Urological device

• US 8,992,410 B2
• Filed: 11/03/2011
• Issued: 03/31/2015
• Est. Priority Date: 11/03/2010
• Status: Active Grant

• Current Assignee: Coloplast A/S
• Original Assignee: Vysera Biomedical Limited
• Inventors: Behan, Niall
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): COX, THADDEUS B
• Application Number:
  US13/288,369
• Publication Number:
  US 20120108889A1
• Time in Patent Office: 1,244 Days
• Field of Search: 600/30, 604/544
• US Class Current: 600/30
• 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 2/042 Urinary bladders
• 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
• CPC Class Codes: A61M 39/24 Check- or non-return valves

Abstract

A urological device comprises a urological valve for location in the bladder of a patient and a valve support stem for location in the urethra of a patient. The valve has a normally closed configuration to prevent flow from the bladder and an open configuration for fluid flow through the valve. The valve is automatically movable from the closed configuration to the open configuration in response to a pre-set hydrodynamic pressure applied for a pre-set time. In one case the valve has a plurality of valve leaflets with a region of co-aption between the valve leaflets. In the normally closed configuration the valve leaflets are engaged at the region of co-aption and in the open configuration the leaflets are separated at the co-aption region for fluid flow through the valve.

Claims

1. A urological device comprising:

a urological valve for location in a bladder of a patient; and

a valve support stem for location in a urethra of a patient, the urological valve at least partially projecting beyond the valve support stem in a direction towards the bladder when the device is positioned in the bladder and urethra,

the valve having a normally closed configuration to prevent flow from the bladder and an open configuration for fluid flow through the valve, the valve being automatically movable from the closed configuration to the open configuration in response to a pre-set hydrodynamic pressure of at least 750 mm H₂O applied for a pre-set time of at least 5 seconds, and

a bladder retainer for locating the valve in the bladder, the bladder retainer including a flare extending radially outwardly of the support stem.

2. The urological device as claimed in claim 1, wherein the valve support stem includes a generally tubular support for extending at least partially through the urethra, the valve being located at one end of the support stem.

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

4. The urological device as claimed in claim 3, wherein the bladder retainer, the support stem and the valve are integrally moulded.

5. The urological device as claimed in claim 1, further comprising a stiffening structure for the bladder retainer.

6. The urological device as claimed in claim 5, wherein the bladder retainer stiffening structure is of a shape memory material.

7. The urological device as claimed in claim 1, further comprising a urethral retainer to prevent migration of the device.

8. The urological device as claimed in claim 7, wherein the urethral retainer includes a meatal tab.

9. The urological device as claimed in claim 7, wherein the urethral retainer includes a bulbous region of compressive material.

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

11. The urological device as claimed in claim 1, wherein the valve includes a plurality of valve leaflets, the valve having a region of co-aption between the valve leaflets, the valve leaflets being engaged at the region of co-aption in the normally closed configuration and the leaflets being separated at the co-aption region in the open configuration for fluid flow through the valve.

12. The urological device as claimed in claim 11, wherein the valve leaflets evert on movement between the closed and the open configuration in response to hydrodynamic pressure.

13. 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.

14. The urological device as claimed in claim 13, wherein the spike pressure is 900 mm H₂O applied for a period of less than 0.5 seconds.

15. 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.

16. The urological device as claimed in claim 1, wherein the valve returns to the closed configuration when flow through the valve has substantially stopped.

17. The urological device as claimed in claim 1, wherein the valve everts on movement from the closed to the open configuration.

18. The urological device as claimed in claim 17, wherein the valve reverts on return from the open to the closed configuration.

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

20. 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.

21. The urological device as claimed in claim 20, wherein the valve includes a stiffening structure.

22. The urological device as claimed in claim 21, wherein the hinge region is at least partially defined adjacent to the stiffening structure.

23. The urological device as claimed in claim 1, further comprising an antimicrobial coating.

24. A urological device comprising

a urological valve for location in a bladder of a patient,

a valve support stem for location in a urethra of a patient, the urological valve at least partially projecting beyond the valve support stem in a direction towards the bladder when the device is positioned in the bladder and urethra,

the urological valve having a normally closed configuration to prevent flow from the bladder and an open configuration for fluid flow through the urological valve, the urological valve being automatically movable from the closed configuration to the open configuration in response to a pre-set hydrodynamic pressure applied for a pre-set time,

a bladder retainer extending circumferentially about the valve support stem for locating the urological valve in the bladder, and

a stiffening structure for the bladder retainer, the stiffening structure being a mesh of shape memory material.

25. The urological device as claimed in claim 24, further comprising a urethral retainer to prevent migration of the device.

26. The urological device as claimed in claim 25, wherein the urethral retainer includes a meatal tab.

27. The urological device as claimed in claim 25, wherein the urethral retainer includes a bulbous region of compressive material.

28. The urological device as claimed in claim 24, wherein the valve includes a plurality of valve leaflets, the valve having a region of co-aption between the valve leaflets, the valve leaflets being engaged at the region of co-aption in the normally closed configuration and the leaflets being separated at the co-aption region in the open configuration for fluid flow through the valve.

29. The urological device as claimed in claim 28, wherein the valve leaflets evert on movement between the closed and the open configuration in response to hydrodynamic pressure.

30. The urological device as claimed in claim 24, wherein the valve is adapted to open in response to a hydrodynamic pressure of at least 750 mm H₂O applied for at least 5 seconds.

31. The urological device as claimed in claim 28, wherein the valve includes at least three valve leaflets.

32. A urological device comprising:

a urological valve for location in a bladder of a patient; and

a valve support stem for location in a urethra of a patient, the urological valve at least partially projecting beyond the valve support stem in a direction towards the bladder when the device is positioned in the bladder and urethra,

the valve having a normally closed configuration to prevent flow from the bladder and an open configuration for fluid flow through the valve, the valve being automatically movable from the closed configuration to the open configuration in response to a pre-set hydrodynamic pressure of at least 750 mm H₂O applied for a pre-set time of at least 5 seconds, and

a bladder retainer for locating the valve in the bladder, the bladder retainer including a stiffening structure.

33. The urological device as claimed in claim 32, wherein the valve support stem includes a generally tubular support for extending at least partially through the urethra, the valve being located at one end of the support stem.

34. The urological device as claimed in claim 32, wherein the bladder retainer includes a flare extending radially outwardly of the support stem.

35. The urological device as claimed in claim 34, wherein the bladder retainer is of a same material as that of the support stem.

36. The urological device as claimed in claim 35, wherein the bladder retainer, the support stem and the valve are integrally moulded.

37. The urological device as claimed in claim 32, wherein the bladder retainer stiffening structure is of a shape memory material.

38. The urological device as claimed in claim 32, further comprising a urethral retainer to prevent migration of the device.

39. The urological device as claimed in claim 38, wherein the urethral retainer includes a meatal tab.

40. The urological device as claimed in claim 38, wherein the urethral retainer includes a bulbous region of compressive material.

41. The urological device as claimed in claim 32, wherein the valve is of a viscoelastic polymeric foam material.

42. The urological device as claimed in claim 32, wherein the valve includes a plurality of valve leaflets, the valve having a region of co-aption between the valve leaflets, the valve leaflets being engaged at the region of co-aption in the normally closed configuration and the leaflets being separated at the co-aption region in the open configuration for fluid flow through the valve.

43. The urological device as claimed in claim 42, wherein the valve leaflets evert on movement between the closed and the open configuration in response to hydrodynamic pressure.

44. The urological device as claimed in claim 32, 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.

45. The urological device as claimed in claim 44, wherein the spike pressure is 900 mm H₂O applied for a period of less than 0.5 seconds.

46. The urological device as claimed in claim 32, wherein the valve remains open as fluid flows therethrough without a requirement for a user to apply urological pressure.

47. The urological device as claimed in claim 32, wherein the valve returns to the closed configuration when flow through the valve has substantially stopped.

48. The urological device as claimed in claim 32, wherein the valve everts on movement from the closed to the open configuration.

49. The urological device as claimed in claim 48, wherein the valve reverts on return from the open to the closed configuration.

50. The urological device as claimed in claim 32, wherein the valve includes at least three valve leaflets.

51. The urological device as claimed in claim 32, 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.

52. The urological device as claimed in claim 51, wherein the valve includes a stiffening structure.

53. The urological device as claimed in claim 52, wherein the hinge region is at least partially defined adjacent to the stiffening structure.

54. The urological device as claimed in claim 32, further comprising an antimicrobial coating.