Multimodal dialysis system

Patent metadata

Field	Value
Publication number	US-9320842-B2
Application number	US-201213451395-A
Country	US
Kind code	B2
Filing date	Apr 19, 2012
Priority date	Apr 29, 2011
Publication date	Apr 26, 2016
Grant date	Apr 26, 2016

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.

First claim

We claim:

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.

Assignees

• Orhan Soykan
• Pudil Bryant J
• Meyer Thomas E
• Medtronic Inc

Inventors

• Orhan Soykan
• Pudil Bryant J
• Meyer Thomas E

Classifications

• A61M2205/3334

  Measuring or controlling the flow rate · CPC title

• B01D61/02

  Reverse osmosis; Hyperfiltration {; Nanofiltration} · CPC title

• B01D61/445

  with bipolar membranes; Water splitting · CPC title

• A61M1/16

  with membranes · CPC title

• A61M1/14

  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 title