Dermal patch for collecting a physiological sample with removable vial
Inventors
Nawana, Namal • Al-Shamsie, Ziad Tarik
Assignees
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Publication Number
US-12048543-B2
Publication Date
2024-07-30
Expiration Date
Abstract
A device for collecting a physiological sample from a subject includes a lancet and a cartridge configured to couple to the lancet. The needle is configured to puncture the subject's skin. The lancet is configured to automatically deploy the needle when coupled to the lancet which allows the needle to puncture the subject's skin and draw a physiological sample. The device further includes a vial disposed within the cartridge. The vial is configured to receive the drawn physiological sample.
Core Innovation
The disclosure describes a dermal patch system and a device for collecting a physiological sample from a subject. The device includes a lancet with a first needle configured to puncture the subject’s skin, and a cartridge configured to couple to the lancet. The lancet is configured to automatically deploy the first needle when the lancet is coupled to the cartridge so as to allow the first needle to puncture the subject’s skin and draw the physiological sample from the subject.
Within the cartridge, a vial assembly is disposed and configured to receive the drawn physiological sample. The vial assembly includes a vial disposed within the cartridge, and a plunger at least partially disposed within the vial assembly. The plunger is configured to create a vacuum within the vial so that the vacuum draws the physiological sample to the vial.
The vial assembly is coupled to the plunger such that removal of the plunger from the cartridge causes the vial assembly to be removed from the cartridge. The removable vial can be sealed using a self-healing elastomeric cap after a needle puncture, and it can include lysis buffer, preservatives, and/or anticoagulants.
Mechanical features constrain plunger motion and rotation and vial positioning between collection, vial removal, and vial storage positions, and allow snap-off separation of the plunger. The document also describes a cover with a viewing aperture configured to visually access a quick response (QR) code.
Claims Coverage
The document contains one independent claim directed to the core device architecture. It adds multiple inventive features through dependent claims that refine sample transfer, vial contents, sealing, handling positions, and traceability/visibility.
Automatically deployed skin-puncturing lancet coupled to a cartridge
A lancet with a first needle configured to puncture the subject’s skin, a cartridge configured to couple to the lancet, and automatic deployment of the first needle when coupled to the cartridge to allow skin puncture and draw of the physiological sample.
Vacuum-created draw of a physiological sample into a vial assembly
A vial assembly disposed within the cartridge and configured to receive the drawn physiological sample, with a vial disposed therein, and a plunger at least partially disposed within the vial assembly and configured to create a vacuum within the vial so the vacuum draws the physiological sample to the vial.
Plunger removal causes vial assembly removal from the cartridge
The vial assembly is coupled to the plunger such that removal of the plunger from the cartridge causes the vial assembly to be removed from the cartridge.
Sample transfer via physiological sample well and second needle
A physiological sample well and a second needle that transfers the physiological sample from the well to a vial.
Vial includes preservative or lysis buffer
A vial configured to contain a preservative or a lysis buffer.
User-breakable plunger separated by a notch
A plunger having a notch that enables a user to break the plunger to separate it from the vial assembly.
Second needle punctures a self-healing cap to transfer sample
A second needle configured to puncture a self-healing cap to transfer the physiological sample to a vial.
Viewing aperture for QR code traceability
A cover with a viewing aperture configured to visually access a quick response (QR) code.
Across the independent claim and dependent refinements, the inventive features focus on an automatically deployed skin-puncturing lancet, vacuum drawing of a physiological sample into a vial assembly within a cartridge, and coupled removal such that plunger removal removes the vial assembly. Dependent claims further specify sample transfer using a physiological sample well and second needle, vial biochemical contents, notch-based plunger separation, self-healing cap puncture transfer, and QR-code viewing via a viewing aperture.
Stated Advantages
Supports collection of a physiological sample from a subject using an automatically deployable skin-puncturing lancet.
Draws the physiological sample into a vial using vacuum created by a plunger.
Enables removal of the vial assembly from the cartridge by removing the plunger.
Provides a removable vial that can be sealed with a self-healing elastomeric cap after needle puncture.
Allows centrifuge-compatible vial placement.
Provides options for vial contents including lysis buffer, preservatives, and anticoagulants.
Supports traceability and workflow support via a QR code with a corresponding viewing aperture.
Documented Applications
Chain of custody and workflow support using QR-code traceability with an electronic medical record (EMR) and an electronic medical record database.
A dermal patch system for collecting physiological samples from a subject using an automatically deployable skin-puncturing lancet.
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