Wound treatment device for photodynamic therapy and method of using same

• US 20060173514A1
• Filed: 02/02/2005
• Published: 08/03/2006
• Est. Priority Date: 02/02/2005
• Status: Abandoned Application

• Current Assignee: Advanced Photodynamic Technologies, Inc. (Ondine Biomedical, Inc.)
• Original Assignee: Advanced Photodynamic Technologies, Inc. (Ondine Biomedical, Inc.)
• Inventors: Sievert, Chester E. Jr., Biel, Merrill A.
• Application Number:
  US11/050,349
• Publication Number:
  US 20060173514A1
• Time in Patent Office: Days
• US Class Current: 607/88
• CPC Class Codes: A61F 13/023 wound covering film layers without a fluid retention layer
• CPC Class Codes: A61F 2013/00187 insulating; warmth or cold applying
• CPC Class Codes: A61F 2013/00523 with hydrogel
• CPC Class Codes: A61F 2013/00646 Medication patches, e.g. transcutaneous
• CPC Class Codes: A61F 2013/0091 with disinfecting or anaesthetics means, e.g. anti-mycrobic
• CPC Class Codes: A61F 2013/00919 for physical therapy, e.g. cold or magnetic
• CPC Class Codes: A61K 41/0057 Photodynamic therapy with a photosensitizer, i.e. agent able to produce reactive oxygen species upon exposure to light or radiation, e.g. UV or visible light; photocleavage of nucleic acids with an agent
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61K 9/703 characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
• CPC Class Codes: A61K 9/7084 Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
• 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: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 2005/0628 including a radiation sensor
• CPC Class Codes: A61N 2005/0645 Applicators worn by the patient
• CPC Class Codes: A61N 2005/0652 Arrays of diodes
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent

Abstract

The invention relates to a light emitting treatment device including one or more light members, which are configured to emit light energy for the purpose of performing localized photodynamic therapy at a targeted field. The light members may be disposed in a substantially uniform array and be configured to emit energy in a substantially uniform pattern. The light treatment device has a self-contained energy supply. The light emitting treatment device may be controlled to deliver one or more various light doses and dose rates at various light frequencies per treatment. The treatment device may be made of a polymeric material configured to conform to a body surface. The treatment device may contain the photosensitizer. The light emitting treatment device may further include a heat dissipating layer such as a layer of gold or gold alloy, or a layer of adhesive disposed on at least one of the one or more surfaces. Methods of using the treatment device are also disclosed.

Claims

1. An assembly comprising:

a flexible dressing adapted to contact a tissue surface;

a light source being powered by an energy source, said light passing through at least a portion of the dressing to illuminate the tissue surface, and said light promoting a therapeutic photodynamic reaction of a photosensitive material; and

an adhesive element for adhesively securing the dressing to the tissue surface.

2. The assembly of claim 1 wherein the flexible dressing is a polymer or copolymer or a silicone or a foam or a combination thereof.

3. The assembly of claim 1 wherein the photosensitive material is either incorporated within the flexible dressing or provided separately from the dressing.

4. The assembly of claim 1 further comprising a light diffuser, said light diffuser being incorporated within the dressing or being an element separate from the dressing.

5. The assembly of claim 4 wherein the flexible dressing has non-uniform diffusivity so that the light intensity applied to the tissue surface is non-uniform.

6. The assembly of claim 1 wherein the adhesive element extends beyond at least part of the flexible dressing.

7. The assembly of claim 1 further comprising:

a reflective element for reflecting light from the light source back toward the tissue surface, said light source being disposed between the reflective layer and the tissue surface.

8. The assembly of claim 7 wherein the reflective element is a reflective layer or a reflective portion of the light source.

9. The assembly of claim 1 wherein the light source is a sheet illuminator.

10. The assembly of claim 1 wherein the light source includes a plurality of VCSEL elements.

11. The assembly of claim 1 wherein the light source is an LED or an OLED or a laser diode or a light emitting plastic or a chemoluminescent material or a combination thereof.

12. The assembly of claim 1 wherein the light source provides a light dosage rate of between 0.1 mW/cm² and 200 mW/cm².

13. The assembly of claim 11 wherein the light source provides a light dosage rate of between 1 mW/cm² and 20 mW/cm².

14. The assembly of claim 12 wherein the light source provides a light dosage rate of between 5 mW/cm² and 20 mW/cm².

15. The assembly of claim 1 wherein the light source provides a light having variable wavelengths that are controlled by a controller.

16. The assembly of claim 1 wherein in the light source is cycled by a controller between an ON state and a substantially OFF state during a treatment protocol utilizing the assembly.

17. The assembly of claim 1 wherein the light source is in its ON state for a period of minutes and then in its substantially OFF period for a period of nanoseconds to hours.

18. The assembly of claim 1 further comprising a surface-acting agent at or near the tissue surface.

19. The assembly of claim 18 wherein the surface-acting agent is provided within the dressing.

20. The assembly of claim 18 wherein the surface-acting agent is provided at or near the tissue surface before or after application of the assembly to the tissue surface.

21. The assembly of claim 18 wherein the surface acting agent contains benzalkonium chloride.

22. The assembly of claim 21 wherein the surface acting agent contains benzalkonium chloride provided in a concentration range of between 0.005% to 0.05%.

23. The assembly of claim 21 wherein the surface acting agent contains polymyxin B sulfate or cetrimide or both.

24. The assembly of claim 23 wherein the energy source includes a battery attached to the assembly.

25. The assembly of claim 24 wherein the battery is controlled by an electronic circuit and/or processor that controls the voltage or current or both applied to the light source so that a light intensity of the light source is generally uniform during application of the assembly at the tissue surface.

26. The assembly of claim 24 wherein the battery is rechargeable through a direct connection or electromagnetic coupling to a remote energy source.

27. The assembly of claim 1 further comprising an electronic circuit or processor for controlling operation of the light source.

28. The assembly of claim 27 wherein the circuit or processor controls the light dose rate or the light intensity or the light wavelengths or a combination thereof.

29. The assembly of claim 1 further comprising an electronic circuit or processor for communicating information associated with the assembly or operation thereof to a remote transceiver.

30. The assembly of claim 1 further comprising a memory element for storing information relating to the assembly or operation thereof.

31. The assembly of claim 27 wherein the electronic circuit or processor is controlled via a remote controller.

32. The assembly of claim 29 wherein the electronic circuit or processor is controlled via a remote controller.

33. The assembly of claim 1 further comprising a fabric element that extends beyond a perimeter of the dressing.

34. The assembly of claim 33 wherein the adhesive element is an adhesive layer between the dressing element and the tissue surface.

35. The assembly of claim 1 further comprising an electrode coupled to a power supply and activated to effect an iontophoretic transfer of a photosensitive material or surfactant into the tissue surface.

36. The assembly of claim 1 wherein the light source provides light having wavelengths of between 380 nm to 900 nm.

37. A method of utilizing the assembly of claim 1 comprising the steps of:

administering a photosensitive material to a tissue site;

adhering the assembly of claim 1 at the tissue site; and

illuminating the tissue site with the light source to provide a therapeutic photodynamic reaction of the photosensitive material at the tissue site.

38. The method of claim 37 wherein the tissue site includes tumor cells or cancer cells or microorganisms or virulence factors or combinations thereof.

39. The method of claim 37 further comprising the step cycling between a period of heightened illumination and a period of substantially reduced illumination.

40. The method of claim 37 further comprising the step of administering a surface-acting agent to the tissue site before or after the step of adhering the assembly at the tissue site.

41. The method of claim 37 further comprising the step of coupling an electrode to a power supply within the assembly to effect an iontophoretic transfer of a photosensitive material or surfactant into the tissue site.

42. A portable assembly adapted to be secured upon a tissue surface comprising:

a source of light powered by a battery;

a flexible dressing adapted to contact a tissue surface, said light passing through at least a portion of the dressing to illuminate the tissue surface, and said light promoting a therapeutic photodynamic reaction of a photosensitive material administered at or near the tissue surface; and

an adhesive element for securing the dressing to the tissue surface.

43. The portable assembly of claim 42 further comprising a light reflector for reflecting light from the light source toward the tissue site.

44. The portable assembly of claim 42 wherein the flexible dressing is a polymer or copolymer or a silicone or a foam or a combination thereof

45. The portable assembly of claim 42 wherein in the light source is cycled between an ON state and a substantially OFF state during a treatment protocol utilizing the portable assembly.

46. The portable assembly of claim 42 further comprising a surface-acting agent at the tissue surface.

47. The portable assembly of claim 42 wherein the surface acting agent is provided within the dressing.

49. The portable assembly of claim 42 further comprising an outer fabric element that extends beyond a perimeter of the dressing.

50. The portable assembly of claim 42 further comprising an electrode capable of being coupled to a power supply for effecting an iontophoretic transfer of a photosensitive material or surfactant into the tissue site.

51. The portable assembly of claim 50 wherein the iontophoretic transfer is achieved with a current density of between 0.15-0.60 mA/cm².

48. The portable assembly of 42 wherein the surface acting agent contains polymyxin B sulfate or cetrimide or benzalkonium chloride or a combination thereof.