Devices and methods for monitoring female arousal

• US 6,169,914 B1
• Filed: 01/13/1999
• Issued: 01/02/2001
• Est. Priority Date: 01/13/1998
• Status: Expired due to Fees

• Current Assignee: Urometrics Incorporated
• Original Assignee: Urometrics Incorporated
• Inventors: Knoll, L. Dean, Hovland, Claire T., Abrams, Jerome H., Olson, Curtis E.
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US09/229,735
• Time in Patent Office: 720 Days
• Field of Search: 600/310, 600/322, 600/323, 600/324, 600/325, 600/340, 600/341, 600/345, 600/437, 600/454, 600/455, 600/456, 600/459, 600/465
• US Class Current: 600/340
• CPC Class Codes: A61B 10/0012 Ovulation-period determination for animals A61D17/002
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/4368 Sexual arousal evaluation
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00

Abstract

Devices and methods according to embodiments of the invention measure physiological changes that occur in the female during sexual arousal. These include changes in clitoral, vaginal-artery, and/or vaginal-capillary blood flow, clitoral engorgement, and bioimpedance, to name a few. Feedback devices and methods assist a patient or medical professional to determine when arousal occurs and what its best triggers are for a particular patient. Overnight arousal-event monitoring, or other continuous monitoring over extended periods of time, either at home or away from home, allows diagnosis of vasculogenic impairment or other problems. The effects of medicinal therapies aimed at female sexual dysfunction can be quantified and used to titrate proper dosages. Embodiments of the invention provide objective, quantifiable measures of multiple physiological variables associated with female arousal, in a manner heretofore unseen in the prior art.

Claims

1. A measurement device, comprising:

at least one sensing element constructed for placement in proximity to at least one female anatomical structure, the at least one female anatomical structure being selected from the group consisting of the vagina and the clitoris, the at least one sensing element being constructed to produce first data signals;

a housing constructed for supporting the at least one sensing element in a substantially fixed relationship with respect to at least one blood vessel within the female anatomical structure, the at least one blood vessel including the clitoral cavernosal artery, such that the first data signals are related to a blood parameter associated with the clitoral cavernosal artery; and

control electronics operably coupled with the at least one sensing element to receive the first data signals.

2. The device of claim 1, wherein the at least one sensing element comprises an ultrasound transducer.

3. The device of claim 2, further comprising an ultrasound standoff in close proximity to the ultrasound transducer, the ultrasound standoff being constructed for passage of ultrasound energy, the ultrasound standoff further being constructed for application to the female clitoris.

4. The device of claim 2, wherein the control electronics process the first data signals to generate second data signals representing clitoral cavernosal artery blood velocity.

5. The device of claim 4, wherein the control electronics additionally process the first data signals to generate third data signals representing clitoral diameter or cavernosal artery diameter.

6. The device of claim 2, wherein the housing comprises an elongate shaft constructed for insertion into the vagina, the ultrasound transducer being disposed at a distal end of the elongate shaft.

7. The device of claim 6, wherein the at least one sensing element comprises a plurality of ultrasound transducers.

8. The device of claim 7, wherein the plurality of ultrasound transducers are disposed on the elongate shaft so as to aim toward both vaginal arteries of the female.

9. The device of claim 8, wherein the plurality of ultrasound transducers are supported for movement relative to the elongate shaft substantially about a longitudinal axis of the elongate shaft.

10. The device of claim 7, further comprising an adjustable housing portion constructed for supporting one of the plurality of ultrasound transducers, the adjustable housing portion being coupled with the elongate shaft to adjust the distance between the elongate shaft and the ultrasound transducer supported by the adjustable housing portion.

11. The device of claim 10, wherein the adjustable housing portion is pivotally connected to the elongate shaft.

12. The device of claim 10, wherein the plurality of ultrasound transducers comprises three ultrasound transducers, a first of the three ultrasound transducers disposed for taking measurements from one vaginal artery, a second of the three ultrasound transducers disposed for taking measurements from the second vaginal artery, and a third of three ultrasound transducers disposed for taking measurements from the clitoral cavernosal artery.

13. The device of claim 1, wherein the control electronics comprise a memory for storing data based on the first data signals.

14. The device of claim 1, further comprising a display constructed to continuously receive data signals from the control electronics for monitoring sexual arousal of the female.

15. The device of claim 1, wherein the at least one sensing element comprises a plurality of electrodes, further wherein the control electronics process the first data signals to produce second data signals that represent blood-volume changes in the female vaginal wall, the labia, and/or the clitoris.

16. The device of claim 15, wherein at least two of the plurality of electrodes are both secured to one adhesive strip.

17. The device of claim 15, further comprising an insertion mechanism on which at least two of the plurality of electrodes are disposed, wherein the plurality of electrodes additionally comprise at least two subumbilical electrodes;

further wherein the first data signals are generated when the insertion mechanism is inserted into the vagina and when the at least two subumbilical electrodes are positioned subumbilically on the patient.

18. The device of claim 15, wherein the housing comprises a vaginal-pressure measurement device for generating vaginal-pressure data signals.

19. The device of claim 18, wherein the vaginal-pressure measurement device comprises a flexible outer material defining a hollowed-out inner portion filled with a fluid.

20. The device of claim 15, wherein the control electronics detect a cardiac signature in an impedance waveform derived at least in part from the first data signals, the control electronics generating third data signals representing the cardiac signature data.

21. A measurement device, comprising:

at least one oximeter probe constructed for placement in proximity to the vaginal wall of a female subject, the at least one oximeter probe generating first data signals;

a housing constructed for supporting the at least one oximeter probe in close association with the vaginal wall; and

control electronics for receiving the first data signals and generating second data signals representing at least one of vaginal blood volume and vaginal pulse amplitude.

22. The device of claim 21, wherein the housing comprises a probe-supporting portion and a neck portion connected thereto, the probe-supporting portion being of wider dimension that the neck portion.

23. The device of claim 21, wherein the control electronics generate third data signals representing oxygenation level of the hemoglobin in the capillaries of the vaginal wall, the device further comprising a display for receiving the third data signals and displaying the oxygenation level as an SpO₂ variable.

24. The device of claim 21, further comprising at least one photoplethysmographic probe supported by the housing and operably coupled with the control electronics.

25. The device of claim 24, further comprising an audio feedback device for receiving the second data signals, the audio feedback device generating an audible sound that is a function of the vaginal pulse amplitude.

26. The device of claim 21, further comprising at least one electrode supported by the housing for generating data signals related to a vaginal parameter, the control electronics receiving the vaginal-parameter data signals.

27. The device of claim 26, wherein the vaginal parameter is selected from the group consisting of pH, bioimpedance, and temperature.

28. The device of claim 21, further comprising a pressure balloon operably coupled with a pressure source, the pressure balloon being disposed so as to urge the oximeter probe toward the vaginal wall with a desired pressure.

29. The device of claim 28, further comprising an automatic pressure-regulation mechanism, operably coupled with the pressure balloon and the control electronics, for automatically maintaining the contact pressure between the vaginal wall and the oximeter probe.

30. A measurement device, comprising:

sensing means for producing first data signals, the sensing means being constructed for placement in proximity to at least one female anatomical structure, the at least one female anatomical structure being selected from the group consisting of the vagina and the clitoris;

means for supporting the sensing means in a substantially fixed relationship with respect to at least one blood vessel within the female anatomical structure, such that the first data signals are related to a blood parameter associated with the at least one blood vessel, the at least one blood vessel including the clitoral cavernosal artery; and

means, operably coupled with the sensing means, for receiving the first data signals.

31. A measurement device, comprising:

at least one sensing element constructed for placement in proximity to at least one female anatomical structure, the at least one female anatomical structure being selected from the group consisting of the vagina and the clitoris, the at least one sensing element being constructed to produce first data signals;

a housing constructed for supporting the at least one sensing element in a substantially fixed relationship with respect to at least one blood vessel within the female anatomical structure, the at least one blood vessel being selected from the group consisting of the vaginal artery and the clitoral cavernosal artery, such that the first data signals are related to a blood parameter associated with the at least one blood vessel; and

control electronics operably coupled with the at least one sensing element to receive the first data signals;

wherein the at least one sensing element comprises an ultrasound transducer;

further wherein the control electronics process the first data signals to generate second data signals representing clitoral cavernosal artery blood velocity.

32. A measurement device, comprising:

at least one sensing element constructed for placement in proximity to at least one female anatomical structure, the at least one female anatomical structure being selected from the group consisting of the vagina and the clitoris, the at least one sensing element being constructed to produce first data signals, wherein the at least one sensing element comprises a plurality of ultrasound transducers;

a housing constructed for supporting the at least one sensing element in a substantially fixed relationship with respect to at least one blood vessel within the female anatomical structure, the at least one blood vessel being selected from the group consisting of the vaginal artery and the clitoral cavernosal artery, such that the first data signals are related to a blood parameter associated with the at least one blood vessel, wherein the housing comprises an elongate shaft constructed for insertion into the vagina, at least one of the plurality of ultrasound transducers being disposed at a distal end of the elongate shaft;

control electronics operably coupled with the at least one sensing element to receive the first data signals; and

an adjustable housing portion constructed for supporting one of the plurality of ultrasound transducers, the adjustable housing portion being coupled with the elongate shaft to adjust the distance between the elongate shaft and the ultrasound transducer supported by the adjustable housing portion;

wherein the plurality of ultrasound transducers comprises three ultrasound transducers, a first of the three ultrasound transducers disposed for taking measurements from one vaginal artery, a second of the three ultrasound transducers disposed for taking measurements from the second vaginal artery, and a third of three ultrasound transducers disposed for taking measurements from the clitoral cavernosal artery.

33. A measurement device, comprising:

at least one sensing element constructed for placement in proximity to at least one female anatomical structure, the at least one female anatomical structure being selected from the group consisting of the vagina and the clitoris, the at least one sensing element being constructed to produce first data signals;

a housing constructed for supporting the at least one sensing element in a substantially fixed relationship with respect to at least one blood vessel within the female anatomical structure, the at least one blood vessel being selected from the group consisting of the vaginal artery and the clitoral cavernosal artery, such that the first data signals are related to a blood parameter associated with the at least one blood vessel; and

control electronics operably coupled with the at least one sensing element to receive the first data signals;

wherein the at least one sensing element comprises a plurality of electrodes, further wherein the control electronics process the first data signals to produce second data signals that represent blood-volume changes in the female vaginal wall, the labia, and/or the clitoris.

34. A measurement device, comprising:

at least one oximeter probe constructed for placement in proximity to the vaginal wall of a female subject, the at least one oximeter probe generating first data signals;

a housing constructed for supporting the at least one oximeter probe in close association with the vaginal wall;

control electronics for receiving the first data signals and generating second data signals representing oxygenation level of the hemoglobin in the capillaries of the vaginal wall; and

at least one photoplethysmographic probe supported by the housing and operably coupled with the control electronics, the control electronics generating third data signals representing at least one of vaginal blood volume and vaginal pulse amplitude.

35. A measurement device, comprising:

at least one oximeter probe constructed for placement in proximity to the vaginal wall of a female subject, the at least one oximeter probe generating first data signals;

a housing constructed for supporting the at least one oximeter probe in close association with the vaginal wall;

control electronics for receiving the first data signals and generating second data signals representing oxygenation level of the hemoglobin in the capillaries of the vaginal wall; and

at least one electrode supported by the housing for generating data signals related to a vaginal parameter, the control electronics receiving the vaginal-parameter data signals.

36. A measurement device, comprising:

at least one oximeter probe constructed for placement in proximity to the vaginal wall of a female subject, the at least one oximeter probe generating first data signals;

a housing constructed for supporting the at least one oximeter probe in close association with the vaginal wall;

control electronics for receiving the first data signals and generating second data signals representing oxygenation level of the hemoglobin in the capillaries of the vaginal wall;

a pressure balloon operably coupled with a pressure source, the pressure balloon being disposed so as to urge the oximeter probe toward the vaginal wall with a desired pressure; and

an automatic pressure-regulation mechanism, operably coupled with the pressure balloon and the control electronics, for automatically maintaining the contact pressure between the vaginal wall and the oximeter probe.