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Publication Number
US-12121353-B2
Publication Date
2024-10-22
Expiration Date
Abstract
The present invention generally relates to systems and methods for delivering and/or receiving a substance or substances such as blood from subjects. In one aspect, the present invention is directed to devices and methods for receiving or extracting blood from a subject, e.g., from the skin and/or from beneath the skin, using devices containing a substance transfer component (for example, one or more needles or microneedles) and a reduced pressure or vacuum chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In some embodiments, the device may contain a “snap dome” or other deformable structure, which may be used, at least in part, to urge or move needles or other suitable substance transfer components into the skin of a subject. In some cases, for example, the device may contain a flexible concave member and a needle mechanically coupled to the flexible concave member such that the needle may be urged or moved into the skin using the flexible concave member. Other aspects of the present invention are directed at other devices for receiving blood (or other bodily fluids, e.g., interstitial fluid), kits involving such devices, methods of making such devices, methods of using such devices, and the like.
Core Innovation
A device for receiving blood from a subject includes a surface configured to be positioned against skin of a subject and a device actuator. At least one cutter moves from a first position to a second position in response to actuation to cause blood to be drawn from a subject. The device includes an opening configured to receive fluid into the device, the opening being part of a first portion of the device.
A collection chamber is moveable relative to the opening, and when the collection chamber is coupled to the first portion of the device, the collection chamber extends in a direction parallel to the surface or parallel to a two-dimensional plane in which the opening lies. The device further includes a vacuum source in which vacuum from the vacuum source is mechanically created.
The disclosure also relates to fluidic or microfluidic devices that include microfluidic channels and fluidic chambers or reservoirs with capillary-sized dimensions and high aspect ratio geometries. The description includes fluid management in channels and chambers, including storage reservoirs and modular device architectures, using separable modules including a vacuum module that is configured to interact with the microfluidic structure.
The invention also provides an indicator system with visual, audio, and color changes, including sensor-based detection such as pH, temperature, and oxygen, with time recording and a time/date stamp. The disclosure describes signaling and display concepts, including icons and logos, possible wireless transmission of indicator or sensor information to a clinician or processor, and analyte concentration or quantity readout concepts with calibration or control reference.
Claims Coverage
The consolidated document includes three independent claim themes for skin-contact blood-receiving devices and additional microfluidic and indicator disclosure. Across the blood-receiving claims, the inventive concepts center on actuator-driven cutters for drawing blood, an opening and a moveable collection chamber extending parallel to a surface or a two-dimensional plane, and vacuum being mechanically created, with one independent claim additionally requiring a flexible concave member that changes configuration upon actuation.
Actuator-driven cutter drawing blood with a skin-contact surface
A surface configured to be positioned against skin of a subject; a device actuator; and at least one cutter configured to move from a first position to a second position in response to actuation of the device actuator to cause blood to be drawn from a subject.
Moveable collection chamber extending parallel to a surface or two-dimensional plane
An opening configured to receive fluid into the device, the opening being part of a first portion of the device; and a collection chamber moveable relative to the opening, wherein when the collection chamber is coupled to the first portion of the device, the collection chamber extends in a direction parallel to the surface or extends in a direction parallel to the two-dimensional plane in which the opening lies.
Mechanically created vacuum source
A vacuum source, wherein vacuum from the vacuum source is mechanically created, including vacuum generated by a deformable structure via shape change or vacuum generated using a piston.
Flexible concave member configuration change upon actuation
A flexible concave member, wherein the flexible concave member is moveable from a first configuration to a second configuration upon actuation of the device actuator.
Together, the independent claims define a skin-contact blood-receiving device with an actuator-driven cutter and a moveable collection chamber extending parallel to a surface or to a two-dimensional plane. The claims further require that vacuum used to draw blood is mechanically created, and one independent claim adds a flexible concave member that changes configuration upon actuation.
Stated Advantages
Documented Applications
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