Packaging assembly to prevent premature activation

• US 8,734,420 B2
• Filed: 02/22/2012
• Issued: 05/27/2014
• Est. Priority Date: 08/25/2010
• Status: Active Grant

• Current Assignee: Takeda Pharmaceutical Company Limited
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Ariagno, Scott R., Schilling, Mark D., Pla, Tomas V.
• Primary Examiner(s): Ho, Tan-Uyen
• Assistant Examiner(s): BRYANT, ERIC C
• Application Number:
  US13/402,560
• Publication Number:
  US 20120277715A1
• Time in Patent Office: 825 Days
• Field of Search: None
• US Class Current: 604/414
• CPC Class Codes: A61J 1/16 Holders for containers
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2065 having aligning and guiding means
• CPC Class Codes: A61J 1/2075 for external venting
• CPC Class Codes: A61J 1/2082 for gas filtration
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096

Abstract

A package assembly for a drug reconstitution assembly includes a body, a drug reconstitution assembly and a removable lid. The body includes a plurality of protrusions configured to mate with a plurality of corresponding features of the drug reconstitution assembly to inhibit axial and rotational translation of the drug reconstitution assembly and its constituent parts during shipping and handling. By preventing axial and rotational shifting during shipment, premature and accidental puncture or contamination of the medication or the spikes within the drug reconstitution assembly is minimized.

Claims

1. A medical package assembly, the medical package assembly comprising:

a drug reconstitution assembly including;

(i) a housing forming at least one aperture, the at least one aperture including a hole having a perimeter completely defined by the housing,

(ii) a container, at least a portion of the container extending within an interior of the housing, and

(iii) a spike assembly arranged within the housing so as to be able to spike the container; and

a body shaped to house the drug reconstitution assembly, the body including at least one protrusion extending through the at least one aperture and into the interior of the housing, wherein the at least one protrusion is positioned and arranged to prevent movement of the container toward the spike assembly prior to the container reaching an undesirable displacement relative to the spike assembly.

2. The medical package assembly of claim 1, which includes a lid attached to the body and configured to sealingly enclose the drug reconstitution assembly within the body.

3. The medical package assembly of claim 2, wherein the lid is attached to the body with heat-activated adhesive.

4. The medical package assembly of claim 2, wherein the at least one protrusion is configured to prevent axial translation of the container relative to the housing.

5. The medical package assembly of claim 1, wherein the at least one protrusion further prevents rotation of the drug reconstitution assembly within the body.

6. The medical package assembly of claim 1, wherein the body is structured with at least one flat surface so as to prevent rolling of the body.

7. The medical package assembly of claim 1, wherein the drug reconstitution assembly includes a syringe port plug and the body includes a cavity shaped to mate with the syringe port plug of the drug reconstitution assembly.

8. The medical package assembly of claim 1, wherein the container is a first container, and which includes a second container, at least a portion of the second container extending within the housing of the drug reconstitution assembly, the housing forming at least one second at least one aperture, the second aperture including a hole having a perimeter completely defined by the housing, wherein the at least one protrusion is a first protrusion and which includes a second protrusion, the second protrusion positioned and arranged to extend through the second at least one aperture and into the interior of the housing and prevent movement of the second container toward the spike assembly prior to the second container reaching an undesirable displacement relative to the spike assembly.

9. The medical package assembly of claim 1, wherein the container is a first container including a neck and a shoulder, the first container is arranged relative to the housing to align first at least a portion of the neck of the first vial with the first at least one aperture, the first at least one protrusion configured to extend toward the neck and engage the shoulder prior to the first vial reaching an undesirable displacement relative to the spike assembly.

10. The medical package assembly of claim 9, wherein the container is a first container, and including a second container, at least a portion of the second container extending within the housing of the drug reconstitution assembly and the second container is a vial including a neck and a shoulder, the housing forming at least one second aperture, the at least one second aperture including a hole having a perimeter completely defined by the housing, the second container arranged relative to the housing to align at least a portion of the neck of the second container with the at least one second aperture wherein the at least one protrusion is a first protrusion and the body forming a second protrusion, the second protrusion positioned and arranged to extend through the at least one second aperture and into the interior of the housing toward the neck of the second container and engage the shoulder of the second container prior to the second container reaching an undesirable displacement relative to the spike assembly.

11. A drug delivery product comprising:

a drug reconstitution assembly including a housing and a container placed within the housing; and

a package including a body shaped to house the drug reconstitution assembly and at least one protrusion extending from the body, the at least one protrusion positioned and arranged to engage the housing and the container through at least one aperture in the housing to inhibit axial translation of the container relative to the housing, the at least one aperture including a hole having a perimeter completely defined by the housing.

12. The drug delivery product of claim 11, wherein the container is a first container and which includes a second container placed within the housing, the at least one protrusion is a first protrusion, the body including a second protrusion positioned and arranged to engage with the housing to inhibit axial translation of the second container relative to the housing.

13. The drug delivery product of claim 12, wherein the first protrusion engages the housing at a first location adjacent the first container and the second protrusion engages the housing at a second location adjacent the second container.

14. The drug delivery product of claim 12, wherein the first and second engagements include the first and second protrusions extending through first and second apertures, respectively, of the housing, wherein the first and second apertures include a first hole and a second hole respectively, the first and second hole each having a perimeter completely defined by the housing.

15. The drug delivery product of claim 14, wherein at least one of:

(i) the first aperture is one of a plurality of first apertures spaced radially about the housing, the plurality of first apertures including a plurality of first holes respectively, each of the plurality of first holes having a perimeter completely defined by the housing or (ii) the second aperture is one of a plurality of second apertures spaced radially about the housing, the plurality of second apertures including a plurality of second holes respectively, each of the plurality of second holes having a perimeter completely defined by the housing.

16. The drug delivery product of claim 14, wherein the first and second protrusions extending through the first and second apertures further inhibit rotational movement of the housing relative to the body.

17. The drug delivery product of claim 12, wherein the first and second containers are accessed by a transfer set assembly, the transfer set assembly including a port configured to be accessible by a user, the body including a well positioned and arranged to engage the port, or a plug plugging the port, to inhibit axial movement of the housing.

18. The drug delivery product of claim 11, wherein engagement of the drug reconstitution assembly by the at least one protrusion also inhibits rotational movement of the housing relative to the body.

19. The drug delivery product of claim 11, wherein engagement of the drug reconstitution assembly by the at least one protrusion also inhibits axial movement of the housing relative to the body.

20. A method of packaging a drug reconstitution assembly, comprising:

providing a package with a removable lid and a body configured to house the drug reconstitution assembly, including at least one protrusion extending from the body;

providing the drug reconstitution assembly with a housing having at least one aperture, and a container, at least a portion of the container extending within the housing, wherein a neck portion of the container aligns with the at least one aperture of the housing, the at least one aperture including a hole having a perimeter completely defined by the housing;

assembling the drug reconstitution assembly within the body of the package, such that the at least one protrusion of the body extends through the at least one aperture of the housing, wherein an orientation of the drug reconstitution assembly within the package is limited to a predetermined number of orientations; and

sealing the drug reconstitution assembly within the body of the package with the removable lid.