Abstract:
A clip for suturing opposed ends of severed tissue. The clip has a body with a first end terminating in a needle and a second end having an opening thereat. The body may also include a bite portion between the first and second ends applying a biasing force to hold the suturing clip in either a default open or default closed condition, wherein the needle is remote from the opening in the open condition and in proximity to the opening in the closed condition. The body may also include a footpad adjacent the needle, wherein the footpad pinches the opposing ends of the severed tissue against the body adjacent to the opening when the clip is in the closed condition. The clips may be applied by a surgical device, which is also disclosed.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]    The present invention relates to U.S. Provisional Patent Application Serial No. 60/433,691 filed Dec. 16, 2002, the disclosure of which is hereby incorporated herein by reference. 
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    The present invention relates to surgical clips, methods of using surgical clips, and devices for installing surgical clips. Surgical clips, such as those for closing external wounds or for anastomosis of internal vessels, are well known in the art. Methods of using such clips are also well known. Often, such clips are referred to as suturing clips.  
           [0003]    The suturing clips of the prior art are typically formed from metal and may be bent into position by the surgeon or other medical professional. Many such clips are held in place by merely by pressure, as the they pinch the wounded tissue. Such clips require skill and judgment to determine the amount of closing pressure required for a particular injury. As such, there is a risk that the clip will be installed with too great a pressure, or too little pressure to properly heal the wound.  
           [0004]    In addition, many of the prior art clips include teeth that are utilized to “bite” into the wounded flesh or vessel. These teeth are typically intended to assist with holding of the wounded flesh or vessel in place. Nevertheless, the teeth may often interject additional complications, such as causing localized tearing around the teeth. If such tearing is left unaddressed, it may spread to the edge of the wound such that the skin or vessel will be completely ruptured and no longer be secured by the teeth, rendering the clip non-functional. In addition, the localized tearing may become infected, even if limited to only a small amount.  
           [0005]    Staples are also known for the closing of wounds. Staples are preferred in many instances. However, staples pierce the wounded tissue, often leading to additional complications.  
           [0006]    Other prior art devices do not employ piercing teeth. Rather, such devices typically rely on pressure generated on a bearing surface through springs or through the resiliency of the clip itself to secure the wound. Such clips may not be capable of generating sufficient force to hold the wound closed without interjecting additional complications. Also, such clips are often not installed with sufficient pressure to permit them to be secured to the wound for the requisite period of time required for the wound to heal. Even if the clips are installed with a proper pressure, necrosis of the tissue may cause the tissue to thin, permitting the clip to slide off. This is especially troublesome for clips that do not include a biasing pressure, but merely retain a predetermined position upon setting.  
           [0007]    When installed externally, such defects are readily curable. However, when installed internally, for example in carotid batch fixation, additional complications arise, in that the clips may only be fixed through surgical intervention.  
           [0008]    Accordingly, it would be beneficial to provide a suturing clip having a combination of a piercing member and a bearing surface, such that the benefits of each of the prior art styles is employed without the inherent limitations of each. It would also be beneficial to provide clips having additional features, even if such features did not include the combination of a piercing member and a bearing surface.  
         SUMMARY OF THE INVENTION  
         [0009]    The aforementioned shortcomings of prior art suturing clips, and others not specifically listed, have been addressed by the present invention, which in one embodiment comprises a suturing clip comprising a body having first and second ends. The first end may terminate in a needle and the second end may form an opening thereat. The body may be adapted to manipulate the needle between a first and second position, the needle arranged spaced from the opening when in the first position and at least partially within the opening when in the second position. The first end may further comprise a hemostatic footpad where the footpad has a dimension larger than the opening such that the footpad may not pass through the opening when the clip is in the closed position. The body may further comprise a spring between said first end and said second end, the spring applying a biasing force to hold the body in either the first position or the second position. The needle may be deformed when in the second position such that the deformed needle interferes with the opening to prevent the body from being placed in the first position.  
           [0010]    In other embodiments, the body may further comprise a bite portion between the first end and said second and a first needle arm extending from the bite portion to the first end. First and second extension members may extend from the bite portion to the second end. The first needle arm, the first extension member and the second extension member may be connected to each other by a pin at the bite portion. The first extension member and the second extension member may be placed in proximity to each other at the second end to form the opening.  
           [0011]    In further embodiments, the suturing clip may comprise a body having a first end, a second end and a bite portion therebetween. The first end may terminate in a needle and the second end may terminate with a needle receiving ring adapted to receive the needle, wherein the bite portion applies a biasing force to hold the suturing clip in either one of a default open or a default closed condition, the needle being remote to the needle receiving ring in the open condition and in proximity with the needle receiving ring in the closed condition.  
           [0012]    In further embodiments, the suturing clip may comprise a wire strand having a first end tapering into a needle, a second end configured to form a needle receiving ring to receive the needle, and a bite portion therebetween. The bite portion may bias the clip in either one of an open condition in which the needle is remote from the needle receiving ring and a closed condition in which the needle is at least partially within the needle receiving ring.  
           [0013]    In a still further embodiment, the suturing clip may comprise a first extension arm, a second extension arm and a needle arm, the first extension arm and the second extension arm being pivotable about a bite portion of the clip to form a needle receiving ring, the needle arm terminating with a needle opposite the bite portion, wherein the needle may penetrate the needle receiving ring to place the clip in a closed condition.  
           [0014]    In still further embodiments, a method of suturing opposing ends of severed tissue with a clamp having a body a first end terminating in a needle and a second end forming an opening thereat is disclosed. The method may comprise placing the opposing ends of the tissue adjacent to each other, piercing the opposing ends of the tissue with the needle, and closing the clamp by moving the first end of the body into proximity with the second end such that the needle extends into the opening.  
           [0015]    Also disclosed is a device for applying surgical clips having a body with a first end terminating in a needle and a second end forming an opening thereat, the device preferably comprises an elongate first member having a first end and a second end with an aperture therebetween, an elongate second member having a first end and a second end with an aperture therebetween, a pin extending through the apertures to connect the first member to the second member such that the members are pivotable about the pin, and an anvil arranged at the second end of the second member. The anvil may be adapted to shape the needle of the clip when the second end of the first member is brought into proximity with the second end of the second member. The first ends of each member may form handles. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0016]    The subject matter regarded as the invention is particularly pointed out and distinctly claimed in the concluding portion of the specification. The invention, however, both as to organization and method of operation, together with features, objects, and advantages thereof will be or become apparent to one with skill in the art upon reference to the following detailed description when read with the accompanying drawings. It is intended that any additional organizations, methods of operation, features, objects or advantages ascertained by one skilled in the art be included within this description, be within the scope of the present invention, and be protected by the accompanying claims.  
         [0017]    In regard to the drawings, FIG. 1 is perspective view of a suturing clip in accordance with one embodiment of the present invention;  
         [0018]    [0018]FIG. 2 is a perspective view of a suturing clip in accordance with another embodiment of the present invention;  
         [0019]    [0019]FIG. 3 is a perspective view of a suturing clip in accordance with yet another embodiment of the present invention;  
         [0020]    [0020]FIG. 4 is a perspective view of a suturing clip in accordance with still another embodiment of the present invention;  
         [0021]    [0021]FIG. 5 is a perspective view of a suturing clip in accordance with another embodiment of the present invention;  
         [0022]    [0022]FIGS. 5A through 5C are side views of the suturing clip of FIG. 5 shown in various stages of closure, FIG. 5A being completely open and FIG. 5C being completely closed;  
         [0023]    [0023]FIG. 6A is a perspective view of a suturing clip in accordance with another embodiment of the present invention in an open condition;  
         [0024]    [0024]FIG. 6B is a perspective view of the suturing clip of FIG. 6A in a closed condition;  
         [0025]    [0025]FIG. 6C depicts a perspective view of a surgical device for inserting a clip with a clip in accordance with one embodiment of the present intention;  
         [0026]    [0026]FIG. 7A is a perspective view of still another embodiment of the suturing clip of the present invention shown in a partially closed condition; and,  
         [0027]    [0027]FIG. 7B is a perspective view of the suturing clip of FIG. 7A shown in a fully open condition. 
     
    
     DETAILED DESCRIPTION  
       [0028]    In the following is described the preferred embodiments of the suturing clip of the present invention. In describing the embodiments illustrated in the drawings, specific terminology will be used for the sake of clarity. However, the invention is not intended to be limited to the specific terms so selected, and it is to be understood that each specific term includes all technical equivalents that operate in a similar manner to accomplish a similar purpose.  
         [0029]    The vascular suturing clip of the present invention may be used to anastomose two pieces of tissue, such as one blood vessel to a second blood vessel. The suturing clips may also be utilized to anastomose vascular prosthetics to blood vessels or other organs. In addition, the suturing clips may be utilized to secure a single piece of tissue which has been split, such as in the case of an external wound to the skin tissue.  
         [0030]    [0030]FIG. 1 depicts one embodiment of the vascular suturing clip of the present invention. As shown in FIG. 1, the vascular suturing clip  100  of this embodiment is formed from a single strand of wire  102 , which is bent and formed into the suturing clip. The suturing clip  100  includes a first end  104 , a second end  106  with a bite portion  108  therebetween. The extreme first end  104  of the suturing clip  100  forms a needle  110 . The needle  110  increases in diameter from its point  112  to its base  113 . At the base  113  is preferably a hemostatic footpad  114 . It will be appreciated that the diameter of the hemostatic footpad  114  is typically greater than the diameter of the wire  102  used to form the suturing clip  100 , as well as wider than the base  113  of the needle  110 .  
         [0031]    The suturing clip  100  extends from this first end  104  along an arcuate path to the bite portion  108 . The bite portion  108  of the suturing clip of this embodiment is formed by wrapping the wire  102  twice around an axis  116  so as to create a spring  109 . It will be appreciated that the strength of the spring  109  is a function of the tightness of the wrapped wire  102 , the number of wraps and the diameter and material of the wire. Each of these elements may be modified so as to create a suturing clip  100  with the desired compression. For example, the bite portion  108  may include wire  102  wrapped four times, if increased spring compression is desired.  
         [0032]    From the bite portion  108 , the wire  102  forming the suturing clip  100  extends along an arcuate path towards the second end  106 . As shown in FIG. 1, this arcuate path is a typically a mirror image of the arcuate path between the first end  104  and the bite portion  108  of the clip  100 , such that the clip generally forms a circle.  
         [0033]    The second end  106  of the clip  100  may form a needle receiving ring  118  having a cavity  120 . Alternatively, the needle receiving ring  118  may be formed as a separate component and then bonded to the second end  106  of the clip  100 . The needle receiving ring  118  of this embodiment is formed by wrapping the wire  102  of the clip  100  around a single circular bend, as shown in FIG. 1. Multiple circular bends may also be employed.  
         [0034]    The needle receiving ring  118  and the cavity  120  are typically sized large enough that the point  112  of the needle  110  may enter the cavity  120  but the footpad  114  may not. In its default, or resting position, the suturing clip  100  of this embodiment is in a closed position, such that the footpad  114  is engaged with the needle receiving ring  118 . Again, the clip  100  may be adapted such that a predetermined compression force is present between the footpad  114  and the needle receiving ring  118 .  
         [0035]    [0035]FIG. 2 depicts a suturing clip  200  in accordance with a second embodiment of the present invention. As with the first embodiment, the suturing clip  200  of the second embodiment is formed from a single wire  102 . The clip  200  comprises a proximal end  201 , a distal end  203 , and a bite position  108  therebetween. A first end  204  of the wire  102  assists with forming the bite portion  108  of suturing clip  200 . The second end  206  of the wire  102  forms a needle  110  at the proximal end  201  of the clip  200 .  
         [0036]    To form the suturing clip  200  of this embodiment, the first end  204  of the wire  102  is placed along an axis  116  around which the bite portion  108  of the suturing clip  200  is to be formed. The wire  102  is then bent along a first curve  202  towards the distal end  203  of the suturing clip  200 . From the first curve  202 , the wire  102  generally follows an arcuate path to the distal end  203 . At the distal end  203 , the wire  102  is looped around to form a needle receiving ring  118  and a cavity  120 , similar to the like elements of the first embodiment. The wire  102  then extends back towards the bite portion  108  following an arcuate path matching the arcuate path followed from the first curve  202  to the distal end  203 , where it is wrapped around the first end  204  of the wire  102  to form a spring  109 . Again, the number of times the wire  102  is wrapped and the tightness of the wrapped wire will partially determine the strength of the spring. After being wrapped, the wire  102  then extends along an arcuate path towards the proximal end  201  of the suturing clip  200 . As with the previous embodiment, the proximal end  201  includes a footpad  114  and a needle  110 . The needle includes a point  112  which tapers from a bas  113  adjacent to the footpad.  
         [0037]    It will be appreciated that the suturing clip  200  of the second embodiment is similar in operation to suturing clip  100  of the first embodiment. However, this embodiment of the suturing clip  200  is generally stronger than the first embodiment of the suturing clip  100  when like materials of like diameters are employed because of its geometry. As with the previous clip  100 , this suturing clip  200  is closed in its resting, or default position, such that the footpad  114  is engaged with the needle receiving ring  118 .  
         [0038]    [0038]FIG. 3 discloses a suturing clip  300  in accordance with a third embodiment of the present invention. The suturing clip  300  is formed in a similar manner as the suturing clip  100  and the suturing clip  200 . However, the suturing clip  300  includes a first leverage loop  302  and a second leverage loop  304 . As is shown in FIG. 3, the leverage loops  302 ,  304  are located adjacent to the bite portion  108  of the suturing clip  300 . Each loop  302 ,  304  is formed from the continuous wire  102 . Generally, the first leverage loop is formed between the bite portion  108  and the proximal end  201  by adding an extra loop of wire  102 . Meanwhile, the second leverage loop  304  is typically formed at the bite portion  108  in a similar manner, as shown in FIG. 3.  
         [0039]    The leverage loops  302 ,  304  are utilized to open the suturing clip  300 , as its resting or default position is closed. By simultaneously applying leverage to each loop generally in the directions indicated by arrows A and B of FIG. 3, pressure will be biased against the spring  109  formed at the bite portion  108  of the suturing clip  300 . Sufficient pressure will open the suturing clip  300 .  
         [0040]    Pressure may be applied manually by the surgeon&#39;s fingers or by the use of a device specially adapted for this purpose. Such devices may be as simple as a standard pair of pliers or as intricate as a specialized device which may house a cartridge of suturing clips  300  with automatic reloading of subsequent clips  300  during installation. It will be appreciated that suturing clips  100  and  200  of FIGS. 1 and 2, as well as those yet to be presented, may also be installed manually or by a similar device having a cartridge of clips.  
         [0041]    As previously mentioned, suturing clips  100 ,  200 ,  300  shown in FIGS. 1-3 are closed in their default or resting position. To install the clips  100 ,  200 ,  300 , the clips must be spread apart such that the needle  110  is moved distant from the needle receiving ring  118 . Two pieces of tissue (not shown) intended to be sutured may then be placed between the needle point  112  and the needle receiving ring  118 . The clip  100 ,  200 ,  300  may then be permitted to return to its natural condition where the needle point  112  will pierce the tissue due to the biasing of the bite portion  108  of the clips  100 ,  200 ,  300 . Such biasing will permit the needle  110  to penetrate both tissue portions until such point as the hemostatic footpad  114  prevents further penetration owing to its oversized relationship with cavity  120  and loop  118 .  
         [0042]    One of the features of suturing clips  100 ,  200 ,  300  is the interaction of the needle  110  with the footpad  114  and the needle receiving ring  118  with cavity  120 . Namely, the needle  110  may pierce tissue to be sutured in a similar manner as many of the prior art references. However, this action alone may permit tearing of the tissue if any subsequent pulling occurs. Footpad  114  assists with preventing this from occurring. Footpad  114  applies pressure to the tissue between itself and needle receiving ring  118  across a portion of its surface area. Thus, the tissue is held in place by both the piercing of the needle  110  and the applied pressure of the footpad  114 . In addition, the pressure applied by footpad  114  assists in maintaining hemostasis so the flow of blood is arrested at the pierced area.  
         [0043]    [0043]FIG. 4 depicts a suturing clip  400  in accordance with a fourth embodiment of the present invention. This suturing clip  400  is substantially similar to the previous suturing clips  100 ,  200 ,  300 , except that its default or resting position is open and it includes a needle  110  which does not include a footpad  114  and is permitted to completely penetrate beyond the needle receiving ring  118  of the clip  400 . In this regard, two pieces of tissue which are intended to be sutured may be placed between point  112  and looped needle receiving ring  118 . The suturing clip  400  may be closed by applying pressure to the proximal end  104  and the distal end  106  in the directions indicated by arrows A and B, such that the point  112  pierces the tissue and extends beyond the cavity  120  formed by the needle receiving ring  118 . The needle  110  may extend beyond the cavity  120  such that the base  113  completely passes through the needle receiving ring  118  and the cavity  120 . To achieve such a result, the pressure must be sufficient to minimally deform the needle receiving ring  118  or the base  113  of the needle  110 . Such deformation is available because of the nature of alloys used to form the clips. Also, the clips may have a non-continuous portion forming the needle receiving ring such as the clips shown in FIGS. 1-3, which are permitted to deform. Other clips, such as those shown in FIGS. 4 and 5, have a continuous needle receiving ring  118 . These rings are formed by stamping the wire flat, and then punching out the cavity  120 , or by other similar means. Of course, the wire  102  may also begin flat rather than cylindrical, such that the entire clip  400  will consist of flat wire.  
         [0044]    Once closed in the such a manner, the base  113  of the needle  110  will be stuck beyond the cavity  120  preventing the suturing clip  400  from opening, despite the biasing of the bite portion  108  attempting to keep the clip  400  in an open condition. Thus, once the suturing clip  400  of this embodiment is engaged, it is difficult, if not impossible, to remove by non-destructive means. This suturing clip  400  may be applied manually by a surgeon or by the use of a specialized mechanical device which may include a cartridge of clips, as with the previous embodiments.  
         [0045]    It will be appreciated that the bite portion  108  of clip  400  is bent with a relatively small radius. FIG. 5 depicts a similar clip  400 A with a bite portion  108  bent into a larger radius. Either type of clip  400 ,  400 A may be employed. Further, it will be noted that the bite portion  108  of clips  400 ,  400 A is not wound to form a spring  109  as with the previous embodiments. Rather, the bite portion  108  comprises a simple arc through a given radius. This permits the clip  400 ,  400 A to have an open default position, rather than closed as with the previous embodiments. Of course, the wire may also be bent into a spiral spring, if so desired.  
         [0046]    [0046]FIGS. 5A-5C depict a suturing clip  500  in accordance with a fifth embodiment of the present invention. Suturing clip  500  is substantially similar to the previous suturing clips  400 ,  400 A. However, the needle  110  of the suturing clip of this embodiment does not include a base  113  extending beyond the outer diameter of the wire  102 . Thus, when this clip is closed, there are no forces acting against the biasing force of the bite portion  108  to prevent opening of the clip other than a minor amount of friction between the needle  110  and the tissue to be clamped. Accordingly, the needle  110  must be bent below the level of the receiving ring  118  after the clip  500  is closed or the clip will open. FIG. 5B depicts a needle in an initial stage of being bent such that the suturing clip  500  will be prevented from opening. Such bending may be performed by a surgeon manually, such as with a special tool, for example, a pair of pliers. Preferably, a specialized device attached to the clip  500 , such as an anvil bucket  502  (FIG. 6A) may be utilized. FIG. 5C depicts a suturing clip  500  having a needle  110  bent so as to prevent the clip from opening in accordance with this embodiment.  
         [0047]    [0047]FIGS. 6A and 6B depict suturing clips  500  with an anvil bucket  502  attached. FIG. 6A depicts the suturing clip  500  in an open condition while FIG. 6B depicts the suturing clip in a closed condition. The anvil bucket  502  is typically attached to the clip  500  below the receiving ring  118  to bend the needle  110 . The anvil bucket  502  typically comprises a relatively flat top surface  504  and a sunken shaped portion  506 . As shown in FIGS. 6A and 6B, the shaped portion  506  may be curved from a shallow portion nearest the flat top surface  504  to its deepest portion near the center of the shaped portion such that the needle  110  may be gradually bent upon contact with the anvil bucket  502 . As previously noted, the anvil bucket  502  may not be attached to the clip  500 , but may in fact form a portion of a specialized applicator  700  for placing such clips  500 , such as shown in FIG. 6C.  
         [0048]    Such an applicator  700  may take the shape of a pair of pliers with two elongate members  702 ,  704  connected by a pin  706 . One of the members may include the anvil bucket  502  at a distal end  708  while the other may include a mechanism  710  for grasping the clip  500 . At the proximal ends  712 ,  714  of each member may be handles  716 ,  718 , such as those formed in traditional scissors, so the surgeon may manipulate the applicator.  
         [0049]    [0049]FIGS. 7A and 7B depict a suturing clip  600  in accordance with still another embodiment of the present invention. In this embodiment, the suturing clip  600  is formed from four pieces. Three of the pieces, a needle arm  604 , a first extension  606  and a second extension  608  extend from the bite portion  108  of the suturing clip  600 . Each of the pieces  604 ,  606 ,  608  is connected by, and is pivotable about, pin  602 . Needle arm  604  extends from the pin  602  towards its terminus at needle  110 . As with suturing clip  400 , the needle  110  includes a point  112  and a base  113 , which may generally form an arrow-shaped head. Each of the first extension  606  and the second extension  608  also extend from the pin  602  towards their respective terminus points which collectively form a needle receiving ring  118  with a cavity  120  when brought adjacent to each other. As shown in FIG. 7A, the first extension  606  and second extension  608  may partially overlap to form the needle receiving ring  118 . However, they may also simply abut each other at their respective terminus points, if aligned on the same plane. Such abutment may still form a needle receiving ring  118 .  
         [0050]    First extension  606  and Second extension  608  may be pivoted about pin  602  such that they are in a closed position as shown in FIG. 7A or in an open position as shown in FIG. 7B. As more clearly shown in FIG. 7B, each of the first extension  606  and the second extension  608  form approximately one-half of the needle receiving ring  118 .  
         [0051]    The suturing clip  600  of this embodiment is installed in a similar manner as the suturing clip  400 ,  400 A previously discussed. Namely, the first extension  606  and the second extension  608  may be spread apart such that the receiving ring  118  is not formed, as shown in FIG. 7B. The needle  110  may then be utilized to pierce the tissue to be sutured. The first extension  606  and second extension  608  may then be pivoted about pin  602  toward each other to form receiving ring  118  above the level of the base  113  of needle  110  so as to be positioned between the base  113  and the bite portion  108 . As the natural biasing of the clip  600  is in the open position, it will be appreciated that such action will cause the needle  110  to remain below the level of the needle receiving ring  118  within cavity  120 , placing the suturing clip  600  in a locked position.  
         [0052]    Once the suturing clip  600  is in a locked position, the tissue will be secured. A feature of suturing clip  600  is that the suturing clip may easily be opened after being locked. To open the suturing clip  600 , the first extension  606  and the second extension  608  may be spread apart as shown in FIG. 7A such that the needle arm  604  may be permitted to be withdrawn from penetrating the tissue. Thus, this suturing clip  600  has the benefits of being lockable as with the suturing clip  400 ,  400 A, but also permits removal in a much simpler manner.  
         [0053]    Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.