Multimodal dialysis system

• US 9,320,842 B2
• Filed: 04/19/2012
• Issued: 04/26/2016
• Est. Priority Date: 04/29/2011
• Status: Active Grant

• Current Assignee: Mozarc Medical US LLC
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Orhan, Soykan, Pudil, Bryant J., Meyer, Thomas E.
• Primary Examiner(s): Kim, John
• Application Number:
  US13/451,395
• Publication Number:
  US 20120273354A1
• Time in Patent Office: 1,468 Days
• Field of Search: 210/645, 210/646, 210/647, 210/739, 210/745, 210/746, 210/85, 210/86, 210/96.1, 210/97, 210/134, 210/143, 210/194, 210/195.2, 210/252, 210/257.1, 210/258, 210/321.71, 210/502.1, 204/519, 204/520, 204/522, 204/627, 204/628, 204/630, 204/633, 604/4.01, 604/5.01, 604/6.11, 604/28, 604/29
• US Class Current: 1/1
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1605 Physical characteristics of the dialysate fluid
• CPC Class Codes: A61M 1/1609 after use, i.e. downstream of dialyser
• CPC Class Codes: A61M 1/1613 Profiling or modelling of patient or predicted treatment evolution or outcome
• CPC Class Codes: A61M 1/1654 Dialysates therefor
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/284 Continuous flow peritoneal dialysis [CFPD]
• CPC Class Codes: A61M 1/287 Dialysates therefor
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3324 PH measuring means
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: B01D 61/02 Reverse osmosis; Hyperfiltration ; Nanofiltration
• CPC Class Codes: B01D 61/422 Electrodialysis
• CPC Class Codes: B01D 61/445 with bipolar membranes; Water splitting
• CPC Class Codes: B01D 61/463 comprising the membrane sequence AC or CA, where C is a cation exchange membrane

Abstract

A dialysis device for operation in multiple modes and for maintaining a known gradient of potassium ion or other electrolyte between the blood of a patient and a dialysate fluid is described. The dialysis device is capable of being used for hemodialysis or peritoneal dialysis, and the dialysis device is capable of operation with a dialysate purification unit outside of a clinical setting or with a supply of water that can be supplied in a clinical setting. The dialysis device has a composition sensor containing a potassium-sensitive electrode for measuring a potassium ion concentration in one or more of the patient'"'"'s blood and the dialysate fluid and an infusate pump operated to adjust a potassium ion concentration in the dialysate fluid based at least in part on data from the composition sensor.

Claims

1. A multimodal dialysis apparatus, comprising:

a blood circuit for transporting blood extracorporeally to a hemodialysis unit;

a dialysate circuit for transporting a fluid to contact the hemodialysis unit, wherein the fluid increases in concentration with at least one waste species during operation;

an infusate pump for adding a potassium salt to the fluid in the dialysate circuit; and

a composition sensor comprising a potassium-sensitive electrode for measuring a potassium ion concentration in one or more of blood in the blood circuit and fluid in the dialysate circuit,

a purification unit comprising an electrodialysis unit having a diluate chamber and a concentrate chamber and a means for producing an electric field, wherein one or more ions are removed from the fluid in the dialysate circuit;

a reverse osmosis unit located at an outlet of the purification unit to selectively remove solutes from the fluid;

a conditioning unit comprising urease;

wherein the conditioning unit is located at an outlet of the reverse osmosis unit; and

a conduit connecting an outlet of the conditioning unit to an inlet of the electrodialysis unit for returning fluid exiting the conditioning unit to the electrodialysis unit;

wherein the infusate pump is controlled by a controller to adjust a rate of addition of potassium ions to the fluid in the dialysate circuit based at least in part on data from the composition sensor.

2. The apparatus of claim 1, wherein the electrodialysis unit further comprises a concentrate solution circulation loop for recirculating a concentrate solution through the concentrate chamber, and the concentrate solution circulation loop has a reservoir containing a volume of concentrate solution.

3. The apparatus of claim 1, further comprising a pump for conveying at least a portion of the concentrate solution exiting the electrodialysis unit from an additional outlet to a reservoir or waste collector.

4. The apparatus of claim 1, further comprising a diluate solution recirculation loop comprising a diluate solution pump, wherein the diluate solution circulation loop connects an outlet of the diluate chamber to an inlet of the diluate chamber for recirculation of at least part of the fluid in the diluate chamber.

5. A multimodal dialysis apparatus, comprising:

a dialysate circuit for conveying fluid to and from the peritoneal cavity of a patient;

an infusion pump for adding a potassium salt to the fluid in the dialysate circuit; and

a composition sensor comprising a potassium-sensitive electrode for measuring a potassium ion concentration in the fluid in the dialysate circuit,

a purification unit comprising an electrodialysis unit having a diluate chamber and a concentrate chamber and a means for producing an electric field, wherein one or more ions are removed from the fluid in the dialysate circuit;

a reverse osmosis unit located at an outlet of the purification unit to selectively remove solutes from the fluid;

a conditioning unit having urease;

wherein the conditioning unit is located at an outlet of the reverse osmosis unit, and a conduit connecting an outlet of the conditioning unit to an inlet of the electrodialysis unit for returning fluid exiting the conditioning unit to the electrodialysis unit;

wherein the infusate pump is controlled by a controller to adjust a rate of addition of potassium ions to the fluid in the dialysate circuit based at least in part on data from the composition sensor.

6. The apparatus of claim 5, wherein the electrodialysis unit further comprises a concentrate solution circulation loop for recirculating a concentrate solution through the concentrate chamber, and the concentrate solution circulation loop has a reservoir containing a volume of concentrate solution.

7. The apparatus of claim 6, further comprising a pump for conveying at least a portion of the concentrate solution exiting the electrodialysis unit from an additional outlet to a reservoir or waste collector.

8. The apparatus of claim 5, further comprising a diluate solution recirculation loop comprising a diluate solution pump, wherein the diluate solution circulation loop connects an outlet of the diluate chamber to an inlet of the diluate chamber for recirculation of at least part of the fluid in the diluate chamber.

9. A method for performing dialysis, comprising:

contacting a dialysate fluid to a patient or to a medical device such that at least one waste species is transferred from the patient to the dialysate fluid;

measuring a potassium ion concentration of the contacted dialysate fluid;

conveying the dialysate fluid to an electrodialysis unit, wherein one or more ions are removed from the dialysate fluid;

conveying the dialysate fluid to a reverse osmosis unit to selectively remove solutes from the dialysate fluid;

conveying the contacted dialysate fluid from the electrodialysis unit to a conditioning unit comprising urease; and

conveying the contacted dialysate fluid from the conditioning unit back to the electrodialysis unit; and

controlling a rate of addition of potassium ions to a dialysate fluid being conveyed to the patient or to the medical device based upon the measured potassium ion concentration in the contacted dialysate fluid.

10. The method of claim 9, wherein the potassium ion concentration of the contacted dialysate fluid is measured with a potassium-sensitive electrode.

11. The method of claim 9, wherein the potassium ion concentration in a dialysate fluid being conveyed to the patient or the medical device is controlled in a manner to maintain a predetermined mass transfer of potassium ions from the patient to the dialysate.

12. The method of claim 9, wherein the potassium ion concentration in a dialysate fluid being conveyed to the patient or the medical device is controlled in a manner to maintain a predetermined rate of decrease in potassium ion concentration in the blood plasma of the patient.

13. The method of claim 9, wherein the medical device is a hemodialyzer and blood from the patient is transported through the hemodialyzer.

14. The method of claim 9, wherein the dialysate fluid is contacted with the patient by being introduced to the peritoneal cavity.

15. The method of claim 9, wherein the dialysate fluid is infused with a controlled amount of a potassium salt, contacted with the patient or the medical device such that at least one waste species is transferred from the patient to the dialysate fluid and potassium ion is transported from the patient to the dialysate.

16. The method of claim 9, further comprising the step of recirculating at least a portion of the dialysate fluid from an outlet of the electrodialysis unit to an inlet of the electrodialysis unit through a diluate circulation loop;

wherein the diluate circulation loop connects an outlet of a diluate chamber in the electodialysis unit to an inlet of the diluate chamber of the electrodialysis unit for recirculation.