Patent Publication Number: US-2012035629-A1

Title: Viscerotomy closure device and method of use

Description:
RELATED APPLICATIONS 
     The present patent document is a continuation of application Ser. No. 12/152,329, filed May 14, 2008, which claims the benefit of the filing date under 35 U.S.C. §119(e) of Provisional U.S. Patent Application Ser. Nos. 61/001,427 filed Nov. 1, 2007 and 60/930,284 filed May 15, 2007. All of the foregoing applications are hereby incorporated by reference. 
    
    
     FIELD 
     The present invention relates to a viscerotomy closure device and method of use for use in connection with closing a hole created during surgery. The viscerotomy closure device and method of use has particular utility in connection with closing a hole in a bodily organ, such as one created during a natural orifice transgastric surgery procedure. 
     BACKGROUND 
     Viscerotomy closure devices and methods of use are desirable for closing a hole in a bodily organ, such as one created during a natural orifice transgastric surgery procedure. At the inception of transgastric surgery, a gastrotomy is created by using a hollow needle to place a hole in a patient&#39;s stomach through the patient&#39;s skin. The gastrotomy must be closed at the completion of the procedure. Conventional methods for creating and closing the gastrotomy are time consuming and increase the possibility of undesirable reopening of the gastrotomy. 
     The use of circular stapler tissue retention spring methods is known in the prior art. For example, U.S. Pat. No. 5,309,927 to Welch discloses a circular stapler tissue retention spring method. However, the Welch &#39;927 patent does not have a suture entrapped by a circle of staples deployed by a circular stapler that acts as a purse string, and has further drawbacks of lacking an augur-shaped blade. 
     U.S. Pat. No. 7,182,239 to Myers discloses a segmented introducer device for a circular surgical stapler that is capable of fitting onto the center rods of circular stapling devices having different stapler head diameters. However, the Myers &#39;239 patent does not have a suture entrapped by a circle of staples deployed by a circular stapler that acts as a purse string, and additionally does not have an augur-shaped blade. 
     Similarly, U.S. Pat. No. 5,197,648 to Gingold discloses a surgical stapling apparatus that joins hollow tubular organs. However, the Gingold &#39;648 patent does not have a suture entrapped by a circle of staples deployed by a circular stapler that acts as a purse string, and cannot does not have an augur-shaped blade. 
     In addition, U.S. Pat. No. 5,261,920 to Main et al. discloses an anvil bushing for circular stapler that is for use with a surgical circular stapler. However, the Main et al. &#39;920 patent does not have a suture entrapped by a circle of staples deployed by a circular stapler that acts as a purse string, and also does not have an augur-shaped blade. 
     Furthermore, U.S. Pat. No. 5,104,025 to Main et al. discloses an intraluminal anastomotic surgical stapler with detached anvil that is a surgical stapling mechanism. However, the Main et al. &#39;025 patent does not have a suture entrapped by a circle of staples deployed by a circular stapler that acts as a purse string, and further lacks an auger-shaped blade. 
     United States Patent Application Publication Number 2007/0021759 to Griffith et al. discloses a flexible endoscopic anastomotic ring applier device that deploys an anastomotic ring device. However, the Griffith et al. 2007/0021759 patent application publication does not have a suture entrapped by a circle of staples deployed by a circular stapler that acts as a purse string, and has the additional deficiency of lacking an auger-shaped blade. 
     In addition, United States Patent Application Publication Number 2005/0228414 to Clanton et al. discloses an apparatus and method of use of a circular surgical stapler that removes a circumferential portion of a hollow body organ from a patient. However, the Clanton et al. 2005/0228414 patent application publication does not have a suture entrapped by a circle of staples deployed by a circular stapler that acts as a purse string, and also does not have an augur-shaped blade. 
     Furthermore, United States Patent Application Publication Number 2004/0217146 to Green discloses a surgical stapler apparatus and method that is a surgical stapler. However, the Green 2004/0217146 patent application publication does not have a suture entrapped by a circle of staples deployed by a circular stapler that acts as a purse string, and further lacks an auger-shaped blade. 
     U.S. Pat. No. 5,441,507 to Ahn discloses a laparoscopic or endoscopic anastomosis technique and associated instruments that performs an anastomosis. However, the Ahn &#39;507 patent does not have a suture entrapped by a circle of staples deployed by a circular stapler that acts as a purse string, and has the additional deficiency of lacking an augur-shaped blade. 
     In addition, United States Patent Application Publication Number 2005/0038456 to Clanton et al. discloses an anastomosis device having a deployable section that includes a deployable section. However, the Clanton et al. 2005/0038456 patent application publication does not have a suture entrapped by a circle of staples deployed by a circular stapler that acts as a purse string, and also does not have a loop of suture. 
     Furthermore, United States Patent Application Publication Number 2007/0129739 to Green discloses an apparatus and method for performing a bypass procedure in a digestive system that performs a bypass procedure in a digestive system. However, the Green 2007/0129739 patent application publication does not have a suture entrapped by a circle of staples deployed by a circular stapler that acts as a purse string, and further lacks an auger-shaped blade. 
     United States Patent Application Publication Number 2007/0203510 to Ahn discloses an annular disk for reduction of anastomotic tension and methods of using the same that forms an anastomosis between adjacent tissue sections. However, the Ahn 2007/0203510 patent application publication does not have a suture entrapped by a circle of staples deployed by a circular stapler that acts as a purse string, and has the additional deficiency of lacking an augur-shaped blade. 
     Furthermore, United States Patent Application Publication Number 2006/0136043 to Green discloses a filament-wound implementable devices that a self-expanding implantable medical device. However, the Green 2006/0136043 patent application publication does not have a suture entrapped by a circle of staples deployed by a circular stapler that acts as a purse string, and further lacks an auger-shaped blade. 
     European Patent Number EP1213989 to Ahn discloses a set of accessories for transitional operations and procedures for their use that remove a cylindrical or tubular section of mucosa from a rectal ampule. However, the Ahn EP1213989 patent does not have a suture entrapped by a circle of staples deployed by a circular stapler that acts as a purse string, and has the additional deficiency of lacking an augur-shaped blade. 
     In addition, U.S. Pat. No. 4,665,917 to Clanton et al. discloses a tissue gripper for use with intraluminal stapling device that holds tissue to be joined in the proper position with respect to the fasteners used to accomplish the fastening. However, the Clanton et al. &#39;917 patent does not have a suture entrapped by a circle of staples deployed by a circular stapler that acts as a purse string, and also does not have a loop of suture. 
     Furthermore, U.S. Pat. No. 4,749,114 to Green discloses a purse string applicator and method of affixing a purse string that fixes a string about the periphery of an aperture with staples for use as a purse string. However, the Green &#39;114 patent does not have a suture attached to a mesh entrapped by a circle of staples deployed by a circular stapler that acts as a purse string, and further lacks an auger-shaped blade. 
     Lastly, U.S. Pat. No. 5,571,117 to Ahn discloses a method of endoscopic stapling and suturing and instrument therefor that removably positions a suture in front of and in registry with the staple discharge opening such that a staple discharge therefrom will affix the suture to a target tissue. However, the Ahn &#39;117 patent application publication does not have a suture attached to a mesh entrapped by a circle of staples deployed by a circular stapler that acts as a purse string, and has the additional deficiency of lacking an augur-shaped blade. 
     While the above-described devices fulfill their respective, particular objectives and requirements, the aforementioned patents do not describe a viscerotomy closure device and method of use that allows closing a hole in a bodily organ, such as one created during a natural orifice transgastric surgery procedure. 
     Therefore, a need exists for a new and improved viscerotomy closure device and method of use that can be used for closing a hole in a bodily organ, such as one created during a natural orifice transgastric surgery procedure. In this regard, the present invention substantially fulfills this need. In this respect, the viscerotomy closure device and method of use according to the present invention substantially departs from the conventional concepts and designs of the prior art, and in doing so provides an apparatus primarily developed for the purpose of closing a hole in a bodily organ, such as one created during a natural orifice transgastric surgery procedure. 
     BRIEF SUMMARY 
     In view of the foregoing disadvantages inherent in the known types of circular stapler tissue retention spring methods now present in the prior art, the present invention provides an improved viscerotomy closure device and method of use, and overcomes the above-mentioned disadvantages and drawbacks of the prior art. As such, the general purpose of the present invention, which will be described subsequently in greater detail, is to provide a new and improved viscerotomy closure device and method of use which has all the advantages of the prior art mentioned heretofore and many novel features that result in a viscerotomy closure device and method of use which is not anticipated, rendered obvious, suggested, or even implied by the prior art, either alone or in any combination thereof. 
     To attain this, the present invention essentially comprises a loop of suture positioned on a circular stapling device so that when the stapling device is fired and a defect created the loop becomes entrapped in such a way as to become a purse-string around the defect. The invention may include a mesh with a hole in its center and a loop of suture having a knot attached to the mesh. 
     There has thus been outlined, rather broadly, the more important features of the invention in order that the detailed description thereof that follows may be better understood and in order that the present contribution to the art may be better appreciated. 
     The invention may also include the mesh and the loop of suture being made from an absorbable suture material. The mesh and the loop of suture may be made from a non-absorbable suture material. The knot may be a Roeder knot. There may be a knot pusher connected to the loop of suture. There may be an end-to-end anastomosis stapler having a staple carrying member with a plurality of staple receiving slots enclosing a plurality of staples and a protruding rod having opposing ends with one end inserted into the staple carrying member. The opposing end of the protruding rod opposite the staple carrying member may be inserted through the mesh hole so that the mesh covers at least a portion of the staple receiving holes. There may be an anvil with its base removably attached to the opposing end of the protruding rod opposite the staple carrying member. There may be an augur-shaped blade attached to the anvil&#39;s exterior and extending from its tip to its base. There may be a notch in the anvil&#39;s base. The anvil may be generally conical in shape. There may be a plurality of staple clinching grooves in the anvil&#39;s base. There are, of course, additional features of the invention that will be described hereinafter and which will form the subject matter of the claims attached. 
     Numerous objects, features, and advantages of the present invention will be readily apparent to those of ordinary skill in the art upon a reading of the following detailed description of presently current, but nonetheless illustrative, embodiments of the present invention when taken in conjunction with the accompanying drawings. In this respect, before explaining the current embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of descriptions and should not be regarded as limiting. 
     As such, those skilled in the art will appreciate that the conception, upon which this disclosure is based, may readily be utilized as a basis for the designing of other structures, methods, and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention. In the drawings: 
         FIG. 1  is a side perspective view of the current embodiment of the viscerotomy closure device and method of use constructed in accordance with the principles of the present invention. 
         FIG. 2  is a top perspective view of the viscerotomy closure device and method of use of the present invention; 
         FIG. 3  is a side view of the viscerotomy closure device and method of use of the present invention; 
         FIG. 4  is a bottom perspective view of the viscerotomy closure device and method of use of the present invention; 
         FIG. 5  is a side perspective view of the viscerotomy closure device and method of use of the present invention; 
         FIG. 6  is a top perspective view of the viscerotomy closure device and method of use of the present invention; 
         FIG. 7  is a top perspective view of the viscerotomy closure device and method of use of the present invention; and 
         FIG. 8  is a top perspective view of the viscerotomy closure device and method of use of the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     In the present application, the term “proximal” refers to a direction that is generally towards a physician during a medical procedure, while the term “distal” refers to a direction that is generally towards a target site within a patient&#39;s anatomy during a medical procedure. 
     Referring now to the drawings, and particularly to  FIGS. 1-8 , a current embodiment of the viscerotomy closure device and method of use of the present invention is shown and generally designated by the reference numeral  10 . 
     In  FIG. 1 , a new and improved viscerotomy closure device and method of use  10  of the present invention for closing a hole in a bodily organ, such as one created during a natural orifice transgastric surgery procedure is illustrated and will be described. More particularly, the viscerotomy closure device and method of use  10  has a loop of suture  12  with a Roeder knot  14  attached to a circular mesh  16 . The loop of suture  12  may be attached to the mesh  16  by weaving it through or suturing it into the mesh  16 . The mesh  16  has a hole  44  in its center. In the current embodiment, the loop of suture  12  and mesh  16  have a rod  24  inserted through their centers so they can be placed on the end of the staple carrying member  20  of an end-to-end anastomosis stapler  18 . Alternatively, the loop of suture  12  and mesh  16  can be placed on the anvil  28  (shown in  FIGS. 3-5 ) of the end-to-end anastomosis stapler  18 . In addition, multiple instances of the loop of suture  12  and mesh  16  can be used so that a loop of suture  12  and mesh  16  is on both the staple carrying member  20  and the anvil  28 . The loop of suture  12  is connected to a knot pusher  42 , which will be described in more detail in the discussion of  FIG. 7 . The staple carrying member  20  has staple receiving slots  22  in the end covered by the loop of suture  12  and mesh  16 . In the current embodiment, loop of suture  12  and mesh  16  are made of polyglactin  910 , an absorbable suture material. Moving on to  FIG. 2 , a new and improved viscerotomy closure device and method of use  10  of the present invention for closing a hole in a bodily organ, such as one created during a natural orifice transgastric surgery procedure is illustrated and will be described. More particularly, the viscerotomy closure device and method of use  10  has a loop of suture  12  with a Roeder knot  14  woven through a mesh  16 . The loop of suture  12  and mesh  16  are placed over the staple receiving slots  22  of the staple carrying member  20  of an end-to-end anastomosis stapler  18 . Rod  24  protrudes through the hole  44  in the center of mesh  16 . Staples  26  are visible within staple receiving slots  22 . Staples  26  are non-absorbable titanium staples in the current invention, but absorbable staples could also be used. 
     Continuing with  FIG. 3 , a new and improved viscerotomy closure device and method of use  10  of the present invention for closing a hole in a bodily organ, such as one created during a natural orifice transgastric surgery procedure is illustrated and will be described. More particularly, the viscerotomy closure device and method of use  10  has an anvil  28  with one end attached to the end of rod  24 . Anvil  28  is generally conical in shape and has an augur-shaped blade  30  that starts at its tip  46  and twists around to end at its base  48  below the level of the anvil  28 . Blade  30  directs any tissue  38  it comes into contact with downward, causing the tissue  38  to become engaged between the staple carrying member  20  and the anvil  28  simply by pushing the anvil  28  against the tissue  38  and rotating the end-to-end anastomosis stapler  18  360° about its axis. The base  48  of anvil  28  has a notch  32  so the final twist of the blade  30  enables the stretched tissue  38  defect it creates to not be greater than the inner diameter of the staple line defined by the staple receiving slots  22 . Additionally, a conical spacer can be used below the anvil  28  to ensure that when the end-to-end anastomosis stapler  18  is fired, the staples  26  engage with the entire circumference of the tissue  38 . In  FIG. 4 , a new and improved viscerotomy closure device and method of use  10  of the present invention for closing a hole in a bodily organ, such as one created during a natural orifice transgastric surgery procedure is illustrated and will be described. More particularly, the viscerotomy closure device and method of use  10  has an anvil  32  with staple clinching grooves  34  in its base  48 . Staple clinching grooves  34  are aligned with staple receiving slots  22  so that the ends of staples  26  are clinched by staple clinching grooves  34  when the end-to-end anastomosis stapler  18  is fired. 
     Furthermore, in  FIG. 5 , a new and improved viscerotomy closure device and method of use  10  of the present invention for closing a hole in a bodily organ, such as one created during a natural orifice transgastric surgery procedure is illustrated and will be described. More particularly, the viscerotomy closure device and method of use  10  is depicted in use with blade  30  of anvil  28  in contact with the tissue  38  of an organ  36 . As the blade is rotated 180°, the tissue  38  self-loads into the space between the anvil  28  and staple carrying member  20  because of the augur-shaped blade  30 . 
     In  FIG. 6 , a new and improved viscerotomy closure device and method of use  10  of the present invention for closing a hole in a bodily organ, such as one created during a natural orifice transgastric surgery procedure is illustrated and will be described. More particularly, the viscerotomy closure device and method of use  10  is depicted in use subsequent to the firing of end-to-end anastomosis stapler  18 . The end-to-end anastomosis stapler  18  has created a viscerotomy  40  in tissue  38  of organ  36  and circumferentially secured the loop of suture  12  and mesh  16  at the margins of the viscerotomy  40  with staples  26 . The end-to-end anastomosis stapler  18  has also cut the center of mesh  16  so the hole  44  in the center of mesh  16  is aligned with the outer edge of the viscerotomy  40 . 
     Moving on to  FIG. 7 , a new and improved viscerotomy closure device and method of use  10  of the present invention for closing a hole in a bodily organ, such as one created during a natural orifice transgastric surgery procedure is illustrated and will be described. More particularly, the viscerotomy closure device and method of use  10  is shown in use subsequent to the firing of end-to-end anastomosis stapler  18 . Staples  26  secure mesh  16  and loop of suture  12  around the exterior of viscerotomy  40 . Knot pusher  42  is used to cinch down the loop of suture  12 , thereby tightly closing the viscerotomy  40 . The Roeder knot  14  is then tightened to maintain the cinch in the current embodiment. Alternatively, extracorporeal knots can be placed using the knot pusher  42 , or some other locking device can be employed. 
     Concluding with  FIG. 8 , a new and improved viscerotomy closure device and method of use  10  of the present invention for closing a hole in a bodily organ, such as one created during a natural orifice transgastric surgery procedure is illustrated and will be described. More particularly, the viscerotomy closure device and method of use  10  is depicted in use with the loop of suture  12  cinched down and secured by the Roeder knot  14 . The portion of loop of suture  12  connected to the knot pusher  42  has been cut off, and the knot pusher  42  has been removed. The cinched loop of suture  12  has tightly closed the viscerotomy  14  in tissue  38  of organ  36 . 
     In use, it can now be understood that a loop of suture with a Roeder knot and a connected knot pusher is attached to a mesh with a hole in its center. The protruding rod of an end-to-end anastomosis stapler is inserted through the hole in the mesh&#39;s center so that the mesh and loop of suture cover the staple receiving slots of the end-to-end anastomosis stapler&#39;s staple carrying member. The base of an anvil is then attached to the end of the protruding rod. A viscerotomy is created by passing a hollow needle through a patient&#39;s skin into a patient&#39;s bodily organ. One end of a wire is advanced through the hollow needle into the bodily organ. This end of the wire is then pulled through the patient&#39;s mouth and attached to the tip of the anvil. The tip of the anvil is brought into contact with tissue by pulling on the other end of the wire. The augur-shaped blade mounted on the anvil is rotated by the end-to-end anastomosis stapler, which feeds the tissue into the space between the anvil and the staple carrying member. Use of the hollow needle and wire ensures there is a safe point on the bodily organ to pass the anvil through and maintains the tissue in tension against the augur-shaped blade while the anvil is rotated by the end-to-end anastomosis stapler. When the tissue is in position, the end-to-end anastomosis stapler is fired. The staples are ejected from the staple receiving slots in the staple carrying member and pass through the mesh and the tissue prior to having their ends clinched by staple clinching grooves in the anvil&#39;s base. The stapled mesh secures the loop of suture to the tissue around the resulting viscerotomy. The end-to-end anastomosis stapler and the wire are then removed from the patient. The knot pusher is used to cinch down the loop of suture and tighten the Roeder knot to tightly close the viscerotomy. The portion of the loop of suture connected to the knot pusher is then severed from the portion of the loop of suture connected to the mesh, and the knot pusher and the severed portion of the loop of suture are removed. 
     While a current embodiment of the viscerotomy closure device and method of use has been described in detail, it should be apparent that modifications and variations thereto are possible, all of which fall within the true spirit and scope of the invention. With respect to the above description then, it is to be realized that the optimum dimensional relationships for the parts of the invention, to include variations in size, materials, shape, form, function and manner of operation, assembly and use, are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by the present invention. For example, any suitable absorbable or non-absorbable suture material may be used instead of the polyglactin  910  described. Also, the non-absorbable titanium staples may be replaced by absorbable staples. Furthermore, the orientation of the circular staples could be changed to make them deploy perpendicularly to the route of the loop of suture, or the loop of suture could be placed in a zigzag pattern over the staple receiving slots so the loop of suture will be entrapped by the staples, thereby eliminating the use of mesh. And although closing a hole in a bodily organ, such as one created during a natural orifice transgastric surgery procedure has been described, it should be appreciated that the viscerotomy closure device and method of use herein described is also suitable for closing a gastrotomy or defect to any hollow viscus, e.g. colon, vagina, or intestine. Furthermore, a wide variety of locking devices, such as a clip, may be used instead of the Roeder knot described. 
     Therefore, the foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention. 
     The foregoing description of various embodiments of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise embodiments disclosed. Numerous modifications or variations are possible in light of the above teachings. The embodiments discussed were chosen and described to provide the best illustration of the principles of the invention and its practical application to thereby enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth to which they are fairly, legally, and equitably entitled.