A hybrid microneedle array and a method of fabricating the array is used for delivery of drugs, vaccines, and other therapeutic agents into tissues, including skin, heart, inner ear, and other tissues. The microneedle array can facilitate precise and reproducible intradermal delivery. Each microneedle has a dissolvable tip with a hollow body permitting the delivery of a variety of therapeutic agents into the skin. A fabrication process utilizes a two part mold to separately mold a dissolvable tip and a solid body portion of each microneedle in the array.

A method of assembling a lancet housing assembly comprising multiple lancets for use in a portable handheld medical diagnostic device for sampling bodily fluids from a skin site of a patient is disclosed. The method includes forming a plurality of lancet structures in a lancet sheet. The lancet sheet has a removable ledge for releasing the lancet structures. The removable ledge of the lancet sheet is flexed for releasing the lancet structures from the removable ledge.

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.

A microneedle has a proximal end portion and a distal end portion and defines a lumen. The proximal end portion is configured to be coupled to a cartridge to place the lumen in fluid communication with the cartridge. The proximal end portion includes a base surface that is configured to be placed in contact with a surface of a target tissue. The distal end portion of the microneedle includes a beveled surface. The beveled surface defines a tip angle of less than about 20 degrees and a ratio of a bevel height to a bevel width of less than about 2.5.

Methods for mass production of new microfluidic devices are described. The microfluidic devices may include an array of micro-needles with open channels in fluid communication with multiple reservoirs located within a substrate that supports the micro-needles. The micro-needles are configured so as to sufficiently penetrate the skin in order to collect or sample bodily fluids and transfer the fluids to the reservoirs. The micro-needles may also deliver medicaments into or below the skin.

A medical puncture needle includes a rod-shaped main body portion; and a blade surface formed at a distal end portion of the main body portion. The blade surface includes a first blade surface portion and a second blade surface portion that intersect to form a blade edge. A needle tip is formed at a location at which a distal end of the blade edge intersects a first ridge line at an outer edge of the first blade surface and a second ridge line at an outer edge of the second blade surface. At least one of the blade surface portions is planar, and, in a central axis direction of the main body portion, said at least one blade surface portion extends to a location proximal of a middle position of a blade surface region in which the blade surface is formed.

A method of manufacturing a plurality of through-holes in a layer of first material, for example for the manufacturing of a probe comprising a tip containing a channel. To manufacture the through-holes in a batch process, a layer of first material is deposited on a wafer comprising a plurality of pits a second layer is provided on the layer of first material, and the second layer is provided with a plurality of holes at central locations of the pits; using the second layer as a shadow mask when depositing a third layer at an angle, covering a part of the first material with said third material at the central locations, and etching the exposed parts of the first layer using the third layer as a protective layer.

A lancet driver is provided wherein the driver exerts a driving force on a lancet during a lancing cycle and is used on a tissue site. The driver comprises of a drive force generator for advancing the lancet along a path into the tissue site, and a manual switch for a user interface input.

In one aspect, the present disclosure relates to a device for obtaining biological tissue. In some embodiments, the device can include a first row of a plurality of hollow tubes; a second row of a plurality of hollow tubes, adjacent the first row of hollow tubes; a third row of a plurality of hollow tubes, adjacent the second row of hollow tubes, the first, second and third rows forming an array of hollow tubes; wherein each hollow tube can include at least one point at the distal end of the hollow tube, the plurality of rows forming a two dimensional array of hollow tubes; wherein an inner diameter of the at least one tube is less than about 1 mm, the distal end of each of the hollow tubes is configured to be inserted into a biological tissue donor site to remove a portion of tissue therefrom when each of the hollow tubes is withdrawn from the donor site.

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.