Drug delivery device

• US 8,827,979 B2
• Filed: 03/19/2008
• Issued: 09/09/2014
• Est. Priority Date: 03/19/2007
• Status: Active Grant

• Current Assignee: InsuLine Medical Ltd.
• Original Assignee: InsuLine Medical Ltd.
• Inventors: Pesach, Benny, Bitton, Gabriel, Weiss, Ram, Nagar, Ron
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Thomas, Jr., Bradley G
• Application Number:
  US12/450,251
• Publication Number:
  US 20100174225A1
• Time in Patent Office: 2,365 Days
• Field of Search: 604112-114, 604/500, 604/501, 604/20, 604/22, 604/83, 604/191, 604/21, 604/181, 604/187, 604/218, 604/66, 604 68- 70, 604/506, 604/131, 604/290
• US Class Current: 604/500
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61F 7/007 characterised by electric heating
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/05 combined with other kinds of therapy
• CPC Class Codes: A61M 2205/051 with radiation therapy
• CPC Class Codes: A61M 2205/052 infrared
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 2205/057 with magnetotherapy
• CPC Class Codes: A61M 2205/058 with ultrasound therapy
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• 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 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• CPC Class Codes: A61M 5/20 : Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/2448 : comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/31 : Details
• CPC Class Codes: A61M 5/422 : Desensitising skin
• 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
• CPC Class Codes: A61N 2005/0645 : Applicators worn by the patient
• CPC Class Codes: A61N 7/00 : Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

The present disclosure presents systems, devices and methods for injection of drugs, substances and/or chemicals to a patient and for improving their effectiveness once they are injected are disclosed. Additional treatment can be applied to a tissue region on the patient into which a drug (e.g., insulin) is injected, to expose the tissue region to various forms of energy or a substance to improve the drug'"'"'s pharmacokinetic and/or pharmacodynamic profile.

Claims

1. An apparatus for delivering therapeutic fluid to a patient at an injection site, comprising:

a fluid injection device having a housing, wherein the housing includes;

an injector for injecting the therapeutic fluid to a bodily tissue of the injection site; and

a reservoir for containing the therapeutic fluid; and

a treatment element comprising a heater coupled to the fluid injection device and configured to modify the temperature of the bodily tissue in a vicinity of the injection site to improve pharmacokinetic and/or pharmacodynamic property of the injected therapeutic fluid in the bodily tissue either a short time before, during and/or following injection of the therapeutic fluid into the patient, wherein the treatment element does not heat the therapeutic fluid above a predetermined limiting temperature.

2. The apparatus according to claim 1, wherein the fluid injection device is selected from a group consisting of:

a syringe, an injection pen, and a jet injector.

3. The apparatus according to claim 1, wherein the treatment element is coupled to the fluid injection device using an adaptor.

4. The apparatus according to claim 3, wherein the treatment element is coupled to the fluid injection device either before or during injection of the therapeutic fluid.

5. The apparatus according to claim 1, wherein the treatment element and the fluid injection device are disposed in the same housing before injection.

6. The apparatus according to claim 1, wherein said treatment is applied to the vicinity of the injection site only during or following the injection of the therapeutic fluid into the patient.

7. The apparatus according to claim 1, wherein the treatment element is configured to apply treatment in order to perform at least one of the functions selected from a group consisting of:

enabling a faster onset of action of the therapeutic fluid infused into the infused region, enabling a faster peak of action of the therapeutic fluid injected into the injection site, enabling a faster clearance of the therapeutic fluid from the injection site and into a circulatory system of the patient, improving the repeatability of the pharmacokinetic and/or pharmacodynamic profile in response to the injection of the therapeutic fluid, reducing a variability of absorption of the therapeutic fluid into the blood system and/or lymphatic system of the patent, reducing a variability of onset of action of the therapeutic fluid, reducing a variability of time to peak of action of the therapeutic fluid, and reducing a variability of the clearance of the therapeutic fluid from the injection site and into the circulatory system of the patient.

8. The apparatus according to claim 1, wherein the therapeutic fluid is configured to be injected subcutaneously and further configured to have a systemic effect.

9. The apparatus according to claim 1, wherein the therapeutic fluid is selected from a group consisting of:

insulin, insulin analogues, and insulin mimetics.

10. The apparatus according to claim 1, wherein the treatment element is configured to heat the tissue vicinity without heating the vicinity of the injection site to a temperature above a limiting temperature that may damage the therapeutic fluid.

11. The apparatus according to claim 10, wherein the apparatus is configured to improve a clinical outcome of an IDDM patient, wherein the therapeutic fluid is a mixed rapid-acting insulin configured to provide an optimal insulin pharmacokinetic profile to better utilize the faster insulin absorption induced by the treatment.

12. The apparatus according to claim 10, wherein the apparatus is configured to improve a clinical outcomes of an IDDM patient, wherein the treatment is configured to be applied only for carbohydrate rich meals.

13. The apparatus according to claim 10, wherein said heater is U shaped or round.

14. The apparatus according to claim 1, wherein the limiting temperature is approximately 37 degrees C.

15. The apparatus according to claim 1, wherein the apparatus is configured to improve a clinical outcome of an Insulin-Dependent Diabetes Mellitus (“

IDDM”

) patient, wherein the therapeutic fluid is a rapid-acting insulin, the treatment element is configured to heat the skin to a temperature in a range of 37-39°

C. at least 1 cm apart of the injection site for a period of time in a range 10-90 min from the time of injection.

16. The apparatus according to claim 1, further comprising a processing unit for controlling the treatment element and configured to control at least one of an amplitude, duration, phase, intensity, and frequency of the treatment applied by the treatment element.

17. The apparatus according to claim 16, further comprising a sensor for detecting the injection of the therapeutic fluid, wherein the treatment element is configured to apply the treatment to the injection site following the detecting by the sensor.

18. The apparatus according to claim 1, wherein the treatment element includes a heater and is configured to regulate heating of the infused region to stabilize its temperature at a pre-determined temperature in order to stabilize pharmacokinetics of the infused therapeutic fluid.

19. The apparatus according to claim 1, wherein the applied treatment is selected from a group consisting of:

heating, cooling, intermittent temperature change, optical radiation, micro-wave, radio frequency, electromagnetic radiation, vibration device, physical stimulation, massage the infused region, suction, vacuum, electric field, magnetic field, acoustic signal, ultrasound, and application of one more additional substances to modify the infused substance pharmacokinetics, and/or a combination of at least two of the above treatments.

20. The apparatus according to claim 1, further comprising a treatment release trigger for actuating treatment delivery via said treatment element.

21. The apparatus according to claim 1, wherein the housing further comprises at least one treatment delivering opening for application of treatment to the injection site.

22. The apparatus according to claims 1, further comprising a treatment selector configured to apply a predetermined amount of a treatment substance to at least one of the injection site and adjacent the injection site;

wherein said treatment substance is selected from a group consisting of;

a liquid, ointment, solution, aerosol, foam, solid, gel foam, pressurized liquid, gas, spray, pain reliever drug, analgesic, vasodilatation drug, septic, alcohol, and any combinations thereof.

23. The apparatus according to claim 22, wherein the treatment selector is configured to apply said treatment to at least one of the injection site and adjacent the injection site, wherein said treatment is selected from a group consisting of:

radiation, heat, mechanical vibrations, suction, massaging, acoustic stimulation, electromagnetic radiation, electric field, magnetic field, electrical stimulation, injection of additional substance(s), and any combination of the foregoing.

24. The apparatus according to claim 1, wherein the housing further comprises a nozzle through which the therapeutic fluid is injected to the injection site.

25. The apparatus according to claim 1, wherein the treatment element is reusable.

26. The apparatus according to claim 1, wherein the treatment element is disposable.

27. The apparatus according to claim 1, wherein the treatment element has a disposable portion and a reusable portion.

28. The apparatus according to claim 1, wherein the treatment element includes an opening for allowing the injector to be positioned therethrough.

29. The apparatus according to claim 1, wherein said treatment element is further configured to be coupled to the injection site upon being detached from the fluid injection device.

30. The apparatus according to claim 1, wherein the treatment element includes a one or more adherable portions for adhering to the skin adjacent an injection site, and includes a malleable portion.

31. The apparatus according to claim 1, wherein the treatment element is configured to apply one or more additional substances in the vicinity of the injection site, wherein the treatment element is selected from the group consisting of:

an injector, a nozzle, an opening and a roller-applicator ball, dispenser.

32. The apparatus according to claim 1, further comprising a remote control unit to control application of treatment by the treatment element.

33. A method for delivering a therapeutic fluid to an injection site on a patient using a fluid delivery device having a fluid injection device having a housing, wherein the housing includes an injector for injecting the therapeutic fluid to a bodily tissue of the injection site and a reservoir for containing the therapeutic fluid, and a treatment element, comprising a heater, coupled to the fluid injection device and configured to apply treatment to the injection site, comprising the steps of:

using the fluid injection device, injecting the therapeutic fluid at the injection site;

using the treatment element, applying a treatment to at least one of the injection site and adjacent the injection site, wherein the applying of the treatment element causes modification of the temperature of the bodily tissue in a vicinity of the injection site; and

improving, based on the applying of the treatment element, a pharmacokinetic and/or pharmacodynamic property of the therapeutic fluid upon application of the treatment.

34. The method according to claim 33, wherein the applying step further comprises applying the treatment at least one of before, during, or after the injecting step.

35. The method according to claim 33, further comprising actuating drug delivery via a trigger.

36. The method according to claim 33, further comprising actuating treatment delivery via a trigger.

37. The method according to claim 33, further comprising selecting a dosage for the therapeutic fluid via a drug dosage selector.

38. The method according to claim 37, wherein the drug dosage selector is configured to apply a bolus dosage of the therapeutic fluid and/or a basal dosage of the therapeutic fluid.

39. The method according to claim 33, further comprising selecting a treatment via a treatment selector.

40. The method according to claim 39, wherein the treatment comprises applying a treatment substance to at least one of the injection site and adjacent the injection site.

41. The method according to claim 40, wherein the treatment substance is selected from a group consisting of:

a liquid, ointment, solution, aerosol, foam, solid, gel foam, pressurized liquid, gas, spray, pain reliever drug, analgesic, vasodilatation drug, septic, alcohol, and any combination thereof.

42. The method according to claim 41, wherein the selected treatment is selected from the group consisting of:

radiation, light, heat, mechanical vibrations, suction, massaging, acoustic stimulation, electrical stimulation, injection of additional substance(s), and any combination thereof.

43. The method according to claim 33, wherein the therapeutic fluid is insulin.

44. The method according to claim 33, further comprising applying the treatment to at least one of the injection site and adjacent the injection site at least one before, during and after with the injection of the therapeutic fluid.

45. The method according to claim 33, further comprising controlling application of the treatment via a processing unit.

46. The method according to claim 45, further comprising controlling at least one of an amplitude, duration, phase, intensity, and frequency of the treatment via the processing unit.