Needle-free injection devices and drug delivery systems therefor

• US 7,744,563 B2
• Filed: 02/25/2008
• Issued: 06/29/2010
• Est. Priority Date: 02/23/2007
• Status: Expired due to Fees

• Current Assignee: Bioject Incorporated
• Original Assignee: Bioject Incorporated
• Inventors: Landau, Sergio, Williamson, Daniel E.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): STOHR, LEAH C
• Application Number:
  US12/036,919
• Publication Number:
  US 20080208114A1
• Time in Patent Office: 855 Days
• Field of Search: 604/69, 604/71, 604/68, 604/110, 604/111
• US Class Current: 604/68
• CPC Class Codes: A61J 1/2044 having slits
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• 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 5/1782 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 5/2053 Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules

Abstract

Needle-free injection devices and drug delivery systems are disclosed. The needle-free injection devices may include a drug delivery system, a power source, an activation system, and a disabling element. The drug delivery system may include a needle-free syringe and a drug storage system. The needle-free syringe may include a plunger slidably disposed within an injection chamber. The injection chamber may include an injection orifice, and the plunger may be configured to expel a volume of fluid from the injection chamber through the injection orifice. The drug storage system may include a storage chamber and an outlet. The drug storage system may be frangibly connected to the needle-free syringe with the outlet proximate to and fluidly connected with the injection orifice. The drug storage system may be configured to inject a fluid from the storage chamber through the outlet, through the injection orifice, and into the injection chamber.

Claims

1. A needle-free injection device, comprising:

a drug delivery system, including;

a needle-free syringe having an injection chamber and a plunger slidably disposed within the injection chamber, wherein the injection chamber includes an injection orifice, and the plunger is configured to expel a volume of fluid from the injection chamber through the injection orifice, and

a drug storage system having a storage chamber and an outlet, wherein the drug storage system is frangibly connected to the needle-free syringe with the outlet proximate to and fluidly connected with the injection orifice, and the drug storage system is configured to inject a fluid from the storage chamber through the outlet, through the injection orifice, and into the injection chamber;

a power source configured to apply an injection force to the plunger to expel the volume of fluid from the injection chamber through the injection orifice;

an activation system configured to selectively cause the power source to apply the injection force, wherein the activation system includes an actuator that is movable between a first position and a second position, and in the second position the actuator is configured to cause the power source to apply the injection force; and

a disabling element configured to prevent movement of the actuator from the first position toward the second position to prevent the activation system from causing the power source to apply the injection force when the drug storage system is frangibly connected to the needle-free syringe, wherein the disabling element is configured to permit application of the injection force when the drug storage system is disconnected from the needle-free syringe, and the disabling element includes a shield element removably disposed on the needle-free injection device and configured to impede access to the activation system when the shield element is disposed on the needle-free injection device.

2. The needle-free injection device of claim 1, wherein the shield element is configured such that the drug storage system prevents removal of the shield element from the needle-free injection device when the drug storage system is connected to the needle-free syringe, and the shield element is configured such that disconnection of the drug storage system from the needle-free syringe permits removal of the shield element from the needle-free injection device.

3. The needle-free injection device of claim 1, wherein the shield element is configured to permit injection of fluid from the storage chamber of the drug storage system and into the injection chamber of the needle-free syringe while the shield element is disposed on the needle-free injection device.

4. The needle-free injection device of claim 1, wherein the injection chamber of the needle-free syringe comprises a thermoplastic material.

5. The needle-free injection device of claim 1, wherein the power source includes a compressed gas cartridge, the compressed gas cartridge is oriented along a first axis, and the plunger is configured for motion along a second axis spaced from and parallel to the first axis.

6. A needle-free injection device, comprising:

a drug delivery system, including;

a needle-free syringe having an injection chamber and a plunger slidably disposed within the injection chamber, wherein the injection chamber includes an injection orifice and the plunger is configured to expel a volume of fluid from the injection chamber through the injection orifice,

a drug storage system having a storage chamber and an outlet, wherein the storage chamber is configured to inject a fluid from the storage chamber through the outlet, through the injection orifice, and into the injection chamber, and

a frangible connector configured to retain the drug storage system proximate the needle-free syringe with the outlet proximate to and fluidly connected with the injection orifice;

a power source configured to apply an injection force to the plunger to expel the volume of fluid from the injection chamber through the injection orifice;

an activation system configured to selectively cause the power source to apply the injection force, wherein the activation system includes a driver that is movable from a first position toward a second position, the driver is biased toward the second position, the driver is releasably retained in the first position, and in the second position the driver is configured to cause the power source to apply the injection force; and

an activation preventing element configured to prevent the activation system from causing the power source to apply the injection force when the frangible connector is retaining the drug storage system proximate the needle-free syringe, wherein the activation preventing element is configured to permit the activation system to cause the power source to apply the injection force when the frangible connector has been broken, and the activation preventing element includes a shield element removably disposed on the needle-free injection device and configured to prevent movement of the driver from the first position toward the second position when the shield element is disposed on the needle-free injection device.

7. The needle-free injection device of claim 6, wherein the frangible connector is configured to permit separation of the drug storage system from the needle-free syringe when the frangible connection has been broken.

8. The needle-free injection device of claim 6, wherein the shield element is configured such that the drug storage system prevents removal of the shield element from the needle-free injection device when the frangible connector is retaining the drug storage system proximate the needle-free syringe, and the shield element is configured such that breaking the frangible connector and separating the drug storage system from the needle-free syringe permits removal of the shield element from the needle-free injection device.

9. The needle-free injection device of claim 6, wherein:

the plunger is configured for motion along a first axis;

the power source includes a compressed gas cartridge and a gas transfer tube, the compressed gas cartridge is oriented along a second axis spaced from and parallel to the first axis, and the gas transfer tube includes a piercing structure disposed on the second axis;

the driver is movable along the second axis from the first position toward the second position;

the driver is configured to urge the gas cartridge onto the piercing structure as the driver moves toward the second position; and

the gas transfer tube is configured to transfer gas from the gas cartridge toward the plunger such that the gas urges the plunger to expel the volume of fluid from the injection chamber through the injection orifice.

10. The needle-free injection device of claim 9, wherein the driver includes at least one latch configured to retain the driver in the second position.

11. A needle-free injection device, comprising:

a drug delivery system, including;

a needle-free syringe having an injection chamber and a plunger slidably disposed within the injection chamber, wherein the injection chamber includes an injection orifice and the plunger is configured to expel a volume of fluid from the injection chamber through the injection orifice,

a drug storage system having a storage chamber and an outlet, wherein the storage chamber is configured to eject a fluid from the storage chamber through the outlet, through the injection orifice, and into the injection chamber, and

a frangible connector configured to retain the drug storage system proximate the needle-free syringe with the outlet proximate to and fluidly connected with the injection orifice, wherein the frangible connector includes a valve disposed between the outlet and the injection orifice, and the fluid ejected from the storage chamber through the outlet opens the valve and passes through the valve, through the injection orifice, and into the injection chamber;

a power source configured to apply an injection force to the plunger to expel the volume of fluid from the injection chamber through the injection orifice;

an activation system configured to selectively cause the power source to apply the injection force; and

an activation preventing element configured to prevent the activation system from causing the power source to apply the injection force when the frangible connector is retaining the drug storage system proximate the needle-free syringe, wherein the activation preventing element is configured to permit the activation system to cause the power source to apply the injection force when the frangible connector has been broken.

12. A drug delivery system for a needle-free injection device, the drug delivery system comprising:

a needle-free syringe including an injection chamber and an injection plunger slidably disposed within the injection chamber, wherein the injection chamber includes an injection orifice, and the injection plunger is configured to expel a volume of fluid from the injection chamber through the injection orifice;

a drug storage system including a storage chamber, an outlet and an ejection plunger, wherein the ejection plunger is configured to eject a fluid from the storage chamber through the outlet; and

a connector configured to retain the drug storage system proximate the needle-free syringe with the outlet proximate the injection orifice, the connector including;

a first connecting region configured to retain the connector to the drug storage system proximate the outlet,

a second connecting region configured to retain the connector to the needle-free syringe proximate the injection orifice,

a fluid path configured to fluidly connect the outlet and the injection orifice,

a valve configured to interrupt the fluid path proximate the outlet, wherein the fluid ejected from the storage chamber through the outlet passes through the valve, through the injection orifice, and into the injection chamber, and

a stress riser configured to assist with separation of the first and second connecting regions and to permit separation of the drug storage system from the needle-free syringe when the connector is broken proximate the stress riser.

13. The drug delivery system of claim 12, wherein the stress riser includes a frangible region disposed intermediate the first and second connecting regions, the connector is configured to retain the drug storage system proximate the needle-free syringe while the frangible region remains unbroken, and the connector is configured such that breaking the frangible region permits separation of the drug storage system from the needle-free syringe.

14. The drug delivery system of claim 12, wherein the injection chamber of the needle-free syringe comprises a thermoplastic material and the storage chamber of the drug storage system comprises a borosilicate glass.

15. The drug delivery system of claim 12, wherein the valve includes a membrane configured to interrupt the fluid path and a plurality of radially oriented intersecting slits through the membrane.