Male impotence diagnostic ultrasound system

• US 6,251,076 B1
• Filed: 08/01/1997
• Issued: 06/26/2001
• Est. Priority Date: 08/01/1997
• Status: Expired due to Fees

• Current Assignee: Urometrics Incorporated
• Original Assignee: Urometrics Incorporated
• Inventors: Wons, Edward J., Hovland, Claire T., Abrams, Jerome H.
• Primary Examiner(s): Jaworski, Francis J.
• Application Number:
  US08/905,260
• Time in Patent Office: 1,425 Days
• Field of Search: 600/459-460, 600/453-456, 600/587, 600/504
• US Class Current: 600/454
• CPC Class Codes: A61B 5/4393 Sexual arousal or erectile dysfunction evaluation, e.g. tumescence 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

Abstract

An apparatus for diagnosing male impotence by measuring blood velocity in a cavernosal artery of a male penis includes at least one transducer for transmitting/receiving energy and reading corresponding Doppler effect to detect blood velocity in the cavernosal artery, a transducer housing for supporting the transducer in a substantially fixed orientation with respect to the penis as the transducer measures blood velocity in the cavernosal artery, and a fixing device, mechanically coupled to the transducer housing, to substantially mechanically fix the transducer housing in place with respect to the penis and hold the at least one transducer in a substantially constant angular orientation with respect to the cavernosal artery during an impotence diagnostic procedure. Corresponding methods are also disclosed.

Claims

1. An apparatus for measuring blood velocity in a cavernosal artery of a male penis, the apparatus comprising:

at least one transducer for transmitting/receiving energy and reading corresponding Doppler effect to detect blood velocity in the cavernosal artery both when the penis is in an erect state and when the penis is in a flaccid state;

a substantially rigid transducer support housing for supporting the at least one transducer in a substantially fixed orientation with respect to the penis as the at least one transducer measures blood velocity in the cavernosal artery, the at least one transducer being adjustable with respect to the transducer support housing; and

a fixing device, mechanically coupled to the transducer support housing, to substantially mechanically fix the transducer support housing in place with respect to the penis and hold the at least one transducer in a substantially constant angular orientation with respect to the cavernosal artery during a measurement procedure, the fixing device being constructed to accommodate the changing size of the penis between the erect and flaccid states such that the at least one transducer remains aligned with the cavernosal artery as the diameter of the penis changes.

2. The apparatus of claim 1, wherein the fixing device comprises a pressure balloon supported by a disposable housing, to maintain substantially constant pressure between the penis and the at least one transducer.

3. The apparatus of claim 1, wherein the fixing device comprises a strap for wrapping around the penis.

4. The apparatus of claim 3, wherein the strap is an elastic strap constructed to expand to accommodate the changing diameter of the penis from the flaccid state to the erect state.

5. The apparatus of claim 1, wherein the at least one transducer comprises at least two transducers, further wherein the at least two transducers are shiftable relative to each other to aim the transmitted/received energy to a desired location.

6. The apparatus of claim 5, wherein each transducer is supported by a subhousing, each subhousing being slideably supported by the transducer support housing, each transducer and respective transducer subhousing being shiftable relative to the transducer housing to aim the transmitted/received energy to a desired location.

7. The apparatus of claim 6, wherein each transducer subhousing comprises at least one rider and the transducer support housing includes at least one corresponding rail, the rider of each transducer subhousing sliding along the rail of the transducer housing for laterally adjusting the respective transducer position.

8. The apparatus of claim 7, wherein each transducer subhousing includes a finger for supporting each transducer subhousing rider, the finger being movable to disengage the rider from the transducer support housing rail to permit the lateral adjustment.

9. The apparatus of claim 1, wherein the at least one transducer transmits ultrasound energy.

10. The apparatus of claim 9, wherein the at least one transducer is constructed to apply continuous wave ultrasound energy.

11. The apparatus of claim 1, wherein the fixing device includes a spring-loaded adjustment mechanism for pressing the apparatus against the penis and holding the transducer housing in place.

12. The apparatus of claim 1, wherein the at least one transducer is constructed to transmit/receive energy continuously over an extended period of time to continuously measure penile blood velocity.

13. The apparatus of claim 1, further including an acoustically conductive film and/or gel disposed to improve acoustic conduction between the at least one transducer and the penis.

14. The apparatus of claim 1, wherein the at least one transducer comprises at least two transducers positioned over respective cavernosal arteries in the penis to measure blood flow on both sides of the penis.

15. The apparatus of claim 1, in combination with a male impotence diagnostic system including at least one display device for display of graphical representations indicative of blood velocity in the cavernosal artery.

16. The apparatus of claim 1, wherein the at least one transducer comprises a single transmit/receive transducer.

33. The apparatus of claim 1, wherein the at least one transducer is moveable along the transducer support housing.

34. The apparatus of claim 1, wherein the at least one transducer consists of multiple transducers, the multiple transducers being supported on the transducer support housing such that the multiple transducers are all disposed at a top portion of the penis.

35. The apparatus of claim 1, wherein the fixing device tightens the transducer support housing with respect to the penis.

36. The apparatus of claim 35, wherein the fixing device is flexible.

37. The apparatus of claim 1, wherein the transducer support housing is constructed to support the at least one transducer only on one side of the penis.

17. A method of diagnosing male impotence, comprising:

placing at least one transducer into contact with the penis, the at least one transducer being supported by a transducer housing;

fixing the transducer housing and the at least one transducer in place on the penis with a fixing device, such that the angular orientation of the at least one transducer with respect to the penis is maintained substantially fixed;

holding the penis substantially in place with a pressure balloon mechanism; and

measuring blood flow velocity in the penis using the energy transmitted and received by the at least one transducer.

18. The method of claim 17, further comprising the steps of introducing a vasodilating agent to the penis and subsequently measuring blood flow velocity continuously over an extended period of time.

19. The method of claim 17, further comprising the step of displaying a graphical representation indicative of blood flow velocity on a display device.

20. The method of claim 19, further comprising the step of displaying an electrocardiogram or pulse oximetry output in correlation with the graphical representation of blood flow velocity.

21. A method of diagnosing male impotence, comprising:

(a) measuring blood flow velocity in at least one cavernosal artery in the penis;

(b) subsequently introducing a vasodilating agent to the penis to induce an erectile response;

(c) continuously measuring blood flow velocity in the at least one cavernosal artery over a time period after introduction of the vasodilating agent; and

(d) continuously measuring the diameter of the penis over the time period of step (c); and

(e) simultaneously displaying graphical representations of blood flow velocity data and penis diameter data over the time period of step (c).

22. An apparatus for measuring blood velocity in at least one blood vessel of a patient, the blood vessel being contained within a surrounding anatomical structure;

the apparatus comprising;

at least one transducer for transmitting/receiving energy and reading corresponding Doppler effect to detect blood velocity in the at least one blood vessel;

a transducer housing for supporting the at least one transducer in a substantially fixed orientation with respect to the anatomical structure as the at least one transducer detects blood velocity the transducer housing defining two distal legs and a bend circumferentially therebetween to substantially conform to the outer circumference of the anatomical structure, the transducer housing being out of physical contact with the at least one blood vessel; and

a fixing device, mechanically coupled to the transducer housing, to substantially mechanically fix the transducer housing in place on the anatomical structure and hold the at least one transducer in a substantially constant angular orientation with respect to the at least one blood vessel.

23. The apparatus of claim 22, wherein the at least one transducer comprises two independently operable transducers.

24. The apparatus of claim 23, wherein one of the transducers is positioned on one of the legs on one side of the bend of the transducer housing to detect blood velocity in a blood vessel within the anatomical structure;

further wherein another one of the transducers is positioned on the other of the legs on the other side of the bend of the transducer housing to detect blood velocity in another blood vessel within the anatomical structure.

25. The apparatus of claim 23, wherein the transducer housing is constructed to substantially straddle the anatomical structure;

further wherein the transducer housing is constructed to position one of the transducers at substantially a 10 o'"'"'clock position about the anatomical structure and another one of the transducers at substantially a 2 o'"'"'clock position about the anatomical structure.

26. The apparatus of claim 23, wherein the transducers are independently movable along the legs of the transducer housing.

27. The apparatus of claim 22, wherein the apparatus is constructed to conform to the shape of a male penis;

further wherein the transducer housing is constructed to position the at least one transducer to detect blood velocity in a cavernosal artery of the penis without interference from a dorsal blood vessel of the penis.

28. The apparatus of claim 27, wherein the fixing device is constructed to accommodate the changing diameter of the penis between erect and flaccid states thereof.

29. An apparatus for diagnosing male impotence by measuring blood velocity in a cavernosal artery of a male penis, the apparatus comprising:

at least one transducer for transmitting/receiving energy and reading corresponding Doppler effect to detect blood velocity in the cavernosal artery, the at least one transducer also being constructed to transmit/receive energy to detect a diameter value related to the penis;

a transducer housing for supporting the at least one transducer in a substantially fixed orientation with respect to the penis as the at least one transducer measures blood velocity in the cavernosal artery;

a fixing device, mechanically coupled to the transducer housing, to substantially mechanically fix the transducer housing in place with respect to the penis and hold the at least one transducer in a substantially constant angular orientation with respect to the cavernosal artery during an impotence diagnostic procedure; and

a display, operably coupled with the at least one transducer, for displaying the diameter value and the blood velocity.

30. The apparatus of claim 29, wherein the diameter value is selected from the group consisting of penis diameter and cavernosal artery diameter.

31. An apparatus for measuring blood velocity in a cavernosal artery of a male penis, the apparatus comprising:

at least one transducer for transmitting/receiving energy and reading corresponding Doppler effect to detect blood velocity in the cavernosal artery both when the penis is in an erect state and when the penis is in a flaccid state;

a transducer housing for supporting the at least one transducer in a substantially fixed orientation with respect to the penis as the at least one transducer measures blood velocity in the cavernosal artery; and

a fixing device, mechanically coupled to the transducer housing, to substantially mechanically fix the transducer housing in place with respect to the penis and hold the at least one transducer in a substantially constant angular orientation with respect to the cavernosal artery during a measurement procedure, the fixing device being constructed to accommodate the changing size of the penis between the erect and flaccid states such that the at least one transducer remains aligned with the cavernosal artery as the size of the penis changes;

wherein the at least one transducer comprises at least two transducers, further wherein the at least two transducers are shiftable relative to each other to aim the transmitted/received energy to a desired location;

further wherein each transducer is supported by a subhousing, each subhousing being slideably supported by the transducer housing, each transducer and respective transducer subhousing being shiftable relative to the transducer housing to aim the transmitted/received energy to a desired location.

32. An apparatus for measuring blood velocity in a cavernosal artery of a male penis, the apparatus comprising:

at least one transducer for transmitting/receiving energy and reading corresponding Doppler effect to detect blood velocity in the cavernosal artery both when the penis is in an erect state and when the penis is in a flaccid state;

a transducer housing for supporting the at least one transducer in a substantially fixed orientation with respect to the penis as the at least one transducer means measures blood velocity in the cavernosal artery, the at least one transducer being shiftable along the transducer housing to aim the transmitted/received energy to a desired location; and

a fixing device, mechanically coupled to the transducer housing, to substantially mechanically fix the transducer housing in place with respect to the penis and hold the at least one transducer in a substantially constant angular orientation with respect to the cavernosal artery during a measurement procedure, the fixing device being constructed to accommodate the changing size of the penis between the erect and flaccid states such that the at least one transducer remains aligned with the cavernosal artery as the size of the penis changes.