Perineometer with wireless biofeedback

• US 7,645,220 B2
• Filed: 11/08/2005
• Issued: 01/12/2010
• Est. Priority Date: 11/08/2005
• Status: Active Grant

• Current Assignee: Anatasol, LLC
• Original Assignee: Anatasol, LLC
• Inventors: England, Michael John, Hoffman, Gerry M., Hoffman, Craig A.
• Primary Examiner(s): BAKER, LORI LYNN
• Application Number:
  US11/268,923
• Publication Number:
  US 20060036188A1
• Time in Patent Office: 1,526 Days
• Field of Search: 482/148, 482112-113, 600/29, 600/46, 600/410, 600/30, 600/38, 600/591, 600/45, 128/905, 128/903, 733/790.1, 733/790.8, 607/138
• US Class Current: 482/148
• 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 a 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:

an elongated shaft having an external surface portion;

a transducer including a distributed sensing arrangement provided by a sensing body extending lengthwise and circumferentially in overlapping relation along the external surface portion of the shaft;

the sensing body including a plurality of variable impedance elements capable of exhibiting a change in electrical impedance in response to pelvic floor muscle contractions against the sensing body, the variable impedance elements being distributed around and lengthwise along a portion of the sensing body;

a dielectric insulating material forming a portion of the sensing body and being disposed between the pelvic cavity and the plurality of variable impedance elements, such that the variable impedance elements are disposed at an external surface of the sensing body; and

a signal processor circuit disposed in the probe and electrically coupled to the variable impedance elements for producing a feedback signal in response to the electrical impedance exhibited by the variable impedance elements.

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

3. A probe according to claim 1, wherein the variable impedance elements comprise a polymer composition that exhibits quantum tunneling conductance when deformed.

4. 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.

5. A probe according to claim 1, the probe comprising distal shaft portion having an enlarged head portion adapted to seat within a pelvic cavity and having a proximal shaft portion adapted 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.

6. A probe according to claim 1, wherein the shaft has an external reaction 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.

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

a probe body having a head portion adapted to seat within a pelvic cavity and a handle extending from the shaft 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 intermediate the handle and head portion.

8. A probe according to claim 1, the probe 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 portion along an outwardly flared profile to a rim, and by a second surface that transitions from the rim along an inwardly tapered profile.

9. A probe according to claim 1, wherein:

the shaft is intersected by a longitudinal pocket; and

the signal processor circuit is contained within the longitudinal pocket.

10. 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.

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

a wireless RF transmitter assembly contained within the probe; and

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

12. A probe according to claim 1, wherein the probe comprises a handle portion attached to the shaft;

the shaft 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 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.

13. A probe according to claim 1, wherein:

the probe comprises a handle portion attached to the shaft;

the shaft 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 on 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 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 according to claim 1, wherein the variable impedance elements comprise a quantum tunneling composition.

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

a shaft that is intersected by a pocket;

a transducer sleeve extending circumferentially and lengthwise in overlapping relation around and along the shaft, 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, the variable impedance element being distributed around and lengthwise through the transducer sleeve to provide a distributed sensing arrangement;

a dielectric insulating material associated with the transducer sleeve, the dielectric insulating material disposed between the pelvic cavity and the variable impedance element such that the variable impedance element is disposed at an external surface of the transducer sleeve; and

an electronic circuit module disposed in 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.

15. 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 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 transducer sleeve extending circumferentially and lengthwise in overlapping relation around and along 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, the variable impedance element being distributed around and lengthwise through the transducer sleeve to provide a distributed sensing arrangement;

a dielectric insulating material associated with the transducer sleeve, the dielectric insulating material disposed between the pelvic cavity and the variable impedance element such that the variable impedance element is disposed at an external surface of 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.

16. Apparatus 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 including a shaft and a sensing transducer extending lengthwise and circumferentially in overlapping relation along the shaft, and the sensing transducer including a variable impedance element capable of exhibiting a change in electrical impedance in response to pelvic floor muscle contractions applied against the sensing transducer, the variable impedance element being distributed around and lengthwise through the transducer sleeve to provide a distributed sensing arrangement;

a dielectric insulating material associated with the transducer sleeve, the dielectric insulating material disposed between the pelvic cavity and the variable impedance element such that the variable impedance element is disposed at an external surface of the transducer sleeve;

a signal processor circuit contained in the probe and electrically coupled to the sensing 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 producing a feedback signal in response to information contained in the wireless signal and in a format that can be observed or heard by a patient while a training exercise is underway.

17. Apparatus for exercising and training a patient'"'"'s pelvic floor muscles according to claim 16, the indicator display device including:

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

18. Apparatus for exercising and training a patient'"'"'s pelvic floor muscles according to claim 16, the indicator display device including:

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

19. Apparatus for exercising and training a patient'"'"'s pelvic floor muscles according to claim 16, the indicator device including:

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