Flow sensors for penile tumescence

• US 8,118,750 B2
• Filed: 10/21/2005
• Issued: 02/21/2012
• Est. Priority Date: 10/21/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin T.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): PORTER, JR, GARY A
• Application Number:
  US11/255,533
• Publication Number:
  US 20070092862A1
• Time in Patent Office: 2,314 Days
• Field of Search: 607/39, 607/116, 607/118, 607/138, 607/143
• US Class Current: 600/504
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/4393 Sexual arousal or erectile dysfunction evaluation, e.g. tumescence evaluation
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61F 2/26 Penis implants
• CPC Class Codes: A61F 5/41 Devices for promoting penis erection penis implants A61F2/26; massage of the genitals A61H19/00
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

The disclosure describes blood flow sensors for detecting penile tumescence. A system according to the invention may include at least one sensor for sensing blood flow into the penis, and one sensor for sensing blood flow away from the penis. Detecting penile tumescence may be accomplished by comparing the flow of blood into the penis to the blood flow out of the penis. A greater inflow of blood indicates an increasing tumescence whereas a greater outflow of blood indicates a decreasing tumescence. The sensors may be used for short- or long-term monitoring of penile tumescence, or as closed-loop feedback in a therapeutic penile tumescence control system, which may deliver electrical or chemical stimulation therapy to control a tumescence or erectile state, thus treating sexual dysfunction or, more specifically, erectile dysfunction.

Claims

1. A method comprising:

detecting an arterial blood flow to an erectile tissue with a first sensor;

detecting a venous blood flow away from the erectile tissue with a second sensor;

generating tumescence information that reflects the degree of tumescence of the erectile tissue based on the detected arterial and venous blood flows; and

delivering a therapy to a patient to treat sexual dysfunction based on the tumescence information,

wherein generating tumescence information comprises comparing the arterial and venous flows.

2. The method of claim 1, wherein the first sensor and the second sensor are implanted proximate to the erectile tissue.

3. The method of claim 2, wherein the first sensor and the second sensor are implanted within a penis.

4. The method of claim 1, wherein delivering a therapy comprises delivering electrical stimulation.

5. The method of claim 4, wherein delivering electrical stimulation comprises delivering electrical stimulation to at least one of a prostate parasympathetic nerve, a cavernous nerve, a pudendal nerve, or a sacral nerve.

6. The method of claim 1, wherein delivering a therapy comprises at least partially restricting venous blood flow from the erectile tissue at one or more locations.

7. The method of claim 1, wherein delivering a therapy comprises delivering a therapy to at least one of initiate or sustain engorgement of the erectile tissue.

8. The method of claim 1, wherein delivering the therapy comprises delivering the therapy via an implantable medical device.

9. The method of claim 1, further comprising storing tumescence information over a period of time, and presenting the stored tumescence information to a user.

10. The method of claim 9, wherein storing tumescence information comprises storing tumescence information within at least one of a therapy-delivering implantable medical device, an external programmer, or at least one of the first and second sensors.

11. The method of claim 9, wherein presenting the stored tumescence information comprises presenting the stored tumescence information via an external programmer.

12. The method of claim 1, wherein the erectile tissue is located at least partially within a penis or a female sexual organ.

13. The method of claim 1, further comprising:

sequentially delivering therapy according to a plurality of therapy parameter values;

detecting the arterial and venous blood flows via first and second sensors during delivery of therapy according to the plurality of therapy parameter values;

for each of the therapy parameter values, generating tumescence information based on the signals detected during delivery of therapy according to the value; and

selecting a therapy parameter value based on the tumescence information.

39. The method of claim 1, wherein generating tumescence information comprises determining a difference between the arterial and venous flows.

40. The method of claim 1, wherein generating tumescence information comprises determining a ratio between the arterial and venous flows.

14. A system comprising:

a first sensor that detects an arterial blood flow to an erectile tissue;

a second sensor that detects a venous blood flow away from the erectile tissue; and

a processor that generates tumescence information that reflects the degree of tumescence of the erectile tissue based on the detected arterial and venous blood flows,

wherein the processor compares the arterial and venous flows, and generates the tumescence information based on the comparison.

15. The system of claim 14, wherein the first sensor and the second sensor each include at least one piezoelectric transducer.

16. The system of claim 14, wherein the first sensor and the second sensor are Doppler sensors.

17. The system of claim 14, wherein the first sensor and the second sensor are implanted proximate to the erectile tissue.

18. The system of claim 17, wherein the first sensor and the second sensor are implanted within a penis.

19. The system of claim 14, further comprising an implantable medical device that delivers a therapy to a patient to treat sexual dysfunction based on the tumescence information.

20. The system of claim 19, wherein the implantable medical device delivers electrical stimulation to the patient to treat sexual dysfunction based on the tumescence information.

21. The system of claim 20, wherein the implantable medical device delivers electrical stimulation to at least one of a prostate parasympathetic nerve, a cavernous nerve, a pudendal nerve, or a sacral nerve.

22. The system of claim 19, wherein the implantable medical device at least partially restricts venous blood flow from the erectile tissue at one or more locations.

23. The system of claim 19, wherein at least one of the first sensor or the second sensor is electrically coupled to the implantable medical device.

24. The system of claim 19, wherein at least one of the first sensor or the second sensor is wirelessly connected to the implantable medical device.

25. The system of claim 19, further comprising an external programmer, wherein at least one of the first sensor or the second sensor is wirelessly connected to the external programmer, and the external programmer controls delivery of therapy by the implantable medical device based on the tumescence information.

26. The system of claim 14, further comprising:

a memory to store the tumescence information over a period of time; and

a user interface to present the stored tumescence information to a user.

27. The system of claim 26, wherein the memory comprises at least one of a memory of a therapy-delivering implantable medical device, a memory of an external programmer, or a memory of at least one of the first and second sensors.

28. The system of claim 26, wherein the user interface comprises a user interface of an external programmer.

29. The system of claim 14, wherein the processor comprises a processor of one of a therapy-delivering implantable medical device, an external programmer, or at least one of the first and second sensors.

30. The system of claim 14, wherein the erectile tissue is located at least partially within a penis or a female sexual organ.

31. The system of claim 14, wherein the first and second sensors are sized for implantation within a sexual organ, and include a power supply and wireless telemetry circuit.

32. The system of claim 31, wherein a housing of at least one of the first and second sensors has a substantially capsule-like shape.

33. The system of claim 14,

wherein the implantable medical device sequentially delivers therapy according to a plurality of therapy parameter values, the first and second flow sensors detecting the arterial and venous blood flows during delivery of therapy according to the plurality of therapy parameter values, and, for each of the therapy parameter values, the processor generates tumescence information based on the signals detected during delivery of therapy according to the value, and

wherein the processor selects a therapy parameter value based on the tumescence information.

41. The system of claim 14, wherein the tumescence information comprises a difference between the arterial and venous flows.

42. The system of claim 14, wherein the tumescence information comprises a ratio between the arterial and venous flows.

34. A system comprising:

means for detecting an arterial blood flow to an erectile tissue;

means for detecting a venous blood flow away from the erectile tissue; and

means for generating tumescence information that reflects the degree of tumescence of the erectile tissue based on the detected arterial and venous blood flows,

wherein the means for generating tumescence information comprises means for comparing the arterial and venous flows.

35. The system of claim 34, wherein the means for detecting an arterial flow and the means for detecting a venous flow are implanted proximate to the erectile tissue.

36. The system of claim 34, further comprising means for delivering a therapy to a patient to treat sexual dysfunction based on the tumescence information.

37. The system of claim 34, wherein the means for delivering a therapy comprises means for delivering electrical stimulation to the patient to treat sexual dysfunction based on the tumescence information.

38. The system of claim 34, further comprising:

means for storing the tumescence information over a period of time; and

means for presenting the stored tumescence information to a user.

43. The system of claim 34, wherein the tumescence information comprises a difference between the arterial and venous flows.

44. The system of claim 34, wherein the tumescence information comprises a ratio between the arterial and venous flows.

45. A method comprising:

detecting an arterial blood flow to an erectile tissue with a first sensor;

detecting a venous blood flow away from the erectile tissue with a second sensor;

generating tumescence information that reflects the degree of tumescence of the erectile tissue based on the detected arterial and venous blood flows; and

presenting the tumescence information to a user via a user interface,

wherein generating tumescence information comprises comparing the arterial and venous flows.

46. The method of claim 45, wherein the first sensor and the second sensor are implanted proximate to the erectile tissue.

47. The method of claim 45, wherein the first sensor and the second sensor are implanted within a penis.

48. The method of claim 45, further comprising delivering a therapy to a patient to treat sexual dysfunction based on the tumescence information.

49. The method of claim 48, wherein delivering a therapy comprises delivering electrical stimulation.

50. The method of claim 49, wherein delivering electrical stimulation comprises delivering electrical stimulation to at least one of a prostate parasympathetic nerve, a cavernous nerve, a pudendal nerve, or a sacral nerve.

51. The method of claim 48, wherein delivering a therapy comprises at least partially restricting venous blood flow from the erectile tissue at one or more locations.

52. The method of claim 48, wherein delivering a therapy comprises delivering a therapy to at least one of initiate or sustain engorgement of the erectile tissue.

53. The method of claim 48, wherein delivering the therapy comprises delivering the therapy via an implantable medical device.

54. The method of claim 45, further comprising storing tumescence information over a period of time, and wherein presenting the tumescence information to the user via the user interface comprises presenting the stored tumescence information to the user via the user interface.

55. The method of claim 54, wherein storing tumescence information comprises storing tumescence information within at least one of a therapy-delivering implantable medical device, an external programmer, or at least one of the first and second sensors.

56. The method of claim 45, wherein presenting the tumescence information to the user via the user interface comprises presenting the tumescence information to the user via an external programmer.

57. The method of claim 45, wherein the erectile tissue is located at least partially within a penis or a female sexual organ.

58. The method of claim 45, further comprising:

sequentially delivering therapy according to a plurality of therapy parameter values;

detecting the arterial and venous blood flows via first and second sensors during delivery of therapy according to the plurality of therapy parameter values;

for each of the therapy parameter values, generating tumescence information based on the signals detected during delivery of therapy according to the value; and

selecting a therapy parameter value based on the tumescence information.