Apparatus and method for surgical suturing

Abstract

A surgical device for use with sutures and associated methods are generally described. In some embodiments, the surgical device may include an elongate body and a plurality of through holes configured to allow the suture to pass through the plate across opposing edges of the defect site. The plate may protect adjacent tissue from tension in the suture by redistributing tension along its body. In some embodiments, the disclosed surgical device may reduce the likelihood of defect closure failure due to the suture pulling through the tissue defect. In some embodiments, the through holes may be located on offset parallel axes to reduce excessive suture friction and suture mishandling. The disclosed surgical device may be used in either an interrupted or continuous suture pattern.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. patent application Ser. No. 63 / 185,668, filed May 7, 2021, the disclosure of which is incorporated herein by reference in its entirety.

[0002] Field

[0002] The present technology relates generally to surgical devices and related methods. More specifically, devices and methods for surgical suturing are disclosed. [Background technology]

[0003]

[0003] Existing surgical methods utilize taut sutures to close defects (e.g., wounds) or to attach implants or prostheses to pre-existing tissue. When defects are formed in soft tissue, tension along the sutures pulls the sutures through the tissue, especially when the sutures are tightened to close the defect. Such pull-through events can not only prevent the defect from closing, but can also unnecessarily introduce new defects into the tissue (e.g., at laceration sites along wound edges).

[0004]

[0004] Surgeons (e.g., surgeons) may use various types of suture patterns to adequately close a defect. Interrupted sutures are generally easy to place and individually controllable (both in position and tension), which may allow the suture path to follow a tortuous defect boundary, but are more time consuming to place and tighten. In contrast, continuous sutures are generally quicker to place and remove than interrupted sutures, and typically use less suture material, but are more difficult to tighten uniformly along the boundary of a tissue defect. Summary of the Invention [Means for solving the problem]

[0005] In some embodiments, a surgical device for securing a suture to soft tissue includes an elongated body having a length and a width, a first plurality of through holes, and a second plurality of through holes. The length of the elongated body exceeds the width of the elongated body. The first plurality of through holes extend from a first side of the elongated body to a second side of the elongated body opposite the first side. The first plurality of through holes are positioned along at least a first portion of the length of the elongated body. The second plurality of through holes extend from the first side of the elongated body to a second side of the elongated body opposite the first side. The second plurality of through holes are positioned along at least a second portion of the length of the elongated body. The second plurality of through holes are offset from the first plurality of through holes in a transverse direction parallel to the width of the elongated body.

[0006] In some embodiments, a method for securing a suture to soft tissue includes passing a first end of a suture from a first side of a defect through a first through hole of a first plurality of through holes of a surgical device, and passing a second end of the suture from an opposite side of the defect through a first through hole of a second plurality of through holes of the surgical device. The first plurality of through holes is positioned along at least a first portion of a length of the surgical device, and the first plurality of through holes extends from a first surface of the surgical device to a second surface of the surgical device. The second plurality of through holes is positioned along at least a second portion of a length of the surgical device, and the second plurality of through holes extends from a first surface of the surgical device to a second surface of the surgical device. The second plurality of through holes is offset from the first plurality of through holes in a transverse direction parallel to a width of the surgical device.

[0007]

[0007] It should be appreciated that the above-mentioned concepts, and additional concepts described below, may be arranged in any suitable combination, as the present disclosure is not limited in this respect. Furthermore, other advantages and novel features of the present disclosure will become apparent from the following detailed description of various non-limiting embodiments when considered in conjunction with the accompanying drawings. [Brief description of the drawings]

[0008]

[0008] The accompanying drawings are not intended to be to scale. In the drawings, each identical or nearly identical component shown in various drawings may be represented by a similar reference number. For clarity, not every component is referenced in every drawing.

[0009] [Figure 1]

[0009] FIG. 1 is a schematic diagram of a series of sutures after tearing through a tissue defect by penetration. [Diagram 2]

[0010] FIG. 13 is a schematic top view of an interrupted suture pattern showing a tear caused by pulling through. [Diagram 3]

[0011] 1 is a schematic top view of an interrupted suture pattern using one embodiment of a surgical device. [Figure 4]

[0012] FIG. 4 is a perspective top view of the surgical device of FIG. 3. [Diagram 5]

[0013] FIG. 4 is a top view of the surgical device of FIG. [Figure 6]

[0014] FIG. 4 is a front view of the surgical device of FIG. [Figure 7]

[0015] 7 is a cross-sectional view of the surgical device of FIG. 5 taken along line 7-7. [Figure 8A]

[0016] 4 is a schematic diagram illustrating a method of wound closure using the surgical device of FIG. 3. [Figure 8B] 4 is a schematic diagram illustrating a method of wound closure using the surgical device of FIG. 3. [Figure 8C] 4 is a schematic diagram illustrating a method of wound closure using the surgical device of FIG. 3. [Figure 8D] 4 is a schematic diagram illustrating a method of wound closure using the surgical device of FIG. 3. [Figure 8E] 4 is a schematic diagram illustrating a method of wound closure using the surgical device of FIG. 3. [Figure 8F]4 is a schematic diagram illustrating a method of wound closure using the surgical device of FIG. 3. [Figure 9]

[0017] 1 shows a flowchart of a wound closure method using a surgical device, according to some embodiments. [Figure 10]

[0018] 1 shows a flowchart of another wound closure method using a surgical device, according to some embodiments. [Figure 11]

[0019] 13 shows a flowchart of yet another method of wound closure using a surgical device, according to some embodiments. [Figure 12]

[0020] FIG. 13 is a schematic top view of a running suture pattern showing a tear caused by pulling through. [Figure 13]

[0021] 1A-1C are schematic top views of a continuous suture pattern using one embodiment of a surgical device. [Figure 14]

[0022] FIG. 14 is a top view of the surgical device from FIG. 13. [Figure 15]

[0023] FIG. 13 is a top view of another embodiment of a surgical device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010]

[0024] Taut sutures are the surgical standard for soft tissue defect closure. The advent of minimally invasive or non-invasive surgical procedures has facilitated defect closure procedures such as robotic. However, the lack of haptic feedback from the robotic instrument to the surgeon may prevent the surgeon (e.g., surgeon) from determining the maximum tensile stress applied along the suture line, which may increase the likelihood of pulling through the suture. As previously mentioned, pulling through the suture may cause defect closure failure and other undesirable outcomes.

[0011]

[0025] In some cases, buttress pledgets formed with perforations for receiving sutures may be used to reduce the risk of suture pull through in surgical applications. Pledgets may be placed along suture lines to prevent approximation of the sutures across the defect (which may occur during suture pull through) by protecting the underlying soft tissue from suture tension. However, the inventors have recognized that the sutures on existing buttress pledgets may experience excessive frictional drag along adjacent suture lines, which may lead to suture breakage. Furthermore, the inventors have recognized that when these pledgets are used in complex suture patterns, the sutures may become entangled, which may lead to suture mishandling, suture breakage, and / or improper defect closure.

[0012]

[0026] In view of the above, the inventors have recognized benefits associated with buttress pledgets, which identify through-holes distributed along alternating parallel lines. For example, in some embodiments, a buttress pledget (also referred to herein as a "device") may include two or more groups of through-holes extending at least partially along the length of the device. The groups of through-holes may be offset from one another. Thus, sutures may be passed through two or more groups of through-holes in a desired suture pattern to close an associated tissue defect. The offset through-holes may physically separate the suture ends to reduce contact between sutures prior to defect closure. In other words, the offset through-holes may reduce suture interference (and subsequent chafing and / or suture breakage) by separating sutures extending from opposite edges of the defect. Specific arrangements of through-holes and corresponding suture patterns that may be used with the various devices disclosed herein are detailed below.

[0013]

[0027] In some embodiments, the device may include an elongate body with multiple through-holes distributed along the body. The through-holes may be configured to accommodate a suture that spans from one edge of the defect to another edge on the opposite side of the defect. The distribution of the through-holes may be determined by the size of the defect, the appropriate puncture size (measured from the edge of the defect to the puncture point of the needle or any other instrument used to deploy the suture), the suture pattern, the suture size, and any number of other factors that the surgeon (e.g., surgeon) may consider. The elongate body may be configured to be placed across the defect, along the defect, or may be oriented in any direction relative to the edge of the defect to assist in closing the tissue defect during use.

[0014]

[0028] According to some embodiments, the through holes can be positioned with respect to a particular suture pattern. As mentioned above, the surgeon can use different suture patterns in response to various factors corresponding to a particular defect closure site. The suture patterns can be interrupted, continuous, apposition, inversion, eversion, detension, or any other type of suture pattern. In some embodiments, the device can be used with a pulley stitch pattern. The device may also be used with interrupted and continuous simple sutures (sometimes known as "multiple repeats"), interrupted and continuous intradermal, interrupted and continuous horizontal mattress, interrupted and continuous vertical mattress, interrupted and continuous Lembert, Cushing, intertwining, Halsted, Connell, purse string, Alpha, zigzag, coil, switchback, finger trap, Gambee, crisscross suture pattern, Ford-interlocking, Parker-Kerr, far-far-near-near, far-near-near-far, near-far-far-near, interlocking loop, 3-loop pulley, or any other suitable suture pattern.

[0015]

[0029] The devices described herein may be used in any suitable surgical or non-surgical application. For example, the devices may be used as buttress pledgets for fascial defect closure procedures in hernia repair. The devices may also be used in other tissue defect closure and / or implant attachment procedures, such as appendectomies, biopsies, carotid endarterectomies, cataract repair, cesarean sections, cholecystectomies, cardiac bypasses, debridement (of wounds, burns, infections, etc.), tissue grafts, tonsillectomies, or any other suitable surgical procedures. The devices may be used in defect closure of soft tissue, cartilage, ligaments, bone, or any other biological material. It should be appreciated that the present disclosure is not limited by the application or type of defect used.

[0016]

[0030] It should be appreciated that the surgical device may be formed of any material or combination of materials. In some embodiments, the device may be formed of a material that is stiffer than the material in which the defect is formed. For example, the device may be formed of a material that is stiffer and / or more tear resistant than soft tissue. In this way, the device may provide a higher resistance to tearing due to penetration than the material used to close. In surgical applications, the device may be formed of a biocompatible material, while in non-surgical applications, the device may be formed of any desired material, including non-biocompatible materials. In some embodiments, the device may be formed of a flexible material, such as foam, felt, or fabric. However, embodiments in which hard plastic and / or metal are used to form the device are also contemplated. The device may also be formed of a material that can absorb fluids from the approximation (e.g., fluids from the defect) and / or may have hemostatic properties. Thus, the device may minimize leakage of either fluids from the original defect site or fluids that may leak due to tissue penetration by the suture needle or suture.

[0017]

[0031] In some embodiments, the device as disclosed herein may be configured to remain at the defect site as an implantable device and not degrade significantly over time. The surgeon may choose to remove the device during the suture removal procedure, or may leave the device in or on the body depending on whether the closure procedure is an external or internal closure procedure. In other embodiments, the device may be made from biodegradable and / or bioabsorbable materials, such that the device degrades over a period of time due to exposure to physiological temperature, hydration, the presence of enzymes, and / or any other degradable factors. With the above in mind, the device may be formed of any suitable biocompatible, non-biocompatible, non-bioabsorbable material, bioabsorbable material, combinations of the foregoing, and / or any other suitable type of material, as the disclosure is not so limited. In some specific embodiments, the device is made of polyurethane, polyamide, polyethylene, polypropylene, polyethylene terephthalate, polyvinyl chloride, polyolefin, polycarbonate, polycarbamate, polyacrylate, polystyrene, polyurea, polyether, polyalkyl ether, polyamine, polytetrafluoroethylene, polylactic acid, polyglycolic acid, poly(lactic-co-glycolic acid), poly(glycolide-co-trimethylene carbonate ... The polymeric material may be formed of any suitable material, including, but not limited to, poly(carbonate), polydioxanone, polycaprolactone, polyhydroxybutyrate, poly(phosphazene), poly(D,L-lactide-co-caprolactone), poly(glycolide-co-caprolactone), poly(phosphatase ester), polyanhydride, polyester, polyphosphazene, polyacrylate, polymethacrylate, copolymer, block polymer, block copolymer, linear polymer, branched polymer, dendritic polymer, crosslinked polymer, metal (e.g., stainless steel, titanium), any combination thereof, or any other suitable material, as the disclosure is not so limited.In some embodiments, the device may be formed of natural materials, such as autologous tissue, natural polymers, such as polysaccharides (e.g., cellulose), proteins, or any other naturally occurring materials, hi some embodiments, the device may be formed of composites, such as fiber-reinforced materials.

[0018]

[0032] As used herein, the terms "bioabsorbable," "degradable," or other similar terms may refer to materials that are bioabsorbable, absorbable, and / or degradable in response to physical or chemical cues within the physiological environment or any other environment in which the device is used. For example, a bioabsorbable material may be eliminated from the physiological environment over a given period of time due to chemical interactions with enzymes, temperature, pH, or any other chemical markers.

[0019]

[0033] In embodiments in which the device is formed of at least one bioabsorbable material, the material may degrade in vivo after the defect has healed. The device may degrade in vivo after 2 days, 4 days, 5 days, 1 week, 2 weeks, 3 weeks, 1 month, 1.5 months, 2 months, 3 months, or any other suitable duration.

[0020]

[0034] The surgical devices described herein are not limited by the material composition or type of suture that may be used in the device. For example, the suture may be formed of natural or synthetic materials. In some embodiments, the suture may be formed of a material that is softer than the device and / or may have an appropriate cross-section so that the suture may not pull through the device or damage the device before reaching the suture's failure load. The suture may be formed of a non-bioabsorbable material, such as polypropylene, polycarbonate, nylon, polyester, polyamide, polypropylene, poly(ethylene terephthalate), stainless steel, titanium, any combination thereof, or any other suitable non-bioabsorbable material. In some embodiments, the suture may be formed of a bioabsorbable material, such as polydioxanone, polylactic acid, polyglycolic acid, poly(lactic-co-glycolic acid), biomaterials (e.g., collagen, cellulose), any combination thereof, or any other suitable material.

[0021]

[0035] In embodiments where both the suture and the device are formed of bioabsorbable materials, the suture and the device may degrade in vivo during the same period of time. In other embodiments, the device may degrade faster than the suture. In other embodiments, the suture may even degrade faster than the device. In some embodiments, a bioabsorbable suture may be used with a non-bioabsorbable device. In other embodiments, a non-bioabsorbable suture may be used with a bioabsorbable device. In other embodiments, a non-bioabsorbable suture may be used with a non-bioabsorbable device. It should be appreciated that the present disclosure is not limited by the material composition or degradation characteristics of the suture or device.

[0022]

[0036] Turning to the drawings, non-limiting specific embodiments are described in further detail. It should be understood that the various systems, components, features, and methods described with respect to these embodiments may be used either individually and / or in any desired combination, as the disclosure is not limited to only the specific embodiments described herein. For example, while all of the embodiments described herein refer to surgical devices used to approximate soft tissue, the devices described herein may be configured for use in any application in which soft materials may be approximated by a taut string or line.

[0023]

[0037] FIG. 1 illustrates one embodiment of a prior art system that tears by suture penetration. A surgeon may attempt to close a defect 14 formed between tissue portions 11a and 11b with a continuous suture 12. However, tension within suture 12 may cause suture 12 to tear through tissue portion 11b by penetration. As shown in FIG. 1, suture 12 tearing through tissue portion 11B not only fails to approximate tissue portions 11a, 11b to close defect 14, but also creates a new tear 13 in tissue portion 11b. It should be appreciated that in some prior art systems, suture 12 may tear or create a tear through penetration through both tissue portions 11a and 11b.

[0024]

[0038] 2 shows one embodiment of a prior art system that tears by suture penetration with an interrupted suture pattern (e.g., pulley stitch). In this embodiment, sutures 12a, 12b cross defect 14 and approximate tissue portions 11a, 11b. However, tension in sutures 12a, 12b can cause tears 13 and prevent closure of defect 14, as shown in FIG.

[0025]

[0039] FIG. 3 illustrates defect closure using a surgical device according to some embodiments. The surgical device 10 may be used with a pulley stitch pattern across the defect 14 to approximate the tissue portions 11a, 11b. The pulley stitch pattern may include a knot 15 after each pass of the interrupted suture. As shown in FIG. 3, the device 10 may reduce the likelihood of the suture 12 pulling through the tissue portions 11a, 11b by distributing the tension of each suture 12 and by acting as a physical barrier to tearing of the tissue due to the associated piercing holes limiting the location of the suture at the surface of the tissue on which the device is placed.

[0026]

[0040] It should be appreciated that the surgeon may determine the optimal location of the device 10 along the defect 14. In some embodiments, the device 10 may be placed at the widest point of the defect 14, which may maximize the tension along the suture line 12, as shown in FIG. 3. In other embodiments, two or more devices 10 may be used to close the defect 14, as shown in the drawings, where multiple devices and separate sutures are used in combination with each other to close the tissue defect. Therefore, it should be appreciated that the present disclosure is not limited to the location, configuration, or number of devices 10 positioned along and used to close the defect 14.

[0027]

[0041] FIG. 4 illustrates a surgical device 10 according to some embodiments. The device 10 may include a number of through holes 20a, 20b, 30a, 30b to allow sutures to pass through the device. In some embodiments, the device 10 may include a midline marker 40, e.g., a line or groove, extending across at least a portion of the width of the device at a location approximately equidistant from opposite ends of the device for alignment purposes. The marker 40 may be visually distinct from the remainder of the device 10 and may allow the surgeon (e.g., a surgeon) to optically determine the midline of the device 10. The device 10 may include an elongated body with rounded end portions 52, 54 for ergonomic functionality, although non-linear shapes and / or non-rounded end portions are also contemplated. The device 10 may also include one or more side walls 50 extending around the periphery of the device and extending between two opposing faces that face toward and away from the underlying tissue, respectively, when the device is placed in tissue during use.

[0028]

[0042] As shown in Figure 5, device 10, in some embodiments, may include an elongated body. In some embodiments, device 10 may be in the shape of a stadium (e.g., a rounded rectangle) with rounded end portions 52, 54. In other embodiments, device 10 may be oval (e.g., circular), rectangular (e.g., square), rounded rectangular, rhomboid, trapezoid, polygonal, curvilinear, any combination thereof, and / or any other suitable shape. It should be appreciated that device 10 is not limited by its body shape, as different body shapes may be used in different applications.

[0029]

[0043] In some embodiments, the device 10 includes a first dimension, e.g., a length L1, which may be perpendicular to a second dimension, e.g., a width W1. In embodiments in which the device 10 has an elongate body, the length L1 of the device 10 may exceed the width W1. Thus, when the device 10 is used in an interrupted suture pattern, the device 10 may be oriented such that its length L1 spans the lateral direction LD of the defect 14 and its width W1 spans the transverse direction TD of the defect (as shown in the defect 14 in FIG. 3). Although the device 10 is shown in FIG. 3 as aligned with the lateral direction LD of the defect 14, it should be appreciated that embodiments in which the device 10 is oriented at an angle relative to the lateral direction LD of the defect 14 are also contemplated. As will be described in more detail below, the length L1 and width W1 of the device 10 may be of any suitable size, as the disclosure is not so limited.

[0030]

[0044] The device 10 may include a first axis AX (e.g., a vertical axis) that extends along the length L1 dimension of the device, and a second axis AX2 that extends along the width W1 dimension. The first axis AX and the second axis AX2 are shown in FIG. 5 as being perpendicular, corresponding to the vertical and horizontal axes, respectively, but it should be recognized that other orientations between the axes AX and AX2 are also contemplated. The axis AX may be at the center of the device 10 as shown in FIG. 5, or at any other location relative to the device. Similarly, in some embodiments, the axis AX2 may be at the center of the device 10 as shown in FIG. 5, but in other embodiments, the axis AX2 may be at any other location relative to the device.

[0031]

[0045] According to some embodiments depicted in FIG. 5, the device 10 may include at least four through holes 20a, 20b, 30a, 30b. Two of the through holes, 20a and 30a, may be on one side of the axis AX2, while the other two through holes, 20b and 30b, may be on the opposite side of the axis AX2. In some embodiments, two of the through holes, 20a and 20b, may be on one side of the axis AX, while the other two through holes, 30a and 30b, may be on the opposite side of the axis AX. In some embodiments, the device 10 may include at least one through hole in each quadrant formed by the intersection of the axes AX and AX2.

[0032]

[0046] According to some embodiments, the through holes 20a and 20b may be on the same axis, for example a third axis AX3, which may be parallel to the axis AX. In other words, the through holes 20a and 20b may be aligned along the axis AX3. It should be appreciated that embodiments are also contemplated in which the through holes 20a and 20b may not be aligned along an axis parallel to the axis AX that extends along the length of the device. In some embodiments, the through holes 30a and 30b may be aligned along an axis parallel to the axis AX, for example a fourth axis AX4, while in other embodiments the through holes 30a and 30b may not be aligned along an axis parallel to the axis AX. In some embodiments, the axes AX3 and AX4 and the associated separate groups of through holes formed along a portion of the length of the device may be parallel to the width of the device and offset with respect to each other. In some embodiments, the through holes along the parallel axes AX3 and AX4 may also be staggered with respect to one another along the length of the device, such that the through holes in each of the separate groups of through holes may be positioned at different locations along the length of the device. Of course, other angled arrangements between the axes AX3 and AX4 are also contemplated. As will be explained in more detail below, the offset nature of the through holes 20a and 20b from the through holes 30a and 30b in both the longitudinal and transverse directions (i.e., length and width) may reduce frictional contact between the sutures passing through the aforementioned through holes when using some suture patterns.

[0033]

[0047] According to some embodiments, the axis AX3 and the associated first group of through holes may be offset from the axis AX by a distance W3, as shown in FIG. 5. The distance W3 may be at least 2 mm, 2.25 mm, 2.5 mm, 2.75 mm, 3 mm, 3.25 mm, 3.5 mm, 3.75 mm, 4 mm, 4.5 mm, 5 mm, or any other suitable size. The distance W3 may also be 5 mm or less, 4.5 mm or less, 4 mm or less, 3.75 mm or less, 3.5 mm or less, 3.25 mm or less, 2.75 mm or less, 2.5 mm or less, 2.25 mm or less, 2 mm or less, or any other suitable size. Combinations of these ranges are contemplated, including, for example, the distance W3 may be 4 mm to 5 mm, 3 mm to 5 mm, 3 mm to 6 mm, or any other suitable range of sizes. In some embodiments, the distance W3 may be 3 mm. It should be appreciated that the distance W3 may be adjusted based on the application, the size of the through hole, and / or the width W1 of the device 10.

[0034]

[0048] Similar to above, axis AX4 and the associated second group of through holes may be offset from axis AX by a distance W4, as shown in FIG. 5. In some embodiments, distance W3 may be substantially equal to distance W4, and axes AX3 and AX4 are mirror images about axis AX. However, embodiments in which distance W4 may be less than or greater than axis AX3 are also contemplated. It should be appreciated that distance W4 may be any suitable size relative to distance W3, as the disclosure is not so limited.

[0035]

[0049] In some embodiments, an axis extending between the first through holes 30a and 20a of each group of through holes, e.g., the fifth axis AX5, may be angled with respect to the transverse dimension TD, which may be the transverse axis of the device. Similarly, an axis, e.g., the sixth axis AX6 formed between the second through holes 20b and 30b present in the two separate groups of through holes, may be angled with respect to the transverse dimension TD. In some embodiments, both axes AX5 and AX6 may be angled with respect to the transverse dimension LD, which may be the longitudinal axis of the device perpendicular to the transverse axis of the device. In some embodiments, the axes AX5 and AX6 may be parallel, as shown in FIG. 5. Of course, non-parallel arrangements of the axes AX5 and AX6 are also contemplated. Furthermore, embodiments are contemplated in which the offset groups of through holes include three or more through holes. In some embodiments, the through holes distributed along the axis AX3 (e.g., the through holes 20a and 20b) may be offset longitudinally (e.g., along the axis AX) from the through holes distributed along the axis AX4 (e.g., the through holes 30a and 30b). In other embodiments, as described in more detail below, through-holes distributed along different longitudinal axes may be aligned with one another.

[0036]

[0050] In some embodiments, the distance measured between the outermost through-holes on AX3 (e.g., through-holes 20a and 20b) entails the first portion of L1, while the distance measured between the outermost through-holes on AX4 (e.g., through-holes 30a and 30b) entails the second portion of L1. In some embodiments, as illustrated by FIG. 5, the first and second portions of L1 may partially overlap. In other words, one through-hole along axis AX3 (e.g., through-hole 20b) may not be within the second portion of L1, and one through-hole along axis AX4 (e.g., through-hole 30a) may not be within the first portion of L1. In other embodiments, the first and second portions of L1 may be coextensive, such that the two portions substantially overlap.

[0037]

[0051] In some embodiments, the through holes 20a may be located a distance L2 away from an axis AX2, which may be the midline of the device, as shown in FIG. 5. The distance L2 may be at least 2.5 mm, 3 mm, 3.5 mm, 3.8 mm, 4 mm, 4.2 mm, 4.5 mm, 4.8 mm, 5 mm, 5.2 mm, 5.5 mm, 6 mm, 7 mm, or any other suitable size. The distance L2 may also be 7 mm or less, 6 mm or less, 5.5 mm or less, 5.2 mm or less, 5 mm or less, 4.8 mm or less, 4.5 mm or less, 4.2 mm or less, 4 mm or less, 3.8 mm or less, 3.5 mm or less, 3 mm or less, 2.5 mm or less, or any other suitable size. Combinations of these ranges are contemplated, including, for example, a distance L2 between 4 mm and 5 mm, between 3 mm and 5 mm, between 3 mm and 6 mm, or any other suitable range of sizes. It should be appreciated that the distance L2 between the through holes 20a may be adjusted to suit the application. For example, a very small defect size may require a smaller puncture size as compared to a larger defect with a larger defect. Thus, distance L2 may be any suitable size as the disclosure is not so limited.

[0038]

[0052] Similarly, as shown in FIG. 5, the through hole 30a may be located at a distance L3 from the axis AX2. The distance L3 may be at least 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 15 mm, 20 mm, 25 mm, 30 mm, 40 mm, 50 mm, or any other suitable size. The distance L3 may also be 50 mm or less, 40 mm or less, 30 mm or less, 25 mm or less, 20 mm or less, 15 mm or less, 12 mm or less, 11 mm or less, 10 mm or less, 9 mm or less, 8 mm or less, 7 mm or less, 6 mm or less, 5 mm or less, or any other suitable size. Combinations of these ranges are contemplated, including, for example, a distance L3 between 10 mm and 20 mm, between 5 mm and 30 mm, between 10 mm and 40 mm, or any other suitable range of sizes. In some embodiments, the distance L3 may be 10 mm. As discussed with respect to distance L2, distance L3 may be any suitable size for any suitable application, as the present disclosure is not limited by the size of distance L3.

[0039]

[0053] In some embodiments, through hole 30b may be spaced apart from axis AX2 by a distance equal to distance L2. In other words, through holes 30B and 20A may be equidistant from axis AX2. In other embodiments, through hole 30b may be spaced apart from axis AX2 by a distance greater than or less than distance L2. Similarly, through hole 20b may be spaced apart from axis AX2 by a distance equal to distance L3, such that through holes 30A and 20B are equidistant from axis AX2. Embodiments with through holes 20B and 20B are also contemplated.

[0040]

[0054] In some embodiments, another way of characterizing the positioning of through holes in different groups of through holes extending along at least a portion of the length of the device may include a longitudinal offset between corresponding through holes of each group of through holes along the length of the device. For example, in the embodiment of FIG. 5, the through holes in each group are spaced apart from each other by the same longitudinal offset along the length of the device (e.g., pitch distance, as described in more detail below). However, the position of each hole relative to the corresponding hole in the other group of through holes may be longitudinally offset. This may correspond to the difference between dimensions L2 and L3 in the illustrated embodiment of FIG. 5. In some embodiments, this difference between corresponding holes in different groups of through holes (e.g., longitudinal offset distance between through holes 20a and 30a) may be at least 2 mm, 2.5 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 10 mm, 12 mm, 14 mm, 15 mm, or any other suitable distance. The longitudinal offset distance between corresponding holes in different groups of through holes can also be 15 mm or less, 14 mm or less, 12 mm or less, 10 mm or less, 8 mm or less, 7 mm or less, 6 mm or less, 5 mm or less, 4 mm or less, 3 mm or less, 2.5 mm or less, 2 mm or less, or any other suitable distance. Combinations of these ranges are also contemplated, including longitudinal offset distances of, for example, 2 mm to 15 mm, 3 mm to 10 mm, 5 mm to 15 mm, 2 mm to 10 mm, or any other suitable range of distances. It should be appreciated that the longitudinal offset distance between through holes in any group can be determined by the number of through holes, the length L1 of the device, and the diameter D of the through holes.

[0041]

[0055] As shown in FIG. 5, the through holes of any group may be uniformly distributed along their respective axes (e.g., groups of through holes 20a and 20b along axis AX3) by a longitudinal pitch distance. In some embodiments, the longitudinal pitch distance of the through holes of any group may be 5 mm. In other embodiments, the longitudinal pitch distance of the through holes of any group may be at least 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 20 mm, 22 mm, 25 mm, or any other suitable distance. The longitudinal pitch distance of the through holes of any group may also be 25 mm or less, 22 mm or less, 20 mm or less, 16 mm or less, 15 mm or less, 14 mm or less, 13 mm or less, 12 mm or less, 11 mm or less, 10 mm or less, 9 mm or less, 8 mm or less, 7 mm or less, 6 mm or less, 5 mm or less, 4 mm or less, or any other suitable distance. Combinations of these ranges are also contemplated, including, for example, longitudinal pitch distances of the through holes of any group of 5 mm to 20 mm, 4 mm to 10 mm, 5 mm to 15 mm, or any other suitable range of distances. It should be appreciated that the longitudinal pitch distance of the through holes of any group may be determined by the number of through holes, the length L1 of the device, and the diameter D of the through holes. Of course, embodiments in which any of the through holes of the multiple groups are not uniformly spaced along any respective axis are also contemplated, as the disclosure is not so limited. In some embodiments, the pitch distance measured for the through holes of the first group may be equivalent to the pitch distance measured for the through holes of the second group. Of course, embodiments in which the through holes of the multiple groups have different pitch distances are also contemplated.

[0042]

[0056] As described in further detail below, through-holes 20a, 20b, 30a, and 30b may have any suitable diameter D. Although circular through-holes are shown in FIG. 5, it should be appreciated that any other suitable shape may be used to enable device 10 to distribute tension from the suture passing through the through-holes. In some embodiments, through-holes 20a, 20b, 30a, and 30b may all have the same diameter D, as shown in FIG. 5, while in other embodiments, through-holes 20a, 20b, 30a, and 30b may be sized differently. The present disclosure is not limited by the shape, size, number, or location of the through-holes.

[0043]

[0057] According to some embodiments, the midline 40 of the device 10 relative to the through-hole formed in the device may be centrally located along the entire length L1 of the device. In other embodiments, the midline 40 may be at any other location along the length L1. The midline 40 may have any suitable optical properties so as to be optically distinguishable. For example, the midline 40 may have a different color, opacity, material, or surface structure compared to the remainder of the device 10. In embodiments where the device is positioned along the transverse direction of the defect (e.g., FIG. 10), the device may not include a midline 40. It should be appreciated that the present disclosure is not limited by the presence, location, or optical properties of the midline 40.

[0044]

[0058] FIG. 6 shows a side view of the device 10 according to some embodiments. The device may have a thickness T measured from a bottom surface 60 of the device, which is oriented toward an underlying support surface (e.g., tissue), to a top surface 70, which is oriented away from the underlying support surface. Although FIG. 6 shows a uniform thickness T, embodiments with variable thickness T across the device 10 are also contemplated. For example, the top surface 70 may not be parallel to the bottom surface 60. In some embodiments, the top surface 70 and / or bottom surface 60 may include surface features to enhance adhesion with the surrounding environment. For example, the bottom surface 60, which may contact tissue, may include surface features, such as grooves, protrusions, or other surface textures configured to better grip tissue. In some embodiments, the bottom surface 60 may be smooth to allow the device 10 to be moved laterally around during the suturing process.

[0045]

[0059] As described in more detail below, thickness T may be any suitable size for the application of device 10. Device 10 may also include a beveled, chamfered, or rounded edge 50a extending between its sidewall 50 and top surface 70. It should be appreciated that sidewall 50 may be formed with any desired type of edge (either between bottom surface 60 and sidewall 50, and / or between top surface 70 and sidewall 50), as the disclosure is not so limited.

[0046]

[0060] FIG. 7 shows a cross-sectional view of the device 10 taken along line 7-7 and through hole 30a from FIG. 5. In some embodiments, through hole 30b (and any other through hole) extends from bottom surface 60 (which may contact the defect site) to top surface 70. Through hole 30b (or any other through hole) may have a rounded or curved inner surface with an inner radius 25 that accommodates a suture passing through the through hole without creating stress concentration points and / or snag points along the length of the associated suture. For example, a sharp edge between the sidewall of through hole 30b and top surface 70 may increase tensile and / or shear stresses in the suture passing through 30b and may cause the suture to break. In some embodiments, the inner radius 25 may be substantially equal to half the thickness H of the device 10 as shown in FIG. 5, although other embodiments of the inner radius 25 are contemplated.

[0047]

[0061] 8A-8F illustrate a method of using the device 10 according to some embodiments. As shown in FIG. 8A, a surgeon (e.g., a surgeon) may seek to close a defect 14 formed between tissue portions 11a and 11b. Thus, the surgeon may use a needle (not shown) or any other suitable tissue puncturing means to thread the suture 12 into tissue portion 11a and out of tissue portion 11b. In some embodiments, the puncture size at tissue portion 11a, measured from the edge of the defect to the puncture point of the needle and / or suture into tissue 11, may be substantially equal to the puncture size at tissue portion 11b. The suture 12 may then be threaded through the device 10, or vice versa, as shown in FIG. 8B. In some embodiments, the midline 40 (as shown in FIG. 5) may facilitate the surgeon to align the device 10 with the defect 14 and the suture 12. In other embodiments, the device 10 may include any other optical feature that allows for alignment. For example, the device 10 may be transparent or translucent, allowing the surgeon to visualize the defect through the device 10. In some embodiments, the suture 12 may be passed through the through holes 30a and 30b in the step shown in FIG. 8B. In other embodiments, the suture 12 may be passed through the through holes 20a and 20b in the step shown in FIG. 8B. It should be appreciated that the suture 12 may be passed through any pattern of through holes according to the preferred suture pattern being used. For example, in the step shown in FIG. 8B, the suture 12 may be passed through the through holes 20a and 30b. As discussed above, the device 10 or associated method of operation is not limited by the suture pattern.

[0048]

[0062] As shown in FIG. 8C, the surgeon may continue to pass the suture 12 through the remaining through-holes. As shown in FIG. 8D, the surgeon may pass the suture 12 through hole 30a, out hole 30b, through hole 20a, and out hole 20b, following a far-near-near-far suture pattern. At the step shown in FIG. 8D, the suture 12 may not have enough tension to close the defect 14. Thus, as shown in FIG. 8C, a suture loop 12d may be formed between two of the through-holes. Although the suture loop 12d is shown between the through-holes 20a and 30b, it should be appreciated that the suture loop 12d may be located between any other pair of through-holes. In some embodiments, the suture 12 may include two or more suture loops 12d. As shown in Figure 8E, the surgeon may thread one end of suture 12 through suture loop 12d to approximate the tissue portions and close defect 14. In some embodiments, suture 12 may not need to be threaded through suture loop 12d to approximate tissue portions 11a, 11b. Both free ends of suture 12 may be tied taut to further tension and secure suture 12 in place (as shown by knot 15 in Figure 3), although other methods of tensioning and securing suture 12 are contemplated.

[0049]

[0063] FIG. 9 shows a flow chart for a defect closure method using a far-near-near-far suture pattern using a surgical device, according to some embodiments. In block 400, a suture may be inserted into tissue from a first side (e.g., tissue portion 11a, as shown in FIG. 8D) of a defect (e.g., defect 14, as shown in FIG. 8D). The suture may then exit the tissue from a second side (e.g., tissue portion 11b, as shown in FIG. 8D), as shown in block 410. In these embodiments, the first puncture size on the first side is larger than the second puncture size on the second side. In block 420, a device (e.g., device 10, as shown in FIG. 8D) may be aligned with a pair of suture ends extending from the tissue so that they pass through. In some embodiments of the method shown in FIG. 9, one suture end may pass through one of the through holes 20a or 30b as the other suture end passes through one of the through holes 20b or 30a (as shown in FIG. 8F). In block 430, the suture end from the second side of the defect may be inserted into the first side of the defect with a third puncture size substantially equal to the second puncture size. In block 440, the suture end from block 430 may pass across the tissue and / or defect and exit the second side of the defect with a fourth puncture size substantially equal to the first puncture size. In block 450, the suture end from the second side of the defect is threaded under the loop (e.g., loop 12d in FIG. 8C) formed between the third and fourth suture punctures (at blocks 530 and 540, respectively). Passing the suture ends under the loops (e.g., between the top surface of the device and the loops) may allow the sutures to be temporarily held in tension as the tissue is approximated prior to formal closure of the defect (e.g., tying the sutures). As previously described and shown in block 460, the suture ends may be pulled taut and / or knotted across the defect with the suture ends pulled taut in opposite directions to approximate the first and second sides of the defect, thereby allowing defect closure. In some embodiments, the arrangement of the piercing holes on the device may allow the sutures to pass through each piercing hole without interference between the sutures when piercing subsequent suture punctures.In other words, the through-hole arrangement of the device may prevent the sutures from crossing their own path (e.g., between the punctures) until the suture ends are finally threaded under the suture loop. The lack of self-crossing and / or self-interference of the suture may allow the suture to directly contact the device on the top surface and resist linear movement of the suture between the fourth puncture and the wound closure, which may lead to slack in the suture and improper suture closure.

[0050]

[0064] FIG. 10 shows a flow chart of a defect closure method using a near-far-far-near suture pattern using a surgical device, according to some embodiments. In block 500, a suture may be inserted into tissue from a first side of the defect. The suture may then exit the tissue from a second side, as shown in block 510. In these embodiments, a first puncture size on the first side may be smaller than a second puncture size on the second side. In block 520, the device may be aligned with a pair of suture ends extending from the tissue so that they pass through. In some embodiments of the method shown in FIG. 10, one suture end may pass through one of the through holes 20A or 30B while the other suture end passes through one of the through holes 20b or 30a (as shown in FIG. 8F). At block 530, the suture end from the second side of the defect may be inserted into the first side of the defect with a third puncture size substantially equal to the second puncture size. At block 540, the suture end from block 530 may pass across the tissue and / or defect and exit the second side of the defect with a fourth puncture size substantially equal to the first puncture size. At block 550, the suture end from the second side of the defect may be threaded under the loop formed between the third and fourth suture punctures (described in blocks 530 and 540, respectively) to temporarily tension the sutures prior to formally closing the defect. As discussed above, and as shown in block 560, the suture ends may be pulled taut and / or knotted across the defect to approximate and secure the first and second sides of the defect, thereby enabling defect closure. In some embodiments, tension may be applied in opposite directions to both suture ends to facilitate defect closure.

[0051]

[0065] FIG. 11 shows a flow chart of a defect closure method using a vertical mattress suture pattern using a surgical device, according to some embodiments. In block 600, a suture may be inserted into tissue from a first side of the defect. The suture may then exit the tissue from a second side, as shown in block 610. In these embodiments, a first puncture size on the first side may be substantially equal to a second puncture size on the second side. In block 620, the device may be aligned with a pair of suture ends extending from the tissue so that they pass through. In some embodiments of the method shown in FIG. 11, the suture ends may pass through through holes 20b and 30a (shown in FIG. 8F). In block 630, the suture ends from the second side of the defect may be inserted into the second side of the defect with a third puncture size that is smaller than the second puncture size. In block 640, the suture ends from block 630 may pass across the tissue and / or defect and exit the first side of the defect at a fourth puncture size substantially equal to the third puncture size. As previously described and as shown in block 650, the suture ends may be tensioned and / or knotted to approximate the first and second sides of the defect, thereby enabling defect closure.

[0052]

[0066] Some embodiments of the surgical device 10 described herein may be used in an interrupted suture pattern, while other embodiments of the device may be used in a continuous suture pattern. Figure 12 shows one embodiment of a prior art system in which a surgeon attempts to close a defect 14 formed between tissue portions 11a and 11b with a continuous suture 12, which is torn by suture penetration. As shown in Figure 12, excessive tension in the suture 12 may cause tears 13 throughout the tissue, which may not only prevent defect closure, but may also cause additional damage to adjacent tissue.

[0053]

[0067] Thus, in some embodiments, the device 100 may be used with a continuous suture, as shown in Fig. 13. The suture 12 may be repeatedly passed between tissue portions 11A and 11B through the defect 14 and the device 100, and knots 15 may be tied to tension or otherwise tighten the suture 12. In these embodiments, the device 100 may be used by alternately passing the suture through through-holes located in two separate groups of through-holes extending along at least a portion of the length of the device and offset from one another in the transverse dimension. Thus, as shown in the drawings, the suture 12 may be passed from through-holes 200 located on one side of the defect 14 to through-holes 300 located on another side of the defect 14 once the suture 12 is in a closed or approximated configuration with the two portions of the defect positioned adjacent to one another. In the illustrated embodiment, the through-holes positioned on opposite sides of the defect are aligned with one another so that groups of through-holes are not offset longitudinally from one another along the length of the device, although embodiments in which a longitudinal offset is used are also contemplated. Although a simple continuous suture pattern (also known as a multi-repeated suture pattern) is shown in Figure 13, any other continuous suture pattern, such as, but not limited to, Ford interlocking, continuous horizontal mattress, continuous vertical mattress, continuous Lembert, Cushing, Connell, purse string, Halsted, interlocking, or any other suitable suture pattern may be used with any of the devices described herein.

[0054]

[0068] Although a single device 100 is shown along the defect 14 in FIG. 13, it should be appreciated that other suitable arrangements of one or more devices are also contemplated. For example, a device that may be smaller than the tissue defect 14 in the transverse direction TD may be used to cover the widest portion of the tissue defect 14. In another example, a device that may be larger than the tissue defect 14 in the transverse direction TD may be used. In these embodiments, the elongate body of the device may facilitate defect closure and reduce the risk of contamination by covering the defect. Of course, any other arrangements and / or orientations of the device relative to the tissue defect 14 may also be used as the disclosure is not so limited.

[0055]

[0069] As shown in Figures 14 and 15, the surgical device 100, 1000 can include a length L1 extending along an axis AX. It should be appreciated that in these embodiments of the device 100, the axis AX can extend parallel to a transverse direction TD of the defect and can extend parallel to a longitudinal axis of the device as opposed to a transverse direction LD, i.e., the transverse axis of the device. This is opposite to the configurations described above in Figures 3 and 5. The device 100, 1000 can also include a width W1 extending along an axis AX2, e.g., the transverse axis of the device. In some embodiments, the axis AX, which may be the longitudinal axis of the device, can be perpendicular to the axis AX2, as shown in Figures 14 and 15, although other arrangements of the axes AX and AX2 are contemplated.

[0056]

[0070] The device 100, 1000 may include a plurality of through holes 200, 2000 aligned along an axis AX3 extending along a portion of the length of the device, which may be parallel to the axis AX, and another plurality of through holes 300, 3000 aligned along an axis AX4 extending along a portion of the length of the device and parallel to the axis AX. In some embodiments, the axes AX3 and AX4 may be mirror images across the axis AX, and the distance W2 measured between the axes AX3 and AX4 may be equal to twice the distance W3 measured between the axes AX4 and AX. In some embodiments, the distance W2 may be at least 6 mm. Of course, embodiments in which the axes AX3 and AX4 are not mirror images along the axis AX are also contemplated. Although the plurality of through holes 200, 2000 and the through holes 300, 3000 are shown as mirror images across the axis AX in Figures 14 and 15, other configurations of through holes are also contemplated. As described in more detail below, each of the multiple through holes may have the same diameter D, or any combination of diameters, as the disclosure is not so limited.

[0057]

[0071] In the embodiment shown in Figures 14 and 15, the device includes at least five through holes in separate groups of through holes extending along a portion of the length of the device. However, any suitable number of through holes may be included in any of the devices disclosed herein. For example, a surgical device according to the present disclosure may include at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, or any other suitable number of through holes in a group of through holes extending along the length of the device. The surgical device may also include 20 or less, 19 or less, 18 or less, 17 or less, 16 or less, 15 or less, 14 or less, 13 or less, 12 or less, 11 or less, 10 or less, 9 or less, 8 or less, 7 or less, 6 or less, 5 or less, 4 or less, 3 or less, 2 or less, or any other suitable number of through holes in separate groups of through holes. It should be appreciated that the devices described herein are not limited by the number of through holes.

[0058]

[0072] As mentioned above, through-holes distributed along any axis may be aligned or offset in the longitudinal direction (e.g., along axis AX) with through-holes distributed along any other axis. For example, as shown in Figures 14 and 15, through-holes 200, 2000 distributed along axis AX3 are aligned with through-holes 300, 3000 along axis AX4. Of course, embodiments in which through-holes on the longitudinal axis are offset from one another (as shown in Figure 5) are also contemplated.

[0059]

[0073] In some embodiments of the device 100, 1000, the outermost through-hole may be located a distance L2 away from the midline of the device, e.g., axis AX2, as shown in Figures 14 and 15. In some embodiments, the distance L2 is 3 cm. The distance L2 may be at least 0.5 cm, 1 cm, 1.25 cm, 1.5 cm, 1.75 cm, 2 cm, 2.25 cm, 2.5 cm, 2.75 cm, 3 cm, 3.5 cm, 4 cm, or any other suitable size. The distance L2 may also be 4 cm or less, 3.5 cm or less, 3 cm or less, 2.75 cm or less, 2.5 cm or less, 2.25 cm or less, 2 cm or less, 1.75 cm or less, 1.5 cm or less, 1.25 cm or less, 1 cm or less, 0.5 cm or less, or any other suitable size. Combinations of these ranges are also contemplated, including, for example, distance L2 between 1 cm and 3 cm, between 0.5 cm and 4 cm, or any other suitable range of sizes.

[0060]

[0074] As shown in Figures 14 and 15, the plurality of through holes 200, 2000, 300, 3000 in each group of through holes may be uniformly spaced apart from one another by a distance L4 (e.g., a pitch distance). In some embodiments, the distance L4 may be 12.7 mm. In other embodiments, the distance L4 may be 5 mm. In some embodiments, the distance L4 may be at least 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, or any other suitable size. The distance L4 may also be 16 mm or less, 15 mm or less, 14 mm or less, 13 mm or less, 12 mm or less, 11 mm or less, 10 mm or less, 9 mm or less, 8 mm or less, 7 mm or less, 6 mm or less, 5 mm or less, 4 mm or less, or any other suitable size. Combinations of these ranges are also contemplated, including, for example, distance L4 between 4 mm and 15 mm, between 5 mm and 12 mm, or any other suitable range of sizes. It should be appreciated that distance L4 may be determined by the number of through holes, length L1 of the device, and diameter D of the through holes. Of course, embodiments in which any of the plurality of through holes 200, 2000, 300, 3000 are not uniformly spaced along any respective axis are also contemplated, as the disclosure is not so limited.

[0061]

[0075] It should be appreciated that the present disclosure is not limited by the size of the suture. In some embodiments, the suture may be of any suitable standard as defined by the United States Pharmacopeia (USP), including, for example and without limitation, 11-0, 10-0, 9-0, 8-0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 1, 2, 3, 4, 5, 6, 7. Thus, the diameter D of any through-hole of the device may be sized to accommodate a particular size suture. In some embodiments, the diameter D of the through-hole may be at least 1, 1.25, 1.5, 1.75, or any other suitable multiple of the diameter of the suture. Correspondingly, the diameter D of any through-hole may be no more than 2, no more than 1.75, no more than 1.5, no more than 1.25, or any other suitable multiple of the diameter of the suture. Combinations of the above ranges are also contemplated, including, for example, through-holes with diameters 1-2 times the diameter of the associated suture. The through-hole diameter D may be 1.5 times the diameter of the suture. In some embodiments, through-hole diameters greater than 3 times the suture diameter may prevent accurate suture placement and may not adequately distribute suture tension.

[0062]

[0076] In some embodiments, the diameter D of any through-hole in the device may be at least 0.02 mm, 0.03 mm, 0.04 mm, 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, 0.1 mm, 0.15 mm, 0.12 mm, 0.14 mm, 0.16 mm, 0.2 mm, 0.3 mm, 0.35 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 1 mm, 1.2 mm, 1.4 mm, 1.6 mm, 2 mm, or any other suitable diameter. Correspondingly, the diameter D of any through hole may be 2mm or less, 1.6mm or less, 1.4mm or less, 1.2mm or less, 1mm or less, 0.8mm or less, 0.7mm or less, 0.6mm or less, 0.5mm or less, 0.4mm or less, 0.35mm or less, 0.3mm or less, 0.2mm or less, 0.16mm or less, 0.14mm or less, 0.12mm or less, 0.15mm or less, 0.1mm or less, 0.08mm or less, 0.07mm or less, 0.06mm or less, 0.05mm or less, 0.04mm or less, 0.03mm or less, 0.02mm or less, or any other suitable diameter. Combinations of the above ranges are also contemplated, including, for example, any through hole diameters between 0.02 mm and 2 mm, between 0.05 mm and 1 mm, between 0.05 mm and 1.2 mm, between 0.06 mm and 2 mm, between 0.02 mm and 0.7 mm, or any other suitable range of sizes.

[0063]

[0077] In some embodiments, as shown in Figures 5, 14, and 15, multiple through-holes in any given device may have the same diameter D. In this manner, the manufacturing process may be simplified. In other embodiments, different through-holes in the same device may have different diameters. Variation in through-hole diameters may allow for adjustment of sutures in some through-holes (e.g., distal through-holes 30a and 20b in Figure 5) that may be larger than other through-holes (e.g., proximal through-holes 20a and 30b in Figure 5) during the defect closure procedure.

[0064]

[0078] Although circular through-holes are shown in Figures 5, 14, and 15, it should be appreciated that any other suitable through-hole shapes may be used. For example, any of the through-hole shapes may be elliptical, slot-shaped, rectangular, curved, polygonal, any combination thereof, or any other suitable shape. Of course, combinations of through-holes of various shapes are also contemplated. For example, distal through-holes 30a and 20b in Figure 5 may be slot-shaped such that the dimension in the transverse direction TD exceeds the dimension in the transverse direction LD, while proximal through-holes 20a and 30b may be circular. It should be appreciated that the present disclosure is not limited by the arrangement, shape, size, orientation, and / or any combination of the factors discussed above.

[0065]

[0079] In some embodiments, the length of the device may be at least 2 cm, 2.1 cm, 2.2 cm, 2.3 cm, 2.4 cm, 2.5 cm, 2.6 cm, 2.7 cm, 2.8 cm, 2.9 cm, 3 cm, 3.5 cm, 4 cm, 4.5 cm, 5 cm, 5.5 cm, 6 cm, or any other suitable size. The length L1 of the device may also be 6 cm or less, 5.5 cm or less, 5 cm or less, 4.5 cm or less, 4 cm or less, 3.5 cm or less, 3 cm or less, 2.9 cm or less, 2.8 cm or less, 2.7 cm or less, 2.6 cm or less, 2.5 cm or less, 2.4 cm or less, 2.3 cm or less, 2.2 cm or less, 2.1 cm or less, 2 cm or less, or any other suitable size. Combinations of these ranges are also contemplated, including, for example, devices with lengths L1 between 2 cm and 6 cm, between 2 cm and 3 cm, between 3 cm and 6 cm, or any other suitable range of sizes. In some embodiments, the length L1 of the device may be 2.5 cm. In other embodiments, the length may be 6 cm. It should be appreciated that the length of the device may be adjusted to match the length of the defect when the length is parallel to the transverse direction of the defect. Thus, the device may be used with any defect size ranging from 2 mm to 15 cm, or any other size, as the present disclosure is not limited by defect size.

[0066]

[0080] In some embodiments, the width of the device may be at least 4 mm, 4.5 mm, 5 mm, 5.5 mm, 6 mm, 6.5 mm, 7 mm, 7.5 mm, 8 mm, 10 mm, or any other suitable size. The width W1 of the device 10, 100, 1000 may also be 10 mm or less, 8 mm or less, 7.5 mm or less, 7 mm or less, 6.5 mm or less, 6 mm or less, 5.5 mm or less, 5 mm or less, 4.5 mm or less, 4 mm or less, or any other suitable size. Combinations of these ranges are also contemplated, including devices with widths of, for example, 4 mm to 10 mm, 5 mm to 8 mm, 6 mm to 10 mm, or any other suitable range of sizes. In some embodiments, the device may be delivered to the defect site through the lumen of a surgical instrument (e.g., laparoscope, endoscope, catheter, trocar). In these embodiments, the width may be less than 8 mm, allowing the device to pass through the instrument. In other embodiments, the device may be placed at a defect site that may be accessible to the surgeon (an "open" surgical event). In these embodiments, the device may be of any suitable width to be manipulated by the surgeon.

[0067]

[0081] In some embodiments, the thickness of the device may be suitably sized to allow the device to flexibly conform to the surface of the defect. In some embodiments, the defect may be across a curved surface. Thus, the device may be sufficiently flexible to conform to the curved surface of the defect. In some embodiments, the thickness may be at least 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, or any other suitable size. The thickness H of the device 10, 100, 1000 may also be 2 mm or less, 1.9 mm or less, 1.8 mm or less, 1.7 mm or less, 1.6 mm or less, 1.5 mm or less, 1.4 mm or less, 1.3 mm or less, 1.2 mm or less, 1.1 mm or less, 1 mm or less, or any other suitable size. Combinations of these ranges are also contemplated, including, for example, devices having thicknesses of 1-2 mm, 1-1.5 mm, 1.2-2 mm, or any other suitable range of sizes.

[0068]

[0082] It should be appreciated that the bending stiffness of the device may be proportional to the cube of the thickness, regardless of the shape of the device (e.g., rounded rectangle, oval, etc.). Thus, the thickness may be selected based on the lateral size of the device (e.g., width W1 and length L1). For example, the thickness of a device with a large width and length may exceed the thickness of a device with a small width and length. The stiffness of the device may be tailored to match a combination of geometry and material properties (e.g., Young's modulus) such that the device may have a stiffness suitable for its desired application. In some embodiments, it may be desirable for the device to have a low stiffness. For example, if the device is placed on a soft but dynamic surface, it may be desirable for the device to be more flexible than if the device is placed on a hard static surface. Thus, the device is not limited to any particular thickness.

[0069]

[0083] It should be appreciated that the devices disclosed herein may be used in surgical or non-surgical applications and therefore may be sized and / or shaped as appropriate for the application. Thus, the devices described herein are not limited to any particular shape or size.

[0070]

[0084] Although several embodiments of the present disclosure have been described and illustrated herein, those skilled in the art will readily envision various other means and / or structures for performing the functions and / or obtaining the results and / or one or more advantages described herein, and each of such variations and / or modifications is deemed to be within the scope of the present disclosure. More generally, those skilled in the art will readily recognize that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary, and that the actual parameters, dimensions, materials, and / or configurations will depend on the particular application or applications for which the teachings of the present disclosure are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the present disclosure described herein. It is therefore understood that the above-described embodiments are presented by way of example only, and that within the scope of the appended claims and equivalents thereof, the present disclosure may be practiced otherwise than as specifically described and claimed. The present disclosure relates to each individual feature, system, article, material, kit, and / or method described herein. Furthermore, any combination of two or more such features, systems, articles, materials, kits, and / or methods is included within the scope of the present disclosure, unless such features, systems, articles, materials, kits, and / or methods are mutually inconsistent.

[0071]

[0085] For example, any term as used herein relating to the shape, orientation, alignment, and / or geometric relationships of or between one or more articles, structures, forces, fields, flows, directions / trajectories, and / or subcomponents and / or combinations thereof, and / or any other tangible or intangible elements not listed above that lend themselves to characterization by such terms, unless otherwise defined or indicated, is understood not to require absolute conformance to the mathematical definition of such term, but rather to exhibit conformance to the mathematical definition of such term to the extent that enables the subject matter to be so characterized as would be understood by one of ordinary skill in the art most closely versed in such subject matter.

Claims

1. 1. A surgical device for securing a suture to soft tissue, comprising: an elongate body comprising a length and a width, said length exceeding said width; a first plurality of through holes extending from a first surface of the elongate body to a second surface of the elongate body opposite the first surface, the first plurality of through holes being positioned along at least a first portion of the length of the elongate body; and a second plurality of through holes extending from the first surface to the second surface of the elongated body, the second plurality of through holes positioned along at least a second portion of the length of the elongated body, the second plurality of through holes offset from the first plurality of through holes in a transverse direction parallel to the width of the elongated body; 13. An apparatus comprising:

2. The surgical device of claim 1 , wherein the first portion of the length of the elongate body and the second portion of the length of the elongate body partially overlap.

3. The surgical device of claim 2 , wherein the first portion of the length of the elongate body and the second portion of the length of the elongate body are coextensive with one another.

4. 2. The surgical device of claim 1, wherein the first plurality of through holes are positioned along a first axis parallel to a longitudinal axis of the elongate body and the second plurality of through holes are positioned along a second axis parallel to the longitudinal axis of the elongate body.

5. The surgical device of claim 1 , wherein at least a portion of the first plurality of through holes are aligned with at least a portion of the second plurality of through holes along a longitudinal direction of the device.

6. The surgical device of claim 1 , wherein at least a portion of the first plurality of thrust holes are offset along a longitudinal direction of the device from at least a portion of the second plurality of thrust holes.

7. The surgical device of claim 1 , wherein the first and second plurality of through holes are offset in the transverse direction by at least 6 mm.

8. The surgical device of claim 4 , wherein a pitch of the first plurality of through holes is equal to a pitch of the second plurality of through holes.

9. The surgical device of claim 1 , wherein the width is less than 8 mm.

10. The surgical device of claim 1 , wherein the first plurality of through holes and the second plurality of through holes are circular.

11. The surgical device of claim 1 , wherein the device is formed of a bioabsorbable material.

12. The surgical device of any one of claims 1 to 11, wherein the first plurality of through holes includes at least two through holes and the second plurality of through holes includes at least two through holes.

13. 1. A method of securing a suture to soft tissue, the method comprising: passing a first end of a suture from a first side of the defect through a first through hole of a first plurality of through holes of a surgical device, the first plurality of through holes being positioned along at least a first portion of a length of the surgical device, the first plurality of through holes extending from a first surface of the surgical device to a second surface of the surgical device; and passing a second end of the suture from an opposite side of the defect through a first through hole of a second plurality of through holes of the surgical device, the second plurality of through holes being positioned along at least a second portion of the length of the surgical device, the second plurality of through holes extending from the first side of the surgical device to the second side of the surgical device. Including, The method, wherein the second plurality of through holes is offset from the first plurality of through holes in a transverse direction parallel to a width of the surgical device.

14. The method of claim 13 , further comprising anchoring the first and second ends of the suture across the defect.

15. Securing the first end and the second end of the suture comprises: passing the first end of the suture through a second through hole of the first plurality of through holes; and passing the first end of the suture through a second one of the second plurality of through holes on the opposite side of the defect.

15. The method of claim 14, comprising:

16. The method of claim 13 , wherein the first portion of the length of the surgical device and the second portion of the length of the surgical device partially overlap.

17. The method of claim 13 , wherein the first portion of the length of the surgical device and the second portion of the length of the surgical device are coextensive with one another.

18. 15. The method of claim 14, wherein a first axis extending between the first plurality of thrust holes is parallel to a longitudinal axis of the surgical device, and a second axis extending between the second plurality of thrust holes is parallel to the longitudinal axis of the device.

19. moreover: forming a loop between the second through hole of the first plurality of through holes and the second through hole of the second plurality of through holes across the defect; and passing the first end of the suture across the defect between the loop and the first surface of the device.

16. The method of claim 15, comprising:

20. The method of claim 14, further comprising tying the first and second ends of the suture together in a knot.

21. The method of claim 13, further comprising forming an interrupted suture pattern by passing the suture through the first plurality of thru-holes and the second plurality of thru-holes.

22. The method of claim 13, further comprising passing the suture through the first plurality of thru-holes and the second plurality of thru-holes to form a continuous suture pattern.

23. The method of any one of claims 13 to 22, wherein at least a portion of the first plurality of through holes are aligned with at least a portion of the second plurality of through holes along a longitudinal direction of the device.

24. 23. The method of any one of claims 13 to 22, wherein at least a portion of the first plurality of through holes are offset along a longitudinal direction of the device from at least a portion of the second plurality of through holes.

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