Dynamic suture material to adapt to the normal soft tissue healing process

Abstract

In general, the disclosed suture includes a filament that includes a first material and a second material, wherein the first material is bonded to the second material, the first material is absorbable, and the second material is non-absorbable.

Description

[0001] DYNAMIC SUTURE MATERIAL TO ADAPT TO THE NORMAL SOFT TISSUE HEALING PROCESS

[0002] TECHNICAL FIELD

[0003] The embodiments generally relate to the field of sutures.

[0004] BACKGROUND

[0005] Sutures are commonly made of either absorbable material or non-absorbable material, but not both absorbable material and non-absorbable material.

[0006] SUMMARY

[0007] This summary is provided to introduce a variety of concepts in a simplified form that is further disclosed in the detailed description of the embodiments. This summary is not intended to identify key or essential inventive concepts of the claimed subject matter, nor is it intended for determining the scope of the claimed subject matter.

[0008] According to a first aspect of the present invention, a suture can include a filament that includes a first material and a second material, wherein: the first material is bonded to the second material; the first material is absorbable; and the second material is nonabsorbable.

[0009] Preferably, the first material includes vicryl, dexon, monocryl, polyglycolic acid (PGA), polydioxanone (PDS), poly-L-lactic acid (PLLA), or any combination thereof.

[0010] Preferably, the second material includes polyester, polyethylene terephthalate (PET), polyethylene, nylon, or any combination thereof.

[0011] Preferably, the suture includes an elongate core made primarily of the second material, wherein the elongate core is surrounded by a sheath made primarily of the first material.

[0012] According to a second aspect, a suture can include a first filament that includes a first material, wherein the first material is absorbable; and a second filament that includes a second material, wherein the second material is non-absorbable; wherein the first filament and the second filament are braided.

[0013] According to a third aspect, a suture can include a first filament that includes a first material and a second material, wherein: the first material is bonded to the second material; the first material is absorbable; and the second material is non-absorbable; a second filament that includes a third material and a fourth material, wherein: the third material is bonded to the fourth material; the third material is absorbable; and the fourth material is non-absorbable; wherein the first filament and the second filament are braided.

[0014] Other illustrative variations within the scope of the invention will become apparent from the detailed description provided hereinafter. The detailed description and enumerated variations, while disclosing optional variations, are intended for purposes of illustration only and are not intended to limit the scope of the invention.

[0015] BRIEF DESCRIPTION OF THE DRAWINGS

[0016] A more complete understanding of the embodiments, and the attendant advantages and features thereof, will be more readily understood by references to the following detailed description when considered in conjunction with the accompanying drawings wherein:

[0017] FIG. 1 illustrates an illustrative depiction of a cross-section of a suture as disclosed herein;

[0018] FIG. 2 illustrates an illustrative depiction of a cross-section of a suture as disclosed herein;

[0019] FIG. 3 illustrates an illustrative depiction of a cross-section of a suture as disclosed herein; and

[0020] FIG. 4 illustrates an illustrative depiction of a cross-section of a suture as disclosed herein.

[0021] The drawings are not necessarily to scale, and certain features and certain views of the drawings may be shown exaggerated in scale or in schematic in the interest of clarity and conciseness.

[0022] DETAILED DESCRIPTION

[0023] The specific details of the single embodiment or variety of embodiments described herein are to the described product or methods of use. Any specific details of the embodiments are used for demonstration purposes only and no unnecessary limitations or inferences are to be understood from there.

[0024] It is noted that the embodiments reside primarily in combinations of components and procedures related to the products. Accordingly, the product and components have been represented where appropriate by conventional symbols in the drawings, showing only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the disclosure with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein.

[0025] Musculoskeletal soft tissue repair has evolved over the decades from natural nonabsorbable sutures to synthetic non-absorbable sutures and to absorbable sutures. With this evolution, sutures of varying diameters were developed and the tensile strength of sutures improved relative to their diameter size. With the advent of polymer-based suture material, the handling and potential soft tissue irritation issues became apparent. Knot tying irritation issues and knot prominence irritation issues became the biggest disadvantages of these polymer-based sutures and the move from monofilament to braided sutures addressed the knot tying irritation issues while the knot prominence irritation issues were exacerbated.

[0026] In general, the embodiments disclosed herein can address these and other issues. In some embodiments, the suture can include at least two materials. In some embodiments, a first material of the at least two materials can be absorbable and a second material of the at least two materials can be non-absorbable. In some embodiments, the first material of the at least two materials is non-absorbable and the second material of the at least two materials is absorbable.

[0027] Suture size and strength are common characteristics used for selecting an appropriate suture for surgical procedures. In some embodiments, since at least one of the at least two materials of the suture can be absorbable, the size (e.g., width and / or diameter) of the suture can decrease over time, and for example, can decrease while a sutured wound heals. When the size of the suture decreases, natural tissue can re-enter the wounded site more quickly, allowing the wounded site to heal faster.

[0028] Since the non-absorbable material(s) of the suture are not absorbed, the strength of the suture is maintained over time while the absorption of the absorbable material(s) allows the natural tissue of the body to regrow and re-enter the wounded site. As the wounded site begins to heal, the required strength of the suture decreases, which prevents the suture from breaking as its size decreases. The suture can remain sufficiently strong for even orthopedic applications. When the size of the suture decreases, the amount of space in the wounded site that is occupied by the suture also decreases, which reduces patient discomfort. Natural bodily processes can begin to repair the wounded site and, with a smaller suture, more of the natural tissue can be restored.

[0029] In general, the embodiments disclosed herein relate to a suture that can be used to perform any musculoskeletal soft tissue repair. For example, the suture can be used to perform a tendon-to-tendon repair, a ligament-to-ligament repair, a tendon-to-bone repair, a ligament-to- bone repair, a fascial tissue repair, a cutaneous repair, a subcutaneous repair, or any combination thereof. In some embodiments, the suture can be of any desired length suitable for performing any musculoskeletal soft tissue repair. In some embodiments, the suture can be formed by bonding the at least two materials. In some embodiments, the at least two materials can be thermally bonded. In some embodiments, the suture can be formed as a single composite filament. In some embodiments, forming the suture can include spinning the at least two materials. Spinning the at least two materials can include melt spinning the at least two materials or solution spinning the at least two materials. In some embodiments, melt spinning the at least two materials can comprise extruding the at least two materials. The at least two materials can be extruded by an extruder. In some embodiments, melt spinning the at least two materials can include heating or melting the at least two materials and passing the at least two materials through, for example, a spinneret. In some embodiments, forming the suture can further comprise drawing the at least two materials to elongate the at least two materials.

[0030] In some embodiments, a material is absorbable if the material can be absorbed by the human body over time, and for example, within approximately 60 days to 180 days.

[0031] In some embodiments, the at least two materials can be bonded to form a suture with any desired cross-section. In some embodiments, cross-sections at different positions along a length of the suture can generally be the same.

[0032] In some embodiments, the suture can be a core-sheath suture. For example, the suture can include an elongate core made primarily of the first material, wherein the elongate core is surrounded by a sheath made primarily of the second material. In some embodiments, the elongate core can be positioned along a center axis of the sheath. In some embodiments, a center axis of the elongate core can be aligned with a center axis of the sheath. In some embodiments, the elongate core is not positioned along the center axis of the sheath. In some embodiments, the center axis of the elongate core is not aligned with the center axis of the sheath.

[0033] In some embodiments, the suture can be an ‘islands-in-the-sea’ suture. For example, the suture can have a cross-section with a plurality of separate regions made of the first material, wherein the separate regions are surrounded by and inside a region made of the second material. In some embodiments, the suture can include a plurality of filaments made primarily of the first material, wherein the plurality of filaments are surrounded by a common sheath made primarily of the second material. In some embodiments, each filament in the plurality of filaments can be separated from any other filament in the plurality of filaments by a predetermined distance.

[0034] In some embodiments, the suture can be a ‘segmented pie’ suture. For example, the suture can have a cross-section that includes a first pie-shaped region made primarily of the first material, the cross-section further including a second pie-shaped region made primarily of the second material. In some embodiments, the first pie shaped region can have a first side extending along a first radius of the cross-section, a second side extending along a second radius of the cross- section, and a third side extending along an arc connecting the first side to the second side. In some embodiments, a first angle can be formed between the first side and the second side of the first pie-shaped region. In some embodiments, the second pie shaped region can have a fourth side extending along the first radius of the cross-section, a fifth side extending along the second radius of the cross-section, and a sixth side extending along a second arc connecting the fourth side to the fifth side. In some embodiments, a second angle can be formed between the fifth side and the sixth side of the second pie-shaped region.

[0035] In some embodiments, the first pie-shaped region and the second pie-shaped region can have any suitable sizes. In some embodiments, the first pie-shaped region can be larger than the second pie shaped region. In some embodiments, the second pie-shaped region can be larger than the first pie-shaped region. In some embodiments, the first pie-shaped region and the second pie-shaped region can be the same size. In some embodiments, the crosssection of the suture can include one or more additional pie-shaped regions made primarily of different materials and having any suitable size(s).

[0036] In some embodiments, the suture can be a braided suture having a first filament made primarily of the first material and a second filament made primarily of the second material, wherein the first filament and the second filament are braided.

[0037] In some embodiments, two or more sutures can be made. In some embodiments, the two or more sutures can be braided to form a multifilament suture. The multifilament suture can have a first filament made primarily of a first suture and a second filament made primarily of a second suture.

[0038] In some embodiments, the suture and an implantable material can be braided to form a braided suture. In some embodiments, the suture and a filament made of the implantable material can be braided to form a braided suture.

[0039] In some embodiments, non-absorbable materials can include polyester, polyethylene terephthalate (PET), ultra-high molecular weight polyethylene (UHMWPE), nylon, or any combination thereof. In some embodiments, absorbable materials can include vicryl, dexon, monocryl, polyglycolic acid (PGA), polydioxanone (PDS), poly-L-lactic acid (PLLA), or any combination thereof.

[0040] In some embodiments, the suture can have a size ranging from approximately 5 / 0 AWG or 5 / 0 SWGto approximately 5 AWG or 5 SWG.

[0041] In some embodiments, two or more sutures can be braided, wrapped over one another, twisted over one another, sheathed by any material, etc. to form a multifilament suture. The multifilament suture can have any picks and / or twists per inch and any material composite ratio of braided, sheathed, cored, etc. strands resulting in suture sizes 5 / 0 to #5. The multifilament suture can have a size ranging from approximately 5 / 0 AWG or 5 / 0 SWGto approximately 5 AWG or 5 SWG.

[0042] In some embodiments, the suture can be attached to a suture anchor.

[0043] In some embodiments, the suture can be attached to a needle.

[0044] In some embodiments, the suture can be elongate.

[0045] The following description of variants is only illustrative of components, elements, acts, products, and methods considered to be within the scope of the invention and are not in any way intended to limit such scope by what is specifically disclosed or not expressly set forth. The components, elements, acts, products, and methods as described herein may be combined and rearranged other than as expressly described herein and are still considered to be within the scope of the invention.

[0046] Many different embodiments have been disclosed herein, in connection with the above description and the drawings. It will be understood that it would be unduly repetitious and obfuscating to describe and illustrate every combination and subcombination of these embodiments. Accordingly, all embodiments can be combined in any way and / or combination, and the present specification, including the drawings, shall be construed to constitute a complete written description of all combinations and subcombinations of the embodiments described herein, and of the manner and process of making and using them, and shall support claims to any such combination or subcombination.

[0047] An equivalent substitution of two or more elements can be made for anyone of the elements in the claims below or that a single element can be substituted for two or more elements in a claim. Although elements can be described above as acting in certain combinations, and even initially claimed as such, it is to be expressly understood that one or more elements from a claimed combination can, in some cases, be excised from the combination and that the claimed combination can be directed to a subcombination or variation of a subcombination.

[0048] It will be appreciated by persons skilled in the art that the present embodiment is not limited to what has been particularly shown and described hereinabove. A variety of modifications and variations are possible considering the above teachings without departing from the following claims.

Claims

CLAIMS1. A suture, comprising: a filament that includes a first material and a second material, wherein: the first material is bonded to the second material; the first material is absorbable; and the second material is nonabsorbable.

2. The suture of claim 1, wherein the first material includes vicryl, dexon, monocryl, polyglycolic acid (PGA), polydioxanone (PDS), poly-L-lactic acid (PLLA), or any combination thereof.

3. The suture of claim 1, wherein the second material includes polyester, polyethylene terephthalate (PET), polyethylene, nylon, or any combination thereof.

4. The suture of claim 1, wherein the suture includes an elongate core made primarily of the second material, wherein the elongate core is surrounded by a sheath made primarily of the first material.

5. A suture, comprising: a first filament that includes a first material, wherein the first material is absorbable; and a second filament that includes a second material, wherein the second material is nonabsorbable; wherein the first filament and the second filament are braided.

6. A multifilament suture, comprising: a first filament that includes a first material and a second material, wherein: the first material is bonded to the second material; the first material is absorbable; and the second material is nonabsorbable;a second filament that includes a third material and a fourth material, wherein: the third material is bonded to the fourth material; the third material is absorbable; and the fourth material is non- absorbable; wherein the first filament and the second filament are braided.

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