Microneedle array assembly, drug delivery device and method for administering liquid across a broad area at low pressure
Inventors
Baker, Andrew T. • Ross, Russell F. • Gadsby, Elizabeth Deibler • Hagan, Luke
Assignees
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Publication Number
US-11179554-B2
Publication Date
2021-11-23
Expiration Date
Abstract
A uniformity control membrane can be securely engaged against an upstream side of a microneedle array and configured so that resistance to flow through the uniformity control membrane is substantially greater than the resistance to flow through the microneedle array. These differences in flow resistance can facilitate uniform administration of a liquid formulation into the patient's skin across a broad area and at a relatively low pressure, such as by way of capillary action. The administration of the liquid formulation into the patient's skin across the broad area can result from the liquid formulation being administered by way of at least a majority of the microneedles of the microneedle array.
Core Innovation
The invention relates to a microneedle array assembly that uses at least one uniformity control membrane engaged against the upstream side of a base. The base has opposite upstream and downstream sides and defines a plurality of apertures extending between the sides, with a plurality of microneedles extending from the downstream side, and the microneedle array and the at least one membrane are cooperatively configured so that a plurality of flow paths extend through the microneedle array assembly.
The cooperative configuration is defined by a quantitative resistance-to-flow relationship across the assembly. The resistance to flow through the at least one membrane at the upstream side of the base is within a range of from about 30 times to about 100 times the resistance to flow through the microneedle array, and the about 30 times to about 100 times is the difference in resistance to flow between the upstream side and the downstream side of the base, measured at the plurality of apertures of the base.
The at least one membrane can have a relatively smooth side and a relatively rough side, with the smooth side engaged against the upstream side of the base. In another embodiment, the at least one membrane is comprised of a track etched membrane, and the membrane cooperates with the base apertures to mitigate variations in participating downstream flow paths and restrict flow between the flow paths at the interface between the membrane’s downstream side and the base’s upstream side.
Claims Coverage
The provided independent claims cover microneedle array assemblies in which a membrane engaged against the upstream side cooperates with a microneedle array to establish multiple flow paths, while maintaining a specified upstream-versus-downstream resistance-to-flow difference measured at base apertures. Additional independent-claim features include membrane surface orientation, membrane type, flow restriction at the interface, and a drug delivery device with liquid supply components.
Cooperatively configured flow paths with upstream membrane resistance
The microneedle array and the at least one membrane are cooperatively configured so that a plurality of flow paths extend through the microneedle array assembly, and the resistance to flow through the at least one membrane at the upstream side of the base is within a range of from about 30 times to about 100 times the resistance to flow through the microneedle array, wherein the about 30 times to about 100 times is a difference in the resistance to flow between the upstream side and the downstream side of the base, and wherein the difference is measured at the plurality of apertures of the base.
Membrane smooth side engaged against base upstream side
The at least one membrane has a relatively smooth side and a relatively rough side, and the at least one membrane being engaged against the upstream side of the base is comprised of the smooth side of the at least one membrane being engaged against the upstream side of the base.
Track etched membrane
The at least one membrane is a track etched membrane.
Membrane restricts flow between flow paths at interface
The membrane is configured so that, at the interface between the membrane’s downstream side and the base’s upstream side, the interface restricts any flow between the flow paths through the microneedle array assembly.
Drug delivery device with reservoir supplying liquid via membrane
A drug delivery device that includes a microneedle array assembly and a reservoir that supplies liquid to the microneedle array through at least one membrane.
Force provider with approximately equal pressure increase and decrease
The drug delivery device includes a force provider that increases the pressure of a liquid and at least one membrane that decreases the liquid’s pressure, with the absolute values of the pressure increase and decrease being approximately equal.
Cannula and plenum flow routing before membrane
A drug delivery device is configured with a cannula connected to a plenum so that, during use, liquid flows from a reservoir through the cannula into the plenum before passing through at least one membrane and out of a microneedle array.
Across the provided independent claims, the core coverage centers on a microneedle array assembly that cooperatively forms multiple flow paths with a uniformity control membrane engaged against a base upstream side, while maintaining the membrane-to-microneedle resistance relationship (about 30× to about 100×, measured at base apertures). Additional limitations specify membrane smooth/rough engagement, membrane type, flow restriction at the interface, and drug delivery device components.
Stated Advantages
Enables uniform administration across a broad skin area.
Maintains a large upstream-vs-downstream resistance-to-flow difference to support flow uniformity across multiple flow paths.
Enables relatively low pressure administration with capillary-driven flow.
Mitigates bubble-pressure variations that otherwise reduce the number of participating downstream flow paths.
Prevents lateral bypass flow by preferring flow through the intended flow paths.
Documented Applications
Transdermal drug delivery using a microneedle array assembly with a uniformity control membrane to administer compound(s) uniformly across a broad skin area.
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