Process for preparing a stock solution composition for a medical treatment, and a soft bag having a magnetic stirrer to be used in the preparation of said stock solution composition

• US 5,533,804 A
• Filed: 09/19/1994
• Issued: 07/09/1996
• Est. Priority Date: 03/19/1992
• Status: Expired due to Fees

• Current Assignee: Gambro KK (Baxter International Inc.)
• Original Assignee: Gambro KK (Baxter International Inc.)
• Inventors: Larsson, Ake, Uno, Kiyoshi
• Primary Examiner(s): Cooley, Charles E.
• Application Number:
  US08/307,653
• Time in Patent Office: 659 Days
• Field of Search: 366/273, 366/274, 366/348, 416/3, 383/127, 206/219, 206/220, 206/221, 206/818, 604/56, 604/82, 604/92, 604/403, 604/416, 604/903, 215/DIG. 3, 215/DIG. 8
• US Class Current: 366/274
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/1666 by dissolving solids
• CPC Class Codes: A61M 1/167 Flexible packaging for solid concentrates
• CPC Class Codes: A61M 1/3455 Substitution fluids
• CPC Class Codes: A61M 1/3462 Circuits for the preparation thereof
• CPC Class Codes: B01F 31/55 the materials to be mixed being contained in a flexible bag submitted to periodical deformation
• CPC Class Codes: B01F 33/452 using independent floating stirring elements
• CPC Class Codes: Y10S 604/903 Medical container with material agitation means

Abstract

Processes for the preparation of stock solutions for use in medical treatments such as dialysis including the steps of providing a flexible bag containing powder components of the stock solution, supplying water to the flexible bag to provide the stock solution, and dissolving the powder in the water within the flexible bag by stirring the powder by application of a magnetic field to a magnetic stirrer disposed within the bag.

Claims

1. A process for the preparation of a stock solution for use in dialysis, hemodialysis, hemofiltration, or hemodiafiltration comprising:

providing a container which is a soft flexible bag, said bag containing components of said stock solution useful in dialysis, hemodialysis, hemofiltration or hemodiafiltration, said components being in the form of a powder, providing a magnetic stirrer within said bag, supplying a predetermined amount of water into said bag, placing said bag in direct contact with a source of a magnetic field, and dissolving said powder in said water within said flexible bag at a temperature of about room temperature or above, to provide a stock solution at a predetermined concentration by stirring said powder and said water together by the application of said magnetic field to said magnetic stirrer, said powder being dissolved and stirred without said bag being placed in any other container.

2. The process of claim 1 wherein said predetermined amount of water comprises a predetermined amount of a water solution.

3. The process of claim 1 wherein said flexible bag has a volume sufficiently large to contain said powder and said predetermined amount of water.

4. The process of claim 1 wherein said stirrer has a weight and size preselected to minimize the time required to completely dissolve said powder.

5. The process of claim 4 wherein said stirring of said powder is carried out at a stirring rate of from about 500 to 1000 rpm.

6. The process of claim 4 wherein said dissolving of said powder is carried out at a temperature of about 37°

C.

7. A process for the preparation of a stock solution for use in dialysis, hemodialysis, hemofiltration, or hemodiafiltration comprising:

providing a container which is a soft flexible bag, said bag containing components of said stock solution including a bicarbonate in the form of a powder, providing a magnetic stirrer within said bag, supplying a predetermined amount of water into said bag, placing said bag in direct contact with a source of a magnetic field, and dissolving said powder in said water within said flexible bag at a temperature of about room temperature or above, to provide a stock solution at a predetermined concentration by stirring said powder and said water together said powder being dissolved and stirred without said bag being placed in any other container.

8. The method of claim 7 wherein said stock solution is dissolved at a temperature of about 37°

C.

9. The method of claim 8 wherein said magnetic stirrer is operated at a speed of approximately 500 rpm or greater.

10. The method of claim 7 wherein said magnetic stirrer is operated at a speed of approximately 500 rpm or greater.

11. The method of claim 7 wherein said stock solution is heated to a temperature of about 37°

C.