Method and device for applying hyperthermia to enhance drug perfusion and efficacy of subsequent light therapy

• US 5,814,008 A
• Filed: 07/29/1996
• Issued: 09/29/1998
• Est. Priority Date: 07/29/1996
• Status: Expired due to Term

• Current Assignee: Purdue Pharmaceutical Products LP (Purdue Pharma L.P.)
• Original Assignee: Light Sciences Limited Partnership
• Inventors: Chen, James C., Wiscombe, Brent
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/688,058
• Time in Patent Office: 792 Days
• Field of Search: 604/19-22, 604/49, 604/113, 604/114, 607/88-89, 607/98, 607/99
• US Class Current: 604/21
• CPC Class Codes: A61N 2005/0644 Handheld applicators
• 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 method and apparatus for applying beat to a treatment site prior to effecting photodynamic therapy. The perfusion of a drug into abnormal tissue in a tumor (12) is enhanced by heating the treatment site at which the tumor is disposed using a heat source (26) mounted on a fixture (20, 34) separate from a light source (28) on a probe used to effect the photodynamic therapy. Alternatively, the heat source and light source may comprise different types of light emitting diodes (LEDs) arranged in an array on a probe (14) disposed at the treatment site. Also mounted on the fixture is a temperature sensor (30), which produces a signal indicative of the temperature at the treatment site. In response to this signal, a controller (24/36) controls the heat source to prevent vascular damage. In addition to enhancing the perfusion of a photoreactive agent into the treatment site, heating the tissue at the site prior to initiating the PDT greatly enhances the efficacy of this treatment.

Claims

1. A method for increasing a perfusion of a drug through tissue at a treatment site where photodynamic therapy is to be administered, comprising the steps of:

a) positioning a probe having thereon a light emitting means for administering photodynamic therapy so that the probe is disposed adjacent to the treatment site, said probe further including means thereon for providing heat separate from said light emitting means;

b) energizing the means for providing heat to supply heat to the tissue at the treatment site without energizing the light emitting means, said heat raising the temperature of the tissue; and

c) delivering the drug to the tissue at the treatment site, an elevated temperature of the tissue caused by the heat increasing the perfusion of the drug through the tissue at the treatment site to enhance an effect of the drug on the tissue.

2. The method of claim 1, wherein the drug comprises a photoreactive agent, further comprising the step of supplying light from a light source on the fixture to irradiate the tissue at the treatment site after the perfusion of the photoreactive agent through the tissue has been increased by heating the tissue, said light being used to administer the photodynamic therapy.

3. The method of claim 2, wherein the probe includes:

(a) a first light source that is adapted to emit a light having a first waveband that substantially overlaps a characteristic absorption waveband of the drug delivered to the tissue at the treatment site, said first light source being energized to administer the photodynamic therapy; and

(b) a second light source that is adapted to emit a light having a second waveband substantially different from the first waveband, said second light source comprising the means for providing heat, the light emitted by the second light source thus heating the tissue, but generally not effecting the photodynamic therapy.

4. The method of claim 1, wherein the probe includes a plurality of light sources, said means for providing heat comprising at least a portion of the light sources.

5. The method of claim 1, further comprising the steps of:

(a) monitoring a temperature of the tissue at the treatment site, producing a signal indicative of the temperature;

(b) controlling the means for providing heat in response to the signal indicative of the temperature of the tissue at the treatment site so that said temperature does not exceed a level that would cause vascular damage at the treatment site.

6. The method of claim 1, wherein the treatment site is internal to a patient'"'"'s body and the probe is disposed at the internal treatment site to provide heat and administer the photodynamic therapy, said fixture comprising a probe that is adapted to be left within the patient'"'"'s body for an extended period of time, while the photodynamic therapy is administered.

7. The method of claim 1, wherein the drug is used for a medical treatment other than the photodynamic therapy.

8. The method of claim 1, wherein the means for providing heat comprise a resistance heating element that produces heat in response to an electrical current flowing through the resistance element.

9. The method of claim 1, wherein the treatment site is heated to an elevated temperature prior to delivering the drug to the tissue at the treatment site.

10. The method of claim 1, wherein the drug is carried to the treatment site by a heat sensitive drug carrier that releases the drug when the treatment site is heated to an elevated temperature.

11. Apparatus for increasing a perfusion of a drug through tissue at a treatment site where photodynamic therapy is to be administered, comprising:

a) a probe configured to be placed at the treatment site having means thereon for emitting light; and

b) said probe having means for heating the tissue at the treatment site separate from said light emitting means to increase the perfusion of the drug into the tissue, said means for heating being disposed on the probe; and

c) a controller connected to said light emitting means which allows the light emitting means to be energized without energizing the heating means.

12. The apparatus of claim 11, further comprising a light source disposed on the fixture, wherein the treatment site is disposed internally of a patient'"'"'s body, and wherein the probe is adapted to be inserted internally of the patient'"'"'s body at the treatment site, said light source being capable of emitting a light that is directed toward the tissue at the treatment site to effect the photodynamic therapy.

13. The apparatus of claim 12, wherein the light source comprises a plurality of light emitting devices mounted to the fixture, at least a portion of said light emitting devices being adapted to produce a light having a waveband corresponding to a characteristic absorption waveband of a photoreactive agent comprising the drug.

14. The apparatus of claim 13, wherein the means for heating the tissue comprise a plurality of light emitting devices that are mounted to the probe and produce light having a waveband substantially different than the characteristic absorption waveband of the photoreactive agent.

15. The apparatus of claim 14, wherein the means for heating and the light source are each selectively separately controlled.

16. The apparatus of claim 11, wherein the means for heating comprise a plurality of light emitting devices arranged in a spaced-apart array.

17. The apparatus of claim 11, further comprising a temperature sensor disposed on the probe, said temperature sensor being adapted to produce a signal indicative of a temperature of the tissue at the treatment site.

18. The apparatus of claim 17, further comprising means for controlling the means for heating in response to the signal indicative of the temperature, so that the temperature of the tissue does not exceed a level that causes vascular damage.

19. The apparatus of claim 18, wherein the means for controlling are adapted to be disposed internally of a patient'"'"'s body.

20. The apparatus of claim 18, wherein the means for controlling are adapted to be disposed externally of a patient'"'"'s body.

21. The apparatus of claim 18, further comprising a transmitter coupled to the probe to receive the signal produced by the temperature sensor for transmission as a wireless telemetry signal from inside the patient'"'"'s body.

22. The apparatus of claim 21, further comprising a receiver disposed outside the patient'"'"'s body, said receiver being adapted to receive the wireless telemetry signal and display the temperature of the tissue.

23. The apparatus of claim 18, wherein the means for controlling are coupled to the temperature sensor via a lead that extends from the fixture and is disposed inside the patient'"'"'s body.

24. A method for increasing an efficacy of a photodynamic therapy, comprising the steps of:

a) applying a photoreactive agent to a treatment site, said photoreactive agent having a characteristic absorption waveband;

b) energizing a light generating device and directing light generated the toward the treatment site from a probe used to administer the photodynamic therapy, said light having a waveband substantially corresponding to the characteristic absorption waveband of the photoreactive agent; and

c) heating the treatment site after terminating the delivery of light from the light generating device using a heat source that is disposed on said probe, thereby raising the temperature of the treatment site to increase the efficacy of the photodynamic therapy.

25. The method of claim 24, wherein the heat source comprises a source of light that is not used for administering the photodynamic therapy.

26. The method of claim 24, wherein the heat source comprises a resistive heating device.

27. The method of claim 24, further comprising the steps of:

(a) monitoring a temperature of the treatment site, producing a signal indicative of the temperature;

(b) controlling heat source in response to the signal indicative of the temperature of the treatment site so that said temperature does not exceed a level that would cause vascular damage.