Systems and methods for monitoring and evaluating penile tumescence

• US 6,015,393 A
• Filed: 03/20/1998
• Issued: 01/18/2000
• Est. Priority Date: 03/24/1997
• Status: Expired due to Fees

• Current Assignee: Urometrics Incorporated
• Original Assignee: Urometrics Incorporated
• Inventors: Dixon, Roger, Knoll, L. Dean, Hovland, Claire T., Abrams, Jerome H.
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): Imam, Ali M.
• Application Number:
  US09/045,599
• Time in Patent Office: 669 Days
• Field of Search: 600/587, 600/507, 346/34, 346/76 R, 346/33 ME, 33/179, 607/143, 514/11
• US Class Current: 600/587
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/0535 Impedance plethysmography for measuring blood flow A61B5/0295
• CPC Class Codes: A61B 5/4393 Sexual arousal or erectile dysfunction evaluation, e.g. tumescence evaluation

Abstract

An apparatus for monitoring the tumescent state of the penis of a patient includes a plurality of sensing elements to be placed in proximity to the penis for sensing penile impedance values. A processing device is operably coupled to the plurality of sensing elements, the processing device determining at least one penile variable using the impedance values. The at least one penile variable is selected from the group consisting of length, volume, volume-change, cross-sectional area and volume-filling rate variables. An output device operably coupled with the processing device to generate a display using the at least one determined penile variable. The output device displays e.g. a plot of penile length, penile volume values and/or penile cross-sectional area values for comparison by a user of the apparatus, readily allowing the user to distinguish artifactual effects from erectile events. According to one embodiment, cardiac-signature data is determined using the penile impedance values, and the apparatus indicates periods of erectile activity using the cardiac-signature data. Corresponding methods also are discussed.

Claims

1. A method of monitoring the tumescent state of the penis of a patient, the method comprising:

(a) placing sensing elements in proximity to the penis;

(b) sensing impedance values of the penis both when the penis is in an erect state and when the penis is in a flaccid state with the sensing elements;

(c) determining at least one penile variable using the impedance values, the at least one penile variable being selected from the group consisting of length, volume, volume-change, and volume-filling rate variables; and

(d) using the at least one penile variable to generate a display output.

2. The method of claim 1, wherein (a) includes placing at least five sensing elements in proximity to the penis.

3. The method of claim 2, wherein the sensing elements are contact electrodes.

4. The method of claim 2, wherein at least four of the sensing elements are supported on the penis.

5. The method of claim 4, wherein at least two of the sensing elements are supported in the base region of the penis, said at least two sensing elements being separated by a substantially fixed separation distance.

6. The method of claim 5, wherein at least two other sensing elements are supported in the tip region of the penis, one of the at least two sensing elements being supported subcoronally, the subcoronal sensing element being used to determine penile length values in (c).

7. The method of claim 1, wherein (b) includes sensing impedance values in at least two regions of the penis, the first region being a base region and the second region extending from substantially within the base region to substantially a tip region of the penis.

8. An apparatus for monitoring the tumescent state of the penis of a patient, the apparatus comprising:

a plurality of sensing elements to be placed in proximity to the penis for sensing impedance values of the penis both when the penis is in an erect state and when the penis is in a flaccid state;

a processing device operably coupled to the plurality of sensing elements, the processing device determining at least one penile variable using the impedance values, the at least one penile variable being selected from the group consisting of length, volume, volume-change, and volume-filling rate variables; and

an output device operably coupled with the processing device to generate a display using the at least one determined penile variable.

9. The apparatus of claim 8, wherein the output device displays a plot of penile length and penile volume values for comparison by a user of the apparatus.

10. The apparatus of claim 8, wherein the output device displays a plot of penile length and penile volume values, the plot allowing a user of the apparatus readily to distinguish artifactual effects from erectile events.

11. The apparatus of claim 8, wherein at least two of the sensing elements are supported by the base region of the penis and separated by a distance that remains substantially fixed.

12. The apparatus of claim 8, wherein the sensing elements sense impedance values of the penis both in a base region and along substantially an entire effective length of the penis.

13. The apparatus of claim 8, wherein the plurality of sensing elements comprises at least five sensing elements.

14. The apparatus of claim 8, wherein at least two of the sensing elements are supported in the base region of the penis and at least two of the sensing elements are supported in the tip region of the penis.

15. The apparatus of claim 14, wherein at least one of the sensing elements is supported off the penis.

16. The apparatus of claim 15, wherein the at least one sensing element supported off the penis is supported in the hip region of the patient.

17. The apparatus of claim 8, wherein the processing device approximates change in an offset volume variable according to the equation:

##EQU20## where Δ

V_os is change in offset volume, ρ

_b and ρ

_t are resistivities of blood and tissue filled penile volumes, respectively, A is cross-sectional area, L_P is penile length at the time of measurement, L_ref is a reference length reflecting average length of the penis in the flaccid state, and C is an integration constant.

18. An apparatus for monitoring the tumescent state of the penis of a patient, the apparatus comprising a plurality of sensing elements to be placed in proximity to the penis for sensing impedance values of the penis both when the penis is in an erect state and when the penis is in a flaccid state, the plurality of sensing elements being operably couplable to a processing device for determining penile variables using the impedance values, the penile variables being suitable for display by an output device.

19. The apparatus of claim 18, wherein the penile variables are used to determine dosage levels of oral or other impotence medication.

20. The apparatus of claim 18, wherein the plurality of sensing elements include a plurality of on-penis electrodes and at least one off-penis electrode.

21. The apparatus of claim 18, wherein the plurality of sensing elements include a first electrode in a base region of the penis, a second electrode in a base region of the penis and spaced from the first electrode, and a third electrode in a distal region of the penis, further wherein the apparatus measures voltage drop between (1) the first electrode and the second electrode and between (2) the first electrode and the third electrode.

22. The apparatus of claim 18, wherein the plurality of sensing elements are used to determine penile length variables over time.

23. The apparatus of claim 18, wherein the plurality of sensing elements are used to determine information reflecting changing width of a cavernosal blood vessel in the penis of the patient substantially before the length of the penis changes during an erectile event.

24. The apparatus of claim 18, wherein the plurality of sensing elements are used to determine cardiac signature data to indicate periods of penile activity.

25. The apparatus of claim 24, wherein the cardiac signature data is used as a template for diagnosis of organic impotence etiology.

26. The apparatus of claim 18, further comprising a data storage device operably coupled to the sensing elements for receiving and storing penile impedance values of the penis and for optional subsequent downloading.

27. The apparatus of claim 18, wherein the processing device approximates change in an offset volume variable according to the equation:

##EQU21## where Δ

V_os is change in offset volume, ρ

_b and ρ

_t are resistivities of blood and tissue filled penile volumes, respectively, A is cross-sectional area, L_P is penile length at the time of measurement, L_ref is a reference length reflecting average length of the penis in the flaccid state, and C is an integration constant.

28. The apparatus of claim 26, wherein the data storage device is constructed to be secured to the patient'"'"'s leg.

29. A method of monitoring the tumescent state of the penis of a patient, the method comprising:

(a) determining impedance values of the penis;

(b) determining cardiac-signature data using the penile impedance values; and

(c) using the cardiac-signature data to indicate periods of penile activity.

30. The method of claim 29, wherein (b) includes determining a pulsatile component of an impedance waveform, the waveform being based on the impedance values determined in (a).

31. The method of claim 29, further including (d) displaying the cardiac-signature data in graphical form to evaluate potential organic causes of erectile dysfunction.

32. The method of claim 29, wherein (c) includes recognizing cardiac-signature activity that occurs before the penis lengthens during an erectile event.

40. The apparatus of claim 30, wherein

a diurnal erectile event is medicinally induced in a flaccid penis while the patient is awake;

the sensing apparatus senses diurnal penile data during said diurnal erectile event; and

the display apparatus facilitates comparison of nocturnal penile data with diurnal penile data to evaluate the quality of nocturnal erectile events.

41. The apparatus of claim 40, wherein the diurnal erectile event is medicinally induced in a medical professional'"'"'s office, further wherein the sensing apparatus senses the diurnal penile data in the patient'"'"'s usual sleep location.

33. An apparatus for monitoring the tumescent state of the penis of a patient, the apparatus comprising:

apparatus for determining impedance values of the penis;

apparatus for determining cardiac-signature data using the penile impedance values; and

apparatus for indicating periods of penile activity using the cardiac-signature data.

34. The apparatus of claim 33, further comprising apparatus for displaying at least cardiac-signature data in graphical form.

35. The apparatus of claim 34, wherein the displaying apparatus further displays total impedance data, the displayed total impedance data being highlighted during corresponding periods of cardiac-signature activity to reflect potential erectile events.

36. The apparatus of claim 33, further comprising apparatus for displaying impedance-based data in graphical form, the impedance-based data being highlighted during selected periods of cardiac-signature activity to reflect potential erectile events.

37. An apparatus for nocturnally monitoring erectile events in a patient, the apparatus comprising:

sensing apparatus for sensing penile data over time while the patient is asleep; and

display apparatus for displaying information determined from the penile data versus time;

wherein the displayed information is used to diagnose vasculogenic and/or psychogenic causes of erectile dysfunction;

wherein the sensing apparatus is used to determine penile-tissue impedance values and blood impedance values.

38. The apparatus of claim 37, wherein the displayed information is in graphical form and is used to evaluate the relative speed of erection-impairing venous leakage.

39. The apparatus of claim 37, wherein the penile-tissue impedance values and blood impedance values are determined substantially continuously over time.

42. An apparatus for nocturnally monitoring erectile events in a patient, the apparatus comprising:

sensing apparatus for sensing penile data over time while the patient is asleep; and

display apparatus for displaying information determined from the penile data versus time;

wherein the displayed information is used to diagnose vasculogenic and/or psychogenic causes of erectile dysfunction;

further wherein the apparatus approximates change in an offset volume variable according to the equation;

##EQU22## where Δ

V_os is change in offset volume, ρ

_b and ρ

_t are resistivities of blood and tissue filled penile volumes, respectively, A is cross-sectional area, L_P is penile length at the time of measurement, L_ref is a reference length reflecting average length of the penis in the flaccid state, and C is an integration constant.

43. An apparatus for monitoring the tumescent state of the penis of a patient, the apparatus comprising means for sensing impedance values of the penis both when the penis is in an erect state and when the penis is in a flaccid state, the means for sensing to be placed in proximity to the penis, the means for sensing being operably couplable to means for processing, the means for processing determining penile variables using the impedance values, the penile variables being suitable for display by an output device.

44. The apparatus of claim 43, the means for sensing comprising at least five sensing elements.

45. The apparatus of claim 43, wherein the output device displays a plot of penile length and penile volume variables for comparison by a user of the apparatus.

46. A method of monitoring the tumescent state of the penis of a patient, the method comprising:

(a) placing at least five sensing elements in proximity to the penis;

(b) sensing penile impedance values with the sensing elements;

(c) determining at least one penile variable using the impedance values, the at least one penile variable being selected from the group consisting of length, volume, volume-change, cross-sectional area and volume-filling rate variables; and

(d) using the at least one penile variable to generate a display output.

47. An apparatus for monitoring the tumescent state of the penis of a patient, the apparatus comprising a plurality of sensing elements to be placed in proximity to the penis for sensing penile impedance values, the plurality of sensing elements being operably couplable to a processing device for determining penile variables using the impedance values, the penile variables being suitable for display by an output device, wherein the processing device approximates change in an offset volume variable according to the equation:

##EQU23## where Δ

V_os is change in offset volume, ρ

_b and ρ

_t are resistivities of blood and tissue filled penile volumes, respectively, A is cross-sectional area, L_P is penile length at the time of measurement, L_ref is a reference length reflecting average length of the penis in the flaccid state, and C is an integration constant.

48. An apparatus for nocturnally monitoring erectile events in a patient, the apparatus comprising:

sensing apparatus for sensing penile data over time while the patient is asleep; and

display apparatus for displaying information determined from the penile data versus time;

wherein the displayed information is used to diagnose vasculogenic and/or psychogenic causes of erectile dysfunction;

further wherein;

a diurnal erectile event is medicinally induced in a flaccid penis while the patient is awake;

the sensing apparatus senses diurnal penile data during said diurnal erectile event; and

the display apparatus facilitates comparison of nocturnal penile data with diurnal penile data to evaluate the quality of nocturnal erectile events.

49. The apparatus of claim 48, further comprising processing apparatus physically distinct from the sensing apparatus and the display apparatus for processing the penile data.