Braided barbed suture with barbed monofilament insert having concave core profile

Abstract

A braided barbed suture includes a barbed monofilament insert including an elongated core having a thickness and a plurality of barbs protruding outward from opposite 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 located in the center of the composite core. The elongated core thickness is about 6 mils to 8 mils and the composite core thickness is about 13 mils to 18 mils. The ratio of the elongated core thickness relative to the composite core thickness is between about 0.16 to 0.91. The elongated core has a transition zone forming a concave profile. The braided barbed suture has a single breaking 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 yarn braided sheath.

Description

[0001] Cross-reference to related applications

[0002] This patent application claims the benefit of U.S. Provisional Application Serial No. 63 / 039,656, filed June 16, 2020, the disclosure of which is incorporated herein by reference. This patent application relates to a co-assigned U.S. Patent Application Serial No. 17 / 336,680, filed on the same day (Attorney’s File No. ETH6071USNP1), which claims the benefit of U.S. Provisional Application Serial No. 63 / 039,649, filed June 16, 2020, the disclosure of which is incorporated herein by reference. Technical Field

[0003] This patent application generally relates to medical devices, and more specifically to surgical sutures for closing wounds.

[0004] Description of Related Art

[0005] Surgical sutures are used to close wounds and surgical incisions, and to repair damaged muscles, blood vessels, and tissues. Typically, a needle is attached to one end of the surgical suture and pulled through the tissue to form one or more loops that hold the tissue together. For conventional sutures, the suture is then knotted with one or more knots, allowing the tissue to remain pulled together.

[0006] Numerous attempts have been made to improve sutures. For example, U.S. Patent No. 4,546,769 to Planck et al. discloses a suture comprising a sheath made of a tubular braided structure, such as non-crimped yarn, and a core containing crimped fibers located within the sheath. The sheath is formed by braiding non-crimped yarn around the core, which provides a suture that is easier to bend and handle and forms better knots.

[0007] While sutures are highly effective at closing wounds, there are many challenges associated with using conventional sutures. Most of these challenges are directly related to the knots used to secure the sutures in place. If the knot is not tied properly, defects can occur, including slippage, knot breakage, and wound reopening. Furthermore, using knots to secure sutures can distort tissue, restrict blood flow, increase scarring, hinder wound healing, and lead to infection.

[0008] In response to the aforementioned drawbacks associated with conventional sutures, barbed sutures have been developed. Unlike conventional sutures, barbed sutures have prominent barbs, which allows them to be used to close wounds, close to tissues, tighten tissues, and attach prosthetic organs without the use of knots.

[0009] For example, U.S. Patent No. 8,216,497, assigned to Ethicon, Inc., teaches a method of manufacturing a barbed suture, the disclosure of which is incorporated by reference herein. See Figure 1 and Figure 2 In one embodiment, a preformed polymer material tape having a cross-sectional profile is punched 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 opposite lateral sides of the core 52. The core 52 provides strength and flexibility to the barbed suture 50.

[0010] One problem associated with barbed sutures is that the barbs can become detached or separated from the core, which results in device failure. In response, braided barbed sutures having 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 by reference herein, teaches a braided barbed suture that provides a 96% improvement in maintaining strength compared to non-braided barbed sutures.

[0011] Traditionally, braided barbed sutures are made by hand-feeding barb inserts into a braided filament assembly. The operator must follow a series of complex steps, including running the braiding machine to form a first length of non-barbed suture, shutting down the braiding machine, positioning one end of the barb insert at the braiding machine eyelet where the filaments converge at the point of braiding, then opening the braiding machine and allowing the filaments to pull the barb insert into the braid.

[0012] When using the above-described manual feeding method, an uneven braided sheath is typically formed around the elongate core of the barbed suture insert due to the vibrations imparted to the elongate core of the barbed suture insert from the braiding apparatus. The vibrations generated by the braiding equipment can cause the barbed suture insert to shake, twist, get caught on the filaments, or accumulate unwanted rotation as it is pulled into the braiding machine eyelet.

[0013] To overcome the above-mentioned problems caused by vibrations and to improve the quality of braided tape barbed suture, there have been some attempts involving improving the control of the orientation of the tape barbed suture insert during the braiding process. 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 manufacturing a braided tape barbed suture that includes a braiding filament assembly and a guide assembly (e.g., a delivery cartridge) having a tape barbed suture insert dispenser opening that defines a passageway for orienting a tape barbed suture insert. Referring to Figure 3 The automated system is adapted to dispense a tape barbed suture insert 60 having barbs 62 from the dispenser opening of the guide assembly and into a braiding filament assembly for braiding a plurality of filaments 64 around the tape barbed suture insert to manufacture a braided tape barbed suture 66. The passageway of the dispenser opening allows longitudinal movement of the tape barbed suture insert 60 relative to the passageway while preventing twisting movement of the tape barbed suture insert relative to the passageway. The passageway includes an elongated slot having a width that is greater than a height for accommodating the barbs 62 of the tape barbed suture insert 60.

[0014] Conventional braided tape barbed sutures include a combination of a tape barbed suture component and a braided sheath component. The tape 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 tape barbed suture such that the barbs project outwardly beyond the braided sheath for engaging tissue. The composite core structure of the elongated core and the braided sheath formed around the elongated core forms a main chain of the braided tape barbed suture.

[0015] In conventional braided tape barbed sutures, the elongated core typically has a convex cross-section having a thickness or diameter that is about equal to or greater than the thickness of the corresponding barbs projecting outwardly from the elongated core. When the filaments are braided over the elongated core, the resulting combination of the elongated core and the braided sheath typically defines an outer diameter that is greater than the thickness of the corresponding barbs, which results in the main chain of the braided tape barbed suture becoming rigid and linear, thereby reducing flexibility.

[0016] Currently, braided tape barbed sutures have two distinct tensile strength break points, a first break point for the braided component that is wound around the core and a second break point for the core segment of the tape barbed suture. If only one of the braided or core components breaks, the braided tape barbed suture can appear intact to the observer despite the fact that the overall tensile strength of the device has been compromised.

[0017] In view of the above-mentioned deficiencies, there remains a need for improved braided tape barbed sutures that maintain flexibility.

[0018] There is also a need for improved braided tape barbed suture having a core with a reduced outer dimension (e.g., reduced width, reduced height, reduced cross-sectional area) to allow a greater proportion of the composite core to be comprised of the braided jacket (i.e., a high braided jacket to core ratio), thereby enabling a suture construction with the benefits of braided suture (e.g., handling, flexibility, compatibility with surgical instruments) while being non-rigid and maintaining flexibility.

[0019] There is also a need for improved braided tape barbed suture in which the primary source of tensile strength and handling properties of the suture is provided by the braided jacket portion rather than the core, whereby the core serves primarily as an anchoring point for the barbs but does not provide sufficient strength for the braided tape barbed suture.

[0020] Furthermore, there remains a need for improved braided tape barbed suture having a single breaking point for both the elongate core segment and the braided segment of the device.

[0021] Furthermore, there remains a need for improved braided tape barbed suture that can be used to close wounds in a robotic surgical environment in which robotic graspers, limited haptic feedback, and limited visualization all contribute to a dampening associated with premature breakage of the tape barbed suture.

[0022] There is also a need for improved braided tape barbed suture having good flexibility and a single breaking point for use in the limited space present in a minimally invasive surgery (MIS) environment. SUMMARY

[0023] In one embodiment, the braided tape barbed suture preferably includes two components joined together, namely, a tape barbed monofilament insert and a braided jacket. In one embodiment, the tape barbed monofilament insert can include an elongate core (e.g., monofilament), a plurality of barbs projecting outwardly from the elongate core, and an end effector (e.g., knot substitute feature) secured to a proximal end of the elongate core. The end effector can be a tab, stop, or collar. In one embodiment, the braided jacket can be wrapped around the elongate core of the tape barbed monofilament insert using an automated braiding machine, such as disclosed 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.

[0024] In one embodiment, the elongated core of the barbed monofilament insert preferably has a reduced thickness, reduced diameter, and / or reduced outer dimension relative to the thickness of the corresponding barb protruding outwardly from the elongated core. The thickness of the elongated core is advantageously less than the thickness found in conventional barbed monofilament inserts. The relatively smaller thickness of the elongated core advantageously minimizes the cross-sectional size of the elongated core within the braided woven composite that retains the flexibility of the braided barbed suture after being encased by the braided sheath while the tensile strength of the braided barbed suture is primarily provided by the braided sheath.

[0025] In one embodiment, the braided sheath encases the elongated core and preferably extends along a majority of the length 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. Controlling the ratio of the thickness, diameter, and / or outer dimension of the elongated core relative to the thickness, diameter, and / or outer dimension of the braided sheath preferably provides the composite core of the braided barbed suture with greater tensile strength and improved flexibility and handling characteristics than can be achieved when using a barbed suture insert having an elongated core with a normal thickness.

[0026] In one embodiment, when the main chain of the braided barbed suture (i.e., the braided woven segment) is viewed in cross-section, the ratio of the thickness (e.g., diameter) of the elongated core relative to the thickness (e.g., diameter) of the composite core (i.e., the ratio of the core to the braided sheath) is preferably less than one. Thus, the braided sheath portion of the braided barbed suture preferably comprises a greater cross-sectional area of the main chain of the braided barbed suture than the elongated core, which enhances the tensile strength of the braided barbed suture via the braided sheath and improves flexibility due to being thinner than a normal elongated core.

[0027] In one embodiment, when the braided sheath encases the elongated core to form the composite core of the braided barbed suture, the ratio of the thickness (e.g., diameter) of the elongated core relative to the total thickness (e.g., total diameter) of the composite core is between about 0.16 and 0.85, and more preferably between about 0.4 and 0.5.

[0028] In one embodiment, the reduced thickness of the elongated core enables a greater proportion of the composite core (i.e., the main chain of the braided barbed suture formed by winding the braided sheath around the elongated core) to be composed of the braided sheath component, thereby achieving a braided barbed suture construction that has the benefits of conventional braided sutures such as handling, flexibility, and compatibility with surgical instruments.

[0029] In one embodiment, the elongated core of the barbed monofilament insert primarily serves as an anchor point for the barbs, and the barbed monofilament insert is not the primary component that provides tensile strength to the braided barbed suture. Rather, the primary source of tensile strength and handling properties of the braided barbed suture is advantageously provided by the braided sheath that is wrapped around the elongated core.

[0030] In one embodiment, the braided sheath component preferably increases the overall tensile strength of the braided barbed suture. At the same time, the reduced thickness of the elongated core of the barbed monofilament insert advantageously minimizes the bulk volume of the elongated core in combination with the braided sheath along the main chain (i.e., the spine) of the braided barbed suture, which preserves the pliability properties of the braided sheath and enhances the overall pliability of the braided barbed suture. Thus, the braided barbed suture configuration disclosed herein provides a balance between the two features (i.e., tensile strength and pliability) that surgeons seek. Moreover, the presence of the barbs that protrude outward from the elongated core and through the braided sheath allows the surgeon to suture tissue without having to tie knots and without the need for a surgical assistant to hold tension on the suture.

[0031] In one embodiment, the barbed monofilament insert preferably includes a PDS monofilament core having a thickness or diameter ranging from 5 mils to 20 mils, and more preferably between 6 mils and 8 mils.

[0032] In one embodiment, the braided sheath preferably includes VICRYL multifilament yarn. In one embodiment, after the braided sheath has been wrapped around the elongated 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 mils to 30 mils, and more preferably between about 13 mils and 18 mils.

[0033] In one embodiment, the braided barbed suture disclosed in this patent application provides improved tensile strength and handling characteristics that are highly desirable for suturing tissue in tight, confined spaces, such as in a minimally invasive surgery (MIS) environment. Historically, surgeons have had to make tradeoffs that have forced them to use different suture products with different benefits and characteristics. The braided barbed suture disclosed herein provides the benefits of optimized strength, efficiency, handling, and pliability in a single suture device.

[0034] In one embodiment, the braided barbed suture preferably includes a barbed monofilament insert including an elongated core and a plurality of barbs protruding outward from opposite sides of the elongated core, and a braided sheath surrounding the elongated core. The composite, overbraided sheath has a thickness (e.g., diameter), whereby the ratio of the thickness or diameter of the elongated core relative to the thickness or diameter of the composite core is between about 0.16 to 0.91.

[0035] In one embodiment, the ratio of the thickness or diameter of the elongated core relative to the thickness or diameter of the composite core is between about 0.24 to 0.73.

[0036] In one embodiment, the barbed monofilament insert preferably includes an elongated core having a first thickness and a first barb projecting outwardly from the elongated core, the first barb including an inner end having a second thickness that is greater than the first thickness of the elongated core and an outer end having a third thickness that is 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 so as to connect the inner end of the first barb with the elongated core.

[0037] In one embodiment, the transition zone is thinner adjacent the elongated core and thicker adjacent the inner end of the first barb. In one embodiment, the transition zone widens from the elongated core to the inner end of the first barb.

[0038] In one embodiment, the first transition zone and the second transition zone can be located on opposite sides of the elongated core of the barbed monofilament insert. The first transition zone and the second transition zone and the 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 transition zone and the second transition zone and the bottom surface of the elongated core can define a second concave profile located on a bottom side of the barbed monofilament insert.

[0039] In one embodiment, the woven sheath preferably includes fibers wrapped around both the elongated core and the transition zone of the barbed monofilament insert to form a composite core of the woven barbed suture.

[0040] In one embodiment, the barb projects outwardly beyond an outer perimeter of the woven sheath after the woven sheath is wrapped around the elongated core.

[0041] In one embodiment, the woven barbed suture preferably has a single breaking point for both the woven sheath component and the barbed monofilament insert component.

[0042] In one embodiment, the elongated core has a convexly curved top surface and a convexly curved bottom surface.

[0043] In one embodiment, the elongated core has a substantially flat top surface and a substantially flat bottom surface.

[0044] In one embodiment, the plurality of barbs on the braided band 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 the ratio of the barb tip to tip distance (BTTD) to the composite core diameter (CCD) is between about 1.92 to 4.5.

[0045] In one embodiment, the ratio of the barb tip to tip distance (BTTD) to the composite core diameter (CCD) is between about 2.5 to 3.8.

[0046] In one embodiment, the braided band barbed suture preferably includes a band barbed monofilament insert including an elongated core having a thickness or diameter and a plurality of barbs projecting outwardly from opposite sides of the elongated core, and a braided sheath surrounding the elongated core. The combination of the elongated core and the braided sheath preferably forms a composite core of the braided band barbed suture, whereby the elongated core is located at the center of the composite core and the braided sheath surrounds the elongated core. The overall thickness of the composite core, which is the combination of the elongated core and the braided sheath surrounding the elongated core, 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 between about 0.16 to 0.91, and more preferably between about 0.40 to 0.50.

[0047] In one embodiment, the elongated core has a concave profile, and the elongated core is thinner than the inner ends of the barbs projecting outwardly from opposite sides of the elongated core.

[0048] In one embodiment, the braided band barbed suture can include a first transition zone between the first lateral side of the elongated core and the inner end of the first barb, whereby the first transition zone widens from the first lateral side of the elongated core to the inner end of the first barb, and a second transition zone between the second lateral side of the elongated core and the inner end of the second barb, whereby the second transition zone widens from the second lateral side of the elongated core to the inner end of the second barb.

[0049] In one embodiment, the braided band barbed suture preferably includes an end effector coupled with the elongated core. In one embodiment, the elongated core advantageously extends through the end effector.

[0050] In one embodiment, the end effector preferably includes a first wing extending laterally from the first lateral side of the elongated core and a second wing extending laterally from the second lateral side of the elongated core. The first wing and the second wing are preferably thicker than the elongated core.

[0051] In one embodiment, the braided barbed suture preferably includes a barbed monofilament insert including an elongated core having a concave profile and a plurality of barbs projecting outwardly from opposite sides of the elongated core, whereby the barbs have inner ends that are thicker than the elongated core. In one embodiment, the barbed monofilament insert preferably includes at least one transition zone 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, whereby the ratio of the thickness or diameter of the elongated core relative to the thickness or diameter of the composite core is between about 0.16 to 0.91, and more preferably between about 0.24 to 0.73.

[0052] In one embodiment, the barbed monofilament insert including the elongated core and the barbs can be formed from a barbed suture blank, such as a polymeric material ribbon. 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 segments located on opposite sides of the elongated core portion. In one embodiment, the first and second lateral wing segments can be punched and / or cut (e.g., using a die) to form the barbs projecting outwardly from the elongated core and an end effector secured to the proximal end of the elongated core. In one embodiment, the elongated core preferably has a thickness that is less than the thickness of the first and second lateral wing segments that are punched in the barbed suture blank to form the barbs and the end effector.

[0053] In one embodiment, the braided barbed suture preferably includes an elongated core having a proximal end, a distal end, and a non-circular cross-section. In one embodiment, the non-circular cross-section of the elongated core preferably has a first thickness located at a center of the elongated core, a first lateral side having a first lateral side thickness, a second lateral side having a second lateral side thickness. A central segment having the first thickness is located between the first and second lateral sides of the core. In one embodiment, the center of the elongated core is thicker than the first and second lateral sides of the elongated core.

[0054] In one embodiment, the elongated core has flat top and bottom surfaces having a constant thickness at a central region and at first and second lateral sides of the elongated core that bound the central region.

[0055] In one embodiment, the banderol monofilament insert for manufacturing a braided banderol suture preferably includes a transition zone between the thinner elongated core and the thicker barb, which allows braiding over the entire core width and height without substantially extending into the barb, thereby providing a more flexible main chain (i.e., the composite of the elongated core and braided sheath) while enhancing tensile strength via the braided sheath surrounding the elongated core. In one embodiment, the transition zone widens and / or thickens between the lateral sides of the elongated core and the inner ends of the barbs to provide a smooth transition surface between the thinner elongated core and the thicker barbs.

[0056] In one embodiment, the transition zone provides a release area between the elongated core and the barbs that accommodates the multifilament braided sheath wrapped around the elongated core, whereby the fibers of the multifilament braided sheath do not encapsulate and / or bury the barbs, which would otherwise limit their functionality.

[0057] In one embodiment, the elongated core having a reduced thickness, diameter, and / or cross-sectional area is preferably braided over with a braided sheath for producing a braided banderol suture that primarily exhibits the mechanical properties of a multifilament suture.

[0058] In one embodiment, the braided banderol suture is configured to control the ratio of multifilament sheath material relative to monofilament core material.

[0059] In one embodiment, manufacturing a braided banderol suture with a predetermined elongated core to braided sheath ratio allows the braided banderol suture device to take full advantage of the uniaxial tensile strength provided by the braided sheath without decreasing the strength of the braided banderol suture due to knotting.

[0060] In one embodiment, manufacturing a braided banderol suture with an appropriate elongated core to braided sheath ratio enables the composite braided banderol suture device to closely replicate the bending stiffness of a traditional multifilament suture to provide handling characteristics that offer benefits in minimally invasive surgical environments (e.g., robotic surgery) where space and visibility are limited.

[0061] In one embodiment, the braided banderol suture preferably includes a composite structure that includes a banderol monofilament insert having an elongated core with a first tensile strength and a braided sheath that encases the elongated core having a second tensile strength. In one embodiment, the combined tensile strength is equal to or greater than the first tensile strength of the elongated core and the second tensile strength of the braided sheath.

[0062] In one embodiment, the braided barbed suture preferably includes both a braided sheath component and a barbed monofilament insert component having an elongate core, whereby both components individually have a combined breaking strength value greater than either of the components, and wherein the tensile break point of each of the components in the composite braided barbed suture and composite structure is substantially the same. Providing a braided barbed suture with both a braided sheath component and an elongate core of a barbed monofilament insert component having a single breaking point preferably minimizes the ability to feel two separate break points when the suture device is under tension.

[0063] Multifilament sutures provide high strength, good damage resistance, and desirable handling characteristics, but multifilament sutures are not themselves suitable for processing into monofilament or having barbed suture features due to the nature of the polymer materials typically used. Monofilament sutures can be manufactured to have barbs, however, monofilament sutures are susceptible to damage without proper handling with surgical instruments.

[0064] The braided barbed sutures disclosed herein provide a suture construction that has the benefits of a braided multifilament suture balanced with the strength of a monofilament suture (e.g., handling, flexibility, damage resistance, compatibility with surgical instruments), while avoiding the ability to feel two separate tensile break points. The composite braided barbed suture preferably has a braided sheath and elongate core that break substantially simultaneously, which minimizes the ability to feel two separate tensile break points.

[0065] In one embodiment, the elongate core component of the braided barbed suture primarily functions as an anchor point for the barbs. In one embodiment, the braided sheath component of the braided barbed suture, rather than the elongate core component, functions as the primary source of tensile strength and handling properties of the braided barbed suture.

[0066] When comparing monofilament sutures to multifilament sutures, multifilament sutures tend to have greater vertical tensile strength due to the braided construction present in multifilament sutures, which enables load distribution and uniaxial elongation of the device. However, in clinical applications, the tensile strength of traditional multifilament and monofilament sutures inherently decreases to the strength of a knot that can be tied. In contrast, barbed sutures eliminate the need for knot tying and thus can utilize vertical tensile strength as the relevant wound retention value. BRIEF DESCRIPTION OF DRAWINGS

[0067] Figure 1 is a cross-sectional view of a prior art barbed suture insert having an elongate core and barbs projecting outwardly from opposite lateral sides of the elongate core.

[0068] Figure 2 is Figure 1is a top view of a prior art barbed suture insert 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 an opposite direction toward a second end of the elongated core.

[0069] Figure 3 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.

[0070] Figure 4A is a perspective view of a barbed suture blank for manufacturing a barbed monofilament insert according to an embodiment of the present patent application.

[0071] Figure 4B is Figure 4A is a top view of a barbed suture blank.

[0072] Figure 4C is Figure 4A and Figure 4B is a side view of a barbed suture blank.

[0073] Figure 4D is Figures 4A-4C is a perspective view of a proximal end of a barbed suture blank.

[0074] Figure 4E is Figure 4B is a cross-sectional view of a barbed suture blank.

[0075] Figure 5A is a barbed monofilament insert formed from a barbed suture blank according to an embodiment of the present patent application. Figures 4A-4E is a perspective view of a barbed monofilament insert including an elongated core, a plurality of barbs, and an end effector formed from a barbed suture blank according to an embodiment of the present patent application.

[0076] Figure 5B is Figure 5A is a top view of a barbed monofilament insert.

[0077] Figure 5C is Figure 5A and Figure 5B is a magnified view of a middle portion of a barbed monofilament insert.

[0078] Figure 5C-1 is Figure 5C is a perspective view of a middle portion of a barbed monofilament insert.

[0079] Figure 5D is Figure 5A and Figure 5BEnlarged view of the proximal end of the barbed monofilament insert shown.

[0080] Figure 5D-1 is Figure 5A 、 Figure 5B and Figure 5D is a perspective view of the proximal end of the barbed monofilament insert shown.

[0081] Figure 5E is Figure 5C is a cross-sectional view of the barbed monofilament insert shown.

[0082] Figure 5F is Figure 5D is a cross-sectional view of the barbed monofilament insert shown.

[0083] Figure 6A is a top view of a braided barbed suture according to one embodiment of the present patent application, the braided barbed suture comprising Figures 5A-5F a barbed monofilament insert of and a braided sheath wrapped around the elongated core of the barbed monofilament insert.

[0084] Figure 6B is Figure 6A is a cross-sectional view of the braided barbed suture shown.

[0085] Figure 7A is a perspective view of a barbed suture blank for making a barbed monofilament insert according to one embodiment of the present patent application.

[0086] Figure 7B is Figure 7A is a top plan view of the barbed suture blank shown.

[0087] Figure 7C is Figure 7A and Figure 7B is a side view of the barbed suture blank shown.

[0088] Figure 7D is Figures 7A-7C is a perspective view of the proximal end of the barbed suture blank shown.

[0089] Figure 7E is Figure 7B is a cross-sectional view of the barbed suture blank shown.

[0090] Figure 8A is a perspective view of a barbed monofilament insert made from Figures 7A-7E the barbed suture blank shown.

[0091] Figure 8B is Figure 8A is a top view of the barbed monofilament insert shown.

[0092] Figure 8C is Figure 8A and Figure 8B is a close-up view of the middle portion of the barbed monofilament insert.

[0093] Figure 8C-1 is Figure 8C is a perspective view of the middle portion of the barbed monofilament insert.

[0094] Figure 8D is Figure 8A and Figure 8B is a top view of the proximal end of the barbed monofilament insert.

[0095] Figure 8D-1 is Figure 8D is a perspective view of the proximal end of the barbed monofilament insert.

[0096] Figure 8E is Figure 8C is a cross-sectional view of the barbed monofilament insert.

[0097] Figure 8F is Figure 8D is a cross-sectional view of the barbed monofilament insert.

[0098] Figure 9 is a graph plotting tensile strength properties of braided barbed suture having different configurations.

[0099] Figure 10 is a graph plotting bending stiffness properties of braided barbed suture having different configurations.

[0100] Figure 11 is a graph of model equations predicting tensile strength of braided barbed suture and non-barbed braided suture.

[0101] Figure 12 is a graph of test results showing no difference in tensile strength between braided barbed suture and non-barbed braided suture having similar configurations.

[0102] Figure 13 is a cross-sectional view of a braided barbed suture according to one embodiment of the present patent application.

[0103] Figure 14A is a top view of a barbed monofilament insert for manufacturing a braided barbed suture according to one embodiment of the present patent application.

[0104] Figure 14Bis a schematic diagram of the composite core diameter of a braided sheath formed over barbed monofilament inserts having different suture sizes according to an embodiment of the present patent application.

[0105] Figure 15A is a top view of a barbed monofilament insert for manufacturing a braided barbed suture according to an embodiment of the present patent application.

[0106] Figure 15B is a schematic diagram of the composite core diameter of a braided sheath formed over barbed monofilament inserts having different suture sizes according to an embodiment of the present patent application.

[0107] Figure 16A is a top view of a barbed monofilament insert for manufacturing a braided barbed suture according to an embodiment of the present patent application.

[0108] Figure 16B is a schematic diagram of the composite core diameter of a braided sheath formed over barbed monofilament inserts having different suture sizes according to an embodiment of the present patent application.

[0109] Figure 17 is a chart showing the ratios related to the barbed tip-to-tip distance (BTTD) and the composite core diameter (CCD) of barbed monofilament inserts having different suture sizes according to an embodiment of the present patent application.

[0110] Figure 18 is a schematic diagram of an automated braiding system for manufacturing a braided barbed suture according to an embodiment of the present patent application.

[0111] Figure 19 is a top view of a braided barbed suture having a braided sheath with weft yarns according to an embodiment of the present patent application.

[0112] Figure 20 is a perspective view of a system for counting weft yarns on a braided sheath of a braided barbed suture according to an embodiment of the present patent application.

[0113] Figure 21 shows a first stage of a method for counting weft yarns on a braided sheath of a braided barbed suture according to an embodiment of the present patent application.

[0114] Figure 22 shows a second stage of a method for counting weft yarns on a braided sheath of a braided barbed suture according to an embodiment of the present patent application.

[0115] Figure 23A third stage of a method of counting the weft yarns on a braided sheath of a braided barbed suture according to one embodiment of the present patent application is shown.

[0116] Figure 24 A fourth stage of a method of counting the weft yarns on a braided sheath of a braided barbed suture according to one embodiment of the present patent application is shown.

[0117] Figure 25 is a chart showing optimized overbraid parameters to be used with an automated braiding system of Figure 18 that control the number of weft yarns in a braided sheath of a braided barbed suture according to one embodiment of the present patent application.

[0118] Figure 26 is a perspective view of a barbed monofilament insert with an end effector according to one embodiment of the present patent application.

[0119] Figure 27 is a perspective view of a barbed monofilament insert with an end effector according to one embodiment of the present patent application.

[0120] Figure 28 is a perspective view of a barbed monofilament insert with an end effector according to one embodiment of the present patent application. DETAILED DESCRIPTION

[0121] Definitions .

[0122] 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 can also be referred to as a leading end, which is the end of the elongated core that is attached to the needle. The barbed monofilament insert has a plurality of barbs that project outwardly from opposite sides of the elongated core to define a barbed section of the barbed monofilament insert. An end effector is fixed to the proximal end of the elongated core, and a connector section of the elongated core is located between the end effector and the barbed section.

[0123] Composite core A section of a braided barbed suture that includes an elongated core of a barbed monofilament insert and a braided sheath that surrounds the elongated core, the elongated core having barbs that project outwardly from opposite lateral sides of the elongated core. The composite core is the combination of the elongated core and the braided sheath that surrounds the elongated core. The composite core has a thickness that is greater than the thickness of the elongated core.

[0124] DenierDenier (D) is a unit of measure for the linear mass density of a fiber. It is the mass in grams of 9000 meters of the fiber. The denier unit of measure is based on a natural benchmark, that is, a single silk thread is about one denier, or a 9000 meter length of the silk thread weighs about one gram. The denier unit is calculated as follows, 1 denier = 1 g / 9,000 m = 0.11 mg / m.

[0125] Lateral width Distance between a first line parallel to the central axis of the elongated core adjacent to the nearest outer lateral edge of the barb extending from the first side of the elongated core and a second line parallel to the central axis of the elongated core adjacent to the nearest outer lateral edge of the barb extending from the second side of the elongated core.

[0126] Leading end Barb-free zone of the elongated core of the barbed monofilament insert. The leading end forms the distal end or needle attachment end of the barbed monofilament insert of the elongated core. The filaments can be wrapped around the leading end of the elongated core to form a segment of the composite core.

[0127] Length core thickness Barbs of the barbed monofilament insert project outward from opposite sides of the elongated core. The barbs lie in a first plane. The thickness measurement of the elongated core is taken along an axis lying in a second plane perpendicular to the first plane defined by the barbs. In one embodiment, the elongated core thickness is the average of three separate thickness measurements taken at the leading end of the barbed monofilament insert. A gauge can be used to record the thickness measurement of the elongated core. The elongated core thickness can also be referred to as the elongated core diameter.

[0128] Composite core diameter Composite core diameter is a measure of the outer diameter of the braided sheath that encases the barbed monofilament insert of the elongated core. The composite core diameter is measured in a plane perpendicular to the longitudinal axis of the elongated core.

[0129] Composite core thickness Thickness measurement of the composite core is taken along an axis lying in a second plane perpendicular to the first plane defined by the barbs. In one embodiment, the composite core thickness is the average of three separate thickness measurements taken at the leading end of the braided barbed suture. A gauge can be used to record the thickness measurement of the composite core. The composite core thickness can also be referred to as the composite core diameter.

[0130] Thickness ratio Thickness ratio of the braided barbed suture is the ratio of the elongated core thickness to the composite core thickness.

[0131] Reference Figures 4A-4CIn one embodiment, a barbed suture blank 100, such as a polymeric material strip, can be used to form a barbed monofilament insert having an elongate core and a plurality of barbs projecting laterally from opposite sides of the elongate core. In one embodiment, the barbed suture blank 100 preferably includes a proximal end 102, a distal end 104, and a longitudinal axis Al extending along the length of the barbed suture blank and between its proximal end 102 and distal end 104.

[0132] In one embodiment, the barbed suture blank 100 preferably includes an elongate core 106 extending along the longitudinal axis Al, a first lateral segment 108 extending along a first lateral side of the elongate core 106, and a second lateral segment 110 extending along a second lateral side of the elongate core 106. The first and second lateral segments 108, 110 can be punched out or cut during the formation of the barbs and / or end effector.

[0133] Referring to Figure 4D and Figure 4E In one embodiment, the barbed suture blank 100 preferably has a pre-shaped cross-sectional shape that advantageously includes the elongate core 106 and the first and second lateral segments 108, 110 located on opposite sides of the elongate core 106. In one embodiment, the elongate core 106 is preferably located at the center of the barbed suture blank 100 and extends along the longitudinal axis Al of the barbed suture blank 100. Referring to Figure 4E In one embodiment, the elongate core 106 has a first thickness Tl that is less than a second thickness T2 of the respective first and second lateral segments 108, 110 of the barbed suture blank 100.

[0134] In one embodiment, the barbed suture blank 100 can be placed in a mold or punch for forming a barbed monofilament insert including an elongate core, a plurality of barbs projecting outwardly from the elongate core, and an end effector (e.g., stopper) connected with a proximal end of the elongate core. In one embodiment, the elongate core is integrally connected with the barbs and end effector.

[0135] Referring to Figure 5A and Figure 5B In one embodiment, the barbed suture blank 100 is advantageously punched or cut to form a barbed monofilament insert having an elongate core and a plurality of barbs projecting laterally from opposite sides of the elongate core. Figures 4A-4Eto form a barbed monofilament insert 120 having a proximal end 122 and a distal end 124. In one embodiment, the barbed monofilament insert 120 advantageously includes an elongated core 126 (e.g., a monofilament) extending along a length of the barbed suture. The barbed monofilament insert 120 advantageously includes a plurality of barbs 128 extending outwardly from opposite sides of the elongated core 126 to define a barbed middle portion 130 of the barbed monofilament insert 120. The barbed monofilament insert 120 advantageously includes an end effector 132 (e.g., a stopper) secured to a proximal end of the elongated core 126 and located at the proximal end 122 of the barbed monofilament insert 120. In one embodiment, the elongated core 126 of the barbed monofilament insert 120 advantageously includes a connector segment 134 securing the end effector 132 with the proximal end of the elongated core 126. In one embodiment, the elongated core 126 and the connector segment 134 are integrally formed with one another.

[0136] In one embodiment, the elongated core 126 of the barbed monofilament insert 120 preferably has a cross-sectional shape similar to that of the elongated core 106 of the barbed suture blank 100 shown and described above in Figure 4E In one embodiment, the elongated core 126 preferably has a thickness that is less than or equal to a thickness of the respective barbs 128 protruding outwardly from opposite sides of the elongated core 126.

[0137] Referring to Figure 5C and Figure 5C-1 In one embodiment, the barbed monofilament insert 120 advantageously includes a first barb 128A protruding outwardly from a first lateral side of the elongated core 126 and a second barb 128B protruding outwardly from a second lateral side of the elongated core 126. As will be described in greater detail herein, the elongated core 126 of the barbed monofilament insert 120 has a thickness that is preferably less than or equal to a thickness of the respective first barb 128A and second barb 128B protruding outwardly from opposite lateral sides of the elongated core 126. Providing the barbed monofilament insert 120 having the elongated core 126 with a thickness that is less than or equal to a thickness of the respective barbs 128A, 128B will preferably reduce an overall size of a braided barbed suture consisting of the elongated core and a braided sheath surrounding the elongated core, thereby preserving a flexibility of the braided barbed suture 120 after the braided sheath has been formed around the elongated core 126.

[0138] Referring to Figure 5D and Figure 5D-1In one embodiment, the barbed monofilament insert 120 preferably includes an end actuator 132 (e.g., a stop) that secures the barbed monofilament insert 120 to the proximal end of the elongated core 126 at the proximal end 122. In one embodiment, the barbed monofilament insert 120 preferably includes a connector section 134 of the elongated core 126, which causes the barb's middle portion 130 of the barbed monofilament insert 120 ( Figure 5A The first track of the guide tube is able to pass through, allowing the end effector 132 to pass through the second track of the guide tube, and allowing the connector segment 134 to pass through the slot that interconnects the first and second tracks of the guide tube, as disclosed in co-assigned U.S. Patent Application Serial No. 17 / 336,680, filed on the same day (Attorney’s File No. ETH6071USNP1), which claims the benefit of U.S. Provisional Application Serial No. 63 / 039,649, filed June 16, 2020, the disclosure of which is incorporated herein by reference.

[0139] In one embodiment, the elongated core 126 preferably extends through the barbed portion 130 of the barbed monofilament insert 120 and through the end actuator 132 located at the proximal end 122 of the barbed monofilament insert 120. Figure 5D-1 As shown, the elongated core 126 has a thickness T1 that is smaller than the corresponding thickness T2 of the first transverse wing 136 and the second transverse wing 138 of the end effector 132.

[0140] refer to Figure 5E In one embodiment, the barbed monofilament insert 120 preferably includes a first barb 128A projecting outward from a first lateral side 140 of the elongated core 126 and a second barb 128B projecting outward from a second lateral side 142 of the elongated core 126. In one embodiment, the elongated core 126 is preferably located at the center of 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 main chain that provides flexibility to the barbed monofilament insert during suturing operations.

[0141] In one embodiment, the first barb 128A preferably has an inner end 144A and an outer end 146A, the inner end being connected to a first lateral side 140 of the elongated core 126 via a first transition region 145A, and the outer end defining a free end of the first barb. The first transition region 145A is located between the first lateral side 140 of the elongated core 126 and the inner end 144A of the first barb 128A. In one embodiment, the first transition region 145A is widened or thickened between the first lateral side 140 of the elongated core 126 and the inner end 144A of the first barb 128A.

[0142] The second barb 128B preferably has an inner end 144B connected to the second lateral side 142 of the elongated core 126 via a second transition region 145B and an outer end 146B defining a free end of the second barb. The second transition region 145B is preferably located between the second lateral side 142 of the elongated core 126 and the inner end 144B of the second barb 128B. In one embodiment, the second transition region 145B widens or thickens between the second lateral side 140 of the elongated core 126 and the inner end 144B of the second barb 128B.

[0143] In one embodiment, the elongated core 126 preferably has a convex top surface 148 located on a top side of the barbed monofilament insert 120 and a convex bottom surface 150 located on a bottom side of the barbed suture. In one embodiment, a central region 152 of the elongated core 126 defines a thickness T3 that is greater than a thickness T4 at the respective first and second lateral sides 140, 142 of the elongated core 126.

[0144] In one embodiment, the top surface 148 of the elongated core, and the first and second transition regions 145A, 145B preferably define a first concave profile located on a top side of the barbed monofilament insert 120, and the bottom surface 150 of the elongated core 126, and the first and second transition regions 145A, 145B preferably define a second concave profile located on a bottom side of the barbed monofilament insert.

[0145] In one embodiment, the first barb 128A has an inner end 144A defining a thickness T5 and an outer free end 146A defining a thickness T6 that is less than the thickness T5 of the inner end. Thus, 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 the respective first and second lateral sides 140, 142 of the elongated core 126 is less than the thickness T5 at the inner end 144A of the first barb 128A and is less than or equal to the thickness T6 at the outer end 146A of the first barb 128A. The first transition region 145A widens and / or thickens between the thinner first lateral side 140 of the elongated core 126 and the inner end 144A of the first barb 128A.

[0146] 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 lateral side 140 and the second lateral side 142 of the elongated core 126 are less than the thickness T7 at the inner end 144B of the second barb 128B and less than or equal to the thickness T8 at the outer end 146B of the second barb 128B. The second transition region 145B widens and / or thickens between the second lateral side 142 of the elongated core 126 and the inner end 144B of the second barb 128B.

[0147] Referring to Figure 5F In one embodiment, the end effector 132 of the barbed monofilament insert 120 preferably includes a first lateral wing 136 extending outwardly from the first lateral side 140 of the elongated core 126 and a second lateral wing 138 extending outwardly from the second lateral side 142 of the elongated core 126. The end effector 132 preferably includes a first transition region 145A between the first lateral side 140 of the elongated core 126 and an inner end of the first lateral wing 136 and a second transition region 145B between the second lateral side 142 of the elongated core 126 and an inner end of the second lateral wing 138. The central region 152 of the elongated core 126 has a thickness T1 that is less than a thickness T2 of the respective first and second lateral wings 136, 138 of the end effector 132. In one embodiment, the thickness T1 of the elongated core 126 extending through the end effector 132 (as shown by the arrow Figure 5F ) is equal to the thickness T3 of the elongated core 126 extending through the barbed section 130 of the barbed monofilament insert 120 (as shown by the arrow Figure 5D-1 ).

[0148] Referring to Figure 6A and Figure 6B In one embodiment, the braided barbed suture 160 can be formed by wrapping filaments around the elongated core 126 of the barbed monofilament insert 120 (as shown by the arrow Figure 5E ) to form a braided sheath 162 that encloses the elongated core 126 of the barbed monofilament insert 120. The combination of the barbed monofilament insert 120 and the braided sheath 162 preferably forms a composite core 165 of the braided barbed suture 160. The first and second barbs 128A, 128B of the barbed monofilament insert 120 preferably extend outwardly beyond an outer periphery of the braided sheath 162 for engaging tissue.

[0149] In one embodiment, the braided suture with barb advantageously includes a barbed monofilament insert having an elongated core with a reduced thickness, diameter, and / or smaller cross-sectional area than that found in the prior art elongated core, whereby the amount of material wrapped around the elongated core to form the braided sheath will be less to provide a braided suture with barb having a lower bending stiffness (i.e., greater flexibility). The properties of the material used to manufacture the braided suture with barb (e.g., size of the core, degree of over-braiding, core and braided material) will directly affect the handling and strength properties of the braided suture with barb.

[0150] The reduced thickness of the elongated core results in a greater proportion of the composite core 165 (i.e., the combination of the braided sheath and the elongated core) being comprised of the braided sheath 162, thereby enabling a braided suture with barb construction that has the benefits (e.g., handling, flexibility, compatibility with surgical instruments) of a braided suture.

[0151] In one embodiment, the ratio of the thickness or diameter of the elongated core 126 relative to the thickness or diameter of the composite core 165 including the braided sheath 162 (i.e., the ratio of the core to the braid) is less than one when the composite core 165 of the braided suture with barb 160 is viewed in cross-section. Thus, the braided sheath 162 comprises a greater area of the composite core 165 than the elongated core 126, which enhances the tensile strength of the braided suture with barb 160 via the braided sheath component and increases the overall flexibility of the braided suture with barb 160 due to being thinner than a plain elongated core component.

[0152] In one embodiment, the barbs 128A, 128B of the braided suture with barb 160 extend in a first plane PI, and the thickness and / or diameter measurements of the elongated core 126 and the composite core 165 are taken along an axis that lies in a second plane P2, which is perpendicular to the first plane PI.

[0153] In one embodiment, the thickness measurements can be obtained using a Starrett Gauge ID-39 test instrument, which includes a circular base having a diameter of ½ inch. In one embodiment, the gauge can include a presser foot that is configured to lower gently until it rests on the suture, at which time the thickness measurement is recorded. The suture is then removed and the height measurement is recorded. In one embodiment, after the presser foot is lowered onto the suture, a period of approximately 0.5 seconds is allowed to elapse before the thickness measurement is recorded. In one embodiment, the thickness measurements are taken at the leading end of the barbed monofilament insert and the braided suture with barb. Preferably, the thickness measurements are taken three times in separate locations along the length of the suture strand. For the barbed suture and the braided suture with barb, one measurement is taken on the leading end of the suture material and two measurements are taken on the barbed section.

[0154] In one embodiment, when the braided sheath 162 is wrapped around the elongated core 126 to form the braided tape barbed suture 160, the thickness T EC The ratio of the thickness T CC of the elongated core 126 to the total thickness T

[0155] In one embodiment, due to the use of a thinner elongated core 126 relative to the thickness of the barbs 128A, 128B, the braided tape barbed suture 160 provides a very low bending stiffness nearly equivalent to a multifilament device, while delivering equal or greater tensile strength as compared to a monofilament barbed device having a similar thickness or outer diameter. Moreover, the smaller elongated core 126 results in the composite core 165 having a thickness or outer dimension (e.g., outer diameter) that is smaller than what would be possible with a tape barbed suture insert utilizing a thicker elongated core of the tape of the prior art.

[0156] Referring to Figures 7A-7C In one embodiment, a tape barbed suture blank 200, such as a polymeric material tape, is used to form a tape barbed monofilament insert having an elongated core and a plurality of barbs projecting outwardly from opposite lateral sides of the elongated core. In one embodiment, the tape barbed suture blank 200 preferably includes a proximal end 202, a distal end 204, and a longitudinal axis A2 extending between the proximal end 202 and the distal end 204 along a length of the tape barbed suture blank. In one embodiment, the tape barbed suture blank preferably includes an elongated core 206 extending along the longitudinal axis A2, a first lateral segment 208 extending along a first lateral side of the elongated core 206, and a second lateral segment 210 extending along a second lateral side of the elongated core 206.

[0157] Referring to Figure 7D and Figure 7E In one embodiment, the tape barbed suture blank 200 preferably has a preformed cross-sectional shape including the elongated core 206 and the first and second lateral segments 208, 210 located on opposite sides of the elongated core 206. In one embodiment, the elongated core 206 is preferably located at a center of the tape barbed suture blank 200 and extends along the longitudinal axis A2 of the tape barbed suture blank 200. In one embodiment, the elongated core 206 has a thickness T 10The thickness T9. The barbed suture blank 200 has a first transition region 209 located between a first lateral side of the elongated core 206 and the inner end of the first lateral segment 208, and a second transition region 211 located between a second lateral side of the elongated core 206 and the inner end of the second lateral segment 210. In one embodiment, the first transition region 209 and the second transition region 211 widen between the relatively thin elongated core 206 and the relatively thick inner ends of the first lateral segment 208 and the second lateral segment 210.

[0158] In one embodiment, a barbed suture blank 200 can be placed in a mold or punch to form a barbed monofilament insert, the barbed monofilament insert including an elongated core, a plurality of barbs protruding outward from the elongated core, and an end effector connected to one end of the elongated core.

[0159] refer to Figure 8A and Figure 8B In one embodiment, it is advantageous to stamp or cut the blank 200 with barbed stitching. Figures 7A-7E This is used 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 advantageously includes an elongated core 226 extending along the length of the barbed suture. The barbed monofilament insert 220 advantageously includes a plurality of barbs 228 extending outward from opposite sides of the elongated core 226 to define a barbed intermediate portion 230 of the barbed monofilament insert 220. The barbed monofilament insert 220 advantageously includes an end actuator 232 (e.g., a stop) fixed to the proximal end of the elongated core 226, the end actuator being located at the proximal end 222 of the barbed monofilament insert 220.

[0160] In one embodiment, the barbed monofilament insert 220 preferably includes a connector section 234 of an elongated core 226, the connector section causing the barb of the barbed monofilament insert 220 to be such that the middle portion 230 of the barb ( Figure 8A The end effector 232 is able to pass through the first track of the guide tube, and the connector segment 234 is able to pass through the slot that interconnects the first and second tracks of the guide tube, as disclosed in co-assigned U.S. Patent Application Serial No. 17 / 336,680, filed on the same day (Attorney’s File No. ETH6071USNP1), which claims the benefit of U.S. Provisional Application Serial No. 63 / 039,649, filed June 16, 2020, the disclosure of which is incorporated herein by reference.

[0161] In one embodiment, the elongated core 226 of the barbed monofilament insert 220 preferably has the same characteristics as described above. Figure 7EThe elongated core 206 of the barbed suture blank 200 shown and described in FIG. 2 has a similar cross-sectional shape. The elongated core 226 preferably defines a segment of barbed suture having a thickness that is less than or equal to the thickness of the respective barbs 228 projecting outwardly from opposite lateral sides of the elongated core 226 and the thickness of the first and second wings of the end effector 232.

[0162] Referring to Figure 8C and Figure 8C-1 In one embodiment, the barbed monofilament insert 220 preferably includes an elongated core 226 extending along a length of the barbed monofilament insert 220 from a proximal end 222 to a distal end 224 thereof Figure 8A The barbed monofilament insert 220 advantageously includes a first barb 228A projecting outwardly from a first lateral side of the elongated core 226 and a second barb 228B projecting outwardly from a second lateral side of the elongated core 226 opposite the first lateral side. As will be described in greater detail herein, the elongated core 226 of the barbed monofilament insert 220 has a thickness that is less than or equal to the thickness of the respective first and second barbs 228A, 228B projecting outwardly from opposite lateral sides of the elongated core 226. As previously noted herein, providing a barbed monofilament insert having an elongated core with a reduced thickness will preferably reduce the overall cross-sectional size of the composite core (i.e., the combination of the elongated core and the braided sheath) to maintain the flexibility of the braided barbed suture after the braided sheath has been formed around the elongated core 226.

[0163] Referring to Figure 8D and Figure 8D-1 In one embodiment, the barbed monofilament insert 220 preferably includes an end effector 232 (e.g., a stopper) fixed to a proximal end of the elongated core 226 at the proximal end 222 of the barbed monofilament insert 220. In one embodiment, the barbed monofilament insert 220 preferably includes a connector segment 234 of the elongated core 226 that enables the barbed middle portion 230 of the barbed monofilament insert 220 Figure 8A to pass through a first track of a guide tube, enables the end effector 232 to pass through a second track of the guide tube, and enables the connector segment 234 to pass through a slot interconnecting the first and second tracks as disclosed in commonly-assigned U.S. Patent Application Serial No. 17 / 336,680, filed on the same day (Attorney Docket No. ETH6071USNP1), which claims the benefit of U.S. Provisional Application Serial No. 63 / 039,649, filed on June 16, 2020, the disclosure of which is incorporated by reference herein.

[0164] In one embodiment, the elongated core 226 preferably extends through the barbed portion 230 of the barbed monofilament insert 220 and through the end effector 232 located at the proximal end 222 of the barbed monofilament insert 220. As shown, the elongated core 226 has a thickness T9that is less than the thickness T Figure 8D-1 of the respective first and second lateral wings 236, 238 of the end effector 232. 10 .

[0165] Referring to Figure 8E , in one embodiment, the barbed monofilament insert 220 preferably includes a first barb 228A projecting outwardly from the first lateral side 240 of the elongated core 226 and a second barb 228B projecting outwardly from the second lateral side 242 of the elongated core 226. In one embodiment, the elongated core 226 is preferably located at the center of the barbed monofilament insert 220 and extends along the longitudinal axis A2of the barbed suture. In one embodiment, the elongated core 226 preferably forms a pliable spine or backbone that provides pliability to the barbed monofilament insert 220 during suturing operations.

[0166] In one embodiment, the first barb 228A preferably has an inner end 244A connected with the first lateral side 240 of the elongated core 226 and an outer end 246A defining a free end of the first barb. The barbed monofilament insert 220 advantageously includes a first transition region 245A located between the first lateral side 240 of the elongated core 226 and the inner end 244A of the first barb 228A. The first transition region 245A widens or thickens between the first lateral side 240 of the elongated core 226 and the inner end 244A of the first barb 228A.

[0167] The second barb 228B preferably has an inner end 244B connected with the second lateral side 242 of the elongated core 226 and an outer end 246B defining a free end of the second barb. The barbed monofilament insert 220 advantageously includes a second transition region 245B located between the second lateral side 242 of the elongated core 226 and the inner end 244B of the second barb 228B. The second transition region 245B widens or thickens between the second lateral side 240 of the elongated core 226 and the inner end 244B of the second barb 228B.

[0168] In one embodiment, the elongated core 226 preferably has a substantially flat top surface 248 located at the top side of the barbed monofilament insert 220 and a substantially flat bottom surface 250 located at the bottom side of the barbed suture. In one embodiment, the substantially flat top and bottom surfaces 248, 250 define a thickness T 11 of the elongated core 226.

[0169] 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 that is less than the thickness T 13 of the inner end 244A. In one embodiment, the thickness T 11 of the elongated core 226 is less than the thickness T 12 of the inner end 244A of the first barb 228A. In one embodiment, the thickness T 11 of the elongated core 226 is less than or equal to the thickness T 13 of the outer end 246A of the first barb 228A.

[0170] 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 that is less than the thickness T 15 of the inner end 144B. In one embodiment, the thickness T 11 of the elongated core 226 is less than the thickness T 14 of the inner end 246A of the second barb 228B. In one embodiment, the thickness T 11 of the elongated core 126 is less than or equal to the thickness T 15 of the outer end 246B of the second barb 228B.

[0171] With reference to Figure 8F , in one embodiment, the end effector 232 of the barbed monofilament insert 220 preferably includes a first lateral wing 236 extending outwardly from a first lateral side 240 of the elongated core 226 and a second lateral wing 238 extending outwardly from a second lateral side 242 of the elongated core 226. The end effector 232 preferably includes a first transition region 245A between the first lateral side 240 of the elongated core 226 and an inner end of the first lateral wing 236 and a second transition region 245B between the second lateral side 242 of the elongated core 226 and an inner end of the second lateral wing 238. The elongated core 226 has a thickness T 10 that is less than the thickness T 11 of the respective first and second lateral wings 236, 238 of the end effector 232. In one embodiment, the thickness T 11 of the elongated core 226 extending through the end effector 232 is equal to the thickness T9of the elongated core 226 extending through the barbed section 230 of the barbed monofilament insert 220.Figure 8D-1 ).

[0172] In one embodiment, the braided barbed stitch can be formed by winding filaments around the elongated core 226 of the barbed monofilament insert 220 to form a braided sheath that surrounds and / or wraps the elongated core 226 of the barbed monofilament insert 220.

[0173] refer to Figure 9 When constructing braided barbed sutures, the tensile strength of the braided barbed sutures can be controlled by selecting the type and size of the material used to manufacture them. Figure 9 The graph shows that the tensile strength of the braided barbed suture depends on the combination of materials used to manufacture it.

[0174] Example 1 In one embodiment, the elongated core with barbed monofilament inserts has a thickness of 6.39 mils. The filaments are wound around the elongated core to form a braided sheath. The combination of the elongated core and the braided sheath surrounding the elongated core forms a composite core with 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).

[0175] Example 2 In one embodiment, the elongated core with barbed monofilament inserts has a thickness of 20.18 mils. The filaments are wound around the elongated core to form a braided sheath. The combination of the elongated core and the braided sheath surrounding the elongated core forms a composite core with 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).

[0176] Example 3 In one embodiment, the elongated core with barbed monofilament inserts has a thickness of 6.34 mils. The filaments are wound around the elongated core to form a braided sheath. The combination of the elongated core and the braided sheath surrounding the elongated core forms a composite core with 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).

[0177] refer to Figure 10 The bending stiffness of the braided barbed stitch can be controlled by selecting the type and size of the material used to manufacture the braided barbed stitch. Figure 10 The graph shows that the bending stiffness of the braided tape barbed stitch depends on the combination of materials used to manufacture the braided tape barbed stitch.

[0178] like Figure 10As shown, in one embodiment, to maintain the flexibility of the braided tape barbed suture, the tape barbed monofilament insert preferably has a thickness of about 5 mils to 20 mils, and more preferably a thickness of about 6 mils to 8 mils, and the composite core (i.e., the combination of the elongated core and the braided sheath) preferably has a thickness of about 13 mils to 30 mils, and more preferably a thickness of about 13 mils to 18 mils. Within the ranges listed above (i.e., 6 mils to 8 mils tape barbed monofilament insert thickness and 13 mils to 18 mils composite core thickness), the bending stiffness of the braided tape barbed suture will match the bending stiffness achievable with multifilament suture devices.

[0179] In one embodiment, braided tape barbed sutures having an elongated core thickness of 5 mils to 10 mils and a composite core thickness of 11 mils to 30 mils are preferred. In one embodiment, for an elongated core / composite core ratio of about 0.47, highly preferred braided tape barbed sutures have an elongated core thickness of 6 mils to 8 mils and a composite core thickness of 11 mils to 25 mils.

[0180] Test models were formulated and tested to evaluate and analyze the failure mechanisms of the braided tape barbed sutures. In particular, tests were conducted to determine 1) the contribution of the tape barbed monofilament insert and the braided sheath to the overall tensile strength of the braided tape barbed suture, and 2) the effect of the mechanical interaction of the barbs of the tape barbed monofilament insert and the braided sheath on the overall tensile strength of the braided tape barbed suture.

[0181] To complete the analysis of the failure mechanisms of the braided tape barbed sutures, data was compiled in two separate phases. The first test phase included analysis of the failure mechanisms of braided suture specimens (Group I), whereby each Group I specimen included a barbless monofilament core and a braided sheath covering the barbless monofilament core. The second test phase included analysis of the failure mechanisms of braided tape barbed suture specimens (Group II), whereby each Group II specimen included a tape barbed monofilament insert and a braided sheath covering the elongated core of the tape barbed monofilament insert.

[0182] Group I specimens were manufactured using barbless monofilament cores having different sizes (e.g., USP 5-0, 2-0, and 1) and diameters ranging from 5 mils to 20 mils, and braided sheaths having different densities (e.g., 56 denier yarn or 80 denier yarn, 1-ply yarn or 2-ply yarn, and 16 carriers), resulting in final composite cores having diameters ranging from 13 mils to 31 mils. The fact that Group I specimens do not have barbs provides a unique opportunity to assess the mechanical coupling of the barbless monofilament core and the braided sheath that encases the monofilament core. Moreover, the construction of Group I specimens enables the barbless monofilament core to be removed from the braided sheath, which allows each component of the braided suture to be mechanically tested independently of one another.

[0183] Utilizing the formulaF CS = F C + F S mechanical failure testing was accomplished using Equation 1, 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, and F S is the tensile strength of the braided sheath. Figure 11 A plot of the relationship between F CS and F C + F S All plotted points were projected onto a slope of one line through the origin.

[0184] Evaluation of failure mechanisms of non-barbed braided sutures (Group I specimens) versus barbed braided suture with a band (Group II specimens). To evaluate and compare the failure mechanisms of Group I specimens versus Group II specimens, Group I and Group II specimens were fabricated to have approximately matching construction. The respective tensile strengths of Group I specimens (i.e., F CS ) and Group II specimens (i.e., F bb ) were then experimentally determined. Referring to Figure 12 , a plot of F CS and F bb was constructed, where a reference line of slope = 1 and passing through the origin (hereinafter referred to as the "reference line") was drawn.

[0185] Referring to Figure 12 , after testing Group I specimens, the plot of the data indicated that the results predicted by Equation 1 held true for all specimens tested and confirmed that the tensile strength of Group I specimens was simply a linear addition of the respective tensile strengths of the non-barbed monofilament core and the braided sheath that encased the core. Analysis of the test results did not reveal any other significant mechanical interactions, such as frictional forces between the monofilament core and the braided sheath components. With Equation 1 validated, further mechanical failure testing of barbed braided suture with a band was performed.

[0186] When evaluating the failure mechanisms of the non-barbed braided suture (Group I specimens) versus the braided barbed suture (Group II specimens), three possible scenarios can theoretically occur: Scenario #1) the data tends to lie above the reference line, which indicates that the interaction of the barb and the braid actually increases the device tensile strength relative to what is predicted by Equation 1; Scenario #2) the data tends to lie on the reference line, which indicates that the barb has no effect on the tensile strength relative to what is predicted by Equation 1; Scenario #3) the data tends to lie below the reference line, which indicates that the barb decreases the device tensile strength as predicted by Equation 1.

[0187] Figure 12 is a plot of the test results and shows the reference line associated with Scenario #2. The test results indicate that the presence of the barb has no significant effect on the tensile strength of the suture. Thus, the overall tensile strength of the braided barbed suture is equal to the combination of the tensile strength of the barbed monofilament insert plus the tensile strength of the braided sheath, which is consistent with Equation 1.

[0188] The test results support the following conclusions. First, for a barbed monofilament insert having an elongated core with a predetermined diameter, it is desirable to provide a braided barbed suture having a relatively larger sheath size and a relatively smaller elongated core size (i.e., a ratio of sheath to core), because this design takes advantage of the inherent strength of the braided sheath portion of the braided barbed suture.

[0189] Second, for a given diameter, utilizing a large ratio of braided sheath to elongated core will provide greater flexibility (i.e., lower bending stiffness), which improves the handling characteristics of the braided barbed suture.

[0190] Third, because the braided sheath is exposed and visible to the surgical personnel, any damage to the braided sheath is readily apparent upon inspection. Thus, in the unlikely event of a breakage of the elongated core, the relatively large amount of braid will result in minimal loss of tensile strength of the device. This degree of robustness to the damage mechanism is not achievable with a braided suture having a smaller ratio of sheath to core.

[0191] 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. Thus, minor adjustments to the barb design are unlikely to have any significant effect on the tensile strength.

[0192] Sutures come 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 the 10-0 suture being the smallest and the 5 suture being the largest. The 3-0 and 2-0 sutures are typically used for skin closure. The 0 and 1 sutures are larger than the 3-0 and 2-0 sutures and are typically used to close fascial layers during abdominal surgery and in knee and hip surgeries.

[0193] The braided barbed suture disclosed herein can include 3-0, 2-0, 0, and 1 sutures. The outer diameter of the composite core 165 Figure 6B Generally, smaller suture sizes (e.g., 3-0) will result in the formation of a composite core having a relatively smaller outer diameter, while larger suture sizes (e.g., 1) will result in the formation of a composite core having a relatively larger outer diameter.

[0194] In one embodiment, it is preferred that the barbs of the braided barbed suture protrude outward beyond the outer diameter of the composite core by a sufficient distance such that the barbs are able 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), then the barbs will not be able to effectively hold the braided barbed suture in place.

[0195] Referring to Figure 13 In one embodiment, the braided barbed suture 360 preferably includes a barbed monofilament insert 320 (i.e., a barb insert) that includes an elongated core 326 and a first barb 328A and a second barb 328B protruding outward from the elongated core 326. The first barb 328A and the second barb 328B define a barb tip-to-tip distance BTTD that extends from an outer surface of the tip of the first barb 328A to an 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, which is designated ECD. The combination of the elongated core 326 and the braided sheath 350 forms a composite core 365 having a composite core diameter, which is designated CCD. The barbed monofilament insert 320 preferably includes the first barb 328A and the second barb 328B that extend outward beyond the outer diameter of the composite core 365 for engaging tissue to anchor the braided barbed suture 360 in place.

[0196] In one embodiment, there is a preferred ratio of barb tip to tip distance (BTTD) to composite core outer diameter (CCD) to ensure that the barbs will protrude a sufficient distance from the composite core for effectively engaging tissue to anchor the braided tape barbed suture 360 in place. Generally, if the BTTD / CCD ratio is close to 1 : 1, the barbs 328A, 328B will not anchor properly into the tissue. If the ratio is larger, for example between about 1.90: 1 to 4.50: 1, the barbs will protrude beyond the composite core outer diameter by a sufficient distance so that the barbs can effectively anchor into the tissue.

[0197] Referring to Figure 14A and Figure 14B In one embodiment, the tape barbed monofilament insert 420 preferably includes an elongated core 426 and a pair of first barbs 428A and second barbs 428B protruding outwardly from opposite sides of the elongated core 426. The first barbs 428A and second barbs 428B define a barb tip to tip distance BTTD1 of about 33 mils.

[0198] Referring to Figure 14B and Figure 17 In one embodiment, the elongated core 426 is a 3-0 suture. In one embodiment, the 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 the barb tip to tip distance BTTD1 (33 mils) to the composite core diameter CCD1 (11.86 mils) is about 2.78: 1.

[0199] In one embodiment, the elongated core 426 is a 2-0 suture. 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 the barb tip to tip distance BTTD1 (33 mils) to the composite core diameter CCD2 (12.93 mils) is about 2.55: 1.

[0200] In one embodiment, the elongated core 426 is a 0 suture. In one embodiment, the braided sheath wrapped around the elongated core defines a third composite core 465C having a composite core diameter CCD3 of 15.07 mils. The ratio of the barb tip to tip distance BTTD1 (33 mils) to the composite core diameter CCD3 (15.07 mils) is about 2.19: 1.

[0201] In an embodiment, the elongated core 426 is a #1 suture. In an 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 the barbed tip-to-tip distance BTTD1 (33 mils) to the composite core diameter CCD4 (17.15 mils) is about 1.92:1.

[0202] Referring to Figure 15A and Figure 15B In an embodiment, the barbed monofilament insert 520 includes an elongated core 526 and a pair of first barbs 528A and second barbs 528B projecting outwardly from opposite sides of the elongated core 526. The first barbs 528A and second barbs 528B define a barbed tip-to-tip distance BTTD2 of about 45 mils.

[0203] Referring to Figure 15B and Figure 17 In an embodiment, the elongated core 526 is a 3-0 suture. In an embodiment, the 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 the barbed tip-to-tip distance BTTD2 (45 mils) to the composite core diameter CCD1 (11.86 mils) is about 3.79:1.

[0204] In an embodiment, the elongated core 526 is a 2-0 suture. In an 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 the barbed tip-to-tip distance BTTD2 (45 mils) to the composite core diameter CCD1 (12.93 mils) is about 3.48:1.

[0205] In an embodiment, the elongated core 526 is a 0 suture. In an embodiment, the braided sheath wrapped around the elongated core defines a third composite core 565C having a composite core diameter CCD3 of 15.07 mils. The ratio of the barbed tip-to-tip distance BTTD2 (45 mils) to the composite core diameter CCD3 (15.07 mils) is about 2.99:1.

[0206] In an embodiment, the elongated core 526 is a #1 suture. In an embodiment, the braided sheath wrapped around the elongated core defines a fourth composite core 565D having a composite core diameter CCD3 of 17.15 mils. The ratio of the barbed tip-to-tip distance BTTD2 (45 mils) to the composite core diameter CCD4 (17.15 mils) is about 2.62:1.

[0207] Referring to Figure 16A and Figure 16BIn one embodiment, the barbed monofilament insert 620 includes an elongated core 626 and a first barb 628A and a second barb 628B projecting outwardly from opposite sides of the elongated core 626. The first barb 628A and the second barb 628B define a barb tip to tip distance BTTD3 of approximately 53 mils.

[0208] Referring to Figure 16B and Figure 17 In one embodiment, the elongated core 626 is a 3-0 suture. In one embodiment, the 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 the barb tip to tip distance BTTD3 (53 mils) to the composite core diameter CCD1 (11.86 mils) is approximately 4.47:1.

[0209] In one embodiment, the elongated core 626 is a 2-0 suture. 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 the barb tip to tip distance BTTD3 (53 mils) to the composite core diameter CCD2 (12.93 mils) is approximately 4.10:1.

[0210] In one embodiment, the elongated core 626 is a 0 suture. In one embodiment, the braided sheath wrapped around the elongated core defines a third composite core 665C having a composite core diameter CCD3 of 15.07 mils. The ratio of the barb tip to tip distance BTTD3 (53 mils) to the composite core diameter CCD3 (15.07 mils) is approximately 3.52:1.

[0211] In one embodiment, the elongated core 626 is a 1 suture. In one embodiment, the braided sheath wrapped around the elongated core defines a fourth composite core 665D having a composite core diameter CCD3 of 17.15 mils. The ratio of the barb tip to tip distance BTTD3 (53 mils) to the composite core diameter CCD4 (17.15 mils) is approximately 3.09:1.

[0212] Referring to Figure 18In one embodiment, the automated braiding system 700 for manufacturing a braided suture with barbed tape preferably includes a spool 702 that holds a continuous spool of barbed monofilament insert 704. In one embodiment, the barbed monofilament insert 704 is guided through an elongate body 706 (in direction DIR1), as disclosed in commonly-assigned U.S. Patent Application Serial No. 17 / 336,680, filed on the same day (Attorney Docket ETH6071USNP1), which claims the benefit of U.S. Provisional Application Serial No. 63 / 039,649, filed June 16, 2020, the disclosure of which is incorporated by reference herein. In one embodiment, the elongate body 706 feeds the barbed monofilament insert 704 into a braider ring 708 for over-braiding a yarn around the elongate core of the respective barbed monofilament insert. The automated braiding system 700 preferably includes a plurality of shuttle guides 710 that surround the elongate body 706 and the braider ring 708. Each shuttle guide 710 preferably has a bobbin 712 mounted thereon that holds a yarn 714 that is advantageously fed into the braider ring 708 for winding around the barbed filament insert 704 to form a braided sheath that extends along the length of the barbed filament insert.

[0213] In one embodiment, the over-braiding parameters used by the automated braiding system 700 can be predetermined and / or modified to control the quality and gauge of the braided sheath formed over the barbed monofilament insert 704. The over-braiding parameters can include the number of bobbins 712 used and the denier of the yarn 714 disposed on the bobbins.

[0214] As used herein, denier (D) is a unit of measure of the linear mass density of a fiber. It is the mass in grams of 9000 meters of the fiber. The denier unit of measure is based on a natural benchmark, namely that a single 9000 meter length of silk thread weighs about one gram or about one denier. The denier unit is calculated as follows, 1 denier = 1 g / 9,000 m = 0.11 mg / m.

[0215] 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 result in more yarn being directed into the braider ring 708, which will result in a braided sheath having a higher filament density, while using fewer bobbins will result in less yarn being directed into the braider ring 708, which will result in a braided sheath having a lower filament density.

[0216] In one embodiment, each bobbin 712 contains yarn 714 that is fed into the braider metal ring 708. The denier of the yarn can be predetermined to control the number of filaments that are directed into the braider metal ring 708. In one embodiment, each filament in the yarn 714 is approximately 2 denier. Thus, a 28 denier yarn includes 14 filaments, a 56 denier yarn includes 28 filaments, and an 80 denier yarn includes 40 filaments. The denier of the yarn 714 can be selected to control the density of the braided sheath formed over the barbed monofilament insert.

[0217] In one embodiment, the braided sheath formed over the barbed monofilament insert has different picks that can be counted along the length of the braided barbed suture. As used herein, the term “pick” is defined to refer to 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 over one inch of the braided barbed suture device.

[0218] Figure 19 A braided barbed suture 860 is shown having a braided sheath 862 extending along a braiding axis. In Figure 19 The start point and end point of a single pick are identified in the

[0219] Referring to Figure 20 In one embodiment, the pick count system 855 can be used to inspect the braided barbed suture 860 ( Figure 19 ) to determine the picks per inch (PPI) of the braided sheath 862. In one embodiment, the pick count system 855 preferably includes a microscope 865 for viewing the braided sheath, a video display screen 875 for viewing the images of the braided sheath captured by the microscope 865, a digital crosshair generator 885 that generates visual crosshairs on the braided sheath shown on the video display screen 875, and a computer 895 that operates one or more software programs (i.e., PPI software) that are configured to assist the operator in counting the picks per inch (PPI) on the braided sheath 862 of the braided barbed suture 860 ( Figure 19 ).

[0220] Referring to Figure 20 and Figure 21In one embodiment, the PPI software is opened for displaying the distance measurement on the video display monitor 875. The braid bar barbed suture 860 can be placed on a microscope plate within the field of view of the microscope 895. In one embodiment, the braid bar barbed suture 860 can be held in place by a securing component (e.g., tape, clamp). In one embodiment, with the braid bar barbed suture 860 and the braid sheath 862 under the microscope 865 visible within the video display monitor 875, the digital crosshair generator preferably aligns the crosshairs with the starting point of the first weft of the braid sheath. In Figure 21 one embodiment, the crosshairs include a Y-axis and an X-axis that intersect at a location indicating the starting point of the first weft of the braid sheath 862. The crosshairs are displayed on the video display monitor 875.

[0221] Referring to Figure 22 and Figure 23 , in one embodiment, the computer 895 of the weft count system counts the number of wefts positioned along the X-axis Figure 21 ) until 1.00 inch is measured along the X-axis of the braid sheath 862. In Figure 23 one embodiment, the starting and ending positions of four wefts are highlighted. In Figure 23 the illustrated embodiment, the four wefts have a total length greater than 1.00 inch.

[0222] Referring to Figure 24 , in one embodiment, the total number of wefts counted over a one inch distance is calculated, and the wefts per inch (PPI) value is displayed on the display screen of the computer 895.

[0223] Referring to Figure 19 , in one embodiment, the braid bar barbed suture 860 has pairs of barbs 828A, 828B that are spaced apart from each other along the length of the braid bar barbed suture. The braid sheath 862 extends along the length of the braid bar barbed suture 860. The distance between pairs of barbs is also referred to herein as the DBBP, and is approximately 0.075 inches.

[0224] Referring to Figure 18 , Figure 25 and Figure 26 , in one embodiment, the overbraid parameters used by the automated braiding system 700 can be controlled to optimize the performance of the braid bar barbed suture 860.

[0225] In one embodiment, if the barbed monofilament insert is 3-0 and the DBBP is 0.075 inches, then a braided configuration using 16 shuttle guides 710 each holding one bobbin 712 of 28 denier yarn (i.e., 14 filaments) will produce a braided sheath of 55 weft yarns per inch (PPI). The PPI number can be used to calculate a value of 0.0182 as weft yarns per inch (IPP), which is the inverse of PPI. The DBBP / IPP ratio will be 0.075 / 0.0182 = 4.13.

[0226] In one embodiment, if the barbed monofilament insert is 2-0 and the DBBP is 0.075 inches, then a braided configuration using 12 shuttle guides 710 each holding one bobbin 712 of 56 denier yarn (i.e., 28 filaments) will produce a braided sheath of 50 weft yarns per inch (PPI). The PPI number can be used to calculate a value of 0.0200 as weft yarns per inch (IPP), which is the inverse of PPI. The DBBP / IPP ratio will be 0.075 / 0.0200 = 3.75.

[0227] In one embodiment, if the barbed monofilament insert is 0 and the DBBP is 0.075 inches, then a braided configuration using 16 shuttle guides 710 each holding one bobbin 712 of 56 denier yarn (i.e., 28 filaments) will produce a braided sheath of 48 weft yarns per inch (PPI). The PPI number can be used to calculate a value of 0.0208 as weft yarns per inch (IPP), which is the inverse of PPI. The DBBP / IPP ratio will be 0.075 / 0.0208 = 3.60.

[0228] In one embodiment, if the barbed monofilament insert is 1 and the DBBP is 0.075 inches, then a braided configuration using 16 shuttle guides 710 each holding one bobbin 712 of 80 denier yarn (i.e., 40 filaments) will produce a braided sheath of 41 weft yarns per inch (PPI). The PPI number can be used to calculate a value of 0.0244 as weft yarns per inch (IPP), which is the inverse of PPI. The DBBP / IPP ratio will be 0.075 / 0.0244 = 3.08.

[0229] In one embodiment, the DBBP / IPP ratio is a braiding parameter that can be optimized to prevent burying the barb underneath the yarn of the braided sheath of the braided barbed suture. If the DBBP / IPP ratio is too low, then the yarn will be braided too tightly and there is a high likelihood that the barb will be buried. In contrast, if the DBBP / IPP ratio is too high, the yarn will be braided too loosely and the braided barbed suture will not benefit from the improved mechanical properties that its presence can provide.

[0230] In one embodiment, the DBBP / IPP ratio is preferably between about 2.75 to 4.50. Depending on the suture size of the barbed suture insert, the denier of the yarn used and the number of bobbins can be modified to ensure that the DBBP / IPP ratio is between 2.75 to 4.50 denier.

[0231] The end effector of the barbed suture insert can have different geometrical shapes (e.g., square, rectangular, circular, oval, diamond, semi-circular, etc.). The end effector can also have a beveled surface for modifying the lateral width of the end effector along its length. Referring to Figure 26 In one embodiment, the barbed suture insert 1020 has an end effector 1032 with a rectangular shape. Referring to Figure 27 In one embodiment, the barbed suture insert 1120 has an end effector 1132 with a rectangular shape with a proximal end 1135 defining a curved surface. Figure 28 In one embodiment, the barbed suture insert 1220 has an end effector 1232 with a square shape with a proximal end 1235 defining a curved surface.

[0232] The braided barbed suture braided end effector can be laminated with or sandwiched between two end attachment pieces that are joined or welded to the braided end effector. The end attachment pieces preferably have the same overall shape (e.g., square, rectangular, circular, oval, diamond, semi-circular, etc.) as the end effector and are made of the same material as the barbed suture blank 100 / barbed monofilament insert. The end attachment pieces can be affixed to the braided end effector in a manner similar to that disclosed in U.S. Patent Nos. 10,336,001 and D780,918, the disclosures of which are incorporated herein by reference.

[0233] While the foregoing is directed to embodiments of the present application, other and further embodiments of the application can be devised without departing from the basic scope thereof, and that such other embodiments are in all respects intended to be embraced herein. For example, any feature described herein as part of one embodiment can be combined with any feature described herein as part of any other embodiment, and the application is intended to encompass any combination of any of the features described herein.

Claims

1. A braided tape barbed suture, comprising: a tape 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; a braided sheath surrounding the elongated core to form a composite core of the braided tape barbed suture having a composite core thickness, wherein a ratio of the elongated core thickness to the composite core thickness is between 0.16 to 0.91; wherein the tape barbed monofilament insert comprises: a first barb projecting outwardly from the elongated core, the first barb comprising an inner end having a first thickness that is greater than the thickness of the elongated core and an outer end having a second thickness that is less than the first thickness at the inner end of the first barb; a transition zone extending between the elongated core and the inner end of the first barb so as to connect the inner end of the first barb with the elongated core.

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

73.

3. The braided tape barbed suture of claim 1, wherein the braided sheath wraps the elongated core, and wherein the elongated core is centered in the composite core.

4. The braided tape barbed suture of claim 1, wherein the plurality of barbs project outwardly from the elongated core in a first plane, and wherein the thicknesses of the elongated core and the composite core are measured along an axis that lies in a second plane that is perpendicular to the first plane.

5. The braided tape barbed suture of claim 1, wherein the transition zone is thinner adjacent the elongated core and thicker adjacent the inner end of the first barb, and wherein the transition zone widens from the elongated core to the inner end of the first barb.

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

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

8. The braided tape barbed suture of claim 1, wherein the tape barbed monofilament insert comprises a PDS monofilament core.

9. The braided tape barbed suture of claim 1, wherein the braided sheath comprises a VICRYL multifilament yarn braided sheath.

10. The braided tape barbed suture of claim 1, wherein the braided tape barbed suture has a single breaking point for both the braided sheath and the tape barbed monofilament insert.

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

12. The woven tape barbed suture of claim 1, wherein the elongated core has a substantially flat top surface and a substantially flat bottom surface, and wherein a diameter of the elongated core extends from the substantially flat top surface to the substantially flat bottom surface of the elongated core.

13. The woven tape barbed suture of claim 1, wherein the plurality of barbs define barb pairs that define a barb tip to tip distance (BTTD), wherein the composite core has a composite core diameter (CCD), and wherein a ratio of the barb tip to tip distance (BTTD) to the composite core diameter (CCD) is between 1.92 to 4.

5.

14. The woven tape barbed suture of claim 13, wherein the ratio of the barb tip to tip distance (BTTD) to the composite core diameter (CCD) is between 2.5 to 3.

8.

15. A woven tape barbed suture comprising: a tape barbed monofilament insert comprising an elongated core having an elongated core thickness and a plurality of barbs protruding outwardly from opposing lateral sides of the elongated core, wherein the plurality of barbs lie within a first plane, and wherein the elongated core thickness of the elongated core is measured along an axis that lies within a second plane that is perpendicular to the first plane; a woven sheath surrounding the elongated core to form a composite core of the woven tape barbed suture, wherein the elongated core is located at a center of the composite core and the woven sheath wraps the elongated core, wherein the composite core has a composite core thickness measured along the axis that lies within the second plane that is perpendicular to the first plane, and wherein a ratio of the elongated core thickness to the composite core thickness is between 0.16 to 0.91; wherein the barbs have inner ends having respective thicknesses that are greater than the elongated core thickness.

16. The woven tape barbed suture of claim 15, wherein the elongated core thickness is 6 mils to 8 mils and the composite core thickness is 13 mils to 18 mils.

17. The woven tape barbed suture of claim 15, wherein the ratio of the elongated core thickness relative to the composite core thickness is between 0.24 to 0.

73.

18. The woven tape barbed suture of claim 15, further comprising: a first transition zone between a first lateral side of the elongated core and an inner end of a first barb, wherein the first transition zone widens from the first lateral side of the elongated core to the inner end of the first barb; a second transition zone between a second lateral side of the elongated core and an inner end of a second barb, wherein the second transition zone widens from the second lateral side of the elongated core to the inner end of the second barb.

19. The woven tape suture of claim 18, wherein the elongate core and the first and second transition zones define a first concave profile on a top side of the woven tape suture and a second concave profile on a bottom side of the woven tape suture.

20. The woven tape suture of claim 15, wherein the woven tape suture has a single breaking point for both the woven sheath and the tape barb monofilament insert.

21. The woven tape suture of claim 15, wherein the tape barb monofilament insert comprises a PDS monofilament core, and wherein the woven sheath comprises a VICRYL multifilament yarn woven sheath.

22. The woven tape suture of claim 15, further comprising: an end effector coupled with the elongate core, wherein the elongate core extends through the end effector; the end effector comprising a first wing extending laterally from a first lateral side of the elongate core and a second wing extending laterally from a second lateral side of the elongate core, wherein the first and second wings are thicker than the elongate core.

23. A woven tape suture, comprising: a tape barb monofilament insert comprising an elongate core having an elongate core thickness and a plurality of barbs protruding outward from opposite sides of the elongate core, wherein the barbs have inner ends that are thicker than the elongate core thickness of the elongate core; the tape barb monofilament insert comprising at least one transition zone between the elongate core and the inner ends of the barbs to form a concave profile; a woven sheath surrounding the elongate core to form a composite core of the woven tape suture, wherein the elongate core is centered in the composite core and the woven sheath surrounds the elongate core, wherein the composite core has a thickness that is greater than the elongate core thickness, and wherein a ratio of the elongate core thickness relative to the composite core thickness is between 0.16 and 0.

91.

24. The woven tape suture of claim 23, wherein the plurality of barbs are in a first plane, and wherein the elongate core thickness and the composite core thickness are measured along an axis that is in a second plane that is perpendicular to the first plane of the plurality of barbs.

25. The woven tape suture of claim 23, wherein the ratio of the elongate core thickness relative to the composite core thickness is between 0.24 and 0.

73.

26. The woven tape suture of claim 23, wherein the woven tape suture has a single breaking point for both the woven sheath and the tape barb monofilament insert.

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