Dispenser and therapeutic package suitable for administering a therapeutic substance to a subject, along with method relating to same

• US 8,663,188 B2
• Filed: 12/24/2008
• Issued: 03/04/2014
• Est. Priority Date: 12/28/2007
• Status: Active Grant

• Current Assignee: Aktivax, Inc.
• Original Assignee: Aktivpak, Inc.
• Inventors: Genosar, Amir, Genosar, Romi
• Primary Examiner(s): HAND, MELANIE JO
• Application Number:
  US12/344,044
• Publication Number:
  US 20090171311A1
• Time in Patent Office: 1,896 Days
• Field of Search: 604/403, 604410-415, 222/92, 222/95, 222/163, 222/206, 222/213, 222/214
• US Class Current: 604/411
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61M 2005/312 comprising sealing means, e.g. severable caps, to be removed prior to injection by, e.g. tearing or twisting
• CPC Class Codes: A61M 2005/314 Flat shaped barrel forms, e.g. credit card shaped
• CPC Class Codes: A61M 2005/3249 Means to disalign the needle tip and the distal needle passage of a needle protection sleeve
• CPC Class Codes: A61M 2005/3252 being extended by a member protruding laterally through a slot in the syringe barrel
• CPC Class Codes: A61M 5/282 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/284 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/288 by piercing without internal pressure increase A61M5/283 takes precedence
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/3216 Caps placed transversally onto the needle, e.g. pivotally attached to the needle base
• CPC Class Codes: A61M 5/3243 being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel devices for protecting guide needles in combination with catheters A61M25/0612
• CPC Class Codes: A61M 5/326 Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user

Abstract

A dispensing device comprises a sealed package including a collapsible compartment and an administration assembly. The administration assembly includes a delivery device in fluid communication with a substance within the sealed package. A compression panel collapses the compartment to dispense a substance through the delivery device. Embodiments for a single use dispenser for hypodermic administration of a unit dose of a therapeutic fluid, as well as therapeutic packages and methods for administering therapeutic substances to subjects, are also provided.

Claims

1. A device for dispensing a dose of a substance to a subject, comprising:

a. a sealed package including a collapsible compartment containing the substance;

b. an administration assembly joined to said sealed package for relative movement therewith, said administration assembly including a delivery device movable from a pre-administration position wherein said delivery device is separated from the substance, to a ready position wherein said delivery device is in fluid communication with the substance;

c. a reinforcement insert joined to a wall of said collapsible compartment to provide a backing for said seal as said delivery device is advanced toward the ready position;

d. a seal interposed between the administration assembly and the substance; and

e. at least one compression panel associated with said sealed package and movable into an engaged state wherein said compression panel collapses said compartment to cause said substance to be dispensed through said delivery device.

2. A device according to claim 1 wherein said reinforcement insert is attached to both said coupler and an interior wall surface of said collapsible compartment.

3. A device according to claim 2 wherein said reinforcement insert is snap-fitted to said coupler.

4. A single use dispenser for hypodermic administration of a unit dose of a therapeutic fluid to a subject, comprising:

a. a hermetically sealed package including a collapsible first compartment containing a first therapeutic substance, said collapsible first compartment comprising a first flexible wall;

b. a rigid backing supporting said hermetically sealed package to facilitate collapsing of the collapsible first compartment;

c. an administration assembly associated with said hermetically sealed package, said administration assembly including;

i. an elongate needle having a piercing end for penetrating the flexible wall of said first compartment, and extending from said piercing end toward a delivery end for administering the therapeutic fluid to the subject; and

ii. a needle actuator for advancing at least a portion of said needle from a pre-administration position, wherein said piercing end is separated from the flexible wall of said first compartment, towards a ready position to cause said proximal end to breach the integrity of said flexible wall and establish fluid communication between the therapeutic substance and said delivery end.

5. A dispenser according to claim 4 comprising a coupler attached to said rigid backing, said coupler configured to removably attach said administration assembly.

6. A dispenser according to claim 5 including a gasket seal interposed between said coupler and the hermetically sealed package.

7. A dispenser according to claim 6 including a reinforcement insert joined to the hermetically sealed package to provide a backing for said gasket seal as said needle is advanced toward the ready position.

8. A dispenser according to claim 7 wherein said collapsible first compartment comprises a multi-layered flexible wall, and wherein said gasket seal is interposed between layers of said flexible wall.

9. A dispenser according to claim 4 wherein said administration assembly includes a hub carrying said needle, said hub frictionally captured within said coupler.

10. A dispenser according to claim 9 wherein said hub is threadedly attached to said coupler such that rotation of said hub relative to said coupler advances said needle from the pre-administration position toward the ready position.

11. A dispenser according to claim 4 including a collapsible second compartment containing a second therapeutic substance, said collapsible first compartment comprising an associated second flexible wall.

12. A dispenser according to claim 11 including a frangible seal disposed between said first and second compartments, and wherein said rigid backing is movably attached relative to the first and second compartments between a flattened state and folded state wherein said rigid backing collapses said second compartment to cause said frangible seal to rupture such that said first and second therapeutic substances are merged.

13. A dispenser according to claim 4 including at least one compression panel associated with said sealed package and movable into an engaged state wherein said compression panel collapses said first collapsible compartment to cause said therapeutic substance to be dispensed through said needle.

14. A dispenser according to claim 13 wherein said compression panel protects said needle when the needle is in the pre-administration position.

15. A dispenser according to claim 13 wherein said compression panel is movable beyond the engaged state to damage, and prevent further use of, said needle.

16. A dispenser according to claim 13 wherein said rigid backing defines said compression panel.