Intraurethral continent prothesis

• US 6,638,208 B1
• Filed: 09/04/1999
• Issued: 10/28/2003
• Est. Priority Date: 09/15/1998
• Status: Expired due to Fees

• Current Assignee: Infinite Biomedical Technologies, LLC
• Original Assignee: Infinite Biomedical Technologies, LLC
• Inventors: Thakor, Nitish V., Natarajan, Ananth
• Primary Examiner(s): Gilbert, Samuel G.
• Application Number:
  US09/391,077
• Time in Patent Office: 1,515 Days
• Field of Search: 600/29-31, 128/DIG.25, 128/885
• US Class Current: 600/30
• CPC Class Codes: A61F 2/0004 Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
• CPC Class Codes: A61F 2/0022 placed deep in the body opening occluding blood vessels by internal devices A61B17/12022

Abstract

An implantable apparatus may include a plug member having a lumen and a valve adapted to open and close the lumen in response to a signal. The apparatus may also include at least one sensor and a controller adapted to control the valve. The controller may be programmable to open the valve to permit the flow of urine under at least one mode of operation selected from a predetermined time interval operation, a sensor operation, and a manual actuation operation.

Claims

1. An apparatus comprising:

a plug member including a lumen therein;

a valve adapted to open and close the lumen in response to a control signal;

a controller adapted to transmit a control signal to the valve; and

at least one sensor adapted to send a sensor signal to the controller;

wherein the plug member is adapted to be positioned entirely within a patient'"'"'s body, and wherein any part of the apparatus that is physically coupled to the plug member is adapted to be positioned entirely within the patient'"'"'s body.

2. An apparatus as in claim 1, wherein the valve and controller are positioned within the plug member.

3. An apparatus as in claim 2, wherein the at least one sensor is positioned in or on the plug member.

4. An apparatus as in claim 1, further comprising an energy storage device electrically coupled to the controller.

5. An apparatus as in claim 1, wherein at least part of the apparatus comprises a polyelectrolytic hydrogel.

6. An apparatus as in claim 5, wherein the plug member is configured to fit into at least one location selected from the group consisting of the bladder and the urethra.

7. An apparatus as in claim 1, wherein the plug member includes a tapered portion.

8. An apparatus as in claim 1, wherein the plug member comprises a shape selected from the group consisting of cylindrical, conical, and combinations of cylindrical and conical.

9. An apparatus as in claim 1, wherein the plug member comprises a resilient material.

10. An apparatus as in claim 1, wherein the plug member comprises a hydrophobic micoporous material.

11. An apparatus as in claim 1, wherein the valve is a one way valve.

12. An apparatus as in claim 1, wherein the valve is a two-way valve.

13. An apparatus as in claim 1, wherein the valve includes a piezoelectric actuator.

14. An apparatus as in claim 1, wherein the valve includes a shape memory alloy.

15. An apparatus as in claim 1, wherein the valve includes a hydrogel polymer.

16. An apparatus as in claim 1, wherein the controller comprises an electronic controller selected from the group consisting of an ASIC and a programmable microprocessor.

17. An apparatus as in claim 1, wherein the controller is programmable to open the valve to permit the flow of urine under at least one mode of operation selected from the group consisting of a predetermined time interval operation, a sensor operation, and a manual actuation operation.

18. An apparatus as in claim 1, wherein the controller is programmable to operate under a time interval mode, a sensor mode, and a manual mode.

19. The apparatus of claim 1, further comprising an external device comprising at least one of a second controller, a receiver, and a signal generator.

20. The apparatus of claim 19, wherein the external device comprises a microprocessor, a transceiver, an input mechanism.

21. The apparatus of claim 20, wherein the external device comprises at least one of a display, an alarm, and a vibrator.

22. The apparatus of claim 1, further comprising an external control device adapted to program the controller, the external control device adapted for use outside of the patient'"'"'s body.

23. An apparatus as in claim 1, wherein the sensor is coupled in direct physical contact with the plug.

24. An apparatus as in claim 1, wherein the controller is electrically connected to the valve.

25. An apparatus as in claim 1, wherein at least a portion of the plug member comprises at least one shape selected from the group consisting of cylindrical and conical.

26. A flow control apparatus comprising an assembly for insertion into a patient'"'"'s body, the assembly adapted to be positioned so that no portion of the assembly and no portion of the flow control apparatus that is physically coupled to the assembly is located outside of the patient'"'"'s body, the assembly comprising:

an intravesicular pressure transducer; and

a polyelectrolytic hydrogel coupled to the transducer, the polyelectrolytic hydrogel being adapted to receive a signal from the intravesicular pressure transducer and to control flow in response to the signal.

27. An apparatus for controlling the flow of a substance in a patient'"'"'s body, comprising:

an implantable valve adapted to be positioned along a route that the substance flows through the body;

an implantable controller for opening and closing the valve in response to an input provided by the patient; and

an implantable sensor which signals the controller to open the valve in response to the input provided by the patient;

wherein the implantable valve, the implantable controller, the implantable sensor, and any additional components physically coupled to at least one of the implantable valve, the implantable controller and the implantable sensor are adapted to be positioned entirely within the patient'"'"'s body.

28. An apparatus as in claim 27, wherein the input provided by the patent is selected from the group consisting of a pressure signal and a timed signal.

29. An apparatus as in claim 27, further comprising an external control device for sending a signal to the sensor from a position outside of the patient'"'"'s body.

30. A method to control the flow of urine in a patient, comprising:

implanting a plug device including an integral controller, a valve, and at least one sensor into the patient so that the plug device and any components physically coupled to the plug device are positioned entirely within the patient;

sensing an increase in an intravesicular pressure in at least one of the bladder and urethra and supplying a signal to the controller in response to the pressure increase;

opening the valve when the pressure reaches a first predetermined amount; and

closing the valve when the pressure decreases to a second predetermined amount.

31. A method as in claim 30, further comprising applying suprapubic pressure to supply a signal to the controller.

32. A method as in claim 30, wherein the valve is formed from a material selected from the group consisting of a shape memory alloy and a hydrogel polymer.

33. A method for controlling the urinary flow of a patient, comprising:

positioning a valve and a lumen in the patient in a location selected from the group of the urethra and the bladder so that the valve and lumen and any components physically coupled to the valve and lumen are positioned entirely within the location selected from the group of the urethra and the bladder;

positioning a sensor in the patient in a location selected from the group consisting of the urethra and the bladder;

sensing a condition in the patient relating to the urinary flow using the sensor; and

applying an electrical signal to actuate the valve and control the urinary flow through the lumen.

34. An apparatus to regulate urine flow, comprising:

a valve adapted to open and close in response to a signal to regulate urine flow;

at least one sensor; and

a controller adapted to control the valve;

wherein the valve, sensor, controller and any component physically coupled to at least one of the valve, sensor and controller is adapted to fit entirely inside of at least one of the bladder and the urethra.

35. A flow control apparatus for insertion into a patient'"'"'s body, comprising:

an intravesicular pressure transducer coupled to a controller;

the controller adapted to receive a transducer signal from the intravesicular pressure transducer; and

a polyelectrolytic hydrogel electrically coupled to the controller, the polyelectrolytic hydrogel being adapted to receive an electric field signal from the controller, wherein the polyelectrolytic hydrogel is further adapted to control flow be undergoing a change in dimension in response to the electric field signal;

wherein the flow control apparatus is adapted to be entirely positioned within the patient'"'"'s body.

36. An apparatus comprising:

a plug member including a lumen;

a valve positioned within the plug member and adapted to open and close the lumen in response to a control signal;

a sensor adapted to transmit a sensor signal; and

a controller positioned within the plug member and adapted to receive the sensor signal, the controller also adapted to control the valve in response to the sensor signal;

wherein the sensor is electrically connected to the controller member and

wherein the plug member is adapted to be positioned entirely within a patient'"'"'s body and any part of the apparatus that is physically coupled to the plug member is adapted to be positioned entirely within the patient'"'"'s body.

37. An apparatus for controlling the flow of urine in a patient, comprising:

implantable means for housing a lumen;

implantable valve means for opening and closing the lumen;

implantable means for sensing a condition related to the flow of urine inside the patient; and

implantable means for controlling the valve means in response to a signal from the sensing means;

wherein any part of the apparatus that is physically coupled to the implantable means for housing a lumen is adapted to be positioned entirely within the patient.

38. An apparatus for controlling the flow of urine in a patient, comprising:

a plug member including a lumen therein;

a valve adapted to open and close the lumen in response to a control signal;

at least one sensor adapted to sense a condition in the patient and provide an output; and

a controller adapted to transmit a control signal to the valve based on the output from the sensor;

wherein the plug member, the valve, the sensor and the controller are positioned entirely within the patient, and wherein any part of the apparatus that is physically coupled to the plug member is adapted to be positioned entirely within the patient.

39. An apparatus as in claim 38, wherein the output from the sensor relates to at least one condition in the patient selected from the group consisting of bladder pressure, bladder wall tension, urine flow rate, and volume of urine voided.

40. An apparatus as in claim 38, wherein the at least one sensor comprises at least one sensor selected from the group consisting of:

(1) strain gauge pressure sensors adapted to sense bladder and/or urine hydrostatic pressure;

(2) pH sensors adapted to sense urine pH;

(3) LEDs and/or photomutlipliers adapted to sense urine optical density and/or concentration;

(4) chemical field effect transistors adapted to sense at least one of pH, ammonia ion glucose and other chemical concentrations;

(5) electrodes for sensing dissolved oxygen concentrations;

(6) flow sensors including at least one selected from the group of ultrasound, electromagnetic and anemometric sensors adapted to sense urine flow rates and/or volumes; and

(7) at least one selected from the group of optical, electrical resistance and LVDT sensors adapted to sense bladder wall tension and/or displacement.

41. An apparatus as in claim 38, wherein the valve includes a default position that configures the valve to be in an open position.