Medical probe for electro-stimulation and bio-feedback training of pelvic floor musculature

• US 8,983,627 B2
• Filed: 05/23/2007
• Issued: 03/17/2015
• Est. Priority Date: 05/23/2006
• Status: Active Grant

• Current Assignee: Novuqare Pelvic Health B.V.
• Original Assignee: Publiekrechtelijke Rechtspersoon Academisch Ziekenhuis Leiden H.O.D.N. Leids Universitair Medisch Centrum
• Inventors: Pelger, Robertus Coenraad Maria, Ouwerkerk, Theodorus Johannes, Voorham-van der Zalm, Pieternella Johanna
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Wu, Eugene
• Application Number:
  US12/302,145
• Publication Number:
  US 20090270963A1
• Time in Patent Office: 2,855 Days
• Field of Search: 607 39- 41, 607/138, 600/546
• US Class Current: 607/138
• CPC Class Codes: A61B 5/391 of genito-urinary organs
• CPC Class Codes: A61B 5/395 Details of stimulation, e.g. nerve stimulation to elicit EMG response
• CPC Class Codes: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61H 19/00 Massage for the genitals; Devices for improving sexual intercourse penis erection devices A61F5/41; vibration or percussion related aspects A61H23/00
• CPC Class Codes: A61H 19/44 Having substantially cylindrical shape, e.g. dildos
• CPC Class Codes: A61H 21/00 Massage devices for cavities of the body , e.g. nose, ears and anus for the genitals A61H19/00; Vibration or percussion related aspects A61H23/00
• CPC Class Codes: A61H 2205/085 Crotch
• CPC Class Codes: A61H 2205/086 Buttocks
• CPC Class Codes: A61H 2230/605 used as a control parameter for the apparatus
• CPC Class Codes: A61N 1/0509 Stomach and intestinal electrodes
• CPC Class Codes: A61N 1/0512 Anal electrodes
• CPC Class Codes: A61N 1/0524 Vaginal electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A63B 23/20 for vaginal muscles or other sphincter-type muscles

Abstract

A probe system for electro-stimulation and bio-feedback training of muscles in the pelvic floor region, in particular for pelvic floor physiotherapy and diagnosis, includes a probe having a probe body which is insertable into a vagina or a rectum, and a plurality of electrodes which are positioned at several locations along the length and around the circumference on the outer surface of the probe, the probe system further includes a control unit, operationally coupled to the probe, adapted for receiving EMG signals from each of the electrodes and for processing each of the signals for mapping the response of the muscles in the pelvic floor region.

Claims

1. A method for bio-feedback training of muscles in the pelvic floor region, or for pelvic floor physiotherapy using a probe system that comprises a probe having a probe body inserted into a vagina or a rectum, a plurality of uni-polar electrodes which are positioned at several locations along the length and around the circumference on the outer surface of said probe thereby defining an electrode matrix pattern, and a control unit operationally coupled to said probe and adapted for receiving absolute value electromyography (EMG) signals from each of said electrodes and for processing each of said absolute value EMG signals for mapping the response of the muscles in the pelvic floor region,

the method comprising the steps of:

determining muscle tension in the pelvic region based on the absolute value EMG signals measured with the electrodes;

providing bio feedback based on said muscle tension; and

repeating these steps in the bio-feedback training for pelvic floor physiotherapy.

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

calculating electric stimulus signals to be applied to the electrodes based on the determined muscular tensions from the absolute value EMG signals only, and

controlling the probe to apply the calculated electric stimulus signals to the electrodes causing at least one of contraction and relaxation of the muscles in the pelvic floor region.

3. A probe system for electro-stimulation and bio-feedback training of muscles in the pelvic floor region, or for pelvic floor physiotherapy and diagnosis, said probe system comprising:

a probe having a probe body which is insertable into a vagina or a rectum;

a plurality of uni-polar electrodes arranged in a matrix and which are positioned at several locations along the length and around the circumference on the outer surface of said probe, each electrode being configured to measure absolute value electromyography (EMG) measurements;

a control unit, operationally coupled to said probe, adapted for receiving absolute value EMG signals from each of said electrodes and for processing each of said absolute value EMG signals for mapping the response of the muscles in the pelvic floor region,

wherein the control unit is configured to;

determine muscle tension in the pelvic region based on absolute value measurement signal values measured with the electrodes,

provide bio-feedback based on said muscle tension, and

repeat these steps in a training for pelvic floor physiotherapy.

4. The probe system according to claim 3, wherein the control unit is further configured to:

calculate electric stimulus signals to be applied to the electrodes based on the determined muscular tensions, and

control the probe to apply the calculated electric stimulus signals to the electrodes causing at least one of contraction and relaxation of the muscles in the pelvic floor region.

5. A computer program product embodied in a non-transitory tangible medium which, when working on the control unit for controlling the probe system according to claim 3, configures said control unit to:

control the uni-polar electrodes for obtaining measurement signal values;

read the electric signals from each of said uni-polar electrodes;

calculate the muscular tension in the muscles in said pelvic floor region from said electric signals; and

provide bio-feedback based on the determined muscular tension.

6. The computer program product according to claim 5, wherein the program further configures the control unit to:

calculate the electric stimulus signals to be applied to each of the electrodes; and

control said probe to apply said calculated electric stimulus signals to respective said electrodes.

7. A probe system for electro-stimulation and bio-feedback training of muscles in the pelvic floor region, in particular for pelvic floor physiotherapy and diagnosis, said probe system comprising:

a probe having a probe body which is insertable into a vagina or a rectum, and a plurality of uni-polar surface electrodes which are positioned, in a matrix, at several locations along the length and around the circumference on the outer surface of said probe, the probe being configured to measure absolute value electromyography (EMG) electrode measurements;

a control unit, operationally coupled to said probe, adapted for receiving only absolute value EMG signals from each of said electrodes and for processing each of the absolute value EMG signals for mapping the response of the muscles in the pelvic floor region,

wherein the control unit is configured to;

(1) determine the absolute value electric signals from muscles or nerves in the pelvic floor region using the uni-polar electrodes,

(2) determine muscular tension of the muscles in the pelvic floor region from the determined absolute value electric signals,

(3) calculate electric stimulus signals to be applied to the electrodes based on the determined muscular tensions,

(4) control the probe to apply the calculated electric stimulus signals to the electrodes causing at least one of contraction and relaxation of the muscles in the pelvic floor region, and

(5) provide bio-feedback on the determined muscular tension,

wherein the control unit is configured to control the uni-polar electrodes for obtaining electrical signals providing measurement of the absolute values.

8. The probe system of claim 7, wherein said electrodes comprise patch-shaped electrodes, located on said outer surface in a regular matrix pattern, wherein said electrodes are grouped in several rings on said surface around said probe and are grouped in several longitudinal rows on said surface of said probe, and wherein the distance between adjacent electrodes in said rings and rows is similar to or larger than the size of the electrodes measured in the same direction and wherein each ring of electrodes is separately usable and/or wherein each row of electrodes is separately usable.

9. The probe system according to claim 8, wherein said electrodes have an electrode surface and said probe body comprises non-conductive material between said electrodes, the electrode surfaces extending above the surface of the probe body, wherein said probe is substantially rod shaped and has a rounded tip, free of electrodes.

10. The probe system of claim 9, wherein the electrodes have a convex surface.

11. The probe according to claim 7, wherein said probe further comprises a stop surface for setting the insertion depth of the probe.

12. The probe of claim 11, wherein said probe further comprises a fixation means for fixing an inserted position of the probe in use.

13. The probe according to claim 7, wherein each electrode is wire-coupled to said control unit.

14. The probe according to claim 13, wherein said wires exit said probe at a rear side of said probe.

15. The probe according to claim 7, wherein said control unit comprises an activation unit for applying the electric stimulus signals to said electrodes for influencing selected muscles, nerves, or part of said selected muscles or nerves, in said pelvic floor region.

16. The probe according to claim 15, wherein said control unit comprises a measurement unit for obtaining measurement signals from said electrodes, and wherein said activation unit is adapted for applying electric stimulus signals based upon measurement signals from said measurement unit.

17. The probe system of claim 7, wherein said electrodes comprise patch-shaped electrodes.

18. The probe system according to claim 7, wherein said electrodes are located on said outer surface in a regular matrix pattern.

19. The probe system according to claim 7, wherein said electrodes are grouped in several rings on said surface around said probe.

20. The probe system according to claim 7, wherein said electrodes are grouped in several longitudinal rows on said surface of said probe.

21. The probe system according to claim 7, wherein said electrodes are grouped into at least 6 groups, each of at least 4 electrodes in a ring.

22. The probe system according to claim 7, wherein said electrodes are grouped in several longitudinal rows on said surface of said probe and wherein each row of electrodes is configured to be activated separately.

23. The probe system according to claim 7, wherein said electrodes are grouped in several rings on said surface around said probe and wherein each ring of electrodes is configured to be separately usable.

24. The probe system according to claim 7, wherein said electrodes have a stainless steel electrode surface.

25. The probe system according to claim 7, wherein said probe body comprises non-conductive material.

26. The probe system according to claim 7, wherein said probe is substantially rod shaped.

27. The probe system according to claim 7, wherein the probe body is substantially cylindrical having a diameter between 1 and 2 cm.

28. The probe system according to claim 7, wherein said probe has a rounded tip.

29. The probe according to claim 7, wherein said location of each electrode on said probe is stored in said control unit.

30. The probe according to claim 7, wherein said control unit is adapted for measuring signals from each electrode separately.

31. The probe system according to claim 7, further comprising a bio feedback representation device.

32. A method for electro-stimulation and bio-feedback training of muscles in the pelvic floor region, or for pelvic floor physiotherapy and diagnosis, using the probe system according to claim 7, comprising the steps of:

determining the electromyography (EMG) signals from the muscles or nerves in the pelvic floor region using said electrodes, wherein the electric signals are determined by using the electrodes as uni-polar electrodes;

determining the muscular tension of the muscles in the pelvic floor region from the determined EMG signals only;

calculating the electric stimulus signals to be applied to each of the electrodes based on the determined muscular tension;

controlling said probe to apply said calculated electric stimulus signals to said electrodes; and

providing bio-feedback based on the determined muscle tension.

33. A computer program product embodied in a tangible non-transitory medium which, when working on the control unit for controlling the probe system according to claim 7, causes said control unit to perform the step of:

controlling said electrodes as uni-polar electrodes for obtaining measurement signal values;

reading the electromyography (EMG) signals from each of said electrodes, said electrodes being configured to measure absolute value EMG measurements;

calculating the muscular tension in the muscles in said pelvic floor region from said absolute value EMG signals;

calculating the electric stimulus signals to be applied to each of the electrodes;

controlling said probe to apply said calculated electric stimulus signals to respective said electrodes; and

providing bio-feedback based on the determined muscle tension.