Abstract:
The present invention comprises a surgical implement guide sized for insertion into and compatible with tissues. The invention includes a hollow shaft formed of a flexible material with memory to return to a predetermined configuration, where the shaft defines a central passageway of variable inside diameter and is adapted to receive a catheter or other surgical tool or instrument. The central passageway terminates in an access opening and allows for insertion and removal of the catheter or tool An elongated tab member having at least one surface or portion thereof which is textured extends from the shaft, and positioned adjacent the access opening, acting as a handle to assist the user in removing the catheter. A tip is included opposite the tab to assist in the insertion of the guide, and thus the catheter or tool.

Description:
TECHNICAL FIELD OF THE INVENTION 
     This invention relates to a surgical implement guide and more particularly to a flexible guide used to percutaneously introduce a surgical instrument, including a cannula and a trocar, into or through various tissue. 
     BACKGROUND OF THE INVENTION 
     Peritoneal dialysis is a procedure in which a sterile glucose and salt solution is placed into the peritoneal cavity. The solution plus impurities are removed from the blood at some later time and fresh fluid is reinfused or the cycle can repeat itself. Peritoneal dialysis is effective for treatment of kidney failure and has been used for more than 30 years for this purpose. 
     One of the most successful devices used for peritoneal dialysis is the Tenckhoff catheter developed in the mid 1960&#39;s. This catheter is a silicon rubber tube with numerous drainage holes on its inner portion. Generally, the catheter has two polyester (e.g. Dacron R ) “cuffs” which are respectively placed in the subcutaneous tissue and the muscle layer of the patient. These cuffs serve to limit peritoneal leakage, minimize infection and enclose the catheter in the body. The issue arises in the placement of the catheter. 
     Likewise, insertion of catheters into blood vessels is frequently accomplished percutaneously, where a needle with a guide wire is used to initially enter the vessel, rather than use a surgical cut-down procedure. Early procedures used the puncture needle itself as the direct conduit into the abdomen or a blood vessel for a catheter of sufficiently small diameter. 
     Subsequent art first developed metal sheaths and/or trocars that were formed with a slot, or were split into two distinct pieces for subsequent removal. Rapid development in the art substituted thin-walled plastic sheaths, or other suitable material, for the metal sheaths. The most common such prior art sheath is generally known as a “split sheath”. It consists of a cylindrical sheath which, at the distal end is formed to taper to a small diameter opening to permit insertion of a guide wire. The opposing proximal end typically has two handles or finger stops formed on opposing sides of the sheath. Score marks are formed along the full length of the sheath and are designed to cause the guide to split apart when the handles are pulled, facilitating the removal of the guide from the body. 
     The process of implanting a catheter with this type of split sheath is called the Seldinger Technique. Specifically, in this technique a needle is inserted into a blood vessel. A stainless steel braided wire is then inserted through the needle into the blood vessel, and then the needle is retracted. 
     The catheter is inserted into the sheath and the opposite or trailing edge of the wire is inserted into the distal opening of the sheath. The wire is pushed through the distal end of the catheter and out the proximal end. Then the sheath with the catheter is pushed into the blood vessel, using the wire as a guide. The cone-shaped end of the guide/sheath enters the vessel wall so that the main body of the sheath can be inserted into the blood vessel. After the majority of the sheath, preferably between about 75% to about 80%, is inserted into the vessel, the wire is removed by pulling it out through the sheath tip. 
     The physician then grasps the handles and simultaneously pulls them apart one from the other, causing the sheath to split. While the sheath is being split, it is simultaneously retracted from the blood vessel. It should be noted that retracting the sheath may cause the catheter to be inadvertently retracted during this step. If so, then the catheter must be advanced again back to its original position. The same procedure is utilized to gain access to the peritoneal region. 
     The process of splitting, retracting, and readvancing is repeated as necessary until the sheath is totally removed, and the catheter fully and accurately positioned. If the catheter does inadvertently come out at any point during the process, the entire process must be repeated, beginning with the insertion of the needle. 
     Generally, during the process, the sheath becomes covered in fluid, making it difficult to grasp. Thus, the above discussed sheaths have a disadvantage in that both hands must be employed to remove the sheath, leaving the catheter unattended, unless an assistant is present. In some instances, it was found that pulling on the sheath caused it to tear prematurely. Another example of a split sheath is disclosed in Y.TEC&#39;s Peritoneoscopic Placement of Peritoneal Dialysis Catheters. This sheath attempts to solve some of the disadvantages of the prior art, displaying a guide with a tip and a substantially flat tab. The tab is substantially flat and smooth and can be difficult to grab when it becomes covered in fluid. Again, both hands must be employed, or some other device, such as a hemostat, must be used. 
     Another disadvantage is that such prior art sheaths tend to be of a predetermined specific diameter which is not adjustable. These sheaths generally don&#39;t provide alternatives, nor are they adaptable to accommodate different types of catheters, trocars, or instruments, or even patient situations. 
     SUMMARY OF THE INVENTION 
     The present invention provides a device which overcomes the above discussed problems using a surgical implement guide sized for insertion into tissue. The guide includes a shaft formed of a flexible material with memory to return to a predetermined configuration, or with ability to have a new or different memory set into it, an opening and passage way of infinitely adjustable dimensions between a predetermined minimum and maximum dimension extendable through the entire length of the shaft and an elongated tab member having at least one textured surface extending from the shaft that acts as a handle for placing, removing or controlling the guide. 
     In particular, the present invention comprises a surgical implement guide sized for insertion into tissue and a surgical assembly employing the guide. The guide includes a shaft formed of a flexible material with memory to return to its predetermined configuration. The shaft is adapted to receive a catheter in a chamber defined in the shaft. Moreover, the shaft includes an elongated tab member, preferably a tab integral with the shaft, extending from the shaft that is used as a handle to both place, control and remove the guide. 
     The guide further includes an opening and passageway of adjustable dimensions as well as a tip portion for the shaft. Preferably the tip is integral with the shaft. The passageway preferably extends axially the entire length of the shaft, although some lesser distance can be utilized depending on the application as long as it allows for removal of the catheter. The tip is situated opposite the elongated tab member. The tip configuration can vary and is selected to assist in the insertion of the guide. 
     The guide may have many different forms to accommodate different surgical instruments, surgical procedures, patients or surgeons. The tab member can be integral with the shaft or joined thereto, and have a width substantially equal to or less than an outer circumference of the shaft. The tab can be substantially flat, curved or pointed in relation to the shaft and rectangular, angled or curved in shape. Moreover, the guide and the tab can have at least one smooth surface and one textured surface, or portion thereof, or two textured surfaces or portions thereof. 
     Likewise, the tip and shaft configurations can vary depending on the application. The tip can have an outer diameter substantially equal to or less than the outer diameter of the shaft, so that the tip is pointed, blunted, round, angled or even curved in some fashion. Furthermore, the shaft&#39;s outer diameter can be substantially the same over its entire length, so that it is substantially cylindrical in shape, or it can vary over the length of the shaft so that it is substantially conical or truncated in shape. 
     Numerous other advantages and features of the present invention will become readily apparent from the following detailed description and from the accompanying drawings. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     In the drawings, 
     FIG. 1 is a top plan view of a surgical implement guide in accordance with the present invention; 
     FIG. 2 is a side elevational view of the surgical implement guide of FIG. 1; 
     FIG. 3 is an end view of the surgical implement guide of FIG. 1; 
     FIG. 4 is an end view of the surgical implement guide of FIG. 2; 
     FIG. 5 is a cross-sectional view of the surgical implement guide of FIG. 1 taken substantially along line  5 — 5 ; 
     FIG. 6 is a side elevational view of a first alternate embodiment of the surgical implement guide of FIG. 1; 
     FIG. 7 is a top plan view of the surgical implement guide of FIG. 6; 
     FIG. 8 is a top plan view of second alternate embodiment of the surgical implement guide of FIG. 1; 
     FIG. 9 is a side elevational view of the second alternate embodiment of the surgical implement guide of FIG. 8; 
     FIG. 10 is a top plan view of third alternate embodiment of the surgical implement guide of FIG. 1; 
     FIG. 11 is a side elevational view of the third alternate embodiment of the surgical implement guide of FIG. 10; 
     FIG. 12 is a top plan view of fourth alternate embodiment of the surgical implement guide of FIG. 1; 
     FIG. 13 is a side elevational view of the fourth alternate embodiment of the surgical implement guide of FIG. 12; 
     FIG. 14 is a side elevational view of fifth alternate embodiment of the surgical implement guide of FIG. 1; 
     FIG. 15 is a bottom plan view of the fifth alternate embodiment of the surgical implement guide of FIG. 14; 
     FIG. 16 is a perspective view of the surgical implement assembly including the trocar in accordance with the present invention; 
     FIG. 17 is an exploded view of the assembly of FIG. 16 depicting the guide and trocar with the obturator removed from the cannula; 
     FIG. 18 is a perspective view of the scope used with the cannula; 
     FIG. 19 is an enlarged partial view of the tip of the guide, with the tip turned in towards the chamber; 
     FIG. 20 is an enlarged partial view of the tip of the guide, with the tip secured by the trocar; 
     FIG. 21 a schematic representation of the assembly of FIG. 16 being used on a patient; 
     FIG. 22 is a schematic representation of the guide implanted in the patient; 
     FIG. 23 is a schematic representation of the dilator used with the guide; 
     FIG. 24 is an enlarged partial view of the dilator and guide of FIG. 23; 
     FIG. 25 is a schematic representation of the flexible catheter inserted through the guide of FIG. 16; 
     FIG. 26 is an enlarged partial view of the flexible catheter and guide of FIG. 25; and 
     FIG. 27 is a schematic representation of the final implanted position of the flexible catheter of FIGS.  25  and  26 . 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Turning now to FIGS. 1 and 2, a surgical implement guide, generally designated  10 , is shown sized for percutaneous insertion into tissue in accordance with the present invention. As shown in FIGS. 1 and 2, guide  10  includes an elongated shaft  12  formed of a flexible material with memory to return to an original configuration. Any suitable material, such as biocompatible polyurethane, is contemplated. In one preferred embodiment, shaft  12  is comprised of polypropylene or other similar material, and may either be clear, opaque or tinted. 
     It is contemplated that guide  10  could be of any length, however it is preferred that guide  10  be between about 4 inches and about 24 inches long, where shaft  12  is preferably between about 1 inch and about 22 inches in length. Shaft  12  is shown with an outer surface  14  and opposed proximal and distal ends  16  and  18 , where it is contemplated that proximal end  16  is straight or flared, and where shaft  12  is adapted to receive a catheter (not shown) or other suitable device in a passageway defined therein (best illustrated in FIG.  5 ). 
     An opening or slot  20  is defined in shaft  12 , to allow for expansion and compression of the guide  10  and to allow for insertion and removal of the catheter into and from the body. As provided above, shaft  12  is formed of a flexible material allowing opposing sides  24  of shaft  12  to slidably pass one over the other so that the guide  10  may be “rolled” into a diameter slightly smaller than its normal diameter prior to insertion into tissue. As guide  10  is formed of a material with memory to return to its original configuration, guide  10  will be biased to return to its original shape. 
     The dimensions of slot  20  are adjustable depending on the length of the shaft  12 , so that slot  20  is extendable through the entire length thereof. In one preferred embodiment, slot  20  axially extends from proximal end  16  to distal end  20  as shown in FIG. 1, providing for easy insertion and removal of the catheter. However, it is also contemplated that slot  20  may not extend the entire length of the shaft  12 , but extend some lesser distance. Moreover, end  16  can be straight or flared to accommodate and/or encapsulate the catheter. 
     Moreover, it is contemplated that shaft  12  can have more than one slot  20 , preferably parallel to each other, although other arrangements are contemplated, which are used to position the guide  10 , place the catheter, or position tools used to place the catheter. 
     An elongated tab member  26  extends from proximal end  16  of shaft  12 , where the elongated member  26  acts as a tab or handle, providing a sure grip for the user during insertion or withdrawal of the guide  10 , or removal of the catheter therefrom. As depicted, elongated member  26  is a tab  28  joined to shaft  12  at proximal end  16 , in one preferred embodiment, tab  28  is formed integral with shaft  12 . 
     FIG. 1 illustrates a tab  28  which is substantially rectangular in shape, having proximal and distal ends  30  and  32  respectively, where distal end  32  is connected to, and preferably integral with, proximal end  16 . While a rectangular embodiment is depicted for tab  28 , many shapes are contemplated, including an angled or curved tab. Tab  28  could further be formed with a blunt proximal end  30  suitable to push the guide  10  into the tissue, or tab  28  could be flared to accommodate and encapsulate various hubs, knobs, etc. 
     It is further contemplated that tab  28  is substantially curved or flat depending on the application. In one embodiment, depicted in FIGS. 1 and 2, tab  28  has a width less than the outer circumference of the shaft  12 , so that tab  28  is substantially flat (best seen in FIGS.  3  and  4 ). While tab  28  has a slight curve when viewed from the end, it is substantially fiat in relation to shaft  12 . Moreover, other embodiments are contemplated in which tab  28  has a width substantially equal to the outer circumference of shaft  12 . 
     Tab  28  is formed with two surfaces, first and second surfaces  34  and  36  respectively. As provided above, tab  28  acts as a handle, providing a sure grip for the user during insertion or withdrawal of the guide  10 , or removal of the catheter therefrom. Therefore, it is contemplated that tab  28  has at least one surface with a texture on all or portion thereof, first surface  34  for example (or second surface  36 ), which would provide a non-slip surface to assure a good grip. In this instance, the other surface, second surface  36  would be smooth. Alternatively, it is contemplated that all or a portion of first and second surfaces  34 ,  36  could be textured, or that first surface  34 , for example, could be texture and only a portion of second surface  36  textured, all to provide a good gripping surface. 
     Turning to FIGS. 3-5, more detail is provided on the chamber. FIGS. 3 and 4 depict an end view of the guide  10  of FIGS. 1 and 2, respectively. In addition to the outside surface  14 , shaft  12  includes a shaft wall  38 , with an inner surface  40  defining passageway or chamber  42 . In the preferred embodiment, outer surface  14  is merged with, and is integral, with second surface  36  while inner surface  40  merges with first surface  34 . Additionally, guide  10  includes a first opening  43  defined by edges  44  and  45  at proximal end  16 . Edges  44  and  45  provide a convenient abutment which coacts with the instrument or catheter within the guide  10 . This arrangement provides visual confirmation of the encapsulation of the instrument or catheter. 
     FIG. 5 is a cross-sectional view of the guide  10  of FIG. 1 taken substantially along line  5 — 5  thereof. FIG. 5 reveals that slot  20  is formed in shaft wall  38  of shaft  12  and in fluid communication with chamber  42 . In this manner, a catheter can be passed through slot  20  into chamber  42  and retained therein. FIG. 5 further reveals that shaft  12  can be rolled into the smaller diameter so that opposing sides  24  slidingly pass one over the other. 
     Turning back to FIGS. 1 and 2, it will be appreciated that guide  10  further includes a tip  46  having proximal and distal ends  48  and  50 , located opposite tab  28  at shaft distal end  18 . While it is understood that tip  46  can be joined to guide  12  by bonding, gluing or the like, it is preferred that tip  46  is integral with guide  12 . Moreover, it is preferred that slot  20  could extend through tip  46  into, and in fluid communication with, tip opening  52  defined at tip distal end  50 , where tip opening  52  is in fluid communication with chamber  42 . However, it is also contemplated that slot  20  could terminate proximate shaft distal end  18  as discussed above. 
     As evidenced by the FIGURES, it is contemplated that tip  46  could have a large variety of configurations depending on the application. It is also contemplated that tip  46  could be designed so that it fits snugly around or fully encloses the catheter. 
     As provided above, tip  46  can be pointed, rounded, angled or blunted depending on the application. In one embodiment, it is contemplated that tip  46  has an outer diameter substantially equal to an outer diameter of shaft  12 , so that shaft  12  and tip  46  are substantially cylindrical in shape. However, in the preferred embodiment tip  46 , as shown in FIGS. 1 and 2, has an outer diameter less than the outer diameter of shaft  12  so that tip  46  is pointed, even tapering to a virtually closed point, to allow easy insertion into the tissue or bent in towards the chamber  42  as shown in FIG.  16 . Tip  46  could also have a smaller outer diameter than shaft  12  and yet not be as pointed as depicted, i.e., tip  46  could be angled, blunted or rounded. 
     Similarly, it is contemplated that shaft  12  could have many configurations depending on the application. In one embodiment, as depicted in FIGS. 1 and 2, it is contemplated that the outer diameter of shaft  12  is substantially the same over its entire length, so that shaft  12  is substantially cylindrical in shape. However, it is also contemplated that the outer diameter of shaft  12  varies over the length of the shaft  12 . For example, the outer diameter of shaft  12  at proximal end  16  could be greater than the outer diameter at distal end  18  so that shaft  12  is substantially conical or truncated. 
     Turning now to FIGS. 6 and 7, an alternate embodiment of the guide  10  of FIGS. 1-5 is depicted. Correspondingly, where appropriate, the last two digits in the  200  series of numerals depicted in FIGS. 6 and 7 are connected to elements which have the same function and/or structure as those described with regard to FIGS. 1-5. 
     FIGS. 6 and 7 depict a guide  210  similar to guide  10  of FIGS. 1 and 2, however tip  246  and tab  228  differ from tip  46  and tab  28 . As depicted, tab  228  is shown with tab proximal end  230  having a more blunted appearance (best seen in FIG. 7) than proximal end  30  (best seen in FIG. 2) providing a better holding surface for pushing guide  210  into the tissue when compared with guide  10 . Additionally, tab distal end  232  has a more blunted or squared appearance when compared to the distal end  32 . 
     Tip  246  also differs from tip  46 . Tip  246  is not as pointed as tip  46 , instead tip  246  has a blunted distal end  250  in addition to a concave transition portion  254  which is in communication with both proximal and distal ends  248  and  250 . Transition portion  254 , in combination with slot  220 , provides for easier insertion of the guide into the body. The bevel formed by converging edges  243  accommodates manufacturing tolerance variations. 
     Like guide  10 , guide  210  is formed so that first opening  343  is defined by edges  244  and  245  in fluid communication with chamber  242 . Edges  244  and  245  also provide a convenient abutment which coacts with the instrument or catheter within the guide  210 . Again, this arrangement provides visual confirmation of the encapsulation of the instrument or catheter. 
     Yet another alternate embodiment of the present invention is revealed in FIGS. 8 and 9. Correspondingly, where appropriate, the last two digits in the 300 series of numerals depicted in FIGS. 8 and 9 are connected to elements which have the same function and/or structure as those described with regard to FIGS. 1-7. 
     FIGS. 8 and 9 depict a guide  310  similar to guide  10  and  210  of FIGS. 1,  2 ,  6  and  7 , however here again tip  346  is different. As depicted, tab  328  is shown with tab proximal end  330  having a blunted appearance (best seen in FIG. 9) than distal end  30  (best seen in FIG. 2) providing a better surface for holding guide  310  in the tissue when compared with guide  10 . Additionally, tab distal end  332  has a more blunted or squared appearance when compared to the distal end  32 . Edges  344  and  345  define opening  343  and provide an abutment similar to that provided by edges  44  and  45  shown in FIG.  1 . 
     Tip  346  also differs from tips  46  and  246 . Tip  346  is not as pointed as tip  46 , instead tip  346  has a more angled appearance in addition to having a convex transition portion  354  which is in communication with both proximal and distal ends  348  and  350 . As shown in FIGS. 8 and 9, tip opening  352  is larger than tip opening  52  but smaller than tip opening  252 . Tip opening  352 , in combination with transition portion  354  and slot  320 , provides for easy insertion of the guide. 
     FIGS. 10 and 11 depict a third alternate embodiment of the present invention similarly to the guide  310  of FIGS. 8 and 9. Correspondingly, where appropriate, the last two digits in the 400 series of numerals depicted in FIGS. 10 and 11 are connected to elements which have the same function and/or structure as those described with regard to FIGS. 1-9. 
     FIGS. 10 and 11 depict a guide  410  with tab  426  and similar to guide  310  of FIGS. 8 and 9, however again tip  446  is different, having a more angled convex transition portion and larger tip opening  452 . Edges  444  and  445  provide an abutment which coacts with the instrument or catheter within the guide similar to edges  44  and  45 . As shown in FIGS. 10 and 11, tip opening  452  is larger than tip opening  52  and  352  but smaller than tip opening  252 . Tip opening  452 , in combination with transition portion  454  and slot  420 , provides for easy insertion of the guide  410 . It is also contemplated that tip  446  could be designed so that it fits snugly around or fully encloses the catheter. 
     Turning now to FIGS. 12 and 13 yet another alternate embodiment of the present invention is revealed. Correspondingly, where appropriate, the last two digits in the  500  series of numerals depicted in FIGS. 12 and 13 are connected to elements which have the same function and/or structure as those described with regard to FIGS. 1-11. 
     FIGS. 12 and 13 depict a guide  510  with tab  526  similar to guides  10 ,  210 ,  310  and  410  above, however again tip  546  differs. As depicted, tab  528  is shown with tab proximal end  530  having a blunted appearance (best seen in FIG. 13) than distal end  30  (best seen in FIG. 2) providing a better surface for holding guide  510  in the tissue when compared with guide  10 . Additionally, tab distal end  532  has a more blunted or squared appearance when compared to the distal end  32 . Edges  544  and  545  also define opening  543  and provide an abutment which coacts with the instrument or catheter within the guide  510  similar to the edges discussed above. 
     Tip  546  also differs from tips  46 ,  246 ,  346  and  446 . Tip  546  has squared, blunted appearance with a blunted tip distal end  550 , in addition to an angled transition portion  554 . As shown in FIGS. 12 and 13, tip opening  552  is larger than tip opening  52  but smaller than tip opening  252 . In fact, tip opening  552  is approximately equal to tip opening  452 . Tip opening  552 , in combination with transition portion  554  and slot  520 , provides for easy insertion of the guide when compared to guide  10 . It is further contemplated that tip  546  could be designed so that it fits snugly around or fully encloses the catheter. 
     FIGS. 14 and 15 reveal yet one more alternate embodiment of the present invention. Correspondingly, where appropriate, the last two digits in the  600  series of numerals depicted in FIGS. 14 and 15 are connected to elements which have the same function and/or structure as those described with regard to FIGS. 1-13. 
     FIGS. 14 and 15 depict guide  610  with tab  626  which is similar to the guides discussed above. In this particular embodiment, edges  644  and  645  also provide visual confirmation of the encapsulated instrument or catheter. Further, in this embodiment, again tip  646  is different. As depicted, tab  628  is shown with tab proximal end  630  having a more blunted appearance (best seen in FIG. 14) than distal end  30  (best seen in FIG. 2) but not as blunt as tab proximal ends  230 ,  330 ,  430  and  530 . Yet tab proximal end  630  still provides a good surface for holding guide  610  in the tissue. Additionally, tab distal end  632  has a more blunted or squared appearance when compared to the distal end  32 . In this particular embodiment, edges  644  and  645  define opening  643  at proximal end  616 . Edges  644  and  645  provide as abutment which coacts with the instrument or catheter within the guide  610 , that provides visual confirmation of the encapsulation of the instrument or catheter. 
     Tip  646  also differs from tips  46 ,  246 ,  346 ,  446  and  546 . Tip  646  has round appearance with a rounded tip distal end  650 . In this embodiment, tip  646  portion has an outer diameter substantially equal to an outer diameter of the shaft  612 , so that guide  610  has a cylindrical appearance. Again, as shown in FIGS. 14 and 15, tip opening  652  is larger than tip opening  52  but smaller than tip opening  252 . As discussed above, tip opening  652 , in combination with slot  620 , is sized to accommodate various sizes and types of catheters, instruments and tools. 
     In addition to the above, guide  610  includes at least one notch  656  defined by wall  638  in shaft  612 . While only one notch  656  is depicted, two or more notches  656  are contemplated. For some applications notch  656  can be omitted, if desired. It is contemplated that notch  656  has many uses, including being used for measuring increments or for attaching to or aligning with other surgical tools to help implant the catheter. However, in a preferred embodiment, it is contemplated that notch  656  is used to position the guide  610  relative to other surgical tools. 
     Turning now to FIGS. 16-28, a method of implanting a catheter, preferably a flexible catheter, or other device is shown. FIGS. 16 and 17 depict a surgical implement assembly  58  sized for insertion into a tissue, where the assembly includes a trocar  60 , with a cannula  62  and obturator  64 , received within guide  10 . While guide  10  is referred to, this discussion of the assembly  58  is generally applicable to any of the guides  210 ,  310 ,  410 ,  510  and  610  provided above. 
     Operably connecting the guide  10  to trocar  60 , specifically to cannula  62 , assists the user in placing the guide. It is contemplated that trocar  60  or cannula  62  is operably assembled with the guide  10  in any number of ways. In the embodiment depicted in FIG. 16, a clip  72  compressedly urges guide  10  against cannula hub  17 , to secure the guide  10  thereto and assist the user in proper placement thereof. In one preferred embodiment, it is contemplated that hub  17  has a groove formed therein for receiving clip  72 . The groove assures proper placement of the clip  72  and good compressed contact. 
     In addition to clip  72 , it is contemplated that other means could be used to operably connect the guide  10  and cannula  62 . For example, guide  10  is operably connected to cannula  62  by adhesive tape, (not shown), where the adhesive tape is wrapped around guide  10  and compressedly urges guide  10  against cannula hub  17 . Additionally, it is contemplated that an adhesive is provided on hub  17  so that the adhesive removably bonds the guide  10  to the cannula  62 . Additionally, guide  10  can be removably joined to cannula  62  by a temporary heat bond. 
     The method of using the assembly  58 , including the guide  10 , is better understood by reviewing FIGS. 16-27. Preferably, the guide  10  is “rolled” into a diameter slightly smaller than its normal diameter prior to insertion and operably connected to the trocar  60 , preferably to cannula  62 , either using the means discussed above, or by fitting the guide  10  tightly to the cannula  62 , so that tip  46  is mechanically interlocked with cannula  62  (best seen in FIGS.  19  and  20 ). 
     The patient&#39;s skin is anesthetized over the desired location in a vertical or horizontal direction for about 3 cm. The skin is then incised with a scalpel, creating about a 2-3 cm long primary incision forming entry point  73 . A closed hemostat is inserted through the incision until the tip meets the resistance of the external fascia of the abdominal wall, where upon the hemostat is opened and withdrawn. A needle, preferably a 21-gauge needle, is inserted through the skin to anesthetize the abdominal wall, directing the needle towards the coccyx. 
     The assembly  58  including the trocar  60 , consisting of the obturator  64  and cannula  62  shown in FIGS. 16 and 17, are removed from their packing with the obturator  64  firmly seated in the cannula  62  so that knob  78  of the obturator  64  opposite pointed tip  79  is fully exposed outside of the cannula  62 . The assembly  58  is held so that the knob  78  of the obturator  64  is seated in the palm of the hand, with the operator&#39;s first finger placed at the middle on the assembly  58  pointing to the tip  46 . The assembly  58  is inserted into the entry point  73  at a predetermined angle, preferably between about 20° to about 30° from vertical towards the coccyx, best seen in FIG.  21 . 
     The assembly  58  is advanced through the subcutaneous tissue  74  and abdominal musculature  76  using a slight twisting/rotating motion in a direction towards the coccyx. Two “pops” should be discerned. Approximately half of the assembly  58  will pass through the skin while at least pointed tip  79  and tip  46  enters the peritoneum. 
     The obturator  64  is removed from the trocar  60  and a scope  80 , consisting of a viewing portion  82  and tip  84  as shown in FIG. 18, is fully inserted into the cannula  62 . It is important that the scope  80  and cannula  62  be fully locked together. Initially very bright white, but occasionally red, blood vessels may be seen when viewed through viewing portion  82  of the scope  80 . Typically tip  84  is in contact with the visceral peritoneum and fixed in stationary position. The assembly  58  and scope  80  is withdrawn in 1 mm increments. At this time, a sweeping cranial-coccyxid movement of visceral surface should be viewed, which is one indication that the assembly  58  is in the correct intraperitoneal position. 
     After confirming the intraperitoneal space, the scope  80  and cannula  62  are advanced slightly. The scope  80  is removed from the cannula  62  and placed in a sterilization tray and the patient placed in a Trendelenburg position so that the apex of the peritoneum is above the end of the cannula  62  within the peritoneum. Up to 1.5 liters of air is infused. 
     Any air bubbles observed moving up between the guide  10  and the cannula  62  during insufflation indicate that the distal tip  86  of the cannula  62  is touching the viscera. This indicates that the infusion of air is blocked so that the air is forced back up between the cannula  62  and guide  10 . Withdrawing the cannula  62  between about 1 and about 2 mm will help remedy that situation, as will compressing the guide onto the cannula  62  while insufflating. After enough air has been infused, the tubing is disconnected from the cannula  62 . 
     The scope  80  is reinserted and locked into the cannula  62 . If the tip of the scope  80  rests upon the visceral peritoneum, a highly reflective surface that moves with inspiration will be observed. The scope  80  should be retracted millimeter by millimeter while inspecting the images. When the tip  84  enters the edge of the airspace, the surfaces of the bowel and omentum will be seen several centimeters from scope  80 . 
     The cannula  62  is advanced until hub  17  of the cannula  62  meets the skin surface, or until the tip of the scope  80  reaches the distant peritoneal surface. The scope  80  is removed from the cannula  62  and returned to the sterilization tray. The assembly  58  is rotated so that tab  28  of guide  10  is next to the patient&#39;s abdomen and the slot  20  is facing up. The tab  28  is firmly gripped, in one preferred embodiment by hand or by attaching a hemostat to the tab  28  at a point between about 1 to about 2 mm from the hub  17  of the cannula  62 . At this point, clip  72  or any other securing device including restraining tape, should be removed. 
     The cannula  62  is removed by twisting it gently back and forth while pulling up to dislodge the tip  46  of the guide  10  from the cannula  62 . If there is resistance and the tip  46  does not release immediately, the cannula  62  is reinserted and twisted while pulling upward on the cannula  62  until only guide  10  remains as shown in FIG.  22 . The diameter of the guide  10  and the “hole”, i.e., entry point  73 , within the musculature  76  is too small to insert the standard peritoneal dialysis catheter and thus needs to be dilated. 
     While the guide  10  is secured by hand or a hemostat, a small dilator  88 , shown in FIGS. 23 and 24 having a handle  90  and distal tip  92 , is wet with saline. The dilator  88  is inserted into the guide  10  and slowly advanced with a slight twisting motion as passes through the musculature  76  and the peritoneum. Advancement of the dilator  88  is stopped as resistance decreases as it passes through the abdominal wall. The dilator  88  is moved in and out of the musculature  76  several times until resistance is minimal. 
     Before the catheter  94  is implanted, it must be immersed in sterile saline. While in the saline, the catheter&#39;s cuff portions  96  are squeezed and rotated several times to eliminate any air trapped within them since air inhibits the ingrowth of fibrous tissue. In one preferred embodiment, cuff portion  96  is comprised of proximal and distal cuffs  96  and  98  respectively. Sterile saline is also injected through the catheter  94  via a syringe. 
     It is important to orient the catheter  94  before a catheter stylette is inserted. Improperly oriented catheters may rotate, kink, migrate or fail. To orient the catheter  94 , it is laid, in its normal predetermined position, flat on the patient&#39;s abdomen. It is important that during the actual insertion step the elongated portion  102  between the cuff portions  96  remains at the same relative position throughout the entire process. If the catheter  94  is not positioned properly, it may rotate, kink, flip, migrate, leak, all of the above, or even fail. A catheter stylette is wet and inserted into the pre-soaked catheter  94 . This makes the catheter  94  sufficiently rigid to insert through the guide  10 . The stylette should stop within about 0.5 to about 1 cm of the catheter tip  104 . 
     With the wetted stylette in the catheter  94 , the catheter  94  is grasped by the surgeon about 12 to about 15 cm (5 to about 6 inches) from the distal end and inserted firmly into the guide  10  as shown in FIGS. 25 and 26. The tip  104  of catheter  94  is watched to ascertain that it is within the guide  10 . The catheter  94  is steadily advanced about 2 to about 3 cm at a time until the distal cuff  100  reaches the anterior sheath of the rectus muscle. 
     During insertion, the catheter  94  is stopped due to the fact that the dilation diameter of the musculature matches that of the catheter  94 , but the cuff portion 96 diameter is larger. In some situations, the final position of catheter  94  can be reached by continuing to advance the catheter  94 , about 1 cm, so that the cuff portion  94  will dilate, reaching its own final position within the muscle. However, the depth and position of the cuff portion  94  can be difficult to control. For maximum stability of the catheter  94 , the distal cuff  100  should be placed within the rectus muscle. (FIG. 27) One secure way to position the distal cuff  100  within the rectus muscle is to use a cuff implantor. The catheter stylette remains in the catheter  94  which is still inside the guide  10 . The implantor “snaps” onto the catheter  94  between the distal and proximal cuffs  100  and  98  and is slid down the catheter  94  inside the guide  10  until the leading edge of the implantor touches the distal cuff  100 . The implantor is carefully advanced about 1 cm, pushing cuff  100  before it into the rectus muscle. Preferably a “finger” on the implantor inhibits the implantor and, therefore, the cuff  100  itself from going through the rectus muscle. When distal cuff  100  is properly positioned, the implantor is removed as shown in FIG.  27 . 
     In this location, fibroblasts can and will grow rapidly into the distal cuff  100 . When the catheter  94  is anchored within the rectus by the cuff  100 , the risks of peri-catheter leaks, peri-catheter hernias and catheter extrusion are greatly reduced. 
     An alternative method to position the distal cuff  100  within the muscle is to take a second hemostat, open the tips, and slide the tips within the guide  10  to the cuff  100 . Distal cuff  100  is firmly and gently advanced about 1 cm into the muscle until properly positioned. 
     With the stylette still within the catheter  94 , and holding the catheter  94  securely so as not to dislodge the distal cuff  100 , the surgeon pulls up on tab  28 , preferably by hand but a hemostat may be employed, to remove guide  10 . A sure grip is assured as tab  28  has at least one surface, or portion thereof, that is textured. Slot  20  in guide  10  allows it to slide around the catheter  94  and the distal cuff  100  without dislodging either one. The catheter stylette can now be removed. A finger is inserted through the primary incision to confirm that the deep cuff is within the musculature. 
     While a particular embodiment of the present invention has been shown and described, it will be appreciated by those skilled in the art that changes and modifications may be made hereto without departing from the invention in its broadest aspects and as set forth in the following claims.