Urological device

• US 8,876,800 B2
• Filed: 12/17/2010
• Issued: 11/04/2014
• Est. Priority Date: 12/18/2009
• Status: Active Grant

• Current Assignee: Coloplast A/S
• Original Assignee: Vysera Biomedical Limited
• Inventors: Behan, Niall
• Primary Examiner(s): Thanh, Loan H
• Assistant Examiner(s): Lo, Andrew S
• Application Number:
  US12/971,451
• Publication Number:
  US 20110160706A1
• Time in Patent Office: 1,418 Days
• Field of Search: 604/34
• US Class Current: 604/544
• CPC Class Codes: A61F 2/0009 placed in or outside the body opening close to the surface of the body plugging an opening in the wall of a hollow or tubular organ A61B17/0057
• CPC Class Codes: A61F 2/0022 placed deep in the body opening occluding blood vessels by internal devices A61B17/12022
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2002/047 Urethrae
• CPC Class Codes: A61M 2039/0633 the seal being a passive seal made of a resilient material with or without an opening
• CPC Class Codes: A61M 2039/0646 Duckbill-valve
• CPC Class Codes: A61M 2039/242 designed to open when a predetermined pressure or flow rate has been reached, e.g. check valve actuated by fluid
• CPC Class Codes: A61M 2039/2426 Slit valve
• CPC Class Codes: A61M 2039/2433 Valve comprising a resilient or deformable element, e.g. flap valve, deformable disc
• 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 25/0075 Valve means
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• CPC Class Codes: A61M 39/0606 without means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

A urological device comprises a urological valve having a plurality of valve leaflets with a region of co-aption between the valve leaflets. The valve has a normally closed configuration in which the valve leaflets are engaged at the region of co-aption and an open configuration in which the leaflets are separated at the co-aption region for fluid flow through the valve. The valve is automatically movable from the closed configuration to the open configuration in response to applied urological pressure.

Claims

1. A urological device comprising

a urological valve,

a support for the valve, the support being generally tubular and adapted for mounting in a urinary tract,

a bladder retainer for locating the device in a bladder and a urethral retainer to prevent migration of the device,

the valve including a plurality of valve leaflets,

the valve having internally located, stiffening reinforcement members the stiffening reinforcement members defining a fulcrum or hinge region about which the valve leaflets are movable from a normally closed configuration to an open configuration, the stiffening reinforcement members extending vertically,

the valve having a region of co-aption between the valve leaflets, the valve having the normally closed configuration in which the valve leaflets are engaged at the region of co-aption and the open configuration in which the leaflets are separated at the co-aption region for fluid flow through the valve, the valve leaflets being configured to evert automatically on movement between the closed configuration and the open configuration in response to applied urological pressure.

2. The urological device as claimed in claim 1, wherein the valve is of a viscoelastic polymeric foam material.

3. The urological device as claimed in claim 1, wherein the valve is adapted to open in response to a preset pressure applied over a preset time.

4. The urological device as claimed in claim 3, wherein the valve is adapted to open in response to a pressure of at least 750 mm H2O applied for at least 5 seconds.

5. The urological device as claimed in claim 1, wherein the valve is adapted to remain closed in response to a spike pressure applied for a short time as would be generated by a user coughing.

6. The urological device as claimed in claim 5, wherein the spike pressure is 900 mm H2O applied for a period of less than 0.5 seconds.

7. The urological device as claimed in claim 1, wherein the valve remains open as fluid flows therethrough without a requirement for a user to apply urological pressure.

8. The urological device as claimed in claim 7, wherein the valve returns to the closed configuration when flow through the valve has substantially stopped.

9. The urological device as claimed in claim 1, wherein the valve reverts on return from the open to the dosed configuration.

10. The urological device as claimed in claim 1, wherein the valve includes at least three valve leaflets.

11. The urological device as claimed in claim 1, wherein the valve includes a main body having a region which defines a hinge about which a portion of the valve main body is movable between the closed and open configurations.

12. The urological device as claimed in claim 1, wherein the stiffening reinforcement members are of the same material as that of the valve.

13. The urological device as claimed in claim 12, wherein the valve and the stiffening reinforcement members are integrally moulded.

14. The urological device as claimed in claim 1, wherein the support is of the same material as that of the valve.

15. The urological device as claimed in claim 14, wherein the valve and support are integrally moulded.

16. The urological device as claimed in claim 1, wherein the bladder retainer includes a flare extending radially outwardly of the support.

17. The urological device as claimed in claim 1, wherein the bladder retainer is of the same material as that of the support.

18. The urological device as claimed in claim 1, wherein the bladder retainer, the support and the valve are integrally moulded.

19. The urological device as claimed in claim 1, further comprising a stiffener for the bladder retainer.

20. The urological device as claimed in claim 19, wherein the stiffener is made of Nitinol shape memory material.

21. The urological device as claimed in claim 1, wherein the urethral retainer includes a meatal tab.

22. The urological device as claimed in claim 1, wherein the urethral retainer includes a bulbous region of compressive material.

23. The urological device as claimed in claim 1, wherein the device includes an antimicrobial coating.

24. A urological device comprising

a urological valve,

a support for the valve, the support being generally tubular and adapted for mounting in a urinary tract,

a bladder retainer for locating the device in a bladder and a urethral retainer to prevent migration of the device,

the valve including a plurality of valve leaflets,

the valve having internally located, stiffening reinforcement members, the stiffening reinforcement members defining a fulcrum or hinge region about which the valve leaflets are movable from a normally closed configuration to an open configuration, the stiffening reinforcement members being spaced about an internal circumference of the valve,

the valve having a region of co-aption between the valve leaflets, the valve having the normally closed configuration in which the valve leaflets are engaged at the region of co-aption and the open configuration in which the leaflets are separated at the co-aption region for fluid flow through the valve, the valve leaflets being configured to evert automatically on movement between the closed configuration and the open configuration in response to applied urological pressure.

25. The urological device as claimed in claim 24, wherein the valve is of a viscoelastic polymeric foam material.

26. The urological device as claimed in claim 24, wherein the valve is adapted to open in response to a preset pressure applied over a preset time.

27. The urological device as claimed in claim 26, wherein the valve is adapted to open in response a pressure of at least 750 mm H2O applied for at least 5 seconds.

28. The urological device as claimed in claim 24, wherein the valve is adapted to remain closed in response to a spike pressure applied for a short time as would be generated by a user coughing.

29. The urological device as claimed in claim 28, wherein the spike pressure is 900 mm H2O applied for a period of less than 0.5 seconds.

30. The urological device as claimed in claim 24, wherein the valve remains open as fluid flows therethrough without a requirement for a user to apply urological pressure.

31. The urological device as claimed in claim 30, wherein the valve returns to the closed configuration when flow through the valve has substantially stopped.

32. The urological device as claimed in claim 24, wherein the valve reverts on return from the open to the closed configuration.

33. The urological device as claimed in claim 24, wherein the valve includes at least three valve leaflets.

34. The urological device as claimed in claim 24, wherein the valve includes a main body having a region which defines a hinge about which a portion of the valve main body is movable between the closed and open configurations.

35. The urological device as claimed in claim 24, wherein the stiffening reinforcement members are of the same material as that of the valve.

36. The urological device as claimed in claim 35, wherein the valve and the stiffening reinforcement members are integrally moulded.

37. The urological device as claimed in claim 24, wherein the support is of the same material as that of the valve.

38. The urological device as claimed in claim 37, wherein the valve and support are integrally moulded.

39. The urological device as claimed in claim 24, wherein the bladder retainer includes a flare extending radially outwardly of the support.

40. The urological device as claimed in claim 24, wherein the bladder retainer is of the same material as that of the support.

41. The urological device as claimed in claim 24, wherein the bladder retainer, the support and the valve are integrally moulded.

42. The urological device as claimed in claim 24, further comprising a stiffener for the bladder retainer.

43. The urological device as claimed in claim 42, wherein the stiffener is made of Nitinol shape memory material.

44. The urological device as claimed in claim 24, wherein the urethral retainer includes a meatal tab.

45. The urological device as claimed in claim 24, wherein the urethral retainer includes a bulbous region of compressive material.

46. The urological device as claimed in claim 24, wherein the device includes an antimicrobial coating.