Docking device made with 3D woven fabric

Abstract

The present disclosure relates to a docking device made of 3D woven fabric. A docking device for a bioprosthesis is disclosed, which can change shape and recover after removing the deforming stress, which is adjusted to the surrounding conditions to adapt to different complex anatomical geometries, and reduces leakage around the bioprosthesis. The docking device may include a 3D woven fabric, which forms an inner surface, an outer surface, and a thickness therebetween. A filler may be coupled to the outer surface. A method for manufacturing a docking device is also provided. The method includes weaving a 3D woven fabric by interweaving a shape memory material, a low-melting point thermoplastic polymer or resin having a melting point, and a high-toughness biocompatible material; and pressing and heating the 3D woven fabric on a shape-setting mold at a temperature higher than the melting point of the low-melting point thermoplastic polymer or resin.

Description

[0001] This application is a divisional application of Chinese patent application 2017800854795 (PCT / US2017 / 067056) filed on December 18, 2017 and entitled “Docking device made of 3D woven fabric”. Technical Field

[0002] The present invention relates to a docking device or docking station for a bioprosthesis such as a heart valve. Background Art

[0003] The unique geometry and sometimes irregular dimensions of a patient's native heart valve anatomy present challenges in providing an implantable bioprosthetic heart valve that fits within and makes intimate contact or seals with the surrounding tissue. Summary of the invention

[0004] The present invention is intended to provide some examples, but is not intended to limit the scope of the present invention in any way. For example, unless the claims clearly state these features, the claims do not require any features included in the examples of the present invention. Moreover, the described features can be combined in various ways. Various features and steps as described elsewhere in this disclosure can be included in the examples summarized here.

[0005] Examples described herein relate to docking devices or docking stations for prostheses or bioprostheses, such as heart valves, and methods of making such docking devices, the prostheses or bioprostheses including the docking devices including a three-dimensional (3D) woven fabric.

[0006] For example, docking device / docking station in this article can be a docking device for prosthesis (for example, bioprosthesis). Docking device includes 3D woven fabric, which forms a shaped element with inner surface, outer surface and thickness therebetween. The shaped element can be annular, and it can be wavy, zigzag or straight. The shaped element can have a rectangular cross section or be concave, convex or sawtooth (other cross-sectional shapes are also possible). Preferably, the shaped element can be shaped to increase the inner surface area (for example, with a rectangular, sawtooth or concave cross section, for example, so that the shaped element is columnar or hourglass-shaped), and the inner surface area can contact or otherwise interact with the prosthesis (for example, bioprosthesis) to increase retention. The docking station can include a filler structure coupled to the outer surface of the shaped element. The prosthesis can be a heart valve or a transcatheter heart valve.

[0007] The 3D woven fabric of the docking device or docking station can include a variety of different types of fibers or yarns, such as 2-10 different types of fibers or yarns. In some embodiments, the 3D woven fabric of the docking station can include first, second and third different types of fibers or yarns. For example, the first type of fiber or yarn can include a shape memory material, the second type of fiber or yarn can include a low melting point thermoplastic polymer or resin, and the third type of fiber or yarn can include a high-toughness biocompatible material. In some embodiments, the shape memory material comprises Nitinol. In some embodiments, the melting point of the low melting point thermoplastic polymer or resin is 85 degrees Celsius to 200 degrees Celsius. For example, the low melting point thermoplastic polymer or resin can include nylon. In some embodiments, the high-toughness biocompatible material includes polyethylene terephthalate (PET).

[0008] If a filler structure is used / included, the filler structure can be covered with a material having low porosity and reduced permeability. In some embodiments, the filler structure comprises a polymer foam. For example, the polymer foam can be at least partially covered with a tubular woven fabric. In some embodiments, the tubular woven fabric comprises PET.

[0009] A docking device or docking station may include additional features or components described elsewhere in this disclosure.

[0010] In one embodiment, a 3D woven fabric for a prosthetic docking device (e.g., a bioprosthetic docking device / docking station) includes a shape memory material, a low melting point thermoplastic polymer or resin, and a high toughness biocompatible material. The shape memory material may include Nitinol. In certain embodiments, the low melting point thermoplastic polymer or resin has a melting point of 85 degrees Celsius to 200 degrees Celsius. The low melting point thermoplastic polymer or resin may include nylon. The high toughness biocompatible material may include PET.

[0011] In some embodiments, the present disclosure relates to a method for manufacturing a docking device for a prosthesis (e.g., a bioprosthesis). The method includes weaving a 3D braided fabric by interweaving a plurality of parts (e.g., wires, yarns, etc.) in a 3D braided pattern. In certain embodiments, the method includes weaving a 3D braided fabric by interweaving a shape memory material, a low melting point thermoplastic polymer or resin, and a high-toughness biocompatible material. The method may include pressing and heating the 3D braided fabric on a shape-setting mold at a temperature higher than the melting point of the low melting point thermoplastic polymer or resin. In certain embodiments, the shape memory material includes nitinol, the low melting point thermoplastic polymer or resin includes nylon having a melting point of 85 degrees Celsius to 200 degrees Celsius, and the high-toughness biocompatible material includes polyethylene terephthalate (PET).

[0012] The method may further include attaching a filler structure to the surface of the 3D woven fabric. For example, attaching the filler structure may include sewing the filler structure to the surface of the 3D woven fabric. The method may further include covering the filler structure with a tubular woven fabric including PET, wherein the filler includes a polymer foam. The manufacturing method(s) may include any combination of the above steps and any other manufacturing or processing steps described elsewhere in this disclosure.

[0013] In some embodiments, a method such as a method for replacing a native heart valve, a method for using a docking station, etc. may include one or more of the following steps:

[0014] (a) implanting a 3D woven fabric docking station at a native heart valve (the docking station may be the same or similar to the docking station described above or elsewhere in this disclosure, for example, the docking station may include interwoven shape memory material, low melting point thermoplastic polymer or resin, and high toughness biocompatible material);

[0015] (b) implanting a prosthesis / bioprosthesis (e.g., a prosthetic heart valve or a transcatheter heart valve) within a docking station at the native heart valve such that forces between the docking station and the prosthesis / bioprosthesis help secure the prosthesis / bioprosthesis in the native heart valve (optionally, this may involve clamping tissue between the docking station and the prosthesis / bioprosthesis, and / or using attachment means such as anchor(s), adhesive(s), suture(s), clip(s), etc. to secure the docking station in place);

[0016] (c) wherein the docking station includes a filler structure (e.g., which is attached to a surface of a three-dimensional (3D) woven fabric), then implanting the docking station at the native heart valve may include implanting the docking station such that the filler structure helps inhibit paravalvular leakage;

[0017] (d) delivering the docking station to the native heart valve prior to implanting the docking station at the native heart valve while the docking station is retained in a compressed configuration within a delivery catheter;

[0018] (e) expanding the docking station from a compressed configuration to an expanded configuration (eg, implanting the docking station at a native heart valve); and / or

[0019] (f) wherein the prosthesis / bioprosthesis is a transcatheter heart valve (THV), the THV is delivered to a docking station at a native heart valve prior to implanting the THV within the docking station while the THV (e.g., in a compressed or delivery configuration) is retained within a THV delivery catheter;

[0020] (g) Expanding the THV within the docking station from a compressed / delivery configuration to an expanded or deployed configuration such that forces between the docking station and the prosthesis / bioprosthesis help secure the prosthesis / bioprosthesis in the native heart valve.

[0021] Other steps described or suggested elsewhere in this disclosure may also be included. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] For illustrative purposes, various embodiments are described in the accompanying drawings and should not be construed as limiting the scope of the present invention. In addition, the various features of the different disclosed embodiments may be combined to form additional embodiments of a part of the present disclosure. Throughout the accompanying drawings, reference numerals may be reused to indicate the corresponding relationship between reference elements.

[0023] Figure 1 is a perspective view of a docking device having a three-dimensional (3D) woven fabric according to one or more embodiments.

[0024] Figure 2 is deployed in accordance with one or more embodiments Figure 1 A perspective view of a frame of an exemplary transcatheter heart valve within a docking device.

[0025] Figure 3A and 3B is similar to Figure 1 A perspective view of an exemplary docking device of a docking device in which a polymer foam is coupled to an outer surface of the docking device and a tubular braided fabric covers the polymer foam.

[0026] Figure 4 is a cross-sectional perspective view of a tubular woven fabric covering a polymer foam according to one or more embodiments.

[0027] Figure 5A is a schematic cross-sectional view of a 3D orthogonal woven unit cell according to one or more embodiments.

[0028] Figure 5B is a schematic cross-sectional view of a 3D multi-layer woven unit cell according to one or more embodiments.

[0029] Figure 5C is a schematic cross-sectional view of a 3D angle interlocking braided unit cell according to one or more embodiments.

[0030] Figure 6 In one or more embodiments, the shape setting mandrel Figure 1 A perspective view of a docking device. DETAILED DESCRIPTION

[0031] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0032] Although certain preferred embodiments and examples are disclosed below, the subject matter of the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses and modifications and equivalents thereof. Therefore, the scope of the claims that may arise therefrom is not limited to any specific embodiment described below. For example, in any method or process disclosed herein, the actions or operations of the method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Various operations may be described as multiple discrete operations in sequence in a manner that helps to understand some embodiments; however, the order of description should not be interpreted as implying that these operations are sequence-dependent. In addition, the structures, systems and / or devices described herein may be embodied as integrated components or separate components. For the purpose of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not all of these aspects or advantages may be achieved by any particular embodiment. Therefore, for example, various embodiments may be performed in a manner that realizes or optimizes an advantage or a group of advantages as taught herein, without necessarily realizing other aspects or advantages that may also be taught or suggested herein.

[0033] Overview

[0034] Docking device and method can use woven or knitted fabric skirt material.In some embodiments, textile skirt can be made by using polyethylene terephthalate (PET) in warp and weft.However, generally, the PET material used may not have a shape memory effect that can change the shape associated with the trigger or stimulation, and may not have enough elasticity to provide recovery after removing the deformation stress.Therefore, it is desirable to realize a docking device including the following fabric and / or feature, that is, the fabric and / or feature allows improved flexibility about shape or form.Some embodiments of the docking device disclosed herein are configured to adjust the shape and / or form at least in part for the surrounding conditions / anatomical structure, and can take complex shapes to adapt to various different anatomical structures.In some embodiments, the use of foam, polymer and / or biocompatible alloy with controlled diameter, size and hardness enables the docking device according to the present disclosure to adjust and / or adapt its shape or form (e.g., different annular sizes and / or shapes) for relatively complex anatomical geometries.That is, some docking devices disclosed herein can be considered as "universal" docking devices, which provide desired adaptation for patient anatomical structures of various sizes and / or shapes.

[0035] It may be desirable to use a universal docking device with certain implantable medical devices. For example, in some configurations, a universal docking device according to the present disclosure may better conform to the complex anatomical structures associated with the implantation site. In addition, particularly for prosthetic heart valves or bioprosthetic heart valves, a universal docking device according to one or more embodiments of the present disclosure may help prevent paravalvular leakage and / or eliminate the need to carefully design the size of existing heart valves. In regard to these benefits, a docking device according to one or more embodiments of the present disclosure may be configured to change shape and / or provide shape recovery after removing deforming stresses, and may be adjusted to accommodate different complex anatomical geometries for ambient conditions. Such properties and / or features may be used to at least partially mitigate paravalvular leakage.

[0036] Some embodiments disclosed herein provide devices that are constructed and / or designed to improve the fit of an implantable prosthetic heart valve (e.g., an implantable bioprosthetic heart valve) within a native valve annulus, which can advantageously at least partially alleviate problems associated with valve size and / or paravalvular leakage. For example, typically, the unique and / or irregular size and / or surface characteristics of the native valve annulus can present challenges to providing an implantable prosthetic / bioprosthetic heart valve that fits within the valve annulus and is in close contact or seal with the valve annulus. To address such challenges, some embodiments disclosed herein advantageously provide a tubular or cylindrical device that can be radially compressed for delivery and implantation in the native valve annulus prior to implantation of the prosthetic / bioprosthetic valve.

[0037] The structure of a tubular or cylindrical device according to the present disclosure may include an inner three-dimensional (3D) woven fabric and an outer covering of a polymer foam. For example, the 3D woven fabric may include three different fibers and / or yarns having different material properties. The different types of fibers and / or yarns that may be used may include shape memory materials (such as nitinol), low melting point thermoplastic polymers or resins (such as nylon) having a melting point in the range of about 166-175°C, and high toughness biocompatible materials (such as PET). In addition, the polymer foam may be attached to the outer surface of the 3D woven fabric and may provide a compressible seal with the native valve annulus.

[0038] In some embodiments, a docking device according to the present disclosure can be manufactured into a desired shape at least in part by pressing and / or heating a 3D woven fabric on a shape-setting mold at a temperature above the melting point of a low-melting thermoplastic polymer or resin. The melting of the low-melting material can be used as an adhesive to set the shape of the fabric. After setting the desired shape of the 3D woven fabric, the foam material can be attached or sewn to the 3-D woven fabric.

[0039] In some embodiments, the present disclosure provides a method for making a universal docking device, wherein the main body of the docking device is made of shape memory material (e.g., nickel titanium alloy, nitinol or other shape memory material) and thermoplastic fiber by utilizing 3D weaving technology. This type of 3D weaving technology can be implemented on a special 3D weaving machine. For example, in some 3D weaving embodiments according to an embodiment of the present disclosure, three sets of yarns are used to interweave with each other compared to two sets of yarns in a plain weave structure. The weaving may be orthogonal or multi-layered, and multiple layers may be woven together to form a 3D fabric. In the width direction (i.e., "weft / filling" or "weft"), in addition to high-tenacity polyethylene terephthalate (PET), memory metal (e.g., nickel titanium) round wire and low-melting nylon may also be used. The melting temperature of the low-melting nylon resin may be designed to be in the range of 166-175°C.

[0040] After weaving the fabric, the method of making a docking device according to one or more embodiments of the present disclosure may involve pressing the fabric on a shape-setting mold (e.g., having a specific custom shape) at a temperature above the melting point of the low-melting nylon resin and heating for a period of time (e.g., 30-60 minutes) to melt the low-melting nylon. The molten nylon can act as an adhesive and can at least partially set the shape of the fabric. The method may further involve leaving the shape-setting fabric on the mold to cool for a period of time (e.g., 1 hour), and then removing the shape-setting fabric and covering it with a tubular braided fabric filled with foam or other at least partially compressible material (e.g., polymers, biocompatible alloys, etc.). The optional use of foam, polymers, or biocompatible alloys on the outside of the device can advantageously help reduce paravalvular leakage because such materials can be compressed during delivery to the annulus, and once deployment is completed, the material can be at least partially decompressed and form an improved seal. The optional use of a tubular textile around or for other compressible materials can help control the porosity of such materials, as foam or polymer materials may not be desired to be porous; an outer textile (eg, PET) cover can reduce permeability.

[0041] Universal docking device

[0042] Referring now to the illustrative drawings Figure 1, showing a universal docking device 100 according to one or more embodiments. The docking device 100 includes a three-dimensional (3D) woven fabric 10, which forms an inner surface 5, an outer surface 35 and has a thickness therebetween provided by the 3D properties of the fabric 10. In one embodiment, the 3D woven fabric can form a substantially hollow cylinder 30 having an outer surface 35 and an inner surface 5. In some embodiments, the 3D woven fabric can be formed into a ring or annular form or structure. Other shapes are also possible, depending on the prosthetic device or bioprosthetic device docked in or on the docking device 100. According to some embodiments, the docking device 100 can be inserted between an implantable heart valve and a native valve annulus to provide an improved conforming fit and / or to reduce the possibility and / or extent of paravalvular leakage.

[0043] The 3D woven fabric 10 can be a hybrid fabric including two or more of the following materials: polyethylene terephthalate (PET), shape memory alloy or metal (e.g., nickel titanium alloy, nitinol, etc.), low melting point nylon alloy and / or other materials, cloth, polymer, etc. The 3D woven fabric 10 can be manufactured using any suitable or desired weaving technology and / or construction / arrangement. For example, in the width direction (i.e., "weft", "weft"), memory alloy or metal (e.g., Ni-Ti) round wire and low melting point nylon can be used with high toughness PET, or memory metal wire can be used entirely in the weft / weft direction to increase the shape memory effect of the fabric. The woven fabric structure 10 can be woven in 2D, 3D, and can be configured to adapt to any anatomical structure by using the shape memory effect or superelastic effect of the memory metal wire or other materials of the fabric. The woven fabric 10 can be configured to adapt to any desired (one or more) human anatomical parts by changing the mold shape using a shape memory alloy. The fabric 10 may also be used in sheet form as a scaffold for tissue engineering, where the shape memory effect is tailored to any human anatomical shape.

[0044] In use, the docking device 100 can be compressed and delivered to an implantation site, such as by a catheter. At the implantation site, the docking device 100 can be expanded to fit and be retained at a local anatomical structure associated with the implantation site (e.g., a native heart valve annulus). The docking device 100 can then serve as a landing site for a prosthesis / bioprosthesis 200, such as a prosthetic heart valve (e.g., a transcatheter heart valve).

[0045] Figure 2 Deployment in accordance with one or more embodiments is shown Figure 1 A perspective view of a frame 200 of an exemplary transcatheter heart valve within a docking device. Figure 2, the docking device 100 can be inserted between a prosthesis / bioprosthesis 200, such as a transcatheter heart valve (THV), and native tissue, such as a native valve annulus (not shown). Optionally, some native tissue (e.g., leaflets, chordae tendineae, etc.) can be clamped between the docking device and the prosthesis / bioprosthesis to better secure or anchor the combination in a desired position. Although Figure 2 Only the frame of an exemplary transcatheter heart valve 200 is shown within the docking device 100, but it should be understood that in some embodiments, other devices besides a THV may also benefit from implantation within the docking device 200 and / or other docking devices according to embodiments of the present disclosure.

[0046] The docking device 100 can be constructed or designed to be implanted at any suitable or desired implantation site. However, the implantation sites of different patients can present relatively irregular shapes from patient to patient. By using the shape memory effect for the fabric 10, the docking device 100 can be used to adapt to irregular shapes. The device 100 can be constructed to be compressed and delivered to the implantation site via a catheter. At the delivery site, depending on whether a superelastic shape memory metal or polymer is used, the device 100 can expand by itself or by temperature stimulation to adapt to the size of the implantation site anatomical structure (e.g., a heart valve ring). The foam or other compressible material ( Figure 1 and Figure 2 The docking device 100 (not shown) can also advantageously fill the open space between the implantation site anatomy (eg, annulus) and the device 100 to create an effective seal. The docking device 100 can serve as a landing site for a prosthetic heart valve.

[0047] Figure 3A and 3B According to one or more embodiments Figure 1 100, wherein the docking device 100 optionally has a polymer foam 40 connected to the outer surface 35 of the docking device 100 and a tubular woven fabric 45 covering the polymer foam 40. Figure 3A and 3BAs shown, the docking device 100 may also include a filler 40 (also referred to herein as a "filler structure"), which is coupled to or can be coupled to the outer surface 35 of the hollow cylinder 30. The filler 40 may include a polymer foam. The polymer foam may be an open-cell foam or a closed-cell foam. In some embodiments, the form or structure of the filler 40 may be provided to partially or completely surround the circumference of the outer surface 35 of the hollow cylinder 30. In some embodiments, the filler 40 may include a compressible or expandable material that can fill the desired space. In some embodiments, the filler 40 may be or include a polymer foam. In some embodiments, the filler 40 may include medical grade silicone and / or a biocompatible alloy. In some embodiments, the filler may include one or more of polymer foam, polyurethane foam, polyvinyl chloride foam, polystyrene foam, polyimide foam, silicone foam, microporous foam and / or other types of fillers.

[0048] The filler structure 40 can be configured to be compressed during delivery of the docking device 100 to the implantation site (e.g., the valve annulus). Once deployed, the filler 40 can be configured to decompress to provide a compressible seal against the surrounding native tissue. This compressible seal can be optimized by varying the shape, size, and stiffness of the filler 40. For example, Figure 3A As shown, the filler 40 may be configured to cover a portion of the outer surface 35 of the hollow cylinder 30. Alternatively, as Figure 3B As shown, the filler can be configured to cover substantially all or at least a majority of the outer surface 35. In this manner, the configuration of the filler 40 can be optimized to enable the docking device 100 to conform itself to complex anatomical geometries and / or reduce paravalvular leakage in the case of a prosthetic heart valve.

[0049] In some embodiments, the filler 40 may be sized to cover at least 10%, at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, or 100% of the outer surface 35 of the hollow cylinder 30. In some embodiments, the filler may also be sized to cover a percentage of the outer surface including and between any two of the foregoing values.

[0050] Figure 4 is a cross-sectional perspective view of a tubular braided fabric 45 covering a polymer foam 40 according to one or more embodiments. In some embodiments, the filler component / structure of the docking device according to aspects of the present disclosure includes a material that is inherently too porous to completely prevent or reduce paravalvular leakage. Therefore, reference Figure 4In some embodiments, the filler 40 can be covered with a tubular woven fabric 45 such as PET. In some embodiments, the filler 40 can be fixed to the docking device by attaching the tubular woven fabric 45 to the outer surface 35 of the hollow cylinder 30 of the docking device, such as Figure 3A and 3B The docking device 100 shown in . For example, the tubular braided fabric 45 can be attached to the outer surface 35 by directly adhering or suturing the tubular braided fabric 45 to the outer surface 35. So constructed, the tubular braided fabric 45 with low porosity and reduced permeability can also reduce paravalvular leakage. The tubular braided fabric 45 can also be provided to protect or ensure that any undesirable particulate matter is prevented from being released from the filler 40, particularly for embodiments in which the filler 40 is made of porous and / or foam materials. Such particulate matter may be released due to friction forces exerted on the filler 40 during (one or more) delivery and / or implantation processes. The release of such particulate matter may be undesirable because it has a higher risk of embolism.

[0051] 3D woven fabric

[0052] In some embodiments, the present disclosure relates to relatively complex textile structures produced by utilizing weaving, plaiting, knitting and / or a combination thereof. Such textile structures can be produced using shape memory fibers or alloys (e.g., nitinol) in combination with one or more thermoplastic textile fibers (such as nylon, polyethylene terephthalate (PET), polypropylene (PP), polybutylene terephthalate (PBT), etc.). According to the hybrid textile structure of the present disclosure, a basic base fabric can be used and shape memory fibers can be laid on top of the base fabric using electrospinning or produced by winding low melting point nylon in a core sheath structure. As described above, the textile structure can be formed into a hollow cylindrical form, wherein the outer side of the cylindrical form is at least partially encapsulated by foam, polymer (e.g., medical grade silicone) and / or a biocompatible alloy.

[0053] The device according to some embodiments may include a three-dimensional (3D) woven fabric formed into a hollow cylinder, and a polymer foam attached to the hollow cylinder. The 3D woven fabric may advantageously include three different types of yarns or fibers as described in detail herein. For example, the 3D woven fabric may include one or more of the following types of yarns and / or fibers: shape memory material, low melting point thermoplastic polymer or resin, and high toughness biocompatible material.

[0054] An example embodiment of a 3D woven fabric for use with a docking device is described below. As described above, a 3D woven fabric according to an embodiment of the present disclosure may include three different types of fibers or yarns. In some embodiments, the three different types of fibers or yarns may include a combination of a shape memory material, a low melting point thermoplastic polymer or resin, and a high toughness biocompatible material. In some embodiments, the shape memory material may be or include a metal alloy. The metal alloy may contain nickel and / or titanium, such as nitinol. In one embodiment, the shape memory material may provide the desired shape and geometry of the device.

[0055] Regarding low melting point thermoplastic polymer or resin materials, in some embodiments, such materials can act as a binder or adhesive to fuse the woven layers of 3D fabric 10 together and conform 3D woven fabric 10 to a desired shape. In some embodiments, the low melting point thermoplastic polymer or resin can be or include, for example, nylon.

[0056] Low melting point thermoplastic polymer or resin can have relatively low melting point. According to optional aspect, the low melting point of low melting point thermoplastic polymer or resin can be 200 ℃ or lower, 195 ℃ or lower, 190 ℃ or lower, 185 ℃ or lower, 180 ℃ or lower, 175 ℃ or lower, 170 ℃ or lower, 165 ℃ or lower, 160 ℃ or lower, 155 ℃ or lower, 150 ℃ or lower, 145 ℃ or lower, 140 ℃ or lower, 135 ℃ or lower, 130 ℃ or lower, 125 ℃ or lower, 120 ℃ or lower, 115 ℃ or lower, 110 ℃ or lower, 105 ℃ or lower and 100 ℃ or lower. Low melting point can be in the range including any two of the aforementioned values ​​and between any two of the aforementioned values.

[0057] About high toughness biocompatible materials, such materials can improve the durability of 3D woven fabric 10 and promote tissue growth. In some embodiments, the toughness or fracture load of high toughness biocompatible materials can be about 5 grams / denier or higher, about 6 grams / denier or higher, about 7 grams / denier or higher, about 8 grams / denier or higher, about 9 grams / denier or higher, about 10 grams / denier or higher, about 11 grams / denier or higher, about 12 grams / denier or higher, about 13 grams / denier or higher, about 14 grams / denier or higher or about 15 grams / denier or higher. The fracture load can also be in the range of including any two of the aforementioned values ​​and / or between any two of the aforementioned values. In some embodiments, the high toughness biocompatible material can be PET.

[0058] In another embodiment, a method for making a docking device 100 for a prosthesis 200 (e.g., for a bioprosthesis) is described. One such method includes weaving a 3D woven fabric 10 by interweaving a shape memory material, a low melting point thermoplastic polymer or resin, and a high toughness biocompatible material. The shape memory material can be a metal alloy. The metal alloy can contain nickel and titanium such as nitinol. The low melting point thermoplastic polymer or resin can be a polymer with a low melting point. The polymer can be nylon. The high toughness biocompatible material can be PET.

[0059] 3D woven fabrics can generally be woven by manipulating yarns in length ("warp" or "ends"), width ("weft", "fill" or "pick"), and through-thickness directions. In some embodiments, the combination of a low-melting thermoplastic polymer and a 3D woven pattern can allow the thickness of the 3D woven fabric to vary based on the number of layers of weft yarns and warp yarns. Thus, in one aspect, the thickness of the 3D woven fabric can be increased by increasing the number of layers of weft yarns and warp yarns, wherein the low-melting thermoplastic polymer and through-thickness yarns bind the multiple layers together.

[0060] The yarns that penetrate the thickness can be orthogonal ( Figure 5A ), Multilayer( Figure 5B ) and angle interlock ( Figure 5C ) are incorporated into the woven structure at different levels and angles to obtain the desired mechanical properties. The weaving step can be performed on a conventional weaving machine or a specially made weaving machine. In some embodiments, braiding or knitting techniques can be used to make 3D fabrics. However, in some embodiments, such methods may not produce sufficient thickness.

[0061] refer to Figure 5A In one embodiment, the 3D woven fabric 10 may include an orthogonal braiding structure. The orthogonal braiding structure may include a group of warp yarns 15, a group of weft yarns 20, and a group of yarns 25 that penetrate the thickness. The warp yarns 15 may be placed along the length direction of the fabric, and the weft yarns 20 may be inserted between the length layers to form a double weft. The yarns 25 that penetrate the thickness may interconnect the other two yarn groups and provide structural integrity. The thickness of the orthogonal structure may be formed by the number of layers of warp yarns or weft yarns. In some embodiments, the yarns are substantially straight in the direction of the warp, weft, and penetration thickness. In some embodiments, the yarns that penetrate the thickness may generally travel vertically between the top and bottom weft yarn layers, and may also be interconnected with the weft yarn layers at other levels.

[0062] In some embodiments, the 3D woven fabric 10 may include an orthogonal woven structure, wherein the set of warp yarns 15 may include a shape memory material, the set of weft yarns 20 may include a low melting point thermoplastic polymer or resin, and the set of through-thickness yarns 25 may include a high tenacity biocompatible material.

[0063] In some embodiments, the 3D woven fabric 10 may include an orthogonal woven structure, wherein the set of warp yarns 15 may include a high tenacity biocompatible material, the set of weft yarns 20 may include a shape memory material, and the set of through-thickness yarns 25 may include a low melting point thermoplastic polymer or resin.

[0064] refer to Figure 5B In some embodiments, the 3D woven fabric 10 may include a multi-layer woven structure. The multi-layer woven structure may include a set of warp yarns 15, a set of weft yarns 20, and a set of binding yarns 25 through the thickness. The warp yarns 15 may be interwoven with the weft yarns 20 in each layer according to a weaving pattern in the in-plane main direction, and the binding yarns 25 may be interwoven with the warp yarns 15 in each layer according to a weaving pattern in the out-of-plane main direction. The multi-layer woven structure may be fully interwoven or semi-interwoven.

[0065] In some embodiments, the 3D woven fabric 10 may include a multi-layer woven structure, wherein the set of warp yarns 15 may include a shape memory material, the set of weft yarns 20 may include a low melting point thermoplastic polymer or resin, and the set of binding yarns 25 may include a high tenacity biocompatible material.

[0066] In some embodiments, the 3D woven fabric 10 may include a multi-layer woven structure, wherein the set of warp yarns 15 may include a high tenacity biocompatible material, the set of weft yarns 20 may include a shape memory material, and the set of binding yarns 25 may include a low melting point thermoplastic polymer or resin.

[0067] refer to Figure 5C In some embodiments, the 3D woven fabric 10 includes an angle interlocking woven structure. The angle interlocking woven structure according to the present disclosure may include a set of warp yarns 15, a set of straight weft yarns 20 (filler), and a set of bias weft yarns 25 woven together with the warp yarns 15 in a diagonal direction through the thickness. In a layer-by-layer angle interlocking weave (not shown), the bias weft yarns 25 may run between two or more consecutive layers, thereby interlacing with several filler yarns 20 according to the weaving pattern. In a through-thickness angle interlocking weave ( Figure 5C ), the bias weft yarns 25 may be bonded diagonally from the top layer to the bottom layer.

[0068] In some embodiments, the 3D woven fabric 10 may include an angled interlocking structure, wherein the set of warp yarns 15 may include a shape memory material, the set of straight weft yarns 20 may include a low melting point thermoplastic polymer or resin, and the set of bias weft yarns 25 may include a high tenacity biocompatible material.

[0069] In some embodiments, the 3D woven fabric 10 may include an angled interlocking structure, wherein the set of warp yarns 15 may include a high tenacity biocompatible material, the set of straight weft yarns 20 may include a shape memory material, and the set of bias weft yarns 25 may include a low melting point thermoplastic polymer or resin.

[0070] It should be understood that other kinds of 3D braided structures can be used in conjunction with the embodiments of the present disclosure, including different kinds of orthogonal, multi-layer and angle interlocking braided structures. In order to optimize the physical properties of the docking device 100 for use with a specific prosthesis / bioprosthesis 200 or installation site, any of the different kinds of 3D braided structures can be used to manufacture the 3D braided fabric 10.

[0071] For example, when used with a prosthetic / bioprosthetic heart valve, the docking device 100 can be subjected to compressive forces between the prosthetic / bioprosthesis 200 and the surrounding native valve tissue. The compressibility of the docking device 100 can be partly a function of the compressibility of the 3D braided fabric, which in turn can be a function of the braid structure, fabric density, and / or other characteristics of the constituent fibers / yarns of the fabric. Therefore, the braid structure and fabric density of the 3D braided fabric 10 can be selected to optimize the compressibility of the docking device 100.

[0072] Fabric density can be quantified by the number of warps per inch (EPI) and / or the number of picks per inch (PPI). In some embodiments, the 3D woven fabric 10 can have about 115EPI, about 120EPI, about 125EPI, about 130EPI, about 135EPI, about 140EPI, about 145EPI, about 150EPI, about 155EPI, about 160EPI, about 165EPI, about 170EPI, about 175EPI, about 180EPI, about 185EPI, about 190EPI, about 195EPI, about 200EPI, about 205EPI, about 210EPI, about 215EPI, about 220EPI, about 225EPI 1, about 230EPI, about 235EPI, about 240EPI, about 245EPI, about 250EPI, about 255EPI, about 260EPI, about 265EPI, about 270EPI, about 275EPI, about 280EPI, about 285EPI, about 290EPI, about 295EPI, about 300EPI, about 305EPI, about 310EPI, about 315EPI, about 320EPI, about 325EPI, about 330EPI, about 335EPI, about 340EPI, about 345EPI or about 350EPI. In some embodiments, the 3D woven fabric 10 can have a warp yarn per inch between and including any two of the aforementioned values.

[0073] In one embodiment, the 3D woven fabric 10 may have a PPI of about 115, about 120, about 125, about 130, about 135, about 140, about 145, about 150, about 155, about 160, about 165, about 170, about 175, about 180, about 185, about 190, about 195, about 200, about 205, about 210, about 215, about 220, about 225, about 230, about 235, about 236, about 237, about 238, about 239, about 240, about 241, about 242, about 243, about 244, about 245, about 246, about 247, about 248, about 249, about 250, about 251, about 252, about 253, about 254, about 256, about 257, about 258, about 259, 260, 261, 262, 263, 264, 265, 266, 267, 268, 269, 270, 271, 272, 273, 274, 275, 276, 277, 278, 279, 280, 281, 282, 283, 284, 285 1, about 230PPI, about 235PPI, about 240PPI, about 245PPI, about 250PPI, about 255PPI, about 260PPI, about 265PPI, about 270PPI, about 275PPI, about 280PPI, about 285PPI, about 290PPI, about 295PPI, about 300PPI, about 305PPI, about 310PPI, about 315PPI, about 320PPI, about 325PPI, about 330PPI, about 335PPI, about 340PPI, about 345PPI or about 350PPI. In some embodiments, the 3D woven fabric 10 can have a pick count per inch between and including any two of the aforementioned values.

[0074] In some embodiments, the docking device 100 exhibits a compressibility of no more than 5%, no more than 10%, no more than 15%, no more than 20%, no more than 25%, no more than 30%, no more than 35%, no more than 40%, no more than 45%, no more than 50%, no more than 55%, no more than 60%, no more than 65%, or no more than 70% throughout its thickness. In some embodiments, the docking device may exhibit a compressibility between and including any two of the foregoing values.

[0075] refer to Figure 6 , a method for manufacturing a docking device 100 for a prosthesis (e.g., for a bioprosthesis) may include the steps of pressing and heating a 3D knitted fabric 10 on a shape setting mold 50 at a temperature above the melting point of a low melting point thermoplastic polymer or resin. This step can melt the low melting point thermoplastic polymer or resin yarn, which can be used as an adhesive to set the shape of the 3D knitted fabric 10 as desired. In some embodiments, the 3D knitted fabric 10 can be heated on the shape setting mold 50 for about 30 minutes to about 60 minutes. In some embodiments, the prosthesis or bioprosthesis can be a transcatheter heart valve, and the 3D knitted fabric 10 can be molded accordingly. However, it should be understood that the 3D knitted fabric 10 can be molded to accommodate other prostheses / bioprostheses, or as a scaffold for tissue engineering.

[0076] In some embodiments, the method may further include a step of attaching filler 40 to surface 35 of 3D woven fabric 10, for example, by sewing filler 40 to surface 35 of 3D woven fabric 10. In another embodiment, the method may include a step of covering filler 40 with a tubular woven fabric 45 comprising, for example, polyethylene terephthalate (PET). In some embodiments, filler 40 may be a polymer foam.

[0077] By foregoing description, it should be understood that the present invention provides a universal docking device that can be radially compressed to deliver and implant and change shape and recover after removing the deforming stress. The docking device is adjusted to adapt to different complex anatomical geometries for surrounding conditions, and provides support that conforms, while minimizing or eliminating leakage around the implant device.

[0078] The present invention has been described in detail with reference only to the currently preferred embodiments. It will be appreciated by those skilled in the art that various modifications may be made without departing from the present invention. Therefore, the present invention is limited only by the following claims.

[0079] Additional Embodiments

[0080] According to an embodiment, some actions, events or functions of any process described herein can be performed in different orders, can be added together, merged or omitted. Therefore, in some embodiments, not all actions or events described are necessary for the practice of the process. In addition, in some embodiments, actions or events can be performed simultaneously.

[0081] Unless otherwise specifically stated or otherwise understood in the context as used, conditional language used herein, such as "can," "may," "might," "could," "for example," and the like, is intended in a general sense and is generally intended to express that some embodiments include certain features, elements, and / or steps, while other embodiments do not. Thus, such conditional language is generally not intended to imply that one or more embodiments require features, elements, and / or steps in any way, or that one or more embodiments must include logic for determining (with or without author input or prompting) whether such features, elements, and / or steps are included in or performed in any particular embodiment. The terms "include," "comprise," "have," and the like are synonymous and are used in their general sense and are used inclusively in an open-ended manner and do not exclude additional elements, features, actions, operations, and the like. In addition, the term "or" is used in its inclusive sense (rather than in its exclusive sense), so when used, for example, to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Unless specifically stated otherwise, conjunctions such as the phrase "at least one of X, Y, and Z" should be understood in light of the commonly used context to convey that an item, term, element, etc. may be any of X, Y, or Z. Thus, such conjunctions are not generally intended to imply that certain embodiments require that at least one of X, at least one of Y, and at least one of Z each be present.

[0082] It should be understood that in the above description of the embodiments, in order to simplify the present disclosure and help understand one or more of the various inventive aspects, various features are sometimes grouped together in a single embodiment, figure or its description. However, this method disclosed should not be interpreted as reflecting the intention that any claim requires more features than the features explicitly stated in the claim. In addition, any parts, features or steps shown and / or described in the specific embodiments of this article can be applied to any other one or more embodiments or used together with them. In addition, for each embodiment, the group of parts, features, steps or parts, features or steps is not necessary or indispensable. Therefore, the scope of the present invention disclosed and claimed herein should not be limited to the above-mentioned specific embodiments, but should only be determined by a fair reading of the attached claims.

Claims

1. A method for manufacturing a docking device for a prosthesis, the method comprising: Weaving a 3D knitted fabric by interweaving a shape memory material, a low melting point thermoplastic polymer having a melting point of 85 degrees Celsius to 200 degrees Celsius, and a high tenacity biocompatible material having a tenacity of 5 g / denier or more capable of improving the durability of the 3D knitted fabric and promoting tissue growth; and The 3D woven fabric is pressed and heated on a shape-setting die at a temperature above the melting point of the low-melting thermoplastic polymer.

2. The method of claim 1, wherein the low melting point thermoplastic polymer comprises a resin.

3. The method according to claim 1 or 2, wherein: The shape memory material includes Nitinol; The low melting point thermoplastic polymer comprises nylon; and The high-toughness biocompatible material includes polyethylene terephthalate (PET).

4. The method according to any one of claims 1 and 2, further comprising attaching a filler structure to a surface of the three-dimensional (3D) woven fabric. 5 . The method of claim 4 , wherein the attaching the filler structure comprises sewing the filler structure to the surface of the 3D woven fabric.

6. The method of claim 5, further comprising covering the filler structure with a tubular woven fabric comprising PET, wherein the filler comprises a polymer foam.

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