Method of producing substances with supersaturated gas, transdermal delivery device thereof, and uses thereof

• US 10,130,800 B2
• Filed: 04/19/2012
• Issued: 11/20/2018
• Est. Priority Date: 01/27/2012
• Status: Active Grant

• Current Assignee: Invisiderm, LLC
• Original Assignee: Invisiderm, LLC
• Inventors: Kiss, Norbert
• Primary Examiner(s): Osinski, Bradley J
• Assistant Examiner(s): Darb, Hazma
• Application Number:
  US14/112,896
• Publication Number:
  US 20140044805A1
• Time in Patent Office: 2,406 Days
• Field of Search: 604 23- 26, 604140, 604142, 604147, 604141, 604143, 604144, 604145, 604118
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• CPC Class Codes: A61M 35/30 Gas therapy for therapeutic treatment of the skin
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04

Abstract

The present specification disclosed a noninvasive transdermal delivery device that relates generally to a handheld mechanical apparatus for noninvasive transdermal administration of gas, small to large water-soluble (hydrophilic) pharmaceutical agents, vitamins, and other therapeutic agents. Components of such delivery devices, methods of producing a substance comprising a supersaturated amount of a dissolved gas, as well as, methods of administering a therapeutic agent using such delivery devices and methods of treating a disease or condition using such delivery devices are also disclosed.

Claims

1. A transdermal delivery device comprising:

a) a housing including

i) an external body shell comprising a fluid chamber assembly access cover movably engaged with the external body shell;

ii) an interior compartment including an open-ended delivery outlet and a vapor producing assembly compartment; and

iii) a cartridge retaining container comprising an external covering shell and an internal cartridge compartment configured to hold a compressed therapeutic carbon dioxide gas cartridge, wherein the cartridge retaining container is detachably engaged with the external body shell;

wherein the vapor producing assembly compartment is located between the open-ended delivery outlet and the cartridge retaining container; and

b) a vapor producing assembly including

i) a fluid chamber assembly comprising a fluid container and a removable fluid container cap;

ii) a permeation valve configured to reduce the pressure of a gas removed from the compressed gas cartridge and delivered to the fluid chamber assembly to a pressure of less than 25 psi; and

iii) a delivery outlet configured to release a vapor from the fluid chamber assembly, the vapor comprising liquid particles and a supersaturated amount of dissolved gas;

wherein the vapor producing assembly is substantially contained within the vapor producing assembly compartment.

2. The transdermal delivery device of claim 1, wherein the external covering shell defines the internal cartridge compartment.

3. The transdermal delivery device of claim 1, wherein the device further includes a control switch assembly.

4. The transdermal delivery device of claim 3, wherein the control switch assembly is a mechanical switch or an electronic switch.

5. The transdermal delivery device of claim 1, wherein the compressed gas cartridge is a 16 g compressed gas cartridge.

6. The transdermal delivery device of claim 1, wherein the compressed gas cartridge includes a compressed gas.

7. The transdermal delivery device of claim 1, wherein the permeation valve comprises a permeable member selected from rubber, cork, textile, porous polymer, densely sintered metal or combinations thereof.

8. The transdermal delivery device of claim 1, wherein the fluid is water.

9. The transdermal delivery device of claim 8, wherein the water in the chamber has a pH not greater than 5.0.

10. The transdermal delivery device of claim 8, wherein the water in the chamber has a pH not greater than 4.0.

11. The transdermal delivery device of claim 1, wherein the permeation valve is configured to reduce the pressure of the gas removed from the compressed gas cartridge and delivered to the fluid chamber assembly to a pressure of about 20 psi or about 25 psi.

12. The transdermal delivery device of claim 1, wherein the supersaturated amount of dissolved gas in the vapor is about 600 ppm to about 60,000 ppm.

13. The transdermal delivery device of claim 1, wherein the supersaturated amount of dissolved gas in the vapor is about 1,000 ppm to about 50,000 ppm.

14. The transdermal delivery device of claim 1, wherein the supersaturated amount of dissolved gas in the vapor is about 2,000 ppm to about 40,000 ppm.

15. A transdermal delivery device comprising:

a) a housing including

i) an external body shell comprising a fluid chamber assembly access cover movably engaged with the external body shell;

ii) an interior compartment including an open-ended delivery outlet and a vapor producing assembly compartment; and

iii) a cartridge retaining container comprising an external covering shell and an internal cartridge compartment configured to hold a compressed therapeutic carbon dioxide gas cartridge, wherein the cartridge retaining container is detachably engaged with the external body shell;

wherein the vapor producing assembly compartment is located in between the open-ended delivery outlet and the cartridge retaining container; and

b) a vapor producing assembly including

i) a fluid chamber assembly comprising a fluid container and a removable fluid container cap;

ii) a permeation valve configured to reduce the pressure of the therapeutic carbon dioxide gas removed from the compressed gas cartridge and delivered to the fluid chamber assembly to a pressure below about 25 psi; and

iii) a delivery outlet configured to release a vapor from the fluid chamber assembly, the vapor comprising liquid particles and a supersaturated amount of dissolved gas;

wherein the vapor producing assembly is substantially contained within the vapor producing assembly compartment, and the permeation valve comprises a permeable member selected from cork, textile, porous polymer or combinations thereof.

16. The transdermal delivery device of claim 15, wherein the supersaturated amount of dissolved gas in the vapor is about 2,000 ppm to about 40,000 ppm.