Autonomous, ambulatory analyte monitor or drug delivery device
First Claim
1. An analyte monitoring device operable to draw a fluid sample from a subject, the device comprising:
- a first plurality of microneedles, a plurality of monitoring microchannels, wherein each of the first plurality of microneedles is at least intermittently in fluid communication with a corresponding monitoring microchannel, and wherein each monitoring microchannel is associated with a reagent, at least one actuator operable to extend each microneedle to draw the fluid sample from the subject, and a controller operable to initiate analyte testing of the fluid sample.
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Accused Products
Abstract
The invention relates to analyte monitoring/drug (pharmaceutical agent) delivery device. The invention is suited for monitoring various blood constituents such as glucose. The device has a housing that at least partially encloses a plurality of microneedles disposed on a carrier and an electronics portion. Each microneedle is in fluid communication with a corresponding microchannel. Each microneedle is individually addressable. That is, each microneedle can be extended and retracted individually via an actuator. The electronics portion includes a processor and associated circuitry (e.g., memory, supporting electronics and the like), a motor or the like, a sensor, a power supply (e.g., battery) and optionally an interface. In general, the processor controls the operation of the device and is data communication with the actuator, motor, sensor and interface. The invention provides for autonomous operation, that is, without intervention of the user. The invention can optionally provide for calibration without intervention of the user. The invention can also provide for semi-continuous monitoring for day and night time. The invention can provide for up to four, or more, weeks of operation. The invention can provide for a device that is relative small in size, and therefore unobtrusive. The invention can also provide for device with remote control and interactive electronics. The invention may be also used for the delivery of various pharmaceutical agents including high potency drugs to minimize patient intervention and minimize discomfort.
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Citations
59 Claims
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1. An analyte monitoring device operable to draw a fluid sample from a subject, the device comprising:
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a first plurality of microneedles, a plurality of monitoring microchannels, wherein each of the first plurality of microneedles is at least intermittently in fluid communication with a corresponding monitoring microchannel, and wherein each monitoring microchannel is associated with a reagent, at least one actuator operable to extend each microneedle to draw the fluid sample from the subject, and a controller operable to initiate analyte testing of the fluid sample. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
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31. A pharmaceutical agent delivery device operable to deliver a pharmaceutical agent to a subject, the device comprising:
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a first plurality of microneedles, a plurality of pharmaceutical agent delivery microchannels, wherein each of the first plurality of microneedles is at least intermittently in fluid communication with a corresponding pharmaceutical agent delivery microchannel, and wherein each pharmaceutical agent delivery microchannel is at least partially filled with a pharmaceutical agent, at least one actuator operable to extend each microneedle to deliver the pharmaceutical agent to the subject, and a controller operable to initiate delivery of the pharmaceutical agent. - View Dependent Claims (32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55)
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56. In combination a device having an analyte monitor portion operable to draw a fluid sample from a subject and a pharmaceutical agent delivery portion operable to deliver a pharmaceutical agent to the subject, the device comprising:
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a first plurality of microneedles, a plurality of monitoring microchannels, wherein each of the first plurality of microneedles is at least intermittently in fluid communication with a corresponding monitoring microchannel, and wherein each monitoring microchannel is associated with a reagent, a second plurality of microneedles, a plurality of pharmaceutical agent delivery microchannels, wherein each of the second plurality of microneedles is at least intermittently in fluid communication with a corresponding pharmaceutical agent delivery microchannel, and wherein each pharmaceutical agent delivery microchannel is at least partially filled with a pharmaceutical agent, at least one actuator operable to extend each microneedle and one of draw the fluid sample from the subject and deliver the pharmaceutical agent to the subject, and a controller operable to initiate analyte testing of the fluid sample and delivery of the pharmaceutical agent. - View Dependent Claims (57)
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58. A method for automated analyte monitoring comprising:
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a) providing a first plurality of microneedles, b) providing a plurality of monitoring microchannels, wherein each of the first plurality of microneedles is at least intermittently in fluid communication with a monitoring microchannel, and wherein each monitoring microchannel is associated with a reagent, c) sequentially extending a microneedle thereby obtaining a fluid sample from a subject, d) initiating analyte testing of the fluid sample, and e) providing a controller operable to automatically repeat steps c and d.
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59. A method for automated pharmaceutical agent delivery comprising:
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a) providing a first plurality of microneedles, b) providing a plurality of pharmaceutical agent delivery microchannels, wherein each of the first plurality of microneedles is at least intermittently in fluid communication with a corresponding pharmaceutical agent delivery microchannel, and wherein each pharmaceutical agent delivery microchannel is at least partially filled with a pharmaceutical agent, c) sequentially extending a microneedle thereby delivering the pharmaceutical agent to a subject, d) providing a controller operable to automatically repeat step c.
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Specification