Systems or apparatuses and methods for performing dialysis
Inventors
Kreymann, Bernhard • HUESSTEGE, Christoph • Schreiber, Catherine Elisabeth
Assignees
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Publication Number
US-11351291-B2
Publication Date
2022-06-07
Expiration Date
Abstract
The invention provides a method and an apparatus or system for dialysis. The method and apparatus or system are useful for removing an undesirable protein-binding substance such as a toxin from a biological fluid such as blood or blood plasma. As such, the method and apparatus or system are useful for treating a subject in need of dialysis such as a subject suffering from hepatic disease. The methods feature a) dialyzing a biological fluid against a dialysis fluid containing an adsorber for a protein-binding substance to be removed through a semipermeable membrane, b) adjusting the dialysis fluid so that the binding affinity of the adsorber for the protein-bound substance to be removed is lowered and the substance to be removed passes into solution, and c) balancing the volume or flow of one or more fluids in the apparatus or system suitable for dialyzing a biological fluid containing a protein-binding substance to be removed. The apparatus or system features a) a biological fluid circuit (3); b) a dialysis fluid circuit (2); c) a means (4; 6; 7; 8; 9) for solubilizing the protein-binding substance to be removed; d) a dialysis, filtration or diafiltration device (5); e) a balancing system or apparatus suitable for balancing the volume or flow of one or more fluids in the apparatus or system suitable for dialyzing a biological fluid containing a protein-binding substance to be removed; and f) a dialysate regeneration unit.
Core Innovation
The patent describes systems and methods for removing an unwanted substance from a biological fluid in an apparatus or a system suitable for dialyzing the biological fluid containing a protein-binding substance to be removed. The approach includes dialyzing the biological fluid against a dialysis fluid containing an adsorber for the protein-bound substance through a semipermeable membrane, and the dialysis fluid is adjusted so that the binding affinity of the adsorber for the protein-bound substance to be removed is lowered, such that the substance passes into solution.
The patent further introduces balancing the total fluid volume in the dialysis apparatus or system using a balancing system. The balancing system includes a container having at least a first reservoir for a dialysis fluid and a second reservoir for a waste fluid, a weighing means for weighing the container, and a controller configured to receive weighing data from the weighing means. All amounts of fluids provided into the dialysis apparatus or system are included in balancing calculations, and the controller defines an initial system weight including the total weight of the container measured before operation begins.
The controller then operates pumping means for the first reservoir fluid and the second reservoir fluid so that the initial system weight is maintained, or is maintained with a predefined surplus, or is maintained with a predefined loss. The disclosed claim set also covers an apparatus/system architecture with a biological fluid circuit, a dialysis fluid circuit, a means for solubilizing the protein-binding substance to be removed, and a dialysis, filtration or diafiltration device, together with the weighing-based balancing system.
In additional embodiments for dialyzing a subject and treating a disease characterized by unwanted accumulation of a protein-binding substance, the fluid volume of the subject remains substantially constant.
Claims Coverage
The independent claims are directed to four inventive feature groups: adsorber-mediated dialysis with lowered binding affinity, weighing-based fluid-volume balancing with an initial system weight, an apparatus/system architecture with biological and dialysis fluid circuits, and subject or disease treatment using the same core approach.
Lowered binding affinity with adsorber-mediated dialysis
Dialyzing a biological fluid containing a protein-binding substance to be removed against a dialysis fluid containing an adsorber through a semipermeable membrane, wherein the dialysis fluid is adjusted so that the binding affinity of the adsorber for the protein-bound substance to be removed is lowered and the substance to be removed passes into solution.
Weighing-based fluid-volume balancing with initial system weight
Balancing the total fluid volume in the apparatus or system using a balancing system comprising a container having at least a first reservoir for a dialysis fluid and a second reservoir for a waste fluid, a weighing means for weighing the container, and a controller configured to receive weighing data from the weighing means, wherein all amounts of fluids provided into the dialysis apparatus or system are included in balancing calculations, the controller defines an initial system weight including the total weight of the container measured before operation begins, and pumping means are controlled so that the initial system weight is maintained, maintained with a predefined surplus, or maintained with a predefined loss.
Dialysis apparatus/system architecture with circuits and device
An apparatus or a system suitable for dialyzing a biological fluid containing a protein binding substance to be removed comprising a biological fluid circuit, a dialysis fluid circuit, a means for solubilizing the protein-binding substance to be removed, a dialysis, filtration or diafiltration device, and a balancing system suitable for balancing the total fluid volume.
Subject fluid-volume maintained substantially constant during dialyzing
A method for dialyzing a subject in need thereof including passing a biological fluid from the subject through a biological fluid circuit, dialyzing the biological fluid against a dialysis fluid containing an adsorber for a protein-binding substance to be removed through a semipermeable membrane, adjusting the dialysis fluid so that the binding affinity of the adsorber for the protein-bound substance to be removed is lowered and the substance to be removed passes into solution, and balancing the total fluid volume so that the fluid volume of the subject remains substantially constant.
Disease treatment characterized by unwanted accumulation with dialyzing and balancing
A method for treating a disease characterized by unwanted accumulation of a protein-binding substance in a biological fluid using the same dialyzing and balancing concept, with the fluid volume of the subject remaining substantially constant.
Across the independent claims, the core claimed concept combines lowering adsorber binding affinity in a dialysis fluid so a protein-bound substance passes into solution during dialysis through a semipermeable membrane, and maintaining total fluid-volume balance using a weighing-based controller that defines an initial system weight and controls pumping while including all supplied fluid amounts in balancing calculations. The independent claims additionally specify an apparatus/system having separate biological and dialysis fluid circuits with a dialysis, filtration or diafiltration device, and they apply the method to dialyzing a subject with substantially constant subject fluid volume and to treating a disease characterized by unwanted accumulation.
Stated Advantages
Improved compliance versus prior balancing limitations.
Documented Applications
Dialyzing a subject in need thereof, with the fluid volume of the subject remaining substantially constant.
Treating a disease characterized by unwanted accumulation of a protein-binding substance in a biological fluid.
Treating hepatic disease, including cirrhosis and liver failure.
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