Abstract:
An applicator instrument has a body portion that has at least one trigger mechanism and a rod extending from the body portion. The applicator instrument has a folding cap mechanism installed or inserted into an end of the rod. The folding cap mechanism has a plurality of extension arms, each of which have a staple clinch bucket. The extension arms are coupled to a trigger of the triggers and are movable between a collapsed position and an extended position by the trigger.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims the benefit of U.S. Provisional Application No. 62,155,493, filed May 1, 2015, having the title for APPLICATOR INSTRUMENT WITH FOLDING STAPLING TIP. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention relates to the field of medicine and more particularly to an applicator instrument with staple system and further, to an applicator instrument for anastomosis between two tubes having an extension that folds like an umbrella. 
       BACKGROUND 
       [0003]    Various types of surgical staplers are known for repair of tears or separations in tissue. The use of various types of staplers has been used in gastric, colon, rectal, and/or esophageal surgery, for example, in gastric reconstructions performed end-to-end, end-to-side, or side-to-side. 
         [0004]    The hand-sewn anastomosis has largely been replaced by the EEA (end to end anastomosis) stapling especially in colorectal and gastric bypass operations. For example, stapling the proximal colon to the lower rectum is easier to perform, and results in a similar anastomotic leak rate when compared to hand-sewn anastomosis. 
         [0005]    The circular stapling device consists of an actuating head portion attached to an elongated tubular body with a handle on the opposed end of the body from the head. The anvil functions essentially as an end plate to turn in and close the ends of the staples. In one example of such a device, an instrument such as that disclosed in U.S. Pat. No. 5,119,983 is used to create an anastomosis. In this device, an anvil assembly is positioned on the end of a rod which is retracted within a tubular housing of the instrument. This instrument is introduced into the lumen of a stomach without the anvil in place, and then the tip of the center rod is passed through an opening which has been made at the anastomotic site and the anvil is then be secured on the end of the center rod. Alternately, the anvil is inserted into the intestine for securement to the rod and the end of the duodenum is then sutured off about the rod. Next, the rod is retracted towards the instrument to clamp the tissue between the anvil and the stapler body and then staples from the instrument are forced through the tissue and against the anvil so as to join the two sections of intestine to be joined such as the colon to the rectum or the stomach to the intestine positioned there between. With such a system, a relatively large incision need be made with attendant trauma to tissue and associated complications. The larger the hole, the less tissue available for staples to set. If the hole is too large, then some of the staples within the circular anastomosis are at risk to misfire and not land within tissue at all, thus causing leakage. 
         [0006]    Even though current methods use detachable anvils; the insertion of the detachable anvil into the patient&#39;s body is still typically performed through a relatively large incision during open surgery and laparoscopic surgery. The smaller the opening in the recipient tissue made for anvil insertion, the more tissue available for the rows of staples in the circular anastomosis. 
         [0007]    The tissue stapled together leaves a smaller opening than the original lumen into which the anvil and stapler were inserted. In order to insert the anvil through the smallest possible defect, it is desirable to provide an anvil which can be collapsed to introduce the anvil into the body through a relatively small incision and for removal of the anvil after stapling through the smaller opening between the staples. 
         [0008]    What is needed is an applicator instrument with either a stationary or removable anvil that collapses to a small enough diameter enabling insertion and removal through small orifices to maximize tissue available for the staples to approximate the tissue. 
       SUMMARY 
       [0009]    In order to eliminate the disadvantages of the state of the art, an object of the present invention is an applicator instrument with either a stationary or removable folding cap mechanism that collapses to a small enough diameter enabling insertion and removal through small orifices to maximize tissue available for the staples to approximate the tissue in an anastomosis procedure. 
         [0010]    A further object of the present invention is that it has folding cap mechanism that can be made to go through a smaller space by reducing the surrounding area when it&#39;s arms are extended or retracted. 
         [0011]    A further object of the present invention is that the folding cap mechanism can be produced in a detachable manner on the main body of the instrument. 
         [0012]    A further object of the present invention is that it provides advantage in both open and laparoscopic interventions. 
         [0013]    A further object of the present invention is to provide a folding cap mechanism that folds up like an umbrella that makes a very tiny hole when inserted rather than the big circular anvil that one must then either create a purse-string suture to approximate the tissue around it (or insert it first, staple across the bowel and poke it through the intestine afterward). 
         [0014]    The present invention generally comprises an applicator instrument that has a folding cap mechanism installed or inserted into an end of a rod. The folding cap mechanism has a plurality of extension arms, each of which have a staple clinch bucket. The extension arms are coupled to a trigger of the triggers and are movable between a collapsed position and an extended position by the trigger. 
         [0015]    These and other objects, features and advantages of the present invention will become readily apparent to those having ordinary skill in the art upon a reading of the following detailed description in view of the appended claims and drawings 
     
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         [0016]    The invention can be best understood by those having ordinary skill in the art by reference to the following detailed description when considered in conjunction with the accompanying drawings in which: 
           [0017]      FIG. 1  illustrates a perspective view of an applicator instrument with folding stapling tip. 
           [0018]      FIG. 2  illustrates a plan view of the folding stapling tip in a retracted configuration. 
           [0019]      FIG. 3  illustrates a plan view of the folding stapling tip in a configuration ready for stapling tissue. 
           [0020]      FIG. 4  illustrates a plan view of the rod of the applicator instrument within a body orifice, the folding stapling tip in a configuration ready for stapling tissue. 
           [0021]      FIG. 5  illustrates a plan view of the rod of the applicator instrument within a body orifice, the folding stapling tip in a configuration ready for extraction from the body orifice. 
           [0022]      FIG. 6  illustrates a plan view of the rod of the applicator instrument within a body orifice, the folding stapling tip in a second configuration ready for extraction from the body orifice. 
       
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
       [0023]    The following detailed description is merely exemplary in nature and is not intended to limit the described embodiments or the application and uses of the described embodiments. As used herein, the word “exemplary” or “illustrative” means “serving as an example, instance, or illustration.” Any implementation described herein as “exemplary” or “illustrative” is not necessarily to be construed as preferred or advantageous over other implementations. All of the implementations described below are exemplary implementations provided to enable persons skilled in the art to make or use the embodiments of the disclosure and are not intended to limit the scope of the disclosure, which is defined by the claims. For purposes of description herein, the terms “upper,” “lower,” “left,” “rear,” “right,” “front,” “vertical,” “horizontal,” and derivatives thereof shall relate to the invention as oriented in  FIG. 1 . 
         [0024]    Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the inventive concepts defined in the appended claims. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting, unless the claims expressly state otherwise. 
         [0025]    It should be clearly understood that like reference numerals are intended to identify the same structural elements, portions, or surfaces consistently throughout the several drawing figures, as may be further described or explained by the entire written specification of which this detailed description is an integral part. The drawings are intended to be read together with the specification and are to be construed as a portion of the entire “written description” of this invention as required by 35 U.S.C. §112. 
         [0026]    Throughout this description, the stapling function of the applicator instrument is described, though it is fully anticipated that the applicator instrument performs other functions including, but not limited to, cutting tissue, clamping tissue, cauterizing, etc. 
         [0027]    Referring to  FIG. 1 , a perspective view of an applicator instrument  10  with folding cap mechanism  50  is shown. The body portion  8  of the stapler  10  is, for example, similar to other such staplers as known in the industry, for example, the applicator instrument (e.g., stapler, cutter, tissue clamp) disclosed in U.S. Pat. No. 5,839,639 which is here in incorporated by reference. In this example, the body portion  8  is shown with two trigger mechanisms  12 / 14 . The first trigger mechanism  12  is operated to extend/retract the folding cap mechanism  50  and the second trigger mechanism  14  is operated to effect an operation such as stapling, cutting, cauterizing, etc. It is fully anticipated that more or less features such as the trigger mechanisms  12 / 14  are provided for actuation of different features, or different degrees of operation of the trigger mechanisms  12 / 14  effect such operations. For example, moving the second trigger mechanism  14  half-way initiates clamping while moving the second trigger mechanism  14  further initiates stapling, etc. Additionally, various locks and interlocks are also anticipated and not shown for clarity purposes. 
         [0028]    The rod  16  of the applicator instrument  10  is typically elongated and tubular so that the rod  16  is insertable and fits within a specific orifice of a body, such as the anus and bowel  2  of a human body (see  FIGS. 4-6 ). In some embodiments, the folding cap mechanism  50  is removable from the rod  16 , as shown in  FIG. 1 , while in other embodiments, the folding cap mechanism  50  is fixed to the rod  16  and is not removed during operation (not shown). 
         [0029]    At the insertion end  18  of the rod  16 , one exemplary interface for the folding stapling tip  50  is shown, including a receiver  22  into which the main shaft  58  of the folding stapling tip  50  is inserted and an actuator  20  arm that interfaces with the extension mechanism  66  of the folding cap mechanism  50  (see  FIGS. 2-6 ). It is anticipated that a trigger  12 / 14  of the applicator instrument  10  initiates linear movement of the actuator arm  20  to extend/retract the folding cap mechanism  50 . 
         [0030]    Referring to  FIGS. 2 and 3 , plan views of the folding cap mechanism  50  are shown in a retracted configuration ( FIG. 2 ) and in a configuration ready for stapling tissue ( FIG. 3 ). 
         [0031]    The folding cap mechanism  50  includes any number of extension arms  52 , similar to ribs of an umbrella. Any or all extension arm  52  include one or more staple clinching buckets  54 . The staple clinching buckets  54  function similar to staple clinching buckets on a paper stapler, bending the extending portion of the staples to hold two or more items together (papers for paper staples, tissue for the applicator instrument  10 ). The extension arms  52  rotatably interface to the main shaft  58  by pivots  56 , enabling the extension arms  52  to open/close as would ribs of an umbrella. 
         [0032]    In  FIG. 2 , the extension mechanism  66  is in a retracted position, pulled in a direction of the body portion  8 . In this mode, the extension arms  52  are pulled into the retracted position (as shown in  FIG. 2 ) by angled arms  60  that are connected between the extension arms  52  and the extension mechanism  66  with pivots  62 / 64 . 
         [0033]    In  FIG. 3 , the extension mechanism  66  is in an extended position, moved in a direction away from the body portion  8  a specific distance such that the extension arms  52  are pushed into the extended position (as shown in  FIG. 3 ) to be approximately at right angles with respect to the main shaft  58  by angled arms  60  that are connected between the extension arms  52  and the extension mechanism  66  with the pivots  62 / 64 . 
         [0034]    Referring to  FIGS. 4, 5, and 6 , plan views of the rod of the applicator instrument  10  within a body orifice  2  are shown. In  FIG. 4 , the folding cap mechanism  50  is in a configuration ready for stapling tissue. In  FIG. 5 , the folding cap mechanism  50  is in a configuration ready for extraction from the body orifice, and In  FIG. 6 , the folding cap mechanism  50  is in a second configuration ready for extraction from the body orifice. 
         [0035]    Although there is no limitation of the use of the applicator instrument  10 , the rod  16  of the applicator instrument  10  is shown inserted into an anal opening  2  of a body, for example, a human body. In  FIG. 4 , the folding cap mechanism  50  is extended and, as an example, the bowel  3  is shown being stapled (anastomosis) to the large intestine  5 . After the staple operation is finished, one can see that the resulting opening through which the folding cap mechanism  50  must travel is considerable smaller than the extended extension arms  52  and extraction of the rod  16  of the applicator instrument  10  in this configuration is not possible without the possibility of causing trauma to the anastomosis that potentially results in leakage. After anastomosis, the folding cap mechanism  50  cannot be detached from the rod  16  of the applicator instrument because there is no opening through which the folding cap mechanism  50  can be removed. 
         [0036]    Therefore, the folding cap mechanism  50  is made smaller by retracting the extension arms  52  (like a folded umbrella) as shown in  FIG. 5  or further extending the extension arms  52  (like an umbrella caught in too much wind) as shown in  FIG. 6 . In the configurations of  FIGS. 5 and 6 , it is possible to remove the rod  16  of the applicator instrument  10  with the folded cap mechanism  50 , whereas the folding cap mechanism  50  smoothly transitions through the anastomosis and through the anus  2 . 
         [0037]    In one mode of operation, the rod  16  of the applicator instrument  10  is inserted through the anus and the folding cap mechanism  50  is inserted into the body through a secondary opening and attached to the rod  16  of the applicator instrument  10 . In another mode of operation, the folding cap mechanism  50  is already attached to the rod  16  of the applicator instrument  10  while the rod  16  of the applicator instrument  10  with the folding cap mechanism  50  attached there to is inserted through the anus  2 . 
         [0038]    The extension arms  52  are extended (e.g., to be at approximately right angles to the main shaft  58 ). Tissue, for example, of the bowel  3  is overlapped with tissue of the large intestine  5  and staples are pushed out of the rod  16 , through the tissue  3 / 5  and the ends of the staples are bent by the staple clinching buckets  54 , forming the anastomosis. As the opening in the anastomosis is too small for passing of the extended extension arms  52 , the extension arms  52  are pulled back (as in  FIG. 5 ) or pushed further out (as in  FIG. 6 ) and the rod  16  of the applicator instrument  10  with the folding cap mechanism  50  in a compressed mode is extracted from the anus  2 . 
         [0039]    Any number extension arms  52  and staple clinch buckets  54  are anticipated to provide one row, two rows, in-line, staggered staples as needed for any specific anastomosis. Although, not shown, other capabilities are anticipated such as cutting of the tissue (either before anastomosis or after anastomosis), cauterization, clamping/holding of tissue  3 / 5 , etc. 
         [0040]    Equivalent elements can be substituted for the ones set forth above such that they perform in substantially the same manner in substantially the same way for achieving substantially the same result. 
         [0041]    The extension arms  52  are extended (e.g., to be at approximately right angles to the main shaft  58 ). Tissue, for example, of the bowel  3  is overlapped with tissue of the large intestine  5  and staples are pushed out of the rod  16 , through the tissue  3 / 5  and the ends of the staples are bent by the staple clinching buckets  54 , forming the anastomosis. As the opening in the anastomosis is too small for passing of the extended extension arms  52 , the extension arms  52  are pulled back (as in  FIG. 5 ) or pushed further out (as in  FIG. 6 ) and the rod  16  of the applicator instrument  10  with the folding cap mechanism  50  in a compressed mode is extracted from the anus  2 . 
         [0042]    Any number extension arms  52  and staple clinch buckets  54  are anticipated to provide one row, two rows, in-line, staggered staples as needed for any specific anastomosis. Although, not shown, other capabilities are anticipated such as cutting of the tissue (either before anastomosis or after anastomosis), cauterization, clamping/holding of tissue  3 / 5 , etc. 
         [0043]    Equivalent elements can be substituted for the ones set forth above such that they perform in substantially the same manner in substantially the same way for achieving substantially the same result. 
         [0044]    It is believed that the system and method as described and many of its attendant advantages will be understood by the foregoing description. It is also believed that it will be apparent that various changes may be made in the form, construction and arrangement of the components thereof without departing from the scope and spirit of the invention or without sacrificing all of its material advantages. The form herein before described being merely exemplary and explanatory embodiment thereof. It is the intention of the following claims to encompass and include such changes. 
         [0045]    It is believed that the system and method as described and many of its attendant advantages will be understood by the foregoing description. It is also believed that it will be apparent that various changes may be made in the form, construction and arrangement of the components thereof without departing from the scope and spirit of the invention or without sacrificing all of its material advantages. The form herein before described being merely exemplary and explanatory embodiment thereof. It is the intention of the following claims to encompass and include such changes.