Modular suture

Sutures are provided having a first elongate body and a separate, second elongate body. The first elongate body includes a first connection structure and the second elongate body may include a second connection structure.

BACKGROUND

1. Technical Field

The present disclosure describes sutures having connection structures which enable various lengths and configurations of sutures to be created.

2. Background of Related Art

Medical sutures may be formed from a variety of materials and may be configured for use in limitless applications. Sutures are provided in various lengths and typically have a needle attached to at least one end thereof. Barbed sutures are also known, the barbs may comprise a single direction, e.g., monodirectional barbed suture or two directions, e.g., bidirectional barbed suture. In certain situations, it may be preferable for the user to choose a different suture configuration.

SUMMARY

The present disclosure is direct to a suture comprising a first elongate body having a first connection structure; and a separate second elongate body selectively connectable to the first connection structure. In certain embodiments, the second elongate body comprises an extension projecting therefrom, the extension being selectively connectable to the first connection structure. The extension may comprise tabs or projections and the first connection structure comprises slots shaped to receive the tabs or projections. The tabs or projections may lock into the slots upon insertion of the extension into the first elongate body and in alternate embodiments, removal of the second elongate body is prevented.

The second elongate body may comprise a second connection structure. The first connection structure may be shaped to receive the second connection structure. In particular embodiments, the first connection structure is releasably connected to the second connection structure. The first or second connection structure may be selected from the group consisting of a ball connection, a socket connection, a threaded connection, and a flared connection. More specifically, the first and second connection structures may form a snap fit connection. In some embodiments, the first connection structure comprises a cavity.

The first or second elongate body may further comprise barbs disposed on a length thereof.

The first or second elongate body may comprise an end effector selected from the group consisting of a loop and a knot.

Further, the first or second elongate body may comprise a needle disposed at one end thereof.

According to another embodiment of the present disclosure, a suture comprising at least two separately connectable elongate bodies, wherein a first elongate body comprises an end portion including a first connection structure that is connectable to a second connection structure of a second elongate body is disclosed. The first elongate body may comprise a first plurality of barbs wherein the first plurality of barbs may prevent suture reversal in a first direction. The second elongate body may comprise a second plurality of barbs and the second plurality of barbs may prevent suture reversal in a second direction.

DETAILED DESCRIPTION

The present disclosure describes sutures including a first elongate body having first connection structure, and a second elongate body which is selectively connectable to the first connection structure. In some embodiments, the second elongate body may include a second connection structure.

The term “suture” as used herein is broadly defined as a medical device which may be used to approximate tissues during wound healing. Sutures described herein may include at least one needle disposed at an end portion of the first or second elongate body.

Sutures of the present disclosure may be provided with materials comprising both absorbable and non-absorbable materials. As used herein, the term “absorbable” includes both biodegradable and bioresorbable materials. By biodegradable, it is meant that the materials decompose, or lose structural integrity under body conditions (e.g., enzymatic degradation, hydrolysis) or are broken down (physically or chemically) under physiologic conditions in the body (e.g., dissolution) such that the degradation products are excretable or absorbable by the body.

Other suitable biodegradable polymers include, but are not limited to, poly(amino acids) including proteins such as collagen (I, II and III), elastin, fibrin, fibrinogen, silk, and albumin; peptides including sequences for laminin and fibronectin (RGD); polysaccharides such as hyaluronic acid (HA), dextran, alginate, chitin, chitosan, and cellulose; glycosaminoglycan; gut; and combinations thereof. Collagen as used herein includes natural collagen such as animal derived collagen, gelatinized collagen, or synthetic collagen such as human or bacterial recombinant collagen.

In certain embodiments, both absorbable and non-absorbable materials may be employed in the suture. For example, a non-absorbable first elongate body may be provided with an absorbable second elongate body.

It should be noted that sutures of the present disclosure include both monofilament and multifilament sutures. In certain embodiments sutures may have a first elongate body which comprises a multifilament braid while a second elongate body may comprise a monofilament. Various combinations of multifilaments, monofilaments and absorbable and non-absorbable materials may be employed in the present disclosure. Further, sutures of the present disclosure may include at least one needle attached to at least one end thereof. Suitable needles include those within the purview of those skilled in the art.

Methods for forming sutures in accordance with the present disclosure include techniques within the purview of those skilled in the art, such as, for example, extrusion, molding and/or solvent casting. In some embodiments, the suture may include a yarn made of more than one filament, which may contain multiple filaments of the same or different materials. Where the suture is made of multiple filaments, the suture may be made using any known technique such as, for example, braiding, weaving or knitting. The suture may also be combined to produce a non-woven suture. The suture may be drawn, oriented, crinkled, twisted, commingled or air entangled to form yarns as part of the suture forming process. In one embodiment, a multifilament suture may be produced by braiding. The braiding may be done by any method within the purview of those skilled in the art.

In certain embodiments, sutures described herein may comprise barbed sutures. The first or second elongate bodies may comprise a plurality of barbs disposed on a portion of a length thereof. In certain embodiments, both the first and second elongate bodies may comprise a plurality of barbs. Sutures of the present disclose may comprise both monodirectional and bidirectional barbed sutures.

Bidirectional barbed sutures include barbs which may be arranged on a first portion of a length of the first elongate body to allow movement of a first end of the elongate body through tissue in one direction, while barbs on a second portion of a length of the second elongate body may be arranged to allow movement of the second end of the elongate body in an second (e.g., opposite) direction.

Suitable barbed sutures include those described in US. Patent Publication Nos. 2009/0210006 and 2009/0248070 both assigned to Tyco Healthcare Group LP (North Haven, Conn.), the entire contents of which are incorporated by reference herein. In general, barbed sutures include barbs which extend outward, from a surface of the suture. The barbs may be disposed on a length of the medical device body (suture) to allow movement of a first end of the medical device through tissue in one direction, while resisting movement in the opposite direction.

The barbs can be arranged in any suitable pattern, for example, helical, spiral, linear, or randomly spaced. The pattern may be symmetrical or asymmetrical. The number, configuration, spacing and surface area of the barbs can vary depending upon the tissue in which the suture is used, as well as the composition and geometry of the material utilized to form the suture. Additionally, the proportions of the barbs may remain relatively constant while the overall length of the barbs and the spacing of the barbs may be determined by the tissue being connected. For example, if the suture is to be used to connect the edges of a wound in skin or tendon, the barbs may be made relatively short and more rigid to facilitate entry into this rather firm tissue. Alternatively, if the suture is intended for use in fatty tissue, which is relatively soft, the barbs may be made longer and spaced further apart to increase the ability of the suture to grip the soft tissue.

The surface area of the barbs can also vary. For example, fuller-tipped barbs can be made of varying sizes designed for specific surgical applications. For joining fat and relatively soft tissues, larger barbs may be desired, whereas smaller barbs may be more suitable for collagen-dense tissues. In some embodiments, a combination of large and small barbs within the same structure may be beneficial, for example when a suture is used in tissue repair with differing layer structures. In particular embodiments, a barbed suture may have both large and small barbs.

Sutures of the present disclosure may additionally include an end effector. End effectors provide resistance to help prevent the suture from being pulled through tissue. Often the end effector may be used in place of a surgeon tying a knot at one end of the suture line. End effectors may be larger in cross-sectional diameter (compared to the elongate body) so that suture pull through is prevented. In other embodiments, end effectors are sized and shaped so as to mitigate suture pull through. Examples of suitable end effectors include a knotted end effector such as one described in U.S. Publication No. 2010/0094337, filed on Oct. 1, 2009, the entire contents of which are incorporated by reference. Another suitable end effector comprises a loop at a distal portion of the suture, the loop is described in U.S. Publication No. 2010/0063540, filed on Aug. 29, 2009, the entire contents of which are incorporated by reference herein.

Other suitable end effectors which may be utilized in accordance with the present disclosure are illustrated inFIGS. 1A-1M. It should be understood that end effectors in accordance with the present disclosure are not limited to those described herein and other end effectors may be employed.

One example of a suture in accordance with the present disclosure is illustrated inFIGS. 2A and 2B. The suture200includes a first elongate body210and a second elongate body220. As illustrated, both the first and second elongate bodies,210,220include a plurality of barbs230disposed on a length thereof. The plurality of barbs230extend in the same direction, outward and away from a surface of the elongate body. As illustrated, the barbs230extend away from a proximal portion of the suture. A first portion of the first elongate body includes a needle240and a second portion of the first elongate body210includes a first connection structure250. As shown herein, the first connection structure250includes a cavity254comprising at least two pockets252. The first connection structure250matingly cooperates with the second elongate body220.

The second elongate body220includes a proximal portion242having an extension225and at least two tabs227. The extension225is shaped to be received within the distal portion of the elongate body210. More specifically, the tabs227are shaped to be received within the pockets252(FIG. 2A). An outer diameter d1of the extension225is less than an inner diameter d2of the cavity254such that the extension225can be inserted within cavity254. The first elongate body210comprises an outer diameter d4which is greater than d2. The second elongate body also comprises a second outer diameter d3, which may be greater than d1. In other embodiments, d1and d3may be of similar size and both less than d2.

In some embodiments, the pockets252and the tabs227form an irreversible connection. Once connected, the configuration of the pockets252and tabs227prevent the second elongate body220from being removed or disconnected from the elongate body210.

Once connected, the first and second elongate bodies210,220create a monodirectional barbed suture. The barbs230on the first and second elongate bodies210,220are arranged to enable the suture to move in one direction. The barbs230extend away from the elongate bodies210,220and away from the needled end of the suture200.

It will be understood thatFIG. 2Cis a similar embodiment toFIG. 2Aand therefore all numerals and descriptions which are the same are designated with the prime mark and the differences will be described below.FIG. 2Cillustrates a suture200′ having first and second elongate bodies210′,221, respectively. The first elongate body210′ comprises a first needle240′ disposed at one end thereof. Additionally, the second elongate body221comprises a second needle,241, disposed at one end thereof. The first elongate body210′ includes a first plurality of barbs230′ which extend outward from the first elongate body210′ in a first direction and away from the needle240′. The second elongate body221includes a second plurality of barbs231, which extend outward from the second elongate body221in a second direction, away from the second needle241. The combination of the first and second plurality of barbs230′,231, respectively, creates a bidirectional barbed suture.

FIG. 2Dis a similar embodiments toFIG. 2Aand therefore all numerals and descriptions which are the same are designated with the prime mark and the differences will be described below.FIG. 2Dillustrates a suture202having first and second elongate bodies210′,222, respectively. The first elongate body210′ comprises a first needle240′ disposed at one end thereof. The first elongate body210′ includes a plurality of barbs230′ which extend in a first direction, outward from the elongate body210′ and away from the needle240′. The second elongate body222comprises a monofilament thread. The two elongate bodies are connected together by the extension225′ and the first connection structure250′. Although not shown, the second elongate body222may include a second needle disposed at one end thereof.

FIG. 3illustrates another example of a suture300having a first elongate body310and a second, separately connectable elongate body320, in accordance with the present disclosure. An end of one or both of the elongate bodies310,320may be configured for needle attachment. Various needles for use are within the purview of those skilled in the art. The distal portion of the first elongate body310includes a first connection structure340. Similar toFIG. 2A, the first connection structure340includes a cavity344which enables insertion of an extension325. Additionally, the first connection structure340also includes slot346, extending from the outer surface310aof the first elongate body310to the cavity344of the first elongate body. The slot346is sized and shaped for reception of a projection327from the surface of the second elongate320.

More specifically, the second elongate body320includes a distal portion and a proximal portion. The proximal portion includes an extension325and at least one projection327formed on a surface thereof. The extension325is shaped to be received within the cavity344of the first connection structure340. More specifically, the projection327is shaped to be received within the slots346(on distal portion of the first elongate body310a). In some embodiments, the slots346and the projections327form a snap fit or a friction fit. Once connected, the snap fit feature of the slots346and the projections327prevent the second elongate body320from being removed or disconnected from the elongate body310.

The projections (found on extension325) may be a variety of shapes, including but not limited to those illustrated inFIGS. 4A-4H. The projections may extend from at least one surface of the extension such as those illustrated inFIGS. 4A-4D. For example,FIG. 4Ais illustrated as extending outward from a first surface of the extension325a, whileFIGS. 4E-4Hillustrate projections extending outward from a first and second surface325a,325b, respectively of the extension325.

For exemplary purposes,FIGS. 5A-Cillustrates in more detail, how an extension similar to that illustrated inFIG. 4Gconnects with a first elongate body. The suture400is illustrated having a first elongate body410and a second, separately connectable elongate body420. A proximal end of one or both of the elongate bodies410,420may be configured for needle attachment. The distal portion of the first elongate body410includes a first connection structure440, having a cavity444which enables insertion of an extension425. Additionally, the first connection structure440also includes two slots446a,446b, each extending from an outer surface410aof the first elongate body410to the cavity444of the first elongate body410(seeFIG. 5C). Each slot446a,446bis sized and shaped for reception of a projection427from the surface of the second elongate320.

More specifically, the second elongate body420includes a distal portion and a proximal portion. The proximal portion includes an extension425and at least one projection427formed on a surface of the extension425. Upon insertion of the extension425into the cavity444, the projections427may bend or fold (FIG. 5A) towards the second elongate body420to enable insertion of the projections427in the direction shown in arrow A. Once the projections427reach the slots426a,426b, the projections427extend outward to a second, unfolded position (seeFIG. 5B), preventing removal of the extension425from the cavity444.

In certain embodiments, both the first and second elongate bodies include first and second connection structures. Connection structures in accordance with the present disclosure are discussed herein below and may include a ball connection, a socket connection, a snap-fit connection, a threaded connection, and a flared connection.

FIGS. 6A-6Cillustrate an alternate embodiment of a suture in accordance with the present disclosure, including both first and second connection structures. More particularly, the suture500includes a first elongate body510and a second elongate body520. A proximal end of the elongate body may include a needle (not shown) and a distal portion of the first elongate body510includes a first connection structure540. The first connection structure540includes a hole or perforation542, which is shaped and sized to receive a second connection structure.

More specifically, the second elongate body520comprises a second connection structure524at a proximal portion of the second elongate body520. The second connection structure524comprises two flexible arms526which slightly separate as the arms526are moved into communication with the hole542(FIG. 6B). The arms526each comprise a bulbous portion526awhich slides across the first connection structure540until the hole542is reached. Once the bulbous portions526areach the hole542, the bulbous portions526aslide into the hole542and the arms526return to their original, unflexed position (FIG. 6C).

The first connection structure540can also be used with a different second connection structure, such as, for example, one illustrated inFIG. 7. The second connection structure600shown inFIG. 7includes two arms626,628, respectively. The first arm626terminates in a bulbous portion626a. The second arm628terminates in a recess configuration628awhich is shaped and sized to receive the bulbous portion626a. The second connection structure600functions in a similar manner as the second connection structure524(FIGS. 6A-6C). In some embodiments, the arms are flexible and slightly separate as they are moved into communication with the hole on a first connection structure540. Once the two arms626,628reach the hole, the first arm626is received within the hole and connects to the second arm628. More specifically, the bulbous portion626ais received within the recess configuration628a. The two arms626,628may require a small manual force to be connected together. As shown, the first and second arms626,628, create a snap fit connection. In some embodiments, the snap fit connection may be reversible.

An alternative embodiment of first and second connection structures are illustrated inFIG. 8. The suture700includes a first elongate body710and a second elongate body720. A proximal end of the first elongate body includes a needle730and a distal portion of the first elongate body710includes a first connection structure740. As shown herein, the first connection structure740has an interior concentric threaded portion742. The concentric threaded portion742surrounds a cavity744in the distal portion of the elongate body710. The cavity744enables insertion of a second connection structure722into the elongate body710.

The second elongate body720may include a distal portion (not shown) which is shaped to mitigate suture pull through. A proximal portion of the second elongate body710includes a second connection structure722which comprises a threaded extension722. The threaded extension722is shaped to be received within first connection structure740and more particularly, within the cavity744. The threaded extension722may comprise a right-handed or left-handed thread, corresponding to the threaded portion742of the first connection structure740. The extension722is threaded within the first connection structure740, creating a reversible connection. In other embodiments, however, the threaded connection may be configured to be irreversible.

FIGS. 9A and 9Billustrate a suture in accordance with an alternate embodiment of the present disclosure. The suture800includes a first elongate body810, having a first connection structure830, and a second elongate body820, having a second connection structure840. The first connection structure830comprises a flange-shaped socket located at a first end of the first elongate body810. The second connection structure840comprises a ball located at a first end of the second elongate body820. The ball840is shaped to be received within the socket830. Once the ball840is inserted into the socket830, the socket830may be crimped or otherwise compressed to fully encompass and contain the ball therein (FIG. 9B). The ball840is free to rotate within the socket830.

Further, the first elongate body810includes a plurality of barbs815located on a surface of the suture, the plurality of barbs extending in a first direction. The second elongate body820includes a second plurality of barbs825located on a surface of the suture, the second plurality of barbs825extending in a second direction. Once the connection is made between the first elongate body and the second elongate body, a bidirectional barbed suture is created.

The elongate bodies described herein may be connected to one another during manufacturing or even in the operating room. For example, by connecting the elongate bodies during manufacturing, several combinations of sutures can be created and packaged. For example, a barbed elongate body can be connected to an unbarbed elongate body. In another non-limiting example, a monofilament elongate body can be connected to a multifilament elongate body. Several combinations and different suture lengths can be created using multifilament and monofilament barbed and unbarbed elongate bodies. It is also envisioned that more than two elongate bodies can be connected together. For example, one elongate body may include a connection structure disposed at each end. In one example an unbarbed elongate body can be connected at each end to a barbed elongate body. The two barbed elongate bodies may comprise barbs which are angled in different directions, therefore creating a bidirectional barbed suture with an unbarbed elongate body disposed between the barbed elongate bodies.

Another alternative is to have the surgeon choose and connect the various elongate bodies, specific to the patient or procedure, in the operating room. For example, a suture kit may be provided having several elongate bodies. The surgeon may create a suture by connecting the separate elongate bodies together, utilizing the connection structures and extension provided.

Further, sutures may additionally include coatings for improved performance/handling characteristics, suitable coatings are within the purview of those skilled in the art.

In certain embodiments, sutures described herein may include at least one therapeutic agent. The term “therapeutic agent,” as used herein, is used in its broadest sense and includes any substance or mixture of substances that provides a beneficial, therapeutic, pharmacological, and/or prophylactic effect. The agent may be a drug which provides a pharmacological effect.

Therapeutic agents may be combined with sutures in various forms. For example, therapeutic agents may be combined with the sutures in the form of a coating. Suitable methods for coating sutures are within the purview of those skilled in the art and include, but are not limited to, spray coating, dip coating, extrusion, coextrusion, overmolding, and the like. Additionally, the therapeutic agent may be combined with polar and non-polar solvents creating a suture coating.

Therapeutic agent may also be polymerized off the surface of the suture or compounded within the polymer resin used to create the suture. In other embodiments, polymer drugs (e.g., polydiflunisol, polyaspirin, and protein therapeutics) may be utilized to create sutures of the present disclosure.

Although the illustrative embodiments of the present disclosure have been described herein with reference to the accompanying drawings, it is to be understood that the disclosure is not limited to those precise embodiments, and that various other changes and modifications may be effected therein by one skilled in the art without departing from the scope or spirit of the disclosure. For example, the disclosure is not limited to those embodiments described herein and various combinations of elongate bodies, with and without barbs may be combined, including monofilament and multifilament configurations. Additionally needles may be disposed at one or both ends of the suture.