Separation assembly for drug delivery device

• US 7,556,614 B2
• Filed: 09/03/2003
• Issued: 07/07/2009
• Est. Priority Date: 10/10/2000
• Status: Expired due to Term

• Current Assignee: Meridian Medical Technologies Incorporated
• Original Assignee: Meridian Medical Technologies Incorporated
• Inventors: Griffiths, Steven, Hill, Robert L., Wilmot, John G.
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): MacNeill; Elizabeth R
• Application Number:
  US10/653,159
• Publication Number:
  US 20040097874A1
• Time in Patent Office: 2,134 Days
• Field of Search: 604/82, 604/83, 604/84, 604/85, 604/86, 604/87, 604/88, 604/89, 604/90, 604/91, 604/92, 604/93.01, 604/187, 604/190, 604/191, 604/200, 604/236
• US Class Current: 604/89
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2005/287 by displacing occluding plugs
• CPC Class Codes: A61M 2005/3132 having flow passages for injection agents at the distal end of the barrel to bypass a sealing stopper after its displacement to this end due to internal pressure increase
• 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 5/2066 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/286 upon internal pressure increase, e.g. pierced or burst A61M5/283 takes precedence
• CPC Class Codes: A61M 5/3145 Filters incorporated in syringes
• CPC Class Codes: A61M 5/34 Constructions for connecting the needle , e.g. to syringe nozzle or needle hub connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 5/343 Connection of needle cannula to needle hub, or directly to syringe nozzle without a needle hub A61M5/322 takes precedence

Abstract

A separation assembly for initially keeping a first component separate from a second component includes a generally cylindrical body slidably supported within a container between the first and second components. The body includes a seal structure having an inner seal member that initially seals the first component from the second component. In response to a predetermined operating condition, the inner seal member allows the first component to flow through at least one flow path in the seal structure to mix with the second component. The body further includes a flow distributing member disposed adjacent the seal structure to evenly distribute the first component into the second component. The seal structure and the flow distributing member form a single unit.

Claims

1. A separation assembly for a container that separates a first component from a second component and that allows the first component to be mixed with the second component upon occurrence of a predetermined operating condition, the separation assembly comprising:

first and second open ends and a generally cylindrical hollow body there between slidably supported within the container between the first component and the second component, the hollow body having an inner sidewall surface and a flow path extending longitudinally from the first open end to the second open end, the flow path formed entirely by one or more longitudinal structures in the hollow body;

a one-piece inner seal member disposed at the first open end to seal the flow path before occurrence of the predetermined operating condition; and

a flow distributing member disposed at the second open end and operative to receive there through and distribute the first component into the second component upon occurrence of the predetermined operating condition;

wherein;

the inner seal member is operative to allow the first component to flow through the flow path and through the flow distributing member to mix with the second component in response to an occurrence of the predetermined operating condition; and

a plurality of circumferential portions of the periphery of the inner seal member maintains contact with the inner sidewall surface at all times.

2. The separation assembly according to claim 1. wherein the flow distributing member comprises a filter.

3. The separation assembly according to claim 1, wherein the inner seal member comprises a movable plug.

4. The separation assembly according to claim 1, further comprising an outer seal member that has an outer periphery that forms a peripheral seal with an interior wall of the container.

5. The separation assembly according to claim 1, wherein the inner seal member comprises a burstable membrane operative to burst in response to an occurrence of the predetermined operating condition.

6. The separation assembly according to claim 1, wherein the first or second component is a medicament.

7. The separation assembly according to claim 1, wherein the first component is a liquid.

8. The separation assembly according to claim 1, wherein the second component is a solid.

9. The separation assembly according to claim 8, wherein the solid is a powdered, lyophilized, or freeze-dried substance.

10. The separation assembly according to claim 1, wherein the flow distributing member comprises a membrane through which a liquid solution is passable.

11. The separation assembly according to claim 1, wherein the predetermined operating condition is activation of an injector activation assembly in communication with the container.

13. The separation assembly according to claim 1, wherein the hollow body comprises two O-rings to provide annular sealing engagement with an interior wall of the container.

14. The separation assembly according to claim 1, wherein the hollow body comprises a unitary gasket to provide annular sealing engagement with an interior wall of the container.

12. The separation assembly according to claim wherein the inner seal member is slidably engaged with the hollow body.

15. An automatic injector comprising:

a housing;

a chamber disposed in the housing, the chamber having at least one opening therein and containing a medicament, the medicament being rearwardly confined by a plunger;

an actuation assembly disposed in the housing, the actuation assembly comprising a stored energy source capable of being released to drive the plunger through the chamber;

a needle assembly in communication with the chamber, the needle assembly comprising a needle support forming a seal with the chamber, the needle assembly further comprising a needle received in the needle support, the needle configured to expel the medicament when the plunger is driven through the chamber; and

a separation assembly that separates a first component of the medicament from a second component of the medicament and that allows the first component to be mixed with the second component upon occurrence of a predetermined operating condition, the separation assembly comprising;

first and second open ends and a generally cylindrical hollow body there between slidably supported within the chamber between the first and second components, the hollow body having an inner sidewall surface and a flow path extending longitudinally from the first open end to the second open end, the flow path formed entirely by one or more longitudinal structures in the hollow body;

a one-piece inner seal member disposed at the first open end and having a peripheral surface in lateral continuous 360 degree contact with the inner sidewall surface to seal the first component from the second component before occurrence of the predetermined operating condition, the inner seal member operative to allow the first component to flow through the flow path to mix with the second component in response to an occurrence of the predetermined operating condition, the peripheral surface of the inner seal member in lateral intermittent 360 degree contact with the inner sidewall surface to allow the first component to flow through the flow path to mix with the second component; and

a flow distributing member disposed at the second open end and operative to receive there through and distribute the first component into the second component in response to an occurrence of the predetermined operating condition.

16. The automatic injector according to claim 15 wherein the inner seal member comprises a movable plug.

17. The automatic injector according to claim 15 wherein the separation assembly further comprises an outer seal member that has an outer periphery that forms a peripheral seal with an interior wall of the chamber.

18. The automatic injector according to claim 15 wherein the first component is a liquid and the second component is a solid.

19. The automatic injector according to claim 15 wherein the flow distributing member comprises a membrane through which a liquid solution is passable.