Laparoscopically implanting bladder control apparatus

• US 5,123,428 A
• Filed: 10/10/1991
• Issued: 06/23/1992
• Est. Priority Date: 10/11/1988
• Status: Expired due to Fees

• Current Assignee: Marger Johnson P.C.
• Original Assignee: Gerald R. Schwarz
• Inventors: Schwarz, Gerald R.
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): BROWN, MICHAEL A
• Application Number:
  US07/774,546
• Time in Patent Office: 257 Days
• Field of Search: 128/885, 128/DIG. 25, 600/29-31, 623/11
• US Class Current: 128/885
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2/004 inflatable
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

A method for implanting an artificial sphincter to control urinary incontinence in a patient includes two implantation procedures and an intervening interval of testing and healing. The first procedure employs a trocar or laparoscope to insert and position an inflatable compression balloon 66 in the patient'"'"'s space of Retzuis between the patients'"'"'s posterior pubic symphysis and bladder neck/urethra 12,14 with a fluid conduit 26 extending transcutaneously through the abdominal wall. Using a trocar and Foley catheter, the patient'"'"'s anterior bladder is elevated and connected to the patient'"'"'s abdominal wall by a felt matrix or mesh patch 32 to effectively lengthen and stabilize the urethra. The conduit is used externally to determine respective first and second fluid pressures needed to occlude the urethra and to permit voiding. The second procedure is to implant a fluid reservoir 22 and manually-actuable valve 46 subcutaneously ofer the patient'"'"'s anterior pubis 16 or abdomen and to connect them to the compression balloon via the conduit in a closed system. The system is filled with a quantity of fluid just sufficient to inflate the balloon to the first pressure occlude the urethra when the reservoir is manually compressed by the patient and to equilibrate to the second pressure to permit voiding when the valve is actuated.

Claims

1. A method for implanting an artificial sphincter to control urinary incontinence in a human patient having a bladder and a urethra, the method comprising:

implanting an inflatable compression balloon intrapelvically above the pelvic diaphragm adjacent one side of the urethra with a transcutaneous conduit;

selectively inflating and deflating said compression balloon via the transcutaneous conduit; and

externally controlling and monitoring a pressure within the compression balloon via the transcutaneous conduit to establish alternately a first pressure sufficient to occlude the urethra and a second pressure sufficient to permit voiding.

2. A method according to claim 1 in which the implanting step includes inserting a sheath-type device anteriorly-inferiorly through the patient'"'"'s preperitoneal space and retropubic space and introducing the compression balloon through the sheath-type device into the space between the patient'"'"'s pubic bone and bladder.

3. A method according to claim 2 further comprising positioning the compression balloon within the space between the patient'"'"'s pubic bone and bladder to compress the urethra against internal tissues of the patient.

4. A method according to claim 2 further comprising positioning the compression balloon within the space between the patient'"'"'s pubic bone and bladder so as to elongate the urethra.

5. A method according to claim 1 including implanting a reservoir subcutaneously within the patient and connecting the reservoir to the conduit to form a closed system for inflating said compressio means after establishing said first and second pressures and charging the closed system with a volume of fluid determinded by said first and second pressures.

6. A method according to claim 5 further comprising relatively sizing the reservoir and compression balloon to expel fluid from the compression balloon into the reservoir..

7. A method according to claim 5 further comprising externally actuating release of fluid from said compression balloon to said reservoir.

8. A method according to claim 5 in which the steps of implanting a reservoir subcutaneous within the patient and connecting it to the conduit are performed in a separate procedure spaced an interval of time after implanting the inflatable compression balloon.

9. A method according to claim 1 further comprising introducing a balloon-type catheter into the patient'"'"'s anterior bladder positioning and securing the bladder against the patient'"'"'s abdominal wall in an elevated position such that the urethra is extended.

10. A method according to claim 9 including affixing the bladder to the patient'"'"'s internal abdominal wall.

11. In the patient having a pelvis including a pubis, a pelvic cavity, an abdominal wall connected inferiorly to the pubis, a urinary bladder located within the pelvic cavity posteriorly of the pubis and a urethra descending inferiorly from the bladder through the pelvic diaphragm, a method of implanting an artificial sphincter for controlling urinary incontinence in a patient, the method comprising:

inserting a sheath-type device anteriorly-inferiorly through the patient'"'"'s abdominal wall and preperitoneal space and retropubic space into the space between the pubic bone and bladder;

introducing an inflatable compression balloon through the sheath-type device, said compression balloon being arranged to compress, when inflated, against the urethra and/or bladder neck along an extended area of one side thereof;

positioning the compression balloon interapelvically above the pelvic diaphragm within the space between the patient'"'"'s pubic bone and bladder between the patient'"'"'s posterior pubic symphysis and urethra for occluding the urethra; and

coupling a conduit to the compression balloon and extending the conduit over the superior pubis and through the abdominal wall to provide external fluid communication with the compression balloon for inflating the compression balloon in response to externally-applied fluid pressure.

12. A method according to claim 11 including implanting a reservoir and valve subcutaneously within the patient and connecting the reservoir and valve to the conduit to form a closed system for inflating said compression means after establishing said first and second pressures and charging the closed system with a volume of fluid determined by said first and second pressures.

13. A method according to claim 12, in which the compression balloon and conduit are introduced and positioned in a first procedure and the reservoir and valve are implanted in a second procedure delayed from the first procedure by a testing interval, testing including externally controlling and monitoring a pressure within the compression balloon via the transcutaneous conduit to establish alternately a first pressure just sufficient to occlude the urethra and a second pressure sufficient to permit voiding.

14. A method according to claim 13 in which the reservoir has an anterior sidewall including a self-sealing diaphragm for inserting a needle transcutaneously to modify the volume of fluid in the apparatus.

15. A method according to claim 12 further comprising sizing the reservoir to a volume greater than a volume of the compression balloon when the system is at equilibrium so that the compression balloon, when distended sufficiently to occlude the urethra, expels fluid under pressure from the compression balloon into the reservoir, when the valve is opened, to open the urethra.

16. A method according to claim 11 in which the compression balloon has an oval cross-sectional shape.

17. A method according to claim 16 in which the compression balloon is shaped to direct inflation of the balloon preferentially in a direction normal to the dimension of said cross-sectional shape so as to compress the urethra in an inferior-posterior direction.

18. A method according to claim 17 in which the sheath-type device includes a laparoscopic instrument.

19. A method according to claim 11 in which the positioning step includes optically viewing through the sheath-type device.