Flexible medical hemodialysis packaging unit for the production of concentrated dialysis solution including a device for the same

• US 5,616,305 A
• Filed: 06/14/1995
• Issued: 04/01/1997
• Est. Priority Date: 06/24/1994
• Status: Expired due to Term

• Current Assignee: Fresenius AG (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius AG (Fresenius SE & Co. KGaA)
• Inventors: Mathieu, Bernd
• Primary Examiner(s): Warden, Robert J.
• Assistant Examiner(s): Thornton, Krisanne M.
• Application Number:
  US08/490,217
• Time in Patent Office: 657 Days
• Field of Search: 422/261, 422/266, 422/267, 422/279, 422/282, 422/283, 604/408-410, 206/568, 206/570, 206/484, 206/524.1, 206/526, 206/828
• US Class Current: 422/261
• 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 2205/3389 Continuous level detection A61M2205/3393 takes precedence
• CPC Class Codes: A61M 2205/3393 by weighing the reservoir
• CPC Class Codes: B01F 35/50 Mixing receptacles
• CPC Class Codes: B01F 35/513 Flexible receptacles, e.g. bags supported by rigid containers

Abstract

A flexible medical packaging unit designed as a bag (14) including a single connector (18) containing a powdered salt concentrate (16), i.e. bicarbonate, with a volume sufficient for one dialysis treatment. The bag (14) has such a capacity that the powdered salt concentrate (16) will only partially be dissolved even when completely filled with water.

Claims

1. A flexible medical packaging unit for hemodialysis for the production of a hemodialysis solution concentrate, comprising a flexible container providing a single connector and a cavity charged with a powdered salt concentrate of a quantity sufficient for one hemodialysis treatment, and wherein the volume of the cavity of the container is so designed that the powdered salt concentrate is only partially dissolved when completely charged with water.

2. A packaging unit according to claim 1, in which the salt concentrate is sodium bicarbonate.

3. A packaging unit in accordance with claim 1 in which the flexible container is a plastic bag.

4. A packaging unit according to claim 1 comprising a filter layer adjacent to the connector in the cavity of the container, creating a flow connection from the connector to the cavity.

5. A packaging unit according to claim 1 in which said container comprising a floor area on which the concentrate is disposed, a top spaced from said concentrate, and a submerged pipe extending from the connector through the cavity of the container from the top to the floor area.

6. A packaging unit according to claim 5, in which the end of the submerged pipe in the floor area is sealed by a filter layer.

7. A packaging unit according to claim 5, comprising a first check valve within the submerged pipe, allowing flow in the direction of the floor area of the container only, the submerged pipe adjacent to the connector including a port, a second check valve being provided at the port having a port filter layer for releasing a flow of liquid only in the direction of either the connector or the port filter layer.

8. A packaging unit in accordance with claim 7, wherein the discharge hose extends to the concentrate.

9. A system for the production and discharge of a liquid hemodialysis concentrate comprising a water supply, a flexible container having a single connector and connecting hose, including a sufficient quantity of a concentrate powdered salt, connecting on the one hand the water supply and on the other the connector and a device for the production of a hemodialysis solution, shut-off systems each opening and/or closing the hose system in a predetermined way, a controller for activating said water supply, a shut-off system and the hemodialysis solution producing device, and a device for compensating dead volume formed by at least one hose passed by both water and liquid concentrate, said controller enabling said dead volume compensating device prior to commencement of discharge of the liquid concentrate.

10. A system according to claim 9, comprising a first hose section including a connecting point and a first valve, a second hose section including a second valve between the connecting point and the connecting hose, a third section including a third valve between the connecting point and the hemodialysis solution producing device, and a fourth hose section connected to the connecting point, connected in circuit with the dead volume compensating device to eliminate the dead volume.

11. A system according to claim 10, in which the dead volume compensating device is a metering pump activated by the controller.

12. A system according to claim 11, wherein said metering pump is operated during elimination of the dead volume by the controller, with the second valve open and other valves closed, ensuring that at least full dead volume in said hoses will be evacuated, and accumulated within said metering pump.

13. A system according to claim 11, wherein the metering pump is controlled by the controller to charge and discharge during the elimination of the dead volume, with the second valve open and other valves closed.

14. A system according to claim 10, in which the dead volume compensating device comprises a fourth valve and a fourth hose section from said valve to said connecting point said fourth valve being opened together with the second valve by the controller for such a period of time that the dead volume is eliminated by the fourth hose section.

15. A system according to claim 9, wherein the device for elimination of the dead volume controls the device for production of the hemodialysis solution in such a way that liquid in the dead volume will be conveyed for the production of hemodialysis solution.

16. A system according to claim 15, including a sensor for continuously determining the composition of any liquid passing through the third hose section and signaling to the controller (54) when a predetermined reading is reached for the composition and/or volume of liquid, whereby the device for the production of hemodialysis solution is switched to convey the liquid concentrate.

17. A system according to claim 9, in which the controller deactivates the device for the production of hemodialysis solution at the end of its discharge, closing the third valve and activating the water supply as well as the first and second valves in a predetermined way in order to initiate charging.