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Assignees
Charles Stark Draper Laboratory Inc
Member
DraperDraper is an independent nonprofit engineering innovation company with a legacy spanning over 90 years, dedicated to delivering transformative solutions for national security, prosperity, and global challenges. Renowned for its pioneering work in guidance, navigation, and control (GN&C) systems, Draper partners with government, industry, and academia to engineer advanced technologies in space, defense, biotechnology, and electronic systems. The company leverages multidisciplinary expertise, digital engineering, and a collaborative approach to provide field-ready prototypes, mission-critical systems, and innovative research. Draper’s mission is to ensure the nation's security and prosperity by delivering sustainable, cutting-edge solutions that address the toughest problems of today and tomorrow, while fostering an inclusive and diverse workforce. Draper also invests in the next generation of innovators through robust educational programs, including internships, co-ops, and the Draper Scholars Program, integrating academic research with real-world problem-solving.
Draper is an independent nonprofit engineering innovation company with a legacy spanning over 90 years, dedicated to delivering transformative solutions for national security, prosperity, and global challenges. Renowned for its pioneering work in guidance, navigation, and control (GN&C) systems, Draper partners with government, industry, and academia to engineer advanced technologies in space, defense, biotechnology, and electronic systems. The company leverages multidisciplinary expertise, digital engineering, and a collaborative approach to provide field-ready prototypes, mission-critical systems, and innovative research. Draper’s mission is to ensure the nation's security and prosperity by delivering sustainable, cutting-edge solutions that address the toughest problems of today and tomorrow, while fostering an inclusive and diverse workforce. Draper also invests in the next generation of innovators through robust educational programs, including internships, co-ops, and the Draper Scholars Program, integrating academic research with real-world problem-solving.
Publication Number
US-11835513-B2
Publication Date
2023-12-05
Expiration Date
Abstract
A method for separating particles in a biofluid includes pretreating the biofluid by introducing an additive, flowing the pretreated biofluid through a microfluidic separation channel, and applying acoustic energy to the microfluidic separation channel. A system for microfluidic separation, capable of separating target particles from non-target particles in a biofluid includes at least one microfluidic separation channel, a source of biofluid, a source of additive, and at least one acoustic transducer coupled to the microfluidic separation channel. A kit for microfluidic particle separation includes a microfluidic separation channel connected to an acoustic transducer, a source of an additive, and instructions for use.
Core Innovation
A method for separating particles in a biofluid includes pretreating the biofluid by introducing an additive, flowing the pretreated biofluid through a microfluidic separation channel, and applying acoustic energy to the microfluidic separation channel to accumulate target particles within a primary stream along the separation channel and accumulate non-target particles within a secondary stream along the separation channel. A system for microfluidic separation, capable of separating target particles from non-target particles in a biofluid includes at least one microfluidic separation channel, a source of biofluid, a source of additive, and at least one acoustic transducer coupled to the microfluidic separation channel. A kit for microfluidic particle separation includes a microfluidic separation channel connected to an acoustic transducer, a source of an additive, and instructions for use.
The background identifies limitations of prior sample purification technologies where centrifugation separates only by density and membrane filtration provides only size exclusion, which can fail when particles and cells are similar in density or size. Aspects and embodiments disclosed herein address these limitations by using acoustic separation in combination with introducing physiologically acceptable additives to alter one or more physical properties of the fluid, target particle, or non-target particles, enabling selective, differential separation of target particles from a biofluid suspension. As described, these aspects and embodiments may enable continuous removal of particles, separation by both size and density, scalability to different sample volumes, and a high degree of purification with the addition of safely injectable, physiologically acceptable additives.
Claims Coverage
Overview: Two independent system claims are recited. Main inventive features are summarized below.
Microfluidic particle separation system with additive dosing and recycle of depleted fluid
A system for microfluidic particle separation configured to separate target particles from non-target particles in a biofluid comprising: at least one microfluidic separation channel with at least one inlet, a first outlet, and a second outlet and first and second collection channels in fluid communication with the respective outlets; a source of the biofluid in fluid communication with the at least one inlet; a source of an additive in fluid communication with the source of the biofluid, the additive capable of altering at least one of size of the target particles, size of the non-target particles, compressibility of the biofluid, compressibility of the target particles, compressibility of the non-target particles, aggregation potential of the target particles, aggregation potential of the non-target particles, density of the biofluid, density of the target particles, and density of the non-target particles; at least one acoustic transducer coupled to a wall of the microfluidic separation channel; a recycle line extending from the second collection channel configured to recycle target particle depleted fluid from the second outlet to the source of the biofluid; at least one sensor configured to measure at least one of density of the biofluid and concentration of target particles or non-target particles; and a control module in electrical communication with the at least one sensor and the source of the additive, configured to introduce a predetermined volume of the additive into the biofluid in response to a measurement of at least one of the density of the biofluid and the concentration of the target particles or the non-target particles in the biofluid.
Microfluidic particle separation system with enriched fluid recycle and output-controlled acoustic regulation
A system for microfluidic particle separation comprising: at least one microfluidic separation channel with at least one inlet, a first outlet, and a second outlet and first and second collection channels in fluid communication with the respective outlets; a source of the biofluid in fluid communication with the at least one inlet; a source of an additive in fluid communication with the source of the biofluid, the additive capable of altering at least one of size of the target particles, size of the non-target particles, compressibility of the biofluid, compressibility of the target particles, compressibility of the non-target particles, aggregation potential of the target particles, and aggregation potential of the non-target particles; at least one acoustic transducer coupled to a wall of the microfluidic separation channel; a recycle line extending from the second collection channel configured to recycle target particle enriched fluid from the second outlet to the source of the biofluid; at least one output sensor configured to measure at least one hematocrit (HCT %) of an output suspension and concentration of the target particles or the non-target particles in the output suspension; and a control module in electrical communication with the at least one output sensor and the acoustic transducer, configured to regulate at least one of power, voltage, and frequency delivered to the acoustic transducer in response to a measurement of the at least one parameter in the output suspension, wherein the additive is further configured to regulate the HCT % of the output suspension and the control module is configured to regulate the HCT % of the output suspension to less than about 1% by regulating a volume of the additive introduced to the microfluidic separation channel.
Both independent claims cover microfluidic separation systems that combine a microfluidic separation channel and acoustic transducer with a source of additive to alter particle or fluid properties, sensors and control modules for feedback-based additive dosing or acoustic regulation, and a recycle line configured to return either target particle depleted or target particle enriched fluid to the biofluid source.
Stated Advantages
Removal of particles can be performed continuously.
Separation by both size and density to enhance particle separation.
Separation processes readily scaled to small or large sample volumes.
High degree of purification can be achieved with the addition of safely injectable, physiologically acceptable additives.
Improved selective separation of target particles from a biofluid suspension relative to centrifugation and membrane filtration limitations.
Thermoplastic microfluidic separation channels may be small, disposable, relatively safer to handle, and relatively less expensive to manufacture.
Documented Applications
Processing of cells for cell therapy, including separation of synthetic capture particles from a blood sample after therapeutic processing.
Large scale bioprocessing, including separation of carrier particles from cell culture suspensions to harvest a final cell product.
Diagnostic or environmental monitoring assays, tissue engineering, in vitro models, and biomanufacturing systems, such as for energy applications.
In-line processing where biofluid is collected from a subject, target particles are separated, the target-particle-depleted fluid is post-treated, and the post-treated fluid is delivered back to a recipient subject (autologous or non-autologous delivery).
Use with leukapheresis products and other biofluids selected from blood buffy coat, peripheral blood, whole blood, lymph fluid, synovial fluid, spinal fluid, bone marrow, ascites fluid, and combinations or subcomponents thereof.
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