Indwelling urethral catheter system and method

• US 4,946,449 A
• Filed: 12/18/1986
• Issued: 08/07/1990
• Est. Priority Date: 12/18/1986
• Status: Expired due to Term

• Current Assignee: Urocath Corporation
• Original Assignee: Richard C. Davis Jr
• Inventors: Davis, Richard C. Jr.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US06/943,014
• Time in Patent Office: 1,328 Days
• Field of Search: 604/256, 604/247, 604/250, 604/275, 604/280, 604/283, 604/27, 604/30, 604/34, 604/49, 604/54, 604/96-103, 128/DIG. 25
• US Class Current: 604/256
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

An indwelling urethral catheter system and method of its use involve a drainage shaft (16) mounted in a urinary tract (24) having an externally-operated, normally-closed, fluid valve (38) mounted therein near the meatus (22) of the urinary tract. A removable insertion conduit assembly (12), separate from the catheter drainage shaft, is for extending from outside the body, through the meatus of the urinary tract to plug into the proximal end of the catheter drainage shaft and impinge on the valve for holding it open to allow free drainage through the valve. Once the insertion conduit is removed from the urinary tract it no longer impinges on the valve for holding it open and the valve is thereafter normally closed unless opened by application of force from outside the body.

Claims

1. An indwelling urethral catheter system for use with a human body comprising:

a catheter drainage shaft defining an enclosed drainage canal for extending through a urinary tract of the human body to provide urinary drainage therethrough and having distal and proximal ends;

an anchoring means attached to the catheter drainage shaft near said distal end thereof for holding said drainage shaft in a proper position in said urinary tact;

a valve means attached to said catheter drainage shaft and being positioned in said drainage canal near said proximal end of said shaft for being in a closed position to prevent flow of urine through said drainage canal but for being selectively moved from said closed position to an open position by applying force thereto from outside the human body for respectively allowing and disallowing fluid flow through said enclosed drainage canal;

said catheter drainage shaft being of a length, and said anchoring means being located at a position therealong, such that when said catheter drainage shaft is held in said proper position in said urinary tract, said valve means and the proximal end of said drainage shaft are located entirely within said urinary tract yet accessible from outside the human body; and

,

a removable insertion conduit separate from said catheter drainage shaft, said removable insertion conduit defining a drainage passage and having a distal end and a proximal end, said removable insertion conduit including at the distal end thereof an elongated connector stint having a cross-sectional size and a length for fitting into the drainage canal of the catheter drainage shaft from the proximal end thereof and extending from outside the human body into the human body to impinge on said valve means for holding said valve means open;

said valve means having the further function of remaining open in response to engagement with said stint to be held open thereby, but upon removal of said stint from engagement therewith, of being allowed to close to prevent further passage of liquid through said drainage canal;

whereby said catheter drainage shaft can be held in a urinary tract by said anchoring means with its proximal end being positioned in said urinary tract accessible to the meatus thereof to outside the human body and the removable insertion conduit can extend through the meatus of the urinary tract with elongated connector stint inserted into the proximal end of the drainage-shaft drainage canal for engaging said valve and thereby holding said valve open to allow continuous flow of urine past said valve and out through the insertion conduit drainage passage to outside the body and said removable insertion conduit can then be removed from the urinary tract, thereby removing said stint from the drainage canal of said catheter drainage shaft and from said urinary tract for disengaging said valve and allowing it to close but to be selectively opened by a force applied there from outside said body.

2. An indwelling urethral catheter system as in claim 1 wherein said stint is a tube that extends through said valve and which has a bore through which urine located upstream of said valve can flow through said valve.

3. An indwelling urethral catheter system as in claim 2 wherein said anchoring means comprises a bladder balloon attached to said catheter drainage shaft and an expendable urethral cuff attached thereto, said bladder balloon and said urethral cuff being spaced along said drainage shaft and said balloon being inflatable through a lumen passing through said removable insertion conduit and said catheter drainage shaft.

4. An indwelling urethral catheter system as in claim 3 wherein said valve means is a mitre valve comprising a resilient dome-shaped member having a slit therein.

5. An indwelling urethral catheter as in claim 3 wherein said expandable urethral cuff is also inflatable and said removable insertion conduit further includes hollow balloon and cuff inflation pins projecting outwardly at said proximal end of said removable insertion conduit for insertion into inflation lumens formed in the wall of said catheter drainage shaft, and wherein the wall of said catheter drainage shaft includes said inflation lumens whereby when said stint extends into said drainage canal of said catheter drainage shaft said pins extend into said inflation lumens of said catheter drainage shaft wall through said cuff and said balloon can be inflated.

6. An indwelling urethral catheter as in claim 2 wherein said valve means is a mitre valve comprising a resilient dome-shaped member having a slit therein.

7. An indwelling urethral catheter as in claim 1 wherein said anchoring means comprises a bladder balloon attached to said catheter drainage shaft and an expandable urethral cuff attached thereto, said bladder balloon and said urethral cuff being spaced along said drainage shaft and said balloon being inflatable through lumens passing through said removable insertion conduit and said catheter drainage shaft for respectively inflating in a bladder and a urethra.

8. An indwelling urethral catheter as in claim 7 wherein said valve means is a mitre valve comprising a resilient dome-shaped member having a slit therein.

9. An indwelling urethral catheter as in claim 1 wherein said valve means is a mitre valve comprising a resilient dome-shaped member having a slit therein.

15. An indwelling urethral catheter as in claim 3 wherein said removable insertion conduit further includes a hollow balloon inflation pin projecting outwardly at said proximal end of said removable insertion conduit for insertion into an inflation lumen formed in the wall of said catheter draining shaft, and wherein the wall of said catheter drainage shaft includes said inflation lumen, whereby when said stint extends into said drainage canal of said catheter drainage shaft said pin extends into said inflation lumen of said catheter drainage shaft wall through which said cuff and said balloon can be inflated.

10. A method for inserting and using an indwelling urethral catheter comprising the steps of:

inserting a catheter drainage shaft in a urinary tract, said catheter drainage shaft defining an enclosed drainage canal to provide urinary drainage through the urinary tract from a bladder, in which the distal end of the drainage shaft is located, to a point downstream thereof in the urinary tract at which a proximal end of the drainage shaft is located, said drainage shaft including an anchoring means for holding said drainage shaft in a proper position in the urinary tract and a valve means positioned in the drainage canal for being in a closed position to prevent flow of urine through said drainage canal but for being selectively opened by applying forces thereto from outside the human body for allowing fluid flow through the said drainage canal, said catheter drainage shaft being of a length, and said anchoring means being located at a position therealong, such that when said catheter drainage shaft is held in the proper position in the urinary tract said valve means and the proximal end of said drainage shaft are located in said urinary tract, but accessible from a meatus thereof from outside the human body;

inserting a removable insertion conduit, which is a separate member from the catheter drainage shaft, through the meatus of the urinary tract, to extend from the meatus of the urinary tract into the catheter-drainage-shaft drainage canal, said removable insertion conduit having at its distal end an elongate connector stint which is inserted into the drainage canal of the catheter drainage shaft to extend to and impinge on said valve means for holding said valve means open;

allowing urine to flow freely from said bladder through said drainage shaft and through said valve to outside the body;

pulling said removable insertion conduit from said urinary tract thereby pulling said elongated connector stint from said drainage canal of said catheter drainage shaft to thereby allow said valve means to move to a closed position and thereby prevent urine flow through said valve means; and

thereafter, selectively opening said valve means by applying forces thereto from said body for allowing selective flow of urine through the meatus of said urinary tract.

11. A method as in claim 10 wherein said stint is tubular in shape, having a bore, and wherein said step of allowing urine to flow freely through said valve includes the substep of draining said urine through a bore in said stint.

12. A method as in claim 11 wherein said valve is a mitre valve comprising a resilient dome having a slit therein and said step of inserting said stint through said valve includes the substep of inserting said stint through said slit in said dome.

13. A method as in claim 10 wherein said anchoring means comprises a bladder balloon and an inflatable urethral cuff attached to said catheter drainage shaft along the length thereof, said bladder balloon and said urethral cuff being spaced from one another with said bladder balloon being located close to the distal end of said drainage shaft and being inflated in a bladder and said cuff being inflated in the urethra during said step of inserting said catheter drainage shaft in said urinary tract.

14. A method as in claim 10 wherein the distal end of said removable insertion conduit is inserted into the drainage canal of the catheter drainage shaft before said catheter drainage shaft is inserted into the urinary tract so that they are inserted into the urinary tract together.