Abstract:
The anvil introducer mechanism facilitates the laparoscopic introduction of an anvil, whether for use with a circular stapler (e.g., Ethicon™ stapler) or for use with an Autosuture EEA device, into the abdominal cavity and into the lumen of the stomach or intestine and the placement of such an anvil where desired by the operator. An advantage is that the anvil introduction mechanism greatly eases the passing of an anvil through an abdominal wall and into a particular location in the stomach or intestine. Furthermore, such an introduction mechanism is amenable to use in a laparoscopic procedure and can be readily introduced to a body through a trocar.

Description:
CROSS REFERENCE TO OTHER APPLICATIONS  
       [0001]     This application claims priority to U.S. Provisional Patent application 60/542,693, filed Feb. 6, 2003, and which is hereby explicitly incorporated by reference. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     1. Field of the Invention  
         [0003]     The present invention relates to an anvil introduction mechanism for use with a surgical stapler, and more particular, for use with a circular stapler in stapling portions of the stomach and/or intestines.  
         [0004]     2. Description of the Related Art  
         [0005]     Laparoscopy is now being used as a less intrusive means of performing bariatric and other surgery such as gastric bypass and of executing colon resections. A key step in laparoscopy and even in open gastrointestinal surgery has been creating successful tissue connections/closures.  
         [0006]     Tissue connections (e.g., stomach to intestine; intestine to intestine) are typically often made using a circular stapler in conjunction with an anvil. Such an anvil has a base portion and a projecting portion. The base portion remains behind a first layer of tissue to be connected for later helping bend a staple during stapling to create a connection with that first layer. Meanwhile, the projecting portion is inserted into and through that same first layer of tissue. This projection can then be targeted with the circular stapler to facilitate connection of a second tissue layer to said first layer.  
         [0007]     Two different types of generally anvils are used. One is an Ethicon™ anvil available from Ethicon, Inc. of Somerville, N.J., with a female projecting portion and the other is an Autosuture™ anvil available from U.S. Surgical of Norwalk, Conn., having a male projecting portion. This female or male projecting portion is able to connect with a mating portion associated with a selected circular stapler or other connector system, for example Autosuture EEA device. By correctly orienting and connecting the anvil and stapler together, appropriate stapling of tissue segments can be ensured.  
         [0008]     Some difficulty has been had in locating, positioning, and controlling the anvil during the stapling procedure. One bariatric procedure has involved introducing the anvil via the esophagus to the appropriate location. This method of introduction has proven to be difficult, especially in achieving the most preferred placement of the anvil. What is needed is an apparatus or device which better facilitates the preferred placement of anvils and which could be used as part of a laparoscopic process and procedure.  
       SUMMARY OF THE INVENTION  
       [0009]     The anvil introducer mechanism of the present invention facilitates the laparoscopic introduction of an anvil, whether for use with a circular stapler (e.g., Ethicon™ stapler) or for use with an Autosuture™ EEA device, into the abdominal cavity and into the lumen of the stomach or intestine and the placement of such an anvil where desired by the operator.  
         [0010]     An advantage of the present invention is that the anvil introduction mechanism greatly eases the passing of an anvil through an abdominal wall and into a particular location in the stomach or intestine. Furthermore, such an introduction mechanism is amenable to use in a laparoscopic procedure and can be readily introduced through a trocar.  
         [0011]     Another advantage of the present invention is that the anvil introduction mechanism employs a controllable, flexible arm to allow a high degree of maneuverability.  
         [0012]     Yet another advantage of the present invention is that any various handle mechanisms which provide for appropriate motion control of the arm and which provide for the controlled detachment/release of an anvil carried thereby may potentially be employed. This ability to potentially employ any of a variety of appropriate handle mechanisms would allow surgeons to choose a handle mechanism with which they feel most comfortable and assured in controlling.  
         [0013]     An additional advantage of the present invention is that any of a variety of control/release anvil holding mechanism may potentially be used. Such a holding mechanism may be for example, magnetic, suction-based, mechanically gripping, and/or frangible in nature.  
         [0014]     A further advantage of the present invention is that, while being especially useful for laparoscopic procedures such as gastric bypass, colon resections, and gastronomy, the use thereof can be readily extended to any surgical procedure in which a circular stapler or an autosuture mechanism might be employed.  
         [0015]     Another advantage of the present invention is that the anvil introducer permits precise location in an anvil in a desired location. The new anvil introducer is operable with both types of anvils (male and female).  
         [0016]     Yet another advantage of the present invention is that it can potentially be made to be inexpensive enough so that at least portions such as the arm and holding mechanisms can be made to be disposable so as to avoid the potential for transmitting foreign material from one patient to another via the anvil introduction mechanism. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0017]     The above-mentioned and other features and advantages of this invention, and the manner of attaining them, will become more apparent and the invention will be better understood by reference to the following description of the embodiments of the invention taken in conjunction with the accompanying drawings, wherein:  
         [0018]      FIG. 1  is a side view of a flexible anvil introduction mechanism of the first embodiment of the present invention;  
         [0019]      FIG. 2  is a side view of the flexible anvil introduction mechanism shown in  FIG. 1 , with the flex arm moved into an angular/flexed position;  
         [0020]      FIG. 3  is a side view of a second embodiment of an anvil introduction mechanism of the present invention;  
         [0021]      FIG. 4  is a side view of a third embodiment of an anvil introduction mechanism of the present invention;  
         [0022]      FIG. 5  is a diagramic side view of a prior art Ethicon™ female anvil;  
         [0023]      FIG. 6  is a diagramic side view of a prior art Autosuture™ anvil; and  
         [0024]      FIG. 7  is a schematic side view of a laparoscopic, bariatric surgery procedure employing the anvil introduction mechanism of  FIGS. 1 and 2 . 
     
    
       [0025]     Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrates at least one preferred embodiment of the invention, in one form, and such exemplifications are not to be construed as limiting the scope of the invention in any manner.  
       DETAILED DESCRIPTION OF THE INVENTION  
       [0026]     FIGS.  14  illustrate three different embodiments of an anvil introduction mechanism, generally  10 , more specifically  10   a - 10   c  for introducing an anvil, generally  12 , more specifically either a female (e.g., Ethicon™) anvil  12   a  or a male (e.g., Autosuture™) anvil  12   b  into an appropriate location within the body and most likely, to a location within the gastrointestinal tract.  FIGS. 1 and 2  illustrate a flexible arm anvil introduction mechanism  10   a . Meanwhile  FIGS. 3 and 4  illustrate a second ( 10   b ) and third ( 10   c ) embodiment, respectively, of an anvil introduction mechanism to locate the anvil  12 .  
         [0027]     In the preferred form of the invention ( FIGS. 1-2 ), flexible arm anvil introduction mechanism  10   a  includes a control handle  14 , a flex arm  16 , and a releasable attachment mechanism  18 .  
         [0028]     Control handle  14  is configured for providing an appropriate motion control of the flex arm  16  releasable attachment mechanism  18  combination and for the controllable release of anvil  12   a ,  12   b  once suitably placed (if necessary). Any of a variety of particular handle mechanisms which are able to provide for one or both of these functions may be employed, thereby allowing surgeons to choose a handle mechanism  14  which with they feel most comfortable and assured in using. Such handle mechanisms may include flex tube controllers, or even simple flexible wire or bendable constructs (for example large gauge wire), that would permit operator control of the placement of anvil  12 . Some handles and embodiments of invention may include no remote releasement mechanism from anvil  12 .  
         [0029]     The flex arm/attachment mechanism combination, along with the anvil  12   a ,  12   b  carried thereby, are together sized to fit through a trocar as typically employed in a laparoscopic procedure. Flex arm  16  is configured for both its flexibility and its controllability, thereby allowing an anvil  12   a ,  12   b  to be both easily and precisely guided into place. As per the design of this first embodiment ( FIGS. 1-2 ), the flex arm actually guides/pushes anvil  12   a ,  12   b  from behind and into the desired location. It is to be understood that flex arm  16  can be produced so as to have any of a variety of desired lengths and potentially be controllably expandable/contractible along its length so as to facilitate its travel to the desired location and back out of the body. Flex arm  16  includes a first arm end  15  and second arm end  17 . Releaseable attachment mechanism is located and associated with second arm end  17 , while handle  14  is located and associated with first arm end  15 .  
         [0030]     Releasable attachment mechanism  18  is configured to retain anvil  12   a ,  12   b  upon flex arm  16  up until the point at which it is desired to release it after having been placed into the desired location (e.g., the position within of the stomach and/or intestine where stapling is desired). It is important that the releasable attachment mechanism  18  be reliable in this manner, as it is not desired be allowed for an anvil  12  to be accidentally released prior to reaching its desired location. It is understood that any one of a variety of potential means may be employed to achieve the desired control-release by the anvil holding mechanism. Such means may be, for example, magnetic, suction-based, mechanically gripping, interference fit, push-pull rod, frangible, or snap-locking in nature. Since there is a potential for an anvil  12   a ,  12   b  to be inadvertently released prior to being located in the appropriate spot, it may prove useful to choose a holding means which may allow for a grip to be easily re-established with an anvil  12   a ,  12   b . A magnetic means would be preferable in this regard, and is one aspect of the present invention.  
         [0031]     Second and third embodiments  10   b ,  10   c  of the anvil introduction mechanism of the present invention are very similar in nature in that both are configured for placing an anvil  12   a ,  12   b  into a desired location, with anvil  12   a ,  12   b  being released once such a location is reached. The second and third embodiments differ from each other in that the second embodiment is configured for carrying a male anvil  12   b  ( FIG. 3 ), while the third embodiment  10   c  is designed for carrying a female anvil  12   a  ( FIG. 4 ). The second embodiment of the anvil introduction mechanism  10   b  includes a carrying rod  20   a , a receiver portion  22   a , and a mechanical release control  24   a . In a similar fashion, third embodiment  10   c  ( FIG. 4 ) of the anvil introduction mechanism includes a carrying rod  20   b , a male receiver portion  22   b , and a mechanical release control  24   b . Male receiver portion  22   b  interfits within the female portion of anvil  12   a.    
         [0032]     Carrying rod  20   a ,  20   b  provides a mechanism by which the particular anvil introduction mechanism  10   b ,  10   c  pushed through a trocar opening, into and through a desired location in a wall of the stomach and/or intestine and, after release of anvil  12   a ,  12   b , eventually therefrom on out through a particular trocar opening. At one distal end of a carrying rod  20   a ,  20   b  is a receiver portion  22   a ,  22   b , while at the opposing distal end has a mechanical release control  24   a ,  24   b , respectively.  
         [0033]     Receiver portion  22   a ,  22   b  and mechanical release control  24   a ,  24   b  are able to work together to ensure that the anvil  12   a ,  12   b  is retained upon receiver portion  22   a ,  22   b  until the desired release location is reached. Receiver portion  22   a  is female in nature so that it may carry a male anvil  12   b  thereupon, while receiver portion  22   b  is a male connector in order to transport a female anvil  12   a  therewith. In relation to the anvil introduction mechanism of the second and third embodiment, it is considered desirable for the anvil  12   a ,  12   b  initially to form a snap fit in relation to receiver portion  22   a ,  22   b . The receiver portion  22   a ,  22   b  is configured to have the means to releasably grip an anvil  12   a ,  12   b . Any of a variety of gripping/holding means may be used for this purpose, but it is advantageously conceived that the particular means for holding may allow for the extrusion of the anvil therefrom upon arriving at the appropriate location. It is contemplated that the mechanical release control  24   a ,  24   b  may, for example, take the form of a push button, push bar, or a twist-control device which will achieve the desired controllable release of anvil  12   a ,  12   b  from receiver portion  22   a ,  22   b.    
         [0034]     Each anvil  12   a ,  12   b  includes an anvil base  26  and an anvil projection  28 . This anvil base  26  facilitates the bending of a staple inserted via a circular stapler schematically in  FIG. 7  as part  30 . Anvil base  26  is wide enough (typically 25 mm in diameter) so as to both facilitate the appropriate bending of a given staple (not shown) and to ensure that the anvil will not be drawn through a particular opening in the wall of the intestine and/or stomach of where it is located and stapling is desired. Anvil projection  28  is configured so as to be able to be inserted through the wall of the stomach and/or intestine and to in turn then act as a locating means for the placement of the circular stapler so as to ensure the desired staple location is met. Such an anvil projection  28  is typically 2 inches in length.  
         [0035]     The anvil locator of the present invention may be contructed of autoclavible materials and metals, or may be constructed primarily of plastic, as a single use and dispose of, style instrument.  
         [0036]     An example of the invention, is shown in a bariatric surgery example shown in  FIG. 7 . The first step of this procedure is to, within stomach  32 , create a pouch  34 . Next, stomach  32  has a stomach cut  36  formed therein (either with a blade or tocar) to permit insertion of anvil  12   a ,  12   b  with flexible arm anvil introduction mechanism  10   a . A tocar (not shown) may be used to insert anvil introduction mechanism. Introduction mechanism  10   a  and anvil  12   a ,  12   b  is directed along an anvil path  38  to an appropriate anvil location  39  within the wall of stomach  32 . Having located anvil  12   a ,  12   b , small intestine  40  is provided with a small intestine cut  42  through which a circular stapler  30  may be introduced. Such a small intestine cut  42  is made with the appropriate instrumentation (not shown) provided through a trocar  41 . Given the tight fit of the circular stapler  30 , its introduction requires the removal of trocar  40 . After having provided for appropriate insertion of circular stapler  30 , small intestine  40  can then be located on pouch  34 . Upon doing so, circular stapler  30  is then located and connected to anvil  12   a ,  12   b , and small intestine  40  is then attached to pouch  34  via stapling. After stapling both the stapler, anvil  12  and anvil introducer may be removed from the location.  
         [0037]     While this invention has been described as having a preferred design, the present invention can be further modified within the spirit and scope of this disclosure and additionally be used on other body parts. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.