Sutures with porosity reducing elements and related medical devices

Abstract

Aspects of the present disclosure relate to devices, systems, and methods that include a flexible and elongate wire of defined length. The wire may include a core having a porous surface and a reduced porosity element on at least a portion of the core.

Description

[0001] This application is a divisional of the invention patent application with application number 201880081326.8 and invention name “Sutures and Related Medical Devices with Porosity Reducing Elements” filed by the applicant WL Gore & Associates Inc., which is the Chinese national phase of the international application with application number PCT / US2018 / 066825 and international application date of December 20, 2018, claiming the U.S. priority of US62 / 608,349.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. Patent Application No. 16 / 227,954, filed on December 20, 2018, which in turn claims the benefit of Provisional Application No. 62 / 608,349, filed on December 20, 2017, the entirety of which is incorporated herein by reference for all purposes. Technical Field

[0004] The present disclosure is generally directed to embodiments of sutures having improved properties. Background Art

[0005] Suture is a medical device used to fix skin, internal organs, blood vessels and other tissues of the human or animal body together when they are broken due to injury, incision, surgery, fracture, etc., and to fix human tissue to non-tissue (e.g., medical equipment). Similar to other methods of wound closure, sutures can be used to keep tissue edges together until healing can occur. Sutures can also be used in cardiovascular surgery, soft tissue approximation, vascular graft anastomosis, carotid endarterectomy, ventral hernia repair, inguinal hernia repair, oral surgery and conventional surgical suspension procedures. There are various sutures with different properties suitable for various uses. Generally, sutures must be strong, biocompatible and flexible to allow them to be used for suturing and forming suitable knots, and are usually long and thin cords or threads.

[0006] In permanent or long-term implants, sutures may degrade, stretch, or lose physical properties, leading to failure. In this sense, failure refers to any condition of the suture that is not conducive to its intended purpose. Therefore, improvements in sutures are needed to avoid suture failure. Summary of the invention

[0007] According to one example (“Example 1”), a suture device includes: a flexible and elongated thread that defines a length; a first end and a second end opposite the first end, the thread including a core extending from the first end to the second end, the core having a porous surface, the core further including an element for reducing porosity on at least a portion of the core, the element for reducing porosity being configured to eliminate pores on the surface of that portion of the core or cover the pores on the surface of that portion of the core.

[0008] According to another example (“Example 2”), which further defines the suture device of Example 1, the element for reducing porosity is an impermeable membrane that wraps around that portion of the core and is connected to that portion of the core.

[0009] According to another example (“Example 3”), which further defines the suture device of Example 2, the impermeable membrane is an ePTFE membrane having a microstructure with smaller pores than the microstructure of the surface of the core.

[0010] According to another example (“Example 4”), which further defines the suture device of any one of Examples 1-3, the element for reducing porosity is an elastomer, an elastic material, or a non-elastic TFE-PMVE copolymer coating on that portion of the core, such that the core surface at that portion of the core is non-porous.

[0011] According to another example (“Example 5”), which further defines the suture device of any one of Examples 1-3, the element for reducing porosity is an elastomer, an elastic material, or a non-elastic TFE-PMVE copolymer that is drawn into the pores of that portion of the core, such that the core surface at that portion of the core is non-porous.

[0012] According to another example (“Example 6”), which further defines the suture device of any one of Examples 1-3, the element for reducing porosity is an elastomer or an elastic material drawn into the pores of that portion of the core, and further includes a non-elastic TFE-PMVE copolymer coating on that portion of the core, such that the core surface at that portion of the core is non-porous.

[0013] According to another example (“Example 7”), which further defines the suture device of any one of Examples 1-3, the element for reducing porosity is a composite membrane that wraps around that portion of the core and is connected to that portion of the core, the composite membrane including: a porous membrane; an elastomer, an elastic material, or a non-elastic TFE-PMVE copolymer coating on the porous membrane or an elastomer, an elastic material, or a non-elastic TFE-PMVE copolymer drawn into the pores of the porous membrane, such that the porous membrane is non-porous.

[0014] According to another example (“Example 8”), which further defines the suture device of any one of Examples 1-3, the element for reducing porosity is an elastomer, elastic material or inelastic TFE-PMVE copolymer coating on that part of the core, and an elastomer, elastic material or inelastic TFE-PMVE copolymer inhaled into the pores of that part of the core, such that the core surface at that part of the core is non-porous.

[0015] According to another example (“Example 9”), which further defines the suture device of any one of Examples 4-7, the core comprises a fluoropolymer.

[0016] According to another example (“Example 10”), which further defines the suture device of Example 9, the TFE-PMVE copolymer comprises from about 40 wt% to about 80 wt% perfluoromethyl vinyl ether and from about 60 wt% to about 20 wt% tetrafluoroethylene, or wherein the TFE-PMVE copolymer comprises from about 33 wt% to about 39 wt% perfluoromethyl vinyl ether and the corresponding from about 72 wt% to about 61 wt% tetrafluoroethylene, or wherein the TFE-PMVE copolymer comprises from about 27 wt% to about 32 wt% perfluoromethyl vinyl ether and the corresponding from about 73 wt% to about 68 wt% tetrafluoroethylene, and the TFE-PMVE copolymer is present in the pores of the fluoropolymer such that the pores are covered or adsorbed.

[0017] According to another example (“Example 11”), which further defines the suture device of Example 9, the TFE-PMVE copolymer comprises from about 40 wt% to about 80 wt% perfluoromethyl vinyl ether and from about 60 wt% to about 20 wt% tetrafluoroethylene, or wherein the TFE-PMVE copolymer comprises from about 33 wt% to about 39 wt% perfluoromethyl vinyl ether and the corresponding from about 72 wt% to about 61 wt% tetrafluoroethylene, the TFE-PMVE copolymer is inhaled into the pores of that part of the core, and further comprises a coating of a TFE-PMVE copolymer comprising from about 27 wt% to about 32 wt% perfluoromethyl vinyl ether and the corresponding from about 73 wt% to about 68 wt% tetrafluoroethylene on that part of the core, such that the core surface at that part of the core is non-porous.

[0018] According to another example (“Example 12”), which further defines the suture device of any one of Examples 4-11, the elastomer or elastic material is configured to increase the viscosity of the core to improve knot retention.

[0019] According to another example (“Example 13”), which further defines the suture device of any one of Examples 1-12, the core comprises ePTFE.

[0020] According to another example ("Example 14"), which further defines the suture device according to any one of claims 1-13, the device further includes a first attachment element at the first end of the line, the first attachment element being configured to attach to a first position at a first tissue; and a second attachment element at the second end of the line, the second attachment element being configured to attach to a second position at a second tissue.

[0021] According to another example ("Example 15"), which further defines the suture device of Example 14, the composite film is helically wrapped around the core.

[0022] According to another example ("Example 16"), which further defines the suture device of Example 15, the line includes a certain length, and the composite film is formed by a first portion and a second portion helically wrapped around the core, the first portion and the second portion being wound in opposite directions along the length of the line.

[0023] According to another example ("Example 17"), which further defines the suture device of any one of Examples 1-16, the core comprises ePTFE, and the porosity-reducing element is a TFE-PMV copolymer comprising from about 40 wt% to about 80 wt% perfluoromethyl vinyl ether and from about 60 wt% to about 20 wt% tetrafluoroethylene, or a TFE-PMVE copolymer comprising from about 33 wt% to about 39 wt% perfluoromethyl vinyl ether and a corresponding from about 72 wt% to about 61 wt% tetrafluoroethylene, the TFE-PMVE copolymer being drawn into the pores of this portion of the core, and further including a coating of a TFE-PMVE copolymer comprising from about 27 wt% to about 32 wt% perfluoromethyl vinyl ether and a corresponding from about 73 wt% to about 68 wt% tetrafluoroethylene on this portion of the core, such that the core surface at this portion of the core is non-porous.

[0024] In Example 18, a chordal repair or replacement device including the line of any one of Examples 1-17, the chordal repair or replacement device further includes: a first attachment element connected to the first end of the line, the first attachment element being configured to attach to a first position at a first tissue; and a second attachment element connected to the second end of the line, the second attachment element being configured to attach to a second position at a second tissue.

[0025] According to another example ("Example 19"), which further defines the chordal repair or replacement device of Example 18, the first attachment element is releasably connected to a first tissue piercing member configured to pierce tissue, wherein the second attachment element is releasably connected to a second tissue piercing member configured to pierce tissue.

[0026] According to another example (“Example 20”), which further defines a chordal repair or replacement device as in any of Examples 18 - 19, at least a first portion of the wire between the first end and the second end is configured to be fixed to the second tissue, and further includes a pledget fixed in place on the first portion and configured to engage the second tissue.

[0027] According to another example (“Example 21”), a method for treating mitral or tricuspid valve defects includes: using a catheter - based device to access a cardiac region percutaneously; and using the device to repair a heart valve, wherein the repair includes reinforcing or replacing at least one chordae tendineae, and the replaced chordae tendineae include a suture device as in any of Examples 1 - 20.

[0028] According to another example (“Example 22”), a method for reducing or avoiding calcification of a suture used as a chordae tendineae substitute includes: using a catheter - based device to access a cardiac region percutaneously; and using the device to repair a heart valve, wherein the repair includes reinforcing or replacing at least one chordae tendineae, and the replaced chordae tendineae include a suture device as in any of Examples 1 - 20. Brief Description of the Drawings

[0030] The drawings are included to provide a further understanding of the present disclosure, are incorporated into and constitute a part of this specification, illustrate embodiments, and together with the specification are used to explain the principles of the present disclosure.

[0031] Figure 1 is a diagram of a suture device according to one embodiment;

[0032] Figure 2 is a diagram of another suture device according to one embodiment;

[0033] Figure 3 is a diagram of a suture device according to one embodiment;

[0034] Figure 4 is a diagram of another suture device according to one embodiment;

[0035] Figure 5 is a diagram of another suture device according to one embodiment;

[0036] Figure 6 is a diagram of a part of a suture device according to one embodiment;

[0037] Figure 7 is a diagram of a part of a suture device according to one embodiment;

[0038] Figure 8is a scanning electron microscope (SEM) image of a flexible wire of a suture device according to one embodiment;

[0039] Figure 9A is a scanning electron microscope (SEM) image of the core of a flexible wire of a suture device according to one embodiment, showing a more open microstructure than the microstructure of the Figure 9B embodiment;

[0040] Figure 9B is a scanning electron microscope (SEM) image of a membrane according to one embodiment, having a lower porosity or denser microstructure compared to the microstructure of the Figure 9A embodiment;

[0041] Figure 10 is a diagram of a patient's heart having chordae tendineae, papillary muscles, mitral valve leaflets, and a suture device according to one embodiment; and

[0042] Figure 11 is a graph of the results of adhesion tests of various compositions of a TFE-PMVE membrane according to an embodiment. DETAILED DESCRIPTION

[0043] Those skilled in the art will appreciate that various aspects of the present disclosure can be implemented by any number of methods and devices configured to perform the desired functions. It should also be noted that the figures referred to herein are not necessarily drawn to scale and may be enlarged to illustrate various aspects of the present disclosure, and in this regard, the figures should not be considered limiting.

[0044] Aspects of the present disclosure relate to sutures having improved properties. The sutures can be used within and around the heart to connect tissues or close wounds. For example, the sutures can be used in the repair or replacement of chordae tendineae. As discussed in detail below, the sutures can include improved knot-holding capabilities (knot strength and knot security) to allow for faster knot tying and smaller knots, as well as optimized surface properties for various applications (e.g., a non-porous surface for within the preperitoneal space to prevent adhesions, or a porous surface that requires tissue ingrowth).

[0045] The sutures (e.g., tissue connectors) discussed herein can be used in devices, methods, and systems and can be configured to reduce the chance of suture breakage. In certain applications, such as the repair or replacement of chordae tendineae, suture breakage can be a failure mode. In certain cases, and as discussed further below, the mechanical properties of the suture are designed to avoid in vivo breakage or rupture. Porous sutures are prone to depositing calcium and other blood components in the pores, leading to hardening and other material property changes that can cause failure. In this sense, failure refers to any suture condition that is adverse to the intended purpose. Calcification of the suture can lead to suture breakage, which can cause tissue injury or reduced heart valve function (e.g., when used for the repair or replacement of chordae tendineae). Calcification hardens the suture and can act as a stress concentrator, ultimately leading to suture failure / rupture. Thus, preventing the penetration of proteinaceous fluids and their retention within the pores of the suture can at least delay the onset of mineralization (e.g., calcification).

[0046] Additionally, some embodiments of the sutures discussed herein are soft, flexible, and compressible. As a result, the sutures minimize tissue irritation and prevent leakage around the tissue in which the sutures are placed. Further, if the sutures need to be knotted, some suture embodiments have surface features that are operable to better hold the knot while maintaining low surface friction, thereby allowing a single throw to slide easily for precise knot positioning.

[0047] As used herein, a suture can include a monofilament or multifilament polymer or natural fiber. A monofilament suture is a suture that includes a single fiber extending along the entire length of the suture. A multifilament suture includes multiple fibers extending along the entire length of the suture. The multifilament suture can include multiple monofilaments twisted or braided together, or a bundle of fibers twisted or braided together. Additionally, the multifilament suture can include multiple fibers twisted together, which are themselves also twisted together. Further, the multifilament suture can include a core that includes a monofilament or multifilament extending along the length of the line, which is surrounded by other monofilaments or multifilaments or a membrane (as in the case of a membrane-wrapped suture).

[0048] The embodiments described herein are referred to as composite sutures. A composite suture can be a monofilament or multifilament suture that also contains an elastomer, an elastic or inelastic TFE-PMVE copolymer, which coats the core of the suture and / or is absorbed into the porous core of the suture. Additionally, a composite suture can be an integral structure that includes an elastomer, an elastic or inelastic polymer.

[0049] Embodiments described herein may include a composite film or porosity-reducing element that wraps around and is attached to a core. The porosity-reducing element is an ePTFE film that also contains an elastomer, an elastic or inelastic TFE-PMVE copolymer, which may coat the film (e.g., an ePTFE core, silicone, urethane, or other similar material) and / or be absorbed into the porous structure of the film. As used herein, the porosity-reducing element may be used as a wrapper, for example, to wrap around a monofilament or multifilament suture core to form a composite suture as described herein.

[0050] For the purposes of this disclosure, a TFE-PMVE copolymer containing from about 40 wt% to about 80 wt% perfluoromethyl vinyl ether and the corresponding from about 20 wt% to about 60 wt% tetrafluoroethylene is considered an "elastomer".

[0051] For the purposes of this disclosure, a TFE-PMVE copolymer containing from about 33 wt% to about 39 wt% perfluoromethyl vinyl ether and the corresponding from about 67 wt% to about 61 wt% tetrafluoroethylene is considered an "elastic material".

[0052] For the purposes of this disclosure, a TFE-PMVE copolymer containing from about 27 wt% to about 32 wt% perfluoromethyl vinyl ether and the corresponding from about 73 wt% to about 68 wt% tetrafluoroethylene is not considered an elastomer or an elastic material, but is referred to herein as a "non-elastic TFE-PMVE copolymer". Compared to the above-mentioned elastomers and elastic TFE-PMVE copolymers, this non-elastic copolymer has the unique property of lower tack and is capable of passing the tack test provided herein. It should be understood that the degree of tack can be selected for a particular purpose. A suture with greater tack may have improved knot-holding ability, while a suture with less or no tack may have better handling properties in transcatheter procedures. Compared to the above-mentioned elastomers and elastic TFE-PMVE copolymers, this non-elastic TFE-PMVE copolymer has the unique property of showing less tack.

[0053] According to one embodiment of the composite suture, the core of the monofilament suture is coated with an elastomer, an elastic material, or a non-elastic TFE-PMVE copolymer. According to one embodiment, the core of the suture is dip-coated in the TFE-PMVE copolymer to form a coating on the suture. According to another embodiment, the core of the suture is dip-coated in the TFE-PMVE copolymer and further processed under heating and / or pressure to form a coating, and the TFE-PMVE copolymer is at least partially absorbed into the pores of the core of the suture. According to another embodiment, the core of the suture is wrapped with the TFE-PMVE copolymer and further processed under heating and / or pressure to form a coating, and / or the TFE-PMVE copolymer is at least partially absorbed into the pores of the suture. According to another embodiment, the core of the suture is wrapped with a second film of the non-elastic TFE-PMVE copolymer and further processed under heating and / or pressure to form a non-elastic TFE-PMVE copolymer coating on the suture. In this embodiment, the non-elastic TFE-PMVE copolymer coating significantly reduces the likelihood of the pores of the porous core of the suture (in one embodiment, an expanded fluoropolymer suture) accepting a fluid that may cause calcium deposition.

[0054] According to one embodiment of the core of the composite suture, the multifilament suture is coated with an elastomer, an elastic or inelastic TFE-PMVE copolymer, and the multifilament suture is coated as a whole or as individual filaments or fibers that make up the multifilament suture. According to one embodiment, the multifilament suture or individual filaments or fibers that make up the multifilament suture are dip-coated in a TFE-PMVE copolymer to form a coating on the suture. According to another embodiment, the suture or individual filaments or fibers that make up the multifilament suture are dip-coated into a TFE-PMVE copolymer and further processed under heat and / or pressure to form a coating, and the TFE-PMVE copolymer is at least partially drawn into the pores of the suture or into the pores of the individual filaments or fibers that make up the multifilament suture. According to another embodiment, the suture is wrapped with a film of TFE-PMVE copolymer and further processed under heat and / or pressure to form a coating, and the TFE-PMVE copolymer is at least partially absorbed into the pores of the suture. According to another embodiment, the suture or individual filaments or fibers that make up the multifilament suture are wrapped with a second film of inelastic TFE-PMVE copolymer and further processed under heat and / or pressure to form an inelastic TFE-PMVE copolymer coating on the suture or individual filaments or fibers that make up the multifilament suture. In this embodiment, the inelastic TFE-PMVE copolymer coating significantly reduces the likelihood that the pores of the porous suture or individual filaments or fibers that make up the multifilament suture (in one embodiment, an expanded fluoropolymer suture) are exposed or open to receive fluids or other blood components that may cause calcium deposition, which is partly due to any creep that may occur in the pores of the suture by the elastomer or elastic TFE-PMVE copolymer material during exposure to high-cycle bending.

[0055] Figure 1 FIG. is a diagram of an exemplary suture device 100 according to one embodiment. In some cases, the suture device 100 may include a composite suture, also referred to herein as line 102, a first tissue piercing member 104 disposed at one end of the line 102, and a second tissue piercing member 106 disposed at the other end of the line 102.

[0056] The first tissue piercing member 104 and the second tissue piercing member 106 may be attached to the line 102. Additionally, the first tissue piercing member 104 and the second tissue piercing member 106 may each be configured to pierce cardiac tissue. In some cases, the first tissue piercing member 104 and the second tissue piercing member 106 are releasably attached or connected to the line 102. In the case where the first tissue piercing member 104 and the second tissue piercing member 106 are releasably attached or connected to the line 102, the first tissue piercing member 104 and the second tissue piercing member 106 may be removed after the line 102 is positioned within the patient.

[0057] In some cases, the suture device 100 may include a suture 102, a first tissue piercing member 104 disposed at one end of the suture 102, and a second tissue piercing member 106 disposed at the other end of the suture 102.

[0058] The first tissue piercing member 104 and the second tissue piercing member 106 may be attached to the suture 102. Additionally, the first tissue piercing member 104 and the second tissue piercing member 106 may each be configured to pierce cardiac tissue. In some cases, a first attachment element 108 may be connected or attached to one end of the suture 102, and a second attachment element 110 may be connected or attached to the other end of the suture 102. The first attachment element 108 and the second attachment element 110 are configured to attach the suture 102 to cardiac tissue. The first attachment element 108 and the second attachment element 110 may be anchors that pierce tissue and hold the suture 102 between a first position and a second position, wherein the first attachment element 108 and the second attachment element 110 respectively pierce and hold tissue at or within the tissue surface at the first position and the second position. The first attachment element 108 and the second attachment element 110 may be barbs, fixation screws, or any similar structure.

[0059] In some cases, the suture 102 may be used to treat mitral or tricuspid valve defects. In these cases, a catheter-based device is used to access the cardiac region (e.g., the apical region) percutaneously. At least one chordae tendineae may be repaired or replaced (e.g., as Figure 10 shown). In some cases, the suture 102 (e.g., a tissue connector) includes a generally circular cross-section. In other cases, the suture 102 may be wound around the heart or valve annulus to ensure closure of the valve that is experiencing regurgitation. In these cases, the suture 102 compresses the heart or valve annulus to ensure complete closure of the valve leaflets. The suture 102 may be used to reduce or avoid calcification of the suture used as a chordae tendineae replacement, as will be described in further detail below.

[0060] In some cases, the suture 102 is flexible and includes an element that reduces porosity (e.g., as referenced Figure 3(Further detailed description). Within the spirit of this embodiment, various types of fluoropolymers and various types of porosity-reducing elements or composite membranes can be combined. It should also be readily understood that within the spirit of the embodiments of the present invention, the porosity-reducing elements or composite membranes can include various elastomers, various types of non-elastomeric components such as inorganic fillers, therapeutic agents, radiopaque markers, etc. The porosity-reducing element can wrap around and be coupled to the core. In one embodiment described in more detail below, by adding a relatively high percentage of a relatively low-strength elastomer, an elastic or non-elastic TFE-PMVE copolymer (e.g., a porosity-reducing element), the failure of line 102 is significantly reduced. Surprisingly, in some embodiments where the porous fluoropolymer membrane absorbs an elastomer, an elastic or non-elastic TFE-PMVE copolymer, the presence of the elastomer, elastic or non-elastic TFE-PMVE copolymer increases the total thickness of the suture, and due to the addition of the elastomer, elastic or non-elastic TFE-PMVE copolymer, the thickness of the fluoropolymer member increases. Unexpectedly, it does not significantly impede or reduce flexibility, but improves the calcification resistance. The pores of the expanded fluoropolymer membrane can absorb elastomers, elastic materials, and non-elastic materials by various methods known to those skilled in the art. It should also be readily understood that within the spirit of the embodiments of the present invention, the porosity-reducing elements or composite membranes can include various elastomers, various types of non-elastomeric components such as inorganic fillers, therapeutic agents, radiopaque markers, etc. The porosity-reducing element can wrap around and be connected to the core.

[0061] In one embodiment described in more detail below, the failure of line 102 is significantly reduced by adding a relatively high percentage of a relatively low-strength elastomer, an elastic or non-elastic TFE-PMVE copolymer (e.g., a porosity-reducing element) into the pores of the fluoropolymer suture core of line 102. Surprisingly, in some embodiments where the porous fluoropolymer membrane absorbs an elastomer, an elastic or non-elastic TFE-PMVE copolymer, the presence of the elastomer, elastic or non-elastic TFE-PMVE copolymer increases the total thickness of the suture, and thus the increase in the thickness of the fluoropolymer member due to the addition of the elastomer, elastic or non-elastic TFE-PMVE copolymer unexpectedly does not significantly impede or reduce flexibility, but improves the calcification resistance. The pores of the expanded fluoropolymer membrane can absorb elastomers, elastic materials, and non-elastic materials by various methods known to those skilled in the art.

[0062] In some embodiments, the composite suture or membrane wrap includes an expanded fluoropolymer material made of porous ePTFE, for example, as generally described in U.S. Patent No. 7,306,729. The expandable fluoropolymer used to form the expanded fluoropolymer suture or membrane wrap may include a PTFE homopolymer. In alternative embodiments, blends of PTFE, expandable modified PTFE, and / or expanded copolymers of PTFE may be used. Non-limiting examples of suitable fluoropolymer materials are described, for example, in U.S. Patent No. 5,708,044 to Branca, U.S. Patent No. 6,541,589 to Baillie, U.S. Patent No. 7,531,611 to Sabol et al., U.S. Patent Application Serial No. 11 / 906,877 to Ford, and U.S. Patent Application Serial No. 12 / 410,050 to Xu et al.

[0063] In one embodiment, the porosity-reducing element combined with ePTFE is a thermoplastic copolymer of tetrafluoroethylene (TFE) and perfluoromethyl vinyl ether (PMVE). This material binds to the surface of the expanded fluoropolymer core such that the material substantially occupies all of the void spaces or pores in the surface of the expanded fluoropolymer core. Filling of the pores in the surface of the expanded fluoropolymer core with the elastomer can be accomplished by a variety of methods, as will be discussed in further detail below. In another embodiment, the non-elastomeric material combined with ePTFE is a thermoplastic copolymer of tetrafluoroethylene (TFE) and perfluoromethyl vinyl ether (PMVE), such as that described above. This material binds to the surface of the expanded fluoropolymer substrate such that the material substantially occupies all of the void spaces or pores in the surface of the expanded fluoropolymer substrate. Filling of the pores in the surface of the expanded fluoropolymer core with the non-elastomeric TFE-PMVE copolymer can be accomplished by a variety of methods, as will be discussed in further detail below.

[0064] In certain cases, the TFE and PMVE components of the TFE-PMVE copolymer are expressed as weight percentages (wt%). For reference, wt% of PMVE of 40, 33 - 39, and 27 - 33 correspond to mol% of 29, 23 - 28, and 18 - 22, respectively. In certain cases, the TFE-PMVE copolymer is an elastomer, an elastic or non-elastic material.

[0065] Embodiments of the expanded fluoropolymer film in combination with a TFE-PMVE copolymer that exhibits elastomeric and inelastic properties provide the performance attributes needed for high-cycle bending implant applications (such as chordae tendineae repair or replacement) in at least several important ways. For example, the addition of a TFE-PMVE copolymer that exhibits elastomeric, elastic, and inelastic properties eliminates or reduces the hardening observed in materials that use only ePTFE, thereby improving the fatigue performance of the suture 102. Additionally, the likelihood of the material undergoing permanent deformation such as wrinkling or creasing, which can lead to a decline in performance, is reduced. In one embodiment, the TFE-PMVE copolymer that exhibits elastomeric, elastic, or inelastic properties substantially occupies all of the pore volume or space in the porous structure of the expanded fluoropolymer film. In another embodiment, the TFE-PMVE copolymer that exhibits elastic or inelastic properties is present in substantially all of the pores of at least one fluoropolymer layer. The filling of the pore volume or the presence of the TFE-PMVE copolymer that exhibits elastomeric, elastic, or inelastic properties in substantially all of the pores reduces the phenomenon of foreign matter potentially binding unfavorably to the suture core space.

[0066] An example of such foreign matter entering the potentially open pores or spaces in the composite suture is calcium, and the composite suture includes a porous expanded fluoropolymer monofilament having an elastomer or elastic TFE-PMVE copolymer in the pores. For example, as used in suture 102, if calcium is incorporated into the composite suture, mechanical damage occurs during cycling, resulting in a decline in structural properties.

[0067] A layer or coating of a TFE-PMVE copolymer containing from about 27 wt% to about 32 wt% perfluoromethyl vinyl ether and the corresponding from about 73 wt% to about 68 wt% tetrafluoroethylene significantly reduces the likelihood of the pores of the porous structure of the expanded fluoropolymer suture receiving or opening to receive calcium deposits or other blood components, and this significant reduction is partly due to the elastomer or elastic material in the pores of the expanded fluoropolymer suture.

[0068] The material according to one embodiment includes an expanded fluoropolymer suture and an elastic material within the pores of the expanded fluoropolymer, and further includes a coating of a TFE-PMVE copolymer that contains from about 27 wt% to about 32 wt% perfluoromethyl vinyl ether and from about 73 wt% to about 68 wt% tetrafluoroethylene. It should be readily understood that within the spirit of the present disclosure, various types of fluoropolymer sutures and various types of elastomeric, elastic, or inelastic TFE-PMVE copolymers can be combined for use in suture 102.

[0069] For the purposes of the present disclosure, a TFE-PMVE copolymer comprising from about 27 wt% to about 32 wt% perfluoromethyl vinyl ether and the corresponding from about 73 wt% to about 68 wt% tetrafluoroethylene is considered not an elastomer or elastic material, but is referred to herein as a "non-elastic TFE-PMVE copolymer". The non-elastic TFE-PMVE copolymer is insoluble and can thus be thermoformed, like extrusion, into a sheet suitable for connection to a suture or individual monofilaments of a multifilament suture.

[0070] In one embodiment, a method of coating a composite suture or individual monofilaments or fibers making up a multifilament suture with a non-elastic TFE-PMVE copolymer comprising from about 27 wt% to about 32 wt% perfluoromethyl vinyl ether and the corresponding from about 73 wt% to about 68 wt% tetrafluoroethylene, the composite suture or individual monofilaments or fibers being incorporated into an expandable fluoropolymer film that has absorbed an elastomer or elastic material, comprises the steps of contacting the composite suture or individual monofilaments or fibers making up a multifilament suture with a sheet of the non-elastic TFE-PMVE copolymer under conditions of heating and / or pressure such that the non-elastic TFE-PMVE copolymer becomes joined to the composite suture or individual monofilaments or fibers making up a multifilament suture.

[0071] For example, but not limited to, joining a 1.5 μm thick layer of the non-elastic TFE-PMVE copolymer to an ePTFE film incorporating an elastic TFE-PMVE copolymer comprising from about 33 wt% to about 39 wt% perfluoromethyl vinyl ether and the corresponding from about 72 wt% to about 61 wt% tetrafluoroethylene is effected by sandwiching the ePTFE film between two layers of the non-elastic TFE-PMVE copolymer at a pressure of 900 kPa and a temperature of 165 °C and holding for 15 minutes to cause bonding between the components.

[0072] In addition to porous membranes or monofilaments, it is to be understood that non-porous membranes or monofilaments can be coated with a non-elastic TFE-PMVE copolymer comprising from about 27 wt% to about 32 wt% perfluoromethyl vinyl ether and the corresponding from about 73 wt% to about 68 wt% tetrafluoroethylene suitable for a particular purpose. In this regard, it is to be understood that the non-elastic TFE-PMVE copolymer provides a non-sticky material that has anti-adhesion properties when the wire 102 is arranged in a delivery configuration prior to transcatheter placement. It is understood that medical devices provided with a non-sticky surface, such as but not limited to the wire 102, have particular operational advantages over those with a sticky or tacky surface.

[0073] According to one embodiment, the composite suture includes an elastic material and an ePTFE monofilament or multifilament suture, the elastic material comprising a TFE-PMVE copolymer having from about 33 wt% to about 39 wt% perfluoromethyl vinyl ether and the corresponding from about 67 wt% to about 61 wt% tetrafluoroethylene. In one embodiment, the TFE-PMVE copolymer is present in the pores of the ePTFE monofilament or multifilament suture.

[0074] According to another embodiment, the composite monofilament or multifilament suture includes an elastomeric material and a film of a fluoropolymer such as ePTFE or PTFE, the elastomeric material comprising from about 40 wt% to about 80 wt% perfluoromethyl vinyl ether and the corresponding from about 60 wt% to about 20 wt% tetrafluoroethylene.

[0075] Other biocompatible polymers that may be suitable for the embodiments of line 102 may include, but are not limited to, the group consisting of nylon, urethane, silicone (organopolysiloxane), copolymers of silicone-urethane, styrene / isobutene copolymers, polyisobutene, polyethylene-co-poly(vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers, and copolymers or mixtures of the foregoing.

[0076] Figure 2 FIG. is a diagram of another exemplary suture device 100 according to one embodiment. In some cases, the suture device 100 may include a line 102, a first tissue piercing member 104 disposed at one end of the line 102, and a second tissue piercing member 106 disposed at the other end of the line 102. The first tissue piercing member 104 and the second tissue piercing member 106 may be attached or releasably connected to the line 102. Additionally, the first tissue piercing member 104 and the second tissue piercing member 106 may each be configured to pierce cardiac tissue.

[0077] In some cases, the line 102 can be used to treat mitral or tricuspid valve defects. In these cases, a catheter-based device is used to access the apex region of the heart percutaneously. The heart valve is repaired by augmenting or replacing at least one chordae tendineae (e.g., as Figure 10 shown). The replaced chordae tendineae may include the line 102, and since the line 102 connects two portions of the cardiac tissue to which the repaired chordae tendineae are attached, the line 102 may be referred to as a tissue connector. In some cases, the line 102 includes a flexible line having a generally circular cross-section. In some cases, the line 102 may further include a swab 212 (or other similar wound stopping structure) secured in place on the line 102. The swab 212 can protect the tissue from tearing. The swab 212 or similar stop device mounted on the end of the line 102 allows the line 102 to be fully pulled through the tissue until it reaches the swab 212. Then, the swab 212 or stopper can be left in place or sutured in place to increase security.

[0078] Figure 3 is a diagram of an exemplary suture device 100 according to one embodiment. The suture device 100 includes a thread 102 having a longitudinal axis 320. As Figure 3 shown, the thread 102 includes a monofilament or multifilament suture in the form of a core 322, the core 322 having a primary strength oriented along the longitudinal axis 320. In some cases, the core 322 extends from a first end to a second end of the thread 102 and includes a porous surface. The thread 102 also includes a porosity-reducing element 324 on at least a portion of the core 322, which is configured to eliminate pores on the surface of that portion of the core 322 or cover the pores on the surface of that portion of the core 322. The porosity-reducing element 324 (e.g., a porous expanded fluoropolymer film having an elastomer, elastic or inelastic TFE-PMVE copolymer in the pores) can be connected to at least a portion of the core 322. In some cases, the porosity-reducing element 324 is a non-permeable membrane that wraps around and is connected to a portion of the core 322. Additionally, the non-permeable membrane is an ePTFE membrane having a microstructure with smaller pores than the microstructure of the surface of the core 322.

[0079] Further, the strength of the core 322 can be oriented along the longitudinal axis 320 and it is the primary strength of the core 322. The core 322 can be a fluoropolymer material having fibrils. Most or a greater number of the fibrils of the core 322 can be oriented along the longitudinal axis 320 such that the primary strength of the core 322 is also oriented in that direction.

[0080] In some cases, the porosity-reducing element 324 can be a strip connected to the surface of the core 322. As Figure 3 shown, the porosity-reducing element 324 wraps helically around the core body 322. In other cases, the porosity-reducing element 324 can be wound around the core 322 in a form similar to joining the edges of the porosity-reducing element 324 together to seal the core 322.

[0081] As discussed in detail above with reference to Figure 3 the core 322 can be formed of a porous expanded fluoropolymer (e.g., ePTFE). In some cases, the thread 102 can include a TFE / PMVE copolymer within the pores of the porous expanded fluoropolymer core. The TFE / PMVE copolymer can contain from about 40 wt% to about 80 wt% perfluoromethyl vinyl ether and from about 60 wt% to about 20 wt% tetrafluoroethylene. The elastic copolymer can include a TFE-PMVE copolymer that contains from about 33 wt% to about 39 wt% perfluoromethyl vinyl ether and the corresponding from about 72 wt% to about 61 wt% tetrafluoroethylene.

[0082] In some cases, the porosity-reducing element 324 is an elastomer, an elastic material, or an inelastic TFE-PMVE copolymer coating on a portion of the core 322 such that the surface of the core 322 at that portion of the core 322 is non-porous. Additionally, the porosity-reducing element 324 can be an elastomer, an elastic material, or an inelastic TFE-PMVE copolymer drawn into the pores of a portion of the core 322 such that the surface of the core 322 at that portion of the core 322 is non-porous. In some cases, the porosity-reducing element 324 is an elastomer or an elastic material drawn into the pores of a portion of the core 322 and further includes an inelastic TFE-PMVE copolymer coating on that portion of the core 322 such that the surface of the core 322 at that portion of the core 322 is non-porous.

[0083] In some cases, the core 322 includes a fluoropolymer. Additionally, the TFE-PMVE copolymer of the porosity-reducing element 324 can include from about 40 wt% to about 80 wt% perfluoromethyl vinyl ether and from about 60 wt% to about 20 wt% tetrafluoroethylene, or the TFE-PMVE copolymer can include from about 33 wt% to about 39 wt% perfluoromethyl vinyl ether and the corresponding from about 72 wt% to about 61 wt% tetrafluoroethylene, or the TFE-PMVE copolymer can include from about 27 wt% to about 32 wt% perfluoromethyl vinyl ether and the corresponding from about 73 wt% to about 68 wt% tetrafluoroethylene, and the TFE-PMVE copolymer is present in the pores of the fluoropolymer such that the pores are covered or adsorbed.

[0084] In some cases, the TFE-PMVE copolymer of the porosity-reducing element 324 can include from about 40 wt% to about 80 wt% perfluoromethyl vinyl ether and from about 60 wt% to about 20 wt% tetrafluoroethylene, or the TFE-PMVE copolymer can include from about 33 wt% to about 39 wt% perfluoromethyl vinyl ether and the corresponding from about 72 wt% to about 61 wt% tetrafluoroethylene, the TFE-PMVE copolymer is drawn into the pores of a portion of the core 322 and can further include a coating of a TFE-PMVE copolymer including from about 27 wt% to about 32 wt% perfluoromethyl vinyl ether and the corresponding from about 73 wt% to about 68 wt% tetrafluoroethylene on that portion of the core 322 such that the surface of the core 322 at that portion of the core is non-porous.

[0085] In some cases, the core 322 comprises ePTFE, the porosity-reducing element 322 is a TFE-PMVE copolymer comprising from about 40 wt% to about 80 wt% perfluoromethyl vinyl ether and from about 60 wt% to about 20 wt% tetrafluoroethylene, or a TFE-PMVE copolymer comprising from about 33 wt% to about 39 wt% perfluoromethyl vinyl ether and the corresponding from about 72 wt% to about 61 wt% tetrafluoroethylene, the TFE-PMVE copolymer is drawn into the pores of a portion of the core 322, and further comprises a coating on this portion of the core 322 of a TFE-PMVE copolymer comprising from about 27 wt% to about 32 wt% perfluoromethyl vinyl ether and the corresponding from about 73 wt% to about 68 wt% tetrafluoroethylene, such that the surface of the core 322 at this portion of the core 322 is non-porous.

[0086] Figure 4 FIG. is a diagram of another exemplary suture device 100 according to one embodiment. The suture device 100 includes a thread 102 having a longitudinal axis 320, wherein the thread 102 includes a core 322 having a strength 426 oriented along the longitudinal axis 320 of the thread 102. Additionally, a porosity-reducing element 324 can be attached to or connected with at least a portion of the core 322. The porosity-reducing element 324 (e.g., a porous expanded fluoropolymer film having an elastomer, elastic or inelastic TFE-PMVE copolymer in the pores) can be configured to reduce the porosity of the surface of the thread 102.

[0087] In some cases, the porosity-reducing element 324 is attached to the core 32, as Figure 4 shown. Additionally, the strength of the core 322 can be oriented along the longitudinal axis 320 and it is the primary strength of the core 322. As Figure 4 shown, the porosity-reducing element 324 covers the core 322. The porosity-reducing element 324 can be wrapped around the core 322 (which can be porous), and then further processed under heating and / or pressurizing conditions to attach the porosity-reducing element 324 to the core 322.

[0088] Figure 5FIG. is an illustration of another exemplary suture device 100 according to one embodiment. The suture device 100 includes a thread 102 having a core 322. The core 322 can be a monolithic thread 102 having a reduced porosity element 324 (e.g., a composite film including an elastomer, an elastic or inelastic TFE-PMVE copolymer, or a composite film including an elastomer, an elastic or inelastic TFE-PMVE copolymer and an ePTFE film) bonded to the core 322. In some cases, the reduced porosity element 324 is absorbed within the core 322. In other cases, the pores of the core 322 are filled by dissolving an elastomer in a solvent that is suitable to make the resulting solution have a viscosity and surface tension suitable for partially or fully flowing into the pores of the core 322. The core 322 having the expanded fluoropolymer elongate body allows the solvent to evaporate, leaving the elastomer or elastic copolymer.

[0089] In one embodiment, a method of filling at least a portion of the pores of the core 322 includes the steps of delivering a filler by dispersion to cause the filler to partially or fully fill the pores. In another embodiment, the pores of the core 322 can be filled by first filling the pores with a prepolymer of an elastomer and then at least partially curing the elastomer, thereby polymerizing the reduced porosity element 324 in the pores of the core 322.

[0090] Figure 6 FIG. is an illustration of a portion of an exemplary suture device according to one embodiment. As Figure 6 shown, the core 322 is formed of a bundled or twisted fluoropolymer or fluoropolymer composite (as described in detail above). As described in detail above, the bundled or twisted core 322 can have uniform or non-uniform ridges to form a flexible thread. The bundled or twisted core 322 can allow for a controlled distribution of strength to align with the core.

[0091] To form the bundled or twisted core 322, a flat membrane is radially gathered, bundled or twisted together to produce a linear structure of the bundled or twisted core 322 having a more uniform diameter.

[0092] Figure 7 FIG. is an illustration of a portion of an exemplary suture device according to one embodiment. As Figure 7 shown, the reduced porosity element 324 is formed of a first portion 732 and a second portion 734. The first portion 732 and the second portion 734 can be woven together along the length of the flexible thread. In some cases, the first portion 732 and the second portion 734 are wound or woven in opposite directions. In these cases, when the first portion 732 and the second portion 734 are disposed on the flexible thread, the first portion 732 and the second portion 734 can tighten as the flexible thread is extended. The first portion 732 and the second portion 734 can allow for a controlled distribution of strength to align with the core.

[0093] Figure 8 is a scanning electron microscope (SEM) image of an exemplary thread 102 of a suture device according to one embodiment. Figure 8 A cross section of an exemplary line 102 is shown, which has been enhanced by wrapping a core 322 with an element 324 that reduces porosity. In some cases, the core 322 is formed of polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE). The element 324 that reduces porosity can be ePTFE, a TFE-PMVE copolymer, or other similar materials that maintain the flexibility and strength of the core 322. The core 322 can be a porous structure having an element 324 that reduces porosity, which is configured to cover the core 322 and reduce the chance of calcification. In addition, the core 322 can be flexible, and the element 324 that reduces porosity maintains the flexibility of the core 322, so that the line 102 is configured to mimic the flexibility of natural tendons.

[0094] Figure 9A is a scanning electron microscope (SEM) image of the core of the flexible wire 102 according to one embodiment, which shows that Figure 9B The microstructure of the embodiment is more open. Figure 9A As shown, the wire 102 includes a core 322 that is a porous structure. Figure 9B The core 322 is shown after the porosity reducing element 324 (e.g., TFE-PMVE copolymer) is imbibed to fill or cover the pores of the core 322. Figure 9A In some cases, the flexible wire 102 can be coated, impregnated or wrapped with a porosity-reducing element 324 to fill or cover the pores of the core 322. The wire 102 with the pores covered, coated or adsorbed reduces the chance of calcification.

[0095] Figure 10 is an illustration of a patient's heart with chordae tendineae, papillary muscles, mitral valve leaflets, and a suture device according to one embodiment. Figure 10 The left side of a patient's heart 1000 is shown, including an aortic arch 1004, a left atrium 1006, a left ventricle 1008, and a mitral valve 1010 located between the left atrium 1006 and the left ventricle 1008. Chordae 1002a-g are attached at one end to the leaflets of the mitral valve 1010 and at the other end to the papillary muscles 1012 in the left ventricle 1008. The leaflets of the mitral valve 1010 (and the tricuspid valve) are thin, transparent structures that rely on a system of chordae 1002a-g to maintain the ability of the valve under load. These chordae 1002a-g attach the papillary muscles to the valve leaflets.

[0096] Stretched, ruptured, or broken chordae tendineae 1002a-g can alter the function of the leaflets of the mitral valve 1010. In these cases, for example, the mitral valve 1010 may no longer fully engage or close. As a result, blood can flow from the left ventricle 1008 back into the left atrium 1006 (e.g., mitral regurgitation). As discussed in detail above, the transcatheter delivery method and implantation of the wire 102 for replacement or repair of the chordae tendineae can reduce the morbidity and mortality risks.

[0097] Figure 11 Is a graph of the results of the tack tests of the various compositions of the TFE-PMVE film. Note that TFE-PMVE films with a weight percentage of a pair of perfluoromethyl vinyl ethers greater than 27% exhibit positive tack results. For TFE-PMVE compositions having equal to or less than about 27 weight % of perfluoromethyl vinyl ether, no tack was found.

[0098] According to some embodiments, the wire 102 will pass a tack test as provided herein. The tack test evaluates the resistance of the wire 102 to adhere to another surface as discussed in detail above. Based on the tackiness tests of the various compositions of the TFE-PMVE copolymer, multiple pairs of TFE-PMVE films were provided, each member of the pair containing a similar weight percentage of perfluoromethyl vinyl ether and a corresponding weight percentage of tetrafluoroethylene, and they were placed in direct contact with each other. Then, each pair of TFE-PMVE films was sandwiched between polyimide films and pressed in an M-type Carver press (Carver Laboratory Press, Wabash, Indiana, USA) at 39 °C and 200 psi for 15 minutes. After 15 minutes, the paired TFE-PMVE films were removed from the press and the polyimide films were removed. Then, if there is no adhesion force between the two TFE-PMVE films and no force is required to separate the two TFE-PMVE films, the TFE-PMVE composition is determined to be "non-tacky". A pair of two TFE-PMVE films that requires the use of force to separate the two TFE-PMVE films from each other is determined to be "tacky". It can be understood that the wire adjusted in the above treatment method will show similar results related to tackiness.

[0099] The invention of the present application has been generally described above and in connection with specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments described herein without departing from the spirit and scope of the invention. Accordingly, the embodiments are intended to cover such modifications and variations of the invention as long as they are within the scope of the appended claims and their equivalents.

Claims

1. A suture device, which comprises: A flexible and elongated thread that defines a length, a first end, and a second end opposite the first end. The thread includes a core extending from the first end to the second end, and the core further includes a composite film. The composite film includes a first portion spirally wrapped around the core in a first direction and a second portion spirally wrapped around the core in a second direction, and the second direction is opposite to the first direction along the length of the thread.

2. The suture device according to claim 1, wherein, It further includes a first attachment element at the first end of the thread, and the first attachment element is configured to attach to a first position at a first tissue; And a second attachment element at the second end of the thread, and the second attachment element is configured to attach to a second position at a second tissue.

3. The suture device according to claim 1, wherein, The core has a porous surface.

4. The suture device according to claim 3, wherein, The composite film is an element that reduces porosity and is located on at least a portion of the core.

5. The suture device according to claim 4, wherein, The composite film covers the porous surface of the core.

6. The suture device according to claim 4, wherein, The composite film is a non-permeable membrane.

7. The suture device according to claim 4, wherein, The composite film includes an ePTFE membrane with a microstructure that has smaller pores than the microstructure of the surface of the core.

8. The suture device according to claim 1, wherein, The composite film is connected to a portion of the core.

9. The suture device according to claim 1, wherein, The core is formed of a twisted fluoropolymer or a fluoropolymer composite material.

10. The suture device according to claim 9, wherein, The core is formed of flat membranes radially aggregated, bundled, or twisted together.

11. The suture device according to claim 1, wherein, The composite film includes an elastomeric TFE-PMVE copolymer, an elastic material TFE-PMVE copolymer, or a non-elastomeric TFE-PMVE copolymer coating on the portion of the core, such that the core surface at the portion of the core is non-porous.

12. The suture device according to claim 1, wherein, The composite film includes an elastomer, an elastic material, or a non-elastomeric TFE-PMVE copolymer inhaled into the pores of the portion of the core, such that the core surface at the portion of the core is non-porous.

13. The suture device according to claim 1, wherein, The composite film includes an elastomer or an elastic material inhaled into the pores of the portion of the core, and further includes a non-elastomeric TFE-PMVE copolymer coating on the portion of the core, such that the core surface at the portion of the core is non-porous.

14. The suture device according to claim 1, wherein, The composite film includes an elastomer, an elastic material, or a non-elastomeric TFE-PMVE copolymer on the portion of the core and inhaled into the pores of the portion of the core, such that the core surface at the portion of the core is non-porous.

15. A suture device, which comprises: A flexible and elongated line that defines a length, a first end, and a second end opposite the first end, the line including a core extending from the first end to the second end, the core being formed of a twisted fluoropolymer or fluoropolymer composite material and having a porous surface, the line further including an element for reducing porosity, the element for reducing porosity including a first portion helically wrapped around the core.

16. The suture device according to claim 15, wherein, the core is formed of flat diaphragms radially aggregated, bundled, or twisted together.

17. The suture device according to claim 15, wherein, the element for reducing porosity includes a second portion helically wrapped around the core along a direction opposite to the first portion of the element for reducing porosity.

18. The suture device according to claim 15, wherein, the element for reducing porosity is a composite film.

19. The suture device according to claim 18, wherein, the composite film is a non-permeable film.

20. The suture device according to claim 18, wherein, the composite film includes an ePTFE film having a microstructure with smaller pores than the microstructure of the surface of the core.

21. A suture device, which comprises: a flexible and elongated line that defines a length, the line including a core, the line further including a film, the film including a first portion helically wrapped around the core along a first direction; and a swab connected to the line.

22. The suture device according to claim 21, wherein, the swab is fixedly positioned on the line.

23. The suture device according to claim 21, wherein, the swab is positioned against the tissue.

24. The suture device according to claim 21, wherein, the swab is configured to be sutured to the tissue.

25. The suture device according to claim 21, wherein, the line includes a second portion helically wrapped around the core.

26. The suture device according to claim 25, wherein, the second portion is helically wrapped along a second direction, the second direction being opposite to the first direction along the length of the line.

27. The suture device according to claim 21, wherein, the core has a porous surface.

28. The suture device according to claim 21, wherein, the film is a composite film.

29. The suture device according to claim 21, wherein, the film is an element for reducing porosity located on at least a portion of the core.

30. The suture device according to claim 21, wherein, the film has a microstructure with smaller pores than the microstructure of the surface of the core.

31. The suture device according to claim 21, wherein, the film includes an elastomeric TFE-PMVE copolymer, an elastic material TFE-PMVE copolymer, or a non-elastic TFE-PMVE copolymer coating on the portion of the core such that the core surface at the portion of the core is non-porous.

32. The suture device according to claim 21, wherein, The membrane includes an elastomer, an elastic material, or an inelastic TFE-PMVE copolymer that is drawn into the pores of the portion of the core such that the core surface at the portion of the core is non-porous.

33. The suture device according to claim 21, wherein, the membrane includes an elastomer or an elastic material drawn into the pores of the portion of the core and further includes an inelastic TFE-PMVE copolymer coating on the portion of the core such that the core surface at the portion of the core is non-porous.

34. The suture device according to claim 21, wherein, the membrane includes an elastomer, an elastic material, or an inelastic TFE-PMVE copolymer on and drawn into the pores of the portion of the core such that the core surface at the portion of the core is non-porous.

35. The suture device according to claim 21, wherein, the thread includes a first end and a second end, the first end being connected to a first tissue piercing member and the second end being connected to a second tissue piercing member.

36. The suture device according to claim 36, wherein, a swab is disposed along the thread between the first tissue piercing member and the second tissue piercing member.

37. The suture device according to claim 36, wherein, the thread passes through the swab twice.

38. A suture device, which comprises: a flexible and elongated thread that defines a length, the thread including a core, the thread further including a membrane that includes a first portion helically wrapped around the core; and a swab connected to the thread, the thread passing through the swab twice.

39. The suture device according to claim 38, wherein, the core has a porous surface.

40. The suture device according to claim 38, wherein, the membrane is a composite membrane.

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