Method for treating Peyronie's disease

• US 10,426,835 B2
• Filed: 04/19/2016
• Issued: 10/01/2019
• Est. Priority Date: 04/19/2016
• Status: Active Grant

• Current Assignee: BMR Medical LLC
• Original Assignee: BMR Medical LLC
• Inventors: Morganstern, Steven, Becerra, Carlos
• Primary Examiner(s): Smith, Ruth S
• Application Number:
  US15/132,418
• Publication Number:
  US 20170296209A1
• Time in Patent Office: 1,260 Days
• CPC Class Codes: A61B 17/22004 using mechanical vibrations, e.g. ultrasonic shock waves A61B17/225 takes precedence
• 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 8/488 involving Doppler signals
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/277 having a ring, e.g. verapamil
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 41/0028 Disruption, e.g. by heat or ultrasounds, sonophysical or sonochemical activation, e.g. thermosensitive or heat-sensitive liposomes, disruption of calculi with a medicinal preparation and ultrasounds
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants

Abstract

In a method of treating a patient having diffuse plaque and/or a plaque mass associated with Peyronie'"'"'s disease in a penile region, a battery of tests is performed to quantify an initial state of parameters associated with Peyronie'"'"'s disease in the patient. Low intensity shock wave therapy is applied to the plaque mass in the penile region, thereby softening the plaque mass and disrupting any calcification in the plaque mass. Carbon dioxide is injected into the plaque mass. The battery of tests is repeated to quantify a current state of parameters associated with Peyronie'"'"'s disease in the patient and the current state is compared to the initial state. The aforementioned treatment steps are repeated until the current state differs from the initial state by at least a predetermined amount.

Claims

1. A method of treating a patient having a plaque mass associated with Peyronie'"'"'s disease in a penile region, comprising the steps of:

(a) performing a battery of tests to quantify an initial state of parameters associated with Peyronie'"'"'s disease in the patient;

(b) applying shock wave treatment to the plaque mass in the penile region, thereby softening the plaque mass and disrupting any calcification in the plaque mass wherein the shock wave treatment comprises a low intensity shock wave treatment having a minimum energy of 0.10 mJmm²;

(c) applying carboxy treatment comprising injecting carbon dioxide into the plaque mass after the step of applying the shock wave treatment;

(d) repeating the battery of tests to quantify a current state of parameters associated with Peyronie'"'"'s disease in the patient and comparing the current state to the initial state; and

(e) until the current state differs from the initial state by at least a predetermined amount, repeating steps (b) through (d).

2. The method of claim 1, further comprising the step of applying external counter-pulsation treatment to the patient concurrently with the step of applying the shock wave treatment, further softening the plaque mass and disrupting any calcification in the plaque mass.

3. The method of claim 2, wherein the step of applying the external counter-pulsation treatment comprises applying a counter-pulsation treatment about twice per week during a period of at least ten weeks.

4. The method of claim 1, wherein the step of applying shock wave treatment to the plaque mass comprises applying shock wave treatment to the plaque mass for about thirteen treatments over a period of seven to eight weeks, including a two week break period of no shock wave treatment.

5. The method of claim 1, further comprising a step of injecting a therapeutically effective dose of an L-type phenylalkylamine class calcium channel blocker into a calcified plaque area of the penile area either before or after applying shock wave treatment to the plaque mass.

6. The method of claim 5, wherein the L-type phenylalkylamine class calcium channel blocker comprises Verapamil.

7. The method of claim 6, wherein the step of injecting a therapeutically effective dose of Verapamil comprises injecting between 0.625 mg to 2.5 mg of Verapamil into a dorsal tunica of the patient.

8. The method of claim 5, wherein the step of injecting a therapeutically effective dose of an L-type phenylalkylamine class calcium channel blocker comprises performing about 12 treatments at a frequency of every 14 days.

9. The method of claim 1, wherein the step of injecting carbon dioxide into the plaque mass comprises injecting a predetermined amount of carbon dioxide into a dorsal tunica of the patient.

10. The method of claim 1, wherein the step of injecting carbon dioxide into the plaque mass comprises injecting a predetermined amount of carbon dioxide into a corpus cavernosum of the patient.

11. The method of claim 1, wherein the step of injecting carbon dioxide into the plaque mass is performed twice per week, but 48 hours apart, for twelve consecutive weeks.

12. The method of claim 1, wherein the battery of tests includes imaging the plaque with an ultrasound imaging device and the current state differs from the initial state by the predetermined amount when no plaque is observed.

13. The method of claim 1, wherein the battery of tests includes measuring blood flow in penile blood vessels of the patient with a duplex Doppler ultrasonography blood flow device and the current state differs from the initial state by the predetermined amount when about a doubling in blood flow is observed.

14. The method of claim 1, wherein the battery of tests includes measuring pulse wave velocity in a brachial artery and an ankle artery of the patient.

15. A treatment method for a patient having a plaque mass associated with Peyronie'"'"'s disease in a penile region, comprising the steps of:

(a) performing a battery of tests to quantify an initial state of parameters associated with Peyronie'"'"'s disease in the patient;

(b) applying shock wave treatment to the plaque mass in the penile region, thereby softening the plaque and disrupting calcification in the plaque mass, wherein the shock wave treatment comprises a low intensity shock wave treatment having a minimum energy of 0.10 mJmm²;

(c) applying a counter pulsation treatment concurrently with the step of applying shock wave treatment to further disrupt calcification in the plaque mass;

(d) injecting a plurality of doses of 160 cc of carbon dioxide per dose into the plaque mass after the concurrently applied steps of applying shock wave treatment and applying a counter pulsation treatment;

(e) before the concurrently applied steps of applying shock wave treatment and applying a counter-pulsation treatment, injecting a therapeutically effective dose of Verapamil into a dorsal area of the penile area;

(f) repeating the battery of tests to quantify a current state of parameters associated with Peyronie'"'"'s disease in the patient and comparing the current state to the initial state; and

(g) until the current state differs from the initial state by at least a predetermined amount, repeating steps (b) through (f).

16. The treatment method of claim 15, wherein the step of injecting a therapeutically effective dose of Verapamil comprises the step of injecting between 0.625 mg to 2.5 mg of Verapamil into the dorsal tunica of the patient.

17. The treatment method of claim 15, wherein the step of injecting carbon dioxide into the plaque mass comprises injecting the carbon dioxide into at least one of a dorsal tunica of the patient and a corpus cavernosum of the patient twice per week, but 48 hours apart, for twelve consecutive weeks.

18. The treatment method of claim 15, wherein the battery of tests includes imaging the plaque with an ultrasound imaging device and the current state differs from the initial state by the predetermined amount when no plaque is observed.

19. The treatment method of claim 15, wherein the battery of tests includes measuring blood flow in penile blood vessels of the patient with a duplex Doppler ultrasonography blood flow device and the current state differs from the initial state by the predetermined amount when about a doubling in blood flow is observed.

20. The treatment method of claim 15, wherein the battery of tests includes measuring pulse wave velocity in a brachial artery and an ankle artery of the patient.