Patent ID: 12193679

DETAILED DESCRIPTION

The invention will now be described with reference to the drawing figures, in which like reference numerals refer to like parts throughout. In accordance with conventional practice, as used herein, and unless otherwise indicated herein, the term “proximal” or “proximal end” shall refer to the specified end of a device or its component which is generally closer to the medical personnel handling or manipulating the device as it is intended to be used, and the term “distal” or “distal end” shall refer to the specified end of a device or its component which is opposite the proximal end.

The present invention involves a surgical ligating clip, preferably made of a polymeric material, which can be used to clamp vessels such as arteries in the body, having a pair of asymmetric, curved concave-convex legs, and including one or more flexible rib portions as well as rows of protruding teeth to provide an improved and superior interlocking means to retain the clip on a vessel. The surgical clip of the present invention includes one or more flexible ribs to apply additional pressure on the tissue of the vessel being ligated, and can additionally provide a cross-clamping action as well as applying pressure normal to the tissue. Additional features of the present invention include exaggerated teeth on either side of the centrally located flexible ribs, which provides a tortuous path and surface for the tissue and increases the area of the tissue being retained by the clip.

FIG.1is an enlarged side elevation view of one embodiment of a surgical ligating clip of the present invention, designated generally as100.FIG.2andFIG.3show alternative perspective view of the surgical clip100. Clip100and others of similar design are particularly useful as hemostatic clips that can be latched around a vessel or other type of tissue to ligate the vessel and thereby stop or reduce the flow of fluid through the vessel.

The body of clip100includes a first leg member102having a proximal end portion102A and distal end portion102B, and a second leg member104having a proximal end portion104A and distal end portion104B. As used herein, the term “longitudinal” and a “longitudinal” direction or span shall mean the dimension along clip100or legs102or104which extends along the length of said legs from their respective proximal end portions102A,104A to their respective distal end portions102B,104B, as would be commonly understood by one of skill in the art, and as shown inFIG.1as longitudinal axes L1and L2. Furthermore, as used herein, the “transverse” direction shall be any axis or direction which is orthogonal of longitudinal axes L1and L2, which would be normal to the plane of view inFIG.1.

First and second legs102and104are joined at their proximal ends by an integral resilient hinge section, generally designated106. First and second legs102and104are curved and have complementary arcuate profiles, and include respective inner vessel clamping surfaces. Thus, as best shown inFIG.1, first leg102has a concave inner vessel clamping surface108and a convex outer surface110, and second leg104has a convex inner vessel clamping surface112and a concave outer surface114. Convex inner surface112of second leg104and concave inner surface108of first leg102have substantially matching radii of curvature.

Hinge section106has a continuous concave inner surface116and a continuous convex outer surface118. Concave inner surface116of hinge106joins concave inner surface108of first leg102and convex inner surface112of second leg104. Convex outer surface118of hinge section106joins convex outer surface110of first leg102and concave outer surface114of second leg104. Curved slot120is located between curved hinge surfaces116and118, and is positioned closer to inner surface116than to outer surface118. Slot120extends completely through hinge section106from side to side and its opposite ends122,124extend into the proximal ends of first and second legs102and104, respectively. Slot120provides added flexibility and resiliency to hinge section106, but the inner concave surface116prevents any portion of a clamped vessel from being trapped within slot120.

First leg102transitions to a curved, C-shaped hook section126at its distal end. Second leg104transitions to a pointed tip section128at its distal end. The distal portion of hook section126curves inwardly and points generally toward inner surface116of hinge106. The hook section126has a transverse beveled surface130and a concave inner surface which mates with concave inner surface108to define a latching recess132. The latching recess132is adapted for conformally engaging tip section128in the course of compressing clip100into a latched or locked position around a vessel or other tissue.

Clip100further includes a flexible rib134disposed on the first vessel clamping inner surface108on the first leg member102. Flexible rib134protrudes from said first leg member102and extends longitudinally a length between the proximal102A and distal102B end portions of the first leg member102. The flexible rib134defines a channel135which extends transversely through said rib134along a majority of the length of the rib134. In the embodiment ofFIGS.1through3, the channel135stretches along a majority of the overall longitudinal length of the rib134, but it is understood that said channel135can also accommodate varying arrangements including one or more discrete transverse channels through the rib134, located at varying positions and longitudinal spans along the rib134.

Clip100can be constructed from any suitable biocompatible material, such as certain metals and polymers. However, the present invention is particularly suitable for practice with polymeric clips. Thus, clip100preferably comprises a one-piece integral polymeric body formed from a suitable strong biocompatible engineering plastic such as the type commonly used for surgical implants. Examples include polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyoxymethylene, or other thermoplastic materials having similar properties that can be injection-molded, extruded or otherwise processed into like articles.

In the embodiment shown inFIGS.1-3, flexible rib134includes a longitudinal span member136spaced from the rest of the leg member102by virtue of the channel135therebetween. The longitudinal span member136is connected to leg member102at the respective proximal102A and distal102B end portions of said leg member, as best shown inFIG.1. This particular structural configuration of flexible rib134renders it somewhat collapsible, such that, upon closure of the clip100around a vessel, the rib134will flex and collapse towards the leg102and more effectively grip and retain tissue, while minimizing potential damage to said tissue.FIG.6is an enlarged side elevation view of the surgical ligating clip inFIGS.1-3in a closed position.

In the embodiment shown inFIGS.1-3, the clip100can include a plurality of teeth137protruding on the second vessel clamping inner surface112on the second leg member104. As best shown inFIG.3, the plurality of teeth137include first137A and second137B rows of teeth extending longitudinally between the proximal104A and distal104B end portions of the second leg member104, the first row137A being transversely separated from the second row137B on opposite sides of a centerline CL of the second vessel clamping inner surface112. The centerline CL is also coincident with a centerplane of symmetry of the clip100, said centerplane spanning the direction of longitudinal axes L1and L2(and parallel to the view ofFIG.1) and dividing clip100into symmetric halves with the exception of the longitudinal staggering of tooth rows137A and137B as best shown inFIG.3. The transverse separation of tooth rows137A and137B about centerline CL is just enough, or slightly greater, than the transverse width of flexible rib134and its longitudinal span member136, as best shown inFIG.2. Flexible rib134is approximately centered between side surfaces138and140of first leg member102such that flexible rib134is also positioned on a centerline of vessel clamping surface108of first leg102, which centerline is also coincident with the centerplane of the clip100and mates with the centerline CL of surface112on second leg104, such that when the clip100is closed about a vessel, the flexible rib134fits into the transverse separation between rows of teeth137A and137B, providing a tortuous path or surface for tissue being clamped, and increasing the effective area of tissue being retained by clip100over the prior art, as well as increasing the effective pressure being applied to the tissue by clip100.

As shown in the embodiment ofFIGS.1-3, because first leg member102has a concave radius of curvature, viewed relative to facing the first vessel clamping inner surface108, and the second leg member104has a convex radius of curvature, viewed relative to facing the second vessel clamping inner surface112, the length of flexible rib134also has a concave radius of curvature when facing the first vessel clamping inner surface108, such that the closure of clip100results in the various radii of curvature mating to effectively close the clip100over a vessel. The combination of flexible rib134and transversely separated rows of teeth137A and137B on respective first and second vessel clamping inner surfaces108and112form an interlocking mechanism which provides improved, robust, flexible, and safer vessel retention by a ligating clip over the prior art.

Adjacent to the distal end of the first leg102and immediately inward of hook section126, cylindrical bosses146and148protrude perpendicular to each of the opposed side surfaces138and140. In the illustrated example of clip100, a bridge section150couples bosses146and148together. As evident inFIGS.1-3, bosses146and148project outwardly beyond convex outer surface110of first leg102. At the distal end of second leg104, cylindrical bosses152and154protrude perpendicular to each of the opposed side surfaces142and144of second leg104and extend longitudinally forward beyond the point of tip128.

In the practice of ligating a vessel as understood by persons skilled in the art, clip100is designed to be compressed into a latched or locked position around the vessel through the use of an appropriate clip applicator instrument, such as a type described in U.S. Pat. No. 5,100,416. The clip applicator instrument engages bosses146,148,152and154of clip100and pivots bosses146,148,152and154inwardly about hinge section106. This causes first and second legs102and104to close around the vessel, with convex inner surface112of second leg104and complementary concave inner surface108of first leg102contacting the outer wall of the vessel. Flexible rib134pushes a portion of the vessel into the transverse spacing between tooth rows137A and137B, where the clamping pressure also pushes portions of the vessel into the longitudinal spacing between teeth on the two rows137A and137B, all of which effectively secures the clip100to the vessel and prevents movement of the clip or vessel during or after clip closure. Tip section128of second leg104also contacts hook section126. Pivotal movement by the applicator instrument longitudinally elongates first leg102and deflects hook section126, allowing tip section128to align with latching recess132. The hook member126can terminates in a sharp pointed tip at the convergence of beveled surface130, which extends toward the proximal end portion102A of first leg member102. The distal end of said second leg member104includes a groove160through which said sharp pointed tip130passes when the leg members102and104are moved to the closed position about a vessel. Upon release of the applicator instrument, tip section128and groove160snaps into and is conformably seated in latching recess132inside hook126, at which point clip100is in its latched condition and the vessel securely engaged thereby.

FIGS.4-5depict an alternate embodiment of an asymmetric surgical clip200in accordance with the invention. Clip200bears many similarities to clip100described above with reference toFIGS.1-3. For example, the materials and procedures used to make and apply clip100may be used to make and apply clip200as well. Similarly, the various features of clip100described above are referenced where appropriate inFIGS.4-5with respect to clip200using the same reference numerals used inFIGS.1-3.

FIG.4is an enlarged side elevation view of clip200. The body of clip200includes a first leg202having a proximal end portion202A and distal end portion202B, and a second leg204having a proximal end portion204A and a distal end portion204B. First and second legs202and204are joined at their proximal ends by integral hinge section106. First and second legs202and204are curved and have complementary arcuate profiles. Thus, first leg202has a concave vessel clamping inner surface208and a convex outer surface110, and second leg104has a convex vessel clamping inner surface212and a concave outer surface114. Convex inner surface212of second leg104and concave inner surface208of first leg202have substantially matching radii of curvature.

Hinge section106has a continuous concave inner surface116and a continuous convex outer surface118. Concave inner surface116of hinge106joins concave inner surface208of first leg202and convex inner surface212of second leg204. Convex outer surface118of hinge section106joins convex outer surface110of first leg102and concave outer surface114of second leg104. Curved slot120is located between curved hinge surfaces116and118, and is positioned closer to inner surface116than to outer surface118. Slot120extends transversely completely through hinge section106from side to side and its opposite ends122,124extend into the proximal ends of first and second legs202and204, respectively. Slot120provides added flexibility and resiliency to hinge section106, but the inner concave surface116prevents any portion of a clamped vessel from being trapped within slot120.

First leg202transitions to a curved, C-shaped hook section126at its distal end. Second leg204transitions to a pointed tip section128at its distal end. The distal portion of hook section126curves inwardly and points generally toward inner surface116of hinge106. The hook section126has a transverse beveled surface130and a concave inner surface which mates with concave inner surface208to define a latching recess132. The latching recess132is adapted for conformally engaging tip section128in the course of compressing clip200into a latched or locked position around a vessel or other tissue.

As best shown inFIG.5, clip200further includes two flexible ribs234A and234B, one each disposed on the respective first vessel clamping inner surface208on first leg member202and second vessel clamping inner surface212on the second leg member204. Flexible ribs234A and234B protrude from respective first leg member202and second leg member204and extend longitudinally a length between the respective proximal202A,204A and distal202B,204B end portions of leg members202,204. The flexible ribs234A and234B each defines a respective channel235A and235B which extend transversely through said ribs234A and234B along a majority of the length of said ribs. In the embodiment ofFIGS.4-5, the channels235A and235B stretch along a majority of the overall longitudinal length of the ribs234A and234B, but it is understood that said channels235A and235B can also accommodate varying arrangements including one or more discrete transverse channels through each rib234A and234B, located at varying positions and longitudinal spans along said ribs. Alternatively, one of channels235A or235B can be missing such that one of ribs234A or234B is solid instead of hollow. Clip200can be constructed from any suitable biocompatible material, such as certain metals and polymers, such as previously discussed above with Clip100.

The ribs234A and234B form complementary parts of an interlocking mechanism. In this embodiment, the complementary parts are arranged in a lock-step, or scissor-like configuration. In the embodiment shown inFIGS.4-5, flexible ribs234A and234B each include a respective longitudinal span member236A and236B spaced from the rest of their respective leg members202and204by virtue of the respective channels235A and235B therebetween. The longitudinal span members236A and236B are each connected to their respective leg members202and204at the respective proximal202A,204A and distal202B,204B end portions of said leg members, as best shown inFIG.4. This particular structural configuration of flexible ribs234A and234B renders said ribs somewhat collapsible, such that, upon closure of the clip200around a vessel, each rib234A and234B will flex and collapse towards their respective attached legs202and204and more effectively grip and retain tissue, while minimizing potential damage to said tissue.

As shown inFIG.5, the first flexible rib234A is disposed on a first side of the clip200, and the second flexible rib234B is disposed on a second side of the clip200opposite the first side. The ribs234A and234B are thus offset of opposite of the longitudinal centerplane of the clip200, creating the complementary parts of a scissor-like interlocking mechanism for ligating and retaining a vessel around which clip200is clamped. As shown inFIGS.4-5, the first flexible rib234A has a concave radius of curvature when facing the vessel clamping inner surface208, and the second flexible rib234B has a convex radius of curvature when facing the vessel clamping inner surface212.

Adjacent to the distal end of the first leg202and immediately inward of hook section126, cylindrical bosses146and148protrude perpendicular to each of the opposed side surfaces238and240. In the illustrated example of clip200, a bridge section150couples bosses146and148together. As evident inFIGS.4-5, bosses146and148project outwardly beyond convex outer surface110of first leg202. At the distal end of second leg204, cylindrical bosses152and154protrude perpendicular to each of the opposed side surfaces242and244of second leg204and extend longitudinally forward beyond the point of tip128.

In the practice of ligating a vessel as understood by persons skilled in the art, clip200is designed to be compressed into a latched or locked position around the vessel through the use of an appropriate clip applicator instrument, in much the same manner as described above with respect to clip100. In clip200however, instead of a single flexible rib on one leg fitting into rows of teeth disposed on the opposite leg as in clip100, the two flexible ribs234A and234B interlock together to provide a cross-clamping action as well as additional pressure applied normal to tissue on a vessel.FIG.7shows the clip200in a closed position.

The many features and advantages of the invention are apparent from the detailed specification, and thus, it is intended by the appended claims to cover all such features and advantages of the invention which fall within the true spirit and scope of the invention. Further, since 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 illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.