Textile and polymer laminate for implants

Abstract

A method for manufacturing a medical implant is provided. Forming an interlayer, the interlayer comprising: a fabric layer; a coating comprising a polymer configured to inhibit growth of tissue thereon; the bonding layer is clamped between the fabric layer and the coating layer; and at least part of a frame, the at least part of the frame being sandwiched between the fabric layer and the bond layer. The interlayer is heated and compressed such that the bond layer bonds the fabric layer to the coating. Other embodiments are also described.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to provisional U.S. patent application US 63 / 341,354 filed on May 12, 2022 to Vaid et al.

[0003] This application relates to international patent application PCT / IB2021 / 060436 granted to Tennenbaum et al., filed on November 11, 2021, and published as WO 2022 / 101817; international patent application PCT / US2021 / 039587 granted to Chau et al., filed on June 29, 2021, and published as WO 2022 / 006087; and international patent application PCT / US2022 / 052834 granted to Chau et al., filed on December 14, 2022.

[0004] Each of the above applications is incorporated herein by reference in its entirety. Background Art

[0005] After the implant is implanted, tissue can grow on the implant. In some cases, such tissue growth is desirable, for example, to help the implant merge with tissue or organs. For example, in some hernia surgeries, a mesh is introduced and anchored around the opening to prevent the organ from passing through the opening undesirably. The mesh promotes tissue growth thereon to "repair" the opening. On the contrary, in some cases, tissue growth on the implant is undesirable. For example, an implant (or its components) intended to move (e.g., oscillate) in vivo may be negatively affected by tissue growth.

[0006] Mechanical properties of an implant, such as strength and / or flexibility, often require that the implant be formed of a particular material. However, promoting or inhibiting tissue growth on an implant may require the use of other materials, and these other materials may not provide the desired mechanical properties. Therefore, it may be advantageous to combine a material that provides the desired mechanical properties with a material that provides the desired tissue growth properties. Summary of the invention

[0007] In some embodiments, systems, devices and / or apparatus used within the heart and / or for tissues of a subject, such as implants, prosthetic valves, stents and / or patches, may benefit from at least one tissue growth inhibition surface. For example, an implant may benefit from such tissue growth inhibition at a surface that is in intermittent, repeated or continuous contact with the tissue and / or at a surface that rarely or never contacts the tissue. Sheets that provide at least one such tissue growth inhibition surface and that may be included in such systems, devices and / or apparatus are described herein. Methods for forming such sheets are also described. Methods for forming implants comprising such sheets are also described.

[0008] In some embodiments, such sheet has a multilayer structure. Typically, the sheet may include a fabric layer and at least one coating and a bonding layer, such as an interlayer, by heating this multilayer structure and / or applying pressure to this multilayer structure. Each bonding layer configured to bond the coating to the fabric layer is sandwiched between the fabric layer and the coating. The coating may include a tissue growth inhibitory material (e.g., a polymer) (e.g., a film that may be a tissue growth inhibitory material). In some embodiments, a frame may be introduced into the interlayer to form a component of the sheet. In some embodiments, the sheet may be attached to the frame after the sheet is formed, such as by using sutures, glue and / or applying heat and / or pressure. In some embodiments, the sheet may be attached to the frame by folding the edge of the sheet over the edge of the frame to produce a hem.

[0009] Implants incorporating such sheets are described herein. The systems, devices, methods, apparatus, etc. may be configured to inhibit tissue growth thereon. Various examples of systems, devices, and / or methods for coating implants that inhibit tissue growth thereon are described. In some embodiments, the implant incorporating the sheet is configured to support and / or guide movement of a valve leaflet of a subject's heart. An example where such an implant may be useful is when used at the posterior leaflet of a mitral valve, which may flail, prolapse, stiffen, and / or have other problems leading to regurgitation.

[0010] Various embodiments of systems, devices, prosthetic implant examples, and the like can be coated using the coating methods disclosed herein, and any combination of the features, components, and options can be made unless specifically excluded. For example, various polymers that inhibit tissue growth thereon can be used with any appropriate method for incorporating them into devices, implants, and the like, even if a specific combination of heat and / or pressure is not explicitly described. Likewise, different structures and features of devices can be mixed and matched, such as by combining any sheet with any form of frame, even if not explicitly disclosed. In short, the various components of the disclosed systems can be combined unless mutually exclusive or physically impossible.

[0011] Examples herein relate to systems, devices, apparatus, methods, etc. for forming a sheet having at least one tissue-inhibiting growth surface and / or for coating a frame to provide it with at least one tissue-inhibiting growth surface. In some embodiments, the sheet alone and / or in combination with a frame can be used to reduce leaflet flail, prolapse, abnormal leaflet movement, and / or other problems.

[0012] According to some embodiments, a method is provided, comprising forming a sandwich comprising a bonding layer sandwiched between (i) a fabric layer and (ii) a coating, the coating comprising a polymer configured to inhibit tissue growth thereon. The method may also comprise bonding the fabric layer to the coating by heating and / or compressing the sandwich to form a sheet.

[0013] In some embodiments: (i) in the interlayer, the tie layer is detached from the fabric layer, (ii) forming the interlayer comprises forming the interlayer in which the tie layer is detached from the fabric layer, and / or (iii) forming the sheet by bonding the fabric layer to the coating comprises bonding the tie layer to the fabric layer and the coating by heating and compressing the interlayer to form the sheet.

[0014] In some embodiments: (i) in the interlayer, the bonding layer is bonded to the fabric layer, (ii) forming the interlayer comprises forming the interlayer in which the bonding layer is bonded to the fabric layer, and / or (iii) forming the sheet by bonding the fabric layer to the coating comprises forming the sheet by bonding the bonding layer bonded to the fabric layer to the coating by heating and compressing the interlayer.

[0015] In some embodiments, the coating consists essentially of a polymer.

[0016] In some embodiments, the coating is a film.

[0017] In some embodiments, the coating is non-porous.

[0018] In some embodiments, the coating is porous.

[0019] In some embodiments, the fabric is a woven fabric.

[0020] In some embodiments, the fabric is a nonwoven fabric.

[0021] In some embodiments, the polymer is ultra high molecular weight polyethylene (UHMWPE).

[0022] In some embodiments, the polymer is fluorinated ethylene propylene (FEP).

[0023] In some embodiments, the tie layer comprises an acrylate.

[0024] In some embodiments, the bonding layer is silicone.

[0025] In some embodiments, the tie layer comprises thermoplastic polyurethane (TPU).

[0026] In some embodiments, the fabric layer is 20-150 microns thick.

[0027] In some embodiments, the bonding layer is 5-30 microns thick.

[0028] In some embodiments: (A) the coating defines a first side of the sheet, and the sheet has a second side opposite the first side; (B) forming the interlayer includes forming the interlayer to define a lip, wherein the lip portion of the coating and the lip portion of the bonding layer together extend beyond the edge of the fabric layer; (C) the method further includes folding the lip around the edge of the fabric layer onto the second side, so that the lip portion of the bonding layer is sandwiched between the lip portion of the coating and the second side; and / or (D) forming the sheet includes forming the sheet by: (i) heating the interlayer including folding the lip around the edge of the fabric layer onto the second side, and / or (ii) compressing the interlayer including folding the lip around the edge of the fabric layer onto the second side.

[0029] In some embodiments, forming the sheet includes forming the sheet by bonding the bonding layer to the fabric layer by heating the bonding layer and compressing the bonding layer against the fabric layer.

[0030] In some embodiments, forming the sheet includes forming the sheet by heating the coating and compressing the coating against the tie layer to bond the coating to the tie layer.

[0031] In some embodiments, forming the interlayer includes defining a lip, wherein a lip portion of the coating layer and a lip portion of the bonding layer together extend beyond an edge of the fabric layer.

[0032] In some embodiments, forming the sandwich includes: (i) forming the sandwich so that the coating defines a first side of the sheet and so that the sheet has a second side opposite the first side, and (ii) folding the lip onto the second side so that the lip portion of the bonding layer is sandwiched between the lip portion of the coating and the second side.

[0033] In some embodiments: (A) the interlayer comprises at least a component of the frame sandwiched between a fabric layer and a bonding layer, and (B) forming the sheet comprises forming the sheet by bonding the fabric layer to the coating by: (i) heating the interlayer comprising at least a component of the frame sandwiched between the fabric layer and the bonding layer, and (ii) compressing the interlayer comprising at least a component of the frame sandwiched between the fabric layer and the bonding layer.

[0034] In some embodiments, forming the sheet includes forming the sheet by heating and compressing the sandwich around a zone of the pocket to define a pocket between the fabric layer and the bonding layer such that at least a component of the frame is disposed in the pocket.

[0035] In some embodiments, the heating sandwich comprises a sandwich between heating plates, at least one of the plates having a recess at the region of the recess.

[0036] In some embodiments, the compressing the interlayer comprises compressing the interlayer between plates, at least one of the plates having a recess at the region of the pocket.

[0037] In some embodiments, forming the sheet includes forming the sheet by bonding the fabric layer to the coating layer in a manner that forms pockets between the fabric layer and the bonding layer.

[0038] In some embodiments, the recess is formed by: (i) heating the interlayer in a region surrounding the recess, and / or (ii) compressing the interlayer in a region surrounding the recess.

[0039] In some embodiments, the interlayer is heated around an enclosed region of the interlayer.

[0040] In some embodiments, the interlayer is compressed around the enclosed region of the interlayer.

[0041] In some embodiments, the method further comprises closing the pocket by bonding the fabric layer and the first bonding layer surrounding the pocket.

[0042] In some embodiments, forming the sheet includes forming the sheet having openings at edges of the sheet by releasing the fabric layer from the first bonding layer.

[0043] In some embodiments, forming the sandwich includes forming the sandwich having a frame and the bonding layer is sandwiched between the fabric layer and the coating.

[0044] In some embodiments, the thickness of the frame between the fabric layer and the bonding layer is 20-500 microns.

[0045] In some embodiments, the method further comprises covering at least a portion of the frame by fixedly attaching a sheet to the frame.

[0046] In some embodiments, forming the sandwich includes forming the sandwich including the frame and the bonding layer is sandwiched between the fabric layer and the coating.

[0047] In some embodiments, the thickness of the frame between the fabric layer and the bonding layer is 20-500 microns.

[0048] In some embodiments, fixedly attaching the sheet to the frame includes sewing the sheet to the frame.

[0049] In some embodiments, the frame has a first side and an opposing second side, and the fabric layer is wrapped around the frame from the first side to the second side such that at least a portion of the frame is sandwiched between (i) a first portion of the fabric layer disposed against the first side of the frame and (ii) a second portion of the fabric layer disposed against the second side of the frame.

[0050] In some embodiments, the method further comprises forming a plurality of holes through the sheet to facilitate blood flow therethrough.

[0051] In some embodiments, the method further includes flattening the sheet and maintaining the sheet flat while forming the plurality of holes through the sheet.

[0052] In some embodiments, forming the hole includes forming the hole by laser cutting.

[0053] In some embodiments, each hole is hexagonal.

[0054] In some embodiments, forming the sheet includes forming the sheet having a recess between the fabric layer and the bonding layer by heating and compressing the interlayer around an area defining the recess such that at least a component of the frame is disposed in the recess.

[0055] In some embodiments, heating the sandwich includes positioning the sandwich between plates, heating at least one of the plates, and at least one of the plates having a recess such that a pocket is formed at the recess.

[0056] In some embodiments, the compressing the sandwich comprises compressing the sandwich between plates, at least one of the plates having a recessed portion so as to form a pocket at the recessed portion.

[0057] In some embodiments, (A) forming a sandwich includes forming a second sandwich, wherein the second sandwich includes a second bonding layer sandwiched between: (i) a fabric layer, and (ii) a second coating configured to inhibit tissue growth thereon; and (B) forming a sheet by bonding the fabric layer to the second coating by: (i) heating the sandwich, and (ii) compressing the sandwich.

[0058] In some embodiments, the coating defines a first side of the sheet, and the sheet has a second side opposite the first side. In some embodiments, forming the sandwich includes forming the sandwich to define a lip portion of the coating and a lip portion of the bonding layer together extending beyond an edge of the fabric layer.

[0059] In some embodiments, the method further comprises folding a lip around an edge of the fabric layer onto the second side such that the lip portion of the bonding layer is sandwiched between the lip portion of the coating and the second side.

[0060] In some embodiments, forming the sheet includes forming the sheet by: (i) heating the sandwich including the lip folded around the edge of the fabric layer onto the second side, and (ii) compressing the sandwich including the lip folded around the edge of the fabric layer onto the second side.

[0061] In some embodiments, the first coating, the second coating, and the first bonding layer together extend beyond the edge of the fabric layer, thereby defining a lip and forming a sandwich containing the lip, and the lip portion of the first coating, the lip portion of the second coating, and the lip portion of the first bonding layer are disposed in the lip.

[0062] In some embodiments, forming the sandwich includes: (i) forming the sandwich so that the coating defines a first side of the sheet and so that the sheet has a second side opposite the first side, and (ii) folding the lip onto the second side so that the lip portion of the bonding layer is sandwiched between the lip portion of the coating and the second side.

[0063] In some embodiments, the first coating, the second coating, the first bonding layer, and the second bonding layer together extend beyond the edge of the fabric layer, thereby defining a lip and forming a sandwich containing the lip, and the lip portion of the first coating, the lip portion of the second coating, and the lip portion of the first bonding layer are arranged in the lip.

[0064] In some embodiments, forming the sheet includes forming the sheet by bonding the fabric layer to the coating layer in a manner that forms pockets between the fabric layer and the bonding layer.

[0065] In some embodiments, forming the sheet in a manner to form the recesses comprises: (i) heating the interlayer in an area surrounding the recesses, and / or (ii) compressing the interlayer in an area surrounding the recesses.

[0066] In some embodiments, the interlayer is heated or compressed around the enclosed region of the interlayer.

[0067] In some embodiments, the method further comprises closing the pocket by bonding between the fabric layer and a first bonding layer surrounding the pocket.

[0068] In some embodiments, the sheet defines an opening into the recess.

[0069] In some embodiments, the fabric layer is detached from the first bonding layer at the opening.

[0070] In some embodiments, the openings are disposed at the edges of the sheet.

[0071] In some embodiments, the sheet further comprises a cord, at least a portion of the cord extending through the recess.

[0072] In some embodiments, the cord is slidable within the recess.

[0073] In some embodiments, the polymer is polytetrafluoroethylene (PTFE).

[0074] In some embodiments, the polymer is expanded PTFE (ePTFE).

[0075] In some embodiments, the coating comprises several stratified sub-layers of polymer.

[0076] In some embodiments, each of the sub-layers is anisotropic, and the sub-layers are arranged such that each of the sub-layers is disposed orthogonally to an adjacent one of the sub-layers.

[0077] In some embodiments, the coating comprises less than ten sublayers.

[0078] In some embodiments, the coating comprises fewer than six sublayers.

[0079] In some embodiments, compressing the interlayer comprises compressing the interlayer at a pressure of 0.01-1 MPa.

[0080] In some embodiments, compressing the sandwich comprises maintaining the sandwich under said pressure for 100-500 seconds.

[0081] In some embodiments, heating the sandwich comprises heating the sandwich to a temperature of 37-260 degrees Celsius.

[0082] In some embodiments, heating the sandwich comprises maintaining the sandwich at the temperature for 100-500 seconds.

[0083] According to some embodiments, a system and / or device is provided, comprising a sheet comprising: (i) a fabric layer; (ii) a coating comprising a polymer configured to inhibit tissue growth thereon; and / or (iii) a bonding layer sandwiched between the fabric layer and the coating and bonding the fabric layer to the coating.

[0084] In some embodiments, the system / device is shaped to define a leaflet reinforcement patch configured to be attached to a valve leaflet of a subject's heart.

[0085] In some embodiments, the coating consists essentially of a polymer.

[0086] In some embodiments, the coating is a film.

[0087] In some embodiments, the coating is non-porous.

[0088] In some embodiments, the coating is porous.

[0089] In some embodiments, the fabric is a woven fabric.

[0090] In some embodiments, the fabric is a nonwoven fabric.

[0091] In some embodiments, the polymer is ultra high molecular weight polyethylene (UHMWPE).

[0092] In some embodiments, the polymer is fluorinated ethylene propylene (FEP).

[0093] In some embodiments, the tie layer comprises an acrylate.

[0094] In some embodiments, the bonding layer is silicone.

[0095] In some embodiments, the fabric layer is 20-150 microns thick.

[0096] In some embodiments, the bonding layer is 5-30 microns thick.

[0097] In some embodiments, the coating and the tie layer together extend beyond an edge of the fabric layer, thereby defining a lip, with the lip portion of the coating and the lip portion of the tie layer being disposed in the lip.

[0098] In some embodiments, the coating defines a first side of the sheet, and the sheet has a second side opposite the first side, and the lip is folded onto the second side such that the lip portion of the bonding layer is sandwiched between the lip portion of the coating and the second side.

[0099] In some embodiments, the lip is folded around an edge of the fabric layer, thereby defining a hem of the sheet material, with the fabric layer disposed within the hem between the lip portion of the bonding layer and another portion of the bonding layer.

[0100] In some embodiments, the sheet defines pockets between the fabric layer and the bonding layer.

[0101] In some embodiments, the bond between the fabric layer and the bonding layer surrounds the pocket, thereby closing the pocket.

[0102] In some embodiments, the sheet defines an opening into the recess.

[0103] In some embodiments, the fabric layer is detached from the first bonding layer at the opening.

[0104] In some embodiments, the openings are disposed at the edges of the sheet.

[0105] In some embodiments, the system / device further comprises a cord, at least a portion of the cord extending through the recess.

[0106] In some embodiments, a portion of the cord may be slidable within the recess.

[0107] In some embodiments, the system / device is shaped as a wing defining a contact surface and an opposing surface opposite the contact surface.

[0108] In some embodiments, the wings have a plurality of holes configured to promote blood flow therethrough.

[0109] In some embodiments, each hole is hexagonal.

[0110] In some embodiments, the wing is configured to anchor to cardiac tissue of a subject having a first leaflet and a second, opposing leaflet such that the wing extends over the first leaflet toward the second leaflet and the contact surface faces the first leaflet.

[0111] In some embodiments, the apparatus further comprises a frame, and the sheet is fixedly attached to the frame in a manner covering at least a portion of the frame.

[0112] In some embodiments, the sheet is fixedly attached to the frame by sewing.

[0113] In some embodiments, the sheet is fixedly attached to the frame by an adhesive.

[0114] In some embodiments, the sheet is fixedly attached to the frame by sandwiching the frame between the fabric layer and the bonding layer.

[0115] In some embodiments: (i) the coating is a first coating, (ii) the bonding layer is a first bonding layer, and / or (iii) the sheet further comprises: (a) a second coating, and / or (b) a second bonding layer, wherein the second bonding layer is sandwiched between the frame and the second coating.

[0116] In some embodiments, the thickness of the frame between the fabric layer and the bonding layer is 20-500 microns.

[0117] In some embodiments, the frame has a first side and an opposing second side, and the fabric layer is wrapped from the first side to the second side such that at least a portion of the frame is sandwiched between (i) a first portion of the fabric layer disposed against the first side of the frame and (ii) a second portion of the fabric layer disposed against the second side of the frame.

[0118] In some embodiments: (A) the coating is a first coating, (B) the tie layer is a first tie layer, and (C) the sheet further comprises: (i) a second coating, and / or (ii) a second tie layer, wherein the second tie layer is sandwiched between the second component of the fabric layer and the second coating.

[0119] In some embodiments, the frame is flexible and the system / device defines a wing having a contact surface and an opposing surface opposite the contact surface.

[0120] In some embodiments, the sheet has a plurality of holes configured to promote blood flow therethrough.

[0121] In some embodiments, the wing is configured to be anchored to an annulus of a heart valve of a subject such that the wing extends over a first leaflet of the valve toward an opposing leaflet of the valve and the contact surface faces the first leaflet.

[0122] In some embodiments, the system / device has a recess between the fabric layer and the bonding layer, and at least a portion of the frame is disposed in the recess.

[0123] In some embodiments, the coating and the bonding layer together extend beyond an edge of the frame, thereby defining a lip, with the lip portion of the coating and the lip portion of the bonding layer being disposed in the lip.

[0124] In some embodiments, the frame is disposed between the fabric layer and the bonding layer, and the fabric layer together with the coating and the bonding layer extend beyond the edge of the frame.

[0125] In some embodiments, the coating and bonding layer together extend beyond the edge of the fabric layer, thereby defining a lip.

[0126] In some embodiments, the coating defines a first side of the sheet, and the sheet has a second side opposite the first side, and the lip is folded onto the second side such that the lip portion of the bonding layer is disposed between the lip portion of the coating and the second side.

[0127] In some embodiments, at least a portion of the frame is disposed between a lip portion of the bonding layer and another portion of the bonding layer.

[0128] In some embodiments, the lip is folded around an edge of the frame, thereby defining a hem of the sheet, with the edge of the frame disposed within the hem between the lip portion of the bonding layer and another portion of the bonding layer.

[0129] In some embodiments, at least a portion of the fabric layer is disposed within the hem.

[0130] In some embodiments, the coating is a first coating, the tie layer is a first tie layer, and the sheet further comprises: (i) a second coating; and (ii) a second tie layer, the second tie layer being sandwiched between the fabric layer and the second coating and bonding the fabric layer to the second coating, the fabric layer being sandwiched between the first tie layer and the second tie layer.

[0131] In some embodiments, the sheet defines a pocket between the fabric layer and the first bonding layer.

[0132] In some embodiments, the first coating, the second coating, and the first bonding layer together extend beyond an edge of the fabric layer, thereby defining a lip, with the lip portions of the first coating, the second coating, and the first bonding layer disposed in the lip.

[0133] In some embodiments, within the lip, the lip portion of the first coating is bonded to the lip portion of the second coating via the lip portion of the first bonding layer.

[0134] In some embodiments, the lip portion of the second bonding layer extends beyond the edge of the fabric layer into the lip such that within the lip, the lip portion of the first coating is bonded to the lip portion of the second coating via the lip portion of the first bonding layer and the lip portion of the second bonding layer.

[0135] In some embodiments, the system / device further comprises a frame disposed between the first bonding layer and the second bonding layer.

[0136] In some embodiments, at least a portion of the sheet, the lip extends beyond the edge of the frame.

[0137] In some embodiments, at least a portion of the frame extends beyond the edge of the lip.

[0138] In some embodiments, the first coating and the first bonding layer together extend beyond an edge of the fabric layer, thereby defining a lip, and the lip portion of the first coating and the lip portion of the first bonding layer are disposed in the lip portion.

[0139] In some embodiments, the first coating defines a first side of the sheet, and the sheet has a second side opposite the first side, and wherein the lip is folded onto the second side such that the lip portion of the first bonding layer is disposed between the lip portion of the first coating and the second side.

[0140] In some embodiments, the lip is folded over onto the second side such that the lip portion of the first bonding layer is disposed between the lip portions of the first coating and the second coating.

[0141] In some embodiments, the system / device further comprises a frame to which the sheet is fixedly attached in a manner covering at least a portion of the frame, wherein: (i) the first coating defines a first side of the sheet and the sheet has a second side opposite the first side, and (ii) a lip portion of the first coating and a lip portion of the first bonding layer together extend beyond an edge of the fabric layer to define a lip, the lip extending beyond an edge of the frame.

[0142] In some embodiments, the lip is folded onto the second face, thereby defining a hem of the sheet, and at least a portion of the frame is disposed within the hem.

[0143] In some embodiments, the lip portion of the second coating layer and the lip portion of the second bonding layer together extend beyond the edge of the fabric layer into the lip.

[0144] In some embodiments, the system / device further comprises a frame, and the sheet is fixedly attached to the frame in a manner covering at least a portion of the frame.

[0145] In some embodiments, the system / device has a recess disposed between the fabric layer and the first bonding layer, and at least a portion of the frame is disposed in the recess between the fabric layer and the first bonding layer.

[0146] In some embodiments, the pocket is closed by bonding between the fabric layer and a first bonding layer surrounding the pocket.

[0147] In some embodiments, the sheet defines an opening into the recess.

[0148] In some embodiments, the fabric layer is detached from the first bonding layer at the opening.

[0149] In some embodiments, the openings are disposed at the edges of the sheet.

[0150] In some embodiments, the system / device further comprises a cord attached to the frame, at least a portion of the cord extending through the recess.

[0151] In some embodiments, a portion of the cord may be slidable within the recess.

[0152] In some embodiments, the polymer is polytetrafluoroethylene (PTFE).

[0153] In some embodiments, the polymer is expanded PTFE (ePTFE).

[0154] In some embodiments, the coating comprises several stratified sub-layers of polymer.

[0155] In some embodiments, each of the sub-layers is anisotropic, and the sub-layers are arranged such that each of the sub-layers is disposed orthogonally to an adjacent one of the sub-layers.

[0156] In some embodiments, the coating comprises less than ten sublayers.

[0157] In some embodiments, the coating comprises fewer than six sublayers.

[0158] In some embodiments, the tie layer comprises thermoplastic polyurethane (TPU).

[0159] In some embodiments, the TPU is a polycarbonate-based TPU.

[0160] In some embodiments, the polycarbonate-based TPU is a polycarbonate-based aliphatic thermoplastic polyurethane.

[0161] In some embodiments, the sheet is formed by compressing the fabric layer, coating layer, and tie layer together and applying heat to bond the tie layer to the fabric layer and coating layer.

[0162] In some embodiments, the sheet is formed by compressing the fabric layer, coating layer, and tie layer together for 100-500 seconds.

[0163] In some embodiments, the sheet is formed by compressing the fabric layer, coating layer, and tie layer together for 20-420 seconds.

[0164] In some embodiments, the sheet is formed by heating the fabric layer, coating layer, and tie layer for 100-500 seconds.

[0165] In some embodiments, the sheet is formed by heating the fabric layer, coating layer, and tie layer for 20-420 seconds.

[0166] In some embodiments, the sheet is formed by compressing the fabric layer, the coating layer, and the tie layer together under a pressure of 0.01-1 MPa.

[0167] In some embodiments, the sheet is formed by compressing the fabric layer, coating layer, and tie layer together under pressure for 100-500 seconds.

[0168] In some embodiments, the sheet is formed by compressing the fabric layer, coating layer, and tie layer together under pressure for 20-420 seconds.

[0169] In some embodiments, the sheet is formed by heating the fabric layer, coating layer, and tie layer to a temperature of 37-260 degrees Celsius.

[0170] In some embodiments, the sheet is formed by maintaining the fabric layer, coating layer, and tie layer at temperature for 100-500 seconds.

[0171] In some embodiments, the sheet is formed by maintaining the fabric layer, coating layer, and tie layer at temperature for 20-420 seconds.

[0172] According to some embodiments, a system and / or device is provided, which includes a cardiovascular implant, the cardiovascular implant including a frame and / or a sheet. The sheet may include a fabric layer fixed against at least a portion of the frame. The sheet may also include a coating, the coating including a polymer configured to inhibit tissue growth thereon. The sheet may also include a bonding layer, the bonding layer being sandwiched between the fabric layer and the coating, and bonding the fabric layer to the coating.

[0173] In some embodiments, the portion of the frame is a first portion of the frame, and wherein a second portion of the frame is exposed from the sheet.

[0174] In some embodiments, the frame is designed as a frame for a prosthetic valve.

[0175] In some embodiments, the frame is designed as a frame for a stent.

[0176] In some embodiments, the frame is designed as a leaflet reinforcement patch.

[0177] In some embodiments, the frame is designed as a wing.

[0178] In some embodiments, the implant is configured to anchor to cardiac tissue of a subject.

[0179] In some embodiments, the sheet is fixedly attached to the frame by sewing.

[0180] In some embodiments, the sheet is fixedly attached to the frame by an adhesive.

[0181] In some embodiments, the system / device has a recess between the fabric layer and the bonding layer, and at least a portion of the frame is disposed in the recess.

[0182] In some embodiments, the coating consists essentially of a polymer.

[0183] In some embodiments, the coating is a film.

[0184] In some embodiments, the coating is non-porous.

[0185] In some embodiments, the coating is porous.

[0186] In some embodiments, the fabric is a woven fabric.

[0187] In some embodiments, the fabric is a nonwoven fabric.

[0188] In some embodiments, the polymer is ultra high molecular weight polyethylene (UHMWPE).

[0189] In some embodiments, the polymer is fluorinated ethylene propylene (FEP).

[0190] In some embodiments, the tie layer comprises an acrylate.

[0191] In some embodiments, the bonding layer is silicone.

[0192] In some embodiments, the fabric layer is 20-150 microns thick.

[0193] In some embodiments, the bonding layer is 5-30 microns thick.

[0194] In some embodiments, the coating and the bonding layer together extend beyond an edge of the frame, thereby defining a lip, with the lip portion of the coating and the lip portion of the bonding layer being disposed in the lip.

[0195] In some embodiments, the frame is disposed between the fabric layer and the bonding layer, and the fabric layer together with the coating and the bonding layer extend beyond the edge of the frame.

[0196] In some embodiments, the coating and bonding layer together extend beyond the edge of the fabric layer, thereby defining a lip.

[0197] In some embodiments, the coating defines a first side of the sheet, and the sheet has a second side opposite the first side, and the lip is folded onto the second side such that the lip portion of the bonding layer is disposed between the lip portion of the coating and the second side.

[0198] In some embodiments, at least a portion of the frame is disposed between a lip portion of the bonding layer and another portion of the bonding layer.

[0199] In some embodiments, the lip is folded around an edge of the frame, thereby defining a hem of the sheet, with the edge of the frame disposed within the hem between the lip portion of the bonding layer and another portion of the bonding layer.

[0200] In some embodiments, at least a portion of the fabric layer is disposed within the hem.

[0201] In some embodiments, the fabric layer is secured against at least a portion of the frame by sandwiching at least a portion of the frame between the bonding layer and the fabric layer.

[0202] In some embodiments, the portion of the frame is a first portion of the frame, and wherein a second portion of the frame is disposed within the recess between the bonding layer and the fabric layer.

[0203] In some embodiments, the sheet is fixedly attached to the frame by sandwiching the frame between the fabric layer and the bonding layer.

[0204] In some embodiments, the thickness of the frame between the fabric layer and the bonding layer is 20-500 microns.

[0205] In some embodiments, the frame has a first side and an opposing second side, and the fabric layer is wrapped from the first side to the second side such that at least a portion of the frame is sandwiched between (i) a first portion of the fabric layer disposed against the first side of the frame and (ii) a second portion of the fabric layer disposed against the second side of the frame.

[0206] In some embodiments, the coating is a first coating, the tie layer is a first tie layer, and the sheet further comprises: (i) a second coating, and (ii) a second tie layer sandwiched between the second component of the fabric layer and the second coating.

[0207] In some embodiments, the frame is flexible and the implant defines a wing having a contact surface and an opposing surface opposite the contact surface.

[0208] In some embodiments, the sheet has a plurality of holes configured to promote blood flow therethrough.

[0209] In some embodiments, the wing is configured to be anchored to an annulus of a heart valve of a subject such that the wing extends over a first leaflet of the valve toward an opposing leaflet of the valve and the contact surface faces the first leaflet.

[0210] In some embodiments, the coating is a first coating, the tie layer is a first tie layer, and the sheet further comprises: (i) a second coating; and (ii) a second tie layer, the second tie layer being sandwiched between the fabric layer and the second coating and bonding the fabric layer to the second coating, the fabric layer being sandwiched between the first tie layer and the second tie layer.

[0211] In some embodiments, the sheet defines a pocket between the fabric layer and the first bonding layer.

[0212] In some embodiments, the first coating and the first bonding layer together extend beyond an edge of the fabric layer, thereby defining a lip, and the lip portion of the first coating and the lip portion of the first bonding layer are disposed in the lip portion.

[0213] In some embodiments, the first coating defines a first side of the sheet, and the sheet has a second side opposite the first side, and wherein the lip is folded onto the second side such that the lip portion of the first bonding layer is disposed between the lip portion of the first coating and the second side.

[0214] In some embodiments, the lip is folded over onto the second side such that the lip portion of the first bonding layer is disposed between the lip portions of the first coating and the second coating.

[0215] In some embodiments, the first coating, the second coating, and the first bonding layer together extend beyond an edge of the fabric layer, thereby defining a lip, with the lip portions of the first coating, the second coating, and the first bonding layer disposed in the lip.

[0216] In some embodiments, within the lip, the lip portion of the first coating is bonded to the lip portion of the second coating via the lip portion of the first bonding layer.

[0217] In some embodiments, the lip portion of the second bonding layer extends beyond the edge of the fabric layer into the lip such that within the lip, the lip portion of the first coating is bonded to the lip portion of the second coating via the lip portion of the first bonding layer and the lip portion of the second bonding layer.

[0218] In some embodiments, at least a portion of the sheet, the lip extends beyond the edge of the frame.

[0219] In some embodiments, at least a portion of the frame extends beyond the edge of the lip.

[0220] In some embodiments, the lip is folded onto the second face, thereby defining a hem of the sheet, and at least a portion of the frame is disposed within the hem.

[0221] In some embodiments, the lip portion of the second coating layer and the lip portion of the second bonding layer together extend beyond the edge of the fabric layer into the lip.

[0222] In some embodiments, the sheet is fixedly attached to the frame in a manner that covers at least a portion of the frame.

[0223] In some embodiments, the system / device has a recess disposed between the fabric layer and the first bonding layer, and at least a portion of the frame is disposed in the recess between the fabric layer and the first bonding layer.

[0224] In some embodiments, the pocket is closed by bonding between the fabric layer and a first bonding layer surrounding the pocket.

[0225] In some embodiments, the sheet defines an opening into the recess.

[0226] In some embodiments, the fabric layer is detached from the first bonding layer at the opening.

[0227] In some embodiments, the openings are disposed at the edges of the sheet.

[0228] In some embodiments, the system / device further comprises a cord attached to the frame, at least a portion of the cord extending through the recess.

[0229] In some embodiments, a portion of the cord may be slidable within the recess.

[0230] In some embodiments, the polymer is polytetrafluoroethylene (PTFE).

[0231] In some embodiments, the polymer is expanded PTFE (ePTFE).

[0232] In some embodiments, the coating comprises several stratified sub-layers of polymer.

[0233] In some embodiments, each of the sub-layers is anisotropic, and the sub-layers are arranged such that each of the sub-layers is disposed orthogonally to an adjacent one of the sub-layers.

[0234] In some embodiments, the coating comprises less than ten sublayers.

[0235] In some embodiments, the coating comprises fewer than six sublayers.

[0236] In some embodiments, the tie layer comprises thermoplastic polyurethane (TPU).

[0237] In some embodiments, the TPU is a polycarbonate-based TPU.

[0238] In some embodiments, the polycarbonate-based TPU is a polycarbonate-based aliphatic thermoplastic polyurethane.

[0239] In some embodiments, the sheet is formed by compressing the fabric layer, coating layer, and tie layer together and applying heat to bond the tie layer to the fabric layer and coating layer.

[0240] In some embodiments, the sheet is formed by heating the fabric layer, coating layer, and tie layer for 100-500 seconds.

[0241] In some embodiments, the sheet is formed by heating the fabric layer, coating layer, and tie layer for 20-420 seconds.

[0242] In some embodiments, the sheet is formed by compressing the fabric layer, coating layer, and tie layer together for 100-500 seconds.

[0243] In some embodiments, the sheet is formed by compressing the fabric layer, coating layer, and tie layer together for 20-420 seconds.

[0244] In some embodiments, the sheet is formed by compressing the fabric layer, the coating layer, and the tie layer together under a pressure of 0.01-1 MPa.

[0245] In some embodiments, the sheet is formed by compressing the fabric layer, coating layer, and tie layer together under pressure for 100-500 seconds.

[0246] In some embodiments, the sheet is formed by compressing the fabric layer, coating layer, and tie layer together under pressure for 20-420 seconds.

[0247] In some embodiments, the sheet is formed by heating the fabric layer, coating layer, and tie layer to a temperature of 37-260 degrees Celsius.

[0248] In some embodiments, the sheet is formed by maintaining the fabric layer, coating layer, and tie layer at temperature for 100-500 seconds.

[0249] In some embodiments, the sheet is formed by maintaining the fabric layer, coating layer, and tie layer at temperature for 20-420 seconds.

[0250] According to some embodiments, a method is provided, which includes temporarily flattening a sheet of an implant by constraining a framework of the implant, the sheet being fixedly attached to the framework. The method may also include forming a hole in the sheet while the sheet remains flattened. The method may also include subsequently allowing the framework to be non-flattened toward a static shape, wherein the framework holds the sheet in a curved configuration.

[0251] In some embodiments, forming the hole includes forming the hole using an automated laser cutting system.

[0252] In some embodiments, forming the hole includes forming the hole by moving a laser head of a laser cutting system along a plane parallel to the planarized sheet.

[0253] In some embodiments, flattening the sheet includes flattening the sheet using a cage having tracks configured to keep the sheet flattened.

[0254] In some embodiments, the method further comprises bonding the fabric layer to the coating layer to form a sheet by: (i) forming a sandwich comprising a bonding layer sandwiched between the fabric layer and the coating layer; and (ii) heating and / or compressing the sandwich.

[0255] In some embodiments, the method further comprises fixedly attaching the sheet to the frame after forming the sheet and before temporarily flattening the sheet.

[0256] In some embodiments: (i) the frame is a first frame of a plurality of frames fixedly attached to the sheet, (ii) flattening the sheet by constraining the frames includes flattening the sheet by constraining the plurality of frames while the plurality of frames remain fixedly attached to the sheet, and (iii) allowing the frames to be non-flattened includes allowing the plurality of frames to be non-flattened.

[0257] In some embodiments, the method further comprises attaching a plurality of frames to the sheet in an arrangement prior to flattening the sheet.

[0258] In some embodiments, the method further comprises, after allowing the plurality of frameworks to be non-planarized, cutting the sheet to separate the plurality of frameworks to form a plurality of implants.

[0259] In some embodiments, cutting the sheet includes cutting the sheet while the plurality of frames remain constrained.

[0260] In some embodiments, forming the hole comprises forming the hole using an automated cutting device.

[0261] The present invention will be more fully understood from the following detailed description of the embodiments in conjunction with the accompanying drawings, in which

[0262] In the figure: BRIEF DESCRIPTION OF THE DRAWINGS

[0263] Figure 1A -D is a schematic diagram of a method for forming an exemplary sheet according to some embodiments;

[0264] Figure 2A - C is a schematic diagram of a sheet defining a recess according to some embodiments;

[0265] Figure 3 is a schematic diagram of an exemplary lamination apparatus according to some embodiments;

[0266] Figure 4A - K is a schematic diagram of an exemplary sheet fixedly attached to a frame according to some embodiments;

[0267] Figure 5A - B is a schematic diagram of an exemplary implant for use with a valve of a subject's heart, according to some embodiments;

[0268] Fig. 6A -D is a schematic diagram of an exemplary implant for use with a valve of a subject's heart according to some embodiments;

[0269] Fig. 7A - B is a schematic diagram of an exemplary lamination apparatus according to some embodiments; and

[0270] Fig. 8A -C is a schematic diagram of a technique for forming a hole through a sheet of an implant, according to some embodiments. DETAILED DESCRIPTION

[0271] Systems, devices, methods, apparatuses, etc. for inhibiting tissue growth on implantable sheets are described herein. In some embodiments, the systems, devices, methods, apparatuses, etc. include an apparatus comprising a sheet constructed of a multilayer structure and / or an implant incorporated into the sheet. The systems, devices, methods, apparatuses, etc. may be configured to inhibit tissue growth thereon. Various examples of apparatus and / or methods for coating implants that inhibit tissue growth thereon are described. In some embodiments, the implant incorporated into the sheet is configured to support and / or guide the movement of a valve leaflet of a subject's heart. An example where such an implant may be useful is when used at the posterior leaflet of the mitral valve, where the mitral valve may flail, prolapse, stiffen, and / or have other problems that cause regurgitation.

[0272] The described systems, equipment, methods, devices, etc. should not be interpreted as limiting in any way. On the contrary, the present disclosure relates to all novel and non-obvious features and aspects of each disclosed coating procedure and embodiment, whether individually or in various combinations and sub-combinations formed with each other. The disclosed systems, equipment, devices, methods, etc. are not limited to any specific aspects, features or combinations thereof, and the disclosed systems, equipment, methods, devices do not require the existence of any one or more specific advantages or solve problems. The treatment techniques, methods, operations, steps, etc. described or implied in this article or in the references cited herein can be performed on living subjects (e.g., people, other animals, etc.) or on non-living simulations (such as corpses, corpse hearts, simulation bodies, virtual people, etc.). When performed on simulations, body parts (e.g., heart, tissue, valve, etc.) can be optionally referred to as "simulated" (e.g., simulated heart, simulated tissue, simulated valve, etc.), and can include computerized and / or physical representations of, for example, body parts, tissues, etc.

[0273] Various embodiments of systems, devices, prosthetic implant examples, and the like can be coated using the coating methods disclosed herein, and any combination of the features, components, and options can be made unless specifically excluded. For example, various polymers that inhibit tissue growth thereon can be used with any appropriate method for incorporating them into the device, even if a specific combination of heat and / or pressure is not explicitly described. Likewise, different structures and features of the devices can be mixed and matched, such as by combining any sheet with any form of frame, even if not explicitly disclosed. In short, the various components of the disclosed systems can be combined unless mutually exclusive or physically impossible.

[0274] Although the operations of some of the disclosed methods are described in a particular sequential order for ease of presentation, it should be understood that unless the specific language set forth below requires a particular ordering, this description encompasses rearrangement. For example, the operations described in sequence may be rearranged or performed simultaneously in some cases. In addition, for simplicity, the accompanying drawings may not show the various ways in which the disclosed systems, devices, apparatuses, methods, etc. may be used in conjunction with other systems, devices, apparatuses, methods, etc.

[0275] Reference now Figure 1A -D, which is a schematic diagram of a method 10 and variations thereof for forming various sheets according to some embodiments. These sheets are typically implantable in a subject alone or as a component of an implant. Figure 1A and 1C Methods 10a and 10c for forming sheet 100 are shown, and are variations of method 10 . Figure 1B and 1DMethods 10b and 10d are shown for forming sheet 150, which are also variations of method 10. In the example shown, sheet 100 has three layers, while sheet 150 has five layers.

[0276] The sheet 100 includes an interlayer 102, which includes a fabric layer 112, a coating 116, and a bonding layer 114, which is sandwiched between the fabric layer and the coating and bonds the fabric layer to the coating. The coating 116 includes a polymer, which is configured to inhibit tissue growth thereon and can be used as the first face 101a of the sheet 100. In some embodiments, the sheet 100 and / or an implant including the sheet 100 can be configured to be placed against a tissue surface of a subject, wherein the first face 101a faces the tissue surface of the subject. In some embodiments, the sheet 100 and / or an implant including the sheet 100 can be configured to be placed against a tissue surface of a subject, wherein the first face 101a faces away from the tissue surface, for example, wherein the second face 101b (which may be defined by the fabric layer 112) faces the tissue surface.

[0277] The sheet 150 includes an interlayer 104 including a fabric layer 112, two coatings 116 (e.g., a first coating 116a and a second coating 116b, one on either side of the fabric layer), and two bonding layers 114 (e.g., a first bonding layer 114a and a second bonding layer 114b), each bonding layer being sandwiched between a respective one of the coatings and a respective side of the fabric layer. In some embodiments, the sheet 150 can be viewed as comprising three interlayers 102 (described above with respect to Figure 1A Detailed description) as well as additional coating 116 and additional bonding layer 114. Since sheet 150 includes two more layers than sheet 100, it can be at least slightly thicker than sheet 100. Compared to sheet 100, the two coatings of sheet 150 can provide tissue growth inhibition on the first side 151a and the second side 151b of the sheet, which can be advantageous in some embodiments.

[0278] In some embodiments, the tissue growth inhibiting polymer of the coating 116 is an ultra high molecular weight polyethylene (UHMWPE). In some embodiments, the tissue growth inhibiting polymer of the coating 116 is a fluorinated ethylene propylene (FEP). In some embodiments, the tissue growth inhibiting polymer of the coating 116 is a thermoplastic polyurethane (TPU), such as a polycarbonate-based TPU and / or an aliphatic TPU. In some embodiments, the tissue growth inhibiting polymer of the coating 116 is a polytetrafluoroethylene (PTFE), such as expanded PTFE (ePTFE).

[0279] In some embodiments, the coating 116 consists essentially of a tissue growth inhibiting polymer. In some embodiments, the coating can include additional compounds.

[0280] In some embodiments, coating 116 may include a woven or nonwoven fabric (different from fabric layer 112) of a tissue growth inhibiting polymer.

[0281] In some embodiments, coating 116 may include a laminate (eg, a film) of a tissue growth inhibiting polymer.

[0282] In some embodiments, the outer surface of the coating (which may define the first side 101a of sheet 100, the first side 151a of sheet 150, and / or the second side 151b of sheet 151b) may be essentially composed of a tissue growth inhibiting polymer (e.g., which may be a film of the polymer), while deeper within the coating, different materials and / or structures may provide other properties, such as adhesion to the bonding layer 114, durability, and / or structural quality.

[0283] In some embodiments where the tissue growth inhibiting polymer is PTFE, the coating 116 may include several sublayers (e.g., thin layers) of PTFE. In some embodiments, the sublayers may be anisotropic and may be arranged so that each sublayer is arranged orthogonally to adjacent sublayers in the sublayers, e.g., each sublayer alternates with the previous sublayer and the next sublayer. In some embodiments, such a coating includes less than ten such sublayers, e.g., at least two and / or no more than six sublayers (e.g., 2-6 sublayers, e.g., 2-5 sublayers), e.g., exactly 5 sublayers.

[0284] In some embodiments, the coating 116 is porous. In some embodiments, the coating is non-porous.

[0285] In some embodiments, the coating is 5-70 microns thick.

[0286] In some embodiments, the fabric layer 112 comprises a woven fabric. In some embodiments, the fabric layer 112 comprises a knitted fabric. In some embodiments, the fabric layer 112 comprises a braided fabric. In some embodiments, the fabric layer 112 comprises a nonwoven fabric. In some embodiments, the fabric layer 112 comprises a 3D fabric. In some embodiments, the fabric layer 112 comprises an electrospun fabric. In some embodiments, the fabric layer 112 comprises a multi-phase fabric.

[0287] In some embodiments, fabric layer 112 is 20-150 microns thick.

[0288] In some embodiments, the bonding layer 114 includes acrylates. For example, the bonding layer can be substantially based on acrylate compounds, such as salts, esters, and conjugate bases of acrylic acid. In some embodiments, the bonding layer includes siloxanes and / or polysiloxanes. In some embodiments, the bonding layer includes thermoplastic polyurethane (TPU).

[0289] In some embodiments, the bonding layer is 50-30 microns thick.

[0290] In methods 10a and 10b, a sandwich is formed in which each bonding layer 114 is sandwiched between a fabric layer 112 and a corresponding coating 116. In method 10a, this sandwich is sandwich 102 ( Figure 1A ), and in method 10b, this interlayer is interlayer 104 ( Figure 1B ). Subsequently, fabric layer 112 is bonded to coating 116 (e.g., by bonding a bonding layer to both the fabric layer and the coating), by heating the interlayer and / or compressing the interlayer ( Figure 1A and 1B (lower screen of the ).

[0291] Methods 10c and 10d are similar to methods 10a and 10b, respectively, except that they each include two heat and / or pressure steps. A bonding layer 114 is placed against a fabric layer 112 (Figures 1c and 1d; Figure A) and then bonded to the fabric layer by compression and / or application of heat to the layer (Figure B). Subsequently, a coating 116 is added, thereby sandwiching the bonding layer 114 between the fabric layer 112 and the coating (Figure C). At this point in method 10c, the interlayer 102 can be considered to have been formed. At this point in method 10d, the interlayer 104 can be considered to have been formed. Subsequently, the layered fabric layers 112, bonding layers 114, and coatings 116 (e.g., interlayers) are heated and / or compressed to form a sheet (Figure D).

[0292] For methods 10c and 10d, in the transition between drawing A and drawing B, the plate can be pressed against the binding layer to apply heat and / or pressure. For example, such a plate can be or can be similar to any one of the plates 310, 320, 710 and 720 described in detail below. Such a plate can be configured to be bonded to other materials such as coating 116, but will not be bonded to the binding layer 114, although the binding layer is configured to be specifically bonded to other materials such as coating 116. The plate can be constructed in this way by having a highly smooth and / or non-porous surface. In contrast, coating 116 (or at least its inner surface) can be sufficiently rough and / or porous to allow the binding layer to be combined, for example, by heating and / or pressing the binding layer into microscopic holes and / or gaps. Even for an embodiment in which coating 116 has a chemical composition similar to that of the plate, it can be so, for example, both can include polytetrafluoroethylene (PTFE), for example, its different characteristics are derived from its structure.

[0293] In some embodiments, methods 10a and 10b may be advantageous, for example, due to the reduced number of steps compared to methods 10c and 10d.

[0294] In some embodiments, methods 10c and 10d can be advantageous, for example, for embodiments in which heat transfer through the entire sandwich may be otherwise slow and / or uneven. For example, for embodiments in which coating 116 is relatively thick and / or insulating, methods 10a and 10b may not be as reliable as methods 10c and 10d in bonding bonding layer 114 to fabric layer 112. In addition, for embodiments in which the sheet includes a frame disposed between layers (e.g., as described in detail below), methods 10c and 10d can facilitate more accurate and / or stable positioning of the frame relative to other layers. For example, the positioning of the frame relative to the fabric layer can first be fixed by at least one component of the frame sandwiched between the fabric layer and the bonding layer bonded to the fabric layer, and then the coating can be added to the other side of the bonding layer.

[0295] In all methods 10a-10d, when heat and pressure are used to bond a bonding layer to another layer, the heat and pressure can be applied simultaneously, or at least overlap in time. However, in some embodiments, pressure and heat can be applied separately (e.g., sequentially and / or alternately).

[0296] In some embodiments, the compression during each of the heating and compressing steps is at a pressure of 0.01-1 megapascal (MPa).

[0297] In some embodiments, the heating during the heating and compressing steps reaches a temperature of 37-260 degrees Celsius (°C).

[0298] In some embodiments of methods 10a and 10b, the heating and compressing step lasts for 100-500 seconds. In some embodiments of methods 10c and 10d, the first heating and compressing step lasts for 20-420 seconds, and / or the second heating and compressing step lasts for 100-500 seconds.

[0299] For example, the sheet may be formed by applying one or more of (i) a pressure of 0.01-1 MPa and (ii) a temperature of 37-260° C. for a duration of, for example, 20-420 seconds or 100-500 seconds.

[0300] In some embodiments, pressure and heat may be applied to the interlayer simultaneously. That is, one or more intervals of applying pressure and heating may be applied.

[0301] In some embodiments, pressure and heat can be applied separately (e.g., sequentially and / or alternately). That is, separate pressure intervals and heating intervals can be applied. In some embodiments, both (i) separate heating intervals and compression intervals, and (ii) combined heating and compression intervals can be applied.

[0302] In some embodiments, sheet 100 and / or sheet 150 (e.g., once coating 116, bonding layer 114, and fabric layer 112 are bonded to one another) may have structural properties that enable the sheet to be used as an implant. For example, the sheet may be implanted alone (e.g., sutured and / or anchored to tissue). Alternatively and / or as described in more detail below, an implant may be provided in which the sheet is attached to a frame.

[0303] Reference now Figure 2A , 2B 2C, which are schematic diagrams of sheets according to some embodiments, such as sheet 200 and sheet 250, which can be considered as variations of sheet 100 and sheet 150, respectively. Sheets 200 and 250 can be the same as sheets 100 and 150, respectively, except that each of the sheets, i.e., sheet 200 and sheet 250, defines a recess. In some embodiments, a recess can be defined between the fabric layer and the bonding layer. For example, recess 220 can be disposed within interlayer 102. As shown in FIG. Figure 2A As shown in FIG. , the pocket 220 may be closed by a bond between the fabric layer 112 and the bonding layer 114 , which may surround the pocket. Figure 2B A sheet 250 having five layers is shown (eg, the pocket 220 may be disposed within the interlayer 104 ) such that the pocket may be closed by a bond between the fabric layer 112 and one of the bonding layers 114 (eg, the second bonding layer 114 b ), which may surround the pocket.

[0304] In some embodiments, the sheet may define an opening into the well, for example, at least one edge of the well is open. Figure 2C Such an arrangement is shown, in which sheet 250' (which can be considered a variation of sheet 250) has a recess 222 disposed within interlayer 104, such that at opening 223, fabric layer 112 is disengaged from second bonding layer 114b. Opening 223 can be disposed at the edge of sheet 250', for example, to enable one or more other components to be inserted into the sheet. For example, in some embodiments, a frame can be introduced into recess 222 via opening 223, which can increase the structural properties of the sheet. Similarly, one or more other components (e.g., a frame) can be contained within recess 220 by forming the sheet to contain the frame, for example, as described in more detail below.

[0305] It should be noted that although reference Figure 2B and 2C The described example refers to the recess being disposed between the fabric layer 112 and the second bonding layer 114b, but the scope of the present disclosure includes recesses that are alternatively or additionally defined between the fabric layer and the first bonding layer 114a.

[0306] Reference now Figure 3, which is a schematic diagram of a laminating apparatus 20 according to some embodiments. The laminating apparatus includes two plates, such as a first plate 310 and a second plate 320, which are configured to be pressed against each other so as to apply pressure and / or heat to an interlayer (e.g., interlayer 102 and / or 104) secured between the two plates so as to form a sheet, such as sheet 200 and / or sheet 250. At least one of the two plates of the laminating apparatus 20 may define a recess, such as recess 312 in the contact surface of the plates. The recess provided at one of the plates may enable a recess to be formed at sheet 200 and / or sheet 250.

[0307] As described above, the sheet can be formed by compressing and / or heating the interlayer, which can cause the layers to bond to each other. The recess can be formed by reducing (e.g., eliminating) such heating and / or compression at discrete areas, which will become the area of ​​the recess. For example, heat and / or compression can be applied to the interlayer surrounding the area of ​​the recess, but not to the actual area of ​​the recess. Having a recess in one of the plates enables compression and / or application of heat to other areas of the sheet (e.g., a large portion of the sheet) without compressing and / or applying heat to the designated area of ​​the recess. Therefore, at the area of ​​the designated recess, the layers are not bonded, thereby creating a recess at the area.

[0308] The recess 312 can be positioned and / or shaped as required for the shape and / or location of the recesses 220 and / or 222. For example, in the example shown, the recess 312 is disposed at a region (e.g., a central region) of the plate 310, which in some embodiments can correspond to the desired location of the recess at the central region of the sheet. Similarly, the shape of the recess 312 is trapezoidal, so a trapezoidal recess will be produced. When a differently shaped recess is desired, the recess 312 can be shaped accordingly. Additionally, when the recess is formed at the edge of the sheet so that the recess can have an opening (e.g., opening 223), the recess 312 can be moved from the center of the plate to the edge of the plate (or the sheet can be positioned differently between the plates).

[0309] Alternatively or in addition, the formation of the pockets may be facilitated by the absence of a bonding layer between the fabric layer and the coating. In some embodiments, the bonding layer may be pre-cut / preformed to define a hole (which may be surrounded by the remainder of the bonding layer and / or may be disposed at the edge of the bonding layer). When forming the interlayer, there is no bonding layer between the fabric layer and the coating at the hole. Therefore, when heat and / or pressure is applied to form the sheet, the fabric layer may not bond to the coating at the hole in the bonding layer.

[0310] In some embodiments, the frame can be introduced into the recess. For example, for embodiments where the recess has an opening (e.g., opening 223) at the edge of the sheet, the frame can be introduced into the recess via the opening and the sheet (and recess) is subsequently formed. In some embodiments, the recess can then be sealed, such as by, for example, again applying heat and / or pressure and / or closing the opening 223 by other means such as sewing, thereby securing the frame therein.

[0311] In some embodiments where the frame is disposed within the sheet, the frame can be positioned between two layers of what will become the sheet (e.g., as described below with respect to Figures 4C to 4E ). Thus, the recess can be formed with at least one component of the frame already disposed in the area where the recess is to be formed. For example, for embodiments where the recess is defined at a recess of at least one of the plates of the laminating apparatus 20, the recess can be positioned above the frame so as to form the recess at the frame. In some embodiments, a component of the frame extends beyond the boundaries of the recess.

[0312] Reference now Figures 4A to 4K , which is a schematic diagram of sheets 100, 150, 200, 250, 300, and 350, or variations thereof, fixedly attached to a frame, according to some embodiments. In some embodiments, a system, device, implant, etc. can include a frame, such as frame 410, such that a sheet can be fixedly attached to the frame in a manner that covers at least a portion of the frame. In some embodiments, attaching the frame to the sheet can increase the structural properties and / or durability of the device, which can enable it to better function as an implant, such as a prosthetic valve, a stent, and / or a leaflet reinforcement patch and / or a wing as disclosed in one or more of the following references, each of which is incorporated herein by reference in its entirety:

[0313] ●International patent application PCT / IB2021 / 060436 filed on November 11, 2021 to Tennenbaum et al., published as WO 2022 / 101817

[0314] ●International patent application PCT / US2021 / 039587 to Chau et al., filed on June 29, 2021, and published as WO 2022 / 006087

[0315] ●International patent application PCT / US2022 / 052834 filed on December 14, 2022 to Chau et al.

[0316] In some embodiments, a device including a cardiovascular implant can be formed by fixedly attaching a sheet to a frame. The implant can be used as a prosthetic valve, a stent, a wing and / or a leaflet reinforcement patch. For example, the implant can be used for a valve of a subject's heart, the valve having a valve ring, a first leaflet, and a second leaflet opposite the first leaflet, the heart having a chamber upstream of the valve. Among other components, the implant may include a frame and a sheet. The sheet may include at least: a fabric layer, the fabric layer being fixed to at least a portion of the frame; a coating, the coating comprising a polymer configured to inhibit tissue growth thereon; and a bonding layer, the bonding layer being sandwiched between the fabric layer and the coating; and bonding the fabric layer to the coating.

[0317] Figure 4A An implant 400 is schematically shown according to some embodiments, comprising a sheet 100 fixedly attached to a frame 410. As described above with respect to Figure 1A-1B As shown, the first side 101a of the sheet can be placed adjacent to the tissue surface of the subject, which can inhibit tissue growth thereon. Therefore, the first side 101a can form at least a portion of the first (e.g., contact) face 400a of the implant 400. Accordingly, for the implant 400, the frame 410 can be, for example, disposed adjacent to (e.g., against) the fabric layer 112 at the second side of the sheet, thereby forming at least a portion of the second (e.g., opposite) face 400b of the implant 400, such as so that the contact face 400a of the implant does not have a frame. In some embodiments, the sheet 100 can be fixedly attached to the frame by suturing and / or gluing the sheet 100 to the frame 410, thereby forming the implant 400, for example, as described below in Figure 5A and 5B Detailed description of implant 500 is given in FIG.

[0318] It should be noted that framework 410 is intended to be universal, for example, with necessary modifications, represents the framework of any implant.For example, framework 410 can represent the framework for implant 500 as herein described and / or implant 600, and / or be used for the framework in the implant described in one or more references that are incorporated by reference into this paper.

[0319] In some embodiments, framework is hidden between one or more sheets and / or its layer can advantageously prevent framework from encountering the surrounding environment of implant, for example tissue, and can contribute to protection framework and / or suppress tissue growth thereon, and protect tissue from damage.Yet, in some embodiments, also can be advantageously, avoid exposing the fabric layer of sheet material, for example, to avoid any tissue growth on implant.Therefore, in some embodiments, in order to suppress the tissue growth on both sides of implant, can comprise the extra coating that can limit the second side of implant. Figure 4B ,4D , 4E, 4I, 4J and 4K schematically illustrate examples of such inclusion according to some embodiments. In some embodiments, an additional sheet 100 may be included to cover the second side 410b of the frame, wherein the coating 116 of the additional sheet defines the second face of the implant.

[0320] Figure 4B Schematically illustrated is an implant 402 comprising two sheets 100, such as a first sheet 100a and a second sheet 100b. According to some embodiments, sheets 100a and 100b may be considered as variations of sheet 100, such as being identical to sheet 100, unless otherwise specified, being connected to one another. Each of sheets 100 may be independently formed, such as by heating and / or compressing each of interlayers 102a and 102b, and each of sheets may be independently fixedly attached to frame 410, such as by suturing and / or adhering. For example, each of sheets 100 may be fixedly attached to different sides of a frame, such that both sides of frame 410 may be covered by a fabric layer. Alternatively or additionally, the two sheets may be fixedly attached to each other, for example, the first fabric layer 112 may be attached to the second fabric layer 112, for example, by sewing and / or adhering to each other, and / or to the frame 410, so that the coatings may define two faces of the implant, for example, the first coating 116 may define the first face 402a, and the second coating 116 may define the second face 402b. Alternatively or additionally, mutatis mutandis, a single sheet 100 may be folded over the edge of the frame 410 so as to cover both sides of the frame in a similar manner.

[0321] Implant 402 can be formed by fixing sheets 100a and 100b to each other and / or to a frame 410 positioned therebetween. For example, first sheet 100a (including first fabric layer 112, first bonding layer 114, and first coating 116) can be fixedly attached to frame 410, for example, by suturing and / or adhering, so that first coating 116 can define first face 402a, and first fabric layer 112 can be adjacent to first side 410a of frame. Second sheet 100b (including second fabric layer 112, second bonding layer 114, and second coating 116) can be fixedly attached to frame 410, for example, by suturing or adhering, so that second coating 116 can define first face 402a, and second fabric layer 112 can be adjacent to second side 410b of frame, thereby covering both sides of frame 410. In some embodiments, the first fabric layer of the first sheet 100a can also be fixedly attached to the second fabric layer of the second sheet 100b, for example, by suturing and / or adhering, which can increase the bond between the two sheets and the overall physical properties of the implant 402. The two sheets are combined, each of which is fixedly attached to the frame 410, so that the two coatings define two faces of the implant, such as the first face 402 and the second face 402b, which can inhibit tissue growth at the faces of the implant 402.

[0322] In some embodiments, an additional bonding layer can be added, for example, adjacent to the framework, such that the implant 402 can be formed by heating and / or compressing the additional bonding layer between the interlayers 102a and 102b.

[0323] Figure 4C An implant 404 according to some embodiments is schematically shown and includes a sheet 100' fixedly attached to a frame 410. Sheet 100' may be considered a variation of sheet 100, e.g., being identical to sheet 100, except that sheet 100' is formed by interlayer 102' (e.g., by heating and / or compressing interlayer 102') rather than by interlayer 102. Interlayer 102' may be considered a variation of interlayer 102, wherein interlayer 102' includes frame 410 sandwiched between other layers of the interlayer. For example, other layers of the sheet (e.g., layers common to both sheet 100 and sheet 100') may be fixedly attached to the frame by the frame being sandwiched between fabric layer 112 and bonding layer 114. Similar to the above description of Figure 4A Detailed implant 400, a first face 404a of implant 404 may be defined by coating 116, which inhibits tissue growth thereon. A second face 404b of implant 404 opposite to first face 404a may be defined by fabric layer 112, and thus tissue growth thereon may be achieved. In some embodiments, first face 404a may be positioned adjacent to a tissue surface of a subject.

[0324] In some embodiments, the thickness of the frame 410 between the fabric layer and the bonding layer may be 20-500 microns.

[0325] In some embodiments, the implant 404 may also include a recess (e.g., as described above with respect to Figure 2A -C). For example, such a recess may enable the cord to move (eg, slide) within the recess relative to the frame 410. Fig. 6A An example of such an application is described.

[0326] Figure 4D Schematically illustrates an implant 406 according to some embodiments, which includes a sheet 150' fixedly attached to a frame 410. Sheet 150' can be considered a variation of sheet 150, for example, the same as sheet 150, except that sheet 150' is formed by interlayer 104' (for example, by heating and / or compressing interlayer 104') instead of being formed by interlayer 104. Interlayer 104' can be considered a variation of interlayer 104, wherein interlayer 104' includes a frame 410 sandwiched between other layers of the interlayer. For example, other layers of the sheet (for example, layers common to both sheet 150 and sheet 150') can be fixedly attached to the frame by sandwiching between a binding layer (for example, a first binding layer 114a as shown) and a fabric layer 112. Therefore, implant 406 can have a first face 406a and a second face 406b, both of which can be defined by corresponding coatings, for example, a first coating 116a and a second coating 116b. The coating may be bonded to the fabric layer 112 via the first bonding layer 114a and the second bonding layer 114b sandwiched therebetween. Thus, the implant 406 may have two faces that inhibit tissue growth thereon.

[0327] Figure 4EAn implant 408 according to some embodiments is schematically shown and includes a sheet 150' fixedly attached to a frame 410. Sheet 150' may be considered a variation of sheet 150', e.g., identical to sheet 150', except that sheet 150' is formed by interlayer 104', rather than interlayer 104'. In interlayer 104', and therefore in sheet 150', a fabric layer 112' is wrapped around frame 410 from a first side to a second side of the frame, such that at least components of the frame are sandwiched between components of the fabric layer. For example, a first component 111a of the fabric layer may be disposed against a second side 410b of the frame, and at each location where the fabric layer is wrapped around the frame, a second component 111b may be disposed against a first side 410a of the frame. In the example shown, there are two such locations. That is, in the example shown, the fabric layer covers the second side 410b of the frame 410, and two components 111b of the fabric layer are folded over the edges of the first side 410a of the frame. In some embodiments, such wrapping may help secure the frame to the fabric layer.

[0328] In some embodiments, and as shown, region 409 of first side 410a may not be sandwiched between components of a fabric layer, and thus may instead be sandwiched between a fabric layer and a bonding layer (eg, bonding layer 114a).

[0329] In some embodiments, an implant described herein, such as implants 400, 402, 404, 406, and / or 408, can have an overall thickness including the framework of 50-1000 microns, such as 200-500 microns.

[0330] In some embodiments, for example, to reduce the likelihood that the edges of the implant may damage and / or injure the subject's tissue (e.g., during intentional or unintentional movement of the implant along and / or against tissue), the edges of the implant may be soft and / or may have blunt angles and / or a rounded shape.

[0331] Figure 4F , 4G, 4H, 4I, 4J and 4K schematically illustrate implants, which can be considered as variations of some of the implants described in detail above. In some embodiments, these implants may have rounded edges and / or soft edges. In some embodiments, in order to provide rounded edges, the implant may be arranged to have a cover, which may be arranged above / around the edge (e.g., a smooth continuous cover). In some embodiments, in order to provide a soft edge, the implant may be arranged to not have fabric and / or a frame at the edge, for example, at least a portion of the periphery of the implant may not have a fabric layer and / or any frame. For example, the implant may have a lip extending beyond the edge of the fabric layer. In some embodiments, the lip is folded to provide a rounded edge. In some embodiments, the lip is more flexible and / or softer than the region of the implant in which the fabric is arranged, and in some embodiments, the lip is not folded.

[0332] In some embodiments, the coating and the tie layer can extend together beyond the edge of the fabric layer to define a lip, with the lip portion of the coating and the lip portion of the tie layer disposed in the lip portion. For example, for embodiments in which the coating defines a first side of the sheet (e.g., first side 101a and first side 151a of sheets 100 and 150, respectively) and in which the sheet has a second side opposite the first side, the lip can be folded onto the second side, e.g., such that the lip portion of the tie layer is sandwiched between the lip portion of the coating and the second side.

[0333] In some embodiments, the lip can be folded to define a hem of the sheet. In some embodiments, the hem can be formed by folding the lip around an edge of the fabric layer so that within the hem, the fabric layer is disposed between the lip portion of the binding layer and another portion of the binding layer (optionally, along with components of the frame, also disposed between the lip portion of the binding layer and another portion of the binding layer).

[0334] Figure 4F Schematically illustrates an implant 420 according to some embodiments, comprising a sheet 300 fixedly attached to a frame 410 so that the implant has two rounded edges. Sheet 300 may be considered a variation of sheet 100', for example, identical to sheet 100', except that in sheet 300, coating 116 and bonding layer 114 together extend beyond edge 113 of fabric layer 112, thereby defining lip 106, in which lip portion 116' of coating and lip portion 114' of bonding layer are disposed. In some embodiments, and as shown, lip 106 may extend beyond edge 411 of frame 410.

[0335] Figure 4FThe upper image shows the sheet 300 before the rounded edge is formed, the middle image shows that the lip 106 has been folded to form the fold 107f providing the rounded edge, and the lower image shows that the sheet has been secured in this arrangement by heat and / or pressure treatment, as described herein above, mutatis mutandis.

[0336] The coating 116 may define a first face 301a of the sheet, the sheet having a second face 301b (upper image) opposite the first face. As shown, the lip 106 may be folded onto the second face 301b so that the lip portion 114' of the bonding layer 114 becomes disposed between (i) the lip portion 116' of the coating and (ii) the second face 301b of the sheet (middle image). For example, and as shown, the lip portion 114' of the bonding layer may be sandwiched between (i) the lip portion 116' of the coating and (ii) the frame 410. Additionally or alternatively, at least a component of the frame 410 may be disposed between (i) the lip portion 114' of the bonding layer and (ii) the fabric layer 112, for example, as shown. As shown, the implant 420 includes a first lip and a second lip so that each of the lips 106 may be folded around a corresponding edge 411 of the frame, thereby defining a corresponding hem 107f. In some embodiments, an edge of the frame can be disposed within the hem 107f, for example, between a lip portion of the bonding layer and another portion of the bonding layer. In some embodiments, at least a component of the fabric layer can be further disposed within the hem.

[0337] In some embodiments, the frame can be attached to the second side of the sheet, for example, by a lip. For example, the lip can be folded over the edge of the frame and fixed to the second side of the frame and / or the sheet, for example by heating the lip and / or pressing the lip against the second side of the frame and / or the sheet, for example, hem 107f, as described above, mutatis mutandis. In some embodiments, at least a component of the frame can be fixedly attached to the sheet by an adhesive and / or by sutures. Additionally or alternatively, sutures can be passed from the lip through the frame to the second side of the sheet, or vice versa, thereby simultaneously sewing the frame to the sheet and the lip.

[0338] In some embodiments, the coating 116 with the first face 420a defining the implant can inhibit tissue growth thereon. In addition, the lip 106 folded over the edge of the frame and fabric layer can shape the implant so as to have a smooth edge. In addition, by this folding over the second face 310b of the sheet, the lip portion of the coating can also provide tissue growth inhibition to the component (or even all) of the second face 420b of the implant.

[0339] In some embodiments, although not shown, the implant can be provided with rounded edges by also folding the fabric layer 112 (e.g., wrapping the fabric layer around the frame) to form a hem. Such an implant can be, for example, similar to implant 400 ( Figure 4A ), but components of the sheet (e.g., fabric layer 112, bonding layer 114, and coating 116) extend beyond the frame and wrap around the edges of the frame. In some embodiments, the sheet can be secured by sutures and / or adhesives. In some embodiments, the sheet can cover a first side 410a of the frame 410, and components of the fabric layer can be placed against a second side 410b of the frame to form a hem. In some embodiments, multiple such hems can be formed (e.g., to help secure the frame to the sheet) while leaving at least a majority of the second side 410b of the frame exposed.

[0340] Figure 4G Schematically illustrates an implant 422 according to some embodiments, which includes a sheet 300' fixedly attached to a frame 410 so that the implant has two circular edges. Sheet 300' can be considered a variation of sheet 300, for example, the same as sheet 300, except that in sheet 300', frame 410 is sandwiched between fabric layer 112 and bonding layer 114. In sheet 300', coating 116 and bonding layer 114 together extend beyond edge 113 of fabric layer 112, thereby defining lip 106, in which lip portion 116' of coating and lip portion 114' of bonding layer are disposed. In some embodiments, and as shown, lip 106 can extend beyond edge 411 of frame 410.

[0341] The coating 116 may define a first face 301a' of the sheet, the sheet having a second face 301b' opposite the first face. As shown, the lip 106 may be folded onto the second face so that the lip portion 114' of the bonding layer 114 may be disposed between (i) the lip portion 116' of the coating 116 and (ii) the second face 301b of the sheet. In the illustrated example, the lip portion 114' of the bonding layer is sandwiched between the lip portion 116' of the (i) coating and (ii) the fabric layer 112. Additionally or alternatively, at least a component of the fabric layer 112 may be disposed between the lip portion 114' of the (i) bonding layer and (ii) the frame 410, for example, as shown. As shown, the implant 420 includes a first lip and a second lip so that each of the lips 106 may be folded around a corresponding edge 113 of the fabric layer, thereby defining a corresponding hem 107g. In some embodiments, an edge of the fabric layer can be disposed within a hem of the implant, for example, between a lip portion of the bonding layer and another portion of the bonding layer. In some embodiments, at least a component of the fabric layer can further be disposed within the hem.

[0342] In some embodiments, the folded lip may become attached to the fabric layer 112 at the second side of the sheet. For example, the lip may be folded over the edge of the fabric layer and secured to the fabric layer (e.g., the second side of the sheet), such as by heating the lip and / or pressing the lip against the fabric layer and / or the second side of the sheet, such as hem 107g, as described above, mutatis mutandis. In some embodiments, at least a portion of hem 107g may be fixedly attached to the sheet by an adhesive and / or by sutures. Additionally or alternatively, sutures may be passed from the lip through the fabric layer and / or frame (or vice versa), thereby sewing the fabric layer and / or frame to the lip.

[0343] Figure 4H An implant 424 according to some embodiments is schematically shown, which includes a sheet 300 fixedly attached to a frame 410 so that the implant has two circular edges. Implant 424 can be considered a variation of implant 420, for example, being identical to implant 420, except that implant 424 has a hem 107h formed by folding the lip 106 onto itself (rather than folding onto the edge of the frame and / or fabric layer). For example, in hem 107h, a lip portion 114' of the bonding layer can be sandwiched between lip portions 116' of the coating. Hem 107h can be fixed by applying heat and / or pressing the hem, for example, as described above, with necessary modifications.

[0344] In some embodiments, the components of the second side 424b of the implant 424 can be provided (e.g., defined) by the fold 107h. In some embodiments, the fold 107h can be arranged so that the lip portion 116' of the coating extends back to the fabric layer 112, for example, so that the edge of each lip portion 116' faces and / or is adjacent to the corresponding edge 113 of the fabric layer.

[0345] It should be noted that a variation of implant 424 may be formed by reversing the positions of frame 410 and fabric layer 112 such that the frame is sandwiched between the bonding layer and the fabric layer.

[0346] Fig. 4IAn implant 426 according to some embodiments is schematically shown, which includes a sheet 350 fixedly attached to a frame 410 so that the implant has two rounded edges. Sheet 350 can be considered a variation of sheet 150', for example, the same as sheet 150', except that in sheet 350, the first coating and the first bonding layer together extend beyond the edge 113 of the fabric layer, thereby defining a lip 106, in which a lip portion 116a' of the first coating and a lip portion 114a' of the first bonding layer are disposed. In some embodiments, the lip can also extend beyond the edge 411 of the frame at least as a component of the sheet, for example, as shown. The first coating 116a can define a first face 351a of the sheet, and at least a portion of a second face 351b of the sheet opposite to the first face can be defined by the second coating 116b. The lip 106 is folded onto the second coating 116b so that the lip portion 114a' of the first bonding layer is sandwiched between the lip portion 116a' and the second coating. Thus, the folding of the lip 106 defines a hem 107i of the sheet. Thus, in some embodiments, the second face 426b of the implant can be defined in part by the second coating 116b and in part by the lip portion 116a' of the first coating. In some embodiments, the entire second face 426b can thus inhibit tissue growth thereon.

[0347] In some embodiments, at least a portion of the frame and / or the fabric layer may be disposed within the hem 107i. In some embodiments, the second side of the frame may be covered by a second bonding layer and a second coating.

[0348] It should be noted that folding the lip to produce the hemming of implant can provide additional benefits (except having rounded edge) for implant.For example, the hemming provides the continuous surface from the first side of the implant to the second side (for example, the face on which the hemming is folded) of coating, thereby hiding the edge of fabric layer and / or the edge of framework.Make fabric layer and / or framework for example be arranged in sheet material completely together with the edge of fabric layer and / or framework, can suppress the tissue growth along the edge of fabric layer and / or framework.The edge of hiding layer by forming hemming can suppress the separation of layer at its edge (for example, at the edge of sheet material) in addition or alternatively, for example, the delamination, wear, peeling or peeling that may be caused due to intermittent and / or repeated contact with tissue over time.

[0349] Similar advantageous features (e.g., inhibiting tissue growth by hiding the edges of the layers comprising the sheet) can also be achieved by extending the two coatings and at least one bonding layer beyond the edges of the fabric and / or frame, thereby defining a lip edge of the sheet / implant (e.g., not folded to form a hem), as described below with respect to Figure 4J and 4K Describe in detail.

[0350] In some embodiments, the lip 106 may not be folded onto the second coating 116b. For example, the second coating 116b may not extend close enough to the edge of the frame 410 and / or the edge of the fabric layer 112 so that the lip reaches the second coating. Some such arrangements can be similar to implant 420 and / or implant 422, where a second coating and a second bonding layer are added at the second face of the implant between the lip 106.

[0351] It should be noted that for any one of implants 4F to 4I, sheets can be formed by, for example, heating and / or compressing the relative interlayer before folding the lip onto the second face of the sheet. In some embodiments, the lip can be folded onto the second side of the interlayer before applying heat and / or compression pressure, which can form a sheet with a rounded edge when heating and / or compressing the interlayer together with the hemming.

[0352] Figure 4J An implant 428 according to some embodiments is schematically shown, comprising a sheet 350' fixedly attached to a frame 410 such that the implant has a lip 106'. Sheet 350' can be considered a variation of sheet 150' (e.g., identical to sheet 150'), except that in sheet 350', the first coating, the second coating, and the first bonding layer together extend beyond one or more edges of the fabric layer and / or the frame, thereby defining a lip 106' in which a lip portion 116a' of the first coating, a lip portion 116b' of the second coating, and a lip portion 114' of the bonding layer are disposed. Lip 106' can be softer and / or more flexible than other portions of sheet 350' (e.g., portions in which fabric layer 112 is disposed). It should be noted that while in implants 420, 422, and 426, lip 106 is folded, lip 106' is not folded and acts as the lip of the final implant, eg, they define the edges of the implant.

[0353] In some embodiments, within the lip 106', the lip portion 116a' of the first coating can be bonded to the lip portion 116b' of the second coating by the lip portion 114' of the first bonding layer. For example, the lip can be heated and / or compressed along the rest of the sandwich, such as when forming the sheet 350' and / or the implant 428. Having the fabric layer and / or the frame completely disposed within the sheet can inhibit tissue growth thereon, such as even along the edges of the fabric layer and / or the edges of the frame.

[0354] Figure 4KA sheet 350" of an implant 429 according to some embodiments is shown. The sheet 350" can be the same as the sheet 350', except that it includes a second bonding layer 114b. That is, the sheet 350" includes a first bonding layer 114a (which corresponds to the bonding layer 114' of the sheet 350') and a second bonding layer 114b. The lip portion 114b' of the second bonding layer 114b can extend beyond the edge of the fabric layer 112 and / or the edge of the frame 410 into the lip, for example, together with the lip portion 116b' of the second coating. For example, within each lip 106", the lip portion 116a' of the first coating can be bonded to the lip portion 116b' of the second coating by both the lip portions 114a' and 114b' (of the first bonding layer and the second bonding layer). The bonding of the lip portion of the first coating to the lip portion of the second coating via the first and second bonding layers may occur as part of the overall formation of the sheet 350", such as by heating and / or compressing the lip 106" and the remainder of the interlayer.

[0355] In some embodiments, for any implant described above as comprising a framework, the framework can extend / protrude beyond the edge of the sheet. For example, the edge of the sheet that the framework can protrude beyond can be defined by any one of the layers, such as the first coating and / or the second coating, the first bonding layer and / or the second bonding layer and / or a fabric layer. Fig.6D An example of this is shown in .

[0356] In some embodiments, the shape of the frame supporting and / or attached to the sheet can determine the shape of the implant.

[0357] In some embodiments, although not shown, any of the implants described above can be formed and / or function without a frame. By way of example only, an implant comprising a sheet but not a frame can still include one or more folded lips (e.g., as described in reference to Figure 4F -I) and / or one or more non-folded lips (e.g., as described in reference Figure 4J -K), mutatis mutandis. In some embodiments, the shape of the implant can be determined by the shape of the formed, cut and / or folded sheet.

[0358] Reference now Figure 5A and 5B , which is a schematic illustration of an implant 500 for use with a valve of a subject's heart, according to some embodiments. Figure 5A An exploded view of an implant 500 is shown according to some embodiments, and Figure 5BAn integral implant is shown. The implant 500 may be anchored to the tissue of the heart in order to repair the function of the native valve leaflets. The implant 500 may be considered to be a variation of and / or may be similar to the implants disclosed in International Patent Application PCT / US2021 / 039587 filed on June 29, 2021 to Chau et al. (published as WO 2022 / 006087) and / or International Patent Application PCT / US2022 / 052834 filed on December 14, 2022 to Chau et al., at least in its general purpose, each of which is incorporated herein by reference mutatis mutandis. Similarly, the techniques described herein may be used mutatis mutandis to form any of the implants described in these references.

[0359] In some embodiments, the implant can be shaped as a wing defining a contact surface 521 and an opposing surface 522 opposite the contact surface. The wing can be configured to be anchored to cardiac tissue of a subject having a first leaflet and a second opposing leaflet, such that the wing can extend over the first leaflet toward the second leaflet, and the contact surface faces the first leaflet.

[0360] In some embodiments, implant 500 may include framework 510 and sheet 550, and other components. Sheet 550 may be or may include any one of the sheets described herein, such as sheet 100, 150, 200, 250, 300, 350 and / or its modification (e.g., including at least one fabric layer, at least one coating and at least one bonding layer). Framework 510 may be considered as a modification of framework 410, with necessary modifications.

[0361] The sheet 550 can be fixedly attached to the frame, thereby defining wings 555. In the example shown, the sheet 550 is sewn to the frame 510 by stitching lines 551, for example, the sheet is formed and then sewn to the frame. The edges of the sheet 550 can be folded over the edges of the frame to facilitate such sewing. However, it should be noted that the sheet 550 can alternatively or additionally be attached to the frame 510 by other means described herein, including using adhesives and / or using hems such as those described elsewhere herein.

[0362] The wings of the implant 500 can be attached to anchoring receivers 560, which are configured to receive anchors for anchoring the implant to tissue, such as to the annulus of a heart valve of a subject. The wings can define a contact surface, which can be defined by, for example, a coating of the contact layer 116 / 116a or the contact layer 116b and an opposing surface opposite the contact surface.

[0363] The frame 510 can be flexible such that the wings can have elastic and / or shape memory properties (e.g., the frame can be formed from and / or include nitinol, cobalt chromium alloy, stainless steel, and / or a polymer) so that it can be folded or rolled up for delivery into a cardiac cavity in a catheter-permeable shaft and can automatically expand to its resting position, i.e., resting and / or original shape, once deployed into the cardiac cavity.

[0364] The wing 555 (e.g., the sheet 550 thereof) can have a plurality of holes 570 therethrough, e.g., to facilitate blood flow through the wing. For example, after the wing is formed from the sheet and frame, the holes 570 can be formed by, e.g., manually, mechanically, or laser cutting the implant and / or wing, as described below with respect to Figures 8A to 8C In some embodiments, the holes 570 can be cut before the sheet 550 is attached to the frame 510 .

[0365] In some embodiments, the implant can be shaped to define a leaflet reinforcement patch that is configured to be attached to the valve leaflets of the subject's heart. For example, after forming sheet 100 and / or sheet 150, the implant and / or wing can be cut, for example manually, mechanically, or by laser, so as to be shaped similarly to the leaflet reinforcement patch, for example, as disclosed in International Patent Application PCT / IB2021 / 060436 to Tennenbaum et al., filed on November 11, 2021, published as WO 2022 / 101817, and incorporated herein by reference. In some embodiments, the shape of the frame supporting and / or attached to the sheet can determine the shape of the implant.

[0366] Reference now Figures 6A to 6D , which is a schematic diagram of an implant 600 and variations thereof according to some embodiments. Implant 600 includes a leaflet reinforcement patch 610 and may also include one or more patch anchors 640 configured to anchor the patch to a valve leaflet of a subject's heart. Patch 610 may include a flexible sheet 620 fixedly attached to a frame 630. Sheet 620 may be or may include any of the sheets described herein, such as sheets 100, 150, 200, 250, 300, 350 and / or variations thereof (e.g., including at least one fabric layer, at least one coating, and at least one bonding layer). Frame 630 may be viewed as a variation of frame 410, with necessary modifications.

[0367] In some embodiments, implant 600 and / or its variants described herein may correspond to and / or may be a variant of one or more upstream / downstream components described in International Patent Application (PCT) Publication WO 2022 / 101817 granted to Tennenbaum et al., such as "upstream component 600", "downstream component 700" and / or its variants. For example, implant 600 may be used to replace "upstream component 600" (and / or the variant described in Tennenbaum et al.) of Tennenbaum et al., and / or patch 610 may be used to replace "patch 610" (and / or the variant described in Tennenbaum et al.) of Tennenbaum et al. Similarly, the technology described herein may be used to form any upstream component and / or patch described in Tennenbaum et al. with necessary modifications.

[0368] In the example shown, and as described in more detail below, the sheet 620 is fixedly attached to the frame 630 by the frame being sandwiched between (other) layers of the sheet, such as between the fabric layer 652 of the sheet and the bonding layer of the sheet (e.g., the second bonding layer 654b of the sheet). Thus, in some embodiments, the frame 630 can be considered to be a component of the sheet 620.

[0369] The frame 630 can be flexible so that the patch 610 can respond to conditions in the heart, such as the shape of one or both leaflets, to promote optimal coaptation. In some embodiments, the frame 630 (and thus the patch 610) can be configured to be more flexible in one axis than in another axis. For example, the frame 630 can provide greater flexibility along the root-to-tip axis ax3 of the patch 610 (e.g., the tip 611 of the patch moves relative to the root 612 of the patch) than along the lateral axis ax4 of the patch transverse to the root-to-tip axis (e.g., one lateral edge 613 moves relative to another lateral edge 615). The frame 630 may include a root support 632 having a first root portion 632a and a second root portion 632b that can extend at the root 612, for example, a first root portion 632a at the lateral edge 613 and a second root portion at the other lateral edge 615. The frame 630 may define a tip cradle 631 which may include a beam extending substantially along the tip 611, such as from one lateral edge 613 to the other lateral edge 615. The tip cradle 631 and the root cradle 632 may provide the patch 610 with a degree of mediolateral stiffness.

[0370] The frame 630 may include a spring 634 that may extend between the tip support 631 and the root support 632, including a lateral protrusion 635. In the example shown, the spring 634 extends substantially along the root-to-tip midline of the patch 610 (e.g., along the axis ax3 if the axis ax3 is the central root-to-tip axis). However, other locations and shapes are possible.

[0371] Implant 600 may include one or more patch anchors 640 configured to anchor patch 610 (and thus implant 600) to cardiac tissue of a subject, such as to a valve leaflet of a heart. In some embodiments, one or more cords 642 couple patch anchor 640 to patch 610. For example, and as shown, each patch anchor may be coupled to the patch by a corresponding cord. Rather than fixing each cord 642 to patch 610 (e.g., its frame 630) at a point 614 near where the cord reaches the patch, the cord passes through the patch at point 614 and extends along the patch to a location where it is fixed (e.g., a location on the frame 630). In the example shown, each cord 642 (e.g., in a root-to-tip direction, such as substantially parallel to axis ax3) extends to a tip support 631 to which it is fixed.

[0372] In some embodiments, each cord 642 extends along the patch within the sheet 620 (e.g., between the layers of the sheet), for example, as shown. Having the cords 642 extend within the sheet 620 (e.g., rather than along the outside of the sheet) advantageously provides a smooth surface for the sheet, thereby providing a surface for the patch 610 to optimally contact the tissue.

[0373] In the example shown, the sheet 620 includes (i) a first coating 656a, which is bonded to the fabric layer 652 by a first bonding layer 654a sandwiched between the first coating and the fabric layer, and (ii) a second coating 656b on the side opposite to the coating 656a of the fabric layer 652 (and the frame 630), which is bonded to the fabric layer by a second bonding layer 654b sandwiched between the second coating and the fabric layer. The second coating 656b defines the second face of the sheet 620, and thus defines the contact face 621 of the implant 600 (e.g., a face placed in long-term contact with the tissue). The first coating 656a defines the first face of the sheet, and thus defines the opposite face 622 of the implant 600 (e.g., a face that can be placed in intermittent and / or repeated contact with the tissue). At the component of the patch 610' where the frame 630 is disposed, the frame can be sandwiched between the second bonding layer 654b and the fabric layer 652, for example, as shown.

[0374] The spring 634 provides a patch anchor fastening function to the implant 600 and its variations. The implant 600 is anchored to the tissue by driving the patch anchor 640 into the tissue (and typically through the tissue). For example, the implant 600 can be anchored to the leaflet of the heart valve to be reinforced by the patch 610 by driving the patch anchor 640 through the leaflet to the second side of the leaflet, while the patch remains on the first side of the leaflet. Thus, when the patch anchor 640 is driven to the second side of the leaflet (e.g., by a driver of a delivery tool for the implant 600), the patch anchor is pushed away from the patch 610, which remains at the first side of the leaflet. This tightening tether 642 puts the spring 634 under stress (e.g., by pulling the tip support 631 toward the root support 632). The resulting tension (e.g., compression) of spring 634 allows cord 642 to be pulled out of patch 610 (e.g., through point 614), thereby allowing patch anchor 640 to be driven away from the patch and through the leaflet. In some embodiments, and as shown, this can be achieved by temporarily reducing the root-to-tip length of the patch, i.e., linearly contracting the patch.

[0375] Upon release of the patch anchor 640 on the second side of the leaflet (e.g., from the actuator), the spring 634 returns toward its original (e.g., resting) state, pulling the patch anchor back toward the patch 610, thereby securing the patch to the leaflet by sandwiching the leaflet between the patch anchor and the patch. Providing an upstream assembly with self-tightening patch anchors such as these (e.g., by including a patch with a spring biased to tighten the patch anchor) can advantageously avoid the need to perform a separate tightening or locking step, and / or the need to include a separate locking component.

[0376] Because the cord 642 is disposed between layers of the sheet 620, such a self-tightening function may require that the cord be slidable between the layers, e.g., in one direction by actuation of an anchor and in the opposite direction by a spring returning to its original (e.g., resting) state.

[0377] In some embodiments, and as shown, the spring 634 is coupled to the root support 632 via a patch anchor support 636 defined by the frame 630, and can be positioned and shaped to partially or completely surround the point 614. The patch anchor support 636 can advantageously provide one or more of the following benefits: (1) serving to reinforce the patch at the point 614, e.g., to prevent the cord 642 from cutting through the sheet 620; (2) serving as a bearing surface on which the cord 642 slides as it moves through the point 614; and / or (3) providing a resistance (e.g., an opposing force) to the fact that the patch anchor 640 can be pressed against the leaflet, thereby improving the clamping of the leaflet between the patch anchor and the patch 610, e.g., compared to a similar patch in which the patch anchor presses the leaflet against a portion of the patch where the sheet 620 is not supported by the frame 630.

[0378] In some embodiments, a tether 670 tethering an upstream component to a downstream component can be attached to the tip region of the patch. For embodiments in which the patch includes a frame defining a tip support, the tether can be attached to the tip support. For example, for the patch 610, the tether 670 can be attached to the tip support 631 at the middle of the tip 611 (e.g., to an eyelet defined by the tip support). It should be noted that although both the tether 670 and the cord 642 are attached to the tip support 631, they function at least partially independently, e.g., the spring 634 tensions the cord 642 regardless of the tension on the tip support. In addition, the tip support 631 can be configured to distribute at least a portion of the force applied by the tether 670 (e.g., during ventricular systole) to the patch 610 (e.g., during ventricular systole) across the width of the patch. However, the limited length of the cord 642 can limit the extent to which such forces are experienced by the patch 610 itself (e.g., by the sheet 620), for example, to prevent the patch from being undesirably stretched. That is, once the cord 642 has its patch anchors tightened against the leaflets, thereby firmly clamping the leaflets to the contact surface 621 of the patch 610, the cord inhibits the tip stent 631 from moving further away from the root stent 632.

[0379] As described above, the self-fastening function of patch 600 may require that cord 634 can slide between layers of sheet 620. Therefore, patch 600 may be provided with features and / or manufactured using techniques that facilitate smooth sliding of the cord between layers of sheet.

[0380] In some embodiments, such smooth sliding is facilitated by the frame 630, which is shaped, sized, and / or positioned to separate (e.g., to limit or prevent) the cord 642 and one or both of the bonding layers 654 (e.g., to limit or prevent contact therebetween), which may be inherently sticky and may otherwise grip the cord. For example, the frame 630 may define a lateral protrusion 635 that may extend laterally from the spring 634 to protrude between the cord 642 and the bonding layers. In the example shown, the protrusion 635 extends between and separates the cord 642 and the second bonding layer 654b. In the example shown, a similar protrusion is not provided on the other side of the cord 642 because the cord is separated from the first bonding layer 654a by the fabric layer 652.

[0381] Alternatively or additionally, such smooth sliding is facilitated by providing a friction reducing area, for example, in the form of a recess 650 in which the spring 634 and / or cord 642 are disposed. Because the recess 650 is formed by bonding the layers of the sheet material without applying heat and / or pressure, the recess can reduce friction between the fabric layer 652 and the cord, for example, by preventing the bonding layer 654 (e.g., the second bonding layer 654b) from bonding to the cord and / or preventing the fabric layer from compressing against the cord, the frame, and / or the second bonding layer. The recess 650 can be as described with reference to Figure 2A-3 and 7A-B, and / or may be formed using the techniques described with reference to these figures.

[0382] Figure 6C An implant 600' is schematically shown according to some embodiments, which can be considered a variation of implant 600, except that implant 600' includes a patch 610', which includes a sheet 620', which is formed with at least one lip 606, and the at least one lip is folded to define a folded edge 607. Mutually modified, the sheet 620' includes a frame 630 similar to (e.g., the same as) the frame used in implant 600, as well as other components. Implant 600' has three lips 606, such as two lateral lips and a root lip, which are folded onto a second side of the sheet 620' (e.g., the contact surface 621 of the implant), thereby defining three corresponding folded edges 607 of the implant. Similar to the above description of Figures 4A to 4K 6, the frame can be disposed within the sheet material such that the layers of the sheet material can cover the frame from both sides. For example, the first coating 656a and the first bonding layer 654a together extend beyond the edge of the fabric layer 652, thereby defining the lip 606. In the present application, at least some components of the patch 610', the three layers of the sheet material (e.g., the first coating 656a, the first bonding layer 654a, and the fabric layer 652) extend beyond the lateral edges of the frame, and similarly, mutatis mutandis, extend to the lateral edges of the frame as described above with respect to the lip. Fig. 4IAs shown, the lip portions of the first coating 656a and the first bonding layer 654a are folded onto the second side of the sheet 620' over the edge of the fabric layer 652 (and generally the frame), thereby forming a hem 607. In the example shown, three lips 606 are folded onto the second side of the sheet, so that the implant has three rounded edges.

[0383] In the example shown, the sheet 620' has a second coating 656b on the side of the fabric layer 652 (and the frame 630) opposite to the coating 656a, and is bonded to the fabric layer by a second bonding layer 654b sandwiched between the second coating and the fabric layer. At the component of the patch 610' where the frame 630 is arranged, the frame can be sandwiched between the second bonding layer 654b and the fabric layer 652, for example, as shown in the figure. Therefore, the lip 606 is folded onto the second face of the sheet 620' and the lip is placed on the second coating 656b, wherein the first bonding layer 654a is sandwiched between the first coating 656a and the second coating, and the first coating and the second coating are combined together, thereby fixing the hem 607.

[0384] For implant 600', the face of patch 610' onto which lip 606 is folded can serve as a contact face 621 of the implant, eg, the face that is placed in long-term contact with tissue.

[0385] Fig.6D An implant 600" is schematically shown according to some embodiments, which can be considered a variation of implant 600 or a variation thereof, except that implant 600" includes a patch 610", which includes a sheet 620", which is formed with at least one lip edge 606". Mutually modified, the sheet 620" includes a frame 630 similar to (e.g., identical to) the frame used in implant 600, as well as other components.

[0386] Similar to the above Figures 4B-4D , 4G and 4I to 4K, the frame 630 can be disposed within the sheet 620" such that the layers of the sheet can cover at least a majority of the frame from both sides. At least a majority of the frame can be covered such that at least the first coating 656a, the second coating 656b and the first bonding layer 654a of the sheet together extend beyond the edge of the fabric layer 652, thereby defining a lip 606". In some embodiments, and as shown, the sheet 620" can include a second bonding layer 654b, which can also extend beyond the edge of the fabric layer 652 into the lip 606". In some embodiments (as shown), the lip 606" and its formation can therefore be similar to the above description of Figure 4K The lip 106" is similarly described mutatis mutandis.

[0387] In some embodiments, the lip 606" can be softer and / or more flexible than other portions of the sheet 620" (e.g., portions in which the fabric layer 652 and / or frame 630 are disposed). The lip 606" can advantageously provide the implant with beneficial features similar to those described above, such as a soft edge to prevent tissue injury.

[0388] In some embodiments, and as shown, one or more portions of the frame 630 extend beyond the edge of the fabric layer 652, thereby entering the lip 606". In some embodiments, and as shown, one or more portions of the frame 630 even protrude beyond the lip 606", for example, beyond the edge 601" defined by the other layers of the sheet so as to be exposed from the other layers of the sheet. In the example shown, portion 632" of the frame 630 extends beyond edge 601".

[0389] The edge of the sheet through which the frame may protrude may be defined by any combination of layers, such as a first coating and / or a second coating, a first bonding layer and / or a second bonding layer and / or a fabric layer. In the particular example shown, the frame extends into, through and beyond the lip 606" to protrude from the edge 601", in which the coating and bonding layers are disposed, rather than the fabric layer.

[0390] The lip 606" may define the perimeter of the sheet, in addition to any portion of the frame that protrudes beyond the edge 601".

[0391] Reference now Fig. 7A and 7B , which is a schematic diagram of a laminating device 22 according to some embodiments. The laminating device includes two plates, for example, a first plate 710 and a second plate 720, which are configured to press against each other so as to apply pressure and / or heat to the interlayer in each layer fixed between the two plates (for example, any interlayer in each layer disclosed herein) so as to form a sheet, for example, any one of the sheets disclosed herein. In the example shown, implant 600a (which can be regarded as a variation of implant 600) is formed with a recess 650. In the present application, the two plates of the laminating device 22 can define a recess, for example, recesses 712a and 712b in the contact surface of the plate. The recess enables the formation of a recess 650 in the sheet (for example, sheet 620) of the implant.

[0392] As described above, the sheet can be formed by compressing and / or heating the interlayer, which can cause the layers to bond to each other. The recess can be formed by reducing (e.g., eliminating) such heating and / or compression at discrete areas, which will become the area of ​​the recess. For example, heat and / or compression can be applied to the interlayer surrounding the area of ​​the recess, but not to the actual area of ​​the recess. Having recesses 712a and 712b at two plates enables compression and / or application of heat to other areas of the sheet (e.g., most of the sheet) without compressing and / or applying heat to the designated area of ​​the recess. Therefore, at the area of ​​the designated recess, the layers are not bonded, thus creating a recess at the area.

[0393] When the frame is disposed within the sheet, the frame can be positioned between the two interlayers that will become the sheet (e.g., as shown) before applying pressure and / or heat to form the sheet. Thus, the recess can be formed with at least one component of the frame that has been disposed in the area where the recess will be formed. For example, and as shown, for embodiments in which a recess in a plate of the laminating device 22 defines a recess therein, the recess can be positioned above the frame so as to form a recess at the frame. In some embodiments, a component of the frame extends beyond the boundaries of the recess.

[0394] Recess 712a and 712b can be positioned and / or shaped according to the shape and / or position of recess 650 and / or its modification.For example, in the example shown, recess 712a and 712b are arranged at the district (for example, central area) of plate 710 and 720, and in some embodiments, the district can correspond to the desired position of recess at the central area of ​​sheet.Similarly, the shape of recess 712a and 712b is trapezoidal (having rectangular shape at the long base of trapezoidal), which will produce the recess of corresponding shape.When implant is positioned between plates, recess 712 can be positioned above the central area of ​​framework and / or along the central area of ​​framework, for example, as shown in the figure, along spring 634 and lateral projection 635 thereof.For example, the short base of trapezoidal can be at the tip support 631, and the long base of trapezoidal can end at the root support 632.

[0395] In some embodiments, the recess 712 can extend beyond the edge of the sheet 620. For example, and as shown, the rectangular component of the recess 712 can extend from the long base of the trapezoidal component of the pocket beyond the root 612 of the implant. Since the recess extends beyond the edge of the sheet, this can result in an opening 623 at the edge of the sheet, for example, as described above for the opening 223. The opening 623 can enable access to the cord 642, or in some embodiments can enable the introduction of the cord 642 after lamination. In some embodiments, the pocket can then be sealed, for example, by, for example, again applying heat and / or pressure at the opening and / or closing the opening by other means such as suturing, thereby securing the frame and / or cord therein.

[0396] In some embodiments, and as shown, the frame is introduced into the sheet before the layers are joined around the pocket, e.g., before heat and / or pressure is applied to the sheet. Additionally, when a pocket having an opening is formed at the edge of the sheet, the cord may extend out of the pocket via the opening (e.g., rather than extending out of point 614).

[0397] Alternatively or additionally, the formation of the recess may be facilitated by the absence of a bonding layer at the area that will become the recess, for example, as described above with reference to Figure 3 described.

[0398] Reference now FIG. 8A to FIG. 8C , which is a schematic diagram of a technique for forming holes through a sheet of an implant according to some embodiments. In the example shown, the technique is used to form such holes to facilitate blood flow through the wings of the implant. Figures 8A to 8C A sequence of at least some steps in the technology is shown, wherein each figure shows a wing of an implant 500 from a top view (upper drawing in the figure) and from a side view (lower drawing in the figure). As described above, the implant 500 includes a wing including a sheet 550 fixedly attached to a frame 510.

[0399] In some embodiments, and as can be seen in Figures 5 and 8A (lower figures), the wings can be curved, for example, so that the contact surface 521 is concave, which can enhance the ability of the implant to guide and / or provide support to the native leaflets, for example along the contact surface, thereby helping the native leaflets to present proper configuration for apposition with the opposing leaflets, as described in detail in international patent application PCT / US2022 / 052834 to Chau et al., filed on December 14, 2022, which is incorporated herein by reference.

[0400] Cutting precise holes in an already curved sheet can be challenging, e.g., can be more time consuming, more expensive, and / or less precise than cutting such holes in a flat sheet. However, cutting such holes from a sheet before the sheet is fixedly attached to a frame can also be challenging, e.g., with respect to aligning the sheet with the frame so that the holes are properly positioned relative to the frame, e.g., to avoid the holes being covered or blocked by a component of the frame. Furthermore, because the shaping of the frame 510 can require temperatures that the sheet 550 cannot withstand, it may not be possible to impart the frame with its curvature after the sheet has been secured to the frame and the holes have been formed. Thus, reference is made to Fig. 8A The technique described in -C advantageously facilitates forming the holes 570 after the sheet is fixedly attached to the frame 510, even though the frame is curved at least when at rest.

[0401] Fig. 8A Sheet 550 is shown fixedly attached to frame 510 prior to forming hole 570. At this point, implant 500 can be temporarily flattened so that hole 570 can be formed in sheet 550 while the sheet is flat. Such flattening of the implant and / or sheet can be facilitated by the elasticity / resilience of the frame, which can enable the implant to be temporarily flattened without the implant losing its curved resting shape.

[0402] Figure 8B The implant 500 is shown having been temporarily flattened by a cage 800 (when positioned within the cage) having rails 810 that constrain the implant (e.g., its wings and / or frame) in a flat configuration therebetween. In some embodiments, the cage 800 may include a first set of rails 810a and a second set of rails 810b disposed on opposite sides of the cage 800, e.g., such that when the cage 800 is in its closed configuration, the rails 810 sandwich portions of the implant (e.g., a relatively flat portion of the implant) therebetween. Fig. 8A and Figure 8B ). For example, the tracks 810a and 810b may be generally positioned such that in the closed configuration of the cage, each track is opposed to and / or aligned with a corresponding track disposed on an opposite side of the cage. Figure 8B -C, only track 810a is visible, as track 810b is obscured by the corresponding track 810a disposed above it. In some embodiments, and as can be seen, the shape of the flattening wing can be generally trapezoidal, triangular, or raindrop-shaped.

[0403] Figure 8CA hole 570 is shown formed in the sheet 550 while the sheet is held in a flat configuration by the track 810 of the cage 800. In some embodiments, the cage 800 (e.g., its track 810) is shaped to hold the implant in a flat configuration while keeping at least a majority of the sheet 550 exposed, i.e., accessible for forming a hole. The exposed wing components can have holes formed therethrough, e.g., by an automated device or using a hand tool. Once the wing is flattened, and while it remains flat, a hole can be formed (e.g., cut through the sheet) by a laser or mechanically (e.g., by a blade, saw, cutting disk, water jet, or any other mechanical cutting machine). For example, the flattened sheet 550 may be particularly advantageous for an automated laser cutting system, e.g., so that movement of the laser head can be in a plane that is parallel and / or coincident with the plane of the flat configuration.

[0404] In some embodiments, the manufacture of multiple implants can be performed by (i) attaching multiple frames in an arrangement (e.g., an array or grid) on a single sheet, (ii) flattening all frames at the same time (e.g., within a large cage), (iii) while constraining the frames, using an automated cutting device to form holes in the sheet of each frame, and (iv) subsequently, while the frames remain constrained or when the frames are subsequently released, cutting the sheet to separate and / or trim individual implants. In some embodiments, cutting the sheet to separate and / or trim the implants can be performed using the same automated cutting machine used to form the holes.

[0405] In some embodiments, and as shown, the holes 570 are hexagonal. In some embodiments, the holes 570 are circular or oval.

[0406] It should be noted that reference Fig. 8A -C The techniques described can be used for implants and / or sheets other than those described herein.

[0407] Any of the various systems, components, devices, parts, equipment, etc. in the present disclosure may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use with patients, and the methods herein may include sterilizing (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) the associated systems, devices, parts, equipment, etc. (or additional methods include or consist of such sterilization).

[0408] Although the above description contains some embodiments, these should not be construed as limiting the scope of the present disclosure, but should be construed as examples.The feature of an embodiment can be combined with the features of other embodiments.For example, with necessary modifications, the feature of one or more modifications of implant 100 can be combined with the feature of one or more other modifications of implant 100, the feature of one or more modifications of implant 200 can be combined with the feature of one or more other modifications of implant 200, and the feature of one or more modifications of implant 100 can be combined with the feature of one or more modifications of implant 200. In addition, the instrument (for example, delivery instrument and / or its parts) described as used together with implant 100 (and / or its modification) can be used together with implant 200 (and / or its modification), and vice versa.

[0409] Exemplary Embodiments (Some non-limiting examples of the concepts herein are listed below):

[0410] Example 1. A method for manufacturing a medical implant, the method comprising: (i) forming a sandwich, the sandwich comprising: (a) a fabric layer, (b) a coating, the coating comprising a polymer configured to inhibit tissue growth thereon, (c) a bonding layer, the bonding layer sandwiched between the fabric layer and the coating, and / or (d) at least a component of a frame, the at least a component of the frame sandwiched between the fabric layer and the bonding layer; and / or (ii) heating and compressing the sandwich so that the bonding layer bonds the fabric layer to the coating.

[0411] Example 2. The method according to Example 1 further includes sterilizing the interlayer after heating and compressing the interlayer.

[0412] Example 3. The method of any one of examples 1 to 2, wherein forming the sandwich comprises sandwiching at least the component of the frame together with the bonding layer between the fabric layer and the coating.

[0413] Example 4. The method of any one of examples 1 to 3, wherein the coating consists essentially of the polymer.

[0414] Example 5. The method of any one of examples 1 to 4, wherein the coating is non-porous.

[0415] Example 6. The method of any one of examples 1 to 4, wherein the coating is porous.

[0416] Example 7. The method of any one of examples 1 to 6, wherein the coating is a film.

[0417] Example 8. The method of any one of examples 1 to 6, wherein the fabric layer comprises a woven fabric.

[0418] Example 9. The method of any one of examples 1 to 6, wherein the fabric layer comprises a nonwoven fabric.

[0419] Example 10. The method of any one of examples 1 to 9, wherein the polymer comprises ultra-high molecular weight polyethylene (UHMWPE).

[0420] Example 11. The method of any one of examples 1 to 9, wherein the polymer comprises fluorinated ethylene propylene (FEP).

[0421] Example 12. The method of any one of examples 1 to 11, wherein the bonding layer comprises an acrylate.

[0422] Example 13. The method of any one of Examples 1 to 12, wherein the bonding layer comprises silicone.

[0423] Example 14. The method of any one of examples 1 to 13, wherein the bonding layer comprises thermoplastic polyurethane (TPU).

[0424] Example 15. The method of any one of Examples 1 to 14, wherein the bonding layer is 5-30 microns thick.

[0425] Example 16. The method of any one of Examples 1 to 15, wherein the component of the frame is 20-500 microns thick.

[0426] Example 17. A method according to any one of Examples 1 to 16, wherein: (i) the coating defines a first side of the interlayer and the interlayer has a second side opposite to the first side, (ii) forming the interlayer includes forming the interlayer to define a lip, wherein the lip portion of the coating and the lip portion of the bonding layer together extend beyond the edge of the fabric layer, and / or (iii) the method also includes folding the lip around the edge of the fabric layer onto the second side so that the lip portion of the bonding layer is sandwiched between the lip portion of the coating and the second side.

[0427] Example 18. A method according to any one of Examples 1 to 16, wherein the frame has a first side and an opposite second side, and wherein forming the interlayer includes wrapping the fabric layer around the frame from the first side to the second side such that at least a portion of the frame is sandwiched between (i) a first portion of the fabric layer disposed against the first side of the frame and (ii) a second portion of the fabric layer disposed against the second side of the frame.

[0428] Example 19. A method according to any one of Examples 1 to 18, wherein heating and compressing the interlayer includes heating and compressing the interlayer in a manner to define a recess between the fabric layer and the bonding layer, wherein at least the component of the frame is disposed in the recess.

[0429] Example 20. The method of Example 19, wherein heating the interlayer comprises heating the interlayer between plates, at least one of the plates having a recess at the region of the pocket.

[0430] Example 21. The method of Example 19, wherein compressing the interlayer comprises compressing the interlayer between plates, at least one of the plates having a recess at the region of the pocket.

[0431] Example 22. The method of Example 19, further comprising closing the recess by bonding the fabric layer and the bonding layer surrounding the recess.

[0432] Example 23. The method of Example 19, wherein heating and compressing the interlayer comprises heating and compressing the interlayer in a manner that provides an opening in the recess, wherein the fabric layer is released from the bonding layer.

[0433] Example 24. The method of any one of Examples 1 to 23, wherein forming the interlayer includes defining a lip, wherein a lip portion of the coating and a lip portion of the bonding layer together extend beyond an edge of the fabric layer.

[0434] Example 25. A method according to Example 24, wherein forming the interlayer includes: (i) forming the interlayer so that the coating defines a first side of the interlayer and so that the interlayer has a second side opposite to the first side, and / or (ii) folding the lip onto the second side so that the lip portion of the bonding layer is sandwiched between the lip portion of the coating and the second side.

[0435] Example 26. The method of any one of Examples 1 to 25, further comprising forming a hole through the interlayer after heating and compressing the interlayer.

[0436] Example 27. The method of Example 26 further comprising flattening the interlayer after heating and compressing the interlayer, and maintaining the interlayer flat while forming the hole through the interlayer.

[0437] Example 28. The method of Example 26, wherein forming the hole comprises forming the hole by laser cutting.

[0438] Example 29. The method of Example 26, wherein the hole is a hexagonal hole, and wherein forming the hole includes forming the hexagonal hole.

[0439] Example 30. A method comprising: (i) forming a sandwich comprising a bonding layer sandwiched between: (a) a fabric layer, and (b) a coating, the coating comprising a polymer configured to inhibit tissue growth thereon; and / or (ii) forming a sheet by bonding the fabric layer to the coating by: (a) heating the sandwich, and / or (b) compressing the sandwich.

[0440] Example 31. The method of Example 1, further comprising sterilizing the sheet after heating and compressing the sandwich.

[0441] Example 32. A method according to any one of Examples 30 to 31, wherein: (i) in the interlayer, the bonding layer is detached from the fabric layer, (ii) forming the interlayer includes forming the interlayer in which the bonding layer is detached from the fabric layer, and / or (iii) forming the sheet by bonding the fabric layer to the coating includes bonding the bonding layer to the fabric layer and the coating by heating and compressing the interlayer to form the sheet.

[0442] Example 33. A method according to any one of Examples 30 to 31, wherein: (i) in the interlayer, the bonding layer is bonded to the fabric layer, (ii) forming the interlayer includes forming the interlayer in which the bonding layer is bonded to the fabric layer, and / or (iii) forming the sheet by bonding the fabric layer to the coating includes forming the sheet by bonding the bonding layer bonded to the fabric layer to the coating by heating and compressing the interlayer.

[0443] Example 34. A method according to any one of Examples 30 to 33, wherein the coating consists essentially of the polymer.

[0444] Example 35. The method of any one of Examples 30 to 34, wherein the coating is non-porous.

[0445] Example 36. The method of any one of Examples 30 to 34, wherein the coating is porous.

[0446] Example 37. The method of any one of Examples 30 to 36, wherein the coating is a film.

[0447] Example 38. The method of any one of Examples 30 to 36, wherein the fabric layer comprises a woven fabric.

[0448] Example 39. The method of any one of Examples 30 to 36, wherein the fabric layer comprises a nonwoven fabric.

[0449] Example 40. The method of any one of Examples 30 to 39, wherein the polymer comprises ultra-high molecular weight polyethylene (UHMWPE).

[0450] Example 41. The method of any one of examples 30 to 40, wherein the polymer comprises fluorinated ethylene propylene (FEP).

[0451] Example 42. The method of any one of Examples 30 to 41, wherein the bonding layer comprises an acrylate.

[0452] Example 43. A method according to any one of Examples 30 to 42, wherein the bonding layer comprises silicone.

[0453] Example 44. The method of any one of Examples 30 to 43, wherein the bonding layer comprises thermoplastic polyurethane (TPU).

[0454] Example 45. The method of any one of Examples 30 to 44, wherein the fabric layer is 20-150 microns thick.

[0455] Example 46. The method of any one of Examples 30 to 45, wherein the bonding layer is 5-30 microns thick.

[0456] Example 47. A method according to any one of Examples 30 to 46, wherein: (i) the coating defines a first side of the sheet, and the sheet has a second side opposite to the first side; (ii) forming the interlayer includes forming the interlayer to define a lip, wherein the lip portion of the coating and the lip portion of the bonding layer together extend beyond the edge of the fabric layer, (iii) the method also includes folding the lip around the edge of the fabric layer onto the second side so that the lip portion of the bonding layer is sandwiched between the lip portion of the coating and the second side; and / or (iv) forming the sheet includes forming the sheet by: (a) heating the interlayer including folding the lip around the edge of the fabric layer onto the second side, and / or (b) compressing the interlayer including folding the lip around the edge of the fabric layer onto the second side.

[0457] Example 48. The method of any one of Examples 30 to 47, wherein forming the sheet comprises forming the sheet by heating the bonding layer and compressing the bonding layer against the fabric layer to bond the bonding layer to the fabric layer.

[0458] Example 49. The method of Example 48, wherein forming the sheet comprises forming the sheet by heating the coating and compressing the coating against the bonding layer to bond the coating to the bonding layer.

[0459] Example 50. The method of any one of Examples 30 to 49, wherein forming the interlayer includes defining a lip, wherein a lip portion of the coating and a lip portion of the bonding layer together extend beyond an edge of the fabric layer.

[0460] Example 51. A method according to Example 50, wherein forming the interlayer includes: (i) forming the interlayer so that the coating defines a first side of the sheet and so that the sheet has a second side opposite to the first side, and / or (ii) folding the lip onto the second side so that the lip portion of the bonding layer is sandwiched between the lip portion of the coating and the second side.

[0461] Example 52. A method according to any one of Examples 30 to 51, wherein: (i) the interlayer comprises at least a component of the frame sandwiched between the fabric layer and the bonding layer, and / or (ii) forming the sheet comprises forming the sheet by bonding the fabric layer to the coating by performing the following operations, wherein at least the component of the frame is arranged between the fabric layer and the bonding layer: (a) heating the interlayer comprising at least the component of the frame sandwiched between the fabric layer and the bonding layer, and / or (b) compressing the interlayer comprising at least the component of the frame sandwiched between the fabric layer and the bonding layer.

[0462] Example 53. A method according to Example 52, wherein forming the sheet includes forming the sheet by heating and compressing the interlayer in an area surrounding a recess to define the recess between the fabric layer and the bonding layer, so that at least a portion of the frame is disposed in the recess.

[0463] Example 54. The method of Example 53, wherein heating the interlayer comprises heating the interlayer between plates, at least one of the plates having a recess in the region of the recess.

[0464] Example 55. The method of Example 53, wherein compressing the interlayer comprises compressing the interlayer between plates, at least one of the plates having a recess at the region of the recess.

[0465] Example 56. The method of Example 52, wherein forming the sheet comprises forming the sheet by bonding the fabric layer to the coating in a manner that forms a recess between the fabric layer and the bonding layer.

[0466] Example 57. A method according to Example 56, wherein forming the recess includes forming the recess by: (i) heating the interlayer in an area surrounding the recess, and / or (ii) compressing the interlayer in the area surrounding the recess.

[0467] Example 58. The method of Example 56, further comprising closing the recess by bonding the fabric layer and the bonding layer surrounding the recess.

[0468] Example 59. The method of Example 53, wherein forming the sheet comprises forming the sheet having openings at edges of the sheet by releasing the fabric layer from the bonding layer.

[0469] Example 60. The method of Example 52, wherein forming the sandwich comprises sandwiching at least the component of the frame together with the bonding layer between the fabric layer and the coating.

[0470] Example 61. The method of Example 60, wherein the thickness of the frame between the fabric layer and the bonding layer is 20-500 microns.

[0471] Example 62. A method according to any one of Examples 30 to 61, wherein the method further comprises covering at least a portion of the frame by fixedly attaching the sheet to the frame.

[0472] Example 63. A method according to Example 62, wherein fixedly attaching the sheet to the frame includes sewing the sheet to the frame.

[0473] Example 64. The method of any one of Examples 30 to 63, wherein forming the interlayer comprises forming the interlayer comprising a frame sandwiched between the fabric layer and the coating together with the bonding layer.

[0474] Example 65. The method of Example 64, wherein the thickness of the frame between the fabric layer and the bonding layer is 20-500 microns.

[0475] Example 66. A method according to Example 64, wherein the frame has a first side and an opposite second side, and wherein forming the interlayer includes wrapping the fabric layer around the frame from the first side to the second side such that at least a portion of the frame is sandwiched between (i) a first portion of the fabric layer disposed against the first side of the frame and (ii) a second portion of the fabric layer disposed against the second side of the frame.

[0476] Example 67. The method of Example 62, further comprising forming a plurality of holes through the sheet to facilitate blood flow therethrough.

[0477] Example 68. The method of Example 67 further comprising flattening the sheet and maintaining the sheet flat while forming the plurality of holes through the sheet.

[0478] Example 69. A method according to Example 67, wherein forming the hole includes forming the hole by laser cutting.

[0479] Example 70. A method according to Example 67, wherein each of the holes is hexagonal.

[0480] Example 71. A method according to any one of Examples 30 to 70, wherein: (i) the bonding layer is a first bonding layer, (ii) the coating is a first coating, (iii) forming the interlayer includes forming the interlayer to include a second bonding layer sandwiched between the fabric layer and a second coating configured to inhibit tissue growth thereon; and / or (iv) forming the sheet includes bonding the fabric layer to the second coating by heating and compressing the interlayer.

[0481] Example 72. A method according to Example 71, wherein: (i) the coating defines a first side of the sheet, and the sheet has a second side opposite to the first side; (ii) forming the interlayer includes forming the interlayer to define a lip, wherein the lip portion of the coating and the lip portion of the bonding layer together extend beyond the edge of the fabric layer; (iii) the method also includes folding the lip around the edge of the fabric layer onto the second side so that the lip portion of the bonding layer is sandwiched between the lip portion of the coating and the second side; and / or (iv) forming the sheet includes forming the sheet by: (a) heating the interlayer including folding the lip around the edge of the fabric layer onto the second side, and / or (b) compressing the interlayer including folding the lip around the edge of the fabric layer onto the second side.

[0482] Example 73. A method according to Example 71, wherein the first coating, the second coating and the first bonding layer together extend beyond the edge of the fabric layer, thereby defining a lip and forming the interlayer including the lip, and the lip portion of the first coating, the lip portion of the second coating and the lip portion of the first bonding layer are arranged in the lip.

[0483] Example 74. A method according to Example 73, wherein forming the interlayer includes: (i) forming the interlayer so that the coating defines a first side of the sheet and so that the sheet has a second side opposite to the first side, and / or (ii) folding the lip onto the second side so that the lip portion of the bonding layer is sandwiched between the lip portion of the coating and the second side.

[0484] Example 75. A method according to Example 71, wherein the first coating, the second coating, the first bonding layer and the second bonding layer together extend beyond the edge of the fabric layer, thereby defining a lip and forming the interlayer including the lip, and the lip portion of the first coating, the lip portion of the second coating and the lip portion of the first bonding layer are arranged in the lip.

[0485] Example 76. The method of any one of Examples 30 to 75, wherein forming the sheet comprises forming the sheet by bonding the fabric layer to the coating in a manner that forms a recess between the fabric layer and the bonding layer.

[0486] Example 77. A method according to Example 76, wherein forming the sheet in a manner to form the recess includes: (i) heating the interlayer in an area surrounding the recess, and / or (ii) compressing the interlayer in the area surrounding the recess.

[0487] Example 78. A method according to Example 77, wherein heating the interlayer around the area of ​​the recess includes positioning the interlayer between plates, at least one of the plates being heated, and at least one of the plates having a recess defining the area of ​​the recess.

[0488] Example 79. A method according to Example 77, wherein compressing the interlayer around the area of ​​the recess includes compressing the interlayer between the plates, at least one of the plates having a recess defining the area of ​​the recess.

[0489] Example 80. The method of Example 76 further comprising closing the recess by bonding between the fabric layer and the bonding layer surrounding the recess.

[0490] Example 81. The method of Example 80, wherein the sheet defines an opening into the recess.

[0491] Example 82. The method of Example 81, wherein the fabric layer is detached from the bonding layer at the opening.

[0492] Example 83. The method of Example 81, wherein the opening is disposed at an edge of the sheet.

[0493] Example 84. The method of Example 76 further comprising a cord, at least a portion of which extends through the recess.

[0494] Example 85. The method of Example 84, wherein the cord is slidable within the recess.

[0495] Example 86. The method of any one of Examples 30 to 85, wherein the polymer is polytetrafluoroethylene (PTFE).

[0496] Example 87. A method according to Example 86, wherein the polymer is expanded PTFE (ePTFE).

[0497] Example 88. A method according to Example 86, wherein the coating includes several stratified sublayers of the polymer.

[0498] Example 89. A method according to Example 88, wherein each of the sublayers is anisotropic, and wherein the sublayers are arranged so that each of the sublayers is disposed orthogonally to an adjacent one of the sublayers.

[0499] Example 90. The method of Example 88, wherein the coating comprises less than ten of the sublayers.

[0500] Example 91. A method according to Example 90, wherein the coating includes less than six of the sublayers.

[0501] Example 92. The method of any one of Examples 30 to 91, wherein compressing the interlayer comprises compressing the interlayer at a pressure of Example 0.01-1 MPa.

[0502] Example 93. The method of Example 92, wherein compressing the interlayer comprises maintaining the interlayer under the pressure for 100-500 seconds.

[0503] Example 94. The method of any one of Examples 30-93, wherein heating the interlayer comprises heating the interlayer to a temperature of 37-260 degrees Celsius.

[0504] Example 95. The method of Example 94, wherein heating the interlayer comprises maintaining the interlayer at the temperature for 100-500 seconds.

[0505] Example 96. A system and / or device comprising a sheet comprising: (i) a fabric layer; (ii) a coating comprising a polymer configured to inhibit tissue growth thereon; and / or (iii) a bonding layer sandwiched between the fabric layer and the coating and bonding the fabric layer to the coating.

[0506] Example 97. A system / device as described in Example 96, wherein the system / device is configured to define a leaflet reinforcement patch that is configured to be attached to a valve leaflet of a subject's heart.

[0507] Example 98. A system / device according to any of Examples 96 to 97, wherein the coating consists essentially of the polymer.

[0508] Example 99. The system / apparatus of any one of Examples 96 to 98, wherein the coating is non-porous.

[0509] Example 100. A system / apparatus according to any one of Examples 96 to 98, wherein the coating is porous.

[0510] Example 101. A system / apparatus according to any one of Examples 96 to 100, wherein the coating is a film.

[0511] Example 102. A system / apparatus according to any one of Examples 96 to 100, wherein the fabric layer comprises a woven fabric.

[0512] Example 103. A system / apparatus according to any one of Examples 96 to 100, wherein the fabric layer comprises a nonwoven fabric.

[0513] Example 104. The system / apparatus of any one of Examples 96 to 103, wherein the polymer is ultra-high molecular weight polyethylene (UHMWPE).

[0514] Example 105. The system / apparatus of any one of Examples 96 to 104, wherein the polymer is fluorinated ethylene propylene (FEP).

[0515] Example 106. A system / device according to any of Examples 96 to 105, wherein the bonding layer comprises acrylate.

[0516] Example 107. A system / device according to any of Examples 96 to 106, wherein the bonding layer comprises silicone.

[0517] Example 108. The system / apparatus of any one of Examples 96 to 107, wherein the fabric layer is 20-150 microns thick.

[0518] Example 109. A system / apparatus according to any one of Examples 96 to 108, wherein the bonding layer is 5-30 microns thick.

[0519] Example 110. A system / apparatus according to any one of Examples 96 to 109, wherein the coating and the bonding layer together extend beyond the edge of the fabric layer, thereby defining a lip, and the lip portion of the coating and the lip portion of the bonding layer are disposed in the lip.

[0520] Example 111. A system / device according to Example 110, wherein the coating defines a first side of the sheet and the sheet has a second side opposite the first side, and wherein the lip is folded onto the second side so that the lip portion of the bonding layer is sandwiched between the lip portion of the coating and the second side.

[0521] Example 112. A system / apparatus according to Example 110, wherein the lip is folded around the edge of the fabric layer, thereby defining a folded edge of the sheet, and the fabric layer is disposed within the folded edge between the lip portion of the bonding layer and another portion of the bonding layer.

[0522] Example 113. The system / apparatus of any of Examples 96 to 112, wherein the sheet defines a recess between the fabric layer and the bonding layer.

[0523] Example 114. A system / device according to Example 113, wherein the bond between the fabric layer and the bonding layer surrounds the recess, thereby closing the recess.

[0524] Example 115. A system / apparatus as described in Example 113, wherein the sheet defines an opening into the recess.

[0525] Example 116. A system / device as described in Example 115, wherein at the opening, the fabric layer is detached from the bonding layer.

[0526] Example 117. A system / apparatus according to Example 115, wherein the opening is disposed at an edge of the sheet.

[0527] Example 118. The system / device of Example 113 further comprising a cord, at least a portion of which extends through the recess.

[0528] Example 119. A system / apparatus as described in Example 118, wherein the portion of the cord is slidable within the recess.

[0529] Example 120. A system / device according to any one of Examples 96 to 119, wherein the system / device is formed as a wing defining a contact surface and an opposing surface opposite the contact surface.

[0530] Example 121. A system / device as described in Example 120, wherein the wing has a plurality of holes configured to promote blood flow therethrough.

[0531] Example 122. A system / device according to Example 121, wherein each of the holes is hexagonal.

[0532] Example 123. A system / device of example 120, wherein the wing is configured to anchor to cardiac tissue of a subject having a first leaflet and a second opposing leaflet such that the wing extends above the first leaflet toward the second leaflet and the contact surface faces the first leaflet.

[0533] Example 124. The system / device of any one of Examples 96 to 123, further comprising a frame, the sheet being fixedly attached to the frame in a manner covering at least a portion of the frame.

[0534] Example 125. A system / device according to Example 124, wherein the sheet is fixedly attached to the frame by sewing.

[0535] Example 126. A system / device according to Example 124, wherein the sheet is fixedly attached to the frame by an adhesive.

[0536] Example 127. A system / apparatus as described in Example 124, wherein the sheet is fixedly attached to the frame by sandwiching the frame between the fabric layer and the bonding layer.

[0537] Example 128. A system / device according to Example 127, wherein: (i) the coating is a first coating, (ii) the bonding layer is a first bonding layer, and / or (iii) the sheet further includes: (a) a second coating, and / or (b) a second bonding layer, wherein the second bonding layer is sandwiched between the frame and the second coating.

[0538] Example 129. The system / apparatus of Example 127, wherein the thickness of the frame between the fabric layer and the bonding layer is 20-500 microns.

[0539] Example 130. A system / device according to Example 127, wherein the frame has a first side and an opposing second side, and the fabric layer is wrapped from the first side to the second side such that at least a portion of the frame is sandwiched between (i) a first portion of the fabric layer positioned against the first side of the frame and (ii) a second portion of the fabric layer positioned against the second side of the frame.

[0540] Example 131. A system / device according to Example 130, wherein: (i) the coating is a first coating, (ii) the bonding layer is a first bonding layer, and / or (iii) the sheet further includes: (a) a second coating, and / or (b) a second bonding layer, wherein the second bonding layer is sandwiched between the second component of the fabric layer and the second coating.

[0541] Example 132. A system / device according to Example 124, wherein the frame is flexible and the system / device defines a wing having a contact surface and an opposing surface opposite the contact surface.

[0542] Example 133. A system / device as described in Example 132, wherein the sheet has a plurality of holes configured to promote blood flow therethrough.

[0543] Example 134. A system / device of Example 132, wherein the wing is configured to be anchored to the annulus of a heart valve of a subject such that the wing extends over a first leaflet of the valve toward an opposing leaflet of the valve and the contact surface faces the first leaflet.

[0544] Example 135. A system / device according to Example 124, wherein the system / device has a recess between the fabric layer and the bonding layer, and at least a portion of the frame is disposed in the recess.

[0545] Example 136. A system / device according to Example 124, wherein the coating and the bonding layer together extend beyond the edge of the frame, thereby defining a lip, and the lip portion of the coating and the lip portion of the bonding layer are disposed in the lip.

[0546] Example 137. A system / device according to Example 136, wherein the frame is disposed between the fabric layer and the bonding layer, and wherein the fabric layer together with the coating and the bonding layer extends beyond the edge of the frame.

[0547] Example 138. A system / apparatus as described in Example 136, wherein the coating and the bonding layer together extend beyond the edge of the fabric layer to define the lip.

[0548] Example 139. A system / device according to Example 136, wherein the coating defines a first side of the sheet and the sheet has a second side opposite the first side, and wherein the lip is folded onto the second side such that the lip portion of the bonding layer is disposed between the lip portion of the coating and the second side.

[0549] Example 140. A system / device according to Example 139, wherein at least a portion of the frame is disposed between the lip portion of the bonding layer and another portion of the bonding layer.

[0550] Example 141. A system / device according to Example 136, wherein the lip is folded around the edge of the frame, thereby defining a folded edge of the sheet, and the edge of the frame is disposed within the folded edge between the lip portion of the bonding layer and another portion of the bonding layer.

[0551] Example 142. A system / apparatus according to Example 141, wherein at least a portion of the fabric layer is disposed within the hem.

[0552] Example 143. A system / device according to any one of Examples 96 to 142, wherein the coating is a first coating, the bonding layer is a first bonding layer, and the sheet further includes: (i) a second coating; and / or (ii) a second bonding layer, the second bonding layer being sandwiched between the fabric layer and the second coating and bonding the fabric layer to the second coating, the fabric layer being sandwiched between the first bonding layer and the second bonding layer.

[0553] Example 144. The system / apparatus of Example 143, wherein the sheet defines a recess between the fabric layer and the first bonding layer.

[0554] Example 145. A system / device according to Example 143, wherein the first coating, the second coating, and the first bonding layer together extend beyond the edge of the fabric layer, thereby defining a lip, and the lip portion of the first coating, the lip portion of the second coating, and the lip portion of the first bonding layer are arranged in the lip.

[0555] Example 146. A system / apparatus as described in Example 145, wherein within the lip, the lip portion of the first coating is bonded to the lip portion of the second coating via the lip portion of the first bonding layer.

[0556] Example 147. A system / device according to Example 145, wherein the lip portion of the second bonding layer extends beyond the edge of the fabric layer into the lip, so that within the lip, the lip portion of the first coating is bonded to the lip portion of the second coating through the lip portion of the first bonding layer and the lip portion of the second bonding layer.

[0557] Example 148. The system / device of Example 145 further includes a frame disposed between the first bonding layer and the second bonding layer.

[0558] Example 149. A system / apparatus as described in Example 148, wherein the lip extends beyond an edge of the frame at least at a portion of the sheet.

[0559] Example 150. A system / device as described in Example 148, wherein at least a portion of the frame extends beyond the edge of the lip.

[0560] Example 151. A system / device according to Example 143, wherein the first coating and the first bonding layer together extend beyond the edge of the fabric layer, thereby defining a lip, and the lip portion of the first coating and the lip portion of the first bonding layer are disposed in the lip portion.

[0561] Example 152. A system / device according to Example 151, wherein the first coating defines a first side of the sheet, and the sheet has a second side opposite the first side, and wherein the lip is folded onto the second side such that the lip portion of the first bonding layer is disposed between the lip portion of the first coating and the second side.

[0562] Example 153. A system / device according to Example 152, wherein the lip is folded onto the second side so that the lip portion of the first bonding layer is disposed between the lip portions of the first coating and the second coating.

[0563] Example 154. A system / device according to Example 143, further comprising a frame to which the sheet is fixedly attached in a manner covering at least a portion of the frame, wherein: (i) the first coating defines a first side of the sheet and the sheet has a second side opposite to the first side, and / or (ii) a lip portion of the first coating and a lip portion of the first bonding layer together extend beyond an edge of the fabric layer to define a lip, which extends beyond an edge of the frame.

[0564] Example 155. A system / apparatus according to Example 154, wherein the lip is folded onto the second side, thereby defining a folded edge of the sheet, and at least a portion of the frame is disposed within the folded edge.

[0565] Example 156. A system / apparatus according to Example 154, wherein the lip portion of the second coating and the lip portion of the second bonding layer together extend beyond the edge of the fabric layer into the lip.

[0566] Example 157. The system / device of Example 143 further includes a frame, and the sheet is fixedly attached to the frame in a manner covering at least a portion of the frame.

[0567] Example 158. A system / device according to Example 157, wherein the system / device has a recess disposed between the fabric layer and the first bonding layer, and at least a component of the frame is disposed in the recess between the fabric layer and the first bonding layer.

[0568] Example 159. A system / device according to Example 158, wherein the recess is closed by a bond between the fabric layer and the first bonding layer surrounding the recess.

[0569] Example 160. A system / apparatus as described in Example 158, wherein the sheet defines an opening into the recess.

[0570] Example 161. A system / device as described in Example 160, wherein at the opening, the fabric layer is detached from the first bonding layer.

[0571] Example 162. A system / device according to Example 160, wherein the opening is disposed at an edge of the sheet.

[0572] Example 163. The system / device of Example 158 further comprising a cord attached to the frame, at least a portion of the cord extending through the recess.

[0573] Example 164. A system / apparatus as described in Example 163, wherein the portion of the cord is slidable within the recess.

[0574] Example 165. A system / apparatus according to any one of Examples 96 to 164, wherein the polymer is polytetrafluoroethylene (PTFE).

[0575] Example 166. A system / device according to Example 165, wherein the polymer is expanded PTFE (ePTFE).

[0576] Example 167. A system / device according to Example 165, wherein the coating comprises several layered sublayers of the polymer.

[0577] Example 168. A system / device according to Example 167, wherein each of the sublayers is anisotropic, and wherein the sublayers are arranged so that each of the sublayers is arranged orthogonally to an adjacent one of the sublayers.

[0578] Example 169. A system / device according to Example 167, wherein the coating includes less than ten of the sublayers.

[0579] Example 170. A system / device according to Example 169, wherein the coating includes less than six of the sublayers.

[0580] Example 171. A system / apparatus according to any one of Examples 96 to 170, wherein the bonding layer comprises thermoplastic polyurethane (TPU).

[0581] Example 172. A system / device according to Example 171, wherein the TPU is a polycarbonate-based TPU.

[0582] Example 173. The system / apparatus of Example 172, wherein the polycarbonate-based TPU is a polycarbonate-based aliphatic thermoplastic polyurethane.

[0583] Example 174. A system / apparatus according to any of Examples 96 to 173, wherein the sheet is formed by compressing the fabric layer, the coating, and the bonding layer together and heating to bond the bonding layer to the fabric layer and the coating.

[0584] Example 175. A system / apparatus according to Example 174, wherein the sheet is formed by compressing the fabric layer, the coating, and the bonding layer together for 100-500 seconds.

[0585] Example 176. A system / apparatus according to Example 174, wherein the sheet is formed by compressing the fabric layer, the coating, and the bonding layer together for 20-420 seconds.

[0586] Example 177. The system / apparatus of Example 174, wherein the sheet is formed by heating the fabric layer, the coating, and the bonding layer for 100-500 seconds.

[0587] Example 178. The system / apparatus of Example 174, wherein the sheet is formed by heating the fabric layer, the coating, and the bonding layer for 20-420 seconds.

[0588] Example 179. The system / apparatus of Example 174, wherein the sheet is formed by compressing the fabric layer, the coating, and the bonding layer together at a pressure of Example 0.01-1 MPa.

[0589] Example 180. The system / apparatus of Example 179, wherein the sheet is formed by compressing the fabric layer, the coating, and the bonding layer together under pressure for 100-500 seconds.

[0590] Example 181. The system / apparatus of Example 179, wherein the sheet is formed by compressing the fabric layer, the coating, and the bonding layer together under pressure for 20-420 seconds.

[0591] Example 182. The system / apparatus of Example 174, wherein the sheet is formed by heating the fabric layer, the coating, and the bonding layer to a temperature of 37-260 degrees Celsius.

[0592] Example 183. The system / apparatus of Example 182, wherein the sheet is formed by maintaining the fabric layer, the coating, and the bonding layer at the temperature for 100-500 seconds.

[0593] Example 184. The system / apparatus of Example 182, wherein the sheet is formed by maintaining the fabric layer, the coating, and the bonding layer at the temperature for 20-420 seconds.

[0594] Example 185. A system and / or device comprising a cardiovascular implant comprising: (ii) a frame; and / or (ii) a sheet comprising: (a) a fabric layer secured against at least a portion of the frame; (b) a coating comprising a polymer configured to inhibit tissue growth thereon; and / or (c) a bonding layer sandwiched between the fabric layer and the coating and bonding the fabric layer to the coating.

[0595] Example 186. A system / device according to Example 185, wherein the portion of the frame is a first portion of the frame, and wherein a second portion of the frame is exposed from the sheet.

[0596] Example 187. A system / device as described in any of Examples 185 to 186, wherein the frame is designed as a frame for a prosthetic valve.

[0597] Example 188. A system / device according to any of Examples 185 to 187, wherein the frame is designed as a leaflet reinforcement patch.

[0598] Example 189. A system / device according to any of Examples 185 to 188, wherein the frame is designed as a wing.

[0599] Example 190. A system / device according to any of Examples 185 to 187, wherein the frame is designed as a frame for a bracket.

[0600] Example 191. A system / device according to any of Examples 185 to 190, wherein the implant is configured to anchor to cardiac tissue of the subject.

[0601] Example 192. A system / device according to any one of Examples 185 to 191, wherein the sheet is fixedly attached to the frame by suturing.

[0602] Example 193. A system / device according to any one of Examples 185 to 192, wherein the sheet is fixedly attached to the frame by an adhesive.

[0603] Example 194. A system / device according to any one of Examples 185 to 193, wherein the system / device has a recess between the fabric layer and the bonding layer, and at least a portion of the frame is disposed in the recess.

[0604] Example 195. A system / device according to any of Examples 185 to 194, wherein the coating consists essentially of the polymer.

[0605] Example 196. A system / device according to any of Examples 185 to 195, wherein the coating is non-porous.

[0606] Example 197. A system / device according to any of Examples 185 to 195, wherein the coating is porous.

[0607] Example 198. A system / device according to any one of Examples 185 to 197, wherein the coating is a film.

[0608] Example 199. A system / apparatus according to any one of Examples 185 to 197, wherein the fabric layer comprises a woven fabric.

[0609] Example 200. A system / apparatus according to any one of Examples 185 to 197, wherein the fabric layer comprises a nonwoven fabric.

[0610] Example 201. A system / apparatus according to any of Examples 185 to 200, wherein the polymer is ultra-high molecular weight polyethylene (UHMWPE).

[0611] Example 202. The system / apparatus of any one of Examples 185 to 201, wherein the polymer is fluorinated ethylene propylene (FEP).

[0612] Example 203. A system / device according to any of Examples 185 to 202, wherein the bonding layer comprises acrylate.

[0613] Example 204. A system / device according to any of Examples 185 to 203, wherein the bonding layer comprises silicone.

[0614] Example 205. The system / apparatus of any one of Examples 185 to 204, wherein the fabric layer is 20-150 microns thick.

[0615] Example 206. A system / device according to any one of Examples 185 to 205, wherein the bonding layer is 5-30 microns thick.

[0616] Example 207. A system / device according to Examples 185 to 206, wherein the coating and the bonding layer together extend beyond the edge of the frame, thereby defining a lip, and the lip portion of the coating and the lip portion of the bonding layer are disposed in the lip.

[0617] Example 208. A system / device according to Example 207, wherein the frame is disposed between the fabric layer and the bonding layer, and wherein the fabric layer together with the coating and the bonding layer extends beyond the edge of the frame.

[0618] Example 209. The system / apparatus of Example 207, wherein the coating and the bonding layer together extend beyond an edge of the fabric layer, thereby defining the lip.

[0619] Example 210. A system / device according to Example 207, wherein the coating defines a first side of the sheet and the sheet has a second side opposite the first side, and wherein the lip is folded onto the second side such that the lip portion of the bonding layer is disposed between the lip portion of the coating and the second side.

[0620] Example 211. A system / device according to Example 210, wherein at least a portion of the frame is disposed between the lip portion of the bonding layer and another portion of the bonding layer.

[0621] Example 212. A system / device according to Example 210, wherein the lip is folded around the edge of the frame, thereby defining a folded edge of the sheet, and the edge of the frame is disposed within the folded edge between the lip portion of the bonding layer and another portion of the bonding layer.

[0622] Example 213. A system / apparatus according to Example 212, wherein at least a portion of the fabric layer is disposed within the hem.

[0623] Example 214. A system / device according to any of Examples 185 to 213, wherein the fabric layer is secured against at least the portion of the frame by sandwiching at least the portion of the frame between the bonding layer and the fabric layer.

[0624] Example 215. A system / device according to Example 214, wherein the portion of the frame is a first portion of the frame, and wherein a second portion of the frame is disposed in a recess between the bonding layer and the fabric layer.

[0625] Example 216. A system / apparatus according to any of Examples 185 to 215, wherein the sheet is fixedly attached to the frame by sandwiching the frame between the fabric layer and the bonding layer.

[0626] Example 217. A system / device according to Example 216, wherein the thickness of the frame between the fabric layer and the bonding layer is 20-500 microns.

[0627] Example 218. A system / device according to Example 216, wherein the frame has a first side and an opposing second side, and the fabric layer is wrapped from the first side to the second side such that at least a portion of the frame is sandwiched between (i) a first portion of the fabric layer positioned against the first side of the frame and (ii) a second portion of the fabric layer positioned against the second side of the frame.

[0628] Example 219. A system / device according to Example 216, wherein: (i) the coating is a first coating, (ii) the bonding layer is a first bonding layer, and / or (iii) the sheet further includes: (a) a second coating, and / or (b) a second bonding layer, wherein the second bonding layer is sandwiched between the fabric layer and the second coating.

[0629] Example 220. A system / device as described in any of Examples 185 to 219, wherein the frame is flexible and the implant defines a wing having a contact surface and an opposing surface opposite the contact surface.

[0630] Example 221. A system / device as described in Example 220, wherein the sheet has a plurality of holes configured to promote blood flow therethrough.

[0631] Example 222. A system / device of Example 220, wherein the wing is configured to be anchored to the annulus of a heart valve of a subject such that the wing extends over a first leaflet of the valve toward an opposing leaflet of the valve and the contact surface faces the first leaflet.

[0632] Example 223. A system / device according to any of Examples 185 to 222, wherein the coating is a first coating, the bonding layer is a first bonding layer, and the sheet further includes: (i) a second coating; and / or (ii) a second bonding layer, the second bonding layer being sandwiched between the fabric layer and the second coating and bonding the fabric layer to the second coating, the fabric layer being sandwiched between the first bonding layer and the second bonding layer.

[0633] Example 224. The system / apparatus of Example 223, wherein the sheet defines a recess between the fabric layer and the first bonding layer.

[0634] Example 225. A system / device according to Example 223, wherein the first coating and the first bonding layer together extend beyond the edge of the fabric layer, thereby defining a lip, and the lip portion of the first coating and the lip portion of the first bonding layer are disposed in the lip portion.

[0635] Example 226. A system / device according to Example 225, wherein the first coating defines a first side of the sheet and the sheet has a second side opposite the first side, and wherein the lip is folded onto the second side such that the lip portion of the first bonding layer is disposed between the lip portion of the first coating and the second side.

[0636] Example 227. A system / device according to Example 226, wherein the lip is folded onto the second side so that the lip portion of the first bonding layer is disposed between the lip portions of the first coating and the second coating.

[0637] Example 228. A system / device according to Example 223, wherein the first coating, the second coating, and the first bonding layer together extend beyond the edge of the fabric layer, thereby defining a lip, and the lip portion of the first coating, the lip portion of the second coating, and the lip portion of the first bonding layer are arranged in the lip.

[0638] Example 229. A system / apparatus as described in Example 228, wherein within the lip, the lip portion of the first coating is bonded to the lip portion of the second coating via the lip portion of the first bonding layer.

[0639] Example 230. A system / device according to Example 228, wherein the lip portion of the second bonding layer extends beyond the edge of the fabric layer into the lip, so that within the lip, the lip portion of the first coating is bonded to the lip portion of the second coating through the lip portion of the first bonding layer and the lip portion of the second bonding layer.

[0640] Example 231. A system / apparatus as described in Example 228, wherein the lip extends beyond an edge of the frame at least at a portion of the sheet.

[0641] Example 232. A system / device as described in Example 228, wherein at least a portion of the frame extends beyond the edge of the lip.

[0642] Example 233. A system / apparatus according to Example 228, wherein the lip is folded to define a folded edge of the sheet, and at least a portion of the frame is disposed within the folded edge.

[0643] Example 234. A system / apparatus according to Example 228, wherein the lip portion of the second coating and the lip portion of the second bonding layer together extend beyond the edge of the fabric layer into the lip.

[0644] Example 235. A system / device according to Example 223, wherein the sheet is fixedly attached to the frame in a manner covering at least a portion of the frame.

[0645] Example 236. A system / device according to Example 235, wherein the system / device has a recess disposed between the fabric layer and the first bonding layer, and at least a component of the frame is disposed in the recess between the fabric layer and the first bonding layer.

[0646] Example 237. A system / apparatus according to Example 236, wherein the recess is closed by a bond between the fabric layer and the first bonding layer surrounding the recess.

[0647] Example 238. A system / apparatus as described in Example 236, wherein the sheet defines an opening into the recess.

[0648] Example 239. A system / device according to Example 238, wherein at the opening, the fabric layer is detached from the first bonding layer.

[0649] Example 240. A system / apparatus according to Example 238, wherein the opening is disposed at an edge of the sheet.

[0650] Example 241. The system / device of Example 238 further comprising a cord attached to the frame, at least a portion of the cord extending through the recess.

[0651] Example 242. A system / apparatus as described in Example 241, wherein the portion of the cord is slidable within the recess.

[0652] Example 243. A system / apparatus according to any one of Examples 185 to 242, wherein the polymer is polytetrafluoroethylene (PTFE).

[0653] Example 244. A system / device according to Example 243, wherein the polymer is expanded PTFE (ePTFE).

[0654] Example 245. A system / device according to Example 243, wherein the coating comprises several layered sublayers of the polymer.

[0655] Example 246. A system / device according to Example 245, wherein each of the sublayers is anisotropic, and wherein the sublayers are arranged so that each of the sublayers is arranged orthogonally to an adjacent one of the sublayers.

[0656] Example 247. A system / device according to Example 245, wherein the coating includes less than ten of the sublayers.

[0657] Example 248. A system / device according to Example 247, wherein the coating includes less than six of the sublayers.

[0658] Example 249. A system / device according to any one of Examples 185 to 248, wherein the bonding layer comprises thermoplastic polyurethane (TPU).

[0659] Example 250. A system / device according to Example 249, wherein the TPU is a polycarbonate-based TPU.

[0660] Example 251. A system / device according to Example 250, wherein the polycarbonate-based TPU is a polycarbonate-based aliphatic thermoplastic polyurethane.

[0661] Example 252. A system / apparatus according to any of Examples 185 to 251, wherein the sheet is formed by compressing the fabric layer, the coating, and the bonding layer together and heating to bond the bonding layer to the fabric layer and the coating.

[0662] Example 253. A system / apparatus according to Example 252, wherein the sheet is formed by heating the fabric layer, the coating, and the bonding layer for 100-500 seconds.

[0663] Example 254. A system / apparatus according to Example 252, wherein the sheet is formed by heating the fabric layer, the coating, and the bonding layer for 20-420 seconds.

[0664] Example 255. A system / apparatus according to Example 252, wherein the sheet is formed by compressing the fabric layer, the coating, and the bonding layer together for 100-500 seconds.

[0665] Example 256. A system / apparatus according to Example 252, wherein the sheet is formed by compressing the fabric layer, the coating, and the bonding layer together for 20-420 seconds.

[0666] Example 257. The system / apparatus of Example 252, wherein the sheet is formed by compressing the fabric layer, the coating, and the bonding layer together at a pressure of 0.01-1 MPa.

[0667] Example 258. The system / apparatus of Example 257, wherein the sheet is formed by compressing the fabric layer, the coating, and the bonding layer together under pressure for 100-500 seconds.

[0668] Example 259. A system / apparatus according to Example 257, wherein the sheet is formed by compressing the fabric layer, the coating, and the bonding layer together under pressure for 20-420 seconds.

[0669] Example 260. The system / apparatus of Example 252, wherein the sheet is formed by heating the fabric layer, the coating, and the bonding layer to a temperature of 37-260 degrees Celsius.

[0670] Example 261. A system / apparatus according to Example 260, wherein the sheet is formed by maintaining the fabric layer, the coating, and the bonding layer at the temperature for 100-500 seconds.

[0671] Example 262. A system / apparatus according to Example 260, wherein the sheet is formed by maintaining the fabric layer, the coating, and the bonding layer at the temperature for 20-420 seconds.

[0672] Example 263. A method comprising: (i) temporarily flattening a sheet of an implant by constraining a frame of the implant, the sheet being fixedly attached to the frame; (ii) forming a hole in the sheet while the sheet remains flattened; and / or (iii) subsequently allowing the frame to deflatten toward a resting shape, wherein the frame holds the sheet in a curved configuration.

[0673] Example 264. A method according to Example 263, wherein forming the hole includes forming the hole using an automatic laser cutting system.

[0674] Example 265. A method according to any of Examples 263 to 264, wherein forming the hole includes forming the hole by moving a laser head of a laser cutting system along a plane parallel to the planarized sheet.

[0675] Example 266. A method according to any one of Examples 263 to 265, wherein flattening the sheet includes flattening the sheet using a cage having a track configured to keep the sheet flattened.

[0676] Example 267. The method according to any one of Examples 263 to 266, further comprising bonding the fabric layer to the coating to form the sheet by: (i) forming a sandwich comprising a bonding layer sandwiched between the fabric layer and the coating; (ii) heating the sandwich, and / or (iii) compressing the sandwich.

[0677] Example 268. The method of Example 267 further includes fixedly attaching the sheet to the frame after forming the sheet and before temporarily flattening the sheet.

[0678] Example 269. A method according to any one of Examples 263 to 268, wherein: (i) the frame is a first frame of a plurality of frames fixedly attached to the sheet, (ii) flattening the sheet by constraining the frames includes flattening the sheet by constraining the plurality of frames while the plurality of frames remain fixedly attached to the sheet, and / or (iii) allowing the frames to be uneven includes allowing the plurality of frames to be uneven.

[0679] Example 270. The method of Example 269 further includes attaching the plurality of frames to the sheet in an arrangement prior to flattening the sheet.

[0680] Example 271. The method of Example 270 further includes cutting the sheet to separate the multiple frames after allowing the multiple frames to be unevenly flattened to form a plurality of implants.

[0681] Example 272. A method according to Example 269, wherein cutting the sheet includes cutting the sheet while the plurality of frames remain constrained.

[0682] Example 273. A method according to Example 269, wherein forming the hole includes forming the hole using an automatic cutting device.

[0683] Those skilled in the art will appreciate that the present invention is not limited to what is specifically shown and described above. On the contrary, the scope of the present invention includes both combinations and sub-combinations of the various features described above, as well as variations and modifications thereof that are not in the prior art, which will occur to those skilled in the art after reading the above description.

Claims

1. A method for manufacturing a medical implant, the method comprising: forming a sandwich, the sandwich comprising: Fabric layer, a coating comprising a polymer configured to inhibit tissue growth thereon, a bonding layer sandwiched between the fabric layer and the coating, and at least a component of a frame, said at least a component of the frame being sandwiched between said fabric layer and said binding layer; as well as The sandwich is heated and compressed so that the bonding layer bonds the fabric layer to the coating.

2. The method of claim 1, further comprising sterilizing the interlayer after heating and compressing the interlayer.

3. The method according to any one of claims 1 to 2, wherein forming the sandwich comprises sandwiching at least the component of the frame together with the bonding layer between the fabric layer and the coating.

4. The method of any one of claims 1 to 3, wherein the coating consists essentially of the polymer.

5. The method according to any one of claims 1 to 4, wherein the coating is non-porous.

6. The method according to any one of claims 1 to 4, wherein the coating is porous.

7. The method according to any one of claims 1 to 6, wherein the coating is a film.

8. The method of any one of claims 1 to 6, wherein the fabric layer comprises a woven fabric.

9. The method according to any one of claims 1 to 6, wherein the fabric layer comprises a nonwoven fabric.

10. The method of any one of claims 1 to 9, wherein the polymer comprises ultra high molecular weight polyethylene (UHMWPE).

11. The method of any one of claims 1 to 9, wherein the polymer comprises fluorinated ethylene propylene (FEP).

12. The method of any one of claims 1 to 11, wherein the bonding layer comprises an acrylate.

13. The method of any one of claims 1 to 12, wherein the bonding layer comprises silicone.

14. The method of any one of claims 1 to 13, wherein the bonding layer comprises thermoplastic polyurethane (TPU).

15. A method according to any one of claims 1 to 14, wherein the bonding layer is 5-30 microns thick.

16. A method according to any one of claims 1 to 15, wherein the components of the frame are 20-500 microns thick.

17. The method according to any one of claims 1 to 16, wherein: The coating defines a first side of the interlayer, and the interlayer has a second side opposite the first side, forming the interlayer includes forming the interlayer to define a lip, wherein a lip portion of the coating layer and a lip portion of the bonding layer together extend beyond an edge of the fabric layer, and The method also includes folding the lip around the edge of the fabric layer onto the second side such that the lip portion of the bonding layer is sandwiched between the lip portion of the coating and the second side.

18. A method according to any one of claims 1 to 16, wherein the frame has a first side and an opposite second side, and wherein forming the sandwich includes wrapping the fabric layer around the frame from the first side to the second side so that at least a portion of the frame is sandwiched between (i) a first portion of the fabric layer disposed against the first side of the frame and (ii) a second portion of the fabric layer disposed against the second side of the frame.

19. The method of any one of claims 1 to 18, wherein heating and compressing the sandwich comprises heating and compressing the sandwich in a manner that defines a pocket between the fabric layer and the bonding layer, wherein at least the component of the frame is disposed in the pocket.

20. The method of claim 19, wherein heating the sandwich comprises heating the sandwich between plates, at least one of the plates having a recess at the region of the pocket.

21. The method of claim 19, wherein compressing the interlayer comprises compressing the interlayer between plates, at least one of the plates having a recess at the region of the pocket.

22. The method of claim 19, further comprising closing the pocket by bonding the fabric layer and the bonding layer surrounding the pocket.

23. The method of claim 19, wherein heating and compressing the interlayer comprises heating and compressing the interlayer in a manner to provide an opening in the pocket, wherein the fabric layer is released from the bonding layer.

24. The method of any one of claims 1 to 23, wherein forming the interlayer comprises defining a lip, wherein a lip portion of the coating and a lip portion of the bonding layer together extend beyond an edge of the fabric layer.

25. The method of claim 24, wherein forming the interlayer comprises: forming the interlayer such that the coating defines a first side of the interlayer and such that the interlayer has a second side opposite the first side, and The lip is folded onto the second side such that the lip portion of the bonding layer is sandwiched between the lip portion of the coating and the second side.

26. The method of any one of claims 1 to 25, further comprising forming holes through the interlayer after heating and compressing the interlayer.

27. The method of claim 26, further comprising planarizing the interlayer after heating and compressing the interlayer, and maintaining the interlayer planar while forming the hole through the interlayer.

28. The method of claim 26, wherein forming the hole comprises forming the hole by laser cutting.

29. The method of claim 26, wherein the hole is a hexagonal hole, and wherein forming the hole comprises forming the hexagonal hole.

30. A method comprising: A sandwich is formed comprising a bonding layer sandwiched between: fabric layer, and a coating comprising a polymer configured to inhibit tissue growth thereon; and The sheet is formed by bonding the fabric layer to the coating layer as follows: heating the sandwich, and The sandwich is compressed.

31. The method of claim 1, further comprising sterilizing the sheet after heating and compressing the sandwich.

32. A method according to any one of claims 30 to 31, wherein: In the sandwich, the bonding layer is separated from the fabric layer, forming the sandwich includes forming the sandwich wherein the bonding layer is separated from the fabric layer, and Forming the sheet by bonding the fabric layer to the coating layer includes bonding the bonding layer to the fabric layer and the coating layer by heating and compressing the interlayer to form the sheet.

33. A method according to any one of claims 30 to 31, wherein: In the sandwich, the bonding layer is bonded to the fabric layer, forming the sandwich comprises forming the sandwich wherein the bonding layer is bonded to the fabric layer, and Forming the sheet by bonding the fabric layer to the coating layer includes bonding the bonding layer bonded to the fabric layer to the coating layer by heating and compressing the interlayer to form the sheet.

34. A method according to any one of claims 30 to 33, wherein the coating consists essentially of the polymer.

35. A method according to any one of claims 30 to 34, wherein the coating is non-porous.

36. A method according to any one of claims 30 to 34, wherein the coating is porous.

37. A method according to any one of claims 30 to 36, wherein the coating is a film.

38. A method according to any one of claims 30 to 36, wherein the fabric layer comprises a woven fabric.

39. A method according to any one of claims 30 to 36, wherein the fabric layer comprises a nonwoven fabric.

40. The method of any one of claims 30 to 39, wherein the polymer comprises ultra high molecular weight polyethylene (UHMWPE).

41. The method of any one of claims 30 to 40, wherein the polymer comprises fluorinated ethylene propylene (FEP).

42. The method of any one of claims 30 to 41, wherein the bonding layer comprises an acrylate.

43. A method according to any one of claims 30 to 42, wherein the bonding layer comprises silicone.

44. The method of any one of claims 30 to 43, wherein the bonding layer comprises thermoplastic polyurethane (TPU).

45. A method according to any one of claims 30 to 44, wherein the fabric layer is 20-150 microns thick.

46. ​​A method according to any one of claims 30 to 45, wherein the bonding layer is 5-30 microns thick.

47. A method according to any one of claims 30 to 46, wherein: The coating defines a first side of the sheet, and the sheet has a second side opposite the first side; forming the interlayer includes forming the interlayer to define a lip, wherein a lip portion of the coating and a lip portion of the bonding layer together extend beyond an edge of the fabric layer, The method further includes folding the lip around the edge of the fabric layer onto the second face such that the lip portion of the bonding layer is sandwiched between the lip portion of the coating and the second face; and Forming the sheet includes forming the sheet by: Heating the sandwich includes folding the lip around the edge of the fabric layer onto the second side, and Compressing the interlayer includes folding the lip around the edge of the fabric layer onto the second side.

48. The method of any one of claims 30 to 47, wherein forming the sheet comprises forming the sheet by bonding the bonding layer to the fabric layer by heating the bonding layer and compressing the bonding layer against the fabric layer.

49. The method of claim 48, wherein forming the sheet comprises forming the sheet by heating the coating and compressing the coating against the bonding layer to bond the coating to the bonding layer.

50. The method of any one of claims 30 to 49, wherein forming the interlayer comprises defining a lip, wherein a lip portion of the coating and a lip portion of the bonding layer together extend beyond an edge of the fabric layer.

51. The method of claim 50, wherein forming the interlayer comprises: forming the sandwich so that the coating defines a first side of the sheet and so that the sheet has a second side opposite the first side, and The lip is folded onto the second side such that the lip portion of the bonding layer is sandwiched between the lip portion of the coating and the second side.

Images