Control device for prosthetic urinary sphincter cuff

Abstract

A device for controlling flow of fluid to and from a resilient inflatable cuff implanted about the urethra to control flow of urine therethrough. The device comprises a flexible bulb reservoir and a control unit that includes a manually operated valve that opens automatically when the bulb is squeezed to force fluid into the cuff for closing the urethra. The control unit also includes a movable valve seat member having a relatively large area exposed to pressure of fluid in a chamber that is connected to the cuff and which moves to a position in which the valve member is unseated by an abutment when fluid pressure in the chamber exceeds a predetermined value to thereby relieve excess fluid pressure in the cuff. The arrangement is such that the valve element is held closed against the seat member by the full differential in fluid pressures acting on both sides of the valve element until the seat member is moved away from the valve element to thus insure positive closing of the valve element until the seat member is moved out of engagement with the valve element by excess pressure differential.

I claim: 
     
       1. A device useful with a prosthetic .[.urinary sphincter valve.]. .Iadd.inflatable implant .Iaddend.for controlling flow of fluid from a reservoir to a receiver, said device comprising an envelope with a movable wall portion and which envelope is closed except for a first duct connectable to the reservoir and a second duct connectable to the receiver, a control unit in said envelope, said unit including a valve element and a ported seat member for controlling flow of fluid between said ducts, said seat member being spring pressed to a first position in which said valve element may be spring pressed into engagement .Iadd.with .Iaddend.the seat member for closing the port therein, manually operable means for moving the seat member to a second position, means to prevent the valve element from seating on the seat member when the seat member is in said second position whereby the port in the seat member will be open, and said seat member having an effective area subject to pressure of fluid in said second duct and movable thereby to said second position. 
     
     
       2. The device of claim 1 in which the control unit includes an abutment engageable with the valve element when the seat member is in the second position. 
     
     
       3. The device of claim 1 in which the force of the spring for the seat member is greater than that of the spring for the valve member and acts in opposition thereto. 
     
     
       4. The device in claim 1 in which the seat member comprises a diaphragm having a flexible peripheral portion sealingly attached to the control unit and a relatively inflexible portion through which said port extends. 
     
     
       5. A device useful with a prosthetic .[.urinary sphincter valve.]. .Iadd.inflatable implant .Iaddend.for controlling flow of fluid to and from a receiver, comprising a reservoir for fluid, a flexible cover and a control unit, said unit including a housing having a sealed connection to the cover to form a chamber therebetween, a duct leading from said chamber for connection to the receiver, the housing having an abutment and having a cavity and carrying a movable valve seat member that separates the cavity from the chamber, a port through the member for connecting the cavity to the chamber, a valve element, a first spring urging the valve element into engagement with the member for closing the port, a second spring urging the member to a first position in which the valve element is out of engagement with said abutment and in its port closing position, manually operable plunger for moving the seat member to a second position in which the abutment engages the valve element for opening said port, and said seat member having an area exposed to fluid in said chamber and movable thereby to its second position when the pressure of fluid in said chamber exceeds a predetermined value. 
     
     
       6. The device of claim 5 in which there is a stop to limit movement of the seat member in the direction toward its first position. 
     
     
       7. The device of claim 5 in which there is a stop to limit movement of the plunger in the direction toward said second position. 
     
     
       8. The device of claim 5 in which the seat member comprises a flexible diaphragm. 
     
     
       9. The device of claim 8 in which the diaphragm has a relatively thick central portion through which said port extends and a relatively thin and readily flexible peripheral portion. 
     
     
       10. The device of claim 9 in which said second spring bears against said central portion. 
     
     
       11. The device of claim 9 in which said plunger is engageable with said central portion. 
     
     
       12. The device of claim 5 in which said plunger has a bore and said valve element is within said bore. 
     
     
       13. The device of claim 5 in which said abutment projects into said port when the seat member is in said second position. 
     
     
       14. The device of claim 6 in which said stop comprises engagement of a portion of the plunger with a portion of said housing. 
     
     
       15. The device of claim 7 in which said stop comprises engagement of a portion of the plunger with a portion of said housing. 
     
     
       16. The device of claim 5 in which said valve element has an effective area subject to pressure fluid in said chamber for urging the valve element against the seat member for closing said port when the member is in said first position. 
     
     
       17. The device of claim 5 in which said plunger has a recess at one end thereof, said valve element is in said recess, said one end engages the seat member, and said plunger has a flange engageable with a shoulder on said housing to limit movement of the plunger in the direction of said first position. .Iadd. 18. A device useful with a prosthetic inflatable implant for controlling flow of fluid from a reservoir to a receiver, said device comprising an envelope with a movable wall portion and which envelope is closed except for a first duct connectable to the reservoir and a second duct connectable to the receiver, a control unit in said envelope, said unit including a valve element and a ported seat member for controlling flow of fluid between said ducts, said seat member being spring pressed to a first position in which said valve element may be spring pressed into engagement with said seat member for closing the port therein, said valve element including an effective area subject to pressure of fluid in said first duct and movable thereby away from said seat member, manually operable means for moving said seat member to a second position, means to prevent said valve element from seating on said seat member when said seat member is in such second position whereby the port in seat said member will be open, and said seat member having an effective area subject to pressure of fluid in said second duct and movable thereby to such second position. .Iaddend..Iadd. 19. A device useful with a prosthetic inflatable implant for controlling flow of fluid from a reservoir to a receiver, said device comprising an envelope with a movable wall portion and a control unit in said envelope, said envelope having a first duct connectable to the reservoir and a second duct connectable to the receiver, and said control unit including a movable valve element and a movable ported valve seat member for controlling flow of fluid between said ducts, spring means for urging said seat member to a first position in which said valve element normally may be spring pressed into engagement with said seat member for closing the port therein, said valve element including an effective area subject to pressure of fluid in said first duct and movable thereby away from said seat member, means adapted to extend through said port into engagement with said valve element for unseating said valve element to open the port, said seat member having an effective area subject to pressure of fluid in said second duct and movable thereby from said first position to a second position in which said means for unseating extends through the port to unseat said valve element, and means responsive to movement of said movable wall portion for effecting relative movement of said seat member and means for unseating to a positional relationship in which said means for unseating extends through the port to unseat said valve element. .Iaddend. .Iadd. 20. A device useful with a prosthetic inflatable implant for controlling flow of fluid from a reservoir to a receiver, said device comprising an envelope with a movable wall portion and a control unit in said envelope, said envelope having a first duct connectable to the reservoir and a second duct connectable to the receiver, and said control unit including a housing having an abutment and a cavity therein, a movable valve seat member in said housing dividing said cavity into first and second chambers, means connecting said first and second chambers respectively to said first and second ducts, said seat member having port means therein for connecting said first and second chambers, a valve element, first biasing means urging said valve element into engagement with said seat member for closing said port means, said valve element including an effective area subject to pressure of fluid in said first chamber and movable thereby against said first biasing means away from said seat member to open said port means, second biasing means for urging said seat member to a first position in which said valve element normally is out of engagement with said abutment, said seat member having an area exposed to fluid in said second chamber and movable thereby against said second biasing means to a second position in which said abutment engages said valve element to unseat same for opening said port means when the pressure of fluid in said second duct exceeds a predetermined value, and means responsive to said movable wall portion for unseating said valve element to open said port means independently of the fluid pressure level in said first and second chambers. .Iaddend..Iadd. 21. The device of claim 20 in which said means for unseating includes manually operable means for effecting relative movement of said seat member and abutment to a positional relationship in which said abutment engages said valve element to open said port means. .Iaddend..Iadd. 22. The device of claim 21 in which there are spring means for urging said valve seat and means for unseating out of such positional relationship. .Iaddend..Iadd. 23. The device of claim 19 or 20 in which the effective area of said seat member is greater than that of said valve element. .Iaddend..Iadd. 24. A device for controlling flow of fluid to and from a prosthetic inflatable implant, comprising a reservoir, an outlet duct connectable to the inflatable implant, and control means for controlling flow of fluid between said reservoir and outlet duct, said control means including passage means connecting said reservoir and outlet duct, first means for normally closing said passage means, said first means having an effective area subject to pressure of fluid in said reservoir and movable thereby for opening said passage means, second means having an effective area greater than that of said first means subject to pressure of fluid in said outlet duct and movable thereby from a first position for permitting said first means to close said passage means to a second position for preventing said first means to close said passage means when the pressure of fluid in said outlet duct exceeds a predetermined valve, and manually actuable means for moving said second means to its second position. .Iaddend..Iadd. 25. The device of claim 22 in which said second means includes a diaphragm. .Iaddend..Iadd. 26. The device of claim 22 in which there is an envelope for said control means, said envelope having a movable wall portion and said manually actuable means being responsive to manual movement of said movable wall portion. .Iaddend..Iadd. 27. The device of claim 22 in which said first means when closed further has an effective area subject to pressure in said outlet duct and is arranged such that said first means normally is held closed by the full fluid pressure differential between said reservoir and outlet duct. .Iaddend.