Abstract:
A clip apparatus for ligature of living tissue is provided. The clip apparatus includes a clip that can be opened and closed multiple times prior to locking in a closed position on the tissue.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit under 35 U.S.C. 119(e) of U.S. Provisional Patent Application No. 61/559,374, filed on Nov. 14, 2011, the disclosure of which is incorporated by reference herein. 
    
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     N/A 
     BACKGROUND OF THE INVENTION 
     Medical doctors are able to perform various procedures within a patient&#39;s gastrointestinal (GI) tract using a flexible endoscopic device. Bleeding from blood vessels or perforations of the GI tract can occur. Sometimes, such occurrences constitute a medical emergency, in which bleeding must be stopped rapidly. Endoscopic clips usable with a flexible endoscopic device are known for clamping blood vessels or a section of tissue to stop bleeding or close perforations. 
     SUMMARY OF THE INVENTION 
     A clip apparatus for ligature of living tissue is provided that can be opened and closed multiple times before being clamped on the section of tissue. The ability to open and close a clip multiple times provides a user with more flexibility in placing a clip. The clip can be closed over a section of tissue, and the area can be washed off. The user can then see whether placement of the clip should be adjusted. If necessary, the user can open the clip and reclose it in a different position. Once the user determines that the clip has been suitably placed, the clip apparatus can be actuated to leave the locked clip in place in the body. 
    
    
     
       DESCRIPTION OF THE DRAWINGS 
       The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings. The drawings illustrate a variety of embodiments and features of the clip apparatus. 
         FIG. 1  is a schematic illustration of an embodiment of a clip apparatus for the ligature of living tissue in a closed position; 
         FIG. 2  is a schematic illustration of the clip apparatus in an open position; 
         FIG. 3  is a schematic illustration of the clip apparatus in a deployed position; 
         FIG. 4  is a cross sectional view of the clip apparatus also illustrating a handle operation unit; 
         FIG. 5  is a cross sectional view of the clip apparatus within an outer sheath; 
         FIG. 6  is a cross sectional view of the clip apparatus with the clip unit in an open position; 
         FIG. 7  is a cross sectional view of the clip apparatus with the clip unit in an closed position; 
         FIG. 8A  is a cross sectional view of the clip apparatus n an open position; 
         FIG. 8B  is a cross sectional view along the line A-A of  FIG. 8A ; 
         FIG. 9A  is a cross sectional view of the clip apparatus beginning to grasp tissue; 
         FIG. 9B  is a cross sectional view along line A-A of  FIG. 9A ; 
         FIG. 10A  is a cross sectional view of the clip apparatus with the clip unit closing to grasp tissue; 
         FIG. 10B  is a cross sectional view along line A-A of  FIG. 10B ; 
         FIG. 11A  is a cross sectional view of the clip apparatus with the clip unit closed to grasp tissue; 
         FIG. 11B  is a cross sectional view along line A-A of  FIG. 11A ; 
         FIG. 12A  is a cross sectional view of the clip apparatus with the clip unit deployed; 
         FIG. 12B  is a cross sectional view along line A-A of  FIG. 12B ; 
         FIG. 13  is an isometric view of a clip unit of the clip apparatus of  FIGS. 4-12B ; 
         FIG. 14  is a cross-sectional view of the clip unit of  FIG. 13 ; 
         FIG. 15A  is an isometric view of the coupling ring; 
         FIG. 15B  is a cross sectional view of the coupling ring of  FIG. 15A ; 
         FIG. 16  is an exploded isometric view illustrating an introducing mechanism, coupling mechanism, and release mechanism of the embodiment of  FIGS. 4-12B ; 
         FIG. 17  is a partial cross sectional view of the introducing mechanism, coupling mechanism, and release mechanism of  FIGS. 4-12B ; 
         FIG. 18  is an isometric view of the spring clip of  FIGS. 4-12B ; 
         FIG. 19A  is an isometric view of the spacer member of the clip unit; 
         FIG. 19B  is a cross sectional view of the spacer member and tightening ring; 
         FIG. 20A  is an isometric, partially exploded view of a further embodiment of a spacer member and tightening ring; 
         FIG. 20B  is a cross sectional view of  FIG. 20A  in an assembled condition; 
         FIG. 21  is an isometric view of a still further embodiment of a clip unit; 
         FIG. 22  is an isometric view of a still further embodiment of a clip unit; 
         FIG. 23  is a cross sectional view of a further embodiment of a clip unit; 
         FIG. 24  is a cross sectional view of a still further embodiment of a clip unit; 
         FIG. 25  is a cross sectional view of a further embodiment of a tightening ring; 
         FIG. 26  is a cross sectional view of a further embodiment of a coupling ring; 
         FIG. 27A  is an isometric view of a further embodiment of a coupling ring; 
         FIG. 27B  is a cross sectional view of the coupling ring of  FIG. 27A ; 
         FIG. 28A  is an isometric view of a further embodiment of a coupling ring; 
         FIG. 28B  is a cross sectional view of the coupling ring of  FIG. 28A ; 
         FIG. 29  is an isometric view of a still further embodiment of a coupling ring; 
         FIG. 30  is an isometric view of a control wire and coupling plate; 
         FIG. 30A  is a cross sectional view taken along line A-A of  FIG. 30 ; 
         FIG. 31  is an isometric view of a further embodiment of a control wire and coupling plate; 
         FIG. 31A  is a cross sectional view taken along line A-A of  FIG. 31 ; 
         FIG. 32  is an isometric view of a still further embodiment of a control wire and coupling plate; 
         FIG. 32A  is a cross sectional view taken along line A-A of  FIG. 32 ; 
         FIG. 33  is an isometric view of a further embodiment of a spring clip; 
         FIG. 34  is an isometric view of a further embodiment of a spring clip; 
         FIG. 35  is an isometric view of a further embodiment of a spring clip; 
         FIG. 36  is an isometric view of a still further embodiment of a spring clip; and 
         FIG. 37  is an isometric view of a still further embodiment of a spring clip. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The disclosure of U.S. Provisional Patent Application No. 61/559,374, filed on Nov. 14, 2011, is incorporated by reference herein. 
     One embodiment of a clip apparatus is illustrated in conjunction with  FIGS. 1-4 . The clip apparatus includes a clip unit  100 , which includes a clip  110 , a tightening ring  120  and a spacer member  130 , such as a pin. The clip includes two arms  111  that are biased outwardly, as shown in  FIGS. 2 and 4 . See also  FIGS. 13 and 14 . The arms are joined at a proximal base  112 , which is formed as a U-shaped bend in the embodiment shown. Each of the two arms includes a jaw end  113 ,  117 , formed with a gripping tooth or gripping teeth. The gripping tooth or teeth can be cooperatively shaped to interlock. The clip  110  can be retracted within the tightening ring  120  to force the arms together, thereby allowing the jaw ends to close together for grasping tissue. See  FIGS. 1 and 7 . See also  FIGS. 10A ,  10 B,  11 A, and  11 B. The spacer member  130  extends radially across a distal opening  124  of the tightening ring  120 . The spacer member  130  forces the arms apart as the clip is extended outside of the tightening ring. See  FIGS. 2 and 4 . See also  FIGS. 6 ,  8 A, and  9 A. The arms can also be formed from a springy metal to aid in biasing them open. The opening  124  can also be chamfered on the inside surface. The spacer member can be fastened to the tightening ring in any suitable manner, such as, without limitation, by a mechanical mechanism, welding, or adhesive. 
     The clip unit  100  is attached to a coupling mechanism  400 . The coupling mechanism includes a coupling plate  410  having a hook  416  at the distal end. See also  FIGS. 8B ,  9 B, and  10 B. The hook attaches to the proximal base  112  of the clip  110 . The coupling mechanism includes a control wire  420  that is attached to a proximal end  412  of the coupling plate  410 . The control wire is sufficiently stiff so that it can exert tensile and compressive forces via the coupling plate  410  on the clip unit  100  to cause the clip unit to extend or retract. The hook  416  on the coupling plate  410  is bendable or frangible so that it is able to detach from the base  112  of the clip  110  upon exertion of a sufficiently large tensile force via the control wire  420 , described further below, when it is desired to lock the clip closed and leave it in place in the body. See  FIGS. 11A ,  11 B,  12 A,  12 B. 
     The control wire  420  may be formed, for example, from a single wire or a plurality of wires twisted together. Any suitable material, for example, a metal such as stainless steel, may be used for the control wire. The coupling plate  410  may be formed of any suitable material, for example, a metal such as stainless steel. It may be formed from a single material, a composite material, as a single unitary piece, or as a lamination. 
     The control wire  420  extends through an outer sheath  200  to a handle operation unit  500 . See  FIG. 4 . The outer sheath includes a tube  210  that houses and protects the clip unit  100  during insertion and maintains the clip  110  in a closed position as it is passed through an endoscope channel. A handle element  220  may optionally be provided on the tube of the outer sheath, if desired. 
     The control wire  420  also extends through an introducing mechanism  300  including an inner sheath or spring tube  320  coaxially disposed within the outer sheath  200 . See  FIG. 4 . The spring tube  320  is attached at a distal end to a coupling ring  310 . The spring tube is attached at a proximal end to a handle operation unit  500 . Both the outer sheath  200  and the spring tube  320  are flexible so that the device can bend. The spring tube may be formed from any suitable material, for example, from twisted metal plates or twisted metal wire. 
     The handle operation unit  500  includes a handle  510  and a slider  520  mounted for linear reciprocating movement with respect to the handle. See  FIG. 4 . A proximal end of the spring tube  320  is attached to a distal end  515  of the handle operation unit  500 , and a proximal end  430  of the control wire  420  is attached to the slider  520 . The handle includes a thumb ring  511  with a hole  514  sized to receive a user&#39;s thumb. The slider includes finger grips  521  defined by flanges or shoulders  522 ,  523  shaped to receive fingers of a user&#39;s hand. When the user grasps the handle operation unit through the thumb hole  514  and the finger grips  521 , the user can reciprocate the slider  520  linearly along tracks or rails  513  of the handle, which in turn moves the control wire in a distal or proximal direction. In this manner, the user can exert tensile and compressive forces via the coupling plate on the clip unit to cause the clip unit to extend or retract. The handle operation unit  500  can also include a rotatable component (such as the handle  510  or slider  520 ) to rotate the clip unit if necessary. 
     As noted above, the distal end of the spring tube  320  is attached to the coupling ring  310 . The coupling ring is cylindrical and includes a pair of opposed openings  312 . See also  FIGS. 15A ,  15 B. The tightening ring  120  is also cylindrical and includes a proximal section  122  of reduced outer diameter that fits within the inner diameter of a distal section  313  of the coupling ring  310 . See also  FIGS. 16 and 17 . The tightening ring  120  also includes a pair of opposed openings  121  on the proximal section that are alignable with the opposed openings  312  of the coupling ring  310 . 
     A release mechanism  600  includes a spring pin  610  provided to releasably couple the coupling ring  310  and the tightening ring  120  when the openings  312 ,  121  are aligned. The spring pin  610  is generally U-shaped and includes a proximal base  612  and two arms  314 . See  FIG. 18 . The distal tips  611  of each of the arms  614  face outwardly, for example, by bending the tips of the arms. The tips fit within the opposed openings  312 ,  121  of both the tightening ring  120  and the coupling ring  310 . 
     Operation of the clip apparatus can be described with reference to  FIGS. 5-12B . In operation, the clip unit  100 , attached to the introducing mechanism  300 , is inserted through the outer sheath  200  to the general location in the body where the clip  110  is to be deployed. The clip arms  111  are held closed while the clip unit is within the outer sheath. See  FIG. 5 . The clip unit  100  is pushed entirely through the outer sheath until it exits the distal end, whereupon the arms of the clip spring open. See  FIGS. 6 ,  8 A,  8 B. 
     The user than manipulates the control wire  420  via the slider  520  on the handle  510  to move the clip  110  proximally or distally. As the clip reciprocates, it translates linearly with respect to the tightening ring  120 . Pulling the clip in a proximal direction causes the clip to retract within the tightening ring, which forces the spring arms  111  closed. See  FIG. 7 . Pushing the clip in a distal direction causes the clip to extend outside of the tightening ring, allowing the spring arms to open. In this manner, the user can open and close the arms until the clip is satisfactorily positioned. See  FIGS. 9A ,  9 B,  10 A, and  10 B. The user can irrigate the area to get a clear view of where the clip is attached to the tissue. The clip can be reopened and reattached to the tissue as often as necessary. 
     When the clip  110  is satisfactorily positioned on a section of tissue, the user pulls on the control wire  420  with a greater force, which causes the hook  416  on the coupling plate  410  to bend or break and detach from the proximal base  112  of the clip  110 . See  FIGS. 11A ,  11 B. Continued tensile force on the control wire causes the coupling plate to withdraw in a proximal direction. As the coupling plate withdraws further, the proximal end  412  of the coupling plate abuts the proximal base  612  of the spring pin  610 . The spring pin is thereby moved in the proximal direction. As the spring pin moves, the distal tips  611  slip out of the aligned openings  121 ,  312  in the tightening ring  120  and the coupling ring  310 . The tightening ring and the coupling ring thus become uncoupled. See  FIGS. 12A ,  12 B. 
     Continued tensile force on the control wire  420  pulls the coupling plate  410 , the spring pin  610 , and the coupling ring  310  away from the clip unit  110 . The tightening ring  120  remains in place over the clip arms  111 , locking the arms in the closed position over the tissue. The rest of the apparatus can be withdrawn from the body. 
     The clip unit  100  is made from a suitable medical grade material, such as a stainless steel or a shape memory alloy. After a period of time, the clamped tissues dies. The clip unit falls off and passes out of the patient&#39;s body through the GI tract. 
     The outer sheath  200  can be made from a suitable material, such as a polymeric resin or other engineered plastics. Examples include, but are not limited, to polytetrafluoroethylene, polyethylene, polypropylene, polyamide, fluorinated ethylene propylene, polyether block amides such as PEBAX®, or a nylon. 
     The other elements can be made from any suitable material, such as stainless steel. 
     The figures illustrate further embodiments having a variety of features and aspects. It will be appreciated the various features and aspects can be used in any of the various embodiments. 
     In one embodiment, the spacer member  130  is a pin that fits through opposed apertures  126  on the tightening ring  120 . See  FIGS. 19A and 19B . A head  132  on one end of the body  131  of the pin fits within a recess  125  surrounding one of the apertures  126 . The other end of the pin protrudes slightly through the opposed aperture  126 , and during manufacture, a head  133  can be formed on the other end of the pin to retain the pin in place across the distal opening of the tightening ring. 
     Alternative embodiments of a spacer member are illustrated in  FIGS. 20A ,  20 B,  21 , and  22 . In  FIGS. 20A-B , the spacer member  130   b  is formed of two pin pieces  131   b  that fit through apertures in the tightening ring  120 . The pin pieces include heads  132   b  that fit within recessed sections surrounding the apertures. The pin pieces can be fastened together within the tightening ring in any suitable manner, such as by welding, adhesive, or the like. Alternatively, the heads of the pin pieces can be fastened to the exterior of the tightening ring in any suitable manner, such as by welding, adhesive, or the like. In  FIG. 21 , the spacer member is formed from a strip  150   c  of metal that fits across the distal opening  124   c  of the tightening ring  120   c . Ends of the strip are bent to fit within opposed recesses formed on the exterior of the tightening ring. The ends can be fastened within the recess in any suitable manner, such as by welding, adhesive, or the like. In  FIG. 22 , two strips  129   b  are formed and fastened within recesses of the tightening ring in any suitable manner, such as by welding, adhesive, or the like. The strips are bent radially inwardly to extend across the opening  124   b.    
     Alternative embodiments of a clip unit are illustrated in  FIGS. 23 and 24 . In  FIG. 23 , the clip  110   c  includes two arms or strips  111   c  that are biased outwardly and are fastened by a member  160   c  at their proximal ends. Member  160   c  includes tabs  161   c  that fit within recesses  115   c  on each arm  111   c . Member  160   c  can be releasably affixed to coupling plate  410  (not shown in  FIG. 23 ) in any suitable manner. The arms or strips  111   c  can be attached at their proximal ends in any other suitable manner. In  FIG. 24 , the clip  110   b  includes two arms  111   b  that are biased outwardly. The arms are joined at a proximal base  112   b  and suitably configured to cross at  115   b.    
     An alternative embodiment of a tightening ring  120   d  is illustrated in  FIG. 25 . The tightening ring includes a proximal section  122   d  having a widened internal diameter to receive a reduced diameter section of a coupling ring (not shown in  FIG. 25 ). The coupling ring may abut a shoulder  129   d  within the tightening ring  120   d . Apertures  121   d  are provided as described above for receiving a release mechanism.  FIG. 26  illustrates a coupling ring  310   d  having a distal section  313   d  with a reduced outer diameter that fits within the inner diameter proximal section  122   d  of the tightening ring  120   d . Apertures  312   d  align with apertures  121   d  for receiving a release mechanism. Further coupling ring configurations are illustrated in  FIGS. 27A and 27B ,  28 A and  28 B, and  29 . 
       FIGS. 30 ,  30 A,  31 ,  31 A,  32 , and  32 A illustrate further embodiments of a control wire and coupling plate. In  FIGS. 30 and 30A , the control wire  420  includes a lengthened wire portion  421  that terminates with a distal wire portion  422  having a widened or oval cross section. The distal portion  422  is attached to the coupling plate  410  in any suitable manner, such as by welding. In  FIGS. 31 and 31A , the control wire  420   b  includes a lengthened wire portion  421   b , having a circular cross section of diameter D, that terminates with a tapered portion  423   b  and a narrowed distal wire portion  422   b , having a circular cross section of diameter d. The narrowed distal wire portion  422   b  is attached to the coupling plate  410  in any suitable manner, such as by welding. In  FIGS. 32 and 32A , the control wire  420   c  has a constant diameter d along its length. A distal portion  420   c  is attached to the coupling plate  410  in any suitable manner, such as by welding. 
     Alternative embodiments of the spring pin are illustrated in  FIGS. 33 ,  34 ,  35 ,  36 , and  37 . In  FIG. 33 , the spring pin  610   b  has a rectangular cross section.  FIGS. 34 and 35  illustrate spring pin  610   d ,  610   h  respectively with a single distal tip  611   d ,  611   h  that faces outwardly.  FIG. 36  illustrates a spring pin  610   e  having a coil spring configuration  612   e  with a distal tip  611   e .  FIG. 37  illustrates a further spring pin  610   f  with distal tip  611   f  and an elongated arm portion  613   f.    
     As set forth above, it will be appreciated that the various features and aspects of the several embodiments can be used interchangeably in embodiments other than the particular embodiment in which a particular feature or aspect is illustrated, as would be apparent to one of skill in the art. The invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.