System and method for assessing urinary function

• US 20030028074A1
• Filed: 06/27/2002
• Published: 02/06/2003
• Est. Priority Date: 06/29/2001
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Tracey, Michael R., Nohilly, Martin
• Granted Patent: US 6,916,283 B2
• Time in Patent Office: Days
• US Class Current: 600/29
• CPC Class Codes: A61B 1/32 Devices for opening or enlarging the visual field, e.g. of a tube of the body dilators A61M29/00
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 5/202 Assessing bladder functions, e.g. incontinence assessment
• CPC Class Codes: A61B 5/204 Determining bladder volume
• CPC Class Codes: A61B 5/205 Determining bladder or urethral pressure
• CPC Class Codes: A61B 5/208 adapted to determine urine quantity, e.g. flow, volume
• CPC Class Codes: A61B 5/7435 Displaying user selection data, e.g. icons in a graphical user interface
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end

Abstract

A system and method for assessing urinary function is provided. The system includes a processor, a tubing assembly forming a first fluid conduit between a first fluid inlet and a first fluid outlet, and an insert member having a channel therethrough and coupled to the first fluid outlet so that fluid flowing through the first fluid conduit may flow through the insert member. The insert member is dimensioned for at least partial insertion into a patient'"'"'s urethral canal distal of the patient'"'"'s urethral sphincter, and dimensioned so that, when inserted, it substantially blocks fluid flow into or out of the urethral canal other than through the insert member channel. The system further includes a fluid delivery device electrically coupled to and controlled by the processor, and coupled to the first fluid conduit for pumping fluid therethrough, and a pressure detection system for detecting pressure within the urethral canal distal of the urethral sphincter and providing information correlating to the detected pressure to the processor. The method includes coupling the test module to the control device, inserting the insert member into a patient, infusing fluid through the insert member until the urethral sphincter opens, and measuring pressure within the urethral canal as fluid is infused therein. Also provided is a test module for coupling to a control device to form a system for assessing urinary function.

Claims

1. A system for assessing urinary function comprising:

a processor;

a tubing assembly forming a first fluid conduit between a first fluid inlet and a first fluid outlet;

an insert member having a channel therethrough and coupled to the first fluid outlet so that fluid flowing through the first fluid conduit may flow through the insert member, the insert member being dimensioned for at least partial insertion into a patient'"'"'s urethral canal distal of the patient'"'"'s urethral sphincter, and being dimensioned so that, when inserted, it substantially blocks fluid flow into or out of the urethral canal other than through the insert member channel;

a fluid delivery device electrically coupled to and controlled by the processor, and coupled to the first fluid conduit for pumping fluid therethrough; and

a detection system for detecting resistance of the urethral sphincter as fluid is infused therein.

2. The system according to claim 1, wherein the detection system is a pressure detection system for detecting pressure within the urethral canal distal of the urethral sphincter and providing information correlating to the detected pressure to the processor.

3. The system according to claim 2, wherein the pressure detection system is in fluid communication with the first fluid conduit at a location such that pressure within the first fluid conduit substantially correlates to pressure within the urethral canal distal of the urethral sphincter.

4. The system according to claim 3, wherein the pressure detection system further comprises a pressure interface in fluid communication with the first fluid conduit, and a pressure sensor electrically coupled to the processor, wherein the pressure interface is in contract with the pressure sensor and provides pressure information thereto.

5. The system according to claim 1, wherein the pressure detection system detects Urethral Resistance Pressure.

6. The system according to claim 1, wherein the fluid delivery device is a peristaltic pump.

7. The system according to claim 1, further comprising a fluid source coupled to the fluid inlet, wherein the fluid delivery device delivers fluid from the fluid source, through the first fluid conduit and insert member channel and into the patient'"'"'s urethral canal.

8. The system according to claim 1, further comprising a display device electrically coupled to the processor and capable of displaying data.

9. The system according to claim 8, wherein pressure detected by the pressure detection system is displayed on the display device.

10. The system according to claim 9, wherein the pressure detection system further comprises a pressure interface in fluid communication with the first fluid conduit, and a pressure sensor electrically coupled to the processor, wherein the pressure interface is in contact with the pressure sensor and provides pressure information thereto.

11. The system according to claim 1, wherein the pressure detection system detects Urethral Resistance Pressure, and wherein the Urethral Resistance Pressure is displayed on the display device.

12. The system according to claim 1, wherein an outer surface of at least a distal portion of the insert member is substantially conical in shape.

13. The system according to claim 1, wherein the insert member channel further comprises an insert member channel inlet at a proximal end, and an insert member channel outlet at a distal end including a plurality apertures spaced apart about an outer surface of the distal end of the insert member.

14. A system for assessing urinary function comprising:

a control device including a processor and pump device electrically coupled to and controlled by the processor;

a test module removably coupled to the control device and including a tubing assembly including a first fluid conduit between a first fluid inlet and a first fluid outlet;

an insert member coupled to the first fluid outlet and having a channel therethrough in communication with the first fluid conduit such that fluid flowing through the first fluid conduit may flow through the insert member, the insert member being dimensioned for at least partial insertion into a patient'"'"'s urethral canal at a location distal of the patient'"'"'s urethral sphincter, and dimensioned to substantially block fluid flow into and out of the urethral canal other than through the insert member channel; and

a detection system for detecting resistance of the urethral sphincter as fluid is infused therein;

wherein the pump device is coupled with the first fluid conduit and capable of pumping fluid through the first fluid conduit and insert member channel and into the urethral canal distal of the urethral sphincter

15. The system according to claim 14, wherein the detection system is a pressure detection system capable of detecting pressure within the urethral canal distal of the urethral sphincter as fluid is pumped therein.

16. The system according to claim 15, wherein the pressure detection system is in fluid communication with the first fluid conduit.

17. The system according to claim 16, wherein the pressure detection system further comprises a pressure interface in fluid communication with the first fluid conduit, and a pressure sensor electrically coupled to the processor, wherein the pressure interface is in contact with the pressure sensor and provides pressure information thereto.

18. The system according to claim 14, wherein the pressure detection system detects Urethral Resistance Pressure.

19. The system according to claim 15, further comprising a display device electrically coupled to the processor and capable of displaying data.

20. The system according to claim 19, wherein pressure detected by the pressure detection system is displayed on the display device.

21. The system according to claim 20, wherein the pressure detection system further comprises a pressure interface in fluid communication with the first fluid conduit, and a pressure sensor electrically coupled to the processor, wherein the pressure interface is in contact with the pressure sensor and provides pressure information thereto.

22. The system according to claim 21, wherein the pressure information includes Urethral Resistance Pressure information, and wherein the Urethral Resistance Pressure information is displayed on the display device.

23. A method for assessing urinary function comprising the steps of:

coupling a test module to a control device, the test module including a tubing assembly having a first fluid conduit between a first fluid inlet and a first fluid outlet, and an insert member coupled to the first fluid outlet and having a channel therethrough in communication with the first fluid conduit so that fluid flowing through the first fluid conduit can flow through the insert member;

coupling the first fluid inlet to a fluid source;

inserting the insert member at least partially into a patient'"'"'s urethral canal at a location distal of the urethral sphincter so as to substantially block fluid flow into or out of the urethral canal other than through the insert member channel;

infusing fluid from the fluid source into the urethral canal through the first fluid conduit and insert member until the urethral sphincter opens; and

measuring the resistance of the urethral sphincter at a location distal of the urethral sphincter as fluid is being infused therein.

24. The method according to claim 23, wherein the step of measuring the resistance includes measuring the pressure within the urethral canal distal of the urethral sphincter as fluid is being infused therein.

25. The method according to claim 23, wherein the coupling step further comprises coupling the first fluid conduit with a pump device in the control device, and the infusing step further comprises activating the pump device to thereby cause fluid to be infused from the fluid source through the first fluid conduit and insert member channel.

26. The method according to claim 23, wherein the pump device is a peristaltic pump.

27. The method according to claim 24, wherein the test module further includes a pressure interface in fluid communication with the first fluid conduit, and the coupling step further comprises coupling the pressure interface with a pressure sensor in the control device so as to enable the pressure interface to transmit pressure information thereto.

28. The method according to claim 24, further comprising the step of transmitting pressure information from the pressure interface to the pressure sensor, wherein the pressure information includes Urethral Resistance Pressure information.

29. The method according to claim 28, further comprising the step of displaying the Urethral Resistance Pressure information on a display device.

30. The method according to claim 23, wherein an outer surface of at least a distal portion of the insert member is substantially conical in shape.

31. The method according to claim 23, wherein the insert member channel further comprises an insert member channel inlet at a proximal end, and an insert member channel outlet at a distal end including a plurality apertures spaced apart about an outer surface of the distal end of the insert member.

32. The method according to claim 24, wherein the measuring step further comprises measuring Urethral Resistance Pressure.

33. The method according to claim 32, further comprising displaying Urethral Resistance Pressure information on a display device.

34. A method for assessing urinary function comprising the steps of:

inserting an insert member having a channel therethrough at least partially into a patient'"'"'s urethral canal at a location distal of the urethral sphincter, the insert member being dimensioned to substantially block fluid flow into and out of the urethral canal other than through the insert member channel;

infusing fluid from a fluid source through the insert member channel and into the urethral canal at a location distal of the patient'"'"'s urethral sphincter until the urethral sphincter opens;

measuring pressure within the urethral canal at a location distal of the urethral sphincter as fluid is being infused therein; and

providing data correlating to the measured pressure to a processor.

35. The method according to claim 34, further comprising the step of displaying data correlating to the measured pressure versus time on a display device.

36. The method according to claim 35 wherein the data correlates to the Urethral Resistance Pressure.

37. A test module for coupling with a control device, comprising:

a test module housing including a plurality of tabs projecting therefrom, the tabs being configured for engagement with the control device;

a tubing assembly located at least partially within the test module housing and including a first fluid conduit between a first fluid inlet and a first fluid outlet; and

an insert member dimensioned for insertion into a patient'"'"'s urethral canal distal of the patient'"'"'s urethral sphincter, the insertion member being coupled to the first fluid outlet and having a channel therethrough in communication with the first fluid outlet so that fluid flowing through the first fluid conduit may flow through the insert member, and being dimensioned to substantially block fluid flow into or out of the urethral canal other than through the insert member channel.

38. The test module according to claim 37, wherein an outer surface of at least a distal portion of the insert member is substantially conical in shape.

39. The test module according to claim 37, wherein the insert member channel further comprises an insert member channel inlet at a proximal end, and an insert member channel outlet at a distal end including a plurality apertures spaced apart about an outer surface of the distal end of the insert member.

40. The test module according to claim 37, further comprising a tubing guide for positioning at least a portion of the first fluid conduit of the tubing assembly, wherein the tubing guide positions said portion of the first fluid conduit to engage a pump device in the control device when the test module is coupled thereto.

41. The test module according to claim 40, wherein the tubing guide positions said portion of the first fluid conduit in a substantially U-shaped configuration.

42. The test module according to claim 37, further comprising a pressure interface in fluid communication with the first fluid conduit, wherein a pressure at the pressure interface substantially correlates to a pressure within the first fluid conduit.

43. The test module according to claim 42, wherein the test module housing has a first port therein dimensioned to receive a pressure sensor associated with the control device, and wherein the pressure interface is positioned within the first port.

44. A test module for coupling with a control device having a pressure sensor comprising:

a tubing assembly defining a first fluid conduit between a first fluid inlet capable of being coupled with a fluid source and a first fluid outlet;

an insert member coupled to the first fluid outlet and having a channel therethrough in communication with the first fluid conduit such that fluid flowing through the first fluid conduit may flow through the insert member, the insert member being dimensioned for at least partial insertion into a patient'"'"'s urethral canal distal of the patient'"'"'s urethral sphincter, and dimensioned to substantially block fluid flow into or out of the urethral canal other than through the insert member channel; and

a pressure interface in fluid communication with the first fluid conduit, wherein when the test module is coupled to the control device, the pressure interface provides pressure information to the control device pressure sensor.

45. The test module according to claim 44, wherein an outer surface of at least a distal portion of the insert member is substantially conical in shape.

46. The system according to claim 44, wherein the insert member channel further comprises an insert member channel inlet at a proximal end, and an insert member channel outlet at a distal end including a plurality apertures spaced apart about an outer surface of the distal end of the insert member form.

47. The test module according to claim 44, further comprising a tubing guide for positioning at least a portion of the first fluid conduit of the tubing assembly, wherein the tubing guide positions said portion of the first fluid conduit to engage a pump device in the control device when the test module is coupled thereto.

48. The test module according to claim 47, wherein the tubing guide positions said portion of the first fluid conduit in a substantially U-shaped configuration.

49. The test module according to claim 44, wherein the test module housing has a first port therein dimensioned to receive the control device pressure sensor, and wherein the pressure interface is positioned within the first port so that when the pressure sensor is received therein the pressure interface contacts the pressure sensor to transmit pressure information thereto.