Sterile fluid storage and dispensing apparatus and method for filling same

• US 4,754,786 A
• Filed: 09/05/1986
• Issued: 07/05/1988
• Est. Priority Date: 09/05/1986
• Status: Expired due to Term

• Current Assignee: Roderick Roberts
• Original Assignee: Roderick Roberts
• Inventors: Roberts, Roderick
• Primary Examiner(s): Bell, Jr., Houston S.
• Application Number:
  US06/904,348
• Time in Patent Office: 669 Days
• Field of Search: 141/234-248, 141/10, 141/67, 141/68, 141/114, 141/313-317, 141/383-386, 141/285-310, 141/19, 141/329, 141/330, 141/382, 141/1-9, 141/11, 141/12, 604/411, 604/412, 604/413, 604/414, 604/415, 604/416, 604/52, 210/257.1, 210/257.2, 222/482
• US Class Current: 141/1
• CPC Class Codes: A61L 2/0005 for pharmaceuticals, biologicals or living parts
• CPC Class Codes: A61L 2/08 Radiation
• CPC Class Codes: A61L 2/18 Liquid substances or solutions comprising solids or dissolved gases
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor

Abstract

A disposable apparatus for sterilizing fluid and dispensing it includes a bag, a filter element, a conduit element, and a plurality of dispensing elements serially communicating with each other for providing a sterile fluid dispensing path that can be serially opened and closed. Methods are also provided for filling such apparatus in conjunction with a closed environment of an assembly having at least one mixing vessel, a reservoir container, a filling area, a filter element, and a plurality of storage elements interfacing the filling area.

Claims

1. A disposable assembly for mixing, sterilizing, storing, and dispensing fluids, all of which occur in a closed and sterile environment, comprising:

at least one disposable mixing vessel for mixing the fluid, the mixing vessel being disposed in a substantially sterile environment;

a disposable reservoir container for holding the fluid transferred from the mixing vessel;

at least one disposable filling area for holding the liquid, the filling area being in communication with the reservoir container and also having been sterilized and placed in communication with the reservoir container prior to sterilizing and storing the fluid;

a sterilizing means for sterilizing the liquid prior to storing, the sterilizing means being located intermediate of and in communication with the reservoir container and the filling area, the sterilizing means also having been sterilized and placed in communication with the filling area prior to sterilizing and storing the fluid; and

at least one storage element in communication with the filling area, the storage element having been sterilized and placed in communication with the filling area prior to sterilizing the fluid, and capable of being filled with the liquid and then sealed off from the filling area, whereby a sterile environment is formed by the filling area, the sterilizing means, and the storage element prior to sterilizing the fluid, and said environment remains sterile while the fluid is being sterilized and while the storage element is being filled.

2. The invention of claim 1 wherein the volumetric capacity of the reservoir container is substantially greater than that of the mixing vessel.

3. The invention of claim 1 wherein each storage element is serially aligned along the filling area.

9. The invention of claim 1 wherein the mixing vessel has been sterilized prior to mixing the fluid.

10. The invention of claim 9 wherein the reservoir container has been sterilized prior to mixing the fluid.

11. The invention of claim 1 further including at least one dispensing element fixed to the storage element.

4. In an assembly for mixing a fluid, transferring the fluid out of a container, and then processing the fluid into at least one receiving element, a disposable apparatus for sterilizing, storing, and dispensing the fluid, comprising:

a sterile environment that remains continuously closed to the entrance of undesired elements outside of the environment and which has been formed prior to transferring the fluid out of the container, the environment being affixed to the container and having;

a conduit means for transferring the fluid along a longitudinally extending filling area having one end interfacing the container, the conduit means having at least one first connector element sealed along the filling area, the conduit means also having been sterilized prior to sterilizing the fluid;

a sterilizing means for sterilizing the fluid, the sterilizing means disposed within the filling area at the end immediately interfacing the container, the sterilizing means also having been sterilized prior to the fluid being sterilized; and

at least one storage element that is sealed to a respective first connector element to remain in fluid communication with the filling area, each storage element also having been sterilized prior to sterilizing the fluid, whereby the conduit means, the sterilizing means, and the storage element have been connected to one another and then sterilized to form the environment prior to sterilizing the fluid.

5. The invention of claim 4 wherein each storage element is serially disposed along the filling area.

6. A method for manufacturing, sterilizing, and dispensing fluids within a closed environment, comprising the steps of:

preparing the fluid in a disposable mixing vessel which is located in a substantially sterile environment;

transferring the fluid from the mixing vessel to a disposable reservoir container;

placing at least one disposable storage element in communication with a disposable liquid filling area which is in communication with the reservoir container;

placing a disposable sterilizing element intermediate of and in communication with the reservoir container and the filling area;

sterilizing the storage element, the sterilizing element, and the filling area as a single entity after they have all been placed in communication with each other;

moving the fluid from the reservoir container through the disposable sterilizing element and into the liquid filling area after the sterilizing element, storage element, and the filling area have been sterilized;

filling the storage element with the prepared fluid from the filling area; and

sealing off the storage element from the liquid filling area to permit the storage element to be disconnected from the liquid filling area while leaving the liquid filling area sealed, whereby the steps of moving the fluid through the sterilizing element and into the filling area, and then filling the storage element occur within a continuously closed and sterile environment.

7. the invention of claim 6 wherein the step of sterilizing the storage element, the filter element, and the liquid filling area occurs prior to the step of moving the fluid into the liquid filling area.

8. The invention of claim 7 wherein the step of placing the storage elements in communication with the liquid filling area includes the step of serially sealably connecting the storage elements to the filling area.