Assembly for extracorporeal treatment of body fluids

Inventors

LANGENEGGER, LukasMORA, CarlosMetzger, Jean-ClaudeHALTINNER, Ursina

Assignees

Hemotune AG

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Publication Number

US-12433985-B2

Patent

Publication Date

2025-10-07

Expiration Date


Abstract

A method for extracorporeal treatment of a body fluid of a patient suffering from sepsis, in an extracorporeal flow line, comprising removing at least one harmful substance from the body fluid of the patient. In a first injection step, a first mixture containing functionalized magnetic particles bound to at least a first binding agent at least directed against a first type of target molecules contained in the body fluid is added to the extracorporeal flow line comprising a sample of the body fluid extracted from a patient and containing at least the first type of target molecules. The first mixture is injected in a therapeutically effective dose necessary to reduce a concentration of the target molecules of at least the first type in the body fluid sample of the patient, followed by a mixing step and a separation step for reduction of the target molecule concentration.

Core Innovation

A method for extracorporeal treatment of a body fluid of a patient suffering from a dysregulated immune response, e.g. sepsis, is provided in an extracorporeal flow line. The method removes at least one harmful substance from the body fluid by adding a therapeutically effective dose of a first mixture containing functionalized magnetic particles bound to at least a first binding agent directed against a first type of target molecules contained in the body fluid. The functionalized magnetic particles are mixed with the body fluid to ensure sufficient binding to the target molecules.

The method separates the functionalized magnetic particles bound to the target molecules from the sample of body fluid such that a concentration of target molecules of at least the first type in the sample is reduced. The method further comprises at least a second injection step, in which a second mixture different from the first mixture and containing functionalized magnetic particles is added to the extracorporeal flow line. The second injection step is carried out downstream of or simultaneously with the first injection step.

In the second injection device, the functionalized magnetic particles in the second mixture are bound to a second binding agent different from the first binding agent and directed against a second type of target molecule different from the first target molecule, or the functionalized magnetic particles are bound to the first binding agent but are present in a different concentration than in the first mixture.

Upstream of the first injection step, a diagnostic step obtains data providing information about an immunological status by measuring expression or concentration of at least one marker molecule in the body fluid in an assay or by a sensor. The data is transmitted to a control unit and the control unit individually controls the first and second injection steps based on the data, including type of binding agent, injection rate, injection time, injection dose, injection concentration, and/or injection pressure, with separate but coordinated control.

Claims Coverage

The document provides one independent claim (clm-00001) that combines an extracorporeal magnetic removal method for harmful substances with a diagnostic, control-unit-based selection and coordination of first and second injection steps. The independent claim contains five main inventive aspects that jointly define the method.

Extracorporeal magnetic removal of harmful target molecules

A method for extracorporeal treatment of a body fluid in an extracorporeal flow line, comprising removing at least one harmful substance by adding a therapeutically effective dose of a first mixture containing functionalized magnetic particles bound to a first binding agent directed against a first type of target molecules, mixing to ensure binding, and separating the bound particles such that the concentration of the first type of target molecules is reduced.

Downstream or simultaneous second injection with distinct magnetic-bound binding behavior

The method further comprises at least a second injection step, in which a second mixture different from the first mixture containing functionalized magnetic particles is added downstream of or simultaneously with the first injection step, where the second injection device binds the particles to a second binding agent directed against a second type of target molecule different from the first, or binds to the first binding agent but uses a different concentration than in the first mixture.

Immunological diagnostic step upstream of magnetic binding

Upstream of the first injection step, a diagnostic step obtains data providing information about an immunological status by measuring expression or concentration of at least one marker molecule in the body fluid in an assay or by a sensor.

Transmission of immunological status data to a control unit

The data obtained in the diagnostic step is transmitted to a control unit arranged in electrical or wireless communication with the extracorporeal circuit.

Individual control and coordination of injection parameters based on immunological status

The control unit individually controls the first injection step and the second injection step based on the immunological status data in terms of at least one of type of binding agent, injection rate, time of injection, injection dose, injection concentration, and/or injection pressure, wherein the injection of the second mixture is controlled separately but in coordination with the injection of the first mixture.

Inventive coverage centers on an extracorporeal magnetic adsorption/removal workflow using functionalized magnetic particles with first and second injection steps, combined with an upstream immunological diagnostic step whose measured marker data is transmitted to a control unit that individually controls and coordinates the injection parameters and binding-agent selection.

Stated Advantages

Documented Applications

No documented applications found

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