US20170209150A1 - Surgical clip having compliant portion - Google Patents

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Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
  • A61B17/122—Clamps or clips, e.g. for the umbilical cord
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00831—Material properties
  • A61B2017/00862—Material properties elastic or resilient
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00831—Material properties
  • A61B2017/00946—Material properties malleable

Definitions

• the present invention relates to surgical instruments and in particular to surgical clips and methods used for ligating vessels, other ducts, and the like.
• One ligation technique is to tie a suture about the vessel to close the vessel.
• a surgeon can place a clip having a pair of legs connected at their proximal ends about the vessel, and urge or squeeze the legs together to close the vessel.
• a surgical clip that includes a pair of opposed first and second leg members with a knee portion formed therebetween. While the apex can have a variety of configurations, in one embodiment, the apex can have opposed ends joining the proximal ends of said first and second members. Moreover, the apex can include a notch formed on an inner surface thereof.
• the first and second leg members can include an inner surface having at least one tissue-grasping element formed thereon.
• the tissue-grasping elements can have a variety of configurations, such as a longitudinal tongue formed on the first leg member, and a longitudinal groove formed on the second leg member.
• the tongue and groove can be complementary and disposed opposite to each other.
• the tongue and groove can extend along the entire length of the inner surface of each leg member, or a portion thereof.
• the tissue-grasping elements of the first and second leg members can also include at least one channel oriented at an angle with respect to the longitudinal axis of the first and second leg members.
• the first and second leg members can include an outer surface having at least one raised portion formed thereon.
• the raised portion can be a pad disposed on an outer surface of each of the first and second leg members located proximal to a point approximately midway between the apex and the knee portion of each leg member.
• the raised area can be approximately one-third of the way between the apex and the knee, and closer to the apex.
• a device for ligating tissue having first and second leg members, with a knee portion formed therebetween.
• An apex can join the proximal ends of the first and second leg members, such that the first leg member and the second leg member are opposed from one another. While the apex can have a variety of configurations, in one exemplary embodiment, the apex includes a notch formed in an inner surface thereof.
• a surgical clip being in the form of a substantially U-shaped member that includes an apex that joins first and second leg members.
• the apex can further include a notch formed therein.
• the leg members can include at least one tissue-grasping element formed on an inner surface thereof, and a knee portion formed between the proximal and distal ends thereof.
• each leg member cart have a width of less than about 0.05 inch, and a yield strength greater than about 28 ksi.
• the clip can include a raised area disposed on an outer surface of each of the first and second leg members proximal to a point between the apex and the knee portion of each leg member.
• the raised area can be approximately one-third of the way between the apex and the knee, and closer to the apex.
• a device for ligating tissue having first and second opposed leg members with proximal and distal ends, and a knee portion formed between the proximal ends of each of the leg members.
• An apex having opposed ends joins the proximal and distal ends of the opposed leg menders.
• the leg members further include inner and outer surfaces, the outer surface having at least one raised urea on a portion thereof. In one embodiment, the raised area is located approximately one-third of the way between the apex and the knee portion, closer to the apex.
• the device can further include at least one tissue-grasping feature formed on the inner surface of the opposed leg members, as well as a notch formed on the inner surface of the apex.
• a ligation clip having pair of opposed legs joined together at a proximal end by an apex.
• the opposed legs each can have a distal end and a knee portion disposed distal of the apex, and a raised area formed on an outer surface of each leg between the apex and the knee.
• the raised area is effective to share with the knee portions a load applied by a closing force such that the knee portions are subjected to less plastic deformation and retain some elasticity, wherein upon release of the closing force the distal ends of the clip remain in contact with one another.
• a ligation dip having a compliant portion on an in surface of at least one leg.
• the compliant portion is more easily movable by tissue than compressed legs of the ligation clip.
• the compliant portion may be formed of a polymer that is absorbable within a patient's body.
• the compliant portion can cover the inner surface of only the proximal portion of the leg, the inner surface of only a distal portion of the leg, or it an cover the inner surface of the entire length of the leg from the apex to the distal end.
• the compliant portion may have raised ribs, varying thickness, and varying compliance.
• the compliant portion can close gaps caused by clips opening elastically after formation, improve clip security, make effectiveness of the clip, less sensitive to form, and compensate for a larger opening caused by the elasticity of clips.
• a method for ligating vessels is also provided where a closing force is applied to each leg member such that in a partially closed position the knee portions of each leg member are substantially parallel to one another when the distal ends of each leg member are in contact with one another.
• the raised areas and the knee portions share a load applied by the closing force such that the knee portions are subjected to less plastic deformation and retain some elasticity, wherein upon release of the closing force the distal ends of the clip remain in contact with one another.
• a method for ligating vessels is provided where, upon release of the closing force, a compliant portion continues to maintain a pressure on tissue within the leg members of the clip.
• FIG. 1 is a perspective view of one embodiment of a surgical clip disclosed herein;
• FIG. 2A is a side perspective view of a clip according to another embodiment of the invention.
• FIG. 2B is a side perspective view of a portion of the distal end of a leg member of the clip of FIG. 2A ;
• FIG. 2C is a plan view of the clip of FIG. 2A ;
• FIG. 2D is a sectional view of the clip of FIG. 2C along the lines 2 D- 2 D;
• FIG. 2E is a sectional view of the clip of FIG. 2C along lines 2 E- 2 E;
• FIG. 3 is another perspective view of a clip.
• FIG. 4A is a perspective view of a clip.
• FIG. 4B is a top plan view of an inner portion of the apex of the clip of FIG. 4A ;
• FIG. 4C is a side perspective view of an inner portion of the apex of the clip of FIG. 4A ;
• FIG. 5A is another side perspective view of a clip in an open position
• FIG. 5B is a side perspective view of the clip of FIG. 5A in a first state of partial closure
• FIG. 5C is a side perspective view of the clip of FIG. 5A in a state of almost full closure
• FIG. 5D is a side perspective view of the clip of FIG. 5A fully closed
• FIG. 5E is a side perspective view of the clip of FIG. 5A following release by a clip applier;
• FIG. 6 is a side view of a clip having a compliant element
• FIG. 7 is a side view of a clip without a compliant element in a state of full closure
• FIG. 8 is a side view of the clip of FIG. 6 in a state of full closure
• FIG. 9 is a side view of a clip having a compliant element comprising a plurality of ribs
• FIG. 10 is a perspective view of a distal end of one leg of a clip having a ribbed compliant element
• FIG. 11 is a side view of a clip having a ribbed compliant element in a state of full closure.
• FIGS. 1-4C illustrate exemplary embodiments of a clip disclosed herein in an open position.
• the clip 10 in its open position is generally U-shaped having opposed leg members 12 , 14 joined at an apex 22 .
• Each leg member 12 , 14 has a knee portion 20 disposed distally of the apex 22 .
• each leg member 12 , 14 has an inner tissue-contacting surface 12 d , 14 d and an opposed outer surface 12 c , 14 c , both of which may have features to provide a more secure ligation of the vessel or duct.
• the inner surface(s) 12 d , 14 d can include various tissue-grasping elements formed therein (discussed in more detail below).
• the outer surface(s) 12 c , 14 c can have at least one raised area 26 (shown in FIG. 3 ) formed thereon between the knee portion 20 and the apex 22 .
• clip 10 is described herein in the context of a device to ligate vessels, one skilled in the art will appreciate that the surgical clip 10 can be used to ligate a variety of other body tissues, including but not limited to, veins, arteries, ducts, or any other tubular member within a patient for which ligation is desired.
• the clip 10 can be used in a variety of clip appliers, thereby effecting a wide range of surgical procedures.
• the clip 10 is described herein with respect to ligation, it is understood that a variety of other applications are possible as well.
• the clip 10 can have any shape in its open configuration that allows it to effectively ligate a vessel, such as a substantially U-shaped or a substantially V-shaped design.
• the clip 10 is substantially U-shaped. That is, proximal portions 12 a , 14 a of the leg members 12 , 14 of the clip 10 are oriented at an acute angle with respect to the central axis A of the clip 10 , and transition at a knee portion 20 , to an orientation where distal portions 12 b , 14 b the leg members 12 , 14 are parallel with respect to one another and to central axis A.
• the size of the clip 10 can vary depending upon its particular application.
• the clip 10 can have a length l in the range of about 5 mm to 15 mm, and more preferably in the range of about 7.5 mm to 85 mm.
• the clip 10 can have a width W as shown in FIG. 3 measured between opposed inner surfaces 12 d , 14 d of the leg members 12 , 14 in the range of about 2 mm to 8 mm. and more preferably in the range of about 3 mm to 4 mm.
• the size of the leg members 12 , 14 can also vary depending upon the particular application, however in one embodiment, each leg member 12 , 14 can have a width w, shown in FIGS.
• each leg member 12 , 14 can have a height H (shown in FIG. 3 ) in the range of about 0.015 inch to 0.030 inch, and more preferably in the range of about 0.018 inch to 0.025 inch, and most preferably in the range of about 0.019 inch to 0.020 inch.
• the clip can also have physical properties, such as yield strength, that are appropriate for a desired application.
• the yield strength is greater than about 28 ksi and less than about 60 ksi, and more preferably in the range of about 30 ksi to 50 ksi.
• clip 10 can have a yield strength that is equivalent to or greater than clips having larger dimensions.
• Clip 10 is further designed so that, upon closure, a vessel, for example, is completely encased between the leg members 12 , 14 of the clip 10 . This is done by urging the leg members 12 , 14 of the clip 10 together, typically with the assistance of an applier, to surround the vessel.
• the clip 10 has opposed first and second leg members 12 , 14 each having proximal and distal ends 12 a , 14 a , 12 b , 14 b .
• the proximal and distal ends 12 a , 14 a , 12 b , 14 b have opposed inner tissue-contacting surfaces 12 d , 14 d and outer compression receiving surfaces 12 c , 14 c that are connected by superior and inferior sides 12 e , 14 e , 12 f , 14 f .
• the leg members 12 , 14 can have any cross-sectional shape that allows them to of close and engage tissue, such as a vessel.
• Exemplary cross-sectional shapes include, but are not limited to, triangular, rectangular, trapezoidal, and pentagonal. As shown, however, the leg members 12 , 14 are substantially rectangular. The substantially rectangular leg shape is believed to provide an optimized design that includes a greater bending resistance for a given cup leg space envelope.
• the leg members 12 , 14 can also have a variety of features formed therein or thereon to assist with the ligation of a vessel or duct.
• the inner surface 12 d , 14 d of each leg member 12 , 14 can include tissue-grasping elements
• the outer surface 12 c , 14 c of each leg member 12 , 14 can include a knee portion 20 as well as at least one raised area 26 .
• one or more grooves may be formed on the outer surface 12 c , 14 c as well.
• the tissue-grasping elements formed on an inner surface 12 d , 14 d of each leg member 12 , 14 can include both primary 16 , 17 and secondary 18 tissue-grasping elements.
• the primary tissue-grasping elements 16 , 17 can have any configuration that allows them to effectively hold a vessel or duct.
• the primary tissue-grasping elements can include at least one tongue 17 formed on the inner surface 14 d of the second leg member 14 and at least one groove 16 formed on the inner surface 12 d the first leg member 12 .
• the groove 16 and tongue 17 can extend continuously along the inner surface 12 d , 14 d of each leg, member 12 , 14 .
• the inner surface 12 d , 14 d can include multiple groove 16 and tongue 17 segments formed therein.
• the groove 16 and tongue 17 can be formed in a variety of locations on each of the first and second leg members 12 , 14 . In one embodiment, the groove 16 and tongue 17 can extend longitudinally along the entire length or along at least a portion of the length of the inner surface 12 d , 14 d of each respective leg member 12 , 14 .
• the groove 16 and tongue 17 can extend from the distal end 12 b , 14 b of each leg member 12 , 14 to just distal from the apex 22 , or from the distal end 12 b , 14 b of each leg member 12 , 14 to just distal to the knee portion 20 , Moreover, the groove 16 and tongue 17 can extend distally from the apex 22 to a position just distal to the knee portion 20 .
• FIG. 1 illustrates a longitudinal groove 16 and a longitudinal tongue 17 that extend through the knee portion 20 and terminate just distal to the notch 24 in the apex 22 .
• FIG. 2A illustrates a longitudinal groove 16 and a longitudinal tongue 17 that extend from the distal end 12 b , 14 b each leg member 12 , 14 to a position just distal to the knee portion 20 .
• a second longitudinal groove 16 ′ and longitudinal tongue 17 ′ combination is then formed just distal to the knee portion 20 , extending just distal to the apex 22 .
• FIG. 1 illustrates a longitudinal groove 16 and a longitudinal tongue 17 that extend through the knee portion 20 and terminate just distal to the notch 24 in the apex 22 .
• FIG. 2A illustrates a longitudinal groove 16 and a longitudinal tongue 17 that extend from the distal end 12 b , 14 b each leg member 12 , 14 to a position just distal to the knee portion 20 .
• FIG. 4A illustrates a longitudinal groove 16 and a longitudinal tongue 17 that are formed along the entire inner surface 12 d , 14 d of each of the first and second leg members 12 , 14 .
• the groove 16 and tongue 17 combination shown in FIG. 4A terminates in the notch 24 of the apex 22 , as will be discussed in more detail below.
• the tongue 17 and groove 16 can be disposed so as to be complementary to one another. Alternatively, the tongue 17 and groove 16 can be located at different locations along each respective leg member 12 , 14 . In an exemplary embodiment, the tongue 17 are groove 16 are complementary and disposed opposite one another, such that once the clip 10 is applied to a vessel the tongue 17 will urge the tissue of the walls of blood vessel into the corresponding juxtaposed groove 16 . This cooperation between the tongue 17 and the groove 16 inhibits longitudinal and angled dislocation of the clip 10 relative to the vessel, and it also effectively reduces the gap between the inner (tissue contacting) surfaces of each respective leg member 12 , 14 .
• the groove 16 can have a variety of shapes.
• the groove 16 is complementary in shape to the tongue 17 and can be hemispherical, rectangular, triangular, trapezoidal, or oblong.
• an exemplary embodiment uses a groove 16 that is somewhat triangular, having opposed sidewalls 16 a , 16 b connected by a base portion 16 c .
• the sidewalls 16 a , 16 b can be oriented at various angles with respect to the inner surface 12 d , 14 d of the leg members 12 , 14 .
• the sidewalls 16 a , 16 b are oriented at an angle less than 120 degrees relative to the inner surface 12 d , 14 d of the leg members 12 , 14 , and more preferably at an angle less than 110 degrees relative to the inner surface 12 d , 14 d of the leg, members 12 , 14 .
• the base portion 16 c can have a variety of configurations.
• the base portion 16 c can be planar or slightly rounded. In an exemplary embodiment, however, the base portion 16 c is slightly rounded.
• the groove 16 should be of dimensions that are effective to ligate tissue.
• the groove 16 can have depths in the range of about 0.0015 inch to 0.007 inch, more preferably, in the range of about 0.0025 inch to 0.004 inch. In one exemplary embodiment, the groove 16 can have a depth of about 0.0025 inch.
• groove 16 can have a width in the range, of about 0.004 inch to 0.020 inch, more preferably in the range of about 0.006 inch to 0.013 inch.
• the width of the groove 16 can be uniform throughout the length of the groove 16 , or it can decrease in the proximal, or distal direction. In an exemplary embodiment, the groove 16 has a uniform width.
• the tongue 17 can also have a variety of configurations.
• the tongue 17 is complementary in shape and size to the groove 16 .
• the tongue 17 can be hemispherical, rectangular, triangular, trapezoidal, or oblong, in an exemplary embodiment, the tongue 17 is substantially rectangular or trapezoidal.
• the tongue 17 can also vary in size, however in an exemplary embodiment, the tongue 17 has a size that is complementary to the size of the groove 16 , with a height and a width no greater than, and preferably slightly less than, the dimensions of the groove 16 . This provides room for the vessel tissue and minimizes shearing action and locally excessive pressures on the vessel tissue during clip forming. That is, the tongue 17 can have a height in the range of about 0.0015 inch to 0.007 inch, more preferably in the range of about 0.0025 inch to 0.004 inch. In one exemplary embodiment, the tongue 17 can have a height of about 0.0025 inch.
• the tongue 17 can also have a width in the range of about 0.004 inch to 0.020 inch, more preferably in the range from about 0.006 inch to 0.013 inch. Moreover, and also similar to the groove 16 above, the tongue 17 can have a uniform width or a width that decreases in the proximal or distal direction. In an exemplary embodiment, the tongue 17 has a uniform width.
• the inner surfaces 12 d , 14 d of each of the first and second leg members 12 , 14 can have at least one secondary tissue-grasping element 18 , as shown in FIG. 2B . While in one embodiment the secondary tissue-grasping elements 18 are formed on the inner surfaces 12 d , 14 d of both the first and second leg members 12 , 14 , the secondary tissue-grasping element 18 can optionally be formed on the inner surface 12 d , 14 d of only one of the first and second leg members 12 , 14 .
• the inner surfaces 12 d , 14 d of the first and second leg members 12 , 14 can have any number of secondary tissue grasping elements 18 . In the exemplary embodiment, the inner surface 12 d , 14 d has at least four secondary tissue-grasping elements 18 .
• the secondary tissue-grasping elements 18 can have any configuration that allows them to grasp tissue following application of the clip 10 to the vessel or duct. As shown in FIG. 2B , exemplary secondary tissue-grasping elements 18 are in the form of channels having opposed first and second walls 18 a , 18 b connected by base wall 18 c . The channels are generally saw-toothed in shape, however can also be undercut, In an exemplary embodiment, the first wall 18 a is formed at an acute angle relative to the inner surface 12 d , 14 d of each leg member. In an exemplary embodiment the angle is in the range of about 40 degrees to 90 degrees, and more preferably the angle is about 75 degrees.
• the second wall 18 b is likewise oriented at an acute angle relative to the inner surface 12 d , 14 d of each leg member.
• the acute angle of the second wall 18 b which is generally shallower than the angle of the first wall 18 a , can be in the range of about 15 degrees to about 75 degrees, and more preferably it is about 45 degrees.
• the walls 18 a , 18 b , 18 c can be straight or arcuate, but in the exemplary embodiment the walls 18 a , 18 b , 18 c are slightly arcuate to facilitate grasping.
• the secondary tissue-grasping elements 18 extend across the width w of the first and second leg members 12 , 14 at an angle (e.g., about 45 degrees) relative to a longitudinal axis of the leg, members 12 , 14 .
• one segment of the secondary tissue -grasping element 18 is located on one side of the tongue 16 or groove 17 on the first leg member 12 , and a second segment 18 continues at the same angle on the other side of the tongue 16 or groove 17 .
• the secondary tissue-grasping elements 18 are similarly constructed on the second leg member 14 , however they are angled at an orientation opposite that of the first leg member 12 .
• leg members 12 , 14 close around a vessel or duct, they form a superimposed “x,” as shown in FIG. 2E .
• This configuration allows for a greater percentage of the tissue to be grasped by the secondary tissue -grasping elements 18 , thereby resulting in more effective ligation.
• the leg members 12 , 14 can have any number of secondary tissue-grasping elements 18 formed thereon. In the exemplary embodiment, however each leg member 12 , 14 has three secondary tissue-grasping elements 18 formed thereon.
• the secondary tissue-grasping elements 18 can be uniformly or non-uniformly spaced apart from one another. In an exemplary embodiment, the secondary tissue-grasping elements 18 are uniformly spaced apart from one another at a distance in the range of about 0.050 inch to 0.080 inch.
• the secondary tissue-grasping elements 16 can have any size and depth that is effective to engage and maintain contact with tissue. However, in an exemplary embodiment, the secondary tissue-grasping elements 18 are sized in the range of about 0.008 inches to 0.012 inches wide by about 0.0015 inches to 0.0035 inches deep.
• leg members 12 , 14 of the exemplary clip 10 can include any combination of primary tissue-grasping elements 16 , 17 and secondary tissue-grasping elements 18 .
• An exemplary clip 10 includes both primary and secondary tissue-grasping elements 16 , 17 , 18 .
• the inner surface 12 d , 14 d of the leg members 12 , 14 can be smooth and free of primary and secondary tissue-grasping elements. The structure and closing properties of the clip 10 , as discussed herein, allow adequate tissue ligation without the need for any type of tissue-grasping elements formed on the inner surface 12 d , 14 d of the leg members 12 , 14 .
• each leg member 12 , 14 can include a bend or knee portion 20 .
• the knee portion 20 allows the leg members 12 , 14 to transition from being acutely angled relative to the central axis A of the clip 10 to being substantially parallel relative to one another and to the central axis A of the clip 10 .
• the angled knee portions 20 of the leg members 12 , 14 can be formed at a variety of angles relative to the central axis A of the clip 10 , however in an exemplary embodiment the angle can be in the range of about 45 degrees to about 65 degrees.
• the knee portion 20 is designed so as to be parallel to the force applying jaws of a clip applier during a part of the clip closing process as shown FIG. 5B , This construction is believed to enhance clip retention by the clip applier during deployment.
• the knee portion 20 can have a variety of configurations to effect the transition of the leg members 12 , 14 , however an exemplary knee portion 20 has a beveled or flattened outer surface 20 a and an arcuate inner surface 20 b .
• the bevel on the outer surface 20 a can extend over any length sufficient to effect the transition, however in an exemplary embodiment the bevel is in the range of about 0.030 inch to 0.050 inch.
• the outer surface 20 a of the knee portion 20 can optionally include a groove (not shown) formed therein to facilitate formation of a raised tongue 17 on the inner surface 12 d , 14 d of the leg members 12 , 14 ,
• the groove can be similar in shape and sire to the longitudinal groove 16 , discussed herein with respect to FIGS.
• the inner surface 20 b of the knee portion 20 can also optionally include features to assist with the ligation of the vessel, duct, or tissue.
• the inner surface 20 b can include primary acid it secondary tissue-grasping elements 16 , 17 , 18 similar to those discussed above with respect to FIGS. 2B-2D .
• each leg member 12 , 14 can have features to help provide a more secure occlusion and clip performance.
• a raised area 26 extends over a portion of the width of the leg members 12 , 14 that is slightly proximal to the knee portion 20 .
• the raised area 26 is located approximately one-third of the way between the apex 22 and the knee portion 20 , closer to the apex 22 .
• the raised portion 26 is believed to help to reduce overbending of the knee 20 as well as to help maintain the legs 12 , 14 of the clip 10 together after the clip 10 is fully closed. While FIG.
• the raised area 26 can be formed on either the first leg member 12 or the second leg member 14 .
• the outer surface 12 c , 14 c of each leg member 12 , 14 can have any number of raised areas 26 .
• the outer surface 12 c , 14 c of each leg member 12 , 14 has one raised area 26 a , 26 b.
• the raised area 26 a , 26 b can have any shape that allows the effective application of compressive force to the apex 22 such that the apex 22 is crimped to a greater degree than the knee portion 20 . That is, the raised area 26 a , 26 b is believed to allow the region of the leg member 12 , 14 between the apex 22 and the knee 20 to, be more elastic, enabling the knee portion 20 to spring back to a small degree while maintaining adequate contact between the distal ends 12 b , 14 b of the leg members 12 , 14 .
• the raised area 26 a , 26 b is a pad having a shape that is complementary to the shape of the leg member 12 , 14 .
• the raised area 26 a , 26 b can be triangular, rectangular, trapezoidal, pentagonal, etc., but in an exemplary embodiment, the raised area 26 a , 26 b is substantially rectangular.
• the raised area 26 a , 26 b can have a variety of sizes, depending upon whether full closure or partial closure of the clip is desired.
• the height of the raised area 26 a , 26 b should be able to maintain the preload at the distal tips of the leg members 12 , 14 .
• the raised area 26 a , 26 b has a height in the range of about 0.0005 inch to 0.0025 inch, and more preferably is about 0.001 inch.
• the raised area 26 a , 26 b can also have a length that is large enough so that it can adequately sustain the applied pressure from a clip applier.
• the raised area 26 a , 26 b can have a length of about 0.020 inch, and a width of about 0.010 inch. If partial closure of the clip is desired, the height of the raised area 26 a , 26 b can be increased.
• each of the leg members 12 a , 14 a are connected to one another by an apex 22 .
• the apex 22 can have a variety of shapes, as shown in FIGS. 4A-4C , the apex 22 is substantially U-shaped or substantially V-shaped, and has opposed inner (tissue-contacting) 22 d and outer (non-tissue contacting) faces 22 c that are connected by superior and inferior surfaces (not shown).
• the inner surface 22 d of the apex 22 can have a variety of configurations in order to assist with ligation, for example, at least one notch 24 can be formed therein. While the inner surface 22 d can have any number of notches formed therein, an exemplary embodiment utilizes rare notch 24 .
• the notch 24 can have any configuration that allows for the ligation of tissue.
• the notch 24 is formed in a U-shaped channel that extends through the inner surface 22 d of the apex 22 . The U-shaped channel may join the tongue 16 and groove 17 that extend along at least a portion of length of the inner surface 12 d , 14 d of the leg members 12 , 14 .
• the notch 24 can further have a vari-ety of shapes to optimize its mechanical properties and make it stiff and strong for the amount of material in it, yet leaving open space for the material in compression on the inner side of the clip 10 to flow into during the plastic deformation that occurs dining clip formation.
• the notch 24 is substantially trapezoidal. That is, as shown in FIGS. 4B-4C , the notch 24 has opposed first and second wails 24 a , 24 b connected by opposed third and fourth walls 24 c , 24 d with a base portion 24 e extending therebetween.
• the walls 24 a , 24 b , 24 c , 24 d are formed at an acute angle relative to the inner surface 224 of the apex 22 .
• the angle can be any acute angle, but it is preferably in the range of about 75 degrees.
• the walls 24 a , 24 b , 24 c , 24 d , 24 e can have also have any shape that provides an area into which deformed tissue can flow. As shown, the walls and the base portion 24 a , 24 b , 24 c , 24 d , 24 e are rounded or slightly contoured.
• the notch 24 can have a variety of sizes and depths, perhaps best described in relationship to the thickness and width of the clip leg members 12 , 14 .
• the width of notch 24 should be such that the webs of material at apex surface 224 are in the range of about 0.005 inch to 0.010 inch wide.
• the depth of notch 24 should be in the range of about 30 percent to 60 percent of the distance between apex surfaces 22 c and 22 d , with an exemplary range of about 30 percent to 40 percent of the distance between surfaces 22 c and 22 d .
• the length of notch 24 should be in the range of about 1 times to 2 times the thickness of the clip leg members 12 , 14 , with an exemplary length in the range of about 1.1 times to 1.4 times the thickness of the clip leg members 12 , 14 .
• optimum results might require the use of two or more notches in order to maintain the webs of material at surface 224 in the range of about 0.005 inch to 0.010 inch. Other aspects of multiple notches would be expected to follow the guidelines listed above.
• the outer face 22 c of the apex 22 can also have a variety of configurations in order to assist with ligation.
• the outer face of the apex 22 c has two opposed beveled surfaces that meet in a rounded tip.
• the outer face 22 c of the apex 22 is not sharply formed, but rather has a fabrication-induced radius, thereby allowing for a more secure ligation.
• the clip 10 disclosed herein can be made from a variety of surgically-appropriate materials including metals and polymers. Moreover, the material can be a bioabsorhable material or a non-bioabsorbable material. In one embodiment, the clip 10 can be made of a metal or a metal alloy having a relatively high annealed state yield strength and a relatively high strain hardening rate, in comparison to existing ligation clips, Suitable metals include tantalum, titanium, stainless steel, or alloys thereof. By way of non-limiting example, the clip 10 can be made from commercially pure titanium or ASTM grade CP 1 titanium. This material, when compared with conventional materials, is able to be strain hardened to a greater extent without causing excessive gaps in the formed clip 10 .
• interstitial elements such as oxygen or nitrogen
• oxygen can be incorporated within the clip material.
• Other interstitial elements can include nitrogen, carbon, and iron.
• the clip 10 can also optionally be coated with an antimicrobial or antibiotic material in order to increase the effectiveness of the clip against a broad range of infectious agents or pathogens.
• FIGS. 5A-5E sequentially illustrates selected steps of clip closure, for example to ligate a vessel.
• an open clip 10 is presented, and it can be placed around a desired vessel.
• a closing force is then applied to the outer surface 12 c , 14 c of the leg members 12 , 14 by, for example, the force-applying jaws 100 of a clip applier.
• clip closure begins, as shown in FIG. 5B , the knee portion 20 and the apex 22 are deformed such that the distal ends 12 b , 14 b of the leg members 12 , 14 are moved inward towards one another.
• the clip features at the knees 20 have become predominately parallel to each other and to the clip applying jaws 100 , helping to stabilize the clip 10 in the jaws 100 of the applier.
• FIG. 5D illustrates a condition of full clip closure, with the closing three still applied to the clip 10 by the closing jaws 100 .
• the raised area 26 a , 26 b takes some load off of the knee portion 20 , thereby reducing the amount of plastic deformation of the knee portion 20 .
• the raised area 26 thus allows the knee portion 20 to have increased elasticity, such that, for example, the knee portion 20 can bend inward slightly when forming loads are released, preloading the tips of the clip 10 . This is particularly advantageous in that when the applier is removed from the clip 10 as shown in FIG. 5E , the raised area 26 allows the leg members 12 , 14 to remain together from the knee portion 20 to the distal ends 12 b , 14 b thereof, thereby lessening the duck-billing of the clip 10 .
• clip tends to be more resistant “duck-billing,” a condition in which the distal tips of the leg members 12 , 14 of the clip 10 tend to separate after the closing force is removed.
• Some previously known clips tend to duckbill as a result of residual elasticity within the apex.
• Clip 10 is believed to overcome the tendency to duckbill because the apex 22 is able to crimp to a greater extent and thus minimize the effect of any springback.
• increased elasticity between the apex 22 and the knee portion 20 enables any springback at the knee portion 20 to direct the distal ends 12 b , 14 b of the leg members 12 , 14 toward each other.
• tissue is able to be captured at any location within the clip 10 , including near the apex 22 or near the distal ends 12 b , 14 b of the leg members 12 , 14 , and still be effectively ligate. As a result, a surgeon can securely ligate vessels having a variety of sizes.
• FIG. 6 illustrates an exemplary embodiment of a clip 100 having a compliant portion 110 .
• FIG. 6 illustrates clip 100 in the open position.
• Clip 100 in its open position is generally U-shaped having opposed leg members 120 , 140 joined at an apex 220 and arranged about a centerline 222 .
• Each leg member 120 , 140 has a knee portion 200 disposed distally of the apex 220 .
• each leg member 120 , 140 has an inner surface 120 d , 140 d and an opposed outer surface 120 c , 140 c .
• clip 100 is described herein in the context of a device to ligate vessels, one skilled in the art will appreciate that surgical clip 100 can be used to ligate a variety of other body tissues, including but not limited to, veins arteries, ducts, or any other tubular member within a patient for which ligation is desired. Moreover, clip 100 can be used in a variety of clip appliers, thereby effecting a wide angel of surgical procedures. Although clip 100 is described herein with respect to ligation, it is understood that a variety of other applications are possible as well. Clip 100 may have tissue grasping elements, elasticity-modifying elements, and open volume-creating elements, which create open volume to receive displaced material, as described previously herein.
• Clip 100 can have any shape in its open configuration that allows it to effectively ligate a vessel, such as a substantially U-shaped or a substantially V-shaped design.
• the clip 100 is substantially U-shaped. That is, proximal portions 120 a , 140 a of the leg members 120 , 140 of the clip 100 are oriented at an acute angle with respect to the central axis A of the clip 100 , and transition at a knee portion 200 , to an orientation where distal portions 120 b , of the leg members 120 , 140 are more nearly parallel with respect to one another and to longitudinal centerline 220 .
• Clip 100 comprises a compliant portion 110 and a rigid portion 105 .
• One or both inner surfaces 120 d , 140 d may have a compliant portion 110 placed upon them.
• Compliant portion 110 may extend from apex 220 distally for a portion of the length of leg members 120 , 140 , as shown in FIG. 6 .
• compliant portion 110 may extend the entire length from apex 220 to the distal ends of leg members 120 , 140 .
• Properties and dimensions of compliant portion 110 are chosen to have enough compliance fill gaps left by springback of clip 100 , but to be less compliant than tissue to be ligated in order to compress the tissue.
• compliant portion 110 may be stiffer near apex 220 and more compliant, or compressible near the distal ends of leg portions 120 , 140 . Also, compliance may change as compliant portion 110 is compressed, for example, more compression may cause compliant portion 110 to stiffen.
• Compliant portion 110 can have properties, such as compressibility, of about four to fifteen psi at 10% to 75% compression. The thickness of compliant portion may be from about 0.01 inch to about 0.05 inch. A designer may use materials and dimensions to cause compliant portion 110 to cooperate with rigid portion 105 to advantageously staunch blood flow within tissue to be ligated.
• Biodegradable absorbable polymers are synthetic or biologic derived.
• biodegradable synthetic absorbable polymers can include polydioxanon film sold under the trademark PDS® or with a Polyglycerol sebacate (PGS) film or other biodegradable films from PGA (Polyglycolic acid, marketed under the trade mark VicrylTM), PCL (Polycaprolactone), PLA or PLLA (Polylactic acid), PHA (polyhydroxyalkanoate), PGCL (poliglecaprone 25, sold under the trademark MonocrylTM), PANAGRYL® (Ethicon, Inc Comperville, N.J.), Polyglactin910, Polyglyconage, PGA/TMC (polyglycolide-trimethylone, carbonate sold under the trademark Biosyn®), polyhydroxybutyrate poly(vinylpyrrolidone) (PVP), poly(vinyl alcohol) (PVA), or a blend of copolymerization of
• Suitable biologic derived materials may include but are not limited to platelet poor plasma (PPP), platelet rich plasma (PRP), starch, chitosan, alginate, fibrin, thrombin, polysaccharide, cellulose, collagen, bovine collagen, bovine pericardium, gelatin-resorcin-formalin adhesive, oxidized cellulose, mussel-based adhesive, poly (amino acid), agarose, polyetheretherketones, amylose, hyaluronan, hyaluronic acid, whey protein, cellulose gum, starch, gelatin, silk, or other material suitable to be mixed with biological material and introduced to a wound or defect site, including combinations of materials, or any material apparent to those of ordinary skill in the art in view of the teachings herein.
• PPP platelet poor plasma
• PRP platelet rich plasma
• starch starch
• chitosan alginate
• fibrin fibrin
• thrombin polysaccharide
• cellulose collagen
• Rigid portion 105 of clip 100 can also have physical properties, such as yield strength, that are appropriate for a desired application.
• the yield strength is greater than about 28 ksi and less than about 50 ksi, and more preferably in the range of about 30 ksi to 50 ksi.
• Rigid portion 105 of clip 100 is generally made of a malleable material that can be formed into a closed shape, but has residual elasticity that causes an amount of spingback.
• Rigid portion 105 of clip 100 disclosed herein can be made from a variety of surgically-appropriate materials including metals and polymers. Moreover, the material can be a bioabsorbable material or a non-bioabsorbable material.
• the clip 100 can be made of a metal or a metal alloy having relatively high annealed state yield strength and a relatively high strain hardening rate, in comparison to existing ligation clips. Suitable metals include tantalum, titanium, stainless steel, or alloys thereof.
• the clip 100 can be made from commercially pure titanium or ASTM grade CP1 titanium, CP9 titanium, or CP5 titanium.
• compliant portion 110 allows for materials and geometry that cause more elasticity in rigid portion 105 of clip 100 than would otherwise be considered. Compliant portion 110 will fill gaps caused by elastic springback after clip formation to create a design more forgiving of material variations.
• cup 100 can vary depending upon its particular application.
• clip 100 can have a length (similar to length l in FIG. 1 ) in the range of about 5 mm to 15 mm, and more preferably in the range of about 7.5 mm to 8.5 mm.
• the clip 100 can have a width W, similar to width W shown in FIG. 3 , between opposed inner surfaces 120 d , 140 d of the leg members 120 , 140 in the range of about 2 mm to 8 mm, and more preferably in the range of about 3 mm to 4 mm.
• each leg member 120 , 140 can also vary depending upon the particular application, however in one embodiment, each leg member 120 , 140 cart have a width w, similar to width w shown in FIG. 2E , less than 0.050 inch, more preferably in the range of about 0.025 inch to about 0.040 inch, most preferably less than about 0.035 inch. Moreover, each leg member 120 , 140 can have a height H (similar to height H shown in FIG. 3 ) in the range of about 0.015 inch to 0.030 inch, and more preferably in the range of about 0.018 inch to 0.025 inch, and most preferably in the range of about 0.019 inch to 0.020 inch.
• Clip 100 is further designed so that, upon closure, a vessel, for example, is completely encased between the leg members 120 , 140 of the clip 100 . This is done by urging the leg members 120 , 140 of the clip 100 together, typically with the assistance of an applier, to surround the vessel.
• a typical applier for clip 100 can be one as described in U.S. Pat. No. 7,731,724 to Huitema et al.
• FIG. 7 shows a clip closed only at the distal end leaving a proximal opening 150 between the legs.
• the material used in rigid portion 105 has elasticity. After clamping the clip closed around tissue, residual elastic forces can cause the proximal portion of the clip to spring back and to open in the directions of the avows in FIG. 7 .
• FIG. 8 depicts a closed clip 100 showing compliant portion 110 filling proximal opening caused by elasticity in rigid portion 105 .
• a user would have an applier or forming tool with a clip 100 in the jaws.
• the user would place clip 100 over tissue to be ligated, such as a blood vessel, and cause the jaws of the applier to move together forcing leg members 120 , 140 to move or deform towards each other.
• the deformation of clip 100 has a plastic component and an elastic component.
• the user of the appiler continues to force leg members 120 , 140 together until ligation of tissue is achieved and clip 100 is in the formed position.
• leg members 120 , 140 of rigid portion 105 After formation of clip 100 , release of the forming tool can cause leg members 120 , 140 of rigid portion 105 to elastically move laterally, or spring back, causing separation of leg members 120 , 140 .
• the residual forces from the elastic portion of the deformation cause the leg members 120 , 140 to separate the amount of elastic deformation, resulting in an opening 150 .
• compliant portion 110 has enough thickness to fill any opening created when leg members 120 , 140 separate.
• Clip 100 can be designed so that the thickness of compliant portion 110 is greater than the gap created by separation after clip formation, or so that the separation amount is less than the total of the thickness of tissue to be ligated and the thickness of compliant portion 110 .
• Clip 100 can further be designed so that force placed upon a vessel by compliant portion 110 is sufficient to keep the vessel closed against the vessel's internal pressure, caused by, for example, blood attempting to flow through a ligated vein or artery. Also, compliant portion 110 may be designed to minimize forces against leg members 120 , 140 to minimize separation after clip formation.
• FIG. 9 shows compliant portion 110 having a plurality of ribs 150 .
• Ribs 150 extend towards longitudinal centerline 222 from a compliant portion base 160 formed along at least one inner surface of inner surfaces 120 d and 140 d of rigid portion 105 .
• Clip 100 may have a compliant portion 110 with at least one, and perhaps a plurality of ribs 150 extending from a base 160 .
• Ribs 150 may be complementary in shape to each other to interlace upon closing, thus providing greater closure and gripping of tissue placed within leg members 120 of clip 100 .
• FIG. 10 shows in isometric view a set of ribs 150 that are angled to the longitudinal length of leg member 120 , and that extend towards longitudinal centerline 222 .
• Ribs 150 may be angled, parallel, or perpendicular to the longitudinal length of leg members 120 , 140 . Angling ribs 150 at different angles may serve to present different cross-sectional areas to tissue to apply optimum pressure to compliant portion 110 to cause optimum compression.
• Ribs 150 of FIG. 10 are shown having a constant thickness “t” from base 160 to the open curls of ribs 150 . Thickness “t” can vary, however, from a thicker portion near base 160 to a thinner portion at the open end. Thickness “t” could also vary from a thinner dimension near base 160 , becoming thicker near the open end, or other variations may occur to a designer of ribs 150 .
• FIG. 10 further shows in isometric view a groove 170 placed along leg members 120 , 140 .
• a portion of one leg member is shown, but groove 170 could be placed along one or both leg members 120 , 140 .
• Such a groove 170 can hold compliant portion 110 to rigid portion 105 .
• Compliant portion 110 may be overmolded to rigid portion 105 , to example, with the polymer flowing into groove 170 and hardening to hold compliant portion 110 to rigid portion 105 .
• Groove 170 may be substantially rectangular, as shown, or it way be wider at the base to create a dovetail joint to more firmly hold compliant portion 110 to rigid portion 105 of leg members 120 , 140 .
• FIG. 11 shows clip 100 in the closed position, with a ribbed compliant portion 110 .
• ribs 150 can overlap and interlock to better grip and hold tissue between log members 120 of clip 100 .
• some ribs 150 may interlock, however, some ribs 150 may interfere upon closure of clip 100 to cause a desired pressure distribution on tissue to be ligated.
• a compliant portion with or without ribs may be used with a clip having, for example, a raised portion, such as a raised portion 26 a or 26 b ( FIG. 3 ) on an outside portion of one or more leg members 120 .
• clip 100 could have tissue contacting surfaces either on compliant portion 110 or rigid portion 105 .
• Clip 100 could have a notch 24 , such as notch 24 depicted in FIG. 4A , or tongue and groove configurations as depleted in FIG. 2B .

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