System and method for assessing urinary function

• US 6,997,884 B2
• Filed: 06/27/2002
• Issued: 02/14/2006
• 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., Ulmsten, Ulf, Nohilly, Martin
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US10/183,295
• Publication Number:
  US 20030027326A1
• Time in Patent Office: 1,328 Days
• Field of Search: 600/561, 600/587, 600/560, 606/191, 604/27, 604/28, 604/30, 604/43, 604/93.01, 604/96.01, 604/97.01
• US Class Current: 600/561
• 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 test module is provided for coupling with a control device to form a portable system for assessing urinary function. The test module includes a test module housing, at least one coupling element for removably coupling the test module to the control device, a tubing assembly located at least partially within the test module housing, and a pressure interface in fluid communication with at least a portion of the tubing assembly. When the test module is coupled to the control device, the pressure interface is positioned relative to a pressure sensor in the control device so as to transmit pressure data thereto. The tubing assembly may also couple with a pump device in the control device so as to enable the pump device to pump fluid through the tubing assembly.

Claims

1. A test module for coupling with a control device to form a portable system for assessing urinary function, comprising:

a test module housing;

at least one coupling element for removably coupling the test module housing to the control device;

a tubing assembly including a first fluid conduit extending from a fluid inlet located exterior of the test module housing, to a first portion located entirely within the test module housing, to a second portion that is exposed to an exterior of the test module housing at an upper side thereof, back through the test module housing to a fluid outlet located exterior of the test module housing;

a pressure interface in fluid communication with at least a portion of the tubing assembly;

wherein when the test module is coupled to the control device, the pressure interface is positioned relative to a pressure sensor in the control device so as to transmit pressure data thereto.

2. The test module according to claim 1, further comprising an insert member dimensioned for at least partial insertion into a patient'"'"'s body, the insert member being coupled to the first fluid outlet so that fluid infused through the first fluid conduit passes through the insert member.

3. The test module according to claim 2, wherein the insert member is a meatus plug dimensioned for at least partial insertion into the patient'"'"'s urethral canal.

4. The test module according to claim 3, wherein the meatus plug has a channel therethrough coupled with the first fluid outlet, and is dimensioned so that, when inserted into the patient'"'"'s urethral canal distal of the patient'"'"'s urethral sphincter, it substantially blocks fluid flow into or out of the urethral canal other than through the meatus plug channel.

5. The test module according to claim 2, wherein the insert member is a catheter.

6. The test module according to claim 1, wherein the pressure interface is in fluid communication with the first fluid conduit.

7. The test module according to claim 1, wherein the second portion of the first fluid conduit is configured to engage a pump device in the control device so as to enable the pump device to pump fluid therethrough.

8. The test module according to claim 1, wherein the test module housing has at least one port therein configured to receive therein the pressure sensor.

9. The test module according to claim 8, wherein the pressure information includes Urethral Resistance Pressure information.

10. The test module according to claim 8, wherein the pressure information includes bladder pressure information.

11. The test module according to claim 8 further comprising a second pressure interface, wherein the test module housing further comprises a second port therein configured to receive a second control device pressure sensor.

12. The test module according to claim 11, wherein the second pressure interface is positioned relative to the second port so that when the second control device pressure sensor is received therein the second pressure interface couples with the second pressure sensor to transmit pressure information thereto.

13. A test module for coupling with a control device to form a portable medical test system, comprising:

a test module housing configured for engagement with the control device;

a tubing assembly located at least partially within the test module and defining at least a first fluid conduit extending from a first fluid inlet located exterior of the test module housing, to a first portion located entirely within the test module housing, to a second portion that is exposed to an exterior of the test module housing at an upper side thereof, back through the test module housing to a first fluid outlet located exterior of the test module housing;

wherein, when the test module is coupled to the control device, a pump device in the control device is in physical communication with the tubing assembly so as to be capable of pumping fluid through the first fluid conduit between the fluid inlet and fluid outlet.

14. The test module according to claim 13, further comprising an insert member dimensioned for at least partial insertion into a patient'"'"'s body, the insert member being coupled to the first fluid outlet so that fluid infused through the first fluid conduit passes through the insert member.

15. The test module according to claim 14, wherein the insert member is a meatus plug dimensioned for at least partial insertion into the patient'"'"'s urethral canal distal of the urethral sphincter.

16. The test module according to claim 15, wherein the meatus plug has a channel therethrough in fluid communication with the first fluid conduit and wherein, and is dimensioned so that, when inserted into the patient'"'"'s urethral canal, it substantially blocks fluid flow into or out of the urethral canal other than through the meatus plug channel.

17. The test module according to claim 14, wherein the insert member is a catheter.

18. The test module according to claim 13, wherein the pump device is a peristaltic pump.

19. The test module according to claim 13, wherein the test module housing has a first port therein, and the test module further comprises a pressure interface is positioned so that it is exposed through said port.

20. The test module according to claim 19, wherein the first port is dimensioned to receive therein a pressure sensor associated with the control device, and wherein the pressure interface is positioned relative to the first port so that when the pressure sensor is received therein, the pressure interface couples with the pressure sensor so as to transmit pressure information thereto.

21. The test module according to claim 20, wherein the pressure information includes Urethral Resistance Pressure information.

22. The test module according to claim 20, wherein the pressure information includes bladder pressure information.

23. A test module comprising:

a test module housing having at least one port therein;

a tubing assembly forming a first fluid conduit extending from a first fluid inlet located exterior of the test module housing, to a first portion located entirely within the test module housing, to a second portion that is exposed to an exterior of the test module housing at an upper side thereof, back through the test module housing to a first fluid outlet located exterior of the test module housing; and

a pressure interface positioned within the at least one port, the pressure interface being in fluid communication with the first fluid conduit.

24. The test module according to claim 23, further comprising an insert member dimensioned for at least partial insertion into a patient'"'"'s body, the insert member being coupled to the first fluid outlet so that fluid infused through the first fluid conduit passes through the insert member.

25. The test module according to claim 24, wherein the insert member is a meatus plug having a channel therethrough and dimensioned for at least partial insertion into the patient'"'"'s urethral canal distal of the urethral sphincter so that, when inserted it substantially blocks fluid flow into or out of the urethral canal other than through the meatus plug channel.

26. The test module according to claim 24, wherein the insert member is a catheter.

27. The test module according to claim 23, wherein the test module housing has a first port therein dimensioned to receive a pressure sensor, and wherein the pressure interface is positioned relative to the first port so that when the pressure sensor is received therein, the pressure interface couples with the pressure sensor so as to transmit pressure information thereto.

28. The test module according to claim 27, wherein the pressure information includes Urethral Resistance Pressure information.

29. The test module according to claim 27, wherein the pressure information includes bladder pressure information.

30. A test module configured for removably coupling with a control device including a processor electrically coupled with a pump device and with at least one pressure sensor, the test module comprising:

a test module housing;

a tubing assembly positioned 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

a tubing guide guiding the position of at least a portion of the first fluid conduit, the tubing guide being configured to guide the portion of the first fluid conduit so that, when the test module is coupled to the control device, said portion of the first fluid conduit engages the pump device.

31. The test module according to claim 30, wherein the pump device is a peristaltic pump capable of pumping fluid through the first fluid conduit when engaged therewith.

32. The test module according to claim 30, wherein the test module housing has a first port therein, and wherein the test module further comprises a pressure interface positioned within the port.

33. The test module according to claim 32, wherein the pressure interface is in fluid communication with the first fluid conduit.

34. The test module according to claim 33, wherein the first port is dimensioned to receive a pressure sensor associated with the control device, and wherein when said pressure sensor is received therein, the pressure interface couples with the pressure sensor to transmit pressure information thereto.

35. The test module according to claim 34, wherein the pressure information includes Urethral Resistance Pressure information.

36. The test module according to claim 34, wherein the pressure information includes bladder pressure information.