Abstract:
A device for facilitating insertion of a surgical instrument into a human body through an opening in a body wall including a cone-shaped member having a rounded front end, an internal cavity extending inward from a rear edge and a through opening arranged at the front end. At least part of the surgical instrument is received in the cavity such that the surgical instrument is insertable into the body through the opening in the body wall by urging the member through the opening with its front end forward and thereby causing tissue surrounding the opening to spread outward as the member passes through the body wall. The instrument is separated from the member after insertion of the member and the instrument into the body. The member can be removed from the body through same opening through which it was inserted into the body.

Description:
CROSS-REFERENCE TO RELATED APPLICATION  
       [0001]     This application claims priority under 35 U.S.C. §119(e) of U.S. provisional patent application Ser. No. 60/538,940 filed Jan. 23, 2004, the entire disclosure of which is incorporated by reference herein. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates generally to devices and methods for enabling the percutaneous introduction of surgical instruments into the human body and more particularly to devices and methods for introducing blunt surgical instruments, such as a surgical circular stapler or stapler anvil, through the body wall, for example, during intracorporeal creation of a surgical anastomoses in laparoscopic surgical procedures.  
       BACKGROUND OF THE INVENTION  
       [0003]     In a variety of surgical procedures, it is necessary to use a surgical stapler to staple separated internal parts of the body together. For example, in some laparoscopic surgical procedures, it is necessary to create an anastomosis by joining, e.g., separated parts of the intestines, and this is usually accomplished by stapling the separated parts together by means of a surgical stapler.  
         [0004]     During such a laparoscopic procedure, it is difficult to insert the surgical stapler and/or stapler anvil through the laparoscopic incision or opening made in the abdominal or body wall in order to enable the stapler or anvil to be subsequently manipulated to the area in which it is needed to staple the body parts together. In particular, since the size of surgical staplers and anvils varies, the laparoscopic incision might not be large enough for the particular stapler or anvil being used. Moreover, common staplers and anvils usually have a blunt forward end which makes it difficult to introduce them easily through the opening in the body wall.  
         [0005]     An additional problem with the insertion of staplers through an opening in the body wall is that fragments of the tissues around the opening in the body wall can become lodged in the open end of the stapler and cause a subsequent malfunction of the stapling mechanism in the stapler.  
       OBJECTS AND SUMMARY OF THE INVENTION  
       [0006]     Accordingly, it is an object of the present invention to provide a new device and method for facilitating the insertion of a surgical instrument into the body through an opening in the body wall. The invention is particularly useful for facilitating the insertion of blunt surgical instruments, such as a surgical stapler or stapler anvil, into the body through an opening in the body wall.  
         [0007]     It is another object of the present invention to provide a new device and method for facilitating the passage of a surgical instrument through a small opening in the abdominal wall which temporarily spreads the tissues around the opening during passage of the surgical instrument therethrough. In this manner, a surgical instrument which is larger than the size of the opening can be effectively inserted through the opening.  
         [0008]     In order to achieve the above objects and other objects, a device for facilitating insertion of a surgical instrument into a human body through an opening in a body wall in accordance with the invention includes a cone-shaped member having a rounded front end, an internal cavity extending inward from a rear edge and a through opening arranged at the front end. The cavity is dimensioned such that at least a part of the surgical instrument is receivable therein. During use, the surgical instrument, after insertion into the cavity of the member, is inserted into the body through the opening in the body wall by urging the member through the opening with its front end forward and thereby causing tissue surrounding the opening to spread outward as the member passes through the body wall. The instrument is separated from the member after insertion of the member and the instrument into the body. The member and/or instrument can be removed from the body through same opening through which it was inserted into the body.  
         [0009]     The member and cavity can be dimensioned to accommodate different surgical instruments, including but not limited to circular surgical staplers and stapler anvils.  
         [0010]     The through hole is used to enable removal of the member from the body once the instrument is situated in the body. This is achieved by inserting a suture thread, or any human-compatible thread, through the through opening and tying its ends together to form a loop. A part of the loop is maintained outside of the body during the insertion of the member into the body, and then after the instrument is removed from the cavity, the thread outside of the body is grasped and pulled to remove the member from the body. The member is preferably removed from the body with its front end forward.  
         [0011]     A method for introducing a surgical instrument into a body through an opening in a body wall in accordance with the invention entails inserting at least a part of the instrument into a cavity formed in a rear of a cone-shaped member having a rounded front end, inserting the member with the instrument at least partially inserted therein into the body through the opening in the body wall with its front end forward and then separating the instrument from the member after the member and instrument are inserted into the body. Additionally, suture thread may be passed through a through opening in the front end of the member prior to inserting the member into the body so that after the instrument is separated from the member, the member is removable from the body by pulling the suture thread and urging the member out of the body through the opening with its front end forward. For the method, other ways to remove the member from the body are also envisioned.  
         [0012]     Other and further objects, advantages and features of the present invention will be understood by reference to the following specification in conjunction with the annexed drawings, wherein like parts have been given like numbers. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0013]     The invention, together with further objects and advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying drawings, wherein like reference numerals identify like elements, and wherein:  
         [0014]      FIG. 1  is a side view of a device in accordance with the invention.  
         [0015]      FIG. 2  is a cross-sectional view of the device taken along the line  2 - 2  of  FIG. 1 .  
         [0016]      FIG. 3  is a rear perspective view of the device.  
         [0017]      FIG. 4  is a view of the device showing a suture thread through an opening at the front end of the device.  
         [0018]      FIG. 5  is a view showing a surgical stapler and the device in accordance with the invention prior to being coupled together.  
         [0019]      FIG. 6  is a view showing the coupling of a surgical stapler and the device in accordance with the invention in a state in which it is ready for insertion into the body.  
         [0020]      FIG. 7  is a view showing a surgical stapler anvil and the device in accordance with the invention prior to being coupled together.  
         [0021]      FIG. 8  is a view showing the coupling of a surgical stapler anvil and the device in accordance with the invention in a state in which it is ready for insertion into the body. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0022]     Referring to the accompanying drawings wherein like reference numerals refer to the same or similar elements, the device for enabling introduction of surgical instruments in accordance with the invention is designated generally as  10  and has the general shape of a cone or bullet with a rounded front end  12  and arcuate side surfaces  14 . An internal cavity  16  extends inward from a rear edge  18  of the device  10  (see  FIGS. 2 and 3 ) and is designed to accommodate at least part of a surgical instrument to be introduced into the body, such as a surgical stapler or stapler anvil. Cavity  16  may have a generally uniform cross-sectional shape and a substantially planar front wall  20  substantially perpendicular to a longitudinal axis of the device  16 . Thus, one form of the cavity  16  may be substantially cylindrical.  
         [0023]     A through hole  22  is formed at the front end  12  of the device  10  to enable suture thread  24  to pass therethrough, the purpose of which is explained below. The diameter of the through hole  22  may be selected as desired for particularly sized devices  10  and/or suture threads  24 . The through hole  22  preferably defines an axis which is substantially perpendicular to the longitudinal axis of the device  10  such that pulling of the thread  24  results in an even application of force to the device  10  which is beneficial during removal of the device  10  from the body in the manner discussed below. The through hole  22  may be substantially cylindrical, and optionally has flanged openings at one or both ends to better accommodate the suture and facilitate insertion thereof.  
         [0024]     Both the diameter and length of the introducing device  10 , as well as the diameter and depth or length of the cavity  16 , can vary depending on the size of the surgical instrument being introduced into the body. For example, several different sized introduction devices  10  can be produced, each designed for use with one or more commercial staplers or commercial stapler anvils. During surgery, the introduction device compatible with the stapler or anvil being used would then be selected and used in order to introduce the stapler or anvil into the patient. In addition, for abdominal surgical applications, longer devices  10  can be produced to accommodate various sizes (thicknesses) of the abdominal wall, e.g., a longer device would be used for obese patients than for thin patients. Another variation in the construction of the device  10  would be to change the tapering radius of the body  10  and/or front end  12  from that in the illustrated embodiment.  
         [0025]     The device  10  may be formed as a unitary member or body and may be made from surgical grade stainless steel, if a reusable device is desired, or from high density polyethylene or plastic, if a single-use disposable device is desired. A device having the same dimensions can be formed from both stainless steel or polyethylene or plastic to provide the surgeon with options for use of the device.  
         [0026]     For a reusable device, the device would be sterilized prior to each use by conventional methods used in the preparation of surgical instruments. For a disposable device, the device would be supplied in a sterile package and discarded after use.  
         [0027]      FIGS. 5 and 6  show the use of the device  10  in combination with a circular surgical stapler  26 . As shown in  FIG. 5 , the stapler  26  has a blunt open forward end  28  which makes it difficult to surgically introduce the stapler through a small opening in the body wall and can also cause fragments of the tissues around the opening in the body wall to become lodged into the opening in the forward end  28  of the stapler  26 . The tissue fragments could cause the stapling mechanism in the stapler  26  to malfunction.  
         [0028]     As shown in  FIG. 6 , in preparation for use, at least the forward end  28  of the stapler  26  is inserted into the cavity  16  in the device  10  to thereby attach the stapler  26  to the device  10 . Suture thread  24  is then inserted through the through hole  22  until it extends on both sides of the through hole. One end or both ends of the thread  24  would also be fixed or tied external to the patient or the ends of the thread  24  are tied together. The device  10  with attached stapler  26  is then inserted with its front end  12  forward through the opening in the body wall, e.g., a laparoscopic opening in the abdominal wall, while maintaining a portion of the thread  24  outside of the body. Insertion of the device  10  is facilitated by the rounded shape of the front end  12  of the device  10  and the smooth arcuate surfaces  14  which are effective to spread the tissues around the opening outward and enable smooth passage of the device  10  and stapler  26  therethrough.  
         [0029]     Once in the abdominal cavity, the device  10  is removed from engagement with the stapler  26  by pulling on the suture thread  24 . After removal of the device  10 , the stapler  26  is situated in the abdominal cavity and ready for use. The forward end  28  of the stapler  26  has thus been prevented from receiving tissue fragments during its insertion into the abdominal cavity.  
         [0030]     After disengagement from the stapler  26  and removal of the stapler  26  after use, the device  10  is removed from the abdominal cavity preferably with its front end  12  forward, for example, through the same opening through which the device  10  and stapler  26  were inserted into the abdominal cavity. Removal of the device  10  is facilitated by the rounded shape of the front end  12  of the device  10  which spreads the tissues around the opening outward and enable smooth passage of the device  10  therethrough.  
         [0031]     The stapler  26  is also removed from the abdominal cavity after use in a conventional manner, i.e., through the same opening through which it was inserted into the patient.  
         [0032]      FIGS. 7 and 8  show the use of the device  10  in combination with a stapler anvil  30 . The anvil  30  has a blunt forward end  32  (see  FIG. 7 ) which makes it difficult to surgically introduce the anvil through a small opening in the body wall. As shown in  FIG. 8 , in preparation for use, at least the forward end  32  of the anvil  30  is inserted into the cavity  16  in the device  10 . Suture thread  24  is then inserted through the through hole  22  and one end or both ends of the thread  24  are fixed or tied external to the patient or the ends of the thread  24  are tied together. The device  10  with the anvil  30  at least partially received therein, is then inserted through the opening in the body wall with its front end  12  forward, e.g., a laparoscopic opening in the abdominal wall, while maintaining a portion of the thread  24  outside of the body. Once in the abdominal cavity, the device  10  is removed from engagement with the anvil  30  by pulling on the suture thread  24 . After removal of the device  10 , the anvil  30  is situated in the abdominal cavity and ready for use.  
         [0033]     After disengagement from the anvil  30 , the device  10  is removed from the abdominal cavity with its front end  12  forward, for example, through the same opening through which the device  10  and anvil  30  were inserted into the abdominal cavity. The anvil  30  is also removed from the abdominal cavity after use in a conventional manner, i.e., through the same opening through which it was inserted into the patient.  
         [0034]     Advantages of the use of the device  10  to insert surgical instruments into the body, such as a surgical stapler and stapler anvil, include a reduction in the time and effort required to introduce the surgical stapler or stapler anvil into the body, a reduction in the trauma caused to the tissue around the opening through which the surgical stapler or stapler anvil is inserted into the body, an improvement in the ergonomic position of the surgeon during the introduction of the surgical stapler or stapler anvil and the prevention of the entrapment of tissues of the body wall surrounding the opening with the stapler mechanism. In addition, the size of the opening in the body wall can be made quite small since the spreading action of the device  10  effectively, but only temporarily, expands the opening to allow the surgical stapler or stapler anvil to pass therethrough.  
         [0035]     While the invention has been described above with respect to specific apparatus and specific implementations, it should be clear that various modifications and alterations can be made, and various features of one embodiment can be included in other embodiments, within the scope of the present invention. For example, although the invention is described above for use in connection with surgery on humans, it can be used for animals. It can also be used to facilitate the insertion of surgical instruments into any part of the body and is not limited to insertion of surgical staplers and stapler anvils into the abdominal cavity. Moreover, although sometimes described for use in connection with laparoscopic openings, the invention can be used to insert surgical instruments through other types of openings in the body or body wall.