Partial-length indwelling urinary catheter and method permitting selective urine discharge

• US 20060111691A1
• Filed: 10/07/2005
• Published: 05/25/2006
• Est. Priority Date: 09/17/2003
• Status: Active Grant

• Current Assignee: ProstaLund AB
• Original Assignee: ProstaLund Operations AB (ProstaLund AB)
• Inventors: Andersson, Per, Dymling, Stephan, Schelin, Sonny, Bolmsjo, Magnus
• Granted Patent: US 7,662,145 B2
• Time in Patent Office: Days
• US Class Current: 604/544
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

A partial-length catheter, or an extendable tube or sleeve member of the catheter, is selectively movable within the prostatic urethra to open a urine drainage passageway through and obstructed portion of the prostatic urethra or to open the external urinary sphincter muscle and thereby discharge urine from the bladder. A control element is manipulated at a position exterior of the urinary canal to selectively move the catheter or the extendable tube or sleeve member, thereby selectively controlling urine discharge. The catheter may also be used to diagnose urinary retention problems caused by a weak bladder or a prostatic obstruction.

Claims

1. A method of draining urine in a urethra of a male human from the bladder through the prostate gland and through the orifice in the external urinary sphincter muscle and into the urinary canal which ends at an exterior opening, the urine flowing from a distal location at the bladder to a proximal location at the exterior opening, the method comprising:

positioning a partial-length indwelling catheter in a normal position in which a distal end of the catheter is located within the bladder and a proximal end of the catheter is located within the prostatic urethra at position distal of the external urinary sphincter muscle;

anchoring the catheter to resist proximal movement of the catheter from the normal position;

conducting urine from the bladder through an interior passageway of the catheter which extends between the distal end and the proximal end of the catheter; and

selectively displacing the proximal end of the catheter in a proximal direction from the normal position through the orifice of the external urinary sphincter muscle to conduct urine from the bladder through the interior passageway and into the urinary canal to drain urine from the bladder.

2. A method as defined in claim 1, further comprising:

displacing the proximal end of the catheter in the distal direction through the orifice of the external urinary sphincter muscle after concluding the drainage of urine from the bladder.

3. A method as defined in claim 2, further comprising:

relying on normal constriction of the orifice through the external urinary sphincter muscle to prevent urine drainage from the distal end of the catheter into the urinary canal while the catheter is in the normal position.

4. A method as defined in claim 1, further comprising:

selectively displacing the proximal end of the catheter in a proximal direction from the normal position through the orifice in the external urinary sphincter muscle while maintaining distal anchoring of the catheter and while maintaining the interior passageway in fluid communication with the urine in the bladder.

5. A method as defined in claim 4, further comprising:

extending a control cord from the catheter through the orifice of the external urinary sphincter muscle and through the urinary canal to a position outside of the exterior opening; and

moving the control cord to selectively displace the proximal end of the catheter in a proximal direction from the normal position through the orifice of the external urinary sphincter muscle.

6. A method as defined in claim 4, further comprising:

selectively displacing the proximal end of the catheter in a proximal direction from the normal position through the orifice in the external urinary sphincter muscle by moving the entire catheter in the proximal direction.

7. A method as defined in claim 6, further comprising:

extending a control cord from the catheter through the orifice of the external urinary sphincter muscle and through the urinary canal to a position outside of the exterior opening; and

moving the control cord to selectively move the entire catheter in the proximal direction and thereby displace the proximal end of the catheter in a proximal direction from the normal position through the orifice of the external urinary sphincter muscle.

8. A method as defined in claim 7, further comprising:

anchoring the catheter at the distal end up by extending a distal anchor element connected to the distal end of the catheter into the bladder to contact the bladder neck adjacent to the opening from the bladder into the prostatic urethra; and

compressing the distal anchor element against the bladder neck when moving the entire catheter in the proximal direction to thereby displace the proximal end of the catheter in a proximal direction from the normal position through the orifice of the external urinary sphincter muscle.

9. A method as defined in claim 8, further comprising:

ceasing applying pulling force on the control cord after concluding the drainage of urine from the bladder; and

relying on natural force arising from compressing the distal anchor element against the bladder neck to displace the proximal end of the catheter in the distal direction through the orifice of the external urinary sphincter muscle after concluding the drainage of urine from the bladder.

10. A method as defined in claim 9, further comprising:

using an inflatable balloon as the distal anchor element;

inflating the balloon;

compressing the inflated balloon against the bladder neck when moving the entire catheter in the proximal direction to thereby displace the proximal end of the catheter in a proximal direction from the normal position through the orifice of the external urinary sphincter muscle; and

relying on force from compressing the inflatable balloon against the bladder neck to displace the proximal end of the catheter in the distal direction through the orifice of the external urinary sphincter muscle after concluding the drainage of urine from the bladder.

11. A method as defined in claim 4, further comprising:

anchoring the catheter to resist distal movement of the catheter from the normal position.

12. A method as defined in claim 4, further comprising:

selectively displacing the proximal end of the catheter in a proximal direction from the normal position through the orifice in the external urinary sphincter muscle by moving an extendable proximal end portion of the catheter in the proximal direction.

13. A method as defined in claim 12, further comprising:

extending the control cord from the extendable proximal end portion of the catheter through the orifice of the external urinary sphincter muscle and through the urinary canal to a position outside of the exterior opening; and

moving the control cord to selectively move the extendable proximal end portion of the catheter in a proximal direction from the normal position through the orifice of the external urinary sphincter muscle.

14. A method as defined in claim 13, further comprising:

using a tube member which telescopically extends relative to a main body of the catheter as the extendable proximal end portion of the catheter.

15. A method as defined in claim 14, further comprising:

extending the control cord from the tube member; and

pulling the control cord to extend the tube member in a proximal direction through the orifice of the external urinary sphincter muscle.

16. A method as defined in claim 15, further comprising:

using a bias element connected within the catheter and between the tube member and the main body to retract the tube member from extending through the orifice of the external urinary sphincter muscle upon ceasing application of pulling force on the control cord.

17. A method as defined in claim 13, further comprising:

using a flexible sleeve member which extends relative to a main body of the catheter as the extendable proximal end portion of the catheter.

18. A method as defined in claim 17, further comprising:

extending the control cord from the sleeve member; and

pulling the control cord to extend the sleeve member in a proximal direction through the orifice of the external urinary sphincter muscle.

19. A method as defined in claim 18, further comprising:

using a sleeve member which flexes in an accordion-like manner.

20. A method as defined in claim 19, further comprising:

using a bias element connected within the sleeve member to retract the sleeve member from extending through the orifice of the external urinary sphincter muscle upon ceasing application of pulling force on the control cord.

21. A method as defined in claim 1, further comprising:

anchoring the catheter to resist proximal movement by inflating an inflatable balloon on the proximal end of the catheter within the bladder and contacting the inflated balloon with the bladder neck adjacent to the opening from the bladder into the prostatic urethra;

extending an inflation tube from the catheter through the orifice of the external urinary sphincter muscle and through the urinary canal and out the exterior opening; and

inflating the balloon by delivering fluid though the inflation tube and into the balloon.

22. A method as defined in claim 21, further comprising:

selectively displacing the proximal end of the catheter in a proximal direction from the normal position through the orifice of the external urinary sphincter muscle to conduct urine from the bladder through the interior passageway and into the urinary canal to drain urine from the bladder while the inflated balloon is in contact with the bladder neck.

23. A method as defined in claim 22, further comprising:

relying on normal constriction of the orifice through the external urinary sphincter muscle around the inflation tube to prevent urine drainage from the distal end of the catheter into the urinary canal while the catheter is in the normal position.

24. A method as defined in claim 23, further comprising:

anchoring the catheter to resist distal movement by positioning a coiled section of the inflation tube within the urinary canal at a position proximal of the external urinary sphincter muscle when the orifice through the external urinary sphincter muscle is constricted; and

selectively displacing the proximal end of the catheter in a proximal direction from the normal position through the orifice of the external urinary sphincter muscle to conduct urine from the bladder through the interior passageway and into the urinary canal to drain urine from the bladder while the coiled section of the inflation tube is within the urinary canal at a position proximal of the external urinary sphincter muscle.

25. A partial-length indwelling catheter for draining urine in a male human from the bladder through the prostate gland and through the orifice in the external urinary sphincter muscle and into the urinary canal which ends at the exterior opening of the urinary canal, the urine flowing from a distal location at the bladder to a proximal location at the exterior opening, the catheter comprising:

a main body having a main body with a distal end and a proximal end, the main body having a length sufficient to establish a normal position in which the distal end is within the bladder and the proximal end is distally adjacent to the external urinary sphincter muscle, the main body defining an interior passageway extending from the distal end to the proximal end, the interior passageway communicating with the urine within the bladder;

a distal anchor element connected to the distal end of the main body, the distal anchor element is expandable in size to contact the bladder neck adjacent to the opening from the bladder into the prostatic urethra and restrain the main body against proximal movement from the normal position; and

a control element connected at a distal end to the main body and having a length sufficient to extend through the orifice of the external urinary sphincter muscle and through the urinary canal to a proximal end located outside the exterior opening, the control element transferring force from the proximal end of the control element to the main body to selectively displace the proximal end of the catheter in a proximal direction from the normal position through the orifice of the external urinary sphincter muscle to conduct urine from the bladder through the interior passageway and into the urinary canal at a position proximal of the external urinary sphincter muscle.

26. An indwelling catheter as defined in claim 25, wherein:

the control element transfers sufficient force to move the entire catheter in the proximal direction to selectively displace the proximal end of the catheter in a proximal direction from the normal position through the orifice in the external urinary sphincter muscle.

27. An indwelling catheter as defined in claim 26, wherein:

the control element comprises a control cord connected to the main body; and

the control cord transfers pulling force which is sufficient to compress the distal anchor element against bladder neck and move the entire catheter in the proximal direction to thereby displace the proximal end of the catheter from the normal position in a proximal direction through the orifice of the external urinary sphincter muscle.

28. An indwelling catheter as defined in claim 27, wherein:

the distal anchor element comprises an inflatable balloon which has been inflated with fluid;

the inflatable balloon is compressed against the bladder neck when the entire catheter is moved in the proximal direction to thereby displace the proximal end of the catheter from the normal position in a proximal direction through the orifice of the external urinary sphincter muscle.

29. An indwelling catheter as defined in claim 28, wherein:

the force of compressing the inflatable balloon against the bladder neck to displace the proximal end of the catheter in the distal direction through the orifice of the external urinary sphincter muscle returns the main body to the normal position after releasing the force on the control cord.

30. An indwelling catheter as defined in claim 25, wherein:

the main body includes an extendable proximal end portion; and

the control element is connected to the extendable proximal end portion of the main body to move the extendable proximal end portion in a proximal direction from the normal position through the orifice of the external urinary sphincter muscle.

31. An indwelling catheter as defined in claim 30, wherein:

a bias element connected between the extendable proximal end portion and the main body to return the extendable proximal end portion from extending through the orifice of the external urinary sphincter muscle upon ceasing application of pulling force on the control cord.

32. An indwelling catheter as defined in claim 30, wherein:

the extendable proximal end portion of the main body comprises a tube member which is telescopically movable relative to the main body.

33. An indwelling catheter as defined in claim 32, wherein:

the control element comprises a control cord connected to the telescoping tube member; and

the control cord transfers pulling force which is sufficient to move the telescoping tube member in the proximal direction relative to the main body and through the orifice of the external urinary sphincter muscle.

34. An indwelling catheter as defined in claim 33, further comprising:

a bias element connected between the tube member and the main body to return the telescoping tube member from extending through the orifice of the external urinary sphincter muscle upon ceasing application of pulling force on the control cord.

35. An indwelling catheter as defined in claim 30, wherein:

the extendable proximal end portion of the main body comprises a flexible sleeve member which is expandable relative to the main body.

36. An indwelling catheter as defined in claim 35, wherein:

the control element comprises a control cord connected to the sleeve member; and

the control cord transfers pulling force which is sufficient to expand the sleeve member in the proximal direction relative to the main body and through the orifice of the external urinary sphincter muscle.

37. An indwelling catheter as defined in claim 36, wherein:

the sleeve member expands by flexing in an accordion-like manner.

38. An indwelling catheter as defined in claim 36, wherein:

the sleeve member includes a bias element to retract the sleeve member from extending through the orifice of the external urinary sphincter muscle upon ceasing application of pulling force on the control cord.

39. An indwelling catheter as defined in claim 30, wherein:

the extendable distal end portion is movable to a retracted position in which the extendable distal end portion is positioned entirely within the interior passageway of the main body.

40. An indwelling catheter as defined in claim 25, wherein:

the distal anchor element comprises an inflatable balloon attached to the main body; and

further comprising;

an inflation tube having a distal end connected to the main body and a length sufficient to extend from the main body through the external urinary sphincter muscle and the urinary canal to the exterior opening at which a proximal end of the inflation tube is located, the inflation tube defining an inflation passageway extending from the proximal end of the inflation tube and in communication with the balloon through which to deliver fluid for expanding the balloon.

41. An indwelling catheter as defined in claim 40, further comprising:

a proximal anchor element connected to the main body and located at a position on the proximal side of the external urinary sphincter muscle when the distal anchor element contacts the bladder neck, the proximal anchor element restraining the main body against distal movement from the normal position, the proximal anchor element comprising a coiled section of the inflation tube within the urinary canal at a position proximal of the external urinary sphincter muscle when the orifice through the external urinary sphincter muscle is constricted.

42. A method of diagnosing urinary tract retention in a male human being caused by one of either a blockage in a prostatic urethra or by a weak bladder, comprising:

flowing urine from a distal location at the bladder through the prostate gland and through the orifice in the external urinary sphincter muscle and through the urinary canal and out of the exterior opening of the urinary canal at a proximal location;

positioning a partial-length indwelling catheter within the prostatic urethra to establish fluid communication from the bladder with an interior passageway of the catheter and to a position at the proximal end of the catheter distally adjacent to the sphincter muscle;

flowing urine through the catheter;

determining whether urine flow from the exterior opening is greater with the catheter positioned in the prostatic urethra compared to the urine flow when the catheter is not positioned in the prostatic urethra;

diagnosing a blockage in the prostatic urethra if the urine flow with the catheter positioned in the prostatic urethra is significantly greater than the urine flow when the catheter is not positioned in the prostatic urethra; and

diagnosing a weak bladder if the urine flow with the catheter positioned in the prostatic urethra is not substantially different than the urine flow when the catheter is not positioned in the prostatic urethra.

43. A method as defined in claim 42, further comprising:

verifying the diagnosis of a weak bladder by selectively displacing the proximal end of the interior passageway in a proximal direction through the orifice of the external urinary sphincter muscle while maintaining the interior passageway in fluid communication with urine in the bladder; and

determining whether urine flow from the exterior opening is greater with the proximal end of the interior passageway extending through the orifice of the external urinary sphincter muscle; and

if so

confirming the diagnosis of a weak bladder.