Abstract:
A system is disclosed for securing a suture. The system includes a deformable suture clip having a pair of closely spaced panels configured for movement between an open position wherein a suture can pass between the two panels and a closed position wherein the suture can be securely clamped between the two panels. The system further includes a clip applicator having an elongated body defining opposed proximal and distal end portions. The distal end portion of the body includes a mounting fixture having structure for supporting the suture clip in an open position. The clip applicator further includes a mechanism for dislodging the suture clip from the mounting fixture, such that the panels of the clip move to the closed position to securely clamp the suture therebetween.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application is a divisional of U.S. patent application Ser. No. 10/930,161 filed 31 Aug., 2004, which is incorporated by reference herein in its entirety. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The subject disclosure relates to a system for securing a suture, and more particularly, to a surgical apparatus for applying a deformable suture clip to a suture used to close a surgical incision or wound formed in a blood vessel or body tissue. 
         [0004]    2. Background of the Related Art 
         [0005]    Sutures have long been used to close wounds and surgical incisions in body tissue. It is common practice to secure a suture in body tissue by tying one or more knots therein. Knots are time consuming to tie, difficult to form in small body cavities and are a relatively unreliable means of securely maintaining a suture in tissue. In view of these shortcomings, various devices and fasteners have been developed to positively secure a suture in place following a surgical procedure. 
         [0006]    For example, U.S. Pat. No. 6,077,277 to Mollenauer et al. discloses a device for joining suture segments together. The device has a pair of grasping jaws with heating surfaces thereon configured to weld the suture together. U.S. Pat. No. 6,086,608 to Ek et al. discloses a suture collet that consists of an outer member defining a passage for receiving a suture. An inner member is threaded into the outer member to retain the suture therein. U.S. Pat. No. 5,520,702 to Sauer et al. and U.S. Pat. No. 6,099,553 to Hart et al. each disclose cinches to retain a suture used to close an incision in body tissue. 
         [0007]    Certain surgical procedures, such as for example angioplasty procedures, require the creation of a small percutaneous incision or opening in the femoral artery. Typically, at the conclusion of the procedure, the incision or opening in the blood vessel is closed by applying a fair amount of pressure to the wound until hemostasis occurs. This technique is time consuming, uncomfortable and can cause thrombosis, thereby presenting a danger to the patient. Fortunately, surgical instruments have been developed to mechanically close incisions in blood vessels, thus avoiding the need for the direct application of pressure to close the wound. 
         [0008]    A particularly useful device for mechanically closing an incision in the wall of a blood vessel following a surgical procedure is disclosed in U.S. Pat. No. 6,454,777 to Green, which is incorporated herein by reference in its entirety. This device applies a suture to the walls of a blood vessel to close an incision formed therein. Once the suture is placed and the apparatus is withdrawn from the incision site, a knot is formed in the suture to secure it in place. However, because the procedure is performed percutaneously through a small entrance wound in the patient&#39;s leg, properly tying a knot to securely fasten the suture and close the incision is a difficult task. For that matter, placing a clip on the suture at the site of the incision in the blood vessel wall is even more difficult, because there is no direct line of sight to ensure the proper placement of the clip. 
         [0009]    Clearly, there is a need in the art for an apparatus that is adapted and configured to effectively and accurately apply a clip to a suture used to close an incision formed in the wall of a blood vessel. 
       SUMMARY OF THE INVENTION 
       [0010]    The subject invention is directed to a new and useful system for securing a clip to suture used to close a wound or surgical incision in body tissue, such an opening in a blood vessel. The system includes a deformable suture clip having a pair of closely spaced panels configured for movement between an open position wherein a suture can pass between the two panels and a closed position wherein the suture can be securely clamped between the two panels. The system further includes a clip applicator having an elongated body defining opposed proximal and distal end portions. The distal end portion of the applicator body includes a mounting fixture or lug having means for releasably supporting the deformable suture clip in an open position. The clip applicator further includes means for dislodging the suture clip from the mounting fixture, such that the panels of the deformable clip move to the closed position to securely clamp the suture therebetween. 
         [0011]    Preferably, the clip applicator further includes means for severing or cutting the suture at a location proximal to the suture clip. The severing means is positioned and preferably operates to cut the suture after the suture clip is dislodged from the mounting fixture. The mounting fixture is oriented at an angle with respect to the longitudinal axis of the elongated body of the clip applicator. The helps to properly align and position the clip at the incision site, so that it is flush against the vessel wall or body tissue that has been sutured. 
         [0012]    The means for supporting the suture clip in an open position preferably includes a clamp block, which extends distally from the mounting fixture and is dimensioned for insertion between the closely spaced panels of the suture clip. The means for dislodging the suture clip from the mounting fixture preferably includes an elongated translating pusher finger adapted to dislodge the suture clip from the clamp block. The mounting fixture preferably includes an opening, which is dimensioned and configured to provide the pusher finger with access to the suture clip. Preferably, the means for dislodging the clip is manually operable from the proximal end portion of the clip applicator. 
         [0013]    The subject invention is also directed to a new and useful deformable suture clip. The suture clip includes a proximal body portion having a pair of abutting surfaces configured for movement between an open position and a normally closed position. In the open position, a suture can pass between the abutting surfaces. In the normally closed position, the suture can be securely clamped between the pair of abutting surfaces. The suture clip further includes a distal body portion defining, at least in part, deformable means for facilitating the movement of the pair of abutting surfaces between the open and closed positions. 
         [0014]    The proximal body portion of the suture clip preferably includes a pair of closely spaced panels each forming one of the abutting surfaces. The deformable means preferably includes, at least in part, a deformable panel extending generally parallel to the closely spaced panels of the proximal body portion. It is envisioned that at least the deformable panel of the clip is formed from a metallic material, and preferably from a spring metal or a shape memory alloy. The distal body portion of the clip preferably includes a guide notch or slot for receiving the suture. 
         [0015]    The subject invention is also directed to an applicator for applying a deformable clip to a suture used to close an incision or wound in a blood vessel or body tissue. The applicator includes an elongated outer tubular body section defining opposed proximal and distal end portions. The distal end portion of the outer body section is truncated and includes a mounting fixture or lug having means for supporting a deformable suture clip in an open position. The applicator further includes an inner body section cooperatively supported for longitudinal translation within the outer body section. The inner body section includes means for dislodging the suture clip supported on the mounting fixture at the distal end of the outer body section, such that the suture clip moves to a closed position to securely engage the suture at a desired location. 
         [0016]    Preferably, the outer body section of the applicator includes a slot for accommodating the passage of the suture from the incision site to a remote location for access by a surgeon. The mounting fixture or lug preferably includes a projection or block for maintaining the clip in an open position. The block fits intimately between the abutting surfaces of the closely spaced panels in the proximal portion of the clip, which are normally biased into a closed position. The mounting fixture also includes means for aligning the suture clip on the distal end of the applicator. The aligning means preferably includes a plurality of stops or tabs, which project from the distal surface of the mounting fixture for contacting the proximal portion of the clip at predetermined locations. 
         [0017]    The applicator further comprises means associated with the inner body section for cutting the suture at a location proximal to the clip. Preferably, the means for dislodging the suture clip from the mounting fixture includes an elongated pusher finger that extends distally from the end of the inner body section. Preferably, means are provided for preventing rotation of the inner body section with respect to the outer body section to ensure proper alignment of the pusher finger with the corresponding aperture in the mounting fixture. Means are also provided for limiting axial translation of the inner shell assembly relative to the outer shell assembly. Preferably, the applicator further includes selectively releasable locking means for preventing axial movement of the inner body section relative to the outer body section until such movement is desired. 
         [0018]    The subject invention is also directed to a method for applying a clip to a suture at a desired location. The method includes the steps of providing a clip applicator having a deformable clip positioned at a distal end thereof, threading a suture through an opening in the deformable clip, positioning the deformable clip at a desired location on the suture, and dislodging the deformable clip from the distal end of the applicator in such a manner so that the opening through which the suture is threaded is closed to securely clamp the suture. The method further includes the step of cutting the suture at a location proximal to the clip. 
         [0019]    These and other unique features of the system, apparatus and method disclosed herein will become more readily apparent from the following description and the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0020]    So that those having ordinary skill in the art to which the subject invention appertains will more readily understand how to make and use the same, reference may be had to the drawings wherein: 
           [0021]      FIG. 1  is a perspective view of a clip applicator constructed in accordance with a preferred embodiment of the subject invention, showing the novel suture clip dislodged from the lug at the distal end of the applicator; 
           [0022]      FIG. 2  is a perspective view of the clip applicator of  FIG. 1  showing the actuation mechanism associated with the proximal end portion of the clip applicator; 
           [0023]      FIG. 3  is an exploded perspective view of the clip applicator of  FIG. 1  with parts separated for ease of illustration; 
           [0024]      FIG. 4  is a localized cross-sectional view as identified in  FIG. 1 , illustrating the cooperative engagement between the inner and outer body sections of the clip applicator; 
           [0025]      FIG. 5  is a plan view of the lug or mounting fixture disposed on the distal end of the clip applicator, which includes structure for releasably supporting the suture clip; 
           [0026]      FIG. 6  is a perspective view of a deformable metallic suture clip adapted and configured for use in conjunction with the clip applicator of  FIG. 1 , wherein the body of the clip is disposed in a normally closed position; 
           [0027]      FIG. 7  is a perspective view of the suture clip of  FIG. 6 , viewed from the proximal surface, wherein the body of the clip is disposed in a deformed or open position; 
           [0028]      FIG. 8  is a perspective view of the suture clip, viewed from the distal surface, wherein the body of the clip is disposed in an open position; 
           [0029]      FIG. 9  is a plan view of the distal end of the clip applicator of  FIG. 1 , with the surgical clip of  FIG. 6  supported on the mounting fixture in an open position; 
           [0030]      FIG. 10  is a cross-sectional view taken along line  10 - 10  of  FIG. 9 , illustrating the manner in which the mounting structures on the lug engage the suture clip; 
           [0031]      FIG. 11  illustrates the advancement of the clip applicator to the site of an incision in the wall of a blood vessel, with the suture to which the clip is to be applied threaded through the clip and a slot in the distal end of the applicator; 
           [0032]      FIG. 12  illustrates the movement of the safety lock-out mechanism from a locked position to an unlocked position so the clip applicator may be fired; 
           [0033]      FIG. 13  illustrates the distal advancement of the inner body section relative to the outer body section to effectuate the dislodgment of the clip from the mounting fixture at the distal end of the applicator; 
           [0034]      FIG. 14  illustrates the manner in which the pusher finger at the distal end of the inner body section dislodges or ejects the clip from the mounting fixture at the distal end of the outer body section, as the cutting blade simultaneously severs the suture; and 
           [0035]      FIG. 15  illustrates the withdrawal of the clip applicator from the site of the incision after the clip has been dislodged from the mounting fixture and the suture has been cut at a location proximal to the clip. 
       
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0036]    Referring now to the drawings wherein like reference numerals identify similar structural elements of the apparatus disclosed herein, there is illustrated in  FIG. 1  a suture clip applicator constructed in accordance with a preferred embodiment of the subject invention and designated generally by reference numeral  100 . In the specification that follows the term “distal” shall refer to the end of the applicator that is nearest to the surgical site, while the term “proximal” shall refer to the end of the applicator that is farthest from the surgical site. 
         [0037]    Referring to  FIGS. 1 and 2 , clip applicator  100  is adapted and configured to apply or otherwise secure a deformable suture clip  102  to a suture at a desired location, to secure the suture in place and ensure effective wound closure. It is envisioned that the clip applicator  100  of the subject invention may be employed in conjunction with a percutaneous procedure, for example, to secure a suture used to close an opening in a blood vessel, or it may be employed in conjunction with a conventional open surgical procedure, for example, to secure a suture used to close an incision or wound in body tissue. 
         [0038]    With continuing reference to  FIGS. 1 and 2 , clip applicator  100  includes an outer tubular body section  106 , which has an outer diameter of about between 5 mm to 10 mm or more, depending upon the application in which the device is employed. The outer body section  106  is adapted and configured to slideably receive and accommodate an inner tubular body section  108  of lesser outer diameter. A mounting fixture or lug  110  mounts on the truncated distal end portion  112  of the outer body section  106  for releasably retaining or otherwise supporting the novel deformable suture clip  102  of the subject invention. In operation, the inner body section  108  is adapted and configured for translation within the outer body section  106  to dislodge the clip  102  from the mounting fixture or lug  110 . A safety lockout mechanism  114 , which will be discussed in greater detail below, is operatively associated with the proximal end portion of clip applicator  100  to prevent the applicator from being fired until such action is desired. In use, this lockout mechanism prevents the undesired relative movement of the inner and outer body sections, so that the clip cannot be dislodged from the lug. 
         [0039]    Referring now to  FIG. 3 , the outer body section  106  of clip applicator  100  has an elongated tubular housing  118  with a truncated distal end portion  112 , as mentioned above. A mounting fixture or lug  110  is disposed at the distal end portion  112  of the housing  118 . The lug  110  may be integrally formed or molded with the housing  118 , or it may be glued and/or press fit thereto as would be appreciated by those of ordinary skill in the art. Preferably, the lug  110  is angled with respect to the longitudinal axis formed by the housing  118 , to ensure proper alignment and placement of the clip relative to a blood vessel during a percutaneous procedure in which the instrument is typically oriented at an angle to the blood vessel. 
         [0040]    Referring to  FIG. 5 , the mounting fixture or lug  110  is generally oval-shaped in order to complimentarily engage the truncated distal end portion  112  of the tubular housing  118 . The lug  110  defines a central slot  120  for allowing a surgeon to thread the suture  104  into the housing  118  and out of a passage or slot  122  defined in the side wall of housing  118  (see  FIG. 1 ). The lug  110  has a distally projecting clamp block  124  provided thereon, adjacent to the central slot  120  for retaining or otherwise supporting the suture clip  102  in an open position. The clamp block may be formed integral with the lug or joined thereto in a conventional manner. The lug  110  further includes three integrally formed stop blocks or tabs  126   a - 126   c  that engage the clip  102  in predefined locations to align or otherwise maintain the clip  102  in a desired orientation on the lug  110 . The lug  110  also defines an opening or aperture  128  for allowing an elongated pusher finger  130  extending distally from the end of the inner body section  108  to access the suture clip  102 , and effectuate the dislodgement or ejection of the clip  102  from the lug  110  upon firing the applicator. 
         [0041]    Referring again to  FIG. 3 , the inner body section  108  includes an elongated tubular body  132 , which is slideably accommodated within the tubular bore of outer body section  106 . The elongated pusher finger  130  extends from a distal end portion of tubular body  132  and is dimensioned and positioned to pass through the opening  128  in lug  110  to eject the suture clip  102  from the distal end of applicator  100 . The distal end of tubular body  132  defines a cutting edge or knife blade  134  for severing or cutting the suture  104  disposed in passage  122  of the housing  118 , as the clip  102  is dislodged from the lug  110 . It is envisioned that the cutting edge or knife blade  134  may be formed integrally with the end of the tubular body  132  or joined thereto in a conventional manner. If the blade  134  is joined to the body  132 , it may be formed from a material that is dissimilar to the tubular body  132 . 
         [0042]    With continuing reference to  FIG. 3 , an end cap  136  is mounted or otherwise disposed at the proximal end portion of tubular body  132 . The end cap  136  has an enlarged outer diameter, relative to the outer body section  106 , and thus serves to limit the depth of movement of the tubular body  132  within the housing  118 . End cap  136  also supports the safety lockout mechanism  114 . The L-shaped lockout mechanism or locking bracket  114  is slideably mounted within a channel  140  formed in end cap  136 . The mechanism  114  includes an upper gripping surface  138 . A detent or button  147  is formed on the lower surface of the mechanism  114 , as best seen in  FIG. 12 . The detent  147  cooperates with a recess  145  formed within the bottom surface of channel  140  to positively retain the mechanism  114  in a locked position. In a locked or engaged position, the lockout mechanism  114  prevents actuation of the clip applicator  100 . This locked position is best seen in  FIG. 2 . In a disengaged or unlocked position, the lockout mechanism  114  allows actuation of the clip applicator  100 , as best seen in  FIG. 12 . 
         [0043]    Referring now to  FIG. 4 , the housing  118  of outer body section defines an elongated slot or aperture  142  for receiving a locking projection  144  that extends radially outwardly from the tubular body  132  of inner body section  108 . The cooperative engagement of these structures serves to prevent axial rotation of the inner body section  108  with respect to the outer body section  106 . By maintaining the orientation of the inner and outer body sections, the pusher finger  130  remains aligned with the opening  128  in lug  110 . Preferably, locking projection  144  is integrally formed with tubular housing  118 . Alternatively, the locking projection  144  may be a distinct structure that is selectively mounted to the tubular body  132  after its insertion within the housing  118 . 
         [0044]    It is envisioned that the components of clip applicator  100  may be formed from a high strength thermoplastic material, such as, for example, LEXAN®. In such a case, the clip applicator can be treated as a disposable instrument and discarded after use. Alternatively, the clip applicator of the subject invention may be constructed from stainless steel or a similar surgical grade material that may be sterilized in an autoclave after use. 
         [0045]    Turning now to  FIGS. 6 through 8 , the deformable suture clip  102  of the subject invention is adapted and configured for movement between a normally closed non-deformed position (shown in  FIG. 6 ) and a deformed or flexed open position (shown in  FIGS. 7 and 8 ). In the open or flexed position, a suture  104  can freely pass through the suture clip  102 , as shown for example in  FIG. 1 . However, in the normally closed position, the suture clip  102  securely clamps the suture  104 , as shown for example in  FIG. 15 . Preferably, the suture clip  102  of the subject invention is fabricated from a metallic material, such as, for example, a spring metal, a shape memory alloy or the like. It is envisioned however, and well within the scope of the subject disclosure, that the clip may be formed from a resilient plastic material that can be flexed or bent without plastically deforming. 
         [0046]    The suture clip  102  is generally rectangular or box-like in configuration and includes opposing proximal and distal surfaces or portions  150  and  152 , respectively. Sidewalls  154  extend between the proximal surface  150  and the distal surface  152  to form a channel  156  through the suture clip  102 . The proximal surface  150  has a pair of closely space panels  159  that form a seam or opening  158  therebetween to accommodate a suture. The seam  158  allows the suture clip  102  to spread open, as denoted by directional arrows “a”. In the open position, a suture  104  can pass through the seam  158  and the clip can be mounted on the block  124  of lug  110 . Each panel  159  forms an end surface  161  that abuts the corresponding end surface on the opposing panel  159 . In the closed position of  FIG. 6 , the abutting surfaces  161  securely clamp suture  104  therebetween. It is envisioned that the abutting surfaces  161  can be textured or include a coating to enhance the gripping action on the suture. 
         [0047]    The distal surface portion  152  of clip  102  forms a notch or groove  160  that substantially aligns with the central slot  120  of the lug  110  when the clip is mounted thereon. The notch  160  allows a surgeon to pass the ends of suture  104  through the notch  160  and central slot  120  when the suture clip  102  is loaded on the clip applicator  100 . The distal surface portion  152  of the clip defines the portion of the clip that undergoes the majority of the deformation when the clip is moved to an open position. This portion of the clip may have a reduced thickness relative to the remainder of the clip or it may be formed at least in part from a material that is different from the remainder of the clip. 
         [0048]    To load the suture clip  102  on the mounting fixture or lug  110  at the distal end of the clip applicator  100 , the suture clip  102  is deformed to open the seam  158 . The clamp block  124  is positioned between the seam  158  and the three stops  126  provide banking surfaces to properly position or align the suture clip  102  on the lug  110 . At such a time, the abutting surfaces on the panels of the proximal surface portion of the clip are compressed against and otherwise intimately engaged with the clamp block  124 . It is envisioned that the suture clip  102  may be loaded onto lug  110  by the surgeon at the time of the procedure, or the clip may be preloaded by the manufacture. 
         [0049]    Referring to  FIGS. 9 and 10 , the suture clip  102  is shown properly mounted or otherwise releasably maintained on the mounting fixture or lug  110  of clip applicator  100 . In this instance, the suture clip  102  is positioned between the three stops  126  to align the seam  158  with the slot  120  in lug  110 . The clamp block  124  securely retains the seam  158  in an open position at this time, and the proximal surface portion  150  of the suture clip  102  is located adjacent to the distal surface of lug  110 . The notch  160  in the distal surface  152  of the suture clip  102  is also aligned with the central slot  120  of the lug  110  at this time, so that the surgeon can readily thread the ends of the suture  104  through the notch  160 , the open seam  158  and central slot  120  of the lug. The ends of the suture  104  pass out of the clip applicator  100  through the passage  122  formed in the side wall of housing  118 . When a clip applicator  100  has a suture clip  102  so positioned, the clip applicator  100  is loaded and ready to be fired. 
         [0050]    Referring now to  FIG. 11 , in use the clip applicator  100  is initially advanced to the site of an incision in the wall of a blood vessel  170 , with the suture  104  to which the clip  102  is to be applied threaded through the clip and the slot  122  in the distal end of the applicator. At such a time, there is slack left in the suture. Then the safety lock-out mechanism  114  is moved or slide by the surgeon from the locked position (see  FIG. 11 ) to the un-locked position, in the direction of indicator arrow “b” in  FIG. 12 . 
         [0051]    Thereafter, the suture  104  is pulled tight by the surgeon from a remote location to take up any slack. At such a time, the applicator is fired. This is done by effectuating the distal advancement of the inner body section  108  into the outer body section  106  in the direction of indicator arrow “c” in  FIG. 13 . Upon firing, the pusher finger  130  at the distal end of the inner body section  108  dislodges or ejects the clip  102  from the mounting fixture  110  at the distal end of the outer body section  106 . Shortly thereafter, the cutting blade  134  severs the suture  104  proximal to the suture clip  102 . Then, as shown in  FIG. 15 , the clip applicator  100  is withdrawn from the site of the incision  170 . 
         [0052]    After a period time in which the suture  104  and suture clip  102  have performed their usefulness, e.g., hemostasis occurs, the suture clip  102  and suture  104  may be removed by deforming the suture clip  102  to the open position. After removing the suture clip  102 , the suture  104  may be removed for the suture location  170  or, if dissolvable, left in place. 
         [0053]    While the subject invention has been described with respect to preferred embodiments, those skilled in the art will readily appreciate that various changes and/or modifications can be made to the invention without departing from the spirit or scope of the invention as defined by the appended claims.