Administration of insulin by jet injection

• US 20030040697A1
• Filed: 08/16/2002
• Published: 02/27/2003
• Est. Priority Date: 08/17/2001
• Status: Abandoned Application

• Current Assignee: Eli Lilly and Company
• Original Assignee: Antares Pharma Incorporated
• Inventors: Pass, Franklin, Velussi, Mario
• Application Number:
  US10/219,757
• Publication Number:
  US 20030040697A1
• Time in Patent Office: Days
• US Class Current: 604/21
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules

Abstract

The invention relates to a method for minimizing mean blood glucose levels in an insulin dependent patient by administering insulin to the patient in a sufficiently fast manner to provide a difference of 50% or less between high and low blood glucose levels. Advantageously, the insulin is administered to the patient by jet injection and the high and low blood glucose levels differ by an amount that is less than that which would be obtained after injection of insulin by a conventional needle syringe. The invention also relates to a method for reducing mean blood glucose levels in an insulin dependent patient that is receiving insulin through a conventional syringe and needle arrangement. This method provides for administration of the insulin to the patient by jet injection rather than by the syringe by substituting a jet injector for the syringe.

Claims

1. A method for minimizing mean blood glucose levels in an insulin dependent patient, which comprises administering insulin to the patient by jet injection to provide high and low blood glucose levels that differ by an amount that is less than that which would be obtained after injection of insulin by needle injection.

2. The method of claim 1, wherein the insulin is administered to the patient in a sufficiently fast manner to provide a difference of 50% or less between high and low blood glucose levels.

3. The method of claim 2, which comprises administering about 0.02 mL to 0.5 mL of insulin to the patient within at most about 0.05 seconds

4. The method of claim 2, wherein the difference between high and low blood glucose levels is about 25% or less.

5. The method of claim 2, wherein the high blood glucose level is less than about 200 mg/dL.

6. The method of claim 2, wherein the blood glucose levels are reduced to minimum differences over a period of about 1 week.

7. A method of treatment of a medical condition caused by elevated blood glucose levels in an insulin dependent patient which comprises minimizing mean blood glucose levels in the patient by the method of claim 2, thus treating the medical condition in the patient.

8. A method for reducing an insulin dependent patient'"'"'s HbA1C value which comprises minimizing mean blood glucose levels in the patient by the method of claim 2, thus reducing the patient'"'"'s HbA1C value.

9. A method for reducing mean blood glucose levels in an insulin dependent patient that is receiving insulin through needle injection, the method comprising administering the insulin to the patient by jet injection rather than by the needle injection or substituting a jet injector for a needle injection assembly for administration of the insulin.

10. The method of claim 9, wherein the jet injector administers about 0.02 mL to 0.5 mL of insulin to the patient within at most about 0.05 seconds

11. The method of claim 9, wherein the difference between high and low blood glucose levels is about 25% or less.

12. The method of claim 9, wherein the high blood glucose level is less than about 200 mg/dL.

13. The method of claim 9, wherein the blood glucose levels are reduced to minimum differences over a period of about 1 week.

14. The method of claim 9, wherein the administration of insulin also reduces the insulin dependent patient'"'"'s HbA1C value.

15. The method of claim 9, wherein the insulin is administered to the patient from a jet injector that comprises:

a jet nozzle configured for firing the insulin in a fluid jet configured and with sufficient velocity to penetrate tissue of the patient to an injection site;

an insulin chamber associated with the nozzle for containing the insulin and feeding the insulin to the nozzle for injection;

a firing mechanism comprising an energy source associated with the insulin chamber for forcing the insulin through the nozzle at said velocity; and

a trigger movable by a user and associated with the firing mechanism for activating the energy source for the forcing of the insulin through the nozzle upon movement of the trigger by the user to a firing position.

16. The method of claim 15, further comprising a safety mechanism that comprises:

a blocking member comprising a blocking position in which the blocking member prevents movement of the trigger to the firing position, and

a user-manipulable member that is movable by the user from a safety position, allowing the blocking member to be positioned in the blocking position, to a release position in which the manipulable portion is associated with the blocking member to move the blocking member to enable movement of the trigger to the firing position, wherein movement of the trigger with respect to the firing position moves the manipulable member to the safety position.

17. The method of claim 16, wherein movement of the trigger to the firing position moves the manipulable member to the safety position

18. The method of claim 16, wherein the manipulable portion is moved in a first direction from the release position to the safety position, and the trigger is moved in substantially the first direction towards the firing position to activate the energy source.

19. The method of claim 16, comprising moving the manipulable member to resiliently move the blocking member from the blocking position, wherein the blocking member is resiliently biased toward the blocking position.

20. The method of claim 16, wherein the injector comprises a latch member interposed with the firing mechanism for preventing the activation of the energy source, wherein the trigger is moved to the firing position to release the latch member from the firing mechanism to enable the activation of the energy source.

21. The method of claim 16, wherein the safety member and the trigger are disposed near an axial end of the injector opposite from the nozzle.

22. The method of claim 21, wherein the safety member and trigger are mounted with a portion of the injector that is rotatable with respect to the nozzle to load the insulin into the chamber.

23. The method of claim 15, further comprising a housing associated with the trigger and having an elastomeric surface disposed and configured for facilitating the users'"'"' grip and control during operation of the injector.

24. The method of claim 15, further comprising a housing associated with the trigger and having an axial cross-section that is generally triangular for facilitating the users'"'"' grip and control during operation of the injector.

25. The method of claim 24 wherein the axial cross-section has rounded sides for comfortably holding in the user'"'"'s hand.

26. The method of claim 25, wherein the axial cross-section comprises a lobe protruding at each apex of the cross-section configured and dimensioned for fitting adjacent the inside of the user'"'"'s knuckles during the injection.

27. The method of claim 9, further comprising:

attaching an adapter to a needless injector with an insulin passage in fluid communication with a jet nozzle of the jet injector, the jet nozzle being configured for firing the insulin in a fluid jet configured and with sufficient velocity to penetrate tissue of the patient to an injection site, wherein said attaching comprises pushing the adapter against the nozzle without substantial relative rotation therebetween to engage the adapter and nozzle with respect to each other to keep the insulin passage in fluid association with the nozzle; and

filling an insulin chamber of the injector through the adapter and nozzle.

28. The method of claim 27, wherein the adapter comprises a first engagement portion and the injector comprises a second engagement portion, one of the engagement portions being resiliently biased and is resiliently displaced by the other engagement member that is displaced when the adapter is moved against the nozzle such that the one engagement member moves to an engagement position in which the first and second engagement members are engaged with each other to keep the insulin passage in fluid communication with the nozzle.

29. The method of claim 27, wherein the nozzle has an axis and said attaching comprises pushing the adapter against the nozzle such that any relative rotation therebetween is at an angle of at most about 15°

tangential to the axis.

30. The method of claim 29, wherein the injector comprises:

a firing mechanism comprising an energy source associated with the insulin chamber for forcing the insulin through the nozzle at a predetermined velocity; and

a trigger movable by the patient and associated with the firing mechanism for activating the energy source for the forcing of the insulin through the nozzle upon movement of the trigger by the user to a firing position;

wherein one of the injector and adapter comprises a slot and the other comprises a protrusion that is received in the slot during said attaching, the slot being substantially straight and configured for guiding and retaining the protrusion when the adapter is attached with the nozzle.

31. The method of claim 27, wherein the nozzle is attached to a power pack of the injector that comprises a firing mechanism associated with the insulin chamber for forcing the insulin through the nozzle at a predetermined velocity, wherein the attachment of the nozzle to the power pack comprises rotation therebetween.