System and method for assessing detrusor instability

• US 7,252,631 B2
• Filed: 09/30/2003
• Issued: 08/07/2007
• 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.
• Primary Examiner(s): Lacyk; John P.
• Application Number:
  US10/674,452
• Publication Number:
  US 20040133067A1
• Time in Patent Office: 1,407 Days
• Field of Search: 600 29- 32, 600/300, 600/561, 600587-588, 600/591, 600/593, 128897-898, 128/DIG.25
• 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 method is provided for diagnosing detrusor instability. The method includes using an insert member having a channel therethrough positioned distal of the urethral sphincter, creating a substantially fluid tight seal to substantially block fluid flow into or out of the urethral canal other than through the channel, infusing fluid from a fluid source through the channel in the insert member and into the urethral canal at a location distal of the urethral sphincter, and measuring a pressure within the urethral canal at a location distal of the urethral sphincter as the fluid is being infused therein. The infusing step further involves infusing fluid until the urethral sphincter opens, and thereafter until at least one detrusor contraction occurs.

Claims

1. A method for diagnosing detrusor instability comprising the steps of:

using an insert member having a channel therethrough positioned distal of the urethral sphincter, creating a substantially fluid tight seal to substantially block fluid flow into or out of the urethral canal other than through the channel;

infusing fluid from a fluid source through the channel in the insert member and into the urethral canal at a location distal of the urethral sphincter;

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

wherein the infusing step further includes infusing fluid until the urethral sphincter opens, and thereafter until at least one detrusor contraction occurs.

2. The method according to claim 1, wherein the fluid is infused at rate of approximately 40-120 mL/min.

3. The method according to claim 2, wherein fluid is infused for at least approximately 3 minutes.

4. The method according to claim 1, further comprising the steps of:

providing data correlating to the measured pressure to a processor; and

displaying on a display device measured pressure versus time.

5. The method according to claim 1, wherein at least a distal portion of the insert member is substantially conical in shape.

6. The method according to claim 5, wherein the insert member channel further comprises an insert member channel inlet at a proximal end and an insert member outlet at a distal end including a plurality of apertures spaced apart about an outer surface of the distal end of the insert member.

7. The method according to claim 1, wherein the insert member is coupled to a device for diagnosing urinary incontinence, the device including a control device having a processor and a pump therein, and a test module removably coupled to the control device, the test module including a tubing assembly coupled to the pump for pumping fluid therethrough, and having a first fluid conduit between a fluid inlet and a fluid outlet, the fluid outlet being coupled to the insert member and in fluid communication with the insert member channel.

8. The method according to claim 7, wherein the fluid inlet of the first fluid conduit is coupled to a fluid source.

9. The method according to claim 8, wherein the control device further includes a pressure sensor, and the test module further includes a pressure interface in fluid communication with the first fluid conduit and in communication with the pressure sensor so as to transmit pressure information thereto.

10. A method for diagnosing detrusor instability 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; and

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

wherein, the infusing step further includes infusing fluid into the urethral canal until the urethral sphincter opens, and thereafter until at least one detrusor muscle contraction occurs.

11. The method according to claim 10, wherein fluid is infused at a rate of approximately 40-120 mL/min.

12. The method according to claim 11, wherein fluid is infused for at least approximately 3 minutes.

13. The method according to claim 10, 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.

14. The method according to claim 13, wherein the pump device is a peristaltic pump.

15. The method according to claim 10, 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.

16. A method for diagnosing detrusor instability comprising the steps of:

inserting an insert member having a channel therethrough at least partially into a patients 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 at a rate of approximately 40-120 mL/min;

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;

wherein the infusing step further includes infusing fluid until the urethral sphincter opens, and thereafter until at least one detrusor contraction occurs.

17. The method according to claim 16, further comprising the step of displaying data correlating to the measured pressure versus time on a display device.

18. The method according to claim 16, wherein the insert member is coupled to a device for diagnosing urinary incontinence, the device including a control device having a processor and a pump therein, and a test module removably coupled to the control device, the test module including a tubing assembly coupled to the pump for pumping fluid therethrough, and having a first fluid conduit between a fluid inlet and a fluid outlet, the fluid outlet being coupled to the insert member and in fluid communication with the insert member channel.

19. The method according to claim 18, wherein the control device further includes a pressure sensor, and the test module further includes a pressure interface in fluid communication with the first fluid conduit and in communication with the pressure sensor so as to transmit pressure information thereto.