Abstract:
Provided is a method of resecting a luminal structure, such as a colon. A first luminal structure and a second luminal structure are defined by severing the original luminal structure. The second luminal structure is secured to the distal end of an elongate body disposed within the second luminal structure. Refraction of the elongate body forms a circumferential fold in the second luminal structure and isolates a tissue mass between the circumferential fold and the distal end of the elongate body. The second luminal structure is then transected circumferentially at or adjacent the circumferential fold, thus severing the tissue mass. The tissue mass is then removed by retracting the distal end of the elongate body. The free end of the second luminal structure is approximated with the free end of the first luminal structure and secured by conventional surgical methods. Instrumentation for use with the inventive method is also provided.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application claims priority to U.S. Provisional Application No. 60/916,899, filed May 9, 2007, which application is incorporated herein by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     In 2001 an estimated 107,300 new cases of Colon Cancer were diagnosed and colon cancer resulted in 48,100 estimated deaths. Resection of the large intestine is a frequently performed operation most commonly used to treat colon cancer, the third most common cancer in both men and women in the U.S. at the time of this writing. Colectomy is also used in the treatment of conditions such as Crohn&#39;s disease, ulcerative colitis, and in cancer prevention in patients with conditions such as Familial Polyposis. 
     A move to less invasive surgeries has seen the advent of the laparoscopic-aided colectomy, in which the surgeon uses laparoscopic instruments to perform the bulk of the operation and finally, when the resected portion of colon is ready to be removed, an incision is made in the abdomen and the colon is removed. This operation spares the patient the large incisions that were required prior to the use of laparoscopic instruments, however, still necessitates a 12 cm incision for specimen removal. 
     SUMMARY OF INVENTION 
     Provided is a method of resecting a luminal structure, such as a colon, which obviates the need for large incisions. The instrumentation used with the inventive method removes the need to make an incision in order to remove the resected structure. 
     In the illustrative embodiment of a colon resection, the instrumentation disclosed herein addresses the need to make an incision in the abdomen in order to remove the resected colon. Rather than subject the patient to any incision other than the small, 1-2 cm, incisions required of the laparoscopic instruments, the invention includes instrumentation and associated methods that allow the resected colon to be removed through the anus. This method reduces duration of hospital stays by decreasing the trauma to the patient in the operating room. By avoiding a large incision the incidence of wound infections is lessened as is the incidence of incisional hernias and wound dehiscence, feared complications of large incisions. 
     In a first embodiment, the invention includes a method of resecting a portion of a luminal structure by defining a first luminal structure and a second luminal structure by severing the original luminal structure. The interior tissue of the second luminal structure is secured to the distal end of an elongate body disposed within the second luminal structure. Partial retraction of the distal end of the elongate body forms a circumferential fold in the second luminal structure and isolates a tissue mass between the circumferential fold and the distal end of the elongate body. The second luminal structure is then transected circumferentially at or adjacent the circumferential fold, thereby severing the tissue mass. The tissue mass is then removed by retracting the distal end of the elongate body. The free end of the second luminal structure is then urged against the free end of the first luminal structure and the two structures are secured by conventional surgical methods, such as with a surgical stapler. 
     In an alternate embodiment, the invention includes a method of resecting a portion of a luminal structure by inserting a device with 3 tissue fixing heads into a luminal structure past a desired point of resection. For ease of reference, the tissue fixing heads are referred to as the distal head, medial head and proximal head. The distal head is disposed on the distal end of a first elongate body. The medial head and proximal head are disposed on the distal end of a second elongate body that has a lumen running through its length. The second elongate body therefore slides over the first elongate body. The medial head is adjacent the distal head when the second elongate body is at its further extent over the first elongate body. 
     Once positioned, a first suture is tied around the outside of the luminal structure between the distal head and medial head such that the tissue of the luminal structure is held securely against the distal head or first elongate body. A second suture is similarly tied around the outside of the luminal structure between the medial head and proximal head. The luminal structure is then transected between the first and second sutures thereby defining a first luminal structure and a second luminal structure. The second elongate body is then partially retracted (over the first elongate body) causing the medial and proximal heads to move away from the distal head and the free end of the second luminal structure to fold in circumferentially on itself (invaginate). 
     A third suture is tied around the interior of the circumferential fold thereby isolating a tissue mass between the third suture the medial head. The tissue mass is then severed and withdrawn by retracting the second elongate body. The free end of the second luminal body (adjacent the third suture) is then urged into contact with the free end of the first luminal body (adjacent the first suture) by sliding a joining device over the first elongate body into operative communication with the distal head. The free ends are then secured to one another by known surgical methods, such as with a surgical stapler. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       For a fuller understanding of the invention, reference should be made to the following detailed description, taken in connection with the accompanying drawings, in which: 
         FIG. 1  is a side view of a surgical device for use with the current invention. 
         FIG. 2  is a block diagram showing the positioning of the surgical device of  FIG. 1  within the luminal structure. 
         FIG. 3  is a block diagram showing how the luminal structure is secured to the surgical device of  FIG. 1 . 
         FIG. 4A  is a block diagram showing one embodiment wherein the free end of the luminal structure is invaginated. 
         FIG. 4B  is a block diagram showing an alternate embodiment wherein the free end of the luminal structure is invaginated. 
         FIG. 5  is a side view of an alternate surgical device, the ring structure, for use with the current invention. 
         FIG. 6  is a side view of an alternate surgical device, the suturing device, for use with the current invention. 
         FIG. 7  is a block diagram showing how the circumferential fold is secured to the surgical device of  FIG. 1 . 
         FIG. 8  is a block diagram showing the insertion and structure of an alternate surgical device, the tissue connecting device, for use with the current invention. 
         FIG. 9  is a block diagram showing the approximation of the free ends of the severed luminal structure as well as the cooperative communication between the tissue connecting device and the distal end of the surgical device of  FIG. 1 . 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     The invention, along with its multiple embodiments, is described here in detail with reference to  FIGS. 1-9  wherein like reference numerals identify similar or identical structures. As used herein, and as is traditional, the term “distal” refers that structure, or that portion of a structure, which is farthest from the point of insertion to the luminal structure and/or the operator. The term “proximal,” in keeping with its traditional meaning, refers that structure, or that portion of a structure, which is closest the point of insertion to the luminal structure and/or the operator. While the description of the invention relates to resection of a portion of the colon, other embodiments may be utilized including utility in other luminal structures. Therefore, structural changes may be made without departing from the scope of the invention. 
     Referring now to  FIG. 1 , colectomy device  10  comprises distal approximating device  20  and folding device  30 . Distal approximating device  20  further comprises guide tube  22  having leading end  24  and distal head  26 . Guide tube  22  is a semi-rigid, non-compressible (lengthwise) structure. Optionally, guide tube  22  is steerable device such as the steerable endoscope described in U.S. Pat. No. 6,468,203. In one embodiment, distal head  26  is an anvil adapted to cooperate with a surgical stapler. In an alternate embodiment, distal head  26  comprises an expandable member and/or a gripping mechanism for gripping the wall of the colon. The expandable member may be an inflatable balloon or a mechanically expandable mechanism, as is known in the art. The gripping mechanism may comprise a plurality of circumferentially located ports within which attachment points, e.g., needles, hooks, barbs, etc., may be retractably positioned about an exterior surface of the expandable member. Alternatively, the gripping mechanism may be a vacuum gripper through a plurality of circumferentially located ports around distal head  26  or other known gripping mechanism. 
     Folding device  30  further comprises elongate body  32  having a lumen there through (not shown) and fixing mechanism  34 . Fixing mechanism  34  further comprises proximal head  36  and medial head  38 . Folding device  30  is provided such that it is slidably moveable over guide tube  22 . Proximal head  36  and medial head  38  can be static structures or can comprise an expandable mechanism as with distal head. Furthermore, proximal head  36  and medial head  38  can include a gripping mechanism, discussed above. 
       FIG. 2  is a cutaway drawing showing colectomy device  10  positioned within luminal structure  12 , here a colon. In this example, distal head  26 , medial head  38  and proximal head  36  are all positioned such that tumor ( 19 ) is proximal in relation to fixing mechanism  34 . In other words, the diseased portion of colon is between the area of insertion (here the anus) and proximal head  36 . The position of fixing mechanism  34  can be confirmed with an x-ray or with visualization with a colonoscope. The operator next inserts the laparoscopic instruments as usual and begins dissecting the colon&#39;s mesentery and ligating its blood supply. It is possible that the operator may find the added weight of colectomy device  10  in the colon slows progress. Optionally, colectomy device  10  can be inserted after the dissection. 
     As seen in  FIG. 3 , when the section of colon to be removed ( 17 ) has been successfully mobilized (its blood supply cut off), first suture  40  is placed around the exterior of the colon wall adjacent the proximal side of distal head  26 . Second suture  42  is similarly placed around the exterior of the colon wall between medial head  38  and proximal head  36 . Following the placement of the sutures the colon would be cut between first suture  40  and second suture  42  thereby forming first luminal structure  100  and second luminal structure  200 . First suture  40  and second suture  42  are placed with laparoscopic techniques. 
     Although this embodiment uses laparoscopically placed sutures, any method of circumferentially securing the luminal tissue firmly against guide tube  22  is contemplated. For example, distal head  26  can be a gripping mechanism (as discussed above), such as a vacuum, that applies sufficient gripping force to hold free end  105  of first luminal structure  100  tightly against guide tube  22  and/or the proximal surface of distal head  26 . Similarly, fixing mechanism  34  can be adapted with a similar gripping mechanism sufficient to hold free end  205  of second luminal structure against elongate body  32  between proximal head  36  and medial head  38 . Alternatively, fixing mechanism  34  can be adapted with a gripping mechanism sufficient to hold free end  205  of second luminal structure against either the proximal surface of medial head  38  and/or the distal surface of proximal head  36 . The circumferentially secure attachment of the luminal wall to a surface of colectomy device  10 , such as guide tube  22 , prevents leakage of the contents of the colon into the peritoneal (i.e. abdominal) cavity. 
     Free end  205  of second luminal structure  200  is then folded inward (invaginates) circumferentially to form a circumferential fold and a tissue mass (see  FIGS. 4A and 4B ). In a first embodiment, shown in  FIG. 4A , a colonoscope (not shown) is inserted through the anus so that fixing mechanism  34  can be visualized. Air, or any suitable gas, is introduced into the second luminal structure causing it to radially expand. Fixing mechanism  34  is then slowly retracted, over guide tube  22 , causing free end  205  of second luminal structure  200  to fold inward forming circumferential fold  220  and tissue mass  230 . Tissue mass  230 , generally, comprises the portion of tissue between circumferential fold  220  and second suture  42 . The stopping point of retraction is where the mesentery (source of blood supply) is still attached to the colon (not shown). A colonoscope and/or laparoscope can be used to monitor the process. 
     An alternate embodiment, shown in  FIG. 4B , utilizes a ring structure ( FIG. 5 ) to assist in forming circumferential fold  220  and tissue mass  230 . Ring structure  60  comprises outer tube  62 , T-shaped head  64  and loop  66 . Outer tube  62  is a hollow, semi-rigid tube with a lumen there through. Loop  66  is formed from semi-rigid, preferably solid, rod  66   a  which exits T-shaped head  64  on a first end  64   a  and then circles around to attach to the other side of the T-shaped head  64  on a second end  64   b . The semi-rigid material of loop  66  is slidably disposed within the lumen of outer tube  62  to dilate loop  66 . 
     Returning now to the alternate embodiment of  FIG. 4B , a colonoscope (not shown) is inserted through the anus so that fixing mechanism  34  can be visualized. Air, or other suitable gas, is introduced into second luminal structure  200  causing it to radially expand. Ring structure  60  is then inserted longitudinally over colectomy device  10  until loop  66  is adjacent the interior of free end  205  of second luminal structure  200 , and by extension fixing mechanism  34 . 
     Once ring structure  60  is inserted to where loop  66  is around fixing mechanism  34 , loop  66  is expanded radially by sliding rod  66   a  forward. Fixing mechanism  34  is then slowly retracted, over guide tube  22 , causing free end  205  of second luminal structure  200  to fold inward forming circumferential fold  220  and tissue mass  230 . Ring structure  60  is also retracted, however, but at about half the rate of fixing mechanism  34  as it is used to ensure the colon folds inward upon itself. A colonoscope and/or laparoscope can be used to monitor the process. The stopping point of retraction is where the mesentery (source of blood supply) is still attached to the colon (not shown). When the colon has been folded upon itself a sufficient amount, ring structure  60  is removed. 
     Once circumferential fold  220  and tissue mass  230  are properly defined, suturing device  70  ( FIG. 6 ) is used to place third suture  44  on the inner surface circumferential fold  220 . Third suture  44  firmly secures the tissue of circumferential fold  220  against guide tube  22  ( FIG. 7 ). Suturing device  70  comprises semi-rigid rod  72  and suture loop  74 . Suture material  74   a  is disposed through lumen  76  in rod  72 . A locking device (not shown) allows suture material  74   a  to be pulled through lumen  76  to tighten suture loop  74  but does not allow the loop to loosen once tightened. The diameter of the locking device is less than the diameter of the inner diameter of rod  72  so that suture loop  74  is tightened when rod  72  is pushed inward and/or the suture material  74   a  is pulled proximally through lumen  76 . 
     Suturing device  70  is inserted longitudinally with folding device  30  in the lumen formed by suture loop  74 . Suture loop  74  passes over folding device  30  and past fixing mechanism  34  until it is adjacent the inner surface of circumferential fold  220 . Rod  72  is then pushed forward, causing the locking device to cinch suture loop  74  against guide tube  22  ( FIG. 7 ). An electric cautery knife on the colonoscope, or other cutting device, is then used to transect the colon wall proximally of circumferential fold  220  thereby severing tissue mass  230 . Tissue mass  23 , which is retained by fixing mechanism  34 , is removed through the anus by retracting fixing mechanism  34 . 
     Proximal approximating device  80  is then used to join free end  205  of second luminal structure  200  to free end  105  of first luminal structure  100 . Proximal approximating device  80  ( FIG. 8 ) comprises elongate body  82 , which has a lumen there through, and joining mechanism  84  disposed on the distal end of elongate body  82 . In one embodiment, joining mechanism  84  is a surgical stapling device similar to the transanal, circumferential staplers known in the art (i.e. PROXIMATE ILS™ and ENDOPATH STEALTH™ intraluminal staplers from Ethicon Endo-Surgery, Inc.). In this embodiment, joining mechanism  84  is a surgical stapler adapted to cooperate with an anvil disposed on distal head  26 . 
     Proximal approximating device  80 , as shown in  FIG. 9 , is inserted longitudinally over guide tube  22 . Proximal approximating device  80  is slidably displaced over guide tube  22 , and/or guide tube  22  is withdrawn through the lumen of proximal approximating device  80 , until free end  205  of second luminal structure  200  and free end  105  of first luminal structure  100  are adjacent. Joining device  84  is then activated thereby affixing free end  205  of second luminal structure  200  to free end  105  of first luminal structure  100 . The final result is the anastomosed colon as shown in  FIG. 9 . 
     It will be seen that the advantages set forth above, and those made apparent from the foregoing description, are efficiently attained and since certain changes may be made in the above construction without departing from the scope of the invention, it is intended that all matters contained in the foregoing description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense. 
     It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described, and all statements of the scope of the invention which, as a matter of language, might be said to fall therebetween. Now that the invention has been described,