Surgical clip and clip applier

Abstract

A clip applier assembly may include a surgical clip and a clip applier. A surgical clip may include a first clip foot member and a second clip foot member configured to ligature tissue. The first clip member may include a first proximal portion, a first distal portion, a first inner surface, and a first outer surface. The first outer surface may have a curvature. The second clip member may include a second proximal portion, a second distal portion, a second inner surface, and a second outer surface. The second clip member may further include an interior and an exterior separated by a channel. The second outer surface may be formed on the outer portion and have a convex curve. The clip applier may have a first jaw member configured to engage the first outer surface and a second jaw member configured to engage the second outer surface.

Description

[0001] This application is a divisional application of the invention patent application with application date of March 21, 2018, application number 201880020554.4, and name “Surgical clip and clip applier”. Technical Field

[0002] The present invention relates generally to surgical clips and clip appliers and, more particularly, to surgical clips and clip appliers having improved stability. Background Art

[0003] Ligating tissue (e.g., blood vessels, lymph nodes, nerves, fallopian tubes, and cardiac tissue) is a common practice in many surgical procedures. This practice is accomplished by closing the blood vessels with surgical clips or suturing the blood vessels with surgical sutures. The use of surgical sutures requires complex manipulation of the needle and surgical sutures to form the knots required to secure the blood vessels. Such complex operations are very time-consuming and difficult to perform, especially in endoscopic surgical procedures characterized by limited space and / or visibility. In contrast, surgical clips are relatively faster and easier to apply. Accordingly, the use of surgical clips in endoscopic and open surgical procedures has shown a sharp increase. Summary of the invention

[0004] The inventors have recognized the need to improve one or more features of surgical clips, such as the stability of the surgical clip in a clip applier. Current clip appliers typically secure the surgical clip at two contact points provided by bosses at the distal ends of the clip's foot members. However, these bosses do not provide sufficient stability for the surgical clip, which may move relative to the clip applier or even fall out between the jaw members during a surgical procedure. For example, the surgical clip may trail when housed between the jaw members, thereby failing to provide sufficient stability along the length of the surgical clip. Current surgical clips are also difficult to feed through the rod of an automatic clip applier. The devices and methods of the present invention are intended to alleviate or solve one or more of the above-mentioned problems and / or other problems in the prior art.

[0005] A first aspect relates to a surgical clip configured to ligate tissue. The surgical clip may include a first clamping foot member having a first proximal portion, a first distal portion, a first inner surface, and a first outer surface. The first outer surface may have a convex curvature. The surgical clip may also include a second clamping foot member having a second proximal portion, a second distal portion, a second inner surface, and a second outer surface. The second clamping foot member may further include an inner portion and an outer portion separated by a channel. The second outer surface may be formed on the outer portion and have a convex curvature.

[0006] In some embodiments, the interior and the exterior can be formed in one piece. In some embodiments, the interior and the exterior can include a polymer. In some embodiments, the exterior can extend at least one quarter of the length of the second clamping foot member. In some embodiments, the exterior can extend at least one half of the length of the second clamping foot member. In some embodiments, the exterior can extend substantially the entire length of the second clamping foot member. In some embodiments, the width of the exterior can be less than the width of the interior. In some embodiments, the convexity of the second outer surface can extend from the proximal end of the exterior to the distal end of the exterior. In some embodiments, the first outer surface can have a first longitudinal protrusion, and the second outer surface can have a second longitudinal protrusion. In some embodiments, the surgical clip can further have a hook member on the distal portion of one of the first and second clamping foot members and a tip member on the other of the first and second clamping foot members, the hook member being configured to accommodate the tip member in the closed configuration. In some embodiments, the hook member can be on the first clamping foot member, and the tip member can be on the second clamping foot member. In some embodiments, at least one tooth portion can be located on the first inner surface, and at least one tooth portion can be located on the second inner surface. In certain embodiments, the first interior surface may include a concave curvature and the second interior surface may include a convex curvature.

[0007] A second aspect relates to a surgical clip configured to ligate tissue. The surgical clip may include a first clamping foot member having a first proximal portion, a first distal portion, a first inner surface, and a first outer surface. The first inner surface may have a concave curve, and the first outer surface may have a convex curve. The surgical clip may include a second clamping foot member, the second clamping foot member including a second proximal portion, a second distal portion, a second inner surface, and a second outer surface. The second clamping foot member may further include an inner portion and an outer portion separated by a channel. The second inner surface may be formed on the inner portion and have a convex curve, and the second outer surface may be formed on the outer portion and have a convex curve. The inner portion and the outer portion may be integrally formed of a polymer, and the outer portion may extend at least one quarter of the length of the second clamping foot member. A hook member may be located on the first distal portion of the first clamping foot member, and a tip member may be located on the second distal portion of the second clamping foot member. The hook member may be configured to bend around the tip member to secure the surgical clip in a closed configuration. The hinge member may pivotally couple the first proximal portion and the second proximal portion.

[0008] A third aspect relates to a clip applier system configured to ligate tissue. The clip applier system may include a surgical clip and a clip applier having a first jaw member and a second jaw member. The surgical clip may include a first clamping foot member and a second clamping foot member. The first clamping foot member may have a proximal portion, a distal portion, a first inner surface, and a first outer surface. The first outer surface may have a convex curve that engages the first jaw member. The second clamping foot member may have a proximal portion, a distal portion, a second inner surface, and a second outer surface. The second clamping foot member may further have an interior and an exterior separated by a channel. The second inner surface may be formed on the interior, and the second outer surface may be formed on the exterior and have a convex curve that engages the second jaw member.

[0009] In some embodiments, the clip applier may include a first flexible member engaging a first clamping foot member and a second flexible member engaging a second clamping foot member. In some embodiments, the first flexible member may be biased to engage with the first outer surface, and the second flexible member may be biased to engage with the second outer surface. In some embodiments, a portion of the first flexible member may be accommodated in a channel of the first jaw member, and a portion of the second flexible member may be accommodated in a channel of the second jaw member. In some embodiments, a distal portion of the first flexible member may be fixed to the first jaw member, and a distal portion of the second flexible member may be fixed to the second jaw member. In some embodiments, the proximal portion of the first flexible member may be spaced apart from the proximal portion of the second flexible member. In some embodiments, the proximal portion of the first flexible member may be connected or integral with the proximal portion of the second flexible member. In some embodiments, the first clamping foot member may have a first longitudinal protrusion configured to be accommodated in a first slot of the first jaw member, and the second clamping foot member may have a second longitudinal protrusion configured to be accommodated in a second slot of the second jaw member.

[0010] A fourth aspect relates to a method for loading a clip applier with a surgical clip. The clip applier may include a first jaw member and a second jaw member, and the surgical clip may include a first clamping foot member and a second clamping foot member. The first clamping foot member may have a first proximal portion, a first distal portion, a first inner surface, and a first outer surface, and the first outer surface may have a convex curve. The second clamping foot member may have a second proximal portion, a second distal portion, a second inner surface, and a second outer surface. The second clamping foot member may further have an interior and an exterior separated by a channel, and the second outer surface is formed on the exterior and has a convex curve. The method may include: accommodating the surgical clip between the first jaw member and the second jaw member; engaging the convex curve of the first outer surface with the first jaw member; and engaging the convex curve of the second outer surface with the second jaw member. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] To facilitate understanding of the present invention, various aspects of the present invention are illustrated by way of the accompanying drawings.

[0012] Figure 1A A side view of a first exemplary embodiment of a surgical clip according to the present invention is shown in an exemplary open configuration.

[0013] Figure 1B Show Figure 1A Side view of a surgical clip in an exemplary closed configuration.

[0014] Figure 2A A first exemplary embodiment of a manual clip applier is shown loaded with Figure 1A to Figure 1B Side view of the surgical clip.

[0015] Figure 2B Show Figure 2A A perspective view of an exemplary manual clip applier and surgical clip is shown in FIG.

[0016] Figure 3 An exemplary embodiment of an automatic clip applier is shown loaded with Figure 1A to Figure 1B Side view of the surgical clip.

[0017] Figure 4 A perspective view of a second exemplary embodiment of a surgical clip according to the present invention is shown in an exemplary open configuration.

[0018] Figure 5A A first exemplary embodiment of a manual clip applier is shown loaded with Figure 4 Side view of the surgical clip.

[0019] Figure 5B Show Figure 5A A perspective view of an exemplary manual clip applier and surgical clip is shown in FIG.

[0020] Figure 5C Show FIG. 5A to FIG. 5B A perspective view of an exemplary embodiment of a flexible member of a manual clip applier in FIG.

[0021] Fig. 6A An exemplary embodiment of a third manual clip applier is shown loaded with Figure 4 Side view of the surgical clip.

[0022] Figure 6B Show Fig. 6A A perspective view of an exemplary manual clip applier in FIG.

[0023] Fig. 7A An exemplary embodiment of a fourth manual clip applier is shown loaded with Figure 4 Side view of the surgical clip.

[0024] Figure 7B Show Fig. 7A A perspective view of a manual clip applier is shown.

[0025] The same or similar reference numbers may be used in the drawings and the following detailed description to refer to the same or similar parts. DETAILED DESCRIPTION

[0026] The present invention will now be described in conjunction with the accompanying drawings, wherein the same reference numerals may refer to the same elements throughout the text. According to conventional practice, as used herein, the term "proximal portion" refers to a specific portion of a component that is generally closer to a medical staff member who operates or manipulates the device as it is used, and the term "distal portion" refers to a specific portion of a component opposite to the proximal portion, unless otherwise specified herein. The term "longitudinal" refers to the dimension extending from the proximal portion to the corresponding distal portion along the length of the component. "Transverse" refers to any axis or direction orthogonal to the longitudinal length of the component. The term "length" simply refers to the dimension of the component along the longitudinal direction. The term "height" or "vertical" refers to the dimension of the component along the compression direction of the clip applier and / or surgical clip. The term "thickness" refers to the dimension between the opposite sides of the component along the compression direction or vertical. The term "width" refers to the dimension of the component in a transverse direction that is substantially transverse to the length and height. The terms "concave" and "convex" refer to the curvature of the surface or component visible when observing the surface or the outside of the component. Approximate terms are used throughout this specification.

[0027] The present invention generally relates to surgical clips and / or clip appliers that can be used for medical procedures such as ligating tissue. The surgical clips and / or clip appliers may include an improved retaining mechanism that reduces the relative movement of the surgical clip when the clip applier is applied. The foot member of the surgical clip may include an interior (e.g., inner ribs) and an exterior (e.g., outer ribs) separated by a channel. Each foot member of the surgical clip may have an outer surface, and the convexity of the outer surface increases the contact area between the surgical clip and the clip applier. The clip applier may have one or more flexible members that receive and / or engage the outer surface of the surgical clip, such as the outer surface of the exterior. The flexible member may be disposed on each jaw member of the clip applier to engage the corresponding foot member of the surgical clip. The flexible member may be a spring-based metal (e.g., spring steel) that is biased to receive and / or engage the foot member of the surgical clip. When the clip applier compresses the surgical clip onto the tissue, the flexible member may be compressed. The flexible member may also be configured to nest into the longitudinal channel of the first jaw member and the second jaw member as the clip applier closes to promote the complete closure of the surgical clip. In certain embodiments, an outer surface of the surgical clip may include a longitudinal protrusion configured to be received in a longitudinal slot of the flexible member to reduce lateral movement of the surgical clip.

[0028] Figure 1A A side view of the surgical clip 100 is shown in an open configuration, and Figure 1BA side view of the surgical clip 100 is shown in a closed configuration. As shown, the surgical clip 100 can have a proximal portion and a distal portion. The surgical clip 100 can further include a first clamping foot member 102 having a proximal portion and a distal portion and a second clamping foot member 104 having a proximal portion and a distal portion. The first clamping foot member 102 and the second clamping foot member 104 can be integrally connected at the proximal portion by a hinge member 106.

[0029] The first clamping foot member 102 and the second clamping foot member 104 may include surfaces having curved portions. For example, the first clamping foot member 102 may include a first inner surface 108 and a first outer surface 110, and the second clamping foot member 104 may include a second inner surface 112 and a second outer surface 114. Figure 1A As shown, the first inner surface 108 can have a concave curvature, while the first outer surface 110 can have a convex curvature. The second inner surface 112 can have a convex curvature, while the second outer surface 114 can have a convex curvature. The concave curvature of the first inner surface 108 and / or the convex curvature of the first outer surface 110 can extend substantially the entire length of the first clamping foot member 102. The convex curvature of the second inner surface 112 and / or the convex curvature of the second outer surface 114 can extend substantially the entire length of the second clamping foot member 104. The inner surfaces 108, 112 can be close or in contact in a closed configuration. The first clamping foot member 102 can also include opposite side surfaces ( Figure 1A to Figure 1B , and the second clamping foot member 104 may include opposite side surfaces ( Figure 1A to Figure 1B in and out of the paper).

[0030] The second clamping foot member 104 may include an inner portion 116 (e.g., inner ribs) and an outer portion 118 (e.g., outer ribs) connected in one piece at a proximal portion 120 and a distal portion 122. The inner portion 116 may form at least a portion of the second inner surface 112 and have an outer surface with a concave curve, while the outer portion 118 may form at least a portion of the second outer surface 114 and have an inner surface with a concave curve. The curved surface of the inner portion 116 and / or the outer portion 118 may extend from a proximal end (e.g., the proximal portion 120) to a distal end (e.g., the distal portion 122) of the corresponding inner portion 116 and the outer portion 118. The thickness of at least one of the inner portion 116 and the outer portion 118 may be less than the thickness of the first clamping foot member 102. The smaller thickness of the inner portion 116 and / or the outer portion 118 may provide greater flexibility to allow the second inner surface 112 to bend around tissues of different thicknesses. The inner portion 116, the outer portion 118, and / or the first clamping foot member 102 may have substantially the same radius of curvature. Due to the convex outer surfaces 110, 114 of the first and second clamping foot members 102, 104, the surgical clip 100 may have a generally symmetrical profile along the longitudinal axis. The general symmetry of the surgical clip 100 may facilitate engagement with a clip applier.

[0031] The inner portion 116 and the outer portion 118 may be separated by at least one transverse hole or channel 124 extending between the side surfaces of the second clamping foot member 104 to encourage compression of the second clamping foot member 104. For example, the channel 124 may encourage the inner portion 116 to resiliently compress toward the outer portion 118 and distribute the load along the length of the tissue while more efficiently clamping and retaining the tissue within the surgical clip 100. In some embodiments, the inner portion 116, the outer portion 118, and / or the channel 124 may extend more than one quarter of the length of the second clamping foot member 104. In some embodiments, the inner portion 116, the outer portion 118, and / or the channel 124 may extend more than one half of the length of the second clamping foot member 104. In some embodiments, the inner portion 116, the outer portion 118, and / or the channel 124 may extend substantially the entire length of the first clamping foot member 102. The width and / or thickness of the outer portion 118 can be less than the width and / or thickness of the inner portion 116 to increase the flexibility of the inner portion 116 and reduce the constraints on the flexibility of the inner portion 116 when the inner portion 116 flexes and flattens during closing and / or occlusion. The inner portion 116 and the outer portion 118 can be integrally formed from the same material (e.g., injection molded from a polymer) for ease of manufacture.

[0032] The hinge member 106 is elastically deformable and is integrally formed with the first clamping foot member 102 and the second clamping foot member 104. The hinge member 106 may have an inner concave surface and an outer convex surface. The inner concave surface of the hinge member 106 may connect the inner surface 108 of the first clamping foot member 102 with the inner surface 112 of the second clamping foot member 104. The outer convex surface of the hinge member 106 may connect the first outer surface 110 of the first clamping foot member 102 with the second outer surface 114 of the second clamping foot member 104. The hinge member 106 may also include a curved groove between the hinge surfaces to increase the flexibility of the hinge member 106.

[0033] The surgical clip 100 may also include a locking mechanism having one or more interlocking or locking elements. For example, the first clamping foot member 102 may transition to a hook member 126 at its distal portion, and the second clamping foot member 104 may transition to a tip member 128 at its distal portion. The distal portion of the hook member 126 may be bent inward and generally pointed toward the concave surface of the hinge member 106. The hook member 126 may have one or more lateral bevels and a concave surface that merges with the inner surface 108 to define a locking recess. The tip member 128 may be V-shaped, and the narrow groove defined is configured to accommodate the bevel when the hook member 126 is bent around the tip member 128. The hook member 126 and the tip member 128 may be joined to form a locking mechanism. For example, when the surgical clip 100 is compressed into a closed configuration (e.g., a closed configuration) secured around a blood vessel or other tissue, Figure 1B ), the locking recess can engage with the tip member 128 during the process.

[0034] The clamping foot members 102, 104 can include one or more bosses 130-136 along their lengths for engaging the jaw members of a clip applier. For example, the first clamping foot member 102 can include bosses 130, 132 that protrude perpendicularly from each opposing side surface adjacent to the distal portion of the first clamping foot member 102 and proximate to the hook member 126. In the illustrated example of the surgical clip 100, the bosses 130, 132 can be cylindrical and protrude outwardly beyond the side surface of the first clamping foot member 102. The bosses 130, 132 can also be connected by a bridge portion ( Figure 4 431) are coupled together. The second clamping foot member 104 may also include bosses 134, 136 at the distal portion of the second clamping foot member 104. The bosses 134, 136 may be cylindrical and protrude perpendicularly from each opposite side surface of the second clamping foot member 104, extending longitudinally distal to the end point of the tip member 128. The bosses 134, 136 may be separated by a V-shaped slot of the tip member 128 (such as Figure 4 ). The jaw members of the clip applier can engage bosses 130-136 and cause the foot members 102, 104 to pivot about hinge member 106 to compress surgical clip 100 into a closed and / or locked configuration about a blood vessel.

[0035] The surgical clip 100 may include at least one first tooth 140 positioned on the inner surface 108 of the first clamping foot member 102 and at least one second tooth 142 positioned on the inner surface 112 of the second clamping foot member 104. For example, the surgical clip 100 may include a plurality of first teeth 140 positioned on the inner surface 108 of the first clamping foot member 102 and a plurality of second teeth 142 positioned on the inner surface 112 of the second clamping foot member 104.

[0036] FIG. 2A to FIG. 2B A manual clip applier 200 is shown loaded with a surgical clip 100. As shown, the clip applier 200 may include a first jaw member 202 and a second jaw member 204 that are pivotally coupled to each other to close and / or latch the surgical clip 100 to the tissue. The first jaw member 202 may be configured to receive and / or engage the outer surface 110 of the first clamping foot member 102, and the second jaw member 204 may be configured to receive and / or engage the outer surface 114 of the second clamping foot member 104. As shown, the first jaw member 202 may include a first flexible member 206 configured to receive and / or engage the outer surface 110 of the first clamping foot member 102, and the second jaw member 204 may include a second flexible member 208 configured to receive and / or engage the outer surface 114 of the second clamping foot member 104.

[0037] The flexible members 206, 208 can have a distal portion (e.g., 516, such as FIG. 5A to FIG. 5C204) which are fixed or fastened (e.g., welded) to the distal portions of the respective first and second jaw members 202, 204. The distal portions of the flexible members 206, 208 can be received in the longitudinal channels 210 on the interior of the respective jaw members 202, 204. The proximal portions of the flexible members 206, 208 can be free from direct attachment to the clip applier 200 and can be spaced apart. The flexible members 206, 208 can be spring-based metals (e.g., spring steel) that are biased to receive and / or engage the foot members 102, 104 of the surgical clip 100. When the first and second jaw members 202, 204 are in an open configuration, the flexible members 206, 208 can have an arcuate shape. The stabilizing members 206, 208 can be configured to deflect and / or straighten as the first and second jaw members 202, 204 close the surgical clip 100. For example, as the first jaw member 202 and the second jaw member 204 close the surgical clip 100, the flexible members 206, 208 can deflect radially outward and / or straighten (stretch) longitudinally toward the corresponding jaw members 202, 204 to accommodate the deflection of the surgical clip 100 and the approach of the first jaw member 102 and the second jaw member 104.

[0038] The flexible members 206, 208 can each include a retaining member 212, 214 on a proximal portion that is configured to laterally stabilize the first and second foot members 102, 104. As shown, the retaining members 212, 214 can each include opposing first and second side walls that are configured to accommodate the foot members 102, 104 and prevent or reduce lateral movement of the first surgical clip 100. Each retaining member 212, 214 can be integrally formed with the corresponding flexible member 206, 208. Further, as shown in FIG. Figure 2B As shown, longitudinal channel 210 of each of first jaw member 202 and second jaw member 204 can have a narrower portion and a wider portion, and when first jaw member 202 and second jaw member 204 are approximated and / or closed, the narrower portion is configured to accommodate the narrower distal portion of flexible members 206, 208, and the wider portion is configured to accommodate the width of retaining members 212, 214. Therefore, when clip applier 200 closes surgical clip 100, flexible members 206, 208 can be configured to nest into first jaw member 202 and second jaw member 204. Flexible members 206, 208 can engage and / or receive surgical clip 100 during the closing and / or occlusion process of surgical clip 100.

[0039] Clip applier 200 may also include features on the distal portion of each of first jaw member 202 and second jaw member 204 configured to secure the distal portion of first clamping foot member 102 and second clamping foot member 104. As shown, each of first jaw member 202 and second jaw member 204 may include at least one recess 220 configured to receive bosses 130-136 of surgical clip 100. Further, as shown in FIG. Figure 6B and Figure 7B As shown, each of first jaw member 202 and second jaw member 204 can have a first recess 220 and a second recess 220 separated by channel 210 and configured to receive bosses 130 - 136 .

[0040] Figure 3 An automated clip applier 300 is shown loaded with one or more surgical clips 100. Clip applier 300 may include a first jaw member 302 and a second jaw member 304 that are configured to close and / or lock surgical clips 100 around tissue.

[0041] As further shown, the clip applier 300 may include an elongated shaft 306, whose channel 308 communicates with the first jaw member 302 and the second jaw member 304. The clip applier 300 may further include a feeder 310 configured to advance the surgical clip 100 from a supply source (e.g., a clip cartridge) through the channel 308 to a position between the first jaw member 302 and the second jaw member 304. The generally symmetrical outer surfaces 110, 114 of the surgical clip 100 may provide an advantageous fit in the channel 308 to align the surgical clip 100 in the vertical direction. The outer portion 118 of the second clamping foot member 104 may facilitate the advancement of the surgical clip 100 by contacting the inner surface of the elongated shaft 306, thereby stabilizing the surgical clip 100 in the vertical direction. The fit of the surgical clip 100 eliminates the need for the pinky to touch the distal end of the feeder 310, which is designed to prevent relative movement of the surgical clip 100 in the vertical direction. The convex outer surface of surgical clip 100 may further increase the surface area where first jaw member 302 engages second jaw member 304 to provide more uniform compression along the length of surgical clip 100 during closure of first jaw member 302 and second jaw member 304 .

[0042] Clip applier 300 may also include features on the distal portion of each of first jaw member 302 and second jaw member 304 configured to secure the distal portion of first and second foot members 102, 104. As shown, each of first and second jaw members 302, 304 may include at least one recess 320 configured to receive bosses 130-136 of surgical clip 100. Outer surfaces 110, 114 of surgical clip 100 may also be received in inner concave surfaces 311 of first and second jaw members 302, 304 to facilitate feeding bosses 130-136 from channel 308 into recess 320.

[0043] Figure 4 4 shows a perspective rear view of surgical clip 400. Surgical clip 400 may have the same features as surgical clip 100 ( Figure 1A to Figure 1B ) Similar features. Similar reference numerals may refer to similar parts of the surgical clip 100.

[0044] As shown, the surgical clip 400 may have a proximal portion and a distal portion. The surgical clip 400 may further include a first clamping foot member 402 having a proximal portion and a distal portion and a second clamping foot member 404 having a proximal portion and a distal portion. The first clamping foot member 402 and the second clamping foot member 404 may be connected as a whole at the proximal portion by a hinge member 406.

[0045] The first clamping foot member 402 and the second clamping foot member 404 may include surfaces having curved portions. For example, the first clamping foot member 402 may include a first inner surface 408 and a first outer surface 410, and the second clamping foot member 404 may include a second inner surface 412 and a second outer surface 414. The first inner surface 408 may have a concave curvature, and the first outer surface 410 may have a convex curvature. The second inner surface 412 may have a convex curvature, and the second outer surface 414 may have a convex curvature. The concave curvature of the first inner surface 408 and / or the convex curvature of the first outer surface 410 may extend substantially the entire length of the first clamping foot member 402. The convex curvature of the second inner surface 412 and / or the convex curvature of the second outer surface 414 may extend substantially the entire length of the second clamping foot member 404. The inner surfaces 408, 412 may be close or in contact in a closed configuration. The first clamping foot member 402 may also include opposing side surfaces, and the second clamping foot member 404 may include opposing side surfaces.

[0046] The second clamping foot member 404 may include an inner portion 416 (e.g., inner ribs) and an outer portion 418 (e.g., outer ribs) connected in one piece at the proximal portion 420 and the distal portion 422. The inner portion 416 may form at least a portion of the second inner surface 412 and have an outer surface with a concave curve, while the outer portion 418 may form at least a portion of the second outer surface 414 and have an inner surface with a concave curve. The curved surface of the inner portion 416 and / or the outer portion 418 may extend from the proximal end (e.g., the proximal portion 420) to the distal end (e.g., the distal portion 422). The thickness of at least one of the inner portion 416 and the outer portion 418 may be less than the thickness of the first clamping foot member 402. The smaller thickness of the inner portion 416 and / or the outer portion 418 may provide greater flexibility to allow the second inner surface 412 to bend around tissues of different thicknesses. The inner portion 416, the outer portion 418, and / or the first clamping foot member 402 may have substantially the same radius of curvature. Due to the convex outer surfaces 410, 414 of the first and second clamping foot members 402, 404, the surgical clip 400 can have a generally symmetrical profile along the longitudinal axis. The general symmetry of the surgical clip 400 can facilitate engagement with a clip applier.

[0047] The inner portion 416 and the outer portion 418 can be separated by at least one transverse hole or channel 424 extending between the side surfaces of the second clamping foot member 404 to promote compression of the second clamping foot member 404. For example, the channel 424 can promote the inner portion 416 to resiliently compress toward the outer portion 418 and distribute the load along the length of the tissue while more efficiently clamping and retaining the tissue within the surgical clip 400. In some embodiments, the inner portion 416, the outer portion 418, and / or the channel 424 can extend more than one-quarter of the length of the second clamping foot member 404. In some embodiments, the inner portion 416, the outer portion 418, and / or the channel 424 can extend more than one-half of the length of the second clamping foot member 404. In some embodiments, the inner portion 416, the outer portion 418, and / or the channel 424 can extend substantially the entire length of the first clamping foot member 402. The width and / or thickness of the outer portion 418 can be less than the width and / or thickness of the inner portion 416 to increase the flexibility of the inner portion 416 and reduce the constraints on the flexibility of the inner portion 116 when the inner portion 416 flexes and flattens during closing and / or occlusion. The inner portion 416 and the outer portion 418 can be integrally formed of the same material (e.g., polymer injection molding) for ease of manufacture.

[0048] The outer surface 410 of the first clamping foot member 402 may include a longitudinal protrusion 450, and the outer surface 414 of the second clamping foot member 404 may include a longitudinal protrusion 452. The longitudinal protrusions 450, 452 may engage and / or be received by a clip applier to prevent lateral movement of the surgical clip 400. The longitudinal protrusions 450, 452 may extend substantially the entire length of the respective outer surface 410, 414.

[0049] The hinge member 406 can be elastically flexible and integrally formed with the first clamping foot member 402 and the second clamping foot member 404. The hinge member 406 can have an inner concave surface and an outer convex surface. The inner concave surface of the hinge member 406 can connect the inner surface 408 of the first clamping foot member 402 with the inner surface 412 of the second clamping foot member 404. The outer convex surface of the hinge member 406 can connect the first outer surface 410 of the first clamping foot member 402 with the second outer surface 414 of the second clamping foot member 404. The hinge member 406 can also include a curved groove located between the hinge surfaces to increase the flexibility of the hinge member 406.

[0050] The surgical clip 400 may also include a latch mechanism having one or more interlocking or latching elements. For example, the first clamping foot member 402 may transition to a hook member 426 at its distal portion, and the second clamping foot member 404 may transition to a tip member 428 at its distal portion. The distal portion of the hook member 426 may be bent inward and generally directed toward the concave surface of the hinge member 406. The hook member 426 may have one or more transverse inclined surfaces and an inner concave surface that merges with the inner surface 408 to define a locking recess. The tip member 428 may be V-shaped, and the narrow slot defined is configured to accommodate the inclined surface when the hook member 426 is bent around the tip member 428. The hook member 426 and the tip member 428 may be engaged to form a locking mechanism. For example, the locking recess may engage with the tip member 428 during the process of compressing the surgical clip 400 into a closed configuration fixed around a blood vessel or other tissue.

[0051] The clamping foot members 402, 404 can include one or more bosses 430-436 along the length for engaging the jaw members of the clip applier. For example, the first clamping foot member 402 can include bosses 430, 432 that protrude perpendicularly from each opposing side surface adjacent to the distal portion of the first clamping foot member 402 and adjacent to the hook member 426. In the example of the surgical clip 400 shown, the bosses 430, 432 can be cylindrical and protrude outwardly beyond the first outer surface 410 of the first clamping foot member 402. The bosses 430, 432 can also be coupled together by a bridge portion 431. The second clamping foot member 404 can also include bosses 434, 436 at the distal portion of the second clamping foot member 404. The bosses 434, 436 can be cylindrical and protrude perpendicularly from each opposing side surface of the second clamping foot member 404, extending longitudinally distal to the end point of the tip member 428. Bosses 434, 436 may be separated by a V-shaped slot of tip member 428. The jaw members of a clip applier may engage bosses 430-436 and pivot foot members 402, 404 about hinge member 406 to compress surgical clip 400 into a closed and / or locked configuration about a blood vessel.

[0052] The surgical clip 400 may include at least one first tooth 440 positioned on the inner surface 408 of the first clamping foot member 402 and at least one second tooth 442 positioned on the inner surface 412 of the second clamping foot member 404. For example, the surgical clip 400 may include a plurality of first teeth 440 positioned on the inner surface 408 of the first clamping foot member 402 and a plurality of second teeth 442 positioned on the inner surface 412 of the second clamping foot member 404.

[0053] FIG. 5A to FIG. 5C , FIG. 6A to FIG. 6B and FIG. 7A to FIG. 7B Various embodiments of manual clip appliers 500, 600, 700 (hereinafter 500-700) configured to apply surgical clip 400 are shown. Although surgical clip 400 is shown, it should be readily understood that clip appliers 500-700 can be used in addition to or in place of surgical clip 100. As shown, clip appliers 500-700 can include first jaw members 502-702 and second jaw members 504-704 that are pivotally coupled to each other to close and / or latch surgical clip 400 to tissue. First jaw member 502-702 can be configured to receive and / or engage outer surface 410 of first clamping foot member 402, while second jaw member 504-704 can be configured to receive and / or engage outer surface 414 of second clamping foot member 404. As shown, the first jaw member 502-702 may include a first flexible member 506-706 configured to receive and / or engage the outer surface 410 of the first clamping foot member 402, while the second jaw member 504-704 may include a second flexible member 508-708 configured to receive and / or engage the outer surface 414 of the second clamping foot member 404.

[0054] The flexible members 506-706, 508-708 can have a distal portion (e.g., 516, such as FIG. 5A to FIG. 5C ), which is fixed or fastened (e.g., welded) to the distal portions of the respective first and second jaw members 502-702, 504-704. The distal portions of the flexible members 506-706, 508-708 can be received in the longitudinal channels 510-710 on the interior of the respective jaw members 502-702, 504-704. In some embodiments, as FIG. 5A to FIG. 5C As shown, flexible members 506, 508 can have free proximal portions 518. Proximal portions 518 can be free from direct attachment to clip applier 200 and can be spaced apart. Proximal portions 518 can be received in longitudinal channel 510 and have curved or curled tips to reduce friction as proximal portions 518 translate as flexible members 506, 508 bend and / or straighten. In certain embodiments, as FIG. 6A to FIG. 6BAs shown, the proximal portions of the flexible members 606, 608 can be connected or welded at the joint 620. In some embodiments, such as FIG. 7A to FIG. 7B The proximal portions of the illustrated flexible members 706 , 708 may be integrally formed with the bend 722 .

[0055] The flexible members 506-706, 508-708 can be spring-based metal (e.g., spring steel) that is biased to receive and / or engage the foot members 402, 404 of the surgical clip 400. In some embodiments, when the first jaw member 502-702 and the second jaw member 504-704 are in the open configuration, the flexible members 506-706, 508-708 can have an arcuate shape (e.g., Figures 5A-5C and Figure 6A-6B ) or can be straightened (e.g. Figure 7A-7B ). Stabilizing members 506-706, 508-708 can be configured to bend radially and / or straighten longitudinally as first jaw members 502-702 and second jaw members 702-704 close surgical clip 400. For example, when first jaw members 502-702 and second jaw members 504-704 close surgical clip 400, flexible members 506-706, 508-708 can bend radially and / or straighten longitudinally to accommodate deflection of surgical clip 400.

[0056] The flexible members 506-706, 508-708 can each include a retaining member configured to laterally stabilize the first and second clamping foot members 402, 404. As shown, the retaining members can each include a longitudinal slot or channel 515-715 configured to engage and / or receive the longitudinal protrusions 450, 452 to prevent or reduce lateral movement of the surgical clip 400 during loading, transporting and / or closing the surgical clip 400. As further shown, the flexible members 506-706, 508-708 can have a narrowed and substantially uniform width, advantageously corresponding to the width of the surgical clip 400. The flexible members 506-706, 508-708 can also be received in the longitudinal channel 510-710 when the first and second jaw members 502-702, 504-704 are closed onto the surgical clip. Flexible members 506-706, 508-708 can be configured to nest into first jaw member 202 and second jaw member 204 when clip applier 200 closes surgical clip 100. Thus, flexible members 506-706, 508-708 can engage and / or receive surgical clip 400 during the closing and / or locking process of surgical clip 400. Longitudinal channels 515-715 can be configured to release longitudinal protrusions 450, 452 when clip applier 500-700 closes and / or locks surgical clip 400, and the bias of flexible members 506-706, 508-708 can urge surgical clip 400 to leave jaw members 502-702, 504-704 when clip applier 500-700 is reopened.

[0057] The clip applier 500-700 may also include features on the distal portion of each of the first jaw member 502-702 and the second jaw member 504-704 configured to secure the distal portion of the first clamping foot member 402 and the second clamping foot member 404. As shown, for example, each of the first jaw member 502-702 and the second jaw member 504-704 may include at least one groove 520-720 configured to accommodate the boss 430-436 of the surgical clip 400. Further, as shown in FIG. Figure 6B and Figure 7B As shown, each of the first jaw member 502-702 and the second jaw member 504-704 can have a first groove and a second groove 520-720 that are separated by a longitudinal channel 510-710 and configured to receive the boss 430-436.

[0058] The various embodiments of the surgical clips 100, 400 of the present invention can be made into 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 various embodiments of the surgical clips 100, 400 can be made of any suitable biocompatible material, such as metals and polymers. However, in practice, the present invention is particularly suitable for polymer clips. Therefore, the various embodiments of the surgical clips 100, 400 are preferably composed of a single-piece integral polymer formed of a suitable strong biocompatible engineering plastic, such as the type commonly used for surgical implants. Exemplary materials include homopolymer or copolymer polyacetal, polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyoxymethylene or other thermoplastic materials with similar properties, which can be injection molded, extruded or otherwise processed into similar products.

[0059] With reference to the specification, many features and advantages of the present invention will be apparent. In addition, those skilled in the art will readily conceive of many modifications and variations, so the present invention is not limited to the exact construction and operation illustrated and described, and all appropriate modifications and equivalents within the scope of the present invention may be adopted.

Claims

1. A clip applier system for ligating tissue, the clip applier system comprising: a clip applier including a first jaw member including a first flexible member having a first slot and a second jaw member including a second flexible member having a second slot; as well as A surgical clip configured to ligate tissue, the surgical clip comprising: a first clamping foot member comprising a first proximal portion, a first distal portion, a first inner surface, and a first outer surface having a convex curvature; and a second clamping foot member, the second clamping foot member comprising a second proximal portion, a second distal portion, a second inner surface, and a second outer surface, the second clamping foot member further comprising an inner portion and an outer portion separated by a channel, the channel extending between opposite side surfaces of the second clamping foot member, and the second outer surface formed on the outer portion and having a convex curvature; wherein the first clamping foot member includes a first longitudinal protrusion configured to engage the first slot of the first flexible member of the clip applier, and the second clamping foot member includes a second longitudinal protrusion configured to engage the second slot of the second flexible member of the clip applier.

2. The clip applier system of claim 1, wherein: The outer portion extends over more than one quarter of the length of the second clamping foot member.

3. The clip applier system of claim 1 , wherein: The outer portion extends over more than one-half of the length of the second clamping foot member.

4. The clip applier system of claim 1, wherein: The width of the outer portion is smaller than the width of the inner portion.

5. The clip applier system of claim 1 , wherein: The convex curvature of the second outer surface extends from a proximal end of the outer portion to a distal end of the outer portion.

6. The clip applier system of claim 1, wherein: The first outer surface includes the first longitudinal protrusion, and the second outer surface includes the second longitudinal protrusion.

7. The clip applier system of claim 1 , further comprising: A hook member on a distal portion of one of the first and second foot members and a tip member on the other of the first and second foot members, wherein the hook member is configured to receive the tip member in a closed configuration of the surgical clip.

8. The clip applier system of claim 1 , further comprising: A hinge member pivotably couples the first proximal portion and the second proximal portion.

9. The clip applier system of claim 1, wherein: The second inner surface includes a convex curvature extending from the second proximal portion to the second distal portion.

10. The clip applier system of claim 1, wherein: The inner portion and the outer portion of the second clamping foot member are integrally formed from a polymer.

11. A clip applier system for ligating tissue, the clip applier system comprising: a clip applier including a first jaw member and a second jaw member; as well as A surgical clip configured to be loaded into the clip applier, the surgical clip comprising: a first clamping foot member comprising a first proximal portion, a first distal portion, a first inner surface, and a first outer surface, the first outer surface having a convex curvature; and a second clamping foot member, the second clamping foot member comprising a second proximal portion, a second distal portion, a second inner surface, and a second outer surface, the second clamping foot member further comprising an inner portion and an outer portion separated by a channel, the channel extending between opposing side surfaces of the second clamping foot member to facilitate compression of the second clamping foot member, and the second outer surface formed on the outer portion and having a convex curvature; Wherein, the first jaw member of the clip applier includes a first flexible member configured to engage the first foot member of the surgical clip, and the second jaw member of the clip applier includes a second flexible member configured to engage the second foot member of the surgical clip.

12. The clip applier system of claim 11, wherein: The first flexible member is biased to engage a first outer surface of the projection, and the second flexible member is biased to engage a second outer surface of the projection.

13. The clip applier system of claim 11, wherein: A portion of the first flexible member is received within the channel of the first jaw member, and a portion of the second flexible member is received within the channel of the second jaw member.

14. The clip applier system of claim 11, wherein: A distal portion of the first flexible member is secured to the first jaw member, and a distal portion of the second flexible member is secured to the second jaw member.

15. The clip applier system of claim 11, wherein: The proximal portion of the first flexible member is spaced apart from the proximal portion of the second flexible member.

16. The clip applier system of claim 11, wherein: The proximal portion of the first flexible member is connected to or integral with the proximal portion of the second flexible member.

17. The clip applier system of claim 11 wherein: The proximal portion of the first flexible member includes a first retaining member configured to laterally stabilize the first clamping foot member, and the proximal portion of the second flexible member includes a second retaining member configured to laterally stabilize the second clamping foot member.

18. The clip applier system of claim 11 wherein: The proximal portion of the first flexible member includes a first curled tip, and the proximal portion of the second flexible member includes a second curled tip.

19. The clip applier system of claim 11 wherein: The second inner surface has a convex curvature extending from the second proximal portion to the second distal portion.

20. The clip applier system of claim 11 wherein: The inner portion and the outer portion of the second clamping foot member are integrally formed from a polymer.

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