Method and Apparatus for Skin Cancer Thermal Therapy

• US 20130197473A1
• Filed: 10/07/2011
• Published: 08/01/2013
• Est. Priority Date: 10/07/2010
• Status: Active Grant

• Current Assignee: Gradiant Research, LLC
• Original Assignee: Gradiant Research, LLC
• Inventors: McMillan, Kathleen
• Granted Patent: US 9,962,225 B2
• Time in Patent Office: Days
• US Class Current: 604/501
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 18/201 with beam delivery through a hollow tube, e.g. forming an articulated arm through a flexible conduit A61B18/22; Hand-pieces therefor
• CPC Class Codes: A61B 18/203 applying laser energy to the outside of the body
• CPC Class Codes: A61B 18/22 the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00452 Skin
• CPC Class Codes: A61B 2018/00476 Hair follicles
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61F 9/008 using laser
• CPC Class Codes: A61N 2005/0652 Arrays of diodes
• CPC Class Codes: A61N 2005/0659 infrared
• CPC Class Codes: A61N 5/0601 Apparatus for use inside the body
• CPC Class Codes: A61N 5/0616 Skin treatment other than tanning
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: A61N 5/067 using laser light

Abstract

An apparatus for treatment of soft tissue includes a source of radiation, a handpiece which is adapted to transmit radiation emitted from the source of radiation to a region of soft tissue, resulting in irradiated soft tissue, said handpiece being positioned adjacent to or in contact with said soft tissue region, a grid element adapted to hold at least one temperature sensor in contact with or embedded in said region of soft tissue, and a microprocessor, which converts a signal from the at least one temperature sensor into a measure of damage produced in at least two components of the irradiated soft tissue, said components comprising at least one normal tissue component and at least one malignant, hypertrophic, diseased, or unwanted component.

Claims

1. An apparatus for treatment of soft tissue, comprising:

a source of radiation;

a handpiece which is adapted to transmit radiation emitted from the source of radiation to a region of soft tissue, resulting in irradiated soft tissue, said handpiece being positioned adjacent to or in contact with said soft tissue region, said soft tissue including at least one normal tissue component surrounding or interspersed with at least one malignant, hypertrophic, diseased, or unwanted component;

a grid element, adapted to hold at least one temperature sensor in contact with or embedded in said region of soft tissue;

a microprocessor, which converts a signal from the at least one temperature sensor into a measure of damage produced in at least two components of the irradiated soft tissue, said components comprising at least one normal tissue component and at least one malignant, hypertrophic, diseased, or unwanted component, the damage produced in the at least one normal tissue component being less than the damage produced in the at least one malignant, hypertrophic, diseased, or unwanted component.

2. The apparatus of claim 1, wherein the source of radiation is a coherent or incoherent source operating in a range of between about 700 nm and about 1310 nm.

5. The apparatus of claim 1, wherein the grid element is attached to the handpiece.

8. The apparatus of claim 1, wherein the at least one temperature sensor comprises a thermocouple or thermistor.

9. The apparatus of claim 8, wherein the thermocouple or thermistor is contained within a needle having a proximal end and a distal end, such that the proximal end is affixed to the grid element and the distal end is embedded in the irradiated soft tissue.

10. The apparatus of claim 1, wherein the at least one normal tissue component is collagen.

11. The apparatus of claim 1, wherein the at least one malignant, hypertrophic, diseased, or unwanted component is tumor cells.

12. The apparatus of claim 1, wherein the at least one normal tissue component is dermal collagen, and the at least one malignant, hypertrophic, diseased, or unwanted component is skin cancer cells.

13. The apparatus of claim 12, wherein the measure of thermal damage is the Arrhenius damage integral.

14. The apparatus of claim 1, wherein the handpiece comprises a cooling element for cooling the region of soft tissue for at least a portion of the time that the at least one temperature sensor is in contact with or embedded in said soft tissue.

15. The apparatus of claim 1, further comprising a display unit, whereby the measure of thermal damage produced in at least two components of the irradiated tissue is displayed for at least a portion of the time that the at least one temperature sensor is in contact with or embedded in said soft tissue.

16. The apparatus of claim 1, wherein the grid element is adapted to hold at least two temperature sensors embedded at least two different depths in the irradiated soft tissue.

3. (canceled)

4. (canceled)

6. (canceled)

7. (canceled)

17-19. -19. (canceled)

20. A method of heating a biological tissue by application of radiation, said tissue comprising at least one normal component and at least one abnormal, diseased, hypertrophic, malignant, or otherwise unwanted component, the method comprising:

irradiating a treatment region of the tissue to cause thermal injury to the at least one normal component and the at least one unwanted component;

monitoring accumulation of thermal injury during irradiation to the at least one normal component and the at least one unwanted component; and

ending irradiation when the at least one unwanted component has been substantially injured by heat.

21. The method of claim 20, wherein ending irradiation occurs when (a) the at least one unwanted component has been substantially injured by heat, and (b) the at least one normal component is substantially uninjured by heat.

22. The method of claim 20, wherein monitoring the accumulation of thermal injury includes measuring tissue temperature as a function of time before and during irradiation at one or more locations within the tissue.

23. The method of claim 20, wherein monitoring the accumulation of thermal injury includes simultaneously (a) measuring tissue temperature as a function of time before and during application of radiation, and (b) calculating the tissue cooling rate and time required for the tissue to cool to a temperature at which accumulation of thermal injury substantially ceases, at one or more locations within the tissue.

24. The method of claim 20, wherein irradiating the treatment region includes applying radiation at a wavelength within a range of about 1100 nm to about 1310 nm.

25. (canceled)

26. A method of treating a region of skin comprising:

irradiating the region of skin with a light source adapted to produce preferential injury to blood vessels of a dermal region; and

irradiating the region of skin with radiation at a wavelength within a range of about 1100 nm to about 1310 nm.

27. The method of claim 26, further including:

waiting for formation of purpura and/or a significant reduction in dermal blood flow after irradiating the region of skin with the light source to produce preferential injury to blood vessels of a dermal region and before irradiating the region of skin with radiation at a wavelength within a range of about 1100 nm to about 1310 nm.

28. The method of claim 26, further including:

applying a topical agent to the skin before irradiating the region of skin with radiation at the wavelength within the range of about 1100 nm to about 1310 nm.