Endoscopic suture needle and suture assembly attachment method

Abstract

A suture assembly may include a needle, a lumen, and a recess; the needle is provided with a cylindrical body, and the cylindrical body is provided with a sharp point on at least one end part; the tube cavity extends transversely to the longitudinal axis of the cylindrical body; and the sunken part is communicated with the opening of the pipe cavity. A suture extends through the lumen and is secured within the recess of the needle by a sleeve that extends over the needle.

Description

Cross - Reference to Related Applications

[0001] This application claims the benefit of priority of U.S. Provisional Application No. 62 / 848,885, filed May 16, 2019, and U.S. Provisional Application No. 62 / 727,783, filed Sep. 6, 2018, the entire contents of both applications are hereby incorporated by reference. Technical Field

[0002] 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

[0003] A variety of endoscopic treatments can result in defects (or wounds) that are too large for known closure procedures. Assemblies including a needle and a suture coupled to the needle can be used to suture tissue together. Tissue attachment methods typically include piercing the tissue with the needle and pulling the needle to draw the suture attached to the needle through a hole formed in the tissue. One way to couple the suture to the needle includes passing the suture through a hole in the needle and tying a knot at one end of the suture to prevent that end from passing through the hole in the needle. However, the knot size can be inconsistent and, in some instances, can be pulled through the hole in the needle and decouple the needle and the suture, thereby increasing the surgical procedure time because the operator may need to reassemble the needle and the suture. Accordingly, there is a need for alternative suture and needle assemblies. Summary of the Invention

[0004] The present disclosure relates to several alternative designs, materials, and manufacturing methods for devices for assembling a needle and a suture. In one example, a medical device includes a needle and a sleeve configured to suture 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 between a first end and a second end of the cylindrical body along a longitudinal axis, the lumen extending transversely to the longitudinal axis through the cylindrical body, the lumen having a first opening and a second opening opposite 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 recess that communicates with the first opening of the lumen and is configured to receive an end region of the suture; the sleeve is configured to slide over the cylindrical body and compress the end region of the suture within the first recess.

[0005] Alternatively or additionally, the sleeve has a slot in its outer wall sized to receive a portion of the suture extending from the second opening of the lumen.

[0006] Alternatively or additionally, the first recess is a first channel that extends longitudinally from the first opening of the lumen toward the first sharp point.

[0007] 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.

[0008] Alternatively or additionally, an outer surface of the cylindrical body defines a second recess that communicates with the first opening of the lumen, wherein the second recess is a second channel that extends longitudinally from the first opening of the lumen in a direction away from the first sharp point.

[0009] Alternatively or additionally, the medical device further includes a second end portion at a second end of the cylindrical body, wherein the second end portion includes a second sharp point configured to pierce tissue.

[0010] Alternatively or additionally, the cylindrical body and the first and second end portions are a single integral element.

[0011] Alternatively or additionally, the single integral element is made of metal.

[0012] Alternatively or additionally, the medical device further includes a recess between the cylindrical body and the first sharp point.

[0013] Alternatively or additionally, the medical device further includes a suture having a first end region that includes a first terminal end, the first end region extending through the lumen and into the 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 within the first recess and compresses it, and the suture extends from a second opening of the lumen.

[0014] Alternatively or additionally, the medical device further includes a weld that secures the sleeve to the cylindrical body.

[0015] Alternatively or additionally, the first end region of the suture is secured to the cylindrical body with an adhesive or resin.

[0016] 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.

[0017] Alternatively or additionally, the sleeve is made of a heat-shrinkable material.

[0018] Alternatively or additionally, the sleeve includes a sharp point configured to pierce tissue.

[0019] Alternatively or additionally, the sleeve includes a chamber configured to receive the second end of the cylindrical body.

[0020] Alternatively or additionally, the chamber is configured to receive the second end portion of the cylindrical body in a friction fit manner.

[0021] Alternatively or additionally, the sleeve is configured to be forged onto the cylindrical body.

[0022] Alternatively or additionally, the sleeve is configured to be fixed to the cylindrical body with an adhesive or a weld.

[0023] 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 extending along a longitudinal axis between a first end and a second end of the cylindrical body; the slot extending transversely to the longitudinal axis through the cylindrical body, the slot having a first opening and a second opening opposite the first opening, wherein the slot includes a central region configured to receive a suture, the slot including first and second elongated regions longitudinally extending from the central region; 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 such that a radially inward force applied to the wall at the central region of the slot causes the wall to deform, thereby compressing and securing the suture received within the central region of the slot.

[0024] Alternatively or additionally, the medical device further includes a second end portion at a second end of the cylindrical body, wherein the second end portion includes a sharp point configured to pierce tissue.

[0025] Alternatively or additionally, the cylindrical body and the first and second end portions are solid.

[0026] Alternatively or additionally, the cylindrical body and the first and second end portions are a single monolithic element.

[0027] 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 a first end and a second end of the cylindrical body; the opening being transverse to the longitudinal axis; wherein the first end portion includes a sharp point configured to pierce tissue; the suture having a coupling member attached to one end, wherein the coupling member is disposed within the opening of the cylindrical body and fixed to the cylindrical body.

[0028] Alternatively or additionally, the coupling member is a metal crimp tube crimped onto the suture, and the metal crimp tube is welded to the cylindrical body.

[0029] Alternatively or additionally, the coupling member is a wire wound around an end of the suture, and the wire is fixed to the cylindrical body with an adhesive or a weld.

[0030] In another example, a medical device includes a metal needle configured to suture tissue and first and second fasteners. The metal needle includes 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 has a longitudinal axis extending between a first end and a second end of the cylindrical body; the first lumen extends transversely to the longitudinal axis through the cylindrical body; the second lumen extends transversely to the longitudinal axis through the cylindrical body and is transverse to and intersects 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.

[0031] Alternatively or additionally, the first and second end fasteners threadedly engage the second lumen.

[0032] Alternatively or additionally, the first and second end fasteners engage the second lumen in a friction fit manner.

[0033] In another example, a medical device includes a needle configured to suture tissue. The needle includes 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 has a longitudinal axis extending between a first end and a 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 transversely to the longitudinal axis, the second portion extending along the longitudinal axis and communicating with the chamber; the second end portion has 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 within the chamber of the cylindrical body.

[0034] Alternatively or additionally, the protrusion engages the chamber in a friction fit manner such that when a suture is disposed within the chamber and passes through the first and second portions of the lumen, the friction fit of the protrusion within the chamber secures the suture to the needle.

[0035] Alternatively or additionally, the medical device further includes a suture disposed within the lumen of the cylindrical body such that a first end of the suture is disposed within the chamber and a second end of the suture extends from the first portion of the lumen, wherein the protrusion is disposed within the chamber and welded to the cylindrical body to secure the suture.

[0036] In another example, a medical device includes a metal needle configured to suture tissue, the metal needle including 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 a first end and a 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 transversely through the cylindrical body relative to the longitudinal axis; the suture extends through the first lumen and is fixed to the cylindrical body.

[0037] Alternatively or additionally, the medical device further includes a second lumen that extends transversely through the cylindrical body relative to the longitudinal axis, wherein the first and second lumens are longitudinally spaced apart.

[0038] 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 fixed to the cylindrical body.

[0039] The foregoing summary of some embodiments is not intended to describe every disclosed embodiment or every implementation of the present disclosure. The following drawings and detailed description more particularly exemplify these embodiments. Brief Description of the Drawings

[0040] The present disclosure may be more fully understood in view of the following description in conjunction with the accompanying drawings, in which:

[0041] Figure 1 Is a perspective view of an exemplary suture assembly according to one example of the present disclosure;

[0042] Figure 2 Is Figure 1 A top perspective view of the needle forming portion of the exemplary suture assembly of;

[0043] Figure 3 Is Figure 2 A bottom perspective view of the needle of;

[0044] Figure 4 Is Figure 1 A perspective view of the sleeve forming portion of the exemplary suture assembly of;

[0045] Figure 5 Is a cross-sectional view of the suture assembly taken along line 5-5 of Figure 1 ;

[0046] Figure 6 Is Figure 1 A bottom perspective view of the exemplary suture assembly of;

[0047] Figure 7ATop view of an exemplary suture assembly in an open configuration according to another example of the present disclosure;

[0048] Figure 7B Is of Figure 7A Top view of the suture assembly in a closed configuration;

[0049] Figure 8 Perspective view of an exemplary suture assembly according to another example of the present disclosure;

[0050] Figure 9 Perspective view of the suture and coupling member of FIG. 7;

[0051] Figure 10 Is of Figure 8 Perspective view of an alternative suture and coupling member;

[0052] Figure 11 Perspective view of an exemplary suture assembly in a separated configuration according to another example of the present disclosure;

[0053] Figure 12 Is of Figure 11 Perspective view of the suture assembly in a connected configuration;

[0054] Figure 13 Top view of an exemplary suture assembly according to another example of the present disclosure;

[0055] Figure 14 Is a cross-sectional view of Figure 13 the suture assembly taken along line 14-14;

[0056] Figure 15 Top view of an exemplary suture assembly in a separated configuration according to another example of the present disclosure;

[0057] Figure 16 Is of Figure 15 the suture assembly in a connected configuration;

[0058] Figure 17 Cross-sectional view of an exemplary suture assembly according to another example of the present disclosure; and

[0059] Figure 18 Cross-sectional view of an exemplary suture assembly according to another example of the present disclosure.

[0060] Although the present disclosure may be modified in various ways and alternative forms, details thereof have been shown by way of example in the drawings and will be described in detail. However, it should be understood that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternative forms falling within the spirit and scope of the present disclosure. Detailed implementation manners

[0061] Regarding the terms defined below, these definitions shall apply unless different definitions are given in the claims or elsewhere in this specification.

[0062] Certain term definitions are provided below and shall apply unless different definitions are given in the claims or elsewhere in this specification.

[0063] All numerical values herein are assumed to be modified by the term "about" whether or not explicitly indicated. The term "about" generally refers to a range of numbers that those skilled in the art would consider equivalent to the stated value (i.e., having the same function or result). In many cases, the term "about" may indicate a number that is rounded to the nearest significant digit.

[0064] Numerical ranges expressed by endpoints include all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0065] Although some suitable dimensions, ranges, and / or values are disclosed that are subordinate to various components, features, and / or the specification, those skilled in the art (to which this disclosure pertains) will understand that the desired dimensions, ranges, and / or values may deviate from those explicitly disclosed.

[0066] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include or otherwise denote both singular and plural referents unless the context clearly indicates otherwise. As used in this specification and the appended claims, the term "or" generally is used to include "and / or" unless the context clearly indicates otherwise. As used in this specification and the appended claims, the terms "about" and "substantially" may denote a numerical range within + / - 5% of the recited numerical value or position.

[0067] The following detailed implementation manners should be read with reference to the accompanying drawings, in which like elements in different drawings are numbered the same. The detailed implementation manners and the drawings (which are not necessarily drawn to scale) illustrate exemplary embodiments and are not intended to limit the scope of this disclosure. The exemplary embodiments shown are only intended to be exemplary. Selected features of any exemplary embodiment may be incorporated into additional embodiments unless clearly stated to the contrary.

[0068] This disclosure pertains to a needle and suture assembly that is configured to be used in combination 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 such that they can be used with suture-based closing devices, such as those described in U.S. Patent Publication No. 2018 / 0235604, the entire content of which is incorporated herein by reference.

[0069] Figure 1 FIG. 3 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, and the recess 28 is configured to receive a first end region 82 of the suture 80. The suture 80 may pass through the lumen 22 ( Figure 2 as shown) to extend generally transverse to the needle 10, as Figure 1 shown. The sleeve 60 may slide over the needle 10 and may compress the first end region 82 of the suture 80 within the recess 28.

[0070] As Figure 2 shown, the needle 10 may have a cylindrical body 20 (having a longitudinal axis X-X), 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 such that the needle 10 can be used to suture tissue. In some instances, the needle 10 may include only the cylindrical body 20, the first end portion 40, and only a single sharp point 42. In such instances, the opposite end may be blunt. One or both of the first end portion 40 and the second end portion 50 may include recesses 44, 54. The recesses 44, 54 may have a curved outer surface that may curve radially inwardly relative to the longitudinal axis of the needle 10. In some instances, the recesses 44, 54 may be concave portions having a curved outer surface that may meet and be flush with the cylindrical body 20 at the ends of the curved surface. In some instances, the recesses 44, 54 may be hourglass-shaped and may have an outer surface that curves radially inwardly relative to the outer surface of the cylindrical body 20. In some instances, the recesses 44, 54 may be equidistant from the lumen 22 of the cylindrical body 20. In some instances, each recess 44, 54 may be configured to receive a bearing ball or other releasable securing member from a medical device. Regions of each of the first and second end portions 40, 50 on opposite ends of each sharp point 42, 52 may be coupled to the cylindrical body 20. In some instances, 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 instances, the cylindrical body 20 and the first and second end portions 40, 50 may be formed as a single integral piece.

[0071] The needle 10 may further include a lumen 22 that extends transversely through the cylindrical body 20 relative to the longitudinal axis X-X. The lumen 22 may extend through a central portion of the cylindrical body 20 and may extend generally perpendicular to the longitudinal axis X-X of the cylindrical body 20, as Figure 2As shown. In other instances, the lumen 22 may extend through a non-central portion of the cylindrical body 20 and / or may be angled relative to the longitudinal axis, but not perpendicular. The lumen 22 may include a first opening 24 on one side of the cylindrical body 20 and a second opening 26 on the side of the cylindrical body 20 opposite the first opening 24( Figure 3 shown). In some instances, the cylindrical body 20 may include at least a first recess 28 that extends longitudinally from the lumen 22 on the 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 manner similar to the recess 28. The first opening 24 of the lumen 22 may be located within or otherwise in communication with the recesses 28, 29. The recesses 28, 29 may be configured to receive a first end region 82 of the suture 80, as Figure 1 shown.

[0072] Figure 3 is shown Figure 2 the bottom of the needle 10 in. The lumen 22 is shown as extending completely through the cylindrical body 20. In some instances, the second opening 26 may include a bevel or a countersink 27. In other instances, the second opening 26 may be flush with the outer surface of the cylindrical body 20.

[0073] Figure 4 The sleeve 60 is shown as a hollow cylinder having two open ends and a slot 62 that extends through the sleeve wall in a longitudinal direction from one end toward the middle of the sleeve 60. The slot 62 may have rounded ends 64 that are configured to engage the suture 80 without damaging or cutting the suture 80.

[0074] Figure 5 is along Figure 1Cross-sectional view of an example suture assembly 100 taken along line 5-5. 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 bent in an L-shape such that the first end region 82 and the terminal end 84 of the suture 80 reside within the recess 28. Alternatively, the first end region 82 of the suture 80 may reside within 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 within the recess 28 and securing the suture 80 to the needle 10. The tapered shape of the recess 28 may provide additional compression of the suture 80.

[0075] 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, a 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 adapted to fix the sleeve 60 and / or the suture 80 to the needle 10, where the needle 10 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-shrinkable sleeve 60 may slide over the needle 10 and the first end region 82 of the suture 80. Then, heat is applied, causing the heat-shrinkable sleeve 60 to shrink and compress the first end region 82 of the suture 80 within the recess 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 may be deformed (e.g., melted) to conform to the shape of the recess 28 to provide additional fixation of the suture to the needle 10. With any of the suture fixation mechanisms described above, the suture 80 is fixedly coupled to the needle 10 such that when a pulling force is applied to the suture 80 exiting the second opening 26, such as when suturing a patient with the needle 10, the suture 80 remains within the lumen 22

[0076] As Figure 6 shown, when the sleeve 60 is disposed on the needle 10, the circular end 64 of the slot 62 engages the suture 80. In some examples, the sleeve 60 may be advanced until the suture 80 is slightly clamped against the side of the lumen 22 and the circular end 64 of the slot 62.

[0077] Figure 7A and Figure 7B show another example suture assembly 200, which includes a needle 210 and a suture 280. Figure 7A and Figure 7BA top view and a bottom view are shown, where the opposite sides are the same. Needle 210 is similar to needle 10 and has a cylindrical body 220 and first and second end portions 240, 250, each of the first and second end portions 240, 250 having a sharp point 242, 252 and a recess 244, 254. The first and second sharp points 242, 252 are configured to pierce tissue such that the needle 210 can be used for suturing tissue. The needle 210 may have a slot 222 that extends transversely to the longitudinal axis X-X through the cylindrical body 220, the slot 222 having a first opening on one side of the cylindrical body 220 and a second opening opposite 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 in opposite directions from the central region 225. The central region 225 may have a slightly circular 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 slot 222 at the central region 225, the wall 221 being deformable such that a radially inward force is applied to the wall 221 in the direction of arrow 230, causing the wall 221 to deform inwardly upon application of the force, as Figure 7B shown. In some instances, once deformed, the wall 221 remains in the Figure 7B deformed configuration shown, 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 deformable than the cylindrical body 220 and / or the remainder of the first and second end portions 240, 250.

[0078] Similar to needle 10, needle 210 may include only a cylindrical body 220 and a single one of first and second end portions 240, 250 having sharp points 242, 252. The opposite end may be blunt. In other instances, both 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 an adhesive. The cylindrical body 220 may be made of the same or a different material than the first and / or second end portions 240, 250. In some instances, the first and / or second end portions 240, 250 are made of a material that is more rigid than the material forming the cylindrical body 220. In other instances, the entire needle 210, including the cylindrical body 220 and the first and / or second end portions 240, 250, may be a single monolithic structure. The cylindrical body 220 and the first and / or second end portions 240, 250 may be solid, except for a slot 222. In some instances, suture 280 may include a knot or deformed (e.g., melted) region that is disposed within or on the center region 225 of the slot 222 and adjacent to the outer surface of the cylindrical body 220. Using any of the suture fixation 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 suturing a patient with the needle 210, the suture 280 remains within the center region 225 of the slot 222.

[0079] Figure 8 and Figure 9Another exemplary suture assembly 300 that is similar to suture assemblies 100 and 200 is shown. The suture assembly 300 includes a suture 380 secured to a needle 310. The needle 310 is similar to needles 10 and 210 and has a cylindrical body 320 and first and second end portions 340, 350, each having a sharp point 342, 352 and a recess 344, 354. The first and second sharp points 342, 352 are configured to pierce tissue such that the needle 310 can be used to suture tissue. The needle 310 may also include a lumen 322 that extends through the cylindrical body 320. The lumen 322 may extend through a central portion of the cylindrical body 320 and may extend generally perpendicular to the longitudinal axis X-X of the cylindrical body 320. In other examples, the lumen 322 may extend through a non-central portion of the cylindrical body 220 and / or may be angled, but not perpendicular, to the longitudinal axis. 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 the same. The lumen 322 is shown as extending completely through the cylindrical body 320. In some examples, the first and / or second opening 324 may include a bevel or a countersink 327. In other examples, the first and / or second opening 324 may be flush with the outer surface of the cylindrical body 320.

[0080] The suture 380 may include a coupling member 390 that is 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. In Figure 9 the example shown, the coupling member 390 may be a metal crimp tube. The crimp tube 390 may be placed over the suture 380 and then squeezed or crimped to secure it to the suture 380. The crimp tube 390 may then be inserted into the lumen 322 and secured therein to secure the suture 380 to the needle 310, as Figure 8 shown. In some examples, the cylindrical body 320 and the crimp tube 390 may be metal and the crimp tube 390 may be welded or soldered within the lumen 322. In other examples, the crimp tube 390 may be secured within the lumen 322 with an adhesive. Figure 10 Another coupling member is shown in the form of a wire 395 that is wound around the suture 380. Like the crimp tube 390, the wire 395 may be welded or soldered within the lumen 322 or secured with an adhesive.

[0081] Similar to needle 10, needle 310 may include only a cylindrical body 320, and only one of a first or second end portion 340, 350 having sharp points 342, 352. In some embodiments, the opposite end may be blunt. In other instances, both 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 instances, 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 instances, 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.

[0082] In some instances, 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 fixation 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 with needle 310, suture 380 remains within lumen 322.

[0083] Figure 11 and Figure 12 Another exemplary suture assembly 400 similar to suture assembly 100 is shown. Suture assembly 400 includes a suture 480 secured to a needle 410. Needle 410 is similar to needle 10 and has a cylindrical body 420 and first and second end portions 440, 450, each having a sharp point 442, 452 and a recess 444, 454. The first and second sharp points 442, 452 are configured to pierce tissue such that needle 410 can be used to suture tissue. Needle 410 may also include a lumen 422 extending through cylindrical body 420. Lumen 422 may extend through a central portion of cylindrical body 420 and may extend generally perpendicular to the longitudinal axis of cylindrical body 420. In other instances, lumen 422 may extend through a non-central portion of cylindrical body 420 and / or may be angled relative to the longitudinal axis, but not perpendicular. Lumen 422 may include a first opening 424 on one side of cylindrical body 420 and a second opening (not shown) on the side of cylindrical body 420 opposite first opening 424. Lumen 422 may extend completely through cylindrical body 420.

[0084] The cylindrical body 420 may include a recess 428 in the outer surface, and the recess 428 is configured to receive a first end region 482 of the suture 480. The suture 480 may be screwed 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, and the sleeve portion 460 is configured to slide on 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 in communication therewith. The sleeve portion 460 of the second end portion 450 may be a hollow cylinder or may have a chamber configured to slide on the blunt end 427 of the cylindrical body 420, wherein a slot 462 extends through the wall in a longitudinal direction from one end towards the middle of the sleeve portion 460. The slot 462 may have a rounded end 464, and the rounded end 64 is configured to engage the suture 480 without damaging or cutting the suture 480. The recess 428 may 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 on the cylindrical body 420 and on the first end region 482 of the suture 480, the sleeve portion 460 compresses the first end region 482 within the recess 428, thereby fixing the suture 480 to the needle 410. The tapered shape of the recess 428 may provide additional compression of the suture 80.

[0085] Then, the sleeve portion 460 may be forged onto the cylindrical body 420 to fix the second end portion 450 to the cylindrical body 420. As Figure 12 shown, the forging region 466 of the sleeve portion 460 may generally include the entire length of the sleeve portion 460. In other instances, only the end regions of the sleeve portion 460 are forged onto the cylindrical body 420. The forging of the sleeve portion 460 onto the cylindrical body 420 fixes the suture 480 to the needle 410 such that when a pulling force is applied to the suture 480, such as when suturing a patient with the needle 410, the suture 480 remains within the lumen 422.

[0086] In addition to forging the sleeve portion 460 onto the cylindrical body 420, in some instances, the sleeve portion 460 may also be welded or soldered to the cylindrical body 420. In other instances, in addition to forging, soldering, and / or welding, an adhesive or resin may also be used to fix the sleeve portion 460 and / or the suture 480 to the needle 410. In other instances, the sleeve portion 460 may be press-fitted with the cylindrical body 420. In other instances, the first end region 482 of the suture 480 may be deformed (e.g., melted) to conform to the shape of the recess 428 to assist in fixing the suture to the needle 410.

[0087] Figure 13 and Figure 14 shows another exemplary suture assembly 500 similar to suture assemblies 100, 200, 300. The suture assembly 500 includes a suture 580 fixed to a needle 510. The needle 510 is similar to needles 10, 210, 310 and has a cylindrical body 520 and first and second end portions 540, 550, each having a sharp point 542, 552 and a recess 544, 554. The first and second sharp points 542, 552 are configured to pierce tissue such that the needle 510 can be used to suture tissue. The 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 generally 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 as extending completely through the cylindrical body 520. In some examples, the first lumen 522 may only partially extend through the cylindrical body 520.

[0088] A second lumen 523 may extend through the cylindrical body 520 transverse to and intersecting the first lumen 522, as Figure 14 shown. The suture 580 may be inserted through the first lumen 522. A first fixing member 592 may be inserted through the second lumen 523 from a first direction, and a second fixing member 594 may be inserted through the second lumen 523 from a second direction. The first and second fixing members 592, 594 may be advanced until they engage and clamp the suture 580 therebetween. In some examples, the first and second fixing members 592, 594 may be screws that threadedly engage an internally threaded second lumen 523. In other examples, the first and second fixing members 592, 594 may engage the second lumen 523 in a friction fit. In some examples, the cylindrical body 520 and the first and second fixing members 592, 594 may be metal, and the first and second fixing members 592, 594 may be welded or soldered within the second lumen 523. In other examples, the first and second fixing members 592, 594 may be fixed within the second lumen 523 with an adhesive.

[0089] Similar to needle 10, needle 510 may include only a cylindrical body 520 and a single one of a first or second end portion 540, 550 having a sharp point 542, 552. The opposite end may be blunt. In other instances, both the first and second end portions 540, 550 and their respective 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 such that 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 portion 540, 550 via welding, soldering, forging, or an adhesive. The cylindrical body 520 may be made of the same or a different material than the first and / or second end portion 540, 550. In some instances, the first and / or second end portion 540, 550 is made of a material that is more rigid than the material forming the cylindrical body 520. In other instances, the entire needle 510, including the cylindrical body 520 and the first and / or second end portion 540, 550, may be a single monolithic structure. The cylindrical body 520 and the first and / or second end portion 540, 550 may be solid.

[0090] In some instances, suture 580 may include a knot or deformed (e.g., melted) region disposed within first lumen 522 or outside of first lumen 522 (adjacent to the outer surface of cylindrical body 520). Using any of the suture fixation mechanisms described above, suture 580 is securely coupled to needle 510 such that when a pulling force is applied to suture 580, such as when suturing a patient with needle 510, suture 580 remains within first lumen 522.

[0091] Figure 15 and Figure 16 Another example suture assembly 600 similar to suture assembly 100 is shown. Suture assembly 600 includes a suture 680 fixed to a needle 610. Needle 610 is similar to needle 10 and has a cylindrical body 620 and first and second end portions 640, 650, each having a sharp point 642, 652 and a recess 644, 654. The first and second sharp points 642, 652 are configured to pierce tissue such that needle 610 can be used to suture tissue. Needle 610 may also include a first lumen portion 622 that extends partially into cylindrical body 620, such as by Figure 15as shown by the dashed line. The first lumen portion 622 can extend into the central portion of the cylindrical body 620 and can extend generally perpendicular to the longitudinal axis of the cylindrical body 620. In other examples, the first lumen portion 622 can extend through a non-central portion of the cylindrical body 620 and / or can be angled relative to the longitudinal axis, but not perpendicular. The first lumen portion 622 can intersect the second lumen portion 625, which extends longitudinally through the cylindrical body 620. In other examples, the cylindrical body 620 can have a single lumen that extends from the chamber 672 to an opening (not shown) in the wall of the cylindrical body 620. The single lumen can be curved or straight.

[0092] The cylindrical body 620 can include a chamber 672 in the end face 674 opposite the sharp point 642. The chamber 672 is in communication with the second lumen portion 625 and can be configured to receive a protrusion 670 disposed on the end of the second end portion 650. The protrusion 670 can be received in the chamber 672 in a friction fit manner. 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 can be screwed through the first lumen portion 622, the second lumen portion 625 and into the chamber 672. The terminal end of the suture 680 can reside within the chamber 672. As Figure 16 shown, the protrusion 670 is then inserted into the chamber 672, thereby fixing the suture 680 to the needle 610 such that when a pulling force is applied to the suture 680, such as when suturing a patient with the needle 610, the suture 680 remains within the chamber 672 and the first and second lumen portions 622, 625.

[0093] In addition to the friction fit of the protrusion 670 within the chamber 672, the protrusion 670 can also be welded or soldered to the chamber 672 or the end face 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 chamber 672, the first lumen portion 622 or the second lumen portion 625 to assist in fixing the suture 680 to the needle 610.

[0094] Figure 17 and Figure 18 Additional example suture assemblies 700, 800 similar to the suture assembly 300 are shown. Figure 17The suture assembly 700 shown includes a suture 780 secured to a needle 710. The needle 710 is similar to the needle 310 and has a cylindrical body 720 and first and second end portions 740, 750, each having a sharp point 742, 752 and a recess 744, 754. The first and second sharp points 742, 752 are configured to pierce tissue such 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, but not perpendicular, to the longitudinal axis. The lumen 722 may include a first opening 724 on one side of the cylindrical body 720 and a second opening 726 on a side of the cylindrical body 720 opposite the first opening 724. The first and second openings 724, 726 may be the same. The lumen 722 is shown as extending completely through the cylindrical body 720. In some examples, the first and / or second opening 724, 726 may include a bevel or a countersink, as Figure 8 shown. In other examples, the first and / or second opening 724, 726 may be flush with the outer surface of the cylindrical body 720, as Figure 17 shown.

[0095] The suture 780 may be inserted through the lumen 722 and a knot 785 tethered at the end to prevent the suture 780 from being removed through the second opening 726 out of the lumen 722, thereby securing the suture 780 to the needle 710, as Figure 17 shown. In some embodiments, the suture 780 may have a balled end such that the end 785 is larger than the lumen 722. For example, the balled end may be formed by deformation or melting. In some examples, the suture 780 may be secured within the lumen 722 with an adhesive, or an adhesive may be added to the knot 785 to secure the knot to the outer surface of the cylindrical body 720.

[0096] Figure 18 A suture assembly 800 is shown that is similar to the suture assembly 700, but a second lumen 821 is longitudinally spaced from a first lumen 822. Figure 18The suture assembly 800 shown includes a suture 880 fixed to a needle 810. The needle 810 is similar to the needle 710 and has a cylindrical body 820 and first and second end portions 840, 850, each of which has a sharp point 842, 852 and a recess 844, 854. The first and second sharp points 842, 852 are configured to pierce tissue such that the needle 810 can be used to suture tissue. The needle 810 includes a first lumen 822 and a second lumen 821 that extend 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 relative to the longitudinal axis, but not perpendicular. The lumens 822, 821 can each include a first opening 824, 825 on one side of the cylindrical body 820 and a second opening 826, 829 on a side of the cylindrical body 820 opposite the first opening 824, 825. The first openings 824, 825 and the second openings 826, 829 can be the same. The first and second lumens 822, 821 are shown as extending completely through the cylindrical body 820. In some examples, the first opening 824, 825 and / or the second opening 826, 829 can include a bevel or a countersink, as Figure 8 shown. In other examples, the first and / or second opening can be flush with the outer surface of the cylindrical body 820, as Figure 18 shown.

[0097] 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 at the end to prevent the suture 880 from being removed through the second opening 826 from the lumens 822, 821, thereby fixing the suture 880 to the needle 810 such that when a pulling force is applied to the suture 880, such as when suturing a patient with the needle 810, the suture 880 remains within the lumens 822, 821. In some examples, the suture 880 can be fixed within the first and / or second lumens 822, 821 with an adhesive, or an adhesive can be added to the knot 885 to fix the knot to the cylindrical body 820.

[0098] Similar to needle 10, needles 710, 810 may include only a cylindrical body 720, 820 and a single one of either 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 instances, needles 710, 810 may include first and second end portions 740, 840, 750, 850 and their associated sharp points, as shown. In either case, the cylindrical body 720, 820 may be made of the same or a different material than the first and / or second end portions 740, 840, 750, 850. In some instances, the first and / or second end portions 740, 840, 750, 850 are made of a material that is more rigid than the material forming the cylindrical body 720, 820. In other instances, 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 monolithic structure.

[0099] It should be understood that a variety of different materials may be used to form the devices described herein. Sutures 80, 280, 380, 480, 580, 680, 780, 880 may be cylindrical and may be polypropylene. In other instances, the suture may be polyester, nylon, polyglycolic acid, polylactic acid, a polymeric material, or any other absorbable or non-absorbable biocompatible material. In some cases, a variety of different materials may be used to fabricate needles 10, 210, 310, 410, 510, 610, 710, 810. Exemplary but non-limiting instances 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 polymeric material, including biocompatible materials 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, e.g., available from DuPont ), polyether block ester, polyurethane (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., available from DSM Engineering Plastics ), ether-based or ester-based copolymers (e.g., butene / poly(alkylene ether) phthalate and / or other polyester elastomers such as available from DuPont ), polyamide (e.g., available from Bayer or available from Elf Atochem )), elastic polyamide, block polyamide / ether, polyether block amide (PEBA, e.g., available under the trade name obtained), ethylene vinyl acetate copolymer (EVA), silicone, 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), polyether ether ketone (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, polyolefin, polystyrene, epoxy resin, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomer, biocompatible polymer, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, etc.

[0100] Those skilled in the art will understand that the present disclosure may be embodied in many forms other than the specific embodiments described and contemplated herein. Accordingly, departures in form and detail 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 configured to suture tissue, the needle comprising: a cylindrical body having a longitudinal axis extending between a first end and a second end of the cylindrical body; a lumen extending transversely to the longitudinal axis through the cylindrical body, 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 configured to pierce tissue; wherein an outer surface of the cylindrical body defines a first recess in communication with the first opening of the lumen and configured to receive an end region of a suture; a sleeve configured to slide on the cylindrical body and compress the end region of the suture within the first recess; and a suture having a first end region including a first terminal end, the first end region extending through the lumen and into the first recess, wherein the first terminal end is disposed within the first recess, wherein the sleeve is disposed on and compresses at least a portion of the first end region within the first recess, and the suture extends from the second opening of the lumen.

2. The medical device according to claim 1, wherein, The first end region of the suture is fixed to the cylindrical body by a weld, an adhesive, or a resin.

3. The medical device according to claim 1, 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.

4. The medical device according to claim 1, wherein, The sleeve is made of a heat-shrinkable material.

5. The medical device according to claim 1, wherein, The sleeve includes a sharp point configured to pierce tissue.

6. The medical device according to claim 5, wherein, The sleeve includes a chamber configured to receive the second end of the cylindrical body.

7. The medical device according to claim 6, wherein, The sleeve is configured to be forged onto the cylindrical body.

8. A medical device, comprising: a needle configured to suture tissue, the needle comprising: a cylindrical body having a longitudinal axis extending between a first end and a second end of the cylindrical body; a slot extending transversely to the longitudinal axis through the cylindrical body, the slot having a first opening and a second opening opposite the first opening, wherein the slot is configured to receive a portion of a suture, and a first end portion at the first end of the cylindrical body, wherein the first end portion includes a first sharp point configured to pierce tissue; and wherein the cylindrical body is deformable along the walls of the slot such that a radially inward force applied to the walls causes the walls to deform to compress and secure the suture received within the slot.

9. The medical device according to claim 8, wherein, The slot in the cylindrical body includes a central region configured to receive the suture.

10. The medical device according to claim 8, wherein, First and second elongated regions longitudinally extend from the central region.

Images