Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-02-04
2001-10-09
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06299598
ABSTRACT:
TECHNICAL FIELD
The invention relates generally to a medical device and, in particular, to a drainage catheter.
BACKGROUND OF THE INVENTION
A radical prostatectomy can be a very difficult procedure because the surgeon cannot fully visualize the surgical site and work within the tight anatomical constraints. Complications from surgery can include impotence and incontinence due to sphincter damage. After the prostate has been excised, the urethra must be reconstructed to restore normal urinary function to the patient. Typically, the surgeon sutures the transected end of the urethral stump to the bladder neck. Occasionally, surgical complications occur at the anastomotic site such as the leakage of urine or, formation of strictures. The vulnerability of the site and the need to keep the lumen patent necessitates a means of support during the healing phase to achieve good anastomosis of the reconstructed urethra.
Radical prostatectomy patients require urinary drainage by an indwelling catheter following the procedure. The standard procedure for prostatectomy patients is to place a Foley drainage catheter at the time of surgery to be left in place for two to three weeks (healing period). While it is placed for drainage, the catheter also serves to keep the anastomotic site patent during the healing process. Although transurethral catheters can maintain urethral patency while providing post-surgical drainage of the bladder, there are disadvantages associated with their use. They are uncomfortable, resulting in a tendency for some patients to pull on the end of the catheter, which may dislodge it from the bladder. Occasionally, the retention balloon will deflate, permitting the catheter to migrate past the anastomotic site and out of the bladder. Another potential complication is that transurethral drainage catheters can become a pathway for pathogens and organisms that are carried or migrate from the skin surface through the urethra to the anastomotic site and the bladder. This may lead to infection and curtail the healing process. Furthermore, transurethral drainage catheters are not ideal for promoting good anastomosis of the surgical site because movement of the balloon may allow urine to leak around the catheter, which provides a suboptimal environment for healing. Foley catheters have only one or two drainage holes which may easily become obstructed by blood clot(s) resulting in poor or no drainage and anastomotic compromise. If the anastomotic site can be kept relatively dry, the likelihood of a good result is increased. Additionally, accidental jerking or other movement of the catheter can cause trauma to the bladder and/or anastomosis before the healing process is complete.
SUMMARY OF THE INVENTION
The foregoing problems are solved and a technical advance is achieved in an illustrative drainage catheter having an elongated member having a drainage passage with at least on e drainage port positioned between first and second retention members, and a closed-ended distal portion sized and configured for maintaining patency of a vessel in the vicinity of an anastomotic site. In one useful application, the drainage catheter is positioned not only in the bladder, but through the anastomotic site in the urethra as well, of a patient who has undergone a radical prostatectomy or other procedure requiring reconstructs of the bladder-urethral anastomosis. The drainage catheter comprises an elongated member having a drainage lumen passage extending longitudinally within and a drainage portion having at least one drainage port that provides external access for bladder contents via the drainage passage. The elongated member also has a distal segment that is located distal to the drainage port. This distal portion/segment has no drainage port or drainage passage. The distal portion of the elongated member is advantageously positioned through the anastomotic site into the urethra of a patient and to maintain patency of the anastomosis and urethra during the healing process. Furthermore, the distal non-draining portion also advantageously minimizes, if not eliminates, urine collected in the bladder from migrating to the anastomotic site. The closed distal portion also blocks external access of the drainage passage so as to eliminate any urine in the drainage catheter from exiting the distal portion and contacting the anastomotic site.
The drainage catheter further includes a first retention member, preferably an expandable balloon that is connected to the elongated member and positioned distal to the drainage segment. When expanded, this first retention balloon advantageously is positioned at the base of the bladder adjacent the bladder neck to further minimize the migration of urine into the urethra and, more importantly, the anastomotic site. A second retention member, preferably another expandable balloon, is connected to the elongated member and positioned proximal to the drainage segment. This second retention balloon is advantageously expanded in its position at the dome of the bladder and works in cooperation with the first retention balloon to maintain the drainage portion of the catheter in the bladder as well as the distal portion in the patient's urethra.
The elongated member of the drainage catheter also includes a proximal portion that is positioned proximal the drainage port and provides external egress from the drainage passage outside the patient. The first and second retention members can include first and second expandable members that are mechanical in nature, each having a collapsed and an expanded state surrounding the elongated member at opposite sides of the drainage port. In one configuration, the retention members, as previously suggested, include first and second balloons. Accordingly, the elongated member includes at least one inflation passage and, preferably, first and second inflation passages extending longitudinally therein and communicating with the first and second retention balloons, respectively. Separate inflation passages advantageously provide for individual and independent inflation and deflation of the balloons.
To further enhance drainage of urine from the bladder, the drainage portion includes a plurality of drainage ports, each preferably having an elliptical shape for maximizing the flow of urine therethrough. The drainage passage of the elongated member also has a preferred crescent, cross-sectional shape to minimize the collection of pathogens and organisms therein as well as the formation of encrustations.
The distal portion of the elongated member is advantageously sized and configured for maintaining the patency of the urethra in the vicinity of the anastomotic site. To further ease insertion thereof and minimize trauma to surrounding tissue, the distal portion includes an atraumatic end preferably having a hemispherical shape. The elongated member preferably comprises a soft, silicone material. However, to enhance fluoroscopic or radiographic visualization of the catheter, the elongated member includes a radiopaque material. Furthermore, to minimize pathogen and organism growth, the elongated member includes a medicant, such as Rifampin/Minocycline, either singly or in combination with other medicants. Surfactants, coatings, chemical bonding, implantation, imbedding, and encapsulation can be used singly or in combination to deliver advantageously one or more medicants at any desired delivery rate.
REFERENCES:
patent: 2642874 (1953-06-01), Keeling
patent: 2799273 (1957-07-01), Oddo
patent: 2936760 (1960-05-01), Gants
patent: 4456011 (1984-06-01), Warnecke
patent: 4634435 (1987-01-01), Ingraham
patent: 4636195 (1987-01-01), Wolinsky
patent: 4660560 (1987-04-01), Klein
patent: 4705502 (1987-11-01), Patel
patent: 4723946 (1988-02-01), Kay
patent: 4781677 (1988-11-01), Wlicox
patent: 4946449 (1990-08-01), Davis, Jr.
patent: 4976692 (1990-12-01), Atad
patent: 5112306 (1992-05-01), Burton et al.
patent: 5188595 (1993-02-01), Jacobi
patent: 5328470 (1994-07-01), Nabel et al.
patent: 5411479 (1995-05-01), Bodden
patent: 5419763 (1995-05-01), H
Cook Urological Incorporated
Hunt James B.
Kennedy Sharon
LandOfFree
Drainage catheter does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Drainage catheter, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Drainage catheter will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2601537