Medical Fluid Transfer and Injection Apparatus and Method

• US 20170196771A1
• Filed: 03/28/2017
• Published: 07/13/2017
• Est. Priority Date: 10/03/2014
• Status: Active Grant

• Current Assignee: Enable Injections, Inc.
• Original Assignee: Enable Injections, Inc.
• Inventors: Stefanchik, David, Huddleston, Matthew J., Hooven, Michael D., Palmer, Joetta Renee
• Granted Patent: US 11,478,583 B2
• Time in Patent Office: Days
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2075 for external venting
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61J 2200/42 Heating means
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• 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 5/28 Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
• CPC Class Codes: A61M 5/3291 Shafts with additional lateral openings
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Drug delivery system, injection device, transfer apparatus, vial holder and method of administering and transferring are disclosed which provide for passive warming of chilled injectable transferred through the transfer apparatus and into the injection device. The injection device may include a skin-facing surface including a skin boundary displacement extension or structure around a needle injection site to create a high pressure zone in the tissue. Radio frequency tracking and monitoring features for tracking patient compliance also may be provided.

Claims

1. A drug delivery system for the transfer and administration of an injectable liquid drug into a subject comprising:

a transfer apparatus including an injection device docking station, an injectable inlet for receiving a chilled injectable having a temperature in range of about 2°

C.-about 8°

C., a fluid passageway communicating between the injectable inlet and the injection device docking station;

an injection device comprising an expandable chamber including an inlet that is configured for placement into fluid communication with the transfer apparatus fluid passageway when the injection device is received in the injection device docking station; and

the transfer and injection device being configured such that when at ambient temperature of about 15°

C.-about 32°

C., the temperature of a single dose of chilled injectable that is transferred through the transfer apparatus into the injection device is passively increased by at least about 5°

C.-about 25°

C.

2. The drug delivery system in accordance with claim 1 in which the passageway has a mass not less than the mass of the injectable dose.

3. The drug delivery system in accordance with claim 1 in which the fluid flow path comprises a material of high thermal conductivity.

4. The drug delivery system in accordance with claim 1 in which the fluid flow path comprises a metal or is in contact with a metal mass.

5. The drug delivery system in accordance with claim 1 in which the passageway is configured to transfer energy to the injectable by pumping it under pressure through the passageway.

6. The drug delivery system in accordance with claim 1 in which the passageway has a cross-sectional size configured to induce substantial shear forces and/or friction between the injectable and passageway.

7. The drug delivery system in accordance with claim 1 in which the passageway includes a metal heat transfer member having a flow path therethrough.

8. The drug delivery system in accordance with claim 1 in which the heat transfer member flow path comprises a plurality of parallel flowpaths or at least one serpentine flow path.

9. The drug delivery system of claim 1 in which the fluid passageway has an inside diameter between about 0.01 and about 0.1 inches (about 0.25 mm-about 2.54 mm) or between about the equivalent cross-sectional areas.

10. The drug delivery system of claim 9 in which the fluid passageway has an inside diameter between about 0.01 and about 0.05 inches (about 0.25 mm and about 1.2 mm) or between about the equivalent cross-sectional areas.

11. The drug delivery system of claim 10 in which the fluid passageway has an inside diameter of about 0.05 inches (about 1.2 mm) or about the equivalent cross-sectional areas.

12. The drug delivery system of claim 1 in which the fluid passageway has a length of about 5 inches (about 12.7 cm) or less.

13. A medication injection device comprising:

a housing having skin-facing surface that includes an injection needle aperture through which an injection needle may extend from the housing;

a skin displacement structure extending from the skin facing surface around the needle aperture; and

the displacement structure serving to compress tissue around the injection aperture and thereby creating a tissue pressure zone around the injection aperture having higher pressure than in tissue outwardly of the tissue pressure zone.

14. The medication injection device of claim 13 including an injection needle that is extendable through the aperture sufficiently to extend not more than about 5 mm into tissue when the skin-facing surface is placed in contact with tissue of a subject.

15. The medication injection device of claim 14 in which the injection needle extends to a subcutaneous depth of about 5 mm and generates a medication bolus depth of about 0.4 cm-about 0.45 cm.

16. The medication injection device of claim 13 including an injection needle that is extendable through the needle aperture sufficiently to extend a selected subcutaneous distance into tissue, the selected distance providing substantially similar medication bolus depth as an injection needle extending substantially twice the selected depth in the absence of tissue displacement.

17. The medication injection device of claim 13 comprising an injection needle movable from an initial retracted position to an injection position extending to a selected subcutaneous depth for injection and back to a final retracted position after injection complete, the device being configured to maintain the tissue pressure zone after the needle returns to the retracted position.

18. A method of injection of medicament using a medication injection device in accordance with claim 13.

19. A medicament delivery system for the transfer and administration of an injectable liquid drug into a subject, comprising a transfer apparatus and an injection device;

the transfer apparatus including an injection device docking station; and

a wireless signal sending unit carried by the transfer apparatus and/or the injection device.

20. The delivery system in accordance with claim 19, the sending unit further comprising a radiofrequency tag containing data identifying such system wherein the radiofrequency tag is an active radiofrequency tag configured to signal activation of the injection device and completion of injection by the injection device.