1115 and the free end 1121 of the posterior anchoring tab 1120. Multiple struts or mounting rails may be used to position and fasten the valve leaflets onto the frame. Each strut may leave a space between consecutive adjacent commissaries. Each strut may have a "U" or arched shape. Specifically, the anterior leaflet mounting rail 1080 may straddle the space between the anterior lateral commissary 1085 and the anterior septal commissary 1086. The anterior leaflet mounting rail 1080 may be used to attach the anterior leaflet (not shown) to the frame. The posterior septal leaflet mounting rail 1130 may straddle the space between the anterior septal commissary 1086 and the posterior commissary 1087. The posterior septal leaflet mounting rail 1130 may be used to attach the posterior septal leaflet (not shown) to the frame. The posterior lateral leaflet mounting rail 1125 may straddle the space between the posterior commissary 1087 and the anterior lateral commissary 1085. The posterior lateral leaflet mounting rail 1125 may be used to attach the posterior lateral leaflet (not shown). The posterior commissure anchor 805, posterior commissure 1087, posterior fixing tab 1120, and the free end 1121 of the posterior fixing tab 1120 are shown on both sides of Figure 9 to highlight how the artificial mitral valve can be laid out in a frame-flat configuration.

[0060] Additional structures may help support radial compression against the natural mitral annulus and / or seal valve inflow against the left atrial base. Multiple rows of annular rhombuses 1150 may be located in the annular region 1140 of the frame, traversing the circumference of the frame. Multiple atrial skirt support struts 1170 may arise from the annular region 1140 and act as support beams for multiple atrial skirt circumferential struts 1165. The atrial skirt support struts may be substantially parallel to each other and may extend longitudinally. The atrial skirt circumferential struts may be substantially parallel to each other and may be substantially "V-shaped". Each atrial skirt support strut may be connected to the atrial skirt circumferential struts at the top and bottom. The combination of the atrial skirt support struts 1170 and the atrial skirt circumferential struts 1165 may form the atrial region 1160 of the valve frame, which may provide a place for the atrial skirt to be sutured onto the valve frame.

[0061] Figure 10 illustrates an embodiment of the frame flat pattern 1180. The frame flat configuration 1180 may comprise any or all of the elements of Figure 9 with further modifications. The frame flat configuration 1180 may also comprise one or more strut features. The configuration may comprise one, two, three, four, five, six, seven, eight, nine, ten, or more than ten strut features. For example, one or more strut features may be added adjacent to two of the leaflet mounting rails. The posterolateral chordal bumper strut 1190 may extend substantially parallel to the posterolateral leaflet mounting rail 1125. The posterolateral chordal bumper strut 1190 may assist valve movement by pushing away the natural chordae tendineae from the prosthetic valve. This may further prevent obstruction in the subvalvular space and LVOT. The configuration may comprise one or more bumper strut mounting points. The configuration may have 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 bumper support mounting points. One or more rear-outer chord bumper support mounting points 1195 may be located at each end of the rear-outer chord bumper support 1190. Each rear-outer chord bumper support mounting point 1195 may effectively connect the end of the rear-outer chord bumper support 1190 to an adjacent commissar. The rear septum chord bumper support 1210 may extend substantially parallel to the rear septum tip mounting rail 1130. One or more rear septum chord bumper support mounting points 1200 may be located at each end of the rear septum chord bumper support 1210. Each rear septum chord bumper support mounting point 1200 may effectively connect the end of the rear septum chord bumper support 1210 to an adjacent commissar. The rear septal chord bumper support 1210 may be functionally equivalent to the rear outer chord bumper support 1190. The rear septal chord bumper support mounting point 1200 may be functionally equivalent to the rear outer chord bumper support mounting point 1195.

[0062] Figure 11 shows an embodiment of the frame flat pattern 1220. The frame flat configuration 1220 may comprise any or all of the elements of Figure 10 with further modifications. The frame flat configuration 1220 may further comprise one or more furculate members and the absence of the previously described commissure anchors. These modifications may provide alternatives for anchoring the valve frame to the delivery system, as described herein. The configuration may comprise one or more furculate struts, one or more furculate anchors, and one or more furculate attachment points. The configuration may comprise one, two, three, four, five, six, seven, eight, nine, ten, or more than ten furculate struts, one, two, three, four, five, six, seven, eight, nine, ten, or more than ten furculate anchors, and one, two, three, four, five, six, seven, eight, nine, ten, or more than ten furculate attachment points. The posterolateral furculate strut 1230 may arise from a first strut attachment point 1240 on the anterolateral commissure 1085. The posterolateral furculate strut 1230 may arc upward across the posterolateral apical space until it intersects with a second strut attachment point 1240 located on the posterior commissure 1087. At the apex of the posterolateral furculate strut 1230 may be a posterolateral furculate anchor 1235, which may replace the previously described anterolateral and posterior commissure anchors (795 and 805 in Figure 10, respectively). The posterolateral furculate anchor 1235 may be functionally and structurally equivalent to the anterolateral and posterior commissure anchors. In addition, the posterior septofucral strut 1250 may arise from a first strut attachment point 1260 on the anterior septofucral commissure 1086. The posterior septofibular post may arc upward across the posterior septal apex space until it intersects with a second post attachment point 1260 located on the posterior commissure 1087. At the apex of the posterior septofibular post 1250, there may be a posterior septofibular anchor 1255, which can replace the previously described anterior septal and posterior commissure anchors (815 and 805 in Figure 10, respectively). The posterior septofibular anchor may be functionally and structurally equivalent to the anterior septal and posterior commissure anchors. The furcular post may be pushed into a configuration that is easily compressible for delivery of an artificial mitral valve using a catheter, as described herein. This may result in a more easily retractable and / or repositionable prosthesis.

[0063] Figure 12 further illustrates an embodiment of the frame flat pattern 1270. The frame flat configuration 1220 may, with further modifications, comprise any or all of the elements of Figure 11. The frame flat configuration 1270 may lack certain elements of Figure 11. For example, the posterolateral chordal bumper strut (1190 as shown in Figure 11) and / or the posteroseptal chordal bumper strut (1210 as shown in Figure 11) may be excluded from the frame flat configuration 1270. Except for the absence of the bumper strut, the frame flat configuration 1270 may be functionally equivalent to the frame flat configuration 1220 of Figure 11. A perspective view of the artificial mitral valve of Figure 12 can be seen in Figure 13.

[0064] Figure 13 shows a perspective view of an artificial mitral valve, shown in Figure 12 as a frame planar configuration 1270. Any or all of the features and elements previously described in Figure 5 may be present in the embodiment of Figure 13. The embodiment of Figure 13 may be functionally and structurally equivalent to the embodiment of Figure 5, except for the addition of one or more furcicular struts and one or more furcicular attachment areas. The embodiment of Figure 13 may comprise one, two, three, four, five, six, seven, eight, nine, ten, or more than ten furcicular struts and one, two, three, four, five, six, seven, eight, nine, ten, or more than ten furcicular attachment areas 1330. A posterior septal furcicular strut 1320 may find a frame and a first insertion in an anterior septal tab furcicular attachment area 1300, which may be located adjacent to the anterior septal commissure. The posterior septofibular support 1320 may be located adjacent to the posterior commissure, and a frame and second insertion may be found in the posterior tabbed furcula attachment area 1290. The posterior septofibular anchor 1255 may be located at the apex of the furcula, as described herein, and enable attachment to the delivery system. The posterolateral furcular support 1330 may be located adjacent to the anterolateral commissure, and a frame and first insertion may be found in the anterolateral tabbed furcula attachment area 1310. The posterolateral furcular support 1330 may be located adjacent to the posterior commissure, and a second insertion using a frame may be found in the posterior tabbed furcula attachment area 1290. The posterolateral furcula anchor 1235 may be located at the apex of the furcula, as described herein, and enable attachment to the delivery system.

[0065] Previous minimally invasive procedures have been developed to deliver artificial heart valves percutaneously via a delivery catheter through the patient's vascular system to the heart, or through the use of transapical procedures to introduce the prosthesis through the chest wall and through the apex (330 as shown in Figure 3). Exemplary prostheses include those described in U.S. Patent No. 8,579,964, whose entire contents are incorporated herein by reference for all purposes. Further embodiments of exemplary delivery catheters and delivery systems are described and illustrated in the following figures.

[0066] Figure 14 shows an artificial mitral valve with the furcular attachment shown in Figure 13. The artificial mitral valve 1280 may comprise any or all of the elements of Figure 13. The artificial mitral valve 1280 may be connected to a delivery system 1340. The delivery system 1340 may comprise a fully withdrawn delivery catheter 1350. It should be readily apparent that the aforementioned posterior septal commissure anchor (1255 as shown in Figure 13) and posterolateral commissure anchor (1235 as shown in Figure 13) are now concealed by the anchoring sleeve member 1360 in Figure 14. The delivery system 1340 is shown in Figure 14 as being connected to a nonspecific anchoring mechanism. Embodiments of the anchoring mechanism are described in Figures 15-19 as being communicated by an enlarged detail element 1345.

[0067] Figures 15A-B illustrate an embodiment of a fixing method used to fix a commutation anchor to a delivery system using multiple threaded connectors. Figure 15A shows multiple threaded connectors 1370 in a connection configuration. In the connection configuration, a first male threaded connector 1390 and a second male threaded connector 1395 may screw into a first female threaded connector 1375 and a second female threaded connector 1380, respectively. Each of the first and second male threaded connectors (1390 and 1395, respectively) may have a section of male threads 1400 appearing at the free end of a furculate post 1410. The furculate post may replace multiple commutation anchors (1255 and 1235 as shown in Figure 13). The male threads may be sized to fasten and mesh with the similarly threaded first and second sections of the female threads 1405. Arrow 1385 indicates the rotation of the first and second female threaded connectors (1375 and 1380, respectively). Depending on the rotation in the direction of arrow 1385, the connector may be in the state depicted in Figure 15B.

[0068] Figure 15B shows multiple threaded connectors (1390 and 1395) in the disconnection configuration 1420. In the state depicted in Figure 15B, it should be clear that the male threaded connector can be completely disconnected from the female threaded connector. In accordance with the disconnection, the artificial valve, which was initially attached to the catheter delivery system through the furcular connector, can be completely released from the delivery system. A further discussion of the internal mechanisms involved in the operation of this embodiment of the delivery system begins with the description of Figure 29.

[0069] Figures 16A–B illustrate an embodiment of a fixing method used to fix a commutation anchor to a delivery system using a single split threaded connector. Figure 16A shows a split threaded connector 1430 in a connection configuration. One or more male split threaded connectors 1450 may screw into one or more female split threaded connectors 1440. Each male split threaded connector 1450 may have a section of male threads 1455 appearing at the free end of a furculate strut 1460. The furculate strut may replace multiple commutation anchors (1255 and 1235 as shown in Figure 13). The male threads may be sized to fasten and mesh with similar threaded sections of female threads 1445 within the female threaded connector 1440. Arrows 1435 indicate the rotation of individual female threaded connectors 1440. Depending on the rotation, the connector may be in the state depicted in Figure 16B.

[0070] Figure 16B shows the split threaded connector 1455 in the disconnection configuration 1470. In the configuration depicted in Figure 16B, it should be clear that the male split threaded connector can be completely disconnected from the female threaded connector. In accordance with the disconnection, the artificial valve, which was initially attached to the catheter delivery system through the furcular connector, can be completely released from the delivery system. A further discussion of the internal mechanisms involved in the operation of this embodiment of the delivery system begins with the description of Figure 27.

[0071] Figures 17A-B illustrate an embodiment of a fixing method used to fix a connecting anchor to a delivery system using a flexible pin connector fixing mechanism. Figure 17A shows the flexible pin connector fixing mechanism 1480 in a connection configuration. One or more flexible sleeves 1490 can be closed around a plurality of pinhole connectors 1530. The flexible sleeve 1490 may comprise a plurality of flexible sleeve portions 1495 that can open and close with a click when the translation sleeves 1500 are pulled over or pulled away from them. This movement of the translation sleeves may be an effective encapsulation of the flexible sleeve portions 1495. The flexible sleeve 1490 may comprise a morphogenic and / or superelastic nitinol material, as is known to those skilled in the art. Each flexible sleeve portion 1495 may comprise a termination point 1510 that appears at the free end of the flexible sleeve 1490. The terminal point may allow connection of the flexible pin connector type anchoring mechanism 1480 to the furculate support 1520.

[0072] Figure 17B shows a flexible pin connector type anchoring mechanism 1480 in a disconnected configuration 1540. Each inner surface of the termination points 1510 may be provided with a connector pin 1555 that can be fitted into a complementary hole 1560 for pin connection. Each of the fucillate struts 1520 of the artificial mitral valve may be terminated with a pinhole connector 1530. The pinhole connector may replace multiple commissure anchors (1255 and 1235 as shown in Figure 13). Arrow 1550 indicates the rotation of each individual flexible sleeve portion 1495. Depending on the rotation, the connector may be in the state depicted in Figure 17B. Arrow 1545 indicates the translation of the translation sleeve 1500 over the flexible sleeve portion 1495. In the state depicted in Figure 17B, it should be clear that the connector pin 1555 can be completely disconnected from the hole 1560 for pin connection. In response to the disconnection, the artificial valve, initially attached to the catheter delivery system via the furcular connector, can be completely released from the delivery system. A further discussion of the internal mechanisms involved in the operation of this embodiment of the delivery system begins with the description of Figure 24A.

[0073] Figures 18A–C illustrate an embodiment of the anchoring method employed, in which a plurality of flexible buckle anchoring mechanisms are used to anchor a commissure anchor to a delivery system. Figure 18A shows a plurality of flexible buckle connectors 1570 in a connection configuration. A plurality of flexible buckles 1580 may be captured and connected to, thereby confined to, or positioned inside, an opening 1575, which is sized to receive and hold the flexible buckles 1580 using counteracting tension. The opening may be formed on the side of a translation sleeve 1500. Each of the flexible buckles may be positioned adjacent to and protruding from the end of a furcicular support 1520, which may replace a plurality of commissure anchors (1255 and 1235 as shown in Figure 13). A sheath catheter 1350 may be positioned concentrically, covering the top of the translation sleeve 1500. The mechanism of action can be achieved when the parallel movement sleeve 1500 is attracted to the sheath catheter 1350.

[0074] Figure 18B illustrates the hidden structure of the flexible buckle 1580 when the translation sleeve 1500 blocks the view of the structure from Figure 18A.

[0075] Figure 18C shows a flexible buckle-type anchoring mechanism in a disconnected configuration. When the translation sleeve 1500 is pulled toward the sheath catheter 1350, the flexible buckle 1585 can be forcibly closed by the inner surface of the sheath catheter 1500 and released from restraint. In the state depicted in Figure 18C, it should be evident that the flexible buckle-type connector can be completely disconnected from their opening 1575 and the associated translation sleeve 1500. In response to the disconnection, the artificial valve, initially attached to the catheter delivery system through the furcular connector, can be completely released from the delivery system. A further discussion of the internal mechanisms involved in the operation of this embodiment of the delivery system begins with the description in Figure 26A.

[0076] Figures 19A-B illustrate an embodiment of an anchoring method used to anchor a commissure anchor to a delivery system using multiple anchor-shaped commissure anchors. Figure 19A shows a connection configuration in which multiple anchor-shaped commissure anchors 1630 are connected adjacent to the ends of multiple furculate supports 1410. The multiple commissure anchors 1630 may be placed in multiple complementary slots 1615. The slots may act to hold the anchors and resist tensions that may occur during the operation of the delivery system. The slots 1615 may be formed on the anchoring end 1610 of the anchoring catheter 1600. The multiple commissure anchors 1630 depicted in Figures 19A-B may be identical in design, structure, and function to multiple commissure anchors (such as 1255 and 1235 shown in Figure 13).

[0077] Figure 19B shows the commissure anchor 1640 in an unrestrained configuration that allows for disconnection. Arrow 1620 indicates the translation of the anchoring sleeve member 1360. Depending on the translation, the state depicted in Figure 19B can be achieved. In the state depicted in Figure 19B, it should be clear that the commissure anchor 1640 is not restrained and can be disconnected from the slot 1615 of the anchoring catheter 1600. Depending on the disconnection, the artificial valve initially attached to the catheter delivery system can be released from the delivery system. Further discussion of the internal mechanisms involved in the operation of this embodiment of the delivery system begins with the description of Figure 21A.

[0078] Figures 20A–20F depict the sequential steps of withdrawing an embodiment of the delivery system and implanting an artificial mitral valve. The effects resulting from the operation of the delivery system (such as the release of a constrained artificial mitral valve) are discussed with reference to relevant elements necessary for the illustration, but the mechanical relationships of the various internal components necessary for the physical realization of the delivery system embodiment are not illustrated or discussed until further down in Figures 21–31. The deployment process, as depicted in Figures 20A–20F, proceeds as follows: A sheath catheter, consisting of tissue, fabric, sutures, and a nitinol frame, which can restrain a compressed artificial valve, can be retracted from the valve while it is in place within the implantation zone. The physiological temperature of the blood in the patient's heart can cause the nitinol material to expand and conform to the space in which it is implanted. As the prosthesis expands, the elements of the invention involved in integrating into the natural biostructure may also expand, allowing the prosthesis to remain in place to function as a one-way valve and support proper blood circulation. While related biological structures have been previously illustrated in Figures 1-4, please note that they will not be repeated in the following figures, leaving room to focus on the prosthesis and delivery system.

[0079] Figure 20A depicts an embodiment of a fully loaded (covered and closed) delivery system 1700. The delivery system may include an artificial mitral valve (shown in Figures 20B-20F) that is compressed prior to implantation and inserted into the sheath catheter 1350. A long, tapered, flexible, self-expanding dilator tip 1710 may assist in the insertion of the delivery system into a small incision prepared in a prospective patient (not shown). The incision may be made in the chest and may lead directly into and through the apex of the heart. The widest end of the dilator tip 1710 may be aligned with an anterior edge 1725 that may appear on the distal end of the sheath catheter 1350 and may be terminated by an edge 1720 that fits concentrically inside it. A lumen 1715 may be formed in the most distal portion of the dilator tip 1710 and may extend throughout the entire catheter to which the dilator tip 1710 is attached.

[0080] Figure 20B depicts an embodiment of the loaded delivery system 1730 in which the atrial skirt is exposed, showing that the sheath catheter 1350, previously described in Figure 20A, has been translated a small distance away from the dilator tip 1710. Specifically, the anterior edge 1725 of the sheath catheter 1350 may be moved away from the edge 1720 of the dilator tip 1710, thereby exposing the partially constrained atrial skirt 1750.

[0081] Figure 20C depicts an embodiment of the loaded delivery system 1760 in which the anterior triangular fixing tab is exposed, showing that the sheath catheter 1350, previously described in Figure 20B, has been translated to a greater extent away from the dilator tip 1710. Specifically, the anterior edge 1725 of the sheath catheter 1350 may be moved further away from the edge 1720 of the dilator tip 1710, thereby exposing a large portion of the structure of the encapsulated artificial mitral valve. The atrial skirt 1770 may now be almost freed, but the still partially constrained annular region 1775 may remain constrained by the sheath catheter 1350. The configuration in Figure 20C may allow for partial self-expansion of the artificial mitral valve, thus removing the constraint. The constrained anterior leaflet 1780, which may remain substantially compressed, may be adjacent to and directly beneath the constrained annular region 1775. Multiple triangular anchoring tabs, such as the anterolateral triangular anchoring tab 790 (with an associated free end 1790) and the anterior septal triangular anchoring tab 540 (with an associated free end 545), may protrude from beneath the anterior edge 1725 of the sheath catheter 1350.

[0082] Figure 20D depicts an embodiment of the loaded delivery system 1800 with the anterior triangular anchoring tab fully open, showing that the sheath catheter 1350, previously described in Figure 20C, has been moved parallel to the dilator tip 1710 to the extent that it has advanced. Specifically, the anterior edge 1725 of the sheath catheter 1350 may be moved further away from the edge 1720 of the dilator tip 1710, thereby exposing the entire structure of the encapsulated artificial mitral valve, except for the commissure attachment (not shown). The atrial skirt 1770 may be completely unconstrained, here to be the annular region 1810. A partially constrained anterior leaflet 1825, which may be almost completely unconstrained, may be adjacent to and directly beneath the annular region 1810. The anterior leaflet 1825 may be able to act and bond to any other valve leaflets (not shown) present in this embodiment. Multiple triangular anchoring tabs (anterolateral triangular anchoring tab 790 and associated free end 1790, and anterior septal triangular anchoring tab 540 and associated free end 545) can be opened and spread apart due to the interaction between the anterior edge 1725 of the sheath catheter 1350 and the still-restricted furcular strut 1820 to which the triangular anchoring tabs can be directly connected. This opening effect may allow the triangular anchoring tabs to reach around the anterior leaflet of the natural mitral valve (460 as shown in Figure 4) and through the anterior chordae tendineae (465 as shown in Figure 4) in order to abut against the triangle after opening. A guidewire catheter 1830, which can be directly connected to the dilator tip 1710 and provide support therefor, may emerge from the sheath catheter 1350 and be concentrically nested inside it.

[0083] Figure 20E shows an embodiment of the loaded delivery system 1840 just before final release, showing that the sheath catheter 1350, previously described in Figure 20D, has been translated to move further away from the dilator tip 1710 to the extent of its advancement. Specifically, the anterior edge 1725 of the sheath catheter 1350 may be moved further away from the edge 1720 of the dilator tip 1710, thereby exposing all of the encapsulated artificial mitral valve structures, such as the fully deployed furculate strut 1880, which may be released from the delivery system. The anterior septum 1860 and anterolateral 1870 triangular anchoring tabs may be released from their restraints and may be in their final positions. The anterior leaflet 1850 may be fully released and may be able to straddle the natural anterior leaflet and operate.

[0084] Figure 20E depicts the final deployment 1890 with the delivery system removed. The furcicular post 1900 and the associated commissure anchor 1910 can be fully released and are not constrained by the delivery system. In this depiction, the prosthesis of the present invention is fully functional and can move freely within the natural biostructure.

[0085] Here, a thorough discussion of several related delivery system embodiments will be presented with reference to the elements appearing in Figures 21-31.

[0086] Figures 21A-23 correspond to the descriptions in Figures 19A-19B and depict an embodiment of a delivery system that may be compatible with the artificial mitral valve embodiment described in Figure 13.

[0087] Figure 21A shows an embodiment of a fully open, extended-length delivery system 1920. The delivery system may include a delivery system handle 1940. The delivery system handle may include an elongated grippable member 1960 that can accommodate various mechanical components and provide space for a concentric nesting catheter array. The delivery system handle 1940 may also provide an operating mechanism such as a rotatable (see arrow 1950 indicating rotation) thumbwheel 1955. The thumbwheel may be substantially cylindrical and may have internal threads (not shown) that convert rotational torque applied by the user into a linear force. The linear force may be used to move one catheter from the concentric nesting catheter array in parallel. The previously discussed sheath catheter 1350 may again be substantially cylindrical with an inner lumen that can pass through a distance between the edge 1720 of the dilator tip 1710, which is located at the most distal end of the entire device, and a set distance proximal to the edge 1725, which may be substantially equal to the restraint length of an artificial valve (not shown). The anchoring sleeve member 1360 may also be concentrically nested within the sheath catheter 1350, and may itself have an inner lumen that extends from within the delivery system handle 1940 to the tip of the anchoring catheter 1930 and slightly beyond. The anchoring catheter 1930 may itself be cylindrical and concentrically nested within the anchoring sleeve member 1360. Further details regarding the anchoring catheter 1930 are provided in Figure 22. The innermost concentric nested catheter is a guidewire catheter 1830, which can be connected to the dilator tip 1710. There may be an inner lumen extending throughout the entire length of the delivery system, which can be appropriately sized to receive and transmit a guidewire (not shown) which may be placed inside it. Arrows 1925 illustrating translation show how the sheath catheter 1350 can be pulled towards the dilator tip 1710 as the thumbwheel 1955 is rotated.

[0088] Figure 21B shows the device introduced in Figure 21A in configuration 1970, with the only difference being the position of the sheath catheter 1350 and the anchoring sleeve member 1360. The sheath catheter can be translated further toward the dilator tip 1710 (as depicted by the arrow 1975 indicating translation). The anchoring sleeve member 1360 can also be translated. By translating toward the dilator tip 1710, the anchoring sleeve member 1360 can effectively cover the anchoring catheter 1930 (Figure 21A). This is the same mechanical relationship depicted in Figures 19A and 19B, but in the reverse order.

[0089] Figure 21C shows a closed delivery system 1980 in which the thumbwheel 1955 can be rotated sufficiently and the sheath catheter 1350 can be closed against the dilator tip 1710.

[0090] Figure 22 shows an embodiment and configuration of the device as illustrated in Figure 21A, with additional details in the form of enlarged view 1985. Specifically, the stabilizer member 1990 may be located between the inner surface of the sheath catheter 1350 and the outer surface of the anchoring sleeve member 1360. The stabilizer member may take the form of a star-shaped cylindrical prism. The stabilizer member can enforce concentricity between the catheters while still allowing excess blood and / or saline to flow. The slotted end of the anchoring catheter 1930 is also depicted. It can be seen that the anchoring sleeve member 1360 is positioned concentrically around the anchoring catheter 1930 and can slidably communicate with it. The guidewire catheter 1830 is shown again, having exited the anchoring catheter 1930.

[0091] Figure 23 illustrates an exploded view of the exemplary device shown in Figures 21A-22B. This device may include a delivery system handle A side 2140 that can entangle with a delivery system handle B side 2145. This device can effectively provide housing and space for a concentric nesting catheter array seen to the left of the handle element (and described in Figures 22-22), and for various elements seen to the right of the handle element. This device may include a needle hub 2130 that can entangle with the proximal end 2000 of a guidewire catheter 1830. The entanglement connection may be formed using adhesive. The needle hub 2130 may act as a connection port through which a syringe (not shown) can be attached to the device and used to flow sterile saline through the innermost lumen to remove air prior to insertion into the patient. A cylindrical anchoring nut 2120 may screw into the threads on the proximal end 2035 of the anchoring catheter 2010. A cylindrical anchoring nut may be located within a plurality of handle halves 2140 and 2145 to fasten the anchoring catheter 2010 to the delivery system. The inner lumen may extend along the entire length of the anchoring catheter 2010, allowing for concentric nesting of an inner guidewire catheter 1830. A spring 2110 may engage with and be pressed against a bell slider cap 2100, which itself may engage with the bell slider 2090. The spring 2110 may provide a biasing force, which may cause the bell slider 2090 to move when the main screw 2080 is disengaged from it. In other words, by rotating the thumbwheel 1955, the main screw 2080 may be linearly translated and brought into contact with the distal portion of the bell slider 2090, which in turn may be biased against the spring 2110. The bell slider 2090 may act as a carriage for the proximal end 2060 of the bell catheter 2040 (formerly referred to as the anchoring sleeve member 1360), allowing the distal end 2050 of the bell catheter 2040 to be separated from the distal end 2020 of the anchoring catheter 2010, which may be a mechanism involved in the release of the final valve commissure. The main screw 2080 may also be translated in the opposite direction by rotating the thumbwheel 1955 to close the delivery system and seal the valve internally.This can be achieved via the connection of the main thread 2080 to the main thread cap 2070, which itself can engage with the proximal end 2065 of the sheath catheter 1350. Thus, rotating the thumbwheel 1955 in a first direction can move the main thread 2080 toward the dilator tip 1710, and upon dilation, can also move the sheath catheter 1350 toward the dilator tip 1710 to close the device. Rotating the thumbwheel 1955 in a second opposite direction can move the main thread 2080 toward the bell slider 2090, and upon dilation, can move both the sheath catheter 1350 and the bell catheter 2040 toward the dilator tip 1710, opening the device and releasing the artificial valve contained inside. It should be understood that while both the sheath catheter 1350 and the bell catheter 2040 can move synchronously via the rotation of the thumbwheel 1955, there may be a delay in contact provided by the dimensions of the associated catheter and the main thread 2080. The delay may allow some parts of the prosthesis to be covered and removed before others as the deployment progresses. It should also be understood that the prosthetic valve can finally be recaptured or retrieved for repositioning or removal by simply closing the sheath catheter 1350 until the anterior edge 1725 of the sheath catheter 1350 contacts the edge 1720 of the dilator tip 1710 again. Finally, the distal end 1995 of the guidewire catheter 1830 can occlude and connect with the dilator tip 1710 and become fixed thereto.

[0092] Figures 24A-25 depict embodiments of the delivery system corresponding to the descriptions in Figures 17A-17B. Similar to the explanatory diagrams depicted in Figures 24A-24C, the relationship between the rotation of the thumbwheel 1955 and the translation of the sheath catheter 1350 is also depicted here. In Figure 24A, the fully open delivery system 2150 may be designed for flexible connection type attachment to an artificial valve (not shown). The arrow 2190 indicating rotation shows that as the thumbwheel 1955 is rotated, the sheath catheter 1350 may be translated again toward the dilator tip 1710 (see arrow 2180 indicating translation). In this embodiment, the multiple flexible connector prongs 2160 may be subject to a cam action due to their inherent arched shape and the gradually increasing level of contact between the flexible connector prongs 2160 and the leading edge 1725 of the sheath catheter 1350. This can cause the flexible connector prongs 2160 to be in close contact with each other. The distal end of each flexible connector prong 2160 may be a connecting element 2170, which may be a substantially cylindrical projection that can engage with substantially cylindrical holes or cavities in the commissural elements of the associated prosthetic valve (elements 1530, 1555, and 1560 shown in Figure 17B). Figures 24B and 24C show the logical continuation of the covering process (2200 partial opening, Figure 24B, and 2210 complete closure, Figure 24C), thereby allowing the anterior edge 1725 of the sheath catheter 1350 to eventually come into contact with the edge 1720 of the dilator tip 1710.

[0093] Figure 25 shows an exploded view of the delivery system introduced in Figures 24A-24C. The components described in this depiction may differ only slightly from those described in Figure 23. Embodiments of the delivery system shown in Figure 25 do not require a bell catheter, as the capture mechanism may be provided by the relationship between the leading edge 1725 of the sheath catheter 1350 and the multiple flexible connector prongs 2160. Therefore, the embodiment in Figure 25 also does not require a bell slider. To operate this device, the user may only need to pull the sheath catheter 1350 back and forth using a thumbwheel 1955 that directly compresses the multiple flexible connector prongs 2160. It should be readily apparent that the flexible connector prongs 2160 may be formed at the distal end of a flexible prong anchoring catheter 2220.

[0094] Figures 26A-26B depict embodiments of the delivery system corresponding to the descriptions related to Figures 18A-18C. Figure 26A shows an exploded view of an embodiment of the delivery system that may be suitable for connection to an artificial valve frame having a flexible buckle anchor. The components described in this depiction may differ only slightly from those described in Figure 23. In the embodiments of Figures 26A-26B, the proximal end 2035 of the anchoring catheter 2010 may mesh with a bell slider 2090 instead of an anchoring nut and may be able to move freely along the bell slider 2090 when in contact with the main screw 2080. The bell slider 2090 may further comprise a plurality of pins 2226 that can transmit force from the main screw 2080 to the bell slider 2090, while also providing a gap for a stationary bell catheter nut 2224 that can anchor and hold the stationary bell catheter 2040 in the delivery system. Therefore, by rotating the thumbwheel 1955, the main screw 2080 can be brought into contact with multiple pins 2226, pushing the bell slider 2090 and the anchoring catheter 2010 toward the proximal part 1710. This can effectively retract the anchoring catheter 2010 into the stationary bell catheter 2040. This relationship is illustrated in more detail in Figure 26B.

[0095] Figure 26B provides an enlarged view 2228 that shows in detail the elements that may be present at the distal ends of the parallel-transfer anchoring catheter 2010 and the stationary bell catheter 2040. When the distal end 2227 of the anchoring catheter 2010 is carried into the distal end 2050 of the bell catheter 2040, the opening 2229 that may be formed within the distal end 2227 of the anchoring catheter 2010 may also be carried into the distal end 2050 of the bell catheter. This action can effectively provide the mechanism behind the embodiment illustrated in Figures 18A-18C.

[0096] Figures 27 and 28 depict embodiments of the delivery system corresponding to the descriptions related to Figures 16A-16B. Figure 27 shows an exploded view 2230 of an embodiment of the delivery system which may be suitable for connection to an artificial valve frame having a single threaded connector anchor. The components described in this depiction may differ only slightly from those described in Figure 23. The embodiment may comprise a plurality of stabilizers 1990. The stabilizers may improve the concentricity of the concentric nested catheter. Again, a plurality of handle halves (side A 2250 and side B 2260) may provide space for various internal components. The delivery system may also comprise a plurality of thumbwheels, such as a first thumbwheel 1955 for operating a sheath catheter 1350 and a second thumbwheel 2270 for rotating a threaded bell catheter 2040. The first and second thumbwheels may allow the catheter to connect to and disconnect from the associated artificial valve. Furthermore, the second thumbwheel 2270 may contain a hole 2275 through which the proximal end 2060 of the rotating bell catheter 2040 can be fastened to the second thumbwheel 2270. An exploded view 2240 of the concentric nesting catheter group is provided, and further details regarding the threaded mechanism at the distal end of the catheter group are provided in Figure 28.

[0097] Figure 28 shows an exploded view 2280 focusing on the distal end of the nested catheter assembly. Arrow 2300 indicates a rotation corresponding to the rotation of the threaded distal end of the bell catheter 2310 to connect to or disconnect from a threaded fastener that may be present in an artificial valve.

[0098] Figures 29-31 depict embodiments of the delivery system corresponding to the descriptions in Figures 15A-15B. Figure 29 shows an exploded view of an embodiment of the delivery system that may be suitable for connection to an artificial valve frame having multiple threaded connector anchors (1400 as shown in Figure 15A). The components described in this depiction may differ only slightly from those described in Figure 23. Figure 29 shows an exploded view of the delivery handle portion of the delivery system 2320 and an exploded view of the concentric nesting catheter 2330. Slots 2390 may be formed at the proximal ends of both the A-side 2370 and B-side 2380 of the delivery system handle. The slots may be perpendicular to the cylindrical torque transmission member 2410, and may allow for rotational displacement of the spirit level 2420 resulting therefrom. The torque transmission member 2410 may mesh with the proximal or driving end 2355 of the torque catheter 2350 and further transmit torque through a geared relationship, and may advance concentrically through the catheter mount 2400, main thread 2080, multiple stabilizers 2360, and sheath catheter 1350 before terminating at the distal or driven end 2352, as further illustrated in Figure 31. The catheter mount 2400 may provide lateral positioning and fixation for the fixed ends 2345 of the multiple torsion thread connector catheters 2340. The thread connector catheters 2340 may be long, thin, flexible members that can be structurally rigid under compression. The thread connector catheters may be capable of torsion around their axes when appropriate torque is applied. To maintain adjacency between the torque catheter 2350 and the multiple threaded connector catheters 2340, the multiple stabilizers 2360 can act as journal bearings both to internally hold the torque catheter 2350 in place and to externally hold the multiple threaded connector catheters 2340 in place. The multiple threaded connector catheters can be concentrically nested within the sheath catheter 1350. As previously described, by rotating the thumbwheel 1955, the main thread 2080 is expanded, and the sheath catheter 1350 can be moved in parallel, thereby advancing the leading edge 1725 of the sheath catheter 1350 toward or retracting it toward the expander tip 1710.

[0099] Figure 30 provides a more detailed view of the exploded view 2330 of Figure 29, showing the nested configuration of the catheter group.

[0100] Figure 31 shows an enlarged view 2430 illustrating in detail the mechanical interactions at the distal end of the delivery system in Figure 29. As previously described, acting a lever (2400 as shown in Figure 29), which can be operably coupled to the driven end 2352 of the torque catheter (2350 as shown in Figure 29), can rotate the torque catheter and, further, rotate the drive gear 2490, which can transmit torque to a plurality of driven gears 2470 adjacent to the distal ends 2342 of the plurality of threaded connector catheters 2340, and, when expanded, also adjacent to the threaded sockets 2480 of each threaded connector catheter 2340. It should be apparent that the rotation of the drive gear 2490 in a first direction (as indicated by the arrow 2460 indicating rotation) can cause each of the driven gears 2470 to rotate in a second direction opposite to the first direction (as indicated by the arrow 2450 indicating rotation). A mechanical advantage may exist between the drive gear 2490 and the driven gear 2470. This mechanical advantage may result in an increase in the rotational displacement of the driven gear relative to the drive gear. The mechanical advantage may provide a 4:1 increase in the rotational displacement of the driven gear relative to the drive gear. The distal end 2342 of each threaded connector catheter 2340 may be a threaded socket (2480 as shown in Figure 31) which can be used to connect to and mesh with a threaded fastener that can be fixed to embodiments of artificial valves (1390 and 1395 as shown in Figure 15A).

[0101] Figure 32 illustrates an artificial valve implanted in the mitral valve of a patient's heart. With conventional implantation methods and devices, the natural blood flow path may be obstructed, and blood flow may become turbulent. Blood can flow toward the apex and toward the septum, generating turbulence.

[0102] Figure 33 illustrates the desired blood flow path from the ventricle through the mitral valve. The natural mitral valve directs blood to flow along the posterior wall of the ventricle toward the apex, where it then continues to flow above the septum in a non-turbulent manner, and then, during cardiac systole, the blood is released through the left ventricular outflow tract (LVOT) into the aorta and into the rest of the body. In this configuration, the blood flow maintains its momentum and conserves its energy, resulting in the most efficient flow.

[0103] Figure 34 illustrates an artificial valve implanted in a natural mitral valve. The artificial mitral valve preferably has features that can help maintain the natural blood flow path to avoid obstruction of the left ventricular outflow tract and to conserve blood flow momentum and avoid turbulence. For example, the artificial valve preferably has a large anterior artificial leaflet 3410 that extends to the width of the natural anterior leaflet. This helps to mimic the size and movement of the natural leaflet, thereby avoiding obstruction of the LVOT. In addition, the prosthesis has a thin profile so as not to extend excessively deep into the ventricle, and an atrial flange or skirt helps to anchor the prosthesis to the atrial base. The atrial skirt 3420 also preferably has a thin profile. The prosthesis may also include one or preferably two anterior anchoring tabs 3430 that extend behind (anterior to) the natural leaflet and anchor the prosthesis to the fibrous triangle on the anterior portion of the valve, or adjacent to the anterior leaflet and anchor to the tissue anterior to it. The valve body 3440 may direct blood flow posteriorly. Further details of the anchoring tab can be found in U.S. Patent No. 8,579,964, whose entire contents have been previously incorporated herein by reference. The body of the prosthesis may be designed to avoid LVOT occlusion, which helps direct blood flow downward along the posterior wall of the heart in a circular manner toward the apex, and then upward along the septum toward the LVOT, thereby maintaining a substantially normal blood flow path that can avoid turbulence and maintain the momentum of blood flow. Further details of these and other features of the prosthesis are discussed in more detail herein.

[0104] Figure 35 illustrates a ventricular diagram of a prosthesis, preferably having a large artificial anterior leaflet and two posterior leaflets. Preferably, three commissures are used to support the artificial valve leaflets and form an artificial tricuspid valve. The prosthesis may include an atrial skirt 3520. In addition, the prosthesis preferably includes two anterior anchor tabs 3510 and optionally one or more posterior anchor tabs 3530. The anterior anchor tabs may be anchored to the fibrous triangle of the valve, or they may be located anterior to the anterior leaflet and anchored to the adjacent tissue. To avoid interfering with the movement of the artificial anterior leaflet, the anterior anchor tabs are also preferably located in the same circumferential position as the commissures. In this exemplary embodiment, the anterior anchor tabs, together with two of the commissures, are located at approximately the 10 o'clock and 2 o'clock positions. The prosthesis is preferably D-shaped to conform to the biostructure of the natural valve. Therefore, the anterior portion of the valve is preferably flat and linear so as not to affect the LVOT, and the posterior portion of the prosthesis is preferably cylindrical so as to conform to the natural valve. In some embodiments, instead of a flat and linear anterior portion, the anterior portion may be concave or slightly convex.

[0105] Figure 36A more clearly illustrates the two anterior anchor tabs extending upward toward the atrium and away from the commissure column extending toward the ventricle, while the posterior anchor also extends upward toward the atrium, while the adjacent commissure column extends downward toward the ventricle. Note that only one of the anterior anchor tabs is visible in this figure. The prosthesis may include an atrial skirt 3610.

[0106] Figure 36B illustrates the outward flow of the prosthesis of Figure 36A, thereby showing the presence of both anterior triangular anchoring tabs, as well as a posterior anchoring tab and commissures associated with each of the tabs. It should be evident that the commissure posts and anchoring tabs are adjacent to each other. The prosthesis may comprise an anterior anchor 3620, an anterior cusp 3630, an anterior commissure 3640, a posterior anchor 3650, and a posterior commissure 3660.

[0107] Figure 37 illustrates two embodiments of the structure on the prosthesis for connecting it to a delivery catheter. This figure shows the pattern of the anchor frame after it has been flattened and expanded. It is formed from a number of interconnected struts that form open or closed cells that may be self-expandable or balloon-expandable. On the left side of Figure 37, the first exemplary embodiment shows a single arched strut that forms a single closed cell on the atrial portion of the device. This strut may be folded radially outward to form a flanged region or atrial skirt that can be anchored to the atrial base. A commissure strut with a D-shaped or mushroom-head-shaped or anchor-shaped portion on the opposite end of the prosthesis may be used to connect and disconnect the device to a delivery catheter, as previously described herein and in U.S. Patent No. 8,579,964, which has been incorporated by reference, generally above the ventricular portion of the device. A triangular anchor tab nests within a single cell between the commissure strut and the atrial flange. Therefore, the anchor tab is located above the commissure column. The anchor tab may be positioned behind the natural flap leaflet (anterior to the natural anterior leaflet or posterior to the natural posterior leaflet) and may be formed to expand radially outward during deployment so that it can engage with anterior or posterior natural biostructure as described herein. The commissure may have suture holes located within it to allow sutures to attach tissue or other material to the commissure column. Nesting of the anchor tab adjacent to the commissure column helps to reduce the overall device outline.

[0108] The right side of Figure 37 illustrates another exemplary embodiment of an anchor structure that allows the prosthesis to be coupled to a delivery catheter. On the right side, multiple closure cells may be formed to extend radially outward, forming an atrial region of the device and creating a flanged region that can be sutured to the atrial base of the atrium. Two commissure columns include slotted regions for receiving sutures so that tissue or other material can be coupled to the device. The commissure columns are connected with furculate columns having central tabs that can be coupled to a delivery catheter. The furculate columns may extend between two, three, or more commissures. Thus, in this embodiment, only a single connector is used to couple the prosthesis to the delivery catheter. The frame columns may be EDM machined or laser cut from tubular materials (e.g., hypotubes) by laser cutting or photoetching a flat sheet and welding the ends together, or by other techniques known in the art.

[0109] Figure 38 illustrates a perspective view of an artificial mitral valve. The upper portion includes an atrial skirt or atrial flange, which generally takes the same form as the atrial skirt or flange described in U.S. Patent No. 8,579,964, which has been previously incorporated herein by reference. Artificial leaflets are also shown, which preferably include one large anterior leaflet extending to the width of the natural mitral valve anterior leaflet, and may include two, three, or more artificial posterior leaflets. Thus, the artificial valve may have only two or three or more artificial leaflets in total. Two anterior anchoring tabs also preferably share the same position as the commissure column. This helps to keep the anterior commissure column and anterior anchoring tab outside the flow path, thereby helping to avoid LVOT occlusion, and also helps to keep the overall shape of the device to a minimum in the desired folded configuration during delivery.

[0110] Figure 39A shows a front view of the prosthetic valve in an expanded configuration, with the fixing tabs extended outward in the expanded configuration.

[0111] Figure 39B shows a top view of a prosthetic valve with four prosthetic leaflets, including one large anterior leaflet extending the width of the natural anterior leaflet and three posterior leaflets, all of which are optionally combined with four commissure columns that can be combined with four anchor tabs. Two of these anchor tabs are preferably anterior fixation tabs for fixing the prosthetic valve to the fibrous triangle or any other anatomical location described herein, including anterior to and adjacent to the anterior leaflet, while the two posterior tabs can fix the prosthetic valve to the posterior shelf of the posterior cruciate and posterior to the natural posterior leaflet.

[0112] Figure 40 shows the deployment of the prosthesis by either a transseptal or transapical delivery system. In either case, preferably, the lateral sheath catheter prevents the device from self-expanding, and the device self-expands when the lateral sheath catheter is retracted. Here, the sheath catheter is partially retracted, and the anterior 4010 and posterior 4020 anchor tabs are partially deployed.

[0113] Figure 41 shows a partial perspective view of the prosthetic valve with a composite large anterior leaflet and two or three posterior leaflets, as well as a composite anchor tab / compression column, along with an upper saddle-shaped atrial skirt for atrial fixation.

[0114] Figure 42 shows a flat pattern of a composite anterior or posterior anchor tab nested within the commissure column. In alternative embodiments, the anchor may be cut above the commissure column and bent posteriorly during heat treatment and shaping so that it can be anchored to the natural heart valve biostructure as described herein. This may require the anchor to be unfolded first in front of the rest of the prosthesis, as seen in Figure 40. This may also involve anchoring the prosthesis to a delivery catheter at both the inlet and outlet ends of the prosthesis for successful delivery.

[0115] Figure 43A shows an unexpanded anchor tab that is triangular in the folded configuration and may have a horizontal paddle shape in the expanded configuration to increase the contact area and thereby minimize tissue trauma and tissue puncture during implantation, as illustrated in Figure 43B. Alternatively, the anchor may have a tip that punctures or implants into the tissue to help implant the device.

[0116] Figure 43C shows an exemplary cross-section pattern of the prosthesis, which provides the results seen in Figures 43A-43B.

[0117] Figure 44 illustrates a top view of an artificial valve with a large anterior leaflet extending to the width of the natural anterior leaflet and two artificial posterior leaflets. The artificial leaflets are joined together with three commissure columns.

[0118] Figure 45 shows a portion of the prosthesis including the upper atrial skirt, an annular region, and an anchor tab that may be combined with a commissure column. The anchor tab is preferably 10 mm to 50 mm in length, more preferably 20 mm to 30 mm in length, so as to allow sufficient length to extend below and behind the natural valve leaflets to reach the fibrous triangle and / or posterior annulus, or to anchor in other anatomical locations described herein, including regions anterior to and adjacent to the natural valve leaflets. Optionally, the prosthesis may not include a posterior anchor tab. Preferably, the annular section, which is D-shaped, may be radially extended to engage with the natural valve annulus, so that the radial force may be sufficient to prevent the posterior portion of the prosthesis from tilting upward into the atrium or otherwise pivoting. Alternatively, teeth may be used to engage with and / or penetrate the posterior annulus.

[0119] In any embodiment, the prosthesis may be recaptured and recovered if necessary, either to interrupt the delivery procedure or to reposition the device.

[0120] A preferred embodiment is formed from self-expanding nitinol or any other biocompatible material. The preferred target size and shape may depend on the patient's biostructure, but is estimated to be a D-shaped prosthesis of about 30mm-50mm x 40mm-50mm that can be delivered in a delivery system of less than 45 French size. More preferably, the prosthesis is D-shaped, 35mm-45mm x 40mm-50mm, and delivered using a delivery system of less than 40 French size. Smaller sizes are preferred, and nominally, the prosthesis is D-shaped, 40mm x 45mm, and delivered using a delivery system of less than 40 French size.

[0121] In some embodiments, a tethering chain may be used to help connect the prosthesis to the delivery system in order to control delivery.

[0122] Figure 46 shows a top view of the prosthetic valve with four prosthetic leaflets and four commissures. Optionally, four anchoring tabs may also be located in the same location as the four commissures.

[0123] Figure 47 shows a top view of the prosthetic valve with three prosthetic leaflets and three commissures. Optionally, three anchoring tabs may also be located in the same location as the three commissures.

[0124] Figure 48 shows a prosthesis that has been widened and flattened, and has three commissure columns along with three artificial valve leaflets and three anchoring tabs. The atrial skirt is also illustrated below the commissure columns and anchoring tabs.

[0125] Figure 49 shows the natural anterior and posterior tips, which have been spread and flattened and overlapped to cover the three anchoring tabs.

[0126] Figure 50 shows an embodiment in which the anchor tab (triangular cell) is connected to a commissure column configured for deployment as depicted in Figure 40, and the anchor tab is initially deployed as an outer sheath when the delivery system is retracted. Alternative catheter attachment methods are described for this embodiment. The use of either a mushroom-shaped anchor tab or a central furculate attachment portion on the atrial side of the device can be used to secure the device to the catheter.

[0127] Figure 51 shows a large anterior tip that covers and overlaps two anterior anchor tabs, and a diamond-shaped posterior segment of the cell that can engage with or puncture the posterior wheel in an exemplary embodiment where a posterior anchor tab is not used.

[0128] Figure 52 illustrates another exemplary embodiment, showing two nested front anchoring tabs formed within the front commissar column, and a series of expandable diamond-shaped cells that can be anchored to or punctured into the rear wheel, thereby avoiding the need for a rear anchoring tab. This embodiment includes four commissar columns.

[0129] Figure 53 illustrates another exemplary flat pattern of a prosthetic valve, having an anterior anchor tab nested within two anterior commissure columns and two posterior commissure columns. The atrial flange is shown below the commissure columns.

[0130] Figure 54 shows a perspective view of the artificial valve, with four commissure columns and a large artificial anterior leaflet connected to two anterior commissure columns.

[0131] Figure 55 shows a natural mitral valve adjacent to the aorta, where preferably the anterior leaflet moves sufficiently away from the LVOT during systole. Preferably, an artificial anterior leaflet would have a similar motion to maintain natural fluid dynamics such as maintaining blood flow momentum and reducing or eliminating turbulence.

[0132] Figure 56 shows another exemplary embodiment of a section of the artificial valve having nested anchoring tabs within the commissure column, and also shows the adjacent closure cells of the frame.

[0133] Figure 57 illustrates yet another exemplary embodiment of an artificial valve, which has a commissure column and a nested anchoring tab with respect to the commissure column.

[0134] Figure 58 shows yet another modification of the artificial valve, which has nested anchoring tabs within the commissure column.

[0135] Figure 59 illustrates how variable post thickness (e.g., thicker 5910 and thinner 5920 regions) can be used to control the material properties of the prosthesis and create areas that are stiffer and less stiff.

[0136] Preferred embodiments of the present invention are illustrated and described herein, but it will be apparent to those skilled in the art that such embodiments are provided only as examples. Numerous modifications, alterations, and substitutions will be conceivable to those skilled in the art without departing from the present invention. It should be understood that various alternatives to the embodiments of the present invention described herein may be employed in practicing the present invention. The following claims define the scope of the present invention, and methods and structures within the scope of these claims and their equivalents are intended to be covered thereby.

Claims

1. An artificial heart valve for implantation into a patient's natural mitral valve, wherein the artificial heart valve is A radially expandable anchor frame having an extended configuration and a folded configuration, wherein the anchor frame comprises a pre-fixation tab and a post-fixation tab, the pre-fixation tab being configured to fix to the anterior portion of the natural mitral valve, the post-fixation tab being located opposite to the pre-fixation tab and in contact with the natural biological structure and configured to rest against the postventricular shelf region, the postventricular shelf region being formed within the ventricle at the junction of the ventricle and the postmitral annulus, and the anchor frame having a D-shaped cross-section, A single prosthetic leaflet, sized to extend across the entire width of the natural leaflet, the single prosthetic leaflet having a free end and a fixed end, the fixed end being connected to the anchor frame, the free end having an open configuration and a closed configuration, the open configuration allowing anterograde blood flow to pass through the outflow region posterior to the single prosthetic leaflet, and the closed configuration being closed to prevent retrograde blood flow. Equipped with, An artificial heart valve in which, during systole, the single artificial anterior leaflet mimics the movement of the natural anterior leaflet to avoid obstruction of blood flow in the left ventricular outflow tract.

2. The artificial heart valve according to claim 1, comprising an atrial region and an annular region, the atrial region comprising an atrial skirt, the atrial skirt traversing the entire circumference of the inlet region of the artificial heart valve, communicating with and connected to the annular region, the annular region also traversing the circumference of the artificial heart valve, and the atrial skirt enabling the inlet region of the artificial heart valve to align with and seal the natural mitral annulus on the bottom surface of the left atrium.

3. The artificial heart valve according to claim 2, wherein a plurality of atrial skirt support struts arise from the annular region and act as support beams for the plurality of atrial skirt circumferential struts, and the plurality of atrial skirt support struts are substantially parallel to one another.

4. The artificial heart valve according to claim 3, wherein each of the plurality of atrial skirt circumferential supports is substantially V-shaped and connected to a corresponding atrial skirt support support, and the combination of the plurality of atrial skirt support supports and the plurality of atrial skirt circumferential supports forms the atrial region and provides a place for the atrial skirt to be sutured onto the anchor frame.

5. The artificial heart valve according to any one of claims 1 to 4, wherein the anchor frame comprises a second pre-fixing tab configured to fix to a second anterior portion of the natural mitral valve.

6. The artificial heart valve according to any one of claims 1 to 5, wherein the D-shaped cross section has a substantially flat front portion and a cylindrical rear portion, the flat front portion preventing the artificial heart valve from colliding with the left ventricular outflow tract, and the cylindrical rear portion engaging with the rear portion of the natural mitral valve.

7. The artificial heart valve according to any one of claims 1 to 6, wherein in the closed configuration, the posterior covering region of the single artificial anterior leaflet is sealed to the leaflet junction edge that appears on the posterior surface of the valve inlet.

8. The artificial heart valve according to any one of claims 1 to 7, wherein the single artificial anterior leaflet is constructed from chemically preserved pericardial tissue taken from a bovine, porcine, or sheep breed.

9. The artificial heart valve according to any one of claims 1 to 8, further comprising a biocompatible fabric, the biocompatible fabric providing sealing properties and being sewn onto the anchor frame.

10. The artificial heart valve according to claim 9, wherein the biocompatible fabric comprises polyester, nylon, or any other biocompatible fabric.

11. The artificial heart valve according to claim 2, or any one of claims 3 to 10 as dependent on claim 2, wherein the atrial skirt is configured to spread radially outward and be sutured to the base of the atrial.

12. The artificial heart valve according to any one of claims 1 to 11, wherein the prefixation tab is configured to expand radially outward during deployment of the artificial heart valve so that the prefixation tab is positioned behind the natural anterior leaflet.

13. The artificial heart valve according to any one of claims 1 to 12, wherein the pre-fixation tab and the post-fixation tab have a length of 10 mm to 50 mm.

14. The artificial heart valve according to claim 13, wherein the pre-fixation tab and the post-fixation tab have a length of 20 mm to 30 mm.

15. The artificial heart valve according to any one of claims 1 to 14, wherein the artificial heart valve is delivered in a delivery system having a size of less than 45 French.

16. The artificial heart valve according to claim 15, wherein the artificial heart valve is delivered in a delivery system having a size of less than 40 French.

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