Covered prosthetic heart valve

Abstract

The present invention relates to a prosthetic heart valve, which includes a support having an inflow end and a discharge end and defining a longitudinal axis. The prosthetic valve also includes a leaflet structure, situated at least partially within the support, and a cover arranged around the support. The cover includes a first woven part, extending circumferentially around the support and including a plurality of textured cords or threads extending along the longitudinal axis of the support. The cover also includes a second woven part, extending circumferentially around the support and spaced from the first woven part along the longitudinal axis of the support. The textured cords 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.

Description

1 / 89 Covered prosthetic heart valve Mutual referral to related patent applications.

[001] The present patent application is a partial continuation of US Patent Application No. 15 / 876,053, filed January 19, 2018. This patent application also claims the benefit of US Provisional Patent Application No. 62 / 703,363, filed July 25, 2018. Both preceding patent applications are incorporated by reference in their entirety in this descriptive report. FIELD

[002] The present invention relates to prosthetic heart valves and, in particular, to prosthetic heart valves including a cover. BACKGROUND OF THE INVENTION

[003] In a procedure to implant a transcatheter prosthetic heart valve, the prosthetic heart valve may be positioned within 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 may 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 becoming dislodged. In other configurations, the prosthetic heart valve may be expanded with a support structure, which is located within the native annulus and configured to retain the prosthetic heart valve in a selected position relative to the annulus. Over time, the relative movement of the prosthetic heart valve and the native heart valve tissue (e.g., leaflets, chordae tendineae, etc. of native valves) in contact with the prosthetic heart valve may cause tissue damage.Consequently, there is a need for it. Petition 870260046292, dated 05 / 15 / 2026, page 8 / 202 2 / 89 improvements in prosthetic heart valves. SUMMARY

[004] Some of the embodiments described relate to coverings for prosthetic heart valves and to methods of production and use thereof. This summary is mentioned to provide some examples and is not intended, in any way, to be limiting to the scope of the invention. For example, any feature included in an example in this summary is not required by the claims, unless the claims explicitly relate to the features. Also, the features described can be combined in various ways. Several features and steps, described at any point in this description, can be included in the summarized examples in this descriptive report.

[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, situated at least partially within the support, and a cover arranged around the support (e.g., partially around, around a part of, or around the entire support). The cover may comprise or be formed of a sealing element or a cover element, which may be arranged partially around or around the entire support to form a part or the entire cover.In some embodiments, the covering and / or sealing element / covering element comprises a first woven part, extending circumferentially around the substrate and including a plurality of cords (e.g., threads, lines, sutures or other materials). Petition 870260046292, dated 05 / 15 / 2026, p. 9 / 202 3 / 89 elongated, useful in a manner similar to that described in this descriptive report) textured, extending along the longitudinal axis of the substrate. In some embodiments, the covering and / or the sealing element / covering element further comprises a second woven part, which extends circumferentially around the substrate and is spaced from the first woven part along the longitudinal axis of the substrate. The textured cords (e.g., yarns, etc.) extend along the longitudinal axis of the substrate 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] In some embodiments, the covering and / or the sealant / covering element is or are resilient stretchable 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] In some embodiments, the floating part / floating wire part is resiliently stretchable between the first state and the second state of the covering and / or the sealant element / covering element.

[008] In some embodiments, textured cords, such as textured yarns, are configured to provide a compressible bulk to the floating portion, or a portion of floating yarns, of the cover and / or sealant / cover element, when the substrate is in the expanded configuration.

[009] In some embodiments, the textured cords (e.g., yarns, etc.) are woven in a leno weave pattern on the first woven part and the second woven part.

[0010] In some embodiments, the covering and / or the sealing element / covering element define(s) a plurality of openings Petition 870260046292, dated 05 / 15 / 2026, page 10 / 202 4 / 89 spaced circumferentially from each other.

[0011] In some embodiments, the openings in the roof and / or in the sealing element / roofing element overlap the openings defined by the bracing elements of the support.

[0012] In some embodiments, the openings were cut into a portion of the sealing element made of a sloping cloth or a sloping fabric to inhibit fraying around the openings.

[0013] In some embodiments, the covering and / or the sealing element / covering element further comprises a third woven part, on the opposite side of the first woven part of the floating part / floating yarn part, the third woven part comprising the textured cords / textured yarns of the first woven part.

[0014] In some embodiments, the textured cords / textured yarns are woven in a flat weave pattern in the woven third.

[0015] In some embodiments, the woven third part is folded over the apices of the brace elements at the influx end of the support.

[0016] In some embodiments, the covering and / or the sealing element / covering element further comprises a woven quarter, on the opposite side of the woven second part of the floating part / floating yarn part. The woven quarter comprises the textured cords / textured yarns, and the textured cords / textured yarns are woven in a flat weave pattern in the woven quarter.

[0017] In some embodiments, the woven fourth part comprises a plurality of extension parts, which overlap the openings defined by the support bracing elements, when the support is in the expanded configuration.

[0018] In some embodiments, the extension parts are Petition 870260046292, dated 05 / 15 / 2026, page 11 / 202 5 / 89 tapered in one direction towards the discharge end of the support.

[0019] In some embodiments, the cover and / or the sealing element / covering element comprises a first protective part, folded over the apices of the bracing elements at the inflow end of the support, and the cover and / or the sealing element / covering element further comprises a second protective part, folded over the apices of the bracing elements at the discharge end of the support.

[0020] In some embodiments, the support is a mechanically expandable support.

[0021] In some embodiments, the support is a plastically expandable support.

[0022] In some embodiments, the covering and / or the sealing element / covering element comprises(s) a plurality of floating parts (e.g., floating wire parts, etc.) spaced apart along the longitudinal axis of the substrate.

[0023] Floating parts or floating yarn parts can be heat-cured to achieve a desired size and texture, for example, to make them softer and more textured.

[0024] The prosthetic heart valve can use PET yarns twisted in a warp direction and PET yarns textured in a weft direction. The PET yarns twisted in a warp direction can be arranged to be woven into a leno pattern, and the PET yarns textured in the weft direction can form a floating yarn section without any weaving structure. The sealing elements can be thermally contracted to achieve a stretch capacity between 80-160%. The support can be a mechanically expandable surface with the cover or sealing element on it.

[0025] The coating and / or sealant may comprise Petition 870260046292, dated 05 / 15 / 2026, page 12 / 202 6 / 89 at least one of: (i) a low-friction layer; or (ii) a low-friction coating on at least part of it. This may include a low-friction layer over another layer of low-friction material and / or strips or a low-friction layer over parts of another layer. The low-friction layer or low-friction coating may be formed by electrospinning a low-friction material onto the backing or another layer of the cover and / or sealant.

[0026] The prosthetic heart valve may also comprise strips of material, which are helically wound around the struts and / or apices at one or both ends of the support.

[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 situated at least partially within the support, and a cover disposed around the support (e.g., partially around, around a part of, or around the whole support). The cover may comprise and may be formed of a sealing element or a cover element, which may be disposed 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 define(s) a plurality of openings that are aligned with the openings in the support.

[0028] In some embodiments, the support comprises an external surface, and the covering and / or sealant / covering element covers the entire external surface of the support. Petition 870260046292, dated 05 / 15 / 2026, page 13 / 202 7 / 89

[0029] In some embodiments, the cover and / or sealant / covering element comprises a first part, adjacent to the inflow end, and the substrate includes a pile layer. The cover and / or sealant / covering element further comprises a second part without a pile layer, adjacent to the discharge end of the substrate, and the second part of the cover and / or sealant / covering element defines the openings of the cover and / or sealant / covering element.

[0030] The preceding and other objects, features, and advantages of the technology described will become clearer from the detailed description presented below, which is developed with reference to the attached figures. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 shows a schematic cross-sectional view of a human heart.

[0032] Figure 2 shows a schematic top view of a mitral valve annulus of a heart.

[0033] Figure 3 is a perspective view of an embodiment of a prosthetic heart valve.

[0034] Figure 4A is a side view in cross section of an annular anchor or docking device arranged in a mitral position of the heart, with a valve prosthesis implanted, according to one embodiment.

[0035] Figure 4B illustrates a cross-sectional side view of an example of a helical anchor or mooring device placed in the mitral position of the heart, with an implanted valve prosthesis.

[0036] Figure 4C is a perspective view of a representative embodiment of an anchor or mooring device. Petition 870260046292, dated 05 / 15 / 2026, page 14 / 202 8 / 89

[0037] Figure 5 is a perspective view of a prosthetic heart valve, including a representative embodiment of a cover.

[0038] Figure 6 is a side elevation view of the prosthetic heart valve of Figure 5.

[0039] Figure 7 is a plan view from the top of the prosthetic heart valve of Figure 5.

[0040] Figure 8 is a side elevation cross-sectional view of the prosthetic heart valve of Figure 5.

[0041] Figure 9 is a perspective view of a representative embodiment of a damping layer including a pile.

[0042] Figure 10 is a side view in cross section of the prosthetic heart valve of Figure 5, positioned in the mitral valve of the heart.

[0043] Figure 11 is a side elevation view of a prosthetic heart valve, including an example of a cover.

[0044] Figure 12 is a perspective view of a support layer, a stencil for producing the support layer, and a damping layer, before the support layer and the damping layer are attached to each other.

[0045] Figure 13 is a side elevation cross-sectional view of a prosthetic heart valve, including an example of a cover.

[0046] Figure 14 is a detailed view of an influx protection part of the cover of Figure 13.

[0047] Figure 15 is a side elevation view of a prosthetic heart valve, including an example of a cover comprising a spacer tissue.

[0048] Figure 16 is a perspective view of a representative embodiment of a spacer cloth including wires of Petition 870260046292, dated 05 / 15 / 2026, page 15 / 202 9 / 89 intertwined fluffs.

[0049] Figure 17 is a side elevation view of the spacer fabric of Figure 16.

[0050] Figure 18 is a plan view from the top of a completed support layer, after it has been cut using a parallelogram stencil.

[0051] Figure 19 is a side elevation view of a prosthetic heart valve, including an example of a cover.

[0052] Figure 20 is a side elevation view of the prosthetic heart valve of Figure 19.

[0053] Figure 21 is a plan view of a discharge end of the prosthetic heart valve of Figure 19.

[0054] Figure 22 is a side elevation cross-sectional view of the prosthetic heart valve of Figure 19.

[0055] Figure 23 is a plan view from the top of the roof of Figure 19 in an unfolded configuration.

[0056] Figure 24 is a perspective view illustrating the placement of the prosthetic heart valve of Figure 19 in the cover, after the cover has been formed into a cylindrical shape.

[0057] Figure 25 is a perspective view of the inflow end of the prosthetic heart valve of Figure 19, illustrating the attachment of the cover to the strut elements of the valve support.

[0058] Figure 26 is a perspective view of the inflow end of the prosthetic heart valve of Figure 19, illustrating a strip element of the cover folded into the strut elements of the valve support to form a protective inflow portion.

[0059] Figure 27 is a perspective view of a support for a prosthetic heart valve, including an example of a cover.

[0060] Figure 28 is a side elevation cross-sectional view of the support and cover of Figure 27. Petition 870260046292, dated 05 / 15 / 2026, page 16 / 202 10 / 89

[0061] Figures 29 - 31A are seen in perspective illustrating a representative method of producing the covering of Figure 27.

[0062] Figure 31B is a detailed view of the electrospun layer of the influx end portion of the cover of Figure 31A.

[0063] Figure 32 is a perspective view of a prosthetic heart valve, including a main cover and a second cover extending over the apices of the support.

[0064] Figure 33 is a side elevation view of the prosthetic heart valve of Figure 32.

[0065] Figure 34 is a plan view of a portion of the prosthetic valve support of Figure 32 in a planar configuration.

[0066] Figure 35 is a perspective view of the prosthetic heart valve of Figure 32 without the main outer covering.

[0067] Figure 36 is a perspective view of the prosthetic heart valve of Figure 32 illustrating how the second cover is wrapped around the apices of the support.

[0068] Figure 37 is a perspective view illustrating the support for the prosthetic valve of Figure 32, including the second cover molded onto an axis of a release device.

[0069] Figure 38A is a side elevation view of the prosthetic valve of Figure 19 including an example of an external cover.

[0070] Figure 38B is a detailed view of the outer covering fabric of Figure 38A.

[0071] Figure 39A is a plan view illustrating the prosthetic heart valve of Figure 38A molded onto a shaft of a delivery device.

[0072] Figure 39B is a detailed view of the outer covering of the prosthetic heart valve in Figure 39A.

[0073] Figure 40A is a side elevation cross-sectional view of the outer covering fabric of Figure 38A in a state Petition 870260046292, dated 05 / 15 / 2026, page 17 / 202 11 / 89 relaxed.

[0074] Figure 40B is a side elevation cross-sectional view of the outer covering fabric of Figure 38A in a state under tension.

[0075] Figure 41A is a plan view of an example of an outer fabric covering for a prosthetic valve in a planar arrangement configuration and including an outer surface defined by a layer of felt.

[0076] Figure 41B is an enlarged view of the outer covering of Figure 41A.

[0077] Figure 42A is a plan view of a base layer of the outer covering of Figure 41A.

[0078] Figure 42B is an enlarged view of the base layer of Figure 42A.

[0079] Figures 43 - 45 are side elevation views of a prosthetic heart valve, including various embodiments of an outer cover including openings.

[0080] Figure 46 is a plan view of an example of a sealing element or a cover element for a prosthetic heart valve, including woven parts and floating parts configured as floating wire parts.

[0081] Figure 47 is an enlarged view of a first woven portion of the sealant or cover element of Figure 46.

[0082] Figure 48 is an enlarged view of a second woven part of the sealant or cover element of Figure 46.

[0083] Figure 49 is an enlarged view of a floating wire portion of the sealant or cover element of Figure 46 in a relaxed state.

[0084] Figure 50 illustrates the floating wire portion of Figure 49 in a stretched state. Petition 870260046292, dated 05 / 15 / 2026, page 18 / 202 12 / 89

[0085] Figure 51 is a plan view of the sealant or cover element of Figure 46 in a stretched state.

[0086] Figure 52 is a perspective view illustrating a portion of the edge of the sealant or cover element of Figure 46.

[0087] Figure 53 is a side elevation view of a prosthetic heart valve having an outer covering including the sealing element or covering element of Figure 46, according to one embodiment.

[0088] Figure 54 illustrates the prosthetic heart valve of Figure 53 molded into a balloon at the distal end of a delivery device.

[0089] Figures 55A - 55J illustrate various examples of leno weaving patterns and leno weaving techniques.

[0090] Figure 56 is a perspective view of a mechanically expandable prosthetic heart valve, according to one embodiment.

[0091] Figure 57 is a side elevation view of an example of a mechanically expandable support for a prosthetic heart valve.

[0092] Figure 58 is a plan view of an example of a sealing element or a cover element for a prosthetic heart valve.

[0093] Figure 59 is an enlarged view of a portion of the sealant or cover element of Figure 58.

[0094] Figure 60 is a side elevation view showing an example of a cover formed from the sealant element or cover element of Figure 58, attached to the support of Figure 57 in the radially expanded configuration.

[0095] Figure 61 is a perspective view of the part of Petition 870260046292, dated 05 / 15 / 2026, page 19 / 202 13 / 89 influx end of the support and cover assembly of Figure 60.

[0096] Figure 62 is a side elevation view of the support and cover of Figure 60 in the radially deformed configuration. DETAILED DESCRIPTION

[0097] The present description relates to embodiments of implantable prosthetic heart valves and to methods of production and use of such devices. In one aspect, a prosthetic heart valve includes a shell or outer covering having a support layer and a main cushioning layer disposed in the support layer, such that the cushioning layer is radially oriented outward around the circumference of the valve. The cushioning layer may be soft and conformable to reduce damage to the native tissues of the heart valve and / or to the surrounding anatomy at the implantation site, due, for example, to movement or relative friction between the prosthetic valve and the tissue as the heart expands and contracts.The cover may also include an inflow protective portion and an discharge protective portion to cushion the surrounding anatomy and prevent native heart valve tissue from contacting the apices of the strut elements of the support, thereby protecting the surrounding tissue. In one embodiment, the cover may include an inflow strip element and a discharge strip element attached to the cushioning layer and folded over the apices of the strut elements to form the inflow and discharge protective portions.

[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 blood flow. Petition 870260046292, dated 05 / 15 / 2026, p. 20 / 202 14 / 89 between the left atrium and the left ventricle. After the left atrium receives oxygenated blood from the lungs via the pulmonary veins, the mitral valve allows oxygenated blood to flow from the left atrium to the left ventricle. When the left ventricle contracts, the oxygenated blood, which was retained in the left ventricle, is released through the aortic valve and into the aorta to the rest of the body. However, the mitral valve closes during ventricular contraction to prevent any blood from flowing back into the left atrium.

[0099] When the left ventricle contracts, blood pressure in the left ventricle increases substantially, which causes the mitral valve to close. 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 into the atrium. A series of chordae tendineae therefore connect the left ventricular leaflets to the papillary muscles located in the walls of the left ventricle, in which both the papillary muscles and the chordae tendineae are tensed 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 into the left atrium. The chordae tendineae are illustrated schematically in both the cross-section of the heart in Figure 1 and the view from above of the mitral valve in Figure 2.

[00100] A general view of the mitral valve and its leaflets, seen from the left atrium, is shown in Figure 2. Several mitral valve complications can potentially cause fatal heart failure. One form of valvular heart disease is mitral valve leakage or mitral regurgitation, characterized by abnormal leakage of blood from the left ventricle through the mitral valve back into the left atrium. This can be caused, for example, by dilation of the Petition 870260046292, dated 05 / 15 / 2026, p. 21 / 202 15 / 89 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 the native leaflets. In these circumstances, it may be desirable to repair the mitral valve, or to replace the functionality of the mitral valve with that of a prosthetic heart valve, such as a transcatheter heart valve.

[00101] Some transcatheter heart valves are designed to be amolded or compressed to facilitate endovascular release at an implantation site in a patient's heart. Once positioned in a native valve annulus, the replacement valve is then expanded to an operational state, for example, by an expansion balloon, so that a leaflet structure of the prosthetic heart valve regulates blood flow by the angle of the native valve. In other cases, the prosthetic valve may be mechanically expanded or radially self-expanded from a compressed release state to the 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 XT™ valve.The prosthetic valve 1 in Figure 3 has an inflow end 2 and an outflow 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 inner surface of the support 10 to form a more suitable attachment surface for the valve leaflets of the leaflet structure 20.

[00102] Support 10 can be made of any expandable material compatible with the human body, which allows both demolding to a radially deformed state and expansion back to the state Petition 870260046292, dated 05 / 15 / 2026, page 22 / 202 16 / 89 functional expanded as illustrated in Figure 3. For example, in embodiments where the prosthetic valve is a self-expanding prosthetic valve, which expands to its functional size under its own resilience, the support 10 may be made of Nitinol or another 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-chromium alloy. Other suitable materials or combinations thereof may also be used.

[00103] The support 10 may comprise an annular structure having several vertically extending commissure fixing columns 11, which attach to and help form the leaflet structure 20 thereon. Additional vertical columns or strut elements 12, together with circumferentially extending strut elements, help form the rest of the support 10. The strut elements 13 of the support 10 make a zigzag motion and form crown parts or pointed apices 14 at the inflow and discharge ends 2, 3 of the valve 1. Furthermore, the fixing columns 11 may also form edges at one or both ends of the support 10.

[00104] In the prosthetic valve 1, the skirt 30 can be attached to an inner surface of the valve support 10 by means of one or more lines 40, which generally wrap around the outside of several supports 11, 12, 13 of the support 10, if necessary. The skirt 30 provides a more substantial attachment surface for the leaflet structure parts 20, positioned closer to the inflow end 2 of the valve 1.

[00105] Figures 4A and 4B show cross-sectional views of different anchor embodiments, which can be used for Petition 870260046292, dated 05 / 15 / 2026, page 23 / 202 17 / 89 to facilitate the implantation of valve 1 in a native valve, such as in the mitral valve position or in the tricuspid valve position of an 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 the left atrium 82 to the left ventricle 84. The mitral valve 86 includes the anterior and posterior leaflets 88, which are connected to an inner wall of the left ventricle 84 by means of the chordae tendineae 90 and the papillary muscles 92.

[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 chordae tendineae 90. The ring 60 tightens or pushes parts of the leaflets inward, to form a more circular opening in the native valve, for 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 docking device), and can be released to the position shown, for example, by positioning the valve 1 in the native valve 86, while the prosthetic valve 1 is released and expanded once it is positioned as shown in Figure 4A. Once expanded, the prosthetic valve 1 pushes outward against the annular anchor 60 to fix the positions of both the valve 1 and the annular anchor 60.In some embodiments, an undersized annular anchor 60, with an inner diameter that is slightly smaller than the diameter of the prosthetic valve 1 in its expanded state, can be used to provide stronger friction between the parts, resulting in a firmer fixation. As can be seen in Figure 4A, at least part of the leaflets 88 and / or part of the chordae tendineae 90 of the native valve is squeezed or sandwiched between the valve 1 and the annular anchor 60 to fix the components to the native anatomy. Petition 870260046292, dated 05 / 15 / 2026, page 24 / 202 18 / 89

[00107] Figure 4B is similar to Figure 4A, except that instead of an annular anchor 60, a helical or spiral anchor or docking device 70 is used. The helical anchor 70 may include more coils or turns than the annular anchor 60, and may extend both upstream and downstream of the native valve 86. The helical anchor 70 may, in some situations, provide a larger and firmer attachment area against which the prosthetic valve 1 may rest. Similar to the annular anchor 60 in Figure 4A, at least part of the leaflets 88 and / or the cords 90 of the native valve is clamped between the valve 1 and the helical anchor 70. The methods and devices for implanting anchors / anchoring devices and prosthetic valves, which can be used with the inventions in this description, are described in US patent application No. 15 / 682,287, filed August 21, 2017 and published as US 2018 / 0055628, US patent application No. 15 / 684.US Patent Application No. 836, filed August 23, 2017 and published as US 2018 / 0055630 and US Patent Application No. 15 / 984,661, filed May 21, 2018 and published as US 2018 / 0318079, which are all incorporated by reference in this descriptive report.

[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 descriptive report. The anchor 300 has a functional coil / turn region or central region 302 and a surrounding lower turn or region 304. The anchor 300 may also optionally have an upper region 306. The lower region 304 includes one or more turns, which can be configured to encircle or capture the chordae tendineae and / or leaflets of a native valve, such as a mitral valve or a tricuspid valve. The central region 302 includes several turns configured to maintain the prosthetic valve in the state. Petition 870260046292, dated 05 / 15 / 2026, page 25 / 202 19 / 89 native. The upper region 306 may include one or more turns, and may be configured to prevent the anchor from being displaced from the valve annulus prior to implantation of the prosthetic valve. In some embodiments, the upper region 306 may be positioned over the floor of the atrium, and may be configured to keep the turns of the central region 302 positioned high within the native valve appliance.

[00109] Anchor 300 may optionally also include an extension portion 308, positioned between the central region 302 and the upper region 306. In some embodiments, the extension portion 308 may be positioned alternatively, for example, entirely in the central region 302 (e.g., in an upper part of the central region) or entirely in the upper region 306. The extension portion 308 includes a coil portion that extends substantially parallel to a central axis of the anchor. In some embodiments, the extension portion 308 may be angled relative to the central axis of the anchor. In some embodiments, the extension portions 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.The extension portion 308 can serve to space the central region 302 from the upper region 306 in a direction along the central axis, so that a gap is formed between the atrial and ventricular sides of the anchor.

[00110] The 308 extension portion of the anchor can be configured to be positioned at, near, and / or around the native valve annulus to reduce the portion of the anchor that passes through, pushes against, or rests against the native annulus and / or native leaflets when the anchor is deployed. This can reduce the force applied by the anchor to the native valve and reduce abrasion of the native leaflets. In one arrangement, the 308 extension portion is positioned at and passes through one of the commissures of the native valve. In this way, the 308 extension portion Petition 870260046292, dated 05 / 15 / 2026, page 26 / 202 20 / 89 can space the upper region 306 from the native valve leaflets to prevent the upper region 306 from interacting with the native leaflets on the atrial side. The extension portion 308 also elevates the upper region 306 so that the upper region contacts the atrial wall above the native valve, which can reduce tension on and around the native valve, as well as provide better anchor retention.

[00111] As shown in Figure 4C, the 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 may serve, for example, as suture holes for attaching a cover layer to the anchor coil, and / or as a point of attachment or tie-down holes for release tools such as a pull wire, a retaining element, a retaining suture, etc. In some embodiments, the width or thickness of the anchor coil 300 may be varied along the length of the anchor. For example, a central portion of the anchor and / or extension 308 may be made thinner than the end portions of the anchor. This may allow the central portion and / or extension 308 to exhibit greater flexibility, while the end portions may be stronger or more robust.In certain examples, producing the coil ends relatively thicker can also provide a larger surface area for suturing or otherwise attaching a covering layer to the anchor coil.

[00112] In certain embodiments, the anchor or docking device 300 may be configured for insertion through the annulus of the native valve in a counterclockwise direction. For example, the anchor may be advanced through the A3P3 commissure, the A1P1 commissure, or another part of the native mitral valve. The counterclockwise direction of the anchor coil Petition 870260046292, dated 05 / 15 / 2026, page 27 / 202 21 / 89 300 may also allow bending of the distal end of the delivery catheter in a similar counterclockwise direction, which may be easier to achieve than bending the delivery catheter in a clockwise direction. However, it should be understood that the anchor can be configured for clockwise or counterclockwise insertion by the valve, as desired.

[00113] Returning 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 apices 14 and protruding commissure fixation columns 11, as well as lines 40, which may be exposed along an outer surface of the support 10. These features can cause damage to native tissue, such as, for example, the tissue lodged between the prosthetic valve 1 and the anchor 60, 70, by movement or friction between the native tissue and the various abrasive surfaces of the prosthetic valve 1. Furthermore, other native tissue very close to the prosthetic valve 1, such as the chordae tendineae, can also potentially be damaged.

[00114] Figures 5-7 illustrate a representative embodiment of a prosthetic heart valve 100 similar to the Edwards Lifesciences SAPIEN XTTM3 valve, which is described in detail in US patent 9,393,110, which is incorporated by reference in this descriptive report. The prosthetic valve 100 includes a support 102, formed by several angled strut elements 104 and having an inflow end 106 and an outflow end 108. The prosthetic valve 100 also includes a leaflet structure, comprising three leaflets 110 situated at least partially within the support 102 and configured to deform in a tricuspid arrangement similar to the aortic valve, although the prosthetic valve may also include two leaflets, configured in a tricuspid arrangement in the manner of the Petition 870260046292, dated 05 / 15 / 2026, page 28 / 202 22 / 89 mitral valve, or more than three leaflets if desired. The strut elements 104 may form a plurality of apices 124, arranged around the inflow and outflow ends of the support.

[00115] The prosthetic heart valve may include a cover or outer covering 112, configured to cushion (protect) native tissue in contact with the prosthetic heart valve after implantation and to reduce tissue damage due to movement or friction between the tissue and the valve surfaces. The cover 112 may also reduce paravalvular leakage. In the embodiment of Figure 5, the cover 112 includes a first layer, configured as a support layer 114 (see, for example, Figure 8), and a second layer, configured as a cushioning layer 116. The cushioning layer 116 may be disposed over the support layer 114 and may comprise a soft plush surface 118, radially oriented outwards so as to protect tissue or objects in contact with the cushioning layer.In the illustrated configuration, the cover 112 also includes an atraumatic influx protective part 120, which extends circumferentially around the influx end 106 of the support, and an atraumatic discharge protective part 122, which extends circumferentially around the discharge end 108 of the support. The cushioning layer part 116, between the influx and discharge protective parts 120, 122, may define a main cushioning part 136. The first layer 114 and the second layer 116 may together form a sealing element or a covering element, which may be placed around the support to form the cover 112. The sealing element / covering element may also comprise the protective parts 120, 122.

[00116] Figure 8 is a cross-sectional view schematically illustrating the 100 prosthetic valve with leaflet structure. Petition 870260046292, dated 05 / 15 / 2026, page 29 / 202 23 / 89 removed for illustration purposes. The cover 112 extends around the outer part of the support 102, so that an inner surface of the damping layer 114 is adjacent to or against the outer surfaces of the strut elements 104. As illustrated in Figure 8, the damping layer 116 may have a length that is greater than the length of the support, measured along a longitudinal axis 126 of the support. Thus, the cover 112 may be situated so that the damping layer 116 extends distally (e.g., in the upstream direction) beyond the apices 124 of the strut elements at the inflow end 106 of the support, with the portion of the damping layer extending beyond the apices being referred to in this descriptive report as the distal end portion 128.At the opposite end of the valve, the damping layer 116 may extend proximally (e.g., in the downstream direction) beyond the apices 124 of the strut elements, with the portion located beyond the apices being referred to as the proximal end portion 130. The distances by which the distal and proximal end portions 128, 130 of the damping layer 116 extend beyond the apices, at the respective end of the valve, may be equal or different depending on, for example, the dimensions of the valve, the particular application, etc.

[00117] The support layer 114 may have sufficient length in the axial direction, such that a proximal end portion, or flap, 132 of the cushioning layer 114 may be folded into the proximal end portion 130 of the cushioning layer 116 in the manner of a cuff to form the discharge protective portion 122. However, a distal end portion, or flap, 134 of the cushioning layer 114 may be folded into the distal end portion 128 of the cushioning layer 116 to form the influx protective portion 120. The proximal and distal flaps 132, 134 of the layer of Petition 870260046292, dated 05 / 15 / 2026, page 30 / 202 24 / 89 cushioning 116 can be fixed to the underlying section of the cushioning layer by means of fastening, for example, sutures 136, adhesive, staples, etc. In this way, the inflow and discharge protective parts 120, 122 are constructed so that the proximal and distal end parts 130, 128 of the cushioning layer 116 are at least partially surrounded by the tabs 132, 134 of the cushioning layer 116. This construction provides sufficient mechanical strength and resistance to bending to the inflow and discharge protective parts 120, 122, so that they extend along the longitudinal axis 126 of the valve without bending or otherwise projecting into the inner diameter of the valve (for example, by bending under their own weight, by blood flow or by blood pressure).In this way, the protective inflow and discharge parts 120, 122 minimally impact the flow through the prosthetic valve and avoid interference with the prosthetic valve leaflets, reducing flow disturbances and potentially reducing the risk of thrombus formation.

[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 by a distance d2. The distances d1 and d2 may be equal or different depending on the type of prosthetic valve, the treatment location, etc. For example, for a 29 mm prosthetic valve, the distances d1 and d2 may be from about 0.5 mm to about 3 mm. In a representative embodiment, the distances d1 and d2 may be from about 1 mm to about 2 mm. By virtue of the inflow and discharge protective parts 120, 122 extending beyond the apices 124 of the respective ends of the support, the inflow and discharge protective parts Petition 870260046292, dated 05 / 15 / 2026, page 31 / 202 25 / 89 can shield the adjacent tissue and / or another implant adjacent to the prosthetic valve from contact with the apices 124 of the support.

[00119] For example, Figure 10 illustrates the prosthetic valve 100 implanted within an anchor or docking device 70 on the native valve 86, similar to Figures 4A and 4B mentioned above. In the illustrated example, the inflow end portion of the prosthetic valve is shown positioned above the superior surface of the native valve annulus and spaced from the surrounding tissue. However, in other implementations, depending on the axial positioning of the prosthetic valve, which may vary, the inflow protective portion 120 may contact the native leaflets 88 and prevent them from directly contacting the apices 124 at the inflow end of the support. Depending on the diameter of the prosthetic valve at the inflow end, the inflow protective portion 120 may serve to prevent the atrial wall from directly contacting the apices 124 of the inflow end of the support.

[00120] As shown in Figure 10, the anchor 70 can rest against the conformable inflow protection part 120. However, the native leaflet portions 88, trapped between the anchor 70 and the prosthetic valve 100, can be cushioned by the plush surface 118 of the main cushioning part 136. In certain embodiments, the conformable, soft nature and texture of the cushioning layer 116 can increase friction between the native leaflets and the prosthetic valve. This can reduce the relative movement of the native leaflets and the prosthetic valve as the left ventricle expands and contracts, reducing the likelihood of damage to the native leaflets and surrounding tissue. The cushioning layer 116 can also provide greater retention forces between the anchor 70 and the prosthetic valve 100. The compressible nature of the plush cushioning layer 116 can also reduce the penetration of the cover 112. Petition 870260046292, dated 05 / 15 / 2026, page 32 / 202 26 / 89 through the openings in the support 120, caused by applying pressure to the cover, thereby reducing interference with the hemodynamics of the valve. Additionally, the valve guide protrusion on the intake side 122 can protect the chordae tendineae 90 from contact with the support's strut elements, and in particular with the apices 124 at the discharge end of the support, thus reducing the risk of injury or rupture of the chordae tendineae.

[00121] The backing layer 114 may comprise, for example, any of various woven fabrics, such as gauze, poly(ethylene terephthalate) (PET) fabric (e.g., Dacron), polyester fabric, polyamide fabric, or any of various 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 polytetrafluoroethylene (PTFE), PET, polypropylene, polyamide, poly(ether-ether-ketone) (PEEK), etc. In this way, the backing layer 114 may be relatively thin and yet strong enough to allow the cover 112 to be sutured to the backing, and allow the prosthetic valve to be molded without tearing.

[00122] As indicated above, the cushioning layer 116 may comprise at least one soft plush surface 118. In certain examples, the cushioning layer 116 may be made of any of several woven or knitted fabrics, wherein the surface 116 is the surface of a down or pile of the fabric. Exemplary fabrics having a pile include velour, velvet, velvet, corduroy, terry cloth, wool, etc. Figure 9 illustrates a representative embodiment of the cushioning layer 116 in more detail. In the embodiment of Figure 9, the cushioning layer 116 may have a base layer 162 (a first layer) from which the pile 158 (a second layer) extends. Petition 870260046292, dated 05 / 15 / 2026, page 33 / 202 27 / 89 base layer 162 may comprise warp and weft cords (e.g., yarns, etc.) woven or knitted in a mesh-like structure. For example, in a representative configuration, the base layer 162 cords / yarns may be flat cords / yarns with a denier range of about 7 dtex to about 100 dtex, and may be knitted with a density of about 20 to about 100 skeins per 2.54 centimeters (one inch) and about 30 to about 110 skeins per 2.54 centimeters (one inch). The cords / yarns may 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] The pile 158 may comprise pile cords or pile yarns 164 woven or knitted into loops. In certain configurations, the pile cords or pile yarns 164 may be warp cords / yarns or weft cords / yarns of the base layer woven or knitted to form the loops. The pile cords or pile yarns 164 may also be separate cords / yarns incorporated into the base layer, depending on the particular characteristics desired. In certain embodiments, the loops may be cut so that the pile 158 is a pile cut in the manner of, for example, a velour fabric. Figures 5-8 illustrate a representative embodiment of the cushioning layer 116 configured as a velour fabric. In some embodiments, the loops may be left intact to form a looped pile in the manner of, for example, a terry cloth.Figure 9 illustrates a representative embodiment of the cushioning layer 116, in which the pile cords or pile yarns 164 are knitted to form loops 166. Figure 11 illustrates an embodiment of the cover 112 incorporating the cushioning layer 116 of Figure 9. Petition 870260046292, dated 05 / 15 / 2026, page 34 / 202 28 / 89

[00124] In some configurations, the plush cords or plush yarns 164 are textured cords / yarns having a larger surface area, due, for example, to a wavy or corrugated structure. In configurations such as the looped plush embodiment of Figure 11, the loop structure and larger surface area afforded by the textured cords or yarns of the loops 166 may allow the loops to act as a platform for tissue growth in and around the plush loops. The promotion of tissue growth in the plush 158 may increase valve retention at the implant site and contribute to long-term valve stability.

[00125] The embodiments of the cushioning layer described in this descriptive report may also contribute to the improved compressibility and shape memory properties of the cover 112 over known valve covers and skirts. For example, the pile 158 may be conformable so that it compresses under load (e.g., when in contact with tissue, implants or the like) and returns to its original size and shape when the load is released. This may help to improve the seal between the cushioning layer 116 and, for example, supporting structures or other devices, such as the helical anchor 70, in which the prosthetic valve is disposed, or between the cushioning layer and the walls of the native annulus. The compressibility provided by the pile 158 of the cushioning layer 116 is also beneficial for reducing the amolding profile of the prosthetic valve.Additionally, cover 112 can prevent leaflets 110 or parts thereof from extending into spaces between the bracing elements 104 as the prosthetic valve is molded, thereby reducing damage to the prosthetic leaflets due to the bracing being squeezed between the bracing elements.

[00126] In some embodiments, the damping layer Petition 870260046292, dated 05 / 15 / 2026, p. 35 / 202 29 / 89 116 is made of nonwoven fabric, such as felt, or fibers, such as nonwoven cotton fibers. The cushioning layer 116 may also be made of porous or spongy materials, such as, for example, any of various conformable polymeric foam materials, or woven or knitted fabrics, such as woven or knitted PET. In some embodiments, the proximal and distal end portions of the cushioning layer 116 of the embodiment in Figure 11 are free of loops 166, and the inflow and discharge protective portions 120, 122 are formed by folding the base layer 162 back upon itself to form cuffs at the inflow and discharge ends of the valve.

[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 (e.g., a PET fabric) with a stencil 138 to form the cushioning layer 114. In the illustrated embodiment, the stencil 138 is formed as a parallelogram, although other configurations and shapes are possible. The corner angles of the 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 damping of the resulting backing layer 114 by, for example, allowing the backing layer to stretch along a direction diagonal to the warp and weft cords / yarns. Figure 18 illustrates a plan view of a representative example of the support layer 114, after being cut using the parallelogram stencil 138.

[00128] The cushioning layer 116 can be attached (e.g., 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 dressing is attached to the support, is represented as dashed lines 140, 141 on the support layer 114. However, the lines Petition 870260046292, dated 05 / 15 / 2026, page 36 / 202 30 / 89 dashed lines 142, 144 represent the location of the proximal and distal edges of the cushioning layer 116, once the cushioning layer is attached to the support layer. For example, the cushioning layer 116 can be sutured to the support layer 114 along the proximal and distal edges at or near lines 142, 144. As shown in Figure 12, line 142, representing the proximal edge of the cushioning layer 116, can be offset from the proximal edge 146 of the support layer 114 by a distance d3 to create the proximal tab 132. However, line 144 representing the distal edge of the cushioning layer 116 can be offset from the distal edge 148 of the support layer 114 by a distance d4 to create the distal tab 134. The distances d3 and d4 can be equal or different, as desired.For example, depending on the valve size 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] Once the cushioning layer 116 is attached to the support layer 114, the resulting template can be folded and sutured into a cylindrical shape. The tabs 132, 134 of the support layer 114 can be folded onto the edges of the cushioning 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 102 by means of fastening, for example, suturing, stapling, adhesion, etc., from it to the bracing elements 104.

[00130] Figures 13 and 14 illustrate an example of the 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 damping layer 116 at the inflow and discharge ends of the valve. For example, the proximal end part 130 of the damping layer 116 can be covered by Petition 870260046292, dated 05 / 15 / 2026, page 37 / 202 31 / 89 an element configured as a strip 150 of material, which wraps around the cushioning layer from the inner surface 170 (e.g., the surface adjacent to the support) of the cushioning layer 116, over the circumferential edge of the proximal end portion 130, and over the outer surface 118 of the cushioning layer to form the discharge protective portion 122. Similarly, a strip element of material 152 may extend from the inner surface 170 of the cushioning layer, over the circumferential edge of the distal end portion 128, and to the outer end of the cushioning layer to form the influx protective portion 120. The strip elements 150, 152 may be sutured to the cushioning layer 116 along the proximal and distal edge portions 130, 128 of the cushioning layer at suture lines 154, 156, respectively.

[00131] In certain configurations, strip elements 150, 152 may be made from any of several materials and / or tissues, such as pericardial tissue (e.g., bovine pericardial tissue). Strip elements 150, 152 may also be made from any of several synthetic materials, such as PET and / or expanded polytetrafluoroethylene (ePTFE). In some configurations, producing strip elements 150, 152 from natural tissues, such as pericardial tissue, may provide desirable properties such as mechanical strength, durability, fatigue resistance and conformability, and reduced damping and friction with materials or tissues surrounding the implant.

[00132] Figure 15 illustrates a prosthetic valve 200, which includes an example of a cover or outer cover 202, comprising a cushioning layer 204 made of a spacer fabric. In the illustrated embodiment, the outer cover 202 is shown without the protective inflow and discharge parts, and with the Petition 870260046292, dated 05 / 15 / 2026, page 38 / 202 32 / 89 cushioning 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 descriptive report. The cushioning layer 204 may be or may form a sealing element or a covering element, which may be attached to the support to form the cover 202.

[00133] With reference to Figures 16 and 17, the spacer fabric cushioning layer 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 may be woven or knitted fabric layers. In certain configurations, one or more of the first and second layers 206, 208 may be woven so as to define a plurality of openings 212. In some examples, the openings, such as the openings 212, may promote fabric growth in the covering 202. In some embodiments, the layers 206, 208 need not define openings but may be porous if desired.

[00134] The spacer layer 210 may comprise a plurality of pile cords or pile yarns 214. The pile cords or pile yarns 214 may be, for example, single-strand cords / yarns arranged to form a plank-like structure between the first and second layers 206, 208. For example, Figures 16 and 17 illustrate an embodiment in which the pile cords or pile yarns 214 extend between the first and second layers 206, 208 in a sinusoidal or spiral pattern.

[00135] In certain examples, plush cords or plush threads 214 may have a stiffness that is greater than the stiffness of the fabric. Petition 870260046292, dated 05 / 15 / 2026, p. 39 / 202 33 / 89 of the first and second layers 206, 208, so that the pile cords or pile yarns 214 can extend between the first and second layers 206, 208 without deformation under the weight of the second layer 208. The pile cords or pile yarns 214 can also be sufficiently resilient so that the pile cords or pile yarns can bend or yield when subjected to a load, allowing the fabric to compress, and return to their undeflected state when the load is removed.

[00136] The spacer fabric can be warp-knitted or weft-knitted as desired. Some spacer fabric configurations can be made on a double-bar knitting machine. In a representative example, the first and second layer cords / yarns 206, 208 can have a denier range of about 10 dtex to about 70 dtex, and the cords / yarns of the 214 single-strand plush cords / yarns can have a denier range of about 0.0051 inch (2 mils) to about 0.0254 centimeter (10 mils). Plush cords or plush yarns 214 can have a knitting density of about 10 to about 100 straps per 2.54 centimeters (one inch) and about 30 to about 110 rows 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 fabric to enhance the overall flexibility of the spacer fabric.

[00137] Figures 19-21 illustrate an example of a prosthetic heart valve 400, which includes an outer covering with protective inflow and discharge parts that encapsulate the apices of the strut 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 Petition 870260046292, dated 05 / 15 / 2026, page 40 / 202 34 / 89 plurality of leaflets 410 can be situated at least partially within the support 402.

[00138] The prosthetic valve may include a cover or an outer cover 412 situated around the support 402. The outer cover 412 may include a main layer or a main cushioning layer 414 including a plush outer surface 432 (e.g., a first surface), similar to the cushioning layer 116 of Figure 13 mentioned above. The cover 412 may also include an inflow protective portion 416, which extends circumferentially around the inflow end 406 of the valve, and a discharge protective portion 418, which extends circumferentially around the discharge end 408 of the valve. The inflow and discharge protective parts 416, 418 can be formed from separate pieces of material, which are folded around the circumferential ends of the damping layer 414 at the inflow and discharge ends of the valve, so that the protective parts encapsulate the apices 420 of the thrust elements.Layer 414, alone or in conjunction with protective parts 416, 418, can form a sealing element or a covering element, which can be placed around the substrate to form the covering 412.

[00139] For example, with reference to Figure 22, the influx protection 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 material strip element 424 may be folded so that the circumferential edge part 426 is adjacent to (e.g., in contact with) an inner skirt 430 disposed within the support 402. The first circumferential edge part 426 thus forms a first or inner layer of the influx protection part 416. The Petition 870260046292, dated 05 / 15 / 2026, page 41 / 202 35 / 89 strip element 424 can extend through the apices 420 of the strut elements and through an influx end portion 422 of the damping layer 414, so that the second circumferential edge portion 428 is disposed on the outer surface 432 of the damping layer 414. In this way, the influx end portion 422 of the damping layer 414 can form a second layer of the influx protective portion 414, and the second circumferential edge portion 428 can form a third or outer layer of the influx protective portion. The first and second circumferential edge parts 426, 428 of the strip element 424 can be fixed to the strut elements 404 (for example, the strut step closest to the influx end 406) with fastening means such as sutures 434 and 435, adhesive, etc.Thus, the strip element 424 can encapsulate the apices 420, together with the influx end portion 422 of the damping layer 414, between the first and second circumferential edge portions 426, 428.

[00140] In the illustrated configuration, the influx protective portion 416 extends beyond the apices 420 of the support, similarly to the embodiments presented above. In particular, the influx protective portion 422 of the cushioning layer 414 can extend beyond the apices 420 of the support and into the influx protective portion 416 within the folded strip 424. In this way, the influx end portion 422 of the cushioning layer 414, together with the strip element 424, can impart a resilient cushioning quality to the influx protective portion 416. This can also allow the influx protective portion 416 to deform resiliently to accommodate and protect, for example, native tissue, other implants, etc., that come into contact with the influx protective portion.

[00141] Optionally, one or more additional materials or layers may be included under and / or form any of the parts. Petition 870260046292, dated 05 / 15 / 2026, page 42 / 202 36 / 89 protective pads (e.g., 120, 122, 416, 418, 518, 520, etc.) to provide additional cushioning and / or protection at the apex of the support.

[00142] In the illustrated embodiment, the influx end portion 422 can extend beyond the apices 420 by a distance d1. The distance d1 can be configured so that the portion 5 and 422 can extend through or cover the apices 420, where the influx protective portion 416 comes into contact with, for example, native tissue at the treatment site. The strip element 424 can also form a dome over the edge of the influx end portion 422, so that the edge of the influx end portion 422 is spaced from the domed portion of the strip element 424. In some embodiments, the strip element 424 is bent so that it contacts the edge of the influx edge portion 422, similarly to the embodiment in Figure 13.

[00143] The discharge protection portion 418 may include an element configured as a strip 436 of folded material such that a first circumferential edge portion 438 is adjacent to (e.g., in contact with) the inner surfaces 440 of the strut elements, and a second circumferential edge portion 442 is disposed on the outer surface 432 of the damping layer 414, similarly to the influx protection portion 416. A discharge end portion 444 of the damping layer 414 may extend beyond the apexes 420 by a distance d2 and may be encapsulated by the strip element 436 together with the apexes 420, between the first and second circumferential edge portions 438, 442. The distance d2 may be equal to or different from the distance d1, as desired. The strip element 436 can be fixed to the bracing elements 404 with fastening means such as sutures 446 and 447, adhesive, etc.The strip element 436 can also generate a dome shape similar to the strip element 424. Petition 870260046292, dated 05 / 15 / 2026, p. 43 / 202 37 / 89

[00144] In certain configurations, the cushioning layer 414 may be a fabric, including a pile, such as a velour fabric, or any other type of woven or non-woven, knitted plush material, as described above. In some embodiments, the cushioning layer 414 may also comprise a relatively thin woven cloth without a pile. In certain configurations, the strip elements 424, 436 may be made of resilient natural woven materials, such as pericardium. Optionally, the strip elements may also be produced from woven or polymeric materials, such as PTFE or ePTFE.

[00145] Figures 23-26 illustrate a representative method of producing the outer cover or cover 412 and attaching the cover to the prosthetic valve 400 to form the inflow and discharge protective parts 416, 418. Figure 23 illustrates the outer cover 412 in an unfolded configuration before attaching the cover to the support 402. As illustrated in Figure 23, the second circumferential edge part 428 of the strip element 424 can be sutured to the plush surface 432 (e.g., the first surface) of the damping layer 414 at the inflow end part 422 of the damping layer. The second circumferential edge part 422 of the strip element 436 can be sutured to the plush surface 432 of the damping layer 414 at the discharge end part 444 of the damping layer.

[00146] In the illustrated configuration, the damping layer 414 and the strip elements 424, 436 may have a length dimension L corresponding to a circumference of the support 402. In a representative example, the length dimension L may be approximately 93 mm. The strip elements 424, 436 may also have respective width dimensions Wi, W2. With reference to the dimension Petition 870260046292, dated 05 / 15 / 2026, p. 44 / 202 38 / 89 width Wi for illustrative purposes, the width dimension Wi 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 apexes 420 of the strut elements, as shown in Figure 22. For example, the width dimension Wi can be configured so that the strip element 424 extends adjacent to the strut element step 404 at the influx end 406 of the support to the outside of the valve, adjacent to the same strut element step, and generates a domed shape over the apexes 420. In certain configurations, the width dimension Wi can be about 6 mm. The width dimension W2 can be the same as or different from W1, as desired.

[00147] With reference to Figure 24, the outer cover 412 can be folded and sutured into a cylindrical shape. The outer cover 412 can then be situated around the support 402, so that a second or inner surface 454 of the cushioning layer 414 is oriented towards the support. In certain configurations, the support 402 may already include the inner skirt 430 and the leaflet structure 410, as shown in Figure 24.

[00148] With reference to Figures 25 and 26, the outer cover 412 can then be sutured to the support. For example, as illustrated in Figure 25, the strip element 424 can be aligned with an adjacent step of strut elements 404 (e.g., the step of strut elements closest to the influx end of the support). The cushioning layer 414 and / or the strip element 424 can be sutured to the strut elements 404 at suture line 434. The strip element 424 can then be bent at the apices 420 at the influx end of the support, and the first and second circumferential edge portions 426, 428 can be sutured together at suture line 435 to form the influx protective portion 416. In some embodiments, the strip element 424 is Petition 870260046292, dated 05 / 15 / 2026, page 45 / 202 39 / 89 folded and sutured to form the protective influx portion 416 before the outer covering 412 is sutured to the support.

[00149] The protective discharge portion 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 be sutured to the strut elements. The strip element 436 can then be bent at the apices 420 and the damping layer 414 at the discharge end of the support, and the first and second circumferential edge portions 438, 442 can be sutured together and to the step of the strut elements 404 adjacent to the discharge end of the support, to form the protective discharge portion 418. The cover 412 can also be sutured to the support at one or more additional locations, such as suture lines 448 and 450, as shown in Figure 22.

[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 US patent 9,393,110. The prosthetic valve 500 may have an inflow end 508 and an discharge end 510 and may include a leaflet structure (not shown) situated at least partially within the support.

[00151] The prosthetic valve may include an outer cover 514, situated around the support 502. The cover or outer cover 514 may include a main cushioning layer 516 (also referred to as a main layer) having a cylindrical shape and made of a woven or knitted fabric (e.g., a PET fabric, an ultra-high molecular weight polyethylene (UHMWPE) fabric, a PTFE fabric, etc.). In some embodiments, the fabric of Petition 870260046292, dated 05 / 15 / 2026, page 46 / 202 40 / 89 main cushioning layer 516 may include a pile. In some embodiments, the main cover fabric 516 may comprise textured cords (e.g., textured yarns, etc.), in which the constituent fibers of the cords / yarns have been bulked up by being, for example, twisted, thermally cured and untwisted, so that the fibers retain their twisted, deformed sizes and create a bulky fabric. The bulk contributed by the textured cords / yarns may enhance the cushioning properties of the cover, as well as increase the friction between the fabric and the surrounding anatomy and / or an anchoring device in which the valve is disposed. Layer 516, alone or in conjunction with protective parts 518, 520 and / or layers 530, 534, can form a sealing element or a covering element, which can be placed around the substrate to form the covering 514.

[00152] The outer cover 514 may include an influx protective portion 518, which extends circumferentially around the influx end 508 of the support, and a discharge protective portion 520, which extends circumferentially around the discharge end 510 of the support. In certain embodiments, the influx and discharge protective portions 518 and 520 may be formed over the fabric of the main cushioning layer 516, so that the outer cover 514 is a single-piece unitary construction, as further described below.

[00153] With reference to Figure 28, the main damping layer 516 may include a first circumferential edge portion 522 (also referred to as an influx edge portion), located adjacent to the influx end 508 of the valve, which may form a portion of the influx protective portion 518. The damping layer 516 may further include a second circumferential edge portion 524 Petition 870260046292, dated 05 / 15 / 2026, p. 47 / 202 41 / 89 (also referred to as a discharge edge portion), located adjacent to the discharge end 510 of the valve, and which may form a portion of the discharge protective portion 520. With further reference to Figure 28, the first circumferential edge portion 522 may comprise an edge 526, and the second circumferential edge portion 524 may comprise an edge 528. The first circumferential edge portion 522 may be folded or wrapped around the apexes 506 of the strut elements 504, so that the edge 526 is disposed within the support 502. The second circumferential edge portion 524 may be folded around the apexes 506 at the discharge end 510 of the support in a similar manner, such that the edge 528 is also disposed within the support opposite the edge 522.

[00154] In the illustrated configuration, the influx 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 discharge protective part 520 may also include a second or outer slippery layer 534 of material, disposed on the outer surface 532 of the main damping layer 516. In some embodiments, layers 530 and 534 may be thin, smooth coatings comprising a low coefficient of friction or slippery material. For example, in certain configurations, one or both of layers 530, 534 may comprise PTFE or ePTFE.

[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 damping layer 516 and through the apexes 506, such that the first circumferential edge 536 is located on the outer part of the support and the Petition 870260046292, dated 05 / 15 / 2026, page 48 / 202 42 / 89 second circumferential edge 538 is disposed on the inner part of the 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 over the apices 506 of the discharge end 510 of the support, and a second circumferential edge 542 (Figure 28) is disposed inside the support. Once implanted in a native heart valve, the protective parts 518 and 520 can prevent direct contact between the apices 506 and the surrounding anatomy. The slippery material of layers 530 and 534 can also reduce friction with the native valve tissue (e.g., chordae tendineae) 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 cushioning layer 516, or a part thereof, is covered with a slippery coating, such as ePTFE, in addition to the influx and discharge protective parts 518 and 520, such that the slippery coating extends axially from the influx end to the discharge end of the cover. In some embodiments, the cushioning layer 516 is formed of fibers, woven, knitted, braided or electrospun, of slippery material, such as PTFE, ePTFE, etc., and may form the influx and discharge protective parts.

[00156] Figures 29 - 31B illustrate a representative method of producing the cover 514. Figure 29 illustrates the main damping layer 516 formed in a tubular, cylindrical body. With reference to Figure 30, the first circumferential edge portion 522 of the damping layer 516 can then be folded (e.g., inwards towards the inner surface of the tubular body), in the direction of the arrows 544 so that the lower edge 526 lies inside the tubular body and is disposed against the inner surface of the tubular body. A Petition 870260046292, dated 05 / 15 / 2026, page 49 / 202 43 / 89 edge part 524 can be folded in a similar manner, as indicated by arrows 546, so that the top edge 528 lies inside the tubular body and is disposed against the inner surface.

[00157] With reference to Figures 31A and 31B, the slip layers 530, 534 can then be applied to the main layer 516 to form the influx and discharge protection parts 518 and 520. In certain embodiments, the slip layers 530, 534 can be formed by electrospinning a low coefficient of friction material (e.g., PTFE, ePTFE, etc.) onto the first and second circumferential edge parts 522 and 524. In certain embodiments, the formation of layers 530 and 534 by electrospinning can provide a uniform, smooth surface, in addition to maintaining the layer thickness within strictly prescribed specifications.

[00158] For example, layers 530 and 534 can be made relatively thin, which can reduce the overall damping profile of the valve. In certain embodiments, the thickness of layers 530 and 534 can be from about 10 µm to about 500 µm, about 100 µm to about 500 µm, about 200 µm to about 300 µm, about 200 µm or about 30 µm. In some embodiments, layer 530 and / or layer 534 is or are made by immersion coating, spray coating or any other suitable method to apply a thin layer of slippery material to the main damping layer 516. The finished cover or outer cover 514 can then be placed on and fixed to the support 502 using fastening means, for example, sutures, adhesive, ultrasonic welding or any other suitable method or means of fastening.In some embodiments, the main cushioning layer 516 is placed around the support 502 before the edges are folded, and / or before the slip layers 530 and 534 are applied. Petition 870260046292, dated 05 / 15 / 2026, page 50 / 202 44 / 89 In some embodiments, one or both of the slippery layers 530 and / or 534 may be omitted from the first and second circumferential edge portions 522 and 524. In some embodiments, one or both of the first and second circumferential edge portions 522 and 524 need not be folded into the support, but may extend to the respective inflow or discharge end of the support, or beyond the ends of the support outward from it, as desired.

[00159] In addition to the cover for the support 502 and the apices 506, the outer cover 514 can provide several other significant advantages. For example, the cover 514 can be relatively thin, allowing the prosthetic valve to achieve a low amolding profile (e.g., 23 Fr - flasks - or below). The one-piece unitary 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] In some embodiments, one or both of the inflow and discharge protective parts may be configured as separate covers or sheaths, which are spaced from the main layer or the main cushioning layer, and may or may not be coupled to the main layer or the main cushioning 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, situated at least partially within the support.

[00161] Figure 34 illustrates a part of support 602 in a Petition 870260046292, dated 05 / 15 / 2026, page 51 / 202 45 / 89 flat arrangement configuration for illustrative purposes. The strut elements 604 can be arranged end-to-end to form a plurality of rows or steps of strut elements, extending circumferentially around the support 602. For example, with reference to Figure 34, the support 602 may comprise: a first or lower row 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 row IV of strut elements above the third row; and a fifth row V of strut elements above the fourth row and forming the discharge end 604 of the support. At the discharge end 610 of the support, the strut elements 604 of the fifth row V may 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 (relative to the direction of implantation, for example, in the mitral valve) to form the apices 606, and joined together at their proximal ends in the junctions 630, which can form part of the commissure windows 638. Further structure and features of the I-V rows of strut elements 604 are described in more detail in US patent 9,393,110, incorporated by reference above.

[00162] Returning to Figures 32 and 33, the prosthetic valve may include a first cover or first layer 614 (also referred to as a main cover layer or main layer) situated around the abutment 602. The valve may also include a protective discharge portion, configured as a second cover or cap 616, arranged around the strut elements 604 and the apices of the fifth row V of strut elements at the discharge end 610 of the abutment. The first cover or layer 614 may comprise Petition 870260046292, dated 05 / 15 / 2026, page 52 / 202 46 / 89 a woven or knitted cloth made, for example, of PET, UHMWPE, PTFE, etc. With reference to Figure 33, the first cover or layer 614 may include an inflow end portion 618, located at the inflow end 608 of the valve, and a discharge end portion 620 located at the discharge end 610 of the valve. In the illustrated embodiment, the discharge end portion 620 of the first cover or layer 614 may be displaced in the direction of the inflow end of the support (e.g., upstream) of the fifth row V of strut elements 604. Put 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 (e.g., distally beyond edge 622, when the prosthetic valve is implanted in the native valve).A lower circumferential edge 624 of the main cover or layer 614 may be disposed adjacent to the first row I of strut 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 apices 606 at the inflow end 608 of the support.

[00163] Figure 35 illustrates the support 602 including the second cover or cap 616 and an inner skirt 640 and without the first cover or layer 614 for illustrative purposes. In certain embodiments, the second cover or cap 616 may be configured as an envelope, which extends around the circumference of the support 602 and encircles the fifth row V of strut elements 604.For example, with reference to Figure 36, the cover or cap 616 can be configured as one or more straps or strips 626 of material, which are helically wrapped around the struts 604 and the apexes 606 of the fifth row V of strut elements at the discharge end 610 of the support, in the direction as indicated by arrow 632. In certain configurations, the second cover or cap 616 is... Petition 870260046292, dated 05 / 15 / 2026, page 53 / 202 47 / 89 made of a slippery or low-friction polymeric material, such as PTFE, ePTFE, UHMWPE, polyurethane, etc. In this way, the second cover or cap 616 can reduce friction between the second cover or cap and the natural tissue, which is in contact with the discharge end 610 of the valve. The cover or cap 616 can also prevent injury to the native tissue by preventing it from coming into direct contact with the apices 606.

[00164] In some embodiments, the 626 strip may be relatively thick to improve the damping characteristics of the second cover or layer 616. For example, in some embodiments, the 626 strip may be a PTFE strip, having a thickness of about 0.1 mm to about 0.5 mm, and a width of about 3 mm to about 10 mm. In a representative embodiment, the 626 strip may 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 layer 616 may also include one or multiple layers. For example, the second cover or layer 616 may include a single layer (e.g., a single 626 strip) wrapped around a line of support braces. The second cover or layer may also include two layers, three layers, or more strips wrapped around a line of support braces.In some embodiments, the second cover or layer 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 second cover / layer material.

[00165] In some embodiments, the first covering or layer 614 and / or the second covering or layer 616 may be fastened to the support by means of fastening, for example, suture, adhesive, etc. In Petition 870260046292, dated 05 / 15 / 2026, page 54 / 202 48 / 89 In some embodiments, the first and second covers 614, 616 may also be fastened to each other by means of fasteners. 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 row V of bracing elements 604, the suture 628 may extend from the point line (e.g., from the surface radially outward from the cover 614) and loop around the second cover / layer 616. The suture 628 may then re-enter the cover 614 (e.g., on the surface radially inward from the cover / layer 614) and re-establish the winding point. In the illustrated embodiment, suture 628 can be looped around the second covering / layer 616 at the junctions 630.The loops of suture 628 thus rest in valleys between the apices 606 and can serve to retain the second cover / layer 616 in place on the strut elements 602. Suture 628 can also retain the first cover 614 in place while the valve is being molded.

[00166] Still referring to Figures 32 and 33, the circumferential edge 622 of the first cover / layer 614 can be relatively straight, while the second cover / layer 616 can conform to the angled or zigzag pattern of the fifth row of bracing elements 604. In this way, the first and second covers 614 and 616 can define a plurality of openings 634 through the support 602, between the first and second covers. In the illustrated embodiment, the openings 634 have a triangular shape, with the base of the triangle being defined by the edge 622 of the first cover 614, and the sides being defined by the second cover / layer 616. The openings 634 can be configured so that, after the valve 600 is implanted, blood can drain to Petition 870260046292, dated 05 / 15 / 2026, page 55 / 202 49 / 89 into and / or out of the support 602 through the openings. In this way, the space between the interior of the support 620 and the ventricular surfaces 638 of the leaflets 612 can receive a discharge or be washed by blood flowing into and out of the openings 634 during the operation of the prosthetic valve. This can potentially reduce the risk of thrombus formation and obstruction of the left ventricular discharge tract.

[00167] Figure 37 illustrates the support 602, including the second cover / cap 616, in a radially deformed or demolded release configuration on a shaft 636 of a release apparatus. As shown in Figure 37, the second cover / cap 616 may conform to a tightly packed serpentine shape of the strut elements 604 as they move into the radially deformed configuration. In certain configurations, the second cover / cap 616 may closely follow the shape and direction of the strut elements 604 without bulging, folding, creasing, or clumping, to maintain a low demolding profile. In some embodiments, the influx end of the support includes a separate cover similar to the cover / cap 616.

[00168] Figures 38A, 38B, 39A and 39B illustrate the prosthetic valve 400 of Figures 19-26, including an exemplary cover or outer cover 700. The outer cover 700 may include a main layer or a main cushioning layer 720 having a plush outer surface 704. The cover 700 may also include an inflow protective part 706, which extends circumferentially around the inflow end 406 of the valve, and a discharge protective part 708, which 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 may be formed with Petition 870260046292, dated 05 / 15 / 2026, page 56 / 202 50 / 89 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 may be constructed of strips of material (e.g., polymeric materials such as PTFE, ePTFE, etc., or natural tissues such as pericardium, etc.) folded so that one circumferential edge of the strips is disposed against the inside of the support 402 (or an inner skirt within the support), and the other circumferential edge is disposed against the outer surface of the main layer 702. The outer cover 700 may be fastened to the support 402 by means of fastening, for example, sutures, ultrasonic welding, or any other suitable means or method of fastening.Layer 702, alone or in conjunction with protective parts 706, 708, can form a sealant or covering element, which can be placed around the substrate to form the covering 700.

[00169] The main layer 702 of the outer cover 700 may comprise a woven or knitted cloth. The cloth of the main layer 702 may be resiliently stretchable between a first natural or relaxed configuration (Figures 38A and 38B) and a second elongated or tensioned configuration (Figures 39A and 39B). When disposed in the support 402, the relaxed configuration may correspond to the radially expanded functional configuration of the prosthetic valve, and the elongated configuration may correspond to the radially deformed release configuration of the valve. Thus, with reference to Figure 38A, the outer cover 700 may have a first length L1, when the prosthetic valve is in the expanded configuration, and a second length L2 (Figure 39A), which is greater than Li, when the valve is molded in the release configuration, as described in more Petition 870260046292, dated 05 / 15 / 2026, page 57 / 202 51 / 89 details below.

[00170] The cloth may comprise a plurality of warp cords / yarns extending circumferentially 712 and a plurality of weft cords / yarns extending axially 714. In some embodiments, the warp cords / yarns 712 may have a denier of about 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 warp cords / yarns 712 may have a thickness t1 (Figure 40A) of 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 cords / yarns 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 712 warp cords / yarns may have a thickness of about 0.06 mm.

[00171] Weft cords / yarns 714 may be textured cords / yarns comprising a plurality of textured cords 716. For example, the cords 716 of weft cords / yarns 714 may be bulked, wherein, for example, the cords 716 are twisted, thermally cured and untwisted, so that the cords retain their twisted, deformed shapes in the unstretched, relaxed configuration. The cords 716 may also be textured by squeezing, winding, etc. When the weft cords / yarns 714 are in an untensioned, relaxed state, the cords 716 may be loosely compressed and may provide a compressible bulk or mass as well as a plush surface. In some embodiments, the 714 weft cords / yarns may have a denier of about 1D to about 500D, about 10D to about 400D, about 20D to about 350D, about 20D to about 300D, or about 40D to about 200D. In certain embodiments, the Petition 870260046292, dated 05 / 15 / 2026, page 58 / 202 52 / 89 weft yarns / strands 714 may have a denier of about 150 D. In some embodiments, a yarn count of the weft yarns / strands 714 may be 2 strands per yarn / strand at 200 strands per yarn / strand at 200 strands per yarn / strand, 10 strands per yarn / strand at 100 strands per yarn / strand, 20 strands per yarn / strand at 80 strands per yarn / strand, or about 30 strands per yarn / strand at 60 strands per yarn / strand. Additionally, although the axially extending textured cords / yarns 714 are referred to as weft cords / yarns in the illustrated configuration, the fabric may also be manufactured so that the axially extending textured cords / yarns are the warp cords / yarns and the circumferentially extending cords / yarns are the weft cords / yarns.

[00172] Figures 40A and 40B illustrate a cross-sectional view of the main layer 702, in which the weft cords / yarns 712 extend to the plane of the page. With reference to Figure 40A, the cloth of the main layer 702 may 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 clamped on a support. In some embodiments, the 702 core layer may have a thickness of about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, or about 0.5 mm, measured in a relaxed state with a heavy drop gauge having a tamper. In a representative example, the 702 core layer may have a thickness of about 1.5 mm when clamped onto a prosthetic valve support in the relaxed state.This can allow the 702 main layer cloth to cushion the leaflets between the valve body and an anchor or ring, in which the valve is implanted, as well as occupy voids or space in. Petition 870260046292, dated 05 / 15 / 2026, page 59 / 202 53 / 89 anatomy. The loosely packed, textured filaments 716 of the weft cords / yarns 714, in the relaxed state, can also promote tissue growth in the main layer 702.

[00173] When the fabric is in the relaxed state, the textured filaments 716 of the weft cords / yarns 714 are widely dispersed so that the individual weft cords / yarns are not easily discernible, as in Figures 38A and 38B. When tensioned, the filaments 716 of the weft cords / yarns 714 can be stretched together as the weft cords / yarns lengthen and the defects, twists, etc. of the filaments are pulled linearly so that the fabric is stretched and the thickness decreases. In certain embodiments, when sufficient tension is applied to the cloth in the axial direction (e.g., weft), such as when the prosthetic valve is molded onto a release shaft, the textured fibers 716 can be pulled together so that the individual weft cords / yarns 714 become discernible, as best shown in Figures 39B and 40B.

[00174] Thus, for example, when fully stretched, the main layer 702 can have a second thickness t3, as shown in Figure 40B, which is less than the thickness t2. In certain embodiments, the thickness of the tensioned weft cords / yarns 714 may be equal to or practically equal to the thickness t1 of the warp cords / yarns 712. Thus, in certain examples, when stretched, the fabric may have a thickness t3, which is equal to or practically equal to three times the thickness t1 of the warp cords / yarns 712, depending, for example, on the degree of smoothness of the weft cords / yarns 714. Consequently, in the example above, in which the warp cords / yarns 712 have a thickness of about 0.06 mm, the thickness of the main layer 702 may vary between about 0.2 mm and about 1.5 mm as the fabric is stretched and relaxed. Petition 870260046292, dated 05 / 15 / 2026, p. 60 / 202 54 / 89 Put differently, the thickness of the fabric can vary by 750% or more as the fabric is stretched and relaxed.

[00175] Additionally, as shown in Figure 40A, the warp cords / yarns 712 can be spaced apart from each other in the fabric by a distance y1 when the outer covering is in a relaxed state. As shown in Figures 39B and 40B, when tension is applied to the fabric in a direction perpendicular to the warp cords / yarns and parallel to the weft cords / yarns 714, the distance between the warp cords / yarns 712 can increase as the weft cords / yarns extend. In the example illustrated in Figure 40B, where the fabric has been stretched so that the weft cords / yarns 714 are extended and narrowed to approximately the diameter of the warp cords / yarns 712, the distance between the warp cords / yarns 712 can increase to a new distance y2, which is greater than the distance y1.

[00176] In certain embodiments, the distance y1 may 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 may be about 3 mm. In some embodiments, when the cloth is stretched as in Figures 39B and 40B, the distance y2 may be about 6 mm to about 10 mm. Thus, in certain embodiments, the length of the outer cover 700 may vary by 100% or more between the relaxed length L1 and the fully stretched length (e.g., L2). The ability of the cloth to stretch in this way may allow the prosthetic valve to be molded to diameters of, for example, 23 Fr, without being limited by the ability of the outer cover to stretch.Thus, the outer cover 700 can be soft and bulky when the prosthetic valve is expanded to its functional size, and relatively thin when the prosthetic valve is remolded, to minimize the profile. Petition 870260046292, dated 05 / 15 / 2026, page 61 / 202 55 / 89 complete amolding of the prosthetic valve.

[00177] Figures 41A, 41B, 42A and 42B show an example of a sealing element or covering element 800 for a prosthetic heart valve (for example, such as the prosthetic heart valve 400). The sealing element 800 may be a double-layered cloth comprising a base layer 802 and a pile layer 804. Figure 41A shows the outer surface of the sealing element 800 defined by the pile layer 804. Figure 42A shows the inner surface of the sealing element 800 defined by the base layer 802. The base layer 802 comprises, in the illustrated configuration, a mesh weave having circumferentially extending rows or stripes 806 of denser mesh parts dispersed with rows or stripes 808 of less dense mesh parts. The 800 sealant / covering element can be used to cover or form a covering on a stent abutment (e.g., on part, part, or all of the stent abutment).

[00178] In some embodiments, the strand count of strands extending in the circumferential direction (side by side or horizontally in Figures 42A and 42B) is greater in the higher density rows 806 than in the lower density rows 808. In some embodiments, the strand count of strands extending in the circumferential direction and the strand count of strands 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] The pile layer 804 may be formed of cords / yarns woven into the base layer 802. For example, the pile layer 804 may comprise a velvety weave formed of cords / yarns incorporated into the base layer 802. With reference to Figure 41B, the pile layer 804 may comprise rows or stripes extending Petition 870260046292, dated 05 / 15 / 2026, page 62 / 202 56 / 89 circumferentially 810 of pile formed in 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 pile layer varies along the height of the sealing element. In some embodiments, the pile layer 804 may be formed without gaps between adjacent rows of pile, but the pile layer may comprise circumferentially extending rows or stripes of higher density pile dispersed with rows or stripes of lower density pile.

[00180] In some embodiments, the base layer 802 may comprise a uniform mesh weave (the density of the weave pattern is uniform) and the plush layer 804 has variable density.

[00181] In some embodiments, the density of the sealant element 800 may vary along the circumference of the sealant element. For example, the pile layer 804 may comprise a plurality of circumferentially spaced rows extending axially from pile yarns, or it may comprise axially extending rows of higher density pile dispersed with axially extending rows of lower density pile. Similarly, the base layer 802 may comprise a plurality of axially extending rows of higher density mesh dispersed with rows of lower density mesh.

[00182] In some embodiments, the sealant element 800 includes a base layer 802 and / or a pile layer 804, which vary(s) in density along the circumference of the sealant element and along the height of the sealant element.

[00183] The variation in density of the pile layer 804 and / or the base layer 802, along the height and / or circumference of the sealant element 800, is advantageous because it reduces the Petition 870260046292, dated 05 / 15 / 2026, page 63 / 202 57 / 89 swelling of the sealing element in the radially deformed state and therefore reduces the integral remolding profile of the prosthetic heart valve.

[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 need not include the protective parts and may extend between the top and bottom rows of bracing elements of a support, or between the intermediate rows of bracing elements, depending on the particular application.

[00185] Figures 43 and 44 illustrate a prosthetic heart valve 900 including an example of a cover or outer cover 902, situated around a support 904, and including a plurality of leaflets 922 (Figure 44), situated at least partially within the support 904. The support 904 may include a plurality of struts 920 and may be configured as the support for the Edwards Lifesciences SAPIEN® 3 prosthetic heart valve, similar to support 402 of Figure 19. The outer cover 902 may include a main cushioning layer or a sealing element / covering element 906 (also referred to as a main layer) having a cylindrical shape, and made of a knitted or braided woven fabric (e.g., PET fabric, ultra-high molecular weight polyethylene (UHMWPE) fabric, PTFE fabric, etc.), a non-woven fabric such as felt, or a extruded polymeric film (e.g., an ePTFE or UHMWPE membrane).The outer cover 902 may also include an influx protective portion 908, which extends circumferentially around the influx end 910 of the support, and a discharge protective portion 912, which extends circumferentially around the discharge end 914 of the support. In the embodiment of Figures 43 and 44, the influx and discharge protective portions 908 and 912 are... Petition 870260046292, dated 05 / 15 / 2026, page 64 / 202 58 / 89 configured as separate pieces of material folded around the circumferential edges of the main layer 906, similar to the embodiment of Figures 19-26, but may comprise slip layers formed on the circumferential edge portions of the main layer 906 by other means, such as by electrospinning, as in the embodiment of Figure 31A.

[00186] With reference to Figure 43, layer 906 of the outer covering 902 may comprise a woven or knitted fabric. Layer 906 may comprise a plurality of holes or openings 916, which are circumferentially spaced around the support 904 and which are aligned with or overlap the openings defined between the braces of the support. For example, in the embodiment illustrated, the openings 916 may be located at the level of the openings 918, defined between the braces of the fourth row IV and the fifth row V of the braces (see also Figure 34), near the discharge end 914 of the support. The openings 916 may be relatively small, as in the embodiment of Figure 43, or larger, depending on the particular characteristics desired.

[00187] For example, with reference to Figure 44, in certain embodiments, the openings 916 may 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 may comprise the polygonal (e.g., hexagonal) shape of the openings 918 of the support and may 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 may extend along the axially oriented braces 920A between the fourth row IV and the fifth row V of braces, and over the corner windows and corner projections 932 of the leaflets 922. Thus, in certain configurations, the openings 916 of the roof Petition 870260046292, dated 05 / 15 / 2026, page 65 / 202 59 / 89 902 can be aligned with the openings 918 of the support, and furthermore, cover 902 can cover the entire outer surface of the support 904. In other words, cover 902 can cover the outer surfaces of all bracing elements 920.

[00188] The openings 916 can be formed in various ways. In certain embodiments, the openings 916 are cut (e.g., by laser) from the cloth of the main layer 906, before the cover is mounted on the support 904. In some embodiments, the cover 902 comprises two separate main or outer layers spaced axially apart on the support 904, with one layer extending, for example, between the first row I of braces 920 and the fourth row IV of braces, and the other layer extending along the fifth row V, so that the openings 918 of the support are exposed. 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 spacing.

[00189] Figure 45 illustrates an example of the prosthetic valve 900, in which the main layer 906 (which may form part or all of the sealing element or covering element) of the outer cover 902 comprises a first part 924, including a fleecy (e.g., knitted) layer 928, similar to the cover 414 of Figure 19, and a second part 926 without a fleece. Additional parts are also possible. The fleecy layer 928 of the first part 924 may extend circumferentially around the support 904 and axially along the support 904, from the influx protective part 910 to the level of the fourth row IV of struts 920. The second part 926 may define a plurality of round openings 916, positioned over the openings 918 of the support and having a smaller area than the openings. Petition 870260046292, dated 05 / 15 / 2026, page 66 / 202 60 / 89 918 of the support, although the openings 916 may have any size, shape, location and / or spacing. The pile layer 928 may be configured to extend along any part of the axis of the prosthetic valve.

[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 pile layer 928 described above, and the second part 926 is a knitted cloth without a pile layer. The first and second parts 924, 926 may be configured to overlap each other (for example, a portion of the first part 924 may extend over the second part 926 where the two pieces of cloth meet). The second part 926 may also have a different knitting pattern than that of the first part 924, and may also comprise cords (e.g., yarns, etc.) having different properties (e.g., denier, material, surface characteristics such as texture, number of filaments, number of layers, number of twists, etc.) from the cords / yarns of the first part 924.In some embodiments, the first part 924 and / or the second part 926 comprise knitting patterns 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 may be knitted in various ways, for example, by using a circular technique, a crochet technique, a knitting technique, a Raschel technique, other techniques, or combinations thereof. The properties of the second part 926 may 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 of certain types of woven cords or yarns. Petition 870260046292, dated 05 / 15 / 2026, page 67 / 202 61 / 89 fabrics may be more prone to unraveling and / or wear if openings are formed in them, so the second part 926 may be made of a sloping cloth or sloping fabric, which is less prone to unraveling or wear when openings are formed in it. Optionally, the first and second parts 924, 926 may comprise a single piece of fabric. In some embodiments, the first part 924 and / or the second part 926 comprise a non-woven material (e.g., foam, felt, etc.).

[00191] The inclusion of openings, such as openings 916, in the outer cover 901 can promote blood flow through the cover, from the inside of the prosthetic valve to the outside, so that the struts 920 and the radially outward surfaces of the leaflets 922 are bathed or wetted by the blood flowing through the prosthetic valve during valve operation. This can help reduce blood stasis around the strut elements 920 and between the struts 920 and the leaflets 922, which can potentially reduce the risk of thrombosis.

[00192] Figures 46-51 show an example of a main cushioning layer or sealing element / covering element 1000. The sealing element 1000 may comprise a fabric body having a plurality of different parts working together, such as a plurality of first parts (e.g., woven parts, multiple sets of woven parts, etc.) and a plurality of second parts (e.g., stretchable elastic parts configured as floating parts, such as floating wire parts), which may be incorporated into any of the external coverings of prosthetic valves described in this descriptive report. Figure 46 illustrates the sealing element / covering element 1000 in a planar arrangement configuration, in which the x-axis corresponds to the circumferential direction and the y-axis corresponds to the direction Petition 870260046292, dated 05 / 15 / 2026, page 68 / 202 62 / 89 axial, when the sealing element is attached to a support of a prosthetic valve. The sealing element 1000 may comprise a plurality of first parts (such as woven first parts 1002 configured as strips or stripes extending along the x-axis), a plurality of second parts (such as woven second parts 1004, configured as woven strips or stripes extending along the x-axis), a plurality of third parts (e.g., floating parts or floating wire parts, strips or stripes 1006 extending along the x-axis), and / or, optionally, additional parts. The various woven and floating / floating wire parts may 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] In an exemplary configuration, as illustrated, the sealant / covering element 1000 comprises a first woven part 1002A, which may be located on the lower or influx edge of the sealant / covering element.With movement 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 / floating yarn part 1006A, a second woven part 1004B, a 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 from the first woven part. 1002A. In other words, a. Petition 870260046292, dated 05 / 15 / 2026, page 69 / 202 63 / 89 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 / floating yarn parts 1006A - 1006E are connected or propelled in a direction along the x-axis by the respective second woven parts 1004.

[00194] With reference to Figures 47 and 48, the main layer or sealing element / covering element 1000 may comprise a plurality of first strands 1008 (e.g., yarns, etc.) generally oriented along the x-axis and a plurality of second strands 1010 generally oriented along the y-axis. In certain configurations, the first strands / yarns 1008 are warp strands / yarns, meaning that, during the weaving process, the first strands / yarns 1008 are held by the loom, while the second strands / yarns 1010 are weft strands / yarns, which are interwoven with the warp strands / yarns by a shuttle or moving weft driving mechanism during the weaving process. However, in some embodiments, the first 1008 strands / yarns may be weft strands / yarns and the second 1010 strands / yarns may be warp strands / yarns.

[00195] Each of the first strands / yarns 1008 and the second strands / yarns 1010 may comprise a plurality of constituent filaments 1012, which are spun, wound, twisted, interwoven, interlaced, etc. together to form the respective strands / yarns. The individual filaments 1012 exemplifying the second strands / yarns 1010 may be seen in Figures 48-50. In some embodiments, the first strands / yarns 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 Petition 870260046292, dated 05 / 15 / 2026, p. 70 / 202 64 / 89 1008 cords / yarns have a filament count of 1 to about 600 filaments per cord / yarn, about 10 to about 300 filaments per cord / yarn, about 10 to about 100 filaments per cord / yarn, about 10 to about 60 filaments per cord / yarn, about 10 to about 50 filaments per cord / yarn, or about 10 to about 30 filaments per yarn. In some embodiments, the first 108 cords / yarns have a denier of about 40 D and a filament count of 24 filaments per yarn. The first 1008 cords / yarns may also be twisted cords / yarns or untwisted cords / yarns. In the embodiment illustrated, the 1012 filaments of the first 1008 cords / yarns are not textured. However, in some embodiments, the first 1008 cords / yarns may comprise textured filaments.

[00196] The second strands / yarns 1010 may be textured strands / yarns, comprising a plurality of textured filaments 1012. For example, the filaments 1012 of the second strands / yarns 1010 may be textured, for example, by twisting the filaments, thermal curing them and distorting the filaments, as described above. In some embodiments, the second 1010 strands / yarns 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, or about 10 D to about 70 D. In some embodiments, a filament count of the second 1010 strands / yarns is between 1 filament per strand / yarn to about 100 filaments per strand / yarn, about 10 to about 80 filaments per strand / yarn, about 10 to about 60 filaments per strand / yarn, or about 10 to about 50 filaments per strand / yarn.In some embodiments, the second 1010 cords / yarns have a denier of about 68 D and a filament count of about 26 filaments per yarn.

[00197] The first 1008 cords / yarns and the second 1010 cords / yarns can be woven together to form the woven parts of the sealant / covering element, as mentioned above. Petition 870260046292, dated 05 / 15 / 2026, page 71 / 202 65 / 89 For example, in the first woven parts 1002A - 1002C, the first and second cords / yarns 1008, 1010 can be woven together in a flat weave pattern, in which the second cords / yarns 1010 (e.g., the weft cords / yarns) pass through a first cord / yarn 1008 (e.g., a warp yarn) and then under the next first cord / yarn in a repeating pattern. This weaving pattern is illustrated in detail in Figure 47. In some embodiments, the density of the first 1008 strands / threads is from about 10 strands / threads per 2.54 centimeters (1 inch) to about 200 strands / threads per 2.54 centimeters (1 inch), from about 50 strands / threads per 2.54 centimeters (1 inch) to about 200 strands / threads per 2.54 centimeters (1 inch), or from about 100 strands / threads per 2.54 centimeters (1 inch) to about 200 strands / threads per 2.54 centimeters (1 inch).In certain embodiments, the first woven part 1002A and the first woven part 1002C may be configured as edge (selvedge) parts, and may have a lower cord / yarn density than the first woven part 1002B to facilitate placement on a valve holder. Other weave patterns may also be used, such as over two under two, over two under one, etc. The first woven parts may also be woven in patterns derived from flat weaves, such as diagonal, satin, or combinations thereof.

[00198] In the second woven parts 1004A - 1004G, the first and second strands / yarns 1008, 1010 can be interwoven in a different pattern, which is different from the weaving pattern of the first woven parts 1002A - 1002C. For example, in the illustrated embodiment, the first and second strands / yarns 1008, 1010 are woven together in a leno weaving pattern in the second woven parts 1004A - 1004G. Figure 48 illustrates the leno weaving of the second woven part 1004B in more detail. With reference to Figure Petition 870260046292, dated 05 / 15 / 2026, page 72 / 202 66 / 89 48, the leno weave may comprise one or more leno strands / yarns or leno ends 1014, and four first strands / yarns 1008A, 1008B, 1008C and 1008D, also referred to as warp ends. The model illustrated in Figure 48 includes a single leno strand / yarn 1014 in the manner of a partial leno weave. However, in some embodiments, the leno weave model may be an integral leno weave, comprising two interlaced leno strands / yarns 1014 or other weaves derived from the leno weave. Examples of partial leno weaves, integral leno weaves and associated weaving techniques are illustrated in Figures 55A - 55J.

[00199] In the partial leno weave illustrated in Figure 48, the first strands / yarns 1008A - 1008D can extend parallel to the x-axis, and the second strands / yarns 1010 can be interwoven with the first strands / yarns 1008A - 1008D in, for example, a flat weave.Leno cord / thread 1014 can be woven around the first cords / threads 1008A - 1008D, so that Leno cord / thread 1014 passes through or over the top of the first cords / threads 1008A - 1008D, with each pass in the positive y direction, passes under or behind the next second thread 1010 in the x direction, and extends back through the first cords / threads 1008A - 1008D in the negative y direction. This pattern can be repeated along the length of the second woven section 1004B. In this way, the second woven sections 1004 can be strong, relatively narrow woven sections spaced axially apart along the support, when the sealing element is placed on a support.Leno cord / wire 1014 can serve to hold the first cords / wires 1008A - 1008D and the second cords / wires 1010 in place relatively close to each other as the prosthetic valve is molded and expanded, and can impart mechanical strength to the second woven parts 1004 while minimizing width. Petition 870260046292, dated 05 / 15 / 2026, page 73 / 202 67 / 89

[00200] In certain embodiments, all woven second parts 1004A - 1005G comprise the leno weave pattern described above. In some embodiments, one or more of the woven second parts 1004A - 1005G are configured differently, such as by incorporating more or fewer first strands / yarns 1008 into the leno weave, having multiple leno ends woven around multiple clusters of strands / yarns 1008, etc. In some embodiments, a chemical locking method is used when the leno weave and / or a flat weave includes or include warp strands / yarns having core and wrap construction filaments. The wrap of the individual filaments may be made of low-melting-point polymers, such as biocompatible polypropylene, and the core of the filaments may be made of another biocompatible polymer, such as polyester.Following the weaving process, the thermal curing process described above can soften and / or fuse the wrap. Upon cooling, the softened wrap polymer can bond together with the polyester filaments. This can create a cohesive body, enabling the woven structure to lock together.

[00201] Referring again to Figure 46, the floating parts or floating yarn parts 1006 may comprise cords / yarns extending along 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 cords / yarns 1010, which leave the leno weave of the second woven part 1004A, extend through 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 cords / yarns in the Petition 870260046292, dated 05 / 15 / 2026, page 74 / 202 68 / 89 floating part / floating wire part. In some embodiments, the density of the second strands / wires in the floating parts / floating wire parts 1006A is about 10 to about 200 strands / wires per 2.54 centimeters (one inch), about 50 to about 200 strands / wires per 2.54 centimeters (one inch), or about 100 to about 200 strands / wires per 2.54 centimeters (one inch). In some embodiments, the density of the second strands / wires 1010 is about 60 - 80 strands / wires per 2.54 centimeters (one inch). In some embodiments, the floating parts / floating yarn parts include the first strands / yarns 1008, arranged over or under, but not interwoven with, the second strands / yarns 1010, so that the second strands / yarns float over the first strands / yarns or vice versa.The floating parts or floating wire parts can also be configured as any other elastically stretchable structure, such as woven, knitted, braided or non-woven fabrics, or polymeric membranes, to name a few, that are elastically stretchable at least in the axial direction of the prosthetic valve.

[00202] In the illustrated embodiment, all woven parts 1002A, 1002C, and 1004A - 1004G and all floating parts 1006A - 1006E have width dimensions in the y-axis direction. The widths of the constituent parts can be configured so that the integral length L1 (Figure 46) of the sealing element / covering 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 Wi. In certain embodiments, the width Wi is configured so that portions of the first woven parts 1002A and 1002C can be folded over the respective inflow and / or outflow ends of a valve support. Petition 870260046292, dated 05 / 15 / 2026, page 75 / 202 69 / 89 prosthetic.

[00203] The first woven part 1002B may have a width of W2. With reference to Figure 52, when the sealing element / covering element 1000 is used in combination with the Edwards Lifesciences SAPIEN® 3 prosthetic heart valve support, the width W2 may be configured to match the axial dimension of the support openings defined 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] The woven second parts 1004A = 1004G can have widths W3 (Figure 48). In the illustrated embodiment, all woven second parts 1004A - 1004G have width W3, but one or more of the braided second 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] 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 or relaxed configuration (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. Thus, the floating parts 1006A-1006E can have initial widths W4 when the sealing element 1000 is in the unstretched, relaxed state. Figure 49 illustrates this. Petition 870260046292, dated 05 / 15 / 2026, page 76 / 202 70 / 89 a portion of the floating part 1006B in the relaxed, natural state. When the fabric is in the relaxed state, the textured filaments 1012 of the second cords / yarns 1010 can be twisted and coiled in many directions, so that the floating part 1006B has a bulky, wavy or cushion-like quality and provides a compressible volume or mass. When tensioned, the braids, twists, etc. of the filaments 1012 can be pulled partially straight along the y-axis, causing elongation of the second cords / yarns 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] 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 strands / wires 1010 of the floating wire parts 1006A - 1006E straightened under tension, so that the total length of the sealing element increases to the second length L2. In certain embodiments, the size, number, spacing, etc.The floating wire parts 1006 and the degree of texturing of the second constituent strands / wires 1010 can be selected so that the second length L2 of the sealing element 1000 corresponds to the length of a support for a prosthetic valve, when the prosthetic valve is molded for release in a release apparatus, as described below with reference to Figures 53 and 54. In some embodiments, the initial relaxed width W4 of the floating wire parts 1006 is about 1 mm to about 10 mm, about 1 mm to. Petition 870260046292, dated 05 / 15 / 2026, page 77 / 202 71 / 89 approximately 8 mm or approximately 1 mm to approximately 5 mm. In some embodiments, the initial width W4 is approximately 4 mm.

[00207] Figure 52 illustrates an edge portion of the sealing element / covering element 1000 clamped between a pair of clamps 1050. In certain embodiments, the bulky, wavy nature of the textured cords / yarns 1010, in the floating parts / floating yarn parts 1006, results in the floating parts / floating yarn parts 1006 having a thickness íi, 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 two times, 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 the floating parts 1006 to cushion the native leaflets between the valve body and / or against an anchor or ring in which the prosthetic valve is implanted.The 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. When tension is applied to stretch the floating parts 1006, the thickness t1 can decrease as the cords / wires 1010 are straightened. In certain embodiments, the thickness t1 is equal to or practically equal to the thickness 12 of the woven parts 1002 and 1004 when the sealing element is in the tensioned state. When the tension in the sealing element 1000 is released, such as during expansion of the prosthetic valve, the cords / wires 1012 can re-establish their textured shapes and the thickness of the floating parts 1006 can return to the initial thickness t1.

[00208] Figure 53 illustrates the sealing element 1000, formed in an outer cover 1018 and placed in the support 1202 of a prosthetic valve 1022. In the illustrated embodiment, the support 1020 is the support Petition 870260046292, dated 05 / 15 / 2026, p. 78 / 202 72 / 89 of the Edwards Lifesciences SAPIEN® 3 prosthetic heart valve, 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 may also include an inflow protective part 1024 and an discharge protective part 1026, similar to the outer covers described above, and can be configured for implantation in a native valve, such as the mitral valve, tricuspid valve, aortic valve, pulmonary valve, Eustachian valve, etc., although, in some embodiments, the outer cover need not include the inflow and / or discharge protective parts, and can also be configured for implantation in other heart valves or body lumens.The sealing element 1000 can be oriented so that the second woven parts 1004A - 1004G and the floating parts / floating wire parts 1006A 1006E extend circumferentially around the support 1020, and so that the floating part / floating wire part 1006A is adjacent to the influx protective part 1024 at the influx end of the prosthetic valve. In this configuration, the second textured cords / wires 1010 extend in one direction along the longitudinal axis 1034 of the prosthetic valve. In the illustrated embodiment, the first woven part 1002A and the second woven part 1004A can be arranged at least partially below the influx protective part 1024 and are not visible in the figure. Similarly, the first woven part 1002C and the second woven part 1004G can be arranged at least partially below the discharge protection part 1026 and are also not visible in the figure.

[00209] Still referring to Figure 53, the outer covering 1018 can be attached to the support by means of fixation, for example, suture, adhesion, etc., of the sealing element 1000 to the support 1020 along one or more of the second woven parts 1004A - 1004G. The first Petition 870260046292, dated 05 / 15 / 2026, page 79 / 202 73 / 89 woven part 1002B may also comprise a plurality of circumferentially spaced openings 1016. The openings 1016 may be sized and positioned to overlap the corresponding openings, defined by the support braces, between the fourth row IV of braces and the fifth row V of braces, similar to the embodiment of Figure 43 mentioned above. In some embodiments, the sealing element 1000 is incorporated into an external covering in the state illustrated in Figure 46, without the openings in the first woven part 1002B.

[00210] Figure 54 illustrates the prosthetic valve 1022, molded for release in a balloon 1028 at the distal end of a balloon catheter 1030 of a release apparatus 1032. Further details of representative release systems, which may be used with the prosthetic valves described in this descriptive report, may be found in US Publication No. 2017 / 0065415 and US Patent 9,339,384, which are incorporated herein by reference. As shown in the example illustrated in Figure 53, the floating parts / floating wire parts 1006A - 1006E are elongated and the second textured cords / wires 1010 are at least partially straightened, allowing the sealing element 1000 to extend to accommodate the greater length of the molded support 1020.In certain embodiments, the floating parts / floating wire parts 1006A - 1006E are configured so that the sealing element 1000 can be elongated by about 10% to about 500%, about 10% to about 300%, about 10% to about 200%, about 10% to about 100%, about 10% to about 80%, or about 10% to about 50%. In some embodiments, the floating parts / floating wire parts 1006A - 1006E are configured to allow the sealing element 1000 to be elongated by about 30%, corresponding to the elongation of the support 1002 between the... Petition 870260046292, dated 05 / 15 / 2026, page 80 / 202 74 / 89 expanded and remolded configurations. As mentioned above, the increase in width of the floating parts / floating wire parts 1006A - 1006E may also result in a corresponding decrease in thickness of the floating parts / floating wire parts, reducing the remolding profile of the prosthetic valve during release.

[00211] In some embodiments, the first and second cords / 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 may be woven on a loom, and may then be heat-treated or heat-cured to obtain the desired size and configuration. For example, depending on the material selected, heat curing may cause shrinkage of the sealant element 1000. Heat curing may also cause a texturing effect, or an increase in the degree of texturing, of the second strands / threads 1010. After heat treatment, openings 1016 may be created in the first woven part 1002B (e.g., by laser cutting), and the sealant element may be incorporated into and / or form an outer covering, such as the covering 1018 for placement on a prosthetic valve.In some embodiments, the 1016 openings can also be created before heat treatment.

[00212] In certain embodiments, the loops, filaments, floating parts, floating wire parts, etc. of the prosthetic sealing elements described in this descriptive report may 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 descriptive report may be configured to form a Petition 870260046292, dated 05 / 15 / 2026, page 81 / 202 75 / 89 seal for a selected period of time. For example, in certain embodiments, the open, porous nature of the loops, filaments, cords / wires, etc., may provide a selected degree of paravalvular leakage around the prosthetic valve in the 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, cords / wires, etc., causes blood coagulation, tissue entrapment, etc. In some embodiments, the sealing elements, and in particular the loops, filaments, cords / wires, etc., of the paravalvular sealing structure, are treated with one or more agents that inhibit the biological response to the sealing structures. For example, in certain embodiments, the loops, filaments, cords / wires, etc., are treated with heparin.In certain embodiments, the content or concentration of the agent(s) is selected so that the agents are depleted after a selected period of time (e.g., days, weeks, or months) following valve implantation. As the agent(s) are depleted, the biological response to the loops, filaments, cords / wires, etc. of the sealing structures may increase so that a paravalvular seal gradually forms over a selected period of time. This can be advantageous in patients suffering from cardiac remodeling, such as left atrial or left ventricular remodeling (e.g., due to mitral regurgitation, etc.), by providing an opportunity for reversal of remodeling as regurgitation after prosthetic valve implantation is gradually reduced.

[00213] Figures 55A - 55J illustrate various leno weaves and various leno weaving techniques, which can be used to produce the sealant / covering element 1000 or any other. Petition 870260046292, dated 05 / 15 / 2026, p. 82 / 202 76 / 89 other sealing elements / covering elements described in this descriptive report. Figure 55A is a cross-sectional view illustrating a shed (e.g., the temporary separation of warp cords / yarns to form lower and upper warp cords / yarns), in which a leno yarn, a leno end or a crossover end 1060 forms the top shed on the left of the figure, above a weft cord / yarn 1064, and a standard type warp cord / yarn 1062 forms the bottom shed. Figure 55B illustrates a successive shed, in which the 1060 leno cord / yarn forms the top shed to the right of the standard type 1062 warp cord / yarn. In Figures 55A and 55B, the 1060 leno cord / yarn can cross under the standard type 1062 cord / yarn in a pattern known as bottom closure. Alternatively, the 1060 leno cord / yarn can cross over the standard type 1062 cord / yarn, known as top closure, as in Figures 55H and 55I.

[00214] Figure 55C illustrates a pattern of interlacing produced when a warp bundle is used on a loom, and the distortions or tensions of the leno 1060 cords / yarns and the standard 1062 cords / yarns are equal so that the 1060 cords / yarns and the 1062 cords / yarns bend around the weft 1064 cords / yarns. Figure 55D illustrates a pattern of leno weaving binding, produced when multiple warp bundles are used, and the leno 1060 cords / yarns are less tensioned than the standard 1062 cords / yarns, so that the standard 1062 cords / yarns remain relatively straight in the weave and perpendicular to the weft 1064 cords / yarns, while the leno 1060 cords / yarns are They bend around the standard 1062 type cords / wires.

[00215] Figure 55E illustrates an interlacing model corresponding to Figure 55C, but in which 1060 leno cords / threads Petition 870260046292, dated 05 / 15 / 2026, page 83 / 202 77 / 89 alternating strands are strung pointwise (for example, a technique in which the leno strands / threads are stretched using heddles), so that adjacent 1060 leno strands / threads have opposite tying directions. Figure 55F illustrates a tying pattern corresponding to Figure 55D, but in which the 1060 leno strands / threads are strung pointwise, so that adjacent leno strands / threads have opposite tying directions.

[00216] Figure 55G is a cross-sectional view of a flat leno weaving structure taken from the weft cords / yarns 1064.

[00217] Figure 55J illustrates a representative scarf weave viewed from the reverse side of the fabric.

[00218] The prosthetic valve covering embodiments described in this descriptive report can also be used on several different types of prosthetic heart valves. For example, the covers can be adapted, and in some embodiments are adapted, for use in mechanically expandable prosthetic heart valves, such as the valve 1100 illustrated in Figure 56. The prosthetic valve 1100 may include an annular stent or support 1102 and a leaflet structure 1104, situated within and coupled with the support 1102. The support 1102 may include an inflow end 1106 and a discharge end 1108. The leaflet structure may comprise a plurality of leaflets 1110, such as three leaflets arranged to deform into a tricuspid arrangement, similar to the aortic valve, so that the leaflets form commissures 1132, in which the respective discharge edge portions 1134 of the leaflets are in contact with each other.Optionally, the prosthetic valve may include two 1110 leaflets, configured to deform into a tricuspid arrangement similar to the mitral valve, or more than three leaflets, depending on the particular application. Petition 870260046292, dated 05 / 15 / 2026, page 84 / 202 78 / 89

[00219] With reference to Figure 56, the support 1102 may include a plurality of interconnected truss struts 1112, arranged in a truss-type pattern and forming a plurality of apexes 1114 at the discharge end 1108 of the prosthetic valve. The struts 1112 also form similar apexes 1114 at the inflow end 1106 of the prosthetic valve. The truss struts 1112 can be pivotally coupled to each other by joints 1116, located where the struts overlap each other, and also at the apices 1114. The joints 1116 can allow the struts 1112 to be pivoted relative to each other as the support 1102 is expanded or contracted, such as during placement, preparation or implantation of the prosthetic valve 1100. The joints 1116 can comprise rivets or pins, which extend through the openings formed in the struts 1112, at the locations where the struts overlap 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. Further details concerning the support 1102 and the devices and techniques for radial expansion and deformation of the support can be found in US publication no. 2018 / 0153689, which is incorporated by reference in this descriptive report.

[00220] As illustrated in Figure 56, the support 1102 may comprise a plurality of actuator components 1118, which may also function as release and locking units (also referred to as locking assemblies), configured to radially expand and contract the support. In the illustrated configuration, the support 1102 comprises three actuator components 1118, Petition 870260046292, dated 05 / 15 / 2026, page 85 / 202 79 / 89 configured as columns and coupled to the support 1102 at circumferentially spaced locations, although the support may include more or fewer actuating components depending on the particular application. Each actuating component 1118 may generally comprise an internal element 1120, such as an internal tubular element, and an external element 1122, such as an external tubular element arranged concentrically around the internal element 1120. The internal elements 1120 and the external elements 1122 may be longitudinally movable relative to each other in a telescopic manner to radially expand and contract the support 1102, as further described in US publication No. 2018 / 0153689.

[00221] In the illustrated configuration, the internal elements 1120 have distal end portions 1124, coupled to the inflow 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 their respective apices 1114 at the inflow end 1106 of the support. The external elements 1122 can be coupled to the apices 1114 at the discharge end 1108 of the support 1102 in, for example, an intermediate portion of the external element, as shown in Figure 56, or in a proximal end portion of the external element, if desired.

[00222] The inner element 1120 and the outer element 1122 can telescoping relatively to each other, between a fully contracted 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 state of the prosthetic valve). In the fully extended state, the inner element 1120 is fully extended from the outer element 1122. In this way, the actuating components 118 allow the valve Petition 870260046292, dated 05 / 15 / 2026, page 86 / 202 80 / 89 prosthetic valve can be fully expanded or partially expanded to different diameters and maintain the prosthetic valve in the partially or fully expanded state.

[00223] In some embodiments, the actuator components 1118 are screw actuators, configured to radially expand and compress the support 1102 by rotation of one of the actuator components. For example, the internal elements 1120 may be configured as threads having external threads that engage with the internal threads of corresponding external components. Further details regarding the screw actuators are described in US Publication No. 2018 / 0153689.

[00224] The prosthetic valve 1100 may also include a plurality of commissure support elements, configured as clasps or clamps 1136. In the illustrated configuration, the prosthetic valve includes a commissure clamp 1136, positioned at each commissure 1132 and configured to secure the commissure leaflets 1110 at a location spaced radially within the support 1102. Further details regarding the commissure clamps are described in US Publication No. 2018 / 0325665, which is incorporated by reference in this descriptive report.

[00225] Figure 57 illustrates an example of a mechanically expandable support 1202 with components, such as leaflets, leaflet clamps, and actuating components, removed for illustrative purposes. The support 1202 may be similar to the support 1102, except that the struts 1204 include seven openings 1206 spaced apart along the length of each strut for the formation of joints similar to the 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 may be parallel to, but offset Petition 870260046292, dated 05 / 15 / 2026, page 87 / 202 81 / 89 circumferentially of 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 a being, the round part 1212A at the influx end 1208 of the support 1202 can define an opening 1206A. With movement along the strut 1204A, in the direction of the 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 1210. The openings, and the joints formed with them, can function substantially as described above to allow the support to be radially deformed to release and expand radially at the treatment location.

[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 offset from each other, and angled so that the struts extend helically around the central axis 1216 of the support. In the embodiment of Figure 57, the struts 1204B and 1204C are part of the first or inner set of struts. The second set of struts 1204 may be arranged radially outside the first set of struts. The second set of struts may be angled so that the openings 1206 align with the openings 1206 of the inner set of struts, and may be oriented with the opposite helicality to that of the first set of struts. In the embodiment illustrated in Figure 57, props 1204A and 1204D are part of the second or outer set of props.The inner and outer sets of braces 1204 can form influx apices 1218 of the support, in which the respective round parts 1212. Petition 870260046292, dated 05 / 15 / 2026, page 88 / 202 82 / 89 align, and can form discharge apices 1220, in which the respective round parts, at opposite ends of the struts, align. In the expanded configuration, the struts 1204 of the inner and outer assemblies can also define a plurality of cells or openings in the shape of a rhombus 1222.

[00227] Figures 58 and 59 illustrate an example of a main cushioning layer, a cover element, or a sealing element 1300. The sealing element 1300 may comprise a body part having a plurality of woven parts and one or more floating parts (e.g., floating wire parts, etc.) similar to the embodiment of Figure 46. Figure 58 illustrates the sealing element 1300 in a planar 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 support. Figure 59 is an enlarged view of a part of the sealing element 1300. Starting at the influx end part 1310 of the sealing element 1300, the sealing element 1300 may comprise a first woven part 1302A.With movement in one direction along the positive y-axis, the sealing element 1300 may further comprise a second woven part 1304A, a floating part / floating wire part 1306, a second woven part 1304B, and a first woven part 1302B. The first woven part 1302B is located at the discharge end part 1312 on the opposite side of the floating part / floating wire part of the first woven part 1302A.

[00228] Still referring to Figure 59, the sealing element 1300 may comprise cords / yarns 1308 extending in the x direction (e.g., warp cords / yarns) and cords / yarns 1314 extending in the y direction (e.g., weft cords / yarns), as in the examples mentioned above. In certain embodiments, at least the cords / yarns 1314 may be textured. The textured cords / yarns Petition 870260046292, dated 05 / 15 / 2026, page 89 / 202 83 / 89 1314 can be interwoven with the cords / yarns 1308 in the first woven section 1302A and in the second woven section 1304A. The textured cords / yarns 1314 can extend into or float through the second woven section 1304B to form the floating sections / floating yarn sections 1306. The cords / yarns 1314 can re-enter the weave in the second woven section 1304B.

[00229] As in the embodiment of Figure 46, the first woven parts 1302A and 1302B may comprise a plain weave. In some embodiments, the first woven part 1302A and / or the first woven part 1302B may have a cord / thread density of 20 cords / threads (or ends) per 2.54 centimeters (one inch) to 150 cords / threads per 2.54 centimeters (one inch), such as 40 cords / threads per 2.54 centimeters (one inch) to 120 cords / threads per 2.54 centimeters (one inch). In some embodiments, the first woven parts 1302A and 1302B may be configured as edges and may prevent the fabric from fraying.

[00230] The second woven part 1304A can extend along the lower edge of the floating part / floating wire part 1306, and the first woven part 1304B can extend along the upper edge of the floating part / floating wire part 1306. In this way, the floating part / floating wire part 1306 can be connected or propelled in a direction along the x-axis by the second woven parts 1304A and 1304B. In some configurations, the widths of the second woven parts 1304A and 1304B may be relatively small compared to the first woven parts 1302A and 1302B, similar to the embodiment in Figure 46. In some embodiments, the second woven parts 1304A and 1304B comprise a leno weave pattern, such as any of the leno weave patterns described above. For example, with reference to the example in Figure 59, both second woven parts Petition 870260046292, dated 05 / 15 / 2026, pp. 90 / 202 84 / 89 1304A and 1304B comprise two ends of leno 1316 interwoven around cords / threads 1314 and cords / threads 1308, and may be closed at the top or closed at the bottom. In some embodiments, the second woven parts 1304A and 1304B comprise one end of leno or more than two ends of leno.

[00231] The sealing element 1300 can be resiliently stretchable between a first natural width, corresponding to an unstressed state, and a second width, when the sealing element is stretched in the y direction, similarly to the embodiment in Figure 46. As in the embodiments described previously, the textured cords / wires 1314 of the floating part / floating wire 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 cords / wires 1314 can be pulled straight, causing the sealing element to extend in the y direction.

[00232] Figure 60 illustrates the sealing element or covering element 1300 attached to the support 1202 of Figure 57 to form a covering on the support. In Figure 60, the support is in the expanded configuration, and the covering and the sealing element are in the first relatively unstressed state. In the illustrated embodiment, the first woven part 1302A can be attached (e.g., by means of fastening such as suture, adhesive, etc.) to the influx end parts of the struts 1204. For example, with reference to Figure 61, the first woven part 1302A can be folded over the influx apices 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 apices.

[00233] With reference to the external struts 1204A and 1204D of Petition 870260046292, dated 05 / 15 / 2026, page 91 / 202 85 / 89 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 that it comprises a plurality of extension parts 1320. The extension parts 1320 can be dimensioned to correspond to the parts of the cells 1222, which extend above the second woven part 1304B. In the illustrated embodiment, the extension parts 1320 are tapered in the flow direction through the valve, so that they have a trapezoidal shape, such as an isosceles trapezoidal shape. However, the extension parts 1320 can have any other shape, such as a triangular shape, a rectangular shape, etc.The extension parts 1320 can be sutured to the support 1202 along the strut segments 1214 (Figure 57) extending between the round parts 1212C and 1212D of the struts on the outer diameter of the support, and to the corresponding strut segments 1204 on the inner part of the support.

[00234] With reference to the outer strut assembly 1204, the floating section / floating wire section 1306 may extend from approximately the level of the round sections 1212B to the round sections 1212C. When the support 1202 is in the expanded configuration, the floating section / floating wire section 1306 may extend or bulge outward from the support to form a bulky, compressible, pillow-like structure or cushion that may aid in sealing against the surrounding anatomy. The textured cords / wires of the floating section / floating wire section 1306 may also provide a porous environment for entrainment of Petition 870260046292, dated 05 / 15 / 2026, p. 92 / 202 86 / 89 fabric.

[00235] Still referring to Figure 60, when the support 1202 is in the expanded configuration, the support may have a length Li. The cover and sealant 1300 may have a corresponding length Hi, which may be measured from the influx apices 1218 to the uppermost or highest discharge edge 1322 of the extension parts. As illustrated in Figure 62, when the support 1202 is radially deformed for release, the length of the support may increase to a second length L2. As the support extends, the cover and sealant 1300, and in particular the floating part / floating wire part 1306, may also stretch so that the cover and sealant extend to a second length H2 (e.g., corresponding to a second tensioned state) to accommodate the greater length of the support 1202.In some embodiments, the support 1202 is configured to extend by 10% to 160% or more between the expanded and deformed configurations. Similarly, the cover and sealant element 1300 can also be configured to stretch by a similar degree, such as 10% to 200%, 10% to 180%, 10% to 160%, etc., to accommodate the variation in support length.

[00236] Although the prosthetic valve covering embodiments described in this descriptive report are sometimes presented in the context of mitral valve repair, it should be understood that the described coverings can be used in combination with any of the various prosthetic heart valves for implantation on any of the native valves in or around the heart. For example, the prosthetic valve coverings described in this descriptive report can be used in combination with transcatheter heart valves, surgical heart valves, minimally invasive heart valves, etc. The covering embodiments Petition 870260046292, dated 05 / 15 / 2026, page 93 / 202 Items 87 / 89 in this descriptive report may be used in prosthetic valves tensioned for implantation in any of an animal's or patient's native valves (e.g., aortic, pulmonary, mitral, tricuspid, and Eustachian valves, etc.), and include valves that are tensioned for implantation within existing prosthetic valves (procedures termed valve-in-valve). The embodiments of the valve covers may also be used in combination with other types of implantable devices within other body lumens outside the heart, or heart valves that are implantable within the heart in locations other than those of native valves, such as transatrial or transventricular septal valves. GENERAL CONSIDERATIONS

[00237] For the purposes of this description, certain aspects, advantages, and novel features of the embodiments of the present invention are described in this descriptive report. The methods, apparatus, and systems described should not be considered, in any way, as limiting. Instead, the present invention is directed to all the novel and non-obvious features and aspects of the various embodiments described, alone and in various combinations and subcombinations with each other. The methods, apparatus, and systems are not limited to any specific feature or aspect or to a combination thereof, nor do the embodiments described require that any one or more of the specific advantages be present or that problems be solved.

[00238] Although the operations of some of the described embodiments are presented in a sequential order, particularly for convenient presentation, it should be understood that this descriptive manner encompasses the rearrangement, unless a particular order is required by the specific language presented below. For example, the Petition 870260046292, dated 05 / 15 / 2026, page 94 / 202 88 / 89 operations described sequentially may, in some cases, be rearranged or executed sequentially. Furthermore, for simplicity, the attached figures may not show the various ways in which the described methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms such as "provide" or "achieve" the described methods. These terms are high-level abstractions of the actual operations that are performed. The effective operations that correspond to these terms may vary depending on the particular implementations and are easily discernible by a person skilled in the art.

[00239] As used in this descriptive report and claims, the singular forms a, an, or include the plural forms unless the context clearly indicates otherwise. Additionally, the term includes means comprises. Furthermore, the terms coupled and associated generally mean coupled or linked electrically, electromagnetically and / or physically (e.g., mechanically or chemically) and do not exclude the presence of specific missing intermediate elements between the coupled or associated items contrary to language.

[00240] In the context of this patent application, the terms lower and upper are used interchangeably with the terms inflow and discharge, respectively. Thus, for example, the lower end of the valve is its inflow end and the upper end of the valve is its discharge end.

[00241] As used in this descriptive report, the term proximal refers to a position, direction, or part of a device that is closer to the user and farther from the implantation site. As used in this descriptive report, the term distal refers to a position, direction, or part of a device that is farther from the user and closer to the implantation site. Thus, by Petition 870260046292, dated 05 / 15 / 2026, page 95 / 202 89 / 89 For example, proximal movement of a device is the movement of the device toward the user, while 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 proximal and distal directions, unless expressly defined otherwise.

[00242] In view of the many possible embodiments to which the principles of the described technology may be applied, it should be recognized that the embodiments illustrated are only preferred examples and should not be considered as limiting the scope of the invention. Instead, the scope of the invention is at least as broad as the claims set forth below. Petition 870260046292, dated 05 / 15 / 2026, p. 96 / 202

Claims

1 / 4 CLAIMS 1. Prosthetic heart valve (1022) comprising: a support (1020) comprising a plurality of strut elements, the support (1020) being radially deformable and expandable between a deformed configuration and an expanded configuration, the support (1020) having an inflow end and a discharge end, and defining a longitudinal axis (1034); a leaflet structure, situated at least partially within the support (1020); and a cover arranged around the support (1020), the cover characterized in that it comprises: a first woven part (1002A-C), which extends circumferentially around the support (1020), the first woven part (1002A-C) comprising a plurality of textured cords extending along the longitudinal axis (1034) of the support (1020);a second woven part (1004A-G), which extends circumferentially around the support (120) and is spaced from the first woven part (1002A-C) along the longitudinal axis (1034) of the support (1020); wherein the textured cords extend along the longitudinal axis (1034) of the support (1020) from the first woven part (1002A-C) to the second woven part (1004A-G) and form a floating part (1006A-E) between the first woven part (1002A-C) and the second woven part (1004A-G), wherein the cover comprises a first protective part (1024), folded over the apices of the strut elements at the influx end of the support (1020); and the cover also includes a second protective part (1026), folded over the apices of the bracing elements at the discharge end of the support (1020). Petition 870260046292, dated 05 / 15 / 2026, page 97 / 202 2 / 4; 2. Prosthetic heart valve (1022), according to claim 1, characterized in that the cover is resiliently stretchable between a first state, corresponding to the radially expanded configuration of the support (1020), and a second state, corresponding to the radially deformed configuration of the support (1020).

3. Prosthetic heart valve (1022), according to claim 2, characterized in that the floating part (1006AE) is resiliently stretchable between the first state and the second state of the cover.

4. Prosthetic heart valve (1022), according to any one of claims 1 to 3, characterized in that the textured cords are configured to provide a compressible volume for the floating part (1006A-E) of the cover when the support (1020) is in the expanded configuration.

5. Prosthetic heart valve (1022), according to any one of claims 1 to 4, characterized in that the textured cords are woven in a leno weave pattern in the first woven part (1002A-C) and in the second woven part (1004A-G).

6. Prosthetic heart valve (1022), according to any one of claims 1 to 5, characterized in that the cover defines a plurality of circumferentially spaced openings (1016), wherein, optionally, the openings (1016) in the cover overlap the openings defined by the support strut elements (1020).

7. Prosthetic heart valve (1022), according to any one of claims 1 to 6, characterized in that the first protective part (1024) and / or the second protective part (1026) comprises a polymeric material such as PTFE or ePTFE, wherein, optionally, the first and second protective parts (1024, 1026) are Petition 870260046292, dated 05 / 15 / 2026, page 98 / 202 3 / 4 constructed of strips of polymeric material, such as PTFE or ePTFE, folded so that one circumferential edge of the strips is disposed against the inside of the support (1020), and the other circumferential edge is disposed against an outer surface of the cover.

8. Prosthetic heart valve (1022), according to any one of claims 1 to 7, characterized in that the cover further comprises a third woven part, on the opposite side of the first woven part (1002A-C) of the floating part (1006A-E), the third woven part comprising the textured cords of the first woven part (1002A-C).

9. Prosthetic heart valve (1022) according to claim 8, characterized in that the woven third part is folded over the apices of the strut elements at the inflow end of the support (1020).

10. Prosthetic heart valve (1022) according to any one of claims 1 to 9, characterized in that the support (1020) is a mechanically expandable support.

11. Prosthetic heart valve (1022) according to any one of claims 1 to 10, characterized in that the cover comprises a plurality of floating parts (1006AE) spaced apart along the longitudinal axis (1034) of the support (1020).

12. Prosthetic heart valve (1022) according to any one of claims 1 to 11, characterized in that the floating parts (1006A-E) are heat-cured to make them softer and / or more textured.

13. Prosthetic heart valve (1022) according to any one of claims 1 to 12, characterized in that twisted PET cords are used in a warp direction and textured PET cords are used in a weft direction. Petition 870260046292, dated 05 / 15 / 2026, page 99 / 202 4 / 4 14. Prosthetic heart valve (1022) according to any one of claims 1 to 13, characterized in that the cover comprises at least one low-friction layer or a low-friction coating on at least part of it.

15. Prosthetic heart valve (1022) according to any one of claims 1 to 14, characterized in that it further comprises strips of material that are helically wound around the struts and apices at one end of the support (1020). Petition 870260046292, dated 05 / 15 / 2026, pp. 100 / 202

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