Closed-Circuit Biomolecule Modification Apparatus

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Solution Overview

Problem

Current apheresis technologies primarily focus on removing detrimental blood components but do not effectively isolate and modify targeted components within an extracorporeal closed-circuit apparatus for re-administration to the patient, requiring large blood volumes and lacking the capability for component modification and return.

Innovation Solution

A novel extracorporeal closed-circuit apparatus that withdraws body fluid, separates and immobilizes a target component, chemically modifies it, and returns the modified component to the subject, utilizing a partitioning chamber for fractionation and a sequestering chamber with a capture support for immobilization and modification, maintaining a closed system to prevent contamination.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If apheresis procedures are used to remove detrimental blood components, then the removal of unwanted components is effective, but the capability to isolate and modify targeted components for re-administration is lacking

Engineering Contradiction:
Improvecapability to isolate and modify targeted componentsVSAvoideffectiveness of component removal and return
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The extracorporeal circuit is divided into distinct functional chambers: a partitioning chamber for separating blood components, a sequestering chamber for capturing and immobilizing target components, and a modification chamber for chemical modification. This segmentation enables each chamber to perform its specific function effectively while maintaining the overall closed-circuit system's reliability.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A capture support medium is introduced as an intermediary substance in the sequestering chamber to immobilize target components during the modification process. This intermediary enables the target components to be held in place for modification while maintaining their recoverability for re-administration, thus enhancing both adaptability and reliability.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Quantity of substance

If large blood volumes are processed through apheresis devices, then sufficient target components can be obtained, but the complexity and risk associated with large-volume extracorporeal circulation increases

Engineering Contradiction:
Improveamount of target components isolatedVSAvoidcomplexity of extracorporeal circuit
Core Design Contradiction:
Quantity of substanceVSDevice complexity

Solution Approach 1:

The partitioning chamber extracts and separates the plasma fraction containing target components from whole blood, concentrating the modification process on this specific fraction rather than processing entire blood volumes. This extraction approach reduces the quantity of blood requiring extracorporeal circulation while maintaining sufficient target component isolation.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The sequestering chamber employs a specialized capture support medium with specific binding properties localized to the plasma fraction. This local quality enhancement allows efficient target component capture from a reduced blood volume, decreasing overall device complexity and procedural risk.

Inventive Principle:
Principle #3Local quality

3Ease of operation

If an open system is used for blood component processing, then manipulation and modification are easier, but contamination risk increases

Engineering Contradiction:
Improveease of component manipulationVSAvoidcontamination of blood components
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The entire extracorporeal circuit operates as a closed system, creating an inert environment that prevents external contamination of blood components during processing. Despite the closed configuration, the system maintains ease of operation through designed access ports and standardized connection interfaces that allow necessary manipulations while preserving sterility.

Inventive Principle:
Principle #39Inert atmosphere (Inert environment)

Solution Approach 2:

The capture support medium serves as an intermediary that facilitates target component manipulation within the closed system. Researchers can modify captured components in the sequestering chamber without directly handling blood, maintaining ease of operation while preventing contamination through the closed-circuit design.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Adaptability or versatility

If targeted components are isolated and modified outside the body, then therapeutic or diagnostic properties can be enhanced, but the risk of exposure to external contaminants increases

Engineering Contradiction:
Improveability to chemically modify biomoleculesVSAvoidexposure to environmental contaminants
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The closed-circuit extracorporeal system creates a controlled inert environment that enables chemical modification of isolated target components while preventing exposure to external contaminants. The modification chamber provides a sealed space where reagents can be introduced through controlled interfaces, maintaining both adaptability for modification and protection from contamination.

Inventive Principle:
Principle #39Inert atmosphere (Inert environment)

Solution Approach 2:

The system segments the modification process into a dedicated modification chamber separated from both the patient's body and the external environment. This segmentation allows chemical modifications to be performed on isolated target components while the closed boundaries prevent contaminant exposure, enhancing both adaptability and safety.

Inventive Principle:
Principle #1Segmentation

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Enables the isolation and modification of biomolecules like antibodies within a closed system, allowing for therapeutic or diagnostic re-administration without exposing the components to the environment, reducing the need for large blood volumes and enhancing treatment efficacy.

Implementation Method 1

separating the plasma from the withdrawn blood

Methodology Applied
Scientific EffectFiltration: Filter (physical)

Implementation Method 2

a sequestering chamber with a capture support for immobilization and modification

Methodology Applied
Scientific EffectAdsorption: Adsorption

Data Source

PatentUS10646638B2Closed-circuit device and methods for isolation, modification, and readministration of specific constituents from a biological fluid source
Publication Date: 2020.05.12 MCNEIL GARY L
  • US10646638B2 patent drawing
  • US10646638B2 patent drawing
  • US10646638B2 patent drawing

AI summary

The present invention relates to a method and apparatus for the isolation, modification and re-administration of a molecule or biomolecule, or a class of biomolecules, from the body fluid of a mammal via an extracorporeal closed circuit device. The device is able to capture and modify the biomolecule by the covalent or non-covalent attachment of a secondary molecule or protein, by cross-linking the captured molecule, or by altering the structure of the molecule (for example, by deglycosylation, peptide cleavage, or aggregation). The apparatus can be used to return the modified molecule or biomolecule to the mammalian subject. The device and methods may be utilized for the patient-specific diagnosis and/or treatment of a disease state which presents an associated molecule or protein in plasma or any other fluidized physiological system. The methods and apparatus may also be employed as a closed system allowing the on-line purification and/or modification of a target molecule or biomolecule from a fluid source such as a bioreactor or perfusion bioreactor.