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

Abstract

The specification provides a suture filament (100, 200, 300), comprising: a first material; and a second material. The first material is absorbable, and the second material is non-absorbable. The first material is bonded to the second material to define a single composite filament. Also provided are suture and mech arrangements comprising one or more of the suture filaments.

Description

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

[0002] FIELD

[0003] The specification relates to the field of sutures for use in medical applications.

[0004] BACKGROUND

[0005] Sutures are commonly made of either absorbable material or non-absorbable material.

[0006] US 2009 / 0143819 describes a suture comprising at least one filament to which a coating is applied to enable the suture to be easily inserted into tissue. The coating is of a different material to the suture. In this case the coating only applied after the filament is formed is of an absorbable material. Thus in this arrangement a filament is simply a coated filament the coating does not affect or contribute to the structure of the filament.

[0007] The arrangements of the present specification are directed to providing improved and alternative arrangements of suture filaments for use in surgical applications including for example in orthopedic applications.

[0008] SUMMARY

[0009] The scope of the invention is in accordance with the amended claims.

[0010] 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.

[0011] In general, the disclosed suture comprises 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.

[0012] 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. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] 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:

[0014] FIG. 1 illustrates an illustrative depiction of a cross-section of a suture filament according to an exemplary arrangement of the specification;

[0015] FIG. 2 illustrates an illustrative depiction of a cross-section of a suture filament according to an exemplary arrangement of the specification;

[0016] FIG. 3 illustrates an illustrative depiction of a cross-section of a suture filament according to an exemplary arrangement of the specification;

[0017] FIG. 4 illustrates an illustrative depiction of a cross-section of a muti-filament suture according to an exemplary arrangement of the specification; and

[0018] Figure 5a shows a perspective view of a suture filament of the exemplary arrangement of Figure 1 and Figure 5b shows a perspective of a suture filament of the exemplary arrangement of Figure 2.

[0019] The drawings are not necessarily to scale, and certain features and certain views of

[0020] The drawings may be shown exaggerated in scale or in schematic in the interest of clarity and conciseness.

[0021] DETAILED DESCRIPTION

[0022] 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.

[0023] 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. Musculoskeletal soft tissue repair has evolved over the decades from natural non-absorbable 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.

[0024] Furthermore, often as a result of musculoskeletal soft tissue repair, the capabilities of the anatomy affected by the repair(s) are heavily altered. For example, replacing or repairing a tendon or ligament with a permanent suture replaces the range of motion, elasticity, and flexibility of the tendon or ligament with the relative elasticity, flexibility and range of motion of the mechanical properties of the suture material. This results in patients experiencing a permanent loss of their normal bodily functions in the repaired area.

[0025] In general, the embodiments disclosed herein can address these and other issues.

[0026] According to the embodiments and exemplary arrangements of specification there is a suture filament 100, 200, 300. The suture filament 100, 200, 300, comprising: a first material; and a second material. The first material is absorbable, and the second material is non-absorbable. The first material is bonded to the second material to define a single composite filament.

[0027] Future in some embodiments, sutures according to the exemplary arrangements described can include at least two materials. In one arrangement a suture comprising a single suture filament according to the specification. The single suture filament as described comprising a first and second material. In a further exemplary arrangement a suture may be provided comprising a suture filament of the specification comprising a first and second material in combination with another material. Sutures provided according to the exemplary arrangements may comprise a single filament suture of the specification. Sutures provided according to the exemplary arrangements may alternatively comprises multiple suture filaments. In some embodiments, a first material of the at least two materials of a filament according to the specification can be absorbable and a second material of the at least two materials can be nonabsorbable. In some embodiments, the first material of the at least two materials is nonabsorbable and the second material of the at least two materials is absorbable.

[0028] 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 and allowing the body to repopulate the evacuated area with its natural cells. With this faster healing and return of natural cells, the body may regain some of its original performance capabilities at the affected site, rather than relying on the capabilities of the materials used in the repair(s).

[0029] 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.

[0030] 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.

[0031] In some embodiments, the suture filament is formed by thermally bonding the at least two materials into a single composite filament. In some embodiments, the at least two materials can be thermally bonded. In some embodiments, forming the filaments includes spinning the two materials. Spinning the two materials can include melt spinning the two materials, electrospinning the at least two materials, or solution spinning the at least two materials. In some embodiments, melt spinning the 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 filament can further comprise drawing the at least two materials to elongate the at least two materials.

[0032] 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.

[0033] In some embodiments, the at least two materials can be bonded to form a filament with any desired cross-section. In some embodiments, cross-sections at different positions along a length of the filament can generally be the same.

[0034] In some embodiments, the filament can be a core-sheath suture. For example, the filament can include an elongate core made primarily of the first material, wherein the elongate core is bonded to 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. In some embodiments, the ratio of the elongate core to the bonded sheath can be as small 20:80. In some embodiments, ratio of the elongate core bonded to the sheath can be as large as 80:20.

[0035] In some embodiments, the filament can be an ‘islands-in-the-sea’ suture filament. For example, the filament can have a cross-section with a plurality of separate regions made of the second material, wherein the separate regions are surrounded by and inside a region made of the first material. In some embodiments, the final filament also referred to as the final single composite filament can include a plurality of regions made primarily of the second material, wherein the plurality of regions of the second material are surrounded by a common sheath made primarily of the first material. The regions of the second material may be considered as strands for example of cylindrical form, as the regions of the second have an elongated form and extend within the filament structure parallel to the longitudinal axis (X-direction) of the final filament. 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. In some embodiments, the ratio of the first filaments to the second material can be as small as 20:80. In some embodiments, the ratio of the first filaments to the second material can be as large as 80:20.

[0036] In some embodiments, the filament can be a ‘segmented pie’ suture. For example, the filament 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 crosssection, 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.

[0037] 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 cross-section of the suture filament can include one or more additional pie-shaped regions made primarily of different materials and having any suitable size(s).

[0038] In some embodiments, the filament can be treated as a monofilament suture. Overall the suture filaments according to the exemplary arrangements of the specification are described as self- contained monofilaments. The two materials are provided in a single monofilament structure.

[0039] In some embodiments, multiple strands of the filament can be braided to form a multifilament suture. In some embodiments, the filament can be used as an elongate core around which to braid a multifilament suture.

[0040] In some embodiments, the filament can be braided around an elongate core to form a multifilament suture.

[0041] 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.

[0042] 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.

[0043] In some embodiments, multiple strands of the filament can be twisted, braided, woven, knitted or chemically bonded to form a suture mesh.

[0044] In some embodiments, the filament can be twisted, braided, woven, knitted or chemically bonded with additional material(s) to form a suture mesh.

[0045] In some embodiments, non-absorbable materials can include, or be selected from the following: polyester, polyethylene terephthalate (PET), ultra-high molecular weight polyethylene (UHMWPE), nylon, or any combination thereof.

[0046] In some embodiments, absorbable materials can include or be selected from the following: polyglactin, dexon, poliglecaprone, polyglycolic acid (PGA), polydioxanone (PDO), poly-L-lactic acid (PLLA), or any comparable polymer or any combination thereof.

[0047] In some embodiments, the suture can have a size ranging from approximately 5 / 0 AWG or 5 / 0 SWG to approximately 5 AWG or 5 SWG.

[0048] In some embodiments, two or more filaments 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 SWG to approximately 5 AWG or 5 SWG. In some embodiments, the suture or mesh can be attached to a suture anchor.

[0049] In some embodiments, the suture or mesh can be attached to a needle.

[0050] In some embodiments, the suture or mesh can be elongate.

[0051] 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.

[0052] According to variation 1 , 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 non-absorbable.

[0053] Variation 2 can include the suture as in variation 1 , wherein the first material is selected from the following or includes one or more of the following: polyglactin, dexon, poliglecaprone, polyglycolic acid (PGA), polydioxanone (PDO), poly-L-lactic acid (PLLA), or any comparable polymer or any combination thereof.

[0054] Variation 3 can include the suture as in variation 1 , wherein the second material is selected from the following or includes one or more of the following polyester, polyethylene terephthalate (PET), ultra-high molecular weight polyethylene (UHMWPE), nylon, or any combination thereof.

[0055] The first and second materials of the filament may be selected depending on applications and intended use. For example, the absorbable material may be chosen based on its total degradation time. For example, when repairing a ligament a suture requires a higher initial strength than when repairing a tendon. In the case of ligament repair, the absorbable material would be chosen for a slower rate of degradation and resorption, allowing the initial strength to remain for a longer period of time.

[0056] Further the ratio of the absorbable material to the non-absorbable material within the filament structure may varied as required depending on applications and intended use. The ratio may for example be determined based on total degradation time of the absorbable material. For example, when repairing a ligament a suture requires a higher initial strength than when repairing a tendon. In the case of ligament repair, the ratio of the absorbable material to the nonabsorbable material would be lesser than the ratio of the absorbable material to the nonabsorbable material in a suture used for tendon repair, allowing more of the non-absorbable material to remain at the repair site permanently.

[0057] Variation 4 can include the suture as in variation 1 , wherein the suture includes an elongate core made primarily of the second material, wherein the elongate core is bonded to a sheath made primarily of the first material.

[0058] According to variation 5, 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.

[0059] According to variation 6, 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.

[0060] According to a variation 7 a multifilament suture may be provided, comprising: a first filament comprising a first and second material and at least one other filament comprising a first and second material, twisted, braided or otherwise mechanically combined to form said multifilament suture, wherein the first and at least one other filament are the same. The first material being absorbable; and the second material is non-absorbable

[0061] According to a variation 8 a multifilament suture may be provided, comprising: at least one filament comprising a first and second material, the first material being absorbable; and the second material is non-absorbable, twisted, braided or otherwise mechanically combined with at least one other filament of a second different type, wherein the filament of the second different type is comprised of materials different from the first and second materials of the filament of the first type. According to a variation 9 a multifilament suture may be provided, comprising: a first filament comprising a first material and a second material, wherein the first material is bonded to the second material to form a single composite filament; and wherein the first material is absorbable; and the second material is non-absorbable; and a second filament comprising a third material and a fourth material, wherein the third material is bonded to the fourth material to form a single composite filament, and wherein the third material is absorbable; and the fourth material is non-absorbable; wherein the first filament and the second filament are braided together.

[0062] According to a variation 10 a suture mesh may be provided, comprising: a first filament and one of more other filaments, the first filament comprising a first material and a second material, wherein the first material is bonded to the second material to form a single composite filament; and wherein the first material is absorbable; and the second material is nonabsorbable; wherein the first filament is woven, knit, or chemically bonded to at least one other filament, wherein the first and at least one other filament are the same.

[0063] According to a variation 11 a suture mesh may be provided, comprising: a first filament, the first filament comprising a first material and a second material, wherein the first material is bonded to the second material to form a single composite filament; and wherein the first material is absorbable; and the second material is non-absorbable; wherein the first filament is woven, knit or chemically bonded to one or more other filaments of different materials.

[0064] Following on from the above description, a filament 100 according to an exemplary arrangement of the specification is described with reference to Figure 1 and Figure 5A. As described above the filament 100 comprises a composite filament or monofilament.

[0065] Figure 1 shows a lateral cross-sectional view of the filament 100 comprises a first material (M1) and a second material (M2).

[0066] In more detail in the arrangement shown, the filament 100 comprises a first component 110 of the first material and a second component 120 of the second material. The first material being different from the second material. The first and second components 110, 120 are arranged such that the first component 110 surrounds or encapsulates the second component 120. The first and second components are structural components of the filament. The filament 100 comprises a core-sheath filament structure, the first component 110 defines an outer sheath portion, and the second component 120 defines an inner core portion 120.

[0067] While Figure 1 provides a lateral cross-sectional view of a body of the filament 100, it will be appreciated that the filament 100 has an elongated form as shown in Figure 5A. The first and second components 110, 120 being arranged about a central longitudinal axis (X1-X1 ) thereof and extending in a longitudinal direction . In the exemplary arrangement shown both the first and second components 110, 120 have a generally cylindrical form and extend co-axially along the central longitudinal axis (X-axis) of the filament 100, the second component being arranged to extend radially outwardly about the first component. The filament 100 comprising the first and second components also has a generally cylindrical form.

[0068] The second component 120 extends radially from the central axis to a first outer surface 121 . The outer surface 121 defines the peripheral boundary thereof at a first radial separation from the central axis. The first component 110 extends radially from an inner surface 112 to a second outer surface 111 which defines an external surface at a second radial separation from the central axis. The second portion 120 is arranged encapsulated within the first portion 110. The outer surface 111 of the first portion 110 defines the external peripheral surface of the filament.

[0069] The proportions of each of the first and second components 110 and 120, and of the first and second materials within the overall volume of the filament 100 can be varied as required. As described above the ratio of the volumes of the first material relative to the second material may be varied between 80% and 20% and vice versa. The proportions may be adjusted depending on the application of the filament 100 as a suture or a component of a suture.

[0070] The first and second components 110 and 120 are bonded together to form the single composite filament 100. The first and second components 120, 110 are bonded together directly at a bonding interface 130. Bonding of the first and second components may be provided by a suitable thermal bonding process, including for example extrusion, spinning or electrospinning. The first component 110 in the exemplary arrangement is bonded to the second component 120 at the bonding interface 130. At the bonding interface 130, the outer peripheral surface 121 of the second component 120 is bonded directly to the inner peripheral surface 122 of the first component 110. The first and second components 110, 120 are accordingly bonded together to define an integrally formed filament structure which defines the monofilament 100.

[0071] The arrangement of the filament in which the first and second materials are bonded as described to form the composite monofilament provides advantage - including relating to the uniformity and structural integrity of final construction. The connection between the components of the first material and second material at the bonding interface 130 maintains uniformity and structural integrity along the length (L1) of the filament.

[0072] Further, prior to thermal bonding the polymers of the first and second material may be dried before bonding to remove moisture. This provides that when bonded contaminant levels in the composite filament are limited within the internal molecular structures of each polymer.

[0073] Contaminants including for example moisture or H2O if present could interfere with the ability of the polymers to bond. The filament 100 thus comprises a monofilament 100 having integrated within a single composite body thereof, the first and second components 110, 120 and having uniformity and structural integrity across the entire body of the filament.

[0074] The first component 110 and the second component 120 are structural components of the filament. These components when bonded together form the filament. The filament includes in the body thereof, portions of both first and second materials components which have been combined together into a single composite filament structure. Further advantageously, the filament 100 of the exemplary arrangement of Figure 1 is comprised of the first and second materials only.

[0075] It will be appreciated that while in the example arrangement of Figures 1 and 5A the first and second components 110, 120 shown have a cylindrical form (in the longitudinal direction) that other suitable forms may be also used.

[0076] The filament 100 is provided for use as a filament of a multi-filament suture or a mesh. A suture or mesh may comprise multiple filaments 100. An exemplary suture may comprise multiple filaments 100 in a braided arrangement with other filaments 100 of the same type, or together with different filament. As described above the first material is absorbable, and the second material is non-absorbable. Filaments 100 and a suture or mesh comprising filaments 100 are thus configured such that in use when the suture or mesh is located at a surgical site, the first material is configured to absorb over a period of time leaving in place the second component comprised of the second non-absorbable material. The parameters relating to the absorption of the first material can be controlled by the selection of material and by the dimensions and form of the components comprising the first material and the second material which together form the composite monofilament 100. For example, the selection of a particular first material may allow for control of the time period over which absorption is expected to occur.

[0077] Following on from the above description, a filament 200 according to an alternative exemplary arrangement of the specification is described with reference to Figure 2 and Figure 5B. Figure 2 shows a lateral cross-sectional view of the filament 200, comprising a first material and a second material.

[0078] In the exemplary arrangement the filament 200 comprises components (also referred to as portions) of a first material and of a second material. As illustrated in the lateral cross-sectional view - the first and second materials are provided arranged together in an “islands in the sea” type structural arrangement, in which a plurality of components (or portions) of the second material are located spaced apart from each of the other components (or portions) of the second material. Each of the components 220 of the second material is in contact only with the surrounding area of the first material. The first material is located surrounding the components of the second material and separating them from each other.

[0079] Thus, filament 200 is formed from a first portion 210 (or component) of a first material and a plurality of portions (or components) 220 of a second material. The plurality of portions 220 are encapsulated within the first material 220. The external surface 211 of the filament 200 is defined by the outer surface of the first portion 210.

[0080] While Figure 2 shows a lateral cross-sectional view only of the filament 200, the filament 200 has an elongated filament form overall as shown in Figure 5B. It will be appreciated that the filament extends longitudinally along and about the central longitudinal axis (X1-X1) thereof. Thus each of the plurality of second portions 220 of the second material comprises a longitudinal strand form. In the arrangement each second portion strand 220 has a radial extent, comprising an outer boundary surface 221 and a longitudinal extent. The strands 220 are arranged spaced apart within the first portion 210. In the exemplary arrangement, each of the portions / strands 220 of the second material are separate from the other portions 220 of the second material. Each portions 220 of the second material is effectively surrounded by, and in contact with the first material 220 of the first component 210.

[0081] In the arrangement shown, the overall form of each of the first material portions 220 and the second material portion are of a generally cylindrical form. While in the arrangement of the drawings there are five portions 220 of the second material arranged within the body of the filament, it will be appreciated that two or more portions may be provided. In the arrangement shown the diameter of each of the portions 220 of the second material is the same, it will be appreciated that different of the portions 220 may be provided having different diameters. It will be appreciated that while the portions 200 have a cylindrical form in the exemplary arrangement shown, portions 220 of a different form may be provided. The portion 210 of the first material defines the outer or external surface 211 of the filament 200.

[0082] As described, above the final filament 200 comprises a monofilament. Each one of the plurality of portions 220 of the second material is bonded to the portion 210 of the first material to provide a single composite monofilament structure.

[0083] The first component 210 and the second components 220 are structural components of the filament. These components when bonded together form the filament. The filament includes in the body thereof, portions of both first and second materials components which have been combined together into a single composite filament structure. The filament 200 of the exemplary arrangement of Figure 2 is comprised of the first and second materials only.

[0084] The proportions of each of the first and second materials within the overall volume of the filament 200 can be varied as required. As described above the ratio of the volumes of the first material relative to the second material may be varied between 80% and 20% and vice versa. The proportions may be adjusted depending on the application of the filament 200 as a suture or a component of a suture. The first component 210 is bonded to each of the plurality of second components 220 to form a single composite filament 200.

[0085] As shown, the first component 210 and each of the plurality of second components 220 are bonded together directly at each of a plurality of bonding interfaces 230. Bonding of the first and the plurality of second components 220 may be provided by a suitable bonding process, including for example extrusion, spinning or electrospinning.

[0086] At the bonding interface 230, the outer peripheral surface 221 of a second component 220 is bonded directly to the surrounding material of the first component 210 at an opposing contact surface 212. The first component 210 is thus bonded to each of the plurality of second components 220 to define a single composite filament structure. The filament 200 comprises a monofilament 200 having integrated within a single composite body form thereof, the first and plurality of second components 210, 220.

[0087] The filament 200 is provided for use as a filament of a suture or a mesh. As described above the first material is absorbable; and the second material is non-absorbable. Thus the filament 200 is configured such that, in use when a suture comprising one or more filaments 200 is located at a surgical site, the first material is configured to absorb over a period of time leaving in place a plurality of separate strands of the second material.

[0088] The filament 200 is provided for use as a filament of a suture or a mesh. A suture or mesh may comprise multiple filaments 200. An exemplary suture may comprise multiple filaments 200 in a braided arrangement with other filaments 200 of the same type, or together with different filament. As described above the first material is absorbable, and the second material is nonabsorbable. Filaments 200 and a suture or mesh comprising filaments 200 are thus configured such that in use when the suture or mesh is located at a surgical site, the first material is configured to absorb over a period of time leaving in place the plurality of second components which in the arrangement described are provided as a plurality of strands comprised of the second non-absorbable material. The parameters relating to the absorption of the first material can be controlled by the selection of material and by the dimensions and form of the components comprising the first material and the second material which together form the composite monofilament 200. For example, the selection of a particular first material may allow for control of the time period over which absorption is expected to occur. Following on from the above description, a filament 300 according to an alternative exemplary arrangement of the specification is described with reference to Figure 3. Figure 3 shows a lateral cross-sectional view of the filament 300, comprising a first material and a second material. In particular the filament 300 comprises a first component 310 of the first material and a second component 320 of the second material. As illustrated in the lateral cross-sectional view - the first and second components 310, 320 are arranged in first and second pie shaped sectors providing a filament having a pie shaped structural arrangement.

[0089] In the cross-section view of the exemplary arrangement of Figure 3, the first component subtends an arc of 90 degrees and the first component 310 is provided as a segment of 1 / 4 of the cross-sectional area. The second component subtends and arc of 270 degrees and is provided as a segment of 3 / 4's of the area. The first and second components together define the whole of the circular cross-section.

[0090] While Figure 3 shows a lateral cross-sectional view only of the filament 300, the filament 300 has an elongated filament form overall. It will be appreciated that the filament extends longitudinally along and about the central longitudinal axis thereof. Thus each of first and second components comprises a longitudinal strand having a pie shaped form in cross-section.

[0091] The outwardly facing surfaces 311 and 321 of each of the first 310 and second 320 components defines a portion of the outer peripheral surface of the filament 300. The second component 320 comprises an internal boundary surface 322. The first component 310 comprises an internal boundary surface 312.

[0092] The first component 310 and the second components 320 are structural components of the filament. These components when bonded together form the filament. The filament includes in the body thereof, portions of both first and second materials components which have been combined together into a single composite filament structure. The filament 300 of the exemplary arrangement of Figure 3 is comprised of the first and second materials only.

[0093] The proportions of each of the first and second materials within the overall volume of the filament 300 can be varied as required. As described above the ratio of the volumes of the first material relative to the second material may be varied between 80% and 20% and vice versa. The proportions may be adjusted depending on the application of the filament 200 as a suture or a component of a suture. In the exemplary arrangement the proportions of the second material to the first material are in the ratio of 75:25.

[0094] As described, above the filament 300 comprises a monofilament. The first component 310 of the first material is bonded to the second portion 320 of the second material to provide a single composite monofilament structure. The first and second components are bonded at a bonding interface 330 at which the opposing interface boundary surfaces 312 and 322 are bonded directly.

[0095] Bonding of the first component 310 and the second components 320 may be provided by a suitable bonding process, including for example extrusion, spinning or electrospinning.

[0096] At the bonding interface 330, the boundary surface 312 of the first component is bonded directly to the opposing contact surface 322 of the second component. The first component 310 is thus bonded to the second component 320 to define a single composite filament structure. The filament 300 comprises a monofilament 300 having integrated within a single composite body form thereof, the first and second components 310, 320 of the first and second materials.

[0097] The filament 300 is provided for use as a filament of a suture or a mesh. As described above the first material is absorbable; and the second material is non-absorbable. Thus the filament 300 is configured such that, in use when a suture comprising one or more filaments 300 is located at a surgical site, the first material is configured to absorb over a period of time leaving in place a strand of the second non-absorbable material.

[0098] The parameters relating to the absorption of the first material can be controlled by the selection of material and by the dimensions and form of the components comprising the first material and the second material which together form the composite monofilament 300. For example, the selection of a particular first material may allow for control of the time period over which absorption is expected to occur.

[0099] The arrangement of the filaments 200, 300 in which the first and second materials are bonded as described to form the composite monofilament provides advantage - including relating to the uniformity and structural integrity of final construction. The connection between the components of the first material and second material at the bonding interface 130 (also 230 and 330) maintains uniformity and structural integrity along the length (L1) of the filament.

[0100] Further, prior to thermal bonding the polymers of the first and second material may be dried before bonding to remove moisture. This provides that when bonded contaminant levels in the composite filament are limited within the internal molecular structures of each polymer.

[0101] Contaminants including for example moisture or H2O if present could interfere with the ability of the polymers to bond. The filaments 200, 300 thus each comprise a monofilament 200, 300 having integrated within a single composite body thereof, the first and second components 110, 120 and having uniformity and structural integrity across the entire body of the filament.

[0102] The filaments 100, 200 and 300 as described comprise suture filament which are used in application for forming multi filament sutures or mesh structures for use in medical and surgical applications. The filaments are single composite monofilaments formed from first and second materials also referred to as bicomponent filaments.

[0103] Referring to Figure 4 multifilament sutures according to exemplary arrangements of the specification are described. The multifilament suture shown comprises a plurality of the monofilaments 100 of Figures 1 and 5A. As described above a multifilament suture may comprise only monofilaments 100, 200, 300 of the same type. Alternatively a multifilament suture may comprise one or more monofilaments 100, 200, 300 of the same or different type in combination with another filament of a different material. A multifilament suture may be formed by twisting, braiding or otherwise mechanically combined the filaments thereof to form said multifilament suture.

[0104] Advantageously, the arrangements of the invention provide dynamic filaments, in which the structure of the filaments which based on the combination of the first and second materials changes over time when in location at a surgical site. Advantages of the dynamic filaments and sutures or meshes comprising the dynamic filaments include:

[0105] Advantages of filament according to the specification include the following:

[0106] • Configured to support the third phase of wound healing (inflammatory, fibroblastic and fibrous phases). During the third phase of wound healing, also referred to as the 'remodeling' or 'rebuilding' phase, our bicomponent filament has reduced in size, leaving negative space for the body to begin rebuilding at the wounded site with natural, healthy tissue. This is in comparison with other sutures arrangement which often support only the first phase of healing and the early portion of the second phase, resulting in stress shielding from the soft tissue at the wound site.

[0107] • The self-contained filaments 100, 200, 300 according to the specification provides a sutures configured to maintains the capability of high initial load strength and has the added advantage of maintaining a load strength proportional to the bodily requirements throughout the three phase healing process.

[0108] • While a coated suture may be designed simply to reduce knot irritation and soft tissue abrasion by utilizing the soft nature of the coating, the arrangements of filaments and suture of the specification comprising the filaments provide advantages and support medical and surgical applications as described above.

[0109] Further, the composite filaments 100, 200, 300 provided in accordance with the invention - which combine within the single composite filament structure portions of the first and second material have the advantages of providing high levels of uniformity and structural integrity across the life time of use of the filament.

[0110] 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.

[0111] 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.

[0112] 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 filament (100, 200, 300), comprising: a first material; and a second material; wherein the first material is absorbable, and the second material is non-absorbable; wherein the first material is bonded to the second material to define a single composite filament.

2. The suture filament of claim 1 , the filament having an elongated form wherein the first and second materials are arranged extending along the longitudinal axis of the filament.

3. The suture filament of claims 1 or 2, wherein the first material and the second material are bonded together wherein the bonding process is selected from the following: a thermal bonding process, an extrusion process, a spinning process and an electro-spinning process.

4. The suture filament of any preceding claim wherein the first material is bonded to the second material directly at one more bonding interfaces, formed at corresponding opposing contact surfaces of the first and second materials.

5. The suture filament of any preceding claim, wherein in a lateral cross-section of the filament, the first material is arranged surrounding the second material, in a sheath and core configuration wherein the second material defines an inner core component, and the first material defines an outer sheath component of the filament.

6. The suture filament of any one of claims 1 to 4, comprising a first component (210) of the first material and a plurality of portions (220) of the second material, the plurality of portions (220) being encapsulated within the first material.

7. The suture filament of claim 6, wherein in a lateral cross-section of the filament, each of the plurality of second portions (220) of the second material is arranged spaced apart from the other second portions of the second material and each being bonded directly to the first material only.

8. The suture filament of any one of claims 1 to 4, wherein in a lateral cross-section of the filament, a first portion (310) of the first material and a second portion (320) of the second (310, 320) are arranged in first and second pie shaped sectors such that the filament has a pie shaped structural arrangement of the first and second materials.

9. The suture filament of any preceding claim, wherein the filament comprises a monofilament.

10. The suture filament of any preceding claim wherein, first and second portions of the first and second material are arranged bonded together to provide an integrally formed filament structure which defines a single composite filament.11 . The suture filament of any preceding claim, wherein the first material is selected from the following: polyglactin, dexon, poliglecaprone, polyglycolic acid (PGA), polydioxanone (PDO), poly-L-lactic acid (PLLA), or any comparable polymer or any combination thereof.

12. The suture filament of any preceding claim, wherein the second material is selected from the following: polyester, polyethylene terephthalate (PET), ultra-high molecular weight polyethylene (UHMWPE), nylon, or any combination thereof.

13. The suture filament as claimed in any preceding claim, wherein the ratio of first material to the second material is adjustable within the range of 20:80 to 80:20.

14. The suture filament of claim 1 , wherein the filament comprises an elongate core made primarily of the second material, wherein the elongate core is bonded to a sheath made primarily of the first material.

15. A monofilament suture comprising a suture filament as claimed in any preceding claim.

16. A multifilament suture, comprising: a first filament and at least one other filament as claimed in any of claims 1 to 14, twisted, braided or otherwise mechanically combined to form said multifilament suture, wherein the first and at least one other filament are the same.

17. A multifilament suture, comprising: at least one filament of a first type as claimed in any of claims 1 -14, twisted, braided or otherwise mechanically combined with at least one other filament of a second different type, wherein the filament of the second different type is comprised of materials different from the first and second materials of the filament of the first type.

18. A multifilament suture, comprising: a first filament comprising a first material and a second material, wherein the first material is bonded to the second material to form a single composite filament; and wherein the first material is absorbable; and the second material is non-absorbable; and a second filament comprising a third material and a fourth material, wherein the third material is bonded to the fourth material to form a single composite filament, and wherein the third material is absorbable; and the fourth material is non-absorbable; wherein the first filament and the second filament are braided together.

19. A suture mesh, comprising: a first filament and one of more other filaments as claimed in any of claims 1 to 14, wherein the first filament is woven, knit, or chemically bonded to at least one other filament, wherein the first and at least one other filament are the same.

20. A suture mesh, comprising: a first filament as claimed in any of claims 1 -14, wherein the first filament is woven, knit or chemically bonded to one or more other filaments of different materials.

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