Transdermal porator and patch system and method for using same
Inventors
McRae, Stuart • Bowerman, Wendy E. • Braun, Stephen Wilson • Spiehl, Regina • Messier, Bernadette • Farquhar, David • Henkel, Erin Koch • O'Leary, Jeremiah Peter • Fisher, Mark James • Kascak, Uros • Lantz, Loren J. • Novakovic, Zoran • Eppstein, Jonathan
Assignees
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Publication Number
US-9918665-B2
Publication Date
2018-03-20
Expiration Date
Abstract
A transdermal permeant delivery of at least one permeant composition into a tissue membrane of a subject including a disposable substrate having at least a portion of a bottom surface of a first release liner connected to an upper surface of the substrate and a patch having a backing layer and a reservoir that is selectively removable from the top surface of the first release liner. In a connected position, a first portion of the backing layer of the patch is releaseably mounted to a top surface of the first release liner in spaced registration with a poration area of the substrate.
Core Innovation
The invention describes a method of transdermal monitoring in which at least one micropore is formed in a tissue membrane by a microporation device while delivering a vacuum to draw the tissue membrane into contact with a micropore-forming means. The microporation device includes a vacuum source and a disposable substrate defining a poration area, with a conduit extending between an upper substrate surface and a lower substrate surface and at least one channel disposed on the upper substrate surface in fluid communication with the conduit to deliver the vacuum to the poration area.
The micropore-forming means is mounted on the substrate and has at least a portion positioned within the poration area. Vacuum acts to draw the tissue membrane into contact with the micropore-forming means when the microporation device forms the at least one micropore in the tissue membrane, creating at least one micropore through which a monitoring device accesses subcutaneous fluid.
The invention further describes a transdermal monitoring system comprising the microporation device and a monitoring device adapted to monitor subcutaneous fluid via the at least one micropore. The monitoring device includes a sensor that measures a characteristic of the subcutaneous fluid, with refinements that the sensor determines an analyte concentration and that the sensor can be a glucose sensor.
Claims Coverage
The document provides two independent claims, a method and a system. Across these claims, the inventive features focus on vacuum-assisted micropore formation in a tissue membrane using a disposable microporation substrate with a conduit and at least one channel vacuum delivery arrangement, and monitoring of subcutaneous fluid through the micropores by a monitoring device and sensor.
Vacuum-assisted micropore formation with disposable substrate and vacuum delivery
forming at least one micropore in a tissue membrane by a microporation device, while delivering a vacuum to draw the tissue membrane; wherein the microporation device comprises a vacuum source, a disposable substrate defining a poration area, a conduit extending between an upper substrate surface and a lower substrate surface, and at least one channel disposed on the upper substrate surface and in fluid communication with the conduit so that the vacuum is delivered to the poration area.
Mounted micropore-forming means positioned within the poration area
a means for forming at least one micropore in the tissue membrane, wherein the means is mounted on the substrate and at least a portion is positioned within the poration area; and wherein the vacuum acts to draw the tissue membrane into contact with the means when the microporation device forms the at least one micropore.
Monitoring subcutaneous fluid via micropores
monitoring a subcutaneous fluid via the at least one micropore by a monitoring device adapted to monitor a subcutaneous fluid via the at least one micropore.
Sensor measurement of subcutaneous fluid characteristic and analyte concentration
the monitoring device includes a sensor that measures a characteristic of the subcutaneous fluid and determines an analyte concentration in subcutaneous fluid.
Glucose sensor for transdermal monitoring
the sensor is a glucose sensor.
Overall, the claims cover vacuum-assisted formation of micropores in a tissue membrane using a disposable substrate with a conduit and at least one channel delivering vacuum to a poration area, with a mounted micropore-forming means positioned within the poration area and contacted by the vacuum-drawn membrane. The monitoring device then monitors subcutaneous fluid via the micropores, with sensor refinements including measuring a characteristic, determining an analyte concentration, and using a glucose sensor.
Stated Advantages
Documented Applications
Transdermal monitoring that forms micropores in a tissue membrane to enable monitoring of subcutaneous fluid via the micropores.
Transdermal monitoring of an analyte concentration in subcutaneous fluid, including using a glucose sensor.
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