DEVICES AND METHODS FOR ENHANCED SKIN PERFORATION FOR CONTINUOUS GLUCOSE MONITORING
First Claim
1. A method of in vivo monitoring of an individual'"'"'s interstitial fluid analyte concentration comprising:
- creating plurality of micropores through a stratum corneum layer of an area of the individual'"'"'s skin, where the plurality of micropores forms a plurality of fluid paths having a distal end in fluid communication with interstitial fluid of the individual and a proximal end in fluid communication with a sensing zone located outside of the patient'"'"'s body, where the fluid paths comprise an interior space extending between the distal and proximal ends;
delivering a sensing fluid filling within the interior space of the fluid paths;
allowing at least one analyte to passively diffuse from the patient'"'"'s interstitial fluid through the fluid paths and into the sensing zone; and
sensing a concentration of the at least one analyte in a sensing fluid within the sensing zone using a sensor located at least partially in the sensing zone, wherein the sensing fluid formulation comprises a chelating agent and or biochemical inhibitors adapted to keep the micropores, created by the tissue piercing elements, open for extended period to maintain an un-interrupted analyte flux through the fluid paths and to mitigate a decrease over time of the analyte flux through the fluid paths.
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Abstract
The efficacy of tissue piercing elements in the area of transdermal drug delivery is well-documented. Multiple studies have shown that enhancement of skin permeation via creation of microscopic pores in the stratum corneum can greatly improve the delivery rates of drugs. However, skin perforation with tissue piercing elements is not the only factor affecting the rate of drug transport. Other factors including such as the formulation of the drug and rate of closure of the micropores closure also need to be considered. Similarly micro tissue piercing elements have been used with less success by several workers for continuous glucose monitoring.
6 Citations
23 Claims
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1. A method of in vivo monitoring of an individual'"'"'s interstitial fluid analyte concentration comprising:
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creating plurality of micropores through a stratum corneum layer of an area of the individual'"'"'s skin, where the plurality of micropores forms a plurality of fluid paths having a distal end in fluid communication with interstitial fluid of the individual and a proximal end in fluid communication with a sensing zone located outside of the patient'"'"'s body, where the fluid paths comprise an interior space extending between the distal and proximal ends; delivering a sensing fluid filling within the interior space of the fluid paths; allowing at least one analyte to passively diffuse from the patient'"'"'s interstitial fluid through the fluid paths and into the sensing zone; and sensing a concentration of the at least one analyte in a sensing fluid within the sensing zone using a sensor located at least partially in the sensing zone, wherein the sensing fluid formulation comprises a chelating agent and or biochemical inhibitors adapted to keep the micropores, created by the tissue piercing elements, open for extended period to maintain an un-interrupted analyte flux through the fluid paths and to mitigate a decrease over time of the analyte flux through the fluid paths. - View Dependent Claims (3, 5, 6, 7, 8, 9, 18, 19, 20, 21, 22, 23)
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2. A method of in vivo monitoring of an individual'"'"'s interstitial fluid analyte concentration comprising:
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creating a plurality of micropores through a stratum corneum layer of an area of the individual'"'"'s skin, where the plurality of micropores define a plurality of fluid paths in communication with an interstitial fluid of the individual, a proximal end of the fluid paths being in fluid communication with a sensing zone located outside of the patient'"'"'s body; and where the sensing zone comprises a flexible sensor laminated to a buffered gel allowing at least one analyte to passively diffuse from the patient'"'"'s interstitial fluid through the fluid paths and into the sensing zone wherein the sensing gel formulation comprises a chelating agent and or biochemical inhibitors adapted to keep the micropores, created by the tissue piercing elements, open for extended period to maintain an uninterrupted analyte flux through the fluid paths and to mitigate a decrease over time of the analyte flux through the fluid paths. - View Dependent Claims (4)
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10. An analyte monitor comprising:
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a plurality of fluid paths, each fluid path comprising a distal opening adapted to be disposed on one side of a stratum corneum layer of a user'"'"'s skin, a proximal opening adapted to be disposed on another side of the stratum corneum layer and an interior space extending between the distal and proximal openings; a sensing zone in fluid communication with the proximal openings of the fluid paths; and sensing fluid extending from the sensing zone into substantially the entire interior space of the fluid paths, wherein the sensing fluid comprises one or more chelating agent adapted to keep the micropores or microchannels open to maintain a constant analyte flux through the fluid paths and an analyte sensor adapted to detect a concentration of analyte in the sensing fluid within the sensing zone. - View Dependent Claims (12, 13, 14, 15, 16, 17)
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11. An analyte monitor comprising:
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a plurality of fluid paths via micropores through a stratum corneum layer of an area of the individual'"'"'s skin, said fluid paths are in communication with interstitial fluid of the individual, a proximal end in fluid communication with a sensing zone located outside of the patient'"'"'s body; and where the sensing zone comprises a flexible sensor laminated to a buffered gel allowing at least one analyte to passively diffuse from the patient'"'"'s interstitial fluid through the fluid paths and into the sensing zone wherein the sensing gel formulation comprises a chelating agent adapted to keep the micropores, created by the tissue piercing elements, open for extended period to maintain a constant analyte flux through the fluid paths and to mitigate a decrease over time of the analyte flux through the fluid paths and an analyte sensor adapted to detect a concentration of analyte in the sensing fluid within the sensing zone.
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Specification