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Publication Number

US-11957465-B2

Patent

Publication Date

2024-04-16

Expiration Date


Abstract

Apparatuses, methods, and systems are disclosed for accelerated ergonomic collection of capillary blood. An apparatus and system include a blood collection module with a proximal portion including a vacuum generation chamber, a distal portion including a blood collection chamber, a concave mid portion including a pressure equalization channel configured to equalize reduced air pressure. The apparatus further includes a sealing surface to stably seal the blood collection module to the skin around a collection site and a slide latch actuated by a lengthwise sliding motion. Also included is a lancet carrier with linearly-arranged lancet strips to puncture rows of blood extraction slits in the collection site. The apparatus also includes an angled transfer port with a low-resistance non-microfluidic blood flow channel to a transfer module, then to a plasma separation module with a multilayer laminate and plasma separation membrane. Methods for accelerated ergonomic collection of capillary blood are disclosed.

Core Innovation

The invention provides an apparatus for accelerated ergonomic capillary blood collection, using a blood collection module that includes a proximal portion having a vacuum generation chamber formed in a base, a vacuum piston, and a precompressed volume expansion spring. The blood collection module further includes a distal portion with a blood collection chamber formed in the base for collecting blood from a collection site in skin of a subject, a concave mid portion for secure holding between two digits, and a sealing surface at a bottom surface configured to stably seal the module to the skin around the collection site.

A slide latch with a tab protruding through a slot is used to reposition blocking elements that unblock upward expansion of a precompressed collar spring and of the precompressed volume expansion spring in response to sliding motion. In response to a sliding motion to a first predetermined distance, the system triggers a lancet carrier with a plurality of linearly-arranged lancet strips to momentarily puncture and retract from a plurality of rows of blood extraction slits in the skin. In response to sliding to a second predetermined distance, the unblocked volume expansion spring begins vacuum generation of reduced air pressure within the vacuum generation chamber, which is distributed to the blood collection chamber and to a transfer module when coupled.

The invention also provides an angled transfer port disposed at the distal portion and extending outward from the blood collection module, angled away from the subject at an acute angle of between 10 and 45 degrees relative to the sealing surface. The blood is guided from an opening in the sealing surface through a non-microfluidic blood flow channel with greater than submillimeter channel dimensions to the transfer module when coupled. The module includes a pressure equalization channel configured to distribute reduced air pressure generated within the vacuum generation chamber to the blood collection chamber and to the transfer module.

Claims Coverage

The partial content includes three independent claims that define the main inventive features: a slide-latched, vacuum-generation capillary blood collection module with multiple rows of lancet-fired blood extraction slits and an angled, non-microfluidic transfer port to a coupled transfer module, plus a prepackaged additive for predetermined laboratory tests.

Slide-latch vacuum-generation blood collection module with pressure equalization

A blood collection module comprising a vacuum generation chamber formed in a base, a vacuum piston, a precompressed volume expansion spring, an enclosure with a slot for a slide latch, and a blood collection chamber formed in the base. A pressure equalization channel distributes reduced air pressure generated within the vacuum generation chamber to the blood collection chamber and to a transfer module when coupled.

Mechanically timed lancet carrier with linearly-arranged lancet strips producing multiple rows of blood extraction slits

A slide latch configured to unblock upward expansion of a precompressed collar spring and trigger a lancet carrier with a plurality of linearly-arranged lancet strips to momentarily puncture and retract from a plurality of rows of blood extraction slits in the skin.

Angled non-microfluidic transfer port coupling to a transfer module

An angled transfer port extending in a distal direction from the blood collection module and angled away from the skin of the subject at an acute angle of between 10 and 45 degrees relative to the sealing surface, such that an outer wall of the coupled transfer module is also angled away at the same acute angle relative to the sealing surface. Blood is guided from an opening in the sealing surface through a non-microfluidic blood flow channel to the transfer module via the angled transfer port.

Prepackaged additive in the transfer module for predetermined laboratory tests

The transfer module comprises a prepackaged additive selected to mix with the blood to facilitate performance of one or more predetermined laboratory tests.

Across the independent claims, the invention centers on an accelerated ergonomic capillary blood collection apparatus with a slide latch that mechanically coordinates lancet firing and vacuum generation, creates multiple rows of blood extraction slits in skin, and transfers collected blood through a non-microfluidic blood flow channel using an angled transfer port to a coupled transfer module, optionally containing a prepackaged additive for predetermined laboratory tests.

Stated Advantages

Accelerated ergonomic collection of capillary blood.

Guides blood from individual blood extraction slits along corresponding rows and then toward the transfer module.

Provides a transfer-path geometry that angles away from the subject at an acute angle of between 10 and 45 degrees relative to the sealing surface.

Facilitates performance of one or more predetermined laboratory tests by mixing a prepackaged additive with the blood.

Documented Applications

Accelerated ergonomic collection of capillary blood from a collection site in skin of a subject, with downstream transfer of blood and components to a transfer module.

Facilitation of predetermined laboratory tests via a transfer module containing a prepackaged additive mixed with collected blood.

Plasma separation using a plasma separation module with a multilayer laminate and plasma separation membrane layers [procedural detail omitted for safety].

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