Electronic control unit and tubing assembly system for automatically controlling urinary irrigation

• US 6,183,437 B1
• Filed: 11/13/1997
• Issued: 02/06/2001
• Est. Priority Date: 07/10/1995
• Status: Expired due to Fees

• Current Assignee: Frank J. Walker Sr
• Original Assignee: Guardian Medical Systems, Inc.
• Inventors: Walker, Frank J.
• Primary Examiner(s): Kennedy, Sharon
• Assistant Examiner(s): Lam, Ann Y.
• Application Number:
  US08/969,396
• Time in Patent Office: 1,181 Days
• Field of Search: 604/96, 604/102, 604/19, 604/27, 604/30, 604/34, 604/65, 604/67, 604/80, 604/101, 604/118, 604/131, 604/132, 604/246, 604/250, 604/257, 604/258, 604/262
• US Class Current: 604/96.01
• CPC Class Codes: A61F 2/0022 placed deep in the body opening occluding blood vessels by internal devices A61B17/12022
• CPC Class Codes: A61F 2/0027 inflatable
• 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 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

An electronic control unit and tubing assembly system for automatically controlling urinary irrigation is provided, including a tubing assembly and two embodiments of an electronic control unit. The tubing assembly includes tubing to connect to an irrigant supply source feeding a supply line, to a urinary catheter, and to a vent line connected to a fluid sensor assembly. The vent line is arranged so that irrigant flows into the vent line should the catheter drain become obstructed or should the supply line become kinked, and actuates a fluid sensor. An electronic control unit is in communication with the fluid sensor, and generates a control circuit that is responsive to the fluid sensor. When the fluid sensor detects a catheter obstruction, the circuit changes states and closes a pinch valve to shut off the flow of irrigant. In this manner, the system prevents the patient from suffering bladder distension, perforation, or rupture due to a “runaway” urinary catheter. The first embodiment of the electronic control unit automatically resumes the flow of irrigant once the obstruction or kink is cleared, with or without human intervention. The second embodiment provides an electromechanical device that must be manually cocked to initiate irrigant flow, that is shut by a mechanical trigger should an obstruction occur, and that must be manually re-cocked to resume irrigant flow.

Claims

1. An electronic control unit for automatically interrupting the flow of irrigant to a urinary catheter, the control unit being connectable to a fluid sensor for automatically detecting an obstruction of a catheter, the control unit comprising:

a) means for generating a control circuit being responsive to the fluid sensor, the control circuit being operable in at least two states, a first one of the at least two states indicating that there is no obstruction, and a second one of the at least two states indicating that there is an obstruction;

b) means for selectively interrupting the flow of irrigant, said interrupting means being responsive to the control circuit so that when the control circuit is in the first state, said interrupting means allows irrigant to flow and so that when the control circuit is in the second state, said interrupting means blocks the flow of irrigant;

c) said generating means including means for emitting a control signal and means for detecting the control signal; and

d) said emitting means including a photon emitter, and said detecting means including a photon detector.

2. The control unit of claim 1, wherein said interrupting means includes a pinch valve assembly being movable between an open and a closed position.

3. The control unit of claim 2, wherein said pinch valve assembly includes a solenoid being responsive to the control circuit, and a ram being joined to said solenoid, said ram for selectively contacting the supply line.

4. A tubing apparatus for use with an irrigating urinary catheter having an irrigant supply line fed by an irrigant source and at least one drain lumen, the tubing apparatus being connectable to a control unit generating a control signal, the tubing apparatus being configured to automatically detect when the drain lumen or the supply line of a catheter becomes obstructed, and for manipulating the control signal to indicate the presence of an obstruction in a catheter, the tubing apparatus comprising:

a) a vent line being arranged so that irrigant flows into said vent line only should an obstruction occur; and

b) a fluid sensor being in fluid communication with said vent line for detecting irrigant within said vent line, said fluid sensor being connectable to the control unit in communication with the control signal, so that said fluid sensor automatically detects obstructions and manipulates the control signal when obstructions are detected.

5. The tubing apparatus of claim 4, wherein said vent line includes an elongated hollow lumen.

6. The tubing apparatus of claim 4, further comprising a junction member being joined to said vent line, the irrigant source, and to a supply line.

7. The tubing apparatus of claim 6, wherein said junction member includes a housing, and wherein said housing defines an interior channel being in fluid communication with the irrigant supply line, the irrigant source, and said vent line.

8. The tubing apparatus of claim 7, wherein the interior channel is generally T-shaped.

9. The tubing apparatus of claim 4, wherein said fluid sensor includes means for manipulating the control circuit, said manipulating means being in fluid communication with said vent line and being responsive to the presence of irrigant within said vent line.

10. The tubing apparatus of claim 9, wherein said manipulating means includes a float.

11. The tubing apparatus of claim 4, wherein said fluid sensor defines an internal cavity being in fluid communication with said vent line, and wherein said fluid sensor includes a float being slidably positionable within the internal cavity between a resting position, wherein the float allows the control signal to pass unmanipulated, and a floating position, wherein the float manipulates the control signal.

12. The tubing apparatus of claim 11, wherein said float includes an exterior surface area and a plurality of knobs protruding from the external surface area, the knobs being for minimizing the area of contact between the external surface area of the float and the wall of the internal cavity.

13. The tubing apparatus of claim 11, wherein the internal cavity is oriented so that gravity biases the float into the resting position, and so that irrigant passing into the internal cavity from said vent line raises the float into the floating position.

14. A system for use with a urinary irrigating catheter having an irrigant supply line and at least one drain lumen, the system being configured to automatically interrupt the flow of irrigant should the drain lumen or the supply line of the catheter become obstructed, and for automatically resuming the flow of irrigant should an obstruction subsequently be cleared from the catheter, the system comprising:

a) a control unit comprising;

i) means for generating a control circuit indicating when an obstruction occurs, the control circuit being operable in at least two states, a first one of the at least two states indicating that no obstruction is present, and a second one of the at least two states indicating that an obstruction is present; and

ii) means for selectively interrupting the flow of irrigant, said interrupting means being responsive to the control circuit so that when the control circuit is in the first state, said interrupting means allows irrigant to flow, and so that when the control circuit is in the second state, said interrupting means blocks the flow of irrigant; and

b) a tubing apparatus comprising;

i) a vent line being in fluid communication with the irrigant supply line so that irrigant flows into said vent line only should an obstruction be present; and

ii) a fluid sensor being in fluid communication with said vent line for detecting irrigant within said vent line, said fluid sensor being connectable to said generating means in communication with the control circuit, so that said fluid sensor alters the state of the control circuit when an obstruction is present.

15. The system of claim 14, wherein said fluid sensor includes means for manipulating the control circuit, said manipulating means being in fluid communication with said vent line and being responsive to the presence of irrigant within said vent line.

16. The system of claim 15, wherein said manipulating means includes a float.

17. The system of claim 14, wherein said fluid sensor defines an internal cavity being in fluid communication with said vent line, and wherein said fluid sensor includes a float being slidably positionable within the internal cavity between a resting position, wherein the float allows the control signal to pass unmanipulated, and a floating position, wherein the float manipulates the control signal.

18. The system of claim 14, wherein said interrupting means includes a pinch valve assembly being movable between an open and a closed position.

19. The system of claim 14, wherein said generating means includes means for emitting a control signal and means for detecting the control signal.

20. The system of claim 19, wherein the emitting means includes a photon emitter, wherein the detecting means includes a photon detector, wherein the float is opaque, whereby the opaque float blocks photons passing between the emitter and the detector when the float is in the floating position to manipulate the control circuit.

21. An electro-mechanical control unit for automatically interrupting the flow of irrigant to a urinary catheter should the catheter become obstructed, the electro-mechanical control unit comprising:

a) means for generating a control circuit, the control circuit being operable in at least two states, the first state indicating no obstruction, and the second state indicating the presence of an obstruction;

b) means for manipulating the state of the control circuit to indicate the presence of an obstruction;

c) a housing defining an annulus being in communication with said manipulating means, the annulus being arranged so that it fills with irrigant should an obstruction occur and so that the irrigant causes said manipulating means to alter the state of the control circuit; and

d) means for selectively interrupting the flow of irrigant, said interrupting means being responsive to the control circuit so that when the control circuit is in the first state, said interrupting means allows irrigant to flow, and so that when the control circuit is in the second state, said interrupting means blocks the flow of irrigant.

22. The electro-mechanical control unit of claim 21, wherein said generating means includes a photon emitter and a photon detector generating the control circuit.

23. The electro-mechanical control circuit of claim 21, wherein said manipulating means includes a float.

24. The electro-mechanical control of claim 23, wherein said housing defines a cavity, and the float is slidably positioned within the cavity.

25. The electro-mechanical control unit of claim 24, wherein the cavity is disposed so that the float is biased by gravity downwardly within the cavity.

26. The electro-mechanical control unit of claim 23, wherein the float is opaque.

27. The electro-mechanical control unit of claim 21, wherein said interrupting means includes a manual ram being movable between an open and a closed position.

28. An electronic control unit for periodically flushing a urinary irrigating catheter with irrigant while providing a plurality of modes, the electronic control unit comprising:

(a) means for selectively interrupting the flow of irrigant to the catheter, said interrupting means being movable between an open position allowing the flow of irrigant and a closed position blocking the flow of irrigant; and

(b) means for selecting the flush mode, said selecting means being operatively connected to said interrupting means periodically to open said interrupting means to flush the catheter with irrigant.

29. The electronic control unit of claim 28, wherein said selecting means includes means for allowing a user to select a one-shot flushing mode.

30. The electronic control unit of claim 28, wherein said selecting means includes means for allowing a user to select a continuous flow mode.

31. The electronic control unit of claim 28, wherein said selecting means includes means for allowing a user to select an automatic flow mode wherein a measured volume of irrigant is released according to a selected periodic time schedule.

32. The electronic control unit of claim 28, further comprising means for controlling the volume of irrigant flushed, said controlling means being operatively connected to said interrupting means.