Infusate containers

• US 10,561,779 B2
• Filed: 05/12/2017
• Issued: 02/18/2020
• Est. Priority Date: 05/12/2017
• Status: Active Grant

• Current Assignee: Mozarc Medical US LLC
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Lura, David B., Meyer, Thomas E., Huang, Jin, Xue, Yue Qiang
• Primary Examiner(s): Orme, Patrick
• Application Number:
  US15/593,437
• Publication Number:
  US 20180326140A1
• Time in Patent Office: 1,012 Days
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 33/14 Alkali metal chlorides; Alkaline earth metal chlorides
• CPC Class Codes: A61M 1/1666 by dissolving solids
• CPC Class Codes: A61M 1/1668 Details of containers
• CPC Class Codes: A61M 2205/584 having a color code
• CPC Class Codes: A61M 2205/6081 Colour codes
• CPC Class Codes: A61M 2205/7545 for solid matter, e.g. microaggregates
• CPC Class Codes: A61M 2209/084 Supporting bases, stands for equipment

Abstract

The invention relates to infusate containers and related systems and methods for housing infusates that can be added to a fluid flow path for use during dialysis. The infusate containers can include a filter partitioning the containers into a first and second compartment, a draw tube for drawing up fluid from a bottom portion, a cap, a fluid connector for delivery and withdrawal of fluid from the two compartments, and a fluid connector for connection to a dialysis system.

Claims

1. An infusate container for use in dialysis, comprising:

a container body;

a cap removably connected to a top portion of the container body;

the cap having a fluid connector for connection to a dialysis system;

a draw tube downwardly extending through the container body;

the draw tube connected to the cap;

the draw tube downwardly extending through a filter and into a bottom portion of the container body;

the filter connected to the draw tube;

the filter separating the container body into the top portion and a bottom portion; and

further comprising at least one support member on an interior of the infusate container, wherein a first end of the at least one support member is connected to the draw tube and a second end of the at least one support member in is contact with the container body.

2. The infusate container of claim 1, further comprising an inwardly tapering portion in the bottom portion of the infusate container.

3. The infusate container of claim 1, further comprising a removable film on a top side of the cap.

4. The infusate container of claim 1, the filter connected to the container body by any of glue, heat sealing, or welding.

5. The infusate container of claim 1, wherein the filter is either a mesh or a frit filter.

6. The infusate container of claim 1, wherein the fluid connector is a bi-channel connector.

7. The infusate container of claim 6, wherein the bi-channel connector has a first channel fluidly connected to the draw tube.

8. The infusate container of claim 1, further comprising a visual indicator indicating a substance inside the container body.

9. The infusate container of claim 8, wherein the visual indicator is a colored band.

10. The infusate container of claim 1, wherein the draw tube is molded to the cap.

11. The infusate container of claim 1, the at least one support member preventing the draw tube from contacting a base of the infusate container.

12. A dialysis system, comprising:

a dialysis machine comprising;

(i) a dialysate flow path;

(ii) one or more fluid connectors fluidly connecting one or more infusate containers to the dialysate flow path wherein the infusate containers comprise;

a container body;

a cap removably connected to a top portion of the container body;

the cap having a fluid connector for connection to the dialysis system;

a draw tube downwardly extending through the container body;

the draw tube connected to the cap; and

a filter connected to the draw tube;

the filter separating the container body into the top portion and a bottom portion;

the draw tube downwardly extending through the filter and into the bottom portion;

wherein the infusate containers contain a solid infusate in the top portion;

the one or more infusate containers each comprising at least one support member on an interior of the infusate container, wherein a first end of the at least one support member is connected to the draw tube and a second end of the at least one support member in is contact with the container body; and

(iii) at least one pump connected to a fluid line fluidly connected to one or more fluid connectors.

13. The dialysis system of claim 12, wherein the fluid connector is a bi-channel connector.

14. The dialysis system of claim 13, wherein a first channel of the bi-channel connector fluidly connects the draw tube to a first fluid line;

and wherein a second channel of the bi-channel connector fluidly connects an infusate container to a second fluid line.

15. The dialysis system of claim 12, wherein an infusate container contains sodium chloride, sodium bicarbonate, a cation infusate, or combinations thereof.

16. The dialysis system of claim 12, further comprising an infusate frame, the infusate frame housing the infusate containers.

17. The dialysis system of claim 16, the infusate frame having one or more apertures for housing the one or more infusate containers;

the one or more apertures sized or shaped complementary to the one or more infusate containers.

18. The dialysis system of claim 12, the at least one support member preventing the draw tube from contacting a base of the one or more infusate containers.

19. A method, comprising the steps of:

flowing water into an infusate container for use in dialysis, the infusate container comprising;

a container body;

a cap removably connected to a top portion of the container body;

the cap having a fluid connector for connection to a dialysis system;

a draw tube downwardly extending through the container body;

the draw tube connected to the cap;

a filter connected to the draw tube;

the filter separating the container body into the top portion and a bottom portion of the container body;

the draw tube downwardly extending through the filter; and

at least one support member on an interior of the infusate container, wherein a first end of the at least one support member is connected to the draw tube and a second end of the at least one support member in is contact with the container body;

wherein the infusate container contains a solid infusate in the top portion;

dissolving at least a portion of the solid infusate to make an infusate solution;

filtering the infusate solution and retaining the infusate solution in the bottom portion of the container body; and

flowing the infusate solution into a dialysate flow path.

20. The method of claim 19, wherein the step of flowing water into the infusate container further comprises flowing water through a first channel of a bi-channel connector;

and wherein the step of flowing the infusate solution into the dialysate flow path comprises flowing the infusate solution through a second channel of the bi-channel connector.

21. The method of claim 19, wherein the step of dissolving at least the portion of the solid infusate to make the infusate solution comprises making a saturated infusate solution.

22. The method of claim 19, wherein an infusate is sodium bicarbonate, sodium chloride, a cation infusate, or a combination thereof.

23. The method of claim 19, the at least one support member preventing the draw tube from contacting a base of the infusate container.