Replenisihing urease in dialysis systems using a urease introducer

• US 10,245,365 B2
• Filed: 06/08/2018
• Issued: 04/02/2019
• 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): Fitzsimmons, Allison G
• Application Number:
  US16/003,245
• Publication Number:
  US 20180289880A1
• Time in Patent Office: 298 Days
• Field of Search: 210234, 210236, 210263, 210287, 210291, 210503, 210638, 210632, 210633, 210660, 210662, 210670, 210749, 210767, 210792, 210807, 210282
• CPC Class Codes: A61M 1/1696 with dialysate regeneration

Abstract

An apparatus and method for replenishing urease in a sorbent cartridge for use in sorbent dialysis. The sorbent cartridge is configured to allow an amount of urease to be added to the sorbent cartridge. A urease solution can be injected into the sorbent cartridge to replenish the urease containing module, or solid urease can be added to the sorbent cartridge. The sorbent module can also comprise other, rechargeable, sorbent materials for removing toxins other than urea from spent dialysate.

Claims

1. A method, comprising the steps of:

detecting an amount of urea directly or indirectly by measuring products proportional to an amount of urea in a sample in a dialysate downstream of a sorbent cartridge;

wherein the sorbent cartridge contains urease and at least one or more other sorbent materials; and

supplying urease to the sorbent cartridge by a urease introducer if the amount of urea downstream of the sorbent cartridge is above a threshold, wherein the sorbent cartridge is adapted to receive an adjustable amount of urease, wherein the urease introducer comprises any one of a slideable tray and a door.

2. The method of claim 1, wherein the step of detecting the amount of urea in the dialysate downstream of the sorbent cartridge is performed by any one of the means selected from the group consisting of an optical sensor, a chemical sensor, a blood urea nitrogen assay, and combinations thereof.

3. The method of claim 1, wherein the step of supplying urease is performed by introducing a urease solution with a concentration between any of 1 mg/mL to 250 mg/mL, 15 mg/mL to 150 mg/mL, 10 mg/mL to 100 mg/mL, or 75 mg/mL to 250 mg/mL of urease into the sorbent cartridge.

4. The method of claim 1, wherein the step of supplying urease is performed by introducing between any of 1.3 mL to 13.3 mL, 1.5 mL to 3.5 mL, 2.3 mL to 10.3 mL, or 5.0 mL to 12.3 mL at an activity of 300 unit/mg of urease activity of a urease solution into the sorbent cartridge.

5. The method of claim 1, further comprising the step of:

recharging the at least one or more other sorbent materials housed inside the sorbent cartridge by passing a solution containing appropriate solutes for recharging the at least one or more other sorbent materials through the sorbent cartridge.

6. The method of claim 1, further comprising the step of:

recharging the at least one or more sorbent materials housed inside the sorbent cartridge by replacing one or more modules of a modular regeneration assembly that make up the sorbent cartridge containing an amount of the at least one or more other sorbent materials.

7. The method of claim 5, wherein the step of supplying urease to the sorbent cartridge is performed after the step of recharging the at least one or more other sorbent materials.

8. The method of claim 1, wherein the step of supplying urease to the sorbent cartridge is performed during dialysis treatment.

9. The method of claim 1, wherein the step of supplying urease to the sorbent cartridge is performed prior to dialysis treatment.

10. The method of claim 1, wherein the step of supplying urease to the sorbent cartridge is performed after dialysis treatment.

11. The method of claim 1, wherein the step of supplying urease to the sorbent cartridge is performed by a dialysis system based on detection of urea in the dialysate downstream of the sorbent cartridge.

12. The method of claim 1, wherein an amount of urease introduced to the sorbent cartridge is based on one or more patient parameters.

13. The method of claim 12, wherein at least one of the one or more patient parameters is selected from the group consisting of:

patient weight, a blood urea nitrogen content of the patient'"'"'s blood, dialysis time, and urea load.

14. The method of claim 1, further comprising the step of injecting urease into the sorbent cartridge via a urease injection port.

15. The method of claim 14, wherein the urease injection port is located upstream of the sorbent cartridge.

16. The method of claim 14, wherein the urease injection port is located on the sorbent cartridge.

17. The method of claim 1, wherein the step of supplying urease to the sorbent cartridge further comprises the step of supplying alumina, silica, or a combination thereof by the slideable tray or door.

18. The method of claim 17, wherein the alumina, silica, or combination thereof includes urease adsorbed onto the alumina silica, or combination thereof.

19. The method of claim 1, wherein the step of supplying urease to the sorbent cartridge comprise supplying solid urease to the sorbent cartridge by the slideable tray or door.

20. The method of claim 19, wherein the sorbent cartridge comprises alumina, silica, or a combination thereof downstream of the slideable tray or door.

21. The method of claim 1, wherein the step of detecting an amount of urea indirectly is performed by measuring ammonia using an ammonia detector located downstream of a urease layer and upstream of a zirconium phosphate layer.

22. The method of claim 1, wherein the step of detecting an amount of urea indirectly is performed by measuring carbonic acid using a conductivity sensor measuring conductivity.

23. The method of claim 1, wherein the step of detecting an amount of urea indirectly is performed by measuring ammonia using photometry.