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