A61B5/150274

Blood collection safety devices and methods of use and manufacture

An automatically locking safety device, e.g., for use in a blood collection procedure, can include a housing, first and second needle covers that are at least partly received in the housing, and a needle that is at least partly received in at least one of the first and second needle covers. The needle can include a proximal tip configured for placement into a patient and a distal tip configured for placement into a blood collection vial. In some embodiments, the first and second needle covers are biased by a biasing member. In some cases, one or both of the first and second needle covers can be locked to prevent axial movement thereof after the blood collection procedure. In certain embodiments, a distal end of the device is configured to connect with a medical connector, such as a needleless IV access device.

Safety needle devices

A safety needle device is disclosed comprising a hub, needle cannula, housing, tether, retractable sleeve, locking member and spring element. The tether is slidably disposed in the housing, the tether having a slot with an enlarged first guide path and a narrowed second guide path extending distally from the enlarged first guide path. The retractable sleeve is configured to move between an initial position, retracted position and an extended position with respect to the housing, wherein the initial position partially exposes a distal tip of the needle cannula, the retracted position fully exposes the needle cannula, and the extended position fully covers the distal tip of the needle cannula.

ATMOSPHERIC-BALANCED VACUUM FOR BLOOD GAS SAMPLE STABILIZATION WITH AN EVACUATED CONTAINER

A biological liquid collection device designed to draw blood using an “atmospheric-balanced vacuum” to ensure the blood is exposed to the sample atmospheric partial pressure oxygen and partial pressure carbon dioxide levels as found in standard arterial blood gas syringes, resulting in blood gas sample stabilization during collection and a superior vacuum shelf-life by reducing the gas permeation rate through the plastic tube. The biological liquid collection device comprises a collection module for receiving a biological liquid sample, an evacuated container having an open end and a closed end wherein the evacuated container contains the collection module therein, and a closure for closing the open end of the evacuated container. The evacuated container comprises a gas composition that is substantially equal to the gas composition of the atmosphere outside of the evacuated container. A method for forming the atmospherically balanced vacuum collection device is also provided.

Body fluid sampling device-sampling site interface

An arrangement for producing a sample of body fluid from a wound opening created in a skin surface at a sampling site includes: a housing, the housing comprising a first opening; a skin interface member disposed in the first opening, the skin interface member comprising an inner member having a second opening, and an outer member at least partially surrounding the inner member and attached to the first opening; and at least one skin-penetration member configured and arranged to project within the second opening. Arrangements having alternatively constructed skin interface members are also described.

Methods of Manufacture to Optimize Performance of Transdermal Sampling and Analysis Device

Methods and systems for manufacturing a transdermal sampling and analysis device for non-invasively and transdermally obtaining biological samples from a subject and determining levels of analytes of the obtained biological samples are provided. A method of manufacturing the device may improve performance and includes forming channel structures on the lid of the device, thereby making the spacer/channel support structures physically independent and separable from the sensing electrode. Other methods of manufacturing the device may improve performance and include forming at least one of the electrodes on each of the base and the lid, and forming a recessed second spacer layer over the channel support structures, thereby separating the channel support structures and the electrode on the lid to allow a larger area of the electrode to be exposed to the biological sample.

Safety connector with needle
10898117 · 2021-01-26 · ·

A safety connector has a needle, and includes a tubular protective sleeve with a distal section, having a movable wall portion arranged in the peripheral wall thereof. The movable wall portion is selectively movable between a retracted position and a protection position. In the retracted position, the movable wall portion is aligned with the peripheral wall of the proximal section of the tubular protective sleeve. In the protection position, the movable wall portion projects into the inner space of the tubular protective sleeve.

Methods of manufacture to optimize performance of transdermal sampling and analysis device

Methods and systems for manufacturing a transdermal sampling and analysis device for non-invasively and transdermally obtaining biological samples from a subject and determining levels of analytes of the obtained biological samples are provided. A method of manufacturing the device may improve performance and includes forming channel structures on the lid of the device, thereby making the spacer/channel support structures physically independent and separable from the sensing electrode. Other methods of manufacturing the device may improve performance and include forming at least one of the electrodes on each of the base and the lid, and forming a recessed second spacer layer over the channel support structures, thereby separating the channel support structures and the electrode on the lid to allow a larger area of the electrode to be exposed to the biological sample.

INTRA-MOLD STERILIZATION OF PLASTIC-EMBEDDED NEEDLE
20200383619 · 2020-12-10 · ·

Methods for intra-mold sterilization of a plastic-embedded metal component of a product, such as a medical lancet having a metal needle embedded within a plastic lancet body. For example, a lancet needle is retained within a mold, plastic is injected to encapsulate the needle, and a specified minimum temperature is maintained for a specified minimum cycle time. In example forms, the specified minimum mold temperature is at least about 370 degrees Fahrenheit and the specified minimum cycle time is at least about 10 seconds.

Compact fluid analysis device and method to fabricate
10843922 · 2020-11-24 · ·

The present disclosure relates to a device for analyzing a fluid sample. In one aspect, the device includes a fluidic substrate that comprises a micro-fluidic component embedded in the fluidic substrate configured to propagate a fluid sample via capillary force through the device and a means for providing a fluid sample connected to the micro-fluidic component. The device also includes a lid attached to the fluidic substrate at least partly covering the fluidic substrate and at least partly closing the micro-fluidic component. The fluidic substrate may be a silicon fluidic substrate and the lid may be a CMOS chip. In another aspect, embodiments of the present disclosure relate to a method for fabricating such a device, and the method may include providing a fluidic substrate, providing a lid, and attaching, through a CMOS compatible bonding process, the fluidic substrate to the lid to close the fluidic substrate at least partly.

Imaging analyzer for testing analytes

The invention provides analyzers that improve tests for detecting specific cellular, viral, and molecular targets in clinical, industrial, or environmental samples. The invention permits efficient and specific selection and sensitive imaging detection of individual microscopic targets at low magnification. Automated embodiments allow efficient walk-away, on-demand, random-access high-throughput testing. The analyzers perform tests without requiring wash steps thus streamlining engineering and lowering costs. Thus, the invention provides analyzers that can deliver rapid, accurate, and quantitative, easy-to-use, and cost-effective tests for analytes.