Methods for packaging a pressure or vacuum sensitive product

• US 5,519,984 A
• Filed: 03/16/1995
• Issued: 05/28/1996
• Est. Priority Date: 03/16/1995
• Status: Expired due to Term

• Current Assignee: Liebel-Flarsheim Company (Mallinckrodt plc)
• Original Assignee: Mallinckrodt Medical Inc. (Mallinckrodt plc)
• Inventors: Beussink, Donald R., Hagen, Ronald W.
• Primary Examiner(s): Culver, Horace M.
• Application Number:
  US08/405,484
• Time in Patent Office: 439 Days
• Field of Search: 53/432, 53/471, 53/489, 53/488, 53/281, 53/510, 53/319, 53/324, 53/330
• US Class Current: 53/489
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like
• CPC Class Codes: B65B 7/2821 applying plugs or threadless stoppers for bottles or jars B67B1/04
• CPC Class Codes: B67B 1/04 by inserting threadless stoppers, e.g. corks

Abstract

Methods for packaging a pressure or vacuum sensitive product, such as an ultrasound contrast media comprised of a gas-filled microshpere or microbubble, or sealing such a product in a single-compartment syringe, in a manner that does not utilize pressure or vacuum in the process, are provided.

Claims

1. A method for packaging a pressure or vacuum sensitive product in a container to seal the product therein, the container having first and second ends, the method comprising:

sealing one of the ends of the container;

introducing the pressure or vacuum sensitive product into the container through the other end;

inserting a compressible closure member of a normal diameter sufficient to sealingly engage the inner wall of the container into a generally conical hollow tube, the generally conical hollow tube having a first end of a diameter permitting the insertion of the compressible closure member therein and a second end of a diameter less than the diameter of the first end, such that the closure member is positioned generally within the second end of the tube and the diameter of the closure member positioned therein is correspondingly reduced;

inserting the tube containing the closure member into the container to position the closure member at a selected location within the container;

providing a means for holding the position of the closure member substantially stationary with respect to the tube at the selected location relative to the container;

withdrawing the tube from the container in a manner placing the closure member in the container such that the closure member expands and sealingly engages the inner wall of the container; and

removing the means for holding the closure member.

2. The method of claim 1 wherein the container is a single compartment syringe.

3. The method of claim 2 wherein the pressure or vacuum sensitive product is a liquid.

4. The method of claim 3 wherein the pressure or vacuum sensitive product is comprised of microbubbles or gas-filled encapsulated microspheres.

5. The method of claim 4 wherein the pressure or vacuum sensitive product is an ultrasound contrast agent.

6. The method of claim 5 wherein the pressure or vacuum sensitive product is an albumin based microbubble.

7. The method of claim 5 wherein the pressure or vacuum sensitive product is a surfactant-based, gas-filled microbubble.

8. The method of claim 5 wherein the pressure or vacuum sensitive product is a polymer-based, gas-filled microbubble.

9. The method of claim 5 wherein the pressure or vacuum sensitive product is a liposome-based, gas-filled microbubble.

10. The method of claim 5 wherein the pressure or vacuum sensitive product is a phospholipid-based, gas-filled microbubble.

11. A method for sealing a pressure or vacuum sensitive product in a container, the container having at least one sealed end, the method comprising:

introducing the pressure or vacuum sensitive product into the container;

inserting a compressible closure member of a diameter sufficient to sealingly engage the inner wall of the container into a generally conical hollow tube, the generally conical hollow tube having a wide end of a diameter substantially the same as the diameter of the closure member and a reduced end of a diameter less than the diameter of the container, such that the closure member is positioned generally within the reduced end of the tube and the diameter of the closure member is correspondingly reduced;

inserting the tube containing the closure member into the container in a manner positioning the closure member at a selected location in the container;

providing a means for holding the position of the closure member substantially stationary with respect to the tube at the selected location relative to the container;

retracting the tube from the container in a manner leaving the closure member in the container such that the closure member expands and sealingly engages the inner wall of the container; and

retracting the means for holding the closure member.

12. The method of claim 11 wherein the container is a single compartment syringe.

13. The method of claim 12 wherein the pressure or vacuum sensitive product is a liquid.

14. The method of claim 13 wherein the pressure or vacuum sensitive product is comprised of microbubbles or gas-filled encapsulated microspheres.

15. The method of claim 14 wherein the pressure or vacuum sensitive product is an ultrasound contrast agent.

16. The method of claim 15 wherein the pressure or vacuum sensitive product is an albumin based microbubble.

17. The method of claim 15 wherein the pressure or vacuum sensitive product is a surfactant-based, gas-filled microbubble.

18. The method of claim 15 wherein the pressure or vacuum sensitive product is a polymer-based, gas-filled microbubble.

19. The method of claim 15 wherein the pressure or vacuum sensitive product is a liposome-based, gas-filled microbubble.

20. The method of claim 15 wherein the pressure or vacuum sensitive product is a phospholipid-based, gas-filled microbubble.