Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-04-07
2001-07-03
Seidel, Richard K. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C606S190000, C604S096010, C604S101010, C604S509000
Reexamination Certificate
active
06254570
ABSTRACT:
TECHNICAL FIELD
The invention relates generally to medical devices and, in particular, to a drainage catheter with a back-up retention member for retaining the catheter in a patient.
BACKGROUND OF THE INVENTION
Since the 1930's, the Foley drainage catheter has remained the preferred option for patients requiring urinary diversion. The basic design of one or more drainage ports at or near the distal end, a central drainage lumen, an elastomeric retention balloon for anchoring the catheter in the bladder, and a proximally-located valve to keep the fluid from leaking out the inflation lumen and deflating the balloon, has not undergone significant evolution other than the change from latex to silicone.
The Foley catheter does have some acknowledged weaknesses. Chief among them is displacement of the catheter due to accidental or intentional dislodgement from the bladder, which may be attributed to the patient pulling on the proximal exposed portion. There is much greater risk of dislodgement if the balloon has partially or fully deflated due to a leak at the proximal valve or balloon itself, or due to the natural diffusion of the balloon contents over time through a semi-permeable balloon material.
While dislodgement of a Foley catheter is not usually serious in most instances, it can be a very large problem in patients who have undergone a radical prostatectomy where the prostate has been removed and the urethra resectioned. The standard procedure for prostatectomy patients is to place a Foley drainage catheter at the time of surgery to be left in place for no more than two to three weeks. Besides providing drainage, the catheter keeps the anastomotic site patent during the healing process and offers some degree of protection from strain and trauma. If the catheter is dislodged, however, it can damage the delicate anastomotic site, especially early in the post-surgical recovery period. Even if the sutures at the site do not pull out during dislodgement, the surgeon may be forced to reopen the patient to place another drainage catheter to prevent possible damage during its introduction through the surgical resection site.
Given the seriousness of having a Foley drainage catheter dislodge following a surgical procedure such as a radical prostatectomy, there is a strong need for a catheter design that helps preclude the balloon or retention member from displacing and causing damage to the surgical site. Existing devices do not provide this important safety feature of retaining the catheter inside the bladder.
In addition to the Foley catheter for urinary drainage, there are catheters used in gastric, vascular, and other procedures that utilize a balloon or other means for retention, occlusion or dilatation in which deflation or a related failure could be critical.
SUMMARY OF THE INVENTION
The foregoing problems are solved and a technical advance is achieved in an illustrative back-up retention member drainage catheter for placement in the bladder of a patient. This drainage catheter is particularly advantageous during and after a radical prostatectomy surgical procedure for insuring that the catheter is retained in the bladder of a patient during the healing process of the resectioned urethra. The drainage catheter of the present invention includes an elongated tubular member having a drainage lumen extending longitudinally therein with at least one external drainage port disposed at least near the distal end thereof. A back-up retention member having an expanded state is disposed on the elongated member at least near the distal end and proximal the external drainage port. A primary retention member having an expanded state is also disposed on the elongated member and about the back-up retention member. As a result, the back-up retention member advantageously maintains the position of the drainage catheter in the bladder of a patient should the primary retention member fail in the expanded state and collapse. The back-up retention member is particularly advantageous during and after a radical prostatectomy surgical procedure to eliminate the need for another surgical procedure to reinsert another drainage catheter in the bladder through the resectioned urethra. Maintaining the drainage catheter through the resectioned urethra is absolutely necessary to maintain the patency of the urethra during the healing process.
In the preferred embodiment, the back-up and primary retention members comprise first and second balloons each having a collapsed and an expanded state. To independently inflate the balloons to the expanded state, the elongated member further includes first and second inflation lumens extending longitudinally therein and communicating internally and independently with the first and second balloons, respectively. In addition, the second inflation lumen communicates externally with the first balloon so as to maintain independent inflation. First and second one-way valves are disposed near the proximal end of the first and second inflations lumen, respectively.
The distal end of the elongated member includes a plug having an atraumatic shape that closes the drainage and inflation lumens thereat. The elongated member, as well as the back-up and primary retention balloons, comprise a soft and flexible material such as silicone. However, the soft and flexible material can comprise at least one from a group consisting of silicone, latex, or any other elastomeric material.
To further advantageously retain the drainage catheter in the bladder of a patient, the elongated member includes a tether lumen extending transversely therethrough and disposed at least near the distal end and distal to the external drainage port. The catheter also includes a tether which is positionable through the tether lumen for percutaneous securement to the patient via the bladder.
In another aspect of the drainage catheter, another external drainage port is disposed at the distal end of the elongated member. This distal end drainage port advantageously permits a wire guide to be extended distally from the drainage lumen and the external drainage port. The wire guide is used to position the drainage catheter in the patient. Furthermore, the external drainage port at the distal end of the catheter advantageously permits endoscopic instruments and other medical devices to be inserted therethrough and in, for example, the ureters of the patient.
To maintain the retention balloons in the expanded state, one way valves are positioned at the proximal end of the inflation lumens to advantageously maintain saline in the expanded balloons and inflation lumens.
In addition to acting as retention arrangements the balloons also act as seals for preventing the flow of fluid from the bladder into the urethra around the outer surface of elongated tube member. Such a flow of fluid would prevent the healing process following a prostatectomy. Collapse of the outer balloon would result in the inner balloon taking over the same function. The inner balloon is fixed to the member in an offset manner with the two balloons in contact with one another at the proximal contact points and spaced from one another at the distal contact or fixing points to member. The offsetting of the balloons in this way unexpectedly maintains the seal between the bladder and the urethra at all times.
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patent: 0 266 957 (198
Roemer Frederick D.
Rutner Alvin B.
Godlewski Richard J.
Hunt James B.
Maynard Jennifer
Ness Anton P.
Seidel Richard K.
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