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

• US 9,656,067 B2
• Filed: 02/12/2015
• Issued: 05/23/2017
• 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): Wu, Eugene T
• Application Number:
  US14/620,277
• Publication Number:
  US 20150151122A1
• Time in Patent Office: 831 Days
• 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 probe system, comprising:

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

a plurality of electrodes which are positioned at several locations along a length and around a circumference on an outer surface of said probe; and

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

wherein

the probe system is configured for electro-stimulation of muscles in a pelvic floor region, and/or for pelvic floor physiotherapy and diagnosis, and

said electrodes are operably coupled to the control unit and are configured for being operated as unipolar electrodes for detecting EMG unipolar signals and applying at least one electrical signal to a muscular layer.

2. The probe according to claim 1, wherein said probe further comprises a stop surface for setting the insertion depth of the probe, wherein the stop surface has an adjustable position on the probe.

3. The probe of claim 2, wherein said probe further comprises a fixation means for fixing the probe'"'"'s inserted position in use, wherein said probe comprises a disk which is slidable over the probe along the probe'"'"'s rotational axis.

4. The probe according to claim 1, wherein said probe further comprises a stop surface for setting the insertion depth of the probe.

5. The probe of claim 4, wherein said probe further comprises a fixation means for fixing the probe'"'"'s inserted position in use.

6. The probe according to claim 1, wherein each electrode is wire-coupled to said control unit.

7. The probe according to claim 6, wherein the probe body has a front side and a rear side, and said wires exit said probe at the rear side of said probe.

8. The probe according to claim 1, wherein said control unit comprises a measurement unit for obtaining measurement signals from said electrodes.

9. The probe according to claim 8, wherein said measurement unit is adapted for measuring signals from each electrode separately.

10. The probe according to claim 1, wherein said control unit comprises an activation unit for applying electrical signals on said electrodes for influencing selected muscles, nerves, or part of said selected muscles or nerves, in said pelvic floor region.

11. The probe according to claim 10, wherein said activation unit is adapted for applying electric signals based upon measurement signals from a measurement unit of the system.

12. The probe system of claim 1, wherein said electrodes comprise patch-shaped electrodes.

13. The probe system according to claim 1, wherein said electrodes are located on said outer surface in a regular matrix pattern.

14. The probe system according to claim 1, wherein said electrodes are grouped in a plurality of rings on said surface around said probe.

15. The probe system according to claim 1, wherein said electrodes are grouped in a plurality of longitudinal rows on said surface of said probe.

16. The probe system according to claim 1, wherein said electrodes are grouped into at least 6 groups of at least 4 electrodes each, the electrodes of each group being functionally coupled through said control unit, wherein each group of electrodes is configured to be separately usable.

17. The probe system according to claim 1, wherein said electrodes are grouped in a plurality of longitudinal rows on said surface of said probe and wherein each row of electrodes is configured to be separately usable.

18. The probe system according to claim 1, wherein said electrodes are grouped in a plurality of rings on said surface around said probe and wherein each ring of electrodes is configured to be separately usable.

19. The probe system according to claim 1, wherein said electrodes have a stainless steel electrode surface.

20. The probe system according to claim 1, wherein said probe body comprises non-conductive material, or synthetic material which is bio-compatible.

21. The probe system according to claim 1, wherein said probe is substantially rod shaped, or said probe substantially is a rigid rod.

22. The probe system according to claim 1, wherein said probe has a rounded tip.

23. The probe according to claim 1, wherein the location of each electrode on said probe is stored in said control unit.

26. A method for electro-stimulation and bio-feedback training using the probe system according to claim 1, comprising the steps of:

determining electric signals from muscles or nerves in the pelvic floor region using said electrodes; and

based upon said determined electric signals, applying electric signals to said electrodes for causing contraction and/or relaxation of muscles or part of these muscles in the pelvic floor region.

27. The method according to claim 26, wherein the step of determining electric signals comprises:

measuring electric signals from muscles or nerves in the pelvic floor region using said electrodes;

determining muscular tension of said muscles in the pelvic floor region from said measured electric signals; and

wherein the step of applying electric signals based upon said determined electric signals comprises;

based upon said determined muscular tension, applying electric signals to said electrodes for causing contraction and/or relaxation of selected muscles or part of said muscles in said pelvic floor region.

24. A probe system for electrostimulation and 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, at several locations along the length and around the circumference on an 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 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,

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

25. The probe system of claim 24, wherein the control unit is further configured to provide bio-feedback on the determined muscular tension.