Pen style injector with automated substance combining feature

• US 6,793,646 B1
• Filed: 01/18/2002
• Issued: 09/21/2004
• Est. Priority Date: 04/16/1999
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Giambattista, Lucio, DeSalvo, David
• Primary Examiner(s): Hayes, Michael J.
• Application Number:
  US09/958,125
• Time in Patent Office: 977 Days
• Field of Search: 604/82-92, 604/56, 604/224, 604/232, 604/234, 604/511, 604/208
• US Class Current: 604/90
• CPC Class Codes: A61M 5/2066 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/284 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/3146 Priming, e.g. purging, reducing backlash or clearance
• CPC Class Codes: A61M 5/315 Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms

Abstract

A pen-style injector (20) includes an automated mover (70) that completes a combination of two substances such as a reconstitution process to reconstitute a lyophilized medicament prior to making an injection. The automated mover (70) is preloaded selectively released to automatically reconstitute the medicament at a controlled rate. The illustrated embodiment includes a mechanical spring (70) that provides the necessary movement of components within the injector (20) to complete the automated reconstitution process. The injector also has safety features (100) to prevent an injection prior to completing the automated combination of the substances.

Claims

1. An injector device for automatically combining two substances, comprising:

a body;

a substance retaining portion having at least a first and second chamber with selective communication between the first and second chambers, the first chamber containing a first substance and the second chamber containing a second substance to be selectively combined with the first substance, wherein the retaining portion includes a front orifice, a front stopper member, a rear stopper member and a second orifice at an end of the retaining portion that is opposite from the front orifice, the front stopper member separates the front chamber from the second chamber, and wherein the automated mover engages and moves the rear stopper member;

an automated mover supported by the body and that automatically moves the second substance from the second chamber and into the first chamber to automatically combine the first and second substances;

a manual trigger for expelling said combined substances from the first chamber and into a patient, said trigger being activatable only once said automated mover has combined the substances;

a needle supported at a first end of the body to perform a hypodermic injection and wherein the retaining portion is supported within the body between the needle and the automated mover and the automated mover is supported within the body between the retaining portion and a second end of the body;

an engaging member that engages the rear stopper and a reconstituting intermediary member that engages the engaging member responsive to a force from the automated mover such that the engaging member engages and moves the rear stopper member; and

an injection intermediary member that engages the engaging member responsive to actuation of the trigger such that the engaging member moves the rear stopper member and the front stopper member to expel the combined substances out of the front orifice of the retaining portion.

2. The device of claim 1, wherein the automated mover includes a spring.

3. The device of claim 1, wherein the automated mover includes a mechanical spring that is preloaded within the body such that a bias of the spring urges the second substance into the first chamber.

4. The device of claim 3, wherein the spring has a preselected spring constant and the spring is preloaded a selected amount such that the substances are automatically combined at a desired rate.

5. The device of claim 1, wherein the automated mover also automatically moves any excess air out of the first chamber such that the first chamber contains only the combined substances.

6. The device of claim 1, wherein the body is generally cylindrical and has a size that is adapted to fit within an individual'"'"'s hand.

7. The device of claim 1, wherein the reconstituting intermediary member has a portion that interacts with a corresponding portion of the injection intermediary member such that the reconstituting intermediary member prevents the injection intermediary member from moving the engaging member and the rear stopper member until after the reconstituting intermediary member has caused the engaging member to move the rear stopper member such that the first and second substances have been combined.

8. The device of claim 1, including a locking element that locks the trigger into a non-use position after an injection has been administered such that the device can only be used for a single injection.

9. The device of claim 1, including a dosage control adjustment that is manually adjustable among a plurality of dosage amounts such that an injection includes dispensing a selected one of the plurality of dosages.

10. The device of claim 1, wherein the engaging member is generally cylindrical having a front end that engages the rear stopper member and a rear end, the reconstituting intermediary member comprises a generally cylindrical sleeve that at least partially surrounds the engaging member and has an internal surface that abuts against the rear end of the engaging member to move the engaging member responsive to the force from the automated mover.

11. The device of claim 10, wherein the reconstituting intermediary member has a front edge and the body includes a stop surface that abuts the front edge to limit an amount of movement of the reconstituting intermediary member and the engaging member responsive to the force from the automated mover.

12. The device of claim 10, wherein the reconstituting intermediary member includes an opening adjacent the internal surface and the injection intermediary member is received through the opening such that the injection intermediary member moves the rear end of the engaging member away from the sleeve internal surface during an injection.

13. The device of claim 1, wherein the body includes a first body portion and a second body portion that is selectively moveable relative to the first body portion and including a locking mechanism that locks the automated mover into a preloaded condition and wherein movement of the second body portion relative to the first body portion releases the locking mechanism to allow the automated mover to automatically combine the substances.

14. The device of claim 13, wherein the locking mechanism includes at least one locking tab that is received within a corresponding slot and wherein axial movement of the second body portion relative to the first body portion releases the locking tab from the slot such that the automated mover is released from the preloaded condition to thereby move the liquid into the first chamber to reconstitute the medicament.

15. The device of claim 1, including a viewing window on the body near the substance retaining portion to allow visual inspection of the contents of the retaining portion.

16. The device of claim 1, wherein the first substance is a lyophilized medicament in a dry form and the second substance is a liquid for reconstituting the lyophilized medicament.

17. The device of claim 16, wherein the lyophilized medicament comprises alpha interferon.

18. The device of claim 1, including a damper that is effective to control a rate of movement of the automated mover.

19. The device of claim 1, including a communication passage between the first and second chambers.

20. The device of claim 19, wherein the communication passage is a channel formed in the retaining portion.