Barbed suture with removable sheath

Abstract

The single-arm suture assembly includes a needle, a flexible suture, and a flexible sheath. The flexible suture is coupled to 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 either an insertion direction or 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 reverse insertion direction is configured to contact tissue when the flexible sheath is advanced in the insertion direction.

Description

[Background technology]

[0001] Bidirectional knotless sutures can offer 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 its end to maintain the desired placement of the suture within the tissue. However, using a double-armed bidirectional knotless suture can be difficult in some situations (e.g., tight spaces). Double-armed means that the suture has only two suture needles attached (e.g., one needle at each end of the suture). In some cases, a rigid hollow introducer is used to deliver a bidirectional barbed suture. The rigid hollow introducer can use a pointed tissue-piercing end to contain and protect the barbed suture, or at least a portion of the barbed suture, so that the barbs oriented in the opposite direction to the direction of suture insertion can be inserted into the tissue. However, a rigid hollow introducer may utilize a relatively large tissue opening to place the suture. Additionally, the rigidity of the rigid hollow introducer may result in the positioning of the pre-placed suture corresponding to the shape of the rigid hollow introducer.

[0002] There is a need for a bidirectional knotless suture that is single-armed (i.e., has only one suture needle attached to one end of the knotless suture). Additionally, there is a need for a bidirectional knotless suture that is flexible and can be placed along a variety of 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 tissue opening and / or reduce the amount of tissue trauma.

[0003] While various barbed sutures and methods of using barbed sutures have been made and used, it is believed that no one prior to the present inventors has made or used the present invention as set forth in the appended claims. [Brief explanation of the drawings]

[0004] While this specification concludes with claims particularly pointing out and distinctly claiming the present technology, the present technology will be better understood from the following description of certain specific embodiments read in conjunction with the accompanying drawings, in which like reference numerals identify the same elements. [Figure 1] FIG. 1 shows a side view of a first example of a single-armed suture assembly. [Figure 2A] 2 illustrates a side view of the single-armed suture assembly of FIG. 1 after it has been advanced in an insertion direction through tissue, with the flexible sheath covering the barb portion of the flexible suture of the single-armed suture assembly. [Figure 2B] 2B shows a side view of the single-armed suture assembly of FIG. 2A, but with the flexible sheath removed in a reverse insertion direction to expose the previously covered barb. [Figure 2C] FIG. 2C shows a side view of the single-armed suture assembly of FIG. 2B, but with the cut portion of the flexible suture removed. [Figure 3] FIG. 10 shows a side view of a second example of a single-armed suture assembly including a helical barb. [Figure 4] 4 illustrates a side view of the single-armed suture assembly of FIG. 3 after advancement in an insertion direction through tissue, with the flexible sheath covering the barb portion of the flexible suture. [Figure 5] FIG. 10 shows a side view of a third example of a single-armed suture assembly including a flexible sheath coupled to a needle. [Figure 6A] 6 shows a side view of the single-armed suture assembly of FIG. 5 after the flexible sheath has been advanced in an insertion direction through tissue over the barbed portion of the flexible suture. [Figure 6B] 6B shows a side view of the single-armed suture assembly of FIG. 6A, but with the flexible sheath removed in the direction of insertion to expose the barb. [Figure 6C] FIG. 6C shows a side view of the single-armed suture assembly of FIG. 6B, but with the cut portion of the flexible suture removed. [Figure 7] FIG. 10 shows a side view of a fourth example of a single-armed suture assembly. [Figure 8] FIG. 10 shows a side view of a fifth example of a single-armed suture assembly. [Figure 9A] FIG. 10 shows a side view of a sixth example of a single-armed suture assembly in which a flexible sheath is advanced in an insertion direction through tissue with the flexible sheath covering the barbed portion of the flexible suture. [Figure 9B] 9B shows a side view of the single-armed suture assembly of FIG. 9A, but with the flexible sheath moved in a reverse insertion direction to expose the barb through the opening in the flexible sheath. [Figure 10] 1A-9C show a flowchart of an example of a method of using the single-armed suture assembly of FIGS. 1-9B.

[0005] The drawings are not intended to be limiting in any manner, and it is contemplated that various embodiments of the invention may be embodied in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings, which are incorporated in and form a part of this specification, illustrate several aspects of the invention and, together with the specification, serve to explain the principles of the invention, it being understood, however, that the invention is not limited to the precise arrangements shown. DETAILED DESCRIPTION OF THE INVENTION

[0006] The following description of specific examples of the present technology should not be used for the purpose of limiting its scope. Other examples, features, aspects, embodiments, and advantages of the present technology will become apparent to those skilled in the art from the following description, which is, by way of example, one of the best modes contemplated for carrying out the present technology. As will be understood, the technology described herein is capable of other different and obvious modes, all without departing from the technology. Therefore, the drawings and descriptions should be regarded as illustrative in nature, and not as restrictive.

[0007] It will also be appreciated that for convenience and clarity of exposition, spatial terms such as "longitudinally" are used herein to refer to relative positions and directions. Such terms are used hereinafter with reference to the figures as illustrated for clarity and are not intended to limit the invention described herein.

[0008] Furthermore, the terms "about," "approximately," and the like, as used herein in connection with any numerical value or range of values, are intended to encompass the exact value referenced, as well as a suitable tolerance that enables the referenced feature or combination of features to function for the intended purpose described herein.

[0009] I. Example of a barbed suture with a removable sheath A. First example of a single-armed suture assembly 1-2C illustrate a first example of a single-armed suture assembly (10). The single-armed suture assembly (10) is shown as a single-armed, bidirectional barbed suture or knotless suture. As shown, the single-armed suture assembly (10) includes a needle (12), a flexible suture (14), and a flexible sheath (16).

[0010] The needle 12 includes a first end 18 and a second end 20. As shown, the first end 18 is pointed and configured to pierce tissue T in an insertion direction 34. The second end 20 is configured to advance in the insertion direction 34 through tissue T based on the path already traveled by the first end 18. While the needle 12 is shown as a curved needle, other types of needles are contemplated, including straight needles (see Figures 7-8) or bendable needles. In the case of a curved needle, the first end 18 and second end 20 may be disposed at different angles, with an angle of approximately 180 degrees being shown between the first end 18 and second end 20. As shown in Figures 1 and 2B, the needle 12 has a needle diameter d1 that defines a cross-sectional thickness that is greater than the diameter d2 of the flexible suture 14. In some variations, the needle 12 can be rigid or substantially rigid. In some variations, the needle 12 can be formed from a metallic material (e.g., stainless steel) and / or a polymeric material.

[0011] A 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), which may be straight or curved. For example, the flexible suture (14) may extend along a helical path. The flexible suture (14) includes a first portion (22) and a second portion (24), which may be the same or different sizes. Additionally, the first portion (22) and the second portion (24) may include the same or different number of barbs. As shown, the first portion (22) is disposed closer to the needle (12) than the second portion (24). The first portion 22 includes a plurality of first barbs 26 having first tips 28 that extend in either an insertion direction 34 or a reverse insertion direction 36 away from the channel 15. The reverse insertion direction 36 is approximately 180 degrees opposite the insertion direction 34. As shown, the first tips 28 of the first barbs 26 each extend in the reverse insertion direction 36 away from the channel 15. In other words, the first tips 28 extend further in the reverse insertion direction 36 than in the insertion direction 34. The first tips 28 are configured to provide little or no resistance to the flexible suture 14 moving through the tissue T following the needle 12 during deployment. For example, the first tip (28) may deflect towards the passageway (15) as the first tip (28) advances in the insertion direction (34) through the tissue (T).

[0012] The second portion (24) includes a plurality of second barbs (30) having second tips (32) that extend in the other of the insertion direction (34) or the reverse insertion direction (36), opposite the first tip (28). In other words, the first barbs (26) and the second barbs (30) are bidirectional. In this example, the second barbs (30) are sometimes referred to as reverse barbs. As shown, each second tip (32) extends in the insertion direction (34) away from the channel (15). In other words, the second tips (32) extend further in the insertion direction (34) than in the reverse insertion direction (36). The second tips (32) of the second barbs (30) are oriented toward the needle (12) opposite the insertion direction (34) of the flexible suture (14). The second tip (32) is covered by the flexible sheath (16) during deployment of the single-armed suture assembly (10). In other words, the second portion (24) housing the barbs is enveloped or covered by a thin, tubular, removable, flexible sheath (16) that covers each barb. If the second tip (32) is uncovered during deployment, the second tip (32) would provide resistance to the flexible suture (14) moving in the insertion direction (34) within the tissue (T). In some variations, the barbs housing the suture portions have a smaller diameter or effective cross-sectional area than the portion housing a normal (non-barb) portion to accommodate the additional dimensions of the flexible sheath (16) that covers the barbs.

[0013] At least one of the first barb portion (26) or the second barb portion (30) may extend helically along the path (15). In other words, at least one of the first barb portion (26) or the second barb portion (30) may be arranged in a helical pattern around the circumference of the flexible suture (14). In some variations, at least one of the first barb portion (26) or the second barb portion (30) may be symmetrical along the path (15). As shown, the first barb portion (26) is helical along the path (15) and the second barb portion (30) is symmetrical along the path (15). However, it is also contemplated that the first barb portion (26) is symmetrical along the path (15) and the second barb portion (30) is helical along the path (15), or that the first barb portion (26) and the second barb portion (30) are each symmetrical, or that the first barb portion (26) and the second barb portion (30) are each helical (e.g., the first barb portion (126) and the second barb portion (130) shown in Figures 3-4).

[0014] As shown, the flexible suture (14) includes an optional elastic intermediate portion (38) configured to stretch to aid in placement of the flexible suture (14). The elastic intermediate portion (38) is disposed between the second portion (22) and the first portion (24). The elastic intermediate portion (38) may be formed by heat treating the elastic intermediate portion (38) or by interposing an elastic section between the first portion (22) and the second portion (24), such that the elastic intermediate portion (38) is formed from a different material. The flexible suture (14) defines a circumference.

[0015] The flexible suture (14) may 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") refers to a suture comprising a material that does not degrade by chain scission, such as by a chemical reaction process (e.g., hydrolysis, oxidation / reduction, enzymatic mechanisms, or a combination thereof), or by a thermal or photodegradation 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, 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 in which the flexible suture (14) is intended to remain permanently within the tissue (T) or is intended to be physically removed from the body.

[0016] Bioabsorbable sutures (also called "nonabsorbable sutures") refer to sutures comprising materials that degrade within the body. Bioabsorbable polymers and medical devices made from such polymers are known in the art. Conventional bioabsorbable polymers include polylactic acid, poly(thiadioxanone), polyglycolic acid, lactide, glycolide, p-dioxanone, trimethylene carbonate, and copolymers of 8-caprolactone in various combinations. Bioabsorbable polymers are designed to have chemical properties that allow the polymer to degrade in vivo and be metabolized or otherwise broken down, for example, by hydrolysis, and eliminated from the patient's body.

[0017] 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 the first tip (28) or second tip (32), which extend 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 barbs (26) or second barbs (30) without covering any portion of the other of the first barbs (26) or second barbs (30). As shown, the flexible sheath (16) covers the second barbs (30) without covering any portion of the first barbs (26). In some variations, the flexible sheath 16 is heat-shrinkable, such that the flexible sheath 16 can be heat-shrunk onto the second barb 30 but not onto the first tip 28. In some variations, the flexible sheath 16 can be heat-shrunk onto the first tip 28 but not onto 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 variations, the flexible sheath 16 can be made of a material with lubricating properties, such as polytetrafluoroethylene (PTFE), or any other low-friction material. In some variations, the outer surface 42 of the flexible sheath 16 can include a coating (e.g., a silicone coating) and / or a liquid lubricant.

[0018] 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 may function as an anchoring mechanism to prevent the flexible suture 14 from advancing further in the insertion direction 34. The pull tab 46 may be grasped by a user when removing the flexible sheath 16 in the reverse insertion direction 36. As shown in FIGS. 1-2C, 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 the sheath diameter d3. In some variations, the sheath diameter (d3) is about 100% to about 150% of the needle diameter (d1), while in other variations, the sheath diameter (d3) is smaller than the needle diameter (d1).

[0019] Placement of the single-armed suture assembly (10) is described below with reference to Figures 2A-2C. Specifically, Figure 2A shows the single-armed suture assembly (10) after advancement in an insertion direction (34) through tissue (T), with the flexible sheath (16) covering the second barb portion (30) of the flexible suture (14). The first tip (28) extends in a reverse insertion direction (36) and is configured to contact the tissue (T) as the flexible suture (14) advances in the insertion direction (34). By extending the first tip (28) in the reverse insertion direction (36), it is meant that the first tip (28) can deflect toward the reverse insertion direction (36) as the flexible suture (14) advances in the insertion direction (34). The flexible suture (14) may be placed by pulling the needle (12) so that the flexible suture (14) follows the path defined by the needle (12) through the tissue (T). Due to the flexible sheath (16) covering each second tip (32) of the second barbs (30), the second barbs (30) do not provide resistance to the flexible suture (14) moving behind the needle (12) during insertion or implantation.

[0020] Figure 2B shows the single-armed suture assembly (10) of Figure 2A as flexible sheath (16) is being actively removed in a reverse insertion direction (36) to expose the previously covered second barb portion (30). After flexible suture (14) is positioned at the desired location, flexible sheath (16) is removed by pulling flexible sheath (16) away from second portion (24), thus leaving second barb portion (30) uncovered and allowing second barb portion (30) to engage tissue (T). For example, once flexible suture 14 is positioned, flexible sheath 16 (which may also be referred to as a compression sleeve) is withdrawn from second barb 30 by pulling pull tab 46, exposing and releasing second barb 30 and allowing second barb 30 to deploy within and engage tissue T. Figure 2C shows single-armed suture assembly 10 of Figure 2A, but with first cutting portion 50 and second cutting portion 52 removed after second barb 30 has been deployed. As shown, first cutting portion 50 is coupled to needle 12.

[0021] B. Second Example of a Single-Armed Suture Assembly 3-4 show a second example of a single-armed suture assembly (110). As shown, single-armed suture assembly (110) includes a needle (112), a flexible suture (114), and a flexible sheath (116). Except as otherwise noted below, needle (112) is similar to needle (12), flexible suture (114) is similar to flexible suture (14), and flexible sheath (116) is similar to flexible sheath (16).

[0022] Similar to needle (12), needle (112) includes a first end (118) and a second end (120). Flexible suture (114) includes a first portion (122) and a second portion (124), with first portion (122) including a plurality of first barbs (126) having a first tip (128). Second portion (124) includes a plurality of second barbs (130) having a second tip (132) and a barbless portion (133) that does not include barbs. First tip (128) extends in a reverse insertion direction (136), and second tip (132) extends in an insertion direction (134). First barbs (126) and second barbs (130) include helical barbs. Flexible suture (114) is longer than flexible suture (14) due to the presence of unbarbed portion (133).

[0023] Similar to flexible sheath (16), flexible sheath (116) includes a generally tubular wall (140) defining an inner surface (142) and an outer surface (144), and a pull tab (146). As shown, flexible sheath (116) is longer than flexible sheath (16), such that the distance between a first end (148) of flexible sheath (116) and the pull tab (146) of flexible sheath (116) is greater than the corresponding distance for flexible sheath (16). Figure 4 shows the single-armed suture assembly (110) of Figure 3 after advancement in an insertion direction (134) through tissue (T), with flexible sheath (116) covering the second barb portion (130) of flexible suture (114). The flexible sheath (116) can be removed in the reverse insertion direction (136) using the pull tab (146) to expose the second barb portion (130).

[0024] C. Third Example of a Single-Armed Suture Assembly 5-6C show a third example of a single-armed suture assembly (210). As shown, single-armed suture assembly (210) includes a needle (212), a flexible suture (214), and a flexible sheath (216). Except as otherwise noted below, needle (212) is similar to needle (12), flexible suture (214) is similar to flexible suture (14), and flexible sheath (216) is similar to flexible sheath (16).

[0025] Similar to needle (12), needle (212) includes a first end (218) and a second end (220). Flexible suture (214) includes a first portion (222) and a second portion (224), with first portion (222) including a plurality of first barbs (226) having a first tip (228). Second portion (224) includes a plurality of second barbs (230) having a second tip (232). Unlike first tips (28, 128) described above, first tip (228) extends in an insertion direction (134) away from channel (215). Unlike second tips (32, 132) described above, second tip (232) extends in a reverse insertion direction (236) away from channel (215). The first barb portion (226) includes symmetric barbs that extend symmetrically away from the channel (215), and the second barb portion (226) includes helical barbs that extend helically away from the channel (215). The flexible suture (214) includes an optional elasticated intermediate portion (238) similar to the optional elasticated intermediate portion (38).

[0026] Similar to flexible sheath (16), flexible sheath (216) includes a generally tubular wall (240) defining an inner surface (242) and an outer surface (244), and a pull tab (246). However, unlike flexible sheaths (16, 116) described above, flexible sheath (216) is coupled to needle (212). As shown, first end (248) of flexible sheath (216) overlaps second end (220) of needle (212). In some variations, needle (212) and flexible sheath (216) may include corresponding locking features for fixably coupling needle (212) to flexible sheath (216). Flexible sheath (216) is removed in an insertion direction (234) to expose first barb (226).

[0027] Placement of the single-armed suture assembly (210) is described below with reference to Figures 6A-6C. Specifically, Figure 6A shows the single-armed suture assembly (210) of Figure 5 after it has been advanced in an insertion direction (234) through tissue (T), with the flexible sheath (216) covering the first barb portion (226) of the flexible suture (214), while the second barb portion (230) of the flexible suture (214) is exposed and in contact with the tissue (T).

[0028] Figure 6B shows the single-armed suture assembly (210) of Figure 6A, but with the flexible sheath (216) removed in the insertion direction (234) to expose the first barb (226). After deploying the flexible suture (214) by pulling the flexible suture (214) behind the needle (212) and through the tissue (T), the flexible sheath (216) is removed. The flexible sheath (216) may be removed by pulling the needle (212) coupled to the flexible sheath (216) to expose and engage the first barb (226) with the tissue (T). Figure 6C shows the single-armed suture assembly (210) of Figure 6B, but with the first cutting portion (250) and second cutting portion (252) removed. The first cutting portion (250) is coupled to the needle (212) and flexible sheath (216), and the second cutting portion (252) is coupled to the pull tab (246).

[0029] D. Fourth Example of a Single-Armed Suture Assembly 7 shows a fourth example of a single-armed suture assembly (310). As shown, the single-armed suture assembly (310) includes a needle (312), a flexible suture (314), and a flexible sheath (316). Except as otherwise noted below, the needle (312) is similar to needle (12), the flexible suture (314) is similar to flexible suture (14), and the flexible sheath (316) is similar to flexible sheath (16).

[0030] Similar to needle (12), needle (312) includes a first end (318) and a second end (320). Unlike needles (12, 112, 212), needle (312) is shown as a longitudinally extending straight needle. Flexible suture (314) includes a first portion (322) and a second portion (324), with first portion (322) including a plurality of first barbs (326) having first tips (328). Similar to first tips (228), each first tip (328) extends in an insertion direction (334) away from channel (315). Second portion (324) includes a plurality of second barbs (330) having second tips (332). Similar to second tips (232), second tips (332) each extend in a reverse insertion direction (336) away from channel (315). First barbs (326) include symmetric barbs that extend symmetrically away from channel (315), and second barbs (326) include helical barbs that extend helically away from channel (315).

[0031] Similar to the flexible sheath (16), the flexible sheath (316) includes a generally tubular wall (340) defining an inner surface (342) and an outer surface (344). A pull tab (346) may be positioned on the end of the flexible suture (314). The flexible sheath (316) includes a first end (348) and a second end (350). As shown, the first end (348) of the flexible sheath (316) is coupled to the needle (312). Unlike the flexible sheath (216) in FIG. 5, which overlaps the needle (212), the flexible sheath (316) terminates at a butt joint on the needle (312). Figure 7 shows the single-armed suture assembly (310) after advancement in an insertion direction (334) through tissue (T), with the flexible sheath (316) covering the first barb portion (326) of the flexible suture (314). The first barb portion (326) may be deployed in a manner similar to the first barb portion (226) shown in Figure 6B. The flexible suture (314) may be trimmed similar to the first cutting portion (250) and second cutting portion (252) shown in Figure 6C.

[0032] E. Fifth Example of a Single-Armed Suture Assembly 8 shows a fifth example of a single-armed suture assembly (410). As shown, the single-armed suture assembly (410) includes a needle (412), a flexible suture (414), and a flexible sheath (416). Except as otherwise noted below, the needle (412) is similar to needle (12), the flexible suture (414) is similar to flexible suture (14), and the flexible sheath (416) is similar to flexible sheath (16).

[0033] Like needle 312, needle 412 is shown as a straight needle. Like needle 12, needle 412 includes a first end 418 and a second end 420. Needle 412 includes at least one inwardly tapering recessed portion 450, two of which are shown. Recessed portion 450 may include a detent, indentation, or another suitable structure for engaging flexible sheath 416.

[0034] The flexible suture (414) includes a first portion (422) and a second portion (424), where 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 in an insertion direction (434) away from the channel (415). Each of the second tips (432) extends in a reverse insertion direction (436) away from the channel (415). The first barbs (426) include symmetric barbs extending symmetrically away from the channel (415), and the second barbs (426) include helical barbs extending helically away from the channel (415). As shown, the single-armed suture assembly (410) has already been advanced in an insertion direction (434) through the tissue (T), with the flexible sheath (416) covering the first barb portion (426) of the flexible suture (414) but allowing the second barb portion (430) to remain exposed during insertion.

[0035] Similar to the flexible sheath (16), the flexible sheath (416) includes a generally tubular wall (440) defining an inner surface (442) and an outer surface (444). A pull tab (446) may be positioned at the opposite end of the flexible suture (414) from the needle (412). 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 the recessed portion (450) of the needle (412). The first barb (426) may be deployed in a manner similar to the first barb (226) shown in FIG. 6B. The flexible suture (414) may be trimmed similarly to the first cut portion (250) and second cut portion (252) shown in Figure 6C.

[0036] F. Sixth Example of a Single-Armed Suture Assembly 9A-9B show a sixth example of a single-armed suture assembly (510). As shown, the single-armed suture assembly (510) includes a needle (512), a flexible suture (514), and a flexible sheath (516). Except as otherwise noted below, the needle (512) is similar to needle (12), the flexible suture (514) is similar to flexible suture (14), and the flexible sheath (516) is similar to flexible sheath (16).

[0037] Similar to needle (12), needle (512) includes a first end (518) and a second end (520). Flexible suture (514) includes a first portion (522) and a second portion (524), with first portion (522) including a plurality of first barbs (526) having a first tip (528). Second portion (524) includes a plurality of second barbs (530). First tip (528) extends in a reverse insertion direction (536), and second tip (532) extends in an insertion direction (534). First barbs (526) are symmetrical along path (515), and second barbs (526) include helical barbs.

[0038] Similar to flexible sheath (16), flexible sheath (516) includes a generally tubular wall (540) defining an inner surface (542) and an outer surface (544). Flexible sheath (516) may be bioabsorbable, such that flexible sheath (516) is not removed but rather retained within (T). For example, flexible suture (514) may be non-degradable, and flexible sheath (516) may be bioabsorbable. In other variations, both flexible suture (514) and flexible sheath (516) are bioabsorbable, with the same or different bioabsorption rates. As shown, flexible suture (514) includes an optional elastic intermediate portion (538), similar to elastic intermediate portion (38).

[0039] 9A shows the single-armed suture assembly (510) after advancement in an insertion direction (534) through tissue (T), with the flexible sheath (516) covering the second barb portion (530) of the flexible suture (514). In other words, the second barb portion (530) is protected by the flexible sheath (516) during deployment. The flexible sheath (516) can be pulled in the reverse insertion direction (136) to expose the second barb portion (530) through an opening in the flexible sheath (516). Alternatively, the flexible sheath (516) can include a slot opening toward the first end (548) of the flexible sheath (516) to allow the flexible sheath (516) to be removed. In some variations, the flexible sheath (516) may be rotated to expose the second barb (530).

[0040] Figure 9B shows the single-armed suture assembly (510) of Figure 9A, but with the flexible sheath (516) moved in a reverse insertion direction (536) to expose the second barb portion (530) through an opening (550) in the flexible sheath (516). In other words, the flexible sheath (516) is pulled back to deploy the barb portion through the opening (550). The opening (550) may be positioned at a variety of different angles around the circumference of the flexible sheath (516). While two openings (550) are illustrated in Figures 9A-9B, additional openings (550) are also contemplated. While the flexible sheath (516) is shown retracted in the reverse insertion direction (536), it is also contemplated that the needle (512) may be advanced further in the insertion direction (534).

[0041] G. Method Example FIG. 10 illustrates a flowchart of an exemplary method (610) of use of the single-armed suture assembly (10, 110, 210, 310, 410, 510) of FIGS. 1-9B. In step (612), the method (610) includes using a needle (12, 112, 212, 312, 412, 512) to penetrate tissue (T) along an insertion direction (34, 134, 234, 334, 434, 534). The single-armed suture assembly (10, 110, 210, 310, 410, 510) can be used in a variety of surgical procedures. In some variations, the single-armed suture assembly (10, 110, 210, 310, 410, 510) can be used for cosmetic lift procedures in the brow, face, and neck region. These cosmetic lift procedures may be similar to those shown and described in U.S. Patent No. 10,548,592, entitled "Suture Methods and Devices," issued February 2, 2020, the disclosure of which is incorporated herein by reference in its entirety.

[0042] In step (614), the method (610) includes advancing a flexible suture (14, 114, 214, 314, 414, 514) using a flexible sheath (16, 116, 216, 316, 416, 516) so that one of the first tip (28, 128, 528) or the second tip (232, 332, 432), extending in the reverse insertion direction (36, 136, 236, 336, 436, 536), contacts the tissue (T), while the other of the first tip (228, 328, 428) or the second tip (32, 132, 532), extending in the insertion direction (34, 134, 234, 334, 434, 534), is prevented from contacting the tissue (T). The flexible sheath (16, 116, 216, 316, 416, 516) may be advanced using the needle (12, 112, 212, 312, 412, 512) and / or the flexible suture (14, 114, 214, 314, 414, 514).

[0043] In step (616), the 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) extending in the insertion direction (34, 134, 234, 334, 434, 534) into the tissue (T). In other words, the first tip (228, 328, 428) or second tip (32, 132, 532) extending in the insertion direction (34, 134, 234, 334, 434, 534) is deployed into the tissue after the first tip (28, 128, 528) or second tip (232, 332, 432) extending in the reverse insertion direction (36, 136, 236, 336, 436, 536).

[0044] II. Combination Examples The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claims that may be presented at any time in this application or any subsequent application related to this application. No disclaimer is intended. The following examples are provided merely for illustrative purposes. It is contemplated that the various teachings herein may be configured and applied in many other ways. It is also contemplated that certain features referred to in the following examples may be omitted in some variations. Accordingly, none of the aspects or features referred to below should be considered critical unless later expressly indicated otherwise by the inventors or their successors. If a claim presented in this application or a subsequent application related to this application includes additional features other than those referred to below, those additional features should not be considered added for any reasons of patentability. [Example]

[0045] 1. A single-armed suture assembly comprising: (a) a needle including a first end and a second end, the second end configured to advance through tissue in an insertion direction; (b) a flexible suture coupled to the second end of the needle, the flexible suture extending along a longitudinal path, the flexible suture including: (i) a first portion including a plurality of first barbs having a first tip extending away from the longitudinal path in either an insertion direction or a reverse-insertion direction opposite the insertion direction; and (ii) a first portion including a plurality of first barbs having a first tip extending away from the longitudinal path in either an insertion direction or a reverse-insertion direction opposite the 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, and configured such that the other of the first tip or the second tip extending in the reverse insertion direction contacts tissue when the flexible sheath is advanced in the insertion direction. [Example]

[0046] The single-armed suture assembly of Example 1, wherein the flexibility of the flexible sheath is greater than the flexibility of the needle. [Example]

[0047] 3. The single-armed suture assembly of any one of Examples 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. [Example]

[0048] 4. The single-armed suture assembly of any one of Examples 1 to 3, wherein at least one of the plurality of first barbs or the plurality of second barbs is symmetrical along the longitudinal path. [Example]

[0049] 5. The single-armed suture assembly of any one of Examples 1-4, wherein the flexible sheath includes a pull tab configured to be manually grasped by a user. [Example]

[0050] 6. The single-armed suture assembly of any one of Examples 1 to 5, wherein the needle is a curved needle. [Example]

[0051] 7. The single-armed suture assembly of any one of Examples 1-6, wherein the single-armed flexible suture further comprises an elastic intermediate portion configured to stretch to aid in placement of the flexible suture, the elastic intermediate portion being disposed between the second portion and the first portion. [Example]

[0052] 8. The single-armed suture assembly of any one of Examples 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 without covering any portion of the other of the plurality of first barbs or the plurality of second barbs. [Example]

[0053] 9. The single-armed suture assembly of any one of Examples 1-8, wherein the outer circumference of the flexible sheath defines a sheath diameter, the outer circumference of the needle defines a needle diameter, and the sheath diameter is about 100% to about 150% of the needle diameter. [Example]

[0054] 10. The single-armed suture assembly of any one of Examples 1-9, wherein each first tip extends in a reverse insertion direction away from the longitudinal path and each second tip extends in an insertion direction away from the longitudinal path. [Example]

[0055] 13. The single-armed suture assembly of any of Examples 10-12, wherein the flexible sheath is heat shrunk onto the first tip but not onto the second tip. [Example]

[0056] 12. The single-armed suture assembly of any of Examples 1-11, wherein the flexible sheath has a first end spaced a distance from the second end of the needle. [Example]

[0057] 13. The single-armed suture assembly of any one of Examples 1 to 12, wherein the flexible sheath is not directly connected to the needle. [Example]

[0058] 14. The single-armed suture assembly of any of Examples 1-13, wherein the flexible sheath includes an outer surface, the outer surface including a lubricious coating configured to reduce friction between the outer surface and tissue. [Example]

[0059] A single-armed suture assembly as described in any of Examples 1-9 and Examples 12-14, wherein each first tip extends in an insertion direction away from the longitudinal path and each second tip extends in a reverse insertion direction away from the longitudinal path. [Example]

[0060] 16. The single-armed suture assembly of any one of Examples 1-15, wherein the flexible sheath is directly coupled to the needle. [Example]

[0061] 17. A single-armed suture assembly as described in any one of Examples 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. [Example]

[0062] 1. A single-armed suture assembly comprising: (a) a needle; (b) a flexible suture coupled to the needle, the flexible suture extending along a longitudinal path, the flexible suture including: (i) a first portion including a plurality of first barbs having a first tip extending in a second direction away from the longitudinal path; and (ii) a second portion including a plurality of second barbs having a second tip extending in the first direction opposite the first tips; and (c) a flexible sheath configured to prevent the second tip from contacting tissue while allowing the first tip extending in the second direction to contact tissue when the flexible sheath is advanced in the first direction. [Example]

[0063] 19. The single-armed suture assembly of Example 18, wherein the flexible sheath has a first end spaced a distance from the needle. [Example]

[0064] 20. The single-arm suture assembly of Example 18 or 19, wherein the flexible suture has a circumference and at least one of the plurality of first barbs or the plurality of second barbs are arranged in a spiral pattern around the circumference of the flexible suture. [Example]

[0065] 1. A method of using a single-armed suture assembly, the single-armed suture assembly comprising: (a) a needle including a first end and a second end, the second end configured to advance through tissue in an insertion direction; (b) a flexible suture coupled to the second end of the needle, the flexible suture body extending along a longitudinal path, the flexible suture including: (i) a first portion including a plurality of first barbs having first tips extending away from the longitudinal path in either an insertion direction or a reverse insertion direction opposite the insertion direction; and (ii) a first portion including a plurality of first barbs having first tips extending away from the longitudinal path in either an insertion direction or a reverse insertion direction opposite the insertion direction. and (c) a flexible sheath, the flexible suture including (a) a needle penetrating tissue along the insertion direction using a needle; and (b) using the flexible sheath to advance the flexible suture in the insertion direction such that one of the first tip or the second tip extending in the reverse insertion direction contacts the tissue while the other of the first tip or the second tip extending in the insertion direction prevents contact of the tissue. [Example]

[0066] 22. The method of example 21, further comprising removing the flexible sheath to deploy the first tip or the second tip extending in the insertion direction into tissue.

[0067] III. Other It is 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. Accordingly, the above teachings, expressions, embodiments, examples, etc. should not be considered in isolation from one another. Various suitable ways in which the teachings herein can be combined will be readily apparent to those skilled in the art in light of the teachings herein. Such modifications and variations are intended to be within the scope of the claims.

[0068] It should be understood that all or part of any patent, publication, or other disclosure referred to as being incorporated herein by reference is incorporated herein only to the extent that the incorporated material does not contradict existing definitions, opinions, or other disclosures set forth in this disclosure. As such, and to the extent necessary, the disclosure explicitly set forth herein shall prevail over any conflicting statements incorporated herein by reference. Any material, or portions thereof, that is referred to as being incorporated herein by reference but that contradicts current definitions, opinions, or other disclosures set forth herein shall be incorporated only to the extent that no conflict arises between the incorporated material and the current disclosures.

[0069] While various embodiments of the present invention have been shown and described, further adaptations of the methods and systems described herein may be achieved by appropriate modifications by those skilled in the art without departing from the scope of the present invention. While some of such potential modifications have been mentioned, other modifications will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, proportions, steps, etc. discussed above are illustrative and not required. Accordingly, it is understood that the scope of the present invention should be considered in terms of the claims that follow, and is not limited to the details of structure and operation shown and described in this specification and drawings.

[0070] [Embodiment] (1) A single-armed suture assembly, comprising: (a) a needle including a first end and a second end, the second end configured to advance in an insertion direction through tissue; (b) a flexible suture coupled to the second end of the needle, the flexible suture extending along a longitudinal path, the flexible suture comprising: (i) a first portion including a plurality of first barbs having first tips extending away from the longitudinal path in either the insertion direction or a reverse insertion direction opposite the insertion direction; (ii) a second portion including a plurality of second barbs having second tips extending opposite the first tips in the other of the insertion direction or the reverse insertion direction; (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, and configured to contact tissue when the other of the first tip or the second tip extending in the reverse insertion direction is advanced in the insertion direction. (2) A single-arm suture assembly as described in embodiment 1, wherein the flexibility of the flexible sheath is greater than the flexibility of the needle. (3) The single-armed suture assembly of any one of claims 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. (4) A single-arm suture assembly according to any one of claims 1 to 3, wherein at least one of the plurality of first barbs or the plurality of second barbs is symmetrical along the longitudinal path. (5) A single-armed suture assembly according to any one of claims 1 to 4, wherein the flexible sheath includes a pull tab configured to be manually grasped by a user.

[0071] (6) The single-armed suture assembly of any one of claims 1 to 5, wherein the single-armed flexible suture further comprises an elastic intermediate portion configured to stretch to aid in placement of the flexible suture, the elastic intermediate portion being disposed between the second portion and the first portion. (7) The single-armed suture assembly of any one of claims 1 to 6, wherein the flexible sheath covers at least a portion of one of the plurality of first barbs or the plurality of second barbs without covering any portion of the other of the plurality of first barbs or the plurality of second barbs. (8) The single-arm suture assembly of any one of claims 1 to 7, wherein the outer circumference of the flexible sheath defines a sheath diameter, the outer circumference of the needle defines a needle diameter, and the sheath diameter is about 100% to about 150% of the needle diameter. (9) The single-armed suture assembly of any one of claims 1 to 8, wherein each of the first tips extends in the reverse insertion direction away from the longitudinal path and each of the second tips extends in the insertion direction away from the longitudinal path. (10) A single-armed suture assembly according to any one of claims 1 to 9, wherein the flexible sheath is not directly connected to the needle.

[0072] (11) The single-armed suture assembly of any one of claims 1 to 10, wherein the flexible sheath has a first end spaced a distance from the second end of the needle. (12) The single-armed suture assembly of any one of claims 1 to 11, wherein the flexible sheath is heat shrunk onto the first tip but not onto the second tip. (13) The single-armed suture assembly of any one of claims 1 to 8, wherein each of the first tips extends in the insertion direction away from the longitudinal path and each of the second tips extends in the reverse insertion direction away from the longitudinal path. (14) The single-arm suture assembly of embodiment 13, wherein the flexible sheath is directly connected to the needle. (15) The single-armed suture assembly of any one of claims 1 to 14, wherein the flexible sheath includes a protrusion, and the needle includes a recessed portion configured to engage the protrusion of the flexible sheath.

[0073] (16) A single-armed suture assembly, comprising: (a) A needle and (b) a flexible suture coupled to the needle, the flexible suture extending along a longitudinal path, the flexible suture comprising: (i) a first portion including a plurality of first barbs having first tips extending in a second direction away from the longitudinal path; (ii) a second portion including a plurality of second barbs having a second tip extending in a first direction opposite the first tip; (c) a flexible sheath configured to prevent the second tip from contacting tissue while allowing the first tip extending in the second direction to contact tissue when the flexible sheath is advanced in the first direction. (17) The single-armed suture assembly of claim 16, wherein the flexible sheath has a first end spaced a distance from the needle. (18) The single-armed suture assembly of any one of claims 16 to 17, wherein the flexible suture has a circumference and at least one of the first plurality of barbs or the second plurality of barbs are arranged in a spiral pattern along the circumference of the flexible suture. (19) A method of using a single-armed suture assembly, the single-armed suture assembly comprising: (a) a needle including a first end and a second end, the second end configured to advance in an insertion direction through tissue; (b) a flexible suture coupled to the second end of the needle, the flexible suture body extending along a longitudinal path, the flexible suture comprising: (i) a first portion including a plurality of first barbs having first tips extending away from the longitudinal path in either the insertion direction or a reverse insertion direction opposite the insertion direction; (ii) a second portion including a plurality of second barbs having second tips extending opposite the first tips in the other of the insertion direction or the reverse insertion direction; (c) a flexible sheath; The method comprises: (a) using the needle to penetrate tissue along an insertion direction; (b) using the flexible sheath to advance the flexible suture in the insertion direction such that one of the first tip or the second tip extending in the reverse insertion direction contacts the tissue while the other of the first tip or the second tip extending in the insertion direction is prevented from contacting tissue. (20) The method of embodiment 19, further comprising removing the flexible sheath to deploy the first tip or the second tip extending in the insertion direction into the tissue.

Claims

1. 1. A single-armed suture assembly comprising: (a) a needle including a first end and a second end, the second end configured to advance through tissue in an insertion direction; (b) a flexible suture coupled to the second end of the needle, the flexible suture extending along a longitudinal path, the flexible suture comprising: (i) a first portion including a plurality of first barbs having first tips extending away from the longitudinal path in either the insertion direction or a reverse insertion direction opposite the insertion direction; (ii) a second portion including a plurality of second barbs having second distal ends extending opposite the first distal ends in the other of the insertion direction or the reverse insertion direction; (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, and configured to allow the other of the first tip or the second tip extending in the reverse insertion direction to contact tissue when the flexible sheath is advanced in the insertion direction.

2. The single-armed suture assembly of claim 1 , wherein the flexible sheath is more flexible than the needle.

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

4. The single-armed suture assembly of claim 1 , wherein at least one of the first plurality of barbs or the second plurality of barbs is symmetrical along the longitudinal path.

5. The single-armed suture assembly of claim 1 , wherein the flexible sheath includes a pull tab configured to be manually grasped by a user.

6. 2. The single-armed suture assembly of claim 1, wherein the single-armed flexible suture further comprises an elastic intermediate portion configured to stretch to aid in placement of the flexible suture, the elastic intermediate portion being disposed between the second portion and the first portion.

7. 2. The single-armed suture assembly of claim 1, wherein the flexible sheath covers at least a portion of one of the first plurality of barbs or the second plurality of barbs without covering any portion of the other of the first plurality of barbs or the second plurality of barbs.

8. 10. The single-armed suture assembly of claim 1, wherein the outer circumference of the flexible sheath defines a sheath diameter and the outer circumference of the needle defines a needle diameter, the sheath diameter being between about 100% and about 150% of the needle diameter.

9. 2. The single-armed suture assembly of claim 1, wherein each of the first tips extends in the reverse insertion direction away from the longitudinal path and each of the second tips extends in the insertion direction away from the longitudinal path.

10. The single-armed suture assembly of claim 1 , wherein the flexible sheath is not directly coupled to the needle.

11. The single-armed suture assembly of claim 1, wherein the flexible sheath has a first end spaced a distance from the second end of the needle.

12. The single-armed suture assembly of claim 1, wherein the flexible sheath is heat shrunk onto the first tip but not onto the second tip.

13. 2. The single-armed suture assembly of claim 1, wherein each of the first tips extends in the insertion direction away from the longitudinal path and each of the second tips extends in the reverse insertion direction away from the longitudinal path.

14. The single-armed suture assembly of claim 13, wherein a flexible sheath is directly coupled to the needle.

15. The single-armed suture assembly of claim 1 , wherein the flexible sheath includes a protrusion, and the needle includes a recessed portion configured to engage the protrusion of the flexible sheath.

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

17. The single-armed suture assembly of claim 16, wherein the flexible sheath has a first end spaced a distance from the needle.

18. 18. The single-armed suture assembly of claim 16 or 17, wherein the flexible suture has a circumference and at least one of the first plurality of barbs or the second plurality of barbs are arranged in a spiral pattern along the circumference of the flexible suture.

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