Methods and apparatus for using controlled heat to regulate transdermal and controlled release delivery of fentanyl, other analgesics, and other medical substances

• US 6,955,819 B2
• Filed: 02/28/2001
• Issued: 10/18/2005
• Est. Priority Date: 09/29/1998
• Status: Expired due to Fees

• Current Assignee: Crescita Therapeutics Inc.
• Original Assignee: Zars, Inc.
• Inventors: Zhang, Jie, Rigby, Larry, Stanley, Theodore, Hull, Wade
• Primary Examiner(s): Dodson, Shelley A.
• Assistant Examiner(s): George, Konata M.
• Application Number:
  US09/796,250
• Publication Number:
  US 20010037104A1
• Time in Patent Office: 1,693 Days
• Field of Search: 424/401, 424/443, 424/449
• US Class Current: 424/449
• CPC Class Codes: A61F 2013/00646 Medication patches, e.g. transcutaneous
• CPC Class Codes: A61F 7/032 using oxygen from the air, e.g. pocket-stoves
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• 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: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/703 characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
• CPC Class Codes: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis

Abstract

The present invention is directed toward an apparatus to rapidly deliver a drug to a patient The invention comprises a drug beneath a patient'"'"'s skin in a drug depot site. A heating component is placed near the drug depot site and generates heat in and near the drug depot site. A control component connected to the heating component is used to control the magnitude and duration of heat generated by the heating component.

Claims

1. A system for rapidly delivering a drug to a patient comprising:

a drug in a drug depot site, wherein said drug depot site comprises at least one of skin and sub-skin tissues;

a heating component to generate heat for heating the drug depot site; and

a control component capable of controlling the magnitude and duration of heat generated by the heating component to achieve selective, precise, on-demand delivery of said drug from said drug depot site.

2. The system of claim 1, wherein said drug is in controlled release formulation.

3. The system of claim 1, wherein the drug depot site is disposed within the skin tissues.

4. The system of claim 1, wherein the drug depot site is disposed within the sub-skin tissues.

5. The system of claim 1, wherein the drug is injected into the skin.

6. The system of claim 1, wherein the drug is implanted into the skin.

7. The system of claim 1, wherein the drug depot site comprises an extra bolus of drug delivered into the patient'"'"'s body.

8. The system of claim 1, wherein the drug is absorbed transdermally into the skin.

9. The system of claim 1, wherein the heating component is capable of generating heat when supplied with electric current.

10. The system of claim 9, wherein the control component receives a temperature signal from a temperature sensor proximate to the skin.

11. The system of claim 10, wherein the control component adjusts the electric current to the heating component according to the temperature sensor.

12. The system of claim 9, wherein the control component has settings that correspond to pre-determined electric power and heating time combinations.

13. The system of claim 9, wherein the control component also has mechanism to lockout a length of time in which the device generates no heat during drug administration.

14. The system of claim 9, wherein the control component is a mechanism that allows the patient to trigger delivery of a pre-determined amount of bolus drug from the depot site.

15. The system of claim 9, wherein the control component is activated using a button.

16. The system of claim 9, wherein the control component is pre-programmed to send an electric current with predetermined magnitude through a wire to the heating component for a pre-determined length of time.

17. The system of claim 16, wherein the magnitude and the pre-determined length of time of the current produce a temperature increase at the skin for a pre-determined length of time that releases a pre-determined amount of the drug from the depot site.

18. The system of claim 16, wherein the magnitude of the current is designed to produce several heating temperature vs. time profiles to accommodate different needs.

19. The system of claim 1, wherein the control component safely and effectively delivers the bolus drug from sub-skin tissues by heating.

20. The system of claim 1, wherein the heating component is preferably an electric heating component.

21. The system of claim 1, further comprising a microprocessor in conjunction with the electric heating component.

22. The system of claim 1, wherein the electric heating component and control component are connected by electric wires.

23. The system of claim 1, wherein the heating component has a temperature sensor that measures the temperature at the drug patch and transmits the measure temperature to the control component to regulate the heating temperature.

24. The system of claim 1, wherein the heating component has a layer of thermal insulating material on the side not in contact with the drug patch for minimizing heat loss.

25. The system of claim 1, wherein the control component has a plurality of settings for controlling heat, each setting delivering a different amount of heating energy to the skin site.

26. The system of claim 12, wherein the electric power associated with each said setting is pre-determined.

27. The system of claim 1, wherein the drug in the drug depot site is delivered into the skin from a transdermal drug patch.

28. The system of claim 27, wherein the drug patch is an analgesic drug patch.

29. The system of claim 27, wherein said patch is applied on the skin of the patient for predetermined period to create a depot site.

30. The system of claim 27, wherein further comprising means for releasably affixing the heating component to the drug patch.

31. The system of claim 30, wherein the heating component and the drug patch have areas with corresponding loop and hook fasteners.

32. The system of claim 30, wherein means for affixing the heating component to the drug patch can only be affixed in a prescribed orientation.

33. The system of claim 30, wherein means for affixing the heating component comprises to an adhesive with appropriate tackiness and reusability.

34. The system of claim 1, wherein said heating component is an exothermic oxidation heating patch.

35. The system of claim 34, wherein the exothermic oxidation heating patch comprises a heating area covers a portion of the drug patch area.

36. The system of claim 34, wherein the heating component is a disposable heating component.

37. The system of claim 1, wherein the drug is selected from the group of:

analgesics, anesthetics, anti-arthritis drugs, anti-inflammatory drugs, anti-migraine drugs, cardiovascularly active drugs, smoke cessation drugs, hormones, androgen, estrogen, non-steroidal anti-inflammatory agents, anti-hypertensive agents, analgesic agents, anti-depressants, antibiotics, anti-cancer agents, local anesthetics, antiemetics, anti-infectants, contraceptives, anti-diabetic agents, steroids, anti-allergy agents, anti-migraine agents, agents for smoking cessation, anti-obesity agents, nicotine, testosterone, estradiol, nitroglycerin, clonidine, dexamethasone, wintergreen oil, tetracaine, lidocaine, fentanyl, sufentanil, alfentanil and other potent mu-receptor agonists, progestrone, insulin, Vitamin A, Vitamin C, Vitamin E, prilocaine, bupivacaine, sumatriptan, scopolamine and dihydroergotamine.