Pubococcygeal training biofeedback device

• US 6,217,529 B1
• Filed: 05/02/2000
• Issued: 04/17/2001
• Est. Priority Date: 12/03/1997
• Status: Expired due to Term

• Current Assignee: JCS Wellness Solutions, Inc.
• Original Assignee: Deschutes Medical Products, Inc.
• Inventors: Hoffman, Gary L., McCoy, William G., Boileau, Michel A., Wax, Michael S., Clem, William E., Mesaros, Robert, Hoskins, Matthew W.
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US09/563,102
• Time in Patent Office: 350 Days
• Field of Search: 600/29, 600/30, 600/31, 600/587, 600/591, 606/191, 606/192, 606/193, 606/197, 601/23, 601/148, 601/149, 601/150, 482/111, 482/112, 482/113, 128/830, 128/834, 128/836, 128/885, 128/898, 733/790--37
• US Class Current: 600/591
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2210/1067 Anus
• CPC Class Codes: A61M 2210/1078 Urinary tract
• CPC Class Codes: A61M 2230/60 Muscle strain, i.e. measured on the user
• 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
• CPC Class Codes: A63B 2071/0638 Displaying moving images of recorded environment, e.g. virtual environment
• CPC Class Codes: A63B 21/008 using hydraulic or pneumatic force-resisters
• CPC Class Codes: A63B 2220/56 Pressure
• CPC Class Codes: A63B 23/20 for vaginal muscles or other sphincter-type muscles
• CPC Class Codes: A63B 24/00 Electric or electronic controls for exercising apparatus of preceding groups; Controlling or monitoring of exercises, sportive games, training or athletic performances

Abstract

A training device is disclosed for exercising the pubococcygeal or pelvic floor muscles, for example in the treatment of incontinence. The device includes a cylindrical, deformable probe for insertion into the vagina or rectum of a user. The probe is connected to a pressure transducer, which detects the pressure applied to the probe by contraction of the pelvic floor muscles and displays a pressure indicator to the user to help direct the contraction of the appropriate muscles. The pressure indicator may take the form of a series of nested figures, such as curves or concentric semi-circles, that incrementally converge toward a common point as pressure on the probe increases. The nested figures incrementally retreat from the common point as pressure on the probe decreases. The training unit guides a user through an exercise routine by tracking the overall exercise time and the timing between flexing and relaxation cycles. The training unit can include a controller, such as a microcontroller, that is coupled to the inflatable probe for detecting the pressure within the probe. The controller tracks the timing of exercises performed by the user and guides the user through alternating cycles of muscular contraction and relaxation to provide a safe and effective biofeedback regimen.

Claims

1. A method for assisting a user through an exercise routine of the user'"'"'s pelvic floor muscles, comprising:

inserting an inflatable probe into an orifice of the user;

detecting a pressure applied to the probe by the user'"'"'s pelvic floor muscles;

displaying a pressure indicator associated with probe pressure on a display, the display having a graphical representation of muscles surrounding the probe; and

modifying the display in response to changes in probe pressure such that there is a physiological correspondence between the graphical representation of muscles on the display and the muscle contraction by the user.

2. The method of claim 1 further including changing a pressure scale associated with the pressure indicator on the display in response to user input.

3. The method of claim 1 further including displaying, on the display, instructions directing the user to manually increase pressure in the inflatable probe.

4. The method of claim 3 further including automatically entering a ready period in response to detection of sufficient pressure in the inflatable probe, the ready period indicating that the user should be ready to begin the exercise routine.

5. The method of claim 1 further including determining an at-rest pressure prior to muscle contraction of the user and wherein displaying a pressure indicator associated with probe pressure on a display includes displaying only a pressure increase over the at-rest pressure.

6. The method of claim 1 further including storing an at-rest pressure in the probe prior to muscle contraction by the user, determining total pressure in the probe, and subtracting the at-rest pressure from the total pressure to obtain a pressure increase caused by the user'"'"'s muscle contraction.

7. The method of claim 1 wherein displaying a pressure indicator associated with probe pressure on a display includes displaying concentric geometric patterns and wherein each concentric geometric pattern represents a different pressure threshold associated with pressure in the probe.

8. The method of claim 1 wherein displaying a pressure indicator associated with probe pressure on a display includes displaying concentric curvilinear lines and wherein curvilinear lines with a smaller diameter are displayed in response to increased probe pressure.

9. The method of claim 1 further including automatically checking pressure in the probe while in an exercise mode of operation and if the pressure is below a predetermined threshold, requesting the user to manually increase pressure.

10. The method of claim 1 further including storing information associated with the exercise routine and providing a data port for downloading the information to an external computer.

11. A method for assisting a user through an exercise routine of the user'"'"'s pelvic floor muscles, comprising:

inserting an inflatable probe into an orifice of the user;

detecting a pressure applied to the probe by the user'"'"'s pelvic floor muscles;

displaying, on a display, a pressure indicator associated with pressure in the inflatable probe, the display having a graphical representation of muscles surrounding the probe including concentric geometric patterns, wherein each concentric geometric pattern represents a different pressure threshold associated with pressure in the probe.

12. The method of claim 11 further including changing a pressure scale associated with the pressure indicator on the display in response to user input.

13. The method of claim 11 further including displaying, on the display, instructions directing the user to manually increase pressure in the inflatable probe.

14. The method of claim 13 further including automatically entering a ready period in response to detection of sufficient pressure in the inflatable probe, the ready period indicating that the user should be ready to begin the exercise routine.

15. The method of claim 11 further including determining an at-rest pressure prior to muscle contraction of the user and wherein displaying a pressure indicator associated with probe pressure on a display includes displaying only a pressure increase over the at-rest pressure.

16. The method of claim 11 further including storing an at-rest pressure in the probe prior to muscle contraction by the user, determining total pressure in the probe, and subtracting the at-rest pressure from the total pressure to obtain the pressure increase caused by the user'"'"'s muscle contraction.

17. The method of claim 11 wherein displaying concentric geometric patterns includes displaying concentric curvilinear lines having predetermined diameters and wherein the curvilinear lines with a smaller diameter are displayed in response to increased probe pressure.

18. The method of claim 11 further including automatically checking pressure in the probe while in an exercise mode of operation and if the pressure is below a predetermined threshold, requesting the user to manually increase pressure.

19. The method of claim 11 further including storing information associated with the exercise routine and providing a data port for downloading the information to an external computer.

20. The method of claim 11 further including displaying alternating flexing and relaxation cycles for guiding the user through an exercise routine of the pelvic floor muscles wherein during the flexing cycle the display directs the user to flex the pelvic floor muscles and wherein during the relaxation cycle the display directs the user to relax the pelvic floor muscles.

21. The method of claim 11 further including automatically monitoring the pressure in the inflatable probe and terminating the exercise routine when the pressure in the probe is below a desired threshold.

22. The method of claim 11 further including providing a solo mode where in the inflatable probe is disabled and the method further includes displaying a fictitious pressure response to the user during the solo mode.

23. A method for assisting a user through an exercise routine of the user'"'"'s pelvic floor muscles, comprising:

inserting an inflatable probe into an orifice of the user;

detecting a pressure applied to the probe by the user'"'"'s pelvic floor muscles;

displaying, on a display, pressure information associated with the pressure detected in the probe caused by the flexing and relaxation of the user'"'"'s pelvic floor muscles;

monitoring the pressure in the probe an d automatically terminating the exercise routine when the pressure in the probe is below a desired threshold.

24. The method of claim 23 wherein displaying pressure information includes displaying a pressure indicator associated with pressure in the inflatable probe, the pressure indicator including a graphical representation of muscles surrounding the probe such that there is a physiological correspondence between the graphical representation of muscles on the display and muscle contraction by the user.