Printed circuit board heater for an amplification module
Inventors
Andreyev, Boris • Ciopyk, Brian • Briones, Victor • Hong, Jonathan • Swenson, David • Loney, Gregory • De La Zerda, Adam • Chu, Steven
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Assignees
Member
Visby MedicalVisby Medical develops rapid at-home molecular diagnostic tests powered by polymerase chain reaction (PCR) technology, focusing on accessible, private, and accurate screening for sexually transmitted infections (STIs). The company offers the first FDA-authorized over-the-counter at-home PCR test for women’s sexual health and is expanding its diagnostics platform to address other infectious diseases for point-of-care and home use. Its technology enables results in approximately 30 minutes via a secure mobile app, with integrated telehealth services for positive results. Visby Medical emphasizes user privacy, scalable manufacturing, and partnerships to broaden access to high-quality diagnostics.
Visby Medical develops rapid at-home molecular diagnostic tests powered by polymerase chain reaction (PCR) technology, focusing on accessible, private, and accurate screening for sexually transmitted infections (STIs). The company offers the first FDA-authorized over-the-counter at-home PCR test for women’s sexual health and is expanding its diagnostics platform to address other infectious diseases for point-of-care and home use. Its technology enables results in approximately 30 minutes via a secure mobile app, with integrated telehealth services for positive results. Visby Medical emphasizes user privacy, scalable manufacturing, and partnerships to broaden access to high-quality diagnostics.
Publication Number
US-10987674-B2
Publication Date
2021-04-27
Expiration Date
Abstract
An apparatus includes a substrate, a first heating element, and a second heating element. The substrate includes a first portion, a second portion, and a third portion that is between the first portion and the second portion. The first portion is characterized by a first thermal conductivity, the second portion is characterized by a second thermal conductivity, and the third portion is characterized by a third thermal conductivity. The third thermal conductivity is less than the first thermal conductivity and the second thermal conductivity. The first heating element is coupled to the first portion of the substrate, and is configured to produce a first thermal output. The second heating element is coupled to the second portion of the substrate, and configured to produce a second thermal output. The second thermal output is different from the first thermal output.
Core Innovation
The invention relates to a disposable molecular diagnostic amplification module that includes a flow member defining a plurality of flow channels through which a sample can flow from an inlet opening to an outlet opening, with a flow axis. A substrate is positioned to interact thermally with the flowing sample and is thermally segmented into first portion, second portion, and a third portion between the first portion and the second portion. Heater elements are coupled to respective substrate portions to generate different thermal outputs for establishing different thermal regions along the flow path.
The module defines apertures in the substrate that separate the third portion from the first portion and separate the second portion from the third portion. Connection portions in the substrate are provided between adjacent apertures, with the connection portions offset along the flow axis such that a temperature difference between a first flow channel and a second flow channel is minimized. In this way, the flow member and substrate coupling cooperate to create controlled temperature variation across different flow channels.
In further implementations, the invention provides heater assemblies coupled between the substrate and the flow member that maintain respective portions of the flow member at different temperatures. The heater assemblies include pluralities of heating elements along the flow axis, where each heating element is electrically isolated from other heating elements within the same plurality. The description also expands to flow-through serpentine channels and multiple temperature zones for amplification, including integration with downstream detection via a heated read lane and hybridization probes.
Claims Coverage
Two independent claims are provided. The independent claims cover a three-portion segmented substrate with different thermal outputs, apertures and connection portions to manage temperature differences across flow channels, and heater assemblies with electrically isolated heating elements along a flow axis.
Three-portion substrate segmentation with different thermal outputs
A substrate including a first portion, a second portion, and a third portion between the first portion and the second portion, wherein a first heating element coupled to the first portion produces a first thermal output, a second heating element coupled to the second portion produces a second thermal output different from the first thermal output, and a third heating element coupled to the third portion produces a third thermal output.
Apertures separating substrate portions with offset connection portions minimizing temperature differences
The substrate defining a first plurality of apertures that separate the third portion from the first portion and a second plurality of apertures that separate the second portion from the third portion, and the substrate including a first connection portion and a second connection portion between adjacent apertures, the connection portions offset along the flow axis so that a temperature difference between a first flow channel and a second flow channel is minimized.
Electrically isolated heating elements maintaining different flow-member temperature portions
A first heater assembly coupled between the substrate and the flow member configured to maintain a first portion of the flow member at a first temperature, including first plurality of heating elements along the flow axis each electrically isolated from other heating elements from the first plurality, and a second heater assembly coupled between the substrate and the flow member configured to maintain a second portion of the flow member at a second temperature, including a second plurality of heating elements along the flow axis each electrically isolated from other heating elements from the second plurality.
Aperture-defined connection portions aligned with different flow channels
The substrate including a first connection portion between a first aperture and adjacent second aperture from the first plurality of apertures, and a second connection portion between a first aperture and adjacent second aperture from the second plurality of apertures, the first connection portion aligned with a first flow channel and the second connection portion aligned with a second flow channel, the first flow channel different than the second flow channel.
Overall, the independent claims focus on segmented substrate portions separated by apertures, coupling of different heating elements or heater assemblies to maintain different thermal outputs or temperatures along a flow axis, and connection portions that are offset or aligned to minimize or define temperature differences between flow channels, with electrically isolated heating elements used in one independent claim.
Stated Advantages
minimized temperature difference between a first flow channel and a second flow channel.
Documented Applications
disposable molecular diagnostic amplification module for sample flow through multiple flow channels, including flow-through serpentine channels and multiple temperature zones for amplification.
downstream detection integration with a heated read lane with hybridization probes [procedural detail omitted for safety].
nucleic acid amplification and downstream detection in a portable disposable point-of-care context.
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