Method and apparatus for loading a delivery system with a prosthesis

Abstract

The present invention relates to a method and apparatus for loading a prosthesis onto a delivery system. A device for loading a prosthesis onto a delivery system includes a first housing having a central hole. One or more actuators on the first housing can be actuated radially inwardly to selectively compress a discrete portion of the prosthesis disposed in the central hole.

Description

[0001] The present application is a divisional application of an application filed on May 30, 2013, with application number 201610647657.6 and invention name “Method and device for loading a prosthesis onto a delivery system”.

[0002] The application with the application date of May 30, 2013, the application number of 201610647657.6, and the invention name of “Method and device for loading a prosthesis onto a delivery system” is a divisional application of the application with the application date of May 30, 2013, the application number of 201380040510.5, and the invention name of “Method and device for loading a prosthesis onto a delivery system”.

[0003] Cross-references

[0004] This application is a nonprovisional application and claims the benefit of U.S. Provisional Patent Application No. 61 / 653,273 (Attorney Docket No. 42194-706.101), filed on May 30, 2012; the entire contents of the above application are incorporated herein by reference. Background of the Invention

[0005] 1. Field of the Invention The present invention relates generally to medical devices and methods, and more particularly to devices and methods for loading a delivery system with a prosthesis. The prosthesis may be any device, but in preferred embodiments is used to treat valvular insufficiency, such as mitral regurgitation, also known as mitral regurgitation. The delivery system may be any system for delivering the prosthesis by conventional surgical implantation or by less invasive percutaneous catheter or minimally invasive transapical approaches.

[0006] The heart of vertebrates is divided into four chambers with four valves (mitral valve, aortic valve, pulmonary valve and tricuspid valve) that ensure that the blood pumped by the heart flows in the forward direction through the cardiovascular system. The mitral valve of a healthy heart prevents blood from flowing back from the left ventricle of the heart into the left atrium and comprises two flexible leaflets (anterior leaflet and posterior leaflet) that close when the left ventricle contracts. The leaflets are attached to the annulus fibrosus and their free edges are tied to the papillary muscles in the left ventricle by subvalvular chordae tendineae to prevent them from prolapsing into the left atrium during left ventricular contraction.

[0007] Various heart diseases or degenerative changes can cause any of these parts of the mitral valve to malfunction, causing the mitral valve to become abnormally narrow or dilated, or to allow blood to leak back from the left ventricle into the left atrium (also known as regurgitation). Any such damage compromises the integrity of the heart and can be debilitating or life-threatening.

[0008] Therefore, many surgical methods and devices have been developed to treat mitral valve dysfunction, including open-heart surgical techniques for replacing, repairing or reshaping the native mitral valve apparatus, and surgical implantation of various prosthetic devices such as annuloplasty rings to change the anatomy of the native mitral valve. Recently, less invasive transcatheter techniques for delivering replacement mitral valve assemblies have been developed. In such techniques, the prosthetic valve is generally mounted in a curled state at the end of a flexible catheter and advanced through the patient's blood vessels or body until the valve reaches the implantation site. Subsequently, the prosthetic valve expands to its functional size at the site of the defective native valve.

[0009] Although these devices and methods are promising therapies for valvular insufficiency, they can be difficult to deliver and difficult to load onto a delivery system. Therefore, it is desirable to provide improved devices and methods for coupling a prosthesis to a delivery system. The devices and methods disclosed below will meet at least some of these goals.

[0010] 2. Description of Background Technology . For example, PCT International Patent No. PCT / US2008 / 05440 (published as PCT International Publication No. WO2008 / 103722), the disclosure of which is incorporated herein by reference, describes a transcatheter mitral valve prosthesis comprising: an elastic ring; a plurality of leaflet membranes mounted relative to the ring to allow blood to flow therethrough in one direction; and a plurality of tissue engaging positioning elements movably mounted relative to the ring and sized to embrace an anatomical structure of a heart valve annulus, heart valve leaflets, and / or heart wall. Each positioning element defines respective proximal, intermediate, and distal tissue engaging regions that are cooperatively configured and sized to simultaneously engage separate corresponding regions of tissue of the anatomical structure, and the positioning elements may include respective first, second, and third elongated tissue piercing elements. The valve prosthesis may also include a skirt mounted relative to the elastic ring for sealing the periphery of the valve prosthesis to prevent backflow of blood around the valve prosthesis.

[0011] PCT International Patent No. PCT / US2009 / 041754 (published as PCT International Publication No. WO2009 / 134701), the disclosure of which is incorporated herein by reference, describes a prosthetic mitral valve assembly comprising an anchor or outer support frame having an open upper end and a tapered portion to fit the contour of a native mitral valve, and a tissue-based one-way valve mounted therein. The assembly is adapted to expand radially outward and contact native heart tissue to form a press fit, and the assembly further comprises a tensioning member that anchors the leaflets of the valve assembly to a suitable position on the heart to perform the function of prosthetic chordae tendineae.

[0012] Also known are prosthetic mitral valve assemblies that utilize a claw structure to attach the prosthesis to the heart (e.g., see U.S. Patent Application Publication No. US2007 / 0016286 to Hermann et al., the disclosure of which is incorporated herein by reference), such prosthetic mitral valve assemblies rely on the application of axial rather than radial clamping forces to facilitate self-positioning and self-anchoring of the prosthesis relative to the native anatomy.

[0013] Another approach proposed as a treatment for mitral regurgitation is the surgical bow tie procedure, which has recently been adapted for minimally invasive catheter-based treatment, in which an implant is used to clip the valve leaflets together. This procedure is more fully disclosed in the scientific and patent literature, such as in U.S. Pat. No. 6,629,534 to St. Goar et al., the entire contents of which are incorporated herein by reference.

[0014] Other relevant disclosures include U.S. Patent Publication No. 2011 / 0015731 to Carpentier et al. and WO 2011137531 to Lane et al. Although some of these devices and methods are promising, there is still a need for improved devices and methods that will further allow for more precise positioning of prosthetic valves and will also more securely anchor the valve in place. In addition to the need for improved devices, there is also a need for improved delivery systems and improved tools or devices and methods for loading devices onto their corresponding delivery systems. The exemplary embodiments disclosed herein will meet at least some of these goals. Summary of the invention

[0015] The present invention relates generally to medical devices and methods, and more specifically to devices and methods for loading a prosthesis onto a delivery system. The prosthesis can be any device, but in a preferred embodiment is used to treat valvular insufficiency, such as mitral regurgitation, also known as mitral regurgitation. The delivery system can be any system for delivering the prosthesis by traditional surgical implantation or by less invasive percutaneous catheter or minimally invasive transapical methods. Although the present disclosure focuses on a clamp for loading a prosthesis onto a delivery system, it is not intended to be limited thereto. The prosthetic valves disclosed herein can also be used to treat other body valves, including other heart valves or venous valves. Exemplary heart valves include the aortic valve, the tricuspid valve, or the pulmonary valve. The loading device disclosed herein can be used to load any prosthesis onto any delivery system.

[0016] In a first aspect of the invention, a device for loading a prosthesis onto a delivery system comprises a first housing including a first inlet, a first outlet, and a first bore extending therebetween. The first housing has one or more actuators configured for radially inward or outward actuation, and the one or more actuators are adapted to selectively compress discrete portions of the prosthesis radially inward when the prosthesis is positioned in the first bore while adjacent portions of the prosthesis remain uncompressed by the one or more actuators.

[0017] The first central hole may include a constant diameter region or a first tapered region adapted to radially contract the prosthesis from a first initial diameter to a smaller diameter when the prosthesis passes therethrough. The one or more actuators may include three actuators disposed circumferentially about the first housing approximately every 120 degrees. The one or more actuators may be operably coupled together so that they are actuated simultaneously. The device may further include a collar threadably engaged with the first housing. Rotating the collar actuates the one or more actuators. The one or more actuators may include a spring-loaded actuator biased to return to a position disposed radially outward from the first central hole. The first housing may further include a plurality of engagement elements for engaging adjacent housings. The device may also include a support element releasably engaged with the first housing. The inner support element may be configured to support an inner surface of the prosthesis.

[0018] The device may further include a second housing that can be coupled end-to-end with the first housing. The second housing may include a second inlet, a second outlet, and a second central bore extending therebetween. The second central bore may have a second tapered region adapted to radially contract the prosthesis from a second initial diameter to a second smaller diameter when the prosthesis is advanced through the second central bore. The second central bore may further include a second constant diameter region that communicates with and is proximal to the first central bore. The second central bore may further include a fillet region disposed between the second tapered region and the second constant diameter region. The second central bore may be at least partially cylindrical. The second housing may include a plurality of engagement elements for releasably engaging the second housing with an adjacent housing, or a plurality of engagement receptacles for receiving engagement elements on adjacent housings. The plurality of engagement elements may include three engagement tabs that are circumferentially arranged about every 120 degrees around the first housing. The penetration of the prosthesis through the second central bore may shape the prosthesis to have a circular cross-section.

[0019] The device may further include a third housing that can be coupled end-to-end with the first housing or the second housing. The third housing may include a third inlet, a third outlet, and a third central hole extending therebetween and communicating with the first central hole or the second central hole. The third central hole may have a third tapered region adapted to radially contract the prosthesis from a third diameter to a diameter less than the third diameter when the prosthesis is advanced through the third central hole. The third central hole may further include a third constant diameter region that is in communication with and distal to the third tapered region. The third central hole may also include a filleted region disposed between the third tapered region and the third constant diameter region. The third central hole may be at least partially cylindrical. The third housing may include a plurality of engagement elements for releasably engaging adjacent housings. The third housing may include a plurality of engagement containers for receiving engagement elements on adjacent housings. The plurality of engagement elements may include three engagement tabs that are circumferentially arranged about every 120 degrees around the first housing. The penetration of the prosthesis through the third central hole may shape the prosthesis to have a circular cross-section.

[0020] The prosthesis may include a prosthetic heart valve and may include a plurality of anchoring tabs, and wherein actuation of the one or more actuators is adapted to move the plurality of anchoring tabs radially inwardly. The plurality of anchoring tabs may be adapted to releasably engage with a securing feature on a delivery catheter. The plurality of anchoring tabs may include commissures on a prosthetic heart valve.

[0021] In another aspect of the invention, a system for loading a delivery system with a prosthesis includes the loading device described above in addition to a prosthetic heart valve and a delivery device.

[0022] In yet another aspect of the invention, a method for loading a prosthesis onto a delivery system includes providing a prosthetic valve having a plurality of commissures coupled thereto, wherein the prosthetic valve includes an unbiased diameter; and reducing the unbiased diameter of the prosthetic valve in selected discrete regions, the selected discrete regions including the commissures. The method also includes loading the reduced diameter prosthetic valve onto the delivery device.

[0023] Reducing the unbiased diameter of the prosthetic valve may include actuating one or more actuators on a first housing, wherein the one or more actuators may selectively engage discrete regions of the prosthetic valve. The method may further include passing the prosthetic valve through a constant diameter portion of a central passage in the first housing. Actuating the one or more actuators may include depressing one or more pins or fingers radially inward to engage the discrete regions of the prosthetic valve. The discrete regions may move radially inward to a reduced profile. Depressing may include depressing the one or more pins or fingers simultaneously.

[0024] The method may further include reducing the diameter of the prosthetic valve from the unbiased diameter to a first diameter that is smaller than the unbiased diameter. Reducing the diameter of the prosthetic valve from the unbiased diameter to the first diameter may include passing the prosthetic valve through a tapered central channel. Passing the prosthetic valve through the tapered central channel may include pushing or pulling the prosthetic valve therethrough. Passing the prosthetic valve through the tapered central channel may include shaping the prosthetic valve to have a circular cross-section.

[0025] The method may further include reducing the diameter of the prosthetic valve from the first diameter to a second diameter that is smaller than the first diameter. Reducing the diameter from the first diameter to the second diameter may include passing the prosthetic valve through a second tapered central channel. Passing the prosthetic valve through the second tapered central channel may include pushing or pulling the prosthetic valve therethrough.

[0026] The delivery device may include an inner shaft and an outer shaft slidably disposed thereon, and loading the reduced diameter prosthetic valve may include disposing the prosthetic valve between the inner shaft and the outer shaft. Loading the reduced diameter prosthetic valve may include releasably engaging the commissure rod with the delivery device.

[0027] The prosthetic valve may be made of nickel-titanium alloy, and the method may further include cooling the prosthetic valve to a temperature less than or equal to the austenite finish temperature of the prosthetic valve. Cooling the prosthetic valve may include cooling the prosthetic valve in cold saline. The diameter of the prosthetic valve may be reduced from the unbiased diameter to the first diameter in a first shell, and the diameter of the prosthetic valve may be reduced from the first diameter to the second diameter in a second shell, and the method may further include coupling the first shell to the second shell. After the diameter has been reduced to the first diameter, the first shell and the second shell may be decoupled from each other. The method may also include supporting the inner surface of the prosthesis with a support element.

[0028] These and other embodiments are described in further detail in the following description relating to the accompanying drawings.

[0029] Specifically, the present invention relates to:

[0030] 1. A device for loading a prosthesis onto a delivery system, the device comprising:

[0031] A first housing comprises a first inlet, a first outlet and a first central bore extending therebetween, and wherein the first housing has one or more actuators configured for radially inward or outward actuation, the one or more actuators being adapted to selectively compress discrete portions of the prosthesis radially inward when the prosthesis is positioned in the first central bore while adjacent portions of the prosthesis remain uncompressed by the one or more actuators.

[0032] 2. A device according to paragraph 1, wherein the first central hole includes a constant diameter area.

[0033] 3. The device of paragraph 1, wherein the first central hole includes a first tapered region adapted to radially contract the prosthesis from a first initial diameter to a smaller diameter when the prosthesis is passed therethrough.

[0034] 4. The device of paragraph 1, wherein the one or more actuators include three actuators, and the three actuators are circumferentially arranged around the first housing approximately every 120 degrees.

[0035] 5. An apparatus according to paragraph 1, wherein the one or more actuators are operably coupled together so that the one or more actuators are actuated simultaneously.

[0036] 6. The device of paragraph 1, further comprising a collar threadably engageable with the first housing, and wherein the collar is rotated to actuate the one or more actuators.

[0037] 7. The device of paragraph 1, wherein the one or more actuators include a spring-loaded actuator that is biased to return to a position disposed radially outward from the first central aperture.

[0038] 8. The device according to paragraph 1, wherein the first shell further includes a plurality of engagement elements for engaging adjacent shells.

[0039] 9. The device of paragraph 1, further comprising an inner support element releasably engaged with the first shell, the inner support element being configured to support an inner surface of the prosthesis.

[0040] 10. The device according to paragraph 1 further includes a second shell that can be coupled to the first shell end to end, wherein the second shell includes a second inlet, a second outlet and a second center hole extending between the second inlet and the second outlet, and the second center hole has a second tapered area, and the second tapered area is suitable for radially contracting the prosthesis from a second initial diameter to a second smaller diameter when the prosthesis is advanced through the second center hole.

[0041] 11. The device according to paragraph 10, wherein the second central hole further includes a second constant diameter region, which is connected to the first central hole and is located proximal to it.

[0042] 12. The device of paragraph 11, wherein the second central hole further comprises a rounded corner region disposed between the second tapered region and the second constant diameter region.

[0043] 13. A device according to paragraph 10, wherein the second central hole is at least partially cylindrical.

[0044] 14. The device of paragraph 10, wherein the second housing comprises a plurality of engagement elements for releasably engaging the second housing with an adjacent housing.

[0045] 15. The device of paragraph 10, wherein the second housing includes a plurality of engagement receptacles for receiving engagement elements on an adjacent housing.

[0046] 16. The device of paragraph 14, wherein the plurality of engagement elements includes three engagement tabs, the three engagement tabs being circumferentially arranged approximately every 120 degrees around the first housing.

[0047] 17. The device of paragraph 10, wherein penetration of the prosthesis through the second central hole shapes the prosthesis to have a circular cross-section.

[0048] 18. The device according to paragraph 1 further includes a third shell that can be coupled to the first shell or the second shell end to end, the third shell includes a third inlet, a third outlet, and a third center hole extending between the third inlet and the third outlet and connected to the first center hole or the second center hole, the third center hole has a third tapered area, and the third tapered area is suitable for radially contracting the prosthesis from a third diameter to a diameter smaller than the third diameter when the prosthesis is pushed through the third center hole.

[0049] 19. The device according to paragraph 18, wherein the third central hole further includes a third constant diameter region, which is connected to the third tapered region and is located distally thereto.

[0050] 20. The device of paragraph 19, wherein the third central hole further includes a rounded corner region disposed between the third tapered region and the third constant diameter region.

[0051] 21. The device of paragraph 18, wherein the third central hole is at least partially cylindrical.

[0052] 22. The device of paragraph 18, wherein the third housing includes a plurality of engagement elements for releasably engaging an adjacent housing.

[0053] 23. The device of paragraph 18, wherein the third housing includes a plurality of engagement receptacles for receiving engagement elements on an adjacent housing.

[0054] 24. The device of paragraph 22, wherein the plurality of engagement elements comprises three engagement tabs, the three engagement tabs being circumferentially arranged approximately every 120 degrees around the first housing.

[0055] 25. The device of paragraph 18, wherein penetration of the prosthesis through the third central hole shapes the prosthesis to have a circular cross-section.

[0056] 26. The device of paragraph 1, wherein the prosthesis comprises a prosthetic heart valve.

[0057] 27. The device of paragraph 1, wherein the prosthesis includes a plurality of anchoring tabs, and wherein actuation of the one or more actuators is adapted to move the plurality of anchoring tabs radially inward.

[0058] 28. The device of paragraph 27, wherein the plurality of anchoring tabs are adapted to releasably engage with a securing feature on a delivery catheter.

[0059] 29. The device of paragraph 27, wherein the prosthesis comprises a prosthetic heart valve and the plurality of anchoring tabs comprise commissures of the prosthetic heart valve.

[0060] 30. A system for loading a prosthesis onto a delivery system, the system comprising:

[0061] An apparatus according to paragraph 1;

[0062] Prosthetic heart valves; and

[0063] Delivery device.

[0064] 31. A method for loading a delivery system with a prosthesis, the method comprising:

[0065] providing a prosthetic valve having a plurality of commissure posts coupled thereto, wherein the prosthetic valve comprises an undeflected diameter;

[0066] reducing the undeflected diameter of the prosthetic valve in selected discrete regions, the selected discrete regions including the commissure posts; and

[0067] The reduced diameter prosthetic valve is loaded onto the delivery device.

[0068] 32. The method of paragraph 31, wherein reducing the undeflected diameter of the prosthetic valve comprises actuating one or more actuators on a first housing that selectively engage discrete regions of the prosthetic valve.

[0069] 33. The method of paragraph 32, further comprising passing the prosthetic valve through a constant diameter portion of a central passage in the first housing.

[0070] 34. The method of paragraph 32, wherein actuating the one or more actuators comprises depressing one or more pins or fingers radially inward to engage the discrete regions of the prosthetic valve, the discrete regions moving radially inward to a reduced profile.

[0071] 35. A method according to paragraph 34, wherein pressing includes pressing one or more of the pins or fingers simultaneously.

[0072] 36. The method of paragraph 31, further comprising reducing a diameter of the prosthetic valve from the undeflected diameter to a first diameter that is smaller than the undeflected diameter.

[0073] 37. The method of paragraph 36, wherein reducing the diameter of the prosthetic valve from the unbiased diameter to the first diameter comprises passing the prosthetic valve through a tapered central passage.

[0074] 38. The method of paragraph 37, wherein passing the prosthetic valve through the tapered central channel comprises pushing or pulling the prosthetic valve through the tapered central channel.

[0075] 39. The method of paragraph 37, wherein passing the prosthetic valve through the tapered central channel comprises shaping the prosthetic valve to have a circular cross-section.

[0076] 40. The method of paragraph 36, further comprising reducing a diameter of the prosthetic valve from the first diameter to a second diameter that is smaller than the first diameter.

[0077] 41. The method of paragraph 40, wherein reducing the diameter of the prosthetic valve from the first diameter to the second diameter comprises passing the prosthetic valve through a second tapered central passage.

[0078] 42. The method of paragraph 41, wherein passing the prosthetic valve through the second tapered central channel comprises pushing or pulling the prosthetic valve through the second tapered central channel.

[0079] 43. The method of paragraph 31, wherein the delivery device comprises an inner shaft and an outer shaft slidably disposed thereon, and wherein loading the reduced diameter prosthetic valve comprises disposing the prosthetic valve between the inner shaft and the outer shaft.

[0080] 44. The method of paragraph 31, wherein loading the reduced diameter prosthetic valve comprises releasably engaging the commissure posts with the delivery device.

[0081] 45. The method of paragraph 31, wherein the prosthetic valve is made of a nickel-titanium alloy, and the method further comprises cooling the prosthetic valve to a temperature less than or equal to an austenite finish temperature of the prosthetic valve.

[0082] 46. ​​The method of paragraph 45, wherein cooling the prosthetic valve comprises cooling the prosthetic valve in cold saline.

[0083] 47. A method according to paragraph 40, wherein the diameter of the prosthetic valve is reduced from the unbiased diameter to the first diameter in a first shell, and wherein the diameter of the prosthetic valve is reduced from the first diameter to the second diameter in a second shell, and wherein the method further includes coupling the first shell to the second shell.

[0084] 48. The method of paragraph 47, further comprising decoupling the first housing from the second housing after the diameter has been reduced to the first diameter.

[0085] 49. The method of paragraph 31 further comprises supporting an inner surface of the prosthesis with a support element.

[0086] Incorporation by reference

[0087] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. BRIEF DESCRIPTION OF THE DRAWINGS

[0088] The novel features of the present invention are particularly set forth in the appended claims. The features and advantages of the present invention will be better understood by referring to the following detailed description and accompanying drawings which illustrate exemplary embodiments in which the principles of the present invention are utilized; in the accompanying drawings:

[0089] Figure 1 is a schematic diagram of the left ventricle of the heart, with arrows showing blood flow during systole.

[0090] Figure 2 is a schematic diagram of the left ventricle of the heart with a prolapsed leaflet in the mitral valve.

[0091] Figure 3 is a schematic diagram of the heart in a patient with cardiomyopathy, in which the heart is dilated and the leaflets do not meet.

[0092] Figure 3A Normal closure of the valve leaflets is shown.

[0093] Figure 3B Abnormal closure of the valve leaflets is shown.

[0094] Figure 4 Illustration of mitral regurgitation in the left ventricle of a heart with damaged papillary muscles.

[0095] Figure 5A-Figure 5B Diagram showing the anatomy of the mitral valve.

[0096] Figure 6 An exemplary embodiment of an uncovered frame in a prosthetic heart valve is illustrated, wherein the frame is flattened and rolled out.

[0097] Figure 7 Another exemplary embodiment of an uncovered frame in a prosthetic heart valve is illustrated, wherein the frame is flattened and rolled out.

[0098] Figure 8 Yet another exemplary embodiment of an uncovered frame in a prosthetic heart valve is illustrated, wherein the frame is flattened and rolled out.

[0099] Fig. 9A A perspective view of an uncovered frame in a prosthetic heart valve after its expansion is shown.

[0100] Fig. 9B Pictured Fig. 9A A top view of an embodiment of the invention.

[0101] Fig.10 Pictured Fig. 9A The frame has a covering to form a prosthetic heart valve.

[0102] Figures 11A-11DAn exemplary embodiment of a delivery system for transapical delivery of a prosthetic heart valve is illustrated.

[0103] Figure 12A-12L An exemplary method of implanting a prosthetic heart valve is illustrated.

[0104] Figures 13A-13L Another exemplary method of implanting a prosthetic heart valve is illustrated.

[0105] Fig.14 is a perspective view of an exemplary loading system for loading a prosthetic valve having commissures into a delivery system.

[0106] Fig.15 yes Fig.14 Side view of the loading system in.

[0107] Fig.16 yes Fig.14 Cross-sectional view of the loading system in FIG.

[0108] Fig.17 yes Fig.14 Partially exploded side view of the loading system in.

[0109] Fig.18A yes Fig.14 End view of the loading system in the unactuated configuration.

[0110] Fig.18B yes Fig.14 End view of the loading system in the actuated configuration.

[0111] Fig.19 is a partial cross-sectional view of the prosthesis with the commissure inserted into Fig.14 The first level of the loading system.

[0112] Fig. 20 yes Fig.19 A partial cross-sectional view of a prosthesis in FIG. Fig.14 The first level of the loading system travels to the second level.

[0113] Fig.21 yes Fig.19 A partial cross-sectional view of a prosthesis in FIG. Fig.14 The second level of the loading system.

[0114] Fig. 22 yes Fig.19 A partial cross-sectional view of a prosthesis in FIG. Fig.14 The second level of the loading system travels to the third level.

[0115] Fig.23 yes Fig.19 A partial cross-sectional view of a prosthesis in FIG. Fig.14 within the third level of the loading system.

[0116] Fig.24 yes Fig.19 A partial cross-sectional view of a prosthesis in FIG. Fig.14 The delivery system is located within the third level of the loading system, and the delivery system is coupled to the loading system.

[0117] Fig.25 yes Fig.19 The prosthesis in Fig.14 Partial cross-sectional view after actuation of the loading system.

[0118] Fig.26A yes Fig.14 End view of the loading system in , showing the prosthesis in a collapsed but unflexed configuration.

[0119] Fig.26B yes Fig.14 An end view of the loading system in FIG. 1 with the prosthesis in a collapsed and flexed configuration.

[0120] Fig. 27 Another exemplary embodiment of a loading system is illustrated.

[0121] Figure 28A-28B The diagram shows the Fig. 27 loading system.

[0122] Figure 29A-29B The diagram shows the Fig. 27 loading system.

[0123] Figure 30-Figure 33 Yet another exemplary embodiment of a loading system is illustrated. DETAILED DESCRIPTION

[0124] Specific embodiments of the disclosed devices, delivery systems and methods will now be described with reference to the accompanying drawings. The content in these detailed descriptions is not intended to imply that any particular component, feature or step is essential to the invention.

[0125] Heart anatomy . Figure 1 , the left ventricle LV of a normal heart H in systole is shown. The left ventricle LV is contracting and blood is flowing outward in the direction of the arrow through the aortic valve AV, i.e., the tricuspid valve. Backflow or "regurgitation" of blood through the mitral valve MV is prevented because the mitral valve is constructed as a "check valve" that prevents backflow when the pressure in the left ventricle is higher than the pressure in the left atrium LA. Figure 1As shown in , the mitral valve MV includes a pair of leaflets having free edges FE that are in uniform contact for closure. The opposite ends of the leaflets LF are attached to the surrounding cardiac structures along an annular region called the annulus AN. The free edges FE of the leaflets LF are fastened to the lower part of the left ventricle LV by chordae tendineae CT (also referred to herein as chordae), which include a plurality of branching tendons fastened to the bottom surface of each valve leaflet LF. The chordae CT are in turn attached to the papillary muscles PM extending upward from the lower part of the left ventricle and the interventricular septum IVS.

[0126] Reference Figure 2-Figure 4 Several structural defects in the heart may lead to mitral regurgitation. Figure 2 As shown in , the ruptured chordae tendineae RCT may cause the valve leaflet LF2 to prolapse due to insufficient tension transmitted to the leaflet via the chordae tendineae. Although the other leaflet LF1 maintains a normal shape, the two valve leaflets cannot properly contact, and leakage from the left ventricle LV to the left atrium LA occurs as shown by the arrow.

[0127] Regurgitation also occurs in patients with cardiomyopathy, in which the heart Figure 3 As shown in the figure, the increased size prevents the valve leaflets LF from properly contacting each other. The enlargement of the heart causes the mitral annulus to enlarge, making it impossible for the free edges FE to contact each other during systole. Figure 3A As shown in FIG, the free edges of the anterior and posterior leaflets normally touch along the line of coaptation C, but as shown in FIG. Figure 3B As shown in , a significant gap G may remain in patients with cardiomyopathy.

[0128] Mitral regurgitation may also occur in patients with ischemic heart disease, such as Figure 4 As shown in , the function of the papillary muscles PM is impaired. When the left ventricle LV contracts during systole, the papillary muscles PM cannot contract sufficiently to achieve correct closure. As a result, leaflets LF1 and LF2 prolapse as shown in the figure. As shown by the arrows, leakage from the left ventricle LV to the left atrium LA occurs again.

[0129] Figure 5A The anatomical structure of the mitral valve MV is more clearly illustrated, which is a bicuspid valve with an anterior side ANT and a posterior side POST. The valve includes an anterior (aortic) leaflet AL and a posterior (mural) leaflet PL. The chordae tendineae CT couple the valve leaflets AL, PL to the anterolateral papillary muscles ALPM and the posterior medial papillary muscles PMPM. The valve leaflets AL, PL are joined to each other along lines referred to as the anterolateral commissure ALC and the posterior medial commissure PMC. The ring AN surrounds the valve leaflets, and two areas adjacent to the front of the ring, located on opposite sides of the anterior leaflet, are called the left fibrous trigone LFT and the right fibrous trigone RFT. These areas are generally indicated by solid triangles. Figure 5BThe left fibrous trigone LFT and the right fibrous trigone RFT are more clearly illustrated.

[0130] Although various surgical techniques and implantable devices have been proposed and appear to be promising therapies for mitral regurgitation, surgical approaches may require a lengthy recovery period, and implantable devices have varying clinical outcomes. Therefore, there remains a need for improved devices, delivery systems, loading fixtures, and methods for treating mitral regurgitation. Although the embodiments disclosed herein are directed to implantable prosthetic mitral valves for treating mitral regurgitation, those skilled in the art will appreciate that this is not intended to be limited thereto, and that the devices and methods disclosed herein may also be used to treat other heart valves, such as the tricuspid valve, aortic valve, pulmonary valve, etc., as well as to treat other valves in the body, such as venous valves.

[0131] Prosthetic valve . Prosthetic valves have been surgically implanted in the heart as a treatment for mitral regurgitation. Some of these valves are valves taken from animals, such as porcine valves, while others are prosthetic mechanical valves with or without tissue coverings. Recently, minimally invasive catheter techniques have been used to deliver prosthetic valves to the heart. These valves typically include anchors for securing the valve to the patient's heart, and a valve mechanism - either a mechanical valve or a valve with animal tissue, or a combination thereof. Once implanted, the prosthetic valve replaces the malfunctioning native valve, thereby reducing or eliminating valvular insufficiency. Although some of these valves appear to be effective, there is still a need for improved valves. Positioning and anchoring prosthetic valves in natural anatomical structures remains a challenge. Disclosed below are exemplary embodiments of prosthetic valves, delivery systems for the prosthetic valves, and methods for delivering the valves that overcome some of the challenges associated with existing prosthetic valves.

[0132] Figure 6An exemplary embodiment of a prosthetic heart valve in a contracted configuration is illustrated. A covering (e.g., fabric or tissue) has been removed from the frame to allow viewing of the frame 600 below. The frame has been spread out and flattened. The prosthetic valve frame 600 has an atrial region 606, an annular region 608, and a ventricular region 610. The frame 600 is formed by a plurality of interconnected struts that form a series of peaks and valleys that can expand and contract relative to each other to allow the frame to be loaded onto a delivery catheter in a contracted configuration, and then radially expanded at the target treatment site for implantation. A preferred embodiment is self-expanding, and can be made of superelastic nitinol or other self-expanding materials. Shape memory alloys that pop open when above a transition temperature can also be used, and expandable members can also be used to expand the frame when plastic deformation (e.g., balloon expansion) is required to open the frame.

[0133] The atrial region 606 has a skirt 616, which includes a plurality of interconnected struts forming a series of peaks and valleys. In this region, the struts are skewed relative to each other, and therefore, the resulting unit pattern has an enlarged end, while the opposite end tapers to a smaller end. In a preferred embodiment, the front of the atrial skirt does not have a flanged area like the rear portion, so the front 602 of the atrial region can have a shorter strut than the rear region 604. Therefore, the peaks and valleys in the front are axially offset from the peaks and valleys in the remaining rear portions of the atrial region. This may be advantageous because it prevents the struts in the front of the atrial skirt from protruding upward and potentially colliding with the left atrium and causing perforations. In addition, the shortened struts and the offset peaks and valleys form an alignment element 614, which can assist the physician in visualizing the delivery of the prosthetic valve to the mitral valve and the alignment of the prosthetic valve before the expansion of the prosthetic valve. Optional radiopaque markers 614a are placed on either side of the offset peaks and valleys and further aid visualization during valve implantation. The atrial region is preferably self-expanding into a cylindrical shape, or it may have a D-shaped cross-section in which the front portion 602 is substantially flat and the rear portion 604 is cylindrical. This allows the atrial skirt to conform to the anatomical structure of the native mitral valve, thereby preventing obstruction of the left ventricular outflow tract. In addition, the atrial skirt may also be formed so that when expanded, the skirt flares outward and forms a flange that can abut against the upper surface of the mitral valve. The flanged area is preferably along the rear portion of the atrial skirt, and the front portion of the atrial skirt remains flangeless. Alternatively, the flange may extend around the entire atrial skirt. The atrial region is connected to the adjacent annular region 608 with connecting struts, which are preferably linear and substantially parallel to the longitudinal axis of the frame.

[0134] The annular region 608 also includes a plurality of axially oriented and interconnected struts that form peaks and valleys that allow radial expansion. The struts are preferably parallel to each other and to the longitudinal axis of the frame. The annular region may also be self-expanding and expand into a cylindrical shape, or more preferably, the annular region may expand to have a D-shaped cross-section as described above with respect to the atrial region. Thus, the annular region may similarly have a flat front and a cylindrical rear. When delivered, the annular region is aligned with the mitral annulus and expanded to engage with the mitral annulus. The connector struts engage the annular region with the ventricular region 610.

[0135] The ventricular region 610 also includes a plurality of interconnected struts forming peaks and valleys. In addition, the struts in the ventricular region form leaflet commissures 613, which are covered with fabric, pericardial tissue or other materials to form prosthetic valve leaflets. The holes in the commissures allow sutures to be attached thereto. The struts in the ventricular region also form a ventricular skirt 628 that expands outward to engage the anterior mitral valve leaflet and the posterior mitral valve leaflet, and the struts in the ventricular region also form anterior ears 624 and posterior ears 630. The anterior ears are designed to capture the anterior mitral valve leaflet between the inner surface of the anterior ears and the outer surface of the ventricular skirt. Any adjacent chordae tendineae may also be captured therebetween. In addition, the tips of the anterior ears engage the fibrous trigone located on the front of the mitral valve, one on the left and one on the right. The posterior tab similarly captures the posterior mitral valve leaflet, along with any adjacent chordae tendineae, between the inner surface of the posterior tab and the outer surface of the ventricular skirt. This will be described in more detail below.

[0136] By controlling the strut length or axial position of the front ear or rear ear along the framework, the deployment of the ear can be controlled. Therefore, in this exemplary embodiment, since the length of the struts in the front ear 624 and the rear ear 630 and their relative positions along the framework are identical to each other, when the constraint sheath is retracted from the ear, the front ear and the rear ear will partially pop outward together. Along with the constraint sheath being further retracted, the remainder of the front ear will radially expand outward. The further retraction of the constraint sheath then allows the remainder of the rear ear to complete its radial expansion, and finally the ventricular skirt will expand radially outward. Although the strut length and axial position of the rear ear and the ventricular skirt are similar, the internal struts connect the ventricular skirt to the commissure, and this slightly delays the expansion of the ventricular skirt, so that the rear ear completes expansion before the ventricular skirt. Using such a prosthetic valve deployment sequence can allow more accurate delivery of the valve, and also allow more firmly to anchor the valve in place.

[0137] Suture holes 621 are arranged along the pillars of the annular area and the ventricular area to allow the attachment of coverings such as pericardium or polymers (such as polyester or ePTFE). Suture holes can also be arranged along any other part of the framework. Barbs 623 are arranged along the ventricular skirt 628 to help anchor the prosthetic valve to adjacent tissues. Commissure tabs or tabs 612 are arranged on the tip of the commissure 613 and can be used to releasably couple the commissure with the delivery system as described below. This allows the framework to expand first, and then the commissure can be released from the delivery system later. It will be understood by those skilled in the art that a variety of pillar geometries can be used, and pillar sizes such as length, width, thickness can be adjusted in addition to provide desired mechanical properties for the anchor, such as stiffness, radial compressive strength, commissure flexure, etc. Therefore, the illustrated geometry is not intended to be restrictive.

[0138] The frame can be formed by EDM, laser cutting, photochemical etching or other techniques known in the art. The frame can be formed using a hypodermic tube or a flat plate. Once the frame has been cut and formed into a cylinder, it can be radially expanded into the desired geometry and heat treated using known processes to solidify the shape. Thus, the prosthetic valve can be loaded onto the delivery catheter in a contracted configuration and constrained to the contracted configuration using a restraining sheath. Removal of the restraining sheath will allow the anchor to self-expand into its unbiased preset shape. In other embodiments, an expandable member such as a balloon can be used to radially expand the anchor into its preferred expanded configuration.

[0139] Figure 7 Another exemplary embodiment of a prosthetic heart valve in a contracted configuration is illustrated, and the prosthetic heart valve is similar to the previous embodiment, the main difference being the length of the struts in the front ear, rear ear, and ventricular skirt. The expansion sequence of the front ear and rear ear and ventricular skirt is controlled by changing the strut length. A covering (e.g., fabric or tissue) has been removed from the frame to allow viewing of the frame 700 below. The frame has been spread out and flattened. The prosthetic valve frame 700 has an atrial region 706, an annular region 708, and a ventricular region 710. The frame 700 is formed by a plurality of interconnected struts that form a series of peaks and valleys that can expand and contract relative to each other to allow the frame to be loaded onto a delivery catheter in a contracted configuration, and then radially expanded at the target treatment site for implantation. The preferred embodiment is self-expanding and can be made of superelastic nitinol or other self-expanding materials. Shape memory alloys that spring open above a transition temperature may also be used, and expandable members may also be used to expand the frame when plastic deformation (eg, balloon expansion) is required to open the frame.

[0140] The atrial region 706 has a skirt 716 that includes a plurality of interconnected struts that form a series of peaks and valleys. In this region, the struts are skewed relative to each other and, therefore, the resulting cell pattern has one enlarged end and the opposite end tapers to a smaller end. The anterior portion 702 of the atrial region has shorter struts than the posterior region 704. Thus, the peaks and valleys in the anterior portion are axially offset from the peaks and valleys in the remaining posterior portion of the atrial region. This allows for the creation of an alignment element 714 to assist the physician in delivering the prosthetic valve to the mitral valve and aligning the prosthetic valve prior to expansion of the prosthetic valve. Other aspects of the atrial region 706 are similar to Figure 6 706 in the atrial region. Optional radiopaque markers 714a are placed on either side of the offset peaks and valleys and aid in visualization during valve implantation. The atrial region is preferably self-expanding into a cylindrical shape, or it may have a D-shaped cross-section in which the front portion 702 is substantially flat and the rear portion 704 is cylindrical. This allows the atrial skirt to conform to the anatomical structure of the native mitral valve, thereby preventing obstruction of the left ventricular outflow tract. In addition, the atrial skirt may also be formed so that when expanded, the skirt flares outward and forms a flange that can abut against the upper surface of the mitral valve. The flanged area is preferably along the rear portion of the atrial skirt, and the front portion of the atrial skirt remains flangeless. Alternatively, the flange may extend around the entire atrial skirt. The atrial region is connected to the adjacent annular region 708 with connecting struts, which are preferably linear and substantially parallel to the longitudinal axis of the frame.

[0141] The annular region 708 also includes a plurality of axially oriented and interconnected struts that form peaks and valleys that allow radial expansion. The struts are preferably parallel to each other and to the longitudinal axis of the frame. The annular region may also be self-expanding and expand into a cylindrical shape, or more preferably, the annular region may expand to have a D-shaped cross-section as described above with respect to the atrial region. Thus, the annular region may similarly have a flat front and a cylindrical rear. When delivered, the annular region is aligned with the mitral annulus and expanded to engage with the mitral annulus. The connector struts engage the annular region with the ventricular region 710.

[0142] The ventricular region 710 also includes a plurality of interconnected struts forming peaks and valleys. In addition, the struts in the ventricular region form leaflet commissures 713, which are covered with fabric, pericardial tissue or other materials to form prosthetic valve leaflets. The holes in the commissures allow sutures to be attached thereto. The struts in the ventricular region also form a ventricular skirt 728 that expands outward to engage the anterior mitral valve leaflet and the posterior mitral valve leaflet, and the struts in the ventricular region also form anterior ears 724 and posterior ears 730. The anterior ears are designed to capture the anterior mitral valve leaflet between the inner surface of the anterior ears and the outer surface of the ventricular skirt. Any adjacent chordae tendineae may also be captured therebetween. In addition, the tips of the anterior ears engage the fibrous trigone located on the anterior portion of the mitral valve, one on the left and one on the right. The posterior tab similarly captures the posterior mitral valve leaflet, along with any adjacent chordae tendineae, between the inner surface of the posterior tab and the outer surface of the ventricular skirt. This will be described in more detail below.

[0143] By controlling the strut length or axial position of the front ear or rear ear along the framework, the deployment of the ear can be controlled. Therefore, in this exemplary embodiment, due to the length of the struts in the front ear 724 and the rear ear 730 and their relative positions along the framework are identical to each other, when the constraint sheath is retracted from the ear, the front ear and the rear ear will partially pop outward together. Along with the constraint sheath being further retracted, the remainder of the front ear will radially expand outwards, because they are the shortest with respect to the struts in the ventricular skirt and the rear ear. The further retraction of the constraint sheath then allows the ventricular skirt to expand radially, and the further retraction of the final sheath allows the remainder of the rear ear to complete its radial expansion. Using such a prosthetic valve deployment sequence can allow the valve to be delivered more accurately, and also allows the valve to be more firmly anchored in place.

[0144] Suture holes 721 are placed along the struts of the annular region and the ventricular region to allow attachment of coverings such as pericardium or polymers (such as polyester or ePTFE). Suture holes may also be placed along any other portion of the frame. Barbs 723 are placed along the ventricular skirt 728 to help anchor the prosthetic valve to adjacent tissue. Commissure tabs or tabs 712 are placed on the tip of the commissure 713 and can be used to releasably couple the commissure to a delivery system as described below. This allows the frame to expand first and then the commissure can be released from the delivery system later. Those skilled in the art will appreciate that a variety of strut geometries can be used and that strut dimensions such as length, width, thickness, etc. can also be adjusted to provide the anchor with desired mechanical properties such as stiffness, radial compressive strength, commissure deflection, etc. Therefore, the illustrated geometry is not intended to be limiting. It can be similar to the above description of Figure 6 The frame is formed as described.

[0145] Figure 8 Another exemplary embodiment of a prosthetic heart valve in a collapsed configuration is illustrated, and the prosthetic heart valve is similar to the previous embodiment, with the main difference that the rear ear is designed to expand to form an elongated horizontal section that allows the rear ear to engage and anchor with the subannular region located between the rear leaflet and the ventricular wall. Therefore, the elongated horizontal section contacts a larger area of ​​the subannular region than the rear ear having only a tapered tip formed by a single hinge between the struts. This provides enhanced anchoring of the prosthetic valve. In this exemplary embodiment, the front ear will first fully self-expand, followed by the rear ear, followed by the ventricular skirt. However, in some cases, external factors such as the delivery system, anatomical structure, etc. may change the order of expansion, so such an order is not intended to be limiting. The covering (e.g., fabric or tissue) has been removed from the frame to allow viewing of the underlying frame 800. The frame has been spread out and flattened. The prosthetic valve frame 800 has an atrial region 806, an annular region 808, and a ventricular region 810. The frame 800 is formed of a plurality of interconnected struts that form a series of peaks and valleys that can expand and contract relative to one another to allow the frame to be loaded onto a delivery catheter in a contracted configuration and then radially expanded at the target treatment site for implantation. The preferred embodiment is self-expanding and can be made using superelastic Nitinol or other self-expanding materials. Shape memory alloys that spring open above a transition temperature can also be used, and expandable members can also be used to expand the frame when plastic deformation (e.g., balloon expansion) is required to open the frame.

[0146] The atrial region 806 has a skirt 816 that includes a plurality of interconnected struts that form a series of peaks and valleys. In this region, the struts are skewed relative to each other and, therefore, the resulting cell pattern has one enlarged end and the opposite end tapers to a smaller end. The anterior portion 802 of the atrial region has shorter struts than the posterior region 804. Thus, the peaks and valleys in the anterior portion are axially offset from the peaks and valleys in the remaining posterior portion of the atrial region. This allows for the creation of an alignment element 814 to assist the physician in delivering the prosthetic valve to the mitral valve and aligning the prosthetic valve prior to expansion of the prosthetic valve. Other aspects of the atrial region 806 are similar to Figure 6606 in the atrial region. Optional radiopaque markers 814a are placed on either side of the offset peaks and valleys and assist in visualization during valve implantation. The atrial region is preferably self-expanding into a cylindrical shape, or it may have a D-shaped cross-section, wherein the front portion 802 is substantially flat and the rear portion 804 is cylindrical. This allows the atrial skirt to conform to the anatomical structure of the native mitral valve, thereby preventing obstruction of the left ventricular outflow tract. In addition, the atrial skirt may also be formed so that when expanded, the skirt flares outward and forms a flange that can abut against the upper surface of the mitral valve. The flanged area is preferably along the rear portion of the atrial skirt, and the front portion of the atrial skirt remains flangeless. Alternatively, the flange may extend around the entire atrial skirt. The atrial region is connected to the adjacent annular region 808 with connecting struts, which are preferably linear and substantially parallel to the longitudinal axis of the frame.

[0147] The annular region 808 also includes a plurality of axially oriented and interconnected struts that form peaks and valleys that allow radial expansion. The struts are preferably parallel to each other and to the longitudinal axis of the frame. The annular region may also be self-expanding and expand into a cylindrical shape, or more preferably, the annular region may expand to have a D-shaped cross-section as described above with respect to the atrial region. Thus, the annular region may similarly have a flat front and a cylindrical rear. When delivered, the annular region is aligned with the mitral annulus and expanded to engage with the mitral annulus. The connector struts engage the annular region with the ventricular region 810.

[0148] The ventricular region 810 also includes a plurality of interconnected struts forming peaks and valleys. In addition, the struts in the ventricular region form leaflet commissures 813, which are covered with fabric, pericardial tissue or other materials to form prosthetic valve leaflets. The holes in the commissures allow sutures to be attached thereto. The struts in the ventricular region also form a ventricular skirt 828 that expands outward to engage the anterior mitral valve leaflet and the posterior mitral valve leaflet, and the struts in the ventricular region also form anterior ears 824 and posterior ears 830. The anterior ears are designed to capture the anterior mitral valve leaflet between the inner surface of the anterior ears and the outer surface of the ventricular skirt. Any adjacent chordae tendineae may also be captured therebetween. In addition, the tips of the anterior ears engage the fibrous trigone located on the anterior portion of the mitral valve, one of the fibrous trigone being located on the left side and one being located on the right side. The posterior tab similarly captures the posterior mitral valve leaflet, along with any adjacent chordae tendineae, between the inner surface of the posterior tab and the outer surface of the ventricular skirt. This will be described in more detail below. Figure 6-Figure 7The posterior ear of the present invention is similar to that of the present invention, except that in this embodiment, the posterior ear includes four interconnecting struts instead of two interconnecting struts. Therefore, in this embodiment, the plurality of interconnecting struts form three hinge areas 836 along the ear. When the posterior ear expands, the hinge area will also expand, thereby forming an elongated horizontal segment that allows the posterior ear to engage and anchor the subannular area between the posterior leaflet and the ventricular wall. This can better help position and anchor the prosthetic valve for engagement with the posterior portion of the mitral valve than a posterior ear with only a smaller footprint or a single tapered tip. The posterior leaflet in this embodiment may be replaced by any other posterior ear described in this specification.

[0149] By controlling the strut length or axial position of the front ear or rear ear along the frame, the deployment of the ear can be controlled. Therefore, in this exemplary embodiment, since the length of the struts in the front ear 824 and the rear ear 830 and their relative positions along the frame are identical to each other, when the constraint sheath is retracted from the ear, the front ear and the rear ear will partially pop outward together. As the constraint sheath is further retracted, the remainder of the front ear will self-expand radially outward, because they are the shortest relative to the struts in the ventricular skirt and the rear ear. The further retraction of the constraint sheath then allows the remainder of the rear ear to complete self-expansion, followed by the self-expansion of the ventricular skirt. Using such a prosthetic valve deployment sequence can allow the valve to be delivered more accurately, and also allows the valve to be more firmly anchored in place.

[0150] Suture holes 821 are arranged along the pillars of the annular area and the ventricular area to allow the attachment of coverings such as pericardium or polymers (such as polyester or ePTFE). Suture holes can also be arranged along any other part of the frame. Barbs 823 are arranged along the ventricular skirt 828 to help anchor the prosthetic valve to adjacent tissues. Commissure tabs or tabs 812 are arranged on the tip of the commissure 813 and can be used to releasably couple the commissure with the delivery system as described below. This allows the framework to expand first, and then the commissure can be released from the delivery system later. Those skilled in the art will understand that a variety of pillar geometries can be used, and in addition, pillar sizes such as length, width, thickness can be adjusted to provide desired mechanical properties for the anchor, such as stiffness, radial compressive strength, commissure flexure, etc. Therefore, the illustrated geometry is not intended to be restrictive. The framework can be formed similarly to the above as described above with respect to the framework previously described above.

[0151] Fig. 9AThe frame 900 of the prosthetic heart valve is shown after it has been expanded. Since each of the above-described frames has a similar geometric structure, any of the above-described frame embodiments can take this form, but they are expanded in different sequences. The frame includes an atrial skirt 906 having a front portion 914 and a rear portion 916. A flanged area is formed around the rear portion, while the front portion remains flangeless. In addition, the front portion is generally flat, while the rear portion is cylindrical, thereby forming a D-shaped cross-section that accommodates the anatomical structure of the mitral valve. Fig. 9B for Fig. 9A 0 is a top view of an embodiment in the embodiment, and more clearly illustrates the D-shaped cross-section.

[0152] The frame also includes an annular region 910 and a ventricular skirt 912. The anterior tabs 904 (only one is visible in this view) are fully expanded so that there is a space between the inner surface of the anterior tab and the outer surface of the ventricular skirt. This allows the anterior leaflet and adjacent chordae to be captured therebetween. Similarly, the posterior tab 902 is also fully expanded and has a similar space between the inner surface of the posterior tab 902 and the outer surface of the ventricular skirt. This allows the posterior leaflet and adjacent chordae to be captured therebetween. Commissure rods 908 can also be seen and are disposed in the inner channel formed by the frame. The commissure rods are used to form prosthetic mitral valve leaflets. The overall shape of the expanded frame is D-shaped, with the front portion being flat and the rear portion being cylindrical.

[0153] Fig.10 The expanded frame is illustrated as being covered by a covering 1002 such as pericardial tissue or a polymer such as ePTFE or a fabric such as Dacron attached to the frame, thereby forming a prosthetic heart valve 1000. The atrial skirt can be completely covered by the material, or in a preferred embodiment, the covering is only placed between adjacent struts 1012 in adjacent cells in the flanged portion of the atrial skirt. The area 1014 between adjacent struts in the same cell remains uncovered. This allows the blood flow to remain substantially unimpeded while the prosthetic valve is implanted. Sutures 1010 can be used to attach the covering to the frame. In this view, only the rear ear 1006 on the rear of the prosthetic valve is visible along with the ventricular skirt 1008 and the atrial skirt 1004.

[0154] Delivery System . Figures 11A-11D An exemplary embodiment of a delivery system that can be used to deliver any of the prosthetic heart valves disclosed in this specification is illustrated. Although the delivery system is designed for preferably transapical delivery of a prosthetic heart valve, those skilled in the art will appreciate that modifications may also be made to allow intracavitary delivery of the prosthetic valve via a catheter, such as using a transseptal approach. Those skilled in the art will appreciate that using a transseptal approach may require modification of the relative motion of the various axes to accommodate the position of the delivery system relative to the mitral valve.

[0155] Fig.11A A perspective view of a delivery system 1100 is illustrated. The delivery system 1100 includes a handle 1112 near the proximal end of the delivery system and a distal tissue penetration tip 1110. Four elongated shafts are included in the delivery system, and these elongated shafts include: an outer sheath catheter shaft 1102; a bell-shaped catheter shaft 1104, which is slidably arranged in the outer sheath catheter shaft 1102; a sleeve catheter shaft 1106, which remains stationary relative to other axes, but the bell-shaped catheter shaft slides relative to the sleeve shaft; and an inner guidewire catheter shaft 1108, which is also fixed relative to other axes and has a lumen whose size is set for receiving a guidewire passing therethrough and passing through the distal tissue penetration tip. As will be explained in more detail below, an actuator mechanism 1114 is used to control the movement of each shaft, and flushing lines 1116, 1118 with a Luer connector are used to flush the annular area between adjacent shafts. The flush line 1118 is used to flush the annular space between the outer sheath catheter shaft 1102 and the bell catheter shaft 1104. The flush line 1116 is used to flush the annular space between the bell catheter 1104 and the hub catheter 1106. The inner guidewire catheter shaft 1108 is stationary relative to the hub catheter 1106, so an O-ring or other material can be used to seal the annular space. The Luer connector 1122 allows flushing of the guidewire lumen, and a hemostatic valve such as Tuohy-Borst can be coupled to the Luer connector to allow advancement of the guidewire through the guidewire catheter shaft while maintaining hemostasis. The screw 1120 keeps the handle housing coupled together.

[0156] Fig. 11B A side view of the delivery system 1100 is illustrated.

[0157] Fig. 11C1100 is a partial exploded view of the delivery system 1100, and more clearly illustrates the components in the handle 1112 and how they interact. The handle 1112 includes a housing with two halves 1112a, 1112b, and the two halves 1112a, 1112b accommodate all the components. The handle is preferably held together by a screw 1120 and a nut 1120b, but it can also be sealed using other techniques such as press fit, snap fit, bonding, ultrasonic welding, etc. The rotation of the actuator wheel 1114 is converted into a linear motion of the threaded insert 1124. The outer sheath catheter shaft 1102 is coupled to the threaded insert 1124, so that the rotation of the actuator wheel 1114 in one direction will advance the sheath catheter shaft 1102, and the rotation in the opposite direction will retract the sheath catheter shaft 1102. Further rotation of the actuator wheel 1114 retracts the threaded insert 1124 enough to encounter a pin 1126 coupled to the insert 1128, thereby also moving the insert 1128. The bell catheter shaft 1106 is coupled to the insert 1128, so further rotation of the actuator wheel 1114 will move the outer shaft 1102 and also move the bell catheter shaft 1106. Rotation of the actuator wheel in the opposite direction advances the sheath and the threaded insert 1124 disengages from the pin 1126. The spring 1130 returns the insert 1128 to its undeflected position, thereby returning the bell catheter shaft to its undeflected position.

[0158] Any prosthetic heart valve disclosed herein can be carried by the delivery system 1100. The atrial skirt, annular skirt, front ear, rear ear, and ventricular skirt are loaded on a bell-shaped catheter shaft and are placed under the outer sheath catheter shaft 1102. The ventricular skirt is loaded at the proximal end so that it is closest to the handle 1112, and the atrial skirt is loaded at the distal end so that it is closest to the tip 1110. Therefore, the retraction of the outer sheath catheter shaft 1102 plays an important role in controlling the deployment of the prosthetic heart valve. The atrial skirt is therefore expanded first when the outer sheath catheter is retracted. The prosthetic valve commissure can be coupled to the sleeve 1106a on the distal portion of the sleeve catheter 1106, and then the bell-shaped catheter shaft is placed thereon, so that the commissure is releasably engaged with the delivery catheter. Once the other parts of the prosthetic heart valve have expanded, the commissure can be released.

[0159] Fig.11DThe distal portion of the delivery system 1100 is highlighted. The outer sheath catheter shaft 1102 is advanced and retracted relative to the bell-shaped catheter shaft 1104 slidably disposed in the outer sheath catheter shaft 1102. The figure shows that the sleeve catheter shaft 1106 is slidably disposed in the bell-shaped catheter shaft 1104 and the bell-shaped catheter shaft 1104 is retracted to expose the sleeve 1106a with the groove 1106b that accommodates the prosthetic valve commissure. The inner guidewire catheter shaft 1108 is the innermost shaft and has a tapered tapered section 1130 that provides a smooth transition for the prosthetic valve and prevents undesirable bending or buckling of the prosthetic heart valve frame. The tissue penetration tip 1110 is suitable for penetrating tissue, particularly in transapical heart surgery.

[0160] Loading fixture The prosthetic valve can be manually loaded onto the delivery system by the physician, but this can be challenging because the valve must be properly oriented relative to the delivery system and then the commissure rods must be engaged with and captured in slots or receptacles on the delivery system. This can require multiple operators to manipulate the prosthesis and delivery system and its actuator mechanism simultaneously. Therefore, it would be advantageous to provide a fixture to facilitate loading of the prosthetic valve onto the delivery system. Figure 14-18B An exemplary embodiment of a loading fixture (also referred to herein as a loading device) is illustrated, which can be used to couple a prosthesis such as a prosthetic valve to a delivery system. The prosthesis can be any prosthesis including the prosthetic valves described in the present disclosure. Similarly, the delivery system can be any delivery system including the delivery systems described herein.

[0161] Fig.14 A loading device 1401 is illustrated having a body 1438 comprising three interlocking stages or housings, including a first housing 1405 (also referred to herein as stage A or A housing), a second housing 1407 (also referred to herein as stage B or B housing), and a third housing 1409 (also referred to herein as stage C or C housing). The loading device 1401 allows a prosthesis, such as a prosthetic valve, to be inserted into one end of the loading device and as the prosthesis passes therethrough, its overall diameter is reduced and when the loading device is actuated, selected areas of the prosthesis are further compressed radially inwardly. This allows the prosthesis to be engaged with a delivery system prior to delivery.

[0162] The internal passage 1439 begins in the first housing 1405 at an inlet opening 1402 and terminates in the third housing 1409 at an outlet opening 1403. Three manually operated spring-loaded actuators 1404 are located in the third housing 1409 and are used to depress certain portions of a prosthesis, such as a prosthetic heart valve, in order to load the valve onto a delivery system, details of which are described in more detail below.

[0163] like Fig.15 As can be seen in the figure, stage A 1405 includes an adapter ring 1406 providing a plurality of cantilevered tabs 1415 for mating with locking windows 1416 of subsequent stages by means of snap fits 1417. Each adapter ring 1406 is fastened to a respective stage with threaded fasteners 1414. By depressing the cantilevered tabs 1415, the snap fits 1417 are released from the locking windows 1416 and the respective stages (1405, 1407 or 1409) can be separated so that each stage of the device can be manipulated individually.

[0164] Fig.16 Shows Fig.15 14. A cross-sectional view of loading system 1401 is shown in FIG. 14. To begin compression of the prosthetic heart valve, stage A 1405 first has an internal tapered segment 1426 coupled to a constant diameter flat segment 1428 via a rounded transition zone 1439. Passing through stage A 1405 has the effect of reducing the prosthetic heart valve diameter from a first, larger input value to a second, smaller output value, and also helps to shape the frame or stent portion of the valve to have a circular cross-section. Stage B 1407 first has an internal tapered segment 1427 coupled to a constant diameter flat segment 1429 via a rounded transition zone 1440. Passing through stage B 1407 has the effect of again reducing the prosthetic heart valve diameter from a first, larger input value (the output diameter of stage A 1405) to a second, smaller final output value.

[0165] exist Fig.151409. The internal mechanical components of the loading system 1401 are shown in cross-section. When the valve is pushed from the B stage 1407 to the C stage 1409, it maintains the output diameter set in the B stage 1407. In order to flex certain parts of the heart valve, such as the commissures, anchors or other necessary positioning features, the spring-loaded actuator 1404 must be depressed, and its action transmits a linear displacement to the positioning features of the prosthetic valve. The spring-loaded actuator 1404 can be arranged in a variable and different circumferential configuration, for example, three such actuators 1404 can be 120° equidistant to flex three separate positioning features of the heart valve prosthesis. Since the design can be modified to include any reasonable number and position of such actuators to operate on a specific part of the stent, this design is not limited to three such actuators, or to any specific positioning scheme. By traveling through the constant diameter channel 1430 in the C stage 1409, the prosthetic heart valve can be brought into contact with the tip 1420 of the spring-loaded actuator 1404. The spring-loaded actuator 1404 includes a push button 1419, a shaft 1418 on which a spring 1411 is accommodated, a shoulder 1421 that abuts against the spring 1411 to provide a rebound force, a cylindrical socket 1441 in which there is space for the spring 1411 to be compressed, and a bearing surface 1442 that allows the shaft 1418 to freely switch between an uncompressed state and a compressed state, and a tip 1420 that protrudes from the hole 1412 and contacts the heart valve to allow compression.

[0166] like Fig.16 As seen in FIG. 14 , the cover plate 1410 is fastened to the C-stage 1409 by threaded fasteners 1413. The cover plate 1410 works together with the C-stage 1409 to accommodate the spring 1411 and the spring-loaded actuator 1404.

[0167] Fig.17 The manner in which the A-stage 1405, B-stage 1407, and C-stage 1409 are combined is illustrated, and the locations of the relevant attachment mechanisms as previously discussed are detailed.

[0168] like Fig.18A , an end view of the C-stage 1409 has an exit hole 1403. Also illustrated is an uncompressed diameter circle 1422, which represents the initial major diameter at which the tip 1420 of the spring loaded actuator 1404 is normally located. Fig.18B It is then shown that when actuated, the tip 1420 of the spring loaded actuator 1404 transforms into and conforms to a smaller, compressed diameter circle 1423. This is the mechanism by which selective prosthetic valve flexure is achieved to mate portions of the prosthetic valve with the delivery system.

[0169] Those skilled in the art will appreciate that the loading device is not limited to three separate housings. Alternative embodiments of the device may include a single housing that includes some or all of the features of the three separate housings. Figure 27-Figure 33 , and described below. An exemplary embodiment of a single shell loading device is described in more detail below. Other alternative implementations may include one of the A shell or the B shell and the C shell, and this configuration may be as two coupleable shells or a single integrated shell. In other embodiments, the entire diameter reduction may be accomplished with a single tapered channel in a single shell, and the selective flexure may be in the same shell or in a separate shell. Those skilled in the art will appreciate that any combination or arrangement of the three shells and their corresponding features may be used in the loading device to load the prosthesis onto the delivery system.

[0170] Figure 19-26B An exemplary method of using the loading device described above to load a prosthetic valve, such as described herein, onto a delivery system, such as described herein, is illustrated. Fig.19 The diagram illustrates the initial interaction between the A-stage 1405 and the universal prosthetic heart valve 1424. In this example, the universal prosthetic heart valve 1424 includes three anchoring tabs 1425 that are required for positioning and attaching the valve model to the delivery system. These three anchoring tabs 1425 can be equivalent to the commissure rods or struts previously described above with respect to the disclosed prosthetic mitral valve. When the universal prosthetic heart valve 1424 is manually pushed through the A-stage 1405, the valve slides down the inner tapered segment 1426, slides through the rounded transition zone 1439, and slides into the constant diameter flat segment 1428. In order to safely reduce the diameter of a heart valve prosthesis that is at least partially made of an alloy such as Nitinol, it is first necessary to cool the prosthesis in cold saline so that the device is below a temperature known as the austenite finish temperature, which is specific to each alloy and depends on the manufacturing process. This is the temperature at which the crystal structure of the Nitinol becomes aligned in a manner that allows plastic deformation with little risk of permanent damage from strain. When the universal prosthetic heart valve 1424 is positioned in the flat segment 1428 and manually adjusted to achieve a round shape, stage A 1405 is ready to be attached to stage B 1407, and this step of the process is described in detail below.

[0171] like Fig. 20, stage A 1405 is snapped onto stage B 1407 by pressing cantilevered tabs 1415 on stage A 1405 terminating in snap fits 1417 into corresponding locking windows 1416 located on stage B 1407. After stage A 1405 is snapped onto stage B 1407, the universal prosthetic heart valve 1424 can be advanced across the commissure and into the inner tapered segment 1427, through the rounded transition zone 1440, and finally into the flat segment 1429 of constant and final diameter. If Fig.21 This step of the process can be more easily understood as it becomes necessary to disassemble stage A 1405 from stage B 1407 when the universal prosthetic heart valve 1424 assumes its final position in stage B 1407 .

[0172] like Fig. 22 , the B-stage 1407 is snapped onto the C-stage 1409 by pressing the cantilevered tabs 1415 on the B-stage 1407 that terminate in snap-fits 1417 that enter into corresponding locking windows 1416 located on the C-stage 1409. After snapping the B-stage 1407 onto the C-stage 1409, the universal prosthetic heart valve 1424 can be advanced across the commissures and into the constant and final diameter flat segment 1430. The diameter of the flat segment 1430 is designed to optimally compress the valve 1424 to a minimum diameter that still allows passage of a corresponding delivery system or components thereof, and still allows access to the relevant stent features required for valve loading and anchoring to the delivery system.

[0173] exist Fig.23 1409. The final compressed position of the universal prosthetic heart valve 1424 can be seen in FIG. Before accurate flexing of the anchoring tabs 1425 can be performed, it may first be necessary to rotate the valve 1424 within the constant diameter flat segment 1430 in order to align all of the anchoring tabs 1425 with the tips 1420 of the corresponding spring-loaded actuators 1404. Fig.23 This is illustrated in . After alignment of the anchoring tab 1425 is performed, accurate operation of the spring loaded actuator 1404 becomes possible.

[0174] like Fig.24 As can be seen, the universal delivery system 1432 can be introduced into the exit hole 1403 of the C-stage 1409, and the fixed socket (also referred to as a container or groove in this article) 1434 located in the anchoring sleeve 1433 can be aligned with the anchoring ear 1425 of the universal prosthetic heart valve 1424.

[0175] Fig.25The diagram illustrates a mechanism by which the tip 1420 of a spring-loaded actuator 1404 is pressed into an anchoring tab 1425 of a universal prosthetic heart valve 1424 so as to flex it by bending and force the anchoring tab 1425 into a corresponding fixed socket 1434 located in an anchoring sleeve 1433 of a universal delivery system 1432.

[0176] Fig.26A An end view of stage C 1409 is shown with a prosthetic heart valve 1444 such as previously described above compressed and in place prior to final flexion. Relevant features of the prosthetic heart valve 1444 include a ventricular skirt 1435, triangular tabs 1436, and commissure anchors (also known as commissure posts or struts) 1437, details of which may be found elsewhere in this specification.

[0177] Fig.26B An end view of the C-stage 1409 is shown with the prosthetic heart valve 1444 compressed and in place after final deflection. Note that relevant features such as the ventricular skirt 1435 and the triangular lugs 1436 are not displaced by any portion of the spring-loaded actuator 1404, and only the commissure anchors 1437 are displaced to the final reduced diameter and are available for corresponding features on the corresponding delivery system, details of which are disclosed elsewhere in this specification. Once the commissure anchors 1437 have been radially deflected inwardly and positioned in the corresponding container on the delivery catheter, an outer shaft or sheath can be slidably placed thereon to capture the commissure anchors. Another outer shaft or sheath can then be slidably placed on the rest of the prosthetic valve to capture the valve and keep it in place during delivery. The release of the prosthetic valve is described below.

[0178] Figure 27-29B Another exemplary embodiment of a loading system is illustrated. While this embodiment is similar to the previously described embodiments, it has the advantage of providing support to both the inner and outer surfaces of the prosthesis during the loading process, and the actuators are also actuated simultaneously.

[0179] like Fig. 27 As seen in FIG, a variation of a valve loading system is illustrated in detail. An inner cone 2701 provides support for the inner surface of the valve or prosthesis to be loaded. Important features of the inner cone 2701 include a tapered ramp 2702 and a twistable locking mechanism 2703, such as a latch bolt. The tapered ramp 2702 helps seat the valve to be loaded, while the twistable locking mechanism 2703 allows the inner cone 2701 to be securely fixed to the outer cone 2704 through a twisting motion that will be further described below.

[0180] Three locking hooks 2705 on the circumference of the outer cone 2704 allow the base of the outer cone 2704 to engage the locking mechanism 2703 of the inner cone 2701. The threaded segment 2706 of the outer cone 2704 begins at the initial end 2709 and terminates at the final end 2710, and is threaded in a manner that allows it to engage with a displacement nut 2708 having matching internal threads. When the displacement nut 2708 is screwed forward from the initial end 2709 to the final end 2710, the leading edge of the displacement nut 2708 forces the fin or other finger-like member 2707 to be pushed down due to the inclined surface of the rib 2713 containing the fin 2707 and the sliding movement of the displacement nut 2708 when riding on the fin 2707. Multiple fins 2707 can be circumferentially spaced around the outer cone 2708 at the final end 2710 to act on the desired mechanism. This embodiment preferably has three fins spaced approximately 120 degrees apart.

[0181] like Fig.28A and Fig.28B As seen in , the end view of the device provides further detail of the inherent mechanical relationship between the relevant components. Fig.28B 27. As can be seen in FIG. 27, the liner 2714 is placed in the unflexed position 2711. When the displacement nut 2708 rides on the threaded segment 2706, the position of the liner 2714 moves radially inward to the flexed position 2712, as shown in FIG. Fig.29A A plurality of pads 2714 may be spaced circumferentially around the outer cone 2708 at the final end 2710 to function with an equal plurality of fins 2707 for the desired mechanism.

[0182] Figure 30-Figure 33 Another exemplary embodiment of a loading fixture is illustrated. Fig.30 is a perspective view of the loading system. The finger 2707a is thicker than the previous embodiment and also has a cam profile rather than a ramp profile. In addition, the displacement nut 2708a is thinner than the previous embodiment. These features help the operator to smoothly actuate the displacement nut and radially retract a portion of the prosthesis for loading onto the delivery system. In addition, this embodiment includes a "D" shaped flange 3001 on the entrance side of the cone (this feature is also Fig.33 ), which can be used for valve alignment purposes. Other alignment features will be Figure 31-Figure 32 The operator will therefore know that the flat portion of the "D" shaped flange is also the flat portion of the "D" shaped prosthesis.

[0183] Fig.3131 is an isometric view of the loading cone with the displacement nut removed, showing optional features that may be used in any loading fixture embodiment. The vertical grooves 3102 present on the tapered portion of the loading cone serve as markers for the sutures (not shown) on the prosthetic valve to be aligned. This allows the valve to be accurately positioned during the loading process. The horizontal grooves 3103 present on the tapered transition portion of the loading cone serve as markers that can be secured against the atrial skirt area of ​​the stent to accurately position the valve prior to commissure capture. The loading cone can be formed from an optically clear polymer such as polycarbonate that allows the user to see the valve features / markers throughout the loading process.

[0184] Fig.32 is an isometric view of the loading cone. Optional dimensioning 3004 has been printed on the tapered section of the cone adjacent to the D-shaped flange 3001. The markings allow the user to easily identify and select the appropriate loading fixture.

[0185] Fig.33 3001. is an end view of the loading cone. The D-shaped flange 3001 can be clearly seen in this view. When loading the valve into the loading cone, the operator can orient the flat side of the valve with the flat portion of the D-shaped flange before insertion.

[0186] Figure 30-Figure 33 The embodiment of provides a single stage for collapsing the prosthetic valve and is therefore easier than a multi-stage loading fixture. As previously discussed above, the prosthetic valve can be cooled in cold saline during the loading process. Since this embodiment is smaller and has fewer parts than other embodiments, it is lighter and easier to use, and also reduces manufacturing costs. It can be actuated with a single hand, while other embodiments may require more than one hand.

[0187] Delivery Method A variety of methods may be used to deliver a prosthetic heart valve to the heart. Exemplary methods of delivering a prosthetic mitral valve may include an intracavitary delivery route, which may also be a transseptal technique through the septum between the right and left sides of the heart, or in a more preferred embodiment, may be delivered using a catheter such as Figure 12A-12L Any of the embodiments of the prosthetic valves described herein may be delivered using the delivery devices previously described herein, or other delivery devices and other prosthetic valves may also be used, such as the delivery devices and prosthetic valves disclosed in U.S. Patent Application No. 13 / 096,572, previously incorporated herein by reference. However, in this preferred exemplary embodiment, a transapical approach is used. Figure 6 The prosthetic heart valve is configured such that the anterior tab is deployed first, followed by the posterior tab, and then the ventricular skirt.

[0188] Fig. 12AThe basic anatomy of the left side of a patient's heart including the left atrium LA and the left ventricle LV is illustrated. The pulmonary veins PV return blood from the lungs to the left atrium, from which blood is then pumped across the mitral valve MV into the left ventricle. The mitral valve includes an anterior leaflet AL located on the anterior side A of the valve and a posterior leaflet PL located on the posterior side P of the valve. The leaflets are attached to chordae tendineae CT, which in turn are fastened to the heart wall by papillary muscles PM. Blood is then pumped out of the left ventricle into the aorta Ao, with the aortic valve AV preventing regurgitation.

[0189] Fig. 12B The illustration shows transapical delivery of a delivery system 1202 through the apex of the heart into the left atrium LA. The delivery system 1202 can be advanced over a guidewire GW into the left atrium, and a tissue penetrating tip 1204 assists the delivery system in passing through the apex of the heart by dilating the tissue and forming a larger channel for the remainder of the delivery system to pass through. The delivery catheter carries a prosthetic heart valve 1208. Once the distal portion of the delivery system has been advanced into the left atrium, the outer sheath 1206 can be retracted proximally (e.g., toward the operator), thereby removing the constraint from the atrial portion of the prosthetic valve 1208. This allows the atrial skirt 1210 to self-expand radially outward. Fig. 12C As the outer sheath is further retracted, the atrial skirt continues to expand and protrude outward until it is as Fig.12D The atrial skirt may have a cylindrical shape, or it may be D-shaped as discussed above and have a flat front and a cylindrical rear to avoid obstruction of the aortic valve and other aspects of the left ventricular outflow tract. The prosthetic heart valve may be advanced upstream or downstream to properly position the atrial skirt. In a preferred embodiment, the atrial skirt forms a flange against the upper surface of the mitral valve, which anchors the prosthetic valve and prevents it from undesirably moving downstream into the left ventricle.

[0190] As the outer sheath 1206 continues to retract proximally, the annular region of the prosthetic heart valve then self-expands into engagement with the valve annulus. The annular region also preferably has a D-shaped geometry, but it can also be cylindrical or have other geometric shapes to match the natural anatomical structure. Fig.12E 12, the retraction of the sheath 1206 eventually allows the front ear 1212 and the rear ear 1214 to partially self-expand outwardly at the same time without preferably engaging the front or rear leaflets or the chordae tendineae. In this embodiment, further retraction of the outer sheath 1206 then allows both front ear pieces 1212 (only one is visible in this view) to complete their self-expansion so that, as shown in FIG. Fig.12F12. The anterior leaflet is captured between the inner surface of each anterior tab and the outer surface of the ventricular skirt 1216. The posterior tab 1214 remains partially open, but its expansion has not yet been completed. In addition, as will be described in more detail below, the tips of the anterior tabs are also anchored into the left and right fibrous trigone of the mitral valve.

[0191] exist Figure 12G Further retraction of the outer sheath 1206 in turn releases the constraint from the posterior tab 1214, allowing it to complete its self-expansion, thereby capturing the posterior leaflet PL between the inner surface of the posterior tab 1214 and the outer surface of the ventricular skirt 1218. Fig.12H , the sheath is further retracted, thereby releasing the ventricular skirt 1220 and allowing the ventricular skirt 1220 to expand radially outward, further capturing the anterior leaflet and the posterior leaflet between the outer surface of the ventricular skirt and their respective anterior or posterior ear pieces. The expansion of the ventricular skirt also pushes the anterior leaflet and the posterior leaflet outward, thereby ensuring that the natural leaflet does not interfere with any portion of the prosthetic valve or prosthetic valve leaflet. The prosthetic valve is now anchored in place above the mitral valve, along the annulus, toward the valve leaflets, and below the mitral valve, thereby securing it in place.

[0192] Now, if Fig.12I As shown in , further actuation of the delivery device retracts the outer sheath 1206 and the bell-shaped catheter shaft 1222 to remove the constraint from the hub catheter 1224. This allows the prosthetic valve commissures 1226 to be released from the hub catheter so that the commissures expand into their deflected configuration. Fig.12J As shown in , the delivery system 1202 and guidewire GW are removed, leaving the prosthetic valve 1208 in its position replacing the native mitral valve.

[0193] Figure 12K and Figure 12L The articulation of the anterior and posterior tabs with the respective anterior and posterior leaflets is highlighted. Figure 12K 12, after the anterior tabs 1212 have been fully expanded, they capture the anterior leaflet AL and adjacent chordae tendineae between the inner surface of the anterior tab and the outer surface of the ventricular skirt 1220. In addition, the tip 1228 of the anterior tab 1212 engages the fibrous trigone FT on the anterior side of the mitral valve. The fibrous trigone is a fibrous area of ​​the valve, so the anterior tabs further anchor the prosthetic valve to the native mitral valve anatomy. One anterior tab is anchored into the left fibrous trigone, while the other anterior tab is anchored into the right fibrous trigone. The trigone is located on opposite sides of the anterior side of the leaflet. Figure 12L The posterior tab 1214 is illustrated in engagement with the posterior leaflet PL, which is captured between the inner surface of the posterior tab and the outer surface of the ventricular skirt 1220. In addition, the adjacent chordae tendineae are also captured between the posterior tab and the ventricular skirt.

[0194] Figures 13A-13L Another exemplary embodiment of a delivery method is illustrated. This embodiment is similar to the previously described embodiments, with the primary difference being the sequence in which the prosthetic heart valve self-expands into engagement with the mitral valve. Any delivery device or any prosthetic heart valve disclosed herein may be used, however, in a preferred embodiment, a delivery device is used. Figure 7 Embodiments of the present invention. Changing the order may allow for better positioning of the implant, easier capture of the valve leaflets, and better anchoring of the implant. The exemplary method also preferably uses a transapical approach, but a transseptal approach may also be used.

[0195] Fig.13A The basic anatomy of the left side of a patient's heart including the left atrium LA and the left ventricle LV is illustrated. The pulmonary veins PV return blood from the lungs to the left atrium, from which blood is then pumped across the mitral valve MV into the left ventricle. The mitral valve includes an anterior leaflet AL located on the anterior side A of the valve and a posterior leaflet PL located on the posterior side P of the valve. The leaflets are attached to chordae tendineae CT, which in turn are fastened to the heart wall by papillary muscles PM. Blood is then pumped out of the left ventricle into the aorta AO, with the aortic valve AV preventing regurgitation.

[0196] Fig. 13B The illustration shows transapical delivery of a delivery system 1302 through the apex of the heart into the left atrium LA. The delivery system 1302 can be advanced over a guidewire GW into the left atrium, and a tissue penetrating tip 1304 assists the delivery system in passing through the apex of the heart by dilating the tissue and forming a larger channel for the remainder of the delivery system to pass through. The delivery catheter carries a prosthetic heart valve 1308. Once the distal portion of the delivery system has been advanced into the left atrium, the outer sheath 1306 can be retracted proximally (e.g., toward the operator), thereby removing the constraint from the atrial portion of the prosthetic valve 1308. This allows the atrial skirt 1310 to self-expand radially outward. Fig. 13C As the outer sheath is further retracted, the atrial skirt continues to expand and protrude outward until it is as Fig.13D The atrial skirt may have a cylindrical shape, or it may be D-shaped as discussed above and have a flat front and a cylindrical rear to avoid obstruction of the aortic valve and other aspects of the left ventricular outflow tract. The prosthetic heart valve may be advanced upstream or downstream to properly position the atrial skirt. In a preferred embodiment, the atrial skirt forms a flange against the upper surface of the mitral valve, which anchors the prosthetic valve and prevents it from undesirably moving downstream into the left ventricle.

[0197] As the outer sheath 1306 continues to be retracted proximally, the annular region of the prosthetic heart valve then self-expands into engagement with the valve annulus. The annular region also preferably has a D-shaped geometry, but it can also be cylindrical or have other geometric shapes to match the natural anatomical structure. Fig.13E 13, the retraction of the sheath 1306 eventually allows the front ear 1312 and the rear ear 1314 to partially self-expand outwardly at the same time without preferably engaging the front or rear leaflets or the chordae tendineae. In this embodiment, further retraction of the outer sheath 1306 then allows both front ear pieces 1312 (only one is visible in this view) to complete their self-expansion so that, as shown in FIG. Fig.13F 13. The anterior leaflet is captured between the inner surface of each anterior tab and the outer surface of the ventricular skirt 1316. The posterior tab 1214 remains partially open, but its expansion has not yet been completed. In addition, as will be described in more detail below, the tips of the anterior tabs are also anchored into the left and right fibrous trigone of the mitral valve.

[0198] exist Figure 13G , further retraction of the outer sheath 1306 in turn releases the constraint from the ventricular skirt 1320, thereby allowing the ventricular skirt to expand radially. This in turn further captures the anterior leaflet AL between the anterior ear 1312 and the ventricular skirt 1316. The expansion of the ventricular skirt also pushes the anterior and posterior leaflets outward, thereby ensuring that the native leaflets do not interfere with the prosthetic valve or any portion of the prosthetic valve leaflets. Fig.13H Further retraction of the sheath 1306 shown in FIG. 1 releases the constraint from the posterior tab 1314, allowing it to complete its self-expansion, thereby capturing the posterior leaflet PL between the inner surface of the posterior tab 1314 and the outer surface of the ventricular skirt 1318. The prosthetic valve is now anchored in place above the mitral valve, along the annulus, toward the valve leaflets, and beneath the mitral valve, thereby securing it in place.

[0199] Now, if Fig.13I As shown in , further actuation of the delivery device retracts the outer sheath 1306 and the bell-shaped catheter shaft 1322 to remove the constraint from the hub catheter 1324. This allows the prosthetic valve commissures 1326 to be released from the hub catheter so that the commissures expand into their deflected configuration. Fig.13J As shown in , the delivery system 1302 and guidewire GW are removed, leaving the prosthetic valve 1308 in its position replacing the native mitral valve.

[0200] Figure 13K and Figure 13L The articulation of the anterior and posterior tabs with the respective anterior and posterior leaflets is highlighted. Figure 13K13, after the anterior tabs 1312 have been fully expanded, they capture the anterior leaflet AL and adjacent chordae tendineae between the inner surface of the anterior tab and the outer surface of the ventricular skirt 1320. In addition, the tip 1328 of the anterior tab 1312 engages the fibrous trigone FT on the anterior side of the mitral valve. The fibrous trigone is a fibrous area of ​​the valve, so the anterior tabs further anchor the prosthetic valve to the native mitral valve anatomy. One anterior tab is anchored into the left fibrous trigone, while the other anterior tab is anchored into the right fibrous trigone. The trigone is located on opposite sides of the anterior side of the leaflet. Figure 13L The posterior tab 1314 is illustrated in engagement with the posterior leaflet PL, which is captured between the inner surface of the posterior tab and the outer surface of the ventricular skirt 1320. In addition, the adjacent chordae tendineae are also captured between the posterior tab and the ventricular skirt.

[0201] Although preferred embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Those skilled in the art will appreciate numerous variations, changes, and substitutions that do not deviate from the present invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the present invention. The following claims are intended to define the scope of the present invention and therefore cover methods and structures within the scope of these claims and their equivalents.

Claims

1. A device for loading a prosthesis onto a delivery system, the device comprising: A first shell includes a first inlet, a first outlet and a first central hole extending between the first inlet and the first outlet, and wherein the first shell has one or more actuators, the one or more actuators are configured to actuate radially inward or outward, and the one or more actuators are suitable for selectively compressing radially inward a discrete portion at one end of the prosthesis when the prosthesis is positioned in the first central hole, while at the same time the ventricular skirt and triangular ears of the prosthesis remain uncompressed by the one or more actuators to engage the prosthesis with the delivery system prior to delivery.

2. The device of claim 1, further comprising a second housing having an internal passage, the second housing configured to be coupled to the first housing, and wherein the second housing is configured to receive the prosthesis.

3. The device of claim 1, wherein the prosthesis reduces a diameter of the prosthesis as it passes through the first tapered region of the first central hole.

4. The device of claim 1, wherein the one or more actuators comprise spring-loaded actuators.

5. The device of claim 1, wherein actuation of the one or more actuators causes the one or more actuators to engage one or more commissure rods on the prosthesis, thereby causing the one or more commissure rods to flex.

6. The apparatus of claim 1, further comprising an inner cone disposed in the first central hole and configured to support an inner surface of the prosthesis.

7. The device of claim 1 further comprising a collar threadably engageable with the first housing, wherein rotation of the collar advances the collar along the first housing to engage and actuate the one or more actuators.

8. The device of claim 1, wherein the first central hole is shaped to align the prosthesis in a desired orientation.

9. A system for loading a prosthesis onto a delivery system, the system comprising: Prosthetic heart valves; a loading fixture comprising a first housing including a first inlet, a first outlet, and a first central bore extending between the first inlet and the first outlet, and wherein the first housing has one or more actuators configured to actuate radially inwardly or outwardly, the one or more actuators being adapted to selectively compress radially inwardly a discrete portion at one end of the prosthetic heart valve when the prosthetic heart valve is positioned in the first central bore while a ventricular skirt and a triangular tab of the prosthetic heart valve remain uncompressed by the one or more actuators to engage the prosthetic heart valve with the delivery system prior to delivery; as well as A delivery device is configured to carry the prosthetic heart valve.

10. The system of claim 9, wherein the prosthetic heart valve is a prosthetic mitral valve.

11. The system of claim 9, wherein the prosthetic heart valve comprises: A radially expandable anchor frame having a first end and a second end opposite the first end, wherein the first end is configured to be positioned in an atrium of a patient's heart and the second end is configured to be positioned in a ventricle of the patient's heart, the radially expandable anchor frame further comprising: an atrial flange coupled to the first end, the atrial flange configured to anchor the prosthetic heart valve to the atrium; the ventricular skirt coupled to the second end, the ventricular skirt configured to be disposed in the ventricle; an annular region disposed between the atrial flange and the ventricular skirt, the annular region configured to be disposed in an annular space of a patient's heart; and A ventricular anchor is coupled to the ventricular skirt, the ventricular anchor being configured to anchor the prosthetic heart valve to a fibrous trigone of a patient's heart.

12. A delivery system for delivering a prosthesis to a patient's heart, the delivery system comprising: a guidewire shaft having a lumen extending therethrough, the lumen being configured to receive a guidewire; a sheath catheter fixedly disposed on the guidewire shaft, the sheath catheter being configured to releasably engage a prosthetic valve; a bell-shaped catheter slidably disposed on the hub catheter, the bell-shaped catheter being configured to maintain engagement of the prosthetic valve with the hub catheter; a sheath slidably disposed on the hub catheter, the sheath configured to maintain engagement of the prosthetic valve with the bell catheter; as well as A loading fixture for loading the prosthetic valve onto the delivery system, the loading fixture comprising a first shell, the first shell comprising a first inlet, a first outlet and a first center hole extending between the first inlet and the first outlet, and wherein the first shell has one or more actuators, the one or more actuators are configured to actuate radially inward or outward, the one or more actuators are suitable for selectively compressing radially inward a discrete portion at one end of the prosthetic valve when the prosthetic valve is positioned in the first center hole, while at the same time the ventricular skirt and triangular ears of the prosthetic valve remain uncompressed by the one or more actuators to engage the prosthetic valve with the delivery system prior to delivery.

13. The delivery system of claim 12, further comprising the prosthetic valve.

14. The delivery system of claim 13, wherein the prosthetic valve is a prosthetic mitral valve.

15. The delivery system of claim 12, wherein the prosthetic valve is a prosthetic heart valve, the prosthetic heart valve comprising: A radially expandable anchor frame having a first end and a second end opposite the first end, wherein the first end is configured to be positioned in an atrium of a patient's heart and the second end is configured to be positioned in a ventricle of the patient's heart, the radially expandable anchor frame further comprising: an atrial flange coupled to the first end, the atrial flange configured to anchor the prosthetic heart valve to the atrium; the ventricular skirt coupled to the second end, the ventricular skirt configured to be disposed in the ventricle; an annular region disposed between the atrial flange and the ventricular skirt, the annular region configured to be disposed in an annular space of a patient's heart; and A ventricular anchor is coupled to the ventricular skirt, the ventricular anchor being configured to anchor the prosthetic heart valve to a fibrous trigone of a patient's heart.

16. A method for loading a delivery system with a prosthesis, the method comprising: reducing a diameter of a prosthetic valve in selected discrete regions, the prosthetic valve including a plurality of commissure posts coupled thereto, the selected discrete regions including the plurality of commissure posts; and The reduced diameter prosthetic valve is loaded onto the delivery device. wherein reducing the diameter comprises loading the prosthetic valve into a loading fixture and actuating the loading fixture to displace the plurality of commissure posts, The loading fixture comprises: A first shell comprising a first inlet, a first outlet and a first center hole extending between the first inlet and the first outlet, and wherein the first shell has one or more actuators, the one or more actuators being configured to actuate radially inwardly or outwardly, the one or more actuators being adapted to selectively compress radially inwardly a discrete portion at one end of the prosthetic valve when the prosthetic valve is positioned in the first center hole, while at the same time maintaining a ventricular skirt and a triangular ear of the prosthetic valve uncompressed by the one or more actuators to engage the prosthetic valve with the delivery system prior to delivery.

17. The method of claim 16, wherein reducing the diameter comprises passing the prosthetic valve through the first central hole and reducing the diameter of the prosthetic valve.

18. The method of claim 16, wherein reducing the diameter comprises actuating one or more spring-loaded actuators into engagement with the plurality of commissure rods and flexing the plurality of commissure rods radially inward.

19. The method of claim 16, wherein reducing the diameter comprises moving a collar along the first housing threads to actuate one or more actuators into engagement with the prosthetic valve.

20. The method of claim 16, further comprising aligning the prosthetic valve with the loading fixture to a desired orientation.

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