Thermotherapy method for treatment and prevention of cancer in male and female patients and cosmetic ablation of tissue

• US 6,725,095 B2
• Filed: 10/15/2002
• Issued: 04/20/2004
• Est. Priority Date: 04/13/2000
• Status: Expired due to Term

• Current Assignee: Celsion Corporation
• Original Assignee: Celsion Corporation
• Inventors: Fenn, Alan J., Mon, John
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US10/270,312
• Publication Number:
  US 20030055471A1
• Time in Patent Office: 553 Days
• Field of Search: 607/96, 607/98, 607/99-102, 607/108-114, 606/2, 606/4, 606/9, 606/10-13, 606/32-34, 606/41-42, 603/2-3
• US Class Current: 607/101
• CPC Class Codes: A61N 5/02 using microwaves

Abstract

A method for treating cancerous or benign conditions of a body or organ employs selective irradiation of the body tissue with energy. The method includes the steps of monitoring temperatures of the skin surface adjacent the body, positioning at least one energy applicator around the body, delivering energy to the at least one energy applicator to selectively irradiate the body tissue with energy and treat at least one of cancerous and benign conditions of the body, adjusting the level of power to be delivered to the at least one energy applicator during treatment based on the monitored skin temperatures, monitoring the energy delivered to the at least one energy applicator, determining total energy delivered to the at least one energy applicator, and completing the treatment when the desired total energy dose has been delivered by the at least one energy applicator to the body.

Claims

1. A method for treating cancerous or benign conditions of a body by selective irradiation of the body tissue with energy, the method comprising the steps of:

a) Monitoring temperatures of the skin surface adjacent the body tissue to be irradiated;

b) Positioning at least one energy applicator about a site of the body to be treated;

c) Setting the initial power level delivered to each at least one energy applicator;

d) Delivering energy to the at least one energy applicator to selectively irradiate the body tissue with energy and treat at least one of cancerous and benign conditions of the body;

e) Adjusting the level of power to be delivered to each at least one energy applicator during treatment based on the monitored skin temperatures;

f) Monitoring the energy delivered to the at least one energy applicator;

g) Determining total energy delivered to the at least one energy applicator in real time during the treatment; and

h) Completing the treatment when the desired total energy dose has been delivered by the at least one energy applicator to the body tissue.

2. The method of claim 1, wherein the energy is at least one of electromagnetic, ultrasound, radio frequency, and laser waves.

3. The method of claim 1, wherein the body is a breast in one of a male patient and a female patient and a single applicator heats the breast.

4. The method of claim 3, wherein the female patient or male patient lies in a prone position.

5. The method of claim 4, further comprising the step of compressing the breast towards the chest wall by means of a tubular shaped cloth material.

6. The method of claim 3, wherein the female patient or male patient lies in a supine position.

7. The method of claim 3, wherein the energy is at least one of electromagnetic, ultrasound, radio frequency, and laser waves.

8. The method of claim 1, wherein the body is an organ.

9. The method of claim 1, wherein the body is a superficial area of one of the head, neck, torso, arms and legs of a patient.

10. The method of claim 1, further comprising the step of pre-conditioning the body tissue to be treated by one of passing chilled air across the site of body to be treated and passing warmed air across the site of the body before the delivery of power to the at least one applicator.

11. The method of claim 1, further comprising the step of post-conditioning the body tissue to be treated by one of passing chilled air across the site of the body to be treated and passing warmed air across the site of the body after the termination of power to the at least one applicator.

12. The method of claim 11, wherein the low loss medium is one of distilled water and deionized water.

13. The method of claim 1, wherein the at least one applicator includes a bolus containing a low loss medium attached to an end of the at least one applicator adjacent the body to be treated where the low loss medium couples the energy from the applicator to the body tissue.

14. A method for treating cancerous or benign conditions of a breast or preventing cancer or recurrence of cancer in the breast of either a male or female patient by selective irradiation of the breast tissue with energy, the method comprising the steps of:

a) Monitoring temperatures of areas surrounding the breast tissue to be treated;

b) Positioning a single energy applicator having an energy feed about the breast, the applicator having a waveguide with an aperture width and an aperture height and being positioned so that the breast tissue to be irradiated is very close to the midpoint of the aperture width and aperture height;

c) Delivering energy to the single energy applicator to selectively irradiate the breast tissue with energy and treat at least one of cancerous and benign conditions of the breast;

d) Adjusting the level of power to be delivered to the single energy applicator during treatment based on the monitored skin temperatures;

e) Determining total energy delivered to the single energy applicator in real time during the treatment; and

f) Completing the treatment when the desired total energy dose has been delivered by the single energy applicator to the breast tissue to be irradiated.

15. The method of claim 14, wherein, when a patient is being treated for a benign breast tumor, breast cancer or prevention of breast cancer, the positioning step of the single applicator is such that energy is aimed at one of a breast tumor or an upper portion of the breast.

16. The method of claim 14, wherein the total energy dose is a microwave dose of up to approximately 360 kilojoules.

17. The method of claim 14, wherein the power delivered to the single energy applicator is up to approximately 200 Watts of microwave power for approximately 30 minutes.

18. The method of claim 14, wherein the step of monitoring temperatures of areas surrounding the breast tissue includes placing skin sensors on the surface of the breast to be treated.

19. The method of claim 18, wherein the skin sensors are monitored and the power of the single applicator is adjusted in order to keep the measured skin temperature below about 41°

C.

20. The method of claim 19, wherein the internal measured temperature controls the power delivered to the single energy applicator and an equivalent dose of between approximately 120 minutes and 240 minutes is delivered to the breast tissue to be irradiated.

21. The method of claim 14, wherein the step of monitoring temperatures of areas surrounding the breast tissue includes inserting a temperature probe within the tissue region to be treated and the internal measured temperature is used to control the power delivered to the single applicator.

22. The method of claim 14, wherein the positioning step includes providing a gap between an end of the applicator adjacent the breast so that the energy is coupled to the breast by air.

23. The method of claim 22, wherein the air which couples the energy from the applicator to the breast has a temperature in the range from approximately 0°

C. to approximately 50°

C.

24. The method of claim 23, further comprising the step of pre-conditioning the breast tissue to be treated by one of passing chilled air across the breast and passing warmed air across the breast before the delivery of power to the single applicator.

25. The method of claim 23, further comprising the step of post-conditioning the breast tissue to be treated by one of passing chilled air across the breast and passing warmed air across the breast after the termination of power to the single applicator.

26. The method of claim 14, wherein the single applicator includes a bolus containing a low loss medium attached to an end of the single applicator adjacent the breast to be treated where the low loss medium couples the energy from the applicator to the breast.

27. The method of claim 26, wherein the low loss medium is one of distilled water and deionized water.

28. The method of claim 14, further comprising the step of employing Tamoxifen or other antiestrogen drug in combination with selective irradiation for blocking estrogen from binding to the estrogen receptors of breast carcinomas and for direct cancer cell kill by heat.

29. The method of claim 28, wherein approximately 10 to 20 mg per day of Tamoxifen or other antiestrogen drug is given to a patient receiving the selective irradiation thermotherapy for 5 years and the thermotherapy is given at regular intervals during the same 5-year period.

30. A method for treating cancerous or benign conditions of a body by selective irradiation of the body tissue with energy, the method comprising the steps of:

a) Monitoring temperatures of the skin surface adjacent the body tissue to be irradiated;

b) Positioning at least one energy applicator about a site of the body to be treated;

c) Setting the initial power level delivered to each at least one energy applicator;

d) Delivering energy to the at least one energy applicator to selectively irradiate the body tissue with energy and heat at least one of cancerous and benign conditions of the body; and

e) Adjusting the level of power to be delivered to each at least one energy applicator during the steps of selectively irradiating and heating the body based on the monitored skin temperatures;

f) wherein the heat achieved by the at least one energy applicator heats proteins in the body tissue to be treated thereby promoting the production of protein inhibitors that suppress the spread and growth of cancer and other associated conditions or diseases.

31. The method according to claim 30, wherein the heat achieved by the at least one energy applicator kills or inhibits anti-apoptosis proteins responsible for the ability of cancer cells to grow and spread outside the primary cancer site.

32. A method for treating cancerous or benign conditions of a body by selective irradiation of the body tissue with energy, the method comprising the steps of:

a) Monitoring temperatures of the skin surface adjacent the body tissue to be irradiated;

b) Positioning at least one energy applicator about a site of the body to be treated;

c) Setting the initial power level delivered to each at least one energy applicator;

d) Delivering energy to the at least one energy applicator to selectively irradiate the body tissue with energy and heat at least one of cancerous and benign conditions of the body; and

e) Adjusting the level of power to be delivered to each at least one energy applicator during the steps of selectively irradiating and heating the body based on the monitored skin temperatures;

f) wherein the heat achieved by the at least one energy applicator removes the protein responsible for the ability of cancer cells to repair themselves when the heat damages the DNA molecule to which the protein is associated thereby enhancing apopotosis of cancerous cells.

33. The method according to claim 32, wherein the heat achieved by the at least one energy applicator deletes the protein responsible for the ability of cancer cells to repair themselves when cytotoxins associated with one of radiation, chemotherapy and heat damages the DNA molecule.

34. A method for reducing cellulite, cancerous or benign conditions of a body by selective irradiation of the body tissue with energy, the method comprising the steps of:

a) Injecting a material into a selected area of a body to be treated before selective irradiation of the body tissue;

b) Monitoring temperatures of the skin surface adjacent the body tissue to be irradiated;

c) Positioning at least one energy applicator about a site of the body to be treated;

d) Setting the initial power level delivered to each at least one energy applicator;

e) Delivering energy to the at least one energy applicator to selectively irradiate the body tissue with energy and reduce at least one of cancerous and benign conditions of the body;

f) Adjusting the level of power to be delivered to each at least one energy applicator during treatment based on the monitored skin temperatures;

g) Monitoring the energy delivered to the at least one energy applicator;

h) Determining total energy delivered to the at least one energy applicator in real time during the treatment; and

i) Completing the treatment when the desired total energy dose has been delivered by the at least one energy applicator to the body tissue,

wherein the injected material has a higher electrical conductivity than the body tissue surrounding the area to be treated so that the area to be treated preferentially absorbs the heat produced by the at least one energy applicator thereby allowing the produced heat to be localized and destroy the selected cancerous or benign tissues including fat.

35. The method according to claim 34, wherein the injected material is one of a saline solution and a solution containing metallic compounds.

36. The method according to claim 35, further comprising the step of applying sufficient pressure to the body to be treated following the production of heat so that at least one of any lumps in the treated body area are smoothed out and the treated body area is molded or shaped.

37. A method for treating cancerous or benign conditions of a breast by selective irradiation of the breast tissue with energy, the method comprising the steps of:

a) Monitoring temperatures of the skin surface adjacent the breast tissue to be irradiated;

b) Positioning at least one energy applicator about a site of the breast to be treated;

c) Setting the initial power level delivered to each at least one energy applicator;

d) Delivering energy to the at least one energy applicator to selectively irradiate the breast tissue with energy; and

e) Adjusting the level of power to be delivered to each at least one energy applicator during the selective irradiation of the breast based on the monitored skin temperatures;

wherein the step of delivering energy heats to destroy at least one of cancerous and benign conditions of the breast and the resultant heat selectively deletes estrogen receptors thereby blocking the binding of estrogen on at least one of cancerous and benign conditions of the breast.

38. The method according to claim 37, further comprising the step of employing Tamoxifen or other antiestrogen drug in combination with the selective irradiation to enhance the blocking of estrogen thereby preventing estrogen from binding to the estrogen receptors of a breast carcinoma.

39. A method for treating cancerous or benign conditions of a breast by selective irradiation of breast tissue with energy, the method comprising the steps of:

a) Monitoring temperatures of the skin surface adjacent the breast tissue to be irradiated;

b) Positioning at least one energy applicator about a site of the breast to be treated;

c) Setting the initial power level delivered to each at least one energy applicator;

d) Delivering energy to the at least one energy applicator to selectively irradiate the breast tissue with energy; and

e) Adjusting the level of power to be delivered to each at least one energy applicator during the selective irradiation of the breast based on the monitored skin temperatures'"'"'

wherein the step of delivering energy heats to destroy at least one of cancerous and benign conditions of the breast and the heat achieved by the at least one energy applicator selectively deletes estrogen receptors so that the resultant heat may enable employment of a hormonal replacement program without a significant risk of breast cancer.

40. A method for treating cancerous or benign conditions of a body by selective irradiation of the body tissue with energy, the method comprising the steps of:

a) Positioning at least one energy applicator about a site of the body to be treated;

b) Administering analgesics to the site of the body to be treated by selective irradiation;

c) Delivering energy to the at least one energy applicator to selectively irradiate the body tissue with energy and treat at least one of cancerous and benign conditions of the body;

f) Monitoring temperatures of the skin surface adjacent the body tissue to be irradiated during the selective irradiation of the body tissue with energy;

e) Adjusting the level of power to be delivered to each at least one energy applicator during treatment based on the monitored skin temperatures;

f) Monitoring the energy delivered to the at least one energy applicator;

g) Determining total energy delivered to the at least one energy applicator in real time during the treatment; and

h) Completing the treatment when the desired total energy dose has been delivered by the at least one energy applicator to the body tissue.