Fabric layers and polymer laminates for implants - Patents.com

Abstract

A method is provided for use in manufacturing a medical implant. A sandwich is formed, the sandwich including a textile layer, a cover layer including a polymer configured to inhibit tissue growth thereon, a tie layer sandwiched between the textile layer and the cover layer, and at least a portion of a frame sandwiched between the textile layer and the tie layer. The sandwich is heated and compressed such that the tie layer bonds the textile layer to the cover layer. Other implementations are also described.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 341,354, filed May 12, 2022, to Vaid et al.

[0002] This application is related to international patent application PCT / IB2021 / 060436 by Tennenbaum et al., filed November 11, 2021, published as WO2022 / 101817, international patent application PCT / US2021 / 039587 by Chau et al., filed June 29, 2021, published as WO2022 / 006087, and international patent application PCT / US2022 / 052834 by Chau et al., filed December 14, 2022.

[0003] Each of the above applications is incorporated herein by reference for all purposes. [Background technology]

[0004] Tissue may grow onto the implant after implantation. In some cases, such tissue growth is desirable, for example to help the implant integrate with tissue or organs. For example, in some hernia treatments, a mesh is introduced and anchored around the opening to prevent organs from passing through the opening undesirably. The mesh encourages tissue to grow over it, "bandaging" the opening. Conversely, in some cases, tissue growth over the implant is undesirable. For example, an implant (or a component thereof) that is intended to move (e.g., vibrate) within the body may be adversely affected by tissue growth. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] WO2022 / 101817 [Patent Document 2] WO2022 / 006087 [Patent Document 3] International Patent Application No. PCT / US2022 / 052834 Summary of the Invention [Problem to be solved by the invention]

[0006] Mechanical properties of an implant, such as strength and / or flexibility, typically require that the implant be made of a particular material. However, the promotion or inhibition of tissue growth on the implant may require the use of other materials, which may not provide the desired mechanical properties. Therefore, it may be advantageous to combine a material that provides desirable mechanical properties with a material that provides desirable tissue growth properties. [Means for solving the problem]

[0007] In some implementations, systems, devices, and / or apparatuses, such as implants, prosthetic valves, stents, and / or patches used in the heart and / or on tissues of a subject, can benefit from at least one tissue growth inhibiting surface. For example, implants can benefit from such tissue growth inhibiting on surfaces that are in intermittent, recurrent, or continuous contact with tissue, and / or on surfaces that rarely or never contact tissue. Described herein are sheets that provide at least one such tissue growth inhibiting surface and that can be included in such systems, devices, and / or apparatuses. Methods of forming such sheets are also described. Additionally, methods of forming implants including such sheets are described.

[0008] In some implementations, such sheets have a multi-layer structure. In general, the sheet is formed by heating and / or pressing this multi-layer structure, which may include a fabric layer and at least one cover layer and a tie layer, e.g., a sandwich. Each tie layer, configured to bond the cover layer to the fabric layer, is sandwiched between the fabric layer and the cover layer. The cover layer may include (e.g., may be a film of) a tissue growth inhibiting material (e.g., a polymer). In some implementations, a frame may be introduced into the sandwich, thereby forming part of the sheet. In some implementations, the sheet may be attached to the frame after formation of the sheet, for example, by stitching, using an adhesive, and / or by applying heat and / or pressure. In some implementations, the sheet may be attached to the frame by folding an edge of the sheet over an edge of the frame to create a hem.

[0009] Implants incorporating such sheets are described herein. The systems, devices, methods, apparatuses, etc. may be configured to inhibit tissue growth thereon. Various examples of systems, devices, and / or methods for covering implants to inhibit tissue growth thereon are described. In some implementations, the implants incorporating the sheets are configured to support and / or guide the movement of the leaflets of a valve of a subject's heart. An example of when such an implant may be useful is when used with the posterior leaflet of the mitral valve, which suffers from flail, prolapse, stiffness, and / or other problems resulting in regurgitation.

[0010] Various implementations of systems, devices, embodiments, such as artificial implants, may be coated using the coating methods disclosed herein, and any combination of the described features, components, and options may be implemented unless specifically excluded. For example, various polymers that inhibit tissue growth thereon may be used in any suitable manner to bond the polymer to the device, implant, etc., even if a specific combination of heat and / or pressure is not explicitly described. Similarly, different structures and features of devices may be mixed and matched, such as by combining any sheet with any form of frame, even if not explicitly disclosed. In summary, individual components of the disclosed systems may be combined unless otherwise mutually exclusive or physically impossible.

[0011] Examples herein are directed to systems, devices, apparatus, methods, etc. for forming a sheet having at least one tissue-inhibiting growth surface and / or for covering a frame, thereby providing at least one tissue-inhibiting growth surface. In some implementations, the sheet may be used alone and / or in combination with a frame to reduce leaflet flutter, prolapse, abnormal leaflet movement, and / or other problems.

[0012] According to some implementations, a method is provided that includes forming a sandwich including a tie layer sandwiched between (i) a textile layer and (ii) a cover layer including a polymer configured to inhibit tissue growth thereon. The method may further include forming a sheet by bonding the textile layer to the cover layer by heating and / or compressing the sandwich.

[0013] In some implementations, (i) in the sandwich, the tie layer is not bonded from the textile layer, (ii) forming the sandwich includes forming a sandwich in which the tie layer is not bonded from the textile layer, and / or (iii) forming a sheet by bonding the textile layer to the cover layer includes forming a sheet by bonding the tie layer to the textile layer and the cover layer by heating and compressing the sandwich.

[0014] In some implementations, (i) in the sandwich, a bonding layer is bonded to a textile layer, (ii) forming the sandwich includes forming a sandwich in which a bonding layer is bonded to a textile layer, and / or (iii) forming a sheet by bonding a textile layer to a cover layer includes forming a sheet by bonding a bonding layer, which is bonded to the textile layer, to a cover layer by heating and compressing the sandwich.

[0015] In some implementations, the cover layer consists essentially of a polymer.

[0016] In some implementations, the cover layer is a film.

[0017] In some implementations, the cover layer is non-porous.

[0018] In some implementations, the cover layer is porous.

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

[0020] In some implementations, the fabric is a non-woven fabric.

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

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

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

[0024] In some implementations, the tie layer is a siloxane.

[0025] In some implementations, the tie layer includes a thermoplastic polyurethane (TPU).

[0026] In some implementations, the fabric layer is between 20 and 150 microns thick.

[0027] In some implementations, the bonding layer is between 5 and 30 microns thick.

[0028] In some implementations, (A) the covering layer defines a first side of the sheet, the sheet having a second side opposite the first side; (B) forming the sandwich includes forming the sandwich to define a lip, where a lip portion of the covering layer and a lip portion of the bonding layer extend together beyond an edge of the textile layer; (C) the method further includes folding the lip onto the second side, around an edge of the textile layer, such that the lip portion of the bonding layer is sandwiched between the lip portion of the covering layer and the second side; and / or (D) forming the sheet includes forming a sheet by (i) heating the sandwich including the lip folded onto the second side, around an edge of the textile layer, and (ii) compressing the sandwich including the lip folded onto the second side, around an edge of the textile layer.

[0029] In some implementations, forming the sheet includes bonding the bonding layer to the textile layer by heating and compressing the bonding layer against the textile layer to form the sheet.

[0030] In some implementations, forming the sheet includes bonding the cover layer to the bonding layer by heating and compressing the cover layer against the bonding layer to form the sheet.

[0031] In some implementations, forming the sandwich includes defining a lip where a lip portion of the cover layer and a lip portion of the tie layer extend together beyond an edge of the fabric layer.

[0032] In some implementations, forming the sandwich includes (i) forming the sandwich such that the cover layer defines a first side of the sheet, the sheet having a second side opposing the first side, and (ii) folding the lip onto the second side such that the lip portion of the bonding layer is sandwiched between the lip portion of the cover layer and the second side.

[0033] In some implementations, (A) the sandwich includes at least a portion of a frame sandwiched between the textile layer and the bonding layer, and (B) forming the sheet includes forming the sheet by bonding the textile layer to the cover layer, and at least a portion of the frame is disposed between the textile layer and the bonding layer by (i) heating the sandwich including at least a portion of the frame sandwiched between the textile layer and the bonding layer, and (i) compressing the sandwich including at least a portion of the frame sandwiched between the textile layer and the bonding layer.

[0034] In some implementations, forming the sheet includes forming the sheet to define a pocket between the fabric layer and the bonding layer by heating and compressing the sandwich around the area of ​​the pocket such that at least a portion of the frame is disposed within the pocket.

[0035] In some implementations, heating the sandwich includes heating the sandwich between plates, at least one of the plates having a recess in the area of ​​the pocket.

[0036] In some implementations, compressing the sandwich includes compressing the sandwich between plates, at least one of the plates having a recess in the area of ​​the pocket.

[0037] In some implementations, forming the sheet includes forming the sheet by bonding a fabric layer to a cover layer in a manner that forms a pocket between the fabric layer and the bonding layer.

[0038] In some implementations, the pocket is formed by (i) heating the sandwich around the area of ​​the pocket, and (ii) compressing the sandwich around the area of ​​the pocket.

[0039] In some implementations, the sandwich is heated around the enclosed area of ​​the sandwich.

[0040] In some implementations, the sandwich is compressed around the enclosed area of ​​the sandwich.

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

[0042] In some implementations, forming the sheet includes having a fabric layer unbonded from a first bonding layer to form a sheet having an opening at an edge of the sheet.

[0043] In some implementations, forming the sandwich includes forming a sandwich having a frame sandwiched between the fabric layer and the cover layer along with a bonding layer.

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

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

[0046] In some implementations, forming the sandwich includes forming a sandwich that includes a frame sandwiched between the fabric layer and the cover layer, along with a bonding layer.

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

[0048] In some implementations, fixedly attaching the sheet to the frame includes stitching the sheet to the frame.

[0049] In some implementations, the frame has a first side and an opposing second side, and the textile 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 textile layer that is positioned against the first side of the frame and (ii) a second portion of the textile layer that is positioned against the second side of the frame.

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

[0051] In some implementations, the method further includes flattening the sheet and keeping it flat while forming a plurality of holes therethrough.

[0052] In some implementations, forming the holes includes forming the holes by laser cutting.

[0053] In some implementations, each of the holes is hexagonal.

[0054] In some implementations, forming the sheet includes forming a sheet having a pocket between the fabric layer and the bonding layer by heating and compressing the sandwich around an area defining the pocket such that at least a portion of the frame is disposed within the pocket.

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

[0056] In some implementations, compressing the sandwich includes compressing the sandwich between plates, at least one of the plates having a recess such that the recess forms a pocket therein.

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

[0058] In some implementations, the cover layer defines a first side of the sheet, and the sheet has a second side opposite the first side, In some implementations, forming the sandwich includes forming the sandwich to define a lip portion of the cover layer and a lip portion of the tie layer that together extend beyond an edge of the textile layer.

[0059] In some implementations, the method further includes folding the lip around an edge of the textile layer and onto the second surface such that the lip portion of the bonding layer is sandwiched between the lip portion of the cover layer and the second surface.

[0060] In some implementations, forming the sheet includes forming a sheet by (i) heating the sandwich including the lip folded onto the second surface around an edge of the textile layer, and (ii) compressing the sandwich including the lip folded onto the second surface around an edge of the textile layer.

[0061] In some embodiments, the first cover layer, the second cover layer, and the first tie layer extend together beyond an edge of the fabric layer, thereby forming a lip, forming a sandwich including a lip in which a lip portion of the first cover layer, a lip portion of the second cover layer, and a lip portion of the first tie layer are disposed.

[0062] In some implementations, forming the sandwich includes (i) forming the sandwich such that the cover layer defines a first side of the sheet, the sheet having a second side opposing the first side, and (ii) folding the lip onto the second side such that the lip portion of the bonding layer is sandwiched between the lip portion of the cover layer and the second side.

[0063] In some implementations, the first covering layer, the second covering layer, the first bonding layer, and the second bonding layer extend together beyond an edge of the textile layer, thereby defining a lip and forming a sandwich including a lip within which the lip portion of the first covering layer, the lip portion of the second covering layer, and the lip portion of the first bonding layer are disposed.

[0064] In some implementations, forming the sheet includes forming the sheet by bonding a fabric layer to a cover layer in a manner that forms a pocket between the fabric layer and the bonding layer.

[0065] In some implementations, forming the sheet in a manner to form a pocket includes (i) heating the sandwich around the area of ​​the pocket, and (ii) compressing the sandwich around the area of ​​the pocket.

[0066] In some implementations, the heating or compression of the sandwich is performed around an enclosed area of ​​the sandwich.

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

[0068] In some implementations, the sheet defines an opening to a pocket.

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

[0070] In some implementations, the openings are located at edges of the sheet.

[0071] In some implementations, the sheet further includes a cord, at least a portion of the cord extending through the pocket.

[0072] In some implementations, the cord is slidable within the pocket.

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

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

[0075] In some implementations, the coating layer includes several laminar sub-layers of polymer.

[0076] In some implementations, each of the sublayers is anisotropic, and the sublayers are arranged such that each of the sublayers is disposed orthogonally to an adjacent one of the sublayers.

[0077] In some implementations, the coating layer includes fewer than ten sublayers.

[0078] In some implementations, the coating layer includes fewer than six sublayers.

[0079] In some implementations, compressing the sandwich includes compressing the sandwich at a pressure of 0.01 to 1 MPa.

[0080] In some implementations, compressing the sandwich includes holding the sandwich under pressure for 100 to 500 seconds.

[0081] In some implementations, heating the sandwich includes heating the sandwich to a temperature between 37 and 260 degrees Celsius.

[0082] In some implementations, heating the sandwich includes holding the sandwich at the temperature for between 100 and 500 seconds.

[0083] According to some implementations, systems and / or devices are provided that include a sheet that includes (i) a textile layer, (ii) a cover layer including a polymer configured to inhibit tissue growth thereon, and / or (iii) a bonding layer sandwiched between the textile layer and the cover layer, bonding the textile layer to the cover layer.

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

[0085] In some implementations, the cover layer consists essentially of a polymer.

[0086] In some implementations, the cover layer is a film.

[0087] In some implementations, the cover layer is non-porous.

[0088] In some implementations, the cover layer is porous.

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

[0090] In some implementations, the fabric is a non-woven fabric.

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

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

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

[0094] In some implementations, the tie layer is a siloxane.

[0095] In some implementations, the fabric layer is between 20 and 150 microns thick.

[0096] In some implementations, the bonding layer is between 5 and 30 microns thick.

[0097] In some implementations, the cover layer and the tie layer extend together beyond an edge of the fabric layer, thereby defining a lip within which the lip portion of the cover layer and the lip portion of the tie layer are disposed.

[0098] In some implementations, the cover layer defines a first side of the sheet, 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 cover layer and the second side.

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

[0100] In some implementations, the sheet defines a pocket between the fabric layer and the bonding layer.

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

[0102] In some implementations, the sheet defines an opening to a pocket.

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

[0104] In some implementations, the openings are located at edges of the sheet.

[0105] In some implementations, the system / device further includes a cord, at least a portion of the cord extending through the pocket.

[0106] In some implementations, a portion of the cord is slidable within the pocket.

[0107] In some implementations, the system / device is shaped as a wing that defines a contact surface and a counter surface opposite the contact surface.

[0108] In some implementations, the wings have a number of holes configured to facilitate blood flow therethrough.

[0109] In some implementations, each of the holes is hexagonal.

[0110] In some implementations, the wings are configured to be secured to tissue of a subject's heart having a first leaflet and a second opposing leaflet, such that the wings extend over the first leaflet toward the second leaflet and the contact surface faces the first leaflet.

[0111] In some implementations, the apparatus further includes a frame, the sheet being fixedly attached to the frame in a manner covering at least a portion of the frame.

[0112] In some implementations, the sheet is fixedly attached to the frame by stitching.

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

[0114] In some implementations, 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 cover layer is a first cover layer, (ii) the tie layer is a first tie layer, and (iii) the sheet further comprises a second cover layer and a second tie layer sandwiched between the frame and the second cover layer.

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

[0117] In some implementations, the frame has a first side and an opposing second side, and the textile layer is wrapped around 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 textile layer that is positioned against the first side of the frame and (ii) a second portion of the textile layer that is positioned against the second side of the frame.

[0118] In some implementations, (A) the cover layer is a first cover layer, (B) the tie layer is a first tie layer, and (C) the sheet further includes (i) a second cover layer and (ii) a second tie layer sandwiched between a second portion of the fabric layer and the second cover layer.

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

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

[0121] In some implementations, the wing is configured to be anchored to an annulus of a valve of a subject's heart such that the wing extends over a first leaflet of the valve toward the opposing leaflet of the valve, with the contact surface facing the first leaflet.

[0122] In some implementations, the system / device has a pocket between the fabric layer and the bonding layer, with at least a portion of the frame being disposed within the pocket.

[0123] In some implementations, the cover layer and the tie layer extend together beyond an edge of the frame, thereby defining a lip within which the lip portion of the cover layer and the lip portion of the tie layer are disposed.

[0124] In some implementations, the frame is disposed between the fabric layer and the bonding layer, and the fabric layer, together with the cover layer and the bonding layer, extends beyond the edges of the frame.

[0125] In some implementations, the cover layer and the tie layer extend together beyond an edge of the fabric layer, thereby defining a lip.

[0126] In some implementations, the cover layer defines a first side of the sheet, 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 cover layer and the second side.

[0127] In some implementations, 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 implementations, the lip is folded around an edge of the frame, thereby defining a hem of the sheet within which the edge of the frame is disposed between the lip portion of the bonding layer and another portion of the bonding layer.

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

[0130] In some implementations, the cover layer is a first cover layer, the bonding layer is a first bonding layer, and the sheet further includes (i) a second cover layer and (ii) a second bonding layer sandwiched between the textile layer and the second cover layer and bonding the textile layer to the second cover layer, and the textile layer is sandwiched between the first bonding layer and the second bonding layer.

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

[0132] In some implementations, the first covering layer, the second covering layer, and the first bonding layer extend together beyond an edge of the fabric layer, thereby defining a lip within which the lip portion of the first covering layer, the lip portion of the second covering layer, and the lip portion of the first bonding layer are disposed.

[0133] In some implementations, within the lip, a lip portion of the first cover layer is bonded to a lip portion of the second cover layer by a lip portion of the first bonding layer.

[0134] In some implementations, the lip portion of the second bonding layer extends beyond the edge of the textile layer into the lip such that, within the lip, the lip portion of the first covering layer is bonded to the lip portion of the second covering layer by the lip portion of the first bonding layer and the lip portion of the second bonding layer.

[0135] In some implementations, the system / apparatus further includes a frame disposed between the first bonding layer and the second bonding layer.

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

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

[0138] In some implementations, the first covering layer and the first bonding layer extend together beyond an edge of the fabric layer, thereby defining a lip within which the lip portion of the first covering layer and the lip portion of the first bonding layer are disposed.

[0139] In some embodiments, the first covering layer defines a first side of the sheet, 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 first bonding layer is disposed between the lip portion of the first covering layer and the second side.

[0140] In some implementations, the lip is folded onto the second surface such that the lip portion of the first tie layer is disposed between the lip portion of the first cover layer and the lip portion of the second cover layer.

[0141] In some implementations, the system / apparatus further includes a frame, the sheet is fixedly attached to the frame in a manner covering at least a portion of the frame, (i) the first covering layer defines a first side of the sheet, the sheet having a second side opposite the first side, and (ii) a lip portion of the first covering layer and a lip portion of the first bonding layer extend together beyond an edge of the textile layer, thereby defining a lip, the lip extending beyond an edge of the frame.

[0142] In some implementations, the lip is folded over onto the second surface, thereby defining a skirt of the seat within which at least a portion of the frame is disposed.

[0143] In some implementations, the lip portion of the second cover layer and the lip portion of the second tie layer extend together beyond the edge of the fabric into a lip.

[0144] In some implementations, the system / apparatus further includes a frame, with the sheet fixedly attached to the frame in a manner covering at least a portion of the frame.

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

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

[0147] In some implementations, the sheet defines an opening to a pocket.

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

[0149] In some implementations, the openings are located at edges of the sheet.

[0150] In some implementations, the system / device further includes a cord attached to the frame, at least a portion of the cord extending through the pocket.

[0151] In some implementations, a portion of the cord is slidable within the pocket.

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

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

[0154] In some implementations, the coating layer includes several layered sub-layers of polymer.

[0155] In some implementations, each of the sublayers is anisotropic, and the sublayers are arranged such that each of the sublayers is disposed orthogonally to an adjacent one of the sublayers.

[0156] In some implementations, the coating layer includes fewer than ten sublayers.

[0157] In some implementations, the coating layer includes fewer than six sublayers.

[0158] In some implementations, the tie layer includes a thermoplastic polyurethane (TPU).

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

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

[0161] In some implementations, the sheet is formed by compressing the fabric layer, the cover layer, and the tie layer together and heating to bond the tie layer to the fabric layer and the cover layer.

[0162] In some implementations, the sheet is formed by compressing the fabric layer, the cover layer, and the tie layer together for 100 to 500 seconds.

[0163] In some implementations, the sheet is formed by compressing the fabric layer, the cover layer, and the tie layer together for 20 to 420 seconds.

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

[0165] In some embodiments, the sheet is formed by heating the fabric layer, the cover layer, and the tie layer for a period of from 20 to 420 seconds.

[0166] In some implementations, the sheet is formed by compressing the fabric layer, the cover layer, and the tie layer together at a pressure of 0.01 to 1 MPa.

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

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

[0169] In some embodiments, the sheet is formed by heating the fabric layer, the cover layer, and the tie layer at a temperature between 37 and 260 degrees Celsius.

[0170] In some implementations, the sheet is formed by holding the fabric layer, the cover layer, and the tie layer at temperature for 100 to 500 seconds.

[0171] In some implementations, the sheet is formed by holding the fabric layer, the cover layer, and the tie layer at a temperature for 20 to 420 seconds.

[0172] According to some implementations, a system and / or device is provided that includes a cardiovascular implant including a frame and / or a sheet. The sheet may include a fabric layer secured to at least a portion of the frame. The sheet may further include a cover layer including a polymer configured to inhibit tissue growth thereon. The sheet may further include a tie layer sandwiched between the fabric layer and the cover layer and connecting the fabric layer to the cover layer.

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

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

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

[0176] In some implementations, the frame is designed as a leaflet augmentation patch.

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

[0178] In some implementations, the implant is configured to be anchored to cardiac tissue of a subject.

[0179] In some implementations, the sheet is fixedly attached to the frame by stitching.

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

[0181] In some implementations, the system / device has a pocket between the fabric layer and the bonding layer, with at least a portion of the frame disposed within the pocket.

[0182] In some implementations, the cover layer consists essentially of a polymer.

[0183] In some implementations, the cover layer is a film.

[0184] In some implementations, the cover layer is non-porous.

[0185] In some implementations, the cover layer is porous.

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

[0187] In some implementations, the fabric is a non-woven fabric.

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

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

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

[0191] In some implementations, the tie layer is a siloxane.

[0192] In some implementations, the fabric layer is between 20 and 150 microns thick.

[0193] In some implementations, the bonding layer is between 5 and 30 microns thick.

[0194] In some implementations, the cover layer and the tie layer extend together beyond an edge of the frame, thereby defining a lip within which the lip portion of the cover layer and the lip portion of the tie layer are disposed.

[0195] In some implementations, the frame is disposed between the fabric layer and the bonding layer, and the fabric layer, together with the cover layer and the bonding layer, extends beyond the edges of the frame.

[0196] In some implementations, the cover layer and the tie layer extend together beyond an edge of the fabric layer, thereby defining a lip.

[0197] In some implementations, the cover layer defines a first side of the sheet, 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 cover layer and the second side.

[0198] In some implementations, 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 implementations, the lip is folded around an edge of the frame, thereby defining a hem of the sheet within which the edge of the frame is disposed between the lip portion of the bonding layer and another portion of the bonding layer.

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

[0201] In some implementations, the fabric layer is secured to 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 implementations, the portion of the frame is a first portion of the frame and a second portion of the frame is disposed within the pocket between the bonding layer and the fabric layer.

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

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

[0205] In some implementations, the frame has a first side and an opposing second side, and the textile layer is wrapped around 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 textile layer that is positioned against the first side of the frame and (ii) a second portion of the textile layer that is positioned against the second side of the frame.

[0206] In some implementations, the cover layer is a first cover layer, the tie layer is a first tie layer, and the sheet further includes (i) a second cover layer, and (ii) a second tie layer sandwiched between a second portion of the fabric layer and the second cover layer.

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

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

[0209] In some implementations, the wing is configured to be anchored to the annulus of a valve of a subject's heart such that the wing extends over a first leaflet of the valve toward the opposing leaflet of the valve, with the contact surface facing the first leaflet.

[0210] In some implementations, the cover layer is a first cover layer, the bonding layer is a first bonding layer, and the sheet further includes (i) a second cover layer and (ii) a second bonding layer sandwiched between the textile layer and the second cover layer and bonding the textile layer to the second cover layer, and the textile layer is sandwiched between the first bonding layer and the second bonding layer.

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

[0212] In some implementations, the first covering layer and the first bonding layer extend together beyond an edge of the fabric layer, thereby defining a lip within which the lip portion of the first covering layer and the lip portion of the first bonding layer are disposed.

[0213] In some embodiments, the first covering layer defines a first side of the sheet, 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 first bonding layer is disposed between the lip portion of the first covering layer and the second side.

[0214] In some implementations, the lip is folded onto the second surface such that the lip portion of the first tie layer is disposed between the lip portion of the first cover layer and the lip portion of the second cover layer.

[0215] In some implementations, the first covering layer, the second covering layer, and the first bonding layer extend together beyond an edge of the fabric layer, thereby defining a lip within which the lip portion of the first covering layer, the lip portion of the second covering layer, and the lip portion of the first bonding layer are disposed.

[0216] In some implementations, within the lip, a lip portion of the first cover layer is bonded to a lip portion of the second cover layer by a lip portion of the first bonding layer.

[0217] In some implementations, the lip portion of the second bonding layer extends beyond the edge of the textile layer into the lip such that, within the lip, the lip portion of the first covering layer is bonded to the lip portion of the second covering layer by the lip portion of the first bonding layer and the lip portion of the second bonding layer.

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

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

[0220] In some implementations, the lip is folded over onto the second surface, thereby defining a skirt of the seat within which at least a portion of the frame is disposed.

[0221] In some implementations, the lip portion of the second cover layer and the lip portion of the second tie layer extend together beyond the edge of the fabric into a lip.

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

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

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

[0225] In some implementations, the sheet defines an opening to a pocket.

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

[0227] In some implementations, the openings are located at edges of the sheet.

[0228] In some implementations, the system / device further includes a cord attached to the frame, at least a portion of the cord extending through the pocket.

[0229] In some implementations, a portion of the cord is slidable within the pocket.

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

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

[0232] In some implementations, the coating layer includes several layered sub-layers of polymer.

[0233] In some implementations, each of the sublayers is anisotropic, and the sublayers are arranged such that each of the sublayers is disposed orthogonally to an adjacent one of the sublayers.

[0234] In some implementations, the coating layer includes fewer than ten sublayers.

[0235] In some implementations, the coating layer includes fewer than six sublayers.

[0236] In some implementations, the tie layer includes a thermoplastic polyurethane (TPU).

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

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

[0239] In some implementations, the sheet is formed by compressing the fabric layer, the cover layer, and the tie layer together and heating to bond the tie layer to the fabric layer and the cover layer.

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

[0241] In some embodiments, the sheet is formed by heating the fabric layer, the cover layer, and the tie layer for a period of from 20 to 420 seconds.

[0242] In some implementations, the sheet is formed by compressing the fabric layer, the cover layer, and the tie layer together for 100 to 500 seconds.

[0243] In some implementations, the sheet is formed by compressing the fabric layer, the cover layer, and the tie layer together for 20 to 420 seconds.

[0244] In some implementations, the sheet is formed by compressing the fabric layer, the cover layer, and the tie layer together at a pressure of 0.01 to 1 MPa.

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

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

[0247] In some embodiments, the sheet is formed by heating the fabric layer, the cover layer, and the tie layer at a temperature between 37 and 260 degrees Celsius.

[0248] In some implementations, the sheet is formed by holding the fabric layer, the cover layer, and the tie layer at temperature for 100 to 500 seconds.

[0249] In some implementations, the sheet is formed by holding the fabric layer, the cover layer, and the tie layer at a temperature for 20 to 420 seconds.

[0250] According to some implementations, a method is provided that includes temporarily flattening a sheet of an implant by constraining a frame of the implant, the sheet being fixedly attached to the frame. The method may further include forming holes in the sheet while the sheet remains flat. The method may further include thereafter allowing the frame to unflatten toward a rest shape in which the frame holds the sheet in a curved configuration.

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

[0252] In some implementations, forming the holes includes forming the holes by moving a laser head of a laser cutting system along a plane parallel to the flat sheet.

[0253] In some implementations, flattening the sheet includes flattening the sheet using a cage having rails configured to hold the sheet in a flat configuration.

[0254] In some implementations, the method further includes (i) forming a sandwich including a bonding layer sandwiched between the textile layer and the cover layer, and (ii) forming a sheet by bonding the textile layer to the cover layer by heating and / or compressing the sandwich.

[0255] In some implementations, the method further includes, after forming the sheet, fastening and attaching the sheet to a frame prior to temporarily flattening the sheet.

[0256] In some implementations, (i) the frame is a first frame of a plurality of frames fixedly attached to the sheet, (ii) flattening the sheet by constraining the frame includes flattening the sheet by simultaneously constraining the plurality of frames while the plurality of frames remain fixedly attached to the sheet, and (iii) rendering the frame unflattenable includes rendering the plurality of frames unflattenable.

[0257] In some implementations, the method further includes attaching a plurality of frames in a transverse arrangement across the sheet prior to flattening the sheet.

[0258] In some implementations, the method further includes cutting the sheet to separate the plurality of frames after the plurality of frames are allowed to be unflattened, thereby forming a plurality of implants.

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

[0260] In some implementations, forming the holes includes forming the holes using an automated cutting device.

[0261] The present invention will be more fully understood from the following detailed description of implementations of the invention taken in conjunction with the drawings. [Brief description of the drawings]

[0262] [Figure 1A] 1A-D are schematic diagrams of an exemplary method of forming a sheet according to some implementations. [Figure 1B] Same as above. [Figure 1C] Same as above. [Figure 1D] Same as above. [Figure 2A] 2A-C are schematic diagrams of sheets defining pockets according to some implementations. [Figure 2B] Same as above. [Figure 2C] Same as above. [Diagram 3] FIG. 3 is a schematic diagram of an exemplary stacking device according to some implementations. [Figure 4A] 4A-K are schematic diagrams of an exemplary seat fixedly attached to a frame according to some implementations. [Figure 4B] Same as above. [Figure 4C] Same as above. [Figure 4D] Same as above. [Figure 4E] Same as above. [Figure 4F] Same as above. [Figure 4G] Same as above. [Figure 4H] Same as above. [Figure 4I] Same as above. [Figure 4J] Same as above. [Figure 4K] Same as above. [Figure 5A] 5A-B are schematic diagrams of an exemplary implant for use in a valve of a subject's heart, according to some implementations. [Figure 5B] Same as above. [Figure 6A] 6A-D are schematic diagrams of an exemplary implant for use in a valve of a subject's heart, according to some implementations. [Figure 6B] Same as above. [Figure 6C] Same as above. [Figure 6D] Same as above. [Figure 7A] 7A-B are schematic diagrams of an exemplary stacked device according to some implementations. [Figure 7B] Same as above. [Figure 8A] 8A-C are schematic diagrams of a technique for forming holes through a sheet of an implant, according to some implementations. [Figure 8B] Same as above. [Figure 8C] Same as above. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0263] Systems, devices, methods, apparatus, etc. for inhibiting tissue growth on an implantable sheet are described herein. In some implementations, the systems, devices, methods, apparatus, etc. include devices with a sheet comprised of a multi-layer structure and / or implant incorporating the sheet. The systems, devices, methods, apparatus, etc. can be configured to inhibit tissue growth thereon. Various examples of devices and / or methods for coating an implant inhibiting tissue growth thereon are described. In some implementations, the implant incorporating the sheet is configured to support and / or guide the movement of the leaflets of a valve of a subject's heart. An example of when such an implant may be useful is when used with the posterior leaflet of the mitral valve, which suffers from flutter, prolapse, stiffness, and / or other problems resulting in regurgitation.

[0264] The disclosed systems, devices, methods, apparatus, etc. should not be construed as limiting in any manner. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed coating procedures and implementations, alone as well as in various combinations and subcombinations with one another. The disclosed systems, devices, methods, apparatus, etc. are not limited to any particular aspect, feature, or combination thereof, nor do the disclosed systems, devices, methods, apparatus, etc. require that any one or more particular advantages be present or problems be solved. Furthermore, the techniques, methods, operations, steps, etc. described or suggested in this specification or the references incorporated herein can be performed on living subjects (e.g., humans, other animals, etc.) or on non-living simulations, such as cadavers, cadaver hearts, simulators, virtual people, etc. When performed in a simulation, body parts, e.g., hearts, tissues, valves, etc., may optionally be referred to as "simulations" (e.g., simulated hearts, simulated tissues, simulated valves, etc.), and may include, for example, computerized and / or physical representations of body parts, tissues, etc.

[0265] Various implementations of systems, devices, embodiments, such as artificial implants, may be coated using the coating methods disclosed herein, and any combination of the described features, components, and options may be implemented unless specifically excluded. For example, various polymers that inhibit tissue growth thereon may be used in any suitable manner to bond them to the device, even if a particular combination of heat and / or pressure is not explicitly described. Similarly, different structures and features of the device may be mixed and matched, such as by combining any sheet with any form of frame, even if not explicitly disclosed. In summary, individual components of the disclosed systems may be combined unless otherwise mutually exclusive or physically impossible.

[0266] Although some operations of the disclosed methods are described in a particular sequential order for convenience of presentation, it should be understood that the described method encompasses rearrangements, unless a particular order is required by specific language described below. For example, operations described sequentially may in some cases be rearranged or performed simultaneously. Moreover, for simplicity, the accompanying drawings may not show various aspects in which the disclosed systems, devices, apparatus, methods, etc. may be used in combination with other systems, devices, apparatus, methods, etc.

[0267] Reference is now made to FIGS. 1A-D, which are schematic illustrations of methods 10 and variations thereof for forming various sheets according to some implementations. These sheets are typically implantable in a subject, either alone or as a component of an implant. FIGS. 1A and 1C show methods 10a and 10c for forming sheet 100, which are variations of method 10. FIGS. 1B and 1D show methods 10b and 10d for forming sheet 150, which are also variations of method 10. In the illustrated embodiment, sheet 100 has three layers, while sheet 150 has five layers.

[0268] Sheet 100 includes a sandwich 102 that includes a fabric layer 112, a coating layer 116, and a bonding layer 114 that is sandwiched between the fabric layer and the coating layer and that bonds the fabric layer to the coating layer. The coating layer 116 includes a polymer configured to inhibit tissue growth thereon and may function as a first surface 101a of the sheet 100. In some implementations, the sheet 100, and / or an implant that includes the sheet 100, may be configured to be placed against a tissue surface of a subject with the first surface 101a facing the tissue surface of the subject. In some implementations, the sheet 100 and / or an implant that includes the sheet 100 may be configured to be placed against a tissue surface of a subject with the first surface 101a facing away from the tissue surface and, for example, a second surface 101b (which may be defined by the fabric layer 112) facing the tissue surface.

[0269] Sheet 150 includes a sandwich 104 that includes a fabric layer 112, two coating layers 116 (e.g., a first coating layer 116a and a second coating layer 116b), one on each side of the fabric layer, and two bonding layers 114 (e.g., a first bonding layer 114a and a second bonding layer 114b), each of which is sandwiched between one of the respective coating layers and a respective side of the fabric layer. In some implementations, the sheet 150 may be considered to include the three layers of the sandwich 102 (detailed above herein with respect to FIG. 1A), as well as an additional coating layer 116 and an additional bonding layer 114. Because the sheet 150 includes two more layers than the sheet 100, the sheet 150 may be at least slightly thicker than the sheet 100. Compared to the sheet 100, the two coating layers of the sheet 150 can provide tissue growth inhibition on both a first surface 151a and a second surface 151b of the sheet, which may be advantageous in some implementations.

[0270] In some implementations, the tissue growth inhibiting polymer of the cover layer 116 is ultra-high molecular weight polyethylene (UHMWPE). In some implementations, the tissue growth inhibiting polymer of the cover layer 116 is fluorinated ethylene propylene (FEP). In some implementations, the tissue growth inhibiting polymer of the cover layer 116 is a thermoplastic polyurethane (TPU), such as a polycarbonate-based TPU and / or an aliphatic TPU. In some implementations, the tissue growth inhibiting polymer of the cover layer 116 is a polytetrafluoroethylene (PTFE), such as expanded PTFE (ePTFE).

[0271] In some implementations, the coating layer 116 consists essentially of the tissue growth inhibiting polymer. In some implementations, the coating layer may include additional compounds.

[0272] In some implementations, the cover layer 116 may include a woven or non-woven fabric (different from the fabric layer 112) of a tissue growth inhibiting polymer.

[0273] In some implementations, the cover layer 116 may include a laminate (eg, a film) of a tissue growth inhibiting polymer.

[0274] In some implementations, the outer surface of the cover layer (which may define first side 101a of sheet 100, first side 151a of sheet 150, and / or second side 151b of sheet 151b) may consist essentially of a tissue growth inhibitory polymer (which may be, for example, a film of a polymer), while deeper in the cover layer, a different material and / or structure may provide other characteristics such as adhesion to tie layer 114, durability, and / or structural qualities.

[0275] In some implementations where the tissue growth inhibiting polymer is PTFE, the coating layer 116 can include several layered sublayers (e.g., lamina) of PTFE. In some implementations, these sublayers can be anisotropic, arranged such that each of the sublayers is disposed orthogonally to an adjacent one of the sublayers, e.g., each sublayer is alternated with the previous sublayer and the next sublayer. In some implementations, such a coating layer includes less than ten such sublayers, e.g., at least two and / or no more than six sublayers (e.g., 2-6 sublayers, such as 2-5 sublayers), e.g., exactly five sublayers.

[0276] In some implementations, the cover layer 116 is porous. In some implementations, the cover layer is non-porous.

[0277] In some implementations, the coating layer is between 5 and 70 microns thick.

[0278] In some implementations, the textile layer 112 comprises a woven fabric. In some implementations, the textile layer 112 comprises a knitted textile. In some implementations, the textile layer 112 comprises a braided textile. In some implementations, the textile layer 112 comprises a nonwoven textile. In some implementations, the textile layer 112 comprises a 3D textile. In some implementations, the textile layer 112 comprises an electrospun textile. In some implementations, the textile layer 112 comprises a multiphasic textile.

[0279] In some implementations, the fabric layer 112 is between 20 and 150 microns thick.

[0280] In some implementations, the tie layer 114 comprises an acrylate. For example, the tie layer may be essentially based on acrylate compounds such as salts, esters, and conjugate bases of acrylic acid. In some embodiments, the tie layer comprises a siloxane and / or a polysiloxane. In some implementations, the tie layer comprises a thermoplastic polyurethane (TPU).

[0281] In some implementations, the bonding layer is between 50 and 30 microns thick.

[0282] In methods 10a and 10b, a sandwich is formed in which each bonding layer 114 is sandwiched between a textile layer 112 and a respective cover layer 116. In method 10a, this sandwich is sandwich 102 (top frame in FIG. 1A), and in method 10b, this sandwich is sandwich 104 (top frame in FIG. 1B). The textile layer 112 is then bonded to the cover layer 116 (e.g., by bonding a bonding layer to both the textile layer and the cover layer) by heating the sandwich and / or compressing the sandwich (bottom frame in FIGS. 1A and 1B).

[0283] Methods 10c and 10d are similar to methods 10a and 10b, respectively, except that each includes two heat and / or pressure steps. A bonding layer 114 is placed against a textile layer 112 (FIGS. 1c and 1d, Frame A) and then bonded to the textile layer by compressing and / or heating the layer (Frame B). A cover layer 116 is then added, thereby sandwiching the bonding layer 114 between the textile layer 112 and the cover layer (Frame C). At this point in method 10c, the sandwich 102 can be considered to be formed. At this point in method 10d, the sandwich 104 can be considered to be formed. The layered textile layer 112, bonding layer 114, and cover layer 116 (e.g., sandwich) are then heated and / or compressed to form a sheet (Frame D).

[0284] For methods 10c and 10d, in the transition between frame A and frame B, the plate may be pressed against the bonding layer for heating and / or pressing. For example, such a plate may be or may be similar to any of plates 310, 320, 710, and 720 detailed below. Such a plate may be configured so as not to be bonded to the bonding layer 114, even though the bonding layer is specifically configured to bond to other materials, such as the cover layer 116. The plate may be configured this way by having a highly smooth and / or non-porous surface. In contrast, the cover layer 116 (or at least its inner surface) may be sufficiently rough and / or porous to allow the bonding layer to be bonded, for example, by the heated and / or pressed bonding layer entering microscopic pores and / or crevices. This may be true even in implementations where the cover layer 116 has a similar chemical composition as the plate, for example, where both may include polytetrafluoroethylene (PTFE) and their different characteristics derive, for example, from their structures.

[0285] In some implementations, methods 10a and 10b may be advantageous due to the fewer steps involved, for example, as compared to methods 10c and 10d.

[0286] In some implementations, methods 10c and 10d may be advantageous, for example, for implementations in which heat transfer through the entire sandwich may otherwise be slow and / or uneven. For example, for implementations in which cover layer 116 is relatively thick and / or insulating, methods 10a and 10b may be less reliable than methods 10c and 10d, which bond bonding layer 114 to textile layer 112. Furthermore, for implementations in which the sheet includes a frame disposed between the layers (e.g., as described in more detail below), methods 10c and 10d may facilitate more accurate and / or stable positioning of the frame relative to other layers. For example, the position of the frame relative to the textile layer may be fixed by first sandwiching at least a portion of the frame between the textile layer and a bonding layer that is bonded to the textile layer, and then the cover layer may be added to the other side of the bonding layer.

[0287] In all of methods 10a-10d, when heat and pressure are used to bond a bonding layer to another layer, the heat and pressure may be applied simultaneously or at least overlap in time, however, in some implementations, the pressure and heat may be applied separately (e.g., sequentially and / or alternating).

[0288] In some implementations, the compression during each of the heating and compressing steps is carried out at a pressure of 0.01 to 1 megapascal (MPa).

[0289] In some implementations, the heating during the heating and compressing step is to a temperature of 37 to 260 degrees Celsius (°C).

[0290] In some implementations of methods 10a and 10b, the heating and compressing steps last for 100-500 seconds. In some implementations 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.

[0291] For example, the sheet may be formed by applying one or more times (i) a pressure of 0.01 to 1 MPa, and (ii) a temperature of 37 to 260° C., for a duration of, for example, 20 to 420 seconds or 100 to 500 seconds.

[0292] In some implementations, pressure and heat may be applied to the sandwich simultaneously, i.e., one or more intervals of applied pressure and heat may be applied.

[0293] In some embodiments, pressure and heat may be applied separately (e.g., sequentially and / or alternating). That is, separate pressure and heating intervals may be applied. In some implementations, both (i) separate heating and compression intervals, and (ii) combined heating and compression intervals may be applied.

[0294] In some implementations, sheet 100 and / or sheet 150 (e.g., once cover layer 116, tie layer 114, and fabric layer 112 are bonded together) may have structural characteristics that allow the sheet to function 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.

[0295] Reference is now made to Figures 2A, 2B, and 2C, which are schematic illustrations of sheets, such as sheets 200 and 250, which may be considered to be variations of sheets 100 and 150, respectively, according to some implementations. Sheets 200 and 250 may be identical to sheets 100 and 150, respectively, except that each of the sheets, sheets 200 and 250, defines a pocket. In some implementations, the pocket may be defined between a fabric layer and a bonding layer. For example, pocket 220 may be disposed within sandwich 102. As shown in Figure 2A, pocket 220 may be closed by a bond between fabric layer 112 and bonding layer 114, which may surround the pocket. Figure 2B illustrates sheet 250 having five layers (e.g., pocket 220 may be disposed within sandwich 104), such that the pocket may be closed by a bond between fabric layer 112 and one of bonding layers 114, such as second bonding layer 114b, which may surround the pocket.

[0296] In some implementations, the sheet may define an opening to the pocket, e.g., at least one edge of the pocket is open. FIG. 2C illustrates such an arrangement, in which a sheet 250′ (which may be considered a variation of sheet 250) has a pocket 222 disposed within the sandwich 104 such that the fabric layer 112 is not bonded from the second bonding layer 114b at the opening 223. The opening 223 may be disposed at an edge of the sheet 250′, e.g., to allow for the insertion of one or more other components into the sheet. For example, in some implementations, a frame may be introduced into the pocket 222 through the opening 223, which may increase the structural properties of the sheet. Similarly, one or more other components (such as a frame) may be included within the pocket 220, e.g., by forming the sheet to include a frame, as described in more detail below.

[0297] It should be noted that although the embodiment described with reference to Figures 2B and 2C refers to a pocket being disposed between the fabric layer 112 and the second bonding layer 114b, the scope of the present disclosure includes alternatively or additionally defining a pocket between the fabric layer and the first bonding layer 114a.

[0298] Reference is now made to FIG. 3, which is a schematic diagram of lamination device 20, according to some implementations. The lamination device comprises two plates, e.g., a first plate 310 and a second plate 320, configured to be pressed together, such as by applying pressure and / or heat to a sandwich (e.g., sandwiches 102 and / or 104) secured between the two plates, to form a sheet, e.g., sheet 200 and / or sheet 250. At least one of the two plates of lamination device 20 may define a recess, such as recess 312, in the contact surface of the plate. The recess located in one of the plates may enable a pocket to be formed in sheet 200 and / or sheet 250.

[0299] As discussed above, the sheets may be formed by compressing and / or heating the sandwiched layers, which may cause the layers to bond together. Pockets may be formed by reducing (e.g., removing) this heating and / or compression in a discrete area that will become the area of ​​the pocket. For example, heat and / or compression may be applied to the sandwich around the area of ​​the pocket, but not to the actual area of ​​the pocket. Having a recess in one of the plates allows other areas of the sheet (e.g., the majority of the sheet) to be compressed and / or heated while not applying compression and / or heat to the area designated for the pocket. Thus, in the area of ​​the designated pocket, the layers do not bond, and thus a pocket is created in that area.

[0300] The recesses 312 may be positioned and / or shaped according to the shape and / or location requirements of the pockets 220 and / or 222. For example, in the illustrated embodiment, the recesses 312 are located in an area (e.g., a central area) of the plate 310, which may correspond to a desired location of a pocket in the central area of ​​the sheet in some implementations. Similarly, the shape of the recesses 312 is trapezoidal, resulting in a trapezoidal shaped pocket accordingly. If a different shape of pocket is desired, the recesses 312 may be shaped accordingly. Furthermore, when forming a pocket at an edge of a sheet such that the pocket can have an opening, e.g., opening 223, the recesses 312 may be moved from the center of the plate to the edge of the plate (or the sheet may be positioned differently between plates).

[0301] Alternatively or additionally, the formation of the pocket may be facilitated by the absence of a bonding layer between the textile layer and the cover layer. In some implementations, the bonding layer may be pre-cut / pre-formed to define holes (which may be surrounded by the remainder of the bonding layer and / or located at the edge of the bonding layer). When the sandwich is formed, at the holes, the bonding layer is not present between the textile layer and the cover layer. Thus, when heat and / or pressure are applied to form the sheet, the textile layer may not be bonded to the cover layer at the holes in the bonding layer.

[0302] In some implementations, the frame may be introduced into the pocket. For example, for implementations where the pocket has an opening at an edge of the sheet, such as opening 223, the frame may be introduced into the pocket through the opening, after which the sheet (and pocket) may be formed. In some implementations, the pocket may then be sealed, for example, by again applying heat and / or pressure and / or by other means such as stitching to secure the frame therein.

[0303] In some implementations where a frame is disposed within a sheet, the frame may be positioned between two layers of the sandwich that will become the sheet prior to pressing and / or heating to form the sheet (e.g., as shown below with respect to FIGS. 4C-4E). Thus, a pocket may be formed with at least a portion of the frame already disposed in the area where the pocket is to be formed. For example, in implementations where a recess in at least one of the plates of the lamination device 20 defines a recess therein, the recess may be positioned on the frame to form a pocket in the frame. In some implementations, a portion of the frame extends beyond the boundaries of the pocket.

[0304] Reference is now made to the diagrams of FIGS. 4A-4K, which are schematic illustrations of sheets 100, 150, 200, 250, 300, and 350 or variations thereof fixedly attached to a frame according to some implementations. In some implementations, the system, device, implant, etc. may comprise a frame, e.g., frame 410, such that the sheet may be fixedly attached to the frame in a manner that covers at least a portion of the frame. In some implementations, attaching the frame to the sheet may enhance the structural properties and / or durability of the device, which may enable the frame to better function as an implant, e.g., a prosthetic valve, a stent, and / or similar to a leaflet augmentation patch and / or as a wing as disclosed in one or more of the following references, which are: · International Patent Application PCT / IB2021 / 060436 by Tennenbaum et al., filed November 11, 2021, published as WO2022 / 101817; International Patent Application PCT / US2021 / 039587, filed June 29, 2021, by Chau et al., published as WO2022 / 006087; ·International Patent Application PCT / US2022 / 052834 by Chau et al., filed December 14, 2022, each of which is incorporated by reference in its entirety herein.

[0305] In some implementations, a device including a cardiovascular implant can be formed by fastening and attaching the sheet to the frame. The implant can be used as a prosthetic valve, a stent, a wing and / or a leaflet augmentation patch. For example, the implant can be used in a valve of a subject's heart, the valve having an annulus, a first leaflet and a second leaflet opposite the first leaflet, and the heart having a chamber upstream of the valve. The implant can include, among other components, a frame and a sheet. The sheet can include at least a fabric layer fastened to at least a portion of the frame, a cover layer including a polymer configured to inhibit tissue growth thereon, and a bonding layer sandwiched between the fabric layer and the cover layer and bonding the fabric layer to the cover layer.

[0306] FIG. 4A illustrates, in accordance with some implementations, an implant 400 including a sheet 100 fixedly attached to a frame 410. As described above with reference to FIGS. 1A and 1B, the first surface 101a of the sheet may inhibit tissue growth thereon and may be placed adjacent to a tissue surface of interest. Thus, the first surface 101a may form at least a portion of the first (e.g., contact) surface 400a of the implant 400. Respectively, for the implant 400, the frame 410 may be disposed adjacent (e.g., against) the textile layer 112, e.g., at the second surface of the sheet, and may form at least a portion of the second (e.g., opposing) surface 400b of the implant 400, e.g., such that the frame is absent from the contact surface 400a of the implant. In some implementations, the sheet 100 is fixedly attached to the frame 410 by sewing and / or gluing the sheet 100 to the frame 410, thereby forming the implant 400, as shown, for example, in Figures 5A and 5B below with respect to implant 500.

[0307] It should be noted that frame 410 is intended to be generic, representing, for example, the frame of any implant, mutatis mutandis. For example, frame 410 may represent a frame used in implant 500 and / or implant 600 described herein and / or a frame used in an implant described in one or more of the references incorporated herein by reference.

[0308] In some implementations, hiding the frame between one or more sheets and / or layers thereof may advantageously prevent the frame from encountering the surroundings of the implant, such as tissue, and may help protect the frame and / or inhibit tissue growth thereon as well as protect the tissue from damage. However, in some implementations, it may also be advantageous to avoid exposing the fabric layer of the sheet, for example, to avoid any tissue growth on the implant. Thus, in some implementations, an additional cover layer may be included that may define a second side of the implant to inhibit tissue growth on both sides of the implant. FIGS. 4B, 4D, 4E, 4I, 4J, and 4K show schematic examples of such inclusions according to some implementations. In some implementations, an additional sheet 100 may be included to cover the second side 410b of the frame, with a cover layer 116 of the additional sheet defining the second side of the implant.

[0309] 4B shows a schematic of an implant 402 comprising two sheets 100, e.g., a first sheet 100a and a second sheet 100b. The sheets 100a and 100b may be considered as variations of the sheet 100, which are identical to the sheet 100, except where noted and connected to each other, according to some implementations. Each of the sheets 100 may be independently formed, e.g., by heating and / or compressing each of the sandwiches 102a and 102b, and each of the sheets may be independently fixedly attached to the frame 410, e.g., by sewing and / or gluing. For example, each of the sheets 100 may be fixedly attached to different sides of the frame 410, such that both sides of the frame 410 may be covered by a fabric layer. Alternatively or additionally, two sheets may be fixedly attached to one another, for example, the first textile layer 112 may be attached to the second textile layer 112, for example by being sewn and / or glued to one another, and / or to the frame 410, such that covering layers may define both sides of the implant, for example, the first covering layer 116 may define the first side 402a and the second covering layer 116 may define the second side 402b. Alternatively or additionally, a single sheet 100 may be folded over an edge of the frame 410 to cover both sides of the frame in a similar manner, mutatis mutandis.

[0310] The implant 402 may be formed by fixedly attaching the sheets 100a and 100b positioned therebetween to one another and / or to a frame 410. For example, the first sheet 100a (including the first textile layer 112, the first bonding layer 114, and the first cover layer 116) may be fixedly attached to the frame 410, e.g., by being sewn and / or glued, such that the first cover layer 116 may define a first surface 402a and the first textile layer 112 may be adjacent a first side 410a of the frame. The second sheet 100b (including the second textile layer 112, the second bonding layer 114, and the second cover layer 116) may be fixedly attached to the frame 410, e.g., by being sewn or glued, such that the second cover layer 116 may define a first surface 402a and the second textile layer 112 is adjacent to the second side 410b of the frame, thereby covering both sides of the frame 410. In some implementations, the first textile layer of the first sheet 100a may also be fixedly attached to the second textile layer of the second sheet 100b, e.g., by being sewn and / or glued, which may increase the bond between the two sheets and the overall physical characteristics of the implant 402. The combination of two sheets, each fixedly attached to the frame 410, such that the two cover layers define both surfaces of the implant, e.g., the first surface 402 and the second surface 402b, may inhibit tissue growth on the surfaces of the implant 402.

[0311] In some implementations, an additional bonding layer may be added, for example adjacent to the frame, such that the implant 402 may be formed by heating and / or compressing the additional bonding layer between the sandwiches 102a and 102b.

[0312] FIG. 4C illustrates a schematic of an implant 404 including a sheet 100′ fixedly attached to a frame 410 according to some implementations. The sheet 100′ can be considered a variation of the sheet 100, e.g., identical to the sheet 100, except that the sheet 100′ is formed from the sandwich 102′ (e.g., by heating and / or compressing the sandwich 102′) rather than from the sandwich 102. The sandwich 102′ can be considered a variation of the sandwich 102, in which the sandwich 102′ includes a frame 410 in which the sandwich 102′ is sandwiched between other layers of the sandwich. For example, the other layers of the sheet (e.g., layers common to both the sheet 100 and the sheet 100′) can be fixedly attached to the frame by the frame being sandwiched between the fabric layer 112 and the bonding layer 114. Similar to the implant 400 detailed herein above with respect to FIG. 4A, the first surface 404a of the implant 404 can be defined by a cover layer 116 that inhibits tissue growth thereon. A second side 404b of the implant 404 opposite the first side 404a may be defined by the textile layer 112 and thus may allow tissue growth thereon. In some implementations, the first side 404a may be positioned adjacent to a tissue surface of interest.

[0313] In some implementations, the thickness of the frame 410 between the fabric layer and the bonding layer can be between 20 and 500 microns.

[0314] In some implementations, the implant 404 may include a pocket (e.g., as described in more detail above with respect to FIGS. 2A-C). For example, such a pocket may allow the cord to move (e.g., slide) within the pocket relative to the frame 410. An example of such an application is described below with reference to FIG. 6A.

[0315] 4D is a schematic illustration of an implant 406 including a sheet 150' fixedly attached to a frame 410 according to some implementations. The sheet 150' can be considered a variation of the sheet 150, e.g., identical to the sheet 150, except that the sheet 150' is formed from the sandwich 104' (e.g., by heating and / or compressing the sandwich 104') rather than from the sandwich 104. The sandwich 104' can be considered a variation of the sandwich 104 in which the sandwich 104' includes a frame 410 sandwiched between other layers of the sandwich. For example, the other layers of the sheet (e.g., layers common to both the sheet 150 and the sheet 150') can be fixedly attached to the frame by the frame being sandwiched between a bonding layer (e.g., the first bonding layer 114a as shown) and the textile layer 112. Thus, the implant 406 may have a first side 406a and a second side 406b, both of which may be defined by respective cover layers, for example, first cover layer 116a and second cover layer 116b. The cover layers may be bonded to the fabric layer 112 by first bond layer 114a and second bond layer 114b sandwiched therebetween. Thus, the implant 406 may have two sides that inhibit tissue growth thereon.

[0316] FIG. 4E illustrates a schematic of an implant 408 including a sheet 150″ fixedly attached to a frame 410 according to some implementations. The sheet 150″ can be considered to be a variation of the sheet 150′, e.g., identical to the sheet 150′, except that the sheet 150″ is formed from the sandwich 104″, rather than from the sandwich 104′. In the sandwich 104″, and thus in the sheet 150″, the textile layer 112′ is wrapped around the frame 410 from a first side to a second side of the frame, such that at least a portion of the frame is sandwiched between the components of the textile layer. For example, a first portion 111a of the textile layer can be positioned against a second side 410b of the frame, and at each location where the textile layer is wrapped around the frame, a second portion 111b can be positioned against the first side 410a of the frame. In the illustrated embodiment, there are two such locations. That is, in the embodiment shown, the fabric layer covers the second face 410b of the frame 410, and the two parts 111b of the fabric layer are folded over the edge of the first side 410a of the frame. In some implementations, this wrapping can contribute to securing the frame to the fabric layer.

[0317] In some implementations, as shown, region 409 of first side 410a may not be sandwiched between portions of a textile layer, and instead may be sandwiched between a textile layer and a bonding layer (e.g., bonding layer 114a).

[0318] In some implementations, the overall thickness of an implant described herein above, including the frame, such as implants 400, 402, 404, 406 and / or 408, can be between 50 and 1000 microns, such as between 200 and 500 microns.

[0319] In some implementations, the edges of the implant may be soft and / or have an obtuse and / or rounded shape, e.g., to reduce the likelihood that the edges of the implant will damage and / or injure the subject tissue, e.g., during intentional or unintentional movement of the implant along and / or relative to the tissue.

[0320] 4F, 4G, 4H, 4I, 4J, and 4K show schematic implants that may be considered some variations of the implants detailed above. In some implementations, these implants may have rounded and / or soft edges. In some implementations, to provide rounded edges, the implants may be arranged to have a cover that may be disposed over / around the edge (e.g., a smooth continuous cover). In some implementations, to provide soft edges, the implants may be arranged to have no fabric at the edge and / or to have no frame, e.g., at least a portion of the implant's periphery may be free of the fabric layer and / or any frame. For example, the implants may have a lip that extends beyond the edge of the fabric layer. In some implementations, the lip is folded over to provide the rounded edge. In some implementations, the lip is more flexible and / or softer than the area of ​​the implant where the fabric is disposed, and in some implementations, the lip is not folded over.

[0321] In some implementations, the cover layer and the tie layer may extend together beyond the edge of the fabric layer to define a lip in which the lip portion of the cover layer and the lip portion of the tie layer are disposed. For example, in implementations in which the cover layer defines a first side of the sheet (such as first side 101a and first side 151a of sheets 100 and 150, respectively), and the sheet has a second side opposite the first side, the lip may be folded, for example, onto the second side such that the lip portion of the tie layer is sandwiched between the lip portion of the cover layer and the second side.

[0322] In some implementations, the lip can be folded to define a hem of the sheet. In some implementations, the hem can be formed by folding the lip around an edge of the textile layer such that within the hem, the textile layer is disposed between the lip portion of the bonding layer and another portion of the bonding layer (optionally with a portion of the frame also disposed between the lip portion of the bonding layer and the other portion of the bonding layer).

[0323] 4F diagrammatically illustrates an implant 420 comprising a sheet 300 fixedly attached to a frame 410 such that the implant has two rounded edges, according to some implementations. The sheet 300 may be considered a variation of the sheet 100', e.g., identical to the sheet 100', except that in the sheet 300, the cover layer 116 and the tie layer 114 extend together beyond the edge 113 of the textile layer 112, thereby defining a lip 106 on which the cover layer lip portion 116' and the tie layer lip portion 114' are disposed. In some implementations, the lip 106 may extend beyond the edge 411 of the frame 410, as shown.

[0324] The top image in FIG. 4F shows sheet 300 prior to the formation of the rounded edge, the middle image shows lip 106 folded over to form hem 107f which provides the rounded edge, and the bottom image shows the sheet fixed in this configuration by heat and / or pressure treatments as described herein above, mutatis mutandis.

[0325] The cover layer 116 may define a first side 301a of the sheet, with the sheet having a second side 301b opposite the first side (top image). As shown, the lip 106 may be folded over the second side 301b such that the lip portion 114' of the bonding layer 114 is disposed between (i) the lip portion 116' of the cover layer and (ii) the second side 301b of the sheet (middle image). For example, as shown, the lip portion 114' of the bonding layer may be sandwiched between (i) the lip portion 116' of the cover layer and (ii) the frame 410. Additionally or alternatively, at least a portion 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 such that each of the lips 106 can be folded around a corresponding edge 411 of the frame, thereby defining a corresponding hem 107f. In some implementations, 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 implementations, at least a portion of the fabric layer can further be disposed within the hem.

[0326] In some implementations, the frame may be attached to the second side of the sheet, for example, by a lip. For example, the lip may be folded over an edge of the frame, as described above, mutatis mutandis, and secured to the frame and / or the second side of the sheet, for example, at the hem 107f, for example, by heating and / or pressing the lip against the frame. In some implementations, at least a portion of the frame may be fixedly attached to the sheet by adhesive and / or stitching. Additionally or alternatively, stitching may pass 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.

[0327] In some implementations, the cover layer 116 may define the first side 420a of the implant, thereby inhibiting tissue growth thereon. Furthermore, by folding the lip 106 over the edges of the frame and fabric layer, the implant may be molded to have smooth edges. Moreover, by folding in this manner over the second side 310b of the sheet, the lip portion of the cover layer may provide tissue growth inhibition to a portion (or even all) of the second side 420b of the implant.

[0328] In some implementations, although not shown, the implant may be provided with a rounded edge by also folding the textile layer 112 (e.g., wrapping the textile layer around the frame) to form a hem. Such an implant may, for example, be similar to implant 400 (FIG. 4A), but with a portion of the sheet (e.g., textile layer 112, bonding layer 114, and covering layer 116) that extends beyond the frame being wrapped around the edge of the frame. In some implementations, the sheet may be secured by stitching and / or adhesive. In some implementations, the sheet may cover a first side 410a of the frame 410, and a portion of the textile layer may be placed against a second side 410b of the frame, thereby creating a hem. In some implementations, multiple such hems may be formed (e.g., contributing to securing the frame to the sheet), for example, while leaving at least a majority of the second side 410b of the frame exposed.

[0329] 4G illustrates, in accordance with some implementations, an implant 422 comprising a sheet 300' fixedly attached to a frame 410 such that the implant has two rounded edges. The sheet 300' can be considered a variation of the sheet 300, e.g., identical to the sheet 300, except that in the sheet 300', the frame 410 is sandwiched between the textile layer 112 and the bonding layer 114. In the sheet 300', the cover layer 116 and the bonding layer 114 extend together beyond the edge 113 of the textile layer 112, thereby defining the lip 106 within which the lip portion 116' of the cover layer and the lip portion 114' of the bonding layer are disposed. In some implementations, the lip 106 can extend beyond the edge 411 of the frame 410, as shown.

[0330] The cover layer 116 may define a first side 301a' of the sheet, with the sheet having a second side 301b' opposite the first side. As shown, the lip 106 may be folded onto the second side such that the lip portion 114' of the bonding layer 114 may be disposed between (i) the lip portion 116' of the cover layer 116 and (ii) the second side 301b of the sheet. In the embodiment shown, the lip portion 114' of the bonding layer is sandwiched between (i) the lip portion 116' of the cover layer and (ii) the textile layer 112. Additionally or alternatively, at least a portion of the textile layer 112 may be disposed between (i) the lip portion 114' of the bonding layer and (ii) the frame 410, for example, as shown. As shown, the implant 420 includes a first lip and a second lip such that each of the lips 106 can be folded around a corresponding edge 113 of the fabric layer, thereby defining a corresponding hem 107g. In some implementations, an edge of the fabric layer can be disposed within the hem of the implant, for example, between a lip portion of the bonding layer and another portion of the bonding layer. In some implementations, at least a portion of the fabric layer can be disposed within the hem.

[0331] In some implementations, the folded lip may be attached to the fabric layer 112 at the second side of the sheet. For example, the lip may be folded over an edge of the fabric layer as described above, mutatis mutandis, and secured to the fabric layer (second side of the sheet) and / or to the second side of the sheet, e.g., to the hem 107g, e.g., by heating and / or pressing the lip against the fabric layer. In some implementations, at least a portion of the hem 107g may be fixedly attached to the sheet by adhesive and / or stitching. Additionally or alternatively, stitching may pass from the lip through the fabric layer and / or to the frame, or vice versa, thereby sewing the fabric layer and / or frame to the lip.

[0332] 4H shows a schematic of an implant 424 comprising a sheet 300 fixedly attached to a frame 410 such that the implant has two rounded edges, according to some implementations. The implant 424 may be considered a variation of the implant 420, e.g., identical to the implant 420, except that the implant 424 has a hem 107h formed by having the lip 106 folded over itself (rather than over the edge of the frame and / or fabric layer). For example, in the hem 107h, the lip portion 114' of the tie layer may be sandwiched between the lip portions 116' of the cover layer. The hem 107h may be secured, for example, by heating and / or pressing the hem, as described above, mutatis mutandis.

[0333] In some implementations, a portion of the second surface 424b of the implant 424 can be provided (e.g., defined) by a hem 107h. In some implementations, the hem 107h can be arranged such that the lip portion 116' of the cover layer extends back to the textile layer 112, such that, for example, an edge of each lip portion 116' faces and / or is adjacent to a respective edge 113 of the textile layer.

[0334] 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.

[0335] FIG. 4I illustrates, in accordance with some implementations, an implant 426 comprising a sheet 350 fixedly attached to a frame 410 such that the implant has two rounded edges. The sheet 350 may be considered a variation of the sheet 150', e.g., identical to the sheet 150', except that in the sheet 350, the first cover layer and the first tie layer extend together beyond the edge 113 of the fabric layer, thereby defining a lip 106 on which the lip portion 116a' of the first cover layer and the lip portion 114a' of the first tie layer are disposed. In some implementations, in at least a portion of the sheet, the lip may also extend beyond the edge 411 of the frame, e.g., as shown. The first cover layer 116a may define a first surface 351a of the sheet, and at least a portion of a second surface 351b of the sheet opposite the first surface may be defined by the second cover layer 116b. The lip 106 is folded over the second cover layer 116b such that the lip portion 114a' of the first tie layer is sandwiched between the lip portion 116a' and the second cover layer. The folding of the lip 106 thus defines a skirt 107i of the sheet. Thus, in some implementations, the second surface 426b of the implant may be defined in part by the second cover layer 116b and in part by the lip portion 116a' of the first cover layer. In some implementations, the entire second surface 426b may thus inhibit tissue growth thereon.

[0336] In some implementations, at least a portion of the frame and / or the fabric layer can be disposed within the hem 107i. In some implementations, the second side of the frame can be covered by a second tie layer and a second cover layer.

[0337] It should be noted that folding the lip to create a hem of the implant can provide additional benefits to the implant (besides having rounded edges). For example, the hem provides a continuous surface of the covering layer from the first side of the implant to the second side (e.g., the side where they are folded), thereby hiding the edges of the fabric layer and / or the frame. For example, fully placing the fabric layer and / or the frame in the sheet, along with the edges of the fabric layer and / or the frame, can inhibit tissue growth along the edges of the fabric layer and / or the frame. Hiding the edges of the layers by forming a hem may additionally or alternatively inhibit separation of the layers at their edges (e.g., edges of the sheet), e.g., delamination, scraping, or peeling, which may result from intermittent and / or repeated contact with tissue over time.

[0338] Similar advantageous features (e.g., inhibiting tissue growth by obscuring the edges of the layers comprising the sheet) may also be achieved by having two covering layers and at least one tie layer that extends beyond the edges of the fabric and / or frame, thereby defining a lip of the sheet / implant (e.g., without folding over to form a hem), as described in more detail below with respect to Figures 4J and 4K.

[0339] In some implementations, the lip 106 may not be folded over the second cover layer 116b. For example, the second cover layer 116b may not extend close enough to the edge of the frame 410 and / or the edge of the fabric layer 112 for the lip to reach the second cover layer. Some such arrangements may be similar to implant 420 and / or implant 422, with the addition of a second cover layer and a second tie layer on the second side of the implant, between the lips 106.

[0340] It should be noted that for any one of implants 4F-4I, a sheet may be formed, for example, by heating and / or compressing the associated sandwich before folding the lip onto the second side of the sheet. In some implementations, the lip may first be folded onto the second side of the sandwich before heat and / or compressive pressure is applied, such that when the sandwich, along with the hem, is heated and / or compressed, a sheet having rounded edges may be formed.

[0341] 4J illustrates, in accordance with some implementations, an implant 428 including a sheet 350' fixedly attached to a frame 410 such that the implant has a lip 106'. The sheet 350' may be considered a variation of (e.g., identical to) the sheet 150', except that in the sheet 350', the first cover layer, the second cover layer, and the first tie layer extend together beyond one or more edges of the textile layer and / or the frame, thereby defining a lip 106' on which the lip portion 116a' of the first cover layer, the lip portion 116b' of the second cover layer, and the lip portion 114' of the tie layer are disposed. The lip 106' may be softer and / or more flexible than other portions of the sheet 350', such as the portion on which the textile layer 112 is disposed. It should be noted that in implants 420, 422, and 426, lip 106 is folded over, while lip 106' is not folded over and serves as the lip of the final implant, eg, defining the edge of the implant.

[0342] In some implementations, within the lip 106', a lip portion 116a' of the first cover layer can be bonded to a lip portion 116b' of the second cover layer by a lip portion 114' of the first bonding layer. For example, the lip can be heated and / or compressed, along with the remainder of the sandwiched layers, for example, during formation of the sheet 350' and / or implant 428. The textile layer and / or frame can be fully disposed within the sheet to inhibit tissue growth thereover, for example, even along the edges of the textile layer and / or frame.

[0343] FIG. 4K illustrates a sheet 350″ of an implant 429 according to some implementations. The sheet 350″ may be identical to the sheet 350′, except for the inclusion of the second bonding layer 114b. That is, the sheet 350″ includes a first bonding layer 114a (corresponding to bonding layer 114′ of the sheet 350′) and a second bonding layer 114b. The lip portion 114b′ of the second bonding layer 114b may extend into the lip beyond the edge of the textile layer 112 and / or the edge of the frame 410, for example, along with the lip portion 116b′ of the second cover layer. For example, within each lip 106″, the lip portion 116a′ of the first cover layer may be bonded to the lip portion 116b′ of the second cover layer by both the lip portions 114a′ and 114b′ (of the first and second bonding layers). Bonding of the lip portion of the first coating layer to the lip portion of the second coating layer by the lip portions of the first and second bonding layers can occur as part of the overall formation of sheet 350'', for example, by heating and / or compressing lip 106'' along with the remainder of the sandwiched layers.

[0344] In some implementations, for any of the implants described above as including a frame, the frame may extend / protrude beyond an edge of the sheet. For example, the edge of the sheet beyond which the frame may protrude may be defined by any one of the layers, e.g., the first and / or second cover layers, the first and / or second tie layers, and / or the fabric layer. One example of this is shown in FIG. 6D.

[0345] In some implementations, the shape of the frame supporting and / or attached to the seat may determine the shape of the implant.

[0346] In some implementations, although not illustrated, any one of the implants described above may be formed and / or function without a frame. By way of example only, an implant that includes a sheet but does not include a frame may nevertheless include one or more folded lips (e.g., as described with reference to FIGS. 4F-I) and / or one or more non-folded lips (e.g., as described with reference to FIGS. 4J-K), mutatis mutandis. In some implementations, the shape of the implant may be determined by the shape into which the sheet is formed, cut, and / or folded.

[0347] Reference is now made to Figures 5A and 5B, which are schematic illustrations of an implant 500 for use in a subject's heart valve, according to some implementations. Figure 5A shows an exploded view of the implant 500, according to some implementations, and Figure 5B shows the entire implant. The implant 500 can be anchored to the tissue of the heart to restore the function of the native leaflets. The implant 500 can be considered a variation of and / or can be similar, at least in its general purpose, to the implants disclosed in International Patent Application No. PCT / US2021 / 039587, filed June 29, 2021, published as International Publication No. WO 2022 / 006087, and / or International Patent Application No. PCT / US2022 / 052834, filed December 14, 2022, by Chau et al., each of which is incorporated herein by reference, mutatis mutandis. Similarly, the techniques described herein can be used, mutatis mutandis, to form any of the implants described in these references.

[0348] In some implementations, the implant may be shaped as a wing defining a contact surface 521 and an opposing surface 522 opposite the contact surface. The wing may be configured to be anchored to tissue of a subject's heart having a first leaflet and a second opposing leaflet, such that the wing may extend over the first leaflet toward the second leaflet, with the contact surface facing the first leaflet.

[0349] In some implementations, implant 500 may comprise, among other components, a frame 510 and a sheet 550. Sheet 550 may be or 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 cover layer, and at least one tie layer). Frame 510 may be considered a variation of frame 410, mutatis mutandis.

[0350] The sheet 550 may be fixedly attached to the frame, thereby defining wings 555. In the embodiment shown, the sheet 550 is sewn to the frame 510 by stitches 551, e.g., sewn to the frame after the sheet is formed. The edges of the sheet 550 may be folded over the edges of the frame to facilitate this sewing. However, it should be noted that the sheet 550 may alternatively or additionally be attached to the frame 510 by other means described herein, including the use of adhesive and / or the use of a hem such as those described elsewhere herein.

[0351] The wings of implant 500 may be attached to anchor anchor receiver 560 configured to receive an anchor used to anchor the implant to tissue, such as the annulus of a valve of a subject's heart. The wings may define a contact surface, which may be defined by a cover layer, e.g., contact layer 116 / 116a or contact layer 116b, and an opposing surface opposing the contact surface.

[0352] The frame 510 may be flexible such that the wings may have elastic and / or shape memory properties (e.g., the frame may be formed from and / or include nitinol, cobalt chrome, stainless steel, and / or polymers) such that the wings may be folded or rolled to pass through the catheter and delivered to the heart chamber within the shaft where they may automatically expand to their resting position, i.e., their original shape, once deployed within the heart chamber.

[0353] The wing 555 (e.g., its sheet 550) may have a number of holes 570 therethrough, for example, to facilitate blood flow through the wing. For example, after the wing is formed from the sheet and frame, the holes 570 may be formed, for example, manually, mechanically, or with a laser, for example, through the implant and / or the wing, as disclosed below with respect to FIGS. 8A-8C. In some implementations, the holes 570 may be cut out prior to attaching the sheet 550 to the frame 510.

[0354] In some implementations, the implant may be shaped to define a leaflet augmentation patch configured to be attached to the leaflets of a valve of a subject's heart. For example, after forming the sheet 100 and / or sheet 150, the implant and / or wings may be cut out, for example, manually, mechanically, or by laser, to be shaped similarly to the leaflet augmentation patch, for example, as disclosed in International Patent Application PCT / IB2021 / 060436, filed November 11, 2021, to Tennenbaum et al., which was published as WO2022 / 101817 and is incorporated herein by reference. In some implementations, the shape of the frame supporting and / or attached to the sheet may determine the shape of the implant.

[0355] Reference is now made to FIGS. 6A-6D, which are schematic illustrations of an implant 600 and variations thereof, according to some implementations. The implant 600 comprises a leaflet augmentation patch 610 and may further comprise one or more patch anchors 640 configured to anchor the patch to the leaflets of a valve of a subject's heart. The patch 610 may include a flexible sheet 620 fixedly attached to a frame 630. The sheet 620 may be or 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 cover layer, and at least one tie layer). The frame 630 may be considered a variation of the frame 410, mutatis mutandis.

[0356] In some implementations, the implant 600 and / or variations thereof described herein may correspond to and / or be a variation of one or more of the upstream / downstream assemblies described in International Patent Application (PCT) Publication No. WO2022 / 101817 to Tennenbaum et al., such as "upstream assembly 600," "downstream assembly 700," and / or variations thereof. For example, the implant 600 may be used in place of the "upstream assembly 600" of the Tennenbaum et al. invention (and / or variations described in Tennenbaum et al.), and / or the patch 610 may be used in place of the "patch 610" of the Tennenbaum et al. invention (and / or variations described in Tennenbaum et al.). Similarly, the techniques described herein may be used, mutatis mutandis, to form any of the upstream assemblies and / or patches described in the Tennenbaum et al. invention.

[0357] In the example shown, sheet 620 is fixedly attached to frame 630 by sandwiching the frame between (other) layers of the sheet, e.g., between a fabric layer 652 of the sheet and a bonding layer of the sheet (e.g., second bonding layer 654b of the sheet), as described in more detail below. Thus, in some implementations, frame 630 can be considered to be a component of sheet 620.

[0358] The frame 630 may be flexible depending on the conditions within the heart of the patch 610, e.g., the shape of one or both leaflets, to facilitate optimal coaptation. In some implementations, the frame 630 (and thus the patch 610) may be configured to be more flexible on one axis than on another axis. For example, the frame 630 may provide greater flexibility along a root-to-tip axis ax3 of the patch 610 (e.g., with the tip 611 of the patch moving relative to the root 612 of the patch) than along a medial-lateral axis ax4 of the patch that crosses the root-to-tip axis (e.g., with one lateral edge 613 moving relative to the other lateral edge 615). The frame 630 may include a root brace 632 having a first root portion 632a and a second root portion 632b, which may extend at the root 612, e.g., the first root portion 632a of the lateral edge 613 and the second root portion of the other lateral edge 615. The frame 630 may also define a tip brace 631, which may comprise, for example, a beam that extends substantially along the tip 611 from one lateral edge 613 to the other lateral edge 615. The tip brace 631 and root brace 632 may provide the patch 610 with a degree of mediolateral stiffness.

[0359] The frame 630 may include a spring 634 that may extend between a tip brace 631 and a root brace 632 that includes a lateral protrusion 635. In the embodiment shown, the spring 634 extends substantially along the root-to-tip midline of the patch 610 (e.g., along axis ax3, where axis ax3 is the median root-to-tip axis). However, other locations and shapes are possible.

[0360] The implant 600 may include one or more patch anchors 640 configured to anchor the patch 610 (and thereby the implant 600) to a subject's cardiac tissue, such as the leaflets of a cardiac valve. In some implementations, one or more cords 642 couple the patch anchors 640 to the patch 610. For example, as shown, each patch anchor may be coupled to the patch by a respective cord. Rather than each cord 642 being anchored to the patch 610 (e.g., its frame 630) near the point 614 where the cord reaches the patch, the cord passes through the patch at point 614 and extends along the patch to a site where the cord is anchored (e.g., a site on the frame 630). In the example shown, each cord 642 extends (e.g., in a root-to-tip direction, such as substantially parallel to axis ax3) to the tip brace 631 to which it is anchored.

[0361] In some implementations, each cord 642 extends along a patch within sheet 620 (e.g., between layers of the sheet), for example, as shown. Having cords 642 extend within sheet 620 (e.g., rather than along the exterior of the sheet) advantageously provides the sheet, and thereby patches 610, with a smooth surface for optimal contact with tissue.

[0362] In the illustrated embodiment, the sheet 620 comprises (i) a first cover layer 656a bonded to the textile layer 652 by a first tie layer 654a sandwiched between the first cover layer and the textile layer, and (ii) a second cover layer 656b on the opposing side of the textile layer 652 (and frame 630) from the cover layer 656a bonded to the textile layer by a second tie layer 654b sandwiched between the second cover layer and the textile layer. The second cover layer 656b defines the second surface of the sheet 620 and thus the contact surface 621 of the implant 600 (e.g., the surface that is placed in chronic contact with tissue). The first cover layer 656a defines the first surface of the sheet and thus the opposing surface 622 of the implant 600 (e.g., the surface that may be placed in intermittent and / or repeated contact with tissue). In the portion of the patch 610' where the frame 630 is disposed, the frame may be sandwiched between the second bonding layer 654b and the fabric layer 652, for example, as shown.

[0363] The spring 634 provides a patch anchor fastening function to the implant 600 and its variations. The implant 600 is anchored to tissue by driving the patch anchor 640 into (and typically through) the tissue. For example, the implant 600 can be anchored to a leaflet of a heart valve augmented by the patch 610 by driving the patch anchor 640 through the leaflet to a second side of the leaflet while the patch remains on a first side of the leaflet. Thus, when the patch anchor 640 is driven (e.g., by a driver of a delivery tool for the implant 600) to the second side of the leaflet, the patch anchor is pushed away from the patch 610, which remains on the first side of the leaflet. This applies tension to the cord 642, which causes the spring 634 to enter a stressed state (by pulling the tip brace 631 towards the root brace 632). The resulting tension (e.g., compression) of spring 634 may pull cord 642 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 implementations, as shown, this may be accomplished by a temporary shortening of the root-to-tip length of the patch, i.e., linearly contracting the patch.

[0364] When the patch anchor 640 on the second side of the leaflet is released (e.g., from a driver), the spring 634 returns to its original (e.g., resting) state, pulling the patch anchor back towards the patch 610, thereby securing the patch to the leaflet by sandwiching the leaflet between the patch anchor and the patch. It is believed that providing these self-fastening patch anchors in the upstream assembly (e.g., by including a patch with a spring biased to pull the patch anchor tight) may advantageously obviate the need to perform a separate fastening or locking step and / or include a separate locking component.

[0365] Because the cord 642 is disposed between layers of the sheet 620, this self-fastening function may require the cord to be slidable between those layers, e.g., sliding in one direction by actuation of the anchor and sliding in the opposite direction by a spring returning toward its original (e.g., resting) state.

[0366] In some implementations, as shown, spring 634 is coupled to root brace 632 via patch anchor support 636 defined by frame 630 and may be positioned and shaped to partially or completely surround point 614. Patch anchor support 636 may advantageously provide one or more of the following benefits: (1) function to stiffen the patch at point 614, e.g., to protect cord 642 from passing through sheet 620; (2) function as a bearing surface over which cord 642 slides as it passes point 614; and / or (3) provide a counterforce (e.g., opposing force) against which patch anchor 640 can press the leaflets, thereby providing improved clamping of the leaflets between patch anchor 640 and patch 610, as compared to a similar patch in which sheet 620 presses the leaflets against a portion of the patch not supported by frame 630.

[0367] In some implementations, the tether 670 that anchors the upstream assembly to the downstream assembly may be attached to a tip region of the patch. For implementations in which the patch includes a frame that defines a tip brace, the tether may be attached to the tip brace. For example, for patch 610, the tether 670 may be attached to tip brace 631 (e.g., to an eyelet defined by the tip brace) at the center of tip 611. Note that while tether 670 and cord 642 are both attached to tip brace 631, they act at least partially independently, e.g., spring 634 applies tension to cord 642 regardless of the tension on the tip brace. Additionally, tip brace 631 may be configured to distribute at least a portion of the force exerted by tether 670 (e.g., during ventricular systole) on patch 610 across the width of the patch. Nonetheless, the finite length of the cord 642 may limit the extent to which such forces are experienced by the patch 610 itself (e.g., by the sheet 620), e.g., to prevent the patch from being detrimentally stretched. That is, once the cord 642 has pulled its patch anchor tight against the leaflet, pinching the leaflet firmly against the contact surface 621 of the patch 610, the cord restrains the tip brace 631 from moving further away from the root brace 632.

[0368] As mentioned above, the self-fastening functionality of patch 600 may require that cord 634 be slidable between layers of sheet 620. Thus, patch 600 may be provided with features and / or manufactured using techniques that facilitate the smooth sliding of the cord between layers of sheeting.

[0369] In some implementations, such smooth sliding is facilitated by the frame 630 being shaped, sized, and / or positioned to separate (e.g., limit or prevent contact between) the cord 642 and one or both bonding layers 654, which may be adhesive in nature and may otherwise grip the cord. For example, the frame 630 may define a lateral protrusion 635, which may extend laterally from the spring 634 and protrude between the cord 642 and the bonding layer. In the embodiment shown, the protrusion 635 extends between and separates the cord 642 and the second bonding layer 654b. In the embodiment 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 textile layer 652.

[0370] Alternatively, or additionally, such smooth sliding is facilitated by providing a friction reducing region, for example, in the form of a pocket 650 within which the spring 634 and / or the cord 642 are disposed. Because the pocket 650 is formed by not bonding the layers of the sheet by application of heat and / or pressure, the pocket may reduce friction between the textile layer 652 and the cord, for example, by avoiding bonding of the bonding layer 654 (e.g., the second bonding layer 654b) to the cord and / or by avoiding compression of the textile layer against the cord, frame, and / or second bonding layer. The pocket 650 may be as described with reference to and / or formed using techniques described with reference to Figures 2A-3 and 7A-B.

[0371] FIG. 6C illustrates, in schematic form, an implant 600′ that may be considered a variation of the implant 600, except that according to some implementations, the implant 600′ comprises a patch 610′ including a sheet 620′ formed with at least one lip 606 folded over to define a hem 607. The sheet 620′ includes, among other components, a frame 630 similar (e.g., identical) to the frame used in the implant 600, mutatis mutandis. The implant 600′ has three lips 606, e.g., two lateral lips and one root lip, folded over a second surface (e.g., contact surface 621 of the implant) of the sheet 620′, thereby defining three respective hems 607 of the implant. Similar to what was disclosed above with reference to FIGS. 4A-4K, a frame may be placed within the sheet such that a layer of the sheet can cover the frame from both sides. For example, the first covering layer 656a and the first bonding layer 654a extend together beyond the edge of the fabric layer 652, thereby defining the lip 606. In the present application, in at least some portions of the patch 610', the three layers of the sheet (e.g., the first covering layer 656a, the first bonding layer 654a, and the fabric layer 652) similarly extend beyond the lateral edges of the frame, as detailed above with respect to FIG. 4I, mutatis mutandis. As shown, the lip portions of the first covering layer 656a and the first bonding layer 654a are folded over the edges of the fabric layer 652 (and typically the frame) on the second side of the sheet 620', thereby forming the hem 607. In the embodiment shown, the three lips 606 are folded over the second side of the sheet such that the implant has three rounded edges.

[0372] In the embodiment shown, the sheet 620' has a second covering layer 656b on the opposite side of the textile layer 652 (and frame 630) from the covering layer 656a, which is bonded to the textile layer by a second bonding layer 654b sandwiched between the second covering layer and the textile layer. In the portion of the patch 610' where the frame 630 is placed, the frame may be sandwiched between the second bonding layer 654b and the textile layer 652, for example, as shown. Thus, folding the lip 606 onto the second side of the sheet 620' places the lip on the second covering layer 656b and the first bonding layer 654a is sandwiched between the first covering layer 656a and the second covering layer, bonding the first and second covering layers together, thereby securing the hem 607.

[0373] For implant 600', the surface of patch 610' over which lip 606 folds may function as a contact surface 621 of the implant, eg, the surface that is placed in chronic contact with tissue.

[0374] 6D illustrates generally an implant 600'' that may be considered a variation or variant of implant 600, except that according to some implementations, implant 600'' includes a patch 610'' that includes a sheet 620'' formed with at least one lip 606''. Sheet 620'' includes, among other components, a frame 630 that is similar (e.g., identical) to the frame used in implant 600, mutatis mutandis.

[0375] Similar to what is disclosed above with reference to FIGS. 4B-4D, 4G and 4I-4K, the frame 630 may be disposed within the sheet 620″ such that the layers of the sheet may cover at least a majority of the frame from both sides. At least a majority of the frame may be covered such that at least the first covering layer 656a, the second covering layer 656b, and the first bonding layer 654a of the sheet extend together beyond the edge of the textile layer 652, thereby defining the lip 606″. In some implementations, as shown, the sheet 620″ may include a second bonding layer 654b, which may also extend beyond the edge of the textile layer 652 to the lip 606″. In some implementations (such as those shown), the lips 606″ and their formation may thus be similar, mutatis mutandis, to the lip 106″ detailed above with respect to FIG. 4K.

[0376] In some implementations, the lip 606'' may be softer and / or more flexible than other portions of the sheet 620'', for example, on which the fabric layer 652 and / or frame 630 are disposed. The lip 606'' may advantageously provide the implant with beneficial features similar to those described above, such as a soft edge to prevent tissue damage.

[0377] In some implementations, as shown, one or more portions of frame 630 extend beyond the edge of fabric layer 652, thereby extending to lip 606''. In some implementations, as shown, one or more portions of frame 630 also protrude beyond lip 606'', e.g., beyond edge 601'' defined by other layers of the sheet, such that they are exposed from other layers of the sheet. In the embodiment shown, portion 632'' of frame 630 extends beyond edge 601''.

[0378] The edges of the sheet through which the frame may protrude may be defined by any combination of layers, e.g., first and / or second cover layers, first and / or second tie layers, and / or fabric layers. In the particular embodiment shown, the frame extends to, through, and beyond the lip 606'' and protrudes from edge 601'' where the cover layers and tie layers are disposed, but not the fabric layers.

[0379] A lip 606'' may define the periphery of the sheet, excluding any portion of the frame that protrudes beyond edge 601''.

[0380] Reference is now made to Figures 7A and 7B, which are schematic diagrams of a lamination device 22, according to some embodiments. The lamination device comprises two plates, e.g., a first plate 710 and a second plate 720, configured to press against each other to apply pressure and / or heat to a sandwich of layers (such as any one of the sandwiches of layers disclosed herein) secured between the two plates to form a sheet, such as any one of the sheets disclosed herein. In the illustrated embodiment, the implant 600a (which may be considered a variant of the implant 600) is formed with a pocket 650. In the present application, both plates of the lamination device 22 may define recesses, such as recesses 712a and 712b, in the contact surfaces of the plates. The recesses allow the pocket 650 to be formed in the sheet (e.g., sheet 620) of the implant.

[0381] As discussed above, the sheets may be formed by compressing and / or heating the sandwiched layers, which may cause the layers to bond together. Pockets may be formed by reducing (e.g., removing) this heating and / or compression in discrete areas that will become the pocket areas. For example, heat and / or compression may be applied to the sandwich around the area of ​​the pocket, but not to the actual area of ​​the pocket. Having recesses 712a and 712b on both plates allows for compression and / or heating in other areas of the sheet (e.g., the majority of the sheet), while not applying compression and / or heat to the area designated for the pocket. Thus, in the area of ​​the designated pocket, the layers do not bond, and thus a pocket is created in that area.

[0382] If the frame is placed within the sheet, the frame may be positioned between two layers of the sandwich that will become the sheet (e.g., as shown) prior to pressing and / or heating to form the sheet. Thus, the pocket may be formed with at least a portion of the frame already positioned in the area where the pocket is to be formed. For example, as shown, for implementations in which the recesses of the plates of the lamination device 22 define a recess therein, the recess may be positioned on the frame to form the pocket in the frame. In some implementations, a portion of the frame extends beyond the boundaries of the pocket.

[0383] The recesses 712a and 712b may be positioned and / or shaped according to the shape and / or location requirements of the pocket 650 and / or its variants. For example, in the illustrated embodiment, the recesses 712a and 712b are located in an area (e.g., a central area) of the plates 710 and 720, which may correspond to the desired location of the pocket in the central area of ​​the sheet in some implementations. Similarly, the shape of the recesses 712a and 712b is trapezoidal (with a rectangular shape at the long base of the trapezoid), resulting in a pocket of a corresponding shape. When positioning the implant between the plates, the recesses 712 may be positioned on and / or along the central area of ​​the frame, for example, along the spring 634 and its lateral projections 635, as shown. For example, the short base of the trapezoid may be at the tip brace 631, while the long base of the trapezoid may terminate at the root brace 632.

[0384] In some implementations, the recess 712 may extend beyond the edge of the sheet 620. For example, as shown, the rectangular portion of the recess 712 may extend from the long base of the trapezoidal portion of the recess to beyond the root 612 of the implant. Because the recess extends beyond the edge of the sheet, this may allow an opening 623 to be created in the edge of the sheet, for example, as described above for opening 223. The opening 623 may allow access to the cord 642, or in some implementations, may allow the cord 642 to be introduced following lamination. In some implementations, the pocket may then be sealed, for example, by again applying heat and / or pressure to the opening, and / or by other means such as suturing, to secure the frame and / or cord therein.

[0385] In some implementations, as shown, the frame is introduced into the sheet prior to bonding of the layers around the pocket, e.g., prior to applying heat and / or pressure to the sheet. Additionally, if a pocket having an opening is formed in an edge of the sheet, the cord may extend out of the pocket (e.g., not out of point 614) through the opening.

[0386] Alternatively or additionally, the formation of the pocket may be facilitated by the absence of a tie layer in the area that is to become the pocket, for example as described above with reference to FIG.

[0387] Reference is now made to Figures 8A-8C, which are schematic illustrations of a technique for forming holes through a sheet of an implant, according to some implementations. In the example shown, the technique is used to form such holes to facilitate blood flow through the wings of the implant. Figures 8A-8C show the sequence of at least some steps in the technique, with each of the figures showing a wing of an implant 500 from a top view (upper frame of the figure) and from a side view (lower frame of the figure). As explained above, the implant 500 includes a wing that includes a sheet 550 fixedly attached to a frame 510.

[0388] In some implementations, as seen in Figures 5 and 8A (lower figure), the wings may be curved, for example so that the contact surface 521 is concave, which may improve the implant's ability to guide and / or support the native leaflets and assist the native leaflets in adopting the proper conformation for coaptation with the opposing leaflets along the contact surface, as detailed, for example, in International Patent Application PCT / US2022 / 052834 to Chau et al., filed December 14, 2022, which is incorporated by reference herein.

[0389] Cutting precise holes in an already curved sheet may be difficult, e.g., more time consuming, more expensive, and / or less accurate, compared to cutting such holes in a flat sheet. However, cutting such holes from a sheet before the sheet is fixedly attached to the frame may also be difficult, e.g., with respect to aligning the sheet to 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 portion of the frame. Furthermore, it may not be possible to impart the curvature to the frame after the sheet is fixed to the frame and the holes are formed, since the shape setting of the frame 510 may require temperatures that the sheet 550 cannot withstand. Thus, the technique described with reference to FIGS. 8A-C advantageously facilitates the formation of holes 570 after the sheet is fixedly attached to the frame 510, even though the frame is at least statically curved.

[0390] 8A shows sheet 550 fixedly attached to frame 510 prior to the formation of holes 570. At this point, implant 500 may be temporarily flattened so that holes 570 may be formed in sheet 550 while the sheet is flat. This flattening of the implant and / or sheet may be facilitated by the stretchability / elasticity of the frame, which may allow such temporary flattening of the implant without the implant losing its curved, resting shape.

[0391] FIG. 8B shows the implant 500 temporarily flattened (when positioned therein) by a cage 800 having rails 810 that restrain the implant (e.g., wings and / or its frame) in a flat configuration therebetween. In some implementations, the cage 800 may include a first set of rails 810a and a second set of rails 810b disposed on opposing sides of the cage 800, such that, for example, when the cage 800 is in its closed configuration, the rails 810 sandwich portions of the implant therebetween (compare, for example, FIGS. 8A and 8B). For example, the rails 810a and 810b may be generally positioned such that, in the cage's closed configuration, each rail faces and / or aligns with a corresponding rail disposed on an opposing side of the cage. In the particular top view of FIGS. 8B-C, only the rails 810a are visible as the rails 810b are obscured by the corresponding rails 810a disposed thereon. In some implementations, as shown, the shape of the flattened wing can be approximately trapezoidal, triangular, or raindrop shaped.

[0392] FIG. 8C shows the formation of holes 570 in the sheet 550 while the sheet is held in a flat configuration by rails 810 of the cage 800. In some implementations, the cage 800 (e.g., its rails 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 holes. The exposed portion of the wing can have holes formed therethrough, for example, by an automated device or using a manual tool. Once the wing is flattened, while being held flat, holes can be formed (e.g., cutting 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 can be particularly advantageous for an automated laser cutting system, such that, for example, the movement of the laser head can be in a plane that can be parallel and / or coincident with the plane of the flat configuration.

[0393] In some implementations, manufacturing of multiple implants may be performed by (i) mounting multiple frames in an arrangement (e.g., an array or grid) across a single sheet, (ii) flattening all of the frames simultaneously (e.g., into a large cage), (iii) using an automated cutting device to form holes in the sheet at each of the frames while constraining the frames, and (iv) then cutting the sheet to separate and / or trim the individual implants while the frames remain constrained or after releasing the frames. In some implementations, cutting the sheet to separate and / or trim the implants may be performed using the same automated cutting machine used to form the holes.

[0394] In some implementations, as shown, the holes 570 are polygonal. In some implementations, the holes 570 are circular or elliptical.

[0395] It should be noted that the techniques described with reference to Figures 8A-C may be used with implants and / or sheets other than those described herein.

[0396] Any of the various systems, assemblies, devices, components, equipment, etc. in the present disclosure may be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use on a patient, and the methods described herein may include (or additional methods may include or consist of) sterilization of the associated systems, devices, components, equipment, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0397] While the above description includes several implementations, these should not be construed as limitations on the scope of the present disclosure, but as examples. Features of one implementation can be combined with features of other implementations. For example, mutatis mutandis, features of one or more variations of implant 100 can be combined with features of one or more other variations of implant 100, features of one or more variations of implant 200 can be combined with features of one or more other variations of implant 200, and features of one or more variations of implant 100 can be combined with features of one or more variations of implant 200. Furthermore, tools (e.g., delivery tools and / or components thereof) described for use with implant 100 (and / or variations thereof) can be used with implant 200 (and / or variations thereof), and vice versa.

[0398] Exemplary Implementations (Some non-limiting examples of the concepts herein are listed below).

[0399] Example 1. A method for use in manufacturing a medical implant, comprising: (i) forming a sandwich including (a) a textile layer, (b) a covering layer including a polymer configured to inhibit tissue growth thereon, (c) a bonding layer sandwiched between the textile layer and the covering layer, and / or (d) at least a portion of a frame sandwiched between the textile layer and the bonding layer; and / or (ii) heating and compressing the sandwich such that the bonding layer bonds the textile layer to the covering layer.

[0400] Example 2. The method of example 1, further comprising sterilizing the sandwich after heating and compressing the sandwich.

[0401] Example 3. The method of any one of the preceding claims, wherein forming the sandwich comprises sandwiching at least a portion of the frame, together with a tie layer, between the fabric layer and the cover layer.

[0402] Example 4. The method of any one of embodiments 1 to 3, wherein the coating layer consists essentially of a polymer.

[0403] Example 5. The method according to any one of the preceding embodiments, wherein the coating layer is non-porous.

[0404] Example 6. The method according to any one of the preceding embodiments, wherein the coating layer is porous.

[0405] Example 7. The method according to any one of Examples 1 to 6, wherein the coating layer is a film.

[0406] Example 8. The method of any one of Examples 1 to 6, wherein the textile layer comprises a woven fabric.

[0407] Example 9. The method of any one of Examples 1 to 6, wherein the textile layer comprises a nonwoven fabric.

[0408] Example 10. The method of any one of Examples 1 to 9, wherein the polymer comprises ultra-high molecular weight polyethylene (UHMWPE).

[0409] Example 11. The method of any one of embodiments 1 to 9, wherein the polymer comprises fluorinated ethylene propylene (FEP).

[0410] Example 12. The method of any one of claims 1 to 11, wherein the tie layer comprises an acrylate.

[0411] Example 13. The method of any one of claims 1 to 12, wherein the tie layer comprises a siloxane.

[0412] Example 14. The method of any one of embodiments 1 to 13, wherein the tie layer comprises a thermoplastic polyurethane (TPU).

[0413] Example 15. The method of any one of claims 1 to 14, wherein the tie layer is 5 to 30 microns thick.

[0414] Example 16. The method of any one of the preceding claims, wherein the portion of the frame is 20 to 500 microns thick.

[0415] Example 17. The method of any one of Examples 1-16, wherein (i) the cover layer defines a first side of the sandwich, the sandwich having a second side opposite the first side; (ii) forming the sandwich includes forming the sandwich to define a lip, where the lip portion of the cover layer and the lip portion of the bonding layer extend together beyond an edge of the textile layer; and / or (iii) the method further includes folding the lip onto the second side, around an edge of the textile layer, such that the lip portion of the bonding layer is sandwiched between the lip portion of the cover layer and the second side.

[0416] Example 18. The method of any one of Examples 1-16, wherein the frame has a first side and an opposing second side, and forming the sandwich comprises wrapping the textile 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 textile layer that is positioned against the first side of the frame, and (ii) a second portion of the textile layer that is positioned against the second side of the frame.

[0417] Example 19. The method of any one of Examples 1-18, wherein heating and compressing the sandwich comprises heating and compressing the sandwich in a manner to define a pocket between the fabric layer and the bonding layer with at least a portion of the frame disposed within the pocket.

[0418] Example 20. 20. The method of example 19, wherein heating the sandwich comprises heating the sandwich between plates, at least one of the plates having a recess in the area of ​​the pocket.

[0419] Example 21. 20. The method of example 19, wherein compressing the sandwich comprises compressing the sandwich between plates, at least one of the plates having a recess in the area of ​​the pocket.

[0420] Example 22. The method of example 19, further comprising closing the pocket by bonding the fabric layer and the bonding layer surrounding the pocket.

[0421] Example 23. The method of example 19, wherein heating and compressing the sandwich comprises heating and compressing the sandwich in a manner that provides openings in the pockets where the textile layers are not bonded from the bonding layers.

[0422] Example 24. The method of any one of claims 1-23, wherein forming the sandwich includes defining a lip where a lip portion of the cover layer and a lip portion of the tie layer extend together beyond an edge of the fabric layer.

[0423] Example 25. The method of Example 24, wherein forming the sandwich includes (i) forming the sandwich such that the coating layer defines a first side of the sandwich, the sandwich having a second side opposing the first side, and / or (ii) folding the lip portion of the tie layer onto the second side such that the lip portion of the coating layer is sandwiched between the lip portion of the coating layer and the second side.

[0424] Example 26. The method of any one of examples 1-25, further comprising forming holes through the sandwich after heating and compressing the sandwich.

[0425] Example 27. The method of example 26, further comprising flattening the sandwich after heating and compressing it, and maintaining the sandwich flat while forming holes therethrough.

[0426] Example 28. 27. The method of example 26, wherein forming the holes comprises forming the holes by laser ablation.

[0427] Example 29. 27. The method of example 26, wherein the pores are hexagonal pores and forming the pores comprises forming hexagonal pores.

[0428] Example 30. A method comprising: (i) forming a sandwich comprising a bonding layer sandwiched between (a) a textile layer and (b) a coating layer comprising a polymer configured to inhibit tissue growth thereon; and / or (ii) forming a sheet by bonding the textile layer to the coating layer by (a) heating the sandwich; and / or (b) compressing the sandwich.

[0429] Example 31. The method of example 1, further comprising sterilizing the sheet after heating and compressing the sandwich.

[0430] Example 32. The method of any one of Examples 30-31, wherein (i) in the sandwich, the tie layer is not bonded from the textile layer, (ii) forming the sandwich includes forming a sandwich where the tie layer is not bonded from the textile layer, and / or (iii) forming a sheet by bonding the textile layer to the cover layer includes forming a sheet by bonding the tie layer to the textile layer and the cover layer by heating and compressing the sandwich.

[0431] Example 33. The method of any one of Examples 30-31, wherein (i) in the sandwich, a tie layer is bonded to the textile layer, (ii) forming the sandwich comprises forming a sandwich in which the tie layer is bonded to the textile layer, and / or (iii) forming a sheet by bonding the textile layer to a cover layer comprises bonding a tie layer, which is bonded to the textile layer, to the cover layer by heating and compressing the sandwich to form a sheet.

[0432] Example 34. The method of any one of Examples 30 to 33, wherein the coating layer consists essentially of a polymer.

[0433] Example 35. The method of any one of Examples 30 to 34, wherein the coating layer is non-porous.

[0434] Example 36. The method according to any one of Examples 30 to 34, wherein the coating layer is porous.

[0435] Example 37. The method according to any one of Examples 30 to 36, wherein the coating layer is a film.

[0436] Example 38. The method of any one of Examples 30 to 36, wherein the textile layer comprises a woven fabric.

[0437] Example 39. The method of any one of Examples 30 to 36, wherein the textile layer comprises a nonwoven fabric.

[0438] Example 40. The method of any one of examples 30 to 39, wherein the polymer comprises ultra-high molecular weight polyethylene (UHMWPE).

[0439] Example 41. The method of any one of embodiments 30 to 40, wherein the polymer comprises fluorinated ethylene propylene (FEP).

[0440] Example 42. The method of any one of embodiments 30 to 41, wherein the tie layer comprises an acrylate.

[0441] Example 43. The method of any one of embodiments 30 to 42, wherein the tie layer comprises a siloxane.

[0442] Example 44. The method of any one of embodiments 30 to 43, wherein the tie layer comprises a thermoplastic polyurethane (TPU).

[0443] Example 45. The method of any one of embodiments 30 to 44, wherein the fabric layer is 20 to 150 microns thick.

[0444] Example 46. The method of any one of embodiments 30 to 45, wherein the tie layer is 5 to 30 microns thick.

[0445] Example 47. 47. The method of any one of Examples 30-46, wherein (i) the covering layer defines a first side of the sheet, the sheet having a second side opposite the first side; (ii) forming the sandwich includes forming the sandwich to define a lip, where the lip portion of the covering layer and the lip portion of the bonding layer extend together beyond an edge of the textile layer; (iii) the method further includes folding the lip onto the second side, about an edge of the textile layer, such that the lip portion of the bonding layer is sandwiched between the lip portion of the covering layer and the second side; and / or (iv) forming the sheet includes forming the sheet by (a) heating the sandwich including the lip folded onto the second side, about the edge of the textile layer, and / or (b) compressing the sandwich including the lip folded onto the second side, about the edge of the textile layer.

[0446] Example 48. The method of any one of Examples 30-47, wherein forming the sheet includes bonding the bonding layer to the fabric layer by heating and compressing the bonding layer against the fabric layer to form the sheet.

[0447] Example 49. The method of example 48, wherein forming the sheet includes bonding the cover layer to the tie layer by heating and compressing the cover layer against the tie layer to form the sheet.

[0448] Example 50. The method of any one of Examples 30-49, wherein forming the sandwich includes defining a lip where a lip portion of the cover layer and a lip portion of the tie layer extend together beyond an edge of the fabric layer.

[0449] Example 51. The method of Example 50, wherein forming the sandwich includes (i) forming the sandwich such that the covering layer defines a first side of the sheet, the sheet having a second side opposing the first side, and / or (ii) folding the lip portion of the tie layer onto the second side such that the lip portion of the covering layer is sandwiched between the lip portion of the covering layer and the second side.

[0450] Example 52. The method of any one of Examples 30-51, wherein (i) the sandwich comprises at least a portion of the frame sandwiched between the textile layer and the bonding layer, and / or (ii) forming the sheet comprises (a) heating the sandwich comprising at least a portion of the frame sandwiched between the textile layer and the bonding layer, and / or (b) compressing the sandwich comprising at least a portion of the frame sandwiched between the textile layer and the bonding layer, thereby forming a sheet by bonding the textile layer to the cover layer with at least a portion of the frame disposed between the textile layer and the bonding layer.

[0451] Example 53. The method of example 52, wherein forming the sheet includes heating and compressing the sandwich around the area of ​​the pocket such that at least a portion of the frame is disposed within the pocket, thereby forming the sheet to define a pocket between the fabric layer and the bonding layer.

[0452] Example 54. 54. The method of example 53, wherein heating the sandwich comprises heating the sandwich between plates, at least one of the plates having a recess in the area of ​​the pocket.

[0453] Example 55. 54. The method of example 53, wherein compressing the sandwich comprises compressing the sandwich between plates, at least one of the plates having a recess in the area of ​​the pocket.

[0454] Example 56. The method of example 52, wherein forming the sheet includes forming the sheet by bonding a fabric layer to a cover layer in a manner that forms a pocket between the fabric layer and the bonding layer.

[0455] Example 57. The method of Example 56, wherein forming the pocket comprises forming the pocket by (i) heating the sandwich around the area of ​​the pocket, and / or (ii) compressing the sandwich around the area of ​​the pocket.

[0456] Example 58. The method of example 56, further closing the pocket by bonding the fabric layer and the tie layer surrounding the pocket.

[0457] Example 59. 54. The method of example 53, wherein forming the sheet includes unbonding the fabric layer from the bonding layer to form a sheet having openings at edges of the sheet.

[0458] Example 60. 53. The method of example 52, wherein forming the sandwich includes sandwiching at least a portion of the frame, along with a tie layer, between the fabric layer and the cover layer.

[0459] Example 61. The method of claim 60, wherein the thickness of the frame between the fabric layer and the bonding layer is 20 to 500 microns.

[0460] Example 62. The method of 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.

[0461] Example 63. 63. The method of example 62, wherein fixedly attaching the sheet to the frame comprises sewing the sheet to the frame.

[0462] Example 64. The method of any one of Examples 30-63, wherein forming the sandwich includes forming a sandwich including a frame sandwiched between the fabric layer and the cover layer, along with a tie layer.

[0463] Example 65. The method of embodiment 64, wherein the thickness of the frame between the fabric layer and the bonding layer is 20 to 500 microns.

[0464] Example 66. The method of example 64, wherein the frame has a first side and an opposing second side, and forming the sandwich includes wrapping the textile 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 textile layer that is positioned against the first side of the frame, and (ii) a second portion of the textile layer that is positioned against the second side of the frame.

[0465] Example 67. The method of example 62, further comprising forming a plurality of holes through the sheet to facilitate blood flow through the sheet.

[0466] Example 68. 68. The method of example 67, further comprising flattening the sheet and maintaining the sheet flat while forming a plurality of holes therethrough.

[0467] Example 69. 68. The method of example 67, wherein forming the holes comprises forming the holes by laser ablation.

[0468] Example 70. The method of example 67, wherein each of the holes is hexagonal.

[0469] Example 71. The method of any one of Examples 30-70, wherein (i) the tie layer is a first tie layer, (ii) the coating layer is a first coating layer, (iii) forming the sandwich includes forming a sandwich to include a second tie layer sandwiched between the textile layer and a second coating layer configured to inhibit tissue growth thereon, and / or (iv) forming a sheet includes bonding the textile layer to the second coating layer by heating and compressing the sandwich.

[0470] Example 72. 72. The method of example 71, wherein (i) the covering layer defines a first side of the sheet, the sheet having a second side opposite the first side; (ii) forming the sandwich includes forming the sandwich to define a lip, where the lip portion of the covering layer and the lip portion of the bonding layer extend together beyond an edge of the textile layer; (iii) the method further includes folding the lip onto the second side, about an edge of the textile layer, such that the lip portion of the bonding layer is sandwiched between the lip portion of the covering layer and the second side; and / or (iv) forming the sheet includes forming a sheet by (a) heating the sandwich including the lip folded onto the second side, about the edge of the textile layer, and / or (b) compressing the sandwich including the lip folded onto the second side, about the edge of the textile layer.

[0471] Example 73. 72. The method of claim 71, wherein the first covering layer, the second covering layer, and the first tie layer extend together beyond an edge of the fabric layer, thereby forming a lip-including sandwich, defining a lip, wherein the lip portion of the first covering layer, the lip portion of the second covering layer, and the lip portion of the first tie layer are disposed.

[0472] Example 74. The method of Example 73, wherein forming the sandwich includes (i) forming the sandwich such that the covering layer defines a first side of the sheet, the sheet having a second side opposing the first side, and / or (ii) folding the lip portion of the tie layer onto the second side such that the lip portion of the covering layer is sandwiched between the lip portion of the covering layer and the second side.

[0473] Example 75. 72. The method of example 71, wherein the first covering layer, the second covering layer, the first tie layer, and the second tie layer extend together beyond an edge of the fabric layer, thereby forming a sandwich including a lip, defining a lip, wherein the lip portion of the first covering layer, the lip portion of the second covering layer, and the lip portion of the first tie layer are disposed.

[0474] Example 76. The method of any one of Examples 30 to 75, wherein forming the sheet includes forming a sheet by bonding a fabric layer to a cover layer in a manner that forms a pocket between the fabric layer and the bonding layer.

[0475] Example 77. The method of Example 76, wherein forming the sheet in a manner to form a pocket comprises (i) heating the sandwich around the area of ​​the pocket, and / or (ii) compressing the sandwich around the area of ​​the pocket.

[0476] Example 78. 78. The method of claim 77, wherein heating the sandwich around the pocket area includes positioning the sandwich between plates, at least one of the plates being heated and at least one of the plates having a recess defining the pocket area.

[0477] Example 79. 78. The method of example 77, wherein compressing the sandwich around the pocket area includes compressing the sandwich between plates, at least one of the plates having a recess defining the pocket area.

[0478] Example 80. 77. The method of example 76, further comprising closing the pocket by a bond between the fabric layer and the tie layer surrounding the pocket.

[0479] Example 81. 81. The method of example 80, wherein the sheet defines an opening to a pocket.

[0480] Example 82. The method of example 81, wherein at the openings, the fabric layer is not bonded from the bonding layer.

[0481] Example 83. The method of example 81, wherein the opening is located at an edge of the sheet.

[0482] Example 84. 77. The method of example 76, further comprising a cord, at least a portion of the cord extending through the pocket.

[0483] Example 85. 85. The method of example 84, wherein the cord is slidable within the pocket.

[0484] Example 86. The method of any one of Examples 30 to 85, wherein the polymer is polytetrafluoroethylene (PTFE).

[0485] Example 87. The method of Example 86, wherein the polymer is expanded PTFE (ePTFE).

[0486] Example 88. The method of example 86, wherein the coating layer comprises several lamellar sublayers of polymer.

[0487] Example 89. 89. The method of example 88, wherein each of the sublayers is anisotropic and the sublayers are disposed such that each of the sublayers is disposed orthogonal to an adjacent one of the sublayers.

[0488] Example 90. 89. The method of example 88, wherein the coating layer comprises less than ten sublayers.

[0489] Example 91. The method of example 90, wherein the coating layer comprises less than six sublayers.

[0490] Example 92. The method of any one of Examples 30 to 91, wherein compressing the sandwich comprises compressing the sandwich at a pressure of 0.01 to 1 MPa.

[0491] Example 93. The method of example 92, wherein compressing the sandwich comprises holding the sandwich under pressure for 100 to 500 seconds.

[0492] Example 94. The method of any one of Examples 30-93, wherein heating the sandwich comprises heating the sandwich to a temperature of 37 to 260 degrees Celsius.

[0493] Example 95. 95. The method of example 94, wherein heating the sandwich comprises holding the sandwich at a temperature for 100 to 500 seconds.

[0494] Example 96. A system and / or device comprising a sheet comprising: (i) a textile layer; (ii) a coating layer comprising a polymer configured to inhibit tissue growth thereon; and / or (iii) a bonding layer sandwiched between the textile layer and the coating layer, bonding the textile layer to the coating layer.

[0495] Example 97. The system / device described in Example 96, wherein the system / device is shaped to define a leaflet augmentation patch configured to be attached to the leaflets of a valve of the subject's heart.

[0496] Example 98. The system / device of any one of Examples 96-97, wherein the coating layer consists essentially of a polymer.

[0497] Example 99. The system / apparatus of any one of Examples 96-98, wherein the coating layer is non-porous.

[0498] Example 100. The system / apparatus of any one of Examples 96-98, wherein the coating layer is porous.

[0499] Example 101. The system / apparatus according to any one of Examples 96 to 100, wherein the covering layer is a film.

[0500] Example 102. The system / apparatus of any one of Examples 96-100, wherein the textile layer comprises a woven fabric.

[0501] Example 103. The system / apparatus of any one of Examples 96-100, wherein the fabric layer comprises a nonwoven fabric.

[0502] Example 104. The system / apparatus of any one of Examples 96-103, wherein the polymer is ultra-high molecular weight polyethylene (UHMWPE).

[0503] Example 105. The system / apparatus of any one of Examples 96-104, wherein the polymer is fluorinated ethylene propylene (FEP).

[0504] Example 106. The system / device of any one of Examples 96-105, wherein the tie layer comprises an acrylate.

[0505] Example 107. The system / apparatus of any one of Examples 96-106, wherein the tie layer comprises a siloxane.

[0506] Example 108. The system / apparatus of any one of Examples 96-107, wherein the fabric layer is 20-150 microns thick.

[0507] Example 109. The system / apparatus of any one of Examples 96-108, wherein the tie layer is 5-30 microns thick.

[0508] Example 110. The system / apparatus of any one of Examples 96-109, wherein the cover layer and the bonding layer extend together beyond the edge of the fabric layer, thereby defining a lip along which the lip portion of the cover layer and the lip portion of the bonding layer are disposed.

[0509] Example 111. The system / apparatus of Example 110, wherein the covering layer defines a first side of the sheet, the sheet having a second side opposite the first side, and the lip is folded over the second side such that the lip portion of the bonding layer is sandwiched between the lip portion of the covering layer and the second side.

[0510] Example 112. The system / apparatus of Example 110, wherein the lip is folded around an edge of the fabric layer, thereby defining a hem of the sheet within which the fabric layer is positioned between the lip portion of the bonding layer and another portion of the bonding layer.

[0511] Example 113. The system / device of any one of Examples 96-112, wherein the sheet defines a pocket between the fabric layer and the bonding layer.

[0512] Example 114. The system / device of Example 113, wherein the bond between the fabric layer and the bonding layer encloses the pocket, thereby closing the pocket.

[0513] Example 115. The system / device of Example 113, wherein the sheet defines an opening to a pocket.

[0514] Example 116. The system / device of Example 115, wherein at the opening, the fabric layer is not bonded from the bonding layer.

[0515] Example 117. The system / device of Example 115, wherein the opening is located at an edge of the sheet.

[0516] Example 118. The system / device of Example 113, further comprising a cord, at least a portion of the cord extending through the pocket.

[0517] Example 119. The system / device of Example 118, wherein the portion of the cord is slidable within the pocket.

[0518] Example 120. The system / device of any one of Examples 96-119, wherein the system / device is shaped as a wing defining a contact surface and an opposing surface opposing the contact surface.

[0519] Example 121. The system / device of Example 120, wherein the wings have a plurality of holes configured to promote blood flow therethrough.

[0520] Example 122. The system / device of Example 121, wherein each of the holes is hexagonal.

[0521] Example 123. The system / device of Example 120, wherein the wing is configured to be anchored 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.

[0522] Example 124. The system / apparatus of any one of Examples 96-123, further comprising a frame, wherein the sheet is fixedly attached to the frame in a manner covering at least a portion of the frame.

[0523] Example 125. The system / device of Example 124, wherein the sheet is fixedly attached to the frame by stitching.

[0524] Example 126. The system / apparatus of Example 124, wherein the sheet is fixedly attached to the frame by an adhesive.

[0525] Example 127. The system / apparatus of Example 124, wherein the sheet is fixedly attached to the frame by sandwiching the frame between the fabric layer and the bonding layer.

[0526] Example 128. The system / apparatus of Example 127, wherein (i) the covering layer is a first covering layer, (ii) the bonding layer is a first bonding layer, and / or (iii) the sheet further comprises (a) a second covering layer, and / or (b) a second bonding layer sandwiched between the frame and the second covering layer.

[0527] Example 129. The system / apparatus of Example 127, wherein the thickness of the frame between the fabric layer and the bonding layer is 20 to 500 microns.

[0528] Example 130. The system / apparatus of Example 127, wherein the frame has a first side and an opposing second side, and the textile layer is wrapped around 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 textile layer that is positioned against the first side of the frame, and (ii) a second portion of the textile layer that is positioned against the second side of the frame.

[0529] Example 131. The system / apparatus of Example 130, wherein (i) the coating layer is a first coating layer, (ii) the bonding layer is a first bonding layer, and / or (iii) the sheet further comprises (a) a second coating layer, and / or (b) a second bonding layer sandwiched between the second portion of the fabric layer and the second coating layer.

[0530] Example 132. The system / device of Example 124, wherein the frame is flexible and the system / device defines a wing having a contact surface and an opposing surface opposing the contact surface.

[0531] Example 133. The system / device of Example 132, wherein the sheet has a plurality of holes configured to promote blood flow therethrough.

[0532] Example 134. The system / device described in Example 132, wherein the wing is configured to be anchored to the annulus of a valve of the subject's heart such that the wing extends over a first leaflet of the valve toward the opposing leaflet of the valve and the contact surface faces the first leaflet.

[0533] Example 135. The system / device described in Example 124, wherein the system / device has a pocket between the fabric layer and the bonding layer, and at least a portion of the frame is disposed within the pocket.

[0534] Example 136. The system / apparatus of Example 124, wherein the cover layer and the bonding layer extend together beyond the edge of the frame, thereby defining a lip within which the lip portion of the cover layer and the lip portion of the bonding layer are disposed.

[0535] Example 137. The system / apparatus of Example 136, wherein the frame is disposed between the fabric layer and the bonding layer, and the fabric layer, together with the covering layer and the bonding layer, extends beyond the edges of the frame.

[0536] Example 138. The system / apparatus of Example 136, wherein the cover layer and the bonding layer extend together beyond the edge of the fabric layer, thereby defining a lip.

[0537] Example 139. The system / apparatus of Example 136, wherein the covering layer defines a first side of the sheet, the sheet has a second side opposite the first side, and the lip is folded over the second side such that the lip portion of the bonding layer is positioned between the lip portion of the covering layer and the second side.

[0538] Example 140. The system / apparatus of 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.

[0539] Example 141. The system / apparatus of Example 136, wherein the lip is folded around an edge of the frame, thereby defining a hem of the sheet within which the edge of the frame is positioned between the lip portion of the bonding layer and another portion of the bonding layer.

[0540] Example 142. The system / apparatus of Example 141, wherein at least a portion of the fabric layer is disposed within the hem.

[0541] Example 143. The system / apparatus of any one of Examples 96-142, wherein the cover layer is a first cover layer, the bonding layer is a first bonding layer, and the sheet further comprises (i) a second cover layer, and / or (ii) a second bonding layer sandwiched between the textile layer and the second cover layer and bonding the textile layer to the second cover layer, and the textile layer is sandwiched between the first bonding layer and the second bonding layer.

[0542] Example 144. The system / device of Example 143, wherein the sheet defines a pocket between the fabric layer and the first bonding layer.

[0543] Example 145. The system / apparatus of Example 143, wherein the first covering layer, the second covering layer, and the first bonding layer extend together beyond the edge of the fabric layer, thereby defining a lip along which the lip portion of the first covering layer, the lip portion of the second covering layer, and the lip portion of the first bonding layer are disposed.

[0544] Example 146. The system / apparatus of Example 145, wherein within the lip, the lip portion of the first coating layer is bonded to the lip portion of the second coating layer by the lip portion of the first bonding layer.

[0545] Example 147. The system / apparatus of Example 145, wherein 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 covering layer is bonded to the lip portion of the second covering layer by the lip portion of the first bonding layer and the lip portion of the second bonding layer.

[0546] Example 148. The system / device of Example 145, further comprising a frame disposed between the first bonding layer and the second bonding layer.

[0547] Example 149. The system / apparatus of Example 148, wherein, in at least a portion of the sheet, the lip extends beyond the edge of the frame.

[0548] Example 150. The system / apparatus of Example 148, wherein at least a portion of the frame extends beyond the edge of the lip.

[0549] Example 151. The system / apparatus of Example 143, wherein the first covering layer and the first bonding layer extend together beyond the edge of the fabric layer, thereby defining a lip within which the lip portion of the first covering layer and the lip portion of the first bonding layer are disposed.

[0550] Example 152. The system / apparatus of Example 151, wherein the first covering layer defines a first surface of the sheet, the sheet has a second surface opposite the first surface, and the lip is folded onto the second surface such that the lip portion of the first bonding layer is positioned between the lip portion of the first covering layer and the second surface.

[0551] Example 153. The system / apparatus of Example 152, wherein the lip is folded onto the second surface such that the lip portion of the first bonding layer is positioned between the lip portion of the first coating layer and the lip portion of the second coating layer.

[0552] Example 154. The system / apparatus of Example 143, further comprising a frame, the sheet fixedly attached to the frame in a manner covering at least a portion of the frame, (i) the first covering layer defining a first surface of the sheet, the sheet having a second surface opposite the first surface, and / or (ii) the lip portion of the first covering layer and the lip portion of the first bonding layer extending together beyond an edge of the fabric layer, thereby defining a lip, the lip extending beyond the edge of the frame.

[0553] Example 155. The system / apparatus of Example 154, wherein the lip is folded over the second surface, thereby defining a hem of the sheet within which at least a portion of the frame is disposed.

[0554] Example 156. The system / apparatus of example 154, wherein the lip portion of the second covering layer and the lip portion of the second bonding layer extend together beyond the edge of the fabric layer into a lip.

[0555] Example 157. The system / apparatus of Example 143, further comprising a frame, the sheet being fixedly attached to the frame in a manner covering at least a portion of the frame.

[0556] Example 158. The system / device described in Example 157, wherein the system / device has a pocket positioned between the fabric layer and the first bonding layer, and at least a portion of the frame is positioned in the pocket between the fabric layer and the first bonding layer.

[0557] Example 159. The system / device of Example 158, wherein the pocket is closed by a bond between the fabric layer surrounding the pocket and the first bonding layer.

[0558] Example 160. The system / device of Example 158, wherein the sheet defines an opening to a pocket.

[0559] Example 161. The system / device of Example 160, wherein at the opening, the fabric layer is not bonded from the first bonding layer.

[0560] Example 162. The system / device of Example 160, wherein the opening is located at the edge of the sheet.

[0561] 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 pocket.

[0562] Example 164. The system / device of Example 163, wherein the portion of the cord is slidable within the pocket.

[0563] Example 165. The system / apparatus of any one of Examples 96-164, wherein the polymer is polytetrafluoroethylene (PTFE).

[0564] Example 166. The system / device of Example 165, wherein the polymer is expanded PTFE (ePTFE).

[0565] Example 167. The system / device of Example 165, wherein the coating layer comprises several layered sublayers of polymer.

[0566] Example 168. The system / apparatus of Example 167, wherein each of the sublayers is anisotropic and the sublayers are arranged such that each of the sublayers is disposed orthogonally to an adjacent one of the sublayers.

[0567] Example 169. The system / device of Example 167, wherein the coating layer comprises less than ten sublayers.

[0568] Example 170. The system / apparatus of Example 169, wherein the coating layer comprises less than six sublayers.

[0569] Example 171. The system / apparatus of any one of Examples 96-170, wherein the tie layer comprises a thermoplastic polyurethane (TPU).

[0570] Example 172. The system / apparatus of Example 171, wherein the TPU is a polycarbonate-based TPU.

[0571] Example 173. The system / apparatus of Example 172, wherein the polycarbonate-based TPU is a polycarbonate-based aliphatic thermoplastic polyurethane.

[0572] Example 174. The system / apparatus of any one of Examples 96-173, wherein the sheet is formed by compressing the fabric layer, the cover layer, and the bonding layer together and heating the bonding layer to bond the fabric layer and the cover layer.

[0573] Example 175. The system / apparatus of example 174, wherein the sheet is formed by compressing the fabric layer, the covering layer, and the tie layer together for 100 to 500 seconds.

[0574] Example 176. The system / apparatus of example 174, wherein the sheet is formed by compressing the fabric layer, the covering layer, and the tie layer together for 20 to 420 seconds.

[0575] Example 177. The system / apparatus of example 174, wherein the sheet is formed by heating the fabric layer, the covering layer, and the tie layer for 100 to 500 seconds.

[0576] Example 178. The system / apparatus of example 174, wherein the sheet is formed by heating the fabric layer, the covering layer, and the tie layer for 20 to 420 seconds.

[0577] Example 179. The system / apparatus of example 174, wherein the sheet is formed by compressing the fabric layer, the covering layer, and the bonding layer together at a pressure of 0.01 to 1 MPa.

[0578] Example 180. The system / apparatus of example 179, wherein the sheet is formed by compressing the fabric layer, the covering layer, and the tie layer together with pressure for 100 to 500 seconds.

[0579] Example 181. The system / apparatus of example 179, wherein the sheet is formed by compressing the fabric layer, the covering layer, and the tie layer together under pressure for 20 to 420 seconds.

[0580] Example 182. The system / apparatus of example 174, wherein the sheet is formed by heating the fabric layer, the covering layer, and the bonding layer to a temperature of 37-260 degrees Celsius.

[0581] Example 183. The system / apparatus of example 182, wherein the sheet is formed by holding the fabric layer, the covering layer, and the tie layer at a temperature for 100 to 500 seconds.

[0582] Example 184. The system / apparatus of example 182, wherein the sheet is formed by holding the fabric layer, the covering layer, and the tie layer at a temperature for 20 to 420 seconds.

[0583] Example 185. (ii) a frame, and / or (ii) a cardiovascular implant including a sheet including (a) a textile layer secured to at least a portion of the frame, (b) a covering layer including a polymer configured to inhibit tissue growth thereon, and / or (c) a bonding layer sandwiched between the textile layer and the covering layer, bonding the textile layer to the covering layer.

[0584] Example 186. The system / apparatus of Example 185, wherein the portion of the frame is a first portion of the frame and a second portion of the frame is exposed from the sheet.

[0585] Example 187. The system / device described in any one of Examples 185 to 186, wherein the frame is designed as a frame for an artificial valve.

[0586] Example 188. The system / device described in any one of Examples 185 to 187, wherein the frame is designed as a leaflet augmentation patch.

[0587] Example 189. The system / apparatus described in any one of Examples 185 to 188, wherein the frame is designed as a wing.

[0588] Example 190. The system / device described in any one of Examples 185 to 187, wherein the frame is designed as a frame for a stent.

[0589] Example 191. The system / device described in any one of Examples 185 to 190, wherein the implant is configured to be anchored to cardiac tissue of a subject.

[0590] Example 192. The system / device of any one of Examples 185-191, wherein the sheet is fixedly attached to the frame by stitching.

[0591] Example 193. The system / apparatus of any one of Examples 185-192, wherein the sheet is fixedly attached to the frame by an adhesive.

[0592] Example 194. The system / device described in any one of Examples 185 to 193, wherein the system / device has a pocket between the fabric layer and the bonding layer, and at least a portion of the frame is disposed within the pocket.

[0593] Example 195. The system / device of any one of Examples 185-194, wherein the coating layer consists essentially of a polymer.

[0594] Example 196. The system / device of any one of Examples 185 to 195, wherein the coating layer is non-porous.

[0595] Example 197. The system / apparatus of any one of Examples 185 to 195, wherein the coating layer is porous.

[0596] Example 198. The system / apparatus described in any one of Examples 185 to 197, wherein the covering layer is a film.

[0597] Example 199. The system / apparatus of any one of Examples 185-197, wherein the textile layer comprises a woven fabric.

[0598] Example 200. The system / device of any one of Examples 185-197, wherein the fabric layer comprises a nonwoven fabric.

[0599] Example 201. The system / apparatus of any one of Examples 185-200, wherein the polymer is ultra-high molecular weight polyethylene (UHMWPE).

[0600] Example 202. The system / apparatus of any one of Examples 185-201, wherein the polymer is fluorinated ethylene propylene (FEP).

[0601] Example 203. The system / device of any one of Examples 185-202, wherein the tie layer comprises an acrylate.

[0602] Example 204. The system / apparatus of any one of Examples 185-203, wherein the tie layer comprises a siloxane.

[0603] Example 205. The system / apparatus of any one of Examples 185-204, wherein the fabric layer is 20-150 microns thick.

[0604] Example 206. The system / apparatus of any one of Examples 185-205, wherein the tie layer is 5-30 microns thick.

[0605] Example 207. The system / apparatus of any one of Examples 185-206, wherein the cover layer and the bonding layer extend together beyond the edge of the frame, thereby defining a lip within which the lip portion of the cover layer and the lip portion of the bonding layer are disposed.

[0606] Example 208. The system / apparatus of Example 207, wherein the frame is positioned between the fabric layer and the bonding layer, and the fabric layer, together with the covering layer and the bonding layer, extends beyond the edges of the frame.

[0607] Example 209. The system / apparatus of Example 207, wherein the covering layer and the bonding layer extend together beyond the edge of the fabric layer, thereby defining a lip.

[0608] Example 210. The system / apparatus of Example 207, wherein the covering layer defines a first side of the sheet, the sheet has a second side opposite the first side, and the lip is folded over the second side such that the lip portion of the bonding layer is positioned between the lip portion of the covering layer and the second side.

[0609] Example 211. The system / apparatus of 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.

[0610] Example 212. The system / apparatus of Example 210, wherein the lip is folded around an edge of the frame, thereby defining a hem of the sheet within which the edge of the frame is positioned between the lip portion of the bonding layer and another portion of the bonding layer.

[0611] Example 213. The system / apparatus of Example 212, wherein at least a portion of the fabric layer is disposed within the hem.

[0612] Example 214. The system / device of any one of Examples 185-213, wherein the fabric layer is secured to at least a portion of the frame by sandwiching at least a portion of the frame between the bonding layer and the fabric layer.

[0613] Example 215. The system / apparatus of Example 214, wherein the portion of the frame is a first portion of the frame and the second portion of the frame is disposed within a pocket between the bonding layer and the fabric layer.

[0614] Example 216. The system / apparatus of any one of Examples 185-215, wherein the sheet is fixedly attached to the frame by sandwiching the frame between the fabric layer and the bonding layer.

[0615] Example 217. The system / apparatus of Example 216, wherein the thickness of the frame between the fabric layer and the bonding layer is 20 to 500 microns.

[0616] Example 218. The system / apparatus of Example 216, wherein the frame has a first side and an opposing second side, and the textile layer is wrapped around 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 textile layer that is positioned against the first side of the frame, and (ii) a second portion of the textile layer that is positioned against the second side of the frame.

[0617] Example 219. The system / apparatus of Example 216, wherein (i) the coating layer is a first coating layer, (ii) the bonding layer is a first bonding layer, and / or (iii) the sheet further comprises (a) a second coating layer, and / or (b) a second bonding layer sandwiched between the fabric layer and the second coating layer.

[0618] Example 220. The system / device described in any one of Examples 185 to 219, wherein the frame is flexible and the implant defines a wing having a contact surface and an opposing surface opposing the contact surface.

[0619] Example 221. The system / device described in Example 220, wherein the sheet has a plurality of holes configured to promote blood flow therethrough.

[0620] Example 222. The system / device described in Example 220, wherein the wings are configured to be anchored to the annulus of a valve of the subject's heart such that the wings extend over a first leaflet of the valve toward the opposing leaflet of the valve and the contact surface faces the first leaflet.

[0621] Example 223. The system / apparatus of any one of Examples 185-222, wherein the cover layer is a first cover layer, the bonding layer is a first bonding layer, and the sheet further comprises (i) a second cover layer, and / or (ii) a second bonding layer sandwiched between the textile layer and the second cover layer and bonding the textile layer to the second cover layer, and the textile layer is sandwiched between the first bonding layer and the second bonding layer.

[0622] Example 224. The system / apparatus of Example 223, wherein the sheet defines a pocket between the fabric layer and the first bonding layer.

[0623] Example 225. The system / apparatus of Example 223, wherein the first covering layer and the first bonding layer extend together beyond the edge of the fabric layer, thereby defining a lip within which the lip portion of the first covering layer and the lip portion of the first bonding layer are disposed.

[0624] Example 226. The system / apparatus of Example 225, wherein the first covering layer defines a first surface of the sheet, the sheet has a second surface opposite the first surface, and the lip is folded onto the second surface such that the lip portion of the first bonding layer is positioned between the lip portion of the first covering layer and the second surface.

[0625] Example 227. The system / apparatus of Example 226, wherein the lip is folded onto the second surface such that the lip portion of the first bonding layer is positioned between the lip portion of the first coating layer and the lip portion of the second coating layer.

[0626] Example 228. The system / apparatus of Example 223, wherein the first covering layer, the second covering layer, and the first bonding layer extend together beyond the edge of the fabric layer, thereby defining a lip along which the lip portion of the first covering layer, the lip portion of the second covering layer, and the lip portion of the first bonding layer are disposed.

[0627] Example 229. The system / apparatus of Example 228, wherein within the lip, the lip portion of the first coating layer is bonded to the lip portion of the second coating layer by the lip portion of the first bonding layer.

[0628] Example 230. The system / apparatus of Example 228, wherein 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 covering layer is bonded to the lip portion of the second covering layer by the lip portion of the first bonding layer and the lip portion of the second bonding layer.

[0629] Example 231. The system / apparatus of Example 228, wherein, in at least a portion of the sheet, the lip extends beyond the edge of the frame.

[0630] Example 232. The system / apparatus of Example 228, wherein at least a portion of the frame extends beyond the edge of the lip.

[0631] Example 233. The system / apparatus of Example 228, wherein the lip is folded to define a hem of the sheet within which at least a portion of the frame is placed.

[0632] Example 234. The system / apparatus of example 228, wherein the lip portion of the second covering layer and the lip portion of the second bonding layer extend together beyond the edge of the fabric layer into a lip.

[0633] Example 235. The system / apparatus of Example 223, wherein the sheet is fixedly attached to the frame in a manner that covers at least a portion of the frame.

[0634] Example 236. The system / device described in Example 235, wherein the system / device has a pocket positioned between the fabric layer and the first bonding layer, and at least a portion of the frame is positioned in the pocket between the fabric layer and the first bonding layer.

[0635] Example 237. The system / device of Example 236, wherein the pocket is closed by a bond between the fabric layer surrounding the pocket and the first bonding layer.

[0636] Example 238. The system / device of Example 236, wherein the sheet defines an opening to a pocket.

[0637] Example 239. The system / device of Example 238, wherein at the opening, the fabric layer is not bonded from the first bonding layer.

[0638] Example 240. The system / device of Example 238, wherein the opening is located at the edge of the sheet.

[0639] Example 241. The system / device described in Example 238, further comprising a cord attached to the frame, at least a portion of the cord extending through the pocket.

[0640] Example 242. The system / device described in Example 241, wherein the portion of the cord is slidable within the pocket.

[0641] Example 243. The system / apparatus of any one of Examples 185 to 242, wherein the polymer is polytetrafluoroethylene (PTFE).

[0642] Example 244. The system / device described in Example 243, wherein the polymer is expanded PTFE (ePTFE).

[0643] Example 245. The system / device of Example 243, wherein the coating layer comprises several layered sublayers of polymer.

[0644] Example 246. The system / apparatus of Example 245, wherein each of the sublayers is anisotropic and the sublayers are arranged such that each of the sublayers is disposed orthogonally to an adjacent one of the sublayers.

[0645] Example 247. The system / apparatus of Example 245, wherein the coating layer comprises less than ten sublayers.

[0646] Example 248. The system / apparatus of Example 247, wherein the coating layer comprises less than six sublayers.

[0647] Example 249. The system / apparatus of any one of Examples 185-248, wherein the tie layer comprises a thermoplastic polyurethane (TPU).

[0648] Example 250. The system / apparatus of Example 249, wherein the TPU is a polycarbonate-based TPU.

[0649] Example 251. The system / apparatus of Example 250, wherein the polycarbonate-based TPU is a polycarbonate-based aliphatic thermoplastic polyurethane.

[0650] Example 252. The system / apparatus of any one of Examples 185-251, wherein the sheet is formed by compressing the fabric layer, the cover layer, and the bonding layer together and heating the bonding layer to bond the fabric layer and the cover layer.

[0651] Example 253. The system / apparatus of example 252, wherein the sheet is formed by heating the fabric layer, the covering layer, and the tie layer for 100 to 500 seconds.

[0652] Example 254. The system / apparatus of example 252, wherein the sheet is formed by heating the fabric layer, the covering layer, and the tie layer for 20 to 420 seconds.

[0653] Example 255. The system / apparatus of example 252, wherein the sheet is formed by compressing the fabric layer, the covering layer, and the tie layer together for 100 to 500 seconds.

[0654] Example 256. The system / apparatus of example 252, wherein the sheet is formed by compressing the fabric layer, the covering layer, and the tie layer together for 20 to 420 seconds.

[0655] Example 257. The system / apparatus of example 252, wherein the sheet is formed by compressing the fabric layer, the covering layer, and the bonding layer together at a pressure of 0.01 to 1 MPa.

[0656] Example 258. The system / apparatus of example 257, wherein the sheet is formed by compressing the fabric layer, the covering layer, and the tie layer together with pressure for 100 to 500 seconds.

[0657] Example 259. The system / apparatus of example 257, wherein the sheet is formed by compressing the fabric layer, the covering layer, and the tie layer together under pressure for 20 to 420 seconds.

[0658] Example 260. The system / apparatus of example 252, wherein the sheet is formed by heating the fabric layer, the covering layer, and the bonding layer at a temperature between 37 and 260 degrees Celsius.

[0659] Example 261. The system / apparatus of example 260, wherein the sheet is formed by holding the fabric layer, the covering layer, and the bonding layer at a temperature for 100 to 500 seconds.

[0660] Example 262. The system / apparatus of example 260, wherein the sheet is formed by holding the fabric layer, the covering layer, and the bonding layer at a temperature for 20 to 420 seconds.

[0661] 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 holes in the sheet while the sheet remains flattened; and / or (iii) thereafter allowing the frame to unflatten toward a rest shape in which the frame holds the sheet in a curved configuration.

[0662] Example 264. The method of example 263, wherein forming the holes comprises forming the holes using an automated laser cutting system.

[0663] Example 265. The method of any one 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 flattened sheet.

[0664] Example 266. The method of any one of Examples 263 to 265, wherein flattening the sheet includes flattening the sheet using a cage having rails configured to hold the sheet flat.

[0665] Example 267. The method of any one of Examples 263-266, further comprising forming a sheet by bonding the textile layer to the coating layer by: (i) forming a sandwich comprising a bonding layer sandwiched between the textile layer and the coating layer; (ii) heating the sandwich; and / or (iii) compressing the sandwich.

[0666] Example 268. The method of example 267, further comprising, after forming the sheet, fastening and attaching the sheet to a frame prior to temporarily flattening the sheet.

[0667] Example 269. The method of any one of Examples 263-268, 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 frame includes flattening the sheet by simultaneously constraining the plurality of frames while the plurality of frames remain fixedly attached to the sheet, and / or (iii) rendering the frame unflattenable includes rendering the plurality of frames unflattenable.

[0668] Example 270. The method of example 269, further comprising positioning and attaching a plurality of frames across the sheet before flattening the sheet.

[0669] Example 271. The method of Example 270, further comprising cutting the sheet to separate the multiple frames after the multiple frames are allowed to be unflattened, thereby forming multiple implants.

[0670] Example 272. 269. The method of claim 269, wherein cutting the sheet includes cutting the sheet while the multiple frames remain constrained.

[0671] Example 273. 269. The method of example 269, wherein forming the holes comprises forming the holes using an automated cutting device.

[0672] Those skilled in the art will appreciate that the present invention is not limited to what has been particularly shown and described above, but rather, the scope of the present invention includes both combinations and subcombinations of the various features described above, as well as variations thereof that would occur to those skilled in the art upon reading the above description and that are not in the prior art.

Claims

1. A method for use in the manufacture of medical implants, To form a sandwich, the sandwich is The woven layer and, A coating layer containing a polymer configured to suppress tissue growth above it, A bonding layer sandwiched between the woven layer and the covering layer, Forming a frame including at least a portion of the frame sandwiched between the fabric layer and the binding layer, A method comprising heating and compressing the sandwich such that the binding layer bonds the fabric layer to the covering layer.

2. The method according to claim 1, further comprising heating and compressing the sandwich, and then sterilizing the sandwich.

3. The method according to claim 1, wherein forming the sandwich includes sandwiching at least a portion of the frame together with the binding layer between the fabric layer and the covering layer.

4. The method according to any one of claims 1 to 3, wherein the coating layer is essentially made of the polymer.

5. The method according to any one of claims 1 to 3, wherein the coating layer is non-porous.

6. The method according to any one of claims 1 to 3, wherein the fabric layer includes a woven fabric.

7. The coating layer defines a first surface of the sandwich, and the sandwich has a second surface opposite to the first surface. Forming the sandwich involves forming the sandwich in order to define a lip in which the lip portion of the coating layer and the lip portion of the binding layer extend together beyond the edge of the fabric layer, The method according to any one of claims 1 to 3, further comprising folding the lip of the binding layer onto the second surface around the edge of the woven layer, such that the lip of the binding layer is sandwiched between the lip of the covering layer and the second surface.

8. The method according to any one of claims 1 to 3, wherein the frame has a first side and an opposing second side, and forming the sandwich involves 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 positioned with respect to the first side of the frame and (ii) a second portion of the fabric layer positioned with respect to the second side of the frame.

9. The method according to any one of claims 1 to 3, wherein heating and compressing the sandwich includes heating and compressing the sandwich such that at least the portion of the frame is positioned within the pocket, and the pocket is defined between the fabric layer and the binding layer.

10. The method according to claim 9, wherein heating the sandwich comprises heating the sandwich between plates, and at least one of the plates has a recess in the area of ​​the pocket.

11. The method according to claim 9, wherein compressing the sandwich comprises compressing the sandwich between plates, and at least one of the plates has a recess in the area of ​​the pocket.

12. The method according to claim 9, further comprising closing the pocket by joining the fabric layer surrounding the pocket and the binding layer.

13. The method according to claim 9, wherein heating and compressing the sandwich is performed such that the pocket has an opening in which the fabric layer is not bonded to the binding layer.

14. The method according to any one of claims 1 to 3, wherein forming the sandwich includes defining a lip such that the lip portion of the covering layer and the lip portion of the binding layer extend together beyond the edge of the fabric layer.

15. Forming the aforementioned sandwich is The sandwich is formed such that the coating layer defines a first surface of the sandwich, and the sandwich has a second surface facing the first surface, and The method according to claim 14, comprising folding the lip portion of the bonding layer onto the second surface such that the lip portion of the coating layer is sandwiched between the lip portion of the coating layer and the second surface.

16. The method according to any one of claims 1 to 3, further comprising heating and compressing the sandwich and then forming a hole through the sandwich.

17. The method according to claim 16, further comprising heating and compressing the sandwich, flattening the sandwich, and maintaining the sandwich flat while forming the holes through the sandwich.

18. The method according to claim 16, wherein forming the hole includes forming the hole by laser cutting.

19. The method according to claim 16, wherein the hole is a hexagonal hole, and forming the hole includes forming the hexagonal hole.

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