Apparatus for treatment of dermatological conditions

• US 10,406,383 B2
• Filed: 07/18/2011
• Issued: 09/10/2019
• Est. Priority Date: 10/11/2004
• Status: Active Grant

• Current Assignee: CareWear Corp.
• Original Assignee: CareWear Corp.
• Inventors: Luebcke, Peter
• Primary Examiner(s): Roy, Baisakhi
• Assistant Examiner(s): Ip, Jason M
• Application Number:
  US13/137,043
• Publication Number:
  US 20110269693A1
• Time in Patent Office: 2,976 Days
• Field of Search: 600407, 600437, 600439
• CPC Class Codes: A61N 2007/0008 Destruction of fat cells
• CPC Class Codes: A61N 2007/0073 using multiple frequencies
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

This invention relates to ultrasound delivery apparatus comprising flexible arrays of transducers and to methods and topical compositions for the treatment of skin, in particular for the treatment of cosmetic skin conditions and to improve the appearance of sun damaged and/or aged skin; the invention further relates to the use of such apparatus and compositions in methods of treating skin, which methods may incorporate the application of ultrasound. The composition may comprise one or more anti-gfycation agent, one or more anti-oxidant, a dermatologically acceptable excipient and optionally one or more substance capable of inducing expression of a molecular chaperone.

Claims

1. A method for the application of ultrasound to the skin for the treatment of a dermatologic skin condition, comprising:

applying to the skin a gel pad, gel cartridge or free flowing gel comprising a composition that includes one or more hyaluronan; and

applying ultrasound directly or indirectly to an area of the skin where the gel pad, gel cartridge or free flowing gel has been applied, or as a pre-treatment to an area of the skin to which the gel pad, gel cartridge or free flowing gel is to be applied, wherein the ultrasound is applied using a plurality of dual frequency transducers each of which comprises a low frequency transducer element that delivers low frequency ultrasound in the range of 20 kHz to 500 kHz and a high frequency transducer element that is different from the low frequency transducer element and delivers high frequency ultrasound in the range of 0.5 MHz to 3.5 MHz, wherein the spatial average power density of the low frequency ultrasound energy is from 20 to 500 mW/cm², wherein the dual frequency transducers are driven in accordance with a treatment protocol for a dermatologic skin condition so as to deliver a desired sequence of low and high frequency ultrasound to the skin under treatment whereby an ultrasound field moves across the ultrasound transducer elements in a preset pattern and at a preset speed to treat the dermatologic skin condition.

2. The method of claim 1, wherein the method is a method of cosmetic treatment.

3. The method of claim 1, wherein the low frequency ultrasound and the high frequency ultrasound are applied simultaneously.

4. The method of claim 1, wherein the dual frequency transducers are arranged as an array in a flexible material in spaced configuration.

5. The method of claim 1, wherein the composition comprises both a low molecular weight hyaluronan having a molecular weight of less than 1×

10⁶ Da and a high molecular weight hyaluronan having a molecular weight of greater than 1×

10⁶ Da.

6. The method of claim 1, wherein the composition further comprises an anti-glycation agent, and wherein the anti-glycation agent is selected from the group consisting of one or more of alanyl-L-histidine (L-carnosine), N-acetylcysteine, aminoguanidine, D-penicillamine, acetylsalicyclic acid (aspirin), paracetamol, indomethacin and ibuprofen and/or a functional derivative or prodrug thereof.

7. The method of claim 1, wherein the composition further comprises an anti-glycation agent selected from the group consisting of one or more of beta-alanylhistamine (carcinine), N-acetyl-beta-alanylhistamine (N-acetyl carcinine), L-prolyl histamine, and/or N-acetyl-L-carnosine.

8. The method of claim 1, wherein the composition further comprises an anti-oxidant, and wherein the anti-oxidant is selected from the group consisting of one or more of arginine, ascorbic acid, a prodrug or derivative of ascorbic acid, ascorbyl palmitate, magnesium ascorbyl phosphate, trisodium ascorbyl phosphate, anserine, carnosine, opidine, homocarnosine and/or acetylanserine.

9. The method of claim 1, wherein the composition further comprises ascorbic acid, and wherein depolymerization of the hyaluronan is encouraged by the ascorbic acid.

10. The method of claim 1, wherein the composition comprises hyaluronan and ascorbic acid in a hydrogel in the form of a gel pad.

11. A kit comprising an ultrasound apparatus and a gel pad, gel cartridge or free flowing gel, wherein the gel pad, gel cartridge or free flowing gel comprises a composition that includes one or more hyaluronan, wherein the ultrasound apparatus comprises a plurality of dual frequency transducers each of which comprises a low frequency transducer element that delivers low frequency ultrasound of 20 kHz to 500 kHz and a high frequency transducer element that is different from the low frequency transducer element and delivers high frequency ultrasound of 0.5 MHz to 3.5 MHz directly or indirectly to an area of skin where the gel pad, gel cartridge or free flowing gel has been applied, or as a pre-treatment to an area of skin to which the gel pad, gel cartridge or free flowing gel is to be applied, wherein the spatial average power density of the low frequency ultrasound energy is from 20 to 500 mW/cm², and wherein the ultrasound apparatus further comprises a drive circuit operable to drive the dual frequency transducers in accordance with a treatment protocol for a dermatologic skin condition so as to deliver a desired sequence of low and high frequency ultrasound to the skin under treatment whereby an ultrasound field moves across the dual frequency transducers in a preset pattern and at a preset speed to treat the dermatologic skin condition.

12. The kit of claim 11, wherein the composition comprises both a low molecular weight hyaluronan having a molecular weight of less than 1×

10⁶ Da and a high molecular weight hyaluronan having a molecular weight of greater than 1×

10⁶ Da.

13. The kit of claim 11, wherein the composition further comprises an anti-glycation agent, and wherein the anti-glycation agent is selected from the group consisting of one or more of alanyl-L-histidine (L-carnosine), N-acetylcysteine, aminoguanidine, D-penicillamine, acetylsalicyclic acid (aspirin), paracetamol, indomethacin and ibuprofen and/or a functional derivative or prodrug thereof.

14. The kit of claim 11, wherein the composition further comprises an anti-glycation agent selected from the group consisting of one or more of beta-alanylhistamine (carcinine), N-acetyl-beta-alanylhistamine (N-acetylcarcinine), L-prolyl histamine, and/or N-acetyl-L-carnosine.

15. The kit of claim 11, wherein the composition further comprises an anti-oxidant, and wherein the anti-oxidant is selected from the group consisting of one or more of arginine, ascorbic acid, a prodrug or derivative of ascorbic acid, ascorbyl palmitate, magnesium ascorbyl phosphate, trisodium ascorbyl phosphate, anserine, carnosine, opidine, homocarnosine and/or acetylanserine.

16. The kit of claim 11, wherein the composition comprises hyaluronan and ascorbic acid in a hydrogel in the form of a gel pad.

17. The kit of claim 11, wherein the dual frequency transducers are arranged as an array in a flexible material in spaced configuration.

18. The kit of claim 17, wherein each of the dual frequency transducers is capable of delivering low and high frequency ultrasound simultaneously or sequentially.

19. The kit of claim 17, wherein each of the dual frequency transducers is capable of delivering low and high frequency ultrasound along a common axis.

20. The kit of claim 17, wherein each of the dual frequency transducers is capable of delivering ultrasound in a pulsed mode or a continuous mode.

21. The kit of claim 17, wherein the array of dual frequency transducers is controllable.

22. The kit of claim 11, wherein the preset pattern comprises one or more of:

movement from left to right or vice versa across a full width of the array;

movement up and down the array; and

movement into the center of the array and then out again.

23. The kit of claim 17, further comprising an ultrasound generator.

24. The kit of claim 23, wherein each of the dual frequency transducers is individually connected to the ultrasound generator.

25. The kit of claim 17, wherein each of the dual frequency transducers is capable of delivering low frequency ultrasound at a frequency of 50 kHz.

26. The kit of claim 17, wherein each of the dual frequency transducers is capable of delivering high frequency ultrasound at a frequency in the range of 1 MHz to 3 MHz.

27. The kit of claim 17, wherein the spatial average power density of the high frequency ultrasound energy is from 0.5 to 3 W/cm².

28. The kit of claim 17, wherein the array of dual frequency transducers is programmable so as to deliver the desired sequence of low and high frequency ultrasound to the skin under treatment.