Perineometer with wireless biofeedback

• US 20060036188A1
• Filed: 11/08/2005
• Published: 02/16/2006
• Est. Priority Date: 11/08/2005
• Status: Active Grant

• Current Assignee: Anatasol, LLC
• Original Assignee: Anatosol LLC
• Inventors: Hoffman, Gerry M., Hoffman, Craig A., England, Michael John
• Granted Patent: US 7,645,220 B2
• Time in Patent Office: Days
• US Class Current: 600/591
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/227 of constricting muscles, i.e. sphincters
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: A63B 2071/0625 Emitting sound, noise or music
• CPC Class Codes: A63B 2220/51 Force
• CPC Class Codes: A63B 23/20 for vaginal muscles or other sphincter-type muscles
• CPC Class Codes: Y10S 128/905 Feedback to patient of biological signal other than brain electric signal

Abstract

A perineometer for home or clinical use assesses the strength of pelvic floor muscles and provides audible and visual biofeedback signals as training aids during pelvic exercises. Impedance signals proportional to vaginal contraction pressure forces are developed by a transducer sleeve that is mounted on a vaginal probe. A battery-powered RF transmitter module contained within the probe transmits wireless impedance signals to hand-held receiver equipped with an audio-visual display monitor. The probe reacts the pelvic contraction forces and thus provides a direct tactile feedback signal that is used in combination with audible and visual feedback signals for improving the endurance and strength of pelvic floor muscles.

Claims

1. A probe receivable within a pelvic cavity for sensing contraction pressure applied by pelvic floor muscles, comprising:

a shaft having an external sidewall surface;

a transducer having a sensing body overlapping the external sidewall surface, the sensing body including a variable impedance element capable of exhibiting a change in electrical impedance in response to pelvic floor muscle contractions against the sensing body; and

a signal processor circuit electrically coupled to the variable impedance element for producing a feedback signal in response to the electrical impedance.

2. A probe according to claim 1, wherein the sensing body comprises an annular sleeve mounted around the external sidewall surface, and the variable impedance element is substantially coextensive in surface area with the annular sleeve.

3. A probe according to claim 1, wherein the sensing body is an annular sleeve mounted around the external sidewall surface, and the variable impedance element comprises multiple transducer strips disposed in the annular sleeve, the transducer strips extending along the length of the shaft and angularly spaced from each other.

4. A probe according to claim 1, wherein the sensing body is an annular sleeve mounted around the external sidewall surface of the shaft, and the variable impedance element comprises multiple transducer bands disposed in the annular sleeve, the transducer bands extending around the external sidewall surface and axially spaced from each other along the length of the external sidewall surface.

5. A probe according to claim 1, wherein the sensing body comprises an continuous transducer strip extending in a spiral wrap pattern around the external sidewall surface of the shaft, and the variable impedance element is substantially coextensive in surface area with the transducer strip.

6. A probe according to claim 1, wherein the sensing body is an annular sleeve mounted around the external sidewall surface of the shaft, and the variable impedance element comprises multiple transducer patches disposed in the annular sleeve and arranged in a grid array extending around the annular sleeve and along the length of the annular sleeve.

7. A probe according to claim 1, wherein the sensing body comprises a compressible body of dielectric, insulating or weakly conductive polymer composition containing a dispersed matrix of particles of at least one strongly conductive material selected from the group consisting of metals, alloys and reduced metal oxides, and first and second conductive electrodes disposed in electrical contact with the compressible body of polymer composition.

8. A probe according to claim 1, wherein the sensing body comprises first and second textile form conductive electrodes and a textile form variable resistance element disposed in electrical contact with the textile form conductive electrodes.

9. A probe according to claim 1, wherein the variable impedance element comprises a polymer composition that exhibits quantum tunneling conductance when deformed.

10. A probe according to claim 1, wherein the sensing body comprises a multi-layer, flexible laminate of a first layer of a dielectric or non-conductive sheet material, a second layer of dielectric or non-conductive sheet material, and intermediate layer of a polymeric piezoelectric material having metallized conductive coating layers on either side thereof disposed between the first and second non-conductive layers.

11. A probe according to claim 1, the probe comprising a probe body having an enlarged head portion adapted to seat within an area of a pelvic cavity and having a proximal shaft portion for seating at the introitus of the pelvic cavity, and the sensing body is disposed intermediate to the proximal shaft portion and the head portion.

12. A probe according to claim 1, wherein the shaft portion has an external surface for reacting compression forces applied by pelvic muscle contractions, and the sensing body is substantially coextensive in length and overlaps a substantial portion of the shaft reaction surface.

13. A probe according to claim 1, wherein the probe comprises:

a probe body having a head portion adapted to seat within an area of a pelvic cavity and a handle extending from the shaft portion to enable the probe body to be manually inserted into and withdrawn from the pelvic cavity; and

the sensing body is fitted in overlapping relation about the shaft portion intermediate the handle and head portion.

14. A probe according to claim 1, the probe member comprising:

a probe body having an enlarged head portion adapted to seat within a pelvic cavity and having a shaft portion attached to the head portion and adapted to seat at the introitus of the pelvic cavity, wherein the enlarged head portion is characterized by a first surface that transitions from the shaft along an outwardly flared profile to a rim, and by a second surface that transitions from the rim along an inwardly tapered profile.

15. A probe according to claim 1, wherein:

the shaft portion is intersected by a longitudinal pocket; and

the signal processor circuit is contained within the longitudinal pocket.

16. A probe according to claim 1, wherein the probe comprises a handle portion and a head portion, and the shaft portion is disposed between the handle portion and the head portion.

17. A probe according to claim 1, wherein the signal processor circuit comprising:

a wireless RF transmitter assembly contained within the shaft portion; and

a DC battery is contained within the probe for supplying electrical operating current to the wireless RF transmitter;

18. A probe according to claim 1, wherein:

the probe comprises a handle portion attached to the shaft portion;

the shaft portion is intersected by a pocket and a wireless RF transmitter module is disposed within the pocket;

a DC battery is disposed within the pocket for electrical contact engagement with the transmitter module;

a spring is interposed between the DC battery and the transmitter module for urging the transmitter module for movement away from electrical contact engagement with the DC battery; and

the handle is disposed in threaded engagement with the shaft portion and is engagable with the transmitter module for moving the transmitter module axially through the pocket against the bias of the spring and thereby moving the transmitter module into and out of electrical contact engagement with the battery in response to clockwise and counter-clockwise rotation of the handle relative to the shaft, respectively.

19. A probe according to claim 1, wherein:

the probe comprises a handle portion attached to the shaft portion;

the shaft portion is intersected by a pocket and a wireless RF transmitter module is disposed within the pocket, the transmitter module including an RF signal output terminal;

an antenna is disposed within the handle portion, and the antenna includes an RF signal input terminal;

a spring is interposed between the shaft and the transmitter module for urging the transmitter module for axial movement through the pocket into electrical contact engagement with the RF signal input terminal; and

the handle is disposed in threaded engagement with the shaft portion and is engagable with the transmitter module for moving the transmitter module axially through the pocket against the bias of the spring in response to rotation of the handle relative to the shaft and thereby maintaining the RF signal output terminal of the transmitter module in signal contact engagement with the RF signal input terminal of the antenna.

20. A probe receivable within a pelvic cavity for sensing contraction pressure applied by pelvic floor muscles against the probe, comprising:

a shaft portion that is intersected by a pocket;

a transducer sleeve disposed around the shaft portion, the transducer sleeve including a variable impedance element capable of exhibiting a change in electrical impedance in response to pressure forces applied to the transducer sleeve; and

an electronic circuit module enclosed within the pocket and electrically coupled to the variable impedance element for transmitting wireless feedback signals in response to pelvic contraction forces applied to the transducer sleeve.

21. A probe receivable within a pelvic cavity for sensing contraction pressure applied by pelvic floor muscles against the probe, comprising:

a probe body having a head portion adapted to seat within an area of a pelvic cavity and having a shaft portion adapted to seat at the introitus of the pelvic cavity;

the shaft portion having a pocket for receiving an electronic circuit module and a DC battery for supplying DC operating power;

a handle attached to the shaft portion;

a transducer sleeve fitted in overlapping relation about the-shaft portion intermediate the closure cap and the head portion, the transducer sleeve including a variable impedance element capable of exhibiting a change in electrical impedance in response to pelvic contraction forces applied to the transducer sleeve; and

an electronic circuit module enclosed within the pocket and electrically coupled to the variable impedance element, the electronic circuit module including an RF transmitter for transmitting wireless feedback signals in response to contraction forces applied to the transducer sleeve.

22. A system for training a patient'"'"'s pelvic floor muscles, comprising In combination:

a probe receivable within a patient'"'"'s pelvic cavity for engaging pelvic floor muscles, the probe supporting a transducer capable of exhibiting a change in electrical impedance in response to pelvic muscle contractions against the transducer;

a signal processor circuit contained in the probe and electrically coupled to the transducer for transmitting a wireless radio frequency signal containing feedback information related to the electrical impedance of the transducer; and

a portable monitor including a radio frequency receiver for receiving the wireless signal and an indicator device coupled to the receiver for displaying a visual representation of feedback information contained in the wireless signal.

23. A system for exercising and training a patient'"'"'s pelvic floor muscles according to claim 22, the indicator display device including:

visual display apparatus for displaying an alphanumeric data representation of feedback information contained in the wireless signal.

24. A system for exercising and training a patient'"'"'s pelvic floor muscles according to claim 22, the indicator display device including:

visual display apparatus for displaying a visual graphic representation of feedback information contained in the wireless signal.

25. A system for exercising and training a patient'"'"'s pelvic floor muscles according to claim 22, the indicator device including:

audio reproduction apparatus for sounding an audible signal that corresponds to feedback information contained in the wireless signal.

26. A probe receivable within a pelvic cavity for sensing contraction pressure applied by pelvic floor muscles against the probe, comprising:

a shaft portion that is intersected by a pocket;

an air bladder disposed around the shaft portion;

an air pressure transducer assembly disposed within the pocket, the air pressure transducer assembly including a sensor element capable of exhibiting a change in electrical impedance in response to compression forces applied to the sensor element, and having a pneumatic input connected in fluid communication with the air bladder and an electrical output for conducting electrical impedance signals proportional to air pressure in the air bladder; and

an electronic circuit module enclosed within the pocket and electrically coupled to the output of the transducer assembly for transmitting wireless feedback signals in response to pelvic contraction forces applied to the air bladder.

27. A probe according to claim 26, the transducer assembly comprising:

a piezoelectric sensor element capable of exhibiting a change in electrical impedance in response to compression applied to the sensor element; and

an air pressure transducer including an air pressure chamber coupled in fluid communication with the air bladder and a deflectable membrane mechanically coupled to the piezoelectric sensor element.

28. A probe according to claim 26, wherein the air bladder comprises a resilient rubber material having a sidewall thickness in the range of 4 mils-6 mils.

29. A probe according to claim 26, wherein the air bladder comprises a seamless, medical grade low-modulus, non-latex, soft nitrile composition.

30. A probe according to claim 26, including a check valve disposed within the pocket and coupled in fluid communication with the air bladder.

31. A method of exercising and training the pelvic floor muscles of a patient comprising the steps:

providing a probe having a transducer capable of exhibiting a change in electrical impedance in response to pelvic contractions applied to the transducer;

inserting the probe into a pelvic cavity;

contracting the patient'"'"'s pelvic muscles against the transducer;

transmitting a wireless radio frequency signal containing feedback information related to the electrical impedance of the transducer;

producing a tactile feedback signal in response to the pelvic contractions;

communicating the tactile feedback signal directly to the patient via transmission of reaction forces through pelvic muscles engaged by the probe;

communicating the wireless radio frequency signal to a portable monitor; and

displaying a visual representation of feedback information contained in the wireless signal on the portable monitor so that it can be observed by the patient during a training exercise.

32. A method of exercising and training pelvic floor muscles according to claim 31, further comprising the step:

sensing the tactile feedback signal by the patient while the patient is observing the visual waveform display on the portable monitor.