System and method for assessing urinary function

• US 7,052,452 B2
• Filed: 06/27/2002
• Issued: 05/30/2006
• Est. Priority Date: 06/29/2001
• Status: Expired due to Term

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Tracey, Michael R., Ulmsten, Ulf, Nohilly, Martin
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US10/183,790
• Publication Number:
  US 20030023135A1
• Time in Patent Office: 1,433 Days
• Field of Search: 600/29, 600/30, 600 33- 35, 600/300, 600/561, 600/573, 600591-593, 600433-435, 600/568, 600/587, 600/589, 604/97.02, 604/100.03, 604/121, 604/204, 604/285, 604/915, 604/919, 604/920, 606/192, 606/193
• 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 medical system is provided for assessing urinary function. The system includes a control device and at least one test module capable of being removably coupled to the control device such that, when coupled, the system is capable of performing a test to assess urinary function. The control device may include a processor and memory having stored therein a plurality of software subroutine, at least one of which directs a test to assess urinary function. The test module may include a module identification device, and the control device selects the software subroutine based upon information obtained from the module identification device. The test module may further include a tubing assembly forming a first fluid conduit between a first fluid inlet and a first fluid outlet and an insert member dimensioned for at least partial insertion into a patient'"'"'s urinary tract and coupled to the first fluid outlet so that fluid infused through the first fluid conduit flows through the insert member.

Claims

1. A portable medical system comprising:

a control device having a control device housing having a microprocessor and pump positioned therein, a display device integral with the control device and visible through the control device housing, and an input device for inputting data to the microprocessor;

a plurality of independent test modules each capable of being removably and interchangeably coupled to the control device in a substantially similar manner;

wherein for each of the plurality of test modules, when removably coupled to the control device, the medical system is capable of performing a different test to assess urinary incontinence, the test being selected from the group consisting of Urethral Resistance Pressure, simple cystometrogram, complex cystometrogram, and uroflowmetry.

2. The medical system according to claim 1, wherein when one of the plurality of test modules is removably coupled to the control device, the medical system measures pressure within a patient'"'"'s urinary tract to thereby assess urinary incontinence.

3. The medical system according to claim 1, wherein when one of the plurality of test modules is removably coupled to the control device, the medical system measures Urethral Resistance Pressure to thereby assess urinary incontinence.

4. The medical system according to claim 1, wherein the plurality of test modules each further comprise at least one module identification component, and the different test to be performed is selected by the control device based upon information obtained by the control device from the at least one module identification component.

5. The medical system according to claim 1, at least one of the plurality of test modules further comprising:

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

an insert member dimensioned for at least partial insertion into a patient'"'"'s urinary tract and coupled to the first fluid outlet so that fluid infused into the first fluid conduit passes through the insert member and into the urinary tract.

6. The medical system according to claim 5, wherein the first fluid inlet is coupled to a fluid source.

7. The medical system according to claim 5, wherein the insert member is dimensioned for insertion into the urethral canal distal of the urethral sphincter, and wherein the at least one test module further comprises a pressure interface in fluid communication with the urethral canal distal of the urethral sphincter when the insert member is so inserted.

8. The medical system according to claim 5, wherein the insert member is dimensioned for insertion into a patient'"'"'s bladder, and the at least one test module further comprises a pressure interface in fluid communication with the bladder when the insert member is so inserted.

9. The medical system according to claim 5, wherein the at least one test module further comprises a pressure interface in fluid communication with the first fluid conduit of the tubing assembly.

10. The medical system according to claim 9, wherein the control device further comprises a pressure sensor, and wherein when the at least one testing module is coupled to the control device, the pressure interface is positioned relative to the control device pressure sensor so as to transmit pressure information thereto.

11. The medical system according to claim 5, wherein the control device further comprises a pump device, and wherein when the at least one testing module is coupled to the control device, the pump device engages the first fluid conduit of the test module tubing assembly for pumping fluid therethrough.

12. The medical system according to claim 11, wherein the pump device is a peristaltic pump.

13. The medical system according to claim 1, wherein the processor is capable of receiving data from the input device and outputting data to the display device.

14. The medical system according to claim 13, wherein the medical system further comprises software including a plurality of software subroutines, wherein the processor executes a selected one of the plurality of software subroutines in response to identifying the test module attached thereto.

15. The medical system according to claim 14, wherein plurality of test modules each further comprise at least one module identification component, and the one software subroutine is selected by the processor based upon information obtained by the control device from the at least one module identification component.

16. The medical system according to claim 1, wherein the input device is a keypad integral with the control device housing.

17. The medical system according to claim 1, wherein the at least one input device is an input pendant including at least one switch providing input to the processor.

18. The medical system according to claim 1, further comprising an interface for coupling with a peripheral device for providing data thereto.

19. The medical system according to claim 18, wherein the peripheral device is a printer.

20. The medical system according to claim 18, wherein the peripheral device is a computer.

24. The portable medical system according to claim 23, wherein the insert member is dimensioned for insertion into the patient'"'"'s bladder, and wherein the pressure information includes bladder pressure information.

25.The medical system accordin to claim 2, wherein the pressure measured within the urinary tract is the Urethral Resistance Pressure.

21. A portable medical system comprising:

a control device including a processor and memory storing therein a plurality of software routines for controlling a plurality of different tests to assess urinary incontinence; and

a test module capable of being removably coupled to the control device, the test module including a module identification device, a pressure sensor for measuring pressure within the urinary tract to thereby assess urinary incontinence, a tubing assembly forming a first fluid conduit between a first fluid inlet and a first fluid outlet, and an insert member dimensioned for at least partial insertion into a patient'"'"'s urinary tract and coupled to the first fluid outlet so that fluid infused through the first fluid conduit passes through the insert member and into the urinary tract,

wherein when the test module is removably coupled to the control device, the control device processor executes a selected one of the plurality of software routines based upon information obtained from the module identification device.

22. The portable medical system according to claim 21, wherein the test module further comprises a pressure interface in fluid communication with the first fluid conduit, and the control device further comprises a pressure sensor, wherein when the test module is coupled to the control device, the pressure interface is coupled with the pressure sensor so as to transmit pressure information thereto.

23. The portable medical system according to claim 22, wherein the insert member is dimensioned for insertion into the patient'"'"'s urethral canal distal of the urethral sphincter, and wherein the pressure information includes Urethral Resistance Pressure information.

25. A portable medical system comprising:

a control device including a processor and memory storing therein a plurality of software routines for controlling a plurality of different tests to assess urinary incontinence; and

a test module capable of being removably coupled to the control device, the test module including a module identification device, and a pressure sensor for measuring pressure within the urinary tract to thereby assess urinary incontinence.

wherein when the test module is removably coupled to the control device, the control device processor executes a selected one of the plurality of software routines based upon information obtained from the module identification device, and wherein at least one of said plurality of different tests to assess urinary incontinence is selected from the group consisting of Urethral Resistance Pressure simple cystometrogram, complex cystometrogram, and uroflowmetry.