Solution containers such as blood bags and system for preparing same

• US 4,223,675 A
• Filed: 07/24/1978
• Issued: 09/23/1980
• Est. Priority Date: 07/24/1978
• Status: Expired due to Term

• Current Assignee: Baxter Travenol Laboratories Incorporated
• Original Assignee: Baxter Travenol Laboratories Incorporated
• Inventors: Williams, Ronald A.
• Primary Examiner(s): Rosenbaum, C. Fred
• Application Number:
  US05/927,342
• Time in Patent Office: 792 Days
• Field of Search: 128/214 R, 128/214 A, 128/214 D, 128/214.2, 128/272, 128/272.1, 128/272.3, 128/DIG. 24, 128/DIG. 28
• US Class Current: 604/410
• CPC Class Codes: A61M 1/0209 Multiple bag systems for separating or storing blood components

Abstract

Packages or containers are formed for body fluids or other solutions within which autoclaved liquids such as anticoagulants are included. The invention, which is particularly suitable for donor blood bags, includes the use of a sterile connector to incorporate autoclaved liquids into sterilized packages that can, if desired, be made of materials that cannot be successfully autoclaved at high temperatures without deformation or discoloration thereof.

Claims

1. A system for producing sterile, non-autoclavable body fluid containers having autoclaved liquid therewithin, comprising a dry-sterilized package formed of a dry-sterilized synthetic resin material, said material being unsuitable for being subjected to autoclave conditions, said material being especially suitable for prolonged storage of body fluids, said dry-sterilized package including a sterile communication with the interior of said package;

an autoclavable dispenser constructed of an autoclavable substance, said autoclavable dispenser substance being an autoclaved heat-resistant glass or an autoclaved high melting point resin suitable for sterilizing a liquid within the dispenser, said liquid having been sterilized within the dispenser, said dispenser including a sterile connector having and initially closed sterile aperture in sterile communication with the interior of said dispenser;

said package sterile connector and said dispenser sterile connector being in mating engagement with each other to open said initially closed sterile apertures to each other while maintaining both said sterile communication with said interior of the package and said sterile communication with the interior of the dispenser for communicating said dry-sterilized package and said autoclavable dispenser in a sterile and secure manner.

2. The system of claim 1, wherein each of said sterile connectors including a generally transparent conduit and each of said initially closed sterile apertures is an opaque thermoplastic wall portion carried within said generally transparent conduit, each of said opaque wall portions being located opposite to each other when in said mating engagement and being fusable by radiant energy into a sterile aperture to form said sterile and secure communication between said package and said dispenser.

3. The system of claim 1, wherein said body fluid containers are blood bag units that are said dry sterilized packages, each blood bag unit having a primary blood receiving container.

4. The system of claim 3, further including at least one secondary container joined to said primary container by a tether and transfer tubing network.

5. The system of claim 1, wherein said autoclavable dispenser is a multiple-unit capacity dispenser having a plurality of said sterile connectors communicating therewith and depending therefrom.

6. A sterile non-autoclaved container for body fluids having autoclaved liquid therewithin, comprising:

a sterile package formed of a dry-sterilized synthetic resin material, said material being unsuitable for being subjected to autoclave conditions, said material being especially suitable for prolonged storage of body fluids, said dry-sterilized package being sterilized at well below autoclave temperatures, said dry-sterilized package having an autoclaved liquid sealed therewithin, wherein said autoclaved liquid sealed within said dry-sterilized package is autoclaved within and together with an autoclavable dispenser, said autoclavable dispenser being constructed of an autoclaved heat-resistant glass or an autoclaved high melting point resin, and wherein said autoclaved liquid is transported in a sterile manner from said dispenser through a sterile connector of the autoclavable dispenser, through a sterile connector of the dry-sterilized package, and into said dry-sterilized package, said dispenser sterile connector and said package sterile connector being in sterile and secure mating engagement with each other when the autoclaved liquid is transported therethrough, said mating engagement being through a sterile aperture of the dispenser and a sterile aperture of the package, both of said sterile apertures being closed until the sterile and secure mating engagement is completed.

7. The container of claim 6, wherein said sterile dry-sterilized package is a donor blood bag having a primary container with a disposable needle in fluid-passing communication therewith.

8. The container of claim 7, further including at least one secondary container, and a tether and transfer tubing network communicating said primary container with said secondary container.

9. The container of claim 6, wherein said dry-sterilized material is a synthetic resin selected from the group consisting of ethylene vinyl acetate polymers, blends of ethylene vinyl acetate polymers, low density polyethylene blends, and blends of styrene-butadiene block copolymers.

10. The container of claim 6, wherein said sterile, non-autoclaved package is a donor blood bag, said material is an ethylene oxide gas sterilized ethylene vinyl acetate polymer, and said sterilized liquid is a blood anti-coagulant that has been wet-sterilized.