Microneedle injection and infusion apparatus and method of using same

Inventors

Burton, Scott A. • Ng, Chin-Yee • Frits, Michael J. • Mathias, Richard R.

Abstract

A microneedle injection and infusion apparatus, and a method of using same. The apparatus can include a housing, a microneedle array holder for holding a microneedle array, and a shuttle that holds a cartridge (e.g., that contains an active agent). The microneedle array holder can be movable between a retracted position and an extended position. The shuttle can be movable between a first position in which the cartridge is not in fluid communication with a fluid path and a second position in which the cartridge is in fluid communication with the fluid path. The apparatus can further include an actuator movable between a first position and a second position. The method can include moving the actuator to its second position to allow the shuttle to move toward its second position, wherein movement of the shuttle toward its second position allows the microneedle array holder to move to its extended position.

Core Innovation

The invention relates to a method of using a microneedle injection apparatus for transdermal delivery in which a microneedle array holder moves between a retracted position and an extended position relative to an opening in a base of a housing. In the retracted position, the microneedle array is recessed within the housing such that the microneedle array does not contact the skin surface when the apparatus is positioned on the skin surface. In the extended position, at least a portion of the microneedle array is positioned to contact the skin surface via the opening when the apparatus is positioned on the skin surface.

The microneedle injection apparatus includes a shuttle configured to hold and carry a cartridge, where the cartridge defines a reservoir configured to contain an active agent. The shuttle is movable between a first position in which the reservoir is not in fluid communication with a fluid path and a second position in which the reservoir is in fluid communication with the fluid path. The actuator is movable between a first position and a second position, and moving the actuator to the second position allows the shuttle to move toward the second position, thereby permitting fluid communication to be established with the fluid path.

Moving the actuator to the second position allows the microneedle array holder to move to the extended position, so that the shuttle movement and the microneedle array holder movement are coordinated as part of the method. The document further describes hollow microneedles defining a lumen and a fluid path configured to pass through the microneedles, with a piston/plunger that forces an active agent from the reservoir into the fluid path. Additional mechanics described include timing/latching and stop features to control shuttle movement, along with sterility features including a piercing element with a deformable sterility seal and an infusion progress indicator visible through a window.

Claims Coverage

The provided independent claims are 1 and 19. Across these claims, three core inventive features are described: actuator-permitted shuttle movement to establish fluid communication, coordinated movement of a microneedle array holder from retracted to extended skin contact, and stop-based release with stored energy driving of shuttle motion.

The independent claims cover methods that coordinate actuator movement with shuttle movement to establish reservoir-to-fluid-path fluid communication, and coordinate the microneedle array holder transition from a retracted, skin-noncontact position to an extended, skin-contact position via the opening. The claim set also includes stop-based release and stored energy driving of shuttle motion.

Stated Advantages

Documented Applications