Needle-free intradermal injection device

• US 9,700,675 B2
• Filed: 08/12/2016
• Issued: 07/11/2017
• Est. Priority Date: 12/13/2011
• Status: Active Grant

• Current Assignee: PharmaJet, Inc.
• Original Assignee: PharmaJet, Inc.
• Inventors: Cappello, Chris, Bingham, John W., Wixey, Matt
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): LEGETTE, TIFFANY
• Application Number:
  US15/235,797
• Publication Number:
  US 20160346476A1
• Time in Patent Office: 333 Days
• Field of Search: 604 68, 604134, 604135, 604137, 604187, 604500
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/202 cocking means, e.g. to bias the main drive spring of an injector
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2005/208 Release is possible only when device is pushed against the skin, e.g. using a trigger which is blocked or inactive when the device is not pushed against the skin
• 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 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules

Abstract

A needle-free injection device suitable for delivering a therapeutic substance into the intradermal space of a patient. The needle-free injection device includes a main spring which can be compressed using one or more handles attached to the device to place the needle-free injection device into an armed configuration. Device embodiments may optionally include an injector tube and associated apparatus which may be moved relative to other device structures when the injector is pressed against the skin of a patient with sufficient force. The disclosed operational switches and release mechanisms cooperate to prevent injection unless the device is properly positioned for an injection. Needle-free injection systems and methods of operating a needle-free injection device are also disclosed.

Claims

1. A needle-free injection device comprising:

an injector body;

an injector tube positioned within the injector body, said injector tube housing a main spring configured to be selectively compressed to place the needle-free injection device in an armed configuration and a hammer, wherein the injector tube is configured to move laterally away from a syringe end of the needle-free injection device when pressure is applied to a nozzle end of a needle-free syringe prior to an injection;

at least one handle attached with a pivot hinge to the injector body such that the handle pivots between an open and a closed position and such that the handle remains attached to the injector body during an injection;

at least one linkage between the handle and the main spring causing the main spring to be compressed into the armed configuration when the handle is moved from the open to the closed position; and

an actuation button in mechanical communication with a hammer release, wherein the actuation button cannot engage the hammer release unless the injector tube is moved to a position fully away from the syringe end of the device.

2. The needle-free injection device of claim 1 further comprising a sleeve engaged with the at least one linkage and the main spring wherein the sleeve is configured to move laterally with respect to the injector tube housing when the handle is moved from the open position to the closed position, to compress the main spring.

3. The needle-free injection device of claim 1 wherein the at least one handle comprises an upper handle and a lower handle and the at least one linkage comprises an upper linkage between the upper handle and the main spring and at least one lower linkage between the lower handle and the main spring.

4. The needle-free injection device of claim 3 further comprising a catch mechanism configured to engage the handles and hold each handle in the closed position.

5. The needle-free injection device of claim 4 further comprising a release mechanism configured to release the handles and allow each handle to move to the open position.

6. The needle-free injection device of claim 1 further comprising a skin tensioning spring configured to bias the injector tube toward the syringe end of the needle-free injection device.

7. The needle-free injection device of claim 1 wherein the hammer release comprises one or more ball bearings housed within a ball lock.

8. The needle-free injection device of claim 1 further comprising a retract button mechanically linked to the injector tube, the retract button causing the injector tube to be locked in a position toward the syringe end of the needle-free injection device unless the retract button is activated.

9. The needle-free injection device of claim 3 further comprising at least one pivot hinge the pivot hinge comprising;

two pivot studs with a first pivot stud being engaged with the upper handle and a second pivot stud being engaged with the lower handle; and

two radius surfaces with a first radius surface mating with a corresponding surface on the upper handle and a second radius surface mating with a corresponding surface on the lower handle.

10. A needle-free injection system comprising:

a needle-free injection device comprising;

an injector body;

an injector tube positioned within the injector body, said injector tube housing a main spring configured to be selectively compressed to place the needle-free injection device in an armed configuration and a hammer, wherein the injector tube is caused to move laterally away from a syringe end of the needle-free injection device when pressure is applied to a nozzle end of a needle-free syringe prior to an injection;

at least one handle attached with a pivot hinge to the injector body such that the handle pivots between an open and a closed position and such that the handle remains attached to the injector body during an injection;

a linkage between the handle and the main spring causing the main spring to be compressed into the armed configuration when the handle is moved from the open to the closed position;

an actuation button in mechanical communication with a hammer release, wherein the actuation button cannot engage the hammer release unless the injector tube is moved to a position fully away from the syringe end of the device; and

a needle-free syringe.

11. The needle-free injection system of claim 10 wherein the needle-free syringe comprises:

a syringe body comprising a nozzle at one end and a dose setting surface substantially opposite the nozzle;

a plunger body comprising a leading end, a seal and a hammer surface substantially opposite the leading end, wherein the syringe body defines a dosage space within the syringe between the nozzle and the plunger seal, wherein the dosage space has a selected dosage volume when the plunger body is positioned within the syringe body such that the dose setting surface and hammer surface are coplanar.

12. The needle-free injection system of claim 11 wherein the selected dosage volume is 0.1 ml.

13. The needle-free injection system of claim 11 wherein the needle-free syringe further comprises:

a handle substantially opposite the plunger body;

a separable shaft between the plunger body and handle; and

a break line defined in the separable shaft.

14. The needle-free injection system of claim 13 wherein the break line defines the hammer surface on the plunger body.

15. The needle-free injection system of claim 13 wherein the handle comprises a plunger positioning surface which cooperates with the hammer surface to position the plunger body in the syringe body such that the dose setting surface and hammer surface are coplanar.

16. The needle-free injection system of claim 15 wherein a hole is defined through the plunger positioning surface.

17. A method of operating a needle-free injection system comprising:

providing a needle-free injection device comprising;

an injector body;

an injector tube positioned within the injector body, said injector tube housing a main spring and a hammer;

at least one handle attached with a pivot hinge to the injector body such that the handle pivots between an open and a closed position and such that the handle remains attached to the injector body during an injection;

a linkage between the handle and the main spring;

an actuation button in mechanical communication with a hammer release, wherein the actuation button cannot engage the hammer release unless the injector tube is moved to a position fully away from a syringe end of the device; and

a needle-free syringe;

moving the handle from the open position to the closed position thereby compressing the main spring of the needle-free injection device from an un-armed position to an armed position;

applying force against a patient'"'"'s skin at a nozzle end of the needle-free syringe thereby causing the injector tube to move laterally within the injector body away from the syringe end of the injector body; and

actuating the actuation button to release the hammer and cause an injection.

18. The method of claim 17 further comprising:

providing a retract button mechanically linked to the injector tube, the retract button causing the injector tube to be locked in a position towards the syringe end of the needle-free injection device unless the retract button is activated; and

activating the retract button prior to causing the injector tube to move laterally within the injector body away from the syringe end of the injector body.