Urological device

• US 9,585,740 B2
• Filed: 09/24/2015
• Issued: 03/07/2017
• Est. Priority Date: 11/03/2010
• Status: Active Grant

• Current Assignee: Coloplast A/S
• Original Assignee: Coloplast A/S
• Inventors: Behan, Niall
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): COX, THADDEUS B
• Application Number:
  US14/864,488
• Publication Number:
  US 20160113750A1
• Time in Patent Office: 530 Days
• US Class Current: 1/1
• 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 valve support stem for location in a urethra of a user, the valve support stem extending between a proximal end and a distal end;

a bladder retainer connected to the proximal end of the valve support stem, the bladder retainer including a concave-shaped exterior surface adapted for placement in a bladder of the user; and

a urological valve disposed in the bladder retainer at a location proximal from the proximal end of the valve support stem, the urological valve including a leaflet extending from an interior surface of the bladder retainer away from the valve support stem;

wherein the leaflet of the urological valve has a closed configuration adapted to prevent a flow of urine through the valve support stem and the leaflet of the urological valve is adapted to respond to a pressure and move to an open configuration adapted to allow a flow of urine through the valve support stem;

wherein the leaflet extends from the interior surface of the bladder retainer to a location that defines a top proximal end of the device.

2. The urological device as claimed in claim 1, wherein the valve support stem is generally tubular.

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

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

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

6. The urological device as claimed in claim 1, wherein the bladder retainer further comprises a stiffener.

7. The urological device as claimed in claim 6, wherein the stiffener is a shape memory material.

8. The urological device as claimed in claim 1, wherein the valve support stem further comprises a urethral retainer adapted to prevent migration of the device in the urethra.

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

10. The urological device as claimed in claim 8, wherein the urethral retainer includes a bulbous region of compressive material.

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

12. The urological device as claimed in claim 1, wherein the urological valve includes a plurality of valve leaflets, and the urological valve has a region of co-aption between adjacent leaflets of the plurality of valve leaflets, with the plurality of valve leaflets engaged at the region of co-aption in the closed configuration and the plurality of valve leaflets separated one leaflet from another leaflet at the region of co-aption region in the open configuration.

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

14. The urological device as claimed in claim 1, wherein the urological valve is adapted to move to the open configuration in response to a hydrodynamic pressure of at least 750 mm H2O applied for at least 5 seconds.

15. The urological device as claimed in claim 1, wherein the urological valve is adapted to remain in the closed configuration in response to a spike in hydrodynamic pressure applied for a time of about 0.5 seconds.

16. The urological device as claimed in claim 15, wherein the spike in hydrodynamic pressure is 900 mm H2O applied for a period of less than 0.5 seconds.

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

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

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

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

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

22. The urological device as claimed in claim 21, wherein the urological valve includes a stiffener.

23. The urological device as claimed in claim 22, wherein the hinge is at least partially defined adjacent to the stiffener.

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

25. The urological device as claimed in claim 1, wherein the interior surface of the bladder retainer has a convex curvature and the leaflet is connected to the convex curvature of the bladder retainer.