Suture-based closure device

Abstract

A suture device includes a suture loop defining an arcuate channel extending therein. A first arcuate needle introducer is slidably disposed within a first side of the arcuate channel, and a second arcuate needle introducer is slidably disposed within a second side of the arcuate channel. An arcuate needle is passable between the first and second arcuate needle introducers and includes a first latching feature adapted to releasably secure the arcuate needle to the first arcuate needle introducer and a second latching feature adapted to releasably secure the arcuate needle to the second arcuate needle introducer.

Description

[0001] Cross-citation of relevant literature

[0002] This application claims the benefit and priority of U.S. Provisional Patent Application Serial No. 63 / 002,822, filed on March 31, 2020, the disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure relates to devices for suturing tissue, and more specifically, to devices that work in conjunction with an endoscope or similar devices for endoscopic suturing of tissue. Background Technology

[0004] Various endoscopic treatments can result in defects (or wounds) that are too large for hemostatic clips to easily bridge, making closure difficult. Examples of such endoscopic treatments include removing large lesions, creating tunnels under the mucosal layer, removing full-thickness tissue, treating other organs by penetrating the outside of the gastrointestinal tract, and repairing postoperative problems such as postoperative leakage, suture failure, and anastomotic leakage. Endoscopic treatments also include weight-reduction procedures. Each of the known devices and methods for endoscopically closing large defects has certain advantages and disadvantages. Summary of the Invention

[0005] This disclosure relates to several alternative designs, materials, and methods for devices used to close large defects in endoscopes. In one example, a suture device includes a mounting structure adapted to fix the distal end of an endoscope, and a suture loop fixed relative to the mounting structure, defining an arcuate channel extending within the suture loop. A first arcuate needle inserter is slidably disposed on a first side of the arcuate channel and includes a working end and a control end. A first control element is operatively coupled to the control end of the first arcuate needle inserter, and an arcuate needle is releasably fixed to the first needle inserter.

[0006] Alternatively or additionally, the suture device may further include a second arcuate needle guide slidably disposed within a second side of the arcuate channel and including a working end and a control end. A second control element is operatively coupled to the control end of the second arcuate needle guide. The arcuate needle is passable between the first and second arcuate needle guides and includes a first latching feature adapted to releasably secure the arcuate needle to the first arcuate needle guide and a second latching feature adapted to releasably secure the arcuate needle to the second arcuate needle guide. The first and second control elements cross each other upon entering the arcuate channel of the suture loop.

[0007] Alternatively or additionally, the first latching feature may include a first pair of radially spaced protrusions disposed within a first portion of the arcuate needle, and the second latching feature may include a second pair of radially spaced protrusions disposed within a second portion of the arcuate needle.

[0008] Alternatively or additionally, the arcuate needle may further include a suture hole disposed between the first latch feature and the second latch feature.

[0009] Alternatively or additionally, the first needle threader may include a first hole complementary to the first protrusion of the first pair of protrusions, and a second hole complementary to the second protrusion of the first pair of protrusions.

[0010] Alternatively or additionally, the first arcuate needle threader may include a first pair of longitudinally arranged slots extending from the working end of the first arcuate needle threader toward its control end, each of the first pair of longitudinally arranged slots extending through one of the first and second holes, so that the first arcuate needle threader can be bent relative to the first and second holes when not constrained by the first side of the arcuate suture loop.

[0011] Alternatively or additionally, the second arcuate needle threader may include a first hole complementary to the first protrusion of the second pair of protrusions, and a second hole complementary to the second protrusion of the second pair of protrusions.

[0012] Alternatively or additionally, the second arcuate needle threader may include a second pair of longitudinally arranged slots extending from the working end of the second arcuate needle threader toward its control end, each of the second pair of longitudinally arranged slots extending through one of the first and second holes, so that the second arcuate needle threader can be bent relative to the first and second holes when not constrained by the second side of the arcuate suture loop.

[0013] Alternatively or additionally, the suture loop may extend circumferentially from the first opening end to the second opening end, the first opening end and the second opening end being spaced apart by a certain distance, which allows tissue to extend therebetween.

[0014] Alternatively or additionally, the annular channel may have a circular cross-sectional profile, except for a first region near the first opening end and a second region near the second opening end.

[0015] Alternatively or additionally, the first region and the second region may each have an oval cross-sectional profile, which allows the first arcuate needle threader and / or the second needle threader to begin bending as the first arcuate needle threader leaves the first opening end and / or the second arcuate needle threader leaves the second opening end.

[0016] Alternatively or additionally, the first control element may enter the first side of the arcuate channel substantially parallel to the tangent of the first arcuate needle threader, near the position where the first control element is fixed to the first arcuate needle threader.

[0017] Alternatively or additionally, the second control element may enter the second side of the arcuate channel substantially parallel to the tangent of the second arcuate needle threader, near the position where the second control element is fixed to the second arcuate needle threader.

[0018] Alternatively or additionally, the suture device may further include a first tubular member housing a first control element and a second tubular member housing a second control element.

[0019] In another example, a suture device suitable for use with an endoscope includes a suture loop having a first side and a second side, defining an arcuate channel extending within the suture loop. A first tubular member includes a curved distal portion whose curvature is opposite to the direction of curvature of the first side of the suture loop. A second tubular member includes a curved distal portion whose curvature is opposite to the direction of curvature of the second side of the suture loop. A first arcuate needle guide is slidably disposed within the first side of the arcuate channel, and a second arcuate needle guide is slidably disposed within the second side of the arcuate channel. A first control element is disposed within the first tubular member and operatively coupled to the first arcuate needle guide. A second control element is disposed within the second tubular member and operatively coupled to the second arcuate needle guide. By manipulating the first and second control elements, an arcuate needle can pass between the first and second arcuate needle guides.

[0020] Alternatively or additionally, the first needle threader may include a working end adapted to releasably secure the arcuate needle.

[0021] Alternatively or additionally, the first arcuate needle threader may include a first pair of longitudinally arranged slots extending through the working end of the first needle threader so that the working end of the first needle threader can be bent when not constrained by the first side of the arcuate suture loop.

[0022] Alternatively or additionally, the second arcuate needle threader includes a working end adapted to releasably secure the arcuate needle.

[0023] Alternatively or additionally, the second arcuate needle threader may include a second pair of longitudinally arranged slots extending through the working end of the second arcuate needle threader so that the working end of the second arcuate needle threader can be bent when not constrained by the second side of the arcuate suture loop.

[0024] In another example, a suture device suitable for use with an endoscope includes an endcap ring adapted to be fixed to the distal end of the endoscope and a C-shaped suture loop fixed to the endcap ring. The C-shaped suture loop has a first side and a second side and defines an arcuate channel extending within the suture loop. A first arcuate needle inserter is slidably disposed on the first side of the arcuate channel, and a second arcuate needle inserter is slidably disposed on the second side of the arcuate channel. A first control element is adapted to enter the first side of the arcuate channel substantially parallel to the tangent of the first needle inserter, near the position where the first control element is fixed to the first needle inserter, and a second control element is adapted to enter the second side of the arcuate channel substantially parallel to the tangent of the second needle inserter, near the position where the second control element is fixed to the second needle inserter. By manipulating the first and second control elements, an arcuate needle can pass between the first and second arcuate needle inserters.

[0025] The foregoing summary of some embodiments is not intended to describe every disclosed embodiment or every implementation of this disclosure. The accompanying drawings and detailed description below illustrate these embodiments in more detail. Attached Figure Description

[0026] This disclosure can be more fully understood in light of the following description relating to the accompanying drawings, wherein:

[0027] Figure 1 It is a perspective view of illustrative components including an illustrative suture device fixed relative to an endoscope;

[0028] Figure 2 yes Figure 1 The end view of the illustrative component;

[0029] Figures 3 to 6 yes Figure 1 A partial cross-sectional view of an illustrative suture device, showing the steps of how an arcuate needle passes from a first arcuate needle threader to a second arcuate needle threader.

[0030] Figure 7 It is possible Figure 1 A perspective view of an arc-shaped needle threader used as a first or second arc-shaped needle threader in an illustrative component;

[0031] Figure 8 yes Figure 1 A perspective view of a portion of an illustrative suture device, showing a portion of a suture loop, an arcuate needle threader, and an arcuate needle fixed relative to the arcuate needle threader.

[0032] Figure 9 It is along Figure 8 The line 9-9 was cut off Figure 8 A cross-sectional view of a portion of the illustrative suture device shown; and

[0033] Figure 10 It is possible Figure 1 A three-dimensional diagram of the curved needle used in illustrative suture equipment.

[0034] While this disclosure can be used in various modifications and alternatives, its specific details have been illustrated by way of example in the accompanying drawings and will be described in detail. However, it should be understood that the invention is not intended to be limited to the specific embodiments described. Rather, the invention is intended to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of the invention. Detailed Implementation

[0035] The terms defined below shall apply unless otherwise specified in the claims or elsewhere in this specification.

[0036] Definitions of certain terms are provided below and should be applied unless otherwise defined in the claims or elsewhere in this specification.

[0037] Whether explicitly stated or not, all numerical values ​​herein are assumed to be modified by the term "about". The term "about" generally refers to a range of numbers that a person skilled in the art would consider equivalent to the referenced value (e.g., having the same function or result). In many cases, the term "about" may refer to a number that includes rounding to the nearest significant figure.

[0038] A description of a range of numbers represented by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0039] Although some suitable dimensions, ranges, and / or values ​​relating to various components, features, and / or specifications are disclosed, those skilled in the art, inspired by this disclosure, will understand that the required dimensions, ranges, and / or values ​​may deviate from those explicitly disclosed.

[0040] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include or otherwise refer to singular and plural objects, unless the content expressly indicates otherwise. As used in this specification and the appended claims, the term “or” is generally used in the sense of including “and / or,” unless the content expressly indicates otherwise.

[0041] The following detailed description should be read with reference to the accompanying drawings, in which similar elements in different drawings are numbered the same. The detailed description and drawings (not necessarily to scale) depict illustrative embodiments and are not intended to limit the scope of this disclosure. The illustrative embodiments described are exemplary only. Selected features of any illustrative embodiment may be incorporated into other embodiments unless explicitly stated otherwise.

[0042] This disclosure relates to devices configured for use in conjunction with endoscopes or similar delivery devices for closing internal wounds. In some cases, the suture devices described herein may be configured for use in conjunction with a single-working-channel endoscope or a dual-working-channel endoscope within a single working channel or available channel of the endoscope, and in some cases may be operated by a single person, although in others a second person may be involved.

[0043] Figure 1 This is a perspective view of illustrative component 10, which includes an illustrative suture device 12 fixed relative to the endoscope 14, and Figure 2 This is an end view of illustrative component 10. As shown, the illustrative suture device 12 includes an end cap ring 16 configured to secure the suture device 12 relative to the endoscope 14. For example, the end cap ring 16 can be any on-endoscope connector. In some cases, the suture device 12 may instead include other structures or features (not shown) adapted to secure the suture device 12 relative to the endoscope 14. The suture device 12 includes a C-shaped suture loop 18. As will be shown with reference to the following figures, the C-shaped suture loop 18 is adapted to allow an arcuate needle inserter to slide within the C-shaped suture loop 18 so as to allow the arcuate needle (in) Figure 1 (Not shown) passes back and forth between a pair of curved needle threaders.

[0044] The C-shaped suture loop 18 can be viewed as drawing a circle, except for the missing portion of the circle shown between the first open end 20 and the second open end 22. This missing portion of the circle can be viewed as defining a region 24 that can accommodate tissue within it for suturing. In some cases, the relative dimensions of the C-shaped suture loop 18, including the relative distance between the first open end 20 and the second open end 22, can be varied to accommodate different tissues, different relative needle threader sizes, etc. Additionally, the C-shaped suture loop 18 shown can be viewed as forming a specific arcuate angle relative to the end cap ring 16. This is merely illustrative, as the C-shaped suture loop 18 can be set at any desired angle relative to the end cap ring 16. The C-shaped suture loop 18 can be attached at any desired position relative to the end cap 16. In some cases, the relative position of the C-shaped suture loop 18 can be adjusted after delivery. In some cases, such as in… Figure 2As best shown, the suture device 12 can be fixed relative to the endoscope 14, such that region 24 is centered or at least substantially centered relative to the main working channel 26 of the endoscope 14, although this is not necessary in all cases. While no additional tools are required to use the suture device 12, in some situations it may be necessary to provide tools that allow access to region 24 through the working channel 26. For example, it may be necessary to use a grasper to help pull tissue toward region 24 during suturing, or to hold tissue relative to region 24. Therefore, region 24 can also be considered as the workspace of the suture device 12.

[0045] The C-shaped suture loop 18 can be considered to include a first side 28 and a second side 30. The suture device 12 includes a first tubular member 32 and a second tubular member 34. While the first side 28 of the C-shaped suture loop 18 points to the right (in the illustrated direction) and the second side 30 of the C-shaped suture loop points to the left, the first tubular member 32 points to the left and the second tubular member 34 points to the right (see, for example...). Figure 3 The first and second control elements are visible. The first tubular member 32 can be considered as including a curved portion 36 and a linear portion 38 extending proximally. Similarly, the second tubular member 34 can be considered as including a curved portion 40 and a linear portion 42 extending proximally. It is understood that the bending direction of the curved portion 36 of the first tubular member 32 is opposite to the bending direction of the first side 28 of the C-shaped suture loop 18, while the bending direction of the curved portion 40 of the second tubular member 34 is opposite to the bending direction of the second side 30 of the C-shaped suture loop 18. In some cases, the side surfaces of the C-shaped suture loop 18 and the relative curvature of the first tubular member 32 and the second tubular member 34 facilitate the connection of the control elements with the arcuate needle threader (in... Figure 1 and 2 Alignment (not shown in the image).

[0046] Figures 3 to 6This is a partial cross-sectional view of the suture device 12, in which a portion of the suture loop 12, the curved portion 36 of the first tubular member 32, and the curved portion 40 of the second tubular member 34 are cut open to reveal further details of the suture device 12. The suture device 12 includes a first arcuate needle threader 44 operatively connected to a first control element 46 and a second arcuate needle threader 48 operatively connected to a second control element 50. It is understood that the control elements 46, 50 intersect each other at a position 52 near where the first control element 46 is fixed to the first arcuate needle threader 44 and the second control element 50 is fixed to the second arcuate needle threader 48. In some cases, allowing the first control element 46 and the second control element 50 to intersect can reduce the effort required to move the first control element 46 and the second control element 50, because the control elements 46, 50 can be better aligned with their respective arcuate needle threaders 44, 48. Although the second control element 50 is shown passing over the first control element 46, this is merely an example. The arc-shaped needle 54 can be considered as passing between the first arc-shaped needle threader 44 and the second arc-shaped needle threader 48.

[0047] In some cases, the first control element 46 enters the first side 28 of the arcuate channel 56 of the C-shaped suture loop 18 in a direction substantially parallel to the tangent of the first arcuate needle inserter 44, and is fixed to the position of the first arcuate needle inserter 44 near the first control element 46. In other cases, the second control element 50 enters the second side 30 of the arcuate channel 56 of the C-shaped suture loop 18 in a direction substantially parallel to the tangent of the second arcuate needle inserter 48, and is fixed to the position of the second arcuate needle inserter 48 near the second control element 50.

[0048] The C-shaped suture loop 18 defines an arcuate channel 56 that extends through the C-shaped suture loop 18 from the first opening end 20 to the second opening end 22. (As you can...) Figure 8 and 9 As discussed in more detail, the arcuate channel 56 has a constant inner diameter and internal cross-sectional profile, which are substantially the same as the outer diameter and external cross-sectional profile of each of the first arcuate needle threader 44 and the second arcuate needle threader 48, except for a first region 58 near the first opening end 20 and a second region 60 near the second opening end 22. In some cases, as shown, the first region 58 includes a slot 62 that accommodates sutures attached to the arcuate needle 54 when the arcuate needle 54 is positioned therein, and the second region 60 includes a slot 64 that accommodates sutures attached to the arcuate needle 54 when the arcuate needle 54 is positioned therein.

[0049] Although the proximal handle or other mechanisms are not shown, it is understood that a user can selectively advance the first arcuate needle threader 44 by actuating the first control element 46 in a first direction, and selectively retract the first arcuate needle threader 44 by actuating the first control element 46 in a second, opposite direction. A user can selectively advance the second arcuate needle threader 48 by actuating the second control element 50 in the first direction, and selectively retract the second arcuate needle threader 48 by actuating the second control element 50 in a second, opposite direction. A user can also hold the first arcuate needle threader 44 or the second arcuate needle threader 48 in a specific position by simply preventing the appropriate control elements 46, 50 from moving.

[0050] from Figure 3 Initially, the first curved needle threader 44 can be seen retracted into the first side 28 of the C-shaped suture loop 18, and the second curved needle threader 48 can be seen retracted into the second side 30 of the C-shaped suture loop 18. The curved needle 54 can be seen secured to the first curved needle threader 44. Further details regarding how the curved needle 54 is secured to the first curved needle threader 44 will follow. Figure 7 and 8 Discussion in the middle. Go to... Figure 4 As can be seen, by advancing the first control element 46 in the appropriate direction, the first arc-shaped needle threader 44 has been partially advanced beyond the first side 28 of the C-shaped suture loop 18 and into region 24. Continue reading... Figure 5 The first arc-shaped needle threader 44 has been further advanced so that the arc-shaped needle 54 has contacted the second arc-shaped needle threader 48. In some cases, when the first arc-shaped needle threader 44 is further advanced to drive the arc-shaped needle 54 into the second arc-shaped needle threader 48, the second arc-shaped needle threader 48 can be held in place by holding the second control element 50 in place. Finally, in Figure 6 In this context, the arc needle 54 can be considered fixed to the second arc needle 48 because the first arc needle threader 44 has been retracted by moving the first control element 46 in the appropriate direction.

[0051] Understandable, Figures 3 to 6 The steps shown will result in the placement of sutures through tissue present in the area or work area 24. This can be achieved by laterally moving the suture device 12 (fixed to the distal end of the endoscope 14) and reversing... Figures 3 to 6 The steps shown are for placing subsequent sutures. As previously mentioned, in some cases, a gripper or other tools may be provided through the working channel 16 of the endoscope 14, although this is not necessary for the operation of the suture device 12.

[0052] Figure 7This is a perspective view of an arcuate needle threader 70, which can be used, for example, as a first arcuate needle threader 44 or a second arcuate needle threader 48. The arcuate needle threader 70 has a curvature that matches the curvature of the C-shaped suture loop 18, allowing it to slide easily within the C-shaped suture loop 18 relative to the arcuate channel 56. Although the arcuate needle threader 70 is shown as having a circular cross-sectional shape, this is not always necessary. For example, the arcuate needle threader 70 can have a non-circular cross-sectional shape, such as a square or rectangular shape. The arcuate needle threader 70 can be considered to have a working end 72 and a control end 74. The working end 72 is adapted to releasably secure the arcuate needle 54, while the control end 74 is adapted to be attached to a control element, such as a first control element 46 or a second control element 50. The arcuate needle threader 70 has a body 76 extending from the working end 72 to the control end 74. In some cases, the main body 76 is formed by a sodium hypochlorite tube and is therefore hollow.

[0053] The working end 72 includes a pair of holes 78 radially spaced approximately 180 degrees apart. As will be discussed, the holes 78 are adapted to releasably secure corresponding and complementary latching features present on the arcuate needle 54. The arcuate needle threader 70 includes a pair of slots 80, which may also be radially spaced approximately 180 degrees apart, such that each slot 80 can pass through one of the holes 78. When the arcuate needle threader 70 is positioned within the arcuate channel 56 of the C-shaped suture loop 18, it is understood that their relative dimensions restrict movement, thereby securing the arcuate needle 54 relative to the arcuate needle threader 70. As the working end 72 extends outward from the arcuate channel 56 of the C-shaped suture loop 18, the slots 80 are adapted to allow the working end 72 to fully bend relative to the holes 78, which allows the arcuate needle threader 70 to release the arcuate needle 54.

[0054] Figure 8 This is a perspective view showing a portion 90 of a C-shaped suture loop 18, an arc-shaped needle threader 70, and an arc-shaped needle 54. The portion 90 of the C-shaped suture loop 18 includes a region 99 corresponding to a first region 58 and / or a second region 60, which has a non-circular cross-sectional profile, such as... Figure 9 As shown, the diagram is along Figure 8 The cross-section is taken by line 9-9. One of the slots 80 can be considered as extending through one of the holes 78, although the other slot 80 and the other hole 78 are on opposite sides and therefore not visible in this view. The arcuate needle 54 includes a protrusion 98 that engages with the visible hole 78. It will be understood that there is also a second protrusion 98 radially spaced approximately 180 degrees and therefore capable of engaging in the other hole 78. Figure 9As shown, the inner contour of region 99 is larger than the outer contour of the arc needle threader 70. When the working end 72 is positioned within region 99, it allows sufficient bending of the working end 72 of the arc needle threader 70 to push the arc needle 54 to align with the working end 72, thereby allowing the arc needle 54 to be transferred from one arc needle threader to another. Figure 8 In the position shown, the curved needle threader 70 is positioned to transfer the curved needle 54 to another curved needle threader.

[0055] It is understood that the curved needle 54 is always held by at least one of the first curved needle threader 44 and the second curved needle threader 48. When the working end 72 of the curved needle threader 70 (representing either the first curved needle threader 44 or the second curved needle threader 48) is positioned within region 99 (e.g., Figure 8 As shown in the diagram, the curved needle threader 70 has sufficient curvature to allow the curved needle 54 to be transferred from another curved needle threader. When the working end 72 of the curved needle threader 70 extends beyond region 99, there may be sufficient curvature relative to the hole 78 and slot 80 to allow the curved needle threader 70 to transfer the curved needle 54 to another curved needle threader. Therefore, the curved needle 54 will not fall out because the curved needle 54 will always be fixed relative to one of the curved needle threaders 44, 48.

[0056] Figure 10 This is a perspective view of the arc-shaped needle 54. The arc-shaped needle 54 includes a curved body 92 whose curvature matches the curvature of the first arc-shaped needle threader 44 and the second arc-shaped needle threader 48, such that the first arc-shaped needle threader 44 and the second arc-shaped needle threader 48 can move freely within the arc-shaped channel 56 in response to the relative movement of the control elements 46, 50. The arc-shaped needle 54 is fixed to either the first arc-shaped needle threader 44 or the second arc-shaped needle threader 48. The arc-shaped body 92 has a pair of protrusions 96, which can be considered as latching features, that can releasably engage with a corresponding hole 78 in one of the first arc-shaped needle threaders 44 and the second arc-shaped needle threader 48. The arc-shaped body 92 has a pair of protrusions 98, which can be considered as latching features, that can releasably engage with a corresponding hole 78 in the other of the first arc-shaped needle threader 44 and the second arc-shaped needle threader 48. Although the cross-sections of the protrusions 96 and 98 shown are circular, other shapes are also possible. The hole 78 can vary depending on the contour of the protrusions 96 and 98. The suture hole 94 passes through the curved body 92 to receive the suture. The curved body 92 has pointed ends 100 and 102, allowing the curved needle 54 to pass through the tissue in either direction.

[0057] It is understood that a variety of different materials may be used in the fabrication of the device described herein. In some cases, a variety of different metals may be used. Illustrative but non-limiting examples of suitable metals include titanium, stainless steel, magnesium, cobalt-chromium, and others. In some cases, the first control element 46 and the second control element may be made of a nickel-titanium alloy. In some embodiments, for example, the device described herein may include any suitable polymeric material, including biocompatible materials such as polyurethane or silicone. Suitable polymers include PEEK (polyether ether ketone) and polycarbonate. Other suitable polymers include, but are not limited to, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), and polyoxymethylene (POM, e.g., provided by DuPont). Polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., those provided by DSM Engineering Plastics). ), ether-based or ester-based copolymers (e.g., butene / poly(alkylene ether) phthalates and / or other polyester elastomers, such as those offered by DuPont). Polyamide (e.g., provided by Bayer) Or provided by ElfAtochem ), elastomer polyamide, block polyamide / ether, polyether block amide (PEBA, for example, trade name) ), ethylene-vinyl acetate copolymer (EVA), silicone resin, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g.) Polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), trimethyl terephthalate, polyethylene terephthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene ether (PPO), poly(p-phenylene terephthalamide) (e.g., Polysulfone, nylon, nylon-12 (e.g., available from EMS American Grilon) Perfluoropropyl vinyl ether (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites thereof.

[0058] Those skilled in the art will recognize that this disclosure can be presented in various forms, rather than the specific embodiments described and contemplated herein. Therefore, deviations in form and detail may be made without departing from the scope and spirit of this disclosure as set forth in the appended claims.

Claims

1. A suture device, the suture device comprising: Mounting structure, the mounting structure being adapted to fix relative to the distal end of an endoscope; A suture loop, fixed relative to the mounting structure, the suture loop defining an arcuate channel extending within the suture loop; A first arc-shaped needle threader is slidably disposed within a first side of the arc-shaped channel. The first arc-shaped needle threader includes a working end and a control end. A first control element, operatively connected to the control terminal of the first arc-shaped needle threader; An arc-shaped needle, which is releasably fixed to the first arc-shaped needle threader; A second arc-shaped needle threader is slidably disposed within the second side of the arc-shaped channel. The second arc-shaped needle threader includes a working end and a control end; and A second control element is operatively connected to the control terminal of the second arc-shaped needle threader; The curved needle is capable of passing between the first curved needle threader and the second curved needle threader, and includes a first latching feature adapted to releasably secure the curved needle to the first curved needle threader and a second latching feature adapted to releasably secure the curved needle to the second curved needle threader; and The first control element and the second control element intersect each other when entering the arc-shaped channel of the suture loop.

2. The suture device of claim 1, wherein the first latching feature includes a first pair of radially spaced protrusions disposed within a first portion of the arcuate needle, and the second latching feature includes a second pair of radially spaced protrusions disposed within a second portion of the arcuate needle.

3. The suture device of claim 1, wherein the arcuate needle further includes a suture hole disposed between the first latch feature and the second latch feature.

4. The suture device of claim 2, wherein the first arcuate needle threader includes a first hole complementary to a first protrusion of the first pair of protrusions, and a second hole complementary to a second protrusion of the first pair of protrusions.

5. The suture device of claim 4, wherein the first arcuate needle threader includes a first pair of longitudinally arranged slots extending from the working end of the first arcuate needle threader toward its control end, each of the first pair of longitudinally arranged slots extending through one of the first hole and the second hole, such that the first arcuate needle threader is bendable relative to the first hole and the second hole when not constrained by the first side of the suture loop.

6. The suture device of claim 2, wherein the second arcuate needle guide includes a first hole complementary to the first protrusion of the second pair of protrusions, and a second hole complementary to the second protrusion of the second pair of protrusions.

7. The suture device of claim 6, wherein the second arcuate needle threader includes a second pair of longitudinally arranged slots extending from the working end of the second arcuate needle threader toward its control end, each of the second pair of longitudinally arranged slots extending through one of the first hole and the second hole, such that the second arcuate needle threader is bendable relative to the first hole and the second hole when not constrained by the second side of the suture loop.

8. The suture device according to any one of claims 1-7, wherein the suture loop extends circumferentially from a first open end to a second open end, the first open end and the second open end being spaced apart by a distance that allows tissue to extend therebetween.

9. The suture device of claim 8, wherein the arcuate channel has a circular cross-sectional profile, except for a first region near the first opening end and a second region near the second opening end.

10. The suture device of claim 9, wherein the first region and the second region each have an oval cross-sectional profile that allows the first arcuate needle threader and / or the second arcuate needle threader to begin bending as the first arcuate needle threader leaves the first opening end and / or the second arcuate needle threader leaves the second opening end.

11. The suture device of claim 1, wherein the first control element enters the first side of the arcuate channel substantially parallel to the tangent of the first arcuate needle threader, and is fixed to the first arcuate needle threader near the position of the first control element.

12. The suture device of claim 1, wherein the second control element enters the second side of the arcuate channel substantially parallel to the tangent of the second arcuate needle inserter, and is fixed to the position of the second arcuate needle inserter near the second control element.

13. The suture device of claim 1, further comprising: A first tubular member, the first tubular member housing the first control element; as well as A second tubular member, which houses the second control element, wherein the first tubular member includes a curved distal portion whose curvature is opposite to the curvature direction of the first side of the suture loop, and the second tubular member includes a curved distal portion whose curvature is opposite to the curvature direction of the second side of the suture loop.

14. The suture device of claim 1, wherein the suture loop comprises a C-shape.

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