Method, system and kit for treatment of Peyronie's disease

• US 7,037,256 B2
• Filed: 10/16/2002
• Issued: 05/02/2006
• Est. Priority Date: 10/16/2002
• Status: Active Grant

• Current Assignee: Augusta Medical Systems LLC
• Original Assignee: Soma Blue, Inc.
• Inventors: Magee, John, Osbon, Julian
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US10/271,821
• Publication Number:
  US 20040077970A1
• Time in Patent Office: 1,294 Days
• Field of Search: 600 38- 41, 601 6- 14
• US Class Current: 600/38
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61F 2005/412 by vacuum 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 9/005 Pneumatic massage

Abstract

A kit and system for treating plaque formation in a patient'"'"'s extremity are provided. A pressure pump and at least two elongated vacuum chambers are included in the kit and system. Each chamber has a proximal longitudinal end adapted to receive a patient'"'"'s extremity and a distal longitudinal end adapted to be positioned in fluid communication with the pressure pump so that a pressure is created inside each of the at least two vacuum chambers and exerted upon the extremity received therein when the pressure pump is operating. One of the at least two vacuum chambers has a different inner circumference than another one of the at least two vacuum chambers so that a different level of prevention from bending is provided to the extremity in the direction of the plaque formation with each of the at least two vacuum chambers during operation of the pressure pump. Methods for treating plaque formation in a patient'"'"'s extremity are also provided.

Claims

1. A kit for treating plaque formation in a patient'"'"'s extremity, the kit comprising:

(a) a container;

(b) a pressure pump positioned in the container; and

(c) at least two noncontiguous elongated vacuum chambers positioned in the container and each having a proximal longitudinal end adapted to receive a patient'"'"'s extremity and a distal longitudinal end adapted to be positioned in fluid communication with the pressure pump so that a pressure is created inside each of the at least two vacuum chambers and exerted upon the extremity received therein when the pressure pump is operating, one of the at least two vacuum chambers having a different inner circumference than another one of the at least two vacuum chambers so that a different level of prevention from bending is provided to the extremity in the direction of the plaque formation with each of the at least two vacuum chambers during operation of the pressure pump.

2. The kit of claim 1, wherein the at least two vacuum chambers comprises three vacuum chambers, each of the three vacuum chambers having a different inner circumference than each of the other ones of the three vacuum chambers so that a different level of prevention from bending is provided to the extremity in the direction of the plaque formation with each of the three vacuum chambers during operation of the pressure pump.

3. The kit of claim 2, wherein the kit further comprises fluid communication establishing means adapted to be connected to each of the three vacuum chambers for establishing fluid communication between each of the three vacuum chambers and the pressure pump, and at least one flexible tube having a first end adapted to be connected to the fluid communication establishing means and a second end adapted to be connected to the pressure pump.

4. The kit of claim 3, wherein the pressure pump comprises a pump housing, a pump actuator positioned in the pump, a handle connected to the housing, and a pump actuation arm connected to the housing and to the pump actuator so that movement of the actuation arm toward the handle by a user actuates the pressure pump.

5. The kit of claim 1, wherein the at least two vacuum chambers comprises an outer vacuum chamber and at least one inner vacuum chamber adapted to be inserted into the outer vacuum chamber, the outer vacuum chamber having a proximal longitudinal end adapted to receive a patient'"'"'s extremity at a preselected time upon a predetennined condition of the patient'"'"'s extremity and a distal longitudinal end adapted to be positioned in fluid communication with the pressure pump, the at least one inner vacuum chamber also having a proximal longitudinal end adapted to receive a patient'"'"'s extremity at a preselected time upon a predetermined condition of the patient'"'"'s extremity and a distal longitudinal end adapted to be positioned in fluid communication with the pressure pump, the outer vacuum chamber having a different inner circumference than the at least one inner vacuum chamber so that a different level of prevention from bending is provided to the patient'"'"'s extremity in the direction of the plaque formation with each of the outer vacuum chamber and the at least one inner vacuum chamber during operation of the pressure pump.

6. The kit of claim 5, wherein the outer vacuum chamber includes interfacing means adapted to be positioned on an inner surface thereof for interfacing with the at least one inner vacuum chamber.

7. The kit of claim 6, wherein the outer vacuum chamber interfacing means comprises an inner flange positioned adjacent the proximal longitudinal end of the outer vacuum chamber and connected to and extending inwardly from an inner surface of the outer vacuum chamber to thereby define an inner step formed therein from the proximal longitudinal end thereof, and wherein the at least one inner vacuum chamber comprises a plurality of stop members extending outwardly from an outer surface of the at least one inner vacuum chamber to interface with and contact the inner step of the outer vacuum chamber to thereby limit the inward movement of the at least one inner vacuum chamber when positioned within the outer vacuum chamber.

8. The kit of claim 7, wherein the at least one inner vacuum chamber further comprises a plurality of spaced-apart ribs connected to and extending outwardly from the outer surface thereof to provide separation between the outer surface of the at least one inner vacuum chamber and the inner surface of the outer vacuum chamber so that an interstitial space is formed therebetween when the at least one inner vacuum chamber is positioned within the outer vacuum chamber.

9. The kit of claim 1, wherein the at least two vacuum chambers each has a substantially cylindrical shape, wherein the patient'"'"'s extremity comprises a male sexual organ, and wherein the plaque formation comprises Peyronie'"'"'s Disease in the male sexual organ.

10. A system for treating plaque formation in a patient'"'"'s extremity, the system comprising:

(a) a pressure pump; and

(b) one of at least two elongated vacuum chambers positioned in fluid communication with the pressure pump at a distal longitudinal end thereof and adapted to receive a patient'"'"'s extremity at a proximal longitudinal end thereof, one of the at least two vacuum chambers having a different inner circumference than another one of the at least two vacuum chambers so that a different level of prevention from bending is provided to the extremity in the direction of the plaque formation with each of the at least two vacuum chambers during operation of the pressure pump.

11. The system of claim 10, wherein the system comprises three vacuum chambers, each of the three chambers having a different inner circumference than each of the other ones of the three vacuum chambers so that a different level of prevention from bending is provided to the extremity in the direction of the plaque formation with each of the three vacuum chambers during operation of the pressure pump.

12. The system of claim 11, wherein the system further comprises:

(a) fluid communication establishing means adapted to be connected to each of the three vacuum chambers for establishing fluid communication between each of the three vacuum chambers and the pressure pump; and

(b) at least one flexible tube having a first end adapted to be connected to the fluid communication establishing means and a second end adapted to be connected to the pressure pump.

13. The system of claim 11, wherein the pressure pump comprises a pump housing, a pump actuator positioned in the pump, a handle connected to the housing, and a pump actuation arm connected to the housing and to the pump actuator so that movement of the actuation arm toward the handle by a user actuates the pressure pump.

14. The system of claim 10, wherein the system comprises an outer vacuum chamber and at least one inner vacuum chamber adapted to be inserted into the outer vacuum chamber, the outer vacuum chamber having a proximal longitudinal end adapted to receive a patient'"'"'s extremity at a preselected time upon a predetermined condition of the patient'"'"'s extremity and a distal longitudinal end adapted to be positioned in fluid communication with the pressure pump, the at least one inner vacuum chamber also having a proximal longitudinal end adapted to receive a patient'"'"'s extremity at a preselected time upon a predetermined condition of the patient'"'"'s extremity and a distal longitudinal end adapted to be positioned in fluid communication with the pressure pump, the outer vacuum chamber having a different inner circumference than the at least one inner vacuum chamber so that a different level of prevention from bending is provided to the patient'"'"'s extremity in the direction of the plaque formation with each of the outer vacuum chamber and the at least one inner vacuum chamber during operation of the pressure pump.

15. The system of claim 14, wherein the outer vacuum chamber comprises interfacing means adapted to be positioned on an inner surface thereof for interfacing with the at least one inner vacuum chamber.

16. The system of claim 15, wherein the outer vacuum chamber interfacing means comprises an inner flange positioned adjacent the proximal longitudinal end of the outer vacuum chamber and connected to and extending inwardly from an inner surface of the outer vacuum chamber to thereby define an inner step formed therein from the proximal longitudinal end thereof, and wherein the at least one inner vacuum chamber comprises a plurality of stop members extending outwardly from an outer surface of the at least one inner vacuum chamber to interface with and contact the inner step of the outer vacuum chamber to thereby limit the inward movement of the at least one inner vacuum chamber when positioned within the outer vacuum chamber.

17. The system of claim 16, wherein the at least one inner vacuum chamber further comprises a plurality of spaced-apart ribs connected to and extending outwardly from the outer surface thereof to provide separation between the outer surface of the at least one inner vacuum chamber and the inner surface of the outer vacuum chamber so that an interstitial space is formed therebetween when the at least one inner vacuum chamber is positioned within the outer vacuum chamber.

18. The system of claim 10, wherein the at least two vacuum chambers each has a substantially cylindrical shape, wherein the patient'"'"'s extremity comprises a male sexual organ, and wherein the plaque formation comprises Peyronie'"'"'s Disease in the male sexual organ.

26. The system of claim 10, wherein the different inner circumference of one of the at least two vacuum chambers extends substantially the entire length of the vacuum chamber.

19. A method for treating plaque formation in a patient'"'"'s extremity, the method comprising the steps of:

(a) placing a patient'"'"'s extremity inside a first elongated vacuum chamber from a proximal longitudinal open end thereof, the proximal longitudinal open end being pressed against the patient'"'"'s body to ensure an airtight seal;

(b) pumping air out of the first vacuum chamber from a distal longitudinal end thereof to create a pressure therewithin;

(c) adjusting amount of the pressure to a level that is adequate to pull the patient'"'"'s extremity tight without causing discomfort to the patient;

(d) removing the first vacuum chamber;

(e) replacing the first vacuum chamber with a second vacuum chamber, the second chamber having a different inner circumference than the first vacuum chamber;

(f) repeating steps (a)–

(d);

(g) removing the second vacuum chamber;

(h) replacing the second vacuum chamber with a third vacuum chamber, the third vacuum chamber having a different inner circumference than the first and second vacuum chambers;

(i) repeating steps (a)–

(d); and

(j) repeating steps (a)–

(i).

20. A method for treating plaque formation in a patient'"'"'s extremity, the method comprising the steps of:

(a) positioning a first elongated vacuum chamber inside a second elongated vacuum chamber, each of the first and second vacuum chambers having a proximal longitudinal open end adapted to receive a patient'"'"'s extremity and a distal longitudinal end adapted to be in fluid communication with a pressure pump;

(b) placing a patient'"'"'s extremity inside the first vacuum chamber from the proximal longitudinal open end thereof; and

(c) pumping air out of the first vacuum chamber from the distal longitudinal end thereof to create a pressure therewithin.

21. The method of claim 20, further comprising the steps of:

adjusting amount of the pressure to a level that is adequate to pull the patient'"'"'s extremity tight without causing discomfort to the patient;

removing the first vacuum chamber from the second vacuum chamber;

placing the patient'"'"'s extremity inside the second vacuum chamber from the proximal longitudinal open end thereof, the proximal longitudinal open end of the second vacuum chamber being pressed against the patient'"'"'s body to ensure an airtight seal; and

pumping air out of the second vacuum chamber from the distal longitudinal end thereof to create a pressure therewithin.

22. A kit for treating plaque formation in a patient'"'"'s extremity, the kit comprising:

(a) a container;

(b) a pressure pump positioned in the container; and

(c) at least two elongated vacuum chambers positioned in the container, the at least two vacuum chambers comprising an outer vacuum chamber and at least one inner vacuum chamber adapted to be inserted into the outer vacuum chamber, the outer vacuum chamber having a proximal longitudinal end adapted to receive a patient'"'"'s extremity at a preselected time upon a predetermined condition of the patient'"'"'s extremity and a distal longitudinal end adapted to be positioned in fluid communication with the pressure pump, the at least one inner vacuum chamber also having a proximal longitudinal end adapted to receive a patient'"'"'s extremity at a preselected time upon a predetermined condition of the patient'"'"'s extremity and a distal longitudinal end adapted to be positioned in fluid communication with the pressure pump, the outer vacuum chamber having a different inner circumference than the at least one inner vacuum chamber so that a different level of prevention from bending is provided to the patient'"'"'s extremity in the direction of the plaque formation with each of the outer vacuum chamber and the at least one inner vacuum chamber during operation of the pressure pump.

23. A system for treating plaque formation in a patient'"'"'s extremity, the system comprising:

(a) a pressure pump; and

(b) one of at least two elongated vacuum chambers, the vacuum chambers comprising an outer vacuum chamber and at least one inner vacuum chamber adapted to be inserted into the outer vacuum chamber, the outer vacuum chamber having a proximal longitudinal end adapted to receive a patient'"'"'s extremity at a preselected time upon a predetermined condition of the patient'"'"'s extremity and a distal longitudinal end adapted to be positioned in fluid communication with the pressure pump, the at least one inner vacuum chamber also having a proximal longitudinal end adapted to receive a patient'"'"'s extremity at a preselected time upon a predetermined condition of the patient'"'"'s extremity and a distal longitudinal end adapted to be positioned in fluid communication with the pressure pump, the outer vacuum chamber having a different inner circumference than the at least one inner vacuum chamber so that a different level of prevention from bending is provided to the patient'"'"'s extremity in the direction of the plaque formation with each of the outer vacuum chamber and the at least one inner vacuum chamber during operation of the pressure pump.

24. A method for treating plaque formation in a patient'"'"'s extremity, the method comprising the steps of:

(a) placing a patient'"'"'s extremity inside a first elongated vacuum chamber from a proximal longitudinal open end thereof, the proximal longitudinal open end being pressed against the patient'"'"'s body to ensure an airtight seal;

(b) pumping air out of the first vacuum chamber from a distal longitudinal end thereof to create a pressure therewithin;

(c) adjusting amount of the pressure to a level that is adequate to pull the patient'"'"'s extremity tight without causing discomfort to the patient;

(d) removing the first vacuum chamber;

(e) replacing the first vacuum chamber with a second elongated vacuum chamber, the second chamber having a different inner circumference than the first vacuum chamber;

(f) placing the patient'"'"'s extremity inside the second vacuum chamber from a proximal longitudinal open end thereof, the proximal longitudinal open end being pressed against the patient'"'"'s body to ensure an airtight seal;

(g) pumping air out of the second vacuum chamber from a distal longitudinal end thereof to create a pressure therewithin;

(h) adjusting amount of the pressure to a level that is adequate to pull the patient'"'"'s extremity tight without causing discomfort to the patient; and

(i) removing the second vacuum chamber.

25. A system for treating plaque formation in a patient'"'"'s extremity, the system comprising:

(a) a pressure pump; and

(b) one of at least two elongated vacuum chambers positioned in fluid communication with the pressure pump at a distal longitudinal end thereof and adapted to receive a patient'"'"'s extremity at a proximal longitudinal end thereof, one of the at least two vacuum chambers having a different inner circumference for substantially its entire length than another one of the at least two vacuum chambers so that a different level of prevention from bending is provided to the extremity in the direction of the plaque formation with each of the at least two vacuum chambers during operation of the pressure pump.