Treatment device for photodynamic therapy and method for making same

• US 6,743,249 B1
• Filed: 02/25/2000
• Issued: 06/01/2004
• Est. Priority Date: 08/25/1997
• Status: Expired due to Term

• Current Assignee: Advanced Photodynamic Technologies, Inc. (Ondine Biomedical, Inc.)
• Original Assignee: Philip G. Alden
• Inventors: Alden, Philip G.
• Primary Examiner(s): Gibson, Roy D.
• Assistant Examiner(s): Vrettakos, Peter J
• Application Number:
  US09/513,573
• Time in Patent Office: 1,558 Days
• Field of Search: 607/88-90, 607/92, 606/1, 606/2, 606/3, 606/9, 606/10, 606/11-16
• US Class Current: 607/88
• CPC Class Codes: A61B 2017/00057 Light
• CPC Class Codes: A61N 2005/005 for cooling the radiator
• CPC Class Codes: A61N 2005/007 for cooling the patient
• CPC Class Codes: A61N 2005/0606 Mouth
• CPC Class Codes: A61N 2005/0645 Applicators worn by the patient
• CPC Class Codes: A61N 2005/0652 Arrays of diodes
• CPC Class Codes: A61N 5/0601 Apparatus for use inside the body
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent

Abstract

A light-emitting treatment device including one or more light-emitting elements disposed in a flexible and stretchable pad (or a body-conforming shaped article) defining a skin- or tissue-adhering surface having an inherently tacky characteristic for secure application to the skin, tissue, or other external or internal regions of the patient'"'"'s body. The light-emitting treatment device is configured to contact and adhere to the skin or tissue of a patient, and irradiate an underlying region for photodynamic therapy. The treatment device may be fabricated from a shell member and a filler material (such as a molded silicone rubber shell member and a silicone gel filler material), to provide a skin-adhering, peelable, washable, and repositionable contact surface.

Claims

1. A light-emitting treatment device for irradiating a region of a patient'"'"'s body to be treated using one or more light-emitting elements which emit a light, the light-emitting treatment device comprising:

a support member fabricated from a flexible pad of a material which at least partially encapsulates the one or more light-emitting elements and intrinsically defines a tissue-adhering surface having an inherently tacky characteristic, the one or more light-emitting elements being disposed on the flexible pad and configured to irradiate the region of the patient'"'"'s body with a portion of the material forming the flexible pad being interposed between the one or more light-emitting elements and the tissue-adhering surface such that the light is transmitted through the portion of the material disposed between the one or more light-emitting members and the tissue-adhering surface, so that the tissue-adhering surface of the support member is placed in contact with the patient'"'"'s body proximate to or covering the region to be irradiated, and the support member conforms and adheres to the patient'"'"'s body such that the one or more light-emitting elements irradiate the region of the patient'"'"'s body to be treated.

2. The light-emitting treatment device of claim 1 wherein the support member comprises:

a shell member defining an area for receiving the one or more light-emitting elements; and

a liner material disposed on or within the shell member and at least partially encompassing the one or more light-emitting elements, the liner material defining the tissue-adhering surface for contacting the patient'"'"'s body proximate to the region being irradiated.

3. The light-emitting treatment device of claim 2 wherein the shell member is fabricated from a molded silicone rubber.

4. The light-emitting treatment device of claim 2 wherein the liner material is fabricated from a curable silicone gel.

5. The light-emitting treatment device of claim 2 wherein the shell member defines a cavity receiving the one or more light-emitting elements, and the liner material is a cured gel disposed within the cavity at least partially encompassing the one or more light-emitting elements.

6. The light-emitting treatment device of claim 5 wherein the shell member and the liner material have flexibility characteristics comparable to one another, such that the shell member and the liner material may be flexed or stretched sufficiently for application to an irregularly-shaped portion of the patient'"'"'s body without separating from one another.

7. The light-emitting treatment device of claim 5 wherein the shell member and the liner material form a substantially unitary and integral assembly.

8. The light-emitting treatment device of claim 1 wherein the support member is a substantially flexible pad which conforms to the portion of the patient'"'"'s body to which the flexible pad is adhered.

9. The light-emitting treatment device of claim 1 wherein the tissue-adhering surface of the support member may be peeled off the patient'"'"'s body, washed, and subsequently repositioned on the patient'"'"'s body while the tissue-adhering surface maintains the inherently tacky characteristic.

10. The light-emitting treatment device of claim 1 wherein the tissue-adhering surface of the support member will responsively peel off the patient'"'"'s body when sufficient lateral force is applied to the support member by stretching the support member across the portion of the patient'"'"'s body above a predetermined threshold for normal use in photodynamic therapy.

11. The light-emitting treatment device of claim 1 wherein a portion of the liner material which defines the tissue-adhering surface covers the light-emitting elements and is disposed between the light-emitting elements and the region of patient'"'"'s body being treated.

12. The light-emitting treatment device of claim 1 wherein the one or more light-emitting elements are entirely embedded within the material.

13. The light-emitting treatment device of claim 1 wherein the material interposed between the one or more light-emitting elements and the tissue-adhering surface diffuses the light as the light is transmitted through the material.

14. A method for fabricating a light-emitting treatment device utilizing one or more light-emitting elements for irradiating a region of a patient'"'"'s body, the method comprising the steps of:

providing a substrate member;

positioning the one or more light-emitting elements on an area of the substrate member;

disposing a covering material in an uncured state onto the substrate member so that the covering material at least partially encompass the one or more light-emitting elements, the covering material defining a tissue-adhering surface which has an inherently tacky characteristic, the tissue-adhering surface being generally exposed; and

curing the covering material such that the tissue-adhering surface remains exposed and retains the inherently tacky characteristic, so that in use the tissue-adhering surface of the covering material may be placed in contact with and adhere to the patient'"'"'s body proximate to or in overlying relation to the region to be irradiated, and the substrate member and covering material will conform to the patient'"'"'s body such that the one or more light-emitting elements irradiate the region of the patient'"'"'s body to be treated.

15. The method of claim 14 wherein the step of providing the substrate member further comprises the step of:

injection molding the substrate member using a silicone rubber material.

16. The method of claim 14 wherein the substrate member defines a cavity receiving the one or more light-emitting elements and the step of disposing the covering material onto the substrate member further comprises the step of:

pouring the covering material in the uncured state as a viscous liquid into the cavity defined by the substrate member so as to at least partially cover the light-emitting elements.

17. The method of claim 16 wherein the covering material is a silicone gel material.

18. The method of claim 14 wherein the light-emitting treatment device is applied to an irregularly-shaped portion of a patient'"'"'s body, and further wherein the substrate member and the covering material form a substantially unitary and integral assembly upon the curing of the covering material, such that the substrate member and the covering material may be flexed or stretched sufficiently for application to the irregularly-shaped portion of the patient'"'"'s body without separating from one another.

19. A method for fabricating a light-emitting treatment device utilizing one or more light-emitting members for irradiating a region of a patient'"'"'s body with light, the method comprising the steps of:

embedding the one or more light-emitting elements in a material forming a tissue-contacting surface; and

curing the material, such that when the material is cured the tissue-contacting surface intrinsically has an inherently tacky characteristic, so that in use the tissue-contacting surface may be placed in contact with and adhere to the patient'"'"'s body proximate to or covering the region to be irradiated, and the light-emitting treatment device will conform to the patient'"'"'s body such that the one or more light-emitting elements irradiate the region of the patient'"'"'s body to be treated.

20. The method of claim 19 wherein the step of embedding the one or more light-emitting members in the material includes disposing a portion of the material between the one or more light-emitting members and the tissue-contacting surface, such that the light is transmitted through the portion of the material disposed between the one or more light-emitting members and the tissue-contacting surface.