Abstract:
A medical clip dispenser apparatus for the pinching of a medical clip or staple about a portion of a mammalian body tissue. The apparatus comprises an elongated support beam having a distal end with a stationary lower housing thereon, and a distally movable hollow cinch slidably disposed on the lower housing. The cinch has a portion of a pair of closable jaws squeezably arranged therewithin. An elongated pusher has a generally cross-shaped pusher member on a distal end thereof in slidable engagement with the jaws, to keep the jaws apart from one another after a new clip has been pushed into position between the jaws.

Description:
This invention is a divisional application of U.S. Patent application No. 10/085,737, filed on Feb. 28, 2002 (now U.S. Pat. No. 6,840,945), which is a continuation in part of U.S. Patent application No.09/795,808 (now U.S. Pat. No. 6,620,184), filed Feb. 28, 2001 and U.S. patent application No. 09/934,378 (now U.S. Pat. No. 6,569,171), filed on Aug. 21, 2001, the contents of which are expressly incorporated by reference herein in their entirety. 

   BACKGROUND OF THE INVENTION 
   1. Field of the Invention 
   This invention relates to medical clip devices and more particularly to guidance and alignment arrangements on the tip of those medical clip devices. 
   2. Prior Art 
   Medical clip devices are utilized to pinch and shut off a body tissue. The clip device usually comprises an elongated support arm having a distal end comprising a pair of squeezable jaws. Medical clip devices are shown in U.S. Pat. Nos. 6,277,131 to Kalikow, and 6,306,149 to Meade, each of which are also incorporated herein by reference. Typically a staple or squeezable wire is pushed tightly between those jaws once the jaws and “still open” staple has surrounded a body tissue to be pinched/shut off. A problem arises occasionally wherein the staple or clip may slip from those jaws as those jaws are unintentionally manipulated and the staple gets lost at the body treatment site. 
   It is an object of the present invention to provide improvement over prior art medical clip applying devices. 
   It is a further object of the present invention to provide a medical clip device which minimizes any problems associated with clip misalignment with respect to the jaws or with a possible loss of a clip by a mis-firing occurring within that clip device. 
   BRIEF SUMMARY OF THE INVENTION 
   The present invention relates to an improvement of the jaw mechanism of a medical clip-applying device. Such a medical clip applying device comprises an elongated beam having a proximal end and a distal end. A pistol-like handle is arranged at the proximal end, with a trigger mechanism arranged with an elongated coupling connected to the jaws so as to permit the jaws to be squeezed together as the attending physician pulls on the trigger. The jaws are biased into the spread-apart or open position and have to be squeezed together for them to pinch a clip or staple, as will be described hereinbelow. 
   A pusher mechanism is arranged with the handle, the pusher having a distalmost end, which sequentially pushes clips into a position between the jaws before the jaws are squeezed together at the distalmost end of the medical clip device. The distalmost end of the pusher in this invention has a generally cross-shaped member, having a pair of wings thereon. The elongated cross-shaped portion has a pair of opposed upstanding rails on the distalmost end of the crossed-shaped member. 
   The upstanding rails each have a proximal sloping edge which permits the cross-shaped member to be cammed downwardly and out of the way of the clip supply when the cross-shaped member is retracted proximally as it moves, in order to engage a successive medical clip or staple to be squeezed between the jaws. The upstanding members each have a distalmost edge which engages the proximal end or bridging portion of the U-shaped clip or staple as it is pushed into the receiving tracks of the opposed jaws on the distal end of the medical clip device. 
   The jaws are movably supported between an upper housing half, called a “cinch”, and a stationary lower housing half called a “brace. The jaws each have an upstanding “limiting” pin on each leg thereof. Each pin is arranged to slide within a respective track disposed on an inner surface wall of the cinch, and each pin may be lodged into a pocket at the distal end of each track to limit or prevent inadvertent closure of the jaws at that point. The jaw pins, when slid into the pockets in the cinch thus prevent the jaws from accidentally closing or pinching a clip or staple between those jaws and force the jaws open before the clip goes between the jaws. The wings on the elongated cross-shaped push member fit into the same track in the jaws as do the generally U-shaped clips do as they are being pushed distally or forwardly and prevent the jaws from partially closing to otherwise partially squeeze a staple or clip and thus have the clip fall accidently into a patient. The outer edges of the wings slide between the jaws as they biasedly spread apart or open so as to enable it to receive the fully spread open generally U-shaped clip as it is being pushed therebetween. This opening of the jaws and distal motion by the outermost ends of the wings of the cross-shaped member occurs as the jaws are being permitted to reopen to accept a new, open U-shaped clip member, ready for a further clip actuation on body tissue. Those wings on the cross-shaped member and the pins on the jaws engaged in the pockets of the cinch work simultaneously to provide the locking open of the jaws for proper receipt of the U-shaped clip therebetween and for proper opposed alignment of the jaws. 
   The jaws are pushed to their squeezed-closed position by an arrangement of cam surfaces each rubbing against a surface of each leg of the jaws, the generally U-shaped (in cross section) cinch being pushed distally on the distal end of a “closing” pushrod. The pushrod is connected to the trigger mechanism in the proximal or handle end of the medical clip device. 
   The distalmost finger of the elongated spring is in rubbing, biased engagement with the underside of the generally cross-shaped pusher member. The biased spring thus also keeps the elongated cross-shaped pusher member in contact with the shoulders or ledges on the inner edges of each respective jaw and keeps the pusher member behind the clip during loading thereof so as to prevent slipping and misfiring of that clip. By maintaining a biased pressure against the jaws in that manner, the jaws are prevented from crossing or misaligning with one another when those jaws are being squeezed together and closing in on a U-shaped clip therebetween. The jaws are thus accurately “opposed” with respect to one another, because of their receipt of a biased pusher and alignment cross arranged therebetween. 
   The invention thus comprises a medical clip dispenser apparatus for the pinching of a medical clip or staple about a portion of a mammalian body tissue, the apparatus comprising an elongated support beam having a distal end with a stationary lower housing thereon; a distally movable hollow cinch slidably disposed on the lower housing, the cinch having a portion of a pair of closable jaws squeezably arranged the therewithin; and an elongated push rod having a generally cross-shaped pusher member on a distal end thereof in slidable engagement with the jaws, to keep the jaws open and in alignment with one another and to concurrently push a new clip into position between the jaws. 
   Each of the jaws may have an inner edge with a shoulder extending therealong, for guided receipt of a clip and for stabilizing receipt of the cross-shaped pusher member. The cross-shaped member includes a pair of wing members extending therefrom, each of the wing members mating with the shoulder to keep the jaws spread apart after a clip has been fed therebetween. The cross-shaped member includes a pair of wings laterally disposed thereon, so as to slidably engage the shoulders in the jaws to keep the jaws open when the cross-shaped member is pushed distally, behind the clip when it is loaded, and to thus prevent the jaws from being inadvertently closed on a staple or clip therebetween. 
   Each of the wings may have an upstanding rail thereon, each of the rails having a distal edge arranged to push distally a new clip in a clip track during distal advancement of the cross-shaped member. Each of the rails may have a sloped proximal edge to permit the rails to be cammed downwardly and out of the way of the clip track during proximal movement of the cross-shaped member. 
   Each of the wings may have an outer edge thereon for respective engagement with each of the jaws during opening of the jaws during distal motion of the cross-shaped member with respect to the lower housing. Each of the jaws has an upstanding pin thereon for sliding engagement into a pocket in the cinch to prevent accidental closing of the jaws. 
   The lower housing or brace comprises the lower side of the stationary support. A spring, which is an elongated member having a distalmost end, is shaped upwardly and arranged to provide a biased finger on the lowermost side of the generally cross-shaped pusher member to keep it aligned and against the bridging portions of the staples or clips. The spring has a proximal end which is bifurcated into two parallel legs. The legs are formed into a generally U-shaped configuration in a longitudinal direction. The elongated arm of the clip pusher rod runs snugly between the bifurcated legs of the spring and is kept in longitudinal alignment thereby. 
   The medical clip dispenser may include the elongated biasing spring secured in the lower housing, the elongated biasing spring having a distal end which is in rubbing engagement with a lower side of the cross-shaped member so as to keep the cross-shaped member in a line behind the clip in the jaws. The elongated biasing spring may have a bifurcated proximal end, the bifurcated proximal end arranged to straddle the elongated pusher rod for alignment of the pusher rod and the cross-shaped member with respect to the spring. 
   The invention may also comprise a method for dispensing a medical clip onto a mammalian body tissue comprising: arranging a pair of closable jaws to be supported between a stationary lower housing and a movable upper housing of an elongated medical clip dispensing device; moving a pusher member between the jaws to slide between the jaws as they spread apart from one another and to concurrently push an open clip into position between the jaws in tracks or shoulders in the jaws; biasing the pusher member into said tracks in the jaws to keep the jaws in alignment by an elongated biasing spring on a lower side of the pusher member; and closing the jaws together by a distally advancing cinch to squeeze the jaws together and crimp the clip between the jaws onto a body tissue as the pusher member is withdrawn proximally from a position between said jaws. The cinch has a pair of cam track arrangements each of which includes the pocket for slidable capture and release of a pin therefrom to permit the jaws to be temporarily locked in the open position. 
   The method may include arranging an outer edge of each wing on the distal end of the pusher member into engagement with the jaws to facilitate the keeping open of the jaws after distal movement of the clip pusher member between the jaws, and after pushing a clip into position between the jaws by engagement of a pair of upstanding rails in the pusher member with a bridging portion of the clip. 
   The method may also include pushing a clip into position between the jaws by engagement of a pair of upstanding rails on the distal end of the pusher member against a bridging portion of the clip; arranging a pin on an intermediate portion of each of the jaws; arranging a pair of cam tracks in an inner surface of the cinch for slidable engagement with the pins on the jaws; biasedly locking open the jaws by cammed motion and receipt of the pins in a pocket arrangement in a distal end of the cam tracks in the inner surface of the cinch; arranging an elongated biasing spring in the brace of the lower housing, the biasing spring having a bifurcated proximal end and an upwardly directed distal end; and aligning the bifurcated end about the pusher member to maintain the pusher member in alignment with respect to the jaws; biasing the distal end of the biasing spring so as to keep the upstanding rails against the bridging portion of the clips during delivery thereof to the jaws; and engaging the pins in the cam track in the cinch to limit distal advance and proximal motion of the cinch with respect to the lower brace. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The objects and advantages of the present invention will become more apparent when viewed in conjunction with the following drawings in which: 
       FIG. 1  is a perspective view of the distal end of the medical clip device of the present invention; 
       FIG. 2  is a side elevational view, in longitudinal central section of the clip device shown in  FIG. 1 ; 
       FIG. 3   a  is a plan view of the medical clip device shown in  FIG. 1 ; 
       FIG. 3   b  is a side elevational view of the device shown in  FIG. 3   a;    
       FIG. 3   c  is a bottom view of the clip device shown in  FIG. 3   a;    
       FIG. 4  is a view taken along the lines  4 - 4  of  FIG. 3   b;    
       FIG. 5   a  is a sectional view taken along the lines  5   a - 5   a  of  FIG. 3   b;    
       FIG. 5   b  is a view taken along the lines  5   b - 5   b  of  FIG. 5   a;    
       FIG. 5   c  is a perspective view of the cinch shown in  FIG. 5   a;    
       FIG. 5   d  is a plan view of the cinch and jaws/pins in a jaw closed position; 
       FIG. 6  is a perspective view of a spring bias member of the present invention; and 
       FIG. 7  is a perspective view of the bottom of the clip device shown in  FIG. 1 . 
   

   DESCRIPTION OF THE PREFERRED EMBODIMENTS 
   Referring now to the drawings and particularly to  FIG. 1 , there is shown the present invention which comprises a medical clip applying device  10  comprises an elongated beam  12  having a proximal end (not shown here for clarity) and a distal end  14  fixedly secured to a stationary lower housing or brace  15 . A pistol-like handle (not shown) is arranged at the proximal end, with a trigger mechanism arranged with an elongated coupling connected to a pair of jaws  16  and  18  so as to permit the jaws  16  and  18  to be squeezed together as the attending physician pulls on the trigger. 
   A pusher mechanism is arranged with the handle (not shown for clarity), the pusher  20 , as may be seen in  FIGS. 2 ,  3   b ,  3   c ,  4  and  7 , has a distalmost end, which sequentially pushes staples or clips  22 , as shown in phantom in  FIG. 1 , into a position between the jaws  16  and  18  before the jaws  16  and  18  are squeezed together at the distalmost end of the medical clip device  10 . The distalmost end of the pusher  20  in this invention has a generally cross-shaped member  24 , having a pair of wings  26  thereon, as may be seen in  FIGS. 1 ,  3   a  and  3   c . The elongated cross-shaped member  24  has a pair of opposed upstanding rails  28  and. 30 , on the distalmost end of the crossed-shaped member  24 , as may be seen in  FIGS. 1 ,  2 ,  3   a  and  3   c.    
   The upstanding rails  28  and  30  each have a proximal sloping edge  32  which permits the cross shaped member  24  to be cammed downwardly and out of the way of the clip supply when the cross-shaped member  24  is retracted proximally as it moves, in order to engage a successive medical clip or staple  22  to be sequentially squeezed between the jaws  16  and  18 . The upstanding rails  28  and  30  each have a distalmost edge  34 , as best shown in  FIG. 2 , which edge  34  engages the proximal or “bridging” end of the U-shaped clip or staple  22  as it is pushed into an arrangement of receiving tracks  36  of the opposed jaws  16  and  18  on the distal end of the medical clip device  10 . 
   The jaws  16  and  18  are movably supported between an upper housing half, called a “cinch”  42 , and a stationary lower housing half called a “brace”  15 . The jaws  16  and  18  each have an upstanding “limiting” pin  40  on each leg thereof, as may be seen in  FIGS. 2 ,  5   a ,  5   b  and  5   d . Each pin  40  is arranged to slide along a respective cam track  41  disposed on an inner surface wall  43  of the cinch  42 . Each pin  40  may reside at least partially in a “pocket”  45  at the distal end of each cam track  41  to limit or prevent inadvertent closure of the jaws  16  and  18  when they are disposed at that point (the cinch  42  fully retracted proximally), with the jaws  16  and  18  fully spread apart. The jaw pins  40 , when slid into and mate with the pockets  45  in the distal end of the track  41  in the cinch  42  thus prevent the jaws  16  and  18  from accidentally closing or pinching a clip or staple  22  between those jaws  16  and  18 . The pins  40  slide along the track  41  as the cinch  42  is moved proximally and distally. The pins  40  move toward and apart from one another correspondingly, as the jaws  16  and  18  move toward and apart from one another. The cinch  42  has a pair of cam surfaces  57  and  59 , which slidingly receive an outer edge  61  and  63 , as may be seen in  FIGS. 5   a  and  5   d . As the cinch  42  is caused to move distally, the jaws are pinched together by the effect of the cam surfaces  59  and  57  on the cinch  42  acting on the side edges  61  and  63  of the jaws  18  and  16 . The relative position of the cinch  42  with the jaws  16  and  18  closed, and its pins  40  in a rearward or proximal position is shown in  FIG. 5   d . The jaws  16  and  18  being open and the pins  40  in the distal pockets  45 , is represented in  FIG. 5   a . The cinch  42  is always proximally disposed relative to the jaws  16  and  18  before the staples or clips  22  are advanced into the tracks  36  in the jaws  16  and  18 . The cinch  42  is shown more clearly in  FIG. 5   c , with a pair of locking rails  49 , as also shown in  FIG. 4 . The rails  49  each slidably engage a shoulder  51  on the upper side of the brace S  1 , as shown in  FIG. 4 . This securement arrangement permits the cinch  42  to be lockably engaged with the brace  15  and secure the jaws  16  and  18 , the pusher  20  and like components in a secure manner as the cinch  42  is slid relative to the brace  15  for squeezedly closing and permitting the biased self opening of the jaws  16  and  18 . The jaws  16  and  18  are locked into their “open” position when the pins  40  on those jaws  16  and  18  are engaged into the pockets  45  of the tracks  41  of the cinch  42 . 
   The wings  26  on the elongated cross-shaped push member  24  also fit into the same track  36  in the jaws  16  and  18  as do the generally U-shaped clips  22  (the wings  26  entering the track  36  after the staples or clips  22  are pushed therein) do as they are being pushed distally or forwardly and prevent the jaws  16  and  18  from partially closing to undesirably squeeze a staple  22  which might fall into a patient. The jaws  16  and  18  close only after proximal withdrawal of the cross-shaped push member  24  from between the jaws  16  and  18 , and distal advance of the cinch  42 . This movement or the cinch  42  proximally permits the jaws  16  and  18  to be “un-pinched” and allows their self-opening by the proximally moving cinch  42 , so as to allow the jaws  16  and  18  to accept a new, open U-shaped clip member  22 , ready for a further clip actuation on a body tissue “T”. The wings  26  withdraw from the tracks  36  in the jaws  16  and  18  to allow closure of the jaws  16  and  18  on the clip  22  pushed therebetween. 
   The jaws  16  and  18  are thus pushed to their “squeezed-closed” position by the distally directed motion of the generally U-shaped cinch  42  on the distal end of a “closing” pushrod  47 , as shown in  FIGS. 1 ,  2 ,  3   a ,  3   b  and  5   a . The closing pushrod  47  has a proximal end (not shown for clarity) which is connected to the trigger mechanism in the proximal or handle end of the medical clip device  10 , which when actuated, effects the proper distal (and subsequent proximal) motion of that pushrod  47 . 
   The lower housing or brace  15  which is disposed in an opposed relationship to the cinch  42 , comprises the lower side of the stationary beam  12  or support channel, as may be seen in  FIGS. 1 ,  2 ,  3   b ,  3   c ,  4  and  7 . The spring  50 , shown in a separate perspective view in  FIG. 6 , is an elongated member, has a distalmost end  52  which is shaped upwardly, as seen in  FIG. 2 , to provide a biased finger on the lowermost side of the generally cross-shaped pusher member  24 , again as best seen in  FIG. 2 . The distal end  52  of the spring  50  keeps the pusher  20  right behind the clip  22  and at the proper level therewith, so that the upstanding rails  28  and  30  on the distalmost end of the cross-shaped member  26  does not slip below the bridging portion of the clip  22 , which otherwise would lead to possible misfiring or jamming of the clip  22  without binding to tissue “T” and possible loss of the clip  22  in the patient. 
   The spring  50  has a proximal end  54  which is bifurcated into two parallel legs  56  and  58 , which are formed into a generally U-shaped configuration in a longitudinal direction. The legs  56  and  58  each have an inner edge  65  between which the pusher member  20  is slidably guided, as may be seen in  FIGS. 2 ,  3   c ,  6  and  7 . The elongated arm of the clip pusher  20  extends between the bifurcated legs  56  and  58  of the spring  50 , as may be best seen however in  FIGS. 3   c  and  7 , to center the pusher  20  and keep it in proper alignment. 
   The distalmost finger  52  of the elongated spring  50  adjacent the brace  15 , as may be seen in  FIG. 2 , is in rubbing, biased engagement with the underside of the generally cross-shaped pusher member  20 . The biased spring  50  keeps the elongated cross-shaped pusher member  20  in line with the back or bridging portion of the clip  22 , The jaws  16  and  18  are prevented from crossing or misaligning with respect to one another when those jaws  16  and  18  are being squeezed together by the distally directed camming force of the cinch  42  and closing in on a U-shaped clip  22  therebetween. The jaws  16  and  18  are also accurately “opposed” with respect to one another, because of their ultimate relationship with the alignment of the cross-shaped member  24  biased by the spring  50  arranged thereadjacent.