Patch, controller, and method for the photodynamic therapy of a dermal lesion

• US 6,231,593 B1
• Filed: 07/24/1998
• Issued: 05/15/2001
• Est. Priority Date: 03/21/1994
• Status: Expired due to Term

• Current Assignee: DUSA Pharmaceuticals Incorporated (Sun Pharmaceutical Industries Limited)
• Original Assignee: DUSA Pharmaceuticals Incorporated (Sun Pharmaceutical Industries Limited)
• Inventors: Meserol, Peter M.
• Primary Examiner(s): Leubecker, John P.
• Assistant Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/000,360
• Time in Patent Office: 1,026 Days
• Field of Search: 607/88-93, 606/9, 604/20
• US Class Current: 607/88
• CPC Class Codes: A61F 13/00051 Accessories for dressings
• CPC Class Codes: A61F 13/0213 the fluid retention member being a layer of hydrocolloid, gel forming material
• CPC Class Codes: A61F 2013/00365 use
• CPC Class Codes: A61F 2013/00676 hydrogel
• CPC Class Codes: A61F 2013/00846 with transparent or translucent part
• CPC Class Codes: A61F 2013/00902 containing means
• 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: 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
• CPC Class Codes: A61N 2005/0645 Applicators worn by the patient
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent

Abstract

An apparatus for photodynamic therapy (PDT) includes a cover (22) shaped to engage skin tissue (12) and a fiber optic panel (31) housed within the cover (22). Hydrogel (26) is located within the cover (22) and is in intimate physical and optical contact with the fiber optic panel (31) for optically coupling light from the fiber optic panel (31) to the skin tissue (12). The hydrogel (26) engages the stratum corneum (14) and hydrates and softens the stratum corneum (14) to enhance its optical transmissiveness to facilitate the transmission of light therethrough and to enhance its chemical transmissiveness to facilitate the transmission therethrough of photopharmaceuticals (28, 54) for treatment of a dermal lesion 10.

Claims

1. An apparatus for photodynamic therapy of tissue, the apparatus comprising:

a source of light for irradiating said tissue with activating light;

a fluid adapted to be in intimate physical contact with the location of said tissue exposed to said light; and

at least one pharmaceutical which is activated by said source of light, wherein the pharmaceutical is adapted to be included in said fluid or provided separately at the location of said tissue, and wherein said fluid is a shapeable hydrogel which is transparent to said activating light.

2. An apparatus according to claim 1, wherein said hydrogel includes said at least one pharmaceutical.

3. An apparatus according to claim 1, wherein said hydrogel is in intimate contact with said source of light.

4. An apparatus according to claim 1, wherein said source of light emits monochromatic light.

5. An apparatus according to claim 1, wherein said source of light is a fiber optic panel.

6. An apparatus according to claim 5, wherein said fiber optic panel is connected to receive light from a laser diode via an optical fiber bundle.

7. An apparatus according to claim 6, wherein said cover includes an internal surface defining a chamber for receiving said hydrogel, wherein said hydrogel resides in said chamber, and wherein said cover further comprises a reflective layer provided on said internal surface for reflecting said light through said hydrogel and to said dermal treatment site.

8. An apparatus according to claim 1 for applying photodynamic therapy to a dermal lesion located at a dermal treatment site of the skin including the stratum corneum, comprising:

a controller and patch for applying photodynamic therapy to the dermal lesion; and

a light delivery unit,

wherein said hydrogel contains a hydration agent, wherein the controller includes said source of light, wherein said source of light is connected to said light delivery unit, wherein said patch is secured to said skin over the dermal treatment site to cause said hydrogel to engage the stratum corneum to cause said hydration agent to hydrate the stratum corneum to enhance its chemical transparency to permit the at least one pharmaceutical to pass therethrough and enter the dermal treatment site and to enhance the optical transparency of the stratum corneum to facilitate the passage therethrough of light, and wherein said light delivery unit delivers said light through said transparent hydrogel and said hydrated stratum corneum to said at least one pharmaceutical at the dermal treatment site to photoactivate said at least one pharmaceutical to cause said at least one pharmaceutical to biologically engage and treat the dermal lesion.

9. An apparatus according to claim 8, wherein said patch includes a cover provided with a seal for sealing said cover over the dermal treatment site to cover the dermal treatment site, wherein said transparent hydrogel includes a water matrix providing said hydration agent and wherein said at least one pharmaceutical is absorbed into said water matrix.

10. An apparatus according to claim 9, wherein said source of light is a laser providing laser light, wherein said light delivery unit comprises an array of optical fibers for emitting laser light from sides thereof, wherein said cover is provided with an internal reflective surface for reflecting said laser light through said hydrogel and said hydrated stratum corneum into the dermal treatment site, wherein said hydrogel is castable, and wherein said hydrogel is cast into intimate physical and optical engagement with said array of optical fibers.

11. An apparatus according to claim 8, wherein said seal comprises a layer of adhesive applied to a peripheral portion of said cover for sealingly engaging the skin to seal said cover to the skin over the dermal treatment site.

12. An apparatus according to claim 8, wherein said hydrogel comprises a first layer of hydrogel in said patch, and a second layer of hydrogel in said patch residing intermediate said first layer of hydrogel and the dermal treatment site, wherein said first layer of hydrogel includes a water matrix providing said hydration agent, wherein said second layer of hydrogel is smaller in size than said first layer and is generally shaped to cover substantially only a dermal lesion located at the dermal treatment site, and wherein said second layer of hydrogel includes a water matrix into which said at least one pharmaceutical is absorbed.

13. An apparatus according to claim 7, wherein said controller includes a power supply for providing power to said source of light, and wherein said controller includes a computer for control by a patient receiving the photodynamic therapy, said computer connected to said power supply to permit said patient to control the amount of power supplied to said source of light and the time said power supply supplies power to said source of light to thereby permit the patient to control and vary the photodynamic therapy applied to the dermal lesion.

14. An apparatus according to claim 1 for photodynamic therapy of a dermal lesion located at a dermal treatment site on skin which includes the stratum corneum, comprising:

a cover which seals to the skin for covering and defining a dermal treatment site and for providing a chamber opposite the dermal treatment site; and

a light delivery unit,

wherein said hydrogel contains a hydration agent and said at least one pharmaceutical, wherein said hydrogel resides in said chamber and engages the skin at the dermal treatment site causing said hydration agent to hydrate the stratum corneum at the dermal treatment site enhancing the passage therethrough of light and said at least one pharmaceutical; and

wherein the light delivery unit is mounted to and inside of said cover and resides in said chamber and photoactivates said at least one pharmaceutical at said dermal treatment site causing said at least one pharmaceutical to treat the dermal lesion.

15. An apparatus according to claim 14, wherein said light delivery unit comprises a fiber optic laser light-emitting panel having a plurality of optical fibers provided with side openings for the lateral transmission of laser light therethrough to photoactivate said at least one pharmaceutical.

16. An apparatus according to claim 14, wherein said cover includes a lower portion having an outwardly extending peripheral portion and a layer of adhesive applied to said peripheral portion for sealingly engaging the skin to seal said cover to the skin over said dermal treatment site.

17. An apparatus according to claim 1 for photodynamic therapy of a dermal lesion located at a dermal treatment site on skin which includes the stratum corneum, comprising:

a cover which seals to the skin for covering and defining a dermal treatment site and for providing a chamber opposite the dermal treatment site; and

a light delivery unit,

wherein said hydrogel is contained in said chamber and covers the dermal treatment site, wherein said hydrogel contains at least one hydration agent and said pharmaceutical, wherein said hydrogel couples said hydration agent to the stratum corneum at the dermal treatment site to hydrate and soften the stratum corneum to enhance the optical transmissiveness of the stratum corneum to facilitate the transmission of light therethrough and to enhance its chemical transmissiveness to facilitate the transmission therethrough of said at least one pharmaceutical for treatment of the dermal lesion, wherein the light delivery unit is mounted to and inside said cover, and wherein the light delivery unit delivers light, through said hydrogel and through the hydrated stratum corneum, which illuminates the dermal treatment site by light diffusion and which photoactivates said at least one pharmaceutical at said dermal treatment site to treat the dermal lesion.

18. A method of applying photodynamic therapy to a dermal lesion located at a dermal treatment site in skin which includes the stratum corneum, comprising the steps of:

hydrating the stratum corneum at the dermal treatment site with a transparent hydrating agent containing at least one photopharmaceutical so as to enhance the chemical and optical transparency of the stratum corneum at the dermal treatment site and to enhance the passage therethrough of said photopharmaceutical and light;

utilizing the transparent hydrating agent to introduce said photopharmaceutical into the dermal treatment site through the hydrated stratum corneum; and

introducing light into the dermal treatment site through the hydrated stratum corneum to photoactivate the photopharmaceutical to treat the dermal lesion.

19. A method of applying photodynamic therapy to a dermal lesion located at a dermal treatment site in skin which includes the stratum corneum, comprising the steps of:

providing a body of transparent hydrogel including a water matrix which acts as a hydrating agent;

introducing photopharmaceutical into said hydrogel;

engaging the dermal treatment site with said hydrogel to cause said water to hydrate the stratum corneum at the dermal treatment site to enhance the chemical and optical transparency of the stratum corneum at the dermal treatment site and to cause said photo-pharmaceutical to be introduced into the dermal treatment site; and

applying light through said transparent hydrogel to the dermal treatment site to photoactivate said photopharmaceutical at the dermal treatment site to cause said photoactivated photopharmaceutical to biologically engage and treat the dermal lesion.

20. A method of applying photodynamic therapy to a dermal lesion located at a dermal treatment site in skin which includes the stratum corneum, comprising the steps of:

providing first and second transparent bodies of hydrogel, said bodies of hydrogel including a water matrix, water in said first body of hydrogel acting as a hydrating agent, said second body of hydrogel being less hydrated than said first body of hydrogel and being sufficiently dehydrated to permit said second body of hydrogel to be cut;

introducing photopharmaceutical into said second body of hydrogel;

cutting said second body of hydrogel into substantially the same shape as the dermal lesion;

applying said first and second bodies of hydrogel to said dermal treatment site with said second body of hydrogel being in direct engagement with the skin at the dermal treatment site to cause said water in said first body of hydrogel to hydrate the stratum corneum at the dermal treatment site to soften and render the stratum corneum thereat more transparent to the passage therethrough of photopharmaceutical and light and to cause said photopharmaceutical to be introduced into the dermal treatment site; and

introducing light into the dermal treatment site through the first and second bodies of hydrogel and softened stratum corneum to photoactivate the photopharmaceutical at the dermal treatment site to cause the photoactivated photopharmaceutical to biologically engage and treat the dermal lesion.

21. A method of applying photodynamic therapy to a dermal lesion located at a dermal treatment site in skin which includes the stratum corneum, comprising the steps of:

using transparent hydrogel containing a photopharmaceutical and water acting as a hydrating agent to hydrate the stratum corneum substantially overlying the dermal lesion and to fluidly introduce the photopharmaceutical through the hydrated stratum corneum to the dermal lesion; and

using said transparent hydrogel to optically couple light through the hydrated stratum corneum to photoactivate e the photopharmaceutical to cause it to biologically engage and treat the dermal lesion.

22. In a method of treating a dermal lesion including the steps of introducing photopharmaceutical to the dermal lesion and introducing light to the photo-pharmaceutical at the dermal lesion to photoactivate the photopharmaceutical to treat the dermal lesion, wherein the improvement comprises:

introducing the photopharmaceutical into transparent hydrogel including a water matrix which acts as a hydrating agent; and

using said hydrogel to couple the photopharmaceutical and light to the stratum corneum of skin substantially overlying the dermal lesion to hydrate the stratum corneum to enhance its transmissiveness to the photopharmaceutical and to the light and introducing the photopharmaceutical to the dermal lesion through the hydrated stratum corneum and introducing the light through the transparent hydrogel and softened stratum corneum to photoactivate the photopharmaceutical and to cause the photoactivated photopharmaceutical to biologically engage and treat the dermal lesion.

23. In a method of treating a dermal lesion including the steps of introducing a photopharmaceutical to the dermal lesion and introducing light to the photo-pharmaceutical at the dermal lesion to photoactivate the photopharmaceutical to treat the dermal lesion, the improvement comprising:

introducing a photopharmaceutical chosen from a group consisting of 5-amino-levulinic acid (5-ALA), hematoporphyrin (HpD), Photofrin II and equivalents into transparent hydrogel comprising a homogeneous uniform mixture of water and at least one water-soluble high molecular weight polymer which acts as a hydrating agent; and

using said hydrogel to couple the photopharmaceutical and light to the stratum corneum of skin substantially overlaying the dermal lesion to hydrate the stratum corneum sufficiently to enhance its transmissiveness to the photopharmaceutical and light and introducing the photopharmaceutical to the dermal lesion through the hydrated stratum corneum and introducing monochromatic light at substantially 635 nm through the transparent hydrogel and hydrated stratum corneum to photoactivate the photopharmaceutical and to cause the photoactivated photopharmaceutical to biologically engage and treat the dermal lesion.

24. A method of photodynamic therapy which comprises the step of applying to a tissue a photopharmaceutical in a shapeable water-containing coupling agent which is transparent to light used for said photodynamic therapy.

25. A shapeable hydrogel for use in photodynamic therapy of tissue, wherein said hydrogel is transparent to light used in said photodynamic therapy, and wherein said hydrogel contains at least one pharmaceutical which is activatable by said light.