Precision recharging of sorbent materials using patient and session data

• US 10,537,875 B2
• Filed: 03/30/2018
• Issued: 01/21/2020
• Est. Priority Date: 11/26/2013
• Status: Active Grant

• Current Assignee: Mozarc Medical US LLC
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Pudil, Bryant J., Hobot, Christopher M., Gerber, Martin T.
• Primary Examiner(s): Barry, Chester T
• Application Number:
  US15/942,229
• Publication Number:
  US 20180221852A1
• Time in Patent Office: 662 Days
• Field of Search: None
• CPC Class Codes: A61M 1/1607 before use, i.e. upstream of dialyser
• CPC Class Codes: A61M 1/1611 Weight of the patient
• CPC Class Codes: A61M 1/1654 Dialysates therefor
• CPC Class Codes: A61M 1/1692 Detection of blood traces in dialysate
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 2202/0225 Carbon oxides, e.g. Carbon dioxide
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: B01J 20/0211 Compounds of Ti, Zr, Hf
• CPC Class Codes: B01J 20/0292 Phosphates of compounds other than those provided for in B01J20/048
• CPC Class Codes: B01J 20/06 comprising oxides or hydroxides of metals not provided for in group B01J20/04
• CPC Class Codes: B01J 20/3433 of sorbents or filter aids other than those covered by B01J20/3408 - B01J20/3425
• CPC Class Codes: B01J 20/3475 in the liquid phase
• CPC Class Codes: B01J 20/3483 by thermal treatment not covered by groups B01J20/3441 - B01J20/3475, e.g. by heating or cooling
• CPC Class Codes: B01J 39/09 Inorganic material

Abstract

The invention relates to devices, systems, and methods for recharging zirconium phosphate and/or zirconium oxide in reusable sorbent modules. The devices, systems, and methods provide for precision recharging of the zirconium phosphate and/or zirconium oxide to avoid the need of excess recharge solutions. The devices systems and methods also provide for calculation of the volumes of recharge solution needed for fully recharging the zirconium phosphate and zirconium oxide modules.

Claims

1. A method, comprising the steps of:

recharging a sorbent material within a sorbent module (402, 702) by pumping one or more recharge solutions through the sorbent module;

wherein a volume and/or a concentration of the one or more recharge solutions is set based on one or more patient parameters and/or one or more dialysis session parameters for a patient and/or dialysis session using the sorbent module.

2. The method of claim 1, wherein the sorbent module contains zirconium oxide, and wherein the one or more patient parameters and/or one or more dialysis session parameters include a total phosphate pumped through the sorbent module during a prior dialysis session.

3. The method of claim 2, wherein the total cation and total CO₂ pumped through the sorbent module is obtained from any of:

a. direct measurement of total cations and total CO₂ in a dialysate flow path during the prior dialysis session;

b. estimation of total cations and total CO₂ based on patient weight;

c. estimation of total cations and total CO₂ based on a dialysis prescription;

d. estimation of total cations and total CO₂ based on pre-dialysis patient cation measurements and/or pre-dialysis patient total CO₂ measurements;

e. estimation of total cations and total CO2 based on a number of previous dialysis sessions;

or

f. combinations thereof.

4. The method of claim 2, wherein the step of recharging the zirconium phosphate comprises pumping:

(a) between 5.0 and 6.0 millimoles of sodium in the one or more recharge solutions per total milliequivalents of total cations pumped through the sorbent module during the prior dialysis session;

or

(b) between 0.3 and 1.0 millimoles of acetate in the one or more recharge solutions per millimole of total CO₂ pumped through the sorbent module during the prior dialysis session.

5. The method of claim 2, wherein the total phosphate pumped through the sorbent module during the prior dialysis session is obtained from direct measurement of phosphate in a dialysate flow path during the prior session, estimated based on phosphate bleed from zirconium phosphate used in the prior dialysis session and pre-dialysis patient phosphate measurements, or estimated based on a total phosphate pumped through the sorbent cartridge in a number of previous dialysis sessions.

6. The method of claim 2, wherein the step of recharging the zirconium oxide comprises pumping between 6.0 and 7.5 moles of sodium hydroxide in the one or more recharge solutions per mole of phosphate pumped through the sorbent module during the prior dialysis session.

7. The method of claim 1, wherein the one or more patient parameters and/or one or more dialysis session parameters include an estimated duration to a next dialysis session for the patient.

8. The method of claim 1, wherein the sorbent module contains zirconium phosphate, and wherein the volume of the one or more recharge solutions is set using an equation V_r=v*Q*t*(C_NH4+C_K+C_Ca+C_Mg+(a*C_HCO3+b));

wherein Vr is the volume of the one or more recharge solutions, Q is a time averaged volume flow rate into the sorbent module, t is a session time, C_NH4, C_K, C_Ca, C_Mg, and C_HCO3 are average concentrations of ammonium ions, potassium ions, calcium ions, magnesium ions and bicarbonate ions entering the sorbent module, a and b are variables related to a pH of the zirconium phosphate, and v is a variable specific to a recharge process being used.

9. A system comprising:

a recharging flow path (401, 701);

the recharging flow path comprising one or more recharge solution sources;

the one or more recharge solution sources (405, 406, 705) fluidly connectable to an inlet (403, 703) of a sorbent module (402, 702) containing at least one sorbent material; and

at least one pump (407, 706) for pumping one or more recharge solutions from the one or more recharge solution sources through the sorbent module; and

a control system, the control system setting a volume and/or concentration of the one or more recharge solutions pumped through the sorbent module necessary to recharge the sorbent material within the sorbent module based on one or more patient parameters and/or one or more dialysis session parameters for a patient and/or dialysis session using the sorbent module.

10. The system of claim 9, wherein:

the sorbent module (401) contains zirconium phosphate, and wherein the one or more recharge solution sources comprise a brine source (405), a water source, and a disinfectant source;

or

wherein the sorbent module contains zirconium oxide (702), and wherein the one or more recharge solution sources comprise a base source (705), a water source, and a disinfectant source.

11. The system of claim 9, further comprising a second recharging flow path;

the second recharging flow path comprising one or more recharge solution sources fluidly connectable to an inlet of a second sorbent module containing at least one sorbent material; and

at least a second pump for pumping one or more recharge solutions from the one or more recharge solution sources through the sorbent module;

wherein the control system sets a volume and/or concentration of the one or more recharge solutions pumped through the second sorbent module necessary to recharge the sorbent material within the second sorbent module based on the one or more patient parameters and/or one or more dialysis session parameters for the patient and/or dialysis session using the sorbent module.

12. The system of claim 9, wherein the sorbent module contains zirconium phosphate,

wherein the one or more patient parameters include at least one from a group consisting of:

pre-dialysis patient potassium, calcium, magnesium, bicarbonate and urea levels, patient weight, patient volume, patient residual kidney function, patient acidotic state, an average number of dialysis sessions per week, and an average dialysis session length; and

wherein the one or more dialysis session parameters include at least one from a group consisting of;

dialysate flow rate, blood flow rate, dialyzer size, dialyzer type, dialysis time, ultrafiltration rate, a potassium, calcium, magnesium, and bicarbonate dialysis prescription, whether ammonia breakthrough occurred, whether a pH alarm occurred, fluid removed during a session, total volume treated, starting water quality, URR target, URR achieved, clearance, whether a blood leak occurred, and whether a hypotensive episode occurred.

13. The system of claim 9, wherein the sorbent module contains zirconium oxide,

wherein the one or more patient parameters include at least one from a group consisting of:

patient weight, patient volume, patient residual kidney function, an average number of dialysis sessions per week, and an average dialysis session length; and

wherein the one or more dialysis session parameters include at least one from a group consisting of;

dialysate flow rate, blood flow rate, dialyzer size, dialyzer type, dialysis time, ultrafiltration rate, a potassium, calcium, magnesium, and bicarbonate dialysis prescription, whether ammonia breakthrough occurred, whether a pH alarm occurred, fluid removed during a session, total volume treated, starting water quality, URR target, URR achieved, clearance, whether a blood leak occurred, and whether a hypotensive episode occurred.

14. The system of claim 9, wherein:

the sorbent module contains zirconium phosphate, and wherein the control system sets the volume and/or concentration of the one or more recharge solutions based on a total cation and total CO₂ pumped through the sorbent module during a prior dialysis session;

or

wherein the sorbent module contains zirconium oxide, and wherein the control system sets the volume and/or concentration of the one or more recharge solutions based on a total phosphate pumped through the sorbent module during a prior dialysis session.