Nonsurgical intraurethral bladder control device

• US 5,512,032 A
• Filed: 12/23/1993
• Issued: 04/30/1996
• Est. Priority Date: 12/23/1993
• Status: Expired due to Fees

• Current Assignee: Christopher Avery, Feelsure Health Corporation, James Avery
• Original Assignee: HK Medical Technologies, Inc.
• Inventors: Migachyov, Valery, Kulisz, Andre A.
• Primary Examiner(s): Sykes, Angela D.
• Application Number:
  US08/173,636
• Time in Patent Office: 859 Days
• Field of Search: 600/29-31, 623/11-12, 137/803, 137/403
• US Class Current: 600/29
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for
• CPC Class Codes: A61F 2/0022 placed deep in the body opening occluding blood vessels by internal devices A61B17/12022
• CPC Class Codes: Y10T 137/7738 Pop valves
• CPC Class Codes: Y10T 137/7832 Plural valves biased closed
• CPC Class Codes: Y10T 137/7846 Mechanically interconnected
• CPC Class Codes: Y10T 137/87989 Delivery cock with terminal valve

Abstract

An improved self contained automatic bladder control device includes a valve assembly mount for releasibly receiving a valve assembly. The preferably cylindrical mount has a textured outer surface designed to interact with urethral tissue. Thus the mount can be placed nonsurgically into a urethra and in time it will be held against movement by the tissue interaction with the textured outer surface, yet the mount will still be removable without surgery. Two embodiments of valve assemblies are disclosed, each of which provides a sphincter-like operation of the bladder control apparatus. A first embodiment is designed to use Bernoulli'"'"'s law to hold open the valve apparatus after a short period of muscle contraction. The second embodiment is designed to use the fact that the force generated by hydrostatic pressure is directly related to the area on which it impinges, to accomplish the desired valve holding period.

Claims

1. In an intraurethral bladder control apparatus including a valve assembly for controlling the flow of urine and a valve assembly mount for holding the valve assembly within a urethra, the improved valve assembly mount comprising:

means including a textured outer wall on the mount for interacting with urethral tissue to hold said bladder control apparatus within the urethra and provide nonsurgical implantation and removal of the mount in the urethra the valve assembly including means for creating a holding force according to Bernoulli'"'"'s principle responsive to a flow of fluid, and means responsive to the holding force to hold the valve assembly open.

2. The apparatus of claim 1 in which the valve assembly mount includes an inner chamber having valve assembly holding means for releasibly holding the valve assembly in the chamber.

3. The apparatus of claim 2 in which the valve assembly includes adjustment control means for setting the pressures at which the valve assembly will open and close.

4. The apparatus of claim 3 including means for operating the adjustment control means for a point external to the urethra.

5. The apparatus of claim 2 in which the valve assembly includes:

means responsive to an opening of the valve for increasing the area of fluid flow impingement; and

means responsive to pressure from fluid flow impingement to hold the valve assembly open.

6. The apparatus of claim 1 or 5 in which the valve assembly includes adjustment control means for setting the pressures at which the valve assembly will open and close.

7. Bladder control apparatus comprising:

a. a valve assembly mount adapted for intraurethral placement;

b. means including a textured outer surface on the mount for holding said bladder control apparatus in contact with urethral tissue;

c. a chamber in the amount;

d. connection means in the chamber for receiving and releasibly holding a valve assembly;

e. a valve assembly adapted to be connected to the connection means;

f. a moveable valve in the valve assembly for opening and closing the assembly to fluid flow;

g. bias means for biasing the valve closed;

h. pressure means for holding the valve open in the presence of a fluid flow of a predetermined level;

i. a first valve ring mounted on the moveable valve and within a fluid flow path within the valve assembly;

j. a second valve ring mounted on the connection means and within the fluid flow path;

k. a spacer mounted in the valve assembly for maintaining a minimum spaced between the first and second rings; and

l. the first and second rings cooperating in the presence of fluid flow of a predetermined level to induce a negative force according to Bernoulli'"'"'s principle for holding the moveable valve open.

8. The apparatus of claim 7 in which the pressure sensing means comprises:

a. a valve ring mounted on the moveable valve and having a predetermined surface area;

b. means for exposing a first portion of the surface area to hydrostatic pressure when the moveable valve is closed; and

c. means for exposing a second and larger portion of the surface area to the hydrostatic pressure when the moveable valve is open for holding the valve open during fluid flow at a predetermined level.

9. The apparatus of claims 7 or 8 in which the valve assembly includes adjustment control means for adjusting the bias of the bias control means to set the pressures at which the valve assembly will open and close.

10. the apparatus of claim 9 including means for operating the adjustment control means from a point external to the body.

11. The apparatus of claims 7 or 8 including fail-safe means for preventing the movement of the moveable valve due to abrupt changes in hydrostatic pressure.

12. The apparatus of claim 7 including fail-safe means for preventing the opening of the valve assembly due to abrupt changes in hydrostatic pressure.

13. Intraurethral bladder control apparatus comprising:

a. a housing having an outer surface and an inner chamber;

b. a valve assembly having an input orifice and an output orifice, and a fluid flow path between the input and output orifices;

c. a moveable valve mounted in the valve assembly and moveable between a closed location adjacent the input orifice and an open position spaced from the input orifice;

d. valve closing means for normally holding the valve in the closed position and responsive to a predetermined pressure to allow movement of the valve to the open position; and

e. valve control means mounted in the valve assembly fluid flow path and responsive to the flow of fluid to hold the valve in the open position when the fluid flow rate is above a predetermined rate.

14. The apparatus of claim 13 in which the valve control means comprises:

means for inducing a negative pressure under Bernoulli'"'"'s principle in the presence of a fluid flow.

15. The apparatus of claim 13 in which the valve control means comprises:

means having a predetermined surface area and means for increasing the portion of the surface area within the fluid flow path when the valve is in the open position, to hold the valve in the open position which the fluid pressure is above a predetermined level.

16. The apparatus of claims 13, 14 or 15 in which the valve closing means comprises:

a spring and spring tension adjustment means.

17. The apparatus of claims 13, 14 or 15 including safety means for preventing movement of the valve to the open position due to momentary changes in bladder pressure.

18. The apparatus of claims 13, 14 or 15 in which:

said housing outer surface is textured for interacting with urethral tissue to releasibly hold said housing in the urethra.

19. In bladder control apparatus adapted to be placed in a urethra and including a valve block having a valve with open and closed positions and a fluid flow path through the valve block, the method of controlling fluid flow comprising the steps of:

a. normally biasing the valve in the closed position;

b. moving the valve to the open position when the hydrostatic pressure in the urethra exceeds a predetermined level;

c. inducing a negative pressure from means in the fluid flow path according to Bernoulli'"'"'s principle;

d. holding the valve in the open position with the negative pressure; and

e. moving the valve to the closed position when the induced negative pressure falls below the normal biasing pressure.

21. The method of claims 19 or 20 including the step of:

preventing movement of the normally closed valve due to an abrupt change in the urethral hydrostatic pressure.

20. In bladder control apparatus adapted to be placed in a urethra and including a valve block having a valve with open and closed positions and a fluid flow path through the valve block, the method of controlling fluid flow comprising the steps of:

a. normally biasing the valve in the closed position;

b. moving the valve to the open position when the hydrostatic pressure in the urethra exceeds a predetermined level;

c. increasing the surface area of impingement of the fluid flow on means in the flow path to create a valve holding pressure;

d. holding the valve in the open position with the valve holding pressure; and

e. moving the valve to the closed position when the valve holding pressure falls below the normal biasing pressure.

22. An intraurethral bladder control apparatus comprising:

a. a housing for removable attachment within a urethra; and

b. valve means coupled to said housing for controlling fluid flow through said urethra, upon exposure to a predetermined pressure said valve means opening to initiate fluid flow, said valve means remaining open under the influence of a holding force according to Bernoulli'"'"'s principle and said fluid flow continuing through said urethra at a pressure less than said predetermined pressure.

23. An intraurethral bladder control apparatus according to claim 22 further comprising means coupled to said housing for resetting said initiating and continuing means to a state which prevents further fluid flow through said urethra until renewed exposure to said predetermined pressure.