Modular dialysate regeneration assembly

• US 10,172,991 B2
• Filed: 03/11/2015
• Issued: 01/08/2019
• Est. Priority Date: 06/24/2014
• Status: Active Grant

• Current Assignee: Mozarc Medical US LLC
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin T., Hobot, Christopher M.
• Primary Examiner(s): Bass, Dirk R
• Application Number:
  US14/644,820
• Publication Number:
  US 20150367056A1
• Time in Patent Office: 1,399 Days
• Field of Search: 210232, 210282, 210662, 210670
• CPC Class Codes: A61M 1/1611 Weight of the patient
• CPC Class Codes: A61M 1/1613 Profiling or modelling of patient or predicted treatment evolution or outcome
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 2205/121 interface between cassette and base
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: B01D 15/08 Selective adsorption, e.g. chromatography

Abstract

A customizable modular dialysate regeneration assembly with connectable sorbent packaging systems. The dialysate regeneration assembly can be customized based on patient parameters or dialysis session parameters. A processor can be included that can determine the correct amount of each sorbent material necessary for a given patient and a given dialysis session.

Claims

1. A modular dialysate regeneration assembly, comprising:

a sorbent cartridge comprising a plurality of sorbent compartments each containing at least one sorbent material wherein each of the plurality of sorbent compartments are attachable to another sorbent compartment to form the modular dialysate regeneration assembly; and

a processor programmed to determine an amount and type of sorbent material in each sorbent compartment for a patient, the modular dialysate regeneration assembly having a desired dialysate regeneration profile based on one or more dialysis parameters and/or one or more patient parameters wherein the processor determines the amount and type of sorbent material in each sorbent compartment of the dialysate regeneration profile based on the dialysis parameters and/or the patient parameters.

2. The modular dialysate regeneration assembly of claim 1, wherein the plurality of sorbent compartments have one or more sizes wherein any sized sorbent compartment is attachable to any other sized sorbent compartment.

3. The modular dialysate regeneration assembly of claim 1, wherein at least one of the plurality of sorbent compartments has a circular or rectangular planar base having a wall extending perpendicularly and upwardly from said base defining an internal area;

and

a circular or substantially rectangular planar top matching the planar base wherein the sorbent compartment has an engagement configuration selected from any one of;

(i) the base cooperatively engaging with the top of another sorbent compartment and the top cooperatively engaging with the base of another sorbent compartment;

(ii) the base not cooperatively engaging with the top of another sorbent compartment and the top cooperatively engaging with the base of another sorbent compartment;

(iii) the base cooperatively engaging with the top of another sorbent compartment and the top not cooperatively engaging with the base of another sorbent compartment; and

(iv) the base not cooperatively engaging with the top of another sorbent compartment and the top not cooperatively engaging with the base of another sorbent compartment.

4. The modular dialysate regeneration assembly of claim 1, wherein the plurality of sorbent compartments are selected from any combination or number of compartments from a selected group of:

(i) a first sorbent compartment having a sorbent weight ranging from 0.1 kg to 0.5 kg;

(ii) a second sorbent compartment having a sorbent weight ranging from 0.5 kg to 1.0 kg;

(iii) a third sorbent compartment having a sorbent weight ranging from 1.0 kg to 1.5 kg;

(iv) a fourth sorbent compartment having a sorbent weight ranging from 1.5 kg to 2.0 kg;

(v) a fifth sorbent compartment having a sorbent weight ranging from 2.0 kg to 2.5 kg;

(vi) a sixth sorbent compartment having a sorbent weight ranging from 2.5 kg to 3.0 kg;

(vii) a seventh sorbent compartment having a sorbent weight ranging from 3.0 kg to 3.5 kg;

(viii) an eighth sorbent compartment having a sorbent weight ranging from 3.5 kg to 4.0 kg;

(ix) a ninth sorbent compartment having a sorbent weight ranging from 4.0 kg to 4.5 kg;

(x) a tenth sorbent compartment having a sorbent weight ranging from 4.5 kg to 5.0 kg; and

(xi) an eleventh sorbent compartment having a sorbent weight ranging from 0.0001 kg to 0.1 kg.

5. The modular dialysate regeneration assembly of claim 1, wherein the plurality of sorbent compartments are selected from any combination or number of compartments from a selected group of:

(i) a first sorbent compartment having a volume ranging from 0.25 L to 1.3 L;

(ii) a second sorbent compartment having a volume ranging from 1.3 L to 2.5 L;

(iii) a third sorbent compartment having a volume ranging from 2.5 L to 3.7 L;

(iv) a fourth sorbent compartment having a volume ranging from 3.7 L to 5.0 L;

(v) a fifth sorbent compartment having a volume ranging from 5.0 L to 6.3 L;

(vi) a sixth sorbent compartment having a volume ranging from 6.3 L to 7.5 L;

(vii) a seventh sorbent compartment having a volume ranging from 7.5 L to 10 L;

(viii) an eighth sorbent compartment having a volume ranging from 0.01 L to 0.25 L; and

(ix) a ninth sorbent compartment having a volume ranging from 0.001 L to 0.01 L.

6. The modular dialysate regeneration assembly of claim 1, wherein the at least one of the sorbent compartments has a planar base with upwardly extending walls connecting to a planar top wherein the walls are constructed from a rigid, fluid impermeable material.

7. The modular dialysate regeneration assembly of claim 6, wherein either:

the base and top are circular and wherein the upwardly extending walls slope inward to an axis of the compartment wherein the top has a smaller surface area than the base or the upwardly extending walls slope outward from the axis wherein the top has a larger surface area than the base;

or the base and top are rectangular having four upwardly extending walls sloping inward to an axis of the compartment wherein the top has a smaller surface area than the base or four upwardly extending walls sloping outward from the axis wherein the top has a larger surface area than the base.

8. The modular dialysate regeneration assembly of claim 6, further comprising one or more of:

(i) an engagement member disposed on and extending upwardly from the planar top of the sorbent compartment;

(ii) a receiving groove disposed on the planar base of the sorbent compartment for receiving an engagement member;

(iii) an engagement member disposed on and extending downwardly from the planar base of the sorbent compartment;

or

(iv) a receiving groove disposed on the planar top of the sorbent compartment for receiving an engagement member.

9. The modular dialysate regeneration assembly of claim 1 wherein the sorbent materials are selected from a group comprising activated carbon, ion exchange resin, hydrous zirconium oxide, alumina, urease, a mixture of alumina and urease, zirconium phosphate, and any combination thereof.

10. The modular dialysate regeneration assembly of claim 1 wherein the one or more dialysis parameters and/or one or more patient parameters are selected from a group comprising patient weight, concentration of one or more compounds in a blood sample from a patient, previous dialysis results of the patient, dialysis rate, length of dialysis session, a level of impurities in the water used, an expected amount of infusates to be added, and combinations thereof.

11. The modular dialysate regeneration assembly of claim 1, wherein the sorbent compartments are sorbent pouches configurable into a stacked assembly of the sorbent pouches wherein each of the sorbent pouches is constructed in-part of a porous material forming the pouch containing inside the at least one sorbent material wherein the porous material allows fluid to pass through the sorbent pouch and substantially retains the at least one sorbent material in the sorbent pouch.

12. The modular dialysate regeneration assembly of claim 11 wherein the sorbent pouch is constructed from a material selected from a group comprising bolting cloth, porous polymer, porous metal, cotton, ashless filter paper, Dacron and polyethylene terephthalate.

13. The modular dialysate regeneration assembly of claim 1, wherein each of the sorbent compartments is a distinct color depending on the sorbent material contained within the sorbent compartment.

14. The modular dialysate regeneration assembly of claim 3, wherein at least one of the sorbent compartments contains urease and at least one of the sorbent compartments contains zirconium phosphate;

wherein the engagement configuration is such that the compartment containing urease can connect to the compartment containing zirconium phosphate, wherein the compartment containing urease is positioned immediately before the compartment containing zirconium phosphate; and

wherein the engagement configuration is such that the top of the compartment containing urease cannot cooperatively engage with any sorbent compartment except the sorbent compartment containing zirconium phosphate and the bottom of the compartment containing zirconium phosphate cannot cooperatively engage with any sorbent compartment except the sorbent compartment containing urease.

15. The modular dialysate regeneration assembly of claim 1, wherein each of the plurality of sorbent compartments comprises one or more selected from:

(i) sidewalls having a thickness different from the sidewall thicknesses of the other sorbent compartments, such that the one or more sorbent compartments have differing interior diameters;

wherein each sorbent compartment has a sidewall thickness greater than that of the previous sorbent compartment in series;

(ii) differing exterior diameters;

wherein each sorbent compartment has an exterior diameter smaller than that of the previous sorbent compartment in series;

or

(iii) one or more annular ring, wherein the one or more annular ring is constructed from a fluid impermeable substance;

wherein the one or more annular ring is disposed on the interior circumference of each of the one or more sorbent compartments and extends radially into the center of each of the one or more sorbent compartments; and

wherein the annular ring has a cross sectional shape selected from the group comprising circular, triangular, and rectangular.

16. The modular dialysate regeneration assembly of claim 1, wherein the processor displays the amount of the at least one sorbent material needed for a particular dialysis session based upon the one or more dialysis parameters and/or the patient parameters.

17. The modular dialysate regeneration assembly of claim 16, wherein the processor is programmed to receive the one or more dialysis parameters and/or patient parameters from a user.

18. The modular dialysate regeneration assembly of claim 1, wherein the at least one sorbent material is selected from the group consisting of zirconium phosphate, zirconium oxide, urease, activated carbon, ion-exchange resin, and combinations thereof.

19. The modular dialysate regeneration assembly of claim 1, wherein the processor is programmed to determine initially a necessary amount of the at least one sorbent material needed for treatment and to determine an updated amount of the at least one sorbent material based on the dialysis parameters and/or the patient parameters.

20. The modular dialysate regeneration assembly of claim 1, wherein plurality of sorbent compartments form a unitary structure.

21. The modular dialysate regeneration assembly of claim 1, wherein the processor is programmed to determine a correct number of the one or more attachable sorbent compartments based on the amount of the at least one sorbent material needed for treatment.

22. The modular dialysate regeneration assembly of claim 21, wherein the processor is programmed to determine the correct number of the one or more attachable sorbent compartments and correct amount of the at least one sorbent material needed for treatment based on one or more internal tables and to update the one or more internal tables based on a remaining capacity of the one or more sorbent materials after a dialysis session.