MECHANICALLY EXPANSIBLE HEART VALVE

专利摘要:
The present invention relates to a prosthetic valve that can comprise a radially expandable and compressible frame, which can include a plurality of supports that are articulated in an articulated manner, without the need for individual rivets. In some embodiments, the supports are intertwined and can be joined using integral joints formed in the supports, such as when making alternate cuts in the supports, folding the supports to form locking flaps adjacent to the joints and / or drilling holes in the supports to facilitate the interconnection of the supports at the junctions or to form integral joints and corresponding holes at the junction points between the supports. In another embodiment, the frame comprises a plurality of internal supports and external supports that are connected by a plurality of interconnected rivet chains, avoiding the need to provide individual rivets at each junction between the supports. In yet another modality, separate joints are provided to interconnect the supports. In yet another embodiment, separate flange rivets are provided to connect the supports.
公开号:BR112019025311A2
申请号:R112019025311-4
申请日:2018-06-05
公开日:2020-06-23
发明作者:Barash Alexander；Alexander Barash；A. NEUMANN Yair；Yair A. Neumann；Saar Tomer；Tomer Saar；Yohanan Ziv；Ziv Yohanan；Nir Noam；Noam Nir
申请人:Edwards Lifesciences Corporation；
IPC主号:

专利说明:

[0001] [0001] This disclosure relates to implantable and mechanically expandable prosthetic devices, such as prosthetic heart valves, and methods and assemblies for providing foldable frames for, and including, such prosthetic devices. Background
[0002] [0002] Dysfunctions in the human heart, such as those resulting from valve disease, often require repair of the original valve or replacement of the original valve with an artificial valve. There are several known repair devices (for example, stents) and artificial valves, as well as several known methods for implanting these devices and valves in humans. In a known technique, a prosthetic device is configured to be implanted in a less invasive procedure through catheterization. For example, a foldable transcatheter prosthetic heart valve can be crimped to a compressed state and percutaneously introduced into the compressed state in a catheter and expanded to a functional size in the desired position by mechanical expansion or with the use of a frame. or self-expanding stent. Current frame assembly designs, however, often require manufacturing processes that require handling and assembly of many small parts. Improved implant frame designs and mounting methods are required. Such frame assemblies would preferably offer one or more of the following advantages over current approaches: minimizing the number of individual parts needed, maintaining flexibility of movement within the patient, folding in a low profile to minimize the size of the catheter needed during introduction into the patient and reduce the risk of rivet embolization. summary
[0003] [0003] The modalities of improved implantable medical devices, such as prosthetic heart valves, are disclosed in this document, as well as the methods for providing such devices and assemblies.
[0004] [0004] In a representative embodiment, a method of mounting an implantable medical device comprises providing a plurality of supports, each support comprising a length and a plurality of openings spaced apart from one another along the length. The method may further comprise providing a plurality of support connectors that comprise an elongated support member and a plurality of projections spaced from one another along the support member. The method may also comprise connecting the supports to each other with the support connectors to form an annular frame, in which the projections of each support connector extend through the respective openings of one of the supports and in the respective openings of one or more other supports to form a plurality of joint joints between the supports.
[0005] [0005] In some modalities, the plurality of supports comprises a first set of internal supports and a second set of external supports, in which the internal supports are connected to the external supports by the support connectors.
[0006] [0006] In some embodiments, the support connectors are placed against the respective external supports and each support connector comprises at least the first and second projections that extend through openings in the same external support and in the openings of different internal supports.
[0007] [0007] In some embodiments, the support connectors are placed against the respective internal supports and each support connector comprises at least the first and second projections that extend through openings of the same internal support and in openings of different external supports.
[0008] [0008] In some embodiments, the method further comprises the assembly of a valve member comprising a plurality of leaflets within the annular frame.
[0009] [0009] In some modalities, the support connectors are formed using electrochemical machining.
[0010] [0010] In some modalities, the support connectors are formed using laser machining.
[0011] [0011] In another representative embodiment, an implantable medical device comprises a first set of a plurality of first supports extending in a first direction and a second set of a plurality of second supports extending in a second direction, in which the the first support is interlaced with the second support to form an annular frame that is radially compressible and expandable. Each first support can be articulated to at least one second support.
[0012] [0012] In some embodiments, each first support can comprise a plurality of projections spaced apart along a length of the first support and each second support can comprise a plurality of openings that extend along a length of the second support and in which the projections of the first support extend to the respective openings of the second support.
[0013] [0013] In some embodiments, each first support has at least one projection that extends radially inward and to an opening of a second adjacent support and at least one projection extends radially outward and to an opening of a second adjacent support.
[0014] [0014] In some modalities, projections are formed entirely on the first support.
[0015] [0015] In some modalities, each first support passes radially out of at least a second support and radially within at least a second support.
[0016] [0016] In some embodiments, the medical device further comprises a valve member which may comprise a plurality of leaflets mounted within the annular frame.
[0017] [0017] In another representative embodiment, a method of mounting a frame for an implantable medical device comprises providing a plurality of individual supports comprising a first set of a plurality of first support and a second set of one plurality of second supports. The method may further comprise intertwining the first support with the second support to form an annular frame.
[0018] [0018] In some modalities, the individual supports, before the act of intertwining, are curved.
[0019] [0019] In some embodiments, the individual supports, before the act of interlacing, have a radius of curvature substantially equal to the radius of curvature of the annular frame formed by the supports.
[0020] [0020] In some modalities, the individual supports are laser cut from a metal tube.
[0021] [0021] In some embodiments, each of the plurality of first supports is formed with a plurality of projections that extends radially and each of the plurality of second supports is formed with a plurality of openings.
[0022] [0022] In some modalities, interlacing comprises connecting the first support to the second support, extending each of the plurality of projections through a respective of the plurality of openings at the junctions between a first support and a second support.
[0023] [0023] In some modalities, the connection comprises articulating connecting each of the first support to a plurality of the second support.
[0024] [0024] In some modalities, the plurality of projections that extends radially is formed with a plurality of projections that extends radially inward and a plurality of projections that extends radially outward.
[0025] [0025] In some modalities, the method also comprises assembling the first set of the plurality of supports in a first mounting angle, in which each of the supports in the first set of supports comprises a plurality of projections that extend radially, which it comprises a central projection with at least two flaps extending outwardly thereafter in a plane parallel to the support formed there. The method may further comprise the assembly of the second set of the plurality of supports on the first set of supports at a second mounting angle, forming a relative mounting angle between the first mounting angle and the second mounting angle. Each of the supports in the second set of supports comprises a plurality of openings, wherein each of the openings comprises a central opening corresponding to the central projection and oblique side openings corresponding to at least two flaps. In this modality, the assembly forms the frame.
[0026] [0026] In certain embodiments, the method may also comprise crimping the frame to cause at least two flaps on the first set of supports to rotate away from the corresponding oblique side openings on the second set of supports. The method
[0027] [0027] In another representative embodiment, an implantable medical device comprises a radially expandable and compressible annular frame comprising a plurality of interconnected supports, the plurality of supports comprising a first set of a plurality of first support and a second a set of a plurality of second supports, in which the first support overlaps with the second adjacent support at the joints, and the expansion or compression of the annular frame causes the first support to rotate in relation to the second support at the joints. Each of the first support can comprise a plurality of pairs of first locking tab radially spaced from each other along the length of the first support, and each of the second support can comprise a plurality of pairs of second locking tab radially extendable, spaced from each other along the second support.
[0028] [0028] In specific embodiments, the first locking tabs of each pair of pins along the first support extend to the opposite sides of a second adjacent support at a joint and can engage the second locking tab of the second adjacent support by rotating the first support in relation to the second support.
[0029] [0029] In some embodiments, the first locking tabs extend radially inward and the second locking tabs extend radially outward.
[0030] [0030] In another representative embodiment, an implantable medical device comprises a radially expandable and compressible annular frame comprising a plurality of intercooler supports.
[0031] [0031] In some embodiments, each rivet comprises a third intermediate flange between the first and the second flange and positioned radially between a first support and a second support at a joint.
[0032] [0032] In another representative embodiment, an implantable medical device comprises a radially expandable and compressible annular frame comprising a plurality of interconnected supports, the plurality of supports comprising a first set of a plurality of first support and a second set of a plurality of second supports, in which the first support overlaps with the second adjacent support at the joints and the expansion or compression of the annular frame causes the first support to rotate in relation to the second support at the joints, where the frame com-
[0033] [0033] In some embodiments, each articulation comprises a cylindrical articulation portion that can rotate in a corresponding opening of a second support and a lock member extending from the articulation portion, in which the lock member is dimensioned and molded in relation to the corresponding opening of the second support, in order to prevent radial separation of the first and second support whenever the locking member is rotatably displaced from the corresponding opening after the radial expansion and compression of the frame.
[0034] [0034] In some embodiments, the second support is formed with recessed portions around the non-circular openings and the joint locking members are arranged within the recessed portions.
[0035] [0035] In some embodiments, the implantable medical device further comprises one or more actuators mounted on the frame and configured to radially expand and compact the frame between a radially compressed state defining a compressed diameter and a radially expanded state defining an expanded diameter. In specific embodiments, each lock member is rotatably displaced from the corresponding non-circular openings in the second support in the compressed diameter, in the expanded diameter and in all diameters between the compressed and expanded diameters.
[0036] [0036] In some modalities, the joints are formed entirely in the first support.
[0037] [0037] In some modalities, the joints are separate components from the first and the second support. Each of the first support can comprise a plurality of non-circulating openings
[0038] [0038] In some embodiments, each of the joints also comprises a retaining member configured to be retained within the non-circular openings in the first support.
[0039] [0039] In some embodiments, each of the joints also comprises a circular base member configured to be retained within a circular recess around one of the non-circular openings in the first support.
[0040] [0040] In some modalities, the locking members comprise a non-circular shape.
[0041] [0041] In some modalities, the locking members comprise a central non-circular projection with at least two flaps extending outwards from there in a plane parallel to the support.
[0042] [0042] In another representative embodiment, a method of mounting an implantable medical device comprises providing a plurality of first support and providing a plurality of second supports, each second support comprising a plurality of non-circular openings spaced along length. The method may further comprise connecting the first and second supports to each other to form an annular frame by inserting the joints through the non-circular openings of the second support, each joint having a cylindrical joint portion arranged in a corresponding non-circular opening and a locking member extending from one end of the hinge portion, where the locking members are rotatably aligned with the corresponding non-circular openings when the joints are inserted into the non-circular openings.
[0043] [0043] In some embodiments, the method may also include rotating the first support relative to the second support to cause the locking members to rotate from their corresponding non-circular openings and mount one or more actuators on the frame , one or more actuators configured to radially expand and compact the frame within a predetermined range of diameters that correspond to a predetermined range of angles between the first and second supports on which the locking members are always rotationally displaced non-circular openings.
[0044] [0044] In some embodiments, each first support comprises a plurality of non-circular openings spaced along a length of it, and connecting the first and second supports also includes inserting the joints through the non-circular openings of the first support and the second support.
[0045] [0045] In some modalities, the joints are an integral part of the first support.
[0046] [0046] In some modalities, the first support is intertwined with the second support.
[0047] [0047] In another representative embodiment, an implantable medical device comprises a radially expandable and compressible annular frame comprising an inner frame subassembly and an external frame subassembly. Each of the frame sub-assemblies can comprise a closed annular frame that comprises the plurality of interconnected frames. The plurality of supports of each frame subassembly can comprise a first set of a plurality of first support and a second set of a plurality of second supports, in which the first support overlaps adjacent and is rotatably connected to the second support at the junctions, and the expansion or
[0048] [0048] In some embodiments, each of the first support may comprise a plurality of projections spaced from one another along a length of the first support or a plurality of openings spaced from each other along a length of the first support, and each of the second support can comprise a plurality of openings and a plurality of projections spaced apart from one another over a length of the second support. In each of the joints, either a projection on a first support can be inserted through an opening of an adjacent second support or a projection on a second support can be inserted through an opening in an adjacent first support to rotatively connect the first support to second support.
[0049] [0049] In specific modalities, each of the subassemblies of the internal frame and the external frame comprises at least three internal frames and three external frames. In specific modes, the assembly of the external frame comprises six internal supports and six external supports.
[0050] [0050] In some modalities, a prosthetic valve leaflet assembly is positioned inside the inner frame subassembly. In specific embodiments, the prosthetic leaflet assembly of the valve is positioned inside and attached to the inner frame subassembly without being attached to the outer frame subassembly. In more specific ways, the prosthetic valve leaflet assembly is positioned so that the prosthetic valve leaflets are prevented from coming into contact with the outer frame subassembly when they open during the cardiac cycle, while in others modalities this contact is minimized.
[0051] [0051] In some modalities, a skirt is positioned in the sub-
[0052] [0052] In some modalities, one or more actuators are positioned on the frame, with one or more actuators being configured to expand and compact the frame radially. In specific modes, the actuators can be configured to expand and compress the frame within a predetermined range of diameters corresponding to a predetermined range of angles between the first and second supports.
[0053] [0053] In another representative modality, a method of mounting an implantable medical device comprises the assembly of an internal frame subassembly comprising a plurality of first support and a plurality of second supports. The method may further comprise connecting the first and second supports to each other to form a first closed annular inner frame subassembly by connecting each of the plurality of first support to at least two of the plurality of second supports. The method may further comprise the assembly of an external frame sub-assembly comprising a plurality of third support and a plurality of fourth support. The method may further comprise connecting the third and fourth supports to each other to form a second annular closed frame subassembly, by connecting each of the plurality of third support to at least two of the plurality of fourth support. The method can also comprise, after the assembly of the internal frame subassembly and the external frame subassembly, insert the internal frame subassembly inside the external frame subassembly and interconnect the two subassemblies in a plurality of junctions along the supports forming a single set of closed annular frame.
[0054] [0054] In some modalities, the method may also include the assembly of a leaflet assembly in the internal frame subassembly. In specific modalities, the leaflet assembly is mounted on the inner frame subassembly without coming into contact with the outer frame subassembly. In some modalities, a skirt is positioned in the inner frame subassembly. In specific modalities, the skirt is positioned between a first set of internal supports and a second set of external supports of the sub-assembly of the internal frame. In another particular embodiment, the skirt is positioned on the outside of the inner frame subassembly and disposed between the inner frame subassembly and the outer frame subassembly. In another particular modality, the skirt is positioned together with a leaflet assembly inside the inner frame subassembly.
[0055] [0055] In some modalities, the internal frame subassembly and the external frame subassembly are rotationally interconnected at the junctions along the supports by means of a plurality of articulation members. The articulation members can comprise, for example, rivets, pins, integral projections or similar mechanisms. In specific modalities, the articulation members can pass through two or more of the inner frame subassembly, the skirt and the outer frame subassembly. In specific modalities, rivets or other projections can pass through three or more subassemblies of the prosthetic valve, the inner frame subassembly, the inner skirt and the outer frame subassembly. In specific embodiments, an external skirt can be attached to the external frame subassembly.
[0056] [0056] The previous and other objectives, characteristics and advantages of the invention will become more evident from the detailed description below, which continues with reference to the attached figures. Brief Description of Drawings
[0057] [0057] Figure 1 is a side elevation view of a type of prosthetic valve release assembly; figure 2 is a side elevation view of a prosthetic valve, according to an embodiment; figures 3A and 3B are enlarged perspective and side views, respectively, of a modality of coupled frame supports usable in the prosthetic valve of figure 2; figure 4 is a side elevation view of the frame that can be used on the prosthetic valve in figure 2; figure 5 is a side view of an embodiment of a flattened support for a prosthetic valve frame, such as the frame of figure 4; figure 6 is a side view of the frame of figure 4 shown in a radially compressed state; figure 7 is a side view of a prosthetic valve that incorporates the frame of figure 4 shown in a radially compressed state; figure 8 is an enlarged perspective view of the distal end portion of the prosthetic valve release assembly of figure 1 figure 9 is an enlarged side view of a locking unit and the distal end portion of a positioning member of the release assembly prosthetic valve of figure 1; figure 10A is an enlarged side view of the locking and positioning member of figure 9, which illustrates the positioning member;
[0058] [0058] Here are described the examples of prosthetic implant release assemblies and components that can improve the physician's ability to control the size of a mechanically expandable prosthetic implant, such as prosthetic valves (for example, prosthetic heart valves or venous valves), stents or grafts, in addition to facilitating the separation of the prosthetic implant from the release assembly, during the implantation procedure. The present disclosure also provides frames for use with these prosthetic implants. The frames may comprise molded supports to reduce or eliminate the compression of the soft components of the prosthetic implant (eg, implant leaflets) when the implant is compressed radially to a release configuration to release to the patient.
[0059] [0059] Figure 1 shows an example of a prosthetic implant release assembly 10 that can be used with one or more of the modalities of the present disclosure. The release assembly 10 can include two main components: a prosthetic heart valve
[0060] [0060] Figure 2 is a side elevation view of the prosthetic valve 14 shown in its implanted and radially expanded configuration. Although only one side of the prosthetic valve 14 is shown in the drawings, it should be considered that the opposite side is similar to the portion shown. The prosthetic valve 14 can include a stent or annular frame 22 and a valve frame 24 that can be coupled to the frame 22. The frame 22 can have an inlet end portion 26, an intermediate portion 28 and an outlet end portion 30. The prosthetic valve 14 can define a longitudinal axis that extends through the input end portion 26 and the output end portion 30.
[0061] [0061] The frame 22 can be made by any of several suitable materials, such as stainless steel or a nickel and titanium ("NiTi") alloy, for example, nitinol or CoCr alloys as well. The frame 22 may include a plurality of interconnected truss supports 32 arranged in a truss-like pattern and form a plurality of apices 34 at the outlet end 30 of the prosthetic valve
[0062] [0062] The truss supports 32 can be coupled articulated to each other. In the illustrated embodiment, for example, the end portions of the supports 32 that form the apexes 34 at the outlet end 30 and the entry end 26 of the frame 22 can have a respective opening 36. The supports 32 can also be formed with openings 38 spaced along their lengths between the opposite ends of the supports. The respective joints can be formed at the apexes 34 and in the places where the supports 32 overlap between the ends of the frame by means of locks 40, which can comprise rivets or individual pins that extend through the openings 36, 38. The joints they can allow the supports 32 to rotate in relation to each other when the frame 22 is expanded or contracted, as during the assembly, preparation or implantation of the prosthetic valve 14. For example, the frame 22 (and, therefore, the prosthetic valve 14) can be manipulated in a radially compressed or contracted configuration (see, for example, figures 6 and 7) and inserted into a patient for implantation. Once inside the body, the prosthetic valve 14 can be manipulated to an expanded state (for example, figures 2 and 4) and then released from the release device 18 (for example, figure 1), as described below .
[0063] [0063] The frame 22 can be formed using any suitable technique. Suitable techniques include separately training
[0064] [0064] In some embodiments, electroforming or physical vapor deposition can be used to form subcomponents of frame 22 or the entire frame 22 with hinged connections between frames. In an application, for example, electroforming or physical vapor deposition can be used to form supports 32 that have integral locks 40. Individual supports can be mounted together on a frame by inserting integral locks 40 on each support through corresponding opening of an adjacent support. In some embodiments, electroforming or physical vapor deposition can be used to form the entire frame in its final, cylindrical or tubular shape. While in the illustrated modalities, the frame 22 is shown as, in general, cylindrical, other forms of frame can be used, for example, conical, hourglass or barrel-shaped. In other modalities, electroforming or physical vapor deposition can be used to form the entire frame in a flattened configuration, after which the ends of the flattened frame are connected together to form the final tubular shape of the frame. The frames formed from supports with integral closures are described in detail below.
[0065] [0065] In other embodiments, the truss supports 32 are not coupled to each other with their respective joints (for example, locks 40), but are dynamically articulated or foldable in relation to each other to allow for radial expansion and contraction the frame. For example, frame 22 can be formed (for example, by laser cutting, electroforming or physical vapor deposition) from a single piece of material (for example, a metal tube).
[0066] [0066] In addition to the truss supports 32, the frame 22 may include one or more support supports that extend longitudinally
[0067] [0067] With reference to figures 3A and 3B, a spacer 46, such as a washer or bushing, can be arranged in a joint between the truss supports 32, or a joint between the truss supports 32 and the supports support 42 (not shown). When truss supports 32 and / or support supports 42 are pivotally coupled to each other, spacers 46 can help truss supports 32, or truss supports 32 and support supports 42, move one at a time. relation to the other. Spacer 46 can also act to space truss supports 32 from each other or from support supports 42. In some implementations, frame 22 does not include spacers 46, or truss supports 32, or truss supports 32 and support brackets 42 are spaced differently.
[0068] [0068] In specific modalities, the locks 40 do not extend radially out of their respective openings 36, 38 in the supports and can be contained completely within the openings. As shown in figure 3B, for example, each of the openings 36 in the radially outer supports 32 can include an enlarged or counter-hole portion 37, which is sized to receive the head portion 41 of a respective closure 40 (for example , a rivet). The head portion 41 can be received entirely inside the counter hole 37 and does not extend radially out of the counter hole, for example, the head portion 41 can be flush with the outer surface of the support 32. Likewise, the openings 38 can also be formed with counter holes to receive the head portions 41 of the fasteners. In this way, the closures 40 do not increase or contribute to the overall crimp profile of the prosthetic valve and do not interfere with or place undue stresses on the valve release housing (for example, housing 82 in figure 1).
[0069] [0069] Returning to figure 2, the prosthetic valve 14 can include a valve frame 24 to regulate blood flow through the prosthetic valve. The valve frame 24 may comprise, for example, a leaflet assembly 48 comprising one or more leaflets made of a flexible material. The leaflets can be configured to move between an open position, allowing blood to flow through the valve in a first direction and a closed position, blocking blood flow through the prosthetic valve in a second direction, opposite the first direction . Brochures of leaflet assembly 48 can be made of total or partial biological material (e.g., pericardial tissue, such as bovine or equine pericardium), biocompatible synthetic materials, or other materials, such as those described in U.S. Patent No. 6,730,118.
[0070] [0070] The prosthetic valve may also include an annular skirt or sealing member 50 that can be attached to the outer surface of the inlet end portion 26 of frame 22, for example, with sutures 56 adjacent to the inlet end portion 26 of frame 22. The inlet end portion of the leaflet assembly 48 can be attached to the frame 22 and / or the skirt 50, for example, using sutures 56. The skirt 50 helps to establish a seal with the native tissue at the implantation site for prevent or minimize paravalvular leakage. In alternative modes, the prosthetic valve may have a skirt or sealing member mounted inside the frame or a skirt or sealing member mounted on the inside and outside of the frame. The skirt may be formed of natural fabric (for example, pericardial fabric) or any of a number of biocompatible synthetic materials, including biocompatible fabrics (for example, polyethylene terephthalate (PET) fabric).
[0071] [0071] More details on transcathetic prosthetic heart valves, including the way in which the structure of valve 24 can be coupled to the frame 22 of prosthetic valve 14, can be found, for example, in US patents No. 6,730,118 , 7,393,360,
[0072] [0072] Figure 4 is a side elevation view of a portion of a frame 200 that can be used with a prosthetic valve in at least certain embodiments of the present disclosure. Although only one side of the frame 200 is shown in Figure 4, it should be noted that the frame 200 forms an annular frame that has an opposite side that is identical to the portion shown. Frame 200 is similar to frame 22 discussed above, but does not include longitudinal supports 42.
[0073] [0073] Frame 200 may include a plurality of truss supports 204, including a set of internal supports 204a and a frame
[0074] [0074] As best shown in the flat view of the support in figure 5, in a design that can be used with certain modalities of this disclosure, each truss support 204 can have a displacement or zigzag pattern, defined by a plurality of displacement portions or linear segments 218. The linear segments 218 in the embodiment of the embodiment are arranged end to end in relation to each other, with adjacent ends interconnected with each other by intermediate segments 220. The support 204 may have enlarged end portions 224 that form the apexes at the entrance and exit end of the frame. Each linear segment 218 is slightly displaced laterally relative to an adjacent linear segment 218 in a direction perpendicular to the total length of the support 204 to provide the zigzag pattern to the support. Each of the intermediate segments 220 and the end portions
[0075] [0075] The amount of displacement of each linear segment 218 with respect to an adjacent linear segment along the length of the support 204 can be constant, so that an imaginary line 214 can pass through the opening 208 of each segment intermediate 220 along the entire length of the support. In alternative modalities, the amount of displacement between two adjacent linear segments 218 can vary over the length of the support. For example, the amount of displacement between the linear segments 218 adjacent to the outlet end of the frame may be greater than the amount of displacement between the linear segments 218 adjacent to the input end of the frame, or vice versa.
[0076] [0076] Linear segments 218 may include at least substantially flat opposite longitudinal edges or linear 226a, 226b extending between the curved or rounded edges 228 of the intermediate segments 220. In alternative embodiments, the opposite edges 228 of the intermediate segments 220 they may have substantially or linear edges that extend at an angle between the respective ends of the edges 226a, 226b of the cladding segments 218.
[0077] [0077] As best shown in figure 5, the WI width of each linear segment 218 is defined as the distance measured between the opposite edges 226a, 226b of a segment 218. In the illustrated embodiment, the WI width! is constant along the length of the support 204. As such, each longitudinal edge 226a is displaced laterally from an adjacent longitudinal edge 226a of an adjacent lineal segment 218, and each longitudinal edge 226b is laterally displaced from an adjacent longitudinal edge 226b of a segment
[0078] [0078] In alternative modalities, the WI width of each linear segment 218 can vary along the length of a support. For example, the WI width of a linear segment 218 adjacent to the inlet end of the frame may be greater than the WI width of a linear segment 218 adjacent to the outlet end of the frame, or vice versa. In addition, where the WI width of the linear segments 218 varies along the length of a support 204, a linear segment can have a longitudinal edge 226a or 226b that is collateral with a longitudinal edge of an adjacent linear segment on the same side of the support, while the other longitudinal edge 226a, 226b is displaced laterally from the longitudinal edge of an adjacent linear support on the same side of the support. In other words, the support 204 can have a general pattern of zigzag or displacement due to the variable WI widths of the linear segments.
[0079] [0079] The displacement or zigzag pattern of the support segments 218 can help to separate the supports 204 in the circumferential direction when the frame 200 is in a radially compressed state, as shown in figures 6 and 7. As shown, the open lattice frame of frame 200 that defines open cells 250 between frames 204 can be preserved even when frame 200 is fully compressed or contracted. For example, with reference to figure 6, although the width of cells 250 along the length of the frame 200 may vary between adjacent frames, a space 256 remains in the middle of a cell 250 between two adjacent hinged joints 254.
[0080] [0080] When frame 200 is incorporated into a prosthetic valve (for example, prosthetic valve 14), the spaced nature of the supports 204, including clearances 256, can help protect the soft components of the prosthetic valve when frame 200 is expanded and contracted. Figure 7, for example, shows a prosthetic valve comprising frame 200, a skirt 266 mounted on the outside of frame 200 and a leaflet assembly 264 mounted within frame 200. An inner skirt (not shown) it can also be mounted inside the frame. Skirt 266 and leaf assembly 264 can be attached to frame 200, as with sutures
[0081] [0081] The release device 18 of figure 1 is particularly suitable for implanting prosthetic valve 14 or any of the other prosthetic valves disclosed in this document. However, it should be noted that any of the prosthetic valves disclosed here can be implanted with the use of other suitable release devices. For example, any of the prosthetic valves disclosed herein can be crimped over an inflatable balloon of a conventional balloon catheter. Once released at the implantation site, the balloon can be inflated to expand the prosthetic valve to its fully functional size.
[0082] [0082] Again, with reference to figure 1, the release apparatus 18 may include a handle 70, an elongated axis 72 that extends distally from the handle 70, a plurality of first members
[0083] [0083] The shaft 72 may have a distal end portion 82 that can function as a sheath to contain or house the prosthetic valve 14 in an initially compressed state for delivery through the patient's vasculature. In this regard, the distal end portion 82 may have a lumen sized to receive the prosthetic valve 14 in a radially compressed state. As shown in figure 12, the proximal end portion of the shaft 72 can extend into an axially extending hole 138 formed in the distal end portion of the handle 70. The proximal end portion of the shaft 72 can be retained within the axial hole 138 through pressure or friction contact with the orifice 138, with the use of an adhesive, a clamp, a fixer, | thermally attaching the catheter 72 to the orifice 138, or by some other technique or mechanism.
[0084] [0084] The positioning members 76 have distal end portions that can be removably connected to the prosthetic valve 14 by means of the respective release units and lock 94 (as best shown in figure 8). As shown in figure 12, the positioning members 76 can extend proximally beyond the proximal end 140 of the axis and into a central hole 142 of the handle 70. A front screw 144 can be arranged inside the central hole 142 of the handle 70. The proximal ends of the positioning members 76 can be fixed to the front screw 144, as being received inside a hole (not shown) of the front screw 144, where they can be fixed by pressure or contact friction with the orifice of the forward screw 144, with the use of an adhesive, a clamp, a fastener, thermal connection or other suitable technique or mechanism.
[0085] [0085] As shown in figures 8 and 9, each actuation member 86 can extend through a lumen of a respective positioning member 76. Actuation members 86 can be coupled in their terminal portions distal to the distal end 60 of frame 22. For example, the distal end portion of each actuating member 86 can be connected to an apex 34 at the distal end 60 of the frame, such as welding, adhesive or mechanical closure. Each actuating member 86 can also extend through a lumen of a respective locking unit 94 that can be coupled to the frame 22, such as an apex 34 at a proximal end 62 of the frame. The actuation members 86 can extend proximally inward and through the handle 70. The proximal end portions 88 of the actuation member 86 can be detachably retained by a clamping member 182 mounted on or in the handle 70 ( figure 12).
[0086] [0086] The actuation members 86 function to apply a pulling force directed proximally to the distal end 60 of the frame in cooperation with the positioning members 76 that apply a pressing force directed distally to the proximal end 62 of the frame. frame to carry out the radial expansion of the frame 22. In specific embodiments, the actuating members 86 can comprise a relatively flexible material, but relatively non-elastic, which can effectively transfer the tensile forces generated in the handle 70 to the end distal from frame 22. For example, actuating members 86 may comprise threads, sutures, cords or similar materials. In other embodiments, the actuating members 86 can be relatively more rigid components, such as an axle or support, which can transfer the tensile forces directed proximally to the frame, as well as the pressure forces directed distally to the frame.
[0087] [0087] The release members 106 have distal end portions 107 that extend coaxially through the respective locking units 94 (figure 9) and proximal end portions 108 that extend towards the handle 70 (figure 12). The proximal end portions 108 of the release members 106 can extend through the front screw 144 and can be attached to a release button 168 within the handle 70.
[0088] [0088] With reference to figures 1 and 12, a threaded actuator nut 148 can be arranged around the front screw 144. The internal threads (not shown) of the threaded actuator nut 148 can engage the threads 150 of the front screw 144. An outer surface 152 of the threaded actuator nut 148 may extend through an opening or window 154 formed on the outer surface 156 of handle 70. The outer surface 152 of the threaded actuator nut 148 may include a texture, such as grooves 158, to assist a user in holding and turning the threaded actuator nut 148.
[0089] [0089] Rotating the threaded actuator nut 148 in a first direction can cause the front screw 144 to be axially rotated in the distal direction relative to the handle 70, causing the positioning members 76 to rotate distally through the lumen of the shaft 72. Rotating the threaded actuator nut 148 in the opposite direction can cause the front screw 144 to rotate proximally to the handle, causing the limbs to be in position. 72 are retracted or rotated proximally through the lumen of axis 72.
[0090] [0090] In specific implementations, the number and spacing of the threads 150 of the front screw 144 (and therefore the corresponding threads of the thread actuator nut 148) and the axial length of the front screw 144, can be selected for provide a desired degree of displacement for positioning members 76 and release members 106. For example, the desired degree of displacement may be sufficient to allow frame 22 (and therefore prosthetic valve 14) be manipulated between a fully expanded state (as shown in figures 2 and 8) and a fully contracted or compacted state (as shown in figures 6 and 7), including the states between fully compacted or contracted and fully expanded, as described below.
[0091] [0091] The release and lock units 94 (also referred to as "lock units") in the illustrated mode are configured to releasably connect the positioning members 76 to the frame 22 of the prosthetic valve 14 and to selectively secure the actuation members 86 to retain the prosthetic valve 14 in an implanted and expanded state. With reference to figures 8 to 11, the locking units 94 can comprise a generally cylindrical body 96, which can be attached to the frame 22 of the prosthetic valve 14 by a fastener 130 (for example, a pin or rivet). The closure 130 can extend through an opening 132 (figure 11) formed in the body 96 and through one or more corresponding openings 36 in the frame supports 32, forming the apices 34 of the frame (figure 8).
[0092] [0092] The body 94 may comprise a locking feature, such as in the form of a clip 98, disposed adjacent to a distal end 100 of the locking unit 94 to selectively engage an actuating member 86. The clip 98 may comprise, for example - plo, a pair of diametrically opposed claws 102 that are tilted radially inward towards each other (as best shown in figure 11). A release member 106 can be arranged within a lumen of each locking unit 94 to retain the clamps 102 of the clamp in an unengaged or unlocked state during delivery of the prosthetic valve 14 (figure 9). Each release member 106 can extend proximally through a respective positioning member 76 to handle 70. As discussed above, the proximal end portions 108 of the release members can be attached to a release button 168 on the handle (figure 12). Each actuating member 86 can extend proximally through a lumen of a respective release member 106 into the handle 70.
[0093] [0093] In specific implementations, release members 106 can be made of any suitable biocompatible metallic material or a polymeric material. In at least some examples, the material can be selected to allow release members 106 to be easily movable relative to grips 102 during valve deployment, as described below. For example, release members 106 may be made of a lubricating or low-friction material (eg, PTFE) or may have an outer layer made of a lubricating or low-friction material (eg, PTFE) .
[0094] [0094] When release members 106 are disposed within locking units 94 that extend between claws 102, claws 102 are kept in an unlocked state and are prevented from contacting actuation members 86. In the state des-
[0095] [0095] Again, with reference to figures 10A and 10B, the locking units 94 can be releasably coupled to the positioning members 76 by the release members 106. In the illustrated embodiment, for example, a distal end portion 110 of each positioning member 76 may include a coupling portion 112 which may include a tab 114 and a notch 116. Each locking unit 94 may include a corresponding notch 120 configured to receive the tab 114 of the positioning member 76. Likewise, each locking unit 94 may include a flap 122 to be inserted and received by, the notch 116 of a respective positioning member 76. The flaps 114.122 and the notches 120, 116, together with the release member 106, collectively, can form a releasable and interlocked joint. The engagement of the flaps 114, 122 with the slots 120, 116 prevents axial separation of the positioning member 76 from the locking unit 94, while the release member 106, which extends through the flaps 114, 122 in the locked state, prevents the lateral separation of the positioning member 76 from the locking unit 94.
[0096] [0096] As shown in figure 10B, the tab 114 of the positioning member 76 may include a groove that extends axially 128. The groove 128 can be dimensioned to allow the tab 114 to be placed around the drive member 86 or removed from drive member 86 by actuating through slot 128. However, slot 128 is desirably narrower than the diameter of release member 106 to prevent lateral separation of positioning member 76 from lock unit 94 when the release member 106 is in a position that extends through the tabs 114, 122, as shown in figure 9. As noted above, retraction of the release member 106 from the claws 102 of the clamp 98 allows the claws to engage the member actuation 86. Additional retraction of the release member 106 until the distal end of the release member 106 is proximal to the flap 122 and the notch 116 allows the distal end portion 110 of the position member 76 is separated from the lock unit 94 in a lateral direction (in a direction perpendicular to the length of the lock unit and the positioning member), as shown in figure 10A. As positioning member 76 moves in a lateral direction away from latch unit 94, drive member 86 can pass through slot 128 in tab 114.
[0097] [0097] As shown further in figure 10A, the flaps 114, 122 can be formed with the respective inclined cam surfaces 124, 126, respectively, to facilitate the separation of the positioning member 76 from the latch unit 94. Each surface - cam 124, 126 is inclined with respect to the longitudinal axis of the positioning member 76 at an angle of less than 90 degrees. As such, apply a force directed proximally to the limb of power.
[0098] [0098] Locking units 94 and / or positioning members 76 may include a cutting mechanism for cutting parts of actuating members 86 that extend proximally beyond the claws 102 of clamps 98 after the prosthetic valve be expanded and the release members retracted to trigger the clamps. For example, a blade, or other cutting surface, can be placed through slot 128, so that actuating members 86 can be cut as they pass through slot 128 during lateral separation of positioning member 76 away from the locking unit 94.
[0099] [0099] In another example, locking units 94 may include a clamping member that may include cutting jaws (such as sharp or serrated jaws) positioned close to jaws 102. Cutting jaws, like jaws 102, can be retained in an open position away from the actuation member by the release member 106. When the release member 106 is retracted from the engagement with the cutting claws, the cutting claws can deviate radially inward against the acting member 86, cutting it in that location. In other examples, a separate cutting device can be used to separate the actuation members 86 at a desired location after the positioning members 76 are released from the prosthetic valve 14 and, optionally, after the release device 18 is removed - of the body.
[00100] [00100] Again, with reference to figures 1 and 12, the front screw 144 includes an extension portion 160 that extends proximally from the threaded portion of the front screw. The extension portion 160 may comprise two leg portions 162 which define a U-shaped opening or slot 164 between the leg portions 162. The release button 168 may comprise a sliding member 170 arranged between the leg portions 162 and a user actionable portion 172 that extends radially outward from the sliding member 170. The proximal end portions 108 of the release members 106 can be fixedly attached to the sliding member 170, as with a suitable adhesive, so that the axial movement of the sliding member 170 in the distal and proximal directions causes the corresponding movement of the release members.
[00101] [00101] Release button 168 can be configured to be movable with and also independently of the front screw
[00102] [00102] Various mechanisms can be used to selectively and freely retain the release button 168 axially in relation to the extension portion 160 of the front screw 144. For example, a movable pin or similar mechanism can be inserted through the mem - sliding broiler 170 and one or both leg portions 162 of the extension portion 160 to retain the axial position of the sliding member 170 with respect to the front screw 144. Removing the pin of the sliding member 170 and / or the leg portions 162 allows axial movement of the release button 168 in relation to the front screw.
[00103] [00103] In another embodiment, the sliding member 170 can be configured to move between a first position in which it is chained by the extension portion 160 and a second position in which the sliding member 170 is no longer engaged by friction by the extension portion 160. In the first position, the axial movement of the front screw 144 causes the corresponding movement of the release button 168. In the second position, the release button 168 can be moved axially independently of the front screw 144 in the distal directions and proximal.
[00104] [00104] The actuation members 86 can extend proximally beyond the proximal end portions 108 of the release members 106 and through an orifice or opening that extends axially 178 formed in the proximal end portion 180 of the handle 70. The actuating members 86 can be selectively fixed in relation to the handle 70 using a clamping or retention mechanism
[00105] [00105] “When button 188 is fully depressed (like turning button 188 in a first direction), the bottom surface of plug member 184 can hold actuating members 86 against surface 192, thus protecting the actuating members 86 against the movement relative to the handle 70, the axis 72, the locking units 94 and the frame 22 of the prosthetic valve. When knob 190 is turned in the opposite direction, plug member 184 can move away from surface 192 and actuating members 86, allowing actuating members to move relative to handle 70, to the axis 72, to the locking units 94 and the frame 22 of the prosthetic valve.
[00106] [00106] To use the delivery device 18 to administer and implant the prosthetic valve 14 in a desired location within the heart (for example, the original aortic valve), the prosthetic valve 14 is connected to the positioning members 76 with the use of locking units 94 and release members 106, as shown in figures 8 and 9. Release button 168 is retained in relation to front screw 144 to prevent relative movement between positioning members 76 and the release members 106. The prosthetic valve 14 can then be compressed radially or compressed to a compressed state, as shown in figure 7. The compressed prosthetic valve 14 can be loaded into sheath 82 of shaft 72.
[00107] [00107] Conventional techniques and devices can be used to insert and advance the release device 18 and prosthetic valve 14 through the patient's vasculature until the desired local implantation. For example, a prosthetic aortic valve can be released in a retrograde approach, advancing the delivery device through a femoral artery and from the aorta to the original aortic valve. At or adjacent to the implantation site, the prosthetic valve 14 can be implanted from the sheath 82 by turning the actuator nut 148 in one direction to cause the front screw 144 to move distally from the handle 70. This causes the positioning members 76 and the release members 106 to move distally in relation to the axis 72. The positioning members 76 push the prosthetic valve 14 distally in relation to the axis
[00108] [00108] As the prosthetic valve 14 is implanted from the sheath 82, the retention mechanism 182 may be in a release position that allows the actuating members 86 to move distally with the prosthetic valve. In this way, the actuating members 86 do not apply the expansion forces to the prosthetic valve, since it is being implanted from the sheath. In order to apply an expansion force to the prosthetic valve, the retention mechanism 182 is tightened to retain the actuating members 86 in relation to the handle 70. The continuous rotation of the actuator nut 148 causes the positioning members to continue to apply a distally directed force to the proximal end of the frame 22, while the actuating members 86 (which are now contained by the retention mechanism 182) are taught and apply a proximally directed force to the distal end of the frame 22. The application of these forces causes the frame 22 to be propped axially and to expand radially.
[00109] [00109] In some embodiments, the retention mechanism 182 can be held in the locked position or engaged against the actuating members 86 during implantation of the valve, as long as the actuating members are long enough and contain sufficient clearance to avoid applying any expansion force to the prosthetic valve as it is advanced from sheath 82. For example, the lengths of actuating members 86 can be selected to avoid applying any expanding force to the prosthetic valve , as it is advanced from the sheath 82 and after the prosthetic valve is fully implanted from the sheath, the acting members 86 are taught and begin to apply an expansion force to the frame opposite the expansion force positioning members 76 to expand the prosthetic valve.
[00110] [00110] If repositioning or completely removing the prosthetic valve from the body is necessary, the user can turn the actuator nut 148 in the opposite direction, which causes the positioning members 76 to pull the prosthetic valve back to the sheath 82. The action of the distal end portions 110 of the positioning members 76 being retracted to the sheath 82 causes the prosthetic valve to compress radially. If desired or necessary, the prosthetic valve can be partially compressed without being retracted into the sheath and then repositioned and re-expanded by turning the actuator nut.
[00111] [00111] Once the prosthetic valve is expanded and positioned in the desired location, the release members 106 can be retracted from the locking units 94. This can be achieved by releasing the release button 168 from the front screw 144 and by retracting the release button 168 proximally, which causes the release members 106 to retract in relation to the lock units 94. When the ends
[00112] [00112] The frame designs discussed above in conjunction with figures 2 and 4 include a set of internal brackets and a set of external brackets articulated to the internal brackets by rivets or equivalent fasteners (for example, internal brackets and external 204a, 204b, respectively, of figure 4). This may require 10 to 50 additional small parts that are attached to the frame by welding or plastic deformation. Individual rivets, for example, can be less than a millimeter (for example, 0.8 mm) in length and less than a millimeter (for example, 0.8 mm) in diameter. As can be seen, the assembly process to assemble the frame can be very time consuming and add a significant cost to the manufacturing process. And these additional members can also increase the overall crimp profile of the frame.
[00113] [00113] In addition, the external supports are usually slightly longer than the internal ones, to explain the fact that the external supports are positioned radially out of the inner supports and have a greater radius of curvature than the inner supports .
[00114] [00114] “As shown in figure 13, a frame 300 for a prosthetic heart valve, according to another modality, comprises a first set of supports and a second set of supports. The first set of supports comprises a plurality of first support 310 (shown in the figure as extending from the lower left to the upper right). The second set of supports comprises a plurality of second supports 320 (shown in the figure as extending from the upper left to the lower right) interlaced with the first support 310, in such a way that each support passes over and under the supports of the other set. As in this modality, there are no "internal supports" and "external supports", but two assemblies of supports intertwined, the supports of both can have the same length. In some modalities, then, the same basic part can be used for all supports; in other words, all supports can be of the same size and shape. In some other modalities, structurally similar supports, with manufacturing differences only within and around areas of potential junctions with other supports, can be used.
[00115] [00115] In addition, in the modalities in which the first support 310 and the second support 320 are of the same length, the frame can reduce or eliminate any "incompatibility" in the foreshortening (ie, all supports can foreshort the same amount and allow - remove the complete movement of supports during the radial expansion) without the need to enlarge or lengthen the openings 340 at the joints of the supports.
[00116] [00116] In some embodiments, the frame 300 may include separate closures (for example, latches 40) that extend through the respective openings 340 at the junctions 315, 325 of the supports. Advantageously, intertwining the supports 310 and 320 can reduce the number of hinge connections at the junctions 315, 325 between the supports. For example, in some embodiments, the frame may include fasteners (for example, fasteners 40) only at joints 325 which define the apexes at the entry and exit ends of the frames. The joints 315 located axially between the joints 325 at the inlet and outlet ends of the frame may be without locks interconnecting a pair of overlapping supports. Instead, due to the interweaving of the supports and the inherent elasticity of the supports, the supports can be placed in tension, thus pressing the first and second supports together at each joint. The voltage transmitted to the supports at junctions 315, together with the mechanical connections at junctions 325, can be sufficient to keep the assembly of the supports together.
[00117] [00117] In alternative modalities, the frame 300 may include fasteners at the selected junctions 315 to reinforce the connection between the frames 310, 320, depending on the general size and shape of the frame. For example, in an implementation, frame 300 may include closures only at joints 315 in the middle of the frame (ie, joints 315 that cross a plane that cuts the frame in the middle between the inlet and outlet ends of the frame). For purposes of illustration, each support 310, 320 is shown having an opening at each junction 325 with an overlapping support. However, in the modalities described above, where there are no closures at the selected joints 315, the supports 310, 320 do not need to be formed with any opening 340 at the selected joints. As can be seen, reducing the number of locks required to assemble the frame can greatly reduce manufacturing costs.
[00118] [00118] In other modalities, instead of using separately formed fasteners (for example, rivets) that are typically inserted manually into the openings at each joint to form a hinge, the frame 300 may have integral closures at joints of support 315, for example, as shown in the embodiments in figures 14A-18, as discussed hereinafter.
[00119] [00119] Figures 14A and 14B illustrate a frame 400 of the type for a prosthetic heart valve, in which the frame has integrated closures to form joints between the overlapping supports. In this embodiment, the frame 400 comprises a first set of supports 410 interlaced with a second set of supports 420. For example, a first support 410a of the first set of supports 410 can be interlaced with at least one second support 420a, a third support 420b and a fourth support 420c of the second set of supports 420.
[00120] [00120] Each first support 410 may include a plurality of projections or integral projections 414 spaced from one another along the length of the support. Each second support 420 may include a plurality of openings or openings 430 spaced from each other along the length of the support, with each opening receiving a respective projection 414 to form an articulation between the two first and second overlapping supports. As shown, the projections 414 alternately extend from one side of the support 410 and the other side of the support from one projection to the next to allow each projection 414 to extend into a corresponding opening 430 of an overlapping support 420 in the intertwine.
[00121] [00121] “As used here, the terms" integral "or" integrally formed "or" unitary construction "refer to a construction of a component that does not include seams between different parts of the component. In addition, the term "integral construction" or "unitary construction" or "unitary construction" refers to a construction that does not include welds, fasteners, adhesives or other means for fixing pieces of material formed separately from one another. Thus, an integral projection 414 (or other characteristic of a support) is formed directly on the support instead of being formed separately and subsequently attached to the support.
[00122] [00122] As shown in figure 14B, the first support 410 can be elastically deformed from the interlacing of the first support through the second successive support 420a, 420b, 420c. Due to the elasticity of the supports, the supports are placed in tension, pressing the first support against each second support in each junction (illustrated by the power lines 432), which helps to retain each projection 414 inside an opening 430 In some modes, the supports can initially be straight and then can be folded elastically as they are woven together. In other embodiments, the first and / or second supports can be preformed with curves or curves (such as by adjusting the heat of a material with shape memory) at the locations of the joints to facilitate the assembly of the frame . Supports can be formed from, for example, superelastic materials (nitinol) or non-superelastic materials (for example, stainless steel or cobalt chromium alloys), although superelastic materials are desirable in certain modalities.
[00123] [00123] In the illustrated embodiment, the supports 410, 420 of the frame 400 are arranged in a basic or smooth weave pattern, in which each first support 410 extends over the top under each second successive support 420. In alternative modalities, the supports 410, 420 can be arranged in various other interweaving patterns. The positioning of the projections 414 can be modified from the configuration shown in figure 14B to correspond to the locations of the joints formed by the specific interlacing pattern of the supports.
[00124] [00124] The supports 410, 420 can be manufactured using any of the various suitable techniques, as previously described here. In some embodiments, the supports can, for example, be laser cut from a tube or laser cut or perforated from a flat sheet of metal. Optionally, the supports can go through an additional lamination process to mold the supports in their final shape before assembly. In some modalities, the supports can be formed with a plurality of spaced flap portions that are plastically folded or adjusted by heat to form the plurality of projections.
[00125] [00125] Figures 15A and 15B illustrate a pair of alternative modalities of the first and second supports 500 and 550, respectively, which can be used to form a frame from a plurality of the first support 500 and a plurality of according to holder 550. In specific modalities, each holder 500, 550 can be formed (for example, laser cutting) from a flat sheet of material (for example, a flat sheet of metal) to form a support with a radius of curvature that defines the outer curved surface of a frame with other similar supports that are mounted together to form the frame.
[00126] [00126] Figures 15A and 15B show the supports as seen from an axial end of the frame. Thus, the support 500 has an inner surface facing radially inward 502 that forms part of the inner surface of the frame and a surface facing radially outward 504 that forms part of the outer surface of the frame. The support 500 has a radial thickness TI defined between the surfaces 502, 504. The support 500 also has axially opposite side surfaces that extend in a longitudinal way 506, 508 (see also figure 16A), defining a width WI equal to the thickness of the sheet of material from which the support is formed.
[00127] [00127] Likewise, support 550 has an inner surface radially facing inward 552 that forms part of the inner surface of the frame and a radially facing surface 554 that forms part of the outer surface of the frame. The support 550 has a radial thickness T2 defined between the surfaces 552, 554. The support 550 also has lateral surfaces 556, 558 that extend longitudinally, facing axially (see also figure 16A) which, as best shown in the side view of the figure 15C, define a width W2 equal to the thickness of the sheet of material from which the support is formed.
[00128] [00128] The supports 500, 550 can be formed with integral characteristics that coincide with the corresponding characteristics of an overlapped support to form joints at the junctions of two supports. In particular, support 500 can be formed with integral projections 510 at opposite ends of the support and integral projections 520 spaced along the length of the support between the final projections 510. Support 550 can be formed with a plurality of openings 560 spaced apart along the length of the support at locations corresponding to the locations of the projections 510,
[00129] [00129] “A support 500, 550, which has integral characteristics to form the joints that interconnect two supports, can be formed with the use of any one of several suitable techniques, including, without limitation, laser cutting, cutting, stamping, machining, electro-marking, electroforming, three-dimensional printing or similar. For example, the integral projection 510, 520 can be formed directly on the support 500, by forming the entire shape shown in figure 15A from a single piece of material.
[00130] [00130] Each projection 510 on an opposite end of the bracket 500 forms an apex of a frame when inserted into a corresponding opening 560 of a bracket 550. As further shown in figure 15 A, the projections 510 can be configured to forming a snap connection or engagement with corresponding openings 560. For example, in the illustrated embodiment, each projection 510 comprises a projection divided with a first portion 512a and a second portion 512b separated by a gap. Each of the first and second portions 512a, 512b may have a relatively narrow base 514 on the inner surface 502 and a tapered end portion,
[00131] [00131] The projections 520 do not necessarily have to be fixed or retained within the corresponding openings 560 with a plug connection or other closures. In specific embodiments, the connections between two supports at the apexes of a frame, together with the intermediate supports, as described above, may be sufficient to retain the projections 520 within the corresponding openings 560 when the frame is assembled.
[00132] [00132] In specific embodiments, a frame can be mounted with a plurality of supports 500, 550 without the use of other components (for example, rivets and / separate washers) to form the connections of the joints at the junctions of the two supports 500 , 550. As can be seen, the assembly process is much less time-consuming and expensive than frames that require separate components to form joint connections.
[00133] [00133] In alternative modalities, all projections 510, 520 can be formed on a single side of the support 500 (side 502 or side 504), in which case the supports 500, 550 are not interlaced with each other. In still other modalities, the projections can be alternated in other intervals, in addition to a single interval, in order to correspond to different "interlacing" patterns for the supports 500, 550. For example, a single support 500 can extend under two adjacent supports 550 and then in the next two adjacent supports 550.
[00134] [00134] Figure 16A is a side view of a joint formed between a first support 500 and a second support 550, according to an embodiment. As shown, the first support 500 passes under the second support 550 at the point of engagement, or junction, between the supports. At this junction, the projection 520 of the first support 500 extends to an opening hole 560 in the second support 550, providing a hinged connection around which the supports can rotate as a frame assembled from several supports 500, 550 radially. expands or contracts.
[00135] [00135] Figure 16B is a cross-sectional view along line 16B-16B of figure 16A. It is understood that at other junctions along the first support 500, where it interacts with another second support 550, the first support can pass over the next second support with the projection 520 facing radially inward towards the second support 550 for extend to the opening corresponding to 560 of this second support. In addition, certain joints between the first bracket 500 and the second bracket 550 may not have a projection 520 or an opening 560 formed in the brackets, provided that each bracket is connected to another bracket at an apex of the frame.
[00136] [00136] In the form of figures 16A and 16B, the projection 520 has a square cross section profile in a plane perpendicular to an articulation axis 522 of the projection. In other modalities, the projection may have other forms of cross section, such as a circle, triangle, etc.
[00137] [00137] Figure 17 shows another modality of an articulated connection 700 formed by a first support 710 and a second support 720. The first support 710 has a projection 712 that can be formed by flow perforation. As in the embodiment shown in figure 15B, the second support 720 can include an opening 722 cut or perforated, within which the projection 712 can rest, so that the two supports are hinged articulated and can rotate one in relation to the another around an articulation axis 714. In another embodiment, instead of drilling an opening 722 entirely through the second support 720, the second support may include a blind or recessed hole, such as formed by stamping, marking or other means, in which the projection 712 can extend to provide a central engagement between the supports.
[00138] [00138] Figures 18A-18C show another modality of an articulation connection 800 between two supports 810, 850 formed by integral features in the supports. In this embodiment, a first support 810 may comprise an enlarged node 812 at the location of each junction between two supports. Knot 812 is wider than the rest of the support and can have a circular shape, as shown, although other shapes can be used in other embodiments.
[00139] [00139] The first support 810 includes a radially outward facing surface 814, a radially inward facing surface 816 and two axially facing surfaces that extend longitudinally 818. Two locking tabs 820 are formed in both sides. both sides of node 812 and extend radially inward towards the second support 850. One locking tab 820 extends radially inward from one surface 818 and the other locking tab 820 extends radially inward from another surface 818. The first support 810 may also have notches 822 formed on the surfaces 818 adjacent the locking tabs 820.
[00140] [00140] The second support 850 is similarly formed with an increased knot 852 at the location of each junction. The second support 850 includes a radially facing surface 854, a volumized surface
[00141] [00141] “As shown in figures 18A and 18B, the supports 810, 850 are placed against each other, so that the node 812 of the first support overlaps the node 852 of the second support to form an articulation 800. The locking tabs 820 of the first support 810 extend radially inward along opposite sides of node 852 of the second support 850, while locking tabs 860 of the second support 850 extend radially outwardly across the opposite sides of node 812 of the first support bracket 810. When brackets 810, 850 are hinged relative to each other on an articulation axis 870, the locking tabs 820 of the first bracket can engage the opposite sides 858 of the second bracket, while the locking tabs 860 of the second support can engage the opposite sides 818 of the first support. In this way, the locking tabs 820, 860 | prevent the rotation movement of the supports in relation to each other. Thus, a frame formed from multiples of the supports 810, 850 can have a maximum expanded diameter and a minimum compacted diameter determined by the range of motion of the supports allowed by the stoppers, can help to avoid over-expansion and / or over-expansion. compression beyond the desired limits.
[00142] [00142] Furthermore, the engagement of the locking tabs 820 against the external side surface of the node 852 and the engagement of the locking tabs
[00143] [00143] Figures 19A-19C illustrate a support connector 900 (also referred to as "rivet chain" in some embodiments) that can be used to interconnect supports of a prosthetic heart valve frame, according to another embodiment. In the illustrated embodiment, the support connector 900 comprises a plurality of rivets or projections 910 connected by a support member 912, which is desirably formed as a unitary part with the projections 910 integrally formed in the support member
[00144] [00144] The support connector 900 does not have to be made of the same material as the frame to which it is attached, since it is a separate part of the frame frames. The support connector 900, including the projections 910 and the support member 912, can be formed from any of several biocompatible metals (for example, stainless steel, nitinol) or polymers (for example, polyurethane). Support connector 900 desirably desires sufficient flexibility to conform to the curvature of the external or internal surface of the support against which it is placed, as described below.
[00145] [00145] Figure 20 is a perspective view of a frame 1000, according to one embodiment, which can be assembled using support connectors 900. The frame 1000 in the illustrated embodiment comprises a plurality of first external supports 1002 connected to a plurality of second internal supports 1004 The frame 1000 can have a construction similar to the frame 200 of figure 4, except for hinged connections between the supports. Each support 1002, 1004 can be formed with a plurality of openings in the places where the supports overlap, as described previously in connection with the frame 200. A support connector 900 can be placed along the outer surface of each outer support 1002, with each projection 910 extending through an opening in outer support 1002 and a corresponding opening in inner support 1004. The hinged connection is thus formed at each junction of a first support 1002 and a second support 1004.
[00146] [00146] In alternative modalities, a support connector 900 can be placed against the inner surface of each inner support 1004, with each projection 910 extending through an opening in the inner support 1004 and a corresponding opening in an external support 1002. In still other embodiments, a support connector 900 does not need to be formed with projections at all junctions between supports 1002, 1004. For example, in a specific implementation, a support connector 900 can be formed with projections. 910 sections at their opposite ends, so as to form joints the connections at the apexes along the entrance and exit ends of the frame and, optionally, may include 910 projections in one or more selected locations along the length of the support connector to form articulated connections between the inlet and outlet ends of the frame.
[00147] [00147] Furthermore, while the illustrated frame 1000 includes the single support connector 900 aligned along each support 1002, in other embodiments, several support connectors 900 can be placed end to end along the length of each support 1002 (or each support 1004 if placed inside the frame). In addition, support connectors 900 can be implemented in other frame designs. For example, in an implementation, a frame can be formed from a plurality of the first and second interlocking supports, similar to figure 13.
[00148] [00148] “As can be seen, the use of support connectors 900 to assemble the frame can greatly facilitate the manufacturing process, eliminating the step of manually placing individual rivets at each junction between the supports.
[00149] [00149] Figures 21-28 illustrate another modality of an 1100 frame for a prosthetic heart valve. As shown in figure 21, the frame 1100 in the illustrated embodiment is formed from a plurality of internal supports 1110 and a plurality of external supports 1120 connected by joints 1115 at the junctions
[00150] [00150] The frame 1100 may include a plurality of 1130 actuators configured to radially expand and contract the frame and maintain an expanded shape when implanted within a patient's body. Each 1130 actuator can include an internal member, or piston, 1132 that extends through an external member or cylinder
[00151] [00151] The components that form the 1115 joints can be integrated into the construction of the supports. As best shown in figures 22-26, for example, each support 1110 comprises a plurality of integral projections 1112 spaced along the length of the support at the junction locations 1105. Each projection 1112 can include a cylindrical base 1114 and a member of latches in the form of a plurality of tabs 1118 that extend laterally from the end of the base 1114. In the illustrated embodiment, each projection includes two tabs 1118 that extend in opposite directions from the end of a base 1114, although more than two 1118 tabs can be used in alternative modes.
[00152] [00152] Each support 1120 can be formed with a plurality of openings 1122 spaced along the length of the support at the junction locations 1105. Each opening 1122 can include two oblong side portions 1124 corresponding to the shape of the flaps 1118 Each opening 1122 can be formed within a recessed portion 1126 formed on an outer surface of a support 1120.
[00153] [00153] In the mounted state of the frame 1100, the base 1114 of each projection 1112 extends through a corresponding opening 1122 with the flaps 1118 residing in the recessed portion 1126 that surrounds the opening. The depth of the recessed portion 1126 is desirable equal to or greater than the height of the flaps 1118, so that the projections do not extend radially beyond the external surfaces of the external supports 1120. The flaps 1118 and the oblong side portions 1124 correspondingly allow the projection tabs 1112 to be inserted through the side portions 1124 when the tabs 1118 and the oblong side portions 1124 are rotationally aligned with each other and then prevent the separation of the two supports 1110, 1120 when the tabs 1118 and the side portions 1124 are rotationally displaced or misaligned.
[00154] [00154] During assembly, the flaps 1118 of a support 1110 are aligned with the oblong side portions 1124 of an opening 1122 of a support 1120 corresponding to a predetermined angle between the supports 1110, 1120, which is greater than the angle maximum between the supports 1110, 1120 allowed by the actuators 1130 during the radial expansion of the frame 1100. Thus, since the projections 1112 of the supports 1110 are inserted through the corresponding openings 1122 of the supports 1120 to form the frame, the supports are then rotated in relation to each other, which causes the flaps 1118 to be offset from the oblong side portions 1124. Actuators 1130 can then be mounted on the frame. The 1130 actuators are configured to expand and contract the frame radially, as noted above, but desirably limit the expansion and radial contraction of the frame within a predetermined range of diameters and a predetermined range of angles between the supports 1110, 1120 on which the flaps 1118 are still rotationally displaced from the oblong side portions 1124. In this way, actuators 1130 can prevent the radial expansion of the frame to a diameter in which the flaps 1118 are rotatably aligned with the oblong side portions. 1124, thus avoiding the separation of supports 1110, 1120 at any of the joints 1105. Likewise, actuators 1130 can prevent the frame from radially contracting to a diameter in which the flaps 1118 are rotatably aligned with the portions oblong sides 1124, thus preventing the separation of the supports 1110, 1120 at any of the joints 1105 when the frame is compacted to a l configuration iberation.
[00155] [00155] “In this way, the joints 1115 formed by the projections 1112 and corresponding openings 1122 can be referred to as" automatic lock "joints, in which the mechanical engagement of the flaps 1118 with the adjacent surface of the recessed portion 1126 block - burn the supports together at junction 1105 and they do not need to rely on putting the supports in tension against each other to maintain a connection between the supports. Consequently, supports do not need to be formed from superelastic materials (eg nitinol) to maximize the stress on the supports. Although supports can be formed from superelastic materials or non-superelastic materials (for example, stainless steel or chromium-cobalt alloys), non-superelastic materials are desirable in some modalities because they can provide greater crush resistance and, typically , are cheaper than superelastic materials.
[00156] [00156] The automatic locking joints 1115 can be formed from the projections 1112 and openings 1122 that have any one of several shapes besides those shown in the illustrated mode. In general, 1112 projections can be formed with a locking member that has a non-circular shape (in a plane perpendicular to the central axis of the projection) and openings 1122 can have any non-circular shape that is rotationally aligned with the locking member to allow the mounting of the supports and then rotatingly displaced from the locking member to prevent the separation of the supports in the joint.
[00157] [00157] In specific embodiments, frame 1100 can be mounted as follows. Referring to figure 27, the inner supports 1110 can be mounted on the mandrel 1150 and then the outer supports 1120 can be placed on the inner supports 1110. The inner and outer supports are placed at an angle predetermined relative to each other to rotatively align the flaps 1118 of the inner supports 1110 with the oblong openings 1124 of the outer supports 1120, allowing projections to be inserted through the openings so that the flaps 1118 can reside within of the recessed portions 1126. After that, the frame can be slightly crimped, causing the flaps 1118 to rotate rotationally from the oblong openings 1124, thus locking the supports in place at each junction 1105, as shown in figure 27. The 1130 actuators can then be mounted on the frame
[00158] [00158] Figures 29-33 illustrate another modality of an articulation assembly 1200 for a prosthetic heart valve. As shown in figure 29, the hinge assembly 1200 in the illustrated manner is formed from an internal support 1220 and an external support 1230 connected by a separate hinge member
[00159] [00159] - As best shown in figures 30A-30C, the hinge member 1202 may include a disk-shaped base 1212, from which a cylindrical projection 1214 extends. At a first end of the cylindrical projection adjacent to the base 1212, there are one or more retaining members in the form of a first set of one or more flaps 1216 that extend laterally from the cylindrical projection 1214. At a second end of the cylindrical projection ( in front of base 1212) there are one or more locking members in the form of a second set of one or more flaps 1218. In the illustrated embodiment, each set of flaps 1216 and 1218 comprises, respectively, two flaps that extend in opposite directions of the cylindrical projection 1214, although more than two tabs can be used in alternative modalities.
[00160] [00160] An internal support 1220 can be formed with a plurality
[00161] [00161] An external support 1230, of the same can, can be formed with a plurality of openings or external openings 1232 spaced along the length of the support at the junction locations 1205 with an internal support 1220, similar to the modality of frame 1100. As best shown in figure 31B, each outer opening 1232 can include two oblong outer side portions 1234 corresponding to the shape of the second set of tabs 1218. Each outer opening 1232 can be formed within an outer circular recessed portion 1236 formed in one external surface of the external support 1230, within which the second end of the cylindrical projection 1214 and the second set of tabs 1218 can be retained, as best shown in figure 33, which shows the mounting configuration of the frame assembly articulation 1200. The depth of the outer circular recessed portion 1236 is desirably equal to or greater than the height of the second set of flaps 1218, so that the limb hinge 1202 does not extend radially beyond the outer surface of the outer bracket 1230 when hinge frame assembly 1200 is mounted.
[00162] [00162] Once mounted on a frame, the cylindrical projection 1214 extends through a corresponding opening 1232 in the outer support 1230, with the second set of tabs 1218 residing in the outer recessed portion 1226 around the opening. The portion of the outer support 1230 that surrounds the opening 1232 within the recessed portion 1236 resides within a space 1240 (figure 30C) between the first set of flaps 1216 and the second set of flaps 1218, allowing the outer support 1230 to rotate or rotate in relation to the inner support 1220 and the hinge member 1202. The second set of tabs 1218 and the correspondingly oblong outer side portions 1234 allow the second set of tabs 1218 to be inserted through the oblong outer side portions 1234 during assembly when the second set of flaps 1218 and the oblong outer side portions 1234 are rotationally aligned with each other and then prevent the separation of the two supports 1220, 1230, when the second set of flaps 1218 and the oblong outer side portions 1234 are rotatably displaced or offset from one another.
[00163] [00163] During the assembly, in a similar way to the one described above in relation to the 1100 frame modality, after the second
[00164] [00164] “As with frame 1100, after mounting all joints, 1130 actuators can be mounted on the frame. The 1130 actuators are configured to expand and contract the frame radially, as noted above, but desirably limit the frame's radial expansion and contraction within a predetermined range of diameters and a predetermined range of angles between the supports 1220, 1230 , in which the second set of flaps 1218 is still rotationally displaced from the oblong outer side portions
[00165] [00165] For example, a frame diameter in the mounting configuration of figure 33 can be 29 mm, while the range of frame diameters between the minimum (crimped) diameter of the frame and the maximum allowed operational diameter of the frame can be between 8 mm and 28 mm, respectively. In this way, actuators 1130 can prevent radial expansion of the frame to a diameter at which the second set of tabs 1218 is rotatably aligned.
[00166] [00166] In this way, the joint assembly can be referred to as "self-locking", in which the mechanical engagement of the flaps 1218 with the adjacent surface of the outer recessed portion 1236 locks the supports together at junction 1105 and does not need to depend on placement the supports in tension against each other to maintain a connection between them. Consequently, supports do not need to be formed from superelastic materials (eg nitinol) to maximize the tension on the supports. Although supports can be formed from superelastic materials or non-superelastic materials (for example, stainless steel or chromium-cobalt alloys), non-superelastic materials are desirable in some modalities, because they can provide greater crush resistance and are generally less expensive than superelastic materials. In addition, the provision of separate joint members can simplify the manufacturing process of the supports, eliminating the need to specifically manufacture a support with three-dimensional projections of the joint. This can reduce overall manufacturing costs.
[00167] [00167] The hinge assembly 1200 can comprise members
[00168] [00168] Likewise, a joint member can be formed with a retaining member (for example, tab 1216) that has a non-circular shape (in a plane perpendicular to the central axis of the joint member) and the opening correspondent 1222 in the inner support 1220 can have any non-circular shape that can be rotationally aligned with the retaining member to allow insertion of the articulation member through opening 1222 and prevent rotation of the articulation member in relation to the support internal
[00169] [00169] In specific modalities (not shown), a frame using a plurality of joint assemblies 1200 can be assembled in a similar manner to the frame 1100 shown in figures 27 and 28. In such modalities, the members of hinge 1202 can first be inserted into each of the appropriate openings 1222 in the inner supports 1220, as shown in figures 31A-32B before mounting them on a mandrel 1150, as described above
[00170] [00170] Figures 34-37 illustrate a rivet or flange connector 1300 that can be used to interconnect the supports of a prosthetic heart valve frame, according to another way. With reference to figure 34, in the illustrated embodiment, the rivet 1300 comprises two elongated cylindrical end portions 1302, 1304 separated by a central width portion or flange 1306. In addition, an open or axially extending hole, cylindrical in shape , 1308 can extend completely through the rivet 1300.
[00171] [00171] Figure 35A is a perspective view of a frame 1400, according to one embodiment, which can be assembled using rivets on flange 1300. The frame 1400 in the illustrated embodiment comprises a plurality of first internal support 1410 connected to a plurality of second external supports 1420. The frame 1400 may have a construction similar to the frame 200 of figure 4, except for the configuration of the hinged connections between the supports. Each support 1410, 1420 can be formed with a plurality of openings 1402 in places where the supports overlap, as previously described in connection with frame 200. In addition, as shown in more detail in figure 36, each of the openings 1402 may include an enlarged or counter-orifice portion 1412, 1422, as described previously in Figure 3B, which is sized to receive one of the two elongated end portions 1302, 1304, respectively, both in an initial configuration and in a second configuration after the deformation of the two elongated end portions 1302, 1304, as will be described hereinafter.
[00172] [00172] “As shown in figures 35B and 36, in an initial configuration (not deformed), the wide flange 1306 of the flange rivet 1300 is placed between a first internal support 1410 and a first external support 1420 in its openings 1402 In this initial configuration, the radially innermost end of the terminal portion 1302 may extend beyond the inner surface of inner support 1410. Likewise, the radially outermost end of the terminal portion 1304 may extend in addition to the external surface of the external support 1420.
[00173] [00173] “As shown in figure 37, in a second configuration, the end portions 1302, 1304 are deformed, as by plastic deformation, in order to form end flanges 1312, 1314 at the opposite ends of the rivet. Each end flange has a larger diameter than the opening 1402 in the adjacent support 1410, 1420. Desirably, at least one of the end flanges is not seated firmly against the adjacent surface of the adjacent support, allowing at least one of the supports to rotate freely in relation to the rivet and other support.
[00174] [00174] In specific embodiments, the end flanges can be received entirely within the recessed portions 1412, 1422 of the adjacent supports 1410, 1420. For example, the end flange 1312 formed by the end portion 1302 can be flush with the inner surface of the inner support 1410 and the end flange 1314 formed by the end portion 1304 can be leveled
[00175] [00175] The end portions 1302, 1304 can be deformed simultaneously or they can be deformed separately. For example, end portions 1302, 1304 can be deformed by applying axially directed compressive forces to opposite ends of the rivet and / or by applying radially outwardly directed forces to orifice 1308 (for example, with use a stamping tool) to make the end portions 1302, 1304 deform with the shape shown in figure 37. In an alternative embodiment (not shown), instead of placing rivet 1300 between two supports in an initial configuration, the end portion 1302 of the rivet 1300 can be inserted through an opening 1402 in a first inner support 1410 and the first end portion 1302 can be deformed to form the end flange 1312, so that the rivet 1300 is effectively retained by the first internal support 1410. Subsequently, the first internal support 1410 can be connected to a second external support 1420 by inserting the second end portion 1304 of the same rivet 1 300 through the opening in the outer support and deforming the second end portion 1304 to form the end flange 1314. In yet another alternative mode, a rivet 1300 can first be connected to an outer support 1420 in a similar manner before the support ex - suit an internal support 1410 is connected.
[00176] [00176] The provision of flange rivets, as described in this disclosure, can provide benefits both for safety and ease of assembly. As the rivet is kept between the supports,
[00177] [00177] Figures 38A, 38B and 39 show another modality of a flange rivet 1500 formed by drilling or forming the first and second blind holes 1508, 1510, in the first and second end portions 1502, 1504 of the rivet. The rivet 1500 may have a wide flange or central middle portion 1506 of the end portions. The rivet 1500 can be mounted on two supports 1410, 1420, as previously described by the deformed end portions 1502, 1504.
[00178] [00178] —Figures 40A-40C show another modality of a flange rivet 1600, formed by the deformation of a single tube or cylindrical member 1602 (figure 40A) that has the first and second end portions 1604, 1606, respectively, and an opening longitudinal orifice 1608 extending through it. The compressive forces can be applied to the opposite ends of the tube 1602 (indicated by arrows 1612), causing the tube to deform plastically and form a central portion or flange 1610 between the first and second end portions 1604, 1606. Rivet 1600 it can be mounted on two supports 1410, 1420, as previously described, deforming the end portions 1604, 1606.
[00179] [00179] Figures 41-44 illustrate the assembly of another modality of a 1700 frame for a prosthetic heart valve. As shown in figure 43, the frame 1700 in the illustrated embodiment is formed from at least two separate frame subassemblies, including a first internal frame subassembly 1710 (shown in figure41) and a second external frame subassembly. term 1720 (shown in figure 42), as described in more detail here. The two frame subassemblies can still be connected to each other and expanded using a plurality of 1730 actuators, also described in more detail here. In other embodiments, frame 1700 may include additional frame subassemblies positioned radially inward and / or radially outward from frame subassemblies 1710, 1720.
[00180] [00180] Similar to the frame 1100 shown in figure 21, the sub-assembly of internal frame 1710, best illustrated in figure 41, can comprise a plurality of internal supports 1712 and a plurality of external supports 1714 connected by joint projections 1716 connections that pass through the 1718 openings at the junctions
[00181] [00181] The components that form the 1716 articulation projections can be integrated in the construction of the supports. As best shown in figure 41, for example, three inner supports 1712 and three outer supports 1714 each comprise a plurality of projections of integral joints 1716 spaced along the length of the support, including at the locations of joints 1715, which can be similar to the 1112 joint projections shown in figure 25. Additional 1716 joint projections can be provided at additional locations along the supports, which can be used to join the 1710 inner frame subassembly to the subassembly of external frame 1720 at junctions 1735. External supports 1714 can also be formed each with a plurality of openings or openings 1718 spaced along the length of the support at the locations of junctions 1715, which can be similar to openings 1122 , as illustrated in figure 24, which can be used to join the inner supports 1710 to the outer supports 1714 by a process similar to that described above in in relation to frame 1100.
[00182] [00182] “Similar to the inner frame subassembly 1710, the outer frame subassembly 1720, best illustrated in figure 42 can comprise a plurality of internal supports 1722 and a plurality of external supports 1724 connected by projections of articulation 1726 of internal supports 1722 that pass through the openings 1728 of the external supports 1724 at the junctions 1725. In alternative modalities (not shown), the supports can be interlaced, as in the modality of figure 13. In other alternative modalities, instead of using integrated joints and openings, the internal supports 1722 and the external supports 1724 can be assembled using rivets or the other connection mechanisms described in this document and in the other patents and applications referenced here in appendices 1711, and / or in some or all junctions
[00183] [00183] The components that form the 1726 articulation projections can be integrated in the construction of the supports. As best shown in figure 42, for example, three inner supports 1722 and three outer supports 1724 each comprise a plurality of projections of integral joints 1726 spaced along the length of the support, including at the locations of joints 1725, which may be similar to the projections of joints 1112 shown in figure 25. The external supports 1724 can also be formed with a plurality of openings or openings 1728 spaced along the length of the support at the locations of the 1725 joints, which can be similar to the openings 1122, as shown in figure 24, which can be used to join the inner brackets 1722 to the outer brackets 1724 by a process similar to that described above for frame 1100. Additional openings 1728 can be provided in additional locations along the supports, which can be used to join the subframe of external frame 1720 to the subassembly of internal frame 1710 at junctions 1735.
[00184] [00184] The supports of each of the subassemblies are arranged to form a plurality of closed cells (each subassembly in the illustrated form forms three diamond-shaped cells), which helps to maintain its pre-assembled annular shape before being attached to each other. others. Once assembled separately, as shown in figures 41 and 42, the inner frame subassembly 1710 can be inserted in the outer frame subassembly 1720, as with the frames rotated by a half cell offset (in this case, 60 degrees) and joined in the junctions 1735 when inserting the articulation projections 1716 in the supports 1712, 1714 of the sub-assembly of internal frame 1710 through the corresponding openings
[00185] [00185] É Alternatively, the articulation projections in the assembly of the external frame can be inserted through openings in the assembly of the internal frame (in the modalities in which the articulation projections extend radially inwards from the supports to which they are connected ). Either separate rivets or other connection mechanisms, such as those described in this document and in the patents and applications referenced here, can pass through openings in both subassemblies at the joints. Or, a combination of suitable connection mechanisms, including those described here, can be used.
[00186] [00186] One or more of the supports 1712, 1714 of the inner frame subassembly 1710 and one or more of the supports 1722, 1724 of the external frame subassembly 1720 can be formed with the openings 1740 spaced along the length of the supports. The 1740 openings can be used to suture leaflets, an internal skirt and / or an external skirt for the selected frame supports, as described below.
[00187] [00187] The 1700 frame can include a plurality of actuators, which can be 1730 threaded actuators configured to radially expand and contract the frame and retain the frame in an expanded form when implanted within a patient's body. Each 1730 actuator may include an internal member in the form of a 1732 screw, which may comprise external threads and extends through a first external member, sleeve or cylinder 1734 positioned at a 1725 joint at one end of the subassembly of outer frame 1720, and on a second outer member, sleeve or cylinder 1736 that can be positioned at a junction 1715 in the inner frame subassembly 1710. One or both of the outer members 1734, 1736 may have internal threads to engage with threaded way the inner member 1732. In addition, the outer members 1734, 1736 can be mounted elsewhere in the frame 1700. For example, the first outer member 1734 can be mounted on the subassembly of inner frame 1710 and the second outer member 1736 can be mounted on the external frame subassembly 1720; or, alternatively, the two outer members 1734, 1736 can be mounted on the inner frame subassembly 1710 or the two outer members 1734, 1736 can be mounted on the outer frame subassembly 1720.
[00188] [00188] The rotational movement of the inner member 1732 in relation to the outer members 1734, 1736 is effective for expanding and compacting the frame 1700 radially. The 1730 actuators can be releasably connected to the corresponding actuators of a release device , for example, each 1732 screw can be releasably connected to a drive shaft or drive corresponding to the release device wire. Additional details of the 1730 actuators are disclosed in copending order No. 15 / 831,197, filed on December 4, 2017. In other modalities, the actuators for expansion and radial compression of the 1700 frame can be “push- pull ”, as previously described in connection with the modalities of figures 1, 8, 12 and 21.
[00189] [00189] In the assembled state of the frame 1700, a plurality of articulation projections 1716, 1726 extends through the corresponding openings 1718, 1728. During assembly, the projections are aligned with the openings and then the supports are rotated one in relation to the other, which causes the projections to rotate in relation to the openings, as described above in connection with the 1100 frame mounting method described with reference to figures 27-28, fixing the brackets of the inner frame subassembly and the subassembly of the external frame together. Although in an alternative modality, not all joints between the supports can have articulation projections inserted through openings, the internal and external supports of each frame subassembly are connected, at least, at the apexes, for example, mos apexes 1711 of the internal frame subassembly, best illustrated in figure 41.
[00190] [00190] After mounting the 1700 frame, the 1730 actuators can then be mounted on the frame. In other modalities, the external sleeves 1734, 1736 of the actuators can be mounted in the frame subassemblies 1720, 1710, respectively, before the assembly of the inner and outer frame subassemblies, and the screws 1732 are added after the assembly of the frame. internal part and sub-assemblies of external frame. The 1730 actuators are configured to expand and compact the frame radially, as noted above, but desirably limit the radial expansion and compression of the frame within a predetermined range of diameters and a predetermined range of angles between the subassembly frames. internal frame 1710 and the external frame subassembly supports 1720, in order to prevent the separation of two subassemblies at junctions 1735, similar to the process described above in relation to frame 1100, making frame 1700 a frame assembly "self-locking".
[00191] [00191] Soft components of the prosthetic valve, such as valve leaflets or an inner skirt can (not shown), can be added to the inner frame subassembly 1710, while other soft components, such as an outer skirt (not shown), can be added to the 1720 outer frame subassembly. In specific embodiments, valve leaflets and / or an inner skirt can be mounted on the 1710 inner frame subassembly and / or an outer skirt can be mounted on the 1720 outer frame subassembly. before the inner frame subassembly 1710 and the outer frame subassembly 1720 are connected to each other to form the fully assembled frame 1700. The formation of separate inner and outer frame subassemblies is advantageous as it facilitates the assembly of the leaflets and / or the prosthetic valve skirt (s), as described below. Additional details on the flexible component set in a frame subassembly are described below. In alternative embodiments, the 1700 frame can be fully assembled before mounting the leaflets and skirt (s) on the 1700 frame.
[00192] [00192] Figures 45-47 illustrate a subassembly of valve 1900, according to another modality. As shown in figure 45, valve subassembly 1900 comprises an inner frame subassembly 1710 and a prosthetic valve leaflet assembly 1910 at least partially mounted on the inner frame subframe assembly 1710. An outer frame subassembly 1720 can be placed in around the 1710 subassembly inner frame, as previously described in conjunction with figures 43-44.
[00193] [00193] The valve leaflet assembly may comprise three 1912 leaflets (as in the illustrated embodiment), although it should be understood that other numbers of leaflets may be used. Each 1912 booklet can be formed with 1914 commissure flaps on opposite sides of the booklet. Each commissure flap 1914 can be paired with an adjacent commissure flap 1914 of an adjacent leaflet
[00194] [00194] The bottom or inflow of the leaflets may comprise inflow or cusp edges 1920 that can be attached, such as by suture or other suitable techniques, to the lower portions of the internal supports 1712 and external supports 1714. For example, the inflow edges 1920 can be sewn on supports 1712, 1714 with sutures that pass through the leaflets and openings 1740 on supports 1712, 1714, such as the use of entry and exit points or suture points that extend along the supports. Alternatively, sutures can pass through the leaflets and around the supports 1712, 1714. An inner skirt 1940 (discussed later) can be used to reinforce the fixation of the 1920 inflow edges of the leaflets to the supports 1712, 1714. One or more narrower reinforcement strips (for example, a narrow strip of fabric) can be placed along the edge of the 1920 cusp of each leaflet and sutured to reinforce the connection between the cusp edge and the supports. For example, the edges of the 1920 cusp can be "interspersed" or arranged between two strips of reinforcement that can be sutured together and at the edges of the cusp.
[00195] [00195] As the 1920 inflow edges of the 1912 leaflets in the illustrated pattern are only attached to the 1710 inner frame subassembly, the attached leaflet edges do not need to pass over a "crossing bracket". In other words, each edge of input
[00196] [00196] Avoid fixing the entry edges of the leaflets to any crossing brackets provides a safer leaflet connection, with less stress on the leaflets between the 1920 flow edges and the 1912 commissure flaps. In addition, this way connecting the leaflets to the holder provides reduces the risk of abrasion of the leaflet and a symmetrical and smooth clamping line to improve valve performance. In addition, it is relatively easier to attach the leaflets to the frames 1712, 1714 before the frame is completely assembled due to the fact that the internal subassembly of the frame has fewer frames than a fully formed frame and therefore there is much greater access to the frame. interior of the frame for the assembler to insert tools and his fingers into the frame during the assembly process. This can greatly simplify the process of sewing the leaflets on the supports and / or any reinforcement straps or skirts.
[00197] [00197] Figure 46 shows a way of assembling an internal skirt 1940 for the subassembly of valve 1900. In the illustrated mode, the inner skirt 1940 is "interspersed" or arranged between the internal supports 1712 and the external supports 1714 of the inner frame sub-assembly 1710. As such, the connection of the inner supports 1712 and the outer supports 1714 at the junctions 1715 can be used to help secure the skirt to the subassembly of the inner frame 1710, such as when passing the projections 1716 through corresponding slits or openings in the skirt. The 1940 skirt can also be attached to supports 1712, 1714 with sutures that pass through the skirt and through the openings 1740 of the selected supports 1712, 1714 (and / or around the selected supports 1712, 1714). The skirt 1940 can be formed with a corrugated outlet edge 1942 which is shaped to correspond to the shape of a line of support segments extending circumferentially adjacent to the line of support segments that defines the outlet end of the assembly frame.
[00198] [00198] In another embodiment, as shown in figure 47, an inner skirt 1940 is mounted entirely external to the subassembly of inner frame 1710. The skirt 1940 can be attached to supports 1712, 1714 of the subassembly of inner frame 1710 with sutures that extend through openings 1740 and / or around the selected supports of the 1710 inner frame subassembly.
[00199] [00199] Figure 48 illustrates another example prosthetic valve 2000. The prosthetic valve 2000 can be formed by the first assembly of the valve subassembly 1900 of figure 47, with an inner skirt 1940 provided totally external to the subassembly of internal frame
[00200] [00200] In alternative modalities in which separate rivets or hinge members are used instead of integral projections 1716 (for example, as shown in figures 29-40), one or more rivets or hinge members may extend through an opening in a support of the inner frame subassembly 1710, through a slot or opening in the skirt 940 and through an opening in a support of the outer frame subassembly 1720.
[00201] [00201] In this way, the inner skirt 1940 can be inserted or maintained between the inner and outer supports of the inner frame subassembly 1710 (figure 46) or between the inner frame subassembly 1710 and the outer frame subassembly 1720 (figure 48) to provide a strong and durable connection to the inner skirt 1940. In still other embodiments, the skirt 1940 can be arranged between the inner and outer frames of the subassembly of the outer frame 1720 and held in place with the projections of the inner supports extending through the slits or openings in the skirt.
[00202] [00202] This way of connecting the skirt to the frame can simplify the assembly process, potentially reducing the amount of stitches using projections, rivets, joints or other mechanisms.
[00203] [00203] The prosthetic valve 2000 may also include an external skirt (not shown) that can be positioned entirely outside the 1720 outer frame subassembly. The external skirt can be attached to the frame using sutures and / or articulation members that hold the internal and external supports of the 1720 external frame subassembly.
[00204] [00204] Another advantage offered by the prosthetic valve 2000 is that, with the external frame subassembly 1720 mounted separately and positioned completely external to the internal frame subassembly 1710, the supports facing the articulated parts of the leaflets (for example, the supports located in the positions where the leaflets of the valve leaflet assembly move in and out of the frame) are part of the 1720 outer frame subassembly. This creates a gap between the hinged parts of the leaflets (especially the edges in order to avoid or minimize the contact between the leaflets and the frame during the operation of the prosthetic valve, thus protecting against abrasion of the leaflets. This may also allow the use of a relatively larger leaflet to improve hemodynamics.
[00205] [00205] In alternative modalities, the 1912 leaflets or portions thereof can be fixed to the frame supports in a similar manner, with the use of one or more articulation members that extend through the leaflets and two overlapping supports in place or in addition to the fixation of the suture of the leaflets. In one implementation, for example, the 1920 inflow edges of the leaflets can be positioned against the internal surfaces of the supports 1712, 1714 and held in place with hinge members (eg rivets) that extend through a leaflet, a support 1712, 1714 and a support 1722, 1724 of the outer frame. In another implementation, the 1912 leaflets can be placed between the inner and outer supports 1712, 1714 at junctions 1715a, 1715b, 1715c and retained in place through projections 1716 (or other joint members) that interconnect the supports at these junctions.
[00206] [00206] Figures 49-52 illustrate another modality of a 2100 frame assembly for a prosthetic valve. The 2100 frame assembly can be used when a relatively larger frame is desired. The frame assembly 2100 can be formed from an internal frame subassembly 2110 (figure 49) and an external frame subassembly 2120 (figure 50). How do I illustrate
[00207] [00207] Figure 49 shows the inner frame subassembly 2110, in addition to the outer frame subassembly 2120. As best shown in figure 49, the inner frame subassembly 2110 can be similar to the inner frame subassembly 1710, with three internal supports 2112 oriented in a first direction and three external crossing supports 2114 of external supports oriented in a second direction. The inner supports 2112 and the outer supports 2114 can be joined together at their ends to form the apices 2111 and at the joints 2115 positioned between the ends of the supports. These joints can be formed using projections, joints, rivets and / or any of the methods and / or mechanisms described here and in the referenced patents and applications.
[00208] [00208] Figure 50 shows the external frame subassembly 2120, in addition to the internal frame subassembly 2110. As best shown in figure 50, the external frame subassembly 2120 is similar to the external frame subassembly 1720, except that instead of three internal supports and three external crossing supports, the subframe of external frame 2120 comprises six internal supports 2212 oriented in a first direction, and six external crossing supports 2214 of external supports oriented in a second direction. The inner supports 2212 and the outer supports 2214 can be joined together at their ends.
[00209] [00209] Figure 51 shows the inner frame subassembly 2110 assembled with the outer frame subassembly 2120. As illustrated in figure 51, once assembled separately, the inner frame subassembly 2110 can be inserted in the outer frame subassembly 2120 and joined at junctions 2135 with the use of joints, rivets and / or any of the methods and / or mechanisms described in this document and in the referenced patents and applications. Stippling has been added to the 2110 inner frame subassembly supports for illustrative purposes only. The stippling is added to distinguish the inner frame subassembly 2110 from the outer frame subassembly 2120 and does not represent the actual surface ornamentation.
[00210] [00210] Furthermore, as illustrated in figure 52, the two sub-assemblies can also be connected to each other through a plurality of 2130 actuators. The 2130 actuators in the illustrated mode are screw actuators that are similar in construction and work to 1730 screw actuators. Similar to 1730 actuators, each 2130 actuator in the illustrated embodiment comprises a 2132 screw that extends through an upper outer member or sleeve 2134 and a lower outer member or sleeve 2136. Rotation of screw 2132 is effective to radially expand or compress the 2100 frame assembly, as previously described. In other modalities, the actuators can be push-pull type actuators, as previously described together with the modalities of figures 1, 8, 12 and 21 and / or any of the various actuators described in the mentioned patents and / or applications .
[00211] [00211] In addition, a pair of commissure fixing members 2140 can be mounted on the upper end portion of each actuator
[00212] [00212] It should be understood that the disclosed modalities can be adapted for use with prosthetic devices that are implantable in any native annular of the heart (for example, pulmonary, mitral and tricuspid annulers) and can be used with any of several release approaches (eg, retrograde, anterograde, transeptal, transventricular, transatrial, etc.). The disclosed modalities can also be used with prostheses implanted in other lumens of the body.
[00213] [00213] For the purposes of this description, certain aspects, advantages and new features of the modalities of this disclosure are described here.
[00214] [00214] Although the operations of some of the disclosed modalities are described in a specific sequential order for a convenient presentation, it should be understood that this way of description encompasses rearrangement, unless a specific order is required by the specific language established below. For example, operations described sequentially can, in some cases, be rearranged or performed simultaneously. In addition, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, the description sometimes uses terms such as "provide" or "achieve" to describe the methods disclosed. These terms are high-level abstractions from the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the specific implementation and are easily discernible by one skilled in the art.
[00215] [00215] As used in this application and in the claims, the singular forms "one", "one" and "o (a)" include plural forms, unless the context clearly indicates otherwise. In addition, the term "includes" means "understands". In addition, the terms "coupled" and "associated" generally mean electrically, electromagnetically and / or physically (for example, mechanically or chemically) coupled or linked, and do not exclude the presence of intermediate members between the coupled or associated items, without specific opposite language.
[00216] [00216] As used herein, the term "proximal" refers to a position, direction or portion of a device that is closest to the user and the furthest from the implantation site. As used here, the term "distal" refers to a position, direction or portion of a device that is farthest from the user and closest to the implantation site. Thus, for example, the proximal movement of a device is the movement of the device towards the user, while the distal movement of the device is the movement of the device away from the user. The terms "longitudinal" and "axial" refer to an axis that extends in the proximal and distal directions, unless expressly defined otherwise.
[00217] [00217] As used in this document, operations that occur "simultaneously" or "concurrently" generally occur at the same time, although delays in the occurrence of one operation in relation to the other due to, for example, spacing, reproduction or clearance between components in a mechanical connection, such as threads, gears, etc., are expressly within the scope of the terms above, in the absence of specific contrary language.
[00218] [00218] In view of the many possible modalities to which the principles of disclosure can be applied, it must be recognized that the illustrated modalities are only preferred examples and not
should be considered as limiting the scope of the disclosure.
Instead, the scope of the disclosure is defined by the following claims.

权利要求:
Claims (19)
[1]
1. Implantable medical device, characterized by the fact that it comprises: a first set of a plurality of first supports that extend in a first direction; and a second set of a plurality of second supports extending in a second direction; wherein the first supports are intertwined with the second supports to form an annular frame that is radially compressible and expandable; in which each of the first support is hingedly connected to at least a second support.
[2]
2. Medical device according to claim 1, characterized by the fact that each first support comprises a plurality of projections spaced apart along a length of the first support and each second support comprises a plurality of openings that they extend along a length of the second support and where the projections of the first supports extend into the respective openings of the second supports.
[3]
3. Medical device according to claim 2, characterized by the fact that each of the first support has at least one projection that extends radially inwards and into an opening of a second adjacent support and at least in us a projection extends radially outward and into an opening of a second adjacent support.
[4]
4. Medical device according to any one of claims 1 to 3, characterized by the fact that the projections are formed entirely in the first supports.
[5]
5. Medical device according to any one of claims 1 to 4, characterized by the fact that each first
port passes radially out of at least a second support and radially out of at least a second support.
[6]
Medical device according to any one of claims 1 to 5, characterized in that it further comprises a valve member comprising a plurality of leaflets mounted within the annular frame.
[7]
7. Implantable medical device, characterized by the fact that it comprises: a radially expandable and compressible annular frame comprising a plurality of interconnected supports, the plurality of supports comprising a first set of a plurality of first supports and a second set of a plurality of second supports, in which the first supports overlap with the second adjacent supports at the joints, and the expansion or compression of the annular frame causes the first supports to rotate in relation to the second supports at the joints ; wherein the frame comprises a plurality of joints at the joints extending from the first supports through corresponding non-circular openings of the second supports at the joints; and wherein each joint comprises a cylindrical articulation portion which can rotate in a corresponding opening of a second support and a lock member extending from the articulation portion, in which the lock member is dimensioned and formed in with respect to the corresponding opening of the second support, in order to prevent the radial separation of the first and second supports whenever the locking member is moved rotationally from the corresponding opening after the radial expansion and compression of the frame.
[8]
8. Medical device according to claim 7, capable of
characterized by the fact that the second supports are formed with recessed portions around the non-circular openings and the joint lock members are arranged inside the recessed portions.
[9]
Medical device according to any one of claims 7 and 8, characterized by the fact that it further comprises one or more actuators mounted on the frame and configured to radially expand and compact the frame between a radially compressed state defining a compacted diameter and a radially expanded state defining an expanded diameter, in which the locking members are rotatably displaced from the corresponding non-circular openings in the second supports in the compressed diameter, in the expanded diameter and in all diameters between the diameters compressed and expanded.
[10]
10. Medical device according to any of claims 7 to 9, characterized by the fact that the joints are integrally formed in the first supports.
[11]
Medical device according to any one of claims 7 to 9, characterized in that: the joints are separate components from the first and second supports: each of the first supports comprises a plurality of non-circular openings; and each joint extends through an opening in a first support and an adjacent opening in a second support at a joint.
[12]
Medical device according to claim 11, characterized in that each of the joints further comprises a retaining member configured to be retained within the non-circular openings in the first supports.
[13]
13. Medical device according to any of claims 11 and 12, characterized in that each of the joints further comprises a circular base member configured to be retained within a circular recess around one of the openings not circular on the first supports.
[14]
Medical device according to any one of claims 7 to 13, characterized in that the locking members comprise a non-circular shape.
[15]
Medical device according to any one of claims 7 to 14, characterized in that the locking members comprise a central non-circular protrusion with at least two tabs extending outwards from it in a parallel plane support.
[16]
16. Method of assembling an implantable medical device, characterized by the fact that it comprises: providing a plurality of first supports; providing a plurality of second supports, each second support comprising a plurality of non-circular openings spaced along a length thereof; connect the first and second supports to each other to form an annular frame by inserting the joints through the non-circular openings of the second supports, each joint having a cylindrical joint portion arranged in a corresponding non-circular opening and a locking member that extends from one end of the hinge portion, wherein the locking members are rotatably aligned with the corresponding non-circular openings when the hinges are inserted into the non-circular openings; rotate the first supports in relation to the second supports to cause the locking members to rotate from their corresponding non-circular openings; and mount one or more actuators on the frame, the one or more actuators configured to radially expand and compact the frame within a predetermined range of diameters corresponding to a predetermined range of angles between the first and second supports on which locking members are often rotated from non-circular openings
[17]
17. Method according to claim 16, characterized by the fact that each first support comprises a plurality of non-circular openings spaced along a length of the same and in which the connection of the first and second supports it also includes the insertion of the joints through the non-circular openings of the first supports and the second supports;
[18]
18. Method, according to claim 16, characterized by the fact that the joints are an integral part of the first supports.
[19]
19. Method, according to any of claims 16 to 18, characterized by the fact that it also comprises the interlacing of the first supports to the second supports.

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同族专利:

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公开号 | 公开日

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WO2018226628A1|2018-12-13|

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US10869759B2|2020-12-22|

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CN110913803A|2020-03-24|

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ZA201907836B|2020-11-25|

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CR20190528A|2020-02-25|

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KR20200005679A|2020-01-15|

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JP2020522367A|2020-07-30|

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US20180344456A1|2018-12-06|

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EP3634316A4|2020-05-13|

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AU2018282160A1|2019-12-05|

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EP3634316A1|2020-04-15|

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CA3063912A1|2018-12-13|

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US20210085454A1|2021-03-25|

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IL270837D0|2020-01-30|

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法律状态:
2021-11-03| B350| Update of information on the portal [chapter 15.35 patent gazette]|

优先权:

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申请号 | 申请日 | 专利标题

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US201762515437P| true| 2017-06-05|2017-06-05|

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US62/515,437|2017-06-05|

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US15/995,528|US10869759B2|2017-06-05|2018-06-01|Mechanically expandable heart valve|

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US15/995,528|2018-06-01|

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PCT/US2018/035961|WO2018226628A1|2017-06-05|2018-06-05|Mechanically expandable heart valve|

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