METHOD AND APPARATUS FOR TREATMENT OF ERECTILE DYSFUNCTION WITH EXTRACORPOREAL SHOCKWAVES

• US 20120215142A1
• Filed: 10/03/2010
• Published: 08/23/2012
• Est. Priority Date: 10/30/2009
• Status: Active Grant

• Current Assignee: Medispec Ltd.
• Original Assignee: Medispec Ltd.
• Inventors: Spector, Avner, Jeshurun-Gutshtat, Michal, Hakim, Gil
• Granted Patent: US 9,913,748 B2
• Time in Patent Office: Days
• US Class Current: 601/46
• CPC Class Codes: A61B 17/2251 characterised by coupling elements between the apparatus, e.g. shock wave apparatus or locating means, and the patient, e.g. details of bags, pressure control of bag on patient
• CPC Class Codes: A61F 2005/417 by vibrating means
• CPC Class Codes: A61F 5/41 Devices for promoting penis erection penis implants A61F2/26; massage of the genitals A61H19/00
• CPC Class Codes: A61H 2201/0153 hand-held
• CPC Class Codes: A61H 2205/086 Buttocks
• CPC Class Codes: A61H 2205/087 Genitals
• CPC Class Codes: A61H 23/008 using shock waves

Abstract

A method and device producing extracorporeal shockwaves for the treatment of erectile dysfunction.

Claims

1. A method for the treatment of Erectile Dysfunction the method comprising:

a. associating a penis with a shockwave generating device within an aqueous environment; and

b. applying a shockwave regimen to said penis wherein said shockwave device produces a focal zone comprising at least a portion of the corpus cavernosa of said penis.

2. The method of claim 1 wherein said focal zone includes most of the corpus cavernosa.

3. The method of claim 1 wherein said focal zone comprises most of the length of said penis.

4. The method of claim 1 wherein said shockwave regimen promotes at least one or more therapies for treating symptoms of Erectile Dysfunction chosen from the group consisting of:

vasodilatation, vasoconstriction, angiogenesis, endothelial function, neuronal, neural regeneration, decalcification, increase cytoplasmic calcium concentration, reduce cytoplasmic calcium concentration, inhibition of PDE5, enzymatic inhibition, enzymatic excitation, or any combination thereof.

5. The method of claim 1 wherein said shock wave regimen produce a treatment regimen determined based on at least one parameter chosen from the group consisting of shockwave parameters, treatment protocol parameters, and anatomical parameters.

6. The method of claim 5 wherein said shockwave parameters comprise number of shockwaves, frequency of shockwaves and intensity of said shockwave.

7. The method of claim 6 wherein said parameters are selected from of at least one of:

shockwave intensity is about from about 50 bar to about 200 bar;

shockwave frequency is from about 60 to about 300 shockwaves per min;

said number of shockwaves is up to about 3500 per session.

10. The method of claim 5 wherein said anatomical parameters comprise at least one of 7 treatment zones.

11. The method of claim 5 wherein said anatomical parameters comprise a single focal zone including up to about 90% of the corpus cavernosa of said penis.

12. The method of claim 1 further comprising placing at least a portion of said corpus cavernosa of said penis in vacuum environment of about 0.1 to 0.8 atm.

13. The method of claim 12 wherein said vacuum environment is an aqueous environment provided for by a liquid chosen from the group consisting of water, oil, gel.

14. The method of claim 1 further comprising coupling said shock wave regimen with a drug or medicinal treatment.

15. The method of claim 14 wherein said medicament or drug is chosen form the group consisting of stem cells, growth factors, hormones, peptides, biologics, DNA, RNA, animal extract, plant extract, oil, gel, balm, cream, angiogenic drugs, PDE5 and vasodilating.

16. The method of claim 1 wherein said treatment protocol targets at least one or more of the penis vasculature chosen from the group consisting of:

cavernosal artery, dorsal artery, bulbar artery, cavernosal vein, dorsal vein and bulbar vein.

17. The method of claim 1 wherein said treatment protocols targets at least one phase of the erectile cycle chosen from the group consisting of initiation, generation, maintenance, and detumescence.

18. The method of claim 1 wherein said treatment protocols targets at least one erectile function chosen from the group consisting of arterial inflow, sufficient corpora cavernosal expansion, and competent venous sinusoidal outflow occlusion.

19. The method of claim 1 wherein said treatment protocol targets at least one or more penile anatomy chosen from the group consisting of corpora cavernosa, corpus spongiosum, and glans.

8. (canceled)

9. (canceled)

20. A shockwave treatment apparatus for the treatment of erectile dysfunction comprising:

a. shockwave applicator comprising a shockwave generator adept for generating shockwaves having a focal treatment zone comprising most of the corpus cavernosum of said penis;

wherein said focal treatment zone comprises dimensions of length and width wherein said focal zone length comprises most of the length of the penis and said width comprises most of the width of said penis; and

b. a penis treatment coupling assembly comprising a proximal opening and a treatment neck for accepting and retaining said penis for undergoing said shockwave treatment;

wherein said treatment neck extends from said proximal opening; and

wherein said treatment neck is aligned with said shockwave generator.

21. The shockwave treatment apparatus of claim 20 wherein said penis treatment coupling assembly further comprises a distal opening for accepting said shockwave treatment applicator.

24. The shockwave treatment apparatus of claim 20 wherein said penis treatment coupling assembly is provided in the form of a flexible ESWT cushion treatment head therein comprising a penis positioning treatment neck and a proximal opening for accepting and retaining said penis in said penis positioning treatment neck.

25. The shockwave treatment apparatus of claim 21 wherein said penis treatment coupling assembly is provided in the form of a flexible ESWT cushion treatment head that is securely coupled with said shockwave applicator, forming a continuous lumen containing an aqueous solution for propagating said generated shockwaves.

26. The shockwave treatment apparatus of claim 25 further comprising at least one vacuum inlet and outlet wherein said vacuum inlet and outlet provides for positioning said penis into said penis positioning treatment neck;

and wherein said vacuum inlet and outlet provide a vacuum strength of about 0.1 to 0.8 atm within said penis positioning treatment neck.

29. The shockwave treatment apparatus of claim 20 wherein said proximal opening comprises a seal for maintaining an aqueous environment.

31. The shockwave treatment apparatus of claim 20 wherein said penis treatment coupling assembly is adept for disposable single time use.

32. The shockwave treatment apparatus of claim 20 wherein said shockwave applicator is a COTS shockwave applicator.

33. The shockwave treatment apparatus of claim 20 wherein said penis treatment coupling assembly is customized for multiuse.

34. The shockwave treatment apparatus of claims 20 wherein said shockwave applicator produces a shockwave based on at least one parameter chosen from the group consisting of shockwave parameters, number of shockwaves, frequency of shockwaves, intensity of shockwave, treatment protocol parameters, and anatomical parameters.

39. The shockwave treatment apparatus of claim 29 wherein said seal provides for maintaining a contiguous aqueous environment along the length of the penis from about the glans to the bulbos.

22. (canceled)

23. (canceled)

27. (canceled)

28. (canceled)

30. (canceled)

35. (canceled)

36. (canceled)

37. (canceled)

38. (canceled)

40. A penile treatment apparatus for the treatment of erectile dysfunction with shockwaves formed with a shockwave generator, said treatment apparatus comprising:

a. a distal opening for accepting said shockwave generator;

b. a proximal opening for accepting and retaining a penis for undergoing said shockwave treatment;

c. a penis treatment neck extending from said proximal opening for retaining and accepting said penis, wherein said treatment neck is aligned with said shockwave generator; and

d. wherein said proximal opening comprises a seal for maintaining an aqueous environment within the penile treatment apparatus.

41. The penile treatment apparatus of claim 40 provided in the form of a flexible ESWT cushion treatment head containing an aqueous solution for propagating said generated shockwaves, therein forming a continuous aqueous environment from said shockwave generator to said proximal opening.

42. The penile treatment apparatus of claim 40 further comprising a vacuum inlet and outlet for positioning said penis within said treatment neck.