Barbed suture with removable sheath

Abstract

A one-armed suture assembly includes a needle, a flexible suture, and a flexible sheath. The flexible suture is coupled with the needle. The flexible suture includes a first portion and a second portion. The first portion includes a plurality of first barbs having a first tip extending away from the longitudinal path in an insertion direction or in a reverse insertion direction opposite the insertion direction. The second portion includes a plurality of second barbs having a second tip extending opposite the first tip. The flexible sheath is configured to prevent one of the first tip or the second tip extending in the insertion direction from contacting tissue when the flexible sheath is advanced in the insertion direction. The other of the first tip or the second tip extending in the counter-insertion direction is configured to contact tissue when the flexible sheath is advanced in the insertion direction.

Description

BACKGROUND OF THE INVENTION

[0001] Bidirectional knotless sutures can provide advantages for tissue fixation. Bidirectional means that the suture includes barbs facing in opposite directions. Knotless means that the suture does not have a knot at the end of the suture to maintain the desired placement of the suture within the tissue. However, in some situations (e.g., in a narrow space), it may be difficult to use a two-armed bidirectional knotless suture. Two-armed means that there are only two suture needles attached to the suture (e.g., one needle at each end of the suture). In some cases, a rigid hollow introducer is used to deliver the bidirectional barbed suture. The rigid hollow introducer can use a sharp tissue-piercing tip to accommodate and protect the barbed suture or at least a portion of the barbed suture such that the barbs oriented against the suture insertion direction can be inserted into the tissue. However, the rigid hollow introducer can utilize a relatively large tissue opening to mount the suture. Additionally, the rigidity of the rigid hollow introducer can result in a preset suture positioning corresponding to the shape of the rigid hollow introducer.

[0002] There is a need for a single-armed bidirectional knotless suture (i.e., having only one suture needle attached at one end of the knotless suture). Additionally, there is a need for a bidirectional knotless suture that is flexible and can be mounted along various tissue fixation and closure paths. Additionally, there is a need for a bidirectional knotless suture that does not incorporate a rigid hollow introducer to reduce the size of the opening in the tissue and / or reduce the amount of tissue trauma.

[0003] Although several barbed sutures have been made and used, and methods of using such several barbed sutures, it is believed that no one prior to the present inventors has made or used the invention described in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0004] Although this specification concludes with claims that particularly point out and distinctly claim such technology, it is believed that the technology will be better understood from the following examples described in conjunction with the accompanying drawings, in which like reference numerals indicate the same elements, and in which:

[0005] Figure 1 A side elevation view of a first example of a single-armed suture assembly is shown;

[0006] Figure 2A Shows Figure 1 A side elevation view of the single-armed suture assembly of

[0007] Figure 2B after it has been advanced through tissue in the insertion direction, where a flexible sheath covers selected barbs of the flexible suture of the single-armed suture assembly; Figure 2A A side elevation view of the single-armed suture assembly of

[0008] Figure 2C Shows Figure 2B a side elevation view of a single - arm suture assembly of

[0009] Figure 3 but with the cut - off portion of the flexible suture removed;

[0010] Figure 4 Shows Figure 3 a side elevation view of a single - arm suture assembly of

[0011] Figure 5 after it has been advanced through tissue in the insertion direction, with a flexible sheath covering selected barbs of the flexible suture;

[0012] Figure 6A Shows Figure 5 a side elevation view of a single - arm suture assembly of

[0013] Figure 6B after it has been advanced through tissue in the insertion direction, with a flexible sheath covering selected barbs of the flexible suture; Figure 6A a side elevation view of a single - arm suture assembly of

[0014] Figure 6C but with the flexible sheath removed in the insertion direction to expose selected barbs; Figure 6B Shows

[0015] Figure 7 a side elevation view of a fourth example of a single - arm suture assembly;

[0016] Figure 8 a side elevation view of a fifth example of a single - arm suture assembly;

[0017] Figure 9A a side elevation view of a sixth example of a single - arm suture assembly being advanced through tissue in the insertion direction, with a flexible sheath covering selected barbs of the flexible suture;

[0018] Figure 9B Shows Figure 9A a side elevation view of a single - arm suture assembly of

[0019] Figure 10 but with the flexible sheath moved in the reverse - insertion direction to expose selected barbs through an opening in the flexible sheath; and Figures 1 through 9B Shows a flowchart of an example of a method of using a single - arm suture assembly of

[0020] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the present invention may be carried out in many other ways, including ways that are not necessarily shown in the drawings. The drawings incorporated in and forming a part of this specification illustrate several aspects of the present invention and, together with the description, serve to explain the principles of the invention; however, it is to be understood that the present invention is not limited to the specific arrangements shown. Detailed Description

[0021] The description of certain examples of the present technology should not be used to limit the scope of the present technology. From the following description, other examples, features, aspects, embodiments, and advantages of the present technology will become apparent to those skilled in the art. The following description is given by way of example, which is one of the best ways contemplated for carrying out the present technology. As will be appreciated, the technology described herein can have other different and distinct aspects, all of which do not depart from the present technology. Accordingly, the drawings and description are to be regarded as illustrative in nature and not restrictive.

[0022] It should also be understood that, for convenience and clarity, spatial terms such as "longitudinal" are also used herein to refer to relative positions and directions. For clarity, such terms are used below with reference to the views and are not intended to limit the invention described herein.

[0023] In addition, as used herein, the terms "about" and "approximately" in connection with any numerical value or range of values are intended to cover the exact value cited, as well as a suitable tolerance that enables the cited feature or combination of features to be used for the intended purpose described herein.

[0024] I. Examples of Barbed Sutures with Removable Sheaths

[0025] A. First Example of a Single-Arm Suture Assembly

[0026] Figures 1 through 2C A first example of a single - arm suture assembly (10) is shown. The single - arm suture assembly (10) is shown as a single - arm two - way barbed or knotless suture. As shown, the single - arm suture assembly (10) includes a needle (12), a flexible suture (14), and a flexible sheath (16).

[0027] The handle (12) includes a first end and a second end (18, 20). As shown, the first end (18) is sharp and is configured to pierce tissue (T) in an insertion direction (34). The second end (20) is configured to be advanced through the tissue (T) in the insertion direction (34) based on the path that the first end (18) has traveled. Although the needle (12) is shown as a curved needle, other types of needles are also contemplated, including straight needles (see Figures 7 through 8) or a bendable needle. For a bent needle, the first end and the second end (18, 20) can be arranged at different angles, with an angle of about 180 degrees shown between the first end and the second end (18, 20). As Figure 1 and Figure 2B shown, the needle (12) has a needle diameter (d1) that defines a cross-sectional thickness, and this needle diameter is greater than the diameter (d2) of the flexible suture (14). In some forms, the needle (12) can be rigid or substantially rigid. In some forms, the needle (12) can be formed from a metallic material (e.g., stainless steel) and / or a polymeric material.

[0028] The flexible suture (14) is coupled to the second end (20) of the needle (12). The flexible suture (14) is shown as a knotless suture. The flexible suture (14) extends along a path (15), and this path can be straight or curved. For example, the flexible suture (14) can extend along a helical path. The flexible suture (14) includes a first portion and a second portion (22, 24) that can have the same or different sizes. Additionally, the first portion and the second portion (22, 24) can include the same or different numbers of barbs. As shown, the first portion (22) is closer to the needle (12) than the second portion (24). The first portion (22) includes a plurality of first barbs (26), and these first barbs have first tips (28) that extend away from the path (15) in the insertion direction (34) or in the reverse insertion direction (36). The reverse insertion direction (36) is about 180 degrees opposite to the insertion direction (34). As shown, the first tips (28) of the first barbs (26) each extend away from the path (15) in the reverse insertion direction (36). In other words, the first tips (28) extend more towards the reverse insertion direction (36) than the insertion direction (34). The first tips (28) are configured to be able to provide minimal or no resistance to the movement of the flexible suture (14) following the needle (12) in the tissue (T) during installation. For example, when the first tips (28) are advanced through the tissue (T) in the insertion direction (34), the first tips (28) can deflect towards the path (15).

[0029] The second portion (24) includes a plurality of second barbs (30) having second tips (32) that extend oppositely to the first tip (28) in the other of the insertion direction (34) or the reverse insertion direction (36). In other words, the first and second barbs (26, 30) are bidirectional. In this example, the second barbs (30) may also be referred to as reverse barbs. As shown, the second tips (32) each extend away from the path (15) in the insertion direction (34). In other words, the second tips (32) extend more in the insertion direction (34) than in the reverse insertion direction (36). The second tips (32) of the second barbs (30) point against the insertion direction (34) of the flexible suture (14) and toward the needle (12). During installation of the single-arm suture assembly (10), the second tips (32) are covered by the flexible sheath (16). In other words, the second portion (24) that houses the reverse barbs is encapsulated or covered by a thin tubular removable flexible sheath (16) that covers each reverse barb. If the second tips (32) were not covered during installation, the second tips (32) would provide resistance to movement of the flexible suture (14) within the tissue (T) in the insertion direction (34). In some forms, the diameter of the suture portion that houses the reverse barbs is less than the diameter or effective cross-section of the portion that includes regular (non-reverse) barbs to accommodate the increased size of the flexible sheath (16) that covers the reverse barbs.

[0030] At least one of the first barbs (26) or the second barbs (30) may extend helically along the path (15). In other words, at least one of the first barbs (26) or the second barbs (30) may be arranged in a helical pattern along the circumference of the flexible suture (14). In some forms, at least one of the first barbs (26) or the second barbs (30) may be symmetric along the path (15). As shown, the first barbs (26) are helical along the path (15), and the second barbs (30) are symmetric along the path (15). However, it is also contemplated that the first barbs (26) are symmetric along the path (15), and the second barbs (30) are helical along the path (15), or that the first and second barbs (26, 30) are each symmetric, or that the first and second barbs (26, 30) are each helical (e.g., Figures 3 through 4 the first and second barbs (126, 130) shown).

[0031] As shown in the figure, the flexible suture (14) includes an optional elastic intermediate portion (38) that is configured to be stretchable to assist in securing the flexible suture (14). The elastic intermediate portion (38) is disposed between a second portion and a first portion (22, 24). The elastic intermediate portion (38) can be formed by heat-treating the elastic intermediate portion (38) or by inserting an elastic section between the first portion and the second portion (22, 24) such that the elastic intermediate portion (38) is formed of a different material. The flexible suture (14) defines a circumference.

[0032] The flexible suture (14) can be formed from a non-degradable material or a bioabsorbable material (e.g., a bioabsorbable polymer). A non-degradable suture (also referred to as a "non-absorbable suture") is a suture that includes a material that does not degrade by chain scission, such as a chemical reaction process (e.g., hydrolysis, oxidation / reduction, enzymatic mechanisms, or combinations thereof) or by a thermal or photolytic process. Non-degradable suture materials include polyamides (also known as nylons, such as nylon 6 and nylon 6,6), polyesters (e.g., polyethylene terephthalate), polytetrafluoroethylene (e.g., expanded polytetrafluoroethylene), polyether esters such as polybutester (a block copolymer of butylene terephthalate and polytetramethylene ether glycol), polyurethanes, metal alloys, metals (e.g., stainless steel wire), polypropylene, polyethylene, silk, and cotton. Flexible sutures (14) made from non-degradable suture materials are suitable for applications where the flexible suture (14) is intended to remain permanently within the tissue (T) or is intended to be physically removed from the body.

[0033] A bioabsorbable suture (also referred to as a "non-absorbable suture") is a suture that includes a material that degrades in the body. Bioabsorbable polymers and medical devices made from such polymers are known in the art. Conventional bioabsorbable polymers include polylactic acid, poly(Thdioxanone), polyglycolic acid, copolymers of lactide, glycolide, p-dioxanone, trimethylene carbonate, ε-caprolactone, etc. in various combinations. Bioabsorbable polymers are designed to have chemical properties such that the polymer decomposes in the body and is metabolized or otherwise broken down (e.g., by hydrolysis) and excreted from the patient's body.

[0034] The flexible sheath (16) includes a generally tubular wall (40) defining an inner surface (42) and an outer surface (42). The inner surface (42) defines a lumen. The flexible sheath (16) is configured to prevent one of a first tip or a second tip (28, 32) extending in the insertion direction (34) from contacting tissue (T) when the flexible sheath (16) is advanced in the insertion direction (34). The flexible sheath (16) covers at least a portion of one of the first barb (26) or the second barb (30), but does not cover any portion of the other of the first barb (26) or the second barb (30). As shown, the flexible sheath (16) covers the second barb (30) but does not cover any portion of the first barb (26). In some forms, the flexible sheath (16) is heat-shrinkable such that the flexible sheath (16) can be heat-shrunk over the second barb (30), but not over the first tip (28). In some forms, the flexible sheath (16) can be heat-shrunk over the first tip (28), but not over the second tip (32). Although not shown, the flexible sheath (16) can have a thicker portion that does not cover the second barb (30). In some forms, the flexible sheath (16) can be made of a material having lubricating properties, such as made of polytetrafluoroethylene (PTFE) or any other low-friction material. In some forms, the outer surface (42) of the flexible sheath (16) can include a coating (e.g., such as a silicone coating) and / or a liquid lubricant.

[0035] The flexible sheath (16) is more flexible than the needle (12). The flexible sheath (16) includes a pull tab (46) configured to be manually grasped by a user. The pull tab (46) can serve as an anchoring feature to prevent further advancement of the flexible suture (14) in the insertion direction (34). The pull tab (46) can be grasped by the user when the flexible sheath (16) is removed in the reverse insertion direction (36). As Figures 1 through 2C shown, the flexible sheath (16) is not directly coupled to the needle (12). The flexible sheath (16) has a first end (48) spaced a distance from the second end (20) of the needle (12). The outer circumference of the flexible sheath (16) corresponds to a sheath diameter (d3). In some forms, the sheath diameter (d3) is between about 100% and about 150% of the needle diameter (d1). In other forms, the sheath diameter (d3) is less than the needle diameter (d1).

[0036] The installation of the single-arm suture assembly (10) is described below with reference to Figures 2A through 2C Specifically, Figure 2AShows a single - arm suture assembly (10) after being advanced through tissue (T) in the insertion direction (34), where a flexible sheath (16) covers the second barbs (30) of the flexible suture (14). A first tip (28) extends in the reverse - insertion direction (36) and is configured to contact the tissue (T) when the flexible suture (14) is advanced in the insertion direction (34). The first tip (28) extending in the reverse - insertion direction (36) means that when the flexible suture (14) is advanced in the insertion direction (34), the first tip (28) can deflect towards the reverse - insertion direction (36). The flexible suture (14) can be mounted by pulling on the needle (12) such that the flexible suture (14) passes through the tissue (T) in a path defined by the needle (12). Since the flexible sheath (16) covers each second tip (32) of the second barbs (30), the second barbs (30) do not provide resistance to the movement of the flexible suture (14) behind the needle (12) during insertion or implantation.

[0037] Figure 2B Shows Figure 2A the single - arm suture assembly (10) at a time when the flexible sheath (16) is actively removed in the reverse - insertion direction (36) to expose the previously covered second barbs (30). After the flexible suture (14) is positioned at the desired location, the flexible sheath (16) is removed by pulling the flexible sheath (16) away from the second portion (24), thereby exposing the second barbs (30) to allow the second barbs (30) to engage the tissue (T). For example, when positioning the flexible suture (14), by pulling on the pull tab (46), the flexible sheath (16) (which may also be referred to as a compression sleeve) is pulled away from the second barbs (30), thereby exposing and releasing the second barbs (30) and allowing the second barbs (30) to deploy in and engage the tissue (T). Figure 2C Shows Figure 2A the single - arm suture assembly (10), but where after deploying the second barbs (30), the first cutting portion and the second cutting portion (50, 52) are removed. As shown, the first cutting portion (50) is coupled to the needle (12).

[0038] B. Second Example of a Single-Arm Suture Assembly

[0039] Figures 3 through 4 Shows a second example of a single - arm suture assembly (110). As shown, the single - arm suture assembly (110) includes a needle (112), a flexible suture (114), and a flexible sheath (116). Except as otherwise described below, the needle (112) is similar to the needle (12), the flexible suture (114) is similar to the flexible suture (14), and the flexible sheath (116) is similar to the flexible sheath (16).

[0040] Similar to the needle (12), the needle (112) includes a first end and a second end (118, 120). The flexible suture (114) includes a first portion and a second portion (122, 124), wherein the first portion (122) includes a plurality of first barbs (126) having a first tip (128). The second portion (124) includes a plurality of second barbs (130) having a second tip (132) and a barb-free portion (133) that does not include barbs. The first tip (128) extends in the anti-insertion direction (136), and the second tip (132) extends in the insertion direction (134). The first barbs and the second barbs (126, 130) include helical barbs. Due to the barb-free portion (133), the flexible suture (114) is longer than the flexible suture (14).

[0041] Similar to the flexible sheath (16), the flexible sheath (116) includes a generally tubular wall (140) defining an inner surface and an outer surface (142, 144) and a pull tab (146). As shown, the flexible sheath (116) is longer than the flexible sheath (16) such that the distance between the first end (148) of the flexible sheath (116) and the pull tab (146) of the flexible sheath (116) is greater than the corresponding distance of the flexible sheath (16). Figure 4 Shown after being advanced through tissue (T) in the insertion direction (134) Figure 3 of the single-arm suture assembly (110), wherein the flexible sheath (116) covers the second barbs (130) of the flexible suture (114). The flexible sheath (116) can be removed in the anti-insertion direction (136) using the pull tab (146) to expose the second barbs (130).

[0042] C. Third Example of a Single-Arm Suture Assembly

[0043] Figures 5 through 6C A third example of a single-arm suture assembly (210) is shown. As shown, the single-arm suture assembly (210) includes a needle (212), a flexible suture (214), and a flexible sheath (216). Except as otherwise described below, the needle (212) is similar to the needle (12), the flexible suture (214) is similar to the flexible suture (14), and the flexible sheath (216) is similar to the flexible sheath (16).

[0044] Similar to the needle (12), the needle (212) includes a first end and a second end (218, 220). The flexible suture (214) includes a first portion and a second portion (222, 224), wherein the first portion (222) includes a plurality of first barbs (226) having a first tip (228). The second portion (224) includes a plurality of second barbs (230) having a second tip (232). Different from the above-mentioned first tip (28, 128), the first tip (228) extends away from the path (215) in the insertion direction (134). Different from the above-mentioned second tip (32, 132), the second tip (232) extends away from the path (215) in the anti-insertion direction (236). The first barbs (226) include symmetric barbs that extend symmetrically away from the path (215), and the second barbs (226) include helical barbs that extend helically away from the path (215). The flexible suture (214) includes an optional elastic intermediate portion (238) similar to the optional elastic intermediate portion (38).

[0045] Similar to the flexible sheath (16), the flexible sheath (216) includes a generally tubular wall (240) defining an inner surface and an outer surface (242, 244) and a pull tab (246). However, different from the above-mentioned flexible sheaths (16, 116), the flexible sheath (216) is coupled to the needle (212). As shown, the first end (248) of the flexible sheath (216) overlaps the second end (220) of the needle (212). In some configurations, the needle (212) and the flexible sheath (216) may include corresponding locking features to securely couple the needle (212) to the flexible sheath (216). The flexible sheath (216) is removed in the insertion direction (234) to expose the first barbs (226).

[0046] Reference is made below to Figures 6A through 6C describe the installation of the single-arm suture assembly (210). Specifically, Figure 6A illustrates the Figure 5 single-arm suture assembly (210) after being advanced through the tissue (T) in the insertion direction (234), wherein the flexible sheath (216) covers the first barbs (226) of the flexible suture (214), but wherein the second barbs (230) of the flexible suture (214) are exposed and in contact with the tissue (T).

[0047] Figure 6B illustrates Figure 6AA single - arm suture assembly (210), but wherein the flexible sheath (216) is removed in the insertion direction (234) to expose the first barb (226). After installing the flexible suture (214) by pulling the flexible suture (214) behind the needle (212) through the tissue (T), the flexible sheath (216) is removed. The flexible sheath (216) can be removed so as to pull the needle (212) coupled to the flexible sheath (216) to expose the first barb (226) and engage the first barb (226) with the tissue (T). Figure 6C shows Figure 6B A single - arm suture assembly (210), but wherein the first cutting portion and the second cutting portion (250, 252) are removed. The first cutting portion (250) is coupled to the needle (212) and the flexible sheath (216), and the second cutting portion (252) is coupled to the pull tab (246).

[0048] D. Fourth Example of a Single-Arm Suture Assembly

[0049] Figure 7 A fourth example of a single - arm suture assembly (310) is shown. As shown, the single - arm suture assembly (310) includes a needle (312), a flexible suture (314), and a flexible sheath (316). Except as otherwise described below, the needle (312) is similar to the needle (12), the flexible suture (314) is similar to the flexible suture (14), and the flexible sheath (316) is similar to the flexible sheath (16).

[0050] Similar to the needle (12), the needle (312) includes a first end and a second end (318, 320). Different from the needles (12, 112, 212), the needle (312) is shown as a longitudinally extending straight needle. The flexible suture (314) includes a first portion and a second portion (322, 324), wherein the first portion (322) includes a plurality of first barbs (326) having a first tip (328). Similar to the first tip (228), the first tips (328) each extend away from the path (315) in the insertion direction (334). The second portion (324) includes a plurality of second barbs (330) having a second tip (332). Similar to the second tip (232), the second tips (332) each extend away from the path (315) in the reverse insertion direction (336). The first barbs (326) include symmetric barbs that extend symmetrically away from the path (315), and the second barbs (326) include helical barbs that extend helically away from the path (315).

[0051] Similar to the flexible sheath (16), the flexible sheath (316) includes a generally tubular wall (340) defining an inner surface and outer surfaces (342, 344). A pull tab (346) may be positioned at the end of the flexible suture (314). The flexible sheath (316) includes a first end and a second end (348, 350). As shown, the first end (348) of the flexible sheath (316) is coupled to the needle (312). Unlike the flexible sheath (216) that overlaps the needle (212) in Figure 5 , the flexible sheath (316) terminates at the needle (312) at the docking joint. Figure 5 The single - arm suture assembly (310) is shown after being advanced through tissue (T) in the insertion direction (334), where the flexible sheath (316) covers the first barb (326) of the flexible suture (314). The first barb (326) may be deployed in a manner similar to the first barb (226) shown in Figure 6B . The flexible suture (314) may be trimmed in a manner similar to the first cutting portion and the second cutting portion (250, 252) shown in Figure 6C . Figure 7 Figure 6B Figure 6C

[0052] E. Fifth Example of a Single-Arm Suture Assembly

[0053] Figure 8

[0054] A fifth example of a single - arm suture assembly (410) is shown. As shown, the single - arm suture assembly (410) includes a needle (412), a flexible suture (414), and a flexible sheath (416). Except as otherwise described below, the needle (412) is similar to the needle (12), the flexible suture (414) is similar to the flexible suture (14), and the flexible sheath (416) is similar to the flexible sheath (16).

[0054] Similar to the needle (312), the needle (412) is shown as a straight needle. Similar to the needle (12), the needle (412) includes a first end and a second end (418, 420). The needle (412) includes at least one recessed portion (450) that tapers inwardly, where two recessed portions (450) are shown. The recessed portion (450) may include a pawl, a dent, or another suitable structure for engaging the flexible sheath (416).

[0055] The flexible suture (414) includes a first portion and a second portion (422, 424), wherein the first portion (422) includes a plurality of first barbs (426) having a first tip (428). The second portion (424) includes a plurality of second barbs (430) having a second tip (432). Each of the first tips (428) extends away from the path (415) in the insertion direction (434). Each of the second tips (432) extends away from the path (415) in the reverse insertion direction (436). The first barbs (426) include symmetric barbs that extend symmetrically away from the path (415), and the second barbs (426) include helical barbs that extend helically away from the path (415). As shown, the single-arm suture assembly (410) has been advanced through the tissue (T) in the insertion direction (434), wherein the flexible sheath (416) covers the first barbs (426) of the flexible suture (414) while allowing the second barbs (430) to remain exposed during insertion.

[0056] Similar to the flexible sheath (16), the flexible sheath (416) includes a generally tubular wall (440) defining an inner surface and an outer surface (442, 444). A pull tab (446) is positionable relative to the needle (412) at an opposite end of the flexible suture (414). As shown, the flexible sheath (416) is coupled to the needle (412). The flexible sheath (416) includes at least one protrusion (452). The protrusion (452) of the flexible sheath (416) is configured to engage a recessed portion (450) of the needle (412). The first barbs (426) may be deployed in a manner similar to the first barbs (226) shown. The flexible suture (414) may be trimmed similar to the first cutting portion and the second cutting portion (250, 252) shown. Figure 6B shown. Figure 6C shown.

[0057] F. Sixth Example of a Single-Arm Suture Assembly

[0058] Figures 9A through 9B A sixth example of a single-arm suture assembly (510) is shown. As shown, the single-arm suture assembly (510) includes a needle (512), a flexible suture (514), and a flexible sheath (516). Except as otherwise described below, the needle (512) is similar to the needle (12), the flexible suture (514) is similar to the flexible suture (14), and the flexible sheath (516) is similar to the flexible sheath (16).

[0059] Similar to the needle (12), the needle (512) includes a first end and a second end (518, 520). The flexible suture (514) includes a first portion and a second portion (522, 524), wherein the first portion (522) includes a plurality of first barbs (526) having a first tip (528). The second portion (524) includes a plurality of second barbs (530). The first tip (528) extends in the anti-insertion direction (536), and the second tip (532) extends in the insertion direction (534). The first barbs (526) are symmetric along the path (515), and the second barbs (526) include helical barbs.

[0060] Similar to the flexible sheath (16), the flexible sheath (516) includes a generally tubular wall (540) defining an inner surface and an outer surface (542, 544). The flexible sheath (516) may be bioabsorbable such that the flexible sheath (516) is not removed but remains within the (T). For example, the flexible suture (514) may be non-degradable and the flexible sheath (516) may be bioabsorbable. In other configurations, both the flexible suture (514) and the flexible sheath (516) are bioabsorbable at the same or different bioabsorption rates. As shown, the flexible suture (514) includes an optional elastic intermediate portion (538) similar to the elastic intermediate portion (38).

[0061] Figure 9A Shown is the single-arm suture assembly (510) after being advanced through the tissue (T) in the insertion direction (534), wherein the flexible sheath (516) covers the second barbs (530) of the flexible suture (514). In other words, the second barbs (530) are protected by the flexible sheath (516) during deployment. The flexible sheath (516) may be pulled in the anti-insertion direction (136) to expose the second barbs (530) through an opening of the flexible sheath (516). Alternatively, the flexible sheath (516) may include a slot opening towards the first end (548) of the flexible sheath (516) to allow removal of the flexible sheath (516). In some configurations, the flexible sheath (516) may be rotated to expose the second barbs (530).

[0062] Figure 9B Shown is Figure 9A the single-arm suture assembly (510), but wherein the flexible sheath (516) is moved in the anti-insertion direction (536) to expose the second barbs (530) through an opening (550) of the flexible sheath (516). In other words, the flexible sheath (516) is pulled back to deploy the reverse barbs through the opening (550). The opening (550) may be arranged at various different angles around the circumference of the flexible sheath (516). Although Figures 9A through 9BTwo openings (550) are shown, but additional openings (550) are also contemplated. Although the flexible sheath (516) is shown as retracting in the anti-insertion direction (536), it is also contemplated that the needle (512) can be further advanced in the insertion direction (534).

[0063] G. Example of a Method

[0064] Figure 10 The use of Figures 1 through 9B is shown in the flowchart of an exemplary method (610) of a single-arm suture assembly (10, 110, 210, 310, 410, 510). At step (612), the method (610) includes penetrating tissue (T) along an insertion direction (34, 134, 234, 334, 434, 534) using a needle (12, 112, 212, 312, 412, 512). The single-arm suture assembly (10, 110, 210, 310, 410, 510) can be used in a variety of surgical procedures. In some forms, the single-arm suture assembly (10, 110, 210, 310, 410, 510) can be used in cosmetic surgeries for the eyebrow, facial, and neck regions. These cosmetic surgeries can be similar to those shown and described in U.S. Patent No. 10,548,592, titled "Suture Methods and Devices," published on February 2, 2020, the entire disclosure of which is incorporated herein by reference.

[0065] At step (614), the method (610) includes advancing the flexible suture (14, 114, 214, 314, 414, 514) such that one of a first tip (28, 128, 528) or a second tip (232, 332, 432) extending in the anti-insertion direction (36, 136, 236, 336, 436, 536) contacts the tissue (T), while using the flexible sheath (16, 116, 216, 316, 416, 516) to prevent the other of a first tip (228, 328, 428) or a second tip (32, 132, 532) extending in the insertion direction (34, 134, 234, 334, 434, 534) from contacting the tissue (T). The flexible sheath (16, 116, 216, 316, 416, 516) can be advanced using the needle (12, 112, 212, 312, 412, 512) and / or the flexible suture (14, 114, 214, 314, 414, 514).

[0066] At step (616), method (610) includes removing the flexible sheath (16, 116, 216, 316, 416, 516) to deploy the first tip (228, 328, 428) or the second tip (32, 132, 532) that extends in the insertion direction (34, 134, 234, 334, 434, 534) into the tissue (T). In other words, the first tip (228, 328, 428) or the second tip (32, 132, 532) that extends in the insertion direction (34, 134, 234, 334, 434, 534) is deployed into the tissue after the first tip (28, 128, 528) or the second tip (232, 332, 432) that extends in the reverse insertion direction (36, 136, 236, 336, 436, 536).

[0067] II. Combined Embodiments

[0068] The following embodiments relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following embodiments are not intended to limit the scope of any claims that may be provided at any time in this patent application or in subsequent filings of this patent application. No disclaimer is intended. The following embodiments are provided merely for illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in many other ways. It is also contemplated that some variations may omit certain features mentioned in the following embodiments. Therefore, none of the aspects or features mentioned below should be considered decisive unless expressly so indicated by the inventor or successors in interest to the inventor at a later date. If any claims presented in this patent application or in subsequent filings related to this patent application include additional features other than those mentioned below, these additional features should not be assumed to have been added for any reason related to patentability.

[0069] Embodiment 1

[0070] A single - arm suture assembly, comprising: (a) a needle including a first end and a second end, wherein the second end is configured to be advanced through tissue in an insertion direction; (b) a flexible suture coupled to the second end of the needle, wherein the flexible suture extends along a longitudinal path and includes: (i) a first portion including a plurality of first barbs having first tips extending away from the longitudinal path in the insertion direction or in a reverse insertion direction opposite to the insertion direction, and (ii) a second portion including a plurality of second barbs having second tips extending opposite to the first tips in the other of the insertion direction or the reverse insertion direction; and (c) a flexible sheath configured to prevent one of the first tip or the second tip extending in the insertion direction from contacting tissue when the flexible sheath is advanced in the insertion direction, wherein the other of the first tip or the second tip extending in the reverse insertion direction is configured to contact tissue when the flexible sheath is advanced in the insertion direction.

[0071] Embodiment 2

[0072] The single - arm suture assembly according to embodiment 1, wherein the flexibility of the flexible sheath is greater than the flexibility of the needle.

[0073] Embodiment 3

[0074] The single - arm suture assembly according to any one of embodiments 1 to 2, wherein at least one of the plurality of first barbs or the plurality of second barbs extends helically along the longitudinal path.

[0075] Embodiment 4

[0076] The single - arm suture assembly according to any one of embodiments 1 to 3, wherein at least one of the plurality of first barbs or the plurality of second barbs is symmetric along the longitudinal path.

[0077] Embodiment 5

[0078] The single - arm suture assembly according to any one of embodiments 1 to 4, wherein the flexible sheath includes a pull tab configured to be manually grasped by a user.

[0079] Embodiment 6

[0080] The single - arm suture assembly according to any one of embodiments 1 to 5, wherein the needle is a curved needle.

[0081] Embodiment 7

[0082] The single - arm suture assembly according to any one of embodiments 1 to 6, wherein the single - arm flexible suture further comprises an elastic intermediate portion configured to be stretchable to assist in fixing the flexible suture, and wherein the elastic intermediate portion is disposed between the second portion and the first portion.

[0083] Embodiment 8

[0084] The single - arm suture assembly according to any one of embodiments 1 to 7, wherein the flexible sheath covers at least a portion of one of the plurality of first barbs or the plurality of second barbs, but does not cover any portion of the other of the plurality of first barbs or the plurality of second barbs.

[0085] Embodiment 9

[0086] The single - arm suture assembly according to any one of embodiments 1 to 8, wherein an outer circumference of the flexible sheath defines a sheath diameter, an outer circumference of the needle defines a needle diameter, and the sheath diameter is between about 100% and about 150% of the needle diameter.

[0087] Embodiment 10

[0088] The single - arm suture assembly according to any one of embodiments 1 to 9, wherein each of the first tips extends away from the longitudinal path in the reverse insertion direction, and each of the second tips extends away from the longitudinal path in the insertion direction.

[0089] Embodiment 11

[0090] The single - arm suture assembly according to any one of embodiments 10 to 12, wherein the flexible sheath is heat - shrunk over the first tip, but not over the second tip.

[0091] Embodiment 12

[0092] The single - arm suture assembly according to any one of embodiments 1 to 11, wherein the flexible sheath has a first end spaced a distance from the second end of the needle.

[0093] Embodiment 13

[0094] The single - arm suture assembly according to any one of embodiments 1 to 12, wherein the flexible sheath is not directly coupled to the needle.

[0095] Embodiment 14

[0096] The single - arm suture assembly according to any one of embodiments 1 to 13, wherein the flexible sheath includes an outer surface, and the outer surface includes a lubricating coating configured to reduce the friction between the outer surface and the tissue.

[0097] Embodiment 15

[0098] The single - arm suture assembly according to any one of embodiments 1 to 9 and embodiments 12 to 14, wherein each of the first tips extends away from the longitudinal path in the insertion direction, and each of the second tips extends away from the longitudinal path in the anti - insertion direction.

[0099] Embodiment 16

[0100] The single - arm suture assembly according to any one of embodiments 1 to 15, wherein the flexible sheath is directly coupled to the needle.

[0101] Embodiment 17

[0102] The single - arm suture assembly according to any one of embodiments 1 to 16, wherein the flexible sheath includes a protrusion, and the needle includes a recessed portion configured to engage the protrusion of the flexible sheath.

[0103] Embodiment 18

[0104] A single - arm suture assembly, comprising: (a) a needle; (b) a flexible suture coupled to the needle, wherein the flexible suture extends along a longitudinal path, and the flexible suture includes: (i) a first portion including a plurality of first barbs having first tips extending away from the longitudinal path in a second direction, and (ii) a second portion including a plurality of second barbs having second tips extending in a first direction opposite to the first tips; and (c) a flexible sheath configured to prevent the second tips from contacting tissue when the flexible sheath is advanced in the first direction, while allowing the first tips extending in the second direction to contact tissue.

[0105] Embodiment 19

[0106] The single - arm suture assembly according to embodiment 18, wherein the flexible sheath has a first end spaced apart from the needle by a distance.

[0107] Embodiment 20

[0108] The single - arm suture assembly according to any one of embodiments 18 to 19, wherein the flexible suture has a circumference, and at least one of the plurality of first barbs or the plurality of second barbs is arranged in a helical pattern along the circumference of the flexible suture.

[0109] Embodiment 21

[0110] A method of using a single - arm suture assembly, comprising: (a) a needle including a first end and a second end, wherein the second end is configured to be advanced through tissue in an insertion direction; (b) a flexible suture coupled to the second end of the needle, wherein the flexible suture body extends along a longitudinal path, and the flexible suture includes: (i) a first portion including a plurality of first barbs having first tips extending away from the longitudinal path in the insertion direction or in a reverse insertion direction opposite to the insertion direction; and (ii) a second portion including a plurality of second barbs having second tips extending opposite to the first tips in the other of the insertion direction or the reverse insertion direction; and (c) a flexible sheath. The method includes: (a) penetrating tissue in the insertion direction using the needle; and (b) advancing the flexible suture in the insertion direction such that one of the first tips or the second tips extending in the reverse insertion direction contacts the tissue while using the flexible sheath to prevent the other of the first tips or the second tips extending in the insertion direction from contacting the tissue.

[0111] Embodiment 22

[0112] The method according to embodiment 21, further comprising removing the flexible sheath to deploy the first tip or the second tip extending into the tissue in the insertion direction.

[0113] III. Miscellaneous

[0114] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein can be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Therefore, the above - mentioned teachings, expressions, embodiments, examples, etc. should not be regarded as isolated from each other. According to the teachings herein, various suitable ways in which the teachings herein can be combined will be apparent to those of ordinary skill in the art. Such modifications and variations are intended to be included within the scope of the claims.

[0115] It should be understood that any patent, patent publication, or other public material, whether in whole or in part, allegedly incorporated herein by reference is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other public materials listed in the present disclosure. Therefore, and to the extent necessary, the disclosure explicitly listed herein supersedes any conflicting material incorporated herein by reference. Any material or portion thereof allegedly incorporated herein by reference but conflicting with existing definitions, statements, or other public materials listed herein will be incorporated only to the extent that there is no conflict between the incorporated material and the existing public materials.

[0116] Various embodiments of the present invention have been shown and described, and further improvements of the methods and systems described herein may be achieved by appropriate modifications by those of ordinary skill in the art without departing from the scope of the present invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those of skill in the art. For example, the embodiments, embodiments, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not required. Therefore, the scope of the present invention should be considered in light of the following claims, and should be understood not to be limited to the details of the structure and operation shown and described in the specification and drawings.

Claims

1. A single - arm suture assembly, comprising: (a) a needle including a first end and a second end, wherein the second end is configured to be advanced through tissue in an insertion direction; (b) a flexible suture coupled to the second end of the needle, wherein the flexible suture extends along a longitudinal path and includes: (i) a first portion including a plurality of first barbs having first tips extending away from the longitudinal path in the insertion direction or in an anti - insertion direction opposite to the insertion direction, and (ii) a second portion including a plurality of second barbs having second tips extending opposite to the first tips in the other of the insertion direction or the anti - insertion direction; and (c) a flexible sheath configured to prevent one of the first tip or the second tip extending in the insertion direction from contacting tissue when the flexible sheath is advanced in the insertion direction, wherein the other of the first tip or the second tip extending in the anti - insertion direction is configured to contact tissue when the flexible sheath is advanced in the insertion direction.

2. The single-arm suture assembly according to claim 1, wherein, The flexible sheath is more flexible than the needle.

3. The single-arm suture assembly according to claim 1 or 2, wherein, At least one of the plurality of first barbs or the plurality of second barbs extends helically along the longitudinal path.

4. The single-arm suture assembly according to any one of the preceding claims, wherein, At least one of the plurality of first barbs or the plurality of second barbs is symmetric along the longitudinal path.

5. The single-arm suture assembly according to any one of the preceding claims, wherein, The flexible sheath includes a pull tab configured to be manually grasped by a user.

6. The single-arm suture assembly according to any one of the preceding claims, wherein, The single - arm flexible suture further includes an elastic intermediate portion configured to stretch to assist in securing the flexible suture, wherein the elastic intermediate portion is disposed between the second portion and the first portion.

7. The single-arm suture assembly according to any one of the preceding claims, wherein, The flexible sheath covers at least a portion of one of the plurality of first barbs or the plurality of second barbs, but does not cover any portion of the other of the plurality of first barbs or the plurality of second barbs.

8. The single-arm suture assembly according to any one of the preceding claims, wherein, The outer circumference of the flexible sheath defines a sheath diameter, wherein the outer circumference of the needle defines a needle diameter, and wherein the sheath diameter is between about 100% and about 150% of the needle diameter.

9. The single-arm suture assembly according to any one of the preceding claims, wherein, The first tips each extend away from the longitudinal path in the anti - insertion direction, wherein the second tips each extend away from the longitudinal path in the insertion direction.

10. The single-arm suture assembly according to any one of the preceding claims, wherein, The flexible sheath is not directly coupled to the needle.

11. The single-arm suture assembly according to any one of the preceding claims, wherein, The flexible sheath has a first end spaced apart from the second end of the needle by a distance.

12. The single-arm suture assembly according to any one of the preceding claims, wherein, The flexible sheath is heat - shrunk over the first tips, but not over the second tips.

13. The single-arm suture assembly according to any one of claims 1 to 8, wherein, The first tips each extend away from the longitudinal path in the insertion direction, wherein the second tips each extend away from the longitudinal path in the anti - insertion direction.

14. The single-arm suture assembly according to claim 13, wherein, The flexible sheath is directly coupled to the needle.

15. The single-arm suture assembly according to any one of the preceding claims, wherein, The flexible sheath includes a protrusion, and the needle includes a recessed portion configured to engage the protrusion of the flexible sheath.

16. A single - arm suture assembly, comprising: (a) a needle; (b) a flexible suture, the flexible suture being coupled to the needle, wherein the flexible suture extends along a longitudinal path, and the flexible suture comprises: (i) a first portion, the first portion comprising a plurality of first barbs, the plurality of first barbs having first tips extending away from the longitudinal path in a second direction, and (ii) a second portion, the second portion comprising a plurality of second barbs, the plurality of second barbs having second tips extending in a first direction opposite to the first tips; and (c) a flexible sheath, the flexible sheath being configured to prevent the second tips from contacting tissue when the flexible sheath is advanced in the first direction, while allowing the first tips extending in the second direction to contact tissue.

17. The single-arm suture assembly according to claim 16, wherein, The flexible sheath has a first end spaced apart from the needle by a distance.

18. The single-arm suture assembly according to claim 16 or 17, wherein, The flexible suture has a circumference, wherein at least one of the plurality of first barbs or the plurality of second barbs is arranged in a helical pattern along the circumference of the flexible suture.

19. A method of using a single - arm suture assembly, the single - arm suture assembly comprising: (a) a needle, the needle comprising a first end and a second end, wherein the second end is configured to be advanced through tissue in an insertion direction, (b) a flexible suture, the flexible suture being coupled to the second end of the needle, wherein a flexible suture body extends along a longitudinal path body, and the flexible suture comprises: (i) a first portion, the first portion comprising a plurality of first barbs, the plurality of first barbs having first tips extending away from the longitudinal path in the insertion direction or in a reverse insertion direction opposite to the insertion direction, and (ii) a second portion, the second portion comprising a plurality of second barbs, the plurality of second barbs having second tips extending in the other of the insertion direction or the reverse insertion direction opposite to the first tips, and (c) a flexible sheath, The method comprises: (a) using the needle to penetrate tissue in the insertion direction; and (b) advancing the flexible suture in the insertion direction such that one of the first tips or the second tips extending in the reverse insertion direction contacts the tissue, while using the flexible sheath to prevent the other of the first tips or the second tips extending in the insertion direction from contacting tissue.

20. The method according to claim 19, further comprising removing the flexible sheath to deploy the first tip or the second tip extending into the tissue in the insertion direction.

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