WO1993004726A1

WO1993004726A1 - Catheterization placement apparatus

Info

Publication number: WO1993004726A1
Application number: PCT/US1992/007204
Authority: WO
Inventors: Henri Decloux; Georges Katsaros; Giancarlo Polese
Original assignee: Sherwood Medical Company
Priority date: 1991-09-05
Filing date: 1992-08-25
Publication date: 1993-03-18
Also published as: AU2549292A

Abstract

A suprapubic catheterization system is disclosed including a kit preferably containing a needle (11) coverable by a splittable cannula (12), and a urine drainage catheter (14). The needle (11), cannula (12) and catheter (14) each may include a mark located therealong to be used as a visual guide for the user in carrying out the catheterization procedure. The marks on the cannula (12) and needle (11), if present, are located in predetermined positions so that once the cannula (12) is positioned in the bladder (50) and the needle (11) is partially withdrawn from the cannula (12) to a position indicated by the needle mark (17), the cannula (12) can be kinked at the position indicated by the cannula mark (30) to prevent inadvertent passage of fluid through the cannula (12) during the placement procedure. The catheter (14) may also have a mark placed at a predetermined position thereon to indicate the proper depth of insertion of the catheter (14) into the cannula (12) corresponding to proper placement of the catheter (14) within the patient's bladder (50). The catheterization system may also include a clamp (15) for closing the catheter (14) to prevent fluid flow therethrough during the catheterization procedure, and at least one catheter (14) fixation device (16, 51) to fix the catheter (14) to the patient's abdomen in its proper position to prevent inadvertent movement thereof during use. The invention also includes a unique suprapubic catheterization procedure and a unique catheterization kit for use in carrying out the procedure.

Description

CATHETERIZATION PLACEMENT APPARATUS

TECHNICAL FIELD The present invention relates generally to apparatus and methods of catheterization, including kits for catheter- ization apparatus. More specifically, the present invention relates to an apparatus, method and kit for placement of a suprapubic catheter into the bladder of a patient.

BACKGROUND ART Suprapubic catheterization is often necessary in con- junction with medical procedures, especially when urologi- cal, or other lower abdominal surgical operations are per¬ formed. Although urethral catheterization has in the past been performed in conjunction with such operations, results have often been less than satisfactory due to high instances of infection, and significant patient inconvenience in regaining normal, spontaneous urination capability. Supra¬ pubic catheterization has the advantage of reduced incidence of infection, and also allows the patient to urinate normal¬ ly if desired, without the prior necessity of removing the catheter as is required with urethral catheterization.

Many prior art suprapubic catheterization apparatus have been difficult to place into the patient's body, others have been unnecessarily complicated in their structural characteristics. For example, many types of prior art suprapubic catheterization systems include major surgery for placement of the catheter into the patient's bladder. Other prior art catheters, such as are exemplified by U.S. Patent No. 4,419,094 to Patel, are structurally complicated to the point of being relatively expensive to manufacture. Also, such complicated apparatus are often inconvenient in that they require medical personnel to be specifically and exten- sively trained in proper placement procedures prior to their use.

DISCLOSURE OF INVENTION It is therefore an object of the present invention to provide a suprapubic catheterization apparatus which is simple in construction and relatively easy to use.

It is another object of the present invention to pro¬ vide a catheterization method in which fluid leakage during the catheterization procedure can be easily avoided if desired.

It is a further object of the present invention to provide a suprapubic catheterization kit which includes the necessary elements of the suprapubic catheterization appara¬ tus for simple and efficient catheterization of a patient. These and other objects, features and advantages of the present inventions are realized in the following presently preferred embodiments, presented by way of example and not necessarily by way of limitation, in which a suprapubic catheterization apparatus made in accordance with the prin- ciples of the present invention includes a hollow elongate needle which may be attached to a syringe if desired, and which is covered by a splittable cannula along substantially its entire length. The needle is used to puncture the abdominal wall and pierce into the bladder of a patient while the syringe (if used) draws a light suction through the needle to cause urine to be drawn thereinto upon suc¬ cessful puncturing of the patient's bladder. The needle may include a needle mark thereon and the cannula may include a cannula mark thereon if desired at predetermined locations whereby, when the needle is partially withdrawn from the cannula to a position where the needle mark thereon becomes exposed and rests adjacent the cannula proximal opening, the cannula may be kinked at the cannula mark without interfer¬ ence from the needle. The needle is thereafter completely removed from the cannula and leakage through the cannula is avoided as long as the kink is maintained in the cannula. An elongate catheter is also provided as part of the suprapubic catheterization apparatus and may have a connec- . tor formed on its proximal end to allow connection to a urine drainage bag. The distal end of the catheter is closed and rounded to avoid trauma to the patient, and a portion of the catheter body adjacent the distal end may be pre-formed to retain a semicoiled (pigtail) shape, with several inches of the length thereof being formed with openings to maximize the catheter's fluid collection capa¬ bilities. The catheter is preferably covered in a soft thin plastic sleeve prior to use in order to maintain its steril¬ ity. Further, the catheter may be made of a very soft and somewhat slippery material, such as silicone, to allow it to be "stripped" or "milked" during use in order to clear obstructions therein during use.

In the catheterization procedure of the present inven¬ tion, the proximal portion of the catheter may be extended from the sleeve and a clamp may be placed there over to pinch the catheter closed and prevent fluid flow there through until the procedure is completed. The distal end of the catheter is then extended from the sleeve and inserted into the cannula up to the cannula mark. If the cannula had been kinked to avoid leakage it is then straightened, re¬ leasing the kink therein, and the catheter is inserted through the cannula into the bladder. The catheter further may include a catheter mark thereon which, when the catheter is inserted into the cannula up to the catheter mark, indi- cates that the distal end of the catheter is properly posi¬ tioned in the bladder. The cannula is then removed and split away from the catheter and discarded, and the sleeve is also torn away and discarded.

The suprapubic catheterization apparatus of the present invention may also include a fixation device (or devices) for securing the catheter in position in the bladder. The one preferred device is preferably formed generally of an oval piece of flexible polymeric material through which an elongate undulating channel is formed. The channel is accessible by the catheter through an elongate slot which extends along the entire length of the channel and through which the catheter is inserted to be secured in the chamber. This fixation device may further. include wing members ex¬ tending therefrom in opposing directions which are adapted to allow it to be secured either by adhesive, tape, sutures or the like to the patient's abdomen.

A second preferred fixation device is formed generally of a flat cylindrical base having a cylindrical extension extending perpendicularly from the center of the disk and forming a cylindrical shoulder at its top. The extension has a cylindrical opening therethrough extending from the shoulder through the disk through which the catheter may be inserted once completely and properly positioned in the patient's bladder. The disk can include an adhesive or suture holes for attaching it to the patient's abdomen at the insertion site of the catheter. The fixation device further includes a clamp which can surround the cylindrical extension above the disk and below the shoulder and which can be clamped to compress the cylindrical extension about the catheter to inhibit relative movement thereof. Upon completion of the insertion procedure, the proxi¬ mal end of the catheter is then connected to a urine drain¬ age bag and the clamp if used to block fluid flow through the catheter is removed therefrom in order to allow flow of urine from the bladder through the catheter into the drain- age bag.

The present invention as described above provides for rapid and reliable suprapubic catheterization and mainte¬ nance of the catheter within the bladder, while at the same time remaining simple in its structure and method of place- mentϊ These and other objects and advantages of the invention will become apparent from the following more detailed de¬ scription, when taken in conjunction with the accompanying drawings in which like elements are identified with like numerals throughout.

BRIEF DESCRIPTION OF DRAWINGS Figure 1 shows a preferred embodiment of a suprapubic catheterization apparatus formed in accordance with the principles of the present invention; Figure 2 shows a subassembly of the suprapubic cathe¬ terization apparatus of the present invention including the syringe, needle and cannula assembled for use;

Figure 3 is a top view of a preferred embodiment of a catheter fixation device for use in conjunction with the suprapubic catheterization apparatus of the present inven¬ tion;

Figure 4 is a side view of the fixation device of Figure 3;

Figure 5 is a bottom view of the fixation device of Figure 3, showing the geometry of the catheter channel therein;

Figures 6 and 7 are representations of alternative geometries of the catheter channel of the fixation device of Figures 3 - 5; Figure 8 is a top view of a second preferred embodiment of a catheter fixation device for use in conjunction with the suprapubic catheterization apparatus of the present invention;

Figure 9 is a top view of a preferred embodiment of a clamping mechanism used in conjunction with the catheter of the present invention and/or the fixation device of Figure 8;

Figure 10 is a side view of the fixation device of Figure 8; Figure 11 is a top view of the fixation device shown in Figure 8 with the clamp device shown in Figure 9 affixed thereto in the open position;

Figure 12 is a top view of the fixation device and clamp of Figure 11 with the clamp in the closed position; Figure 13 shows a catheter formed in accordance with the principles of the present invention in an initial stage of preparation for the suprapubic catheterization procedure of the present invention; Figure 14 shows a preferred step of the catheterization procedure of the present invention which includes piercing the abdominal wall with the needle to insert the splittable cannula into the bladder;

Figure 15 shows a subsequent preferred step in the catheterization procedure of the present invention which includes partial removal of the needle from the splittable cannula;

Figure 16 shows a subsequent preferred step of the catheterization procedure of the present invention which includes kinking the splittable cannula and inserting a portion of the catheter therein;

Figure 17 shows a subsequent preferred step of the catheterization procedure of the present invention which includes inserting the distal portion of the catheter through the cannula into the patient's bladder;

Figure 18 shows a subsequent preferred step of the catheterization procedure of the present invention which includes removing the splittable cannula from the abdominal wall and splitting it away from the catheter; and Figure 19 shows a subsequent preferred step of the catheterization procedure of the present invention which includes attaching the catheter to the abdominal wall of the patient with the fixation devices. BEST MODE(S) FOR CARRYING OUT THE INVENTION As shown in the exemplary drawings for the purposes of illustration, an embodiment of a catheterization apparatus made in accordance with the principles of the present inven- tion, referred to generally by the reference numeral 10, is provided for suprapubic insertion of a catheter into the bladder of a patient.

More specifically, as shown in Figure 1, the apparatus 10 of the present invention includes a needle 11 over which a splittable cannula 12 is to be placed and to which a syringe 13 may be attached (see Figure 2) . The apparatus 10 also includes a catheter 14 which is sized to be insertable within the splittable cannula 12 once the needle 11 is removed therefrom, and which is formed of a sufficient length to extend from the exterior of the patient through the patient's abdominal wall and well into the bladder.

Further, as part of the preferred apparatus 10 of the present invention, a closing device such as slidable clamp 15 may be used if desired to clamp catheter 14 against fluid flow there through during the placement procedure. Also, a fixation device 51 and/or 16 may be used to fix the catheter 14 in proper position within the patient's bladder, and to prevent inadvertent relative movement respectively, between the fixation device 16 and the catheter 14 while in use. As best shown in Figures 1 and 2, the needle 11 is formed of an elongate hollow body portion 17 having a sharp distal tip 18 formed at the distal end 19 thereof, and a hub 20 having threading 21 thereon formed at the proximal end 22 for fluid tight attachment with syringe 13. A needle mark 23 may be located on the needle body 17 at a predetermined distance from the tip 18 to be used in conjunction with the splittable cannula 12 during the catheterization procedure to give indication to the user of the location of the tip 18 within the cannula 12 for purposes as will be explained below. The splittable cannula 12 is formed of an elongate hollow cannula body 24 of polymeric material, which has formed at its proximal end 25, a hub 26 which is shaped to conform with the needle hub 20. The cannula body 24 and hub 26 are weakened at two diametrically opposed locations by score lines 27 so that a medical worker, as part the cathe¬ terization procedure, can grip the hub 26 by the gripping wings 28 thereof, and split the hub 26 and body portion 24 along their entire length. The hollow cannula body 24 is sized to snugly fit over the hollow needle body 17 and is of a length so as to extend from the hub 20 to the distal end 19 of the needle 11 when hub 26 and hub 20 are properly connected. With the cannula 12 in place over the needle 11, the tip 18 of the needle 11 extends from the distal end 29 of the cannula body 24 a distance approximately equal to or slightly greater than the sharpened portion thereof.

The syringe 13, if used in the procedure, is attachable to the needle 11 at hub 20 thereof by matching the internal- ly threaded end 30 with threads 21, allowing plunger 31 to draw suction through the needle 11 in a well known manner. The catheter 14 includes an elongate hollow catheter body 32 which has a connector 34 formed at its proximal end 33. The connector 34 is designed for connection to a urine drainage bag (not shown) in a well known manner. It is to be understood that any well known type connector.34 may be formed at proximal end 33 of the catheter 14 to allow at¬ tachment to any design of drainage bag, and the invention is not intended to be limited in any way by the particular connector 34 shown in the drawings.

The distal portion of catheter body 32 is preferably formed into a pigtail 35, including a plurality of inlet openings 36 extending uniformly therearound from the distal end 37 around at least a portion of the pigtail. The cathe- ter body 32 also may include a catheter mark 38 thereon if desired, located a predetermined distance from the distal end 37. If the catheter mark 38 is placed on the catheter body 32, its position is predetermined to correspond to the distance necessary to allow insertion of the catheter 14 into the splittable cannula 12 such that the pigtail 35 is properly inserted into the patient's bladder when the cathe¬ ter mark 38 is just visible at the hub 26 of the splittable cannula 12. The catheter may be formed of any well known material but is preferably formed of silicone.

The slide clamp 15, as shown in the drawings, is a generally flat rigid member having a pair of arms 39 which form a slot 40 therebetween. The clamp 15 is sized to allow the catheter body 32 to be placed therein and pinched closed at slot 40 to prevent fluid flow therethrough during cathe¬ ter placement into the bladder. Referring now to Figures 3-5, the fixation device 16 of the present invention is preferably formed of a single molded piece of elastomeric material and includes a central body portion 43 which is shown in its preferred form as generally flat and ovular in shape, but which also may be formed of any other general geometry if desired. The fixa¬ tion device 16 also has formed thereon on a pair of diamet¬ rically opposed wing members 44 which, in conjunction with the central body portion 43, form a continuous flat bottom surface 45 which is intended to be placed next to, and in contact with, the abdomen of the patient while in use. The central body portion 43 forms a channel 46 of circular cross-section which extends generally longitudinally there¬ through between the wing members 44. The channel 46 is accessed through slot 47 which extends from surface 45 into channel 46 along the entire length thereof.

The channel 46 is formed of a diameter which allows the catheter body 32 to be snugly received therein, and is formed of a generally undulating geometry. The undulating shape of channel 46 causes the catheter body 32, once placed therein, to encounter significant frictional resistance when subjected to pulling forces. Thus, the catheter body 32 is prevented from moving through the channel 46 as a result of pulling forces along the longitudinal axis of the catheter body 32 due to the channel's 26 undulating shape.

The bottom surface 45 of the fixation device 16 may be coated with an adhesive of any well known type, or alterna¬ tively may include openings 48 through the wing members 44 to accept sutures for securing to the patient's body. The device 16 may be formed of any relatively flexible material, although it is preferably formed of an elastomeric elastomer such as styrene ethylene butylene styrene.

It should be understood that the important features of the channel 46 are its snug fitting relationship with the catheter body 32, and its undulating shape. The diameter of channel 46 may be equal to or slightly different (larger or smaller) than the diameter of the catheter body 32 as de¬ sired, as long as it is sufficiently snug with the catheter body 32 to contact a substantial portion of the length thereof located within the channel 46 in such a manner as to frictionally resist longitudinal movement therethrough. Also, the channel 46 may be formed of any desired undulating shape, such as that shown in Figure 5, or alternatively, as shown by the undulating geometries of Figures 4 and 7.

Referring now to Figures 8 and 10, the fixation device 51 of the present invention is preferably formed of a single molded piece of elastomeric material and includes a central cylindrical portion 53 having a relatively large diameter cylindrical disk 54 attached at one end thereof, and a smaller cylindrical shoulder 55 attached at the opposite end thereof. The cylindrical portion 53 further includes a cylindrical opening passing through the central longitudinal axis thereof and extending through the disk 54 and shoulder 55. The disk 54 forms a bottom surface 57 which is placed adjacent to the abdomen of the patient during use, and held in position either by adhesive (not shown) or by sutures (not shown) attached through suture holes 58, or both as desired. The cylindrical opening 56 is sized to a diameter generally equal to the outer diameter of the catheter body 32.

As shown in Figure 9, the clamp 52 includes a pair of arms 59 which are joined as an integral piece of material and which form a generally circular opening 60 sized to be slightly smaller in diameter than the outer diameter of the cylindrical member 53 of the fixation device 51 (see Figure 10) . Arms 59 are shaped to form interlocking ends 61 and 62 which function to hold the clamp 52 in its closed position against a natural open bias of the arms 59.

As seen in Figure 11, the clamp 52 is placed around the fixation device 51 such that the opening 60 thereof sur¬ rounds the cylindrical member 53. As can be seen, the clamp 52 is formed to be open in its unbiased position to simplify its placement on the fixation device 51.

As shown in Figure 12, the arms 59 of the clamp 52 can be squeezed, such as by a medical worker's fingers, to cause locking members 61 and 62 to interconnect into their locked position. When the catheter 14 is inserted through cylin¬ drical opening 56, and the clamp 52 is locked in position about cylindrical member 53, the clamp 52 squeezes the cylindrical member 53 and thus reduces the diameter of the cylindrical opening 56 which in turn squeezes against the catheter body 32 such that a frictional resistance is gener¬ ated between the cylindrical opening 56 and the catheter body 32 to prevent relative movement therebetween.

Figures 13 through 19 illustrate the various steps of the catheterization procedure of the present invention. Initially if desired, as shown in Figure 13, the catheter sleeve 42 may be slid down from the connector 34 and proxi¬ mal portion 33 of the catheter body 32 in order to expose a sufficient length of the catheter body 32 to allow the placement of slide clamp 15 thereover. The clamp 15 is slid to its clamping position in which the catheter body 32 is pinched within the slot 40 thereof. This assembly is then set aside momentarily until it is needed in a subsequent step of the procedure as will be explained. It should be understood that, although the particular slide clamp 15 is shown and described for this use, any clamping device capa- ble of closing off fluid flow through the catheter is con¬ templated, and intended to call within the scope of the invention.

In the next step of the procedure, as shown in Figure 14, the needle 11 is covered with a splittable cannula 12, and if desired, attached to the syringe 13 in the manner has been shown and described in relation to Figure 2 above. Then, with the protective cannula sleeve 41 removed from the splittable cannula 12, the tip 18 of the needle is pierced through the patient's abdominal wall 49 into the patient's bladder 50 a sufficient distance to fully insert the distal end 29 of the splittable cannula 12 within the bladder 50. During insertion of the needle 11, if the syringe 13 is used, the plunger 31 thereof is slightly withdrawn to cause a suction through the needle 11 so that bladder fluid from the bladder will enter the syringe 13 and become visible to the medical worker upon entrance of the distal end 19 of the needle into the bladder 50. The presence of bladder fluid in the syringe 13 gives an indication to the medical worker that the bladder 50 has been successfully entered by the needle 11.

If the needle 11 is formed with the needle mark 23 thereon and the cannula is formed with the cannula mark 30 thereon, then once the splittable cannula 12 is properly within the bladder 50, the needle 11 can be partially with- drawn in the manner shown in Figure 15 to the position where the needle mark 23 is just visible beyond the cannula hub 26. As can be seen in the drawings, the tip 18 of the needle 11 is located within the splittable cannula 12 at a position immediately behind the position of the cannula mark 30. In this position, fluid can flow from the bladder 50 through the distal end 29 of the splittable cannula 12 and pass therethrough up to the cannula mark 30. Fluid is prevented from filling the remainder of the splittable cannula 12 due to the presence of the needle 11 therein. As shown in Figure 16, the splittable cannula 12 can then be kinked at the cannula mark 30 to prevent fluid from passing proximally thereof, and the needle 11 can be completely withdrawn.

The catheter assembly previously prepared as described in relation with Figure 13 above, is now further prepared for insertion into the cannula 12 by sliding catheter sleeve 42 away from the distal end 37 thereof, to allow end 37 to be slid into the splittable cannula 12. As the catheter body 32 moves into the cannula 12, the catheter sleeve 42 is pushed away from the catheter body 32 by the hub 26, thus maintaining sterility of the catheter body 32 as it enters the cannula 12. As shown in Figure 17, once the catheter body distal end 27 has reached the cannula mark 30, the cannula 12 can be unkinked and restraightened to allow the catheter body 32 to continue to be inserted therethrough until the pigtail 35 thereof becomes located within the bladder 50. Insertion of the catheter body 32 is continued until the catheter mark 38 thereon is positioned adjacent the hub 26, which position assures that the proper amount of the catheter 14 has been inserted into the bladder 50. Once catheter insertion is complete, as shown in Figure 18, the splittable cannula 12 is removed from the bladder 50 and the abdominal wall 49 and split by separating gripping wings 28 of the hub 26 and continuing separation until the entire catheter body 24 is separated into two pieces. Once the splittable cannula 12 is completely removed, the cathe¬ ter sleeve 42 may be split or cut and removed also. The catheter 14 is now prepared to be affixed to the patient's abdomen.

At this point, although the catheter 14 is properly positioned within the patient's bladder, it is generally necessary to secure the catheter 14 against inadvertent movement relative to the patient in order to avoid displace¬ ment thereof caused by accidental pulling forces being applied thereto. If desired, either one or both of fixation devices 16 and/or 51' respectively may be used to affix the catheter 14 to the patient's abdomen. If it is desired to use the fixation device 51 to aid in fixing the catheter 14 to the patient's abdomen, it is necessary that the portion of the catheterization procedure described in relation to Figure 16 be modified such that the distal end 37 of the catheter 14 is passed through the cylindrical opening 56 of the fixation device 51 just prior to being inserted into the cannula 12. All subsequent steps of the procedure remain identical until the catheter 14 is finally properly posi¬ tioned within the bladder 50. As shown in Figure 19, the bottom surface 57 of the fixation device 51 is affixed to the patient's abdomen (either by sutures or adhesive) and the clamp 52 is placed around the cylindrical member 53 and pinched to its closed and locked position.

Next if it is also desired to attach the fixation device 16, the fixation device 16 is squeezed in the medical worker's hand in such a way as to cause the bottom surface 45 thereof to be forced into a convex shape and drawn open the slot 47 to the greatest extent possible. The catheter 14 is then placed therein such that a portion of the cathe- ter body 32 is inserted along the entire length of the channel 46. The bottom surface 45 is then allowed to return to its flat configuration, causing the slot 47 to return to its pre-formed shape and substantially enclose the catheter body 32 within the channel 46. As shown in Figure 19, the fixation device 16 is then secured to the patient's abdomen either by means of adhesive or sutures (or both) . Movement of the catheter body 32 relative to the fixation device 16 is thereafter inhibited by the frictional fit thereof with the undulating channel 26, which in turn prevents subsequent movement of the cathe¬ ter 14 into or out of the bladder 50 due to any subsequent inadvertent force applied thereto. The connector 34 of the catheter 14 is then attached to a urine drainage bag (not shown) in a well known manner, and the slide clamp 15 (if it had been used to close the catheter 14 against fluid flow) is completely removed from a catheter body 32 to allow fluid to flow from the bladder 50, through the catheter 14 and into the drainage bag.

It will be apparent from the foregoing that, while particular embodiments of the invention have been illustrat- ed and described, various modifications can be made thereto without departing from the spirit and scope of the inven¬ tion. Accordingly, it is not intended that the invention be limited, accept as by the appended claims.

Claims

1. A suprapubic catheterization apparatus (10) com¬ prising: an elongate hollow needle (11) for piercing the abdomi¬ nal wall (49) and bladder (50) of a patient, said needle (11) including a proximal (22) and a distal end (19) , a splittable cannula (12) locatable over said needle (11) such that said cannula (12) can be partially inserted into the bladder (50) as a result of said needle (11) pierc¬ ing into the bladder (50) , said splittable cannula (12) including a proximal (25) and a distal end (29) , and a catheter (14) insertable through said cannula (12) into the patient's bladder (50) when said needle (11) is withdrawn from said cannula (12) , whereby, said splittable cannula (12) can be withdrawn from the bladder (50) and the abdominal wall (49) and split apart to be removed from the catheter (14) while the cathe¬ ter (14) remains in position in the bladder (50) .

2. The suprapubic catheterization apparatus of claim 1 wherein said catheter (14) further includes a catheter mark (38) thereon whereby, insertion of said catheter (14) through said cannula (12) into bladder (50) until said catheter mark (38) is located adjacent said cannula proxi¬ mal end (25) properly positions said catheter (14) in the bladder (50) .

3. The suprapubic catheterization apparatus of claim 1 wherein said needle (11) further includes a needle mark (17) thereon and said cannula (12) further includes a cannula mark (30) thereon, whereby, when said needle (11) is par¬ tially withdrawn from said cannula (12) to a position in which said needle mark (17) is located adjacent to said cannula proximal end (25) , said cannula mark (30) indicates the position of said needle distal end (19) in said cannula (12).

4. The suprapubic catheterization apparatus of claim 1 further included clamping means (15) attachable to said catheter (14) for preventing fluid flow therethrough during insertion of said catheter (14) into the bladder (50) .

5. The suprapubic catheterization apparatus of claim 1 further including at least one fixation device (16,51) for securing said catheter (14) to the patient.

6. The suprapubic catheterization apparatus of claim 5 including two fixation devices (16, 51) for securing said catheter (14) to the patient.

7. The suprapubic catheterization apparatus of claim 5 wherein said fixation device (16) forms an undulating chan¬ nel (46) therein into which a portion of said catheter (14) can be inserted, whereby, said catheter (14) is fixed against movement relative to said fixation device (16) by said undulating shape of said channel (46) .

8. The suprapubic catheterization apparatus of claim 7 wherein said fixation device (16) further forms an elongated slot (47) therein which is formed in conjunction with, and extends the entire length of said channel (46) whereby, said portion of said catheter (14) is insertable into said chan¬ nel (46) through said slot (47) .

9. The suprapubic catheterization apparatus of claim 1 further including a suction means for applying suction to said needle proximal end (22) to cause fluid to be drawn through said needle (11) into said suction means as an indication of proper positioning of said needle distal end (19) in the bladder (50) .

10. A method of suprapubic catheterization comprising the steps of: inserting a needle (11) and splittable cannula (12) through a patient's abdominal wall (49) into the patient's bladder (50) , withdrawing the needle (11) from the cannula (12) , inserting a catheter (14) through the cannula (12) into the bladder (50) , removing the cannula (12) from the bladder (50) and abdominal wall (49) of the patient, and, splitting the cannula (12) and removing it from the catheter (14) while the catheter (14) remains positioned in the bladder (50) .

11. A method according to claim 10 further including the step of fixing the catheter (14) to the patient's abdo¬ men using at least one catheter (14) fixation device.

12. A method according to claim 10 wherein said step of inserting a catheter (14) into the cannula (12) includes first applying a clamping means (15) to the catheter (14) to prevent fluid flow therethrough, and said method also fur¬ ther includes removing said clamping means (15) after the catheter (14) is positioned in the patient's bladder (50) .

13. A method according to claim 10 wherein the needle (11) includes a needle mark (17) thereon and the cannula (12) includes a cannula mark (30) thereon and said step of withdrawing the needle (11) further includes first partially withdrawing the needle (11) from the cannula (12) until the needle mark (17) is withdrawn from, but adjacent to the cannula (12) , and blocking fluid flow through the cannula (12) includes kinking the cannula (12) at the cannula mark .

14. A method according to claim 10 wherein the cathe¬ ter (14) includes a catheter mark (38) and said step of inserting the catheter (14) through the cannula (12) into the bladder (50) includes inserting the catheter (14) until the catheter mark (38) is adjacent to the cannula (12) .

15. A method according to claim 11 wherein said step of fixing the catheter (14) to the abdomen of the patient with a fixation device (16) includes inserting a portion of the catheter (14) into an undulating channel (46) within the fixation device (16) whereby subsequent movement of the catheter (14) relative to the fixation device (16) is pre¬ vented due to frictional resistance between the catheter (14) and the undulating channel (46) .

16. A method according to claim 13 wherein said step of inserting the catheter (14) into the cannula (12) further includes inserting the catheter (14) into the cannula (12) to the cannula mark , unkinking the cannula (12) , and then inserting the catheter (14) through the cannula (12) into the bladder (50) .

17. A method according to claim 10 wherein said step of inserting the catheter (14) through the cannula (12) includes first removing a protective sleeve (42) from a distal portion of the catheter (14) prior to inserting a distal portion of the catheter (14) into the cannula (12) .

18. A method according to claim 12 further including the steps of partially removing a proximal portion of the catheter (14) from a protective sleeve (42) prior to the step of inserting the clamping means (15) thereon.

19. A method according to claim 11 including using two fixation devices (16, 51) to fix the catheter (14) to the patient's abdomen.

20. A suprapubic catheterization kit including: a needle, a splittable cannula (12) being slidably ountable on said needle, and a catheter (14) sized to be insertable within said splittable cannula (12) , whereby, when said needle (11) is withdrawn from said cannula (12) said catheter (14) can be inserted into the bladder (50) , and said cannula (12) can be withdrawn from the bladder (50) and abdominal wall (49) and split and removed from said catheter (14) while said cathe¬ ter (14) is in place in the bladder (50) .

21. The suprapubic catheterization kit of claim 20 wherein said catheter (14) includes a cathete mark (38) located at a predetermined position thereon for indicating the proper positioning of said catheter (14) within said cannula (12) .

22. A suprapubic catheterization kit according to claim 21 wherein said catheter (14) is completely enclosed within a catheter sleeve (41) .

23. A suprapubic catheterization kit according to claim 20 further including a clamp (15) sized to be attach¬ able to said catheter (14) for pinching said catheter (14) closed to prevent fluid flow therethrough during the cathe¬ terization procedure.

24. A suprapubic catheterization kit according to claim 20 further including at least one catheter (14) fixa¬ tion device (16,51) for fixing said catheter (14) to the pa¬ tient.

25. A suprapubic catheterization kit according to claim 24 including two catheter (14) fixation devices (16, 51) for fixing said catheter (14) to the patient.

26. A suprapubic catheterization kit according to claim 24 wherein said fixation device (16) forms an undulat¬ ing channel (46) therein into which a portion of said cathe¬ ter (14) can be inserted, whereby, said undulating channel (46) can frictionally resist movement of said catheter (14) relative to said fixation device (16) when said catheter (14) is located therein.

27. A suprapubic catheterization kit according to claim 20 further including a fluid collection means which is attachable to said catheter (14) .

28. A suprapubic catheterization kit according to claim 20 further including a cannula (12) sleeve fixable over said cannula (12) for ensuring sterility of said cannu¬ la (12) prior to use.

29. A suprapubic catheterization kit according to claim 20 wherein said needle (11) further includes a needle mark (17) located at a predetermined position thereon and said splittable cannula (12) further includes a cannula mark (30) located at a predetermined position thereon, whereby, when said needle (11) is partially withdrawn from said cannula (12) such that said needle mark (17) is adjacent said cannula (12) , said cannula (12) can be kinked at said cannula mark (30) to prevent fluid flow therethrough.

30. A suprapubic catheterization kit according to claim 20 further including a suction means attachable to said needle.