The biological test kit is a device for drawing and, optionally, testing biological samples. The biological test kit is an array of lancets set in wells in a rigid base. Each lancet well is covered by a protective cover which when deformed permits the lancet to puncture a user or other patient. In one embodiment the biological test kit employs distinct covers for each lancet and in another the covers are formed from sheet material formed into blisters which cover the lancet.

Methods of fabricating a probe are described. In an example, a structure may be formed on a surface of a substrate. The structure may include the probe, a hinge, and an anchor arranged linearly, where an angle is formed between the probe and the hinge. The hinge may be positioned between the probe and the anchor, and the structure may be parallel to the substrate. An amount of solder may be deposited on an area of the structure that spans from a portion of the probe to a portion of the anchor, and across the hinge. The deposited solder may be reshaped by an execution of a solder reflow process. The reshape of the deposited solder may cause the probe to rotate about the hinge in order to reduce the angle between the probe and the hinge.

A lancet needle with an alignment and engagement notch, with material of the lancet body extending into the notch to more securely retain the needle to the lancet body, whereby a shorter needle can be utilized than with typical lancets. The notch optionally also provides a registration point for rotational and/or axial alignment of the needle during overmolding to form the lancet body, for example to maintain consistent positioning of the needle's beveled point.

A microsensor and method of manufacture for a microsensor, comprising an array of filaments, wherein each filament of the array of filaments comprises a substrate and a conductive layer coupled to the substrate and configured to facilitate analyte detection. Each filament of the array of filaments can further comprise an insulating layer configured to isolate regions defined by the conductive layer for analyte detection, a sensing layer coupled to the conductive layer, configured to enable transduction of an ionic concentration to an electronic voltage, and a selective coating coupled to the sensing layer, configured to facilitate detection of specific target analytes/ions. The microsensor facilitates detection of at least one analyte present in a body fluid of a user interfacing with the microsensor.

In one aspect, the dual bevel needle can include a hollow tube having a proximal end, a distal end, a first lateral side, and a second lateral side opposite the first lateral side; a first needle point at the distal end of the hollow tube; a second point at the distal end of the hollow tube; a first bevel on each of the first lateral side and the second lateral side, the first bevel comprising a first bevel angle relative to a longitudinal axis of the tube; and a second bevel on each of the first lateral side and the second lateral side, the second bevel having a second bevel angle relative to the longitudinal axis of the tube, wherein the first and second bevels each form a portion of an ellipse, the ellipse having an inner cutting edge and terminating in the first and second needle points at the distal end of the tube, the second bevel angle being shallower than the first bevel angle, the second bevel being located adjacent the proximal end of the first bevel, and the inner cutting edge converging to a narrow heel.

A microsensor and method of manufacture for a microsensor, comprising an array of filaments, wherein each filament of the array of filaments comprises a substrate and a conductive layer coupled to the substrate and configured to facilitate analyte detection. Each filament of the array of filaments can further comprise an insulating layer configured to isolate regions defined by the conductive layer for analyte detection, a sensing layer coupled to the conductive layer, configured to enable transduction of an ionic concentration to an electronic voltage, and a selective coating coupled to the sensing layer, configured to facilitate detection of specific target analytes/ions. The microsensor facilitates detection of at least one analyte present in a body fluid of a user interfacing with the microsensor.

This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.

Provided are a microneedle template including: a substrate on which at least one microneedle shapes are formed; and a diamond layer formed on the surface of the at least one microneedle shapes, a method for preparing the microneedle template, a microneedle prepared using the microneedle template, and a method for preparing the microneedle.

A lancet magazine is disclosed which includes a housing and a plurality of lancets each of which is enclosed in a sterile chamber of the housing, wherein the chambers each have a puncturing opening which is closed with a foil, wherein the lancets include a sample receiving device for receiving body fluid and the chambers each include a further opening which is closed with a membrane that is permeable to gas and fluid and includes a lower side that faces the lancet and serves to receive body fluid from the sample receiving device and an upper side that serves to transfer body fluid to a test field arranged on the membrane.

In one aspect, the dual bevel needle can include a hollow tube having a proximal end, a distal end, a first lateral side, and a second lateral side opposite the first lateral side; a first needle point at the distal end of the hollow tube; a second point at the distal end of the hollow tube; a first bevel on each of the first lateral side and the second lateral side, the first bevel comprising a first bevel angle relative to a longitudinal axis of the tube; and a second bevel on each of the first lateral side and the second lateral side, the second bevel having a second bevel angle relative to the longitudinal axis of the tube, wherein the first and second bevels each form a portion of an ellipse, the ellipse having an inner cutting edge and terminating in the first and second needle points at the distal end of the tube, the second bevel angle being shallower than the first bevel angle, the second bevel being located adjacent the proximal end of the first bevel, and the inner cutting edge converging to a narrow heel.