Prosthetic valve with mechanically coupled leaflets

Abstract

The described embodiments relate to a prosthetic valve device with a centrally opened leaflet having a leaflet frame and mechanically coupled leaflets. The described leaflet frame has protrusions configured to couple with leaflet attachment areas of the leaflets. Some embodiments include leaflet retention features that engage the leaflet frame protrusions and operate to secure the leaflets to the leaflet frame. Methods of making and using such a prosthetic valve device are also described.

Description

[0001] This application is a divisional application of the application filed on March 20, 2020, with application number 201880061216.5 and titled “Prosthetic valve with mechanically connected leaflets”.

[0002] Priority information

[0003] This application claims priority to U.S. Application No. 16 / 129,682, filed September 12, 2018, which is incorporated herein by reference in its entirety, which claims the benefit of U.S. Provisional Application No. 62 / 572,274, filed October 13, 2017, which is incorporated herein by reference in its entirety. This application also claims the benefit of U.S. Provisional Application No. 62 / 579,753, filed October 31, 2017, which is incorporated herein by reference in its entirety. This application also claims the benefit of U.S. Provisional Application No. 62 / 564,031, filed September 27, 2017, which is incorporated herein by reference in its entirety. Technical Field

[0004] The present disclosure relates generally to prosthetic valves, and more particularly to flexible leaflet-type prosthetic valve devices. Background Art

[0005] Prosthetic valves with flexible leaflets typically require some method (means) of securing the leaflets to a supporting structure such as a leaflet frame. Therefore, the prosthetic valve leaflets are typically connected to a supporting structure to form a prosthetic valve. In operation, when the inflow fluid pressure is greater than the outflow fluid pressure, the leaflets open, and when the outflow fluid pressure is greater than the inflow fluid pressure, the leaflets close. The free edges of the leaflets are tightened under the influence of the outflow fluid pressure, thereby closing the valve to limit the retrograde flow of outflowing blood through the prosthetic valve. The commissure is the area where adjacent leaflets come together at the supporting structure. The commissure posts are typically those structures of the leaflet frame located within the commissure area to which adjacently positioned leaflets are attached.

[0006] Some conventional methods of attaching the leaflets to the leaflet frame include suturing or adhesively / thermally bonding the leaflets to the leaflet frame. Both of these techniques have disadvantages that affect the longevity and performance of the prosthetic valve. Specifically, in an aqueous environment, and particularly on the time scale of a prosthetic valve, the integrity of the adhesive bond tends to be negatively impacted. The suturing process tends to be labor intensive, and the quality of the result may depend on the skill level of the assembler. In addition, the tension applied to the suture may not be well controlled, which may affect the local geometry of the leaflet. In the long term, all of these factors may adversely affect the functional and structural integrity of the leaflet. For example, as disclosed in U.S. Patent No. 9,855,141 to Dienno, other approaches include positioning the leaflets on multiple protrusions on the leaflet frame.

[0007] However, leaflet failure due to tearing in the commissure region and / or detachment from the leaflet frame remains an undesirable risk to the patient. One factor contributing to leaflet tearing and / or detachment is the peak stresses in the leaflets that are typically observed in the commissure region when the prosthetic valve is closed and under fluid backpressure.

[0008] Many attempts have been made to alleviate such stresses, including increasing the ultimate tensile strength of the leaflet material to increase tear resistance (e.g., by increasing the thickness of the leaflet material), increasing the height of the commissure posts to help distribute the load on the leaflets over a greater length and / or greater area of the commissure post region, and changing the geometry of those portions of the commissure posts that interface with the leaflets. However, increasing the leaflet thickness can reduce the overall performance of the prosthetic valve, at least in part due to increased bending stiffness of the leaflets. Furthermore, increasing the leaflet thickness and / or the height of the commissure posts increases the prosthetic valve profile, which is undesirable in transcatheter applications. Furthermore, a prosthetic valve with an increased commissure post height (and therefore overall prosthetic valve height) may have undesirable interactions with native anatomy, such as ventricular wall interaction at the mitral valve site or left ventricular outflow tract obstruction and coronary artery obstruction at the aortic site.

[0009] New methods of securing the leaflets to the support structure are needed to further minimize the likelihood of leaflet failure while minimizing the profile of the prosthetic valve. Summary of the Invention

[0010] Various embodiments relate to a prosthetic valve having a leaflet frame and one or more leaflets, wherein the leaflets are coupled to the leaflet frame by one or more leaflet frame projections. Some examples relate to devices, systems, and methods for valve replacement (e.g., heart valve replacement), although a variety of applications are contemplated.

[0011] According to one example ("Example 1"), a prosthetic valve includes: a plurality of leaflets, the leaflets including a first leaflet and a second leaflet, each leaflet having a leaflet attachment area; and a frame including a commissure post, the commissure post including: a first tooth portion including a first inner edge and a first outer edge opposite the first inner edge, the first outer edge including a first protrusion extending from the first outer edge of the first tooth portion; a second tooth portion including a second inner edge and a second outer edge opposite the second inner edge, the second outer edge including a second protrusion extending from the second outer edge of the second tooth portion two protrusions; a ridge positioned between the first tooth and the second tooth so that inner edges of the first tooth and the second tooth face the ridge; and a plurality of slots comprising a first slot and a second slot, the first slot being defined at least between the first tooth and the ridge, the second slot being defined at least between the second tooth and the ridge, wherein a leaflet attachment region of the first leaflet extends through the first slot and wraps around the first tooth and engages the first protrusion, and wherein a first portion of the leaflet attachment region of the second leaflet extends through the second slot and wraps around a portion of the second leaflet and engages the second protrusion.

[0012] According to another example (“Example 2”) that is further than Example 1, the ridge is positioned between the first leaflet and at least a portion of the second leaflet.

[0013] According to another example ("Example 3") that is further than any one of Examples 1 to 2, wherein the first leaflet and the second leaflet each include a leaflet free edge, and wherein a gap adjacent to the commissure is defined between the leaflet free edges of the first leaflet and the second leaflet.

[0014] According to another example ("Example 4") further than any of Examples 1 to 3, the first protrusion extends through the leaflet attachment area of the first leaflet, and wherein the second protrusion extends through the leaflet attachment area of the second leaflet.

[0015] According to another example (“Example 5”) further than any one of Examples 1 to 4, one end of the first slot is an open end, and wherein one end of the first slot is a free end.

[0016] According to another example (“Example 6”) further than any one of Examples 1 to 5, the first tooth portion has a first end and a second end, and wherein the first end and the second end are each integral with the frame.

[0017] According to another example (“Example 7”) that is further developed relative to any one of Examples 1 to 6, the first tooth extends from the commissure post at a position near the free end of the commissure post.

[0018] According to another example ("Example 8") further than any of Examples 1 to 7, the frame further includes a third protrusion, and wherein the second portion of the leaflet attachment area of the first leaflet engages the third protrusion without wrapping around the frame.

[0019] According to another example ("Example 9") that is further relative to any one of Examples 1 to 8, the valve also includes a leaflet retention member connected to the leaflet frame so that the leaflet attachment area of the leaflet is between the leaflet frame and the leaflet retention member.

[0020] According to another example ("Example 10") that is further than Example 9, the leaflet retaining member engages a first frame and a second frame to fix the leaflet retaining member to the leaflet frame, wherein the leaflet retaining member includes a first portion extending along an inner surface of the leaflet frame protruding from the first frame, and wherein the leaflet retaining member includes a second portion extending along an outer surface of the leaflet frame protruding from the second frame.

[0021] According to another example ("Example 11") further than any of Examples 9 to 10, the leaflet-retaining member is a fiber.

[0022] According to another example ("Example 11") that is further than any of Examples 1 to 11, the valve further includes a sheath molded over the leaflet retaining member.

[0023] According to another example ("Example 13") further than Example 12, the sheath is formed of a TFE-PMVE copolymer.

[0024] According to another example ("Example 14") further than any of Examples 12 to 13, the sheath is formed of a flexible polymer.

[0025] According to another example (“Example 15”) further than Example 14, the flexible polymer is silicone resin.

[0026] According to another example ("Example 16") that is further than any one of Examples 1 to 15, the first leaflet and the second leaflet each define two terminals at the intersection of the leaflet free edge and the leaflet attachment area of the corresponding leaflet, and the leaflet attachment area of each leaflet is connected to the frame so that when positioned adjacent to each other, the leaflet attachment areas adjacent to the terminals of the first leaflet and the second leaflet diverge from positions away from the terminals to the terminals relative to each other.

[0027] According to another example ("Example 17"), a prosthetic valve includes: a plurality of leaflets, the leaflets including a first leaflet and a second leaflet, each leaflet having a leaflet attachment area; and a frame, the frame including: a ridge; a plurality of teeth, the teeth positioned adjacent to the ridge such that a first slot is defined between the ridge and a first tooth of the plurality of teeth, and such that a second slot is defined between the ridge and a second tooth of the plurality of teeth; and a plurality of protrusions extending from the first tooth and the second tooth, the plurality of protrusions including a first protrusion extending from the first tooth and a second protrusion extending from the second tooth, wherein the leaflet attachment area of the first leaflet extends through the first slot and wraps around the first tooth and engages with the first protrusion extending from the first tooth, and wherein the leaflet attachment area of the second leaflet extends through the second slot and wraps around the second tooth and engages with the second protrusion extending from the second tooth.

[0028] According to another example ("Example 18") that is further than Example 17, the ridge is positioned between the first lobe and at least a portion of the second lobe so that a gap adjacent to the ridge is formed between the free edges of the lobe of the first lobe and the second lobe.

[0029] According to another example ("Example 19") that is further relative to any of Examples 17 to 18, the first protrusion extends through the leaflet attachment area of the first leaflet, and wherein the second protrusion extends through the leaflet attachment area of the second leaflet.

[0030] According to another example (“Example 20”) further than any one of Examples 17 to 19, one end of the first slot is an open end, and one end of the first slot is a free end.

[0031] According to another example ("Example 21") that is further relative to any one of Examples 17 to 20, the frame also includes a third protrusion, and wherein the second portion of the leaflet attachment area of the first leaflet engages the third protrusion without wrapping around the frame.

[0032] According to another example ("Example 22") that is further than any one of Examples 17 to 21, the valve also includes a leaflet retaining member connected to the leaflet frame so that the leaflet attachment area of the leaflet is between the leaflet frame and the leaflet retaining member.

[0033] According to another example ("Example 23") that is further than Example 22, the leaflet retaining member engages a first frame and a second frame to fix the leaflet retaining member to the leaflet frame, wherein the leaflet retaining member includes a first portion extending along an inner surface of the leaflet frame protruding from the first frame, and wherein the leaflet retaining member includes a second portion extending along an outer surface of the leaflet frame protruding from the second frame.

[0034] According to another example ("Example 24") further than any of Examples 22 to 23, the leaflet-retaining member is a fiber.

[0035] According to another example ("Example 25") that is further than any of Examples 17 to 24, the valve further includes a sheath molded over the leaflet retaining member.

[0036] According to another example ("Example 26") further than Example 25, the sheath is formed of a TFE-PMVE copolymer.

[0037] According to another example ("Example 27") further than any of Examples 25-26, the sheath is formed of a flexible polymer.

[0038] According to another example further than Example 28 ("Example 28"), the flexible polymer is silicone.

[0039] According to another example ("Example 29") that is further than any one of Examples 22 to 28, the leaflet retaining member has a body comprising a plurality of adjacently positioned struts (support rods) extending from a first side of the body, wherein an area is defined between the adjacently positioned struts, and wherein a first frame protrusion extends through the area defined between the adjacently positioned struts such that the adjacently positioned struts engage the frame protrusion.

[0040] According to another example ("Example 30") that is further relative to Example 29, the body of the leaflet retaining member also includes a first end, a second end opposite to the first end, a first side extending between the first end and the second end, and a second side extending between the first end and the second end, wherein adjacently positioned pillars extend between the first side and the second side and are located between the first side and the second end, the leaflet retaining member includes a first unit and a second unit, the first unit is defined between the first side and the pillar, and the second unit is defined adjacent to the first unit between the second side and the pillar, wherein the first frame protrusion extends through the first unit, and wherein the second frame protrusion extends through the second unit.

[0041] According to another example ("Example 31") that is further than any one of Examples 17 to 30, the first leaflet and the second leaflet each define two terminals at the intersection of the leaflet free edge and the leaflet attachment area of the corresponding leaflet, and the leaflet attachment area of each of the first leaflet and the second leaflet is connected to the frame so that the leaflet attachment areas adjacent to the terminals of the first leaflet and the second leaflet diverge from a position away from the terminal to the terminal relative to each other (diverge from a position away from the terminal to the terminal relative to each other).

[0042] According to another example ("Example 32") that is further relative to any one of Examples 17 to 30, wherein the frame includes a plurality of support attachment areas, each support attachment area defines two frame support attachment areas having distal ends, the corresponding two support attachment areas diverge relative to each other from a position away from the corresponding distal ends toward the corresponding distal ends, thereby defining corresponding divergent areas, and wherein the first leaflet and the second leaflet are each defined by leaflet free edges intersecting at two terminal ends of the leaflet and leaflet attachment areas, wherein the leaflet attachment area adjacent to the corresponding terminal of each of the first leaflet and the second leaflet is connected to one of the corresponding support attachment areas along the corresponding divergent area, wherein the corresponding leaflet attachment areas adjacent to the corresponding terminal ends of the first leaflet and the second leaflet diverge relative to each other from a position away from the corresponding terminal ends to the corresponding terminal ends.

[0043] According to another example ("Example 33") that is further than any one of Examples 17 to 30, the frame includes a support structure defining a plurality of commissure areas, each commissure area defining two support attachment portions that diverge relative to each other along the outflow direction from a position away from the end of the commissure post toward the end of the commissure post; and wherein each of the first leaflet and the second leaflet defines two leaflet commissure attachment portions adjacent to the leaflet free edge, wherein the corresponding leaflet commissure attachment portion of each of the first leaflet and the second leaflet is connected to one of the two support attachment portions so that at the leaflet commissure attachment portions, the corresponding leaflet free edges of the first leaflet and the second leaflet diverge relative to each other.

[0044] According to another example ("Example 34") that is further than any one of Examples 17 to 30, each of the first and second leaflets is attached to the support structure of the frame along a divergent region of the support structure, so that adjacent leaflet free edges of the first and second leaflets diverge relative to each other at the support structure.

[0045] In accordance with another example ("Example 35") that is further than any one of Examples 17 to 30, each of the first leaflet and the second leaflet includes a leaflet free edge, wherein the first leaflet and the second leaflet are attached to the support structure of the frame along a diverging region of the support structure so that the leaflet free edges of the first leaflet and the second leaflet diverge relative to each other at the support structure, whereby, when exposed to a peak closing pressure of approximately 135 mmHg, the stress within the leaflet along the diverging region is reduced by more than 40% relative to a non-diverging attachment relative to a given support structure length.

[0046] According to another example ("Example 36"), a method of manufacturing a heart valve includes providing a plurality of leaflets, the leaflets including a first leaflet and a second leaflet, each leaflet having a leaflet attachment area; and providing a frame including a commissure post, the commissure post including: a first tooth portion, the first tooth portion including a first inner edge and a first outer edge opposite the first inner edge, the first outer edge including a first protrusion extending from the first outer edge of the first tooth portion; a second tooth portion, the second tooth portion including a second inner edge and a second outer edge opposite the second inner edge, the second outer edge including a second protrusion extending from the second outer edge of the second tooth portion; a ridge, the ridge positioned between the first tooth portion and the second tooth portion so that the inner edges of the first tooth portion and the second tooth portion face the ridge; and a plurality of slots, the slots including a first slot and a second slot, the first slot being defined at least between the first tooth portion and the ridge, and the second slot being defined at least between the second tooth portion and the ridge. The method also includes connecting the leaflet attachment area of the first leaflet to the frame by extending the leaflet attachment area of the first leaflet through the first slot and wrapping the leaflet attachment area of the first leaflet around the first tooth so that the leaflet attachment area of the first leaflet engages the first protrusion; and connecting the leaflet attachment area of the second leaflet to the frame by extending the leaflet attachment area of the second leaflet through the second slot and wrapping the leaflet attachment area of the second leaflet around the second tooth so that the leaflet attachment area of the second leaflet engages the second protrusion.

[0047] Although multiple embodiments are disclosed, other embodiments of the present application will become apparent to those skilled in the art from the following detailed description, which shows and describes exemplary embodiments of the present invention. Therefore, the drawings and detailed description are to be regarded as illustrative rather than restrictive in nature. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] The accompanying drawings are included to provide a further understanding of the application and are incorporated in and constitute a part of this specification, illustrate embodiments and together with the description serve to explain the principles of the application.

[0049] Figure 1A is a perspective view of an outflow side of a prosthetic valve according to some embodiments;

[0050] Figure 1B yes Figure 1A An enlarged view of box 1B in FIG;

[0051] Figure 1C yes Figure 1A An enlarged view of box 1C in FIG;

[0052] Figure 1D yes Figure 1A A top view of an embodiment of a prosthetic valve;

[0053] Figure 2A is an outflow perspective view of a leaflet frame according to some embodiments;

[0054] Figure 2B yes Figure 2A A side view of an embodiment of a leaflet frame;

[0055] Figure 2C yes Figure 2A Representation of the leaflet frame shown deployed into a flat orientation;

[0056] Figure 2D yes Figure 2C A magnified view of the box 2D in ;

[0057] Figure 2E yes Figure 2C Enlarged view of box 2E in ;

[0058] Figure 2F yes Figure 2D a cross-sectional view of the commissures along line 2F showing the folded portions of the leaflets;

[0059] Figure 2G is a cross-sectional view showing the commissure posts of the folded portion of the leaflet according to another embodiment;

[0060] Figure 2H is a cross-sectional view showing the commissure posts of the folded portion of the leaflet according to another embodiment;

[0061] Figure 2I is a cross-sectional view showing the commissure posts of the folded portion of the leaflet according to another embodiment;

[0062] Figures 3A to 3E is a perspective view of various leaflet frame protrusions defining various tongue-like shapes according to some embodiments;

[0063] Figure 4A and 4B is a side view of a leaflet frame protrusion according to some embodiments;

[0064] Figure 5A and 5B is a side view of a leaflet frame protrusion according to some embodiments;

[0065] Figure 6A and 6B is a side view of a leaflet frame protrusion according to some embodiments;

[0066] Figure 7A It is in a flat structure Figure 1A Side view of the leaflets of a prosthetic valve;

[0067] Figure 7B yes Figure 7A An enlarged view of box 7B in FIG.

[0068] Figure 8 is an enlarged view of a commissure post according to some embodiments;

[0069] Figure 9A is a perspective view of a leaflet frame for use in a transcatheter delivery procedure, according to some embodiments;

[0070] Figure 9B yes Figure 9A Magnified view of circle B in .

[0071] Figure 10 is a top view of a leaflet retaining member according to some embodiments.

[0072] Figure 11 is a perspective view of a leaflet retention member disposed around a protrusion of a leaflet frame, according to some embodiments.

[0073] Figure 12 is a top perspective view of a leaflet retention member disposed around a protrusion of a leaflet frame, according to some embodiments.

[0074] Figure 13 is an elevational view of a leaflet retention member disposed about a protrusion of a leaflet frame, according to some embodiments.

[0075] Figure 14 is a top view of a leaflet retaining member according to some embodiments.

[0076] Figure 15 is a side view showing a leaflet retaining member interfacing with a protrusion of a leaflet frame, according to some embodiments.

[0077] Figure 16 is a perspective view of a leaflet frame for use in a transcatheter delivery procedure, according to some embodiments;

[0078] Figure 17 yes Figure 16 An enlarged view of circle 17 in FIG.

[0079] Figure 18 is an illustration of a leaflet retention feature according to some embodiments;

[0080] Figure 19 is a diagram showing a leaflet retention feature coupled to a leaflet frame according to some embodiments. Figure 18 An enlarged top view of region 19;

[0081] Figure 20 is an illustration of a leaflet retention feature according to some embodiments;

[0082] Figure 21 is a diagram showing a leaflet retention feature coupled to a leaflet frame according to some embodiments. Figure 20 An enlarged top view of region 21;

[0083] Figure 22 is an illustration of a leaflet retention feature according to some embodiments;

[0084] Figure 23 is a diagram showing a leaflet retention feature coupled to a leaflet frame according to some embodiments. Figure 22 An enlarged top view of region 23;

[0085] Figure 24 is in a pre-installed configuration according to some embodiments Figure 22 Illustration of the leaflet retention features;

[0086] Figure 25 is an illustration of a leaflet retention feature according to some embodiments;

[0087] Figure 26 is a diagram showing a leaflet retention feature coupled to a leaflet frame according to some embodiments. Figure 25 an enlarged top view of region 26;

[0088] Figure 27A is a perspective view of a closed prosthetic valve according to some embodiments, the closed prosthetic valve including a frame supporting leaflets having adjacent support regions of commissure posts, the support attachment regions of the commissure posts diverging in an outflow direction from locations distal to commissure post ends toward the commissure post ends;

[0089] Figure 27B is in closed position Figure 1A Axial view of the prosthetic valve;

[0090] Figure 27C is in the open position Figure 1A Axial view of the prosthetic valve;

[0091] Figure 27D yes Figure 1A Side view of the prosthetic valve;

[0092] Figure 27E yes Figure 1A Another side view of the prosthetic valve;

[0093] Figure 28A According to some embodiments Figure 1A Planar view of the leaflets used in a prosthetic valve;

[0094] Figure 28B According to another embodiment Figure 1A Planar view of the leaflets used in a prosthetic valve;

[0095] Figure 29 yes Figure 1A a side view of a portion of a frame of a prosthetic valve of an embodiment;

[0096] Figure 30 yes Figure 1B Detailed view of region 4 of an embodiment of the present invention;

[0097] Figure 31 is a side view of a portion of a prosthetic valve frame, wherein Figure 27A or 29 (superimposed thereon with dashed lines), the adjacent bearing attachment regions of the commissure posts are parallel;

[0098] Figure 32A The results of performing finite element analysis show a non-divergent bearing attachment area connected to Figure 31 stress distribution of leaflets of the frame of an embodiment;

[0099] Figure 32B The results of performing finite element analysis show a Figure 27A stress distribution of leaflets of the frame of an embodiment;

[0100] Figure 33 is a side view of a frame according to another embodiment, the figure showing a support attachment area defined by a continuous slot through the frame, which defines a proximal edge;

[0101] Figure 34 A frame operable for use in a transcatheter procedure according to another embodiment is shown, wherein the frame has a variable diameter;

[0102] Figure 35 yes Figure 9A Alternative configurations of commissure posts are shown, wherein, according to some embodiments, the slots diverge from one another;

[0103] Figure 36 is a perspective view of an illustration of an exemplary sheath coupled to a prosthetic valve according to some embodiments;

[0104] Figure 37 According to the embodiment Figure 36 , which is a cross-sectional view of a sheath and prosthetic valve shown in , is a perspective view of another exemplary sheath for a prosthetic valve according to some embodiments;

[0105] Figure 38 is a perspective view of an illustration of another exemplary sheath coupled to a prosthetic valve according to some embodiments;

[0106] Figure 39is provided in the catheter according to an embodiment Figure 38 a cross-sectional view of the sheath and prosthetic valve shown;

[0107] Figure 40 is a perspective view of an illustration of another exemplary sheath coupled to a prosthetic valve according to an embodiment;

[0108] Figure 41 According to the embodiment Figure 40 a cross-sectional view of the sheath and prosthetic valve shown;

[0109] Figures 42A-42B According to some embodiments, the Figures 40-41 Illustration of the leaflets within the sheath shown. DETAILED DESCRIPTION

[0110] The present disclosure relates to prosthetic valves for use in heart valve replacement or other applications associated with native valves or other valve orifices, as well as related systems, methods, and devices. In various embodiments, the prosthetic valve can operate as a one-way prosthetic valve that defines a valve orifice, with leaflets that open to allow flow into the valve orifice and close to block or occlude the valve orifice and partially or completely prevent flow in response to a fluid pressure differential.

[0111] In this disclosure, examples are primarily described in conjunction with surgical or transcatheter heart valve applications, but it should be readily understood that embodiments within the scope of this disclosure may be applied to any prosthetic valve or mechanism having similar structure and / or function. For example, Figure 1A The prosthetic valve 100 can be used in non-cardiac applications, such as respiratory or gastrointestinal applications. An implantable valve orifice includes an anatomical structure into which a prosthetic valve can be placed. Such anatomical structures include, but are not limited to, locations where a heart valve may or may not have been surgically removed. Other anatomical structures that can receive a prosthetic valve include, but are not limited to, veins, arteries, ducts, and shunts. A valve orifice or implant site can also refer to a location in a synthetic or biological conduit that can receive a prosthetic valve.

[0112] The term "leaflet" as used herein in the context of a prosthetic valve is generally a flexible member that is operable to move between an open position and a closed position under the influence of a pressure differential. When in the open position, the leaflet allows blood to flow through the prosthetic valve. When in the closed position, the leaflet substantially blocks reverse flow through the prosthetic valve. In embodiments comprising a plurality of leaflets, each leaflet cooperates with at least one adjacent leaflet to block reverse flow of blood. Examples of suitable leaflet configurations and methods of attachment to the leaflet frame are shown and described in the above-mentioned U.S. patent application Ser. No. 13 / 833,650, U.S. Patent No. 9,855,141 to Dienno, and U.S. Patent No. 9,801,712 to Bruchman, the contents of each of which are incorporated herein by reference.

[0113] Various embodiments provided herein relate to a non-sutured or minimally sutured, mechanically coupled leaflet that is mechanically coupled to a leaflet frame along a leaflet attachment region or a segment thereof by means of a leaflet frame protrusion. The leaflet frame protrusions allow for simple, reproducible coupling of the leaflets to the leaflet frame, which can be beneficial in either a manufacturing or research scenario. The leaflet frame protrusions on the leaflet frame can be an integral part of the leaflet frame that protrudes from one or more leaflet retaining surfaces. According to one embodiment, the leaflet frame protrusions are configured to extend through the leaflet attachment region. According to one embodiment, the leaflet frame protrusions are configured to extend through an aperture defined by the leaflets in the leaflet attachment region.

[0114] Some embodiments provided herein relate to leaflets made of flat patterns. The leaflets can be made separately from the leaflet frame, and then after being attached to the leaflet frame, the leaflets acquire their operable shape, because the shape of the leaflet frame elements, the two-dimensional shape of the leaflets, and the attachment lines are the primary determinants of the resulting three-dimensional operable shape of the leaflets. Thus, in some embodiments, this aspect can eliminate the need to set (shape) the leaflet shape to a three-dimensional shape.

[0115] Because the leaflets and leaflet frame can be manufactured independently and the attachment process does not require suturing or adhesive / thermal bonding (although suturing and adhesive / thermal bonding can still be used as secondary fixation options), the production process of the prosthetic valve can be simplified, which can translate into manufacturing efficiencies. Moreover, due to the options for simplifying the process when making the leaflets and leaflet frame and coupling the two together, the embodiments provided herein may be particularly useful in research scenarios, allowing for rapid prototyping.

[0116] According to the present disclosure, a prosthetic valve may include a leaflet frame defining an annular ring and having a leaflet retaining surface configured to impart a shape to the leaflets to provide proper function of the valve, and one or more leaflet retaining surfaces to assist in retaining the leaflets to the leaflet frame. A plurality of leaflet frame protrusions spaced apart from one another may be coupled to or integral with the leaflet retaining surfaces. The leaflet frame protrusions are configured to assist in maintaining the connection between the leaflets and the leaflet frame.

[0117] The prosthetic valve also includes one or more leaflets. In some embodiments, each leaflet includes a leaflet attachment area and an area that ends at the free edge of the leaflet, as will be discussed in more detail below. In some embodiments, the leaflet attachment area of the leaflet includes a plurality of leaflet holes spaced apart from each other and complementary to the leaflet frame protrusions of the leaflet frame. In some embodiments, when the two components are coupled together, the leaflet frame protrusions extend through corresponding holes in the plurality of leaflet holes. In other words, in various embodiments, the spatial pattern (spatial pattern) of the leaflet frame protrusions is the same as the spatial pattern (spatial pattern) of the leaflet holes. The connection of the leaflet frame protrusions to the leaflets helps to retain the leaflets on the leaflet frame. It should be understood that embodiments of the present disclosure are applicable to prosthetic valves having one, two, three, or more than three leaflets.

[0118] Figure 1A is an outflow perspective view of prosthetic valve 100 shown in a closed position, according to one embodiment. Figure 1B yes Figure 1A Magnified view of box 1B in FIG. Figure 1C yes Figure 1A Magnified view of box 1B in . Figure 1C is also shown in a closed configuration Figure 1A A top view of the prosthetic valve 100 in FIG. Figure 1A The components of the prosthetic valve 100 that can be observed in the figure include a plurality of leaflets 310 and a leaflet frame 200, which includes a plurality of commissure posts 210 flanked on each side by (sandwiched by) leaflet window frame elements (e.g., two commissure support struts 208 and a leaflet window base 207 therebetween) that define the leaflet windows 204 (at Figure 2A In various embodiments, the leaflet free edges 312 of adjacently positioned leaflets 310 come together at a coaptation region 316. In some embodiments, the leaflet free edges 312 of adjacently positioned leaflets come together in a Y-shaped pattern when viewed from above (e.g., see Figure 1DIn various embodiments, coaptation of adjacent leaflets operates to block the flow of fluid (e.g., blood) through prosthetic valve 100. It will be appreciated that in some instances, coaptation of adjacent leaflets may operate to completely block the flow of fluid (e.g., blood) through prosthetic valve 100, while in other instances, coaptation of adjacent leaflets may operate to block less than all flow of fluid (e.g., blood) through prosthetic valve 100.

[0119] In some embodiments, the leaflet free edges 312 of adjacently positioned leaflets coapt in response to pressure on the leaflet outflow side A exceeding pressure on the leaflet inflow side B of the prosthetic valve 100. In some embodiments, as will be appreciated by those skilled in the art, pressure on the leaflet outflow side A increases in response to ventricular contraction. Conversely, in various embodiments, the leaflet free edges 312 of adjacently positioned leaflets 310 separate to open the prosthetic valve 100 and allow fluid (e.g., blood) to flow through the prosthetic valve 100 (e.g., from the leaflet inflow side B to the leaflet outflow side A) when pressure on the leaflet inflow side B exceeds pressure on the leaflet outflow side A.

[0120] Figure 1B An enlarged view of the leaflet frame projection 260 on the leaflet frame 200 is shown with the leaflet apertures 308 disposed on the leaflet frame 200. In various embodiments, the leaflet apertures 308 are disposed around the leaflet frame projection 260 after a portion of the leaflet 310 is folded over or otherwise wrapped and / or wrapped around a portion of the leaflet frame 200, as discussed in more detail below. Figure 1B and 1C In the example shown, the leaflet frame protrusions 260 are positioned along multiple surfaces and / or edges of the leaflet frame 200 .

[0121] Figure 2A and 2B A perspective view and a side view are respectively shown of a leaflet frame 200 according to an embodiment. Figure 2C yes Figure 2A An illustration of the leaflet frame shown in , which has been cut longitudinally, unfolded, and laid flat to better illustrate the elements of the leaflet frame 200. Figure 2D yes Figure 2C A 2D zoomed-in view of the circle in . Figure 2E yes Figure 2C Magnified view of circle 2E in FIG.

[0122] Figure 7A Shown in a flat configuration Figure 1A A top view of the leaflets, and Figure 7B Shown Figure 7A An enlarged view of box 7B. Figure 7A and7B The leaflet 310 is shown flat to better illustrate its shape and features, but it should be understood that when the leaflet is coupled to the frame, the shape of the leaflet is determined at least in part by the shape of the leaflet frame, the shape of the leaflet attachment surface, and the fluid pressure encountered by the leaflet during operation.

[0123] In various embodiments, leaflet frame 200 defines an annular shape having a leaflet frame inner surface 202 and a leaflet frame outer surface 203 opposite leaflet frame inner surface 202. In some embodiments, leaflet frame 200 further comprises a leaflet frame first edge 205 and a leaflet frame second edge 206 opposite leaflet frame first edge 205.

[0124] In various embodiments, the various leaflet frames described herein can be formed primarily by etching, cutting, laser cutting, stamping, three-dimensional printing or winding, and other suitable processes. The leaflet frame can be self-expanding or capsule-expandable (for example, when configured for transcatheter implantation) or non-expandable (for example, when configured for surgical implantation). The various leaflet frames can include, but are not limited to, any metal or polymeric material, such as a metal or polymeric material that is generally biocompatible and elastically deformable (for example, nitinol) or plastically deformable (for example, stainless steel). Other materials suitable for any leaflet frame described herein include, but are not limited to, other titanium alloys, stainless steel, cobalt-nickel alloys, polypropylene, acetyl homopolymers, acetyl copolymers, drawn filling tubes (for example, nitinol wire with a platinum core), other alloys or polymers, or any other material that is substantially biocompatible with sufficient physical and mechanical properties to be used as a frame described herein. The leaflet frame can be formed into an annular structure or a piece of material, which is then formed into an annular structure. The leaflet frame shape can be configured for transcatheter or surgical devices.

[0125] Furthermore, in various embodiments, the leaflet frame 200 can comprise any rigid or semi-rigid biocompatible material. Suitable materials for the leaflet frame 200 include, but are not limited to, titanium alloys, stainless steel, cobalt-nickel alloys, polypropylene, acetyl homopolymers, acetyl copolymers, other alloys or polymers, or any other substantially biocompatible material having sufficient physical and mechanical properties to function as the leaflet frame 200 described herein. In some embodiments, the frame 200 can comprise a shape memory material such as nitinol, a nickel-titanium alloy.

[0126] In various embodiments, the leaflet frame 200 can be wrapped with a material suitable for promoting tissue ingrowth, such as an ePTFE membrane. Prior to attaching the leaflets, all surfaces of the leaflet frame can be wrapped with the film. Additionally or alternatively, a polyethylene terephthalate fabric suitable for promoting tissue ingrowth (e.g., a fabric sold under the trade name "DACRON") can be coupled to one or both of the leaflet frame inner surface and the leaflet frame outer surface of the leaflet frame, and optionally positioned between each leaflet frame protrusion prior to attaching the leaflets.

[0127] According to some embodiments, leaflet frame 200 is annular about the central longitudinal axis AB of prosthetic valve 100, such as Figure 1A In some embodiments, the leaflet frame 200 defines a plurality of leaflet windows 204, each leaflet window 204 being complementary in shape to the leaflet attachment region 330 of the leaflet 310. In some embodiments, the leaflet windows 204 are defined in part by a leaflet window base 207 and a plurality of commissure post supports 208. Figure 1A In the illustrated example, the leaflet window base 207 is flanked on each side by commissure strut supports 208, which together define three sides of an arcuate isosceles trapezoid, wherein the leaflet frame second edge 206 at the leaflet window base 207 is substantially flat.

[0128] In some embodiments, the commissure posts 210 of the leaflet frame 200 are spaced equidistant from one another around the leaflet frame 200. In some embodiments, the commissure post supports 208 include portions of the leaflet frame 200 that are disposed beneath each commissure post 210 and between adjacent leaflet windows 204. In some embodiments, openings or holes are formed in one or more of the commissure post supports 208, as discussed further below.

[0129] A plurality of leaflet frame projections 260 are positioned on portions of the leaflet frame second edge 206 at the commissure post supports 208, the leaflet window bases 207, and the commissure posts 210 (referred to as leaflet retaining surfaces 233). Each, but not necessarily all, of the plurality of leaflet frame projections 260 can be disposed within a respective one of the plurality of leaflet apertures 308 of the leaflets 310, as discussed further below. Figure 1B An exemplary protrusion-hole junction (intersection) 333 is shown in the enlarged view of frame 1B shown in FIG.

[0130] As shown, in some embodiments, leaflet frame projections 260 may extend from one or more leaflet retention surfaces 233 and may be configured such that each projection extends through one of the leaflet apertures 308 to constrain the leaflets 310 and / or prevent the leaflets from lifting (bulging) away from the leaflet retention surfaces 233. The leaflet frame projections 260 may be an integral part of or integral with the leaflet frame 200 and may project from one or more leaflet retention surfaces 233, such as the leaflet frame second edge 206, in a direction that is orthogonal to the surface or non-orthogonal (i.e., at an angle of less than 90 degrees to the leaflet retention surface 233) (as shown). In various embodiments, each leaflet frame projection 260 of the leaflet frame 200 projects from the leaflet retention surface 233 in a direction that is substantially orthogonal to the leaflet retention surface 233. However, in various other embodiments, it will be appreciated that one or more of the leaflet frame projections 260 project from the leaflet retention surface in a direction that is different from the direction that is substantially orthogonal to the leaflet retention surface 233. For example, one or more leaflet frame projections 260 may extend substantially parallel to the central longitudinal axis AB, and for those leaflet retaining surfaces that are not perpendicular to the central longitudinal axis AB (or are at other angles relative to the central longitudinal axis), the central longitudinal axis may be oriented differently from being substantially orthogonal to the leaflet retaining surface. Figures 3A-3E , 4A-4B, 5A-5B and 6A-6B.

[0131] In various embodiments, adjacently positioned leaflet frame projections 260 can be spaced apart from each other by a distance X (e.g., see Figure 1B ), the distance X sufficiently distributes the load on the leaflet attachment area 330 of the leaflet 310 without significantly affecting its structural integrity. Moreover, the distance can be small enough so that the leaflet attachment area 330 is sufficiently adjacent to the leaflet retention surface 233 such that fluid leakage therebetween is insignificant or non-existent. Various non-limiting example distances range from 0.5 mm to 2 mm, such as 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, or 2 mm.

[0132] In various embodiments, the leaflet frame projections 260 are coupled to or integral with a restraining element that is configured to provide mechanical interference to prevent the leaflets from detaching from each leaflet frame projection 260. For example, in some embodiments, the leaflet frame projections 260 themselves can be configured to prevent the leaflets from detaching. Specifically, as Figures 3A-3EAs shown, the leaflet frame protrusion 260 can define a protrusion base 262 and a protrusion head 264 that defines a protrusion tip 266 (eg, a protrusion head tip).

[0133] In various embodiments, the leaflet frame 200 can be operable to mechanically couple and support the leaflets 310 at least in part with a plurality of leaflet frame projections 260 that are spaced apart and project from one or more leaflet retention surfaces 233 of the leaflet frame 200 (e.g., the leaflet frame 200 can be operable to engage the leaflets 310). In various embodiments, the one or more leaflet retention surfaces 233 are one or more leaflet frame edges, such as one or more of the leaflet frame first edge 205, the leaflet frame second edge 206, and the respective edges of the commissure posts 210, as described below. As described above, in various embodiments, the leaflet frame projections 260 are each configured to extend through the leaflet apertures 308 defined by the leaflets 310 within one or more leaflet attachment regions 330 of the leaflets 310. In some embodiments, the leaflet frame projections 260 can have a tongue-like shape that operates to minimize the likelihood of the leaflets 310 becoming disengaged (or "backing off") from the leaflet frame projections 260, as discussed further below.

[0134] In some embodiments, the leaflet frame 200 defines an annular shape and has a central longitudinal axis AB ( Figure 1A ). In various embodiments, the leaflet frame includes a plurality of commissure posts 210 to which one or more leaflets are attached. In some embodiments, the commissure posts are spaced apart from one another. In some embodiments, one or more of the commissure posts extend substantially parallel to a central longitudinal axis (e.g., axis AB) of the leaflet frame. In various embodiments, the commissure posts 210 are arranged such that leaflet windows 204 are defined between adjacently positioned commissure posts 210. It will be appreciated that in various embodiments, the leaflet frame 200 includes a plurality of leaflet windows 204. In some embodiments, each commissure post 210 extends from one or more commissure post supports 208. In various embodiments, one or more commissure post supports 208 extend from or are otherwise supported by the base 201 of the leaflet frame 200 and include a plurality of sides including a first side 236 of the commissure post support and a second side 238 of the commissure post support. In some embodiments, one or more of the commissure post supports 208 include one or more apertures, as discussed in more detail below. That is, while Figures 1A-1DThe leaflet frame 200 shown in Figures 2A-2F includes commissure post supports 208 below the commissure posts 210, which include continuous walls, but in various embodiments, one or more of the commissure post supports 208 include openings or holes. For example, in some embodiments, one or more of the commissure post supports 208 is configured as an open triangular frame defined by the first and second sides 236, 238 of the commissure post supports and the base 201.

[0135] exist Figure 1A and 2A In the exemplary illustration shown, each leaflet window 204 is further defined by a leaflet frame second edge 206. In some embodiments, the leaflet frame second edge 206 extends between adjacently positioned commissure posts 210. Specifically, in some embodiments, the leaflet frame second edge 206 extends along a plurality of commissure post supports 208 from which adjacently positioned commissure posts 210 extend, and the leaflet frame second edge extends along a leaflet window base 207 located between the plurality of commissure post supports 208. In some embodiments, the leaflet frame second edge 206 defines a leaflet frame recess 240 within which the leaflet window 204 is defined. Typically, the leaflet frame recess 240 can be curved, angled, or include a combination of angled and curved features. In various embodiments, the leaflet window 204 flanks each side of the commissure posts 210. As Figure 1A As shown, the leaflet window base 207 and commissure post support 208, in combination with two adjacently positioned commissure posts 210, form the perimeter of the leaflet support structure that supports the leaflets 310 (except for the leaflet free edges 312).

[0136] As described above, in various embodiments, the commissure post 210 extends from or is supported by the commissure post support 208. In some embodiments, the apex 232 is formed at the intersection or transition between the commissure post support 208 and the commissure post 210. In some embodiments, the apex 232 is formed at the junction of the first side 236 and the second side 238 of the commissure post support, such as Figure 2B In some embodiments, as shown Figure 9A As shown, an apex 232 is formed at the junction of two leaflet frame elements (eg, two commissure post supports 208).

[0137] Typically, each commissure post 210 includes a post outer side 211 and a post inner side 212 opposite the post outer side 211. In some embodiments, the post outer side 211 includes a surface corresponding to or otherwise continuous with the leaflet frame outer surface 203. Similarly, in some embodiments, the post inner side 212 includes a surface corresponding to or otherwise continuous with the leaflet frame inner surface 202.

[0138] In various embodiments, each commissure post 210 includes a spine 213, a plurality of teeth extending from the spine 213, and a plurality of slots extending along and between the teeth and at least the spine 213. It will be understood that, unless otherwise noted, the slots are typically free of leaflet frame protrusions. The spine 213 is typically located between the first tooth 214 and the second tooth 215 and extends from the commissure post support 208 to a commissure tip 221. In some examples, the commissure tip 221 defines the free end of the commissure post 210. As discussed in more detail below, the spine 213 provides for separation between adjacently positioned leaflets 310 at the commissure post 210. Thus, the width of the spine 213 is typically selected based on the desired degree of separation between adjacently positioned leaflets 310 at the commissure post 210. For example, a wider spine 213 is associated with a greater degree of separation between adjacently positioned leaflets 310 at the commissure post 210. It will be appreciated that a configuration including a wider ridge that imparts a greater degree of separation between adjacently positioned leaflets 310 at commissure posts 210 can be associated with some flow of fluid through these areas even during coaptation of adjacently positioned leaflets 310. Flow in this configuration serves to minimize thrombus formation in these areas. Thus, the width of ridge 213 can be selected based on the desired degree of flow through prosthetic valve 100 during coaptation (e.g., valve closure).

[0139] In various embodiments, the teeth of each commissure post 210 extend from or are otherwise coupled to the ridge 213. For example, Figure 2D As shown, the commissure post 210 includes a first tooth portion 214 and a second tooth portion 215, both of which extend from the ridge portion 213. Figure 2DIn the example shown, the first and second teeth 214, 215 are shown extending from the ridge 213 at or near the commissure tips 221. However, in some embodiments, one or more of the first and second teeth 214, 215 can extend from the ridge at or near the commissure post supports 208 or the apex 232, or from any point between the commissure tips 221 and the commissure post supports 208 or the apex 232. In some embodiments, the first and second teeth 214, 215 converge from opposite sides of the ridge 213 to form the commissure tips 221.

[0140] In various embodiments, one or more of the teeth of commissure posts 210 comprise free ends or ends that are not otherwise coupled to or integral with leaflet frame 200 (including commissure posts 210), but are instead extensions of a portion of a tooth that is coupled to or otherwise integral with leaflet frame 200 (including commissure posts 210). Figure 2E As shown, first tooth 214 includes a free end 218, and second tooth 215 includes a free end 219. However, as discussed in more detail below, in various embodiments, one or more of the teeth of commissure post 210 are configured such that each respective end of the tooth is coupled to or otherwise integral with leaflet frame 200. That is, in some embodiments, one or more of the teeth do not include a free end.

[0141] As described above, one or more of the commissure posts 210 generally include a plurality of slots located between the teeth of the commissure posts 210 and the ridges 213. In other words, in various embodiments, one or more of the teeth of the commissure posts 210 are offset from the ridges 213 such that one or more slots or depressions are formed therebetween. Figure 2D The slots, shown as first slot 216 and second slot 217, extend along each side of ridge 213 between first tooth 214 and second tooth 215. In some embodiments, ridge 213 includes a first edge 222 and a second edge 223. In some embodiments, first edge 222 of ridge 213 faces first tooth 214 and partially defines first slot 216. Similarly, in some embodiments, second edge 223 of ridge 215 faces second tooth 214 and partially defines second slot 217.

[0142] One or more of the slots of the commissure posts 210 may extend or be oriented such that the longitudinal length of the slot is substantially parallel to the central longitudinal axis AB of the leaflet frame 200. In some embodiments, the slots of the commissure posts 210 are parallel to one another. Additionally or alternatively, one or more of the slots of the commissure posts 210 may not be parallel to one another. For example, the slots of the commissure posts 210 may diverge from one another in the direction of the outflow side A toward the commissure ends 221 at a position below the commissure ends 221. In some examples, one or more of the slots of the commissure posts 210 may be slightly curved or include a non-linear portion along the length of the slot.

[0143] In various embodiments, each slot of the commissure post 210 is sized to have a width to accommodate the thickness of at least one of the leaflets 310 and a length to accommodate a portion of the length of a leaflet attachment region 330 that can be coupled to a corresponding tooth of the commissure post 210, as discussed in further detail below.

[0144] In various embodiments, the first slot 216 is further defined by the first inner edge 224 of the first tooth 214. Figure 2D As shown in , the first inner edge 224 of the first tooth 214 extends along a portion of the ridge 213 of the first tooth 214 that faces the commissure post 210 between the first free end 218 of the first tooth 214 and the area where the first tooth 214 is coupled to the commissure post 210 or otherwise extends from the commissure post 210. Similarly, in various embodiments, the second slot 217 is also defined by the second inner edge 226 of the second tooth 215. Figure 2D , the second inner edge 226 of the second tooth 215 extends along a portion of the spine 213 of the second tooth 215 that faces the commissure post 210, between the second free end 219 of the second tooth 214 and the area where the second tooth 215 is coupled to or otherwise extends from the tooth 213. It will be understood that in embodiments where the teeth of the commissure posts do not include free ends, the inner edge of each tooth generally extends between the area where the teeth are coupled to or otherwise extend from the leaflet frame 200 (including the commissure posts 210). As discussed in more detail below, each slot of the commissure posts 210 is configured to receive a portion of a leaflet 310 extending therethrough to enable the leaflet 310 to mate with or otherwise be coupled to the leaflet frame 200.

[0145] It should be understood that in embodiments where the teeth of the commissure posts 210 include free ends, the slots defined between the spines of the commissure posts 210 and such teeth are open slots. That is, rather than being accessible only from the post exterior 211 or post interior 212, the slots are open on one end, or otherwise include at least one end that is open and accessible from one end of the slot. As will be understood by those skilled in the art, configurations including slots having at least one open end generally facilitate assembly because, rather than requiring a portion of the leaflet 310 to be threaded into a closed slot, the leaflet 310 can be slid into the slot from the open end thereof.

[0146] In addition to the inner edge, each tooth of the commissure post 210 typically includes an outer edge. Typically, as discussed in more detail below, the inner and outer edges of the teeth of the commissure post 210 interface with the leaflets 310 and facilitate coupling between the leaflets 310 and the leaflet frame 200. In some embodiments, the outer edge of the tooth typically extends between a first region where the tooth is coupled to or otherwise extends from the ridge 213 and a free end of the tooth (or alternatively, a second region where the tooth is coupled to or otherwise extends from the ridge 213 or other portion of the leaflet frame 200). Figure 2D As shown, first tooth 214 includes a first outer edge 225 extending between first free end 218 and commissure end 221 of first tooth 214. Similarly, second tooth 215 includes a second outer edge 227 extending between second free end 219 and commissure end 221 of second tooth 215.

[0147] In various embodiments, the first edge 222 of the ridge 213 is continuous with or otherwise intersects the first inner edge 224 of the first tooth 214. Similarly, in various embodiments, the second edge 223 of the ridge 215 is continuous with or otherwise intersects the second inner edge 226 of the second tooth 214. In embodiments including teeth with free ends, the transition between the inner and outer edges of the teeth occurs at or near the free ends of the teeth. For example, the transition or intersection between the first inner edge 224 and the first outer edge 225 of the first tooth 214 occurs at or near the first free end 218 of the first tooth 214. Similarly, the transition or intersection between the second inner edge 226 and the second outer edge 227 of the second tooth 215 occurs at or near the second free end 219 of the second tooth 215.

[0148] In various embodiments, one or more leaflet frame projections 260 extend from first outer edge 225 of first tooth 214 and second outer edge 227 of second tooth 215, respectively. Thus, in various embodiments, one or more of the teeth of commissure post 210 include one or more leaflet frame projections 260 extending from a surface of the tooth opposite the surface defining the slots through which leaflets 310 extend, so as to mate or otherwise couple leaflets 310 to leaflet frame 200.

[0149] As discussed above and further below, this configuration provides for a portion of the leaflet 310 to be wrapped (completely or partially) around a corresponding tooth (e.g., one or more edges of a corresponding tooth and / or one or more surfaces of a corresponding tooth) prior to being secured to one or more leaflet frame projections 260 extending from the corresponding tooth. In various embodiments, wrapping the leaflet 310 around one or more portions of the leaflet frame 200 prior to securing the leaflet 310 to the leaflet frame projections 260 can be operable to maintain the coupling between the leaflet 310 and the leaflet frame 200. It will be appreciated that one factor contributing to leaflet failure (e.g., due to tearing and / or separation of the leaflet from the leaflet frame) is that when the prosthetic valve is closed and under fluid backpressure, peak stresses in the leaflet typically occur at the commissure regions (e.g., where the leaflet is attached, engaged, or otherwise coupled to the leaflet frame). It has been observed that wrapping the leaflet 310 around a portion of the leaflet frame 200 before securing the leaflet 310 to the leaflet frame protrusions 260 extending from corresponding teeth of the commissure posts 210 can help reduce undesirable loads and stress concentrations in the leaflet 310 (at least in part due to the "capstan effect") and help minimize the likelihood of leaflet 310 failure.

[0150] As described above, according to some embodiments, the leaflet frame 200 includes a plurality of leaflet frame protrusions 260 that facilitate mechanical interference to prevent the leaflets from detaching from each leaflet frame protrusion 260. Referring again to Figures 3A-3E In various embodiments, the protrusion base 262 meets the leaflet retaining surface 233 (in this case, the leaflet frame second edge 206) at one end and meets the protrusion head 264 at its opposite end. In some embodiments, the protrusion head 264 meets the protrusion base 262 at one end and terminates at a protrusion tip 266 at its opposite end.

[0151] In various embodiments, the protrusion head 264 has a second transverse dimension 265 that is wider than the first transverse dimension 263 of the protrusion base 262. The transition between the wider protrusion head 264 and the narrower protrusion base 262 can be gradual, abrupt, or somewhere in between. For example, the protrusion head 264 can define a bulbous shape (e.g., Figure 3D In various embodiments, the relative difference between the largest second transverse dimension 265 within the projection head 264, referred to as the projection head transverse dimension 265a, and the narrowest first transverse dimension 263 within the projection base 262, referred to as the projection base transverse dimension 263a, can be between 20% and 160%, such as greater than 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 110%, 120%, 130%, 140%, 150%, or any value or range therein. In various embodiments, the narrowest first transverse dimension 263 within the projection base 262 can be directly adjacent to the leaflet retention surface 233 where the projection base 262 meets.

[0152] Other protrusion configurations are also contemplated, and those shown and described herein should not be construed as limiting. For example, in some other embodiments, the protrusion head 264 and the protrusion base 262 have substantially the same transverse dimensions or cross-sectional areas. For example, the leaflet frame protrusion 260 may define a helical post. In another example, the leaflet frame protrusion 260 is a straight post protruding from the leaflet retaining surface 233, an embodiment of which is shown in FIG. Figure 3E Shown in.

[0153] In various embodiments, projection head 264 can be tapered such that the surface area of projection tip 266 is smaller than the cross-section at the maximum cross-section of projection head 264. Furthermore, in some embodiments, projection tip 266 is sized such that the surface area of projection tip 266 is smaller than the area of leaflet aperture 308. It will be appreciated that during manufacturing, this shape operates to help guide leaflet 310 onto leaflet frame projection 260 at one of leaflet apertures 308 during the attachment process of leaflet 310 to leaflet frame 200.

[0154] In some embodiments, the protrusion head 264 can be pointed to facilitate penetration of the leaflets 310. Such an example can include forming the leaflet holes 308 during the attachment process. That is, in some embodiments, the leaflets 310 do not include pre-formed leaflet holes 308 (or alternatively include fewer than all desired leaflet holes 308). In some embodiments, the pointed portion of the leaflet frame protrusion 260 can also facilitate penetration of the prosthetic valve catheter when forming the catheter, as described below.

[0155] The cross-sectional shape of the projection base 262 can be any shape, such as a triangle, a rectangle (e.g., a square), or an inverted rounded shape (e.g., an ellipse or a perfect circle). In various embodiments, the shape and size of the projection base 262, particularly at the leaflet retaining surface 233, are substantially the same as the shape and size of the leaflet aperture 308, except that the size of the leaflet aperture 308 can be slightly larger, such that when the projection base 262 is positioned adjacent to the leaflet retaining surface 233 of the leaflet frame 200, no strain or only negligible strain is applied to the portion of the leaflet attachment region 330 that defines the leaflet aperture 308.

[0156] Other embodiments of the leaflet frame protrusions 260 include leaflet frame protrusions that are operable to change shape or deform to retain the leaflets 310 on the leaflet retaining surface 233. Figures 4A-4B In the example shown, the protruding head 264 has a protruding head transverse dimension 265a that is uniform along the length on which the leaflet holes 308 can be disposed. In some embodiments, after the leaflet holes 308 are disposed on the protruding head 264, the protruding head 264 can be deformed in a manner that operates to retain the leaflets 310 on the leaflet retaining surface 233, as shown. Figure 4B As shown, the protruding head 264 includes a protruding head transverse dimension 265a that is greater than the dimension of the leaflet aperture 308 .

[0157] Similarly, in Figures 5A-5B In the embodiment of the present invention, the protrusion head 264 has an "O" shape, which has a maximum protrusion head transverse dimension 265a that is equal to or slightly larger than the size of the leaflet hole 308, as shown in FIG. Figure 5A In some embodiments, after the leaflet hole 308 is set on the protruding head 264, the protruding head 264 can be deformed in a manner that operates to hold the leaflet 310 on the leaflet retaining surface 233, as shown. Figure 5B As shown, the protruding head 264 includes a protruding head transverse dimension 265a that is greater than the dimension of the leaflet aperture 308 .

[0158] Similarly, in Figures 6A-6B In the embodiment of the present invention, the protrusion head 264 has the shape of two prongs 267, and the two prongs have a maximum protrusion head transverse dimension 265a, which is equal to or slightly larger than the size of the leaflet hole 308, such as Figure 6A In some embodiments, after the leaflet hole 308 is set on the protruding head 264, the two prongs 267 can be deformed away from each other and downwardly toward the leaflet retaining surface 233 to help promote the retention of the leaflet 310 on the leaflet retaining surface 233, as shown. Figure 6BAs shown, the protruding head 264 includes a protruding head transverse dimension 265a that is greater than the dimension of the leaflet aperture 308.

[0159] exist Figures 4A-6B In some embodiments, the protruding head 264 can be deformed in a variety of ways. In some embodiments, the protruding head 264 can be plastically deformed using mechanical means such as, but not limited to, crimping. In other embodiments, the protruding head 264 can additionally or alternatively include a shape memory material that can deform when exposed to high temperatures.

[0160] It should be understood that other restraining elements may be used to prevent the leaflets from separating from the leaflet frame projections 260, such as by preventing the leaflets from lifting away from the leaflet retaining surface, and the examples shown and described herein should not be construed as limiting.

[0161] Although the illustrated embodiments show leaflet windows in the shape of isosceles trapezoids, it will be understood that the elements or components of the leaflet frame 200 that define the leaflet windows may be configured to define other leaflet window shapes. Specifically, in some embodiments, the two leaflet window sides (the two leaflet window sides) and the leaflet window base therebetween may together define a parabola. Similarly, although the illustrated embodiments show commissures spaced equidistantly around the leaflet frame, it will be understood that the commissures may not be equidistantly spaced. Similarly, although the illustrated embodiments include three leaflets, it will be understood that the prosthetic valves and valved catheters of the present disclosure may include more or less than three leaflets, such as 2, 4, or 5 leaflets.

[0162] For later reference Figure 7A and 7B As described, the leaflet attachment region 330 of each leaflet 310 is a portion that extends through one of the first slot 216 and the second slot 217 of the commissure post 210 and is secured to the leaflet frame projection 260 along various portions of the leaflet frame 200 (e.g., the first and second teeth 214, 216 of the commissure post 210 and / or the commissure post support 208 and / or the leaflet window base 207). As described above, the folded portion 324 of the leaflet base 325 is wrapped around or otherwise wrapped around one or more portions (e.g., one or more edges and / or one or more surfaces) of the corresponding teeth of the commissure post 210. Figure 2F It is along line 2F of commissure column 210 Figure 2E , which shows the first folded portion 324a and the second folded portion 324b of the first lobe 310a and the second lobe 310b, respectively, which are wrapped around the respective parts of the corresponding teeth 214 and 215. Figure 2FAs shown, in some embodiments, the first and second folded portions 324a, 324b of the first and second leaflets 310a, 310b wrap around respective teeth 214, 215 such that less than all of the surfaces and edges of the respective teeth 214, 215 are covered by the folded portions 324. In this example, the folded portions 324a, 324b of the first and second leaflets 310a, 310b at least partially wrap around respective teeth 214, 215 of the commissure post 210. However, as discussed in more detail below, in various other embodiments, the folded portions 324 of one or more leaflets 310 can wrap around respective teeth such that all of the surfaces and edges of the respective teeth are covered by the folded portions 324.

[0163] Continue to refer Figure 2F First tooth portion 214 includes a first inner edge 224, a first outer surface 228, a first outer edge 225, and a first inner surface 229. In various embodiments, first outer surface 228 extends between and adjacent to first inner edge 224 and first outer edge 225. In various embodiments, first inner surface 229 also extends between and adjacent to first inner edge 224 and first outer edge 225. Therefore, in various embodiments, each of first inner edges 224 and 225 extends between and adjacent to each of first outer surfaces 228 and 229. As shown in the figure, first inner edge 224 and first outer surface 228 intersect at a first corner. Similarly, as shown in the figure, first outer surface 228 and first outer edge 225 intersect at a second corner. Similarly, as shown in the figure, first outer edge 225 and first inner surface 229 intersect at a third corner. Similarly, as shown in the figure, first inner surface 229 and first inner edge 224 intersect at a fourth corner. In some examples, first inner edge 224 , first outer surface 228 , first outer edge 225 , and first inner surface 229 at least partially define first tooth 214 .

[0164] like Figure 2FAs shown, the second tooth portion 215 includes a second inner edge 226, a second outer surface 230, a second outer edge 227, and a second inner surface 231. In various embodiments, the second outer surface 230 extends between and adjacent to the second inner edge 226 and the second outer edge 227. In various embodiments, the second inner surface 231 also extends between and adjacent to the second inner edge 226 and the second outer edge 227. Therefore, in various embodiments, each of the second inner edges 226 and 227 extends between and adjacent to the second outer surfaces 230 and 231. As shown, the second inner edge 226 and the second outer surface 230 intersect at a first corner. Similarly, as shown, the second outer surface 230 and the second outer edge 227 intersect at a second corner. Similarly, as shown, the second outer edge 227 and the second inner surface 231 intersect at a third corner. Similarly, as shown, the second inner surface 231 and the second inner edge 226 intersect at a fourth corner. In some examples, second inner edge 226 , second outer surface 230 , second outer edge 227 , and second inner surface 231 at least partially define second tooth 215 .

[0165] like Figure 2F As shown, the folded portion 324a of the first lobe 310a extends through the first slot 216 between the first edge 222 of the ridge 213 and the first inner edge 224 of the first tooth 214. As shown, the folded portion 324a of the first lobe 310a includes a first fold 326a, such that the folded portion 324a of the first lobe 310a extends along the first outer surface 228 of the first tooth 214. In some embodiments, the first fold is adjacent to the first corner. As shown, the folded portion 324a of the first lobe 310a includes a second fold 327a, such that the folded portion 324a of the first lobe 310a extends along the first outer edge 225 of the first tooth 214. In some embodiments, the second fold is adjacent to the second corner. As shown, the folded portion 324a of the first lobe 310a is disposed on a lobe frame protrusion 260 extending from the first outer edge 225 of the first tooth 214. As shown, in this embodiment, the folded portion 324a of the first lobe 310a does not extend along the first interior surface 229 of the first tooth 214. It will be understood that although the folded portion 324a of the first lobe 310a is Figure 2F22. The first outer surface 228 is shown as including gaps between the first inner surface 224 and the corresponding folded portion 324a extending along it, the first outer surface 228 and the corresponding folded portion 324a extending along it, and the first outer edge 225 and the corresponding folded portion 324b extending along it, but the folded portion 324a may contact one or more of the first inner surface 224, the first outer surface 228 and the first outer edge 225.

[0166] Similarly, and continuing with reference to Figure 2F The folded portion 324b of the second leaflet 310b extends through the second slot 217 between the second edge 223 of the ridge 214 and the second inner edge 226 of the second tooth 215. As shown, the folded portion 324b of the second leaflet 310b includes a second fold 326b, such that the folded portion 324b of the second leaflet 310b extends along the second outer surface 230 of the second tooth 215. In some embodiments, the first fold is adjacent to the first corner. As shown, the folded portion 324b of the second leaflet 310b includes a second fold 327b, such that the folded portion 324b of the second leaflet 310b extends along the second outer edge 227 of the second tooth 215. In some embodiments, the first fold is adjacent to the second corner. As shown, the folded portion 324b of the second leaflet 310b is disposed on a leaflet frame protrusion 260 extending from the second outer edge 227 of the second tooth 215. As shown, in this embodiment, the folded portion 324b of the second leaflet 310b does not extend along the second inner surface 231 of the second tooth 215. It will be understood that although the folded portion 324b of the second leaflet 310b is Figure 2F 22. The second outer surface 230 is shown as including gaps between the second inner edge 226 and the corresponding folded portion 324b extending along it, the second outer surface 230 and the corresponding folded portion 324b extending along it, and the second outer edge 227 and the corresponding folded portion 324b extending along it, but the folded portion 324b may contact one or more of the second inner edge 226, the second outer surface 230 and the second outer edge 227.

[0167] Figure 2G FIG2G is a cross-sectional view of a commissure post 210 according to another embodiment of the present invention. FIG2G shows the first folded portion 324a and the second folded portion 324b of the first leaflet 310a and the second leaflet 310b, respectively, which are wrapped around the respective portions of the corresponding teeth 214 and 215. Figure 2GAs shown, in some embodiments, first and second folded portions 324a, 324b of first and second leaflets 310a, 310b are wrapped around respective teeth 214, 215 such that less than the entire surface and edge of respective teeth 214, 215 are covered by folded portions 324. In this example, folded portions 324a, 324b of first and second leaflets 310a, 310b are at least partially wrapped around respective teeth 214, 215 of commissure post 210.

[0168] Continue to refer Figure 2G , the folded portion 324a of the first lobe 310a passes through the first narrow slot 216 between the first edge 222 of the ridge 213 and the first inner edge 224 of the first tooth 214. As shown, the folded portion 324a of the first lobe 310a includes a first fold 326a, so that the folded portion 324a of the first lobe 310a extends along the first outer surface 228 of the first tooth 214. As shown, the folded portion 324a of the first lobe 310a is set on the lobe frame protrusion 260 extending from the first outer surface 228 of the first tooth 214. As shown, in this embodiment, the folded portion 324a of the first lobe 310a does not extend along the first outer edge 225 or the first inner surface 229 of the first tooth 214 (see Figure 2H ). It will be understood that although the folded portion 324a of the first leaflet 310a is Figure 2G 224 and the corresponding folded portion 324a extending along the same, and the first outer surface 228 and the corresponding folded portion 324a extending along the same, but the folded portion 324a may contact one or more of the first inner surface 224 and the first outer surface 228.

[0169] Similarly, and continuing with reference to Figure 2G , the folded portion 324b of the second lobe 310b extends through the second narrow groove 217 between the second edge 223 of the ridge 214 and the second inner edge 226 of the second tooth 215. As shown, the folded portion 324b of the second lobe 310b includes a first fold 326b, so that the folded portion 324b of the second lobe 310b extends along the second outer surface 230 of the second tooth 215. As shown, the folded portion 324b of the second lobe 310b is set on the lobe frame protrusion 260 extending from the second outer surface 230 of the second tooth 215. As shown, in this embodiment, the folded portion 324b of the second lobe 310b does not extend along the second outer edge 227 or the second inner surface 231 of the second tooth 215. It will be understood that although the folded portion 324b of the second lobe 310b is Figure 2G22 and 23. The folded portion 324b is shown as including a gap between the second inner edge 226 and the corresponding folded portion 324b extending along it and the second outer surface 230 and the corresponding folded portion 324b extending along it, but the folded portion 324b may contact one or more of the second inner edge 226 and the second outer surface 230.

[0170] Figure 2H FIG2H is a cross-sectional view of a commissure post 210 according to another embodiment of the present invention. FIG2H shows the first folded portion 324a and the second folded portion 324b of the first leaflet 310a and the second leaflet 310b, respectively, which are wrapped around the respective portions of the corresponding teeth 214 and 215. Figure 2H As shown, in some embodiments, the first folded portion 324a and the second folded portion 215b of the first leaflet 310a and the second leaflet 310b are wrapped around the respective teeth 214 and 215 such that the folded portions 324a and 324b extend along each of the surfaces and edges of the respective teeth 214 and 215. In this example, the folded portions 324a and 324b of the first leaflet 310a and the second leaflet 310b are at least partially wrapped around the respective teeth 214 and 215 of the commissure post 210.

[0171] Continue to refer Figure 2H , the folded portion 324a of the first lobe 310a passes through the first slot 216 between the first edge 222 of the spine 213 and the first inner edge 224 of the first tooth 214. As shown, the folded portion 324a of the first lobe 310a includes a first fold 326a, such that the folded portion 324a of the first lobe 310a extends along the first outer surface 228 of the first tooth 214. As shown, the folded portion 324a of the first lobe 310a includes a second fold 327a, such that the folded portion 324a of the first lobe 310a extends along the first outer edge 225 of the first tooth 214. As shown, the folded portion 324a of the first lobe 310a includes a third fold 328a, such that the folded portion 324a of the first lobe 310a extends along the first inner surface 229 of the first tooth 214. In some embodiments, the third fold is adjacent to the third corner. As shown, the folded portion 324a of the first leaflet 310a is disposed on the leaflet frame protrusion 260 extending from the first interior surface 229 of the first tooth 214. It will be understood that although the folded portion 324a of the first leaflet 310a is disposed on the first interior surface 229 of the first tooth 214, Figure 2H22. The embodiment of the present invention is shown as including gaps between the first interior surface 224 and the corresponding folded portion 324a extending along it, the first exterior surface 228 and the corresponding folded portion 324a extending along it, the first exterior edge 225 and the corresponding folded portion 324b extending along it, and the first interior surface 229 and the corresponding folded portion 324b extending along it, but the folded portion 324a may contact one or more of the first interior surface 224, the first exterior surface 228, the first exterior edge 225 and the first interior surface 229.

[0172] Similarly, and continuing with reference to Figure 2H The folded portion 324b of the second lobe 310b extends through the second slot 217 between the second edge 223 of the spine 214 and the second inner edge 226 of the second tooth 215. As shown, the folded portion 324b of the second lobe 310b includes a first fold 326b, such that the folded portion 324b of the second lobe 310b extends along the second outer surface 230 of the second tooth 215. As shown, the folded portion 324b of the second lobe 310b includes a second fold 327b, such that the folded portion 324b of the second lobe 310b extends along the second outer edge 227 of the second tooth 215. As shown, the folded portion 324b of the second lobe 310b includes a third fold 328b, such that the folded portion 324b of the second lobe 310b extends along the second inner surface 231 of the second tooth 215. In some embodiments, the third fold is adjacent to the third corner. As shown, the folded portion 324b of the second leaflet 310b is disposed on the leaflet frame protrusion 260 extending from the second interior surface 231 of the second tooth 215. It will be understood that although the folded portion 324b of the second leaflet 310b is disposed on the second interior surface 231 of the second tooth 215, the folded portion 324b of the second leaflet 310b is disposed on the leaflet frame protrusion 260 extending from the second interior surface 231 of the second tooth 215. Figure 2H 2 and 3. The folded portion 324b is shown as including gaps between the second inner edge 226 and the corresponding folded portion 324b extending along it, the second outer surface 230 and the corresponding folded portion 324b extending along it, and the second outer edge 227 and the corresponding folded portion 324b extending along it, and the second inner surface 231 and the corresponding folded portion 324b extending along it, but the folded portion 324b may contact one or more of the second inner edge 226, the second outer surface 230, the second outer edge 227 and the second inner surface 231.

[0173] Figure 2I is a cross-sectional view of a commissure post 210 according to another embodiment of the present invention. Figure 2I The first folded portion 324a and the second folded portion 324b of the first lobe 310a and the second lobe 310b are shown, respectively, wrapped around the corresponding teeth 214 and 215. Figure 2IAs shown, in some embodiments, the first folded portion 324a and the second folded portion 324b of the first leaflet 310a and the second leaflet 310b are wrapped around the respective teeth 214 and 215, such that the surfaces and edges of the respective teeth 214 and 215 are completely covered by the folded portions 324. Thus, in this example, the folded portions 324a and 324b of the first leaflet 310a and the second leaflet 310b are completely wrapped around the respective teeth 214 and 215 of the commissure post 210.

[0174] Continue to refer Figure 2I , the folded portion 324a of the first lobe 310a passes through the first slot 216 between the first edge 222 of the ridge 213 and the first inner edge 224 of the first tooth 214. As shown, the folded portion 324a of the first lobe 310a includes a first fold 326a, such that the folded portion 324a of the first lobe 310a extends along the first outer surface 228 of the first tooth 214. As shown, the folded portion 324a of the first lobe 310a includes a second fold 327a, such that the folded portion 324a of the first lobe 310a extends along the first outer edge 225 of the first tooth 214. As shown, the folded portion 324a of the first lobe 310a includes a third fold 328a, such that the folded portion 324a of the first lobe 310a extends along the first inner surface 229 of the first tooth 214. As shown, the folded portion 324a of the first lobe 310a includes a fourth fold 329a such that the folded portion 324a of the first lobe 310a extends multiple times along the first inner edge 224 of the first tooth 214. That is, as shown, the folded portion 324a of the first lobe 310a is wrapped around the first tooth 214 such that the folded portion 324a of the first lobe 310a overlaps itself. In some embodiments, the fourth fold is adjacent to the fourth corner. As shown, the folded portion 324a of the first lobe 310a is disposed on a lobe frame protrusion 260 extending from the first inner edge 224 of the first tooth 214. It will be understood that although the folded portion 324a of the first lobe 310a is Figure 2I 22. The first outer surface 228 and the corresponding folded portion 324a extending along it are shown as including gaps between the first inner surface 224 and the corresponding folded portion 324a extending along it, the first outer surface 228 and the corresponding folded portion 324a extending along it, the first outer edge 225 and the corresponding folded portion 324b extending along it, and the first inner surface 229 and the corresponding folded portion 324b extending along it, but the folded portion 324a may contact one or more of the first inner surface 224, the first outer surface 228, the first outer edge 225 and the first inner surface 229.

[0175] Similarly, and continuing with reference to Figure 2I The folded portion 324b of the second lobe 310b extends through the second slot 217 between the second edge 223 of the spine 214 and the second inner edge 226 of the second tooth 215. As shown, the folded portion 324b of the second lobe 310b includes a first fold 326b, such that the folded portion 324b of the second lobe 310b extends along the second outer surface 230 of the second tooth 215. As shown, the folded portion 324b of the second lobe 310b includes a second fold 327b, such that the folded portion 324b of the second lobe 310b extends along the second outer edge 227 of the second tooth 215. As shown, the folded portion 324b of the second lobe 310b includes a third fold 328b, such that the folded portion 324b of the second lobe 310b extends along the second inner surface 231 of the second tooth 215. As shown, the folded portion 324b of the second lobe 310b includes a fourth fold 328b such that the folded portion 324b of the second lobe 310b extends multiple times along the second inner edge 226 of the second tooth 215. That is, as shown, the folded portion 324b of the second lobe 310b is wrapped around the second tooth 215 such that the folded portion 324b of the second lobe 310b overlaps itself. In some embodiments, the fourth fold is adjacent to the fourth corner. As shown, the folded portion 324b of the second lobe 310b is disposed on a lobe frame protrusion 260 extending from the second inner surface 231 of the second tooth 215. It will be understood that although the folded portion 324b of the second lobe 310b is Figure 2H 2 and 3. The folded portion 324b is shown as including gaps between the second inner edge 226 and the corresponding folded portion 324b extending along it, the second outer surface 230 and the corresponding folded portion 324b extending along it, the second outer edge 227 and the corresponding folded portion 324b extending along it, and the second inner surface 231 and the corresponding folded portion 324b extending along it, but the folded portion 324b may contact one or more of the second inner edge 226, the second outer surface 230, the second outer edge 227 and the second inner surface 231.

[0176] The above reference Figures 2F-2IThe various wrapping schemes shown and described should not be construed as limiting. That is, it should be understood that various alternative wrapping schemes can be envisioned and that these wrapping schemes fall within the scope of the present disclosure. It should also be understood that while the teeth shown and described herein are polygonal, one or more of the teeth can be cylindrical. That is, in some embodiments, one or more of the teeth include a continuous exterior surface. In some embodiments, similar to the embodiments and examples shown and described herein, one or more leaflet frame protrusions extend from a continuous exterior surface. Thus, in various examples, in a manner similar to the embodiments and examples shown and described herein, the leaflet 310 can be (partially or completely) wrapped around one or more teeth having a continuous exterior surface.

[0177] It should also be understood that the above reference Figures 2F-2I One or more of the various wrapping schemes shown and described may be used to secure, attach, or otherwise couple the leaflet 310 to the leaflet frame 200. For example, according to the above Figure 2F The wrapping scheme shown and described in FIG, the first leaflet can be connected to the leaflet frame 200, and according to the above Figure 2I Similarly, for a given leaflet 310, the leaflet 310 may be attached to the leaflet frame 200 according to the wrapping scheme shown and described above (e.g., Figure 2G ) is coupled to the first commissure post 210 and is wrapped according to a first of the wrapping schemes illustrated and described above (e.g., Figure 2H ) is connected to the second commissure post 210 of the leaflet frame 200.

[0178] Generally, the leaflets 310 extend radially inward from the leaflet frame 200 when coupled to the leaflet frame 200. As described above, the leaflets 310 are configured to be coupled to the leaflet frame 200 via a plurality of leaflet holes 308 located in the leaflet attachment region 330 of the leaflets 310, the leaflet holes 308 having a shape, size, and / or pattern complementary to the corresponding leaflet frame projections 260 of the leaflet frame 200.

[0179] In various embodiments, each leaflet 310 defines a leaflet attachment region 330, a leaflet belly region 322, and a leaflet free edge 312; the leaflet belly region 322 terminates at the leaflet free edge 312. The leaflet base 325 generally refers to the intersection between the leaflet attachment region 330 and the leaflet belly region 322. When assembled into the completed prosthetic valve 100, the leaflet belly region 322 of each leaflet 310 is the operative portion (working portion) of the leaflet 310. The leaflet attachment region 330 of each leaflet 310 is the portion that is used to secure the leaflet 310 to the leaflet frame 200.

[0180] According to various embodiments, the leaflet attachment region 330 can be coupled to the leaflet frame 200 at the commissure posts 210, the commissure post supports 208, and the leaflet window bases 207. More specifically, similar to Figure 1A , the leaflet attachment region 330 defines a plurality of leaflet apertures 308 that are configured to each receive a leaflet frame projection 260. As previously described, in various embodiments, the shape and size of the leaflet apertures 308 can be substantially the same as the shape and size of the projection bases 262 of the leaflet frame projections 260.

[0181] In some embodiments, the leaflets 310 are reinforced around one or more leaflet apertures 308. The reinforcement can be, for example, a thickened portion of the leaflet material that defines the leaflet aperture 308 in the leaflet attachment region 330. In some embodiments, the reinforcement can be a reinforcement strip 332 that is added to the leaflet 310 within the leaflet attachment region 330 and defines the leaflet aperture 308. In some embodiments, the reinforcement can be a folded portion to provide a double layer or three or more layers of leaflet material and define the leaflet aperture 308. In some embodiments, the reinforcement strip 332 can include the same leaflet material as the leaflet 310. In various embodiments, when connected to the leaflet frame 200, the reinforcement strip 332 can be located on the leaflet first side 311 of the leaflet 310, which faces the leaflet retaining surface 233 of the leaflet frame 200. Alternatively, the reinforcement strip 332 can be on the leaflet second side 313 opposite the leaflet first side 311. Alternatively, the reinforcement strip 332 may be on both the leaflet first side 311 and the leaflet second side 313 .

[0182] In various embodiments, when the leaflets 310 are in the fully open position, the prosthetic valve 100 has a substantially circular valve orifice 101 and, when the leaflets 310 are in the open position, allows fluid to flow through the valve orifice 101. In some embodiments, in the open position, each leaflet 310 extends from the leaflet frame inner surface 202 at an angle greater than 45 degrees.

[0183] In various embodiments, when the prosthetic valve 100 is closed, approximately half of each leaflet free edge 312 generally abuts an adjacent half of the leaflet free edge 312 of an adjacently positioned leaflet 310, e.g., as shown in FIG. Figure 1D In some embodiments, the leaflets 310 of the prosthetic valve converge at a central point. Figure 1A and 1DAs shown, the leaflets 310 meet or nearly meet at the triple point 348. When the leaflets 310 are in the closed position, the valve orifice 101 is generally blocked, thereby preventing or significantly reducing fluid flow through the valve orifice 101. In some embodiments, in the closed position, each leaflet 310 extends substantially perpendicularly from the leaflet frame inner surface 202. In some embodiments, the leaflets 310 exhibit a bias toward the closed position because the leaflets 310 extend from the leaflet frame inner surface 202 substantially perpendicularly to the central longitudinal axis AB of the leaflet frame 200, which defines the central longitudinal axis of the prosthetic valve 100. It will be appreciated that this configuration is beneficial in that the leaflets 310 will tend to close earlier during the phase of the cardiac cycle where blood deceleration or reversal occurs. This configuration generally tends to reduce backflow through the prosthetic valve 100.

[0184] When connected to the leaflet frame 200, the shape of each leaflet 310 is determined in part by the shape of the leaflet retaining surface of the leaflet frame element that defines the leaflet window 204 and the specific attachment method (e.g., wrapping around one or more portions of the leaflet frame 200 before the leaflet hole 308 engages the leaflet frame protrusion 260), as well as the shape of the leaflet attachment area 330 and the leaflet free edge 312.

[0185] Figure 7A Shown in a flat configuration Figure 1A FIG. 1 is a top view of a leaflet 310 used in prosthetic valve 100 of FIG. This view shows that leaflet 310 has a substantially isosceles trapezoidal shape with curved sides at leaflet attachment region 330. In some embodiments, the curvature corresponds to the curvature of leaflet frame 200 at the two commissure post supports 208 and leaflet window base 207, respectively. Figure 7A Also shown is an exemplary configuration in which the leaflet free edge 312 comprises a scalloped shape having an apex at the center flanked on each side by straight, generally concave edges near the apex. By modifying the geometry and dimensions of this flat pattern, the three-dimensional shape of the leaflet 310 can be varied. Of course, while not required, the shape of the leaflet 310 can also be influenced by other techniques, such as, but not limited to, leaflet molding and shape setting (forming).

[0186] In various embodiments, the leaflet 310 includes a folded portion 324 adjacent to the leaflet base 325. In some embodiments, the folded portion 324 includes a reinforcing strip 332. In various embodiments, the leaflet 310 is configured to wrap around a portion of one or more elements or components of the leaflet frame 200. For example, as described above, each commissure post 210 includes a first tooth 214 and a second tooth 215, and the folded portion 324 of the leaflet 310 is configured to wrap around or otherwise "fold" at least a portion of the first tooth 214 and the second tooth 215 of the commissure post 210.

[0187] In various embodiments, to facilitate wrapping around various leaflet frame elements (e.g., the teeth of commissure posts 210), the leaflet attachment region 330 can define one or more notches 323. The notches 323 can be located on the leaflets 310 such that, when coupled to the leaflet frame 200, the notches 323 are located at an intersection, joint, or other location between two leaflet frame elements (e.g., a location between the ends of the teeth and the supporting sides of the commissure posts). In some embodiments, as discussed in more detail below, the notches 323 are located on the leaflets such that, when coupled to the leaflet frame 200, the notches 323 are located between adjacent, discrete receiving slots (e.g., side, base, or commissure receiving slots) along the leaflet frame 200.

[0188] When connected to Figures 2A-2F When the leaflet frame 200 is provided, the first slot 216 and the second slot 217 of the commissure post 210 each receive a corresponding portion of the leaflet attachment region 330. In some embodiments, as Figure 2F As shown, the folded portion 324 of the leaflet 310 is disposed in the first slot 216 and wraps around the first tooth portion 214 from the inner side 212 to the outer side 211 of the commissure post 210. Figure 2F As further shown in FIG, the leaflet attachment region 330 including the leaflet holes 308 is disposed on the first outer edge 225 of the first tooth 214 such that each leaflet hole 308 is disposed about a corresponding leaflet frame protrusion 260 on the leaflet retaining surface 233, in this case the first outer edge 225 of the first tooth 214. In various embodiments, the folded portions 324 of adjacently positioned leaflets 310 are separated from one another at the commissure posts 210 by the ridges 213, as shown in FIG. Figure 2FAs shown and described above. In some embodiments, this configuration provides that the free edges 312 of the leaflets proximate or near the inner side 212 of the commissure posts 210 do not close together or otherwise contact each other (e.g., a slight gap is formed between adjacently positioned leaflets 310 proximate or near the inner side 212 of the commissure posts 210). It will be understood that the adjacently positioned leaflets close together at a point radially inward of the gap between the inner side 212 and the triple point 348. In some embodiments, this configuration helps minimize thrombosis at or near the inner side 212 of the commissure posts 210. However, it will be understood that alternative configurations provide folded portions 324 of adjacently positioned leaflets 310 that pass through a single post slot of the commissure posts so that the leaflet free edges 312 of the adjacently positioned leaflets 310 are operable to close together or contact each other at or near the inner side 212 of the commissure posts 210. An example of such a configuration is shown and described in the above-referenced U.S. Patent No. 9,855,141 to Dienno, the entire contents of which are incorporated herein by reference. In various embodiments, in addition to being engaged with one or more leaflet frame projections 260, leaflets 310 can be secured to one or more portions of leaflet frame 200, such as by adhesive, suturing, or some other suitable means, such as via one or more wrappings around one or more fibers, as discussed further below.

[0189] In various embodiments, as described herein, wrapping leaflets 310 around one or more portions of leaflet frame 200 helps to more evenly distribute loads applied to leaflets 310 and avoids stress concentrations in critical areas of leaflets 310, which could lead to premature failure of leaflets 310. In some embodiments, forces can be more evenly distributed by additionally or alternatively increasing the distance between leaflet orifices 308 and leaflet bases 325, which is the intersection between leaflet attachment regions 330 and leaflet belly regions 322.

[0190] In various embodiments, the leaflets 310 can be made of a polymer (non-biological tissue) or biological tissue, as discussed in more detail below. For example, in some embodiments, the leaflets 310 are made of a sheet of polymer material or biological tissue that has been cut into the shape of the leaflet holes 308 as shown in Figures 7A-7B. In various embodiments, the leaflets 310 can become "shaped" when attached to the leaflet frame 200. That is, before being coupled to the leaflet frame 200, the leaflets 310 are flat sheets of material, and when the leaflets 310 are coupled to the leaflet frame 200, the leaflets 310 take the shape of the leaflet holes 308. Figure 1A and 1DIn some embodiments, the leaflet 310 may be pre-formed. Pre-formed polymer leaflets are typically formed by cutting a polymer material cylinder into the following shapes: Figures 7A-7B 310 and the reinforcing strip 332. In some embodiments, the leaflet holes 308 are cut into both the leaflets 310 and the reinforcing strip 332. This can occur simultaneously or before the leaflets 310 and the reinforcing strip 332 are mated.

[0191] It will be understood that in some embodiments, while the leaflets 310 are passed through one or more slots and wrapped around one or more portions of the leaflet frame 200 prior to being positioned on one or more leaflet frame projections 260 on the leaflet retaining surface 233, one or more other portions of the leaflet frame 200 are positioned around one or more leaflet frame projections 260 on the leaflet retaining surface 233 without first passing through the leaflet frame's slots or being wrapped or wrapped around a portion of the leaflet frame 200. That is, in some embodiments, one or more other portions of the leaflets 310 are positioned around one or more leaflet frame projections 260 without being (partially or completely) wrapped or wrapped around the leaflet frame 200. For example, as Figure 1A As shown, those portions of leaflets 310 are coupled to leaflet frame 200 along commissure post supports 208, and leaflet window bases 207 do not first pass through slots or wrap around a portion of leaflet frame 200. Examples of other configurations in which leaflets 310 are coupled to leaflet frame 200 without first passing through slots or wrapping around a portion of leaflet frame 200 are shown and described in the aforementioned U.S. Patent No. 9,855,141 to Dienno.

[0192] Furthermore, while the examples shown and described above include slots without leaflet frame protrusions, in various embodiments, one or more slots of the leaflet frame may include one or more leaflet frame protrusions 260. In such embodiments, it will be understood that the leaflets 310 are wrapped around the surface of the leaflet frame 200 prior to being inserted into the slots and disposed around the one or more leaflet frame protrusions 260 included in the one or more slots.

[0193] Furthermore, while the embodiments shown and described above include a commissure post 210 having a plurality of teeth with free ends, in various other embodiments, one or more teeth of the commissure post are coupled to the leaflet frame 200 at both ends. That is, in various embodiments, the leaflet frame 200 includes one or more closed slots. Specifically, in various embodiments, one or more of the slots of the commissure post 210 are closed slots, such that a tooth defining a portion of the closed slot is coupled to the leaflet frame 200 at each end thereof. For example, a first end of a tooth is coupled to or extends from the spine 213 of the commissure post (e.g., at or near the commissure tip 221), and a second end of the tooth is coupled to or extends from below or below the first end. In some embodiments, the second end of the tooth is coupled to or extends from a portion of the spine 213 that is below or below the location where the first end of the tooth is coupled to or extends from the spine 213. In some other embodiments, the second end of the tooth is coupled to or extends from a portion of the leaflet frame below or inferior to the ridge 213 (eg, commissure post supports 208, leaflet window base 207, etc.).

[0194] While relatively sharp corners are shown in the various representative drawings of the present invention, it will be understood that chamfers, radii, recesses, coatings, and other features may be provided to avoid stress concentrations or other wear of the leaflets or other components in contact therewith.

[0195] Now go to Figure 8 The commissure post 210 of the leaflet frame 200 is shown to include a ridge 213, a first tooth 214, a second tooth 215, a first slot 216 defined between at least the first tooth 214 and the ridge 213, and a second slot 217 defined between at least the second tooth 215 and the ridge 213. As shown, each end of the first tooth 214 and the second tooth 215 terminates at or extends from the leaflet frame 200. Specifically, as shown, the first tooth 214 includes a first end extending from or otherwise coupled to (or terminates at) the commissure post 210 at a position above or above the first slot 216, and a second end extending from or otherwise coupled to (or terminates at) the apex 232 of the commissure post support 208. The respective ends of the first tooth 214 terminate at the first slot 216 of the leaflet frame 200, which can provide a closed position. It will be understood that passage of any portion of the leaflet 310 through the first slot 216 will require passing the leaflet 310 through the first slot 216 from one of the post inner side 212 and the post outer side 211 .

[0196] Similarly, the second tooth 215 includes a first end extending from or otherwise coupled to (or terminating at) the commissure post 210 at a position above or above the second slot 217, and a second end extending from or otherwise coupled to (or terminating at) the apex 232 of the commissure post support 208. The respective ends of the second tooth 215 terminating at the leaflet frame 200 can provide a closed second slot 217. It will be understood that passage of any portion of the leaflet 310 through the second slot 217 will require the leaflet 310 to be passed through the second slot 217 from one of the post inner side 212 and the post outer side 211.

[0197] As described above, the prosthetic valve 100 of the present invention can be configured for use in both transcatheter and surgical settings. Figure 9A and 9B , the leaflet frame 900 is operable for use in a transcatheter procedure, wherein the leaflet frame 900 has a smaller pre-deployment diameter and a larger deployed diameter. As described above, it should be understood that the embodiments of the specific configurations of the leaflet frame projections 260 and commissure posts 210 discussed herein can be used in either surgical or transcatheter prosthetic heart valves.

[0198] Figure 9A is an outflow side perspective view of a non-limiting example of a leaflet frame 900 for use in a transcatheter procedure. Figure 9B yes Figure 9A . Similar to the leaflet frame 200 discussed above, the leaflet frame 900 defines three leaflet windows 204, each of which follows the shape of the leaflet attachment area 330 of the leaflet. An exemplary transcatheter configuration in which the leaflets 310 are coupled to the leaflet frame for a transcatheter procedure is illustrated and described in the above-referenced U.S. Patent No. 9,855,141 to Dienno.

[0199] However, in various embodiments, the configuration of commissure post 210 discussed above, including a plurality of teeth and a plurality of slots separated by ridges, is an operable alternative to the commissure post configuration of the aforementioned US Patent No. 9,855,141 to Dienno.

[0200] Specifically, and with continued reference to Figure 9A and 9B , the leaflet frame 900 includes one or more commissure posts 210. Figure 9B As shown, and as described above, commissure post 210 of leaflet frame 900 includes ridge 213 , first tooth 214 , second tooth 215 , first slot 216 defined between at least first tooth 214 and ridge 213 , and second slot 217 defined between at least second tooth 215 and ridge 213 .

[0201] Although Figure 9A and 9B The first tooth portion 214 and the second tooth portion 215 of the commissure post 210 shown in FIG include a first free end 218 and a second free end 219, respectively. However, it should be understood that one or more of the first tooth portion 214 and the second tooth portion 215 can be configured to terminate at both ends at the leaflet frame 900 (inside), as described above with reference to FIG. Figure 8 discussed.

[0202] As shown, the first slot 216 and the second slot 217 extend along both sides of the ridge 213 between the ridge 213 and the first and second teeth 214, 215. In some embodiments, the ridge 213 includes a first edge 222 and a second edge 223. In some embodiments, the first edge 222 of the ridge 213 faces the first tooth 214 and partially defines the first slot 216. Similarly, in some embodiments, the second edge 223 of the ridge 215 faces the second tooth 214 and partially defines the second slot 217. As described above, in various embodiments, one or more of the slots of the commissure post 210 can extend or be oriented such that the longitudinal length of the slot is substantially parallel to the central longitudinal axis of the leaflet frame 900. Additionally or alternatively, one or more of the slots of the commissure post 210 can be slightly curved. In various embodiments, each slot of the commissure post 210 is sized to have a width to accommodate the thickness of at least one of the leaflets 310 and a length to accommodate a portion of the length of a leaflet attachment region 330 that can be coupled to a corresponding tooth of the commissure post 210, as discussed in further detail below.

[0203] In various embodiments, the first slot 216 is further defined by a first inner edge 224 of the first tooth 214. The first inner edge 224 of the first tooth 214 generally extends along a portion of the spine 213 of the first tooth 214 that faces the commissure post 210, between the first free end 218 of the first tooth 214 and the area where the first tooth 214 is coupled to or otherwise extends from the commissure post 210. Similarly, in various embodiments, the second slot 217 is further defined by a second inner edge 226 of the second tooth 215. The second inner edge 226 of the second tooth 215 generally extends along a portion of the spine 213 of the second tooth 215 that faces the commissure post 210, between the second free end 219 of the second tooth 214 and the area where the second tooth 215 is coupled to or otherwise extends from the tooth 215. It will be understood that in embodiments where the teeth of the commissure posts do not include free ends, the inner edge of each tooth generally extends between the regions where the teeth are coupled to the leaflet frame 900 (including the commissure posts 210) or otherwise extend from the leaflet frame 900. As described above, each slot of the commissure posts 210 is configured to receive a portion of a leaflet 310 extending therethrough to mate or otherwise couple the leaflet 310 to the leaflet frame 900. In some embodiments, the width of the slot remains constant, while in other embodiments, one or more slots include one or more tapered regions, such as one or more tapered ends where the slot width decreases.

[0204] As similarly discussed above, in addition to the inner edge, each tooth of the commissure post 210 generally includes an outer edge. For example, the first tooth 214 includes a first outer edge 225 extending between the first free end 218 of the first tooth 214 and the commissure end 221. Similarly, the second tooth 215 includes a second outer edge 227 extending between the second free end 219 of the second tooth 215 and the commissure end 221.

[0205] In various embodiments, the first edge 222 of the ridge 213 is continuous with or otherwise intersects the first inner edge 224 of the first tooth 214. Similarly, in various embodiments, the second edge 223 of the ridge 215 is continuous with or otherwise intersects the second inner edge 226 of the second tooth 214.

[0206] In various embodiments, one or more leaflet frame projections 260 extend from first outer edge 225 of first tooth 214 and second outer edge 227 of second tooth 215, respectively. Thus, in various embodiments, one or more teeth of commissure post 210 include one or more leaflet frame projections 260 extending from a surface of the tooth opposite a surface defining the slot through which leaflets 310 extend, so that leaflets 310 mate with or otherwise couple to leaflet frame 900.

[0207] As described above, this configuration provides for a portion of leaflet 310 to be wrapped (partially or fully) around the teeth prior to being secured to one or more leaflet frame projections 260 extending from the outer edges of the teeth. In various embodiments, wrapping leaflet 310 around a portion of leaflet frame 900 prior to securing leaflet 310 to leaflet frame projections 260 extending from the outer edges of the teeth of commissure posts 210 can operate to minimize undesirable loads and stress concentrations in leaflet 310 and minimize the likelihood of leaflet 310 failing due to fatigue (at least in part due to the "capstan effect").

[0208] As described above, in addition to engaging with one or more of the leaflet frame protrusions 260, the leaflets 310 can also be secured to one or more portions of the leaflet frame 200 by wrapping one or more portions of the leaflet frame around one or more retaining elements, such as one or more fibers, or otherwise coupled to one or more portions of the leaflet frame 200. For example, a retaining element is positioned on either side of the slot, and a portion of the leaflet is passed back and forth through the slot multiple times such that the leaflet forms a portion of a ring on either side of the slot. In some embodiments, a retaining element is positioned within each ring formed on either side of the slot such that the leaflet surrounds each retaining element. Typically, the width of the ring formed by the leaflet surrounding the retaining element exceeds the width of the slot, thereby preventing the leaflet and retaining element from being pulled through the slot.

[0209] According to various additional embodiments, the prosthetic valves shown and described herein can be incorporated into a valved catheter. A valved catheter can be used to replace a patient's natural heart valve and associated blood vessels. The pulmonary valve and pulmonary artery represent a non-limiting example of such a valve and associated blood vessels. The aortic valve and ascending aorta are another such example. The catheter portion of such a valved catheter typically includes an elongated tube, such as an elongated polymer tube, wherein the prosthetic valve 100 is disposed within the elongated polymer tube. In some embodiments, the catheter is formed from expanded polytetrafluoroethylene (ePTFE). The prosthetic valve (e.g., 100, 900, 1010) can be coupled to the elongated polymer tube using known methods, including, but not limited to, adhesives, fasteners, suturing, and friction retention. The catheter typically defines a first catheter end and a second catheter end. In various examples, the prosthetic valve (e.g., 100, 900, 1010) is disposed within the catheter. In some examples, the prosthetic valve is disposed within the catheter at one of the first and second ends of the catheter. In some examples, the prosthetic valve is disposed within the catheter between the first end and the second end. For example, in some examples, the prosthetic valve is disposed within the catheter such that a portion of the catheter extends axially outward from one or more of the inflow and outflow ends of the prosthetic valve to define a catheter lumen that is continuous along the longitudinal axis of the prosthetic valve, the prosthetic valve having a plurality of leaflets 310 operable within the catheter lumen. Examples of valved catheters and integration of various prosthetic valves therein are shown and described in U.S. Patent No. 9,855,141 to Dienno cited above. It will be appreciated that the prosthetic valve 100 of the present disclosure (e.g., including leaflet frames 200, 900, and 1020) can be operated to be incorporated into a valved catheter in the same or similar manner as those prosthetic valves shown and described in U.S. Patent No. 9,937,037 to Dienno.

[0210] According to various embodiments, a method of manufacturing a prosthetic valve includes forming (e.g., by cutting a metal tube, casting, molding, printing, etc.) a leaflet frame defining a leaflet frame window and one or more leaflet retention surfaces, having a commissure post therebetween, and forming a plurality of spaced-apart protrusions extending from the one or more leaflet retention surfaces. In various embodiments, each leaflet frame protrusion is configured to couple to the leaflets. The leaflet frame protrusion can have a protrusion base and a protrusion head, wherein the protrusion base meets the leaflet retention surface on one side and the protrusion head meets the leaflet retention surface on the opposite side. Some embodiments of the leaflet frame can further define one or more slots extending through one or more frame elements defining the leaflet frame window. Each slot is sized to accommodate leaflets of at least single thickness, such as a leaflet attachment area. The slot can be a base-receiving slot or a side-receiving slot. In addition, each commissure post defines a post slot sized to accommodate leaflets of double thickness. In further embodiments, the frame can include one or more attachment slots or other frame openings that define an inner edge from which the leaflet frame protrusions can extend.

[0211] The same or different methods may include obtaining a sheet or tube of material comprising one or more layers of expanded polytetrafluoroethylene composite, and cutting leaflets from the sheet or tube of material, wherein one or more holes are formed in the leaflet attachment area of the leaflet. The holes may be cut to a size suitable for coupling to a leaflet frame protrusion on the leaflet frame. Specifically, the hole may have a size and shape that is substantially the same as the cross-sectional size and shape of the base of the protrusion of the leaflet frame protrusion. The method may also include coupling a leaflet reinforcement to the leaflet, and further, cutting the leaflet holes into both the leaflet and the leaflet reinforcement.

[0212] The same or different methods may include coupling the leaflets to the leaflet frame by aligning the holes in the leaflets with corresponding protrusions on the leaflet frame, pressing the leaflet frame so that the leaflet protrusions extend through the holes, and / or pressing the leaflet frame so that multiple leaflet protrusions extend through multiple holes. In further embodiments, the method may include pressing the leaflets or leaflet frame so that the leaflet surfaces defining the holes contact the leaflet retaining surfaces. These steps may be repeated for adjacent holes and corresponding adjacent protrusions until each hole extends through a corresponding one of the leaflet frame protrusions.

[0213] In some embodiments, before pressing the leaflet frame to extend the leaflet projection through the leaflet orifice, one or more portions of the leaflet are passed through one or more slots in the leaflet frame and wrapped around the leaflet frame to achieve one of the various passing and wrapping configurations shown and described above. That is, in some embodiments, coupling the leaflet to the leaflet frame can include first passing a portion of the leaflet defining the leaflet attachment area through a receiving slot (e.g., in a commissure post, a commissure post support, a leaflet window base, or some other appropriate feature of the leaflet frame as described herein), then wrapping the leaflet attachment area around one or more features of the leaflet frame (e.g., a tooth of a commissure post), and then aligning one of the holes in the leaflet with a corresponding projection on the leaflet frame, thereby pressing the leaflet frame projection through the hole and positioning the leaflet around the leaflet frame. These steps can be repeated for adjacent holes and corresponding projections until all holes extend through the projections. Alternatively, in some embodiments, the leaflet attachment region can be wrapped around one or more features of the leaflet frame (e.g., teeth of the commissure posts) before the portion of the leaflet defining the leaflet attachment region is passed through one or more receiving slots.

[0214] Additionally or alternatively, in various embodiments, one or more leaflet retention features can be employed to secure the leaflets to the leaflet frame 200. In various embodiments, the leaflet retention features are configured to couple to the leaflet frame 200. In some examples, the leaflet retention features can include one or more structural elements configured to interface with one or more portions of the leaflet frame 200, such as one or more of the leaflet frame protrusions 260, wherein interaction of the one or more structural elements with the one or more portions of the leaflet frame 200 operates to couple the leaflet retention features to the leaflet frame 200. In some examples, the leaflet retention features include fibers or wires interwoven with one or more features of the leaflet frame 200 (e.g., one or more features of the leaflet frame protrusions 260). The leaflet retention features are typically coupled to the leaflet frame 200 such that the leaflets 310 are positioned between the leaflet frame 200 and the leaflet retention features, such that after being disposed on the leaflet frame protrusions 260, the leaflets 310 can be secured to the leaflet frame 200. In some examples, a plurality of discrete leaflet retention features are employed to secure leaflets 310 to leaflet frame 200 .

[0215] In some examples, the leaflet retention features operate to minimize the likelihood of the leaflets 310 detaching from the leaflet frame 200. For example, in some examples, the leaflet retention features help minimize the likelihood of the leaflets 310 "pushing back (detaching / pushing back)" of the leaflet frame protrusions 260. That is, in some examples, the leaflet retention features are positioned adjacent to the leaflets 310 and engage the leaflet frame 200 (e.g., by engaging the leaflet frame protrusions 260) such that the leaflets 310 are physically hindered by the leaflet retention features and are unable to pull back the leaflet frame protrusions 260. In some examples, the leaflet retention features are configured so that when coupled to the leaflet frame 200, they exert a normal force on the leaflets 310, thereby compressing the portion of the leaflets 310 that is between the leaflet frame 200 and the leaflet retention member. In some examples, the configuration that includes compressing a portion of the leaflets 310 helps reduce or minimize wear of the leaflets 310 under normal operating conditions.

[0216] Figures 10 to 13 An illustration of an exemplary leaflet retention feature 400 is provided that can be used to secure the leaflets 310 to the leaflet frame 200. The leaflet retention feature 400 generally includes one or more features, elements, or components that accommodate, receive, or otherwise engage one or more of the leaflet frame protrusions 260 in a manner that maintains the coupling between the leaflet retention feature 400 and the leaflet frame 200. Such coupling is generally one of friction and / or interference. The leaflet retention feature 400 can be formed from any of the metals, metal alloys, or polymer materials discussed herein and can be formed by one or more known chemical etching, laser cutting, or microforming (molding) processes.

[0217] Leaflet retention feature 400 generally includes a body 402 having a first end 404, a second end 406 opposite first end 404, a first side 408, and a second side 410 opposite first side 408. In some examples, first side 408 and second side 410 extend between first end 404 and second end 406. In various examples, leaflet retention feature 400 includes one or more struts 412 extending between first side 408 and second side 410. That is, in various examples, one or more struts 412 interconnect or otherwise link first side 408 and second side 410. In some examples, one or more of these struts define first end 404 and second end 406.

[0218] In various examples, one or more struts 412 divide the leaflet retention feature into multiple cells, such as 414 and 416. As shown, multiple cells are defined between the first side 408 and the second side 410 and the adjacent struts 412. In various examples, one or more cells are "closed cells" because adjacent struts 412 define holes that extend between the first side 408 and the second side 410 and terminate therein, thereby defining a closed interior area 418 between the first side 408 and the second side 410 and the adjacent struts 412. In some examples, each cell of the leaflet retention feature 400 is a closed cell. However, in various other examples, the leaflet retention feature 400 may additionally or alternatively include one or more "open cells," or one or more of the cells that do not otherwise define a closed interior area, as discussed in more detail below. For example, in some examples, the leaflet retention feature 400 includes one or more struts 412 having free ends (e.g., one or more struts 412 that do not otherwise extend between the first side 408 and the second side 410).

[0219] In various examples, the interior region 418 is configured to accommodate the leaflet frame protrusions 260 when coupled to the leaflet frame 200. For example, in various examples, the leaflet retention features 400 are disposed on the leaflet frame 200 such that the leaflet frame protrusions 260 are received within or otherwise extend through the interior regions 418 of the cells of the leaflet retention features 400. In various examples, one or more of the first and second sides and the adjacently positioned struts engage or otherwise interface (interact) with the leaflet frame protrusions extending through the interior region. This engagement or interaction (interaction) between the leaflet frame protrusions 260 and one or more features of the leaflet retention features 400 can operate to maintain the coupling between the leaflet frame 200 and the leaflet retention features 400.

[0220] As will be appreciated by those skilled in the art, in some examples, engagement or interaction (interface) between leaflet frame projection 260 and one or more features of leaflet retention feature 400 is facilitated by having the spacing between adjacently positioned struts 412 be less than the maximum transverse dimension of leaflet frame projection 260. Additionally or alternatively, as will be appreciated by those skilled in the art, in some examples, the distance between first side 408 and second side 410 is less than the maximum transverse dimension of leaflet frame projection 260. Thus, it will be appreciated that engagement or interaction (interface) between leaflet frame projection 260 and one or more features of leaflet retention feature 400 can be facilitated by an interference fit (e.g., a friction fit or a press fit).

[0221] In various examples, the leaflet-retention feature 400 includes one or more deflectable ears 420 that protrude into the interior region 418 and are configured to engage the leaflet frame projections 260 extending through the interior region 418. In some examples, the ears 420 engage the leaflet frame projections 260 extending through the interior region 418 via an interference fit (see discussion above). In some examples, the one or more ears 420 extend from one or more of the struts 412. Additionally or alternatively, in some examples, the one or more ears 420 extend from one or more of the first side 408 and the second side 410.

[0222] Continue to refer Figures 11 to 13 , the leaflet retention feature 400 is a porous structure that includes a plurality of struts 412 extending between a first side 408 and a second side 410. Each cell includes a plurality of ears 420 that extend into its cell interior region and engage the leaflet frame protrusions 260 extending through the cell. Figure 12 and 13 As shown, in various examples, the ears 420 are deflectable. Specifically, as will be understood by those skilled in the art, as the leaflet retention feature 400 is disposed on the leaflet frame protrusion 260, the interference between the leaflet retention feature 400 and the leaflet frame protrusion 260 (see explanation above) causes the ears 420 to deflect. This configuration provides that the energy stored in the deflected ears 420 is used to maintain the connection between the leaflet frame protrusion 260 and the leaflet retention feature 400, thereby retaining the leaflets 310 between the leaflet frame 200 and the leaflet retention feature 400.

[0223] Typically, leaflet-retention feature 400 is coupled to leaflet frame 200 by positioning leaflet-retention feature 400 on leaflet frame projection 260 such that the leaflet-retention feature extends through the interior region of each cell of leaflet-retention feature 400. Then, in some examples, leaflet-retention feature 400 is advanced along leaflet frame projection 260 toward leaflet-retention surface 233, from which leaflet frame projection 260 extends. Typically, leaflet-retention feature 400 is advanced until leaflet-retention feature 400 contacts leaflets 310, and / or until leaflet-retention feature 400 is advanced to a designated position along leaflet frame projection 260, and / or until leaflet-retention feature 400 is properly seated within one or more features of leaflet frame projection 260 (see further explanation below), and / or until leaflet-retention feature 400 contacts leaflets 310 and leaflets 310 contact leaflet-retention surface 233.

[0224] In some embodiments, the leaflet retention feature 400 may be bonded or otherwise coupled to the leaflet 310. In some examples, the leaflet retention feature 400 is bonded or otherwise coupled to the leaflet attachment region 330 of the leaflet 310. The leaflet retention feature 400 may be bonded or otherwise coupled to the leaflet 310 using known methods (e.g., suturing, adhesives, heat treatment, chemical treatment, etc.). In general, the leaflet retention feature 400 may be bonded or otherwise coupled to either side of the leaflet 310 (e.g., the inflow side or the outflow side), depending on the desired attachment structure (e.g., whether the associated portion of the leaflet attachment region 330 is wrapped around the leaflet frame 200 prior to positioning the leaflet 310 and the leaflet retention feature 400 on the leaflet frame protrusion 206). For example, in some examples where the associated portions of the leaflet attachment region 330 are not wrapped or wrapped around the leaflet frame prior to being disposed on the leaflet frame projections 260, the leaflet retention features 400 may be coupled to the outflow side of the leaflets 310. Conversely, in some examples where the associated portions of the leaflet attachment region 330 are wrapped or wrapped around the leaflet frame 200 prior to being disposed on the leaflet frame projections 260, the leaflet retention features 400 may be coupled to the inflow side of the leaflets 310. However, in some examples where the leaflet retention features are bonded to or otherwise coupled to the leaflet attachment region 330 of the leaflets 310, it may be desirable to position the leaflets 310 and the leaflet retention features 400 around the leaflet frame projections 260 such that the leaflet frame projections 260 are between the leaflet retaining surface 233 of the leaflet frame 200 and the leaflets 310.

[0225] In some examples, the leaflets 310 may additionally or alternatively be wrapped or wrapped around the leaflet-retaining member before the leaflets 310 and the leaflet-retaining features 400 are positioned on the leaflet-frame projection 206. In some such examples, the leaflets 310 may be wrapped around the leaflet-retaining features 400 such that, when coupled to the leaflet frame 200, a first portion of the leaflet 310 is sandwiched between the leaflet-retaining features 400 and the leaflet-frame 200, and such that the leaflet-retaining features 400 are sandwiched between the first portion of the leaflet 310 and the second portion of the leaflet 310. In some examples, the leaflet attachment region 330 is folded back onto itself to form a recess, and the leaflet-retaining features 400 are positioned within the recess such that an interior area of the leaflet attachment region is aligned with the leaflet orifices 308 of the leaflets 310, so that the leaflets 310 and the leaflet-retaining features 400 can be positioned on the leaflet-frame projection 260 of the leaflet frame 200. Thus, in some embodiments, the leaflet retention feature 400 may be completely enclosed or encapsulated by the leaflet 310.

[0226] In some examples, leaflet 310 folds back upon itself to form a recess for receiving leaflet retention feature 400, and leaflet 310 generally includes multiple rows of leaflet apertures 308, including a first row and a second row, such that corresponding leaflet apertures 308 of the first row and the second row of apertures align with one another when folded back upon itself to form a recess for receiving leaflet retention feature 400. In some examples, when disposed on leaflet frame projections 260, each leaflet frame projection extends through leaflet 310, and leaflet retention feature 400 extends through a first aperture of the first row of apertures, a first interior region of a first cell of the leaflet retention member, and a first aperture of the second row of apertures.

[0227] In various examples, such as Figure 12 and 13 As shown, and as will be understood by those skilled in the art, as the leaflet retention feature 400 is advanced along the leaflet frame protrusion 260, the ears 420 of the leaflet retention feature 400 deviate from the leaflet retention surface 233. Figure 15 4. In various examples, the leaflet frame projections 260 are sandwiched between or otherwise positioned between adjacently positioned ears 420 (see FIG. Figures 11 to 13 As described above, adjacently positioned ears 420 may extend from adjacently positioned posts 412 and / or from opposing first and second sides 408 and 410 .

[0228] In various examples, one or more holes 422 are formed in the ear 420 of the leaflet retention feature 400. In some examples, the holes operate to increase flexibility or otherwise reduce the stiffness of the ear 422. In other words, in some examples, the holes act to reduce the amount of force required to deflect the ear 422 to the amount required to achieve a desired interference fit between the ear 422 and the leaflet frame protrusion 260. It will be understood that the size and shape of the holes 422 illustrated and described herein should not be construed as limiting, and that the size and shape of the holes 422 can be determined according to any desired profile to achieve a specified flexibility of the ear 422. Similarly, in some examples, the leaflet retention feature 400 is formed without any holes 422.

[0229] In various examples, releasing the leaflet-retaining feature 400 from the leaflet-frame protrusion 260 generally requires sliding the leaflet-retaining feature 400 along the leaflet-frame protrusion 260 away from the leaflet-retaining surface 233. As will be appreciated by those skilled in the art, in some examples, due to the interference fit between the leaflet-retaining feature 400 (e.g., including the ears 420) and the leaflet-frame protrusion 260, releasing the leaflet-retaining feature 400 from the leaflet-frame protrusion 260 additionally requires one of: bending the ears 420 away from the leaflet-frame protrusion 260, and / or flipping the ears 420 so that they are deflected toward the leaflet-retaining surface 233.

[0230] Figure 14 5 is a top view of a leaflet retention feature 500. The leaflet retention feature 500 is generally similar to the leaflet retention feature 400 discussed above, but the struts 512 have free ends 524. As shown, the leaflet retention feature 500 generally includes a body 502, a first end 506, a second end 508 opposite the first end 504, and a first side 508 extending between the first end 504 and the second end 506. The leaflet retention feature 500 also includes a plurality of struts 512 extending from the first side 508. However, as Figure 14 As shown, each of the plurality of struts 512 includes a free end 524 that protrudes from where the strut is coupled to the body 502. Similar to the leaflet retention feature 400, the leaflet retention feature 500 includes a plurality of cells, such as cells 514 and 516. However, unlike cells 414 and 416, cells 514 and 516 are "open cells" in that they are not completely enclosed (or otherwise bounded) by elements of the leaflet retention feature 500. Rather, as shown, the area 518 defined between adjacently positioned struts 512 is exposed or not otherwise enclosed. In various examples, similar to the leaflet retention feature 400, the leaflet retention feature 500 includes a plurality of ears 520 that protrude into the area 518 defined between adjacently positioned struts 512.

[0231] Leaflet-retention feature 500 is coupled to leaflet frame 200 of prosthetic valve 100 in the same manner as leaflet-retention feature 400. Specifically, as described above, leaflet-retention feature 500 is coupled to leaflet frame 200 by positioning leaflet-retention feature 500 on leaflet frame projection 260 such that the leaflet frame projection extends through the interior region of each cell of leaflet-retention feature 500. As described above, in some examples, leaflet-retention feature 500 is advanced along leaflet frame projection 260 toward leaflet-retention surface 233, from which leaflet frame projection 260 extends. Typically, the leaflet retention feature 500 is advanced until the leaflet retention feature 500 contacts the leaflet 310, and / or until the leaflet retention feature 500 is advanced to a specified position along the leaflet frame protrusion 260, and / or until the leaflet retention feature 500 is properly positioned within one or more features of the leaflet frame protrusion 260, and / or until the leaflet retention feature 500 contacts the leaflet 310 and the leaflet 310 contacts the leaflet retention surface 233.

[0232] In various examples, the configuration of leaflet retention feature 500 provides a lower profile leaflet retention feature with additional degrees of freedom. In some examples, the lower profile leaflet retention feature can be coupled to leaflet frame 200 such that leaflet retention feature 400 does not protrude from the maximum outer profile of leaflet frame 200. Specifically, and in contrast to leaflet retention feature 400, leaflet retention feature 400 includes a first side 408 and a second side 410. When coupled to leaflet frame 200, first side 408 and second side 410 effectively straddle leaflet frame protrusion 260. In examples where leaflet frame protrusion 260 is as wide as the leaflet retention surface 233 from which it protrudes, first side 408 and second side 410 extend radially inward and radially outward from leaflet retention surface 233 (and in some configurations radially inward from leaflet frame inner surface 202 and radially outward from leaflet frame outer surface 203). In some examples, this configuration causes the leaflet retention feature 400 to extend radially outward from the maximum outer contour of the leaflet frame 200 (e.g., radially outward from the leaflet frame outer surface 203). On the other hand, because the leaflet retention feature 500 includes only one side 508, the leaflet retention feature 500 can be coupled to the leaflet frame 200 such that the first side 508 extends radially inward along (along and within) the leaflet frame inner surface 202 without extending radially outward from the maximum outer contour of the leaflet frame 200 (e.g., radially outward from the leaflet frame outer surface 203). Specifically, in some examples, the struts 512 extend from the first side 508 a distance that is less than the width of the leaflet retention surface 233 defined between the leaflet frame inner surfaces 202 and 203.

[0233] Furthermore, as described above, the construction of leaflet retention feature 500 provides a leaflet retention feature with additional degrees of freedom compared to leaflet retention feature 400 having a first side and a second side. For example, leaflet retention feature 500 can bend about the longitudinal axis of leaflet frame 200. On the other hand, bending leaflet retention feature 400 in a similar manner generally requires that one of first side 408 and second side 410 be extended and the length of the other of first side 408 and second side 410 be compressed / shortened, as will be understood by those skilled in the art. Thus, the construction of leaflet retention feature 400 is more rigid and less conformable (less compliant) than the construction of leaflet retention feature 500.

[0234] Such a configuration is generally associated with improved compliance. For example, in some examples, the leaflet frame 200 is curved or cylindrical (see, e.g., Figure 1D ) and includes leaflet frame protrusions 260 extending from a leaflet retention surface 233 that is arcuate or curved according to the curved or cylindrical contour of the leaflet frame 200. Thus, in some cases, the leaflet frame protrusions 260 are not linearly (straight) arranged. Alternatively, in various examples, because the leaflet frame protrusions 260 protrude from some of the arcuate or curved leaflet retention surfaces 233, some of the leaflet frame protrusions 260 are in a curved or non-linear (non-straight) structure. As described above, highly conformable (highly compliant) leaflet retention features, such as leaflet retention feature 500, are operable to adopt or otherwise conform to such a non-linear structure (e.g., operable to bend around the longitudinal axis of the leaflet frame 200).

[0235] However, it should be understood that in various examples, the leaflet retention features 400 may be pre-formed according to the curvature or curved structure of the leaflet frame protrusions 260 .

[0236] As described above, in various examples, when the leaflet retention feature 400 is coupled to the leaflet frame 200, the leaflet retention feature 400 is advanced along the leaflet frame protrusion 260 until the leaflet retention feature 500 is advanced to a specified position along the leaflet frame protrusion 260 and / or until the leaflet retention feature 500 is properly seated in one or more features of the leaflet frame protrusion 260. In some examples, one or more retention features 261 are formed in the leaflet frame protrusion 260. These one or more retention features may include one or more recesses, one or more protrusions and / or one or more textured surfaces. As described above, in various examples, the protrusion head 264 of the leaflet frame protrusion 260 has a second transverse dimension 265 that is wider than the narrowest first transverse dimension 263 of the protrusion base 262 of the leaflet frame protrusion 260 (see, e.g., Figures 3A-3D and 14).

[0237] In some examples, such as Figure 14 As shown, the narrowest first transverse dimension 263 can correspond to a retention feature in the form of a recess 261. In some examples, the recess 261 extends around the entire periphery of the leaflet frame protrusion 260. In some other examples, the recess 261 extends around only a portion of the periphery of the leaflet frame protrusion 260. For example, in some examples, the leaflet frame protrusion 260 includes multiple recesses 261 (e.g., recesses on either side of the leaflet frame protrusion), wherein each recess 261 extends along a portion of the leaflet frame protrusion between the leaflet frame inner surface 202 and the outer surface 203. In some other examples, the wider second transverse dimension 265 can correspond to a retention feature in the form of a protrusion (not shown). It should be understood that if the leaflet retention feature 400 can be advanced along the leaflet frame protrusion 260 and can traverse the protrusion so that the wider second transverse dimension of the protrusion is between the leaflet retention feature 400 and the protrusion end 266 of the leaflet frame protrusion 260, then the protrusion can be of any suitable shape and size.

[0238] like Figure 15 As shown, in some examples, the leaflet retention feature 400 has advanced along the leaflet frame protrusion to a position where the leaflet retention feature 400 engages with the recess 261 of the leaflet frame protrusion 260. Although the recess 261 is Figure 15 It is shown as an arc or continuous curvature, but it should be understood that the recess can be any suitable shape, such as a rectangular or triangular recess (see for example Figures 3A-3C and 8-9B). As described above, in various examples, releasing the leaflet-retaining feature 400 from the leaflet-frame protrusion 260 generally requires sliding the leaflet-retaining feature 400 along the leaflet-frame protrusion 260 away from the leaflet-retaining surface 233. As will be appreciated by those skilled in the art, in some examples, due to an interference fit between the leaflet-retaining feature 400 (e.g., including the ears 420) and the leaflet-frame protrusion 260, releasing the leaflet-retaining feature 400 from the leaflet-frame protrusion 260 additionally requires one of: bending the ears 420 away from the leaflet-frame protrusion 260, and / or flipping the ears 420 so that they are deflected toward the leaflet-retaining surface 233.

[0239] As described above, the prosthetic valve 100 of the present invention can be configured for use in both transcatheter and surgical settings. Figure 16 and 17 , the leaflet frame 1600 is operable for use in a transcatheter procedure, wherein the leaflet frame 1600 has a smaller pre-deployment diameter and a larger deployed diameter. As described above, it should be understood that the embodiments of the leaflet frame protrusions 260 and leaflet retention features 400 discussed herein can be used in either surgical or transcatheter prosthetic heart valves.

[0240] Figure 16 is an outflow side perspective view of a non-limiting example of a leaflet frame 1600 for a transcatheter procedure. Figure 17 yes Figure 16 17. Similar to the leaflet frames 200 and 900 discussed above, the leaflet frame 1600 defines a plurality of leaflet windows, each window following the shape of the leaflet attachment region 330 of the leaflet. Figure 16 and 17 Not shown, but as will be understood, the leaflets 310 may extend through one or more slots prior to being disposed on the leaflet frame projections 260. Similarly, Figure 16 and 17 Without being shown in FIG, it will be understood that, as discussed herein, leaflets 310 may be wrapped and / or wound around one or more portions of leaflet frame 1600 (e.g., one or more portions of the commissure posts and / or teeth) prior to being disposed on leaflet frame projections 260. Figure 16 The embodiments shown in Figures 1 and 17 should not be construed as limiting, but are intended to illustrate leaflet retention features 400 associated with transcatheter prosthetic heart valves.

[0241] It will also be understood that although Figure 16 and 17 Not shown, but in various examples, as described above, one or more surfaces, sections, or regions of the leaflet frame 1600 can be wrapped or covered with a film.

[0242] Figure 18 and 19 A view of the leaflet retention feature 600 is provided. Figure 18 is a perspective view of a portion of a leaflet frame 200 with a leaflet retention feature 600 coupled to a leaflet frame protrusion 260 of the leaflet frame 200. It should be understood that Figure 18 The illustrated configuration of the leaflet frame 200 should not be construed as limiting, and any leaflet frame configuration including the plurality of leaflet frame protrusions 260 described herein may be employed. Figure 18 (and Figure 20 、 22 25) is a rectangular configuration, but it should be understood that the leaflet frame protrusion 260 can be configured according to any leaflet frame protrusion described or referenced herein (see, e.g., Figure 1B 、 2D , 3A-3E). Figure 19 Provided Figure 18An exemplary illustration of a leaflet retention feature 600 is shown. As with the leaflet retention feature 500 described above, the leaflet retention feature 600 is configured to help retain or otherwise secure the leaflets 310 to the leaflet frame 200. As shown, the leaflet retention feature 600 includes a body 602 having a first end 604 and a second end 606. Between the first end 604 and the second end 606, the body 602 of the leaflet retention feature 600 includes a frame defined by one or more longitudinal portions, such as longitudinal portions 608a-608c and one or more transverse portions, such as transverse portions 610a-610c. The frame of the leaflet retention feature 600 is generally configured such that the longitudinal elements extend (or are otherwise connected together) between adjacent transverse elements. Similarly, the frame of the leaflet retention feature 600 is generally configured such that the transverse elements extend (or are otherwise connected together) between adjacent longitudinal elements.

[0243] In some examples, the frame of leaflet retention feature 600 can be configured to include one or more "open cells," such as open cells 612a-612b, which are cells that are not completely enclosed (or otherwise bounded on all sides) by the longitudinal and transverse portions of leaflet retention feature 600. For example, Figure 19 As shown, the leaflet retention feature 600 includes a first open cell 612a and a second open cell 612b. One or more of these open cells are configured to receive the leaflet frame protrusion 260 therein, as further described below.

[0244] As shown, the first open cell 612a is defined by a longitudinal portion 608b and a plurality of transverse elements 610a and 610b, wherein the longitudinal portion 608b extends between the transverse elements 610a and 610b. In some examples, one or more of the longitudinal elements are configured to span the length of one or more of the leaflet frame protrusions 260, while one or more of the longitudinal elements are configured to span between adjacently positioned leaflet frame protrusions 260. In some examples, one or more of the transverse elements are configured to span the width of one of the leaflet frame protrusions (e.g., from at least the leaflet frame outer surface 202 to at least the leaflet frame inner surface 202). As described above with respect to various other leaflet retention features, the leaflet retention feature 600 can be configured such that, when coupled to the leaflet frame 200, the leaflet retention feature 600 does not protrude from the maximum outer contour (e.g., the leaflet frame outer surface 203) and / or the maximum inner contour (e.g., the leaflet frame inner surface 202) of the leaflet frame 200.

[0245] The leaflet retention feature 600 may be formed from any of the metal, metal alloy, or polymer materials discussed herein and may be formed by one or more known chemical etching, laser cutting, micromolding, stamping, bending, or other processes.

[0246] Leaflet-retention feature 600 can be coupled to leaflet frame 200 of prosthetic valve 100 in a manner similar to leaflet-retention features 400 and 500 described above. In some examples, coupling leaflet-retention feature 600 to leaflet frame 200 includes positioning leaflet-retention feature 600 on leaflet frame protrusion 260 such that the leaflet frame protrusion extends through one or more of the open cells of leaflet-retention feature 600. As similarly discussed above, in some examples, leaflet-retention feature 600 can be advanced along leaflet frame protrusion 260 toward leaflet-retention surface 233, from which leaflet frame protrusion 260 extends. Leaflet-retention feature 600 can be advanced until leaflet-retention feature 600 contacts leaflet 310, and / or until leaflet-retention feature 600 is advanced to a specified position along leaflet frame projection 260, and / or until leaflet-retention feature 600 is properly seated within one or more features of leaflet frame projection 260, and / or until leaflet-retention feature 600 contacts leaflet 310 and leaflet 310 contacts leaflet-retention surface 233. In some examples, leaflet-retention feature 600 is advanced along leaflet frame projection 260 until leaflet-retention feature 600 is properly seated between leaflet-retention surface 233 and a flange extending from an end of leaflet frame projection 260 (e.g., within recess 261).

[0247] Figure 20 and 21 A view of the leaflet retention feature 700 is provided. Figure 20 is a perspective view of a portion of a leaflet frame 200 with a leaflet retention feature 600 coupled to a leaflet frame protrusion 260 of the leaflet frame 200. As described above, Figure 20 The illustrated leaflet frame 200 should not be construed as limiting, and any leaflet frame configuration including the plurality of leaflet frame projections 260 described herein may be employed. Figure 21 Provided Figure 20An exemplary illustration of a leaflet retention feature 700 is shown. As with the leaflet retention feature 600 described above, the leaflet retention feature 700 is configured to help retain or otherwise secure the leaflets 310 to the leaflet frame 200. As shown, the leaflet retention feature 700 includes a body 706 having a first end 702 and a second end 704. Between the first end 704 and the second end 706, the body 702 of the leaflet retention feature 700 includes a frame (architecture) defined by one or more longitudinal portions, such as longitudinal portions 708a-708c and one or more transverse portions, such as transverse portions 710a-710c. The frame (architecture) of the leaflet retention feature 700 is generally configured such that the longitudinal elements extend (or are otherwise connected together) between adjacent transverse elements. Similarly, the frame of the leaflet retention feature 700 is generally configured such that the transverse elements extend (or are otherwise connected together) between adjacent longitudinal elements.

[0248] In some examples, the frame of leaflet retention feature 700 can be configured to include one or more "open cells," such as open cells 712a-712b, which are cells that are not completely enclosed (or otherwise defined on all sides) by the longitudinal and lateral portions of leaflet retention feature 700. For example, Figure 21 As shown, the leaflet retention feature 700 includes a first open cell 712b and a second open cell 712b. One or more of these open cells are configured to receive the leaflet frame protrusion 260 therein, as further described below.

[0249] As shown, the first open cell 712a is defined by a longitudinal portion 708b and a plurality of transverse portions 710a and 710b, wherein the longitudinal portion 708b extends between the transverse portions 710a and 710b. In some examples, one or more longitudinal elements are configured to span the length of one or more leaflet frame projections 260, while one or more longitudinal elements are configured to span between adjacently positioned leaflet frame projections 260. In some examples, one or more of the transverse elements are configured to span the width of one of the leaflet frame projections (e.g., from at least the leaflet frame outer surface 202 to at least the leaflet frame inner surface 202). As described above with respect to various other leaflet retention features, the leaflet retention feature 700 can be configured such that, when coupled to the leaflet frame 200, the leaflet retention feature 700 does not protrude from the maximum outer contour (e.g., the leaflet frame outer surface 203) and / or the maximum inner contour (e.g., the leaflet frame inner surface 202) of the leaflet frame 200.

[0250] The leaflet retention feature 700 may be formed from any of the metal, metal alloy, or polymer materials discussed herein and may be formed by one or more known chemical etching, laser cutting, micromolding, stamping, bending, or other processes.

[0251] Leaflet-retention feature 700 can be coupled to leaflet frame 200 of prosthetic valve 100 in a manner similar to leaflet-retention features 400 and 500 described above. In some examples, coupling leaflet-retention feature 700 to leaflet frame 200 includes positioning leaflet-retention feature 700 on leaflet frame protrusion 260 such that the leaflet frame protrusion extends through one or more of the open cells of leaflet-retention feature 700. As similarly discussed above, in some examples, leaflet-retention feature 700 can be advanced along leaflet frame protrusion 260 toward leaflet-retention surface 233, from which leaflet frame protrusion 260 extends. Leaflet-retention feature 700 can be advanced until leaflet-retention feature 700 contacts leaflet 310, and / or until leaflet-retention feature 700 is advanced to a specified position along leaflet frame projection 260, and / or until leaflet-retention feature 700 is properly seated within one or more features of leaflet frame projection 260, and / or until leaflet-retention feature 700 contacts leaflet 310 and leaflet 310 contacts leaflet-retention surface 233. In some examples, leaflet-retention feature 700 is advanced along leaflet frame projection 260 until leaflet-retention feature 700 is properly seated between leaflet-retention surface 233 and a flange extending from an end of leaflet frame projection 260 (e.g., within recess 261).

[0252] However, as shown, the leaflet retention feature 700 also includes one or more retention tabs (retention protrusions / bumps), such as retention tabs 714a-714c, which are configured to help minimize the possibility of the leaflet retention feature 700 being disengaged from the leaflet frame protrusion 260. Specifically, as shown, the retention tabs 714a-714c are configured to minimize displacement of the leaflet retention feature 700 by lateral translation (e.g., in a radially inward or radially outward direction) of the leaflet retention feature 700 relative to the leaflet frame protrusion 260. Although Figure 20 and 21 700 , but it will be appreciated that various alternative configurations are contemplated. For example, in some examples, one or more retention tabs may additionally or alternatively project longitudinally from transverse elements (e.g., 710a-710c) and engage leaflet frame protrusion 260 along leaflet frame protrusion 260 between leaflet frame inner surface 202 and leaflet frame outer surface 203.

[0253] Figure 22 and 23 A view of the leaflet retention feature 700 is provided. Figure 22 is a perspective view of a portion of the leaflet frame 200, wherein the leaflet retention feature 700 is coupled to the leaflet frame protrusion 260 of the leaflet frame 200. As described above, Figure 22 The illustrated leaflet frame 200 should not be construed as limiting, and any leaflet frame configuration including the plurality of leaflet frame projections 260 described herein may be employed. Figure 23 Provided Figure 22 An exemplary illustration of a leaflet retention feature 700 is shown. As with the leaflet retention feature 600 described above, the leaflet retention feature 800 is configured to help retain or otherwise secure the leaflets 310 to the leaflet frame 200. As shown, the leaflet retention feature 800 includes a body 806 having a first end 802 and a second end 804. Between the first end 804 and the second end 806, the body 8802 of the leaflet retention feature 800 includes a frame (framework) defined by one or more longitudinal portions, such as longitudinal portions 808a-808c and one or more transverse portions, such as transverse portions 810a-810c. Thus, the frame of the leaflet retention feature 800 is similar to the frame of the leaflet retention feature 600. For example, the frame of the leaflet retention feature 800 includes one or more "open cells," such as open cells 812a-812b, that are configured to accommodate the leaflet frame protrusions 260 therein. However, the leaflet retention feature 800 includes a smooth transition between the longitudinal elements and the transverse elements that define the frame (architecture). For example, although the frame of the leaflet retention feature 800 is generally configured so that the longitudinal elements (e.g., 808a-808c) extend between (or are otherwise connected together) adjacent transverse elements (e.g., 810a-810c), the longitudinal elements (e.g., 808a-808c) are curved or non-linear (non-straight) in shape. In some examples, the transverse elements (e.g., 810a-810c) are curved or non-linear (non-straight). The curvature of the longitudinal elements (e.g., 808a-808c) and / or the transverse elements (e.g., 810a-810c) can be concave, convex, or a combination thereof to achieve optimal locking force or force of engagement with the leaflet frame protrusions (e.g., 260 and / or 1260).

[0254] As with the various leaflet retention features shown and described above, leaflet retention feature 800 can be formed from any metal, metal alloy, or polymer material discussed herein and can be formed by one or more known chemical etching, laser cutting, micromolding, stamping, bending, or other processes.

[0255] The leaflet retention feature 800 can also be coupled to the leaflet frame 200 of the prosthetic valve 100 in a manner similar to the leaflet retention feature 600 described above. In some examples, the leaflet retention feature 800 can be configured to transition between a pre-installation configuration and an installed configuration, wherein the shape of the leaflet retention feature 800 is different in the installed configuration relative to the pre-installation (pre-installation) configuration. For example, in some examples, the leaflet retention feature 800 can be configured such that, in the pre-installation (pre-installation) configuration, the structure of its open cells (e.g., 812a-812c), such as the size and shape of its open cells (e.g., 812a-812c), is different from the structure of the leaflet frame protrusions 260 of the leaflet frame 200.

[0256] For example, Figure 24 An illustration of the leaflet retention feature 800 is provided in a pre-installation (pre-installation) configuration, while Figure 22 and 23 Each of provides an illustration of the leaflet retention feature 800 in an installed configuration. Figure 24 and Figure 22 and 23 As shown in comparison with each of the above, the leaflet retention feature 800 transitions to the installed configuration by deforming to accommodate or otherwise conform to (comply with) the structure of the leaflet frame protrusion 260. In some examples, in the pre-installation (pre-installation) configuration, adjacently positioned lateral portions (e.g., 810a and 810b) may be non-parallel or otherwise angled relative to each other, while in the installed configuration, the leaflet frame protrusion 260 causes adjacently positioned lateral portions (e.g., 810a and 810b) to become parallel, more parallel, or at a lesser angle relative to each other than in the pre-installation configuration. For example, in Figure 23 and Figure 24 For comparison, the installed configuration ( FIG. 24 ) is shown relative to the pre-installed (pre-installed) configuration ( FIG. 25 ). Figure 23 ), the shape of the open cells (e.g., 812a-812b) is different. In some examples, the longitudinal portions (e.g., 808a-808c) of the leaflet retention feature 800 may become more curved (e.g., curved around a smaller radius) than in the installed configuration. In some examples, these deformations of the leaflet retention feature 800 in the installed configuration cause the leaflet retention feature 800 to store potential energy that causes one or more longitudinal portions (e.g., 808a-808c) and / or one or more transverse portions (810a-810c) to engage one or more leaflet frame protrusions 260 of the leaflet frame 200.

[0257] It should be understood that, although not shown above, leaflet retention features 600 and 700 may be similarly configured to be similarly oversized such that the leaflet retention features deform when coupled with leaflet frame 200 .

[0258] Figure 25 and 26 A view of the leaflet retention feature 900 is provided. Figure 25 is a perspective view of a portion of leaflet frame 200 with leaflet retention features 900 coupled to leaflet frame protrusions 260 of leaflet frame 200. As described above, Figure 25 The illustrated leaflet frame 200 should not be construed as limiting, and any leaflet frame configuration including the plurality of leaflet frame projections 260 described herein may be employed. Figure 26 Provided Figure 25 1 is an exemplary illustration of a leaflet retention feature 900 shown in FIG. In some examples, the leaflet retention feature 900 may include one or more fibers interwoven with the leaflet frame protrusion 260 of the leaflet frame 200. In some examples, multiple fibers or wires may be interwoven with the leaflet frame protrusion 260 of the leaflet frame 200. For example, Figure 26 As shown, leaflet retention feature 900 includes first fibers 902 and second fibers 904. First fibers 902 and second fibers 904 can be the same fibers. That is, in some examples, first fibers 902 and second fibers 904 form a single or integral fiber, wherein first fibers 902 correspond to a first portion of the single fiber that is guided around or interwoven with leaflet frame projection 260 along a first direction (e.g., a first longitudinal direction), and second fibers 904 correspond to a second portion of the single fiber that is guided around or interwoven with leaflet frame projection 260 along a second direction (e.g., a second longitudinal direction).

[0259] In some examples, the first direction and the second direction can be opposite directions. In various examples, the ends of the first fiber 902 and the second fiber 904 can be coupled together or otherwise terminated to each other. For example, in some examples, the first end of the first fiber 902 can be coupled to the first end or the second end of the second fiber 906. Figure 26 As shown, the end 906 of the first fiber 902 is connected to the end 908 of the second fiber 904 at a junction (intersection) 910. The ends of the fibers can be connected together according to known methods, including but not limited to welding, bundling, sewing, and gluing. It should be understood that although the first fiber 902 and the second fiber 904 are connected together at the junction (intersection) 910, the fibers 902 and 904 can be a continuous fiber. That is, the junction 910 can represent the only joint between the fibers 902 and 904. Therefore, in some examples, such as Figure 26 As shown in region 912 of , leaflet retention feature 900 can loop around another leaflet frame projection in a continuous manner (e.g., without joints) from a first side of a leaflet frame projection to an opposite side of the leaflet frame projection. Thus, it should be understood that leaflet retention feature 900 can be a continuous element having a first end and a second end that interweaves with one or more leaflet frame projections and then couples to itself, such as at its first and second ends.

[0260] In some examples, the leaflet retention feature 900 can optionally include separate, independent fibers. For example, the first fiber 902 and the second fiber 904 can be replaced by two independent fibers. In examples where the leaflet retention feature 900 includes two independent fibers, it will be understood that such fibers can be coupled together to form the leaflet retention feature 900, or can alternatively be guided through or interwoven with the leaflet frame projections 260 of the leaflet frame 200 without being coupled together. In addition, although Figure 25 and 26 Included is a leaflet retention feature 900 comprising a first fiber 902 and a second fiber 904, but it should be understood that the leaflet retention feature 900 may comprise any number of fibers, such as three (3), four (4), five (5) or more than five (5) fibers, provided that the leaflet retention feature is operable to help secure the leaflet 310 to the leaflet frame 200.

[0261] The interwoven fibers may be single strand, multi-strand, braided, or woven in construction and may include expanded fluoropolymer materials made from porous ePTFE, such as generally described in U.S. Patent No. 7,306,729 to Bacino. The expandable fluoropolymer may include a PTFE homopolymer. In alternative embodiments, a mixture of PTFE, expandable modified PTFE, and / or expanded copolymers of PTFE may be used. Non-limiting examples of suitable fluoropolymer materials are described, for example, in U.S. Patent No. 5,708,044 to Branca, U.S. Patent No. 6,541,589 to Ballie, U.S. Patent No. 7,531,611 to Sabol et al., U.S. Patent Application Serial No. 11 / 906,877 to Ford, and U.S. Patent Application Serial No. 12 / 410,050 to Xu et al.

[0262] like Figure 25 and 26As shown, the leaflet retention feature 900 is interwoven with the leaflet frame protrusions such that fibers (e.g., first fibers 902 and / or second fibers 904) extend from a first leaflet frame protrusion to a second leaflet frame protrusion adjacent to the first leaflet frame protrusion, with the fibers traversing the width of the leaflet frame (e.g., from the leaflet frame outer surface 203 to the leaflet frame inner surface 202, or vice versa). Thus, in some examples, the path of the fibers of the leaflet retention feature 900 extends along the leaflet frame inner surface 202 of the first leaflet frame protrusion 260 to the second leaflet frame protrusion 260 adjacent to the first leaflet frame protrusion, and then extends along the leaflet frame outer surface 203 of the second leaflet frame protrusion 260, wherein the fibers extend across the width of the leaflet frame 200 between the first leaflet frame protrusion 260 and the second leaflet frame protrusion 260 (from the leaflet frame inner surface 202 to the leaflet frame outer surface 203). The path of the fiber of the leaflet retention feature 900 then extends along the leaflet frame outer surface 202 of the second leaflet frame protrusion 260 to the third leaflet frame protrusion 260 adjacent to the second leaflet frame protrusion, and then extends along the leaflet frame inner surface 203 of the third leaflet frame protrusion 260, wherein the fiber extends across the width of the leaflet frame 200 between the second leaflet frame protrusion 260 and the third leaflet frame protrusion 260 (from the leaflet frame outer surface 203 to the leaflet frame inner surface 202). Figure 25 and 26 This meandering or alternating pattern is shown in It will be appreciated that the fibers of leaflet retention feature 900 may continue this type of alternating pattern along as many leaflet frame projections 260 as desired.

[0263] like Figure 25 and 26 As shown, in the case where the leaflet retention feature includes a first fiber 902 and a second fiber 904, the second fiber 904 may be guided along a path opposite to the path of the first fiber 902. For example, in the case where the first fiber 902 extends along the leaflet frame inner surface 202 of the first leaflet frame protrusion 260 toward the second leaflet frame protrusion 260 adjacent to the first leaflet frame protrusion, and then extends along the leaflet frame outer surface 203 of the second leaflet frame protrusion 260, the second fiber 904 may, in contrast, extend along the leaflet frame outer surface 203 of the first leaflet frame protrusion 260 toward the second leaflet frame protrusion 260 adjacent to the first leaflet frame protrusion, and then extend along the leaflet frame inner surface 202 of the second leaflet frame protrusion 260. In such an example, as shown in FIG. Figure 25 and 26As shown, the first fiber and the second fiber cross each other in the area between adjacently positioned leaflet frame protrusions 260. In some examples, the first fiber 902 passes over the second fiber 904 in such an area so that the second fiber 904 is between the first fiber 902 and the leaflet 310, while in other examples, the second fiber 904 passes over the first fiber 902 in such an area so that the first fiber 902 is between the second fiber 904 and the leaflet 310. In some examples, the leaflet retention feature 900 can be directed so that the first fiber 902 always extends over the second fiber 904 in such an area (or vice versa). For example, as Figure 25 and 26 , first fibers 902 always pass over second fibers 904. In some examples, leaflet retention feature 900 may be alternately directed such that first fibers 902 and second fibers 904 cross over one another in an alternating manner or pattern. In some examples, such an alternating pattern may be repetitive or may be random. In some examples, first fibers 902 and second fibers 904 of leaflet retention feature 900 may be twisted or knotted together in their intersection regions to provide redundancy to the system in the event that first fibers 902 and / or second fibers 904 fail (e.g., tear, split, and / or separate) in one or more regions of leaflet frame 200.

[0264] Although the leaflet retention feature 900 described above includes one or more fibers, it should be understood that the leaflet retention feature 900 may additionally or alternatively include one or more wires, such as one or more wires formed from known suture materials, nitinol, stainless steel, or other biocompatible materials.

[0265] In some examples, the cross-sectional dimension (e.g., height or diameter) of any of the various leaflet retention features shown and described herein (e.g., 400, 500, 600, 700, 800, 900) may exceed the distance between the leaflet 310 and the flange of the leaflet frame protrusion 260, such that when the leaflet retention feature is positioned between the leaflet 310 and the flange of the leaflet frame protrusion 260, the leaflet retention feature applies a normal force to the leaflet, thereby compressing the portion of the leaflet 310 that is between the leaflet frame 200 and the leaflet retention member. In some examples, the configuration that includes compressing a portion of the leaflet 310 helps reduce or minimize wear of the leaflet 310 under normal operating conditions. It should be understood that in some other examples, the distance between the leaflet 310 and the flange of the leaflet frame protrusion 260 may exceed or be substantially equal to the cross-sectional dimension (e.g., height or diameter) of the leaflet retention feature. It should also be understood that the cross-section of the leaflet retention feature can present almost any geometric shape, including circular, oval, square, rectangular, polygonal or other suitable geometric shapes. Additionally or alternatively, in some examples, the leaflet retention feature can be configured such that the leaflet retention feature is more deformable than the leaflet 310. In such examples, the leaflet retention feature is thus configured to deform more than the leaflet 310 under similar loading conditions. Similarly, in these examples, a leaflet retention feature that presents a cross-sectional dimension that is larger than the distance between the leaflet 310 and the flange of the leaflet frame protrusion 260 will deform into a profile that is consistent with the leaflet retention feature located between the leaflet 310 and the flange of the leaflet frame protrusion 260 (e.g., a circular cross-sectional profile deforms into an oval cross-sectional profile) without causing or requiring significant deformation of the leaflet between the leaflet retention feature and the leaflet frame.

[0266] In various examples, the leaflet frame 200 having leaflets 310 and leaflet retention features (e.g., 400, 500, 600, 700, 800, 900) can undergo one or more molding processes in which material is applied to the leaflet frame to cover at least those areas where the leaflet retention features are present. For example, a sheath of material (e.g., sheath 300 described further below) can be applied over one or more leaflet frame protrusions 260 and / or leaflet retention features. The sheath can be formed from at least one of polyetheretherketone (PEEK), expanded polytetrafluoroethylene (ePTFE), fluorinated ethylene propylene (FEP), a copolymer of tetrafluoroethylene (TFE) and perfluoromethyl vinyl ether (PMVE) (TFE-PMVE copolymer), polyurethane, polyimide, thermoplastic, thermoset, nylon, or any other biocompatible material. In some examples, a sheath of overmolding material may be applied to leaflet frame 200 , such as via an injection molding process, heat and / or pressure molding processes, one or more dip coating processes, one or more spray coating processes, and other known methods and combinations thereof.

[0267] Prosthetic valve leaflets that detach from a support structure, such as a leaflet frame, pose a high risk to the patient in whom such leaflets are placed. One factor contributing to leaflet detachment may be the peak stresses in the leaflets at the commissure region when the prosthetic valve is closed and under fluid back pressure. In some examples, the leaflet detachment and stress concentration issues can be addressed by changing the geometry of the uppermost adjacent commissure attachment regions on the support structure from non-divergent to divergent in the outflow direction from a position distal to the ends of the commissure posts. Specifically, by using adjacent, divergent leaflet attachment regions, a beneficial overall stress pattern can be achieved. Therefore, it should be understood that the geometry of the leaflets at or near the commissure posts (e.g., a change from parallel to divergent) has a purpose-appropriate effect on the stress distribution in the leaflets during operation, including when the leaflets are closed and resisting reverse flow. In some examples, employing adjacent, diverging leaflet attachment regions provides a method by which prosthetic valve height, if not shortening, is maintained while reducing peak commissural stresses in the leaflets at the commissural post points without altering the leaflet material properties. Figure 27A-35 Commissure attachment region variations at the outflow end and associated leaflet closure profiles are shown, which may be employed in any of the aforementioned embodiments and examples herein. Figure 27A 27A and 27B are stereoscopic and axial views, respectively, of a closed prosthetic valve 1010, and 27D and 27E are side views of the closed prosthetic valve 1010, which includes a leaflet frame 1020 connected to and supporting a plurality of leaflets 1040, the plurality of leaflets 1040 having adjacent support attachment areas 1030 (which may correspond to modified versions of the slots 216 and 217 discussed above) of a commissure 1022 (which may correspond to the commissure 210 discussed above), and according to an embodiment, the support attachment areas 1030 diverge from a position away from the commissure end 1024 (which may correspond to the commissure end 221 discussed above) toward the commissure end 1024 along the outflow direction 1018. Figure 27C is an exemplary illustration of the prosthetic valve 1010 during opening of the prosthetic valve 100. It should be understood that Figure 27C is intended to illustrate one potential open configuration of the prosthetic valve 100 and is therefore not intended to be limiting. When the outflow pressure downstream of the prosthetic valve 1010 is greater than the inflow pressure, a closed prosthetic valve 1010 exists wherein the leaflets 1040 are closed to limit backflow (regurgitation) through the prosthetic valve 1010. For clarity, Figure 27A The leaflet frame projections 1260 and 1260a shown in FIG have been removed from Figures 27B-27E Removed.

[0268] Figure 28A and 28B are plan views of various configurations of leaflets 1040 (which may correspond to leaflets 310 discussed above) that may be used with prosthetic valve 1010. In some examples, leaflets 1040 may have a shape similar to leaflets 310. Figure 28A The leaflet 1040 is shown having a cusp 1050, a free edge 1054, and a commissure region 1052. The free edge 1054 extends to two terminal ends 1056. Figure 27A As shown, in this embodiment, the (dashed) fold lines 1058 define the outer edges 1042 of the cusps 1050 and the commissure regions 1052, which are used to secure the leaflets 1040 to the leaflet frame 1020. The free edge regions 1046 are locations of the leaflets 1040 that include and are adjacent to the leaflet free edges 1054. As will be apparent from the following discussion, the outer edges 1042 of each leaflet 1040 are coupled to the frame, and the free edges 1054 of the leaflets 1040 are as shown. Figure 27A As shown, the leaflets 1040 extend through the cylindrical area defined by the leaflet frame 1020 and are generally free to move within this area. In various examples, the leaflets 1040 can include one or more leaflet holes 1308 (which can correspond to the leaflet holes 308 discussed above) along the commissure regions 1052, the leaflets 1308 being configured to interface with one or more leaflet frame projections 1260. As shown in Figures 28A and 28B, the leaflets 1040 can optionally include one or more leaflet holes 1308 (which can correspond to the leaflet holes 308 discussed above) along those portions of the leaflets 1040 extending between the commissure regions 1052, the leaflet holes 1308 being configured to interface with one or more leaflet frame projections 1260a. As described above, the interface between leaflet apertures 1308 and leaflet frame projections 1260 and / or between leaflet apertures 1308a and leaflet frame projections 1260a helps couple leaflets 1040 to leaflet frame 1020 .

[0269] Figure 28B Shown with Figure 28A The leaflets 1040 are substantially identical and, therefore, similar elements are given the same element numbers. The leaflets 1040 include a pair of commissure tabs 1044 in the commissure region 1052. The commissure tabs 1044 are used to assist in coupling each leaflet 1040 primarily to the commissure posts of the frame and / or to adjacent commissure tabs 1044 of adjacent leaflets 1040, etc.

[0270] exist Figure 27A and Figures 28A-28BIn the illustrated embodiment, the profile of the fold lines 1058 of the leaflets 1040 and the corresponding support attachment areas 1030 of the leaflet frame 1020 is substantially that of an isosceles trapezoid when viewed as a flat profile, although other shapes are contemplated (e.g., Figure 7A The leaflet frame 1020 includes a support attachment region 1030 that has substantially the three-sided (three-sided) contour of an isosceles trapezoid.

[0271] The fold lines 1058 may define a profile that is predetermined for a specific purpose.According to another embodiment, the profile of the fold lines 1058 of the leaflets 1040 and the corresponding support attachment areas 1030 of the leaflet frame 1020 are substantially parabolic profiles.

[0272] Figure 29 is based on Figure 27A The leaflet frame 1020 defines a plurality of commissure posts 1022 that are operable to couple with the commissure regions 1052 of the leaflets 1040, as shown in FIG. Figure 28A and 28B As shown. Figure 28A and 28B As shown, leaflet frame 1020 also defines a base 1025 that is operable to couple with cusps 1050 of leaflets 1040, as will be described below. A plurality of leaflet frame protrusions 1260 are shown projecting from commissure posts 1022. Leaflet frame protrusions 1260 correspond to leaflet frame protrusions 260 described and referenced herein. In some examples, a plurality of leaflet frame protrusions 1260a are also shown in phantom as projecting from leaflet frame 1020 to illustrate that the leaflets described and referenced herein (e.g., 1040 and 310) can be coupled to leaflet frame 1020 via one or more leaflet frame protrusions 1260 along one or more commissure posts 1022 and / or one or more leaflet frame protrusions 1260a along one or more non-commissural regions of leaflet frame 1020 (e.g., regions between adjacent commissure posts, such as base 1025).

[0273] Between the commissure posts 1022 is a support attachment region 1030 operable to support the leaflets 1040 along at least the (dashed) fold lines 1058 that define the outer edges 1042 of the cusps 1050 of the leaflets 1040 when coupled to the leaflet frame 1020, as shown. Figure 30In various examples, the support attachment area 1030 can include a plurality of leaflet frame protrusions 1260a (which can correspond to the leaflet frame protrusions 260 shown and described above), and / or can optionally include one or more slots 1031a (shown in phantom) through which the leaflets (e.g., 1040 or 310) can extend. Figure 30 yes Figure 29 30 - 30 , showing the commissure posts 1022 and the support attachment area 1030 .

[0274] Figure 30 Provides something similar to Figures 2F-2I , wherein the leaflets 1040 are wrapped around one or more portions of the leaflet frame 1020. Figure 30 As shown, the outer edge 1042 of the leaflet 1040 extends along the support attachment area 1030 of the leaflet frame 1020. As shown, the cusp 1050 is folded along the fold line 1058. In some examples, the outer edge 1042 can be coupled to the leaflet frame 1020 along the support attachment area 1030. Figure 30 It is not shown, but it should be understood that the leaflets 1040 may be, for example, Figures 2I-2F The leaflets 1040 are fixed to the leaflet frame 1020 via one or more leaflet frame protrusions (e.g., 1260, 260). Figure 30 1260, but it should be understood that the leaflets 1040 may be provided with any of the leaflet frame projections 1260, as discussed above. Figure 30 One or more leaflet frame projections 1260 are shown coupled in the area of commissure posts 1022 .

[0275] Continue to refer Figure 30 Each leaflet 1040 is received within a corresponding slot 1031 defined in the commissure posts 1022 of the leaflet frame 1020, wherein the commissure regions 1052 of the leaflet 1040 extend through the slots 1031 of the commissure posts 1022. Figure 29 The slots 1031 are shown extending along the leaflet frame 1020, including along those portions of the leaflet frame 1020 corresponding to the leaflet frame second edge 206 described above (e.g., the area between the commissure posts 1022 and 210), but it should be understood that the slots 1031 may be present in the area of the commissure posts 1022 and not in other areas of the leaflet frame 1020 (see, for example, Figure 2C ). Continue to refer to Figure 29, each outer edge 1042 of the leaflet 1040 can be "inserted" into or otherwise extend through the slot 1031 of the leaflet frame 1020. Attachment means including but not limited to one or more leaflet frame protrusions 1260 can be operable to couple the outer edge 1042 of the leaflet 1040 to the leaflet frame 1020. Other suitable attachment methods include but are not limited to suturing, adhering or bonding, welding, wrapping, and coupling the leaflet to itself. For example, Figure 28A As shown, the commissure regions 1052 of two adjacent leaflets 1040 can be coupled to the frame exterior 1034 of the leaflet frame 1020 and / or to each other, as shown. Figure 30 1031 at commissure posts 1022, thereby limiting the pulling back of commissure regions 1052 through corresponding slots 1031 at commissure posts 1022. Furthermore, while shown as at least partially wrapped around a portion of leaflet frame 1020, in some examples, one or more regions of leaflet 1040, including all or less than all of commissure regions 1052, may be coupled to leaflet frame 1020 without first being wrapped around leaflet frame 1020. For example, leaflet 1040 may be coupled to one or more of those portions of leaflet frame 1020 that define slots 1031 (e.g., walls or surfaces) without first being wrapped around a portion of leaflet frame 1020 (e.g., without folding leaflet 1040 along fold lines 1058). Furthermore, in some examples, one or more portions of the leaflet frame 1020 defining the slot 1031 may include one or more leaflet frame protrusions 1260 that protrude into the slot 1031, and one or more of the leaflet holes 1308 of the leaflets 1040 are disposed on the leaflet frame protrusions. Figures 2F-2I Various wrap configurations are shown and described. Figure 1B , the leaflet frame 200 is shown in an unwrapped configuration in the region below the commissure posts 210 .

[0276] In various examples, commissure regions 1052 of leaflets 1040 can be coupled to commissure posts 1022 of leaflet frame 1020 around one of the diverging support attachment regions 1030 . Figure 29 The illustrated commissure post 1022 defines a diverging region 1038 having two slots 1031 defining respective support attachment regions 1030 that diverge in the outflow direction 1018 from a location distal to the commissure post end 1024 toward the commissure post end 1024 (see also FIG. Figure 27A), so that the two slots 1031 of the corresponding commissure post 1022 diverge from each other in the outflow direction in the region of the commissure post end 1024. Thus, when coupled to the leaflet frame 1020, each of the two commissure regions 1052 of the corresponding leaflet 1040 will diverge from a position away from the commissure post end 1024 in the outflow direction 18, as shown in FIG. Figure 27A The commissure regions 1052 of a respective leaflet 1040 are coupled to the commissure posts 1022 of the leaflet frame 1020 around one of the respective diverging support attachment regions 1030 , such as the one beginning at the leaflet fold line 58 .

[0277] Reference again Figure 27A and 28A , each of the plurality of leaflets 1040 defines two terminal ends 1056 at the intersection of the leaflet free edge 1054 and the leaflet attachment region 1043. The leaflet attachment region 1043 of each leaflet 1040 is coupled to the leaflet frame 1020 at the support attachment region 1030 such that the leaflet attachment regions 1043 adjacent to the terminal ends 1056 of two adjacent leaflets 1040 diverge from each other from locations distal to the terminal ends 1056.

[0278] By comparison, Figure 31 is a side view of the leaflet frame 1020a, which shows the commissure 1022a, which defines two narrow slots 1031, which define corresponding support attachment areas 1030a that are aligned with and parallel to the axis X of the leaflet frame 1020a at the commissure 1022a; in other words, this is an example in which the support attachment areas 1030a do not diverge along the outflow direction 1018 from a position away from the tip 1024 of the commissure.

[0279] When coupled to the leaflet frame 1020, the commissure region 1052 of each leaflet 1040 is under tension during dynamic motion of the prosthetic valve 1010 and when the prosthetic valve 1010 is closed and there is downstream pressure against the closed leaflets 1040. It has been found that the non-diverging support attachment region 1030a at the commissure posts 1022a, corresponding to the leaflet fold lines 1058 at the commissure region 1052, is the region with the greatest stress when the leaflets 1040 are in the closed position and restricting reverse flow. Specifically, the greatest stress is located in the region of the terminal ends 1056.

[0280] like Figures 27A-30As shown in the embodiment of FIG, each respective commissure region 1052 of a respective leaflet 1040 is coupled to a respective commissure post 1022 along one of the respective diverging support attachment regions 1030. Thus, when the leaflets are in a closed position under the influence of downstream fluid pressure closing the valve, each leaflet 1040 is under stress, with the maximum stress at the commissure region 1052, but with the maximum stress at the commissure region 1052. Figure 31 In contrast to the embodiment of , the location of the maximum stress is away from the end point 1056, distributed over a larger area and with a reduced magnitude.

[0281] Figure 32A Provided Figure 31 von Mises stress distribution within the commissure region of the leaflet 1040 of an embodiment, which is connected to the non-divergent leaflet attachment region 1043 corresponding to the support attachment region 1030a, the stress distribution being generated by performing a finite element analysis. Figure 32B Provided Figure 27A The von Mises stress distribution in the commissure region of the leaflet 1040 of the embodiment of Figure 31 1063, which is coupled to the diverging leaflet attachment region 1043, is shown by the dashed lines in FIG. 1064, which was generated by performing a finite element analysis. The commissure region of the corresponding leaflet 1040 is shown as having a free edge 1054 and a leaflet attachment region 1043 that intersect at a terminal end 1056. The von Mises stress distribution is shown based on the leaflet 1040 experiencing a peak closing pressure of approximately 135 mmHg. Stress contour 1066 represents a stress value of approximately 2.85e+03 psi, stress contour 1064 of approximately 1.67e+03 psi, stress contour 1063 of approximately 1.10e+03 psi, and stress contour 1062 of approximately 0.67e+03 psi. From Figure 32A As can be seen in the embodiment with a non-diverging leaflet attachment region 1043 , the location of the maximum loading stress at the leaflet attachment region 1043 is located at the terminal end 1056 of the stress contour 1066 .

[0282] In this embodiment, because the diverging profile of the support attachment region at the commissure posts is predetermined, the stress along each leaflet attachment region can be calculated and a profile of the support attachment region can be selected that distributes the stress away from the terminal ends of the leaflets and reduces the stress at the terminal ends. According to some embodiments, the stress vectors within the leaflets along the diverging regions can be reduced relative to non-diverging frame attachments, such that at a given frame length, the peak stress within the leaflets adjacent to the free edge at the frame is reduced by 41%. In another embodiment, at a given support structure length, when exposed to a peak closing pressure of approximately 135 mmHg in the leaflets adjacent to the free edge at the support structure, the stress within the leaflets along the diverging regions can be reduced by more than 40% relative to non-diverging attachments. As Figure 32B As shown in the embodiment with divergent leaflet attachment areas 1043, Figure 27A shown, and in Figure 31 In the dashed line (corresponding to support attachment region 1030), the maximum stress is away from terminal end 1056 (stress contour 1062) and at a location on leaflet attachment region 1043 (stress contour 1064). Figure 32A Compared to the embodiment of the present invention, the stress of the leaflet 1040 at the leaflet attachment area 1043 is generally more evenly distributed, and the maximum stress (stress contour 1064) is greater than Figure 32A The maximum stress encountered in the embodiment of FIG104 is approximately 40% less. This indicates that the location of the maximum loading stress can be moved to a predetermined and more favorable location, and that by changing the geometry of the support attachment area 1030 and thereby the leaflet attachment area 1043, specifically by modifying the divergence and curvature of the support attachment area 1030, the magnitude and distribution of the stress experienced by a given area of the leaflet 1040 can be changed.

[0283] Figure 33 is basically corresponding to Figure 29 A side view of an embodiment of the leaflet frame 1020b of an embodiment of the invention, but for commissure posts 1022b and alternative configurations thereof. Figure 33 In the embodiment of FIG. 1 , the commissure posts 1022b define continuous slots 1031 that define adjacent support attachment regions 1030 that diverge along the outflow direction 1018 from locations distal to the commissure post ends 1024 toward the commissure post ends 1024 . Figure 29 33 includes one slot 1031 defined at the neck 1037 of the commissure post 1022. Thus, in some embodiments, the commissure post 1022 may include multiple slots 1031 that converge into a single slot 1031 at the neck 1037 of the commissure post 1022. Figure 33Compared to the commissure regions 1052 of adjacent corresponding leaflets 1040 in the configuration shown in FIG. Figure 29 The commissure regions 1052 of adjacent corresponding leaflets 1040 of the configuration shown in FIG will be closer to each other in the neck 1037. Figures 28A-28B According to an embodiment, when Figure 33 When constructed as shown, the commissure regions 1052 of adjacent respective leaflets 1040 will contact and sealingly engage one another at the neck 1037. Each leaflet 1040 is received within a slot 1031 defined in the leaflet frame 1020, with the commissure regions 1052 extending through the slots 1031 of the frame commissure posts 1022. Thus, each outer edge 1042 of each leaflet 1040 can be "inserted" into or otherwise extend through the slots 1031 of the leaflet frame 1020b. The outer edge 1042 of each leaflet 1040 is folded under the support attachment region 1030b along the fold line 1058. At this point, the attachment means couples the outer edge 1042 to the leaflet frame 1020b in a manner consistent with the description of the leaflet to leaflet frame coupling hereinabove. As shown Figure 33 As shown and as referenced above Figure 29 As depicted, the slots 1031 can optionally extend between adjacent commissure posts 1022 to define one or more slots 1031a.

[0284] Also refer to Figure 27A and 28A , each of the multiple leaflets 1040 defines two terminals 1056 at the intersection of the leaflet free edge 1054 and the leaflet attachment area 1043, and the leaflet attachment area 1043 of each leaflet 1040 is connected to the leaflet frame 1020 at the support attachment area 1030, so that the leaflet attachment areas 1043 adjacent to the terminals 1056 of two adjacent leaflets 1040 diverge from a position away from the terminal 1056 toward the terminal 1056 relative to each other.

[0285] In the previous embodiment, the divergent support attachment areas 1030 at the commissure posts 1022 can be geometrically configured to distribute the maximum load stress to meet the design requirements. In the previously presented embodiment, the respective divergent support attachment areas 1030 at the commissure posts 1022 are curved around a radius toward each other from a position away from the commissure post ends 1024 in the outflow direction 1018, as shown in FIG. Figure 27A and 29 It should be understood that the corresponding diverging support attachment regions 1030 at the commissure posts 1022 can diverge from one another in a linear manner, such as in a Y-shape.

[0286] Figure 341020d, which is an example of a cut tube, but may also be in the form of a continuous wire or braided wire, depending on the embodiment. Leaflet frame 1020d is an example of a transcatheter valve frame that defines a plurality of interconnected diamond-shaped holes 1029, wherein each leaflet commissure region may follow a diverging portion of one of the holes 1029. Alternatively, each leaflet commissure region of the transcatheter valve frame may correspond to a portion of the leaflet commissure region of the transcatheter valve frame. Figure 9A and 9B A portion of the leaflet frame 1020d consistent with the embodiment depicted in FIG. Figure 35 , showing the slots 216 and 217 diverging in the outflow direction near the commissure end 221). Figure 34 As shown, leaflet frame 1020d defines commissure posts 1022 that define necks 37 adjacent to connecting members of the frame element that define apertures 1029 .

[0287] The commissure posts 1022d define adjacent support attachment regions 1030d that diverge along the outflow direction 1018 from a location distal to the commissure post ends 1024 toward the commissure post ends 1024. Thus, each of the two corresponding commissure regions 1052 of the complementary leaflets 1040 will diverge along the outflow direction 1018 from the neck 1037, i.e., from a location distal to the commissure post ends 1024 toward the commissure post ends 1024. The commissure regions 1052 of the corresponding leaflets 1040 are coupled to the commissure posts 1022d of the leaflet frame 1020d around the corresponding diverging support attachment regions 1030d at the leaflet fold lines 1058. The leaflet frame 1020d is operable to retain and support the plurality of leaflets 1040. As shown, the leaflet frame 1020d includes a plurality of leaflet frame projections 1260 along the diverging support attachment region 1030d, and one or more optional leaflet frame projections 1260a that can extend between adjacent commissure posts 1022d of the leaflet frame 1020d, these projections 1260a being consistent with the above discussion of the optional leaflet frame projections 1260a. The leaflet frame 1020d is annular, i.e., it defines a cylinder having an interior cavity defining an axis X, and defines a plurality of commissure posts 1022d spaced apart from one another and extending parallel to the axis X.

[0288] Also refer to Figure 27A and 28A, each of the multiple leaflets 1040 defines two terminals 1056 at the intersection of the leaflet free edge 1054 and the leaflet attachment area 1043, and the leaflet attachment area 1043 of each leaflet 1040 is connected to the leaflet frame 1020d at the support attachment area 1030d, so that the leaflet attachment areas 1043 adjacent to the terminals 1056 of two adjacent leaflets 1040 diverge relative to each other from a position away from the terminal 1056 to the terminal 1056.

[0289] In the previously proposed embodiments, because the diverging support attachment areas (e.g., 1030, 1030b, 1030d) at the commissure posts (e.g., 1022, 1022b, 1022d) diverge from one another along the outflow direction 1018 from a position away from the commissure post end 1024 toward the commissure post end 1024, the diverging support attachment areas (e.g., 1030, 1030b, 1030d) can have the same length as the corresponding non-diverging support attachment areas (e.g., 1030a), but with a reduced overall frame height. This is particularly true for the diverging support attachment areas (e.g., 1030, 1030b, 1030d), which further reduces the frame height. Again referring to Figure 31 , the frame height H2 of the non-divergent support attachment area 30 a is longer than the frame height H2 of the divergent support attachment area 30 .

[0290] Figure 35 is an illustration of an alternative leaflet frame design including a commissure post 210 consistent with the leaflet frame 900 shown and described above, except that the slots 216 and 217 diverge from each other along the commissure post 210 in the outflow direction such that the slots 216 and 217 are further apart at the commissure tip 221 than near the free ends 218 and 219 of the first tooth 214 and the second tooth 215, respectively (e.g., near the base of the commissure post).

[0291] Figure 36 is a perspective view of a diagram of an exemplary sheath coupled to a prosthetic valve, according to an embodiment. Figure 37 According to an embodiment, the cross-section is taken at points equidistant between adjacent commissure posts 210 along the longitudinal axis. Figure 36 The components of the prosthetic valve 100 include a plurality of leaflets 310 and a leaflet frame 200 (which corresponds to the leaflet frame 200 of the above reference Figure 2A The leaflet frame 200 shown and described includes a plurality of commissure posts 210 flanked on either side by (one or more) leaflet window frame elements. The leaflet frame 200 is operable to mechanically couple and support the leaflets 310 at least in part by means of a plurality of leaflet frame projections 260.

[0292] Sheath 300 can be coupled to leaflet frame 200 to enhance the biocompatibility of leaflet frame 200 and prosthetic valve 100. More specifically, sheath 300 is configured to cover gaps, spaces, interfaces, or other structural aspects present in leaflet frame 200 and / or interfaces between leaflet frame 200 and one or more leaflets 310 attached thereto, and / or one or more leaflet retention features (e.g., leaflet retention features 400, 500, 600, 700, 800, 900) to enhance the biocompatibility of leaflet frame 200. In some examples, sheath 300 additionally helps maintain the mechanical connection between leaflet 310 and leaflet frame 200, including leaflet frame protrusions 260. Furthermore, sheath 300 can be configured to include a smooth transition with prosthetic valve 100 to help minimize gaps and cracks, thereby helping to minimize areas of stagnant blood and / or thrombus formation.

[0293] The components of the prosthetic valve 100 include a plurality of leaflets 310 and a leaflet frame 200, which includes a plurality of commissure posts 210 flanked on both sides by (one or more) leaflet window frame elements. Consistent with the above discussion, the leaflet frame 200 is operable to mechanically couple and support the leaflets 310 at least in part by means of a plurality of leaflet frame protrusions 260.

[0294] The sheath 300 can be attached to the leaflet frame 200 to enhance the biocompatibility of the leaflet frame 200 and the prosthetic valve 100. More specifically, the sheath 300 is configured to cover gaps, spaces, interfaces, or other structural aspects present in the leaflet frame 200 and / or interfaces between the leaflet frame 200 and one or more leaflets 310 attached thereto, and / or one or more leaflet retention features (e.g., leaflet retention features 400, 500, 600, 700, 800, 900), which helps enhance the biocompatibility of the leaflet frame 200. Furthermore, the sheath 300 can be configured to include a smooth transition with the prosthetic valve 100 to help minimize gaps and cracks, thereby helping to minimize areas of stagnant blood and / or thrombus formation. Furthermore, as shown, the sheath 300 can extend to the covered (outflow-side) ends of the commissure posts 210. Sheath 300 formed and configured in this manner can help minimize areas of stagnant blood and / or thrombus formation by filling gaps 1500 behind the leaflets 310 and the outflow side of the leaflet frame 200. While sheath 300 is shown coupled to leaflet frame 200, it should be understood that sheath 300 can be coupled to any other leaflet frame shown and described herein (e.g., 1020).

[0295] In some cases, sheath 300 can include an inflow portion and an outflow portion that are coupled together around leaflet frame 200. In other cases, sheath 300 can be a single piece that is directly coupled to or overmolded onto leaflet frame 200. Additionally, portions of sheath 300 can also be coupled to or overmolded onto portions of leaflets 310.

[0296] In some cases, sheath 300 can include an inflow portion and an outflow portion that are coupled together around leaflet frame 200. In other cases, sheath 300 can be a single piece that is directly coupled to or overmolded onto leaflet frame 200. Additionally, a portion of sheath 300 can be coupled to or overmolded onto leaflet frame 200 such that sheath 300 extends over (and can be bonded to) one or more portions of leaflets 310.

[0297] In some cases, the sheath 300 can be formed from a rigid polymer. In some cases, the sheath 300 can be formed from a fluoropolymer (eg, a TFE-PMVE copolymer). In these cases, the TFE-PMVE copolymer sheath 300 can be bonded to the synthetic leaflet 310.

[0298] In some cases, the prosthetic valve 100 (with the sheath 300) can be implanted directly into the patient's body, and in other cases, the prosthetic valve 100 (with the sheath 300) can be placed in a catheter as described above. Figure 36 and 37 As shown, prosthetic valve 100 having wall heights extending adjacent to or up to the ends of commissure posts 210 can help minimize stagnant blood areas and / or thrombus formation by extending gaps 1500 behind the outflow side of leaflet frame 200 and leaflets 310.

[0299] Figure 38 is a perspective view of an illustration of an exemplary sheath 300 coupled to a prosthetic valve 100, according to an embodiment. Components of the prosthetic valve 100 include a plurality of leaflets 310 and a leaflet frame 2000, the leaflet frame 200 including a plurality of commissure posts 2210 (which can be understood to generally correspond to the various other commissure posts 210 and 1022 shown and described above) flanked on both sides by (one or more) leaflet window frame elements. Consistent with the above discussion, the leaflet frame 2000 is operable to mechanically couple and support the leaflets 310, at least in part, by a plurality of leaflet frame projections 2260 (corresponding to the leaflet frame projections 260 and 1260 described above).

[0300] The leaflet frame 2000 includes a recess or slot 2031 extending along one or more portions thereof (which may be understood to correspond to the slot 1031 described above, such that one or more leaflets may extend through the slot 2031 to couple to the leaflet frame 2000). Figure 38 As shown, the slot 2031 is used to define an inflow portion 2242 (which corresponds to those areas on the inflow side of the slot 2031 of the leaflet frame 2000) and an outflow portion 2244 (which corresponds to those areas on the outflow side of the slot 2031 of the leaflet frame 2000). The leaflet frame 2000 includes one or more portions (e.g., frame elements such as struts or links) extending between the inflow portion 2242 and the outflow portion 2244. As shown, in some examples, the slot 2031 may include one or more leaflet frame protrusions 2260. In addition, as shown, the leaflet frame 2000 may include a second slot or recess 2032 adjacent to the slot 2031 along the commissure posts 2210. As shown, in some examples, the slots 2031 and 2032 may include one or more leaflet frame protrusions 2260. Consistent with the above discussion, the leaflets (e.g., 310 and 1040) are coupled to the leaflet frame 2000 via one or more slots 2031 and 2032 and one or more leaflet frame protrusions 2260. The leaflet frame 2000 may be etched, cut, laser cut, stamped, three-dimensionally printed, wire wound, or formed according to any other method referenced herein.

[0301] The sheath 300 can be coupled to the leaflet frame 2000 to enhance the biocompatibility of the leaflet frame 2000 and the prosthetic valve 100. More specifically, the sheath 300 is configured to cover gaps, spaces, interfaces, or other structural aspects present in the leaflet frame 2000 and / or interfaces between the leaflet frame 2000 and one or more leaflets 310 attached thereto, and / or one or more leaflet retention features (e.g., leaflet retention features 400, 500, 600, 700, 800, 900) to enhance the biocompatibility of the leaflet frame 2000. In some examples, the sheath 300 additionally helps maintain the mechanical connection between the leaflets 310 and the leaflet frame 2000, including the leaflet frame protrusions 2260. Furthermore, the sheath 300 can be configured to include a smooth transition with the prosthetic valve 100 to help minimize gaps and cracks, thereby helping to minimize areas of stagnant blood and / or thrombus formation. Additionally, and as shown, the sheath 300 can extend to the covered (outflow-side) ends of the commissure posts 2210. Formed and configured in this manner, the sheath 300 can help minimize areas of stagnant blood and / or thrombus formation by filling the gaps 1500 behind the outflow side of the leaflets 310 and leaflet frame 2000.

[0302] In some cases, the sheath 300 can include an inflow portion and an outflow portion that are coupled together around the leaflet frame 2000. In other cases, the sheath 300 can be a single piece that is directly coupled to (e.g., affixed to, coated on, molded onto) the leaflet frame 2000. Furthermore, a portion of the sheath 300 can also be coupled to or overmolded onto the leaflet frame 2000 such that the sheath 300 extends over one or more portions of the leaflets 310.

[0303] In some cases, sheath 300 can include an inflow portion and an outflow portion that are coupled together around leaflet frame 2000. In other cases, sheath 300 can be a single piece (single piece) that is directly coupled to or overmolded onto leaflet frame 2000. Furthermore, a portion of sheath 300 can also be coupled to or overmolded onto leaflet frame 2000 such that sheath 300 extends over (and can be bonded to) one or more portions of leaflets 310.

[0304] In some cases, the sheath 300 can be formed from a rigid polymer. In some cases, the sheath 300 can be formed from a fluoropolymer (e.g., a TFE-PMVE copolymer). In these cases, the TFE-PMVE copolymer sheath 300 can be bonded to the synthetic leaflet 310.

[0305] Figure 39 According to an embodiment, the sectional view is taken at points equidistant between adjacent commissure posts 2210 along the longitudinal axis. Figure 36 , a cross-sectional view of sheath 300 and prosthetic valve 100 is shown in . As shown, leaflets 310 are coupled to leaflet frame 2000 such that inflow portions 2242 are positioned on the inflow side of leaflets 310 and such that outflow portions 2244 are positioned on the outflow side of leaflets 310 .

[0306] like Figure 38 and 39 As shown, a prosthetic valve 100 having wall heights extending adjacent to or up to the ends of the commissure posts 2210 can help minimize stagnant blood areas and / or thrombus formation by extending gaps 1500 behind the outflow side of the leaflet frame 2000 and leaflets 310.

[0307] Figure 40is a perspective view of another exemplary sheath coupled to a prosthetic valve, according to an embodiment. Components of prosthetic valve 100 include a plurality of leaflets 310 and a leaflet frame 2000a, the leaflet frame 200 including a plurality of commissure posts 2210a (which can be understood to generally correspond to the various other commissure posts 210, 1022, and 2210a shown and described above) flanked on both sides by (one or more) leaflet window frame elements. Consistent with the above discussion, the leaflet frame 2000 is operable to mechanically couple and support the leaflets 310, at least in part, via a plurality of leaflet frame protrusions 2260 (corresponding to leaflet frame protrusions 260 and 1260 described above).

[0308] The leaflet frame 2000a is similar to the leaflet frame 2000 shown and described above, and includes a recess or slot 2031a extending along one or more portions thereof (which can be understood to correspond to the slots 1031 and 2031 described above, such that one or more leaflets can extend through the slot 2031a to couple to the leaflet frame 2000a). Figure 40 As shown, the slot 2031a can be operated to define an inflow portion 2242a (which corresponds to those areas of the leaflet frame 2000 on the inflow side of the slot 2031a) and an outflow portion 2244a (which corresponds to those areas of the leaflet frame 2000 on the outflow side of the slot 2031a). Similar to the leaflet frame 2000, the leaflet frame 2000a also includes one or more portions (e.g., frame elements such as struts or links) extending between the inflow portion 2242a and the outflow portion 2244a. As shown, in some examples, the slot 2031a may include one or more leaflet frame protrusions 2260. In addition, as shown, the leaflet frame 2000a may include a second slot or recess 2032a adjacent to the slot 2031a along the commissure posts 2210. As shown, in some examples, the slots 2031a and 2032a may include one or more leaflet frame protrusions 2260. Consistent with the above discussion, the leaflets (eg, 310 and 1040 ) are coupled to the leaflet frame 2000a via one or more slots 2031a and 2032a and one or more leaflet frame protrusions 2260 .

[0309] The leaflet frame 2000a may be etched, cut, laser cut, stamped, three-dimensionally printed, wire wound, or formed according to any other method referenced herein.

[0310] Figure 41 According to an embodiment, the sectional view is taken at points equidistant between adjacent commissure posts 2210 along the longitudinal axis. Figures 42A-42B, a cross-sectional view of a sheath 3000 and prosthetic valve 100 is shown in FIG. As shown, the leaflets 310 are coupled to the leaflet frame 2000a such that the protrusions of the outflow portion 3002 of the sheath 3000 are received within the voids 2248a of the leaflet frame 2000a and such that the protrusions of the inflow portion 3004 of the sheath 3000 are received within the voids 2246a of the leaflet frame 2000a.

[0311] Now refer to Figure 42A and 42B , sheath 3000 can be attached to leaflet frame 2000a to enhance the biocompatibility of leaflet frame 2000a and prosthetic valve 100. More specifically, sheath 3000 is configured to cover gaps, spaces, interfaces, or other structural aspects present in leaflet frame 200 and / or the interface between leaflet frame 2000 and one or more leaflets 310 attached to leaflet frame 2000a to enhance the biocompatibility of leaflet frame 2000a. In some cases, as described above, if leaflet frame 200 is overmolded, sheath 3000 can be attached to the leaflets.

[0312] In some cases, it may be beneficial for the sheath 3000 to be formed of a flexible component such as silicone. The sheath 3000 can minimize the seam and form a seal in the gap between the leaflet 310 and the frame 2000a with the help of compression force. In some cases, the various parts of the sheath 3000 can be formed of different materials. The sheath 3000 may include a first portion 3002 (outflow sheath portion) and a second portion 3004 (inflow sheath portion). For example, the inflow portion 3004 of the sheath 3000 (also referred to as the first portion of the sheath) may be formed of a different material than the outflow portion 3002 of the sheath 3000 (also referred to as the second portion). In some cases, the outflow portion 3002 of the sheath 3000 may be formed of a more flexible material (e.g., silicone) than the inflow portion 3004 of the sheath 3000 (e.g., a thermoplastic polymer or a rigid material overmolded with silicone). The outflow portion 3002 and the inflow portion 3004 are configured to be coupled to the leaflet frame 2000 to form the sheath 3000 .

[0313] In some embodiments, as Figure 42A and 42BAs shown, the leaflet frame 2000a includes one or more voids, such as voids 2246a and 2248a. The voids 2246a and 2248a are configured to receive one or more protrusions of one or more of the inflow portion 3004 and the outflow portion 3002 of the sheath 3000, respectively. Thus, in various embodiments, the protrusions of the inflow portion 3004 and the outflow portion 3002 of the sheath 3000 and the voids of the leaflet frame 2000a complement each other, such that the sheath 3000 can be coupled to the leaflet frame 2000a by aligning the protrusions with the voids of the leaflet frame 2000a.

[0314] In some cases, the inflow portion 3004 and the outflow portion 3002 of the sheath 3000 are secured by at least one of swaging, snap fitting, press fitting, one or more staples, tape, adhesive, or other known methods.

[0315] In some cases, prosthetic valve 100 (with sheath 300) may be implanted directly into a patient, and in other cases, prosthetic valve 100 may be positioned within a catheter as described above.

[0316] Figures 42A-42B According to the embodiment, the Figure 40 and 41 3000 and the leaflets 310 within the leaflet frame 2000a. Figure 42B As shown, the sheath 3000 is flexible and compressible (e.g., one or more of the inflow portion 3004 and the outflow portion 3002 is flexible and compressible). When arranged with the frame 2000a, the sheath 3000a can be longitudinally compressed and take the shape of the compressed sheath 3000b, as shown. Figure 42B As shown. Figure 42AAs shown, due to the compressibility of the sheath 3000, the sheath 3000 can minimize seams and create a compressive seal in the gap between the leaflets 310 and the frame 2000. That is, by providing one or more of the inflow portion 3004 and the outflow portion 3002 of the sheath 3000 as being flexible and compressible, when the sheath 3000 is coupled to the leaflet frame 2000a, the sheath 3000 can be pressed against those portions of the leaflets 310 that extend between the inflow portion 3004 and the outflow portion 3002 of the sheath 3000. In various embodiments, the interstices of the leaflet frame 2000a (e.g., leaflet frames 2246a and 2248a) can be configured such that when the inflow portion 3004 and the outflow portion 3002 are coupled to the leaflet frame 2000a, one or more of the inflow portion 3004 and the outflow portion 3002 are pressed against the leaflets 310. It will be appreciated that achieving such a compressed configuration can be achieved by oversizing one or more of the inflow portion 3004 and the outflow portion 3002 of the sheath 3000 relative to the leaflet frame 2000a. For example, where the distance from the leaflets 310 to the void 2246a is a first distance, the inflow portion 3004 of the sheath 3000 can be configured such that the area of the inflow portion 3004 of the sheath 3000 that interfaces with the leaflets 310 is a second distance (greater than the first distance) from a protrusion that is complementary to (and configured to be received in) the void 2246a when the inflow portion 3004 of the sheath 3000 is in an uncompressed state.

[0317] Leaflet material

[0318] The various leaflets disclosed herein (e.g., 310 and 1040) can comprise any biocompatible material that is sufficiently compliant and flexible, such as biocompatible polymers (e.g., synthetic) and biological tissue (e.g., animal-derived). For example, in various embodiments, the leaflets (e.g., 310 and 1040) are formed from biocompatible synthetic materials (e.g., including ePTFE and ePTFE composites, or other materials as desired). According to an embodiment, the composite material includes an expanded fluoropolymer material made from a porous ePTFE membrane, for example, as generally described in U.S. Patent No. 7,306,729 to Bacino, cited above. In other examples, the leaflets are formed from natural materials such as repurposed tissue, such tissue including bovine tissue, porcine tissue, and the like.

[0319] The expandable fluoropolymer used to form the expandable fluoropolymer material may include a PTFE homopolymer. In some embodiments, a mixture of PTFE, expandable modified PTFE and / or an expandable copolymer of PTFE may be used. For example, non-limiting examples of suitable fluoropolymer materials are described in U.S. Patent No. 5,708,044 to Branca, U.S. Patent No. 6,541,589 to Ballie, U.S. Patent No. 7,531,611 to Sabol et al., U.S. Patent Application No. 11 / 906,877 to Ford, and U.S. Patent Application No. 12 / 410,050 to Xu et al. The expandable fluoropolymer membrane may include any suitable microstructure, such as pores, to achieve the desired leaflet performance. Other biocompatible polymers suitable for leaflets (e.g., 310 and 1040) include, but are not limited to, polyurethanes, silicones (organopolysiloxanes), silicon-polyurethane copolymers, styrene / isobutylene copolymers, polyisobutylene, polyethylene copolymers (vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers, and copolymers or mixtures of each of the above.

[0320] As used herein, the term "elastomer" refers to a polymer or mixture of polymers that has the ability to stretch to at least 1.3 times its original length and quickly retract to its original length when released. The term "elastomeric material" refers to a polymer or polymer mixture that exhibits stretch and recovery properties similar to those of an elastomer, although not necessarily to the same extent of stretch and / or recovery. The term "non-elastic material" refers to a polymer or polymer mixture that exhibits stretch and recovery properties different from those of an elastomer or elastomeric material, i.e., is not considered an elastomer or elastomeric material.

[0321] According to some embodiments herein, the leaflet (e.g., 310 and 1040) includes a composite material comprising: at least one porous synthetic polymer membrane layer with a plurality of pores and / or spaces, and an elastomer and / or elastomeric material and / or non-elastomeric material filling the pores and / or spaces of the at least one synthetic polymer membrane layer. According to other examples, the leaflet (e.g., 310 and 1040) further includes a layer of elastomer and / or elastomeric material and / or non-elastomeric material on the composite material. According to various examples, the composite material includes the porous synthetic polymer membrane in a range of approximately 10% to 90% by weight.

[0322] Examples of porous synthetic polymer membranes include expanded fluoropolymer membranes having a node and fibril structure defining pores and / or spaces. In some examples, the expanded fluoropolymer membrane is an expanded polytetrafluoroethylene (ePTFE) membrane. Another example of a porous synthetic polymer membrane includes a microporous polyethylene membrane.

[0323] Examples of elastomers and / or elastomeric materials and / or non-elastomeric materials include, but are not limited to, copolymers of tetrafluoroethylene and perfluoromethyl vinyl ether (TFE / PMVE copolymers), (per)fluoroalkyl vinyl ethers (PAVE), polyurethanes, silicones (organopolysiloxanes), silicone-polyurethane copolymers, styrene / isobutylene copolymers, polyisobutylene, polyethylene-co-poly(vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers, and copolymers or mixtures of each of the above. In some examples, the TFE / PMVE copolymer is an elastomer consisting essentially of between 60 and 20 weight percent tetrafluoroethylene and between 40 and 80 weight percent perfluoromethyl vinyl ether. In some examples, the TFE / PMVE copolymer is an elastomeric material consisting essentially of between 67 and 61 weight percent tetrafluoroethylene and between 33 and 39 weight percent perfluoromethyl vinyl ether. In some examples, the TFE / PMVE copolymer is a non-elastomeric material consisting essentially of between 73 and 68 weight percent tetrafluoroethylene and between 27 and 32 weight percent perfluoromethyl vinyl ether. The TFE and PMVE components of the TFE-PMVE copolymer are expressed in weight %. For reference, 40, 33-39, and 27-32 weight % of PMVE correspond to 29, 23-28, and 18-22 mole % respectively.

[0324] In some examples, the TFE-PMVE copolymer exhibits elastomeric, elastic, and / or inelastic properties.

[0325] In some examples, the composite material further includes a layer or coating of a TFE-PMVE copolymer comprising from about 73 to about 68 weight percent tetrafluoroethylene and correspondingly from about 27 to about 32 weight percent perfluoromethyl vinyl ether.

[0326] In some examples, the leaflet is an expanded polytetrafluoroethylene (ePTFE) membrane into which a TFE-PMVE copolymer has been imbibed, wherein the TFE-PMVE copolymer comprises about 60 to about 20 weight percent tetrafluoroethylene and correspondingly about 40 to about 80 weight percent perfluoromethyl vinyl ether, and the leaflet further comprises a coating of a TFE-PMVE copolymer on the blood contacting surface, wherein the TFE-PMVE copolymer comprises about 73 to about 68 weight percent tetrafluoroethylene and correspondingly about 27 to about 32 weight percent perfluoromethyl vinyl ether.

[0327] As described above, the elastomer and / or elastomeric material and / or non-elastomeric material may be combined with the expanded fluoropolymer membrane such that the elastomer and / or elastomeric material and / or non-elastomeric material occupies substantially all of the space or pores within the expanded fluoropolymer membrane.

[0328] Many features and advantages have been given in the previous description, including various alternative schemes, and details of the structure and function of the device and / or method. In addition, the scope of the invention of the various concepts addressed in this disclosure has been described generally and with respect to specific examples. What is described in this disclosure is intended to be illustrative only and is not intended to be exhaustive. For example, various such forces of the present disclosure are described in the context of medical applications, but can also be used in non-medical applications. It will be apparent to those skilled in the art that various modifications can be made within the scope of the principles of the inventive concepts discussed herein, particularly in the arrangement of structures, materials, elements, parts, shapes, sizes and parts, and combinations thereof, within the maximum scope indicated by the broad general meanings of the terms expressed in the appended claims. To the extent that these various modifications do not depart from the spirit and scope of the appended claims, they are intended to be included therein.

Claims

1. A prosthetic valve defining an inflow direction into the valve and an outflow direction out of the valve during operation, the valve comprising: a plurality of leaflets, the plurality of leaflets comprising a first leaflet and a second leaflet, each leaflet having a leaflet attachment region and a free edge opposite a base; as well as A frame comprising a commissure post comprising: a first tooth portion, the first tooth portion comprising a first inner edge and a first outer edge opposite the first inner edge, a second tooth portion, the second tooth portion comprising a second inner edge and a second outer edge opposite the second inner edge, a ridge positioned between the first tooth and the second tooth such that an inner edge of the first tooth and an inner edge of the second tooth face the ridge; a first slot defined between the first tooth and the ridge, the leaflet attachment region of the first leaflet being coupled to the frame at the first slot, and A second slot is defined between the second tooth and the ridge, the leaflet attachment region of the second leaflet being coupled to the frame at the second slot, the first and second slots diverging from each other in an outflow direction.

2. The valve according to claim 1, wherein The leaflet attachment region of the first leaflet and the leaflet attachment region of the second leaflet diverge in the outflow direction at the first slot and the second slot.

3. The valve according to claim 1, wherein: The first leaflet and the second leaflet each define two terminals at the intersection of the leaflet free edge and the leaflet attachment area of the corresponding leaflet, and the leaflet attachment area of each leaflet is connected to the frame so that when positioned adjacent to each other, the leaflet attachment areas adjacent to the terminals of the first leaflet and the second leaflet diverge from positions away from the terminals to the terminals relative to each other.

4. The valve according to claim 1, wherein: The free edges of the first and second lobes diverge in the outflow direction adjacent the first and second slots.

5. The valve according to claim 1, wherein: The first outer edge of the first tooth portion includes a first protrusion extending from the first outer edge of the first tooth portion, the second outer edge of the second tooth portion includes a second protrusion extending from the second outer edge of the second tooth portion, and further wherein the leaflet attachment area of the first leaflet extends through the first slot, wraps around the first tooth portion, and engages the first protrusion, and wherein a first portion of the leaflet attachment area of the second leaflet extends through the second slot, wraps around a portion of the second tooth portion, and engages the second protrusion.

6. The valve according to claim 5, wherein: The first protrusion extends through a leaflet attachment area of the first leaflet, and wherein the second protrusion extends through the leaflet attachment area of the second leaflet.

7. The valve according to claim 1, wherein: The ridge is positioned between the second lobe and at least a portion of the first lobe.

8. The valve according to claim 1, wherein: A gap is defined between the free edge of the first leaflet and the free edge of the second leaflet adjacent the commissure posts.

9. The valve according to claim 1, wherein: One end of the first slot is an open end, and wherein one end of the first tooth is a free end.

10. The valve according to claim 1, wherein The first tooth has a first end and a second end, and wherein the first end and the second end are each integral with the frame.

11. The valve according to claim 1, wherein The first tooth extends from the commissure post at a location proximate the free end of the commissure post.

12. The valve according to claim 1, wherein The valve also includes a leaflet retaining member coupled to a leaflet frame such that the leaflet attachment region of the leaflet is located between the leaflet frame and the leaflet retaining member.

13. The valve according to claim 12, wherein: The leaflet retaining member engages a first frame and a second frame to secure the leaflet retaining member to the leaflet frame, wherein the leaflet retaining member includes a first portion extending along an inner surface of the leaflet frame protruding from the first frame, and wherein the leaflet retaining member includes a second portion extending along an outer surface of the leaflet frame protruding from the second frame.

14. The valve according to claim 12, wherein: The leaflet retaining member is fiber.

15. The valve according to claim 12, wherein: The valve also includes a sheath molded over the leaflet retaining member.

16. The valve according to claim 15, wherein The sheath is formed from a flexible polymer.

17. A prosthetic valve, comprising: a plurality of leaflets, the plurality of leaflets comprising a first leaflet and a second leaflet, each leaflet having a leaflet attachment region and a free edge opposite a base; as well as A framework, comprising: a first tooth portion, the first tooth portion comprising a first inner edge and a first outer edge opposite the first inner edge, a second tooth portion, the second tooth portion comprising a second inner edge and a second outer edge opposite the second inner edge, a ridge positioned between the first tooth and the second tooth such that the inner edges of the first tooth and the second tooth face the ridge; as well as a first slot defined between the first tooth and the ridge, the leaflet attachment region of the first leaflet extending through the first slot, and A second slot is defined between the second tooth portion and the ridge portion, the leaflet attachment area of the second leaflet extends through the second slot, the first slot has a first diverging portion, the second slot has a second diverging portion, the first diverging portion of the first slot and the second diverging portion of the second slot diverge from each other in the outflow direction.

18. The valve according to claim 17, wherein The first slot further includes a first parallel portion, and the second slot further includes a second parallel portion, the first parallel portion and the second parallel portion extending parallel to each other along the outflow direction.

19. The valve according to claim 17, wherein The leaflet attachment regions of the first leaflet and the second leaflet diverge in the outflow direction at the first slot and the second slot.

20. The valve according to claim 17, wherein The first leaflet and the second leaflet each define two terminals at the intersection of the leaflet free edge and the leaflet attachment area of the corresponding leaflet, and the leaflet attachment area of each leaflet is connected to the frame so that when positioned adjacent to each other, the leaflet attachment areas adjacent to the terminals of the first leaflet and the second leaflet diverge from positions away from the terminals to the terminals relative to each other.

21. The valve according to claim 17, wherein The first outer edge of the first tooth portion includes a first protrusion extending from the first outer edge of the first tooth portion, the second outer edge of the second tooth portion includes a second protrusion extending from the second outer edge of the second tooth portion, and further wherein the leaflet attachment area of the first leaflet extends through the first slot, wraps around the first tooth portion, and engages the first protrusion, and wherein a first portion of the leaflet attachment area of the second leaflet extends through the second slot, wraps around a portion of the second tooth portion, and engages the second protrusion.

22. A prosthetic valve defining an inflow direction into the valve and an outflow direction out of the valve, the valve comprising: a plurality of leaflets, the plurality of leaflets comprising a first leaflet and a second leaflet, each leaflet having a leaflet attachment region and a free edge; as well as A frame comprising a commissure extending in the outflow direction, the commissure defining a first slot and a second slot, the first slot and the second slot diverging relative to each other in the outflow direction, at least a portion of the leaflet attachment area of the respective first leaflet and the second leaflet being coupled to the frame at the respective first slot and the second slot.

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