Braided barbed suture having a barbed monofilament insert with a concave core profile

Abstract

The braided barbed suture includes an elongated core having a thickness and a barbed monofilament insert including a plurality of barbs protruding outward from both sides of the elongated core. The braided barbed suture includes a braided sheath surrounding the elongated core to form a composite core of the braided barbed suture. The composite core has a thickness, and the elongated core is centered within the composite core. The elongated core thickness is approximately 6-8 mils, and the composite core thickness is approximately 13-18 mils. The ratio of the elongated core thickness to the composite core thickness is approximately 0.16-0.91. The elongated core has a transition zone that forms a concave profile. The braided barbed suture has a single break point for both the braided sheath and the barbed monofilament insert. The barbed monofilament insert has a PDS monofilament core, and the braided sheath is a VICRYL multifilament braided sheath.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This patent application claims the benefit of U.S. Provisional Application No. 63 / 039,656, filed June 16, 2020, the disclosure of which is incorporated herein by reference. This patent application is related to U.S. Patent Application No. _______________ (Attorney Docket No. ETH6071USNP1), filed on even date herewith and assigned to the assignee of the present invention, the disclosure of which claims the benefit of U.S. Provisional Application No. 63 / 039,649, filed June 16, 2020, the disclosure of which is incorporated herein by reference.

[0002] FIELD OF THEINVENTION This patent application relates generally to medical devices, and more particularly to surgical sutures used to close wounds. [Background technology]

[0003] Surgical sutures are used to close wounds and surgical incisions and to repair damaged muscles, blood vessels, and tissue. Typically, a surgical suture is attached to one end and pulled through the tissue to form one or more loops that hold the tissue together. With conventional sutures, the suture is then tied with one or more knots to keep the tissue pulled together.

[0004] Many attempts have been made to improve sutures. For example, U.S. Patent No. 4,546,769 (Planck et al.) discloses a suture including a jacket made of a tubular braided structure such as non-crimped yarn and a crimped fiber-containing core disposed within the jacket. The jacket is formed by braiding non-crimped yarn around the core, providing a suture that is easier to bend and handle and that ties knots better.

[0005] Although sutures are very effective in closing wounds, there are numerous challenges associated with the use of traditional sutures. Many of these challenges are directly related to the knots used to secure the sutures in place. If the knot is not tied correctly, it can cause problems such as slippage, undoing, and wound reopening. Additionally, the use of knots to secure sutures can distort tissue, restrict blood flow, increase scar formation, inhibit wound healing, and lead to infection.

[0006] To address the above-mentioned shortcomings associated with traditional sutures, barbed sutures have been developed that, unlike traditional sutures, have protruding barbs that allow the suture to be used to close wounds, approximate tissue, tighten tissue, and attach prosthetic devices without the use of knots.

[0007] For example, U.S. Patent No. 8,216,497 assigned to Ethicon, Inc., the disclosure of which is incorporated herein by reference, teaches a method of creating a barbed suture. With reference to Figures 1 and 2, in one embodiment, a ribbon of preformed polymeric material having a cross-sectional profile is stamped to form a barbed suture 50 having a core 52 extending along the length of the barbed suture 50 and a plurality of barbs 54 extending outwardly from either outer side of the core 52. The core 52 provides strength and flexibility to the barbed suture 50.

[0008] One problem associated with barbed sutures is that the barbs can peel or separate from the core, causing failure of the device. In response, braided barbed sutures with more durable barbs have been developed. U.S. Patent No. 8,663,277 to Collier et al., assigned to Ethicon, Inc., the disclosure of which is incorporated herein by reference, teaches a braided barbed suture that offers a 96% improvement in strength retention compared to non-braided barbed sutures.

[0009] Traditionally, braided barbed sutures have been made by manually delivering a barbed insert to a braided fiber assembly, where the operator must adhere to a complex series of steps including running the braiding machine to form a first length of barbless suture, turning the braiding machine off, positioning an end of the barbed insert in the braiding machine's yarn path where the fibers converge at the braid point, then turning the braiding machine back on and allowing the fibers to pull the barbed insert into its braid.

[0010] When using the manual delivery methods described above, a non-uniform braided sheath typically results around the elongated core of the barbed suture insert due to vibrations transmitted from the braiding device to the elongated core of the barbed suture insert. The vibrations generated by the braiding equipment can cause the barbed suture insert to wrap, twist, roll, or accumulate undesirable rotations in the fibers as it is drawn into the braiding machine thread track.

[0011] To overcome the above problems resulting from vibration and to improve the quality of the braided barbed suture, efforts have been made towards improving the control of the orientation of the barbed suture insert during the braiding procedure. For example, U.S. Patent Nos. 8,210,085, 8,733,223, and 9,206,535, assigned to Ethicon, Inc., the disclosures of which are incorporated herein by reference, teach an automated system for making a braided barbed suture, including a braided fiber assembly and a guide assembly (e.g., a delivery cartridge) having a barbed suture insert dispenser opening that defines a passage for directing the barbed suture insert. With reference to FIG. 3, the automated system is adapted to feed a barbed suture insert 60 having barbs 62 from the dispenser opening of the guide assembly into the braided fiber assembly, and braid a plurality of fibers 64 around the barbed suture insert to make a braided barbed suture 66. The passageway at the dispenser opening allows longitudinal movement of the barbed suture insert 60 relative to the passageway while preventing torsional movement of the barbed suture insert relative to the passageway. The passageway includes an elongated slit having a width greater than its height for accommodating the barbs 62 of the barbed suture insert 60.

[0012] A conventional braided barbed suture includes a combination of a barbed suture component and a braided sheath component. The barbed suture component includes an elongated core and barbs projecting outwardly from the elongated core. The braided sheath component is formed around the elongated core of the barbed suture, and the barbs project outwardly beyond the braided sheath for engaging tissue. The combined core structure of the elongated core and the braided sheath formed around the elongated core forms the bone of the braided barbed suture.

[0013] In conventional braided barbed sutures, the elongate core typically has a convex cross-section with a thickness or diameter generally equal to or greater than the thickness of each barb projecting outwardly from the elongate core. When the fibers are braided over the elongate core, the resulting combination of the elongate core and braided sheath typically defines an outer diameter greater than the thickness of each barb, which makes the scaffold of the braided barbed suture stiff and wirey, thereby reducing flexibility.

[0014] Currently, braided barbed sutures have two distinct tensile strength break points, a first break point in the braided component that is wrapped around the core, and a second break point in the core portion of the barbed suture. If only one of the braided or core components breaks, the braided barbed suture may appear to remain intact to an observer, despite the fact that the overall tensile strength of the device has been compromised. Summary of the Invention [Problem to be solved by the invention]

[0015] In view of the above shortcomings, a need remains for an improved braided barbed suture that maintains flexibility.

[0016] There also remains a need for improved braided barbed sutures with cores having reduced outer dimensions (e.g., reduced width, reduced height, reduced cross-sectional area) to allow a greater percentage of the composite core to be composed of braided sheath (i.e., a higher braided sheath to core ratio), allowing the suture structure to have the advantages of braided sutures (e.g., handling, flexibility, compatibility with surgical instruments) while at the same time not becoming stiff and maintaining flexibility.

[0017] There is also a need for an improved braided barbed suture in which the primary source of tensile strength and handling characteristics of the suture are provided by the braided sheath portion, rather than the core, whereby the core serves primarily as an anchor point for the barbs but does not provide the substantial strength of the braided barbed suture.

[0018] Additionally, a need remains for an improved braided barbed suture that has a single break point for both the elongate core portion and the braided portion of the device.

[0019] Additionally, there remains a need for improved braided barbed sutures that can be used to close wounds in robotic surgical environments where robotic graspers, limited tactile feedback, and limited visualization all contribute to failures associated with premature breakage of barbed sutures.

[0020] There also remains a need for an improved braided barbed suture with good flexibility and a single break point for use in the confined spaces present in minimally invasive surgery (MIS) environments. [Means for solving the problem]

[0021] In one embodiment, the braided barbed suture preferably includes two components joined together: a barbed monofilament insert and a braided sheath. In one embodiment, the barbed monofilament insert can include an elongated core (e.g., a monofilament), a plurality of barbs projecting outwardly from the elongated core, and an end effector (e.g., a knot-changing feature) secured to the proximal end of the elongated core. The end effector can be a tab, a stop, or a loop. In one embodiment, the braided sheath can be wrapped around the elongated core of the barbed monofilament insert using an automated braiding machine, as disclosed, for example, in commonly assigned U.S. Patent Nos. 8,210,085, 8,733,223, and 9,206,535, the disclosures of which are incorporated herein by reference.

[0022] In one embodiment, the elongated core of the barbed monofilament insert preferably has a reduced thickness, reduced diameter, and / or reduced outer dimension compared to the thickness of each barb projecting outwardly from the elongated core. The thickness of the elongated core is desirably less than that found in conventional barbed monofilament inserts. The relatively small thickness of the elongated core desirably minimizes the cross-sectional dimension of the elongated core within an over-braided composite that, after being encased by a braided sheath, maintains the flexibility of the braided barbed suture while the tensile strength of the braided barbed suture is primarily provided by the braided sheath.

[0023] In one embodiment, the braided sheath preferably encases the elongated core and extends along a majority of the elongated core. In one embodiment, the combination of the elongated core and the braided sheath forms a flexible composite core of the braided barbed suture. By controlling the ratio of the thickness, diameter, and / or outer dimensions of the elongated core to the thickness, diameter, and / or outer dimensions of the braided sheath, a composite core of the braided barbed suture is preferably provided that has greater tensile strength, as well as improved flexibility and handling characteristics, than can be obtained when using a barbed suture insert having an elongated core having a normal thickness.

[0024] In one embodiment, when the skeletal portion (i.e., the over-braided portion) of the braided barbed suture is viewed in cross-section, the ratio of the thickness (e.g., diameter) of the elongated core to the thickness (e.g., diameter) of the composite core (i.e., core to braided sheath ratio) is preferably less than 1. Thus, the cross-sectional area of ​​the skeletal portion of the braided barbed suture defined by the braided sheath portion of the braided barbed suture is preferably greater than the cross-sectional area of ​​the elongated core, which provides increased tensile strength of the braided barbed suture through the braided sheath and improved flexibility due to being thinner than typical elongated cores.

[0025] In one embodiment, when the braided sheath encases the elongate core to form the composite core of the braided barbed suture, the ratio of the thickness (e.g., diameter) of the elongate core to the aggregate thickness (e.g., aggregate diameter) of the composite core is about 0.16 to 0.85, and more preferably about 0.4 to 0.5.

[0026] In one embodiment, the reduced thickness of the elongate core allows a greater percentage of the composite core (i.e., the skeleton of the braided barbed suture formed by wrapping the braided sheath around the elongate core) to be composed of braided sheath components, allowing for a braided barbed suture construction that has the advantages of traditional braided sutures, such as handling, flexibility, and compatibility with surgical instruments.

[0027] In one embodiment, the elongated core of the barbed monofilament insert serves primarily as an anchor point for the barbs and is not the primary component providing tensile strength to the braided barbed suture. Rather, the primary source of tensile strength and handling characteristics of the braided barbed suture is desirably provided by the braided sheath that is wrapped around the elongated core.

[0028] In one embodiment, the braided sheath component preferably improves the overall tensile strength of the braided barbed suture. At the same time, reducing the thickness of the elongated core of the barbed monofilament insert desirably minimizes the bulk of the elongated core and braided sheath combination along the backbone (i.e., spine) of the braided barbed suture, which preserves the flexible nature of the braided sheath and improves the overall flexibility of the braided barbed suture. Thus, the braided barbed suture structure disclosed herein provides a balance between the two characteristics sought by surgeons: tensile strength and flexibility. Furthermore, the presence of barbs projecting outwardly from the elongated core and through the braided sheath allows the surgeon to suture tissue without the need to tie knots and without the need for a surgical assistant to maintain tension on the suture line.

[0029] In one embodiment, the barbed monofilament insert preferably comprises a PDS monofilament core having a thickness or diameter ranging from 5 to 20 mils, more preferably 6 to 8 mils.

[0030] In one embodiment, the braided sheath preferably comprises VICRYL multifilament yarn. In one embodiment, after the braided sheath is wrapped around the elongate core to form the composite core of the braided barbed suture, the composite core preferably has a thickness or outer diameter ranging from about 13 to 30 mils, more preferably from about 13 to 18 mils.

[0031] In one embodiment, the braided barbed sutures disclosed in this patent application provide enhanced tensile strength and handling characteristics that are highly desirable for suturing tissue within tightly confined spaces, such as in minimally invasive surgical (MIS) environments. Historically, surgeons have had to make compromises by constraining the use of various suture products with different advantages and characteristics. The braided barbed sutures disclosed herein offer the advantages of optimized strength, efficiency, handling, and flexibility in a single suture device.

[0032] In one embodiment, the braided barbed suture preferably comprises an elongate core, a barbed monofilament insert including a plurality of barbs projecting outwardly from either side of the elongate core, and a braided sheath surrounding the elongate core. The composite, over-braided sheath has a thickness (e.g., diameter) and the ratio of the thickness or diameter of the elongate core to the thickness or diameter of the composite core is between about 0.16 and 0.91.

[0033] In one embodiment, the ratio of the thickness or diameter of the elongate core to the thickness or diameter of the composite core is between about 0.24 and 0.73.

[0034] In one embodiment, the barbed monofilament insert preferably includes an elongated core having a first thickness and first barbs projecting outwardly from the elongated core, the first barbs preferably including an inner end having a second thickness greater than the first thickness of the elongated core and an outer end having a third thickness less than the second thickness of the inner end of the first barb. In one embodiment, the barbed monofilament insert preferably includes a transition zone extending between the elongated core and the inner end of the first barb for connecting the inner end of the first barb to the elongated core.

[0035] In one embodiment, the transition zone is thinner near the elongate core and thicker near the inner end of the first barb, hi one embodiment, the transition zone widens from the elongate core to the inner end of the first barb.

[0036] In one embodiment, the first and second transition zones can be located on opposite sides of the elongated core of the barbed monofilament insert. The first and second transition zones and a top surface of the elongated core can define a first concave profile located on a top side of the barbed monofilament insert, and the first and second transition zones and a bottom surface of the elongated core can define a second concave profile located on a bottom side of the barbed monofilament insert.

[0037] In one embodiment, the braided sheath preferably comprises fibers wrapped around both the elongated core and the transition zone of the barbed monofilament insert to form the composite core of the braided barbed suture.

[0038] In one embodiment, the barbs project outwardly beyond the outer periphery of the braided sheath after the braided sheath is wrapped around the elongate core.

[0039] In one embodiment, the braided barbed suture preferably has a single break point for both the braided sheath component and the barbed monofilament insert component.

[0040] In one embodiment, the elongate core has a convexly curved top surface and a convexly curved bottom surface.

[0041] In one embodiment, the elongate core has a substantially planar top surface and a substantially planar bottom surface.

[0042] In one embodiment, the plurality of barbs on the braided barbed suture preferably includes pairs of barbs extending along the length of the device. In one embodiment, each pair of barbs preferably defines a barb tip-to-tip distance (BTTD). In one embodiment, the composite core has a composite core diameter (CCD) and a ratio of barb tip-to-tip distance (BTTD) to composite core diameter (CCD) is between about 1.92 and 4.5.

[0043] In one embodiment, the ratio of barb tip to barb tip distance (BTTD) to composite core diameter (CCD) is about 2.5 to 3.8.

[0044] In one embodiment, the braided barbed suture preferably includes an elongated core having a thickness or diameter, a plurality of barbs projecting outwardly from either side of the elongated core, and a braided sheath surrounding the elongated core. The combination of the elongated core and the braided sheath forms a composite core of the braided barbed suture, the elongated core being preferably located at the center of the composite core, and the braided sheath surrounding the elongated core. The total thickness of the composite core is the combination of the elongated core and the braided sheath surrounding the elongated core, and is preferably greater than the thickness of the elongated core. In one embodiment, the ratio of the thickness or diameter of the elongated core to the thickness or diameter of the composite core is about 0.16 to 0.91, more preferably about 0.40 to 0.50.

[0045] In one embodiment, the elongated core has a concave profile, the elongated core being thinner than the inner ends of the barbs that project outwardly from either side of the elongated core.

[0046] In one embodiment, the braided barbed suture can include a first transition zone located between a first outer portion of the elongated core and an inner end of the first barb, the first transition zone widening from the first outer portion of the elongated core to the inner end of the first barb, and a second transition zone located between a second outer portion of the elongated core and the inner end of the second barb, the second transition zone widening from the second outer portion of the elongated core to the inner end of the second barb.

[0047] In one embodiment, the braided barbed suture preferably includes an end effector coupled with an elongate core, hi one embodiment, the elongate core desirably extends through the end effector.

[0048] In one embodiment, the end effector preferably includes a first wing extending laterally from a first outer portion of the elongated core and a second wing extending laterally from a second outer portion of the elongated core, the first and second wings preferably being thicker than the elongated core.

[0049] In one embodiment, the braided barbed suture preferably includes an elongated core having a concave profile, and a barbed monofilament insert including a plurality of barbs projecting outwardly from either side of the elongated core, the barbs having inner ends that are thicker than the elongated core. In one embodiment, the barbed monofilament insert preferably includes at least one transition zone located between the elongated core and the inner ends of at least some of the barbs. In one embodiment, a braided sheath is wrapped around the elongated core and the at least one transition zone to form a composite core of the braided barbed suture, the ratio of the thickness or diameter of the elongated core to the thickness or diameter of the composite core being about 0.16 to 0.91, more preferably about 0.24 to 0.73.

[0050] In one embodiment, the barbed monofilament insert, including the elongated core and barbs, may be formed from a barbed suture blank, such as a ribbon of polymeric material. In one embodiment, the barbed suture blank preferably has a cross-sectional shape having an elongated core (e.g., a concave core, a core having flat or rounded top and bottom surfaces) and first and second lateral wing portions located on either side of the elongated core. In one embodiment, the first and second lateral wing portions may be punched and / or cut (e.g., using a mold) to form the barbs projecting outwardly from the elongated core and / or the end effector secured to the proximal end of the elongated core. In one embodiment, the elongated core preferably has a thickness less than the thickness of the first and second lateral wing portions that are punched in the barbed suture blank to form the barbs and end effector.

[0051] In one embodiment, the braided barbed suture preferably includes an elongate core having a proximal end, a distal end, and a non-circular cross section. In one embodiment, the non-circular cross section of the elongate core preferably has a first thickness located at the center of the elongate core, a first outer portion having a first outer portion thickness, and a second outer portion having a second outer portion thickness. The central portion having the first thickness is located between the first outer portion and the second outer portion of the core. In one embodiment, the center of the elongate core is thicker than the first outer portion and the second outer portion of the elongate core.

[0052] In one embodiment, the elongate core has flat top and bottom surfaces with a constant thickness at the central region and at first and second outer portions of the elongate core that define the central region.

[0053] In one embodiment, the barbed monofilament inserts used to make the braided barbed sutures preferably include a transition zone located between the thinner elongated core and the thicker barbs, which allows for overbraiding the entire core width and / or height without extending substantially into the barbs, thereby providing a more flexible scaffold (i.e., the composite elongated core and braided sheath) while increasing tensile strength through the braided sheath surrounding the elongated core. In one embodiment, the transition zone is wider and / or thicker between the outer portion of the elongated core and the inner ends of the barbs, providing a smooth transition surface between the thinner elongated core and the thicker barbs.

[0054] In one embodiment, the transition zone provides a buffer area between the elongated core and the barbs that house the multifilament braided sheath wrapped around the elongated core, such that the fibers of the multifilament braided sheath do not encapsulate and / or embed the barbs, which would limit their functionality.

[0055] In one embodiment, an elongated core having a reduced thickness, diameter, and / or cross-sectional area is preferably overbraided with a braided sheath to produce a braided barbed suture that predominantly exhibits the mechanical properties of a multifilament suture.

[0056] In one embodiment, the braided barbed suture is constructed to control the ratio of multifilament sheath material to monofilament core material.

[0057] In one embodiment, creating a braided barbed suture with a predetermined elongated core to braided sheath ratio allows the braided barbed suture device to take full advantage of the uniaxial tensile strength provided by the braided sheath without reducing the strength of the braided barbed suture by tying knots.

[0058] In one embodiment, creating a braided barbed suture with an appropriate elongated core to braided sheath ratio allows a composite braided barbed suture device to nearly replicate the bending stiffness of traditional multifilament sutures, providing handling characteristics that confer advantages in minimally invasive surgical environments where space and visualization are limited (e.g., robotic surgery).

[0059] In one embodiment, the braided barbed suture preferably comprises a composite structure including a barbed monofilament insert having an elongated core having a first tensile strength and a braided sheath encasing the elongated core having a second tensile strength, hi one embodiment, the combined tensile strength is greater than or equal to either the first tensile strength of the elongated core or the second tensile strength of the braided sheath.

[0060] In one embodiment, a braided barbed suture preferably includes both a braided sheath component and a barbed monofilament insert component having an elongated core, whereby the two components have a greater combined breaking strength value than either of those components alone, where the tensile failure point of the composite braided barbed suture and the tensile failure points of each of the components in the composite structure are substantially the same. Providing a braided barbed suture with a single break point for both the braided sheath component and the elongated core of the barbed monofilament insert component preferably minimizes the sense of two separate failure points when the suturing device is in tension.

[0061] Multifilament sutures offer high strength, good damage resistance, and desirable handling characteristics, but are not inherently suitable to be processed as monofilaments or to have barbed suture characteristics due to the nature of the polymeric materials typically used. Although monofilament sutures can be made with barbs, they are susceptible to damage if not properly handled with surgical instruments.

[0062] The braided barbed sutures disclosed herein provide a suture structure that has the advantages of a braided multifilament suture (e.g., handling, flexibility, damage resistance, compatibility with surgical instruments) balanced with the strength of a monofilament suture while avoiding the sensation of two separate tensile failure points. Composite braided barbed sutures preferably have a braided sheath and an elongated core that are essentially simultaneously tension-poor, thereby minimizing the excitement of two separate tensile failure points.

[0063] In one embodiment, the elongated core component of the braided barbed suture functions primarily as the anchor points for the barbs, hi one embodiment, the braided sheath component of the braided barbed suture functions as the primary source of tensile strength and handling properties for the braided barbed suture, rather than the elongated core component.

[0064] When comparing monofilament sutures to multifilament sutures, multifilament sutures tend to have greater linear tensile strength due to the braided structure present in the multifilament suture, which allows for load sharing and uniaxial elongation of the device. However, in the clinical field, the tensile strength of traditional multifilament and monofilament sutures is inherently reduced towards the strength of the knot that can be tied. In comparison, barbed sutures eliminate the need to tie knots, and therefore can leverage linear tensile strength as an appropriate wound retention value. [Brief description of the drawings]

[0065] [Figure 1] FIG. 1 is a cross-sectional view of a prior art barbed suture insert having an elongate core and barbs projecting outwardly from either outer side of the elongate core. [Diagram 2] FIG. 2 is a top view of the prior art barbed suture insert shown in FIG. 1 having an elongated core, a first set of barbs extending toward a first end of the elongated core, and a second set of barbs extending in the opposite direction toward a second end of the elongated core. [Diagram 3]FIG. 1 is a top plan view of a prior art braided barbed suture including a barbed suture insert having an elongated core and barbs, and a braided sheath formed over the elongated core of the barbed suture. [Figure 4A] FIG. 1 is a perspective view of a barbed suture blank used to make a barbed monofilament insert according to one embodiment of the present patent application. [Figure 4B] FIG. 4B is a top view of the barbed suture blank shown in FIG. 4A. [Figure 4C] FIG. 4C is a side view of the barbed suture blank shown in FIGS. 4A and 4B. [Figure 4D] FIG. 5 is a perspective view of the proximal end of the barbed suture blank shown in FIGS. 4A-4C. [Figure 4E] FIG. 4C is a cross-sectional view of the barbed suture blank shown in FIG. 4B. [Figure 5A] FIG. 5 is a perspective view of a barbed monofilament insert formed from the barbed suture blank shown in FIGS. 4A-4E including an elongated core, a plurality of barbs, and an end effector according to one embodiment of the present patent application. [Figure 5B] FIG. 5B is a top view of the barbed monofilament insert shown in FIG. 5A. [Figure 5C] FIG. 5C is an enlarged view of a central portion of the barbed monofilament insert shown in FIGS. 5A and 5B. [Figure 5C-1] FIG. 5D is a perspective view of a central portion of the barbed monofilament insert shown in FIG. 5C. [Figure 5D] FIG. 5C is an enlarged view of the proximal end of the barbed monofilament insert shown in FIGS. 5A and 5B. [Figure 5D-1] FIG. 5B is a perspective view of the proximal end of the barbed monofilament insert shown in FIGS. 5A, 5B, and 5D. [Figure 5E] FIG. 5D is a cross-sectional view of the barbed monofilament insert shown in FIG. 5C. [Figure 5F] FIG. 5E is a cross-sectional view of the barbed monofilament insert shown in FIG. 5D. [Figure 6A] FIG. 5C is a top view of a braided barbed suture including the barbed monofilament insert of FIGS. 5A-5F and a braided sheath wrapped around an elongated core of the barbed monofilament insert, according to one embodiment of the present patent application. [Figure 6B] FIG. 6B is a cross-sectional view of the braided barbed suture shown in FIG. 6A. [Figure 7A] FIG. 1 is a perspective view of a barbed suture blank used to make a barbed monofilament insert according to one embodiment of the present patent application. [Figure 7B] FIG. 7B is a top plan view of the barbed suture blank shown in FIG. 7A. [Figure 7C] FIG. 7C is a side view of the barbed suture blank shown in FIGS. 7A and 7B. [Figure 7D] FIG. 8 is a perspective view of the proximal end of the barbed suture blank shown in FIGS. 7A-7C. [Figure 7E] FIG. 7C is a cross-sectional view of the barbed suture blank shown in FIG. 7B. [Figure 8A] FIG. 7B is a perspective view of a barbed monofilament insert made with the barbed suture blank shown in FIGS. 7A-7E, according to one embodiment of the present patent application. [Figure 8B] FIG. 8B is a top view of the barbed monofilament insert shown in FIG. 8A. [Figure 8C] FIG. 8C is an enlarged view of a central portion of the barbed monofilament insert shown in FIGS. 8A and 8B. [Figure 8C-1] FIG. 8D is a perspective view of a central portion of the barbed monofilament insert shown in FIG. 8C. [Figure 8D] FIG. 8C is a top view of the proximal end of the barbed monofilament insert shown in FIGS. 8A and 8B. [Figure 8D-1] FIG. 8E is a perspective view of the proximal end of the barbed monofilament insert shown in FIG. 8D. [Figure 8E] FIG. 8D is a cross-sectional view of the barbed monofilament insert shown in FIG. 8C. [Figure 8F] FIG. 8E is a cross-sectional view of the barbed monofilament insert shown in FIG. 8D. [Figure 9] 1 is a graph plotting tensile strength properties for braided barbed sutures having different constructions. [Figure 10] 1 is a graph plotting bending stiffness properties for braided barbed sutures having different constructions. [Figure 11]1 is a graph of a model equation predicting the tensile strength of a braided barbed suture and a braided non-barbed suture. [Figure 12] 1 is a graph of test results showing no difference in tensile strength between braided barbed and braided non-barbed sutures of similar construction. [Figure 13] FIG. 1 is a cross-sectional view of a braided barbed suture according to one embodiment of the present patent application. [Figure 14A] FIG. 1 is a top view of a barbed monofilament insert used to make a braided barbed suture, according to one embodiment of the present patent application. [Figure 14B] 1 is a schematic diagram of the composite core diameter of a braided sheath formed over a barbed monofilament insert having different suture sizes, according to an embodiment of the present patent application. [Figure 15A] FIG. 1 is a top view of a barbed monofilament insert used to make a braided barbed suture, according to one embodiment of the present patent application. [Figure 15B] 1 is a schematic diagram of the composite core diameter of a braided sheath formed over a barbed monofilament insert having different suture sizes, according to an embodiment of the present patent application. [Figure 16A] FIG. 1 is a top view of a barbed monofilament insert used to make a braided barbed suture, according to one embodiment of the present patent application. [Figure 16B] 1 is a schematic diagram of the composite core diameter of a braided sheath formed over a barbed monofilament insert having different suture sizes, according to an embodiment of the present patent application. [Figure 17] 1 is a chart illustrating ratios related to barb tip to barb distance (BTTD) and composite core diameter (CCD) for barbed monofilament inserts having different suture sizes according to one embodiment of the present patent application. [Figure 18] FIG. 1 is a schematic diagram of the use of an automated braiding system to create a braided barbed suture, according to one embodiment of the present patent application. [Figure 19] FIG. 1 is a top view of a braided barbed suture having a braided sheath with a pick, according to an embodiment of the present patent application. [Figure 20] FIG. 1 is a perspective view of a system for counting picks on a braided sheath of a braided barbed suture, according to one embodiment of the present patent application. [Figure 21] 1 illustrates a first step of a method for counting picks on a braided sheath of a braided barbed suture, according to one embodiment of the present patent application. [Figure 22] FIG. 13 illustrates a second stage of a method for counting picks on a braided sheath of a braided barbed suture, according to one embodiment of the present patent application. [Figure 23] FIG. 13 illustrates a third step of a method for counting picks on a braided sheath of a braided barbed suture, according to an embodiment of the present patent application. [Figure 24] FIG. 13 illustrates a fourth step of a method for counting picks on a braided sheath of a braided barbed suture, according to an embodiment of the present patent application. [Diagram 25] 20 is a chart illustrating optimized over-braid parameters used with the automated braiding system of FIG. 18 to control the number of picks in the braided sheath of a braided barbed suture, in accordance with an embodiment of the present patent application. [Figure 26] FIG. 1 illustrates a perspective view of a barbed monofilament insert having an end effector according to one embodiment of the present patent application. [Figure 27] FIG. 1 illustrates a perspective view of a barbed monofilament insert having an end effector according to one embodiment of the present patent application. [Figure 28] FIG. 1 illustrates a perspective view of a barbed monofilament insert having an end effector according to one embodiment of the present patent application. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0066] Definition. A barbed monofilament insert. A first component of a braided barbed suture. The barbed monofilament insert includes an elongated core having a proximal end and a distal end. The distal end of the elongated core, which may also be referred to as the leader end, is the end of the elongated core that is attached to the needle. The barbed monofilament insert has a plurality of barbs that protrude outwardly from opposite sides of the elongated core to define a barbed portion of the barbed monofilament insert. An end effector is secured to the proximal end of the elongated core, and a connector portion of the elongated core is located between the end effector and the barbed portion. Composite core. A portion of a braided barbed suture including an elongated core of a barbed monofilament insert having barbs projecting outwardly from both outer sides of the elongated core, and a braided sheath surrounding the elongated core. The composite core is a combination of the elongated core and the braided sheath that encases the elongated core. The thickness of the composite core is greater than the thickness of the elongated core. Denier. Denier (D) is a unit of measure for the linear mass density of a fiber, the mass in grams per 9,000 meters of fiber. The denier unit of measure is based on the natural standard, i.e., a single twist of silk is approximately 1 denier, or a 9,000 meter long twist of silk weighs approximately 1 gram. The denier unit is calculated as follows: 1 denier = 1 g / 9,000 m = 0.11 mg / m. Width. The distance between a first line parallel to the central axis of the elongated core adjacent the closest exterior edge of a barb extending from a first side of the elongated core and a second line parallel to the central axis of the elongated core adjacent the closest exterior edge of a barb extending from a second side of the elongated core. Leader end. A barbless strip of the elongated core of the barbed monofilament insert. The leader end forms the distal or needle-attached end of the elongated core of the barbed monofilament insert. A fiber may be wrapped around the leader end of the elongated core to form a portion of the composite core. Elongated core thickness. The barbs of the barbed monofilament insert project outwardly from both sides of the elongated core. The barbs lie in a first plane. A thickness measurement of the elongated core taken along an axis that lies in a second plane that is perpendicular to the first plane defined by the barbs. In one embodiment, the elongated core thickness is the average of three separate thickness measurements made at the leader end of the barbed monofilament insert. A gauge can be used to record the thickness measurements of the elongated core. The elongated core thickness may also be referred to as the elongated core diameter. Composite Core Diameter. The composite core diameter is a measurement of the outside diameter of the braided sheath that encases the elongated core of the barbed monofilament insert. The composite core diameter is measured in a plane that is perpendicular to the longitudinal axis of the elongated core. Composite core thickness. A composite core thickness measurement taken along an axis that lies in a second plane that is perpendicular to the first plane defined by the barbs. In one embodiment, the composite core thickness is the average of three separate thickness measurements made at the leader end of the braided barbed suture. A gauge can be used to record the composite core thickness measurements. The composite core thickness may also be referred to as the composite core diameter. Thickness Ratio. The thickness ratio of a braided barbed suture is the ratio of the elongated core thickness to the composite core thickness.

[0067] 4A-4C, in one embodiment, a barbed suture blank 100, such as a ribbon of polymeric material, may be used to form a barbed monofilament insert having an elongated core and a plurality of barbs projecting laterally from either side of the elongated core. In one embodiment, barbed suture blank 100 preferably includes a proximal end 102, a distal end 104, and a longitudinal axis A1 extending along the length of the barbed suture blank and between the proximal and distal ends 102, 104.

[0068] In one embodiment, barbed suture blank 100 preferably includes an elongate core 106 extending along longitudinal axis A1, a first outer portion 108 extending along a first outer side of elongate core 106, and a second outer portion 110 extending along a second outer side of elongate core 106. First outer portion 108 and second outer portion 110 may be punched or cut during formation of the barbs and / or end effectors.

[0069] 4D and 4E, in one embodiment, the barbed suture blank 100 preferably has a preformed cross-sectional shape that desirably includes an elongated core 106 and first and second outer portions 108, 110 located on either side of the elongated core 106. In one embodiment, the elongated core 106 is preferably located at the center of the barbed suture blank 100 and extends along a longitudinal axis A1 of the barbed suture blank 100. With reference to FIGURE 4E, in one embodiment, the elongated core 106 has a first thickness T1 that is less than a second thickness T2 of the first and second outer portions 108, 110, respectively, of the barbed suture blank 100.

[0070] In one embodiment, the barbed suture blank 100 may be placed into a mold or punch to form a barbed monofilament insert that includes an elongated core, a plurality of barbs projecting outwardly from the elongated core, and an end effector (e.g., a stop) connected to a proximal end of the elongated core. In one embodiment, the elongated core is integrally connected with the barbs and the end effector.

[0071] 5A and 5B, in one embodiment, the barbed suture blank 100 (FIGS. 4A-4E) is desirably punched or cut to form a barbed monofilament insert 120 having a proximal end 122 and a distal end 124. In one embodiment, the barbed monofilament insert 120 desirably includes an elongated core 126 (e.g., a monofilament) extending along the length of the barbed suture. The barbed monofilament insert 120 desirably includes a plurality of barbs 128 extending outwardly from opposite sides of the elongated core 126 to define a barbed central portion 130 of the barbed monofilament insert 120. The barbed monofilament insert 120 desirably includes an end effector 132 (e.g., a stop) secured to the proximal end of the elongated core 126 and located at the proximal end 122 of the barbed monofilament insert 120. In one embodiment, the elongate core 126 of the barbed monofilament insert 120 desirably includes a connector portion 134 that secures the end effector 132 to the proximal end of the elongate core 126. In one embodiment, the elongate core 126 and the connector portion 134 are integrally formed with one another.

[0072] In one embodiment, the elongated core 126 of the barbed monofilament insert 120 preferably has a cross-sectional shape that is similar to the shape of the elongated core 106 of the barbed suture blank 100 shown in FIGURE 4E and described above. In one embodiment, the elongated core 126 preferably has a thickness that is less than or equal to the thickness of each of the barbs 128 projecting outwardly from either side of the elongated core 126.

[0073] 5C and 5C-1, in one embodiment, the barbed monofilament insert 120 desirably includes a first barb 128A projecting outwardly from a first outer side of the elongated core 126 and a second barb 128B projecting outwardly from a second outer side of the elongated core 126. As described in more detail herein, the thickness of the elongated core 126 of the barbed monofilament insert 120 is preferably equal to or less than the thickness of each of the first barbs 128A and second barbs 128B projecting outwardly from both outer sides of the elongated core 126. By providing a barbed monofilament insert 120 having an elongated core 126 with a thickness that is equal to or less than the thickness of each of the barbs 128A, 128B, preferably, the overall dimensions of the braided barbed suture, which is comprised of the elongated core and the braided sheath surrounding the elongated core, are reduced, thereby maintaining flexibility of the braided barbed suture 120 after the braided sheath is formed around the elongated core 126.

[0074] 5D and 5D-1, in one embodiment, the barbed monofilament insert 120 preferably includes an end effector 132 (e.g., a stop) secured to the proximal end of the elongated core 126 at the proximal end 122 of the barbed monofilament insert 120. In one embodiment, as disclosed in commonly assigned U.S. Patent Application No. 63 / 039,649, filed on June 16, 2020, which claims the benefit of U.S. Provisional Application No. 63 / 039,649, filed on June 16, 2020, the disclosure of which is incorporated herein, the barbed monofilament insert 120 preferably includes a connector portion 134 of the elongated core 126 that enables the barbed central portion 130 (FIG. 5A) of the barbed monofilament insert 120 to pass through a first track of the guide cartridge, the end effector 132 to pass through a second track of the guide cartridge, and the connector portion 134 to pass through a slot interconnecting the first and second tracks of the guide cartridge.

[0075] In one embodiment, the elongated core 126 preferably extends through the barbed portion 130 of the barbed monofilament insert 120, as well as through an end effector 132 located at the proximal end 122 of the barbed monofilament insert 120. As shown in FIG. 5D-1, the thickness T1 of the elongated core 126 is less than a thickness T2 of each of the first and second side wings 136, 138 of the end effector 132.

[0076] 5E, in one embodiment, the barbed monofilament insert 120 preferably includes a first barb 128A projecting outwardly from a first outer side 140 of the elongated core 126 and a second barb 128B projecting outwardly from a second outer side 142 of the elongated core 126. In one embodiment, the elongated core 126 is preferably centrally located in the barbed monofilament insert 120 and extends along the longitudinal axis A1 of the barbed suture. In one embodiment, the elongated core 126 preferably forms a flexible scaffold that provides flexibility to the barbed monofilament insert during a suturing action.

[0077] In one embodiment, the first barb 128A preferably has an inner end 144A that is connected to the first outer portion 140 of the elongated core 126 via a first transition zone 145A, and an outer end 146A that defines a free end of the first barb. The first transition zone 145A is located between the first outer portion 140 of the elongated core 126 and the inner end 144A of the first barb 128A. In one embodiment, the first transition zone 145A widens or becomes thicker between the first outer portion 140 of the elongated core 126 and the inner end 144A of the first barb 128A.

[0078] The second barb 128B preferably has an inner end 144B that connects with the second outer side 142 of the elongated core 126 via a second transition zone 145B, and an outer end 146B that defines a free end of the second barb. The second transition zone 145B is preferably located between the second outer side 142 of the elongated core 126 and the inner end 144B of the second barb 128B. In one embodiment, the second transition zone 145B widens or becomes thicker between the second outer side 140 of the elongated core 126 and the inner end 144B of the second barb 128B.

[0079] In one embodiment, the elongate core 126 preferably has a convex top surface 148 located on the top side of the barbed monofilament insert 120 and a convex bottom surface 150 located on the bottom side of the barbed suture. In one embodiment, the central region 152 of the elongate core 126 defines a thickness T3 that is greater than a thickness T4 at each of the first and second outer portions 140, 142 of the elongate core 126.

[0080] In one embodiment, the top surface 148 of the elongated core and the first and second transition zones 145A, 145B preferably define a first concave profile located on the top side of the barbed monofilament insert 120, and the bottom surface 150 of the elongated core 126 and the first and second transition zones 145A, 145B preferably define a second concave profile located on the bottom side of the barbed monofilament insert.

[0081] In one embodiment, the first barb 128A has an inner end 144A that defines a thickness T5 and an outer free end 146A that defines a thickness T6 that is less than the thickness T5. As a result, the inner end 144A of the first barb 128A is thicker than the outer end 146A of the first barb 128A. In one embodiment, the thickness T3 at the central region 152 of the elongated core 126 and the thickness T4 at each of the first and second outer portions 140 and 142 of the elongated core 126 are less than the thickness T5 at the inner end 144A of the first barb 128A and are equal to or less than the thickness T6 at the outer end 146A of the first barb 128A. The first transition zone 145A is wider and / or thicker between the thinner first outer portion 140 of the elongated core 126 and the inner end 144A of the first barb 128A.

[0082] In one embodiment, the second barb 128B is preferably thicker at its inner end 144B and thinner at its outer free end 146B. In one embodiment, the inner end 144B of the second barb 128B has a thickness T7 and the outer end 146B of the second barb 128B has a thickness T8 that is less than the thickness T7 of the inner end 144B. In one embodiment, the thickness T3 at the central region 152 of the elongated core 126 and the thickness T4 at the first outer portion 140 and the second outer portion 142 of the elongated core 126 are less than the thickness T7 at the inner end 144B of the second barb 128B and are equal to or less than the thickness T8 at the outer end 146B of the second barb 128B. The second transition zone 145B becomes wider and / or thicker between the second outer portion 142 of the elongated core 126 and the inner end 144B of the second barb 128B.

[0083] 5F, in one embodiment, the end effector 132 of the barbed monofilament insert 120 preferably includes a first side wing 136 extending outwardly from a first outer side 140 of the elongated core 126 and a second side wing 138 extending outwardly from a second outer side 142 of the elongated core 126. The end effector 132 preferably includes a first transition zone 145A located between the first outer side 140 of the elongated core 126 and an inner end of the first side wing 136 and a second transition zone 145B located between the second outer side 142 of the elongated core 126 and an inner end of the second side wing 138. A thickness T1 of the central region 152 of the elongated core 126 is less than a thickness T2 of each of the first and second side wings 136, 138 of the end effector 132. In one embodiment, the thickness T1 (shown in FIG. 5F) of the elongate core 126 extending through the end effector 132 is equal to the thickness T3 (shown in FIG. 5D-1) of the elongate core 126 extending through the barbed portion 130 of the barbed monofilament insert 120.

[0084] 6A and 6B, in one embodiment, the braided barbed suture 160 may be formed by wrapping fibers around the elongated core 126 (FIG. 5E) of the barbed monofilament insert 120 to form a braided sheath 162 that surrounds the elongated core 126 of the barbed monofilament insert 120. The combination of the barbed monofilament insert 120 and the braided sheath 150 preferably forms a composite core 165 of the braided barbed suture 160. The first barb 128A and the second barb 128B of the barbed monofilament insert 120 preferably extend outwardly beyond the outer periphery of the braided sheath 162 to engage tissue.

[0085] In one embodiment, the braided barbed suture desirably includes a barbed monofilament insert having an elongated core having a reduced thickness, diameter, and / or smaller cross-sectional area than found in prior art elongated cores, so that the amount of material wrapped around the elongated core to form the braided sheath is less bulky to provide a braided barbed suture with less bending stiffness (i.e., more flexible). The properties of the materials used to make the braided barbed suture (e.g., core size, degree of overbraiding, core and braid materials) will directly and significantly affect the handling and strength properties of the braided barbed suture.

[0086] The reduced thickness of the elongate core allows a greater percentage of the composite core 165 (i.e., the combination of the braided sheath and the elongate core) to be comprised of the braided sheath 162, allowing the braided barbed suture structure to have the advantages of a braided suture (e.g., handling, flexibility, compatibility with surgical instruments).

[0087] In one embodiment, when the composite core 165 of the braided barbed suture 160 is viewed in cross-section, the ratio of the thickness or diameter of the elongated core 126 to the thickness or diameter of the composite core 165 including the braided sheath 162 (i.e., the braid to core ratio) is less than 1. Thus, the area of ​​the composite core 165 defined by the braided sheath 162 is greater than the area defined by the elongated core 126, which improves the tensile strength of the braided barbed suture 160 through the braided sheath component and improves the overall flexibility of the braided barbed suture 160 due to its thinner than typical elongated core component.

[0088] In one embodiment, the barbs 128A, 128B of the braided barbed suture 160 extend in a first plane P1, and measurements of the thickness and / or diameter of the elongated core 126 and the composite core 165 are taken along an axis that lies in a second plane P2 that is perpendicular to the first plane P1.

[0089] In one embodiment, thickness measurements can be taken using a Mitutoyo Gauge ID-39 test instrument that includes a circular foot having a 1 / 2 inch diameter. In one embodiment, the gauge can include a pressure foot that is configured to gently lower until it rests on the suture, at which point the thickness is recorded. The suture is then removed and a height measurement is recorded. In one embodiment, a period of about 0.5 seconds can elapse after the pressure foot is lowered onto the suture before a thickness measurement is recorded. In one embodiment, thickness measurements are taken at the leader end of the barbed monofilament insert and the braided barbed suture. Three thickness measurements are preferably taken at separate locations along the length of the suture strand. For a barbed braided barbed suture, one measurement is taken on the leader end of the suture material and two measurements are taken on the barbed portion.

[0090] In one embodiment, when the braided sheath 162 encases the elongated core 126 to form the composite core 165 of the braided barbed suture 160, the total thickness T CC Thickness T of the elongated core 126 EC The ratio is about 0.16 to 0.91, and more preferably about 0.24 to 0.73.

[0091] In one embodiment, due to the use of a thin elongate core 126 relative to the thickness of the barbs 128A, 128B, the braided barbed suture 160 provides a very low bending stiffness almost equivalent to a multi-filament device, while at the same time providing equal or greater tensile strength compared to a monofilament barbed device having a similar thickness or outer diameter. Additionally, the smaller elongate core 126 results in a composite core 165 having a smaller thickness or outer dimension (e.g., outer diameter) than would be possible with prior art barbed suture inserts having thicker elongate cores.

[0092] 7A-7C, in one embodiment, a barbed suture blank 200, such as a ribbon of polymeric material, is used to form a barbed monofilament insert having an elongated core and a plurality of barbs projecting outwardly from both outer sides of the elongated core. In one embodiment, the barbed suture blank 200 preferably includes a proximal end 202, a distal end 204, and a longitudinal axis A2 extending along the length of the barbed suture blank between the proximal and distal ends 202, 204. In one embodiment, the barbed suture blank preferably includes an elongated core 206 extending along the longitudinal axis A2, a first outer portion 208 extending along a first outer portion of the elongated core 206, and a second outer portion 210 extending along a second outer portion of the elongated core 206.

[0093] 7D and 7E , in one embodiment, the barbed suture blank 200 has a preformed cross-sectional shape that preferably includes an elongated core 206 and first and second outer portions 208, 210 located on either side of the elongated core 206. In one embodiment, the elongated core 206 is preferably located at the center of the barbed suture blank 200 and extends along a longitudinal axis A2 of the barbed suture blank 200. In one embodiment, the thickness T9 of the elongated core 206 is preferably less than the thickness T of the first and second outer portions 208, 210 of the barbed suture blank 200. 10 The barbed suture blank 200 has a first transition zone 209 located between a first outer side of the elongated core 206 and an inner end of the first outer portion 208, and a second transition zone 211 located between a second outer side of the elongated core 206 and an inner end of the second outer portion 210. In one embodiment, the first transition zone 209 and the second transition zone 211 widen between the relatively thin elongated core 206 and the relatively thicker inner ends of the first outer portion 208 and the second outer portion 210.

[0094] In one embodiment, the barbed suture blank 200 may be placed into a mold or punch machine to form a barbed monofilament insert that includes an elongated core, a plurality of barbs projecting outwardly from the elongated core, and an end effector connected to an end of the elongated core.

[0095] 8A and 8B, in one embodiment, a barbed suture blank 200 (FIGS. 7A-7E) is desirably punched or cut to form a barbed monofilament insert 220 having a proximal end 222 and a distal end 224. In one embodiment, the barbed monofilament insert 220 desirably includes an elongated core 226 extending along the length of the barbed suture. The barbed monofilament insert 220 desirably includes a plurality of barbs 228 extending outwardly from opposite sides of the elongated core 226 to define a barbed central portion 230 of the barbed monofilament insert 220. The barbed monofilament insert 220 desirably includes an end effector 232 (e.g., a stop) located at the proximal end 222 of the barbed monofilament insert 220 and secured to the proximal end of the elongated core 226.

[0096] In one embodiment, as disclosed in commonly assigned U.S. Patent Application No. 63 / 039,649, filed on June 16, 2020, which claims the benefit of U.S. Provisional Application No. 63 / 039,649, filed on June 16, 2020, the disclosure of which is incorporated herein, the barbed monofilament insert 220 preferably includes a connector portion 234 of the elongated core 226 that enables a barbed central portion 230 (FIG. 9A) of the barbed monofilament insert 220 to pass through a first track of the guide cartridge, an end effector 232 to pass through a second track of the guide cartridge, and the connector portion 234 to pass through a slot interconnecting the first and second tracks of the guide cartridge.

[0097] In one embodiment, the elongated core 226 of the barbed monofilament insert 220 preferably has a cross-sectional shape that is similar to the elongated core 206 of the barbed suture blank 200 shown in FIG 7E and described above. The elongated core 226 preferably defines a portion of the barbed suture having a thickness that is less than or equal to the thickness of each barb 228 projecting outwardly from either side of the elongated core 226 and the thickness of the first and second wings of the end effector 232.

[0098] 8C and 8C-1, in one embodiment, the barbed central portion 230 of the barbed monofilament insert 220 preferably includes an elongated core 226 extending along the length of the barbed monofilament insert 220 from the proximal end 222 to the distal end 224 (FIG. 8A). The barbed monofilament insert 220 desirably includes first barbs 228A projecting outwardly from a first outer side of the elongated core 226 and second barbs 228B projecting outwardly from a second outer side of the elongated core 226 opposite the first outer side. As described in more detail herein, the thickness of the elongated core 226 of the barbed monofilament insert 220 is equal to or less than the thickness of the first and second barbs 228A and 228B projecting outwardly from both outer sides of the elongated core 226. As previously described herein, by providing a barbed monofilament insert having an elongated core with a reduced thickness, the overall cross-sectional dimension of the composite core (i.e., the combination of the elongated core and braided sheath) is preferably reduced in order to maintain flexibility of the braided barbed suture after the braided sheath is formed around the elongated core 226.

[0099] 8D and 8D-1, in one embodiment, the barbed monofilament insert 220 preferably includes an end effector 232 (e.g., a stop) secured to the proximal end of the elongated core 226 at the proximal end 222 of the barbed monofilament insert 220. In one embodiment, as disclosed in commonly assigned U.S. Patent Application No. 63 / 039,649, filed on June 16, 2020, which claims the benefit of U.S. Provisional Application No. 63 / 039,649, filed on June 16, 2020, the disclosure of which is incorporated herein, the barbed monofilament insert 220 preferably includes a connector portion 234 of the elongated core 226 that enables a barbed central portion 230 (FIG. 8A) of the barbed monofilament insert 220 to pass through a first track of the guide cartridge, an end effector 232 to pass through a second track of the guide cartridge, and the connector portion 234 to pass through a slot interconnecting the first track and the second track.

[0100] In one embodiment, the elongated core 226 preferably extends through the barbed portion 230 of the barbed monofilament insert 220, as well as through an end effector 232 located at the proximal end 222 of the barbed monofilament insert 220. As shown in FIG. 9D-1, the thickness T9 of the elongated core 226 is approximately equal to the thickness T 10 Less than.

[0101] 8E, in one embodiment, the barbed monofilament insert 220 preferably includes a first barb 228A projecting outwardly from a first outer side 240 of the elongated core 226 and a second barb 228B projecting outwardly from a second outer side 242 of the elongated core 226. In one embodiment, the elongated core 226 is preferably centrally located in the barbed monofilament insert 220 and extends along the longitudinal axis A2 of the barbed suture. In one embodiment, the elongated core 226 preferably forms a flexible spine or backbone that provides flexibility to the barbed monofilament insert 220 during a suturing action.

[0102] In one embodiment, the first barb 228A preferably has an inner end 244A connected to the first outer portion 240 of the elongated core 226, and an outer end 246A defining a free end of the first barb. The barbed monofilament insert 220 desirably includes a first transition zone 245A located between the first outer portion 240 of the elongated core 226 and the inner end 244A of the first barb 228A. The first transition zone 245A widens or becomes thicker between the first outer portion 240 of the elongated core 226 and the inner end 244A of the first barb 228A.

[0103] The second barb 228B preferably has an inner end 244B connected to the second outer portion 242 of the elongated core 226, and an outer end 246B defining a free end of the second barb. The barbed monofilament insert 220 desirably includes a second transition zone 245B located between the second outer portion 242 of the elongated core 226 and the inner end 244B of the second barb 228B. The second transition zone 245B widens or becomes thicker between the second outer portion 240 of the elongated core 226 and the inner end 244B of the second barb 228B.

[0104] In one embodiment, the elongated core 226 preferably has a substantially flat top surface 248 located on the top side of the barbed monofilament insert 220, and a substantially flat bottom surface 250 located on the bottom side of the barbed suture. In one embodiment, the substantially flat top surface 248 and bottom surface 250 are spaced apart from each other by a thickness T of the elongated core 226. 11 Define.

[0105] In one embodiment, the first barb 228A is preferably thicker at its inner end 244A and thinner at its outer free end 246A. In one embodiment, the inner end 244A of the first barb 228A has a thickness T 12 and the outer end 246A of the first barb 228A has a thickness T 12 Thickness T smaller than 13 In one embodiment, the elongated core 226 has a thickness T 11 is the thickness T at the inner end 244A of the first spine 228A. 12In one embodiment, the thickness T of the elongated core 226 is 11 is the thickness T at the outer end 246A of the first spine 228A. 13 The following is the result.

[0106] In one embodiment, the second barb 228B is preferably thicker at its inner end 244B and thinner at its outer free end 246B. In one embodiment, the inner end 244B of the second barb 228B has a thickness T 14 and the outer end 146B of the second barb 128B has a thickness T 14 Thickness T smaller than 15 In one embodiment, the elongated core 226 has a thickness T 11 is the thickness T at the inner end 246A of the second spine 228B. 14 In one embodiment, the thickness T of the elongated core 126 is 11 is the thickness T of the outer end 246B of the second spine 228B. 15 The following is the result.

[0107] 8F, in one embodiment, the end effector 232 of the barbed monofilament insert 220 preferably includes a first side wing 236 extending outwardly from a first outer portion 240 of the elongated core 226, and a second side wing 238 extending outwardly from a second outer portion 242 of the elongated core 226. The end effector 232 preferably includes a first transition zone 245A located between the first outer portion 240 of the elongated core 226 and an inner end of the first side wing 236, and a second transition zone 245B located between the second outer portion 242 of the elongated core 226 and an inner end of the second side wing 238. The thickness T of the elongated core 226 may be 0.1 mm or more. 11 is the thickness T of each of the first side wing 236 and the second side wing 238 of the end effector 232. 10 In one embodiment, the thickness T of the elongated core 226 extending through the end effector 232 is less than 11 is equal to the thickness T9 of the elongated core 226 that extends through the barbed portion 230 of the barbed monofilament insert 220 (FIG. 8D-1).

[0108] In one embodiment, a braided barbed suture may be formed by wrapping fibers around the elongated core 226 of the barbed monofilament insert 220 to form a braided sheath that surrounds and / or encases the elongated core 226 of the barbed monofilament insert 220.

[0109] With reference to Figure 9, when constructing a braided barbed suture, the tensile strength of the braided barbed suture can be controlled by selecting the type and dimensions of materials used to make the braided barbed suture. The graph in Figure 9 shows that the tensile strength of the braided barbed suture is dependent on the combination of materials used to make the braided barbed suture.

[0110] Example 1. In one embodiment, the thickness of the elongated core of the barbed monofilament insert is 6.39 mils. Fibers are wrapped around the elongated core to form a braided sheath. The combination of the elongated core and the braided sheath encasing the elongated core forms a composite core having a thickness of 23.44 mils. The ratio of the thickness of the elongated core to the thickness of the composite core is 0.27 (6.39 / 23.44=0.27). Example 2. In one embodiment, the thickness of the elongated core of the barbed monofilament insert is 20.18 mils. Fibers are wrapped around the elongated core to form a braided sheath. The combination of the elongated core and the braided sheath encasing the elongated core forms a composite core having a thickness of 24.47 mils. The ratio of the thickness of the elongated core to the thickness of the composite core is 0.82 (20.18 / 24.47=0.82). Example 3. In one embodiment, the thickness of the elongated core of the barbed monofilament insert is 6.34 mils. Fibers are wrapped around the elongated core to form a braided sheath. The combination of the elongated core and the braided sheath encasing the elongated core forms a composite core having a thickness of 13.4 mils. The ratio of the thickness of the elongated core to the thickness of the composite core is 0.47 (6.34 / 14.4=0.47).

[0111] With reference to Figure 10, the bending stiffness of a braided barbed suture can be controlled by selecting the type and dimensions of materials used to make the braided barbed suture. The graph in Figure 10 shows that the bending stiffness of a braided barbed suture depends on the combination of materials used to make the braided barbed suture.

[0112] As shown in Figure 10, in one embodiment, to maintain flexibility of the braided barbed suture, the thickness of the barbed monofilament insert is preferably about 5-20 mils, more preferably about 6-8 mils, and the thickness of the composite core (i.e., the combination of the elongated core and braided sheath) is preferably about 13-30 mils, more preferably about 13-18 mils. Within the ranges recited above (i.e., a barbed monofilament insert thickness of 6-8 mils, and a composite core thickness of 13-18 mils), the bending stiffness of the braided barbed suture will match that which can be achieved with a multifilament suture device.

[0113] In one embodiment, a braided barbed suture having an elongated core thickness of 5-10 mils and a composite core thickness of 11-30 mils is preferred. In one embodiment, a highly preferred braided barbed suture has an elongated core thickness of 6-8 mils and a composite core thickness of 11-25 mils, with an elongated core / composite core ratio of about 0.47.

[0114] Test models were constructed and tests were performed to evaluate and analyze the failure mechanisms of braided barbed sutures. In particular, tests were performed to determine 1) the contribution of the barbed monofilament insert and braided sheath to the overall tensile strength of the braided barbed suture, and 2) the effect of the mechanical interaction of the barbs of the barbed monofilament insert and braided sheath on the overall tensile strength of the braided barbed suture.

[0115] To complete the analysis of the failure mechanisms of the braided barbed sutures, the data were compiled in two separate phases. The first test phase included an analysis of the failure mechanisms of the braided suture samples (Group I), where each Group I sample included a barbed monofilament core and a braided sheath covering the barbed monofilament core. The second test phase included an analysis of the failure mechanisms of the braided barbed suture samples (Group II), where each Group II sample included a barbed monofilament insert and a braided sheath covering an elongated core of barbed monofilament insert.

[0116] Group I specimens were made using barbless monofilament cores of various sizes (e.g., USP 5-0, 2-0, and 1) with diameters ranging from 5 to 20 mils, and braided sheaths with various densities (e.g., 56 or 80 denier yarns, single or double, and 16 supports), resulting in final composite cores with diameters ranging from 13 to 31 mils. The fact that the Group I specimens did not have barbs provided a special opportunity to estimate the mechanical bond of the barbless monofilament core and the braided sheath encasing the monofilament core. Additionally, the construction of the Group I specimens allowed the barbless monofilament core to be removed from the braided sheath, which allowed each component of the braided suture to be mechanically tested independently of one another.

[0117] formula F CS =F C +F S Equation 1 is utilized to complete the mechanical fracture test, where F CS is the combined tensile strength of the monofilament core and braided sheath composite, F C is the tensile strength of the monofilament core, F S is the tensile strength of the braided sheath. CS Against F C +F S All of the plotted points are shown to lie on a line that passes through the origin and has a slope equal to 1.

[0118] Evaluation of the failure mechanisms of braided sutures without barbs (Group I samples) versus braided barbed sutures with barbs (Group II samples). To evaluate and compare the failure mechanisms of Group I samples versus Group II samples, Group I and Group II samples were fabricated with nearly matching structures. The tensile strength (i.e., F CS ) versus the tensile strength of the Group II specimens (i.e., F bb ) were experimentally determined. CS and F bb A plot of is constructed and a reference line is shown having slope=1 and passing through the origin.

[0119] Referring to Figure 12, after testing the Group I samples, a plot of the data shows that the results predicted by Equation 1 hold for all of the samples tested, verifying that the tensile strength of the Group I samples is simply a linear addition of the tensile strengths of the unbarbed monofilament core and the braided sheath surrounding the core. Analysis of the test results showed no other significant mechanical interactions, such as frictional forces, between the monofilament core and the braided sheath components. With Equation 1 verified, further mechanical rupture testing of the braided barbed sutures was performed.

[0120] When evaluating the failure mechanisms of braided non-barbed sutures (Group I samples) versus braided barbed sutures (Group II samples), there are three possible scenarios that could theoretically play out: Scenario #1) the data tends to be above the baseline, indicating that the interaction of the barbs and braid is actually increasing the tensile strength of the device relative to that predicted by Equation 1; Scenario #2) the data tends to be above the baseline, indicating that the barbs are not having any effect on the tensile strength relative to that predicted by Equation 1; and Scenario #3) the data tends to be below the baseline, indicating that the barbs are reducing the tensile strength of the device as predicted by Equation 1.

[0121] FIG. 12 is a plot of the test results and shows the baseline associated with Scenario #2. The test results indicate that the presence of barbs does not significantly affect the tensile strength of the suture. Thus, the aggregate tensile strength of the braided barbed suture is equal to the additive combination of the tensile strength of the barbed monofilament insert and the tensile strength of the braided sheath, which is consistent with Equation 1.

[0122] The test results support the following conclusions: First, for a barbed monofilament insert having an elongated core with a given diameter, it is ideal to provide a relatively large sheath size and a relatively small elongated core size (i.e., sheath to core ratio) because that design takes advantage of the inherent strength of the braided sheath portion of the braided barbed suture.

[0123] Second, for a given diameter, utilizing a large braided sheath to elongated core ratio will provide greater flexibility (i.e., lower bending stiffness), which improves the handling characteristics of the braided barbed suture.

[0124] Third, because the braided sheath is exposed and visible to the surgical personnel, any damage to the braided sheath will be apparent upon inspection. Thus, in the unlikely event of failure of the elongated core, the relatively large amount of braid will result in minimal loss in the tensile strength of the device. This degree of robustness against failure mechanisms cannot be achieved for braided sutures with smaller sheath to core ratios.

[0125] Fourth, the physical interaction between the barbed monofilament insert and the braided sheath material does not change the tensile strength of the braided barbed suture, so minor adjustments to the barb design are unlikely to have a significant effect on tensile strength.

[0126] Sutures are supplied in different sizes, i.e. 10-0, 9-0, 8-0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 1, 2, 3, 4, and 5, with suture size 10-0 being the smallest and suture size 5 being the largest. Suture sizes 3-0 and 2-0 are often used for skin closure. Suture sizes 0 and 1 are larger than sizes 3-0 and 2-0 and are often used to close fascial layers during abdominal surgery, as well as in knee and hip surgery.

[0127] Braided barbed sutures disclosed herein may include suture sizes 3-0, 2-0, 0, and 1. The outer diameter of the composite core 165 (FIG. 6B) may vary depending on the suture size. Generally, a smaller suture size (e.g., size 3-0) will result in a composite core having a relatively small outer diameter, and a larger suture size (e.g., size 1) will result in a composite core having a relatively large outer diameter.

[0128] In one embodiment, the barbs of the braided barbed suture preferably project outwardly beyond the outer diameter of the composite core a sufficient distance to allow the barbs to engage tissue to hold the braided barbed suture in place If the tips of the barbs are embedded within the composite core (and do not extend outside of the composite core), the barbs will be ineffective in holding the braided barbed suture in place.

[0129] 13, in one embodiment, a braided barbed suture 360 ​​preferably includes an elongated core 326 and a barbed monofilament insert 320 (i.e., barbed insert) including a first barb 328A and a second barb 328B projecting outwardly from the elongated core 326. The first barb 328A and the second barb 328B define a barb tip to barb tip distance BTTD that extends from the outer surface of the tip of the first barb 328A to the outer surface of the tip of the second barb 328B. In one embodiment, a braided sheath 362 is braided over the elongated core 326 of the barbed monofilament insert 320. The elongated core 326 has a cross-sectional dimension that defines an elongated core diameter, referred to as the ECD. The combination of the elongated core 326 and the braided sheath 350 forms a composite core 365 having a composite core diameter referred to as the CCD. The barbed monofilament insert 320 preferably includes a first barb 328A and a second barb 328B that extend outwardly beyond the outer diameter of the composite core 365 to engage tissue and secure the braided barbed suture 360 ​​in place.

[0130] In one embodiment, there is a preferred ratio of barb tip to barb distance (BTTD) to composite core outer diameter (CCD) to ensure that the barbs protrude a sufficient distance from the composite core to effectively engage tissue and secure the braided barbed suture 360 ​​in place. Generally, if the BTTD / CCD ratio is close to 1:1, the barbs 328A, 328B will not be able to adequately anchor in tissue. If the ratio is greater, for example, about 1.90:1 to 4.50:1, the barbs protrude a sufficient distance beyond the composite core outer diameter so that they can effectively anchor in tissue.

[0131] 14A and 14B, in one embodiment, the barbed monofilament insert 420 preferably includes an elongated core 426 and a pair of first and second barbs 428A, 428B projecting outwardly from opposite sides of the elongated core 426. The first and second barbs 428A, 428B define a barb tip to barb tip distance BTTD1 of approximately 33 mils.

[0132] 14B and 17, in one embodiment, the elongated core 426 is a suture size 3-0. In one embodiment, a braided sheath wrapped around the elongated core defines a first composite core 465A having a composite core diameter CCD1 of 11.86 mils. The ratio of barb tip to barb tip distance BTTD1 (33 mils) to composite core diameter CCD1 (11.86 mils) is approximately 2.78:1.

[0133] In one embodiment, the elongated core 426 is suture size 2-0. In one embodiment, the braided sheath wrapped around the elongated core defines a second composite core 465B having a composite core diameter CCD2 of 12.93 mils. The ratio of barb tip to barb tip distance BTTD1 (33 mils) to composite core diameter CCD2 (12.93 mils) is about 2.55:1.

[0134] In one embodiment, the elongate core 426 is suture size 0. In one embodiment, the braided sheath wrapped around the elongate core defines a third composite core 465C having a composite core diameter CCD3 of 15.07 mils. The ratio of barb tip to barb tip distance BTTD1 (33 mils) to composite core diameter CCD3 (15.07 mils) is approximately 2.19:1.

[0135] In one embodiment, the elongated core 426 is suture size 1. In one embodiment, the braided sheath wrapped around the elongated core defines a fourth composite core 465D having a composite core diameter CCD4 of 17.15 mils. The ratio of barb tip to barb tip distance BTTD1 (33 mils) to composite core diameter CCD4 (17.15 mils) is approximately 1.92:1.

[0136] 15A and 15B, in one embodiment, the barbed monofilament insert 520 includes an elongated core 526 and a pair of first and second barbs 528A, 528B projecting outwardly from opposite sides of the elongated core 526. The first and second barbs 528A, 528B define a barb tip to barb tip distance BTTD2 of approximately 45 mils.

[0137] 15B and 17, in one embodiment, the elongated core 526 is a suture size 3-0. In one embodiment, a braided sheath wrapped around the elongated core defines a first composite core 565A having a composite core diameter CCD1 of 11.86 mils. The ratio of barb tip to barb tip distance BTTD2 (45 mils) to composite core diameter CCD1 (11.86 mils) is approximately 3.79:1.

[0138] In one embodiment, the elongated core 526 is suture size 2-0. In one embodiment, the braided sheath wrapped around the elongated core defines a second composite core 565B having a composite core diameter CCD2 of 12.93 mils. The ratio of barb tip distance BTTD2 (45 mils) to composite core diameter CCD2 (12.93 mils) is about 3.48:1.

[0139] In one embodiment, the elongate core 526 is suture size 0. In one embodiment, the braided sheath wrapped around the elongate core defines a third composite core 565C having a composite core diameter CCD3 of 15.07 mils. The ratio of barb tip distance BTTD2 (45 mils) to composite core diameter CCD3 (15.07 mils) is approximately 2.99:1.

[0140] In one embodiment, the elongate core 526 is suture size 1. In one embodiment, the braided sheath wrapped around the elongate core defines a fourth composite core 565D having a composite core diameter CCD3 of 17.15 mils. The ratio of barb tip distance BTTD2 (45 mils) to composite core diameter CCD4 (17.15 mils) is about 2.62:1.

[0141] 16A and 16B, in one embodiment, the barbed monofilament insert 620 includes an elongated core 626 and a pair of first and second barbs 628A, 628B projecting outwardly from opposite sides of the elongated core 626. The first and second barbs 628A, 628B define a barb tip to barb tip distance BTTD3 of approximately 53 mils.

[0142] 16B and 17, in one embodiment, the elongated core 626 is a suture size 3-0. In one embodiment, a braided sheath wrapped around the elongated core defines a first composite core 665A having a composite core diameter CCD1 of 11.86 mils. The ratio of barb tip to barb tip distance BTTD3 (53 mils) to composite core diameter CCD1 (11.86 mils) is approximately 4.47:1.

[0143] In one embodiment, the elongated core 626 is suture size 2-0. In one embodiment, the braided sheath wrapped around the elongated core defines a second composite core 665B having a composite core diameter CCD2 of 12.93 mils. The ratio of barb tip to barb tip distance BTTD3 (53 mils) to composite core diameter CCD2 (12.93 mils) is about 4.10:1.

[0144] In one embodiment, the elongate core 626 is suture size 0. In one embodiment, the braided sheath wrapped around the elongate core defines a third composite core 665C having a composite core diameter CCD3 of 15.07 mils. The ratio of barb tip distance BTTD3 (53 mils) to composite core diameter CCD3 (15.07 mils) is approximately 3.52:1.

[0145] In one embodiment, the elongate core 626 is suture size 1. In one embodiment, the braided sheath wrapped around the elongate core defines a fourth composite core 665D having a composite core diameter CCD3 of 17.15 mils. The ratio of barb tip distance BTTD3 (53 mils) to composite core diameter CCD4 (17.15 mils) is about 3.09:1.

[0146] 18, in one embodiment, an automated braiding system 700 for making a braided barbed suture preferably includes a spool 702 holding a continuous roll of barbed monofilament inserts 704. In one embodiment, the barbed monofilament inserts 704 are directed (in a direction of DIR1) through an elongated body 706, as disclosed in commonly assigned U.S. Patent Application Serial No. _______________, filed on even date herewith, which claims the benefit of U.S. Provisional Application No. 63 / 039,649, filed June 16, 2020, the disclosure of which is incorporated herein. In one embodiment, the elongated body 706 feeds the barbed monofilament inserts 704 to a braider threadway 708 for over-braiding around an elongated core of each barbed monofilament insert. The automated braiding system 700 preferably includes a plurality of shuttle supports 710 surrounding an elongated body 706 and a braider threadway 708. Each shuttle support 710 preferably includes a bobbin 712 mounted thereon that holds a thread 714 that is desirably fed into the braider threadway 708 for wrapping around the barbed fiber insert 704 to form a braided sheath that extends along the length of the barbed fiber insert.

[0147] In one embodiment, the overbraid parameters used by the automated braiding system 700 can be predetermined and / or modified to control the quality and specifications of the braided sheath formed over the barbed monofilament insert 704. The overbraid parameters can include the number of bobbins 712 used and the denier of the yarn 714 provided on the bobbins.

[0148] As used herein, Denier (D) is a unit of measure for the linear mass density of a fiber, and is the mass in grams per 9,000 meters of fiber. The denier unit of measure is based on the natural standard, i.e., a single 9,000 meter long strand of silk has a weight of about 1 gram, or is about 1 denier. Denier units are calculated as follows: 1 denier = 1 g / 9,000 m = 0.11 mg / m.

[0149] In one embodiment, the number of bobbins 712 used in the automated braiding system 700 can be predetermined and / or modified to control the density of the braided sheath formed over the barbed suture insert. For example, using more bobbins will cause more threads to be directed into the braider threadway 708, resulting in a braided sheath having a higher fiber density, and using fewer bobbins will cause fewer threads to be directed into the braider threadway 708, resulting in a braided sheath having a lower fiber density.

[0150] In one embodiment, each bobbin 712 contains a yarn 714 that is fed into the braider yarn way 708. The denier of the yarn can control the number of fibers that are directed into the braider yarn way 708. In one embodiment, each fiber in the yarn 714 is about 2 denier. Thus, a 28 denier yarn contains 14 fibers, a 56 denier yarn contains 28 fibers, and an 80 denier yarn contains 40 fibers. The denier of the yarn 714 can be selected to control the density of the braided sheath formed over the barbed monofilament insert.

[0151] In one embodiment, the braided sheath formed over the barbed monofilament insert has distinct picks that can be counted along the length of the braided barbed suture. As used herein, the term "pick" is defined to mean one repetition of the braid measured along the longitudinal axis of the braided sheath. The term "picks per inch" (PPI) refers to the number of picks along the longitudinal axis of the braided sheath across one inch of the braided barbed suture device.

[0152] Figure 19 shows a braided barbed suture 860 having a braided sheath 862 extending along the braid axis. The start and end points of a single pick are identified in Figure 19. The distance between barb pairs (DBBP) may be approximately 0.075 inches.

[0153] 20, in one embodiment, a pick counting system 855 can be used to inspect a braided barbed suture 860 (FIG. 19) to determine the picks per inch (PPI) of the braided sheath 862. In one embodiment, the pick counting system 855 preferably includes a microscope 865 for viewing the braided sheath, a video display screen 875 for viewing an image of the braided sheath captured by the microscope 865, a digital crosshair generator 885 for generating visual crosshairs on the braided sheath shown on the video display screen 875, and a computer 895 running one or more software programs (i.e., PPI software) configured to assist an operator in counting picks per inch (PPI) on the braided sheath 862 of the braided barbed suture 860 (FIG. 19).

[0154] 20 and 21, in one embodiment, the PPI software is opened to display, among other things, distance measurements on a video display monitor 875. The braided barbed suture 860 can be placed on a microscope plate within the field of view of the microscope 895. In one embodiment, the braided barbed suture 860 can be held stationary by a fixation component (e.g., adhesive tape, clamps). In one embodiment, with the braided barbed suture 860 under the microscope 865 and the braided sheath 862 visible in the video display monitor 875, the digital crosshair generator preferably aligns the crosshair with the start of the first pick of the braided sheath. In FIG. 21, the crosshair includes a Y-axis and an X-axis that intersect at a location that indicates the start of the first pick of the braided sheath 862. The crosshair is displayed on the video display monitor 875.

[0155] 22 and 23, in one embodiment, the pick counting system computer 895 counts the number of picks located along the X-axis until 1.00 inch is measured along the X-axis of the braided sheath 862 (FIG. 21). In FIG. 23, the start and end locations of four picks are highlighted. In the embodiment shown in FIG. 23, the four picks have a combined length of more than 1.00 inch.

[0156] Referring to FIG. 24, in one embodiment, the total number of picks counted over a distance of one inch is calculated and the Picks Per Inch (PPI) value is displayed on the display screen of computer 895.

[0157] 19, in one embodiment, a braided barbed suture 860 has pairs of barbs 828A, 828B that are spaced apart from one another along the length of the braided barbed suture. A braided sheath 862 extends along the length of the braided barbed suture 860. The distance between the barb pairs, also referred to herein as DBBP, is approximately 0.075 inches.

[0158] 18, 25, and 26, in one embodiment, the overbraiding parameters used by the automated braiding system 700 can be controlled to optimize the performance of the braided barbed suture 860.

[0159] In one embodiment, if the barbed monofilament insert is size 3-0 and the DBBP is 0.075 inches, a braiding configuration using 16 shuttle supports 710, each securing one bobbin 712 holding 28 denier yarn (i.e., 14 fibers), will produce a braided sheath with 55 picks per inch (PPI). Using this PPI number, one can calculate an inch per pick (IPP) value of 0.0182, which is the reciprocal of the PPI. The DBBP / IPP ratio is 0.075 / 0.0182=4.13.

[0160] In one embodiment, if the barbed monofilament insert is size 2-0 and the DBBP is 0.075 inches, a braiding configuration using 12 shuttle supports 710, each securing one bobbin 712 holding 56 denier yarn (i.e., 28 fibers), will produce a braided sheath with 50 picks per inch (PPI). Using this PPI number, one can calculate a value of 0.0200 inches per pick (IPP), which is the reciprocal of the PPI. The DBBP / IPP ratio is 0.075 / 0.0200=3.75.

[0161] In one embodiment, if the barbed monofilament insert is size 0 and the DBBP is 0.075 inches, a braiding configuration using 16 shuttle supports 710, each securing one bobbin 712 holding 56 denier yarn (i.e., 28 fibers), will produce a braided sheath with 48 picks per inch (PPI). Using this PPI number, one can calculate a value of 0.0208 inches per pick (IPP), which is the reciprocal of the PPI. The DBBP / IPP ratio is 0.075 / 0.0208=3.60.

[0162] In one embodiment, if the barbed monofilament insert is size 1 and the DBBP is 0.075 inches, a braiding configuration using 16 shuttle supports 710, each securing one bobbin 712 holding 80 denier yarn (i.e., 40 fibers), will produce a braided sheath with 41 picks per inch (PPI). Using this PPI number, one can calculate a value of 0.0244 inches per pick (IPP), which is the reciprocal of the PPI. The DBBP / IPP ratio is 0.075 / 0.0244=3.08.

[0163] In one embodiment, the DBBP / IPP ratio is an over-braiding parameter that may be optimized to prevent barbs from becoming buried under the threads of the braided sheath of the braided barbed suture. If the DBBP / IPP ratio is too low, the threads will be too tightly braided and the barbs will be more likely to become buried. In contrast, if the DBBP / IPP ratio is too high, the threads will be too loosely over-braided and the braided barbed suture will not benefit from the improved mechanical properties provided by its presence.

[0164] In one embodiment, the preferred DBBP / IPP ratio is about 2.75 to 4.50. Depending on the suture size of the barbed suture insert, the denier of the thread and the number of bobbins used can be modified to ensure that the DBBP / IPP ratio is 2.75 to 4.50 denier.

[0165] The end effector of the barbed suture insert can have a variety of geometric shapes (e.g., square, rectangular, circular, oval, diamond, semicircular, etc.). The end effector can also have a bevel to vary the lateral width of the end effector along the length of the end effector. With reference to FIG. 27, in one embodiment, the barbed suture insert 1020 has an end effector 1032 having a rectangular shape. With reference to FIG. 28, in one embodiment, the barbed suture insert 1120 has an end effector 1132 having a rectangular shape with a proximal end 1135 defining a curved surface. With reference to FIG. 29, in one embodiment, the barbed suture insert 1220 has an end effector 1232 having a square shape with a proximal end 1235 defining a curved surface.

[0166] The braided end effector of the braided barbed suture may be laminated or sandwiched between two end attachment pieces that are glued or welded to the braided end effector. The end attachment pieces are preferably of the same conventional shape as the end effector (e.g., square, rectangular, circular, oval, diamond, semicircular, etc.) and made of the same material as the barbed suture blank 100 / barbed monofilament insert. The end attachment pieces may be secured to the braided end effector in a manner similar to that disclosed in U.S. Pat. Nos. 10,336,001 and D780,918, the disclosures of which are incorporated herein by reference.

[0167] While the above description is directed to embodiments of the present invention, other and further embodiments of the invention may be made without departing from the basic scope of the invention, which is limited only by the scope of the appended claims. For example, it is intended that the present invention may incorporate any feature shown in any embodiment described herein or incorporated by reference herein with any feature shown in any embodiment described herein or incorporated by reference herein and still fall within the scope of the present invention.

[0168] [Embodiment] (1) A braided barbed suture, comprising: a barbed monofilament insert including an elongated core having an elongated core thickness and a plurality of barbs projecting outwardly from opposite sides of the elongated core; and a braided sheath surrounding the elongated core to form a composite core of the braided barbed suture having a composite core thickness, the ratio of the elongated core thickness to the composite core thickness being between about 0.16 and 0.91. (2) The braided barbed suture of claim 1, wherein the ratio of the elongated core thickness to the composite core thickness is about 0.24 to 0.73. (3) The braided barbed suture of embodiment 1, wherein the braided sheath encases the elongated core, and the elongated core is centered within the composite core. (4) The braided barbed suture of claim 1, wherein the barbs protrude outwardly from the elongated core in a first plane, and the thickness of the elongated core and the thickness of the composite core are measured along an axis that lies in a second plane that is perpendicular to the first plane. (5) The barbed monofilament insert is a first barb projecting outwardly from the elongated core, the first barb including an inner end having a first thickness greater than the thickness of the elongated core and an outer end having a second thickness less than the first thickness at the inner end of the first barb; 5. The braided barbed suture of embodiment 4, further comprising a transition zone extending between the elongate core and the inner end of the first barb for connecting the inner end of the first barb to the elongate core.

[0169] (6) The braided barbed suture of embodiment 5, wherein the transition zone is thinner near the elongated core and thicker near the inner end of the first barb, the transition zone widening from the elongated core to the inner end of the first barb. (7) The braided barbed suture of claim 6, wherein the braided sheath comprises fibers wrapped around the elongated core and the transition zone of the barbed monofilament insert. (8) The braided barbed suture of claim 7, wherein the barbs protrude outward beyond the outer periphery of the braided sheath. 9. The braided barbed suture of claim 1, wherein the barbed monofilament insert comprises a PDS monofilament core. (10) The braided barbed suture of claim 1, wherein the braided sheath comprises a VICRYL multifilament yarn braided sheath.

[0170] 11. The braided barbed suture of claim 1, wherein the braided barbed suture has a single break point for both the braided sheath and the barbed monofilament insert. (12) The braided barbed suture of embodiment 1, wherein the elongate core has a convexly curved upper surface and a convexly curved bottom surface, and the thickness of the elongate core extends from the convexly curved upper surface to the convexly curved bottom surface of the elongate core. (13) The braided barbed suture of embodiment 1, wherein the elongated core has a substantially flat top surface and a substantially flat bottom surface, and a diameter of the elongated core extends from the substantially flat top surface to the substantially flat bottom surface of the elongated core. (14) The braided barbed suture of claim 1, wherein the plurality of barbs define barb pairs defining a barb tip-to-tip distance (BTTD), the composite core has a composite core diameter (CCD), and a ratio of the barb tip-to-tip distance (BTTD) to the composite core diameter (CCD) is about 1.92 to 4.5. (15) The braided barbed suture of claim 14, wherein the ratio of the barb tip to tip distance (BTTD) to the composite core diameter (CCD) is about 2.5 to 3.8.

[0171] (16) A braided barbed suture, comprising: a barbed monofilament insert including an elongated core having an elongated core thickness and a plurality of barbs projecting outwardly from opposite outer sides of the elongated core, the plurality of barbs lying in a first plane and the elongated core thickness of the elongated core being measured along an axis lying in a second plane that is perpendicular to the first plane; and a braided sheath surrounding the elongated core to form a composite core of the braided barbed suture, the elongated core being centered on the composite core and the braided sheath enveloping the elongated core, the composite core having a composite core thickness measured along the axis that lies in the second plane that is perpendicular to the first plane, the ratio of the elongated core thickness to the composite core thickness being between about 0.16 and 0.91. (17) The braided barbed suture of claim 16, wherein the elongate core thickness is about 0.15-0.2 mm (about 6-8 mils) and the composite core thickness is about 0.33-0.46 mm (about 13-18 mils). (18) The braided barbed suture of claim 16, wherein the ratio of the elongated core thickness to the composite core thickness is about 0.24 to 0.73. (19) The braided barbed suture of claim 16, wherein the barbs have inner ends having respective thicknesses greater than the elongated core thickness. (20) a first transition zone located between a first outer portion of the elongated core and an inner end of a first spine, the first transition zone widening from the first outer portion of the elongated core to the inner end of the first spine; 20. The braided barbed suture of claim 19, further comprising a second transition zone located between the second outer portion of the elongate core and the inner end of the second barb, the second transition zone widening from the second outer portion of the elongate core to the inner end of the second barb.

[0172] (21) The braided barbed suture of embodiment 20, wherein the elongated core and the first and second transition zones define a first concave profile on a top side of the braided barbed suture and a second concave profile on a bottom side of the braided barbed suture. (22) The braided barbed suture of claim 16, wherein the braided barbed suture has a single break point for both the braided sheath and the barbed monofilament insert. (23) The braided barbed suture of embodiment 16, wherein the barbed monofilament insert comprises a PDS monofilament core and the braided sheath comprises a VICRYL multifilament yarn braided sheath. (24) A method for manufacturing a stent, comprising: a) providing a stent having an end effector coupled to an elongated core, the elongated core extending through the end effector; 17. The braided barbed suture of claim 16, wherein the end effector includes a first wing extending laterally from a first outer portion of the elongated core and a second wing extending laterally from a second outer portion of the elongated core, the first wing and the second wing being thicker than the elongated core. (25) A braided barbed suture, comprising: a barbed monofilament insert comprising an elongated core having an elongated core thickness and a plurality of barbs projecting outwardly from opposite sides of the elongated core, the barbs having inner ends that are thicker than the elongated core thickness of the elongated core; a barbed monofilament insert, the barbed monofilament insert including at least one transition zone located between the elongated core and the inner ends of the barbs to form a concave profile; and a braided sheath surrounding the elongated core to form a composite core of the braided barbed suture, the elongated core being centered on the composite core and the braided sheath surrounding the elongated core, the composite core having a thickness greater than the elongated core thickness, the ratio of the elongated core thickness to the composite core thickness being between about 0.16 and 0.91.

[0173] (26) The braided barbed suture of embodiment 25, wherein the plurality of barbs lie in a first plane and the elongated core thickness and the composite core thickness are measured along an axis that lies in a second plane that is perpendicular to the first plane of the plurality of barbs. (27) The braided barbed suture of claim 25, wherein the ratio of the elongated core thickness to the composite core thickness is about 0.24 to 0.73. (28) The braided barbed suture of claim 25, wherein the braided barbed suture has a single break point for both the braided sheath and the barbed monofilament insert.

Claims

1. 1. A braided barbed suture comprising: a barbed monofilament insert including an elongated core having an elongated core thickness and a plurality of barbs projecting outwardly from opposite sides of the elongated core; a braided sheath surrounding the elongated core to form a composite core of the braided barbed suture having a composite core thickness, the ratio of the elongated core thickness to the composite core thickness being between 0.16 and 0.91; the plurality of barbs project outwardly from the elongated core in a first plane, the elongated core thickness and the composite core thickness being measured along an axis that lies in a second plane that is perpendicular to the first plane; The barbed monofilament insert comprises: a first barb projecting outwardly from the elongated core, the first barb including an inner end having a first thickness greater than the elongated core thickness and an outer end having a second thickness less than the first thickness at the inner end of the first barb; a transition zone extending between the elongate core and the inner end of the first barb for connecting the inner end of the first barb to the elongate core.

2. The braided barbed suture of claim 1, wherein the ratio of the elongated core thickness to the composite core thickness is between 0.24 and 0.

73.

3. The braided barbed suture of claim 1 , wherein the braided sheath encases the elongated core, the elongated core being centrally located within the composite core.

4. 2. The braided barbed suture of claim 1, wherein the transition zone is thinner near the elongated core and thicker near the inner end of the first barb, the transition zone widening from the elongated core to the inner end of the first barb.

5. The braided barbed suture of claim 4 , wherein the braided sheath comprises fibers wrapped around the elongated core and the transition zone of the barbed monofilament insert.

6. The braided barbed suture of claim 5 , wherein the barbs project outwardly beyond an outer periphery of the braided sheath.

7. 2. The braided barbed suture of claim 1, wherein the elongated core has a convexly curved top surface and a convexly curved bottom surface, the elongated core thickness extending from the convexly curved top surface to the convexly curved bottom surface of the elongated core.

8. 2. The braided barbed suture of claim 1, wherein the elongated core has a substantially planar top surface and a substantially planar bottom surface, the elongated core thickness extending from the substantially planar top surface to the substantially planar bottom surface of the elongated core.

9. 2. The braided barbed suture of claim 1, wherein the plurality of barbs define barb pairs defining a barb tip-to-tip distance (BTTD), the composite core having a composite core diameter (CCD), and a ratio of the barb tip-to-tip distance (BTTD) to the composite core diameter (CCD) is between 1.92 and 4.

5.

10. 10. The braided barbed suture of claim 9, wherein the ratio of the barb tip to barb distance (BTTD) to the composite core diameter (CCD) is between 2.5 and 3.

8.

11. 1. A braided barbed suture comprising: a barbed monofilament insert including an elongated core having an elongated core thickness and a plurality of barbs projecting outwardly from opposite outer sides of the elongated core, the plurality of barbs lying in a first plane and the elongated core thickness of the elongated core being measured along an axis lying in a second plane that is perpendicular to the first plane; a braided sheath surrounding the elongated core to form a composite core of the braided barbed suture, the elongated core being centered on the composite core and the braided sheath encasing the elongated core; the composite core has a composite core thickness measured along the axis in the second plane perpendicular to the first plane, and a ratio of the elongated core thickness to the composite core thickness is between 0.16 and 0.91; A braided barbed suture, wherein each of the plurality of barbs has an inner end having a thickness greater than the elongated core thickness.

12. 12. The braided barbed suture of claim 11, wherein the elongated core thickness is 0.15-0.2 mm (6-8 mils) and the composite core thickness is 0.33-0.46 mm (13-18 mils).

13. 12. The braided barbed suture of claim 11, wherein the ratio of the elongated core thickness to the composite core thickness is between 0.24 and 0.

73.

14. a first transition zone located between a first outer side of the elongated core and an inner end of a first barb, the first transition zone widening from the first outer side of the elongated core to the inner end of the first barb; 12. The braided barbed suture of claim 11, further comprising a second transition zone located between the second outer side of the elongate core and the inner end of the second barb, the second transition zone widening from the second outer side of the elongate core to the inner end of the second barb.

15. 15. The braided barbed suture of claim 14, wherein the elongated core and the first and second transition zones define a first concave profile on a top side of the braided barbed suture and a second concave profile on a bottom side of the braided barbed suture.

16. The method of claim 1, further comprising: an end effector coupled to the elongated core, the elongated core extending through the end effector; 12. The braided barbed suture of claim 11, wherein the end effector includes a first wing extending laterally from a first outer side of the elongated core and a second wing extending laterally from a second outer side of the elongated core, the first wing and the second wing being thicker than the elongated core.

17. 1. A braided barbed suture comprising: A barbed monofilament insert comprising an elongated core having an elongated core thickness and a plurality of barbs projecting outwardly from opposite sides of the elongated core, the barbs having inner ends that are thicker than the elongated core thickness of the elongated core; a barbed monofilament insert including at least one transition zone located between the elongated core and the inner ends of the barbs to form a concave profile; a braided sheath surrounding the elongated core to form a composite core of the braided barbed suture, the elongated core being centered on the composite core and the braided sheath surrounding the elongated core; A braided barbed suture, wherein the composite core has a composite core thickness greater than the elongated core thickness, the ratio of the elongated core thickness to the composite core thickness being between 0.16 and 0.

91.

18. 18. The braided barbed suture of claim 17, wherein the plurality of barbs lies in a first plane and the elongated core thickness and the composite core thickness are measured along an axis that lies in a second plane that is perpendicular to the first plane of the plurality of barbs.

19. 18. The braided barbed suture of claim 17, wherein the ratio of the elongated core thickness to the composite core thickness is between 0.24 and 0.73.

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