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Urethral catheterless radical prostatectomy

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Urethral catheterless radical prostatectomy


A method and device for facilitating the anastomotic healing of a patient after a radical prostatectomy surgical procedure, without a urethral catheter, comprising the steps of performing a radical prostatectomy, fixedly positioning a splinting element between the urethra and the bladder, across the urethral opening, placing the splinting element during the performing of the radical prostatectomy and prior to surgical closure. The fixed positioning is effected from a position within the bladder with anchoring the splinting element in position relative to the interior of the bladder, setting a separate urine drainage tube, and removing the splinting element, after anastomotic healing, with a retrieval element on the splinting element or with dissolving of the splinting element.
Related Terms: Prostatectomy Radical Prostatectomy Urethra

Browse recent Cornell University patents - Ithaca, NY, US
Inventor: Ashutosh K. Tewari
USPTO Applicaton #: #20120277658 - Class: 604 9 (USPTO) - 11/01/12 - Class 604 
Surgery > Devices Transferring Fluids From Within One Area Of Body To Another (e.g., Shunts, Etc.) >With Flow Control Means (e.g., Check Valves, Hydrocephalus Pumps, Etc.)

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The Patent Description & Claims data below is from USPTO Patent Application 20120277658, Urethral catheterless radical prostatectomy.

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CROSS REFERENCE TO RELATED APPLICATION

This application is a divisional of of U.S. application Ser. No. 12/355,807, filed on Jan. 19, 2009, the disclosure of which is hereby incorporated by reference in its entirety.

FIELD OF THE INVENTION

This invention relates to procedures for performing radical prostatectomy and post operative anastomotic healing and particularly to splinting procedures not involving urethral catheters in robotic procedures.

BACKGROUND OF THE INVENTION

Radical prostatectomy involves a rejoining of bladder to urethra and a catheter for 1-3 weeks. If the new joint is not splinted with a catheter it will close due to scarring. Additionally urine needs an outlet (provided by the catheter).

Radical prostatectomy is the most common oncological procedure performed by urologists and leaving an indwelling urethral catheter is considered mandatory after open or laparoscopic radical prostatectomy to allow anastomotic healing. The duration of catheterization averages about 5-7 days in most minimally invasive series. However, urinary catheterization is a source of infection, discomfort, anxiety and embarrassment to the patient undergoing radical prostatectomy. Definitive morbidity, such as discomfort, bacteriuria and urethral stricture, is also directly associated with the time a catheter is left in place after surgery.

There have been no published clinical trials of radical prostatectomy performed without a urethral catheter. In gynecological and vascular procedures, a suprapubic catheter has been shown to be better than a urethral catheter. In a review of 5 randomized control trials comparing suprapubic catheter and urethral catheter in colorectal surgery it was demonstrated that patients with a suprapubic catheter experienced less pain and discomfort than the urethral group and the suprapubic catheter was preferred by those patients who had experience with both. In addition the ability to attempt normal voiding is enhanced with the later. There is also evidence to suggest that suprapubic catheters are better than indwelling urethral catheters in term of bacteriuria, need for re-catheterization and discomfort. The risk of developing bacteriuria from a catheter increases by 3-6% per day with the urethral catheter. This would mean that by 7 to 10 days the risk would increase to 50%.

Suprapubic catheterization is a standard procedure performed routinely in urological practice for other indications. The anticipated adverse events include blocked catheter, slippage and displacement of catheter. Displacement is a rare event and can be remedied simply by placing a urethral catheter with no consequences to the final result.

Other problems associated with indwelling urethral catheters include encrustation of the catheter, bladder spasms resulting in urinary leakage, hematuria and urethritis. A suprapubic tube is more patient-friendly, with no risk of urethral damage. Bladder spasms occur less frequently and suprapubic tubes are generally more sanitary. They may also cause fewer urinary tract infections than standard urethral catheters. Thus the benefits of the suprapubic route are reduced infection, control and monitoring of return of normal voiding, reduced need to recatheterize, avoidance of possible urethral damage and improved patient satisfaction. Drainage tubes using the suprapubic route however have a major drawback since this alternative to a urethral catheter does not splint the anastomosis, thus increasing the risk of bladder neck contracture.

Postoperative urethral catheterization is often a source of major discomfort and pain to the patient and may cause more concern to the patient than the procedure itself. Less invasive robotic radical prostatectomy has emerged as a commonly utilized surgical procedure in the management of clinically localized prostate cancer. Patients choosing this procedure are usually driven by its cosmetic benefits, earlier continence, shorter recovery time and minimal blood loss. However, despite the smaller incisions, early ambulation and shorter hospital stay, a few patients, especially the younger ones, continue to complain about the urethral Foley catheter remaining in place for extended time periods. Patients tend to experience urethral discomfort, penile tip pain and meatal encrustation and irritation due to the indwelling catheter. Despite postoperative recovery being essentially uneventful and smooth, patients continue to focus on the catheter and complain—“I wish you did not have to place a urethral catheter . . . ”

SUMMARY

OF THE INVENTION

It is accordingly an object of the present invention to avoid using a urethral catheter in prostatectomy procedures without compromising the time tested principle of splinting the anastomosis in the initial few days following robotic prostatectomy and the minimization of the potential for complications which can occur following urethral catheterization such as urethral stricture, meatal stenosis, urethritis and ascending urethral bacterial colonization.

It is a further object of the present invention to provide a prostatectomy procedure which provides an alternative to the post surgical catheter which a) splints the anastomosis and prevents the formation of cross synechia and b) drains the bladder, without the need for a tube coming out through the penis.

It is a still further object of the present invention to provide a procedure with improvements over the suprapubic catheter whereby splinting of the anastomosis is effected as well.

In accordance with the present invention the prostatectomy procedure is followed by the placement positioning of a short splinting element such as a small flexible tube with a closed outer end or a solid plug of structural rigidity (hereinafter, referred to collectively as a “splinting tube”) across the urethral opening, without significant further extension, in order to splint it open to prevent stricture and bladder neck contracture. The splinting tube, contrary to the normally used urethral catheter, does not permit urine drainage therethrough, but is used in conjunction with a separate drainage tube such as a suprapubic catheter.

The splinting tube is readily placed in position, with minimal steps or traumatization, by a forceps in the bladder during the prostatectomy procedure. The tube is configured to have a larger diameter than the urethral opening to provide a frictional resistance to accidental dislodgement by urinal pressure and is preferably about 30 to 35 mm in length. It is also preferably provided with a diameter comparable to that of the urethral catheter (generally about 5 to 10 mm). It is desirable that the tube or plug have a degree of flexibility for it to conform to the walls of the urethral opening to provide and maintain a snug fit and seal to prevent urine leakage. Placement of the splinting tube or plug requires no trans-urethral movement nor does it require a suprapubic placement procedure. It is desirable that the tube or plug be provided with anchoring means such as a suture connection with the bladder or with the use of integral wing elements at an inner end thereof. These expedients prevent or retard expulsion of the tube or plug as a result of built up urine pressure. The tube or plug is provided with removal means whereby it is removed from the urethral opening after the usual 5-7 day anastomotic healing time. Removal may be effected by utilizing a suture material which dissolves in situ after seven days and/or by the partial or full dissolving of the tube or plug.

The closed or outer end of the tube is preferably connected or tied to a line member which is snaked through the urethra such as by a Foley catheter during other procedures. After the seven days of healing the line member of the splinting tube is externally pulled to disconnect the tube or plug from any anchoring suture and the tube or plug is removed through the urethra. In order to facilitate removal, the tube or plug has an outer diameter no larger than a urethral catheter and is removed in a manner similar to removal of a urethral catheter through the urethra. A line member may not be necessary with self dissolving tubes or plugs which automatically provide the requisite opening in the bladder leading to the urethra. Generally the present invention comprises a method for facilitating the anastomotic healing of a patient after a radical prostatectomy surgical procedure, without a urethral catheter, comprising the steps of: a) performing a radical prostatectomy, b) fixedly positioning a splinting element such, as a closed end tube or solid plug between the urethra and the bladder, across the urethral opening, c) placement of the splinting element is effected during the performing of the radical prostatectomy and prior to surgical closure, the fixed positioning being effected from a position within the bladder. d) anchoring the splinting element in position such as by suturing the inner end of the anchor to the interior of the bladder or by use or expanding wing elements, e) setting a separate urine drainage tube or suprpubic catheter,

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stats Patent Info
Application #
US 20120277658 A1
Publish Date
11/01/2012
Document #
13541277
File Date
07/03/2012
USPTO Class
604/9
Other USPTO Classes
International Class
61M1/00
Drawings
2


Prostatectomy
Radical Prostatectomy
Urethra


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