Patent Document

This a continuation of application Ser. No. 07/885,789 filed May 20, 1992, now U.S. Pat. No. 5,221,253 which is a continuation of application Ser. No. 07/704,718, filed May 20, 1991 now U.S. Pat. No. 5,116,309, which is a continuation of application Ser. No. 07/301,090, filed Jan. 25, 1989, now abandoned. 
    
    
     TECHNICAL FIELD OF THE INVENTION 
     The present invention relates to a universal catheter inserted by conventional means which, once in place, functions as an external ureteral catheter which can be easily converted into an internalized ureteral catheter or stent. 
     BACKGROUND OF THE INVENTION 
     Ureteral catheters and stents are fundamental to the practice of Urology. These devices allow one to bypass and drain an obstructed ureter, determine urine output from a particular renal unit, and inject contrast to study the upper urinary tract. With the advent of newer methods to manage upper urinary tract stones (ESWL and ureteroscopy), the indications and use of ureteral catheters have and will continue to further increase. 
     The ideal ureteral catheter should allow one to measure urine output from a particular renal unit, drain even tenaciously purulent material, allow injection of contrast for imaging and finally remain indwelling and self contained if longterm ureteral stenting or drainage is required. 
     The presently available devices consist of external or internal ureteral catheters. Both types are usually passed through the ureteral meatus via a cystoscope, though they can be placed openly through different sites in the urinary tract. 
     Externalized ureteral catheters drain the upper urinary tract and pass through the bladder, exiting the urethra and draining into an external collecting device. They allow drainage through ports and a central lumen and can be irrigated as needed to drain tenacious and obstructing material. By draining externally, the output from the involved renal unit can be carefully monitored. Contrast can be injected as needed to evaluate the upper tract. 
     Unfortunately, these devices are not self contained and must be secured to an indwelling urethral catheter or they will migrate and be extruded by ureteral peristalsis. They therefore are not suitable for longterm outpatient care. 
     With this objective in mind, internalized ureteral catheters were developed. The most commonly used type is a plastic catheter with a curl at both the proximal and distal ends; i.e. Double J catheter. The curls are straightened over a central stiffening wire in order to pass the stent, but are reformed when the stiffening wire is removed. The proximal curl prevents distal migration and thereby keeps the device in the renal pelvis. The distal curl is positioned in the bladder to allow completely internalized drainage. No urethral catheter is needed to secure this type of stent, making it ideal for outpatient management. 
     U.S. Pat. No. 4,713,049 to Carter; 4,307,723 to Finney and 4,610,657 to Densaw all show this general approach while U.S. Pat 4,531,933 shows a variation of this concept by using helixes to replace hooks. 
     The devices shown by these patents, however, have disadvantages. The urine output from the involved renal unit can not be recorded as only total urethral urine output can be recorded and this would include both kidneys. Also, since the distal end of the catheter is internalized, it is not possible to irrigate the tube should it become obstructed. Under these circumstances the obstructed catheter could be more detrimental than beneficial as it would occlude an already narrowed ureteral lumen. Since the ureteral catheter can become obstructed without any external indication, the situation can become dramatically acute before it is realized that the internalized stent is no longer serving its purpose. Lastly, as the stent is not externalized, contrast cannot be injected if needed to image the upper tract. 
     A modification of the usual Double J catheter is available at present that allows injection of contrast via a small lumen--in the stiffening wire. This lumen however, is too small to allow reliable and accurate monitoring of urine output or drainage and irrigation of tenacious debris from the involved kidney. 
     SUMMARY AND OBJECT OF THE INVENTION 
     It is an object of the present invention to provide a combination catheter-stent that improves on the known prior art devices in that it has the advantages of both an externalized ureteral catheter and the advantage of an internalizable ureteral catheter once the necessity of externalized drainage or access is overcome. 
     The device of the present invention comprises a Double J catheter with side ports along its proximal half. The proximal end is preferably closed. The distal one-third of the Double J catheter has a wider lumen diameter and is open ended and has consequently a somewhat wider outer diameter than the proximal end. This allows the distal end of the ureteral stent to accept the insertion of a rigid open-ended ureteral catheter. The distal end of the Double-J catheter terminates in a flange of greater outer diameter in order to allow retraction of the stiff ureteral catheter from the stent against an immobilizing abutting device. This rigid ureteral catheter is long enough to exit the urethra and can be drained by an external drainage system. 
     When the necessity of outside drainage, contrast injection, or monitoring no longer exists, the rigid catheter can be easily disconnected from the flexible ureteral catheter. This allows the part of the stent in the bladder to return to its preformed curl or J shape and then function as a prior art stent of the Double J shape. 
    
    
     DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a view of the device as assembled for packaging. 
     FIG. 2 is a view of the device after insertion and with the stiffening wire removed. 
     FIG. 3 is a view of the stiff pusher needed for removal of the stiff ureteral catheter. 
     FIG. 4 is a view of the device in its internalized (stent) form after detachment of the rigid ureteral catheter. 
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
     In a preferred embodiment as shown in the figures the ureteral catheter 1 of the subject invention comprises a flexible plastic tube 2 having apertures 3 along the proximal end 4. The apertures extend between the outside of the catheter and the lumen 5. The catheter 1 may be constructed from any plastic material, preferably a soft flexible material provided with conventional indicating means 6 and is more preferably formed from a radiopaque silicone or silastic material of the type conventionally used for ureteral catheters or stents. The catheter should be marked with conventional centimeter markings to indicate the catheter&#39;s position. 
     Only the proximal tip 14 of the ureteral catheter need be made of radiopaque material but it is preferable that the entire ureteral catheter including the flange be of radiopaque material to facilitate placement of the device. 
     The distal one third 12 of the flexible plastic tube has an inside and outside diameter wider than that of the proximal end and has a flange 7 that begins about 1 centimeter proximal to the distal end. The distal end of the tube is open. A rigid open ended catheter 8 of the same diameter as the proximal end of the flexible tube is fitted through the flanged end and into the distal end of the flexible plastic tube. The rigid catheter is inserted far enough into the flexible tube to assure secure engagement of the flexible tube. The rigid catheter is held in place by reason of its close fit with the flexible tube. The flange design functions to allow the pusher 16 to disengage the rigid ureteral catheter from the flexible tube by abutting against and immobilizing the flexible tube while the rigid ureteral tube is disengaged. The outside flange diameter is larger than the internal diameter of the pusher. The flange is formed of the same material as the flexible tube. 
     As shown in FIG. 1 a stiffening wire 9 is used to keep the flexible tube stiff while the catheter as a unit is being inserted. The stiffening wire can be passed through a rubber stopper 10 within the distal end of the rigid catheter. The stopper prevents the wire from receding from the distal end of the ureteral catheter during insertion. When the apparatus has been properly placed, withdrawing the rigid wire will also withdraw the stopper. 
     Portions adjacent each of the ends 11 and 12 of the flexible tubular member 2 are formed and set in the shape of gentle curls 13 and 14 as shown in FIG. 4. The insertion of the stiff catheter 8 into the flanged end of the flexible stent straightens the curl or J 14 and holds it in straight alignment as shown in FIG. 2. 
     A stiffening wire 9 straightens the device including the proximal end 11 of the Double J catheter for easy insertion. 
     A thread or suture 15 can be attached to the distal end of the flexible catheter in order to allow easy removal of the device by pulling on the suture. 
     The rigid ureteral catheter 8 is formed of material conventionally used for such catheters and is preferably a stiff polymeric material with a hard smooth surface that glides such as polytetrafluoroethylene or nylon. 
     The rigid ureteral catheter is marked near its distal end. With the rigid ureteral tube inserted in the flexible catheter, the length of rigid tubing between the flange and the marking 17 is equal to the length of the &#34;pusher&#34; 16. 
     The length of the &#34;pusher&#34; is such that when passed over the rigid ureteral catheter, the flange of the flexible tube will be abutted just as the marking on the rigid ureteral catheter is visualized. This allows the operator to know when the flanged end of the flexible ureteral catheter is immobilized prior to extraction of the rigid ureteral catheter. 
     The device is sterilely packaged assembled. Different sizes and diameters can be made available with component sizes scaled appropriately. The sizes, lengths and diameters of the various elements are those conventionally used in the art. 
     As an example of procedure, consider a #7 French Universal Stent. The proximal two thirds of the catheter has a size 7 French lumen and the distal third of the catheter has a size 8.5 French lumen. The distal end of the silastic catheter has a size 9 French flange that begins 1 centimeters proximal to the distal end. 
     The proximal J is straightened over a O.038 mm stiff guide wire. This wire also passes through a rigid plastic 7 French ureteral catheter which is inserted into the 8.5 French distal third of the silastic catheter. The wire exits the distal part of the rigid ureteral catheter and is held in place securely by a detachable rubber stopper. 
     With the wire in place, the proximal end of the J catheter is straightened and can be inserted through a #22 French cystoscope and passed up in the ureteral orifice to the renal pelvis. The wire then is removed along with the rubber stopper, allowing the proximal curl to form. The rigid ureteral catheter exits through the urethra and the system can be used for an immediate imaging study if needed. To continuously drain the kidney (i.e. to monitor urine output, drain purulent debris, or irrigate to free the system of purulent material) one can secure the rigid ureteral catheter to an indwelling urethral catheter and attach the rigid ureteral catheter to an external drainage bag. 
     Once the patient is stable and there is no more need for external drainage, the stent can be internalized. The rigid catheter is then completely cleansed with a topical disinfectant and sterile gloves are donned. Packaged separately is a sterile size 8.5 French &#34;pusher&#34; (open ended tube) which then is lubricated and passed over the rigid ureteral catheter until resistance is met as it abuts the flanged distal end of the silastic ureteral catheter. The operator will also know that the flanged distal end of the silastic ureteral catheter has been abutted because the marking on the rigid ureteral catheter will be visualized. Then gently pull the rigid catheter through the pusher, holding the pusher in place. Then gently extract the pusher from the urethra. This will allow the distal end of the silastic catheter to form a curl in the bladder and thereby leave a completely internalized stent. The thread or suture can be left attached to the distal end of the silastic catheter to allow easy extraction through the urethra. 
     If desired, the stiffening wire can be inserted first using conventional means. After cutting off the proximal tip of the stent, the stent-ureteral catheter device is passed over the wire in order to insert the catheter combination. 
     Also if desired, various adapters can be secured to the external end of the stiff ureteral catheter in order to permit irrigation, application of contrast solutions to the renal cavity etc. 
     The thread or suture is preferably of a synthetic polymer with opaque characteristics. It is attached to the stent at any convenient location. 
     The advantages of the above described device are many. The materials of construction are conventional. The device can be packaged intact and ready to insert. The various elements can be formed in a variety of sizes, lengths and diameters with component sizes scaled appropriately. 
     The device obviates the need for separate externalized and internalized ureteral catheters. Further, the device is simple in operation and makes use of concepts and designs proven to be effective and reliable. 
     The device as described in the preferred embodiment specifies insertion of the rigid catheter into the distal third of the flexible tube. However, it is only necessary that the rigid tube be held securely in the stent until it is removed. Further, it can be seen that the specific type of connection described is not critical. Any method of connection that allows the apparatus to function as described is contemplated. Also, as described, the flange, in connection with the stiff pusher, serves only to hold the apparatus in place while the stiff catheter is removed. Any structure that serves to prevent the catheter from being pulled out of the renal cavity when the stiff catheter is removed is contemplated. 
     It will be readily apparent to those skilled in the art that a number of modifications and changes can be made without departing from the spirit of the invention. Therefore, it is to be understood that the scope of the invention is not to be limited by the foregoing description, but only by the claims.

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