Urological device
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.
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.