Combination Kidney and Liver Dialysis System and Method

• US 20170252497A1
• Filed: 03/03/2016
• Published: 09/07/2017
• Est. Priority Date: 03/03/2016
• Status: Active Grant

• Current Assignee: Micromedics, Inc. (Nordson Corporation)
• Original Assignee: Micromedics, Inc. (Nordson Corporation)
• Inventors: Nosrati, Saeid Mordechai
• Granted Patent: US 9,950,103 B2
• Time in Patent Office: Days
• CPC Class Codes: A61K 31/795 Polymers containing sulfur
• CPC Class Codes: A61K 33/44 Elemental carbon, e.g. charcoal, carbon black
• CPC Class Codes: A61K 38/38 Albumins
• CPC Class Codes: A61M 1/1633 with more than one dialyser unit
• CPC Class Codes: A61M 1/1654 Dialysates therefor
• CPC Class Codes: A61M 1/1676 containing proteins, e.g. albumin
• CPC Class Codes: A61M 1/1698 Blood oxygenators with or without heat-exchangers intracorporal A61M1/1678; manufacturing of membranes therefor B01D67/00; semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi-permeable membranes characterised by their material B01D71/00
• CPC Class Codes: A61M 1/3413 Diafiltration
• CPC Class Codes: A61M 1/3417 using distinct filters for dialysis and ultra-filtration
• CPC Class Codes: A61M 1/3431 upstream of the filter
• CPC Class Codes: A61M 1/3479 by dialysing the filtrate
• CPC Class Codes: A61M 1/3482 by filtrating the filtrate using another cross-flow filter, e.g. a membrane filter
• CPC Class Codes: A61M 1/3496 Plasmapheresis; Leucopheresis; Lymphopheresis A61M1/3472 takes precedence
• CPC Class Codes: A61M 1/3622 with a cassette forming partially or totally the blood circuit
• CPC Class Codes: A61M 2202/07 Proteins
• CPC Class Codes: A61M 2202/08 Lipoids

Abstract

A combination kidney and liver dialysis system and method provides a portable, lightweight hemodialysis device that removes uremic toxins, hepatic toxins, water, and impurities from the blood. The method comprises separating the blood into a plasma portion and a cellular portion, immediately returning the cellular portion to the body, providing large volumes of replacement fluids, diluting the plasma portion with replacement fluids, and then manipulating the plasma portion of the blood to pass through hemoperfusion membranes, hemodiafiltration membranes, and extracorporeal membrane oxygenation membranes. Dialysis is performed on the plasma portion of the blood with an albumin dialyzer against an albumin dialysate and a high molecular weight cut off membrane. Dialysis is performed on the plasma portion of blood with a lipid dialysate comprising 10-30% lipid composition, and a high flux dialyzer. The system can also use any form of dialysis technology including hollow fiber, flat plate and microfluidic technology.

Claims

1. A system for treating multiple organ dysfunction syndrome through a complex multicomponent hemodialysis device, the system comprising:

at least one pump, the at least one pump configured to enable pumping of blood;

at least one replacement fluid mixer, the at least one replacement fluid mixer configured to enable adding at least one replacement fluid to the blood;

a membrane plasma separator, the membrane plasma separator configured to enable separation of the blood into a cellular portion and a plasma portion;

a high flux dialyzer, the high flux dialyzer comprising different dialysates having a low concentration of minerals;

a plurality of hemodiafiltration membranes;

a hemoperfusion membrane, the hemoperfusion membrane defined by high molecular weight cut off;

an albumin dialyzer, the albumin dialyzer comprising a high molecular weight cut off membrane and an albumin dialysate, the albumin dialysate comprising at least one of the following;

a 5%-25% albumin solution, an activated charcoal, a polystyrene sulfonate, and resin;

a lipid dialysate, the lipid dialysate comprising about 10 to 30 percent lipids or oils; and

an extracorporeal membrane oxygenation membrane, the extracorporeal membrane oxygenation membrane configured to enable at least partial oxygenation of the cellular portion of the blood.

2. The system of claim 1, wherein the at least one replacement fluid comprises a first replacement fluid, a second replacement fluid, and a third replacement fluid.

3. The system of claim 2, wherein the first replacement fluid is a mixture consisting of 3 amps of bicarbonate in 1 liter of D5W.

4. The system of claim 1, wherein the plurality of hemodiafiltration membranes comprising a first hemofilter and a second hemofilter arranged in series or only one hemodiafiltration.

5. The system of claim 1, wherein the membrane plasma separator and a plasmapheresis membrane are configured to separate the blood into a ratio of plasma portion to cellular portion by volume.

6. The system of claim 5, wherein the ratio comprises at least one of the following:

1;

1, 2;

1, and 3;

1.

7. The system of claim 1, wherein the dialysate of the high flux dialyzer comprises a standard dialysate or a calcium bath concentration.

8. The system of claim 7, wherein the calcium bath concentration comprises a zero calcium bath-optional.

9. The system of claim 1, wherein the plurality of hemodiafiltration membranes comprise a first hemofilter and a second hemofilter, the first hemofilter and the second hemofilter disposed in a circuit and connected in series or in parallel.

10. The system of claim 1, wherein the hemoperfusion membrane comprises a suspension that includes at least one member selected from the group consisting of:

an activated charcoal, a polystyrene sulfonate, and a resin operable as a dialysate.

11. The system of claim 1, wherein the lipid dialysate comprises different biocompatible lipid emulsions for human intravenous use commonly used in partial parenteral nutrition and/or total parenteral nutrition approved by FDA for use intravenously in human subjects such as intralipid.

12. The system of claim 1, further including a warming device, the warming device configured to warm the plasma portion to about 42 degrees Celsius at one or more locations in a circuit/assemblage.

13. The system of claim 12, wherein the warming device is operable in different portions of the circuit/assemblage, the warming device configured to increase diffusion of a substance.

14. The system of claim 13, wherein the warming device is configured to warm the plasma portion at different location in the circuit/assemblage.

15. The system of claim 14, further including a cooling device, the cooling device configured to cool the plasma portion up to 35 degrees Celsius at various locations in the circuit/assemblage.

16. The system of claim 15, wherein the cooling device is configured to cool the plasma portion after passing through the albumin dialyzer.

17. A method for treating multiple organ dysfunction syndrome through dialysis of blood, the method comprising:

pumping blood from a body;

adding a first replacement fluid to the blood;

passing the blood through a high flux dialyzer, the high flux dialyzer comprising a standard dialysate or a low calcium bath;

separating the blood into a plasma portion and a cellular portion;

returning the cellular portion of the blood to the body upon separation of the blood;

adding a second replacement fluid to the plasma portion of the blood;

passing the plasma portion through a plurality of hemodiafiltration membranes;

passing the plasma portion through a hemoperfusion membrane;

adding a third replacement fluid to the plasma portion of the blood;

dialyzing the plasma portion of the blood through an albumin dialyzer, the albumin dialyzer comprising a high molecular weight cut off membrane and an albumin dialysate, the albumin dialysate comprising at least one of the following;

albumin, activated charcoal, a polystyrene sulfonate, and resin;

dialyzing the plasma portion against a lipid dialysate, the lipid dialysate comprising about 10 to 30 percent lipids or oils by weight or volume; and

passing the cellular portion through an extracorporeal membrane oxygenation membrane, the extracorporeal membrane oxygenation membrane configured to oxygenate the cellular portion.

18. The method of claim 17, further including the step of warming the plasma portion after passing through the albumin dialyzer and hemodiafiltration portion.

19. The method of claim 17, further including the step of passing the blood through a high flux dialyzer a second time for discarding ultrafiltration.

20. A system for treating multiple organ dysfunction syndrome through a multi-component hemodialysis device, the system comprising:

at least one replacement fluid mixer, the at least one replacement fluid mixer configured to enable adding several replacement fluids to the blood and its portions in prespecified positions;

a membrane plasma separator, the membrane plasma separator having a plasmapheresis membrane, the membrane plasma separator configured to enable separation of the blood into a cellular portion and a plasma portion;

a high flux dialyzer, the high flux dialyzer comprising a standard dialysates and a dialysate having a low concentration of calcium;

at least one hemofilter, the at least one hemofilter comprising hollow fibers defined by a small diameter;

a hemodialysis filter, the hemodialysis filter disposed in series with the at least one hemofilter;

a hemoperfusion membrane, the hemoperfusion membrane comprising activated microporous charcoal and a resin;

an albumin dialyzer, the albumin dialyzer comprising a high molecular weight cut off membrane and an albumin dialysate, the albumin dialysate comprising at least one of the following;

a 5%-25% albumin solution alone or in solution with activated charcoal, polystyrene sulfonate, and second resin; and

21. The system of claim 20, further including a lipid dialyzer comprising a lipid dialysate, the lipid dialysate comprising about 10 to 30 percent lipids or oils by weight or volume.

22. The system of claim 21, wherein the lipids or oils comprise inert and biocompatible lipids or oils.

23. The system of claim 22, further including an extracorporeal membrane oxygenation membrane, the extracorporeal membrane oxygenation membrane configured to enable at least partial oxygenation of the cellular portion of the blood before it is returned back to the patient.

24. The system of claim 23, wherein the system is based on a microfluidic technology.

25. The system of claim 24, wherein the microfluidic technology is operable with at least one of the following:

the replacement fluid mixer, the membrane plasma separator, the high flux dialyzer, the at least one hemofilter, the hemodialysis filter, the hemoperfusion membrane, the albumin dialyzer, the lipid dialyzer, and the extracorporeal membrane oxygenation membrane.