covered prosthetic heart valve

专利摘要:
The present invention relates to a prosthetic heart valve, which includes a support having an inflow end and a discharge end and which defines a longitudinal axis. The prosthetic valve also includes a leaflet structure, located at least partially within the support, and a cover arranged around the support. The cover includes a first woven part, which extends circumferentially around the support and which includes a plurality of textured cords or threads extending along the longitudinal axis of the support. The cover also includes a second woven part, which extends circumferentially around the support and which is spaced from the first woven part along the longitudinal axis of the support. The textured strands extend along the longitudinal axis of the support from the first woven part to the second woven part and form a floating part, between the first woven part and the second woven part.
公开号:BR112020014367A2
申请号:R112020014367-7
申请日:2019-01-18
公开日:2020-12-01
发明作者:Evan T. Schwartz；Michael Bukin；Boaz Manash；Sara Haivatov；Tamir Levi；Sean Chow；Sandip Vasant Pawar；Darshin S. Patel；Chambory Chhe；Arpit Laddha；Ngoc Hoang Thi Nguyen；Waina Michelle Chu；Yuanlong Du
申请人:Edwards Lifesciences Corporation；
IPC主号:

专利说明:

[001] [001] This patent application is a partial continuation of US Patent Application No. 15 / 876,053, filed on January 19, 2108. This patent application also claims the benefit of US Provisional Patent Application No. 62 / 703,363, filed on July 25, 2018. Both previous patent applications are incorporated by reference in their entirety in this specification. FIELD
[002] [002] The present invention relates to prosthetic heart valves and, in particular, prosthetic heart valves including a cover. BACKGROUND OF THE INVENTION
[003] [003] In a procedure to implant a transcatheter prosthetic heart valve, the prosthetic heart valve can be positioned at the annulus of a native heart valve and expanded or allowed to expand to its functional size. To retain the prosthetic heart valve in the desired location, the prosthetic heart valve can be larger than the annulus of the native valve, so that it applies force to the surrounding tissue to prevent the prosthetic heart valve from being dislodged. In other configurations, the prosthetic heart valve can be expanded with a support structure, which is located inside the native annulus and configured to retain the prosthetic heart valve in a selected position with respect to the annulus. Over time, the relative movement of the prosthetic heart valve and native heart valve tissue (eg, leaflets, tendon cords, etc. from native valves) in contact with the prosthetic heart valve can cause
[004] [004] Some of the described embodiments refer to coverings for prosthetic heart valves and their method of production and use. This summary is mentioned to provide some examples and is in no way intended to limit the scope of the invention. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly list the features. Also, the features described can be combined in several ways. Several characteristics and steps, described at any point in this description, can be included in the examples summarized in this specification.
[005] [005] In a representative embodiment, a prosthetic heart valve comprises a support comprising a plurality of strut elements, the support being radially deformable and expandable between a deformed configuration and an expanded configuration, the support having an inflow end and a discharge end, and defining a longitudinal axis. The prosthetic heart valve further comprises a leaflet structure, located at least partially within the support, and a cover arranged around the support (for example, partially around, around a part or around the entire support). The cover can comprise or be formed of a sealing element or a cover element, which can be arranged partially around or around the entire support to form part or all of the cover. In some embodiments, the cover and / or the sealing element / cover element comprises (m) a first woven part, which extends circumferentially around the support and which includes a plurality of strands (for example, threads, threads, sutures or other elongated materials useful in a similar way to that described in this specification) extending along the longitudinal axis of the support. In some embodiments, the cover and / or the sealing element / cover element further comprises (m) a second woven part, which extends circumferentially around the support and which is spaced from the first woven part along the longitudinal axis of the support. Textured strands (for example, yarns, etc.) extend along the longitudinal axis of the support from the first woven part to the second woven part and form a floating part, such as a floating yarn part, etc. , between the first woven part and the second woven part.
[006] [006] In some embodiments, the cover and / or the sealing element / cover element is or are resilient to be stretched between a first state, corresponding to the radially expanded configuration of the support, and a second state, corresponding to the radially deformed configuration of the Support.
[007] [007] In some embodiments, the floating part / floating yarn part is resiliently stretchable between the first state and the second state of the cover and / or the sealing element / cover element.
[008] [008] In some embodiments, the textured strands, such as textured strands, are configured to provide a compressible volume for the floating part, or a part of floating strands, of the cover and / or the sealing element / cover element, when the support is in the expanded configuration.
[009] [009] In some embodiments, the textured cords (for example, yarns, etc.) are woven in a leno weave model in the first woven part and the second woven part.
[0010] [0010] In some embodiments, the cover and / or the sealing element / cover element defines (m) a plurality of openings spaced circumferentially between themselves.
[0011] [0011] In some embodiments, the openings in the cover and / or in the sealing element / cover element overlap with the openings defined by the support strut elements.
[0012] [0012] In some embodiments, the openings were cut into a part of the sealing element made of an inclined cloth or an inclined fabric to inhibit defibration around the openings.
[0013] [0013] In some embodiments, the cover and / or the sealing element / covering element comprises (m) a third woven part, on the opposite side of the first woven part of the floating part / part of floating yarns, the third woven part comprising the textured strands / textured yarns of the first woven part.
[0014] [0014] In some embodiments, the textured cords / textured yarns are woven in a flat weave pattern in the third woven part.
[0015] [0015] In some embodiments, the third woven part is folded over the apices of the strut elements at the inflow end of the support.
[0016] [0016] In some embodiments, the covering and / or the sealing element / covering element further comprises (m) a fourth woven part, opposite the second woven part of the floating part / part of floating yarns. The fourth woven part comprises the textured strands / textured yarns, and the textured strands / textured yarns are woven in a flat weave pattern in the fourth woven part.
[0017] [0017] In some embodiments, the fourth woven part comprises a plurality of extension parts, which overlap the openings defined by the strut elements of the support, when the support is in the expanded configuration.
[0018] [0018] In some embodiments, the extension parts are attached
[0019] [0019] In some embodiments, the cover and / or the sealing element / cover element comprises (m) a first protective part, folded over the apices of the strut elements at the inflow end of the support, and the cover and / or the sealing element / cover element further comprises (m) a second protective part, folded over the apices of the strut elements at the discharge end of the support.
[0020] [0020] In some embodiments, the support is a mechanically expandable support.
[0021] [0021] In some embodiments, the support is a plastic expandable support.
[0022] [0022] In some embodiments, the cover and / or the sealing element / cover element comprises (m) a plurality of floating parts (e.g., parts of floating wires, etc.) spaced apart along the longitudinal axis support.
[0023] [0023] The floating parts or parts of floating threads can be thermally cured to obtain a desired size and texture, for example, to make them softer and more textured.
[0024] [0024] The prosthetic heart valve can use twisted PET threads in a warp direction and textured PET threads in a weft direction. PET yarns twisted in a warp direction can be arranged to be woven into a woven pattern, and textured PET yarns in the weft direction can form a part of floating yarns without any weaving structure. The sealing elements can be thermally contracted to obtain a stretching capacity between 80 - 160%. The support can be a mechanically expandable surface with the cover or the sealing element on it.
[0025] [0025] The cover and / or the sealing element may comprise at least one of a low friction coefficient layer or a low friction coating on at least part of it. This may include a low friction layer over another layer of material and / or strips with a low friction coefficient or a low friction layer over parts of another layer. The low coefficient of friction layer or the low coefficient of friction coating may be formed by electrospinning on a low friction coefficient material on the support or other layer of the cover and / or the sealing element.
[0026] [0026] The prosthetic heart valve can also comprise strips of material, which are helically wound around the struts and / or the apexes at one or both ends of the support.
[0027] [0027] In another representative embodiment, a prosthetic heart valve comprises a surface, comprising a plurality of strut elements, the support having an inflow end and a discharge end, the strut elements defining a plurality of openings in the support at the discharge end of the support. The prosthetic heart valve further comprises a leaflet structure located at least partially within the support, and a cover arranged around the support (for example, partially around, around a part or around the entire support). The cover can comprise and can be formed of a sealing element or a cover element, which can be arranged partially around the support or around the whole support to form part or all of the cover. The cover and / or the sealing element / cover element defines (m) a plurality of openings that are aligned with the openings in the support.
[0028] [0028] In some embodiments, the support comprises an external surface, and the cover and / or sealing element / cover element covers (m) the entire external surface of the support.
[0029] [0029] In some embodiments, the cover and / or the sealing element / cover element comprises (m) a first part, adjacent to the inflow end, and the support includes a layer of plush plush. The cover and / or the sealing element / cover element further comprises (m) a second part without a layer of fluff, adjacent to the discharge end of the support, and the second part of the cover and / or the sealing element / cover element defines the openings of the cover and / or the sealing element / cover element.
[0030] [0030] The objects, characteristics and preceding advantages and others of the technology described will become more evident from the detailed description presented below, which is developed with reference to the attached figures. BRIEF DESCRIPTION OF THE DRAWINGS
[0031] [0031] Figure 1 shows a schematic cross-sectional view of a human heart.
[0032] [0032] Figure 2 shows a schematic top view of a mitral valve annulus of a heart.
[0033] [0033] Figure 3 is a perspective view of an embodiment of a prosthetic heart valve.
[0034] [0034] Figure 4A is a cross-sectional side view of an annular anchor or a mooring device arranged in a mitral position of the heart, with an implanted valve prosthesis, according to one embodiment.
[0035] [0035] Figure 4B illustrates a lateral cross-sectional view of an example of a helical anchor or a mooring device arranged in the mitral position of the heart, with an implanted valve prosthesis.
[0036] [0036] Figure 4C is a perspective view of a concrete
[0037] [0037] Figure 5 is a perspective view of a prosthetic heart valve, including a representative embodiment of a cover.
[0038] [0038] Figure 6 is a side elevation view of the prosthetic heart valve in Figure 5.
[0039] [0039] Figure 7 is a plan view from the top of the prosthetic heart valve in Figure 5.
[0040] [0040] Figure 8 is a side elevation view in cross section of the prosthetic heart valve in Figure 5.
[0041] [0041] Figure 9 is a perspective view of a representative embodiment of a cushioning layer including a plush plush.
[0042] [0042] Figure 10 is a side view in cross section of the prosthetic heart valve of Figure 5, arranged in the mitral position of the heart.
[0043] [0043] Figure 11 is a side elevation view of a prosthetic heart valve, including an example of a cover.
[0044] [0044] Figure 12 is a perspective view of a backing layer, a stencil to produce the backing layer, and a cushioning layer, before the backing layer and the cushioning layer are attached to each other.
[0045] [0045] Figure 13 is a side elevation view in cross section of a prosthetic heart valve, including an example of a cover.
[0046] [0046] Figure 14 is a detailed view of a protective inflow part of the cover of Figure 13.
[0047] [0047] Figure 15 is a side elevation view of a prosthetic heart valve, including an example of a cover comprising
[0048] [0048] Figure 16 is a perspective view of a representative embodiment of a spacer cloth including interlaced plush threads.
[0049] [0049] Figure 17 is a side elevation view of the spacing fabric of Figure 16.
[0050] [0050] Figure 18 is a plan view from the top of a rendering of a support layer, after it has been cut using a parallelogram stencil.
[0051] [0051] Figure 19 is a side elevation view of a prosthetic heart valve, including an example of a cover.
[0052] [0052] Figure 20 is a side elevation view of the prosthetic heart valve in Figure 19.
[0053] [0053] Figure 21 is a plan view of a discharge end of the prosthetic heart valve of Figure 19.
[0054] [0054] Figure 22 is a side elevation view in cross section of the prosthetic heart valve in Figure 19.
[0055] [0055] Figure 23 is a top plan view of the roof of Figure 19 in an unfolded configuration.
[0056] [0056] Figure 24 is a perspective view illustrating the placement of the prosthetic heart valve of Figure 19 on the cover, after the cover is formed into a cylindrical shape.
[0057] [0057] Figure 25 is a perspective view of the influx end of the prosthetic heart valve of Figure 19, illustrating the fixation of the cover on the strut elements of the valve support.
[0058] [0058] Figure 26 is a perspective view of the inflatable end of the prosthetic heart valve of Figure 19, illustrating a cover strip element bent at the strut elements of the valve holder to form a protective inflow part. .
[0059] [0059] Figure 27 is a perspective view of a support for a prosthetic heart valve, including an example of a cover.
[0060] [0060] Figure 28 is a side elevation view in cross section of the support and cover of Figure 27.
[0061] [0061] Figures 29 - 31A are seen in perspective illustrating a representative method of producing the cover of Figure 27.
[0062] [0062] Figure 31B is a detailed view of the electroplated layer of the inflow end part of the cover of Figure 31A.
[0063] [0063] Figure 32 is a perspective view of a prosthetic heart valve, including a main cover and a second cover extending through the apexes of the support.
[0064] [0064] Figure 33 is a side elevation view of the prosthetic heart valve in Figure 32.
[0065] [0065] Figure 34 is a plan view of a part of the prosthetic valve support of Figure 32 in a flat layout.
[0066] [0066] Figure 35 is a perspective view of the prosthetic heart valve in Figure 32 without the main external cover.
[0067] [0067] Figure 36 is a perspective view of the prosthetic heart valve in Figure 32 illustrating how the second cover is wrapped around the apexes of the support.
[0068] [0068] Figure 37 is a perspective view illustrating the prosthetic valve support of Figure 32, including the second cover dented on an axis of a release device.
[0069] [0069] Figure 38A is a side elevation view of the prosthetic valve of Figure 19 including an example of an external cover.
[0070] [0070] Figure 38B is a detailed view of the fabric of the outer cover of Figure 38A.
[0071] [0071] Figure 39A is a plan view showing the prosthetic heart valve of Figure 38A dented on an axis of a device.
[0072] [0072] Figure 39B is a detailed view of the external cover of the prosthetic heart valve in Figure 39A.
[0073] [0073] Figure 40A is a side elevation view in cross section of the external cover fabric of Figure 38A in a relaxed state.
[0074] [0074] Figure 40B is a side elevation view in cross section of the fabric of the external cover of Figure 38A in a state under tension.
[0075] [0075] Figure 41A is a plan view of an example of an external fabric cover for a prosthetic valve in a flat layout configuration and including an external surface defined by a layer of plush.
[0076] [0076] Figure 41B is an enlarged view of the external cover of Figure 41A.
[0077] [0077] Figure 42A is a plan view of a base layer of the outer cover of Figure 41A.
[0078] [0078] Figure 42B is an enlarged view of the base layer of Figure 42A.
[0079] [0079] Figures 43 - 45 are seen in side elevation of a prosthetic heart valve, including various embodiments of an external cover including openings.
[0080] [0080] Figure 46 is a plan view of an example of a sealing element or a covering element for a prosthetic heart valve, including woven parts and floating parts configured as parts of floating wires.
[0081] [0081] Figure 47 is an enlarged view of a first woven part of the sealing element or cover element of Figure 46.
[0082] [0082] Figure 48 is an enlarged view of a second woven part of the sealing element or cover element of Figure 46.
[0083] [0083] Figure 49 is an enlarged view of a portion of floating wires of the sealing element or the covering element of Figure 46 in a relaxed state.
[0084] [0084] Figure 50 illustrates the part of floating wires of Figure 49 in a stretched state.
[0085] [0085] Figure 51 is a plan view of the sealing element or cover element of Figure 46 in a stretched state.
[0086] [0086] Figure 52 is a perspective view illustrating an edge part of the sealing element or cover element of Figure 46.
[0087] [0087] Figure 53 is a side elevation view of a prosthetic heart valve having an external cover including the sealing element or cover element of Figure 46, according to one embodiment.
[0088] [0088] Figure 54 illustrates the prosthetic heart valve of Figure 53 dented in a balloon at the distal end of a release device.
[0089] [0089] Figures 55A - 55J illustrate various examples of woven woven models and woven woven techniques.
[0090] [0090] Figure 56 is a perspective view of a mechanically expandable prosthetic heart valve, according to one embodiment.
[0091] [0091] Figure 57 is a side elevation view of an example of a mechanically expandable support for a prosthetic heart valve.
[0092] [0092] Figure 58 is a plan view of an example of a sealing element or a cover element for a prosthetic heart valve.
[0093] [0093] Figure 59 is an enlarged view of part of the sealing element or cover element of Figure 58.
[0094] [0094] Figure 60 is a side elevation view showing an example of a cover formed from the sealing element or cover element of Figure 58, attached to the support of Figure 57 in the radially expanded configuration.
[0095] [0095] Figure 61 is a perspective view of the inflow end part of the support and cover set of Figure 60.
[0096] [0096] Figure 62 is a side elevation view of the support and cover of Figure 60 in the radially deformed configuration. DETAILED DESCRIPTION
[0097] [0097] The present description is related to embodiments of implantable prosthetic heart valves and to methods of production and use of these devices. In one aspect, a prosthetic heart valve includes a cover or an outer cover having a backing layer and a main damping layer arranged on the backing layer, so that the damping layer is radially oriented outward around the circumference of the valve. The damping layer can be soft and conformable to reduce damage to native heart valve tissues and / or the surrounding anatomy at the implantation site, due, for example, to movement or relative friction between the prosthetic valve and tissue in the as the heart expands and contracts. The cover may also include a protective inflow part and a protective discharge part to cushion the surrounding anatomy and prevent the native tissue of the heart valve from contacting the apices of the support strut elements, thereby protecting the surrounding tissue. . In one embodiment, the cover may include an inflow strip element and a discharge strip element attached to the damping layer and folded over the apices of the strut elements to form the inflow and discharge protective parts.
[0098] [0098] The embodiments of the described technology can be used in combination with various prosthetic heart valves, configured for implantation in various locations within the heart. A non-limiting, representative example is a prosthetic heart valve to replace the function of the native mitral valve. Figures 1 and 2 illustrate the mitral valve of the human heart. The mitral valve controls the flow of blood between the left atrium and the left ventricle. After the left atrium receives oxygenated blood from the lungs through the pulmonary veins, the mitral valve allows the flow of oxygenated blood from the left atrium to the left ventricle. When the left ventricle contracts, oxygenated blood, which was retained in the left ventricle, is released by the aortic valve and the aorta to the rest of the body. However, the mitral valve closes during ventricular contraction to prevent some blood from seeping back into the left atrium.
[0099] [0099] When the left ventricle contracts, the blood pressure in the left ventricle increases substantially, which prevents the closed left ventricle. Due to the large pressure differential between the left ventricle and the left atrium during this period, there is a possibility of prolapse or eversion of the left ventricular leaflets back to the atrium. A series of tenin cords, therefore, connect the left ventricular leaflets to the papillary muscles located in the left ventricular walls, in which both the papillary muscles and the tendinous cords are tensioned during ventricular contraction to retain the leaflets in the closed position and prevent them from extending back into the left atrium. This generally prevents the reverse flow of oxygenated blood back to the left atrium. The tendinous cords are illustrated schematically in both the cross section of the heart in Figure 1 and the view from the top of the mitral valve in Figure 2.
[00100] [00100] A general form of the mitral valve and its leaflets, seen from the left atrium, is shown in Figure 2. Several complications of the mitral valve can potentially cause fatal heart failure. One form of valvular heart disease is leakage from the mitral valve or mitral regurgitation, characterized by abnormal leakage of blood from the left ventricle through the mitral valve back to the left atrium. This can be caused, for example, by dilation of the left ventricle, which can cause incomplete coaptation of the native mitral leaflets resulting in leakage through the valve. Mitral valve regurgitation can also be caused by damage to native leaflets. In these circumstances, it may be desirable to repair the mitral valve, or replace the functionality of the mitral valve with that of a prosthetic heart valve, such as a transcatheter heart valve.
[00101] [00101] Some transcatheter heart valves are designed to be dented or compressed to facilitate endo-vascular release at an implant site in a patient's heart. Once placed in a native valve annulus, the replacement valve is then expanded to an operational state, for example, by an expansion balloon, so that a prosthetic heart valve leaflet structure regulates blood flow by the angle of the valve. native valve. In other cases, the prosthetic valve can be mechanically expanded or radially self-expanded from a release state compressed to an operational state, under its own resilience of a release envelope. An embodiment of a prosthetic heart valve is illustrated in Figure 3. A transcatheter heart valve, with a valve profile similar to that of the prosthetic valve shown in Figure 3, is the Edwards Lifesciences SAPIEN XTTM valve. The prosthetic valve 1 in Figure 3 has an inflow end 2 and a discharge end 3, which includes a support or stent 10, and a leaflet structure 20 supported within the support 10. In some embodiments, a skirt 30 is attached to an internal surface of the
[00102] [00102] The support 10 can be made of any expandable material compatible with the human body, which allows both the denting to a radially deformed state, and the expansion back to the expanded functional state illustrated in Figure 3. For example, in the embodiments in which the prosthetic valve is a self-expanding prosthetic valve, which expands to its functional size under its own resilience, support 10 can be made of Nitinol or other self-expanding material. In some embodiments, the prosthetic valve may be a plastically expandable valve, which is expanded to its functional size by a balloon or other expansion device, in which case the support may be made of a plastically expandable material, such as stainless steel or a cobalt and chromium alloy. Other suitable materials or combinations of them can also be used.
[00103] [00103] The support 10 can comprise an annular structure having several vertically extending commissure columns 11, which are attached and help to form the structure of leaflets 20 therein. Vertical columns or additional anchor elements 12, together with the anchor elements extending circumferentially, help to form the rest of the support 10. The support elements 13 of the support 10 make a zigzag movement and form parts with crown or pointed apexes 14 at the inflow and discharge ends 2, 3 of the valve 1. Furthermore, the fixing columns 11 can also form edges at one or both ends of the support 10.
[00104] [00104] On the prosthetic valve 1, the skirt 30 can be attached to an internal surface of the valve support 10 by means of one or more lines 40, which generally wrap around the outside of several struts 11, 12, 13 of the support 10 if necessary. The skirt 30 provides a more substantial fixing surface for the parts of the booklet structure 20, positioned closer to the inflection end 2 of the valve 1.
[00105] [00105] Figures 4A and 4B show cross-sectional views of embodiments of different anchors, which can be used to facilitate the implantation of valve 1 in a native valve, such as in the position of the mitral valve or in the position of the tricuspid valve of a animal or patient. As shown, for example, in Figures 4A and 4B, a left side of a heart 80 includes a left atrium 82, a left ventricle 84, and a mitral valve 86 connecting left atrium 82 to left ventricle 84. Mitral valve 86 includes the anterior and posterior leaflets 88, which are connected to an internal wall of the left ventricle 84 through the tendinous cords 90 and the papillary muscles 92.
[00106] [00106] In Figure 4A, a first anchoring device includes a flexible ring or halo 60, which surrounds the native leaflets 88 of the native valve 86 and / or the tendinous cords 90. Ring 60 tightens or impinges parts of the leaflets inward, to form a more circular opening in the native valve, for a more effective implantation of the prosthetic valve 1. The valve prosthesis 1 is retained in the native valve 86 by the annular anchor 60 (which acts as a mooring device) , and can be released to the position shown, for example, by positioning valve 1 on native valve 86, while prosthetic valve 1 is released and expanded once it is positioned as shown in Figure 4A. Once expanded, prosthetic valve 1 pushes out against annular anchor 60 to secure the positions of both valve 1 and annular anchor 60. In some embodiments, an undersized annular anchor 60, with an internal diameter that is slightly smaller nor than the diameter of the prosthetic valve 1 in its expanded state,
[00107] [00107] Figure 4B is similar to Figure 4A, except that instead of an annular anchor 60, a helical or spiral anchor or mooring device 70 is used. Helical anchor 70 can include more coils or loops than annular anchor 60, and can extend both upstream and downstream of native valve 86. Helical anchor 70 can, in some situations, provide an area of bigger and firmer fixation against which the prosthetic valve 1 can lean. Similar to annular anchor 60 in Figure 4A, at least part of the leaflets 88 and / or the ropes 90 of the native valve are clamped between valve 1 and helical anchor 70. Methods and devices for deploying anchors / anchors and valves prosthetics, which can be used with the inventions in this description, are described in US patent application No. 15 / 682,287, filed on August 21, 2017 and published as US 2018/0055628, US patent application No. 15 / 684,836, filed on August 23, 2017 and published as US 2018/0055630 and US patent application No. 15 / 984,661, filed on May 21, 2018 and published as US 2018/0318079, which are all incorporated by reference in this specification.
[00108] [00108] Figure 4C illustrates another representative embodiment of an anchor or anchoring device 300, which can be used in combination with any of the prosthetic valves described in this specification. Anchor 300 has a functional coil / loop region or central region 302 and a loop or lower region
[00109] [00109] Anchor 300 can optionally also include an extension part 308, positioned between the central region 302 and the upper region 306. In some embodiments, the extension part 308 can be positioned alternatively, for example, entirely in the central region 302 (for example, in an upper part of the central region) or entirely in the upper region 306. The extension part 308 includes a part of the coil, which extends substantially parallel to a central axis of the anchor. In some embodiments, the extension part 308 can be angled relative to the central axis of the anchor. In some embodiments, extension parts 308 may be longer or shorter than those shown and may have a greater or lesser angle relative to region 302 and / or region 306. Extension part 308 may serve to space the region central 302 of the upper region 306 in a direction along the central axis, so that a gap is formed between the atrial side and the ventricular side of the anchor.
[00110] [00110] The extension part 308 of the anchor can be configured to be positioned by, close to and / or around the
[00111] [00111] As shown in Figure 4C, anchor 300 may further include one or more openings configured as through holes 310 at or near one or both of the proximal and distal ends of the anchor. The through holes 310 can serve, for example, as suture holes for attaching a covering layer to the anchor coil, and / or as a fixing location or mooring holes for release tools, such as a tension wire, a retaining element, a retaining suture, etc. In some embodiments, the width or thickness of the anchor coil 300 can be varied along the length of the anchor. For example, a central part of the anchor and / or extension 308 can be made thinner than the end parts of the anchor. This can allow the center part and / or extension 308 to have greater flexibility, while the end parts can be stronger or more robust. In certain examples, the production of relatively thicker coil end parts can also provide a larger surface area for suturing or, otherwise,
[00112] [00112] In certain embodiments, the anchor or mooring device 300 can be configured for insertion by the annulus of the native valve in a counterclockwise direction. For example, the anchor can be advanced through the A3P3 commissure, the A1P1 commissure or another part of the native mitral valve. The counterclockwise direction of the anchor coil 300 may also allow the distal end of the release catheter to be bent in a similar counterclockwise direction, which may be easier to reach than to bend the release catheter clockwise. However, it must be understood that the anchor can be configured for hourly or counterclockwise insertion by the valve, as desired.
[00113] [00113] Going back to the example of the prosthetic valve in Figure 3, the prosthetic valve 1 generally includes a metallic support 10, which forms several edges. In addition, many supports 10 are constructed with pointed crowns or apexes 14 and protruding commissure fixing columns 11, as well as lines 40, which can be exposed along an external surface of the support 10. These characteristics can cause damage to native tissue, such as, for example, tissue lodged between prosthetic valve 1 and anchor 60, 70, by movement or friction between native tissue and the various abrasive surfaces of prosthetic valve 1. In addition, another well-developed native tissue close to the prosthetic valve 1, such as the tendinous cords, can also be potentially damaged.
[00114] [00114] Figures 5 - 7 illustrate a representative embodiment of a prosthetic heart valve 100 similar to the Edwards Lifesciences SAPIEN XTTM 3 valve, which is described in detail in the U.S. patent.
[00115] [00115] The prosthetic heart valve can include a cover or an external cover 112, configured to cushion (protect) native tissue in contact with the prosthetic heart valve, after implantation, and reduce tissue damage due to movement or friction between the fabric and the surfaces of the valve. Cover 112 can also reduce paravalvular leakage. In the embodiment of Figure 5, cover 112 includes a first layer, configured as a backing layer 114 (see, for example, Figure 8), and a second layer, configured as a cushion layer 116. A damping layer 116 can be arranged on support layer 114 and may comprise a soft plush surface 118, radially oriented outwardly to protect fabric or objects in contact with the damping layer. In the illustrated configuration, cover 112 also includes an atraumatic influx protective part 120, which extends circumferentially around the inflow end 106 of the support, and an atraumatic discharge protective part 122, which extends circumferentially around the discharge end 108 of the support. The part of the damping layer 116, between the protective inflow and discharge parts 120, 122, can define a main damping part 136. The first layer 114 and the second layer 116 can together form an element.
[00116] [00116] Figure 8 is a cross-sectional view schematically illustrating the prosthetic valve 100 with the leaflet structure removed for purposes of illustration. The cover 112 extends around the outside of the support 102, so that an internal surface of the damping layer 114 is adjacent to or against the outer surfaces of the strut elements 104. As shown in Figure 8, the layer damping 116 may have a length that is greater than the length of the support, measured along a longitudinal axis 126 of the support. In this way, the cover 112 can be located so that the damping layer 116 extends distally (for example, in the upstream direction) beyond the apices 124 of the strut elements at the inflating end 106 of the support, with the part of the damping layer extending beyond the apexes being referred to in this specification as the distal end part 128. At the opposite end of the valve, the damping layer 116 can extend proximally (for example, in the downstream direction) beyond the apexes 124 of the strut elements, with the part located beyond the apexes being referred to as the proximal end part 130. The distances by which the distal and proximal end parts 128, 130 of the damping layer 116 extend beyond the apexes, in the respective end of the valve, can be the same or different depending on, for example, the dimensions of the valve, the particular application, etc.
[00117] [00117] The backing layer 114 may be of sufficient length in the axial direction, so that an end part, or flap, proximal 132 of the damping layer 114 can be folded into the proximal end part 130 of the damping layer 116 in the manner of a handle to form the protective discharge part
[00118] [00118] In the illustrated configuration, the inflow protective part 120 can extend beyond the apices 124 of the strut elements at the inflow end of the support by a distance d1 and the discharge protective part 122 can extend beyond the apices 124 of the strut elements at the discharge end of the support for a distance d2. The distances d1 and d2 can be the same or different depending on the type of prosthetic valve, the treatment site, etc. For example, for a 29 mm prosthetic valve, the distances d1 and d2 can be from about 0.5 mm to about 3 mm. In a representative embodiment, the distances d1 and d2 can be from about 1 mm to about 2 mm. Because the inflow and discharge protective parts 120, 122 extend beyond the apexes 124 of the respective ends of the support, the inflow and discharge protective parts can shield adjacent tissue and / or another implant adjacent to the prosthetic valve of contact with the apex 124 of the support.
[00119] [00119] For example, Figure 10 illustrates the prosthetic valve 100 implanted within an anchor or mooring device 70 in native valve 86, similar to Figures 4A and 4B mentioned above. In the illustrated example, the inflow end part of the prosthetic valve is shown positioned above the upper surface of the annulus of the native valve and spaced from the surrounding tissue. However, in other implementations, depending on the axial positioning of the prosthetic valve, which can be varied, the inflow protection part 120 can contact native leaflets 88 and prevent them from coming into direct contact with the apices 124 at the inflow end support. Depending on the diameter of the prosthetic valve at the inflection end, the inflow protection part 120 can serve to prevent the atrial wall from coming into direct contact with the apex 124 of the inflow end of the support.
[00120] [00120] As shown in Figure 10, the anchor 70 can be supported against the conformable inflatable protective part 120. However, parts of native leaflets 88, caught between anchor 70 and prosthetic valve 100, can be cushioned by the plush surface 118 of the main cushion part 136. In certain embodiments, the conformable nature and texture , soft cushion layer 116 can increase the friction between native leaflets and the prosthetic valve. This can reduce the relative movement of the leaves.
[00121] [00121] The backing layer 114 may comprise, for example, any of several woven fabrics, such as gauze, poly (ethylene terephthalate) fabric (PET) (for example, Dacron), polyester fabric, polyester fabric polyamide or any of several non-woven fabrics, such as felt. In certain embodiments, the backing layer 114 may also comprise a film, including any of various crystalline polymeric materials, such as poly-tetrafluroethylene (PTFE), PET, polypropylene, polyamide, poly (ether - ether - ketone) (PE-EK ), etc. In this way, the support layer 114 can be relatively thin and still strong enough to allow the cover 112 to be sutured in the support, and to allow the prosthetic valve to be dented without tearing.
[00122] [00122] As indicated above, the cushion layer 116 can comprise at least one soft plush surface 118. In certain examples, the cushion layer 116 can be made of any of several woven or knitted fabrics, where surface 116 is the surface of a plush down or fluff from the fabric. Exemplary fabrics having a terry cloth include velvety fabric, velvet, velvet, corduroy, terry fabric, wool, etc. Figure 9 illustrates a representative embodiment of softening layer 116 in more detail. In the embodiment of Figure 9, the damping layer 116 may have a base layer 162 (a first layer) from which the plump 158 (a second layer) extends. The base layer 162 may comprise strands (for example, yarns, etc.) of warp and weft woven or knitted in a mesh-like structure. For example, in a representative configuration, the strands / threads of the base layer 162 can be flat strands / threads with a denier strip of about 7 dtex to about 100 dtex, and can be knitted with a density from about 20 to about 100 straps per 2.54 centimeters (one inch) and from about 30 to about 110 strands per 2.54 centimeters (one inch). The strands / threads can be made of, for example, biocompatible thermoplastic polymers, such as PET, nylon, ePTFE, etc., other suitable natural or synthetic fibers, or soft monolithic materials.
[00123] [00123] The plush 158 may comprise plush cords or plush yarns 164 woven or knitted into loops. In certain configurations, the fluff strands or fluff yarns 164 can be warp strands / yarns or base layer weft strands / threads woven or knitted to form the loops. The plush strands or plush strands 164 can also be separate strands / strands incorporated into the base layer, depending on the particular characteristics desired. In certain embodiments, the loops can be cut so that the fluff 158 is a fluff cut in the manner of, for example, a velvety fabric. Figures 5 - 8 illustrate a representative embodiment of the cushion layer 116 configured as a velvety fabric. In some embodiments, the loops can be left intact to form a looped pile in the manner of, for example, a fluffy fabric. Figure 9 illustrates a representative embodiment of the cushion layer 116, in which the fleece strips or fleece strands 164 are knitted to form loops
[00124] [00124] In some configurations, the plush strands or plush strands 164 are textured strands / strands having a greater surface area, due, for example, to a wavy or wavy structure. In configurations such as the tangled plume embodiment of Figure 11, the loop structure and the larger surface area provided by the textured strands or strands of loops 166 can allow the loops to act as a platform for tissue growth in and around - in the loops of the fluff. Promoting tissue growth in plush 158 can increase valve retention at the implant site and contribute to long-term valve stability.
[00125] [00125] The embodiments of the damping layer described in this specification can also contribute to the improved compressibility and memory properties of the cover 112 over the known valve covers and valves. For example, the plush 158 can be conformable so that it compresses under load (for example, when in contact with tissue, implants or the like) and returns to its original size and shape when the load is released. This can help to improve the sealing between the damping layer 116 and, for example, support structures or other devices, such as the helical anchor 70, on which the prosthetic valve is arranged, or between the damping layer and the walls of the native annulus. The compressibility provided by the plump 158 of the cushion layer 116 is also
[00126] [00126] In some embodiments, the cushion layer 116 is made of non-woven cloth, such as felt, or fibers, such as non-woven cotton fibers. The damping layer 116 may also be made of porous or spongy materials, such as, for example, any of several comfortable polymeric foam materials, or woven or knitted cloths, such as woven or knitted PET. In some embodiments, the proximal and distal end portions of the cushion layer 116 of the embodiment of Figure 11 are free of loops 166, and the inflow and discharge protective parts 120, 122 are formed by folding the base layer 162 of it returns to itself to form fists at the inflow and discharge ends of the valve.
[00127] [00127] In a representative example illustrated in Figure 12, the cover 12 of Figures 5 - 8 is made, at least partially, by cutting a fabric material (for example, a PET fabric) with a stencil 138 to form the cushion layer 114. In the illustrated embodiment, stencil 138 is formed as a parallelogram, although other configurations and shapes are possible. The corner angles of stencil 138 can be formed so that the fabric material is cut at an angle of about 45 degrees relative to the direction of the fibers in the fabric. This can improve the dentability of the resulting backing layer 114 by, for example, allowing the backing layer to stretch along a diagonal direction to the warp and weft strands. Figure 18 illustrates a plan view of a representative example of support layer 114, after being cut using the parallelogram stencil 138.
[00128] [00128] The cushion layer 116 can be attached (for example, by sutures, adhesive, etc.) to the support layer 114. In Figure 12, the location of the proximal and distal ends of the support 102, when the cover is stuck in the support, is shown as dashed lines 140, 141 in the support layer 114. However, the dashed lines 142, 144 represent the location of the proximal and distal edges of the damping layer 116, once the damping layer is attached in the support layer. For example, the cushion layer 116 can be sutured in the support layer 114 along the proximal and distal edges at or near lines 142, 144. As shown in Figure 12, line 142, which represents the proximal edge of damping layer 116, can be displaced from the proximal edge 146 of the backing layer 114 by a distance d3 to create the proximal flap 132. However, line 144 representing the distal edge of the damping layer 116 can be displaced from the distal edge 148 of the support layer 114 by a distance d4 to create the distal flap 134. The distances d3 and d4 can be the same or different, as desired. For example, depending on the size of the valve and the size of the inflow and discharge damping parts, the distances d3 and d4 can be, for example, about 3 - 5 mm. In some embodiments, the distances d3 and d4 can be about 3.5 mm.
[00129] [00129] Once the cushion layer 116 is attached to the backing layer 114, the resulting template can be folded and supported in a cylindrical shape. The flaps 132, 134 of the support layer 114 can be folded at the edges of the damping layer 116 and sutured to form the inflow and discharge protective parts 120, 122. The resulting cover 112 can then be attached to the support
[00130] [00130] Figures 13 and 14 illustrate an example of cover 112, in which the protective inflow and discharge parts 120, 122 are formed with separate pieces of material, which wrap around the ends of the buffer layer 116 in the inflow and discharge ends of the valve. For example, the proximal end part 130 of the cushion layer 116 can be covered by an element configured as a strip 150 of material, which wraps around the cushion layer of the inner surface 170 (for example, the adjacent surface to the support) of the softening layer 116, over the circumferential edge of the proximal end part 130, and over the outer surface 118 of the softening layer to form the protective discharge part 122. Likewise, a strip element of material 152 may extend from the inner surface 170 of the damping layer, through the circumferential edge of the distal end part 128, and to the outer edge of the damping layer to form the inflow protective part
[00131] [00131] In certain configurations, strip elements 150, 152 can be made of any of the various materials and / or fabrics, such as pericardial tissue (e.g., bovine pericardial tissue). Strip elements 150, 152 can also be made of any of several synthetic materials, such as PET and / or expanded polytetrafluoroethylene (ePTFE). In some configurations, the production of strip elements 150, 152 of natural fabrics, such as pericardial fabric, can provide desirable properties, such as mechanical strength, durability, resistance to fatigue and forming, and reduced damping and friction with materials or tissues surrounding the implant.
[00132] [00132] Figure 15 illustrates a prosthetic valve 200, which includes an example of a cover or an outer cover 202, which comprises a damping layer 204 made of a spacer fabric. In the illustrated embodiment, the outer cover 202 is shown without the inflow and discharge protective parts, and with the damping layer 204 extending along the entire length of the support from the inflow end to the discharge end of the valve. However, the outer cover 202 may also include the inflow and / or discharge protective parts, as described elsewhere in this specification. The damping layer 204 can be or can form a seal element or a cover element, which can be attached to the support to form the cover.
[00133] [00133] With reference to Figures 16 and 17, the cushioning layer of spacer fabric or sealing element / covering element may comprise a first layer 206, a second layer 208, and a spacer layer 210 extending between the first and second layers to create a three-dimensional fabric. The first and second layers can be layers of woven or knitted cloth. In certain configurations, one or more of the first and second layers 206, 208 can be woven so as to define a plurality of openings 212. In some instances, the openings, such as openings 212, can promote tissue growth in the cover 202 In some embodiments, layers 206, 208 need not define openings, but can be porous, if desired.
[00134] [00134] The spacer layer 210 may comprise a plurality of plush strands or plush strands 214. Plush strands or plush strands 214 may be, for example, single strand strands / strands arranged to form a structure in the form of a platform between the first and second layers 206, 208. For example, Figures 16 and 17 illustrate an embodiment in which the fluff strands or fluff yarns 214 extend between the first and second layers 206, 208 in a model sinusoidal or spiral.
[00135] [00135] In certain examples, plush strands or plush yarns 214 may have a stiffness, which is greater than the stiffness of the first and second layer fabrics 206, 208, so that the strands of pile or pile 214 can extend between the first and second layers 206, 208 without deformation of them under the weight of the second layer 208. The pile strands or pile 214 can also be sufficiently resilient so that the strands of fluff or fluff threads may bend or sag when subjected to a load, allowing the fabric to compress, and return to their undeflected state when the load is removed.
[00136] [00136] The spacer fabric can be knitted in warp or knitted in weft, as desired. Some settings of the spacer cloth can be made on a double bar knitting machine. In a representative example, the strands / threads of the first and second layers 206, 208 may have a denier strip of about 10 dtex to about 70 dtex, and the strands / threads of the 214 mono-plush fleece strands / threads they can have a denier strip of about 0.0051 inch (2 mils) to about 0.0254 centimeter (10 mils). The plush strands or plush yarns 214 can have a knitting density of about 10 to about 100 straps per 2.54 centimeters (one inch) and from about 30 to about 110 strands per 2.54 centimeters (one inch). Additionally, in some configurations (for example, warp-knitted spacer fabrics), materials with different flexibility properties can be incorporated into the spacer cloth to optimize the total flexibility of the spacer cloth.
[00137] [00137] Figures 19 - 21 illustrate an example of a prosthetic heart valve 400, which includes an external cover with protective inflow and discharge parts, which encapsulate the apices of the prop elements. For example, the prosthetic heart valve may include a support 402, formed by a plurality of strut elements 404 defining the apices 420 (Figures 22 and 24), and may have an inflow end 406 and a discharge end 408. A plurality of leaflets 410 can be located at least partially within the support 402.
[00138] [00138] The prosthetic valve may include a cover or an outer cover 412 located around the support 402. The outer cover 412 may include a main layer or a main softening layer 414 including an external plush surface 432 (for example, a first surface), similar to the softening layer 116 of Figure 13 mentioned above. The cover 412 may also include a protective inflow part 416, which extends circumferentially around the inflow end 406 of the valve, and a protective discharge part 418, which extends circumferentially around the end of discharge 408 from the valve. Protective inflow and discharge parts 416, 418 can be formed with separate pieces of material, which are folded around the circumferential ends of damping layer 414 at the inflow and discharge ends of the valve, so that the protective parts encapsulate the apexes 420 of the anchor elements. The layer 414, alone or together with the protective parts 416, 418, can form a sealing element or a covering element, which can be placed around the support to form the covering
[00139] [00139] For example, with reference to Figure 22, the inflow protective part 416 may comprise an element configured as a strip 424 of material, including a first circumferential edge part 426 and a second circumferential edge part 428. The strip element 424 of material can be folded so that the circumferential edge portion 426 is adjacent to (for example, in contact with) an inner skirt 430 disposed within the support 402. The first edge portion circumferential layer 426 thus forms a first or an inner layer of the inflow protective part 416. The strip element 424 can extend through the apices 420 of the strut elements and an inflow end part 422 of the ca - damping layer 414, so that the second circumferential edge part 428 is arranged on the outer surface 432 of the damping layer 414. In this way, the inflow end part 422 of the damping layer 414 can form u A second layer of the inflow protective part 414, and the second circumferential edge part 428 can form a third or an outer layer of the inflow protective part. The first and second circumferential edge parts 426, 428 of the strip element 424 can be attached to the strut elements 404 (for example, the strut step closest to the inflow end 406) with securing means, such as sutures 434 and 435, adhesive, etc. In this way, the strip element 424 can encapsulate the apices 420, together with the inflow end part 422 of the damping layer 414, between the first and the second circumferential edge parts 426, 428.
[00140] [00140] In the illustrated configuration, the protective inflow part 416 extends beyond the apices 420 of the support, similarly to the embodiments presented above. In particular, the inflow protective part 422 of the damping layer 414 may extend beyond the apexes 420 of the support and to the inflow protective part 416 den-
[00141] [00141] Optionally, one or more additional materials or layers can be included under and / or form any of the protective parts (for example, 120, 122, 416, 418, 518, 520, etc.) to provide provide additional cushioning and / or protection at the apex of the support.
[00142] [00142] In the illustrated embodiment, the inflection end part 422 may extend beyond the apexes 420 by a distance d1. The distance d1 can be configured so that the parts 5 and 422 can extend through the hairs or cover the apices 420, when the inflow protective part 416 comes into contact with, for example, native tissue at the treatment site. The strip member 424 can also form a dome over the edge of the inflow end portion 422, so that the edge of the inflow end portion 422 is spaced from the cupped portion of the strip element 424. In some embodiments tizations, the strip element 424 is folded so that it contacts the edge of the inflow edge portion 422, similarly to the embodiment of Figure 13.
[00143] [00143] The discharge protective part 418 may include an element configured as a strip 436 of folded material so that a first circumferential edge part 438 is adjacent to (for example, in contact with) inner surfaces 440 of the strut elements , and a second circumferential edge part 442 is arranged on the outer surface 432 of the cushion layer 414, similarly to the inflow protective part 416. A discharge end part 444 of the cushion layer 414 can be - tending beyond the apexes 420 by a distance d2 and can be encapsulated by the strip element 436 together with the apexes 420, between the first and second parts of circumferential edges 438, 442. The distance d2 can be equal to or different from distance d1, as desired. The strip element 436 can be attached to the strut elements 404 with fixation means, such as sutures 446 and 447, adhesive, etc. Strip element 436 can also generate a dotted shape similar to strip element 424.
[00144] [00144] In certain configurations, the cushion layer 414 can be a fabric, including a plush plush, such as a velvety fabric, or any other type of woven or non-woven material, knitted from plush, as described above. In some embodiments, the damping layer 414 may also comprise a relatively low thickness woven cloth without a plush plush. In certain configurations, the strip elements 424, 436 can be made of natural, resilient fabric materials, such as pericardium. Optionally, the strip elements can also be made of fabric or polymeric materials, such as PTFE or ePTFE.
[00145] [00145] Figures 23 - 26 illustrate a representative method of producing the outer cover or cover 412 and fixing the cover on the prosthetic valve 400 to form the inflow and discharge protective parts 416, 418. Figure 23 illustrates the cover outer 412 in an unfolded configuration before fixing the cover to the support 402. As shown in Figure 23, the second circumferential edge part 428 of the strip element 424 can be sutured to the plush surface 432 (for example, the first surface ) of the damping layer 414 at the inflow end part 422 of the damping layer. The second circumferential edge portion 422 of the strip element 436 can be sutured on the plush surface 432 of the cushion layer 414 at the discharge end part 444 of the cushion layer.
[00146] [00146] In the illustrated configuration, the damping layer 414 and the strip elements 424, 436 can have a dimension of length L corresponding to a circumference of the support 402. In a representative example, the dimension of length L can be about 93 mm. The strip elements 424, 436 can also have the respective width dimensions W1, W2. With reference to the width dimension W1 for purposes of illustration, the width dimension W1 can be configured so that the strip element 424 extends from the inside of the valve to the outside of the valve without contacting the apices 420 of the strut elements, such as shown in Figure 22. For example, the width dimension W1 can be configured so that the strip element 424 extends adjacent the step of strut elements 404 at the inflow end 406 of the support to the outside of the valve , adjacent to the same step of strut elements, and generates a domed shape over the apices 420. In certain configurations, width dimension W1 can be about 6 mm. The width dimension W2 can be the same or different from W1, as desired.
[00147] [00147] With reference to Figure 24, the external cover 412 can be folded and sutured in a cylindrical shape. The outer cover 412 can then be located around the support 402, so that a second or inner surface 454 of the damping layer 414 is oriented in the direction of the support. In certain configurations, support 402 may already include inner skirt 430 and leaflet structure 410, as shown in Figure 24.
[00148] [00148] With reference to Figures 25 and 26, the external cover 412 can then be sutured in the support. For example, as illustrated in
[00149] [00149] The protective discharge part 418 can be formed in a similar manner. For example, the strip element 426 can be aligned with the step of strut elements 402 adjacent to the discharge end 408 of the support, and the strip element 426 and / or the damping layer 414 can or can be sutured in the anchor elements. The strip element 436 can then be folded at the tips 420 and the damping layer 414 at the discharge end of the support, and the first and second circumferential edge parts 438, 442 can be sutured together and at the strut elements 404 adjacent to the discharge end of the support, to form the protective discharge part 418. The cover 412 can also be sutured on the support at one or more additional locations, such as suture lines 448 and 450, as shown in Figure 22.
[00150] [00150] Figures 27 and 28 illustrate an example of a prosthetic heart valve 500, including a support 502 formed by a plurality of strut elements 504 defining the apices 506 (Figure 28), similarly to the support 102 described above and in the US patent
[00151] [00151] The prosthetic valve can include an external cover 514, located around the support 502. The external cover or cover 514 can include a main damping layer 516 (also referred to as a main layer) having a cylindrical shape and made of a braided or knitted cloth, fabric (for example, a PET fabric, an ultra-high molecular weight polyethylene fabric (UHMWPE), a PTFE fabric, etc.). In some embodiments, the fabric of the main damping layer 516 may include a plush plush. In some embodiments, the fabric of the main cover 516 may comprise textured strands (for example, textured strands, etc.), in which the fibers constituting the strands / strands have been swelled by being, for example, twisted, heat-cured and distorted, so that the fibers keep their sizes twisted, deformed and create a bulky fabric. The volume contributed by the textured cords / threads can improve the cushioning properties of the cover, as well as increase the friction between the tissue and the surrounding anatomy and / or an anchoring device in which the valve is arranged. The layer 516, alone or together with the protective parts 518, 520 and / or the layers 530, 534 can form a sealing element or a covering element, which can be placed around the support to form the covering 514.
[00152] [00152] The outer cover 514 may include a protective inflow part 518, which extends circumferentially around the inflow end 508 of the support, and a protective discharge part 520, which extends circumferentially around the discharge end. 510 of the support. In certain embodiments, the inflow and discharge protective parts 518 and 520 can be formed on the fabric of the main damping layer 516, so that the outer cover 514 is a single piece unit construction, as further described below.
[00153] [00153] Referring to Figure 28, the main damping layer 516 may include a first circumferential edge part 522 (also referred to as an inflow edge part), located adjacent to the inflow end 508 of the valve, which can form a inflow protective portion 518. Damping layer 516 may further include a second circumferential edge portion 524 (also referred to as a discharge edge portion), located adjacent the discharge end 510 of the valve, and which may form a portion of the protective discharge part 520. Referring further to Figure 28, the first circumferential edge part 522 may comprise an edge 526, and the second circumferential edge part 524 may comprise an edge 528. The first circumferential edge part 522 can be folded or rolled at the apexes 506 of the strut elements 504, so that edge 526 is disposed within support 502. The second edge part circumferential 524 can be folded around the tips 506 at the discharge end 510 of the support in a similar manner, such that the edge 528 is also arranged within the support opposite the edge 522.
[00154] [00154] In the illustrated configuration, the inflow protective part 518 may include a second or outer layer, configured as a slippery layer 530 of material disposed on an outer surface 532 of the main damping layer 516. The protective part of discharge 520 may also include a second or outer sliding layer 534 of material, disposed on the outer surface 532 of main damping layer 516. In some embodiments, layers 530 and 534 may be thin coatings, smooth, comprising a low friction or slippery material. For example, in certain configurations, one or both of the layers 530, 534 may comprise PTFE or ePTFE.
[00155] [00155] In the illustrated configuration, the slippery layer 530 may have a first circumferential edge 536 (Figure 27) and a second circumferential edge 538 (Figure 28). The slippery layer 530 may extend from the outer surface 532 of the main softening layer 516 and through the apexes 506, so that the first circumferential edge 536 is arranged on the outside of the support and the second circumferential edge 538 is arranged on the inside support. The slippery layer 534 can be configured similarly, so that a first circumferential edge 540 (Figure 27) is disposed outside the support, layer 534 extends through the tips 506 of the discharge end 510 of the support, and a second edge circumferential 542 (Figure 28) is disposed within the support. Once implanted in a native heart valve, protective parts 518 and 520 can prevent direct contact between the apexes 506 and the surrounding anatomy. The slippery material of layers 530 and 534 can also reduce friction with the native valve tissue (for example, the strings) in contact with the inflow and discharge ends of the prosthetic valve, thereby preventing tissue damage. In some embodiments, the entire outer surface 532 of the main damping layer 516, or part of it, is covered with a slippery coating, such as ePTFE, in addition to the inflow and discharge protective parts 518 and 520, so that the slip cover extends axially from the inflow end to the discharge end of the cover. In some embodiments, the cushioning layer 516 is formed of fibers, woven, knitted, braided or electrospun from slippery material, such as PTFE,
[00156] [00156] Figures 29 - 31B illustrate a representative method of producing cover 514. Figure 29 illustrates the main damping layer 516 formed in a tubular, cylindrical body. Referring to Figure 30, the first circumferential edge part 522 of the damping layer 516 can then be folded (for example, inwardly towards the inner surface of the tubular body), in the direction of arrows 544 so that the edge bottom 526 is inside the tubular body and is arranged against the inner surface of the tubular body. The edge part 524 can be folded in a similar manner, as indicated by arrows 546, so that the top edge 528 is within the tubular body and is arranged against the inner surface.
[00157] [00157] Referring to Figures 31A and 31B, the slippery layers 530, 534 can then be applied to the main layer 516 to form the inflow and discharge protection parts 518 and 520. In certain embodiments, the slippery layers 530, 534 can be formed by electrospinning a material with a low friction coefficient (eg, PTFE, ePTFE, etc.) over the first and second parts of circumferential edges 522 and 524. In certain embodiments, the formation of layers 530 and 534 by electrophy- tion can provide a uniform, smooth surface, in addition to maintaining the thickness of the layers within strictly prescribed specifications.
[00158] [00158] For example, layers 530 and 534 can be made relatively thin, which can reduce the total denting profile of the valve. In certain embodiments, the thickness of layers 530 and 534 can be about 10  to about 500 m, about 100  to about 500 m, about 200  to about 300 ,m, about 200 Oum or about 30 m. In some embodiments, the layer
[00159] [00159] In addition to the cover for the support 502 and the apexes 506, the external cover 514 can provide several other significant advantages. For example, cover 514 can be relatively thin, allowing the prosthetic valve to achieve a low denting profile (for example, 23 Fr - vials - or below). The unitary one-piece construction of the outer cover 514 and the protective parts 518 and 520 can also significantly reduce the time required to produce the cover and fix it to the support and can increase production throughput.
[00160] [00160] In some embodiments, one or both of the inflow and discharge protective parts may be configured as separate covers or covers, which are spaced from the main layer or the main damping layer, and may or may not be coupled to the main layer or main damping layer. For example, Figures 32 - 36 illustrate an example of a prosthetic heart valve 600, including a support 602, formed by a plurality of strut elements 604 defining the apices 606, similar to the support 102 described above and in US patent 9,393 .110. The prosthetic valve 600 may have an inflow end 608 and a discharge end 610, and may include a plurality of leaflets 612, located at least partially within the holder.
[00161] [00161] Figure 34 illustrates a part of support 602 in a flat layout configuration for purposes of illustration. The anchor elements 604 can be arranged end to end to form a plurality of lines or steps of the anchor elements, which extend circumferentially around the support 602. For example, with reference to Figure 34, the support 602 may comprise: a first or lower line I of angled strut elements forming the inflow end 608 of the support; a second row II of strut elements above the first row; a third row III of strut elements above the second row; a fourth line IV of strut elements above the third line; and a fifth line V of strut elements above the fourth line and forming the discharge end 604 of the support. At the discharge end 610 of the support, the anchor elements 604 of the fifth row V can be arranged at alternating angles in a zigzag pattern. The strut elements 604 of the fifth row V can be joined together at their distal ends (in relation to the implantation direction, for example, at the mitral valve) to form the apices 606, and joined together at their proximal ends at junctions 630, which form part of the 638 commissure windows. Additional structure and characteristics of the I - V lines of elements
[00162] [00162] Returning to Figures 32 and 33, the prosthetic valve can include a first cover or a first layer 614 (also referred to as a main cover layer or main layer) located around the support 602. The valve can also include a part discharge protector, configured as a second cover or cover 616, arranged around the anchor elements 604 and the apexes of the fifth row V of anchor elements at the discharge end 610 of the support. The first covering or layer 614 may comprise a woven or knitted cloth made, for example, from PET, UH-MWPE, PTFE, etc. Referring to Figure 33, the first cover or layer 614 may include an inflow end part 618, located at the inflow end 608 of the valve, and a discharge end part 620 located at the discharge end 610 of the valve. In the illustrated embodiment, the discharge end part 620 of the first cover or layer 614 can be moved towards the inflow end of the support (for example, in the upstream direction) of the fifth line V of strut elements 604. Said differently, the strut elements 604 of the fifth row V may extend beyond a more upper circumferential edge 622 of the first cover or layer 614 (for example, distally beyond edge 622, when the prosthetic valve is implanted in the native valve go). A lower circumferential edge 624 of the cover or main layer 614 can be arranged adjacent the first row I of anchor elements 604 at the inflow end 608 of the valve. In some embodiments, the first cover or layer 614 may extend over and cover the tips 606 at the inflow end 608 of the support.
[00163] [00163] Figure 35 illustrates support 602 including the second co-
[00164] [00164] In some embodiments, strip 626 may be relatively thick to improve the damping characteristics of the second cover or layer 616. For example, in some embodiments, strip 626 may be a PTFE strip, having a thickness from about 0.1 mm to about 0.5 mm, and a width, from about 3 mm to about 10 mm. In a representative embodiment, strip 626 can have a thickness of about 0.25 mm and a width of about 0.25 mm and a width of about 6 mm. The second cover or cover 616 can also include one or multiple layers. For example, the second cover or cover 616 may include a single layer (e.g., a single strip 626) wound around a line of struts on the support. The second cover or cover may also include two layers, three layers or more strips wrapped around a line of struts on the support. In some embodiments, the second cover or cover 616 may comprise multiple layers made of different materials. In certain configurations, the second cover or layer 616 may also be porous, and may have a pore size and pore density configured to promote tissue entrainment in the material of the second cover / layer.
[00165] [00165] In some embodiments, the first cover or layer 614 and / or the second cover or cover 616 can be attached to the support by means of fixation, for example, suture, adhesive, etc. In some embodiments, the first and second covers 614, 616 can also be secured together with fixing means. For example, with reference to Figures 32 and 33, the first cover or layer 614 may include one or more sutures 628 extending circumferentially around the discharge end portion 620 of the first cover at, for example, a winding point. . At or near the junctions 630 (Figure 34) of the fifth V line of strut elements 604, the suture 628 may extend from the stitch line (for example, from the surface radially out of the cover 614) and wrap around the second cover / cover 616. Suture 628 can then re-enter cover 614 (for example, the surface radially into the cover / layer 614) and restore the wrapping point. In the illustrated embodiment, suture 628 can wrap around the second cover / layer 616 at the junctions 630. The loops of suture 628 thus support each other in "valleys" between the apices 606 and can serve to retain the second cover / cap 616 in place on strut elements 602. Suture 628 can also hold the first cap 614 in place while the valve is being dented.
[00166] [00166] Still with reference to Figures 32 and 33, the circumferential
[00167] [00167] Figure 37 illustrates the support 602, including the second cover / cover 616, in a radially deformed or dented release configuration on a 636 axis of a release device. As shown in Figure 37, the second cover / cover 616 can conform to a serpentine shape, well compacted from the anchor elements 604, as they move towards the radially deformed configuration. In certain configurations, the second cover / cover 616 can closely follow the shape and direction of the anchor elements 604, without bulging, folding, pleating or agglutination, to maintain a profile of low dent. In some embodiments, the bending end of the support includes a separate cover similar to the cover / cover
[00168] [00168] Figures 38A, 38B, 39A and 39B illustrate the prosthetic valve 400 of Figures 19 - 26, including an exemplary outer cover or cover 700. The outer cover 700 may include a main layer or a main damping layer 720 ten - providing an external plush surface 704. The cover 700 may also include a protective inflow portion 706, which extends circumferentially around the inflow end 406 of the valve, and a protective discharge portion 708, which extends extends circumferentially around the discharge end 408 of the valve. As in the embodiment of Figures 19 - 26, the inflow and discharge protective parts 706, 708 can be formed with separate pieces of material, which are folded around the circumferential ends of the main layer 702, so that the damping parts encapsulate the apices 420 of the strut elements at the inflow and discharge ends of the valve. For example, the inflow and discharge protective parts 706, 708 can be constructed of strips of material (for example, polymeric materials, such as PTFE, ePTFE, etc. or natural fabrics, such as pericardium, etc.) folded so that one circumferential edge of the strips is arranged against the inside of the support 402 (or an inner skirt inside the support), and the other circumferential edge is arranged against the outer surface of the main layer 702. The outer cover 700 can be attached to the support 402 by using fixation means, for example, sutures, ultrasonic welding or any other suitable fixation method or method. The layer 702, alone or together with the protective parts 706, 708, can form a sealing element or a cover element, which can be placed around the support to form the cover 700.
[00169] [00169] The main layer 702 of the outer cover 700 may comprise a woven or knitted cloth. The main layer cloth
[00170] [00170] The cloth can comprise a plurality of warp strands / threads extending circumferentially 712 and a plurality of axially extending weft strands / threads 714. In some embodiments, the warp strands / threads 712 may have a denier of about from 1 D to about 300 D, about 10 D to about 200 D, or about 10 D to about 100 D. In some embodiments, the 712 warp strands / yarns can be t1 thick (Figure 40A) from about 0.01 mm to about 0.5 mm, about 0.02 mm to about 0.3 mm, or about 0.03 mm to about 0.1 mm. In some embodiments, the 712 warp strands / threads may have a t1 thickness of about 0.03 mm, about 0.04 mm, about 0.05 mm, about 0.06 mm, about 0.007 mm, about 0.08 mm, about 0.09 mm or about 0.1 mm. In a representative embodiment, the warp strands / yarns 712 can have a thickness of about 0.06 mm.
[00171] [00171] The strands / weft threads 714 can be textured strands / threads comprising a plurality of textured strands 716. For example, the strands 716 of the strands / weft threads 714 can be swollen, for example, strands 716 are twisted, thermally cured and distorted, so that the strands retain their twisted shapes, deformed in the relaxed, stretched configuration. The strands 716 can also be textured by denting, wrapping, etc. When the weft strands 714 are in a relaxed, relaxed state, the strands 716 can be loosely compacted and can provide a compressible volume or mass, as well as a plush surface. In some embodiments, the weft strands 714 may have a denier of about 1 D to about 500 D, about 10 D to about 400 D, about 20 D to about 350, about 20 D to about 300 D, or about 40 D to about 200 D. In certain embodiments, the weft strands / yarns 714 may have a denier of about 150 D. In some embodiments, a string / weft yarn 714 can be 2 strands per strand / yarn at 200 filaments per strand / yarn at 200 filaments per strand / yarn, 10 filaments per strand / yarn at 100 filaments per strand / yarn, 20 filaments per strand / yarn at 80 filaments per cord / yarn or about 30 filaments per cord / yarn at 60 filaments per cord. Additionally, although the axially extending textured strands / threads 714 are referred to as weft strands / threads in the illustrated configuration, the cloth can also be manufactured so that the textured strands / threads extending axially are the strands / warp threads and the strands / threads extending circumferentially are the weft strands / threads.
[00172] [00172] Figures 40A and 40B illustrate a cross-sectional view of main layer 702, in which the weft strands / threads 712 extend to the plane of the page. With reference to Figure 40A, the main layer cloth 702 can have a thickness t2 of about 0.1 mm to about 10 mm, about 1 mm to about 8 mm, about 1 mm to about 5 mm, about 1 mm to about 3 mm, about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm or about 3 mm, when in a relaxed state and attached to a support. In some embodiments, the main layer 702 may be about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm or about 0.5 mm thick. mm, measured in a relaxed state with a heavy drop gauge having a presser foot. In a representative example, the main layer 702 can be about 1.5 mm thick when attached to a prosthetic valve holder in the relaxed state. This can allow the main layer 702 cloth to soften the leaflets between the valve body and an anchor or ring, in which the valve is implanted, as well as occupying voids or space in the anatomy. Loosely compacted, textured filaments 716 of weft strands / threads 714, in a relaxed state, can also promote tissue growth in main layer 702.
[00173] [00173] When the cloth is in a relaxed state, the textured filaments 716 of the weft strands / yarns 714 are widely dispersed so that the individual weft strands / wires are not easily discerned, as in Figures 38A and 38B. When tensioned, the filaments 716 of the weft strands / yarns 714 can be stretched together as the weft strands / wires elongate and defects, twists, etc. the filaments are pulled in line so that the cloth is stretched and the thickness decreases. In certain embodiments, when sufficient tension is applied to the cloth in the axial direction (for example, weft), such as when the prosthetic valve is dented on a release axis, the textured fibers 716 can be pulled together so that the strands / individual weft yarns 714 are discernible, as best shown in Figures 39B and 40B.
[00174] [00174] Thus, for example, when fully stretched, the main layer 702 can have a second thickness t3, as shown
[00175] [00175] Additionally, as shown in Figure 40A, the warp strands / threads 712 can be spaced from each other in the field by a distance y1, when the outer cover is in a relaxed state. As shown in Figures 39B and 40B, when tension is applied to the cloth in a direction perpendicular to the warp strands / threads and parallel to the weft strands / threads 714, the distance between the 712 warp strands / threads may increase in as the weft strands / threads extend. In the example illustrated in Figure 40B, in which the cloth has been stretched so that the weft strands / threads 714 are extended and narrowed to approximately the diameter of the warp strands / threads 712, the distance between the strands / warp threads 712 can increase to a new distance y2, which is greater than distance y1.
[00176] [00176] In certain embodiments, the distance y1 can be, for example, about 1 mm to about 10 mm, about 2 mm to about 8 mm or about 3 mm to about 5 mm. In a representative example, the distance y1 can be about 3 mm. In some con-
[00177] [00177] Figures 41A, 41B, 42A and 42B show an example of a sealing element or cover element 800 for a prosthetic heart valve (for example, such as prosthetic heart valve 400). The sealing element 800 may be a double layered cloth, comprising a base layer 802 and a layer of fluff
[00178] [00178] In some embodiments, the titration of strands / strands of strands / strands extending in the circumferential direction (side by side or horizontally in Figures 42A and 42B) is greater in rows of higher density 806 than in rows of lower density 808 In some embodiments, the cord / cord titration of the cord / cord extending in the circumferential direction and the cord / cord titration of the cord / cord extending in the axial direction (vertically in Figures 42A and 42B) are greater in the higher density rows 806 than in the lower density rows 808.
[00179] [00179] The pile layer 804 can be formed of woven strands / threads in the base layer 802. For example, the pile layer 804 can comprise a velvety weave formed of strands / threads incorporated in the base layer 802. With reference to Fig. 41B, the pile layer 804 may comprise rows or stripes extending circumferentially 810 of pile formed at axially spaced locations along the height of the secure infrastructure device 800, so that there are gaps extending axially between adjacent rows 810 . In this way, the density of the fluff layer varies along the height of the sealing element. In some embodiments, the pile layer 804 may be formed without gaps between the adjacent rows of pile, but the pile layer may comprise rows or stripes extending circumferentially from pile of greater density dispersed with rows or stripes of pile of lower density.
[00180] [00180] In some embodiments, the base layer 802 may comprise a uniform weave weave (the density of the weave pattern is uniform) and the pile layer 804 has a variable density.
[00181] [00181] In some embodiments, the density of the sealing element 800 may vary along the circumference of the sealing element. For example, the pile layer 804 may comprise a plurality of circumferentially spaced rows extending axially from fluff yarns, or it may comprise rows extending axially and alternately of higher density fluff dispersed with the rows extending axially from fluff of lower density. Similarly, the base layer 802 may comprise a plurality of rows extending axially from the higher density dispersed mesh with the rows from the lower density mesh.
[00182] [00182] In some embodiments, the sealing element 800 includes a base layer 802 and / or a layer of plush 804, which varies (m) in density along the circumference of the sealing element and along the height of the sealing element .
[00183] [00183] The variation in the density of the plush layer 804 and / or the base layer 802, along the height and / or the circumference of the sealing element 800, is advantageous in that it reduces the swelling of the sealing element in the radially deformed condition and therefore reduces the integral denture profile of the prosthetic heart valve.
[00184] [00184] In certain embodiments, the outer cover 800 may include inflow and / or discharge protective parts, similar to the protective parts 416 and 418 mentioned above. However, in some embodiments, the outer cover 800 does not need to include the protective parts and can extend between the top and bottom rows of strut elements on a support, or between the intermediate rows of strut elements, depending on of the particular application.
[00185] [00185] Figures 43 and 44 illustrate a prosthetic heart valve 900 including an example of a cover or an outer cover 902, located around a support 904, and including a plurality of leaflets 922 (Figure 44), located at least partially inside support 904. Support 904 can include a plurality of struts 920 and can be configured as the prosthetic heart valve support Edwards Lifesciences SAPIEN 3, similar to support 402 in Figure 19. The outer cover 902 can include a main damping layer or a seal element / cover element 906
[00186] [00186] Referring to Figure 43, layer 906 of outer cover 902 may comprise a woven or knitted cloth. The layer 906 can comprise a plurality of holes or openings 916, which are circumferentially spaced around each other around the support 904 and which are aligned or overlap with the openings defined between the struts of the support. For example, in the illustrated embodiment, the openings 916 can be located at the level of the openings 918, defined between the struts of the support 920 of the fourth row IV and the fifth row V of the struts (see also Figure 34), near the end - discharge capacity 914 of the support. The openings 916 can be relatively small, as in the embodiment of Figure 43, or larger, depending on the particular characteristics desired.
[00187] [00187] For example, with reference to Figure 44, in certain embodiments, the openings 916 can have the same sizes and shapes or practically the same sizes and shapes as the openings 918 of the support. Thus, in the embodiment of Figure 44, the openings 916 can comprise the polygonal (e.g., hexagonal) shape of the openings 918 of the support and can be of the same size or area as the openings 918 of the support. In this configuration, relatively narrow strips 930 of the main layer 906 can extend along the axially oriented struts 920A between the fourth row IV and the fifth row V of struts, and over the commissure windows and the commissure projections 932 of the leaflets 922. Thus, in certain configurations, the openings 916 of the cover 902 can be aligned with the openings 918 of the holder, and even more so the cover 902 can cover the entire outer surface of the holder.
[00188] [00188] The openings 916 can be formed in several ways. In certain embodiments, the openings 916 are cut (for example, by using a laser) from the main layer 906 cloth, before the cover is mounted on the support 904. In some embodiments, the cover 902 comprises two main or outer layers - in separate axially spaced brackets on support 904, with one layer extending, for example, between the first row I of struts 920 and the fourth row IV of struts, and the other layer extending along the fifth row V , so that the openings 918 of the support are uncovered. The openings 916 of the main layer 906 can be of any size or shape, can be located anywhere along the axis of the prosthetic valve and / or at different axial locations. The openings 916 can also have any suitable circumferential space.
[00189] [00189] Figure 45 illustrates an example of prosthetic valve 900, in which the main layer 906 (which can form part or all of the sealing element or cover element) of the outer cover 902 comprises a first part 924, including a layer of plush plush (for example, knitted) 928, similar to cover 414 of Figure 19, and a second part 926 without a plush. Additional parts are also possible. The plush plush layer 928 of the first part 924 can extend circumferentially around the support 904 and axially along the support 904, from the inflow protective part 910 to the level of the fourth row IV of struts 920. The second part 926 can defining a plurality of round openings 916, positioned over the openings 918 of the holder and having a smaller area than the openings 918 of the holder, although the openings 916 can be of any size, shape, location and / or spacing. The plush layer 928 can be configured to extend along any part of the prosthetic valve shaft.
[00190] [00190] In certain embodiments, the first part 924 and the second part 926 comprise different pieces of material. For example, in some embodiments, the first part 924 is a knitted cloth, comprising the layer of plush plush 928 described above, and the second part 926 is a knitted cloth without a layer of plush. The first and second parts 924, 926 can be configured to overlap each other (for example, a portion of the first part 924 can extend over the second part 926, where the two pieces of cloth meet). The second part 926 can also have a different knitting pattern than that of the first part 924, and can also comprise cords (for example, yarn, etc.) having different properties (for example, denier, material, surface characteristics, such as texture, number of filaments, number of layers, number of twists, etc.) of the strands / threads of the first part 924. In some embodiments, the first part 924 and / or the second part 926 comprises (m ) knitting models formed by using a two-bar system, a three-bar system, a four-bar system, etc., or as a multi-bar system, such as eight bars. The first part 924 and / or the second part 926 can be knitted in various ways, for example, using a circular technique, a crochet technique, a knitting technique, a Raschel technique, others techniques or combinations of them. The properties of the second part 926 can be optimized to allow the openings 916 to be created more easily (for example, by laser cutting) and to ensure that the cloth maintains its structural integrity. For example, cloth or fabric made from certain types of woven cords or woven yarns may be more prone to dismantling and / or wear if openings are formed in it, so that second part 926 can be made of an inclined cloth or inclined fabric , which is less likely to collapse or wear out when openings are formed in it. Optionally, the first and second parts 924, 926 can comprise a single piece of fabric. In some embodiments, the first part 924 and / or the second part 926 comprises (a) a non-woven material (e.g., foam, felt, etc.).
[00191] [00191] The inclusion of openings, such as openings 916, in the outer cover 901 can promote the flow of blood through the cover, from the inside of the prosthetic valve to the outside of it, so that the struts 920 and the surfaces radially out of the 922 leaflets are bathed or wetted by the blood flowing through the prosthetic valve, during valve operation. This can help to reduce blood stasis around strut elements 920 and between struts 920 and leaflets 922, which can potentially reduce the risk of thrombosis.
[00192] [00192] Figures 46 - 51 show an example of a main damping layer or a sealing element / covering element 1000. The sealing element 1000 can comprise a fabric body having a plurality of different parts working together, such as as a plurality of first parts (for example, woven parts, multiple sets of woven parts, etc.) and a plurality of second parts (for example, elastic stretch parts configured as floating parts, such as parts of fl - tuantes), which can be incorporated into any of the external covers of prosthetic valves described in this descriptive report. Figure 46 illustrates the sealing element / cover element 1000 in a flat arrangement configuration, in which the x axis corresponds to the circumferential direction and the y axis corresponds to the axial direction, when the sealing element is attached to a support of a prosthetic valve. The sealing element 1000 can comprise a plurality of first parts (such as the first woven parts 1002 configured as strips or stripes extending along the x axis), a plurality of second parts (such as the second woven parts 1004, configured such as woven strips or stripes extending along the x-axis), a plurality of third parts (for example, floating parts or parts of floating yarns, strips or stripes 1006 extending along the x-axis), and / or, optionally, additional parts. The various floating and woven parts / floating yarn parts can be spaced from each other along the y-axis. In the illustrated configuration, the first woven parts 1002 comprise a weaving pattern, which is different from the weaving pattern of the second woven parts 1004, as described in more detail below.
[00193] [00193] In an exemplary configuration, as illustrated, the sealing element / cover element 1000 comprises a first woven part 1002A, which can be on the lower or inflow edge of the sealing element / cover element. By moving in one direction along the positive y-axis, the sealing element / covering element 100 may further comprise a second woven part 1004A, a floating part / part of floating yarns 1006A, a second woven part 1004B, a second part floating part / floating yarn part 1006B, a second woven part 1004C, a floating part / floating yarn part 1006C, a second woven part 1004D, a floating part / floating yarn part 1006D, a second woven part 1004E, a first woven part 1002B, a second woven part 1004F, a floating part / floating yarn part 1006E, a second woven part 1004G and a first woven part 1002C at the opposite end of the sealing element / covering element of the first woven part 1002A . In other words, the first woven part 1002B and each of the floating parts / floating yarn parts 1006A - 1006E can be located between two woven parts 1004, so that the first woven part 1002B and each of the floating parts / parts of floating threads 1006A - 1006E are connected or pushed in a direction along the x axis by the respective second woven parts 1004.
[00194] [00194] With reference to Figures 47 and 48, the main layer or the sealing element / covering element 1000 may comprise a plurality of first strands 1008 (for example, wires, etc.) oriented generally along the x-axis and a plurality of second wires 1010 generally oriented along the y axis. In certain configurations, the first strands / threads 1008 are warp strands / threads, meaning that, during the weaving process, the first strands / threads 1008 are retained by the loom, while the second strands / threads 1010 are strands / weft threads, which are interwoven with the warp strands / threads by a shuttle or conductive weft mechanism during the weaving process. However, in some embodiments, the first strands / threads 1008 may be weft strands / threads and the second strands / threads 1010 may be warp strands / threads.
[00195] [00195] Each of the first strands / threads 1008 and the second strands / threads 1010 can comprise a plurality of constituent filaments 1012, which are spun, wound, twisted, blended, interlaced, etc. together to form the respective strands / wires. The individual strands 1012 exemplary of the second strands / threads 1010 can be seen in Figures 48 - 50. In some embodiments, the first strands / threads 1008 have a denier of about 1 D to about 200 D, about 10 D to about 100 D, about 10 D to about 80 D, about 10 D to about 60 D or about 10 D to about 50 D. In some embodiments, the first 1008 strands / threads have a filament titration of 1 to about 600 filaments per strand / yarn, about 10 to about 300 filaments per strand / yarn, about 10 to about 100 filaments per strand / yarn, about 10 to about 60 strands per strand / strand, about 10 to about 50 strands per strand / strand or about 10 to about 30 strands per strand. In some embodiments, the first strands / threads 108 have a denier of about 40 D and a filament titration of 24 threads per thread. The first strands / threads 1008 can also be twisted strands / threads or untwisted strands / threads. In the illustrated embodiment, the filaments 1012 of the first strands / threads 1008 are not textured. However, in some embodiments, the first strands / threads 1008 may comprise textured filaments.
[00196] [00196] The second strands / threads 1010 can be textured strands / threads, comprising a plurality of textured filaments
[00197] [00197] The first strands / threads 1008 and the second strands / threads 1010 can be woven together to form the woven parts of the sealing element / cover element, as mentioned above. For example, in the first woven parts 1002A - 1002C, the first and second strands / threads 1008, 1010 can be woven together in a flat weave pattern, in which the second strands / threads 1010 (for example, the weft strands / yarns) pass through a first strand / yarn 1008 (for example, a warp yarn) and then under the next first strand / yarn in a repetitive pattern. This weave pattern is illustrated in detail in Figure 47. In some embodiments, the density of the first 1008 strands / threads is about 10 strands / 2.54 centimeters (1 inch) to about 200 strands / strands by 2.54 centimeters (1 inch), about 50 strands / strands by 2.54 centimeters (1 inch) to about 200 strands / strands by 2.54 centimeters (1 inch), or about from 100 strands / strands per 2.54 centimeters (1 inch) to about 200 strands / strands per 2.54 centimeters (1 inch). In certain embodiments, the first woven part 1002A and the first woven part 1002C can be configured as edge parts (selvedge), and may have a lower string / yarn density than the first woven part 1002B to facilitate laying in a valve support. Other weaving models can also be used, such as two under two, two under one, etc. The first woven parts can also be woven in models derived from flat weaves, such as diagonal, satin or combinations of any of these.
[00198] [00198] In the second woven parts 1004A - 1004G, the first and second strands / threads 1008, 1010 can be woven into another model, which is different from the weaving model of the first woven parts 1002A - 1002C. For example, in the illustrated embodiment, the first and second strands / threads 1008, 1010 are woven together in a leno weave pattern on the second woven parts 1004A - 1004G. Figure 48 illustrates the weaving of the second woven fabric 1004B in more detail. Referring to Figure 48, the woven weave may comprise one or more strands / yarn of leno or "lene ends" 1014, and four first strands / yarns 1008A, 1008B, 1008C and 1008D, also referred to as "warp ends" . The pattern illustrated in Figure 48 includes a single 1014 loom strand / yarn in the manner of a partial loom weave. However, in some embodiments, the woven weave pattern may be an integral woven weave, comprising two interwoven loom strands / threads 1014 or other woven fabrics derived from that of leno. Examples of partial woven fabrics, integral woven fabrics and associated weaving techniques are illustrated in Figures 55A - 55J.
[00199] [00199] In the partial leno weave illustrated in Figure 48, the first strands / threads 1008A - 1008D can extend parallel to the x axis, and the second strands / threads 1010 can be interwoven with the first strands / threads 1008A - 1008D in, for example, a flat weave. The 1014 cord / yarn can be woven around the first 1008A - 1008D strands / yarns, so that the 1014 leno cord / yarn goes through or passes through the top of the first
[00200] [00200] In certain embodiments, all second woven parts 1004A - 1005G comprise the leno weave model described above. In some embodiments, one or more of the second woven parts 1004A - 1005G are configured differently, such as by incorporating more or less first strands / threads 1008 in the woven weave, having multiple woven ends around multiple bundles of strands / threads 1008, etc. In some embodiments, a chemical locking method is used when the woven weave and / or a flat weave includes or includes warp strands / threads having core and wrap construction filaments. The wrapping of the individual filaments may be made of low melting temperature polymers, such as biocompatible polypropylene, and the filament core may be made of another biocompatible polymer, such as polyester. After the weaving process, the thermal curing process, described above, can cause the wrap to soften and / or melt. Upon cooling, the softened wrapping polymer can bond together with the polyester filaments. This can create an agglutinated body providing locking of the woven structure.
[00201] [00201] With reference again to Figure 46, the floating parts or parts of floating threads 1006 may comprise strands / threads extending on only one axis between the respective second woven parts 1004, which are spaced apart along the y-axis . For example, considering the floating part / floating yarn part 1006A as a representative example, the floating part / floating yarn part 1006A may comprise a plurality of second strands / yarns 1010, which leave the second weave woven part 1004A, extend over the floating part / floating yarn part 1006A and are incorporated into the leno weave of the second woven part 1004B, without being interwoven with any other strands / yarns in the floating part / floating yarn part. In some embodiments, the density of the second strands / threads in the floating parts / parts of floating threads 1006A is about 10 to about 200 strands / threads per 2.54 centimeters (one inch), about 50 to about 200 colors - donations / threads per 2.54 centimeters (one inch) or about 100 to about 200 strands / threads per 2.54 centimeters (one inch). In some embodiments, the density of the second 1010 strands / threads is about 60 - 80 strands / threads per 2.54 centimeters (one inch). In some embodiments, the floating parts / parts of floating yarns include the first strands / threads 1008, arranged over or under, but not interwoven with, the second strands / threads 1010, so that the second strands / threads float over the first strands / threads or vice versa. The floating parts or the parts of floating yarns can also be configured like any other elastically stretchable structure, such as woven, knitted, braided or non-woven cloths, or polymeric membranes, to name a few, which are elasticly stretchable by least in the axial direction of the
[00202] [00202] In the illustrated embodiment, all woven parts 1002A - 1002C and 1004A - 1004G and all floating parts 1006A - 1006E have width dimensions in the direction of the y axis. The widths of the constituent parts can be configured so that the integral length L1 (Figure 46) of the sealing element / cover element 1000 generally corresponds to the axial length of a prosthetic heart valve in the expanded configuration. For example, in the illustrated embodiment of the first woven parts 1002A and 1002C, both have a width W1. In certain embodiments, the width W1 is configured so that the portions of the first woven parts 1002A and 1002C can be folded over the respective inflow and / or discharge ends of the support of a prosthetic valve.
[00203] [00203] The first woven part 1002B can have a width W2. Referring to Figure 52, when the sealing element / cover element 1000 is used in combination with the Edwards Lifesciences SAPIEN 3 prosthetic heart valve holder, the width W2 can be configured to match the axial dimension of the defined support openings by the strut elements between the fourth row IV and the fifth row V of struts, as described in more detail below. In some embodiments, the width W2 of the first woven part 1002B is about 2 mm to about 20 mm, about 2 mm to about 12 mm or about 3 mm to about 10 mm. In some embodiments, the width W2 is about 7 mm.
[00204] [00204] The second woven parts 1004A = 1004G can have widths W3 (Figure 48). In the illustrated embodiment, all second woven parts 1004A - 1004G are W3 in width, but one or more of the second woven parts can also be different widths. In certain embodiments, the width W3 can be relatively short, such as about 0.1 mm to about 3 mm, about 0.1 mm to about 2 mm or about 0.1 mm to about 1 mm. In some embodiments, the width W3 is about 1 mm.
[00205] [00205] With reference to Figures 46 and 49 - 52, in certain embodiments, the sealing element / covering element 1000 and, in particular, the floating parts / floating wire parts 1006A - 1006E are resiliently stretchable between a first natural configuration or relaxed (Figures 46 and 49), corresponding to the radially expanded state of the prosthetic valve, and a second elongated or tensioned configuration (Figures 50 and 51), corresponding to the radially compressed state of the prosthetic valve. In this way, the floating parts 1006A - 1006E can have initial widths W4, when the sealing element 1000 is in the unstretched, relaxed state. Figure 49 illustrates a portion of the floating part 1006B in a relaxed, natural state. When the fabric is in a relaxed state, the textured filaments 1012 of the second strands / threads 1010 can be twisted and twisted in many directions, so that the floating part 1006B has a voluminous, wavy or cushion-like quality and protects it. provide a compressible volume or mass. When intended, braids, twists, etc. of the filaments 1012 can be pulled partially straight along the y-axis, elongating the second strands / threads 1010. With reference to Figure 50, the width of the floating parts 1106 can thus increase to a second width W5, which is greater than the initial width W4.
[00206] [00206] The cumulative effect of the floating parts / floating wire parts 1006A - 1006E, increasing in width from the initial width W4 to the second width W5, is that the total axial dimension of the sealing element / covering element 1000 can increase from the initial length L1 (Figure 46) to the second total length L2 (Figure 51), which is greater than the first length L1. Figure 51 illustrates the sealing element 1000 in the stretched configuration with the second
[00207] [00207] Figure 52 illustrates a border part of the sealing element / covering element 1000 tightened between a pair of tweezers 1050. In certain embodiments, the bulky, wavy nature of the textured strands / wires 1010, in the floating parts / parts of floating yarns 1006, results in floating parts / floating yarn parts 1006 having a thickness t1, which is greater than a thickness t2 of the woven parts 1002 and 1004. For example, in certain embodiments, the thickness t1 of the floating parts 1006 is twice, three times, four times, five times, six times or even ten times greater than the thickness t2 of the woven parts 1002 and 1004, or more, when the sealing element is in the relaxed state. This can allow floating parts 1006 to soften native leaflets between the valve body and / or against an anchor or ring in which the prosthetic valve is implanted. Floating parts 1006 can also occupy voids or space in the anatomy, and / or promote tissue growth in the floating parts, as in the embodiments described above.
[00208] [00208] Figure 53 illustrates the sealing element 1000, formed in an external cover 1018 and placed in the support 1202 of a prosthetic valve 1022. In the illustrated embodiment, support 1020 is the support of the prosthetic heart valve Edwards Lifesciences SAPIEN  3, similar to the supports described above, although the sealing element 1000 can also be configured for use in other prosthetic valves, including the support in Figure 56. The outer cover 1018 can also include a protective inflow part 1024 and a protective part of discharge 1026, similar to the external coverages described above, and can be configured for implantation in a native valve, such as the mitral valve, the tricuspid valve, the aortic valve, the pulmonary valve, the Eustachian valve, etc., although , in some embodiments, the external cover does not need to include the inflow and / or discharge protective parts, and can also be configured for implantation in other heart valves or lumen corporeal mens. The sealing element 1000 can be oriented so that the second woven parts 1004A - 1004G and the floating parts / parts of floating threads 1006A - 1006E extend circumferentially around the support 1020, and so that the floating part / part of floating wires 1006A is adjacent to the inflow protective part 1024 at the inflow end of the prosthetic valve. In this configuration, the second textual strands / wires
[00209] [00209] Still with reference to Figure 53, the external cover 1018 can be attached to the support by means of fixation, for example, suture, adhesion, etc., of the sealing element 1000 in the support 1020 along one or more of the second parts woven 1004A - 1004G. The first woven part 1002B can also comprise a plurality of openings spaced circumferentially from each other 1016. The openings 1016 can be dimensioned and positioned to overlap with the corresponding openings, defined by the support struts, between the fourth line IV of struts and the fifth row V of scopes, similar to the embodiment of Figure 43 mentioned above. In some embodiments, the sealing element 1000 is incorporated in an external cover in the state illustrated in Figure 46, without the openings in the first woven part 1002B.
[00210] [00210] Figure 54 illustrates the prosthetic valve 1022, dented for release in a balloon 1028 at the distal end of a balloon catheter 1030 of a delivery device 1032. Other details of the representative delivery systems, which can be used with the valves Prosthetics, described in this specification, can be found in US publication No. 2017/0065415 and in US patent 9,339,384, which are incorporated into this specification by reference. As shown in the example illustrated in Figure 53, the floating parts / floating wire parts 1006A - 1006E are elongated
[00211] [00211] In some embodiments, the first and second strands / threads 1008 and 1010 may comprise any of several biocompatible thermoplastic polymers, such as PET, nylon, ePTFE, UHMWPE, etc., or other suitable natural or synthetic fibers . In certain embodiments, the sealing element 1000 can be woven on a loom, and can then be heat treated or heat cured to obtain the desired size and configuration. For example, depending on the material selected, thermal curing can cause retraction of the sealing element 1000. Thermal curing can also cause a texturing effect, or an increase in the degree of texturing, of the second 1010 strands. After heat treatment, the 1016 openings can be created in the first woven part
[00212] [00212] In certain embodiments, loops, filaments, floating parts, parts of floating yarns, etc. of the prosthetic sealing elements, described in this specification, can be configured to promote a biological response to form a seal between the prosthetic valve and the surrounding anatomy. In certain configurations, the sealing elements, described in this specification, can be configured to form a seal for a selected period of time. For example, in certain embodiments, the open, porous nature of the loops, filaments, strands / threads, etc. it can provide a degree of paravalvular leakage selected around the prosthetic valve in the period of time following implantation. The degree of paravalvular leakage after the sealing structure can be gradually reduced over a selected period of time, as the biological response to the loops, filaments, strands / threads, etc. causes blood clotting, tissue entrainment, etc. In some embodiments, the sealing elements and, in particular, the loops, filaments, strands / threads, etc., of the paravavalvular sealing structure, are treated with one or more agents, which inhibit the biological response to the structures sealants. For example, in certain embodiments, the loops, filaments, strands / threads, etc. are treated with heparin. In certain embodiments, the content or concentration of the agent (s) is selected so that the agents are exhausted after a selected period of time (for example, days, weeks or months) after implantation of the valve. As the agent (s) are exhausted, the biological response to the bonds,
[00213] [00213] Figures 55A - 55J illustrate various woven woven fabrics and various woven woven techniques, which can be used to produce the sealing element / covering element 1000 or any other sealing elements / covering elements described in descriptive report. Figure 55A is a cross-sectional view illustrating a shed (for example, the temporary separation of warp strands / threads to form lower and upper warp strands / threads), in which a leno thread, an "end of warp" leno "or a" crossing end "1060 forms the top shed to the left of the figure, above a 1064 weft cord / yarn and a standard type 1062 warp yarn forms the bottom shed . Figure 55B illustrates a successive shed, in which the leno cord / yarn 1060 forms the top shed to the right of the standard type warp cord / yarn
[00214] [00214] Figure 55C illustrates an interlacing pattern produced when a warp bundle is used on a loom, and the distortions or stresses of the 1060 leno strands and strands / strands of the standard type 1062 are the same that the 1060 strands / threads and
[00215] [00215] Figure 55E illustrates an interlacing pattern corresponding to Figure 55C, but in which altered 1060 leno strands / yarns are delivered on time (for example, a technique in which the leno strands / yarns are stretched by use of healds), so that the adjacent 1060 leno strands / threads have opposite mooring directions. Figure 55F illustrates an interlacing model corresponding to Figure 55D, but in which the 1060 leno strands / threads are punctually delivered, so that the adjacent leno strands / threads have opposite mooring directions.
[00216] [00216] Figure 55G is a cross-sectional view of a flat loom weave structure taken by the weft strands / threads
[00217] [00217] Figure 55J illustrates a representative woven weave seen from the reverse side of the fabric.
[00218] [00218] The prosthetic valve cover embodiments, described in the present specification, can also be used in several different types of prosthetic heart valves. For example, covers may be adapted, and are, in some embodiments, adapted, for use in mechanically expandable prosthetic heart valves, such as valve 1100 shown in Figure 56. Prosthetic valve 1100 may include a stent or annular support 1102 and a structure of 1104 leaflets, located inside and coupled with the support
[00219] [00219] Referring to Figure 56, support 1102 may include a plurality of interconnected truss struts 1112, arranged in a truss-type model and forming a plurality of apexes 1114 at the discharge end 1108 of the prosthetic valve. The scraps 1112 also form similar apexes 1114 at the inlet end 1106 of the prosthetic valve. The lattice struts 1112 can be pivotally coupled to each other by joints 1116, located where the struts overlap, and also at the apexes 1114. The joints 1116 can allow the struts 1112 to be pivoted relatively to each other, as far as that the support 1102 is expanded or contracted, as during the placement, preparation or implantation of the prosthetic valve 1100. The joints 1116 may comprise rivets or pins, which extend through the openings formed in the struts 1112, in the locations in which the struts overlap with each other. In the embodiment of Figure 56, the struts 1112 include openings for five joints 1116. However, the struts may include any number of joints, depending on the particular size of the support, etc. For example, in some embodiments, the struts comprise seven joints, as in the configuration shown in Figure 57. Additional details regarding the support
[00220] [00220] As illustrated in Figure 56, support 1102 can comprise a plurality of actuator components 1118, which can also function as release and locking units (also referred to as locking sets), configured to radially expand and contract the support . In the illustrated configuration, support 1102 comprises three actuator components 1118, configured as columns and coupled to support 1102 in circumferentially spaced locations, although the support may include more or less actuator components, depending on the particular application. Each actuator component 1118 can generally comprise an inner element 1120, such as an inner tubular element, and an outer element 1122, such as an outer tubular element arranged concentrically around inner element 1120. Inner elements 1120 and outer elements 1122 can be mobile longitudinally relative to each other in a telescopic way to expand and contract radially support 1102, as further described in US publication No. 2018/0153689.
[00221] [00221] In the illustrated configuration, the internal elements 1120 have distal end parts 1124, coupled to the inlet end 1106 of the support 1102 (for example, with a coupling element, such as a pin element). In the illustrated embodiment, all internal elements 1120 are coupled to the support at the respective apexes 1114 at the inflow end 1106 of the support. The outer elements 1122 can be coupled to the tips 1114 at the discharge end 1108 of the support 1102 in, for example, an intermediate part of the outer element, as shown in Figure 56,
[00222] [00222] The inner element 1120 and the outer element 1122 can telescope relatively between them, between a fully constrained state (corresponding to a radial and fully expanded state of the prosthetic valve) and a fully extended state (corresponding to a radial and fully compressed from the prosthetic valve). In the fully extended state, the inner element 1120 is fully extended from the outer element 1122. In this way, the actuator components 118 allow the prosthetic valve to be fully expanded or partially expanded to different diameters and to keep the prosthetic valve in partial state or fully expanded.
[00223] [00223] In some embodiments, actuator components 1118 are thread actuators, configured to radially expand and compress support 1102 by rotating one of the actuator components. For example, internal elements 1120 can be configured as threads having external threads that mate with the internal threads of corresponding external components. Further details regarding thread actuators are described in U.S. Publication No. 2018/0153689.
[00224] [00224] The prosthetic valve 1100 may also include a plurality of commissure support elements, configured as locks or clamps 1136. In the illustrated configuration, the prosthetic valve includes a commissure clamp 1136, positioned at each commissure 1132 and configured for attach the 1110 commissure leaflets in a location radially spaced into the support 1102. Further details regarding the commissure clamps are described in US Publication No. 2018/0325665, which is incorporated by reference in the present descriptive report.
[00225] [00225] Figure 57 illustrates an example of a mechanically expandable support 1202 with components, such as booklets, booklet clips and actuator components, removed for illustration purposes. Support 1202 may be similar to support 1102, except that struts 1204 include seven openings 1206 spaced apart from each other along the length of each strut for the formation of joints similar to joints 1116. For example, each strut 1204 may include a plurality of round, curved or circular parts 1212 connected by straight parts or segments 1214. Each successive segment 1214 can be parallel to, but circumferentially displaced from, the preceding segment 1214, as described in US Publication No. 2018/0153689. Each round part 1212 can define an opening 1206. Thus, considering the strut element 1204A as one, the round part 1212A at the inlet end 1208 of the support 1202 can define an opening 1206A. Moving along strut 1204A, towards discharge end 1210, part 1212B can define an opening 1206B, part 1212C can define an opening 1206C, part 1212D can define an opening 1206D, part 1212E can define an opening 1206E, part 1212F can define an opening 1206F and part 1212G can define an opening 1206G at the discharge end
[00226] [00226] In the illustrated configuration, the struts 1204 are arranged in two sets, with the first set being on the inside of the support 1202, circumferentially displaced from each other, and angled so that the struts extend helically around the axis center 1216 of the support. In the embodiment of Figure 57, the struts 1204B and 1204C are part of the first or the internal set of struts. The second set of struts 1204 can be arranged radially outside the first set of struts. The second set of struts can be angled so that the openings 1206 align with the openings 1206 of the internal set of struts, and can be oriented with the opposite helicity to that of the first set of struts. In the embodiment illustrated in Figure 57, struts 1204A and 1204D are part of the second or external set of struts. The inner and outer strut assemblies 1204 can form inflow points 1218 of the support, in which the respective round parts 1212 align, and can form discharge points 1220, in which the respective round parts, at the opposite ends of the braces, line up. In the expanded configuration, the struts 1204 of the internal and external assemblies can also define a plurality of cells or openings in the shape of a diamond 1222.
[00227] [00227] Figures 58 and 59 illustrate an example of a main damping layer, a covering element or a sealing element 1300. The sealing element 1300 can comprise a body part having a plurality of woven parts and one or more floating parts (for example, floating wire parts, etc.) similar to the embodiment of Figure 46. Figure 58 illustrates the sealing element 1300 in a flat arrangement configuration, in which the x axis corresponds to the circumferential direction and the y-axis corresponds to the axial direction, when the sealing element 1300 is attached to a prosthetic valve holder. Fig. 59 is an enlarged view of a portion of the sealing element 1300. Beginning at the inflated end portion 1310 of the sealing element 1300, the sealing element 1300 may comprise a first woven portion 1302A. Moving in one direction along the positive y-axis, the sealing element 1300 may further comprise a second woven part 1304A, a floating part / floating yarn part 1306, a second woven part
[00228] [00228] Still referring to Figure 59, the sealing element 1300 may comprise strands / threads 1308 extending in the x direction (for example, strands / warp threads) and strands / threads 1314 extending in the y direction (for example, strands / weft threads), as in the examples mentioned above. In certain embodiments, at least 1314 strands / threads can be textured. Textured strands / threads 1314 can be woven with strands / threads 1308 in the first woven part 1302A and in the second woven part 1304A. The textured strands / yarns 1314 can extend to or "float" through the second woven part 1304B to form the floating parts / floating yarn parts 1306. The strands / yarns 1314 can re-enter the weave at the second woven part 1304B .
[00229] [00229] As in the embodiment of Figure 46, the first woven parts 1302A and 1302B can comprise a flat weave. In some embodiments, the first woven part 1302A and / or the first woven part 1302B may (m) have a strand / yarn density of 20 strands / threads (or ends) per 2.54 centimeters (one inch) to 150 strands / strands per 2.54 centimeters (one inch), such as 40 strands / strands per 2.54 centimeters (one inch) to 120 strands / strands per 2.54 centimeters (one inch). In some embodiments, the first woven parts 1302A and 1302B can be configured as edges and can prevent the fabric from being frayed.
[00230] [00230] The second woven part 1304A can extend along the bottom edge of the floating part / part of floating yarn 1306, and the first woven part 1304B can extend along the top edge of the floating part / part of floating yarn 1306. In this way,
[00231] [00231] The sealing element 1300 can be resiliently stretchable between a first natural width, corresponding to a non-tensioned state, and a second width, when the sealing element is stretched in the y direction, similar to the embodiment of Figure 46. As in the previously described embodiments, the textured strands / strands 1314 of the floating part / floating strand part 1306 can be configured to provide a compressible, bulky volume when in the relaxed state. When the sealing element 1300 is tensioned in the y direction, the textured strands / wires 1314 can be pulled straight, causing the sealing element to extend in the y direction.
[00232] [00232] Figure 60 illustrates the sealing element or cover element 1300 attached to the support 1202 of Figure 57 to form a cover on the support. In Figure 60, the support is in the expanded configuration, and the cover and the sealing element are in the first relatively unstressed state. In the illustrated embodiment, the first woven part 1302A can be secured (for example, by means of fastening, such as suture, adhesive, etc.) to the inflow end parts of the struts 1204. For example, with reference to Figure 61, the the first woven part 1302A can be folded over the inflow apexes 1218 so that the free edge 1318 of the fabric is located within the support 1202, and so that the first woven part 1302A covers the apexes.
[00233] [00233] With reference to the external struts 1204A and 1204D of Figure 60, the first woven part 1302B can be dimensioned so that it extends from approximately the level of the round parts 1212C to the round parts 1212D. In certain embodiments, the first woven part 1302B can be formed to follow the shape of the cells 1222 (Figure 57) formed by the struts 1204, when the support 1202 is in the expanded configuration. For example, the first woven part 1302B can be cut or formed so as to comprise a plurality of extension parts 1320. The extension parts 1320 can be sized to correspond to the parts of cells 1222, which extend above the second part 1304B. In the illustrated embodiment, the extension parts 1320 are tapered in the direction of flow through the valve, so that they have a trapezoidal shape, such as an isosceles trapezoidal shape. However, extension parts 1320 can have any other shape, such as a triangular shape, a rectangular shape, etc. The extension parts 1320 can be sutured in the support 1202 along the strut segments 1214 (Figure 57) extending between the round parts 1212C and 1212D of the struts on the outside diameter of the support, and in the corresponding strut segments 1204 on the part internal support.
[00234] [00234] With reference to the external set of struts 1204, the floating part / floating wire part 1306 may extend between approximately the level of the round parts 1212B to the round parts 1212C. When support 1202 is in the expanded configuration, the floating part / floating yarn part 1306 can extend or bulge out of the support to form a bulky, compressible pillow-like structure or cushion that can help with sealing against the surrounding anatomy. The textured strands / yarns of the floating part / floating yarn part 1306 can also provide a porous environment for tissue braiding.
[00235] [00235] Still with reference to Figure 60, when the support 1202 is in the expanded configuration, the support can have an L1 length. The cover and the sealing element 1300 can have a corresponding length H1, which can be measured from the inflow apexes 1218 to the uppermost edge or the highest discharge 1322 of the extension parts. As illustrated in Figure 62, when support 1202 is radically deformed for release, the length of the support may increase to a second length L2. As the support extends, the cover and sealing element 1300 and, in particular, the floating part / floating yarn part 1306 can also stretch so that the cover and sealing element extend to a second length H2 (for example, corresponding to a second tensioned state) to accommodate the longer length of support 1202. In some embodiments, support 1202 is configured to span 10% to 160% or more between the expanded and the deformed configuration. In this way, the cover and the securing element 1300 can also be configured to stretch to a similar degree, such as from 10% to 200%, 10% to 180%, 10% to 160%, etc., to accommodate the length variation of the support.
[00236] [00236] Although the embodiments of prosthetic valve cover, described in this specification, are sometimes presented in the context of mitral valve repair, it should be understood that the coverings described can be used in combination with any of the several prosthetic heart valves for implantation in any of the native valves in or around the heart. For example, prosthetic valve covers, described in this specification, can be used in combination with transcatheter heart valves, surgical heart valves, minimally invasive heart valves, etc. The coverage embodiments in this specification can be used in prosthetic valves intended for implantation in any of the native valves of an animal or patient (for example, the aortic, pulmonary, mitral, tricuspid and Eustachian, etc.), and include valves that are intended for implantation into existing prosthetic valves (procedures called "valve to valve"). The cover embodiments can also be used in combination with other types of implantable devices within other cormoral lumens outside the heart, or heart valves that are implantable within the heart in locations other than native valves, such as heart valves. transatrial or transventricular septa. GENERAL CONSIDERATIONS
[00237] [00237] For the purposes of this description, certain aspects, advantages and new features of the embodiments of the present invention are described in the present specification. The methods, devices and systems described should not be considered in any way as limiting. Instead, the present invention is directed to all the new and not obvious features and aspects of the various embodiments described, alone and in various combinations and subcombination between them. The methods, devices and systems are not limited to any specific feature or aspect or a combination of them, nor do the described embodiments require any or more of the specific advantages to be present or problems to be solved.
[00238] [00238] Although the operations of some of the described embodiments are presented in a sequential order, particularly for a convenient presentation, it should be understood that this descriptive way encompasses redistribution, unless a particular order is required by the specific language presented below. For example, the operations described sequentially may, in some cases, be rearranged or executed sequentially. Furthermore, for the sake of simplicity, the attached figures may not show the various ways in which the methods described can be used in conjunction with other methods. In addition, the description sometimes uses terms such as "providing" or "attaining" the described methods. These terms are high-level abstractions from the actual operations that are performed. The actual operations, which correspond to these terms, may vary depending on the particular implementations and are easily discernible by a person skilled in the art.
[00239] [00239] As used in this specification and in the claims, the singular forms "um", "uma", "o" and "a" include plural forms unless the context clearly indicates otherwise. In addition, the term "includes" means "comprises". Furthermore, the terms "coupled" and "associated" generally mean coupled or connected electrically, electromagnetically and / or physically (for example, mechanically or chemically) and does not exclude the presence of intermediate elements between the coupled items or specific absent associates contrary to language.
[00240] [00240] In the context of the present patent application, the terms "lower" and "upper" are used interchangeably with the terms "inflow" and "discharge", respectively. Thus, for example, the ex-
[00241] [00241] As used in this specification, the term "proximal" refers to a position, direction or part of a device, which is closer to the user and further away from the implantation site. As used in this specification, the term "distal" refers to a position, direction or part of a device that is further from the user and closer to the implantation site. In this way, for example, the proximal movement of a device is the movement of the device to 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 extending in the proximal and distal directions, unless expressly defined differently.
[00242] [00242] In view of the many possible embodiments, to which the principles of the described technology can be applied, it must be recognized that the illustrated embodiments are only the preferred examples and should not be considered as limiting the scope of the invention. Instead, the scope of the invention is at least as wide as the claims presented below.

权利要求:
Claims (47)
[1]
1. Prosthetic heart valve, characterized by the fact that it comprises: a support comprising a plurality of strut elements, the support being radially deformable and expandable between a deformed configuration and an expanded configuration, the support having an inflow end and a discharge end, and defining a longitudinal axis; a booklet structure, located at least partially within the support; and a sealing element arranged around the support, the sealing element comprising: a first woven part, which extends circumferentially around the support, the first woven part comprising a plurality of textured strands extending along the longitudinal axis support; a second woven part, which extends circumferentially around the support and which is spaced from the first woven part along the longitudinal axis of the support; wherein the textured strands extend along the longitudinal axis of the support from the first woven part to the second woven part and form a part of floating threads between the first woven part and the second woven part.
[2]
2. Prosthetic heart valve, according to claim 1, characterized by the fact that the sealing element is resiliently stretchable, a first state, corresponding to the radially expanded configuration of the support, and a second state, corresponding to the radially deformed configuration support.
[3]
3. Prosthetic heart valve, according to claim 2, characterized by the fact that the part of the floating wires is resilient
then stretchable between the first state and the second state of the sealing element.
[4]
4. Prosthetic heart valve according to any one of claims 1 to 3, characterized by the fact that the textured wires are configured to provide a compressible volume for the floating wire part of the sealing element, when the support is in the configuration expanded.
[5]
5. Prosthetic heart valve according to any one of claims 1 to 4, characterized by the fact that the textured cords are woven in a leno weave model in the first woven part and the second woven part.
[6]
6. Prosthetic heart valve according to any one of claims 1 to 5, characterized in that the sealing element defines a plurality of openings spaced circumferentially from each other.
[7]
7. Prosthetic heart valve, according to claim 6, characterized by the fact that the openings in the sealing element overlap with the openings defined by the support strut elements.
[8]
8. Prosthetic heart valve according to any one of claims 1 to 7, characterized in that the sealing element further comprises a third woven part, on the opposite side of the first woven part of the floating yarn part, the third part comprising the textured cords of the first woven part.
[9]
9. Prosthetic heart valve according to claim 8, characterized by the fact that the textured threads are woven in a flat weave model in the third woven part.
[10]
10. Prosthetic heart valve, according to claim 8 or 9, characterized by the fact that the third woven part is folded over the apices of the strut elements at the inflow end of the support.
[11]
Prosthetic heart valve according to any one of claims 8 to 10, characterized by the fact that: the sealing element further comprises a fourth woven part, on the opposite side of the second woven part of the floating yarn part; and the fourth woven part comprises the textured strands, and the textured strands are woven in a flat weave model in the fourth woven part.
[12]
12. Prosthetic heart valve, according to claim 11, characterized by the fact that the fourth woven part comprises a plurality of extension parts, which overlap the openings defined by the support strut elements, when the support is in the expanded configuration.
[13]
13. Prosthetic heart valve according to claim 12, characterized in that the extension parts are tapered in one direction towards the discharge end of the support.
[14]
14. Prosthetic heart valve according to any one of claims 1 to 10, characterized by the fact that: the sealing element comprises a first protective part, folded over the apices of the strut elements at the inflow end of the support; and the sealing element also comprises a second protective part, folded over the apices of the strut elements at the discharge end of the support.
[15]
15. Prosthetic heart valve according to any one of claims 1 to 14, characterized by the fact that the support is a mechanically expandable support.
[16]
16. Prosthetic heart valve according to any one of claims 1 to 14, characterized by the fact that the support
te is a plastically expandable support.
[17]
17. Prosthetic heart valve according to any one of claims 1 to 14, characterized in that the sealing element comprises a plurality of part of floating wires spaced apart along the longitudinal axis of the support.
[18]
18. Prosthetic heart valve, characterized by the fact that it comprises: a support comprising a plurality of strut elements, the support being radially deformable and expandable between a deformed configuration and an expanded configuration, the support having an inflow end and a discharge end, and defining a longitudinal axis; a booklet structure, located at least partially within the support; and a cover arranged around the support, the cover comprising: a first woven part, which extends circumferentially around the support, the first woven part comprising a plurality of textured strands extending along the longitudinal axis of the support; a second woven part, which extends circumferentially around the support and which is spaced from the first woven part along the longitudinal axis of the support; wherein the textured strands extend along the longitudinal axis of the support from the first woven part to the second woven part and form a part of floating threads between the first woven part and the second woven part.
[19]
19. Prosthetic heart valve, according to claim 18, characterized by the fact that the cover is resiliently stretchable in a first state, corresponding to the expanded configuration
radially of the support, and a second state, corresponding to the radially deformed configuration of the support.
[20]
20. Prosthetic heart valve according to claim 19, characterized by the fact that the floating part is resiliently stretchable between the first state and the second state of the cover.
[21]
21. Prosthetic heart valve according to any one of claims 18 to 20, characterized in that the textured cords are configured to provide a compressible volume for the floating part of the cover, when the support is in the expanded configuration.
[22]
22. Prosthetic heart valve according to any one of claims 18 to 21, characterized in that the textured cords are woven in a leno weave model in the first woven part and the second woven part.
[23]
23. Prosthetic heart valve according to any of claims 18 to 22, characterized by the fact that the cover defines a plurality of openings spaced circumferentially from each other.
[24]
24. Prosthetic heart valve, according to claim 23, characterized by the fact that the openings in the cover overlap with the openings defined by the support strut elements.
[25]
25. Prosthetic heart valve, according to claim 23, characterized by the fact that the openings have been cut in a part made of an inclined cloth or an inclined fabric to inhibit defibration around the openings.
[26]
26. Prosthetic heart valve according to any one of claims 18 to 24, characterized in that the cover further comprises a third woven part, on the opposite side of the first woven part of the floating part, the third woven part comprises endorsing the textured cords of the first woven part.
[27]
27. Prosthetic heart valve, according to claim 26, characterized by the fact that the textured cords are woven in a flat weave model in the third woven part.
[28]
28. Prosthetic heart valve according to claim 26 or 27, characterized in that the third woven part is folded over the apexes of the strut elements at the inflow end of the support.
[29]
29. Prosthetic heart valve according to any one of claims 26 to 28, characterized in that: the cover further comprises a fourth woven part, on the opposite side of the second woven part of the floating part / part of floating threads; and the fourth woven part comprises the textured strands, and the textured strands are woven in a flat weave pattern on the fourth woven part.
[30]
30. Prosthetic heart valve, according to claim 29, characterized by the fact that the fourth woven part comprises a plurality of extension parts, which overlap the openings defined by the support strut elements, when the support is in the expanded configuration.
[31]
31. Prosthetic heart valve according to claim 30, characterized in that the extension parts are tapered in one direction towards the discharge end of the support.
[32]
32. Prosthetic heart valve, according to any one of claims 18 to 28, characterized by the fact that: the cover comprises a first protective part, folded over the apices of the strut elements at the inflow end of the support; and the cover also comprises a second protective part, folded over the apices of the strut elements at the discharge end of the support.
[33]
33. Prosthetic heart valve according to any of claims 18 to 32, characterized by the fact that the support is a mechanically expandable support.
[34]
34. Prosthetic heart valve according to any one of claims 18 to 32, characterized by the fact that the support is a plastically expandable support.
[35]
35. Prosthetic heart valve according to any one of claims 18 to 32, characterized in that the cover comprises a plurality of floating parts spaced apart along the longitudinal axis of the support.
[36]
36. Prosthetic heart valve according to any one of claims 18 to 35, characterized in that the parts of the floating wires are thermally cured to make them softer and / or more textured.
[37]
37. Prosthetic heart valve according to any one of claims 18 to 20, characterized in that the twisted PET strands are used in a warp direction and the textured PET strands are used in a weft direction.
[38]
38. Prosthetic heart valve according to claim 37, characterized by the fact that the twisted PET strands, in the warp direction, are arranged to weave in a linen model, and the textured PET strands, in the direction weave, form the floating part without any weaving structure.
[39]
39. Prosthetic heart valve according to claim 38, characterized by the fact that the cover is thermally contracted to obtain a stretching capacity between 80 - 160%.
[40]
40. Prosthetic heart valve according to any of claims 37 to 39, characterized by the fact that the support is a mechanically expandable support.
[41]
41. Prosthetic heart valve according to any one of claims 18 to 40, characterized in that the cover comprises at least one of a low friction coefficient layer or a low friction foot coating. it less a part of it.
[42]
42. Prosthetic heart valve according to claim 41, characterized by the fact that the layer of low friction coefficient or the coating of low friction coefficient is formed by electrospinning.
[43]
43. Prosthetic heart valve according to any of claims 18 to 41, characterized by the fact that it also comprises strips of material, which are helically wound around the struts and apexes at one end of the support.
[44]
44. Prosthetic heart valve, characterized by the fact that it comprises: a support comprising a plurality of strut elements, the support being radially deformable and expandable between a deformed configuration and an expanded configuration, the support having an inflow end and a discharge end, and defining a longitudinal axis; a booklet structure, located at least partially within the support; and a cover arranged around the support, the cover defining a plurality of openings, which are aligned with the openings in the support.
[45]
45. Prosthetic heart valve, according to claim 44, characterized by the fact that: the support comprises an external end; and the cover covers the entire external surface of the support.
[46]
46. Prosthetic heart valve according to claim 44 or 45, characterized by the fact that: the cover comprises a first part adjacent to the inflow end of the support including a layer of plush plush; the cover also comprises a second part without a layer of fluff adjacent to the discharge end of the support; and the second part of the cover defines the openings of the cover.
[47]
47. Prosthetic heart valve according to claim 46, characterized in that the second part of the cover is formed of an inclined tissue.

类似技术:

---

公开号 | 公开日 | 专利标题

---

US11013600B2|2021-05-25|Covered prosthetic heart valve

---

BR112020014367A2|2020-12-01|covered prosthetic heart valve

---

KR20200003424A|2020-01-09|Sealing member for artificial heart valve

---

US11185406B2|2021-11-30|Covered prosthetic heart valve

---

AU2018313983B2|2021-04-01|Sealing element for prosthetic heart valve

---

US20190365530A1|2019-12-05|Sealing member for prosthetic heart valve

---

KR20200040891A|2020-04-20|Sealing member for artificial heart valve

---

US20190374337A1|2019-12-12|Covered prosthetic heart valve

---

CA2813419A1|2012-04-12|Prosthetic heart valve

---

AU2019272011B2|2020-06-18|Prosthetic heart valve

---

US20220079750A1|2022-03-17|Covered prosthetic heart valve

同族专利:

---

公开号 | 公开日

---

JP2021511139A|2021-05-06|

---

CN111836602A|2020-10-27|

---

IL276116D0|2020-08-31|

---

AU2019208326A1|2020-07-23|

---

WO2019144036A1|2019-07-25|

---

SG11202006501PA|2020-08-28|

---

EP3740162B1|2022-01-26|

---

CA3088320A1|2019-07-25|

---

KR20200112887A|2020-10-05|

---

EP3740162A1|2020-11-25|

引用文献:

---

公开号 | 申请日 | 公开日 | 申请人 | 专利标题

---

---

CN105073068B|2013-03-12|2017-03-15|爱德华兹生命科学公司|Can rapid deployment Surgical heart valve|

---

EP3669829B1|2010-10-05|2021-09-15|Edwards Lifesciences Corporation|Prosthetic heart valve|

---

US9339384B2|2011-07-27|2016-05-17|Edwards Lifesciences Corporation|Delivery systems for prosthetic heart valve|

---

US10588744B2|2015-09-04|2020-03-17|Edwards Lifesciences Corporation|Delivery system for prosthetic heart valve|

---

CR20190069A|2016-08-26|2019-05-14|Edwards Lifesciences Corp|Heart valve docking coils and systems|

---

US10603165B2|2016-12-06|2020-03-31|Edwards Lifesciences Corporation|Mechanically expanding heart valve and delivery apparatus therefor|

---

CN113288514A|2016-12-16|2021-08-24|爱德华兹生命科学公司|Deployment systems, tools, and methods for delivering anchoring devices for prosthetic valves|

---

US11185406B2|2017-01-23|2021-11-30|Edwards Lifesciences Corporation|Covered prosthetic heart valve|

---

US11135056B2|2017-05-15|2021-10-05|Edwards Lifesciences Corporation|Devices and methods of commissure formation for prosthetic heart valve|

---

EP3639792B1|2017-05-31|2021-10-27|Edwards Lifesciences Corporation|Sealing member for prosthetic heart valve|

---

WO2019032992A2|2017-08-11|2019-02-14|Edwards Lifesciences Corportion|Sealing element for prosthetic heart valve|US10595994B1|2018-09-20|2020-03-24|Vdyne, Llc|Side-delivered transcatheter heart valve replacement|

---

US11071627B2|2018-10-18|2021-07-27|Vdyne, Inc.|Orthogonally delivered transcatheter heart valve frame for valve in valve prosthesis|

---

US11109969B2|2018-10-22|2021-09-07|Vdyne, Inc.|Guidewire delivery of transcatheter heart valve|

---

US11253359B2|2018-12-20|2022-02-22|Vdyne, Inc.|Proximal tab for side-delivered transcatheter heart valves and methods of delivery|

---

US11185409B2|2019-01-26|2021-11-30|Vdyne, Inc.|Collapsible inner flow control component for side-delivered transcatheter heart valve prosthesis|

---

US11076956B2|2019-03-14|2021-08-03|Vdyne, Inc.|Proximal, distal, and anterior anchoring tabs for side-delivered transcatheter mitral valve prosthesis|

---

US11173027B2|2019-03-14|2021-11-16|Vdyne, Inc.|Side-deliverable transcatheter prosthetic valves and methods for delivering and anchoring the same|

---

AU2020267390A1|2019-05-04|2021-11-11|Vdyne, Inc.|Cinch device and method for deployment of a side-delivered prosthetic heart valve in a native annulus|

---

WO2021035032A1|2019-08-20|2021-02-25|Vdyne, Inc.|Delivery and retrieval devices and methods for side-deliverable transcatheter prosthetic valves|

---

US11234813B2|2020-01-17|2022-02-01|Vdyne, Inc.|Ventricular stability elements for side-deliverable prosthetic heart valves and methods of delivery|

---

AU2021246049A1|2020-04-03|2021-12-23|Edwards Lifesciences Corporation|A multi-layer covering for a prosthetic heart valve|

---

WO2022010958A1|2020-07-07|2022-01-13|Anteris Technologies Corporation|Exteriorly mounted tissue on expandable frame for improved hemodynamic performance|

法律状态:
2021-12-07| B350| Update of information on the portal [chapter 15.35 patent gazette]|

优先权:

---

申请号 | 申请日 | 专利标题

---

US15/876,053|2018-01-19|

---

US15/876,053|US11185406B2|2017-01-23|2018-01-19|Covered prosthetic heart valve|

---

US201862703363P| true| 2018-07-25|2018-07-25|

---

US62/703,363|2018-07-25|

---

PCT/US2019/014338|WO2019144036A1|2018-01-19|2019-01-18|Covered prosthetic heart valve|

---