DEVICE, SYSTEM AND METHOD FOR DELIVERY OF A LONG-ACTING DRUG

• US 20160166777A1
• Filed: 07/03/2014
• Published: 06/16/2016
• Est. Priority Date: 07/04/2013
• Status: Abandoned Application

• Current Assignee: InsuLine Medical Ltd.
• Original Assignee: InsuLine Medical Ltd.
• Inventors: Bitton, Gabriel, Nagar, Ron
• Application Number:
  US14/902,837
• Publication Number:
  US 20160166777A1
• Time in Patent Office: Days
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• 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 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3379 Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/445 the media being heated in the reservoir, e.g. warming bloodbags

Abstract

Embodiments of the present disclosure present systems, methods and devices relate to regulating drug absorption in a body of a patient, including delivering a dose of long-acting drug at a delivery site of a patient, applying a treatment to a treatment area surrounding and including the delivery site. A substantial portion of the drug may reside in tissue adjacent the treatment area for an extended period of time and may include a drug depot. The treatment may be configured to modify the level of at least one property of at least a portion of the treatment area. The absorption rate of the long-acting drag from the drug depot changes according to the level of the property.

Claims

1. (canceled)

2. A method for regulating the absorption of a long-acting drug in the body of a patient, comprising:

delivering a dose of a long-acting drug at a delivery site of a patient;

applying a treatment to a treatment area surrounding and including the delivery site, wherein a substantial portion of the delivered drug resides in tissue adjacent the treatment area for an extended period of time and comprises a drug depot;

wherein said treatment is configured to modify a level of at least one property of at least a portion of the treatment area; and

wherein an absorption rate of the long-acting drug from the drug depot changes according to the level of the property.

3. (canceled)

4. A system for regulating a glucose level in a body of a patient, comprising:

a treatment element configured to apply treatment to the surface of the skin surrounding and including an injection site where a dose of a long-acting insulin is injected into subcutaneous tissue,

wherein

the subcutaneous tissue adjacent and including the injection site comprises a long-acting insulin depot for containing the injected long-acting insulin for an extended period of time, and the treatment is configured to modify a level of at least one property of the treatment area so as to effect a change in an absorption rate of the long-acting insulin from the insulin depot;

a processor having computer instructions operational thereon configured for causing the processor to operate the treatment element to apply treatment.

5. The system of claim 4, wherein the treatment element comprises at least one of:

a heater, a cooling device, a suction device, a transducer, a radiation delivery element, one or more electrodes, an injector, and a dispenser.

6. The system of claim 4, wherein the treatment comprises at least one of:

heating, cooling, suction, depression, massage, energy, radiation, mechanical vibration, electrical stimulation, acoustic stimulation, magnetic stimulation, electromagnetic stimulation, radio frequency irradiation, microwave irradiation, injection of an additional substance, application of a cream, Transcutaneous Electrical Nerve Stimulation (“

TENS”

), drugs, medicament, chemicals, biologically active bacteria, biologically inactive bacteria, an analgesic and a vasodilator.

7. The system of claim 4, wherein the at least one property of the treatment area comprises at least one of:

temperature, pH, blood perfusion, chemical structure of the insulin and oxygen saturation.

8. The system of claim 4, wherein the absorption rate of the long-acting insulin is increased or decreased based upon the treatment applied by the treatment element.

10. The system of claim 7, wherein the computer instructions are additionally configured to cause the processor to operate the treatment element to cause at least one of:

a modification of the pH level of at least a portion of the treatment area; and

a change in the chemical structure of the long-acting insulin from at least any one of;

a microprecipitated structure to a hexamer structure and a hexamer structure to a monomer structure.

11. The system of claim 4, wherein the computer instructions are additionally configured to cause the processor to operate the treatment based on an activity level of the patient.

12. The system of claim 4, wherein the computer instructions are additionally configured to cause the processor to operate the treatment element to modify the level of the at least one property so as to change the absorption rate to mimic a bolus dose injection.

15. The system of claim 4, wherein the treatment element is activated by the patient or based on computer instructions configured to cause the processor to operate the treatment element to apply treatment.

16. The system of claim 4, wherein the computer instructions configured to cause the processor to operate the treatment element to apply treatment based on a predetermined schedule.

17. The system of claim 4, further comprising a sensor to detect when an injection has been made.

18. The system of claim 4, further comprising a blood glucose monitor provided with the treatment element, wherein the blood glucose monitor is configured to detect a blood glucose level of the patient.

19. The system of claim 18, wherein the computer instructions are additionally configured to cause the processor to operate the treatment element to apply treatment when the blood-glucose monitor detects a pre-determined blood glucose level or to cause the processor to operate the treatment element to cease applying the treatment when the blood-glucose monitor detects the pre-determined glucose level.

20. The system of claim 18, wherein the computer instructions are additionally configured to cause the processor to operate the treatment element to apply a first treatment to the treatment area when a first blood glucose level is detected wherein the first treatment comprises at least heating the treatment area, and wherein the computer instructions are additionally configured to cause the processor to operate the treatment element to apply a second treatment to the treatment area when a second blood glucose level, lower than the first blood glucose level is detected, wherein the second treatment comprises at least cooling the treatment area.

25. The system of claim 4, further comprising a sensor to determine a size of the insulin depot or to determine a rate of change of the size of the insulin depot and wherein the computer instructions are additionally configured to cause the processor to operate the treatment element to apply treatment based upon the determined rate of change in the size of the insulin depot.

9. (canceled)

13. (canceled)

14. (canceled)

21. (canceled)

22. (canceled)

23. The system of claim 22, further comprising a sensor configured to monitor blood perfusion at or adjacent the insulin depot and wherein the computer instructions are additionally configured to cause the processor to operate the treatment element to apply treatment when the blood perfusion is equal or lower than a predetermined threshold or to cause the processor to operate the treatment element to stop treatment when the blood perfusion is equal to or greater than the predetermined threshold.

24. (canceled)

26. A system for regulating a glucose level in a body of a patient, comprising:

a processor to receive an indication of delivery of a long-acting drug into a drug depot of a patient, the drug depot comprising subcutaneous tissue adjacent and including the delivery site which retains a substantial amount of the delivered drug;

at least one sensor to detect at least one measurement associated with at least one of the patient and the drug;

a processor having computer instructions operational thereon configured to cause the processor to determine at least one treatment to apply to the surface of the skin of the patient in an area surrounding and including the delivery site, wherein the at least one treatment is configured to modify the absorption of the long-acting drug from the drug depot into the bloodstream of the patient based on the measurement; and

a treatment element to apply the at least one treatment, wherein the application of the at least one treatment element varies an absorption rate of the long-acting drug.

28. The system of claim 26, further comprising a sensor to detect an amount of physical activity of the patient, and wherein the computer instructions are additionally configured to vary the application of the at least one treatment based on the amount of physical activity of the patient.

30. The system of claim 26, further comprising:

a sensor to detect that an amount of the long-acting drug in the drug depot is below a predetermined threshold; and

an alerting mechanism to generate an alert.

27. (canceled)

29. (canceled)