UROLOGICAL DEVICE

• US 20110160706A1
• Filed: 12/17/2010
• Published: 06/30/2011
• Est. Priority Date: 12/18/2009
• Status: Active Grant

• Current Assignee: Coloplast A/S
• Original Assignee: Vysera Biomedical Limited
• Inventors: Behan, Niall
• Granted Patent: US 8,876,800 B2
• Time in Patent Office: Days
• 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, the valve comprising a plurality of valve leaflets, the valve having a region of co-aption between the valve leaflets, the valve having 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 being automatically movable from the closed configuration to the open configuration in response to applied urological pressure.

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

3. A urological device as claimed in claim 1 wherein the valve leaflets evert on movement between the closed and the open configuration in response to applied urological pressure.

4. A 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.

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

6. A 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.

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

8. A 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.

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

10. A urological device as claimed in claim 1 wherein the valve everts on movement from the closed to the open configuration.

11. A urological device as claimed in claim 10 wherein the valve reverts on return from the open to the closed configuration.

12. A urological device as claimed in claim 1 wherein the valve comprises at least three valve leaflets.

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

14. A urological device as claimed in claim 1 wherein the valve comprises stiffening means.

15. A urological device as claimed in claim 14 when dependent on claim 13 wherein the hinge region is at least partially defined adjacent to the stiffening means.

16. A urological device as claimed in claim 1 comprising a support for the valve.

17. A urological device as claimed in claim 16 wherein the support is generally cylindrical.

18. A urological device as claimed in claim 16 wherein the support is of the same material as that of the valve.

19. A urological device as claimed in claim 18 wherein the valve and support are integrally moulded.

20. A urological device as claimed in claim 16 comprising a first retainer for locating the device in the bladder.

21. A urological device as claimed in claim 20 wherein the first retainer comprises a flare extending radially outwardly of the support.

22. A urological device as claimed in claim 20 wherein the first retainer is of the same material as that of the support.

23. A urological device as claimed in claim 20 wherein the first retainer, the support and the valve are integrally moulded.

24. A urological device as claimed in claim 20 comprising stiffening means for the first retainer.

25. A urological device as claimed in claim 24 wherein the retainer stiffening means is of a shape memory material such as Nitinol.

26. A urological device as claimed in claim 16 comprising a second retainer to prevent proximal migration of the device.

27. A urological device as claimed in claim 26 wherein the second retainer comprises a meatal tab.

28. A urological device as claimed in claim 26 wherein the second retainer comprises a bulbous region of compressive material.

29. A urological device as claimed in claim 1 wherein the device comprises an antimicrobial coating.

30. A urological device as claimed in claim 1 comprising a support to which the valve is mounted.

31. A urological device as claimed in claim 30 wherein the support is adapted for mounting in a urinary tract.

32. A urological device as claimed in claim 30 wherein the support comprises a generally tubular member.

33. A urological device as claimed in claim 32 wherein the tubular member comprises a catheter.

34. A urological device as claimed in claim 30 comprising an anchor for anchoring the support and valve in situ.

35. A urological device as claimed in claim 1 comprising a housing for the valve, the housing having an inlet on one side of the valve and an outlet on the opposite side of the valve.

36. A urological device as claimed in claim 35 wherein the inlet is adapted for mounting to a catheter such as a Foley catheter.

37. A urological device as claimed in claim 35 wherein the outlet is adapted for mounting to a drainage bag.

38. A urological device as claimed in claim 35 comprising a collar to support the valve in the housing.

39. A urological device as claimed in claim 38 wherein the valve comprises a valve body and the collar is arranged to engage the valve body to control the pressure at which the valve moves from the open to the closed configuration and/or from the closed to the open configuration.

40. A drainage catheter system comprising a valve, the valve having:

a normally closed configuration in which the valve is closed; and

an open configuration in which the valve is opened for flow through the valve;

the valve being automatically movable from the closed to the open configuration for flushing of the catheter.

41. A catheter system as claimed in claim 40 wherein the valve is one-way valve.

42. A catheter as claimed in claim 40 wherein the valve is movable from the closed to the open position in response to a predefined yield pressure.

43. A catheter system as claimed in claim 40 wherein valve is of a biocompatible viscoelastic foam material.

44. A catheter system as claimed in claim 40 wherein the catheter comprises a urological catheter.