Surgical staple-clip and applier

Abstract

A surgical staple-clip including a clip component and a securing member is used in a wide range of surgical procedures. The staple-clip may be introduced to a surgical site in an un-assembled condition through a small port or trocar. An applier for the staple-clip comprising a pair of opposed jaw-like channels is provided to position and apply the clip component and the securing member. The clip component is positioned around a target tissue and is compressed or clamped upon the tissue using only the force required for a specific surgical procedure such as occlusion, ligation or fixation. When the clip component is properly applied, the securing member is urged forward and over the clip component to secure the staple-clip. The clip component may include traction enhancement features such as surface interruptions, bumps, valleys and ridges. With the staple-clip of the invention, the force required to constrict or occlude the tissue is separate from the force required to secure and maintain the staple-clip in position and, as a result, the body tissue is not over-compressed and nourishment to the body tissue is maintained. Other aspects of the invention include thumb actuated clip appliers for use in hand assisted laparoscopy (HAL). In one embodiment, a clip applier includes a handle and a thumb actuated mechanism that is used to slidably release clips onto a body tissue or vessel by sliding the thumb actuated mechanism forward and backward using only one hand. In another aspect of the invention, a two-stage clip is disclosed having a clip component and a staple component for securing the clip after it has been properly positioned.

1 . A medical device to constrict or occlude a body tissue or vessel, comprising: 
 a first tissue-engaging member  205  having opposed walls  230 ,  232  and a first connecting wall  234  defining a first elongate channel  236 ;    a second tissue-engaging member  210  opposed to the first tissue-engaging member  205  having opposed walls  240 ,  242  and a second connecting wall  244  defining a second elongate channel  246 ; and    a securing member  220  for securing the first and the second tissue-engaging members  205 ,  210  such that front faces of the first and the second connecting walls  234 ,  244  are opposed to each other.    
   
   
       2 . The medical device of  claim 1 , wherein each of the front faces of the first and the second connecting walls  234 ,  244  includes a plurality of tissue-penetrating elements  238 ,  248 .  
   
   
       3 . The medical device of  claim 1 , wherein the securing member  220  is sized and configured to slide into the first and the second elongate channels  236 ,  246  to securely clamp the first and the second tissue-engaging members  205 ,  210  around the body tissue or vessel with minimal compressive force.  
   
   
       4 . The medical device of  claim 3 , wherein the force required to secure and maintain adequate traction is independent from the force required to constrict or occlude the body tissue or vessel.  
   
   
       5 . The medical device of  claim 4 , wherein only a compressive force needed to perform a specific surgical procedure such as occlusion, ligation or fixation is applied to the body tissue.  
   
   
       6 . The medical device of  claim 5 , wherein tissue necrosis due to over-compression is eliminated.  
   
   
       7 . The medical device of  claim 1 , wherein at least one of the first and the second tissue engaging-members  205 ,  210  includes a plurality of bumps, ridges, slots, and holes.  
   
   
       8 . The medical device of  claim 1 , wherein the securing member  220  is a spring clip or a deformable clip acting as a retention member and providing uniform pressure across the occluded tissue or vessel.  
   
   
       9 . The medical device of  claim 2 , wherein the first and the second connecting walls  234 ,  244  and the tissue-penetrating elements  238 ,  248  are formed as an integral, one-piece construction.  
   
   
       10 . The medical device of  claim 2 , wherein the tissue-penetrating elements  238 ,  248  are formed in a plurality of rows.  
   
   
       11 . The medical device of  claim 10 , wherein the number of tissue-penetrating elements  238 ,  248  per row and the number of rows vary according to each application.  
   
   
       12 . The medical device of  claim 10 , wherein the tissue-penetrating elements  238 ,  248  are aligned or staggered.  
   
   
       13 . The medical device of  claim 2 , wherein the tissue-penetrating elements  238 ,  248  and the securing member  220  have cross-sections of any configuration including polygonal, circular and elliptical configurations.  
   
   
       14 . A medical device  500  to constrict or occlude a body tissue or vessel, comprising: 
 a first tissue-engaging portion  505  having a first face including a plurality of tissue penetrating elements or protrusions  525 ;    a second tissue-engaging portion  510  opposing the first tissue-engaging portion  505  having a second face including a plurality of tissue penetrating elements or protrusions  530 ; and    a deformable portion  520  connecting the first and the second tissue-engaging portions  505 ,  510 .    
   
   
       15 . The medical device of  claim 14 , wherein only a force required to perform a specific surgical procedure such as occlusion, ligation or fixation is applied to the body tissue or vessel.  
   
   
       16 . The medical device of  claim 15 , wherein tissue necrosis due to over-compression is eliminated.  
   
   
       17 . The medical device of  claim 14 , wherein the medical device is formed from a flat metal sheet that is die-cut, stamped or etched forming a first notched or tooted portion of the first tissue-engaging portion  505 , a smooth connecting portion of the deformable portion  520  and a second notched or toothed portion of the second tissue-engaging portion  510 .  
   
   
       18 . The medical device of  claim 17 , wherein a plurality of notches or teeth of the first and the second portions are bent so as to extend in the same direction or plane and to form channels within the notches or teeth.  
   
   
       19 . The medical device of  claim 17 , wherein the device is formed in a U-shape by bending the deformable portion  520  so that the notches or teeth of the first and the second tissue-engaging portions  505 ,  510  are opposed.  
   
   
       20 . The medical device of  claim 14 , wherein the device is formed from any medically acceptable metal or plastic material that is ductile, malleable or deformable.  
   
   
       21 . The medical device of  claim 20 , wherein the metal includes titanium and stainless steel.  
   
   
       22 . An applier  600  for applying a medical device to constrict or occlude a body tissue or vessel, the device having a first tissue-engaging member  205  having opposed walls  230 ,  232  and a first connecting wall  234  defining a first elongate channel  236 , a second tissue-engaging member  210  opposed to the first tissue-engaging member having opposed walls  240 ,  242  and a second connecting wall  244  defining a second elongate channel  246 , and a securing member  220  for securing the first and the second tissue-engaging members  205 ,  210  such that front faces of the first and the second connecting walls  234 ,  244  are opposed to each other, the applier comprising: 
 an elongate shaft  605  having a proximal end and a distal end  610 ;    a pair of opposed jaws  615 ,  620  connected at the distal end of the elongate shaft  605 ;    a handle operably connected at the proximal end of the elongate shaft  605  to open and close the opposed jaws  615 ,  620 ; and    a sliding member  625  operably connected within the elongate shaft  605  to advance the securing member  220  over the first and the second tissue-engaging members  205 ,  210  after closure of the jaws  615 ,  620 .    
   
   
       23 . The applier of  claim 22 , wherein the jaws  615 ,  620  operate to apply the first and the second tissue-engaging members  205 ,  210  around a target body tissue or vessel.  
   
   
       24 . The applier of  claim 23 , wherein the first and the second tissue-engaging members  205 ,  210  are applied to the jaws  615 ,  620  either manually or automatically.  
   
   
       25 . The applier of  claim 23 , wherein the jaws  615 ,  620  are compressed using only a force required for a specific surgical procedure such as occlusion, ligation or fixation.  
   
   
       26 . The applier of  claim 25 , wherein the first and the second tissue-engaging members  205 ,  210  and the securing member  220  are introduced to a surgical site in an un-assembled condition through a small port or trocar.  
   
   
       27 . The applier of  claim 26 , wherein the sliding member  625  operates to urge the securing member  220  forward and over the first and second tissue-engaging members  205 ,  210  to secure the medical device.  
   
   
       28 . The applier of  claim 27 , wherein the applier and the medical device are sized and configured for use in a minimally invasive or laparoscopic surgical procedure.  
   
   
       29 . The applier of  claim 22 , further comprising a plurality of slots in each of the opposed jaws  615 ,  620  to receive a plurality of the medical devices or multiple staple-clips to simultaneously apply the medical devices or staple-clips.  
   
   
       30 . The applier of  claim 29 , further comprising a cutting member to be advanced between the medical devices or staple-clips after they have been applied to transect the body tissue or vessel between the medical devices or staple-clips.  
   
   
       31 . A clip applier  850  for applying a clip to constrict or occlude a body tissue or vessel, the clip having a first arm  880  including a latch mechanism  890  at a distal end and a second arm  885  folded over the firm arm  880  at a distal end and configured to interlock or mate with the latch mechanism  890  of the first arm  880 , the applier comprising: 
 a handle  885  for storing the clip; and    a thumb actuated mechanism  860  operably slidable along the handle  885  by sliding the thumb actuated mechanism  860  forward  870   a  and backward  870   b  to release the clip.    
   
   
       32 . The clip applier of  claim 31 , wherein the handle  855  further comprises a reservoir for storing a plurality of clips  865 .  
   
   
       33 . The clip applier of  claim 32 , wherein the plurality of clips  865  are strung end-to-end in a clip sleeve  892  suspended through an end port.  
   
   
       34 . The clip applier of  claim 33 , wherein the plurality of clips  865  are formed from a single piece of material.  
   
   
       35 . A clip  875  to constrict or occlude a body tissue or vessel, comprising: 
 a first arm  880  including a latch mechanism  890  at a distal end; and    a second arm  885  folded over the firm arm  880  at a distal end and configured to interlock or mate with the latch mechanism  890  of the first arm  880 .    
   
   
       36 . The clip of  claim 35 , wherein the latch mechanism  890  is a hook.  
   
   
       37 . The clip of  claim 36 , wherein at least one of the first and the second arms  880 ,  885  includes tissue-penetrating elements  898  or securing elements  1023 , 1024  on an inner face.  
   
   
       38 . The clip of  claim 35 , further comprising a third arm  899  connecting the first arm  880  and the second arm  885 .  
   
   
       39 . A clamp  950  to constrict or occlude a body tissue or vessel, comprising: 
 a tubular section  955  having an opening  960  extending from a proximal end  965  to a distal end  970 ; and    a lead-in wire  975  operably attached to the proximal end  965  and is movable between an open position and a closed position,    wherein in the closed position, the lead-in wire  975  is slidably received and secured in the opening  960  of the tubular section  955 .    
   
   
       40 . The clip of  claim 39 , wherein the lead-in wire  975  is bent against a wall of the tubular section  955  to further secure the body tissue or vessel.  
   
   
       41 . The clip of  claim 39 , wherein the clamp is used in donor nephrectomy.  
   
   
       42 . A medical device  1010  to constrict or occlude a body tissue or vessel, comprising: 
 a clip  1011  formed from a first wire including opposed arms  1013 ,  1014  and openings  1015 , 1916 ; and    a staple  1012  for securing the clip  1011 , the staple  1012  formed from a second wire having legs  1017 ,  1018  to puncture the body tissue or vessel and to interlock the clip  1011  through the openings  1015 ,  1016 .    
   
   
       43 . The medical device of  claim 42 , wherein the arms  1013 ,  1014  further comprise a latch mechanism at their distal ends to mate with each other when the arms  1013 ,  1014  are closed or clamped together.