Endoscopic suture needle and suture assembly attachment method

Abstract

A suture assembly may include a needle, a lumen, and a recess; the needle having a cylindrical body with a sharp point on at least one end; the lumen extending transversely to the longitudinal axis of the cylindrical body; the recess communicating with an opening of the lumen. A suture extends through the lumen and is secured within the recess of the needle by a sleeve extending over the needle.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 848,885, filed on May 16, 2019, and U.S. Provisional Application No. 62 / 727,783, filed on September 6, 2018, the entire contents of both applications are hereby incorporated by reference. Technical Field

[0003] The present disclosure relates to devices for suturing tissue, and more particularly to devices that work with an endoscope or similar device for endoscopically suturing tissue. Background of the Invention

[0005] A variety of endoscopic treatments can result in defects (or wounds) that are too large for known closed surgeries. An assembly comprising a needle and a suture connected to the needle can be used to sew tissues together. Tissue attachment methods typically include piercing the tissue with a needle and pulling the needle to pull the suture attached to the needle through a hole formed in the tissue. One way to connect the suture to the needle includes passing the suture through the hole of the needle, and tying a knot at one end of the suture to prevent the end from passing through the hole of the needle. However, the knot size may be inconsistent, and in some examples the hole through the needle may be pulled and the needle and suture may be disengaged, thereby increasing the surgical operation time because the operator may need to reassemble the needle and suture. Therefore, there is a need for alternative suture and needle assemblies. Summary of the invention

[0006] The present disclosure relates to several alternative designs, materials and manufacturing methods for devices for assembling needles and sutures. In one example, a medical device includes a needle and a sleeve configured for suturing tissue, the needle including: a cylindrical body, a lumen, and a first end portion at a first end of the cylindrical body, the cylindrical body extending along a longitudinal axis between the first end and the second end of the cylindrical body, the lumen extending through the cylindrical body transverse to the longitudinal axis, the lumen having a first opening and a second opening opposite to the first opening, wherein the first end portion includes a first sharp point configured to pierce tissue, wherein an outer surface of the cylindrical body defines a first recessed portion, the first recessed portion communicating with the first opening of the lumen and configured to receive an end region of a suture; the sleeve is configured to slide on the cylindrical body and compress the end region of the suture within the first recessed portion.

[0007] Alternatively or additionally, the sleeve has a slot in an outer wall thereof that is sized to receive a portion of a suture extending from the second opening of the lumen.

[0008] Alternatively or additionally, the first recess is a first channel extending longitudinally from the first opening of the lumen towards the first sharp point.

[0009] Alternatively or additionally, the first channel tapers such that a first end of the first channel adjacent to the first opening of the lumen has a first depth that is greater than a second depth at a second end of the first channel opposite the first end of the first channel.

[0010] Alternatively or additionally, the outer surface of the cylindrical body defines a second recess in communication with the first opening of the lumen, wherein the second recess is a second channel extending longitudinally from the first opening of the lumen in a direction away from the first sharp point.

[0011] Alternatively or additionally, the medical device further comprises a second end portion at the second end of the cylindrical body, wherein the second end portion comprises a second sharp point configured to pierce tissue.

[0012] Alternatively or additionally, the cylindrical body and the first and second end portions are a single integral element.

[0013] Alternatively or additionally, the single monolithic element is made of metal.

[0014] Alternatively or additionally, the medical device further comprises a recessed portion between the cylindrical body and the first sharp point.

[0015] Alternatively or additionally, the medical device further comprises a suture having a first end region including a first terminal end, the first end region extending through the lumen and into a first recess, wherein the first terminal end is disposed within the first recess, wherein a sleeve is disposed over at least a portion of the first end region and compresses it within the first recess, and the suture extends from a second opening of the lumen.

[0016] Alternatively or additionally, the medical device further comprises a weld securing the sleeve to the cylindrical body.

[0017] Alternatively or additionally, the first end region of the suture is secured to the cylindrical body with an adhesive or resin.

[0018] Alternatively or additionally, the first end region of the suture within the first recess is deformed such that the suture conforms to the shape of the first recess.

[0019] Alternatively or additionally, the sleeve is made of a heat shrinkable material.

[0020] Alternatively or additionally, the sleeve includes a sharp point configured to pierce tissue.

[0021] Alternatively or additionally, the sleeve comprises a chamber configured to receive the second end of the cylindrical body.

[0022] Alternatively or additionally, the chamber is configured to receive the second end of the cylindrical body in a friction fit.

[0023] Alternatively or additionally, the sleeve is configured to be forged onto the cylindrical body.

[0024] Alternatively or additionally, the sleeve is configured to be secured to the cylindrical body with an adhesive or a weld.

[0025] In another example, a medical device includes a needle configured to pierce tissue, the needle including a cylindrical body, a slot, and a first end portion at a first end of the cylindrical body; the cylindrical body extends along a longitudinal axis between the first end and the second end of the cylindrical body; the slot extends through the cylindrical body transverse to the longitudinal axis, the slot having a first opening and a second opening opposite the first opening, wherein the slot includes a central area configured to receive a suture, the slot including first and second elongated areas extending longitudinally from the central area; wherein the first end portion includes a sharp point configured to pierce tissue, wherein the wall of the cylindrical body along the slot is deformable so that a radially inward force applied to the wall at the central area of ​​the slot causes the wall to deform, thereby compressing and fixing the suture received in the central area of ​​the slot.

[0026] Alternatively or additionally, the medical device further comprises a second end portion at the second end of the cylindrical body, wherein the second end portion comprises a sharp point configured to pierce tissue.

[0027] Alternatively or additionally, the cylindrical body and the first and second end portions are solid.

[0028] Alternatively or additionally, the cylindrical body and the first and second end portions are a single integral component.

[0029] In another example, a medical device includes a metal needle configured for suturing tissue and a suture, the metal needle including a cylindrical body, an opening in the cylindrical body, and a first end portion at a first end of the cylindrical body; the cylindrical body having a longitudinal axis extending between the first end and the second end of the cylindrical body; the opening is transverse to the longitudinal axis; wherein the first end portion includes a sharp point configured to pierce tissue; the suture has a connecting member attached to one end, wherein the connecting member is disposed in the opening of the cylindrical body and is fixed to the cylindrical body.

[0030] Alternatively or additionally, the coupling member is a metal crimp tube that is crimped onto the suture and the metal crimp tube is welded to the cylindrical body.

[0031] Alternatively or additionally, the coupling member is a wire wrapped around the end of the suture and the wire is secured to the cylindrical body with an adhesive or weld.

[0032] In another example, a medical device includes a metal needle configured for suturing tissue and first and second fasteners, the metal needle including a cylindrical body, a first lumen, a second lumen, and a first end portion at a first end of the cylindrical body; the cylindrical body having a longitudinal axis extending between the first and second ends of the cylindrical body; the first lumen extending through the cylindrical body transverse to the longitudinal axis; the second lumen extending through the cylindrical body transverse to the longitudinal axis and transverse to and intersecting the first lumen; wherein the first end portion includes a sharp point configured to pierce tissue; the first and second fasteners are configured to be disposed within the second lumen and configured to compress and secure a suture disposed within the first lumen.

[0033] Alternatively or additionally, the first and second end fasteners threadably engage the second lumen.

[0034] Alternatively or additionally, the first and second end fasteners engage the second lumen in a friction fit.

[0035] In another example, a medical device includes a needle configured for suturing tissue, the needle comprising a cylindrical body, a first end portion at a first end of the cylindrical body, a chamber in a second end of the cylindrical body, a lumen, and a second end portion; the cylindrical body having a longitudinal axis extending between the first end and the second end of the cylindrical body; wherein the first end portion includes a sharp point configured to pierce tissue; the lumen extends through the cylindrical body, the lumen having a first portion and a second portion, the first portion extending transverse to the longitudinal axis, the second portion extending along the longitudinal axis and communicating with the chamber; the second end portion having a first end and a second end, the first end defining a sharp point configured to pierce tissue, the second end defining a protrusion configured to be received in the chamber of the cylindrical body.

[0036] Alternatively or additionally, the projection engages the chamber in a friction fit such that when a suture is disposed within the chamber and passed through the first and second portions of the lumen, the friction fit of the projection within the chamber secures the suture to the needle.

[0037] Alternatively or additionally, the medical device further comprises a suture disposed within the lumen of the cylindrical body such that a first end of the suture is disposed within the lumen and a second end of the suture extends from a first portion of the lumen, wherein a protrusion is disposed within the lumen and welded to the cylindrical body to secure the suture.

[0038] In another example, a medical device includes a metal needle configured for suturing tissue, the metal needle comprising a cylindrical body, first and second end portions at opposite ends of the cylindrical body, at least a first lumen, and a suture; the cylindrical body having a longitudinal axis extending between the first end and the second end of the cylindrical body; wherein the first and second end portions each include a sharp point configured to pierce tissue; the at least first lumen extends through the cylindrical body transverse to the longitudinal axis; the suture extends through the first lumen, and the suture is secured to the cylindrical body.

[0039] Alternatively or additionally, the medical device further comprises a second lumen extending through the cylindrical body transverse to the longitudinal axis, wherein the first and second lumens are longitudinally spaced apart.

[0040] Alternatively or additionally, the suture extends through the first lumen in a first direction, across the cylindrical body, and through the second lumen in a second direction opposite the first direction, wherein the suture is secured to the cylindrical body.

[0041] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The following figures and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] The present disclosure may be more fully understood upon consideration of the following description taken in conjunction with the accompanying drawings, in which:

[0043] Figure 1 is a perspective view of an exemplary suture assembly according to one example of the present disclosure;

[0044] Figure 2 for Figure 1 A top perspective view of a needle forming portion of an exemplary suture assembly;

[0045] Figure 3 for Figure 2 Bottom stereogram of the needle;

[0046] Figure 4 for Figure 1 A perspective view of a sleeve forming portion of an exemplary suture assembly;

[0047] Figure 5 Taken along line 5-5 Figure 1 A cross-sectional view of a suture assembly;

[0048] Figure 6 for Figure 1 A bottom perspective view of an exemplary suture assembly;

[0049] Fig. 7Ais a top view of an exemplary suture assembly in an open configuration according to another example of the present disclosure;

[0050] Figure 7B For closed structures Fig. 7A A top view of a suture assembly;

[0051] Figure 8 is a perspective view of an exemplary suture assembly according to another example of the present disclosure;

[0052] Fig. 9 is a perspective view of the suture and connecting member of FIG. 7;

[0053] Fig.10 for Figure 8 A perspective view of an alternative suture and connecting member;

[0054] Fig.11 is a perspective view of an exemplary suture assembly in a separated configuration according to another example of the present disclosure;

[0055] Fig.12 For the connected structure Fig.11 A stereoscopic view of a suture assembly;

[0056] Fig.13 is a top view of an exemplary suture assembly according to another example of the present disclosure;

[0057] Fig.14 Taken along line 14-14 Fig.13 A cross-sectional view of a suture assembly;

[0058] Fig.15 is a top view of an exemplary suture assembly in a separated configuration according to another example of the present disclosure;

[0059] Fig.16 For the connected structure Fig.15 A top view of a suture assembly;

[0060] Fig.17 is a cross-sectional view of an exemplary suture assembly according to another example of the present disclosure; and

[0061] Fig.18 is a cross-sectional view of an exemplary suture assembly according to another example of the present disclosure.

[0062] Although the present disclosure may be modified into various modifications and alternatives, the details thereof have been shown in the drawings by way of example and will be described in detail. However, it should be understood that it is not intended to limit the present invention to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents and alternative forms that fall within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0063] With respect to the following defined terms, these definitions shall apply, unless a different definition is given in the claims or elsewhere in this specification.

[0064] Definitions of certain terms are provided below and shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0065] All numerical values ​​are assumed herein to be modified by the term "about", whether or not explicitly indicated. The term "about" is generally an index range that a person skilled in the art would consider to be equivalent to the stated value (i.e., having the same function or result). In many cases, the term "about" may be indicated to include numbers rounded to the nearest significant figure.

[0066] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0067] Although some suitable dimensions, ranges and / or values ​​are disclosed pertaining to various components, features and / or specifications, a person skilled in the art (to which this disclosure pertains) will understand that the desired dimensions, ranges and / or values ​​may deviate from those expressly disclosed.

[0068] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include or otherwise refer to singular as well as plural referents, unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally intended to include "and / or," unless the context clearly dictates otherwise. As used in this specification and the appended claims, the terms "about" and "substantially" may indicate a numerical range within + / - 5% of a stated value or position.

[0069] 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 the accompanying drawings (which are not necessarily drawn to scale) illustrate exemplary embodiments and are not intended to limit the scope of the present disclosure. The exemplary embodiments shown are intended to be exemplary only. Selected features of any exemplary embodiment may be incorporated into additional embodiments unless clearly stated to the contrary.

[0070] The present disclosure pertains to needle and suture assemblies configured to be used in conjunction with an endoscope or similar delivery device for closing wounds within the body. In some cases, the needle and suture assemblies described herein may be configured so that they can be used with suture-based closure devices, such as the closure devices described in U.S. Patent Publication No. 2018 / 0235604, the entire contents of which are incorporated herein by reference.

[0071] Figure 1 1 is a perspective view of an exemplary suture assembly 100, which includes a needle 10, a sleeve 60, and a suture 80. The needle 10 may include a recess 28 in an outer surface, the recess 28 being configured to receive a first end region 82 of the suture 80. The suture 80 may be passed through the lumen 22 ( Figure 2 ) to extend generally transversely to the needle 10, as Figure 1 The sleeve 60 can be slid over the needle 10 and can compress the first end region 82 of the suture 80 within the recess 28 .

[0072] like Figure 2 As shown, the needle 10 may have a cylindrical body 20 (having a longitudinal axis XX), a first end portion 40 (having a first sharp point 42), and a second end portion 50 (having a second sharp point 52). The first and second sharp points 42, 52 are configured to pierce tissue so that the needle 10 can be used to suture tissue. In some examples, the needle 10 may include only the cylindrical body 20, the first end portion 40, and only a single sharp point 42. In such examples, the opposite ends may be blunt. One or both of the first end portion 40 and the second end portion 50 may include a recessed portion 44, 54. The recessed portion 44, 54 may have a curved outer surface that may be curved radially inward relative to the longitudinal axis of the needle 10. In some examples, the recessed portion 44, 54 may be a concave portion having a curved outer surface that may meet and be flush with the cylindrical body 20 at the end of the curved surface. In some examples, the recessed portion 44, 54 may be hourglass shaped and may have an outer surface that is curved radially inward relative to the outer surface of the cylindrical body 20. In some examples, the recessed portion 44, 54 may be equidistant from the lumen 22 of the cylindrical body 20. In some examples, each recessed portion 44, 54 may be configured to receive a bearing ball or other releasable fixing member from a medical device. The area of ​​each of the first and second end portions 40, 50 on the opposite ends of each sharp point 42, 52 may be coupled to the cylindrical body 20. In some examples, the first and second end portions 40, 50 may be attached to the cylindrical body 20 by welding, soldering, forging, or with an adhesive. In other examples, the cylindrical body 20 and the first and second end portions 40, 50 may be formed as a single, integral piece.

[0073] The needle 10 may further include a lumen 22 extending through the cylindrical body 20 transverse to the longitudinal axis XX. The lumen 22 may extend through a central portion of the cylindrical body 20 and may extend generally perpendicular to the longitudinal axis XX of the cylindrical body 20, such as Figure 2In other examples, the lumen 22 may extend through a non-central portion of the cylindrical body 20 and / or may be angled transversely to the longitudinal axis, but not perpendicularly. The lumen 22 may include a first opening 24 on one side of the cylindrical body 20 and a second opening 26 ( Figure 3 ). In some instances, the cylindrical body 20 may include at least a first recess 28 that extends longitudinally from the lumen 22 on a radially outer surface of the cylindrical body 20. In some instances, the first and second recesses 28, 29 may extend from opposite sides of the lumen 22. In some instances, the recess 28 is a channel that tapers such that a first end 31 of the recess 28 adjacent to the first opening 24 of the lumen 22 has a first depth that is greater than a second depth at a second end 32 of the recess 28 opposite the first end 31. When present, the second recess 29 may taper in a similar manner as the recess 28. The first opening 24 of the lumen 22 may be located within the recesses 28, 29 or otherwise communicate therewith. The recesses 28, 29 may be configured to receive a first end region 82 of a suture 80, such as Figure 1 shown.

[0074] Figure 3 Shows Figure 2 The bottom of the needle 10 in the tubular body 20. The lumen 22 is shown extending completely through the cylindrical body 20. In some examples, the second opening 26 may include a bevel or counterbore 27. In other examples, the second opening 26 may be flush with the outer surface of the cylindrical body 20.

[0075] Figure 4 Sleeve 60 is shown as a hollow cylinder having two open ends and a slot 62 extending through the sleeve wall in a longitudinal direction from one end toward the middle of sleeve 60. Slot 62 may have a rounded end 64 configured to engage suture 80 without damaging or cutting suture 80.

[0076] Figure 5 For along Figure 15-5 of the embodiment of the suture assembly 100. The first end region 82 of the suture 80 is screwed into the second opening 26 and exits the first opening 24 of the lumen 22 in the needle 10, and then bends in an L shape so that the first end region 82 and the terminal end 84 of the suture 80 reside in the recess 28. Alternatively, the first end region 82 of the suture 80 may reside in the recess 29. The sleeve 60 slides over the needle 10 and the first end region 82 of the suture 80. The recess 28 may have a depth measured transverse to the longitudinal axis that is less than the width of the suture 80, thereby compressing the suture 80 in the recess 28 and fixing the suture 80 to the needle 10. The tapered shape of the recess 28 can provide additional compression of the suture 80.

[0077] In some examples, the needle 10 and the sleeve 60 may be metal, and the sleeve 60 may be welded to the needle 10. For example, the weld 90 may be formed between the needle 10 and the sleeve 60 on the bottom of the needle 10, adjacent to the second opening 26. In other examples, the sleeve 60 and / or the suture 80 may be fixed to the needle 10 with an adhesive or resin. The adhesive or resin may be particularly suitable for fixing the sleeve 60 and / or the suture 80 to the needle 10, which is formed of a polymer or other non-metallic biocompatible material. In other examples, the sleeve 60 may be made of a heat shrinkable material. The heat shrink sleeve 60 may slide over the first end region 82 of the needle 10 and the suture 80. Then, heat is applied, thereby causing the heat shrink sleeve 60 to shrink and compress the first end region 82 of the suture 80 into the recessed portion 28. In some examples, the sleeve 60 and the needle 10 may be an interference fit. In some examples, the first end region 82 of the suture 80 can be deformed (e.g., melted) to conform to the shape of the recessed portion 28 to provide additional fixation of the suture to the needle 10. Using any of the suture fixation mechanisms described above, the suture 80 is fixedly coupled to the needle 10 so that when a pulling force is applied to the suture 80 exiting the second opening 26, such as when the needle 10 is used to suture a patient, the suture 80 remains within the lumen 22.

[0078] like Figure 6 As shown, when the sleeve 60 is disposed on the needle 10, the rounded end 64 of the slot 62 engages the suture 80. In some examples, the sleeve 60 can be advanced until the suture 80 is slightly clamped against the sides of the lumen 22 and the rounded end 64 of the slot 62.

[0079] Fig. 7A and Figure 7B Another example suture assembly 200 is shown and includes a needle 210 and a suture 280 . Fig. 7A and Figure 7BA top view and a bottom view are shown, wherein the opposite sides are identical. The needle 210 is similar to the needle 10, having a cylindrical body 220 and first and second end portions 240, 250, each of which has a sharp point 242, 252 and a recessed portion 244, 254. The first and second sharp points 242, 252 are configured to pierce tissue so that the needle 210 can be used to suture tissue. The needle 210 may have a slot 222 extending through the cylindrical body 220 transverse to the longitudinal axis XX, the slot 222 having a first opening on one side of the cylindrical body 220 and a second opening opposite to the first opening. The slot 222 may include a central region 225, a first elongated region 228, and a second elongated region 229, the central region 225 being configured to receive a suture 280. The first and second elongated regions 228, 229 may extend longitudinally from the central region 225 in opposite directions. The central region 225 may have a slightly rounded or semi-circular shape to match the outer shape of the suture 280. The cylindrical body 220 may have a wall 221 extending along the narrow groove 222 at the central region 225, and the wall 221 is deformable so that a radially inward force is applied to the wall 221 in the direction of arrow 230, causing the wall 221 to deform inwardly under the application of the force, as shown in FIG. Figure 7B In some examples, once deformed, the wall 221 remains in Figure 7B 210, thereby permanently securing the suture 280 to the needle 210. The wall 221 is deformable because its thickness is thinner than the radial thickness of the cylindrical body 220. In other embodiments, the wall 221 may be formed of a material that is more easily deformed than the rest of the cylindrical body 220 and / or the first and second end portions 240, 250.

[0080] Similar to needle 10, needle 210 may include only a cylindrical body 220, and a single one of the first and second end portions 240, 250 having sharp points 242, 252. The opposite ends may be blunt. In other examples, the first and second end portions 240, 250 and their respective sharp points 242, 252 may be attached to the cylindrical body. In either case, the cylindrical body 220 may be attached to the first and / or second end portions 240, 250 via welding, soldering, forging or adhesive. The cylindrical body 220 may be made of the same or different material as the first and / or second end portions 240, 250. In some examples, the first and / or second end portions 240, 250 are made of a more rigid material than the material forming the cylindrical body 220. In other examples, the entire needle 210 including the cylindrical body 220 and the first and / or second end portions 240, 250 may be a single integral structure. The cylindrical body 220 and the first and / or second end portions 240, 250 can be solid, except for the slot 222. In some examples, the suture 280 can include a knot or deformed (e.g., melted) region disposed within the central region 225 of the slot 222 or above the slot 222 (adjacent to the outer surface of the cylindrical body 220). Using any of the suture securing mechanisms described above, the suture 280 is securely coupled to the needle 210 such that when a pulling force is applied to the suture 280, such as when the needle 210 is used to suture a patient, the suture 280 is retained within the central region 225 of the slot 222.

[0081] Figure 8 and Fig. 9Another example suture assembly 300 similar to suture assemblies 100 and 200 is shown. Suture assembly 300 includes a suture 380 fixed to a needle 310. Needle 310 is similar to needles 10 and 210, having a cylindrical body 320 and first and second end portions 340, 350, each of which has a sharp point 342, 352 and a recessed portion 344, 354. The first and second sharp points 342, 352 are configured to pierce tissue so that needle 310 can be used to suture tissue. Needle 310 may also include a lumen 322 extending through the cylindrical body 320. Lumen 322 may extend through a central portion of the cylindrical body 320 and may extend generally perpendicular to the longitudinal axis XX of the cylindrical body 320. In other examples, lumen 322 may extend through a non-central portion of the cylindrical body 220, and / or may be angled transversely to the longitudinal axis, but not perpendicular. The lumen 322 may include a first opening 324 on one side of the cylindrical body 320, and a second opening (not shown) on the side of the cylindrical body 320 opposite the first opening 324. The first and second openings 324 may be identical. The lumen 322 is shown extending completely through the cylindrical body 320. In some examples, the first and / or second openings 324 may include a bevel or counterbore 327. In other examples, the first and / or second openings 324 may be flush with the outer surface of the cylindrical body 320.

[0082] The suture 380 may include a coupling member 390 secured adjacent to the terminal end 384 of the suture 380. The coupling member 390 may be inserted through the lumen 322 and secured therein. Fig. 9 In the example shown, the coupling member 390 can be a metal crimp tube. The crimp tube 390 can be placed over the suture 380 and then squeezed or crimped to secure it to the suture 380. The crimp tube 390 can then be inserted into the lumen 322 and secured therein to secure the suture 380 to the needle 310, as shown. Figure 8 In some examples, the cylindrical body 320 and the crimp tube 390 can be metal, and the crimp tube 390 can be welded or soldered within the lumen 322. In other examples, the crimp tube 390 can be fixed within the lumen 322 using an adhesive. Fig.10 Another coupling member is shown in the form of a wire 395 wrapped around suture 380. As with crimp tube 390, wire 395 may be welded or soldered within lumen 322 or secured with an adhesive.

[0083] Similar to needle 10, needle 310 may include only a cylindrical body 320, and a single one of the first or second end portions 340, 350 having sharp points 342, 352. In some embodiments, the opposite ends may be blunt. In other examples, the first and second end portions 340, 350 and their associated sharp points 342, 352 may be attached to the cylindrical body 320. The cylindrical body 320 may be made of the same or different material as the first and / or second end portions 340, 350. In some examples, the first and / or second end portions 340, 350 are made of a material that is more rigid than the material forming the cylindrical body 320. In other examples, the entire needle 310 including the cylindrical body 320 and the first and / or second end portions 340, 350 may be a single integral structure. The cylindrical body 320 and the first and / or second end portions 340, 350 may be solid.

[0084] In some examples, suture 380 may include a knot or deformed (e.g., melted) region disposed within or above coupling member 390 (adjacent to the outer surface of cylindrical body 320). Using any of the suture securing mechanisms described above, suture 380 is securely coupled to needle 310 such that when a pulling force is applied to suture 380, such as when suturing a patient using needle 310, suture 380 remains within lumen 322.

[0085] Fig.11 and Fig.12 Another example suture assembly 400 similar to suture assembly 100 is shown. Suture assembly 400 includes a suture 480 fixed to a needle 410. Needle 410 is similar to needle 10, having a cylindrical body 420 and first and second end portions 440, 450, each of which has a sharp point 442, 452 and a recessed portion 444, 454. The first and second sharp points 442, 452 are configured to pierce tissue so that needle 410 can be used to suture tissue. Needle 410 may also include a lumen 422 extending through the cylindrical body 420. Lumen 422 may extend through a central portion of the cylindrical body 420 and may extend generally perpendicular to the longitudinal axis of the cylindrical body 420. In other examples, lumen 422 may extend through a non-central portion of the cylindrical body 420 and / or may be angled transversely to the longitudinal axis, but not perpendicular. The lumen 422 may include a first opening 424 on one side of the cylindrical body 420, and a second opening (not shown) on the side of the cylindrical body 420 opposite the first opening 424. The lumen 422 may extend completely through the cylindrical body 420.

[0086] The cylindrical body 420 may include a recess 428 in the outer surface configured to receive a first end region 482 of a suture 480. The suture 480 may be threaded through the lumen 422, and then the first end region 482 may be bent in an L-shape and disposed within the recess 428. The second end portion 450 may include a sleeve portion 460 configured to slide over the cylindrical body 420 and compress the first end region 482 of the suture 480 within the recess 428. The recess 428 may be a channel that tapers as described for the recess 28 in the needle 10. The first opening 424 of the lumen 422 may be located within the recess 428 or otherwise communicate therewith. The sleeve portion 460 of the second end portion 450 can be a hollow cylinder, or can have a chamber configured to slide over the blunt end 427 of the cylindrical body 420, wherein a slot 462 extends through the wall in a longitudinal direction from one end toward the middle of the sleeve portion 460. The slot 462 can have a rounded end 464 configured to engage the suture 480 without damaging or cutting the suture 480. The recess 428 can have a depth measured transverse to the longitudinal axis that is less than the width of the suture 480. As the sleeve portion 460 slides over the cylindrical body 420 and over the first end region 482 of the suture 480, the sleeve portion 460 compresses the first end region 482 within the recess 428, thereby securing the suture 480 to the needle 410. The tapered shape of the recess 428 can provide additional compression of the suture 80.

[0087] Then, the sleeve portion 460 may be forged onto the cylindrical body 420 to secure the second end portion 450 to the cylindrical body 420. Fig.12 As shown, the forged region 466 of the sleeve portion 460 may include substantially the entire length of the sleeve portion 460. In other examples, only the end region of the sleeve portion 460 is forged on the cylindrical body 420. The forging of the sleeve portion 460 on the cylindrical body 420 secures the suture 480 to the needle 410 so that when a pulling force is applied to the suture 480, such as when the needle 410 is used to suture a patient, the suture 480 remains within the lumen 422.

[0088] In addition to forging the sleeve portion 460 onto the cylindrical body 420, in some examples, the sleeve portion 460 can also be welded or soldered to the cylindrical body 420. In other examples, in addition to forging, soldering and / or welding, adhesives or resins can also be used to secure the sleeve portion 460 and / or the suture 480 to the needle 410. In other examples, the sleeve portion 460 can be an interference fit with the cylindrical body 420. In other examples, the first end region 482 of the suture 480 can be deformed (e.g., melted) to conform to the shape of the recessed portion 428 to assist in securing the suture to the needle 410.

[0089] Fig.13 and Fig.14 Another example suture assembly 500 similar to suture assembly 100, 200, 300 is shown. Suture assembly 500 includes a suture 580 fixed to a needle 510. Needle 510 is similar to needle 10, 210, 310, having a cylindrical body 520 and first and second end portions 540, 550, each of which has a sharp point 542, 552 and a recessed portion 544, 554. The first and second sharp points 542, 552 are configured to pierce tissue so that needle 510 can be used to suture tissue. Needle 510 may also include a first lumen 522 extending through the cylindrical body 520. The first lumen 522 may extend through a central portion of the cylindrical body 520 and may extend substantially perpendicular to the longitudinal axis of the cylindrical body 520. In other examples, the first lumen 522 may extend through a non-central portion of the cylindrical body 520. The first lumen 522 is shown extending completely through the cylindrical body 520. In some examples, the first lumen 522 may extend only partially through the cylindrical body 520.

[0090] The second lumen 523 may extend through the cylindrical body 520 transversely to and intersecting the first lumen 522, such as Fig.14 As shown. The suture 580 can be inserted through the first lumen 522. The first fixing member 592 can be inserted through the second lumen 523 from a first direction, and the second fixing member 594 can be inserted through the second lumen 523 from a second direction. The first and second fixing members 592, 594 can be advanced until they engage the suture 580 and clamp the suture 580 therebetween. In some examples, the first and second fixing members 592, 594 can be screws that threadedly engage the internally threaded second lumen 523. In other examples, the first and second fixing members 592, 594 can engage the second lumen 523 with a friction fit. In some examples, the cylindrical body 520 and the first and second fixing members 592, 594 can be metal, and the first and second fixing members 592, 594 can be welded or soldered into the second lumen 523. In other examples, the first and second fixing members 592, 594 can be fixed into the second lumen 523 with an adhesive.

[0091] Similar to needle 10, needle 510 may include only a cylindrical body 520, and a single one of the first or second end portions 540, 550 having sharp points 542, 552. The opposite ends may be blunt. In other examples, the first and second end portions 540, 550 and their corresponding sharp points 542, 552 may be attached to the cylindrical body 520. The first and second sharp points 542, 552 are configured to pierce tissue so that the needle 510 can be used to suture tissue. In either case, the cylindrical body 520 may be attached to the first and / or second end portions 540, 550 via welding, soldering, forging or adhesive. The cylindrical body 520 may be made of the same or different material as the first and / or second end portions 540, 550. In some examples, the first and / or second end portions 540, 550 are made of a material that is more rigid than the material forming the cylindrical body 520. In other examples, the entire needle 510 including the cylindrical body 520 and the first and / or second end portions 540, 550 can be a single unitary structure.The cylindrical body 520 and the first and / or second end portions 540, 550 can be solid.

[0092] In some examples, the suture 580 may include a knot or a deformed (e.g., melted) region disposed within the first lumen 522 or disposed outside the first lumen 522 (adjacent to the outer surface of the cylindrical body 520). Using any of the suture securing mechanisms described above, the suture 580 is securely coupled to the needle 510 so that when a pulling force is applied to the suture 580, such as when the needle 510 is used to suture a patient, the suture 580 remains within the first lumen 522.

[0093] Fig.15 and Fig.16 Another example suture assembly 600 is shown, which is similar to suture assembly 100. Suture assembly 600 includes a suture 680 secured to a needle 610. Needle 610 is similar to needle 10, having a cylindrical body 620 and first and second end portions 640, 650, each of which has a sharp point 642, 652 and a recessed portion 644, 654. The first and second sharp points 642, 652 are configured to pierce tissue so that needle 610 can be used to suture tissue. Needle 610 may also include a first lumen portion 622 that partially extends into cylindrical body 620, such as by Fig.15672 to an opening (not shown) in the wall of the cylindrical body 620. The first lumen portion 622 may extend into a central portion of the cylindrical body 620 and may extend generally perpendicular to the longitudinal axis of the cylindrical body 620. In other examples, the first lumen portion 622 may extend through a non-central portion of the cylindrical body 620 and / or may be angled transversely to the longitudinal axis, but not perpendicularly. The first lumen portion 622 may intersect a second lumen portion 625 that extends longitudinally through the cylindrical body 620. In other examples, the cylindrical body 620 may have a single lumen extending from the chamber 672 to an opening (not shown) in the wall of the cylindrical body 620. The single lumen may be curved or straight.

[0094] The cylindrical body 620 may include a chamber 672 in an end face 674 opposite the sharp point 642. The chamber 672 is in communication with the second lumen portion 625 and may be configured to receive a protrusion 670 disposed on the end of the second end portion 650. The protrusion 670 may be received in the chamber 672 in a friction fit. The combination of the first and second lumen portions 622, 625 and the chamber 672 provides a path for the suture 680. The suture 680 may be threaded through the first lumen portion 622, the second lumen portion 625 and into the chamber 672. The terminal end of the suture 680 may reside within the chamber 672. Fig.16 As shown, the protrusion 670 is then inserted into the cavity 672, thereby securing the suture 680 to the needle 610 so that when a pulling force is applied to the suture 680, such as when a patient is sutured using the needle 610, the suture 680 is maintained within the cavity 672 and the first and second tubular lumen portions 622, 625.

[0095] In addition to the friction fit of the protrusion 670 within the cavity 672, the protrusion 670 can also be welded or soldered to the cavity 672 or the end surface 674 of the cylindrical body 620. In other examples, the protrusion 670 and / or the suture 680 can be fixed to the needle 610 with an adhesive or resin. In other examples, the end region of the suture 680 can be deformed (e.g., melted) to conform to the shape of one or more of the cavity 672, the first tubular lumen portion 622, or the second tubular lumen portion 625 to assist in fixing the suture 680 to the needle 610.

[0096] Fig.17 and Fig.18 Additional example suture assemblies 700 , 800 similar to suture assembly 300 are shown. Fig.17The suture assembly 700 shown includes a suture 780 fixed to a needle 710. The needle 710 is similar to the needle 310, having a cylindrical body 720 and first and second end portions 740, 750, each of which has a sharp point 742, 752 and a recessed portion 744, 754. The first and second sharp points 742, 752 are configured to pierce tissue so that the needle 710 can be used to suture tissue. The needle 710 may also include a lumen 722 extending through the cylindrical body 720. The lumen 722 may extend through a central portion of the cylindrical body 720 and may extend generally perpendicular to the longitudinal axis of the cylindrical body 720. In other examples, the lumen 722 may extend through a non-central portion of the cylindrical body 720 and / or may be angled transversely to the longitudinal axis, but not perpendicular. The lumen 722 may include a first opening 724 on one side of the cylindrical body 720, and a second opening 726 on the side of the cylindrical body 720 opposite the first opening 724. The first and second openings 724, 726 may be identical. The lumen 722 is shown extending completely through the cylindrical body 720. In some examples, the first and / or second openings 724, 726 may include a bevel or countersunk hole, such as Figure 8 In other examples, the first and / or second openings 724, 726 may be flush with the outer surface of the cylindrical body 720, such as Fig.17 shown.

[0097] Suture 780 can be inserted through lumen 722 and knot 785 tied at the end to prevent suture 780 from being removed from lumen 722 through second opening 726, thereby securing suture 780 to needle 710, as shown in FIG. Fig.17 In some embodiments, suture 780 may have a bulbous end such that end 785 is larger than lumen 722. For example, the bulbous end may be formed by deformation or melting. In some instances, suture 780 may be fixed within lumen 722 with an adhesive, or an adhesive may be added to knot 785 to fix the knot to the outer surface of cylindrical body 720.

[0098] Fig.18 Suture assembly 800 is shown that is similar to suture assembly 700 , but with second lumen 821 longitudinally spaced from first lumen 822 . Fig.18The suture assembly 800 shown includes a suture 880 fixed to a needle 810. The needle 810 is similar to the needle 710, having a cylindrical body 820 and first and second end portions 840, 850, each of which has a sharp point 842, 852 and a recessed portion 844, 854. The first and second sharp points 842, 852 are configured to pierce tissue so that the needle 810 can be used to suture tissue. The needle 810 includes a first lumen 822 and a second lumen 821 extending through the cylindrical body 820. The lumens 822, 821 can extend through a central portion of the cylindrical body 820 and can extend generally perpendicular to the longitudinal axis of the cylindrical body 820. In other examples, the lumens 822, 821 can extend through a non-central portion of the cylindrical body 820 and / or can be angled transversely to the longitudinal axis, but not perpendicular. The lumens 822, 821 may each include a first opening 824, 825 on one side of the cylindrical body 820, and a second opening 826, 829 on the side of the cylindrical body 820 opposite the first opening 824, 825. The first opening 824, 825 and the second opening 826, 829 may be identical. The first and second lumens 822, 821 are shown extending completely through the cylindrical body 820. In some examples, the first opening 824, 825 and / or the second opening 826, 829 may include a bevel or countersunk hole, such as Figure 8 In other examples, the first and / or second openings may be flush with the outer surface of the cylindrical body 820, such as Fig.18 shown.

[0099] The suture 880 can be inserted through the second opening 826, into the first lumen 822, out of the first opening 824 of the first lumen 822, across the outer surface of the cylindrical body 820, into the first opening 825 of the second lumen 821, through the second lumen 821, and out of the second opening 829 of the second lumen 821. A knot 885 can be tied to the end to prevent the suture 880 from being removed from the lumens 822, 821 through the second opening 826, thereby securing the suture 880 to the needle 810 so that when a pulling force is applied to the suture 880, such as when suturing a patient using the needle 810, the suture 880 remains within the lumens 822, 821. In some examples, the suture 880 can be secured within the first and / or second lumens 822, 821 with an adhesive, or an adhesive can be added to the knot 885 to secure the knot to the cylindrical body 820.

[0100] Similar to needle 10, needle 710, 810 may include only a cylindrical body 720, 820 and a single one of a first end portion 740, 840 or a second end portion 750, 850 having its associated sharp point 742, 842, 752, 852. The opposite end may be blunt. In other examples, needle 710, 810 may include a first and a second end portion 740, 840, 750, 850 and its associated sharp point, as shown. In either case, cylindrical body 720, 820 may be made of the same or different material as first and / or second end portion 740, 840, 750, 850. In some examples, first and / or second end portion 740, 840, 750, 850 is made of a material that is more rigid than the material forming cylindrical body 720, 820. In other examples, the entire needle 710 , 810 including the cylindrical body 720 , 820 and the first and / or second end portions 740 , 840 , 750 , 850 may be a single, unitary structure.

[0101] It should be understood that a variety of different materials can be used to form the devices described herein. Sutures 80, 280, 380, 480, 580, 680, 780, 880 can be cylindrical and can be polypropylene. In other examples, the suture can be polyester, nylon, polyglycolic acid, polylactic acid, a polymer material, or any other absorbable or non-absorbable biocompatible material. In some cases, a variety of different materials can be used to prepare needles 10, 210, 310, 410, 510, 610, 710, 810. Illustrative but non-limiting examples of suitable metals include titanium, stainless steel, magnesium, cobalt nickel, and the like. In some embodiments, for example, the devices described herein may include any suitable polymer material, including a biocompatible material such as polyurethane or silicone. Other suitable polymers include, but are not limited to, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, available from DuPont) ), polyether block esters, polyurethanes (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., available from DSM Engineering Plastics) ), ether- or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers such as those available from DuPont ), polyamides (e.g., available from Bayer or available from Elf Atochem ), elastic polyamides, block polyamide / ether, polyether block amide (PEBA, for example, available under the trade name ), ethylene vinyl acetate copolymer (EVA), siloxane, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g., ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polybutylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., ), polysulfone, nylon, nylon-12 (such as, available from EMS American Grilon) ), perfluoro(propyl 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, etc. thereof.

[0102] Those skilled in the art will appreciate that the present disclosure may be embodied in a variety of forms other than the specific embodiments described and contemplated herein. Therefore, departures in form and details may be made without departing from the scope and spirit of the present disclosure as described in the appended claims.

Claims

1. A medical device comprising: A needle, the needle being configured to sew tissue, the needle comprising: a cylindrical body extending along a longitudinal axis between a first end and a second end of the cylindrical body; a lumen extending through the cylindrical body transverse to the longitudinal axis, the lumen having a first opening and a second opening opposite the first opening; and a first end portion at the first end of the cylindrical body, wherein the first end portion includes a first sharp point, the first sharp point being configured to pierce tissue; wherein an outer surface of the cylindrical body defines a first recessed portion, the first recessed portion being in communication with the first opening of the lumen, and the first recessed portion being configured to receive an end region of a suture; and A sleeve having a narrow groove in its outer wall, the narrow groove extending from one end of the sleeve toward the middle region of the sleeve, the narrow groove being configured to receive a portion of the suture extending from the second opening of the tubular cavity, the sleeve being configured to slide on the cylindrical body and compress the end region of the suture within the first recess. 2 . The medical device of claim 1 , wherein the slot in the outer wall of the sleeve is configured to engage the portion of the suture without damaging or cutting the portion of the suture.

3. The medical device of claim 1 or 2, wherein the first recess is a first channel extending longitudinally from the first opening of the lumen toward the first sharp point.

4. The medical device of claim 3, wherein the first channel tapers such that a first end of the first channel adjacent to the first opening of the lumen has a first depth that is greater than a second depth at a second end of the first channel opposite the first end of the first channel.

5. A medical device according to claim 3 or 4, wherein the outer surface of the cylindrical body defines a second recessed portion, which is connected to the first opening of the tubular cavity, and wherein the second recessed portion is a second channel extending longitudinally from the first opening of the tubular cavity in a direction away from the first sharp point.

6. The medical device of any one of claims 1 to 5, further comprising a second end portion at the second end of the cylindrical body, wherein the second end portion comprises a second sharp point, the second sharp point being configured to pierce tissue.

7. The medical device according to any one of claims 1 to 6, further comprising a suture, the suture having a first end region including a first terminal end, the first end region extending through the lumen and extending into the first recess, wherein the first terminal end is disposed in the first recess, wherein the sleeve is disposed on at least a portion of the first end region and compresses it in the first recess, and the suture extends from the second opening of the lumen.

8. The medical device of claim 7, wherein the first end region of the suture within the first recess is deformed such that the suture conforms to the shape of the first recess.

9. The medical device according to any one of claims 1 to 8, wherein the sleeve is made of a heat shrinkable material.

10. The medical device of claim 1, wherein the sleeve comprises a sharp point configured to pierce tissue.

11. The medical device of claim 10, wherein the sleeve comprises a chamber configured to receive the second end of the cylindrical body.

12. The medical device of any one of claims 1 to 11, wherein a portion of the outer wall of the sleeve opposite the slot compresses the end region of the suture within the first recess.

13. The medical device of claim 10, wherein the sleeve is configured to be forged onto the cylindrical body.

14. The medical device of claim 1, wherein the first recess extends from the first opening toward the first sharp point, and the end region of the suture resides within the first recess.

15. The medical device of claim 1, wherein the end region of the suture is threaded into the second opening and out of the first opening of the lumen in the needle and then bent in an L shape such that the end region of the suture resides within the first recess.

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