Diagnostic urethral assembly and method

• US 6,719,709 B2
• Filed: 08/31/2001
• Issued: 04/13/2004
• Est. Priority Date: 08/31/2000
• Status: Expired due to Term

• Current Assignee: SRS Medical Systems, LLC
• Original Assignee: AbbeyMoor Medical, Inc.
• Inventors: Willard, Lloyd K., Reid, John M., Whalen, Mark J.
• Primary Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US09/943,975
• Publication Number:
  US 20020065476A1
• Time in Patent Office: 956 Days
• Field of Search: 600/561, 600/29, 600/587, 600/591, 600/593, 604/264, 604/544, 604/96.01, 604/162.02
• US Class Current: 600/587
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/205 Determining bladder or urethral pressure
• CPC Class Codes: A61B 5/208 adapted to determine urine quantity, e.g. flow, volume
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2210/1085 Bladder
• CPC Class Codes: A61M 2210/166 Prostate
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

A diagnostic urethral assembly includes an elongate body having a fluid passageway and an elongate support member selectively positionable within the fluid passageway of the elongate body. The elongate body has a radially responsive wall segment that is being positionable within a lower urinary tract such that the radially responsive wall segment is adjacent a prostatic urethra. The elongate body is adapted to be in fluid communication with a bladder. The assembly has a first condition wherein the elongate support member is translatable relative to the elongate body so as to permit sequential and incremental radial compression of the radially responsive wall segment by the prostatic urethra in furtherance of defining architecture associated with the prostatic urethra and a second condition wherein fluid distally introduced into the elongate body radially expands the radially responsive wall segment into conforming engagement with the prostatic urethra in furtherance of obtaining a mold of same.

Claims

1. A diagnostic urethral assembly comprising:

a. an elongate support member having opposing first and second ends, said elongate support member being adapted to pass fluid therethrough; and

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b. a urethral catheter positionable for communication with a bladder, said urethral catheter adapted to receive, and be in fluid communication with said support member, said urethral catheter having a placid segment positionable so as to traverse a prostatic urethra and be physiologically responsive to structures of a lower urinary tract, said elongate support member selectively supporting said placid segment, progressive retraction of said elongate support member permitting the structures of the lower urinary tract to physiologically act in a sequential and incremental manner upon portions of said placid segment, the action upon said placid segment resulting in an observable change in fluid dynamics in furtherance of lower urinary tract symptoms diagnosis.

2. The assembly of claim 1 wherein said elongate support member includes longitudinally extending graduations.

3. The assembly of claim 2 wherein said first end of said elongate support member is a distal end, said second end being a proximal end.

4. The assembly of claim 3 wherein said urethral catheter includes proximal and distal portions, said proximal portion of said urethral catheter being a free end thereof.

5. The assembly of claim 3 wherein said distal end of said elongate support member is adapted to receive a pressure sensing apparatus.

6. The assembly of claim 5 further comprising a pressure sensing apparatus.

7. The assembly of claim 6 wherein said pressure sensing apparatus includes proximal and distal ends, and a pressure indicator disposed therebetween.

8. A diagnostic urethral assembly comprising:

a. an elongate support member having opposing first and second ends and longitudinally extending graduations upon a surface thereof, said elongate support member being adapted to pass fluid therethrough, said first end of said elongate support member is a distal end, said second end being a proximal end;

b. a urethral catheter positionable for communication with a bladder, said urethral catheter adapted to receive, and be in fluid communication with said support member, said urethral catheter having proximal and distal portions, said proximal portion of said urethral catheter being a free end thereof, and a placid segment positionable so as to traverse a prostatic urethra and be physiologically responsive to structures of a lower urinary tract, said elongate support member selectively supporting said placid segment; and

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c. a resilient linkage, said resilient linkage securing said distal end of said elongate support member to said distal portion of said urethral catheter, progressive retraction of said elongate support member permitting the structures of the lower urinary tract to physiologically act in a sequential and incremental manner upon portions of said placid segment, the action upon said placid segment resulting in an observable change in fluid dynamics in furtherance of lower urinary tract symptoms diagnosis.

9. The assembly of claim 8 wherein said resilient linkage is elongatingly responsive to retraction of said elongate support member relative to said urethral catheter.

10. The assembly of claim 8 wherein said resilient said resilient linkage is transparent.

11. The assembly of claim 8 wherein said longitudinally extending graduations of said elongate support member are visible through said resilient linkage.

12. The assembly of claim 11 wherein said resilient linkage comprises a sleeve.

13. The assembly of claim 11 wherein said resilient linkage comprises a bellows.

14. The assembly of claim 11 wherein said proximal portion of said urethral catheter includes an anchoring element for securing said urethral catheter within the lower urinary tract, and said assembly thereby.

15. The assembly of claim 14 wherein said anchoring element comprises a reversibly expandable member.

16. The assembly of claim 15 wherein said reversibly expandable member circumferentially extends about said proximal portion of said urethral catheter.

17. The assembly of claim 11 wherein said distal end of said elongate support member is adapted to receive a pressure sensing apparatus.

18. The assembly of claim 17 further comprising a pressure sensing apparatus.

19. The assembly of claim 18 wherein said pressure sensing apparatus includes proximal and distal ends, and a pressure indicator disposed therebetween.

20. The assembly of claim 19 wherein said pressure sensing apparatus includes a pressure recorder.

21. A diagnostic urethral assembly comprising:

a. an elongate support member having opposing first and second ends and longitudinally extending graduations upon a surface thereof, said elongate support member being adapted to pass fluid therethrough, said first end of said elongate support member is a distal end, said second end being a proximal end;

b. a urethral catheter positionable for communication with a bladder, said urethral catheter adapted to receive, and be in fluid communication with said support member, said urethral catheter having a placid segment positionable so as to traverse a prostatic urethra and be physiologically responsive to structures of a lower urinary tract, said elongate support member selectively supporting said placid segment, progressive retraction of said elongate support member permitting the structures of the lower urinary tract to physiologically act in a sequential and incremental manner upon portions of said placid segment, the action upon said placid segment resulting in an observable change in fluid dynamics in furtherance of lower urinary tract symptoms diagnosis;

c. a pressure sensing apparatus receivable upon said distal end of said elongate support member, said pressure sensing apparatus includes proximal and distal ends, and a pressure indicator disposed therebetween; and

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d. means for introducing a mold forming substance into said urethral catheter so as to obtain a mold of the prostatic urethra, said means being joinable with said distal end of said pressure sensing apparatus.

22. The assembly of claim 21 wherein said mold forming substance fills a fluid passageway of said urethral catheter.

23. The assembly of claim 22 wherein said mold forming substance conforms said placid segment of said urethral catheter to architecture of the prostatic urethra so as to thereby form a casting reflecting the architecture.

24. The assembly of claim 22 wherein said mold forming substance radially expands said placid segment of said urethral catheter outwardly.

25. The assembly of claim 22 wherein said mold forming substance is conveyed to said fluid passageway of said urethral catheter under pressure.

26. A diagnostic urethral assembly comprising an elongate body having a fluid passageway and an elongate support member selectively positionable within said fluid passageway of said elongate body, said elongate body having a radially responsive wall segment and being positionable within a lower urinary tract such that said radially responsive wall segment is adjacent a prostatic urethra, said elongate body adapted to be in fluid communication with a bladder, said assembly having a first operably selective condition wherein said elongate support member is translatable relative to said elongate body so as to permit sequential and incremental radial compression of said radially responsive wall segment by the prostatic urethra in furtherance of defining architecture associated with the prostatic urethra, and a second operably selective condition wherein fluid distally introduced into said elongate body radially expands said radially responsive wall segment into conforming engagement with the prostatic urethra in furtherance of obtaining a mold of same.

27. A diagnostic urethral kit comprising:

a. a catheter securably positionable so as to be in fluid communication with a bladder and adapted to receive and pass urine therefrom, said catheter having a radially responsive wall segment for engaging a prostatic urethra, said radially responsive wall segment being physiologically responsive to structures of a lower urinary tract; and

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b. an elongate tubular member receivable within said catheter, said elongate tubular member having a wall, opposing first and second ends, and a lumen, said wall extending between said opposing first and second ends and having longitudinally extending graduations, said elongate tubular member providing support for said radially responsive wall segment of said catheter, said elongate tubular member being selectively retractable from said catheter such that the structures of the lower urinary tract are permitted to physiologically act upon a portion of said segment adjacent said first end of said elongate tubular member.

28. A diagnostic urethral assembly comprising;

a. an elongate body, positionable for fluid communication with a bladder, said elongate body having a pliable wall segment for engagement with a prostatic urethra, and a distal end opposite a free end thereof;

b. an elongate support member receivable within said elongate body to selectively support said pliable wall segment and the prostatic urethra thereby, said elongate support member adapted to be in fluid communication with said elongate body, said elongate support member having a distal end opposite a free end thereof, said assembly having a first operably selective condition wherein said elongate support member is distally retractable relative to said elongate body to permit the prostatic urethra to sequentially and incrementally physiologically act upon said pliable segment in furtherance of defining architecture associated with the prostatic urethra, and a second operably selective condition wherein fluid distally introduced into said elongate body is acted upon such that said pliable segment substantially conforms to the prostatic urethra.

29. In a urethral diagnostic assembly including a urethral catheter having a radially responsive wall segment positionable to substantially traverse a prostatic urethra, means for regulated introduction of a casting agent at least indirectly into the urethral catheter such that the radially responsive wall section expands to engage the prostatic urethra, a dynamic casting being thereby formable to ascertain prostatic urethral architecture.

30. A diagnostic urethral assembly comprising:

a. an elongate support structure adapted to receive and pass fluid therethrough;

b. a urethral catheter having a radially responsive prostatic segment for traversing a prostatic urethra, said elongate support structure receivable within said urethral catheter for selective support of said radially responsive prostatic segment; and

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c. a resilient sleeve for linking a distal end of said elongate support structure to a distal portion of said urethral catheter, progressive retraction of said elongate support structure relative to said urethral catheter permitting a prostate to physiologically act in a sequential and incremental manner upon portions of said radial responsive prostatic segment in furtherance of bladder outlet obstruction diagnosis.

31. A diagnostic urethral device comprising a tubular body having proximal and distal end portions, and a physiologically responsive flexible wall segment therebetween, said proximal end portion of said tubular body adapted to be anchored at a bladder neck of a lower urinary tract for urine ingress, said physiologically responsive flexible wall segment of said tubular body being adapted to transverse a prostatic urethra in furtherance of assessing prostate contribution to bladder outlet obstruction.