Abstract:
A method for performing a surgical procedure is disclosed which uses an anvil delivery system including an anvil assembly, a flexible tube having a first end portion and a second end portion, and a fitting to deliver the anvil assembly to a desired site. The method includes the steps of cutting a second end portion of the flexible tube, attaching a fitting to the second end portion of the flexible tube which has been cut, inserting the insertion tip into tissue, advancing the insertion tip along with the flexible tube and anvil assembly to the desired site within a patient&#39;s body, and removing the flexible tube from the anvil assembly and from the desired site leaving the anvil assembly in a patient&#39;s body at the desired site.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application is a divisional application of U.S. application Ser. No. 12/207,562, filed Sep. 10, 2008, which claims priority to, and the benefit of, U.S. Provisional Patent Application No. 60/995,023, filed on Sep. 24, 2007, the entire contents of each of which are hereby incorporated by reference. 
     
    
     BACKGROUND 
       [0002]    1. Technical Field 
         [0003]    The present disclosure relates generally to a surgical apparatus for use during anastomosis procedures. More particularly, the present disclosure relates to methods and apparatus to deliver an anvil assembly to a surgical site. 
         [0004]    2. Description of the Related Art 
         [0005]    Surgical anastomosis is the surgical connection of severed or separate of hollow organs. Typically, an anastomosis procedure follows another surgical procedure where a diseased or defective section of hollow tissue is removed and the remaining end sections are joined. The end sections may be joined by circular, end-to-end, or side-to-side organ reconstruction methods. 
         [0006]    In a circular anastomosis procedure, the two ends of the organ sections are joined by means of a stapling instrument that drives a circular array of staples through the end section of each organ section and simultaneously cores any tissue interior of the driven circular array of staples to free the tubular passage. Examples of instruments for performing circular anastomosis of hollow organs are described in U.S. Pat. Nos. 7,168,604; 6,053,390; 5,588,579; 5,119,983; 5,005,749; 4,646,745; 4,576,167; and 4,473,077, each of which is incorporated herein in its entirety by reference. Typically, these instruments include an elongated shaft having a handle portion at a proximal end to actuate the instrument and a staple holding component disposed at a distal end. An anvil assembly including an anvil rod with an attached anvil head is mounted to the distal end of the instrument adjacent the staple holding component. Opposing end portions of tissue of the hollow organ(s) to be stapled are clamped between the anvil head and the staple holding component. The clamped tissue is stapled by driving one or more staples from the staple holding component so that the ends of the staples pass through the tissue and are deformed by the anvil head. An annular knife is concurrently advanced to core tissue within the hollow organ to free a tubular passage within the organ. 
         [0007]    Certain circular anastomosis procedures entail minimally invasive techniques. In these procedures, surgeons often position an anvil assembly in the desired hollow organ by inserting an anvil delivery system through a patient&#39;s esophagus. U.S. Pat. No. 7,179,267, for example, describes a method and apparatus for delivering an anvil assembly through a patient&#39;s esophagus. Although surgical apparatus that can deliver an anvil assembly into a hollow organ are well-known in the art, there is a need for more versatile anvil delivery systems. 
       SUMMARY 
       [0008]    The present disclosure relates to an anvil delivery system including an anvil assembly, a flexible tube, and a fitting coupled to the flexible tube. The fitting includes a body having a proximal end portion and a distal end portion, and a tip on the distal end portion. The proximal end portion is adapted to attach the body of the fitting to the flexible tube. The tip is configured for insertion into a body lumen. 
         [0009]    The present disclosure also relates to an anvil delivery system comprising an anvil assembly, a flexible tube having a first end portion and a second end portion, and a fitting. The fitting has a proximal end portion and a distal end portion, wherein the proximal end portion is removably coupled to the second portion of the flexible tube and the distal end portion includes a tip for advancing through tissue. 
         [0010]    In one embodiment, anvil delivery system further includes a bore extending through the distal end portion of the fitting to receive a suture. In one embodiment the anvil delivery system includes a plurality of protrusions disposed on a proximal end portion of the body of the fitting. In one embodiment, the anvil is pivotable with respect to the flexible tube. 
         [0011]    The present disclosure also relates to a kit. The kit includes a flexible tube having a distal end an open proximal end, an adapter configured to be releasably secured to the flexible tube, and a fitting configured to be attached to the flexible tube after the distal end of the flexible tube has been cut. The fitting includes a body having a proximal end portion configured to attach to the flexible tube and a distal end portion. 
         [0012]    In one embodiment, the kit also includes the anvil assembly. 
         [0013]    In one embodiment, the proximal end portion of the body of the fitting is dimensioned to be supported within the flexible tube. 
         [0014]    In one embodiment, the tip is blunt and configured for insertion into a body lumen. In one embodiment, the fitting includes a bore extending through the distal end portion of the body. In one embodiment, the plurality of protrusions is adapted to operatively attach the body of the fitting to the flexible tube. 
         [0015]    The present disclosure also relates to method of performing a surgical procedure comprising:
       providing an anvil assembly having an anvil head and a flexible tube having a first end portion extending from the anvil assembly;   cutting a second end portion of the flexible tube, the second end portion being disposed on an opposite end of the flexible tube from the first end portion;   attaching a fitting to the second end portion of the flexible tube, the fitting having an insertion tip;   inserting the second end portion of the flexible tube into a body;   positioning the anvil assembly within the body using the flexible tube; and   detaching the flexible tube from the anvil assembly while the anvil assembly is positioned within the body.       
 
         [0022]    The fitting may include a bore to receive a suture and the inserting step may include the step of grasping the suture to pull the insertion tip to advance the fitting, flexible tube and anvil assembly. The step of attaching the fitting may include the step of inserting a portion of the fitting within the second end portion of the flexible tube to frictionally engage the tube. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0023]    Various embodiments of the presently disclosed surgical apparatus are disclosed herein with reference to the drawings, wherein: 
           [0024]      FIG. 1  is a top plan view of an anvil delivery system according to an embodiment of the present disclosure; 
           [0025]      FIG. 1A  is a top plan view of an anvil delivery system with a fitting attached thereto according to an embodiment of the present disclosure; 
           [0026]      FIG. 1B  is a side plan view of the anvil delivery system with the fitting shown in  FIG. 1A ; 
           [0027]      FIG. 2  is a perspective view of a portion of the anvil delivery system shown in  FIG. 1 ; 
           [0028]      FIG. 3  is a side cross-sectional view of a portion of the anvil-delivery system shown in  FIG. 1 ; 
           [0029]      FIG. 4  is perspective view of a portion of the anvil delivery system shown in  FIG. 1 ; 
           [0030]      FIG. 5  is a side plan view of a fitting according to an embodiment of the present disclosure; 
           [0031]      FIG. 6  is a cross-sectional rear view of the fitting shown in  FIG. 5 , taken along section line C-C of  FIG. 5 ; 
           [0032]      FIG. 7  is a front plan view of the fitting shown in  FIG. 5 ; 
           [0033]      FIG. 8  is a cross-sectional side view of the fitting shown in  FIG. 5 , taken along section line A-A of  FIG. 7 ; 
           [0034]      FIG. 9  is a cross-sectional side view of a portion of the fitting shown in  FIG. 5 , taken along section line B-B of  FIG. 6 ; and 
           [0035]      FIG. 10A  is a top plan view of an anvil delivery system according to another embodiment of the present disclosure; 
           [0036]      FIG. 10B  is a side plan view of the anvil delivery system with the fitting shown in  FIG. 10A ; 
           [0037]      FIG. 11  is a top plan view of the fitting according to the embodiment of  FIG. 10A ; 
           [0038]      FIG. 12  is a side plan view of the fitting shown in  FIG. 11 ; 
           [0039]      FIG. 13  is a cross-sectional side view of the fitting shown in  FIG. 11 ; and 
           [0040]      FIG. 14  is a rear plan view of the fitting shown in  FIG. 11 . 
       
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
       [0041]    Embodiments of the presently disclosed anvil delivery system will now be described in detail with reference to the drawings wherein like reference numerals designate identical or corresponding elements in each of the several views. In the description that follows, the term “proximal,” as is traditional, will refer to the end of anvil delivery system, or a portion thereof, that is closer to the operator, while the term “distal” will refer to the end of the anvil delivery system that is farther from the operator. 
         [0042]    With reference to  FIG. 1 , an anvil delivery system is generally shown as  10 . Anvil delivery system  10  includes a flexible tube  12 , an adapter  14 , and an anvil assembly  16 . Anvil assembly  16  may be a 21 mm or a 25 mm anvil assembly, sold under the trademark EEA ORVIL™. Alternatively, other anvil assemblies may be used with the presently disclosed anvil delivery system. Flexible tube  12  has an open end  12   a  and a blunt end on the opposite end. Adapter  14  and anvil assembly  16  are supported on open end  12   a  of flexible tube  12 , as described in detail below. 
         [0043]    Referring to  FIGS. 2 and 3 , anvil assembly  16  includes an anvil head  30 , an anvil center rod  20 , and an anvil  60 . Anvil  60 , which is supported on anvil head  30 , has a plurality of pockets  60   a  for receiving and deforming surgical staples. Center rod  20  is operatively connected to anvil head  30 . In the embodiment shown in  FIG. 2 , center rod  20  is pivotably coupled to anvil head  30 . Further, center rod  20  includes flexible legs  26  configured to capture at least a portion of adapter  14  therebetween. 
         [0044]    With continued reference to  FIGS. 2 and 3 , adapter  14  includes a first end  14   a  dimensioned to be received within open end  12   a  of flexible tube  12  and a second end  14   b  configured to be received in the center rod  20  of anvil assembly  16 . First end  14   a  includes a series of annular rings  22  dimensioned to frictionally retain first end  14   a  of adapter  14  within open end  12   a  of flexible tube  12 . It is envisioned that other retaining structure can be provided to retain first end  14   b  of adapter  14  to flexible tube  12 , e.g., clamps, pins, threads, etc. Second end  14   b  of adapter  14  includes a longitudinal guide member  24  dimensioned to be received between flexible legs  26  of center rod  20  of anvil assembly  16 . In addition, second end  14   b  of adapter  14  is dimensioned to allow center rod  20  of anvil assembly  16  to freely slide on and off second end  14   b  of adapter  14 . 
         [0045]    Referring to  FIG. 4 , anvil head  30  of anvil assembly  16  includes spaced apart openings  32  that are in communication with each other. Adapter  14  includes a first throughbore  40  formed in a central hub portion  14   c  and a second throughbore  42  formed in first end  14   a.  As will be discussed below, anvil delivery system  10  includes a suture  50  to secure anvil assembly  16  to adapter  14 . 
         [0046]    Referring to  FIGS. 2 and 4 , suture  50  has a first end  50   a  and a second end  50   b.  To secure adapter  14  to anvil assembly  16 , first end  50   a  of suture  50  is inserted into one opening  32  of anvil head  30  and pulled out of the other opening  32  such that the ends  50   a  and  50   b  of suture  50  are positioned on opposite sides of center rod  20  of anvil assembly  16 . Next, second end  14   b  of adapter  14  is positioned within center rod  20  and each end  50   a  and  50   b  of suture  50  is inserted through an opposite end of throughbore  40  of central hub portion  14   c  of adapter  14  to define a first suture loop  54  (see  FIG. 2 ). Each end  50   a  and  50   b  of suture  50  is pulled tight such that adapter  14  is held against center rod  20 . Thereafter, each end  50   a  and  50   b  is inserted through an opposite end of throughbore  42  of first end  14   a  of adapter  14  to define a second suture loop  56  (see  FIG. 2 ). Second suture loop  56  extends about first end  14   a  of adapter  14 . The frictional contact between rings  22  of first end  14   a  of adapter  14  and the inner surface of flexible tube  12  secures adapter  14  to flexible tube  12  and prevents suture  50  from loosening up. 
         [0047]    With reference to  FIGS. 1A and 1B , after operatively connecting flexible tube  12  to anvil assembly  16  via adapter  14 , a healthcare professional may decide to shorten flexible tube  12 . In some bariatric surgeries, for instance, short flexible tubes  12  are beneficial. Therefore, the healthcare professional may decide to cut flexible tube  12 , thereby creating another open end  12   b  on the new distal end of flexible tube  12 . Because the cut end of flexible tube  12  may be abrasive and/or include jagged or irregular surfaces, a fitting  62  may be attached to open end  12   b  of tube  12  to facilitate smooth atraumatic passage of tube  12  through or into a body lumen. 
         [0048]    With reference to  FIGS. 5-9 , fitting  62  includes a body  64  having a proximal end portion  66  adapted to be supported in open end  12   b  of flexible tube  12 , a distal end portion  68 , and a middle portion  70 . Distal end portion  68  has bore  74  defined therethrough and a blunt tip  72  configured for insertion into a body lumen such as the esophagus. In a preferred embodiment, the tip  72  is bullet-shaped to aid insertion. Bore  74  may be dimensioned to receive a suture (not shown) so it can be pulled through the lumen if desired. Middle portion  70  is between proximal end portion  66  and distal end portion  68 . Proximal end portion  66  includes a plurality of protrusions  76  adapted to frictionally retain proximal end portion  66  of fitting  62  within open end  12   b  of flexible tube  12 . 
         [0049]    In operation, a surgeon employs anvil delivery system  10  to position anvil assembly  16  in the body during minimally invasive procedures. During such procedures, the surgeon initially secures adaptor  14  to open end  12   a  of flexible tube,  12  and sutures anvil assembly  16  to central hub portion  14   c  of adapter  14 . Flexible tube  12  may then be cut at any desired length. The cut creates a distal open end  12   b  from the blunt closed end in flexible tube  12 . After cutting flexible tube  12 , the surgeon secures fitting  62  in open end  12   b.  Specifically, proximal end portion  66  of fitting  62  is inserted into open end  12   b.  The frictional contact between protrusions  76  of distal end portion  66  of fitting  62  and the inner surface of flexible tube  12  secures fitting  62  to flexible tube  12 . 
         [0050]    For transoral applications, once fitting  62  has been secured to flexible tube  12 , the surgeon inserts fitting  62  in the patent&#39;s mouth and moves fitting  62  along with flexible tube  12  down through the esophagus to the surgical site, e.g., stomach. It is also contemplated that the anvil delivery system can be used for other applications besides transoral insertion, such as transgastric and transanal approaches for colorectal, bariatric and other applications. This can be achieved due to the bullet shaped tip which can penetrate tissue, e.g. the stomach wall to deliver the anvil assembly. Other penetrating tip configurations could be provided. 
         [0051]    After insertion, the surgeon should then make a small incision at the surgical site to create an inner access to the fitting  62 . After making the incision, the surgeon pulls fitting  62  through the incision, thereby pulling anvil assembly  16  through the esophagus (or other body tissue or organ depending on the procedure) to the surgical site. If a suture is used through bore  74 , the suture can be grasped and pulled to pull the anvil assembly. As flexible tube  12  is pulled through the incision, the distal end of center rod  20  of anvil assembly  16  advances through the incision. When anvil assembly  16  is properly positioned at the surgical site, the surgeon may release adapter  14  from anvil assembly  16  by cutting suture  40  and sliding center rod  20  from end  14   b  of adapter  14 . Next, the flexible tube  12  (with fitting  62 ) and adapter  14  may be pulled from the body through the incision. The surgeon can now mount center rod  20  of anvil assembly  16  on a surgical stapling device (not shown) and perform the desired surgical procedure. 
         [0052]    The components of anvil delivery system  10  may be provided in kit form. The kit may include a flexible tube  12  adapted to be secured to the anvil assembly  16 , an adapter  14  configured to secure an anvil assembly  16  to the flexible tube  12  and a fitting  62  configured to be attached to flexible tube  12 . Fitting  62 , in turn, may include a body  64  having a proximal end portion  66  and a distal end portion  68 , a blunt tip  72  disposed on the distal end portion  68 , and a plurality of protrusions  76  disposed on the proximal end portion  66 . Proximal end portion  66  of body  64  may be dimensioned to be supported within flexible tube  12 . The plurality of protrusions  76  may be adapted to operatively attach the body  64  of the fitting  62  to flexible tube  12 . Blunt tip  72  may be configured for insertion into a body lumen. Fitting  62  may include a bore  74  extending through distal end portion  68  of body  64 . The kit may further include an anvil assembly  16 . In one embodiment, the anvil assembly  16 , the flexible tube  12 , and adapter  14  are fastened together with a suture  50 , as discussed above, and the fitting  62  is provided to blunt the end of flexible tube  12  if the flexible tube  12  has to be cut and to provide an insertion tip. 
         [0053]    With reference to  FIGS. 10A and 10B , another embodiment of anvil delivery system  10  includes an alternative fitting  82 . Like fitting  62 , fitting  82  is attached to open end  12   b  of tube  12  to facilitate smooth atraumatic passage of tube  12  through or into a body lumen. Since the structure and operation of an anvil delivery system  10  with fitting  62  is substantially identical to the structure and operation of an anvil delivery system  10  with fitting  82 , the present disclosure only discusses in detail the structural features of fitting  82 . 
         [0054]    Referring to  FIGS. 11-14 , fitting  82  includes a body  84  having a proximal end portion  86  supported in open end  12   b  of flexible tube  12 , a distal end portion  88 , and a middle portion  90 . Distal end portion  88  has a bore  94  defined therethrough and a blunt tip  92  configured for insertion into a body lumen such as the esophagus. Body  90  of fitting  82  has a tapered surface  98  leading to blunt tip  92 . Tip  92  is bullet-shaped to aid insertion. Bore  94  is dimensioned to receive a suture (not shown). The suture is attached to tip  92  and pulled to pull tube  12  through a lumen if desired. Proximal end portion  86  includes a plurality of protrusions  96  adapted to frictionally retain proximal end portion  86  of fitting  82  within open end  12   b  of flexible tube  12 . Protrusions  96  are disposed around an outer periphery of proximal end portion  86 . 
         [0055]    It will be understood that various modifications may be made to the embodiments disclosed herein. For example, the particular configuration of fitting  62  need not be exactly as shown but rather may be configured in any manner capable of facilitating atraumatic passage of tube  12  through a body lumen. Therefore, the above description should not be construed as limiting, but merely as exemplifications of the embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.