Integrated fluid module and test device

Inventors

Kelly, JohnWallis, HuwBocchicchio, KeithYan Kong, Shing

Assignees

Atomo Diagnostics Ltd

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Publication Number

US-11633733-B2

Patent

Publication Date

2023-04-25

Expiration Date


Abstract

An integrated testing device and fluid module are disclosed, as well as a method of manufacture. Fluid module contains a reservoir containing a test fluid, and a control vessel. The reservoir discharges test fluid into the control vessel, which discharges the test fluid in a controlled way to a test component.

Core Innovation

The invention relates to an integrated testing device and test fluid module in which a test-fluid reservoir discharges through an unsealed conduit into a control vessel or well. A user-actuated actuator pressurizes the reservoir to cause a frangible seal to fail, and the well delivers the fluid to a test component at a controlled, measurable rate dependent on the well outlet geometry. Venting is provided to prevent pressure lock and avoid uncontrolled bursts.

The invention also addresses a manufacturing process for forming a liquid filled reservoir with a fluid conduit having a frangible seal that prevents egress of fluid from the reservoir through the conduit. The process includes forming a reservoir body, filling the reservoir body with a liquid, positioning a base component on the reservoir body, and using a first set of tools to heat seal the base component to the reservoir body to create a fluid tight seal around the reservoir body while leaving the fluid conduit unsealed.

A separate set of second tools is then positioned to heat seal across the conduit, where the heat applied by the second tool creates a frangible seal across the conduit. The manufacturing approach is described as a two-stage heat-sealing process using multi-layer packaging, with a first perimeter seal leaving the conduit unsealed followed by a second narrow heated seal forming the frangible seal. The invention further describes minimizing unwanted first-stage heat sealing of the conduit using conduit or body shaping and heat sealing tool design features such as an open section or recess to prevent heat transfer.

Claims Coverage

The independent claims define a process for forming a liquid filled reservoir with a fluid conduit that has a frangible seal. The inventive features are implemented through a two-stage, tool-separated heat-sealing approach and further constraints regarding tool geometry, minimized conduit contact, and liquid fill/air presence.

Two-stage heat sealing leaving conduit unsealed, then forming frangible seal across conduit

Forming a reservoir body, filling the reservoir body with a liquid, positioning a base component on the reservoir body and using a first set of tools to heat seal the base component to the reservoir body to create a fluid tight seal around the reservoir body apart from the fluid conduit which remains unsealed, and positioning a separate set of second tools to heat seal across the conduit where the heat applied by the second tool creates a frangible seal across the conduit.

Tool opening above conduit during base sealing

Configuring the first set of tools to include an opening above the conduit so that heating used to heat seal the base component to the reservoir body does not seal across the conduit.

Shaping to minimize contact at the conduit before forming frangible seal

Shaping the reservoir body and/or base component to minimize contact at the conduit prior to applying the second tool to create the frangible seal across the conduit.

Substantially filled reservoir to leave little or no air

Specifying that the liquid volume substantially fills the reservoir so little or no air remains after the package is sealed.

Across the independent claim and its dependents, the claimed subject matter centers on forming a fluid-tight reservoir seal while intentionally leaving the conduit unsealed during a first heat-sealing stage, then using separate tools to heat seal across the conduit to create a frangible seal, with further limitations that control tool geometry, reduce conduit contact, and ensure substantial liquid fill to minimize residual air.

Stated Advantages

Minimized unwanted first-stage heat sealing of the conduit by controlling heat transfer.

Controlled discharge dependent on well outlet geometry.

Venting to prevent pressure lock and avoid uncontrolled bursts.

An interlock mechanism to prevent premature release.

Reduced air content to lower required burst force.

Minimized fluid-path losses.

Documented Applications

Integrated testing device/test fluid module for delivering a test fluid to a test component such as a lateral flow strip, including delivery of a test material blood sample and buffer delivery.

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