surgical clips

Abstract

To provide a ligation clip having an improved locking mechanism to ensure that the ligation clip remains closed during intended use. [Solution] The surgical clip includes a first leg member and a second leg member, each having an inner surface. The inner surface of the first leg member is concave, and the inner surface of the second leg member is convex. The surgical clip also includes a first locking member disposed at a distal end portion of the first leg member, a second locking member disposed at a distal end portion of the second leg member, a third locking member disposed between the proximal and distal end portions of the first leg member, and a fourth locking member disposed between the proximal and distal end portions of the second leg member. The first locking member and the second locking member, as well as the third locking member and the fourth locking member, are configured to interact with each other to secure the surgical clip in a closed configuration.

Description

[Technical Field]

[0001] This application claims priority to U.S. Provisional Patent Application No. 62 / 585,795, filed November 14, 2017, and entitled "Surgical Clip," the entire disclosure of which is incorporated herein by reference.

[0002] FIELD OF THE INVENTION The present invention relates generally to medical devices, and more particularly to surgical clips for ligating tissue. [Background technology]

[0003] Ligation of tissue (such as blood vessels, lymph nodes, nerves, fallopian tubes, cardiac tissue, etc.) is a common practice in many surgical procedures. For example, temporary ligation of blood vessels (e.g., veins or arteries) is often required during vascular resection procedures to remove aneurysms. On the other hand, more permanent ligation of fallopian tubes is often desired. Ligation clips are becoming increasingly popular because they are relatively quick and easy to apply. Summary of the Invention [Problem to be solved by the invention]

[0004] The present inventors have recognized a need for improvement in one or more features of ligation clips. Current ligation clips often lack sufficient strength to remain closed during their intended use. This is particularly problematic for ligation clips formed from absorbable materials, which can be substantially weaker than non-absorbable materials. This weaker material can potentially wear and / or break surgical clips implanted within the body, causing the ligation clip to open. For example, uneven absorption and / or degradation of the material can cause the ligation clip to open before the desired tissue necrosis of vascular tissue. It would be desirable to provide a ligation clip with an improved locking mechanism to ensure the ligation clip remains closed during its intended use. The disclosed ligation clip is directed to alleviating or overcoming one or more of these problems. [Means for solving the problem]

[0005] A first aspect of the present invention relates to a surgical clip configured to ligate tissue. The surgical clip can include a first leg member and a second leg member. The first leg member can have an inner surface with a concave curvature along its length, and the second leg member can have an inner surface with a convex curvature along its length. The first and second leg members are configured to move between an open configuration in which the inner surfaces are spaced apart and a closed configuration in which the inner surfaces are approximated. The surgical clip includes a first locking member and a second locking member, the first locking member disposed at a distal end portion of the first leg member and the second locking member disposed at a distal end portion of the second leg member, the first and second locking members configured to interact to secure the first and second leg members in the closed configuration. The surgical clip also includes a third locking member and a fourth locking member, the third locking member disposed between the proximal end portion and the distal end portion of the first leg member and the fourth locking member disposed between the proximal end portion and the distal end portion of the second leg member, the third locking member and the fourth locking member configured to interact with each other in the closed configuration to secure the first leg member and the second leg member.

[0006] In some embodiments, the first locking member comprises a hook and the second locking member comprises a recessed portion, the hook configured to bend around the distal end portion of the second leg member and snap into the recessed portion. In some embodiments, the third locking member comprises an elongated member having a protrusion, and the fourth locking member comprises a channel with an undercut, the channel configured to receive the elongated member, the undercut configured to engage the protrusion. In some embodiments, the protrusion is spaced from the undercut in the closed configuration. The third locking member comprises a single protrusion without a ratchet mechanism, the channel extending through a first section of the second leg member, the first section having a width greater than a width of the second section of the second leg member. In some embodiments, the second section of the second leg member is configured to engage tissue. In some embodiments, the third locking member is arcuate. In some embodiments, the third locking member comprises an atraumatic end. In some embodiments, the third locking member is disposed on a proximal half portion of the inner surface of the first leg member. In some embodiments, the surgical clip further comprises a hinge portion connecting the proximal end portion of the first leg member to the proximal end portion of the second leg member, the hinge portion configured to pivot the first leg member relative to the second leg member. In some embodiments, the third locking member forms part of the hinge portion connecting the proximal end portion of the first leg member to the proximal end portion of the second leg member. In some embodiments, the hinge portion comprises a barrel portion disposed on the proximal end portion of the first leg member and configured to rotate about a hinge pin disposed on the proximal end portion of the second leg member, the barrel portion comprising the third locking member. The third locking member comprises a protrusion on the barrel portion, and the fourth locking member is an undercut in the proximal end portion of the second leg member.In some embodiments, the protrusion is spaced from the undercut in the closed configuration. In some embodiments, the barrel portion comprises an opening between an end of the third locking member and the proximal end portion of the first leg member, the hinge pin comprising at least one flat surface, and the opening is substantially offset from the flat surface when the surgical clip is in the closed configuration. In some embodiments, the at least one flat surface is disposed at an angle of approximately 135 degrees from a longitudinal axis of the second leg member. In some embodiments, the surgical clip further comprises a boss disposed on the distal end portion of at least one of the first and second leg members. In some embodiments, the surgical clip comprises an absorbable polymer material. In some embodiments, at least one of the interior surfaces of the first and second leg members comprises a plurality of teeth angled toward the proximal end portion of the surgical clip. In some embodiments, the inner surfaces of both the first leg member and the second leg member include a plurality of teeth angled toward the proximal end portion of the surgical clip. In some embodiments, the plurality of teeth are disposed distally of the third locking member in the closed configuration, the third locking member including first and second extension members extending from opposite sides of the first leg member, and the fourth locking member including an outer surface of the second leg member. In some embodiments, the first and second extension members include protrusions configured to engage the outer surface of the second leg member.

[0007] In order that the invention may be more readily understood, embodiments thereof are shown by way of example in the accompanying drawings, in which: [Brief explanation of the drawings]

[0008] [Figure 1] 1 illustrates a perspective view of a first exemplary embodiment of a surgical clip of the present invention; [Figure 2] 2 illustrates a cross-sectional view of a first exemplary embodiment of the surgical clip of FIG. 1; [Figure 3]3 illustrates a first exemplary embodiment of the surgical clip of FIGS. 1 and 2 in a closed configuration. [Figure 4] 4 illustrates a cross-sectional view of a first exemplary embodiment of the surgical clip of FIGS. 1-3 in a closed configuration. [Figure 5] 1 shows a perspective view of a second exemplary embodiment of a surgical clip of the present invention; [Figure 6] 6 illustrates an exploded view of a second exemplary embodiment of the surgical clip of FIG. 5. [Figure 7] 7 illustrates a second exemplary embodiment of the surgical clip of FIGS. 5 and 6 in a closed configuration. [Figure 8] FIG. 8 illustrates a cross-sectional view of a second exemplary embodiment of the surgical clip of FIGS. 5-7 in a closed configuration. [Figure 9] 10 shows a perspective view of a third exemplary embodiment of a surgical clip of the present invention; [Figure 10] 10 shows a front view of a third exemplary embodiment of the surgical clip of FIG. 9; [Figure 11] 12 illustrates the third exemplary embodiment of the surgical clip of FIGS. 9 and 11 in a closed configuration. DETAILED DESCRIPTION OF THE INVENTION

[0009] The same reference numbers are used in the drawings and the following detailed description to refer to the same or like parts.

[0010] The present invention generally relates to a surgical clip configured to ligate tissue (e.g., blood vessels). The surgical clip can include first and second leg members configured to pivot between an open configuration and a closed configuration. The surgical clip can also have first and second locking mechanisms along the length of the surgical clip to provide strength and more reliably maintain the surgical clip in the closed configuration. For example, the surgical clip can include a first latching or locking mechanism on a distal end portion of the surgical clip and a second latching or locking mechanism between the distal and proximal end portions. Each of the first and second locking mechanisms can include a latch, interlock, and / or interference member that collectively secures the surgical clip in the closed configuration. For example, the first locking mechanism can include a hook on the first leg member configured to bend deflectively around a tip member on the second leg member. The second locking mechanism can include one or more arcuate elongate members on the first leg member that are configured to engage with the second leg member. In some embodiments, the arcuate elongate members can pass through a channel in the second leg member and form an interference fit with an undercut in the channel when in the closed configuration. In some embodiments, the second locking mechanism can include a portion of a barrel section of a hinge portion of the first leg member, where the barrel section can be configured to releasably receive an axle pin of the second leg member. In some embodiments, the second locking mechanism can include first and second arcuate elongate members that extend from a side of the first leg member and are configured to engage an outer surface of the second leg member. The second locking mechanism can include interference members (e.g., faces of the elongate members and / or the second leg member) that are spaced apart from each other in the closed configuration to reinforce the first locking mechanism while allowing for flexibility along the length of the surgical clip and / or to accommodate tissues of different thicknesses. Surgical clips can be particularly useful as hemostatic clips configured to latch around a blood vessel, thereby reducing and / or stopping the flow of fluid through the vessel.However, it is also envisioned that embodiments of the surgical clip may have non-surgical uses, such as holding hair.

[0011] The present invention is described herein with reference to the drawings, in which like reference numerals refer to like parts throughout. In accordance with conventional practice used herein, and unless otherwise indicated herein, the term "proximal end portion" shall refer to the identified end portion of a surgical clip and / or associated components that is generally closer to the medical professional who will handle or manipulate the device when it is intended for use, and the term "distal end portion" shall refer to the identified end portion of a surgical clip and / or associated components that is opposite the proximal end portion. As used herein, the term "longitudinal" refers to an area extending along the length of a surgical clip and / or associated components, as commonly understood by those skilled in the art. Furthermore, as used herein, the term "lateral" refers to any axis or direction perpendicular to the longitudinal length of a surgical clip and / or associated components.

[0012] 1-4 illustrate a first embodiment of a surgical clip 100 of the present invention. Surgical clip 100 may have a proximal end portion 100A and a distal end portion 100B. Surgical clip 100 may further include a first leg member 102 having a proximal end portion 102A and a distal end portion 102B, and a second leg member 104 having a proximal end portion 104A and a distal end portion 104B. Proximal end portions 102A, 104A may be connected by a hinge portion 106.

[0013] The first leg member 102 and the second leg member 104 can include surface portions having curved portions. For example, the first leg member 102 can include a first inner surface 108 and a first outer surface 110, and the second leg member 104 can include a second inner surface 112 and a second outer surface 114. As shown in FIG. 1 , the first inner surface 108 can have a concave configuration and the first outer surface 110 can have a convex configuration, or vice versa. The second inner surface 112 can have a convex configuration and the second outer surface 114 can have a concave configuration, or vice versa. The first inner surface 108 and the second inner surface 112 can be approximated in a closed configuration and are resiliently flexible along their lengths to distribute pressure across the width of tissue as it is ligated. The first inner surface 108 and the second inner surface 112 can each have a continuous curvature between their proximal and distal end portions to provide a preferred compression of the tissue.

[0014] The hinge portion 106 can have a concave inner surface 116 and a convex outer surface 118. The concave inner surface 116 of the hinge portion 106 can continuously join the first inner surface 108 of the first leg member 102 and the second inner surface 112 of the second leg member 104. The convex outer surface 118 of the hinge portion 106 can join the first outer surface 110 of the first leg member 102 and the second outer surface 114 of the second leg member 104. The hinge portion 106 can also include a curved slot 120 located between the curved hinge surfaces 116, 118, and the curved slot 120 can be positioned closer to the concave inner surface 116 than the convex outer surface 118. Curved slot 120 can extend completely through hinge portion 106 from one side to the other, with its opposite ends 122, 124 extending into proximal end portions 102A, 104A of first leg member 102 and second leg member 104, respectively. Curved slot 120 can provide additional flexibility and resilience to hinge portion 106, while concave inner surface 116 can prevent any portion of the clamped vessel from becoming trapped within curved slot 120. In some embodiments, hinge portion 106 can be resilient and integrated into proximal end portions 102A, 104A of first leg member 102 and second leg member 104. For example, hinge portion 106 can bias surgical clip 100 into an open configuration (e.g., FIG. 1 ).

[0015] Surgical clip 100 may also include one or more latching or locking mechanisms. For example, first leg member 102 can transition at its distal end portion 102B to a hook section 126, and second leg member 104 can transition at its distal end 104B to a pointed tip portion 128. The distal end portion of hook section 126 curves inwardly and generally faces the concave inner surface 116 of hinge portion 106. Hook section 126 can have one or more lateral inclined surfaces 130 and a concave inner surface that, together with first inner surface 108, defines a recess 132. When hook portion 126 is bent around pointed tip portion 128, pointed tip portion 128 can be V-shaped, defining a slot formed to receive lateral inclined surface 130. Hook section 126 and pointed tip portion 128 can engage to form a first latching or locking mechanism. For example, recesses 132 may engage pointed tip portion 128 in the process of compressing surgical clip 100 into a closed configuration (eg, FIGS. 3-4) that may secure it in position about a vessel or other tissue.

[0016] Surgical clip 100 may also include a second latching or locking mechanism. For example, as shown in FIGS. 1-4 , elongated member 156 can extend from first inner surface 108 of first leg member 102 between proximal end portion 102A and distal end portion 102B. Elongated member 156 can be positioned anywhere along the length of first leg member 102. In some embodiments, elongated member 156 can be positioned closer to proximal end portion 102A than to distal end portion 102B (e.g., on the proximal half of first leg member 102) to secure proximal end portion 100A of surgical clip 100. In some embodiments, elongate member 156 can be positioned closer to proximal end portion 102A than the centerline of first leg member 102 (e.g., on the proximal quarter of first leg member 102) to distribute the latching force along the length of surgical clip 100. Elongate member 156 can extend in an arcuate configuration from first leg member 102 to approximate the arcuate path of second leg member 104 relative to first leg member 102. When surgical clip 100 is in the closed configuration (e.g., FIGS. 3-4 ), elongate member 156 can be received within an opening or channel 158 that extends through at least a portion of the thickness of second leg member 104. As shown in FIG. 1 , channel 158 can have a width that is substantially equal to or greater than the width of the remainder of second leg member 104, and the width of the portion of second leg member 104 through which channel 158 extends can be greater than the width of the remainder of second leg member 104 that is configured to engage tissue. While FIGS. 1-4 show elongate member 156 on first leg member 102 and channel 158 on second leg member 104, surgical clip 100 may additionally or alternatively include elongate member 156 on second leg member 104 and channel 158 on first leg member 102. It is further envisioned that surgical clip 100 may include multiple elongate members 156 on first leg member 102 and / or second leg member 104, and may further include multiple corresponding channels 158 on the opposing leg members 102, 104.

[0017] As further shown in the cross-sectional views of FIGS. 2 and 4, elongate member 156 may include teeth or protrusions 160 configured to engage undercuts 162 in channel 158 to provide a second latching or locking mechanism. When surgical clip 100 is in a closed configuration and in the absence of tissue (e.g., FIGS. 3 and 4), protrusions 160 can be spaced from undercuts 162. For example, the first locking mechanism may be engaged in the closed configuration, and the second locking mechanism may be disengaged. The spacing between protrusions 160 and undercuts 162 in the closed configuration allows flexibility of surgical clip 100 along its length to accommodate tissues of different thicknesses and distribute pressure across the width of the tissue during ligation. The second locking mechanism may also reinforce the first locking mechanism. For example, when surgical clip 100 (e.g., first locking mechanism) becomes worn and / or broken, e.g., uneven absorption and / or degradation of surgical clip 100 can cause first locking mechanism to disengage and the second locking mechanism can prevent surgical clip 100 from opening. In this sense, elongated member 156 can include only a single protrusion 160 without any type of ratcheting or tightening mechanism.

[0018] Channel 158 may extend through and through the entire thickness of second leg member 104. Elongated member 156 may have a length greater than the length of channel 158 to provide an exposed distal end portion 159 of elongated member 156. Exposed distal end portion 159 of elongated member 156 may be proximally engaged and directed to release the second locking mechanism. Elongated member 156 may also be atraumatic, having an atraumatic end and may provide a stop to prevent tissue from being pinched by hinged portion 106.

[0019] As further shown in FIGS. 1 and 3 , surgical clip 100 can include a first plurality of teeth 134 protruding on first inner surface 108 and a second plurality of teeth 136 protruding on second inner surface 112. Teeth 134, 136 can maximize security of compressed tissue and minimize tissue migration. Teeth 134, 136 can be angled toward proximal end portion 102A of surgical clip 100 to secure tissue toward hinge portion 106. As shown in FIG. 1 , first plurality of teeth 134 and second plurality of teeth 136 can include two or more staggered rows of teeth that collectively extend the width of inner surfaces 108, 112. Furthermore, as shown in FIGS. 3 and 4 , first plurality of teeth 134 do not engage second plurality of teeth 136 in the closed configuration, increasing the separated contact points along the length of surgical clip 100 and enhancing security. In some embodiments, one or more of the teeth 134, 136 may be omitted.

[0020] The first and second leg members 102, 104 may include one or more bosses along their lengths for engaging a clip applier. For example, the first leg member 102 may include cylindrical bosses 146, 148 (e.g., as shown in FIGS. 1 and 3 ) adjacent the distal end portion 102B of the first leg member 102 and projecting perpendicularly to opposing side surfaces 138, 140, respectively, just inside the hook section 126. In the illustrative surgical clip 100, the bosses 146, 148 are cylindrical and may project outward beyond the first outer surface 110 of the first leg member 102. The bosses 146, 148 may also be connected to one another by a bridge section 150. The second leg member 104 may also include bosses 152, 154 at the distal end portion 104B. Bosses 152, 154 are cylindrical and project perpendicularly from each of opposing sides 142, 144 of second leg member 104 and may extend longitudinally forward beyond the prongs of prong tip portion 128. In performing tissue ligation, surgical clip 100 is designed to be compressed into a latching or locking configuration around a blood vessel by application of a suitable clip applicator such as that described in U.S. Pat. No. 5,100,416, the entire disclosure of which is incorporated herein by reference.

[0021] 5-8 illustrate a second exemplary embodiment of a surgical clip 200 of the present invention. Surgical clip 200 has a proximal end portion 200A and a distal end portion 200B. Surgical clip 200 further includes a first leg member 202 having a proximal end portion 202A and a distal end portion 202B, and a second leg member 204 having a proximal end portion 204A and a distal end portion 204B. Proximal end portions 202A, 204A of first leg member 202 and second leg member 204 may be releasably coupled at a hinge portion 206. Surgical clip 200 has similar components and / or aspects to surgical clip 100 and may be similarly illustrated in FIGS. 5-8. For purposes of brevity, similar components and / or aspects to those of surgical clip 100 may not be discussed with reference to surgical clip 200.

[0022] The first leg member 202 and the second leg member 204 may include surfaces having curved portions. For example, the first leg member 202 may include a first inner surface 208 and a first outer surface 210, and the second leg member 204 may include a second inner surface 212 and a second outer surface 214. The first inner surface 208 may have a concave configuration and the first outer surface 210 may have a convex configuration, or vice versa. The second inner surface 212 may have a convex configuration and the second outer surface 214 may have a concave configuration, or vice versa. The first inner surface 208 and the second inner surface 212 may be approximated in a closed configuration and may be resiliently flexible along their lengths to distribute pressure across the width of the tissue as it is ligated. The first inner surface 208 and the second inner surface 212 may each have a continuous curvature between their proximal and distal end portions to provide preferred compression of the tissue.

[0023] Surgical clip 200 may also include one or more latching or locking mechanisms. For example, first leg member 202 may transition at its distal end portion 202B to a hook section 226, and second leg member 204 may transition at its distal end 204B to a pointed tip portion 228. The distal end portion of hook section 226 is curved inwardly and generally faces the concave inner surface 216 of hinge portion 206. Hook section 226 may have one or more lateral inclined surfaces 230, the concave inner surface defining a recess 232 in conjunction with first inner surface 208. Pointed tip portion 228 may be V-shaped defining a slot configured to receive lateral inclined surfaces 230 when hook section 226 is bent around pointed tip portion 228. Hook section 226 and pointed tip portion 228 can engage to form a first latching or locking mechanism. For example, recess 232 can engage pointed tip portion 228 during the process of compressing surgical clip 200 into a closed configuration (e.g., FIGS. 7-8) that can secure it in position about a vessel or other tissue.

[0024] First leg member 202 and second leg member 204 of surgical clip 200 can be separable. For example, proximal end portions 202A, 204A of first leg member 202 and second leg member 204 can be separable at hinge portion 206. As shown in FIGS. 5-8 , proximal end portion 202A of first leg member 202 can include a barrel portion 264 formed from a proximal elongate member 266 and a distal elongate member 268. Proximal elongate member 266 may form at least a portion of proximal end portion 202A of first leg member 202. One or more elongate members 266, 268 of barrel portion 264 can be spaced apart to form arcs in opposite directions and define a slot 270 having an opening 272. In some embodiments, slot 270 can have a concave recess having a generally circular cross-section. 5-8 , slot 270 and opening 272 may extend across the entire width of first leg member 202 and be sized to receive hinge pin 274 on proximal end portion 204A of second leg member 204. Hinge pin 274 includes sides 276 on opposite sides of hinge pin 274. Sides 276 may be substantially flat and allow surgical clip 200 to be selectively assembled or disassembled when hinge pin 274 passes through opening 272 at a predetermined angle. In other words, hinge pin 274 may not fit into opening 272 at any angle other than the predetermined angle. 5, side 276 can be disposed at an angle between approximately 90° and 135° relative to a longitudinal axis of second leg member 204, such that assembly or disassembly of surgical clip 200 can occur when opening 272 in second leg member 204 is disposed at a predetermined angle relative to hinge pin 274 of second leg member 204. Advantageously, selective assembly / disassembly of surgical clip 200 can prevent disassembly during the normal course of use of surgical clip 200. For example, when surgical clip 200 is in a closed configuration, side 276 can be substantially offset (e.g., by at least approximately 90°) from opening 272, preventing surgical clip 200 from disassembling.It is also envisioned that surgical clip 200 may be assembled in situ, for example, immediately prior to compression of surgical clip 200 onto tissue.

[0025] 5-8, surgical clip 200 can be assembled by barrel portion 264 of first leg member 202 being received in channel 278 of second leg member 204. Channel 278 is defined by hinge pin 274, a proximal surface 280 of second leg member 204, and first and second leg extension members 282 extending between the body of second leg member 204 and hinge pin 274. Channel 278 allows passage of distal elongate member 268 to transition surgical clip 200 from an open configuration (e.g., FIG. 5) to a closed configuration (e.g., FIGS. 7-8).

[0026] The interaction of distal elongate member 268 and channel 278 can provide a second latching or locking mechanism for securing surgical clip 200 in the closed configuration. For example, distal elongate member 268 can include teeth or protrusions 284 that engage undercuts 286 on proximal surface 280 of second leg member 204. One or more of protrusions 284 and undercuts 286 can be bent to deflect protrusions 284 as they pass through channel 278, and protrusions 284 and undercuts 286 can provide a latching, interlocking, and / or interference fit to prevent surgical clip 200 from pivoting from the closed configuration (e.g., FIGS. 7 and 8 ) to the open configuration (e.g., FIGS. 5 and 6 ). When surgical clip 200 is in the closed configuration and no tissue is present, protrusions 284 can be spaced from undercuts 286. For example, in the closed configuration, the first locking mechanism can be engaged, but the second locking mechanism can be disengaged. The spacing between the protrusion 284 and the undercut 286 in the closed configuration allows surgical clip 200 flexibility along its length, allowing it to accommodate tissues of different thicknesses and distribute pressure across the width of the tissue during ligation. The second locking mechanism can also reinforce the first locking mechanism. For example, the second locking mechanism can prevent surgical clip 200 from opening when surgical clip 200 (e.g., first locking mechanism) is worn and / or broken, e.g., when uneven absorption and / or degradation of surgical clip 200 causes the first locking mechanism to disengage. In this sense, elongate member 268 can include only a single protrusion 284 without any type of ratcheting or tightening mechanism.

[0027] Surgical clip 200 may include a first plurality of teeth 234 protruding on first inner surface 208 and a second plurality of teeth 236 protruding on second inner surface 212. Teeth 234, 236 can maximize security of compressed tissue and minimize tissue migration. Teeth 234, 236 can be angled toward proximal end portion 202A of surgical clip 200 to secure tissue toward hinge portion 206. First plurality of teeth 234 and second plurality of teeth 236 may include two or more staggered rows of teeth that collectively extend the width of inner surfaces 208, 212. First plurality of teeth 234 do not engage second plurality of teeth 236 in the closed configuration, increasing the separated contact points along the length of surgical clip 200 and enhancing security. In some embodiments, one or more of teeth 234, 236 may be omitted.

[0028] First leg member 202 and second leg member 204 may include one or more bosses along their lengths for engaging a clip applier. For example, first leg member 202 may include cylindrical bosses 246, 248 that protrude perpendicularly from opposing side surfaces 238, 240 adjacent distal end portion 202B of first leg member 202 and immediately inward of hook section 226. In the illustrative surgical clip 200, bosses 246, 248 are cylindrical and may protrude outward beyond first outer surface 210 of first leg member 202. Bosses 246, 248 may also be connected to one another by bridge section 250. Second leg member 204 may also include bosses 252, 254 at distal end portion 204B. Bosses 252, 254 are cylindrical and project perpendicularly from opposite sides 242, 244 of second leg member 204, respectively, and may extend longitudinally forward beyond the prongs of prong tip portion 228. In performing tissue ligation, surgical clip 200 is designed to be compressed into a latching or locking configuration around a blood vessel by application of a suitable clip applier, such as that described in U.S. Pat. No. 5,100,416, the entire disclosure of which is incorporated herein by reference.

[0029] 9-11 illustrate a third exemplary embodiment of a surgical clip 300 of the present invention. Surgical clip 300 may have a proximal end portion 300A and a distal end portion 300B. Surgical clip 300 may further include a first leg member 302 having a proximal end portion 302A and a distal end portion 302B, and a second leg member 304 having a proximal end portion 304A and a distal end portion 304B. The proximal end portions 302A, 304A of first leg member 302 and second leg member 304 may be joined by a hinge portion 306. Surgical clip 300 may have similar components to at least one of surgical clips 100, 200 and is similarly illustrated in FIGS. 9-11. For purposes of brevity, components and / or aspects similar to those of surgical clips 100, 200 may not be discussed with reference to surgical clip 300.

[0030] The first and second leg members 302, 304 may include surfaces having curved portions. For example, the first leg member 302 may include a first inner surface 308 and a first outer surface 310, and the second leg member 304 may include a second inner surface 312 and a second outer surface 314. The first inner surface 308 may have a concave configuration and the first outer surface 310 may have a convex configuration, or vice versa. The second inner surface 312 may have a convex configuration and the second outer surface 314 may have a concave configuration, or vice versa. The first inner surface 308 and the second inner surface 312 may be approximated in a closed configuration and may be resiliently flexible along their lengths to distribute pressure across the width of the tissue as it is ligated. The first inner surface 308 and the second inner surface 312 may each have a continuous curvature between their proximal and distal end portions to provide preferred compression of the tissue.

[0031] The hinge portion 306 can have a concave inner surface 316 and a convex outer surface 318. The concave inner surface 316 of the hinge portion 306 can contiguously join the first inner surface 308 of the first leg member 302 and the second inner surface 312 of the second leg member 304. The convex outer surface 318 of the hinge portion 306 can join the first outer surface 310 of the first leg member 302 and the second outer surface 314 of the second leg member 304. The hinge portion 306 can also include a curved slot 320 located between the curved hinge surfaces 316, 318, and the curved slot 320 can be positioned closer to the concave inner surface 316 than to the convex outer surface 318. Curved slot 320 can extend completely through hinge portion 306 from one side to the other, with its opposite ends 322, 324 extending into proximal end portions 302A, 304A of first leg member 302 and second leg member 304, respectively. Curved slot 320 can provide additional flexibility and resilience to hinge portion 306, while concave inner surface 316 can prevent any portion of the clamped vessel from becoming trapped within curved slot 320. In some embodiments, hinge portion 306 can be resilient and integral with proximal end portions 302A, 304A of first leg member 302 and second leg member 304. For example, hinge portion 306 can bias surgical clip 300 into an open configuration.

[0032] Surgical clip 300 may include one or more latching or locking mechanisms. For example, first leg member 302 can transition at its distal end portion 302B to a hook section 326, and second leg member 304 can transition at its distal end 304B to a pointed tip portion 328. The distal end portion of hook section 326 curves inwardly and generally faces the concave inner surface 316 of hinge portion 306. Hook section 326 can have one or more lateral inclined surfaces 330 and a concave inner surface that, together with first inner surface 308, defines a recess 332. When hook portion 326 is bent around pointed tip portion 328, pointed tip portion 328 can be V-shaped, defining a slot formed to receive lateral inclined surface 330. Hook section 326 and pointed tip portion 328 can engage to form a first latching or locking mechanism. For example, recesses 332 may engage pointed tip portion 328 in the process of compressing surgical clip 300 into a closed configuration (eg, FIG. 11) that may be secured in position about a vessel or other tissue.

[0033] The surgical clip 300 may also include a second latching or locking mechanism. For example, as shown in FIGS. 8-11 , one or more elongate members 390 can extend from the first leg member 302 along its length between the proximal end portion 302A and the distal end portion 302B. For example, the one or more elongate members 390 can include first and second elongate members 390 extending from opposing sides 338, 340 of the first leg member 302 in an external or “outboard” configuration and configured to receive the second leg member 304 therebetween. The elongate members 390 can be positioned anywhere along the length of the first leg member 302. In some embodiments, elongate member 390 can be positioned closer to proximal end portion 302A than to distal end portion 302B (e.g., on the proximal half of first leg member 302) to secure proximal end portion 300A of surgical clip 300. In some embodiments, elongate member 390 can be positioned closer to proximal end portion 302A than to the centerline of first leg member 302 (e.g., on the proximal quarter of first leg member 302) to distribute the latching force along the length of surgical clip 300. Elongate member 390 can extend in an arcuate configuration from first leg member 302 to approximate the arcuate path of second leg member 304 relative to first leg member 302. Although FIGS. 8-11 show elongate members 390 on first leg member 302, surgical clip 300 may additionally or alternatively include one or more elongate members 390 on second leg member 304.

[0034] 8-11, elongate member 390 may include teeth or protrusions 392 configured to engage outer surface 314 of second leg member 304 to provide a second latching or locking mechanism. When surgical clip 300 is in the closed configuration and in the absence of tissue (e.g., FIG. 11), protrusions 392 may be spaced from outer surface 314. For example, the first locking mechanism may be engaged in the closed configuration, and the second locking mechanism may be disengaged. The spacing between protrusions 392 and outer surface 314 in the closed configuration allows flexibility of surgical clip 300 along its length to accommodate tissues of different thicknesses and distribute pressure across the width of tissue during ligation. The second locking mechanism may also reinforce the first locking mechanism. For example, when surgical clip 300 (e.g., first locking mechanism) wears and / or breaks, e.g., uneven absorption and / or degradation of surgical clip 300 can cause first locking mechanism to disengage and the second locking mechanism can prevent surgical clip 300 from opening. In this sense, elongated member 390 can include only a single protrusion 392 without any type of ratcheting or tightening mechanism.

[0035] Surgical clip 300 may include a first plurality of teeth 334 protruding on first inner surface 308 and a second plurality of teeth 336 protruding on second inner surface 312. Teeth 334, 336 can maximize security of compressed tissue and minimize tissue migration. Teeth 334, 336 can be angled toward proximal end portion 302A of surgical clip 300 to secure tissue toward hinge portion 106. First plurality of teeth 334 and second plurality of teeth 336 may include two or more staggered rows of teeth that collectively extend the width of inner surfaces 308, 312. First plurality of teeth 334 do not engage second plurality of teeth 336 in the closed configuration, increasing separated contact points along the length of surgical clip 300 and enhancing security. In some embodiments, one or more of teeth 334, 336 may be omitted.

[0036] The first leg member 302 and the second leg member 304 may include one or more bosses along the length of the first leg member 102 and the second leg member 104 for engaging a clip applier. For example, the first leg member 302 may include cylindrical bosses 346, 348 that protrude perpendicularly from opposing side surfaces 338, 340 adjacent the distal end portion 302B of the first leg member 302 and immediately inward of the hook section 326. In the illustrative surgical clip 300, the bosses 346, 348 are cylindrical and may protrude outward beyond the first outer surface 310 of the first leg member 302. The bosses 346, 348 may also be connected to one another by a bridge section 350. The second leg member 304 may also include bosses 352, 354 at the distal end portion 304B. Bosses 352, 354 are cylindrical and project perpendicularly from opposite sides 342, 344 of second leg member 304, respectively, and may extend longitudinally forward beyond the prongs of prong tip portion 328. In performing tissue ligation, surgical clip 300 is designed to be compressed into a latching or locking configuration around a blood vessel by application of a suitable clip applicator, such as that described in U.S. Pat. No. 5,100,416, the entire disclosure of which is incorporated herein by reference.

[0037] The surgical clips 100, 200, 300 can be made in any suitable size and can be applied to any number of tissues, such as blood vessels, lymph nodes, nerves, fallopian tubes, or cardiac tissue. The surgical clips 100, 200, 300 can be formed from any suitable biocompatible material, such as certain metals and polymers. The surgical clips 100, 200, 300 can include absorbable and / or non-absorbable polymeric materials. Exemplary polymeric materials include one or more homopolymers or copolymers of polyacetal, polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyoxymethylene (POM), polymethyl methacrylate (PMMA), polylactic acid (PLA), polyglycolic acid (PGA), and other thermoplastic materials with similar properties that can be injection molded, extruded, or otherwise processed into similar articles. However, surgical clips 100, 200, 300 of the present invention are particularly suited to absorbent materials, which are sometimes weaker and of lower quality in uneven proportions. Surgical clips 100, 300 may be a one-piece, unitary polymer body for ease of manufacturing. It is also contemplated that each of leg members 202, 204 of surgical clip 200 may be a one-piece, unitary polymer body for ease of manufacturing.

[0038] The many features and advantages of the present invention are apparent from the detailed description, and it is, therefore, intended by the appended claims to cover all features and advantages of the present invention that fall within the true spirit and scope of the invention. Further, because numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described; therefore, all suitable modifications and equivalents may be resorted to as falling within the scope of the invention.

Claims

1. A surgical clip comprising: a first leg member and a second leg member, the first leg member having an inner surface with a curvature that forms a first vascular clamping surface, and the second leg member having an inner surface with a curvature that forms a second vascular clamping surface, the first leg member and the second leg member being configured to move between an open configuration in which the inner surfaces are spaced apart and a closed configuration in which the inner surfaces are approximated to clamp a blood vessel or other tissue between the first vascular clamping surface and the second vascular clamping surface; a first locking member and a second locking member, the first locking member being disposed at a distal end portion of the first leg member and the second locking member being disposed at a distal end portion of the second leg member, the first locking member and the second locking member being configured to engage with each other in the closed configuration to provide a first locking mechanism that secures the first leg member and the second leg member; a first elongate member extending laterally outward from a first side of the first leg member and disposed between the proximal end portion and the distal end portion of the first leg member; a second elongate member extending laterally outward from a second side of the first leg member and disposed between the proximal end portion and the distal end portion of the first leg member, the first side being opposite the second side of the first leg member; a distal portion of each of the first and second elongate members configured to receive the second leg member therebetween when the first and second leg members are in the closed configuration, and each of the distal portions of the first and second elongate members has a protrusion spaced from an outer surface of the second leg member when the first and second leg members are in the closed configuration and the first locking mechanism is engaged, the outer surface of the second leg member being located on an opposite side of the second leg member from the inner surface of the second leg member, and each protrusion of the first and second elongate members configured to provide a second locking mechanism that locks the first leg member to the second leg member when the first and second leg members are in the closed configuration and the first locking mechanism is disengaged.

2. 2. The surgical clip according to claim 1, wherein the first locking member includes a hook portion and the second locking member includes a pointed tip portion, the hook portion configured to bend around the distal end portion of the second leg member.

3. The surgical clip of claim 1 or claim 2, wherein the first elongate member and the second elongate member are arcuate.

4. The surgical clip of claim 1 , wherein the first elongate member and the second elongate member are disposed on a proximal half of the first leg member.

5. 5. The surgical clip of claim 1, further comprising a hinge portion connecting the proximal end portion of the first leg member and the proximal end portion of the second leg member, the hinge portion configured to pivot the first leg member relative to the second leg member.

6. The surgical clip of claim 1 , further comprising at least one boss disposed on the distal end portion of at least one of the first leg member and the second leg member.

7. The surgical clip of claim 1 , wherein at least one of the inner surface of the first leg member and the inner surface of the second leg member comprises a plurality of teeth.

8. 8. The surgical clip of claim 1, wherein the inner surface of the first leg member has a concave curvature and the inner surface of the second leg member has a convex curvature.

9. 9. The surgical clip of claim 1, wherein the curvature of the first leg members extends from the respective proximal end portions to the respective distal end portions, and the curvature of the second leg members extends from the respective proximal end portions to the respective distal end portions.

10. The surgical clip of any preceding claim, wherein the surgical clip comprises an absorbable polymer material.

Images