Analyte-controlled liquid delivery device and analyte monitor

• US 5,820,622 A
• Filed: 12/18/1996
• Issued: 10/13/1998
• Est. Priority Date: 11/04/1994
• Status: Expired due to Fees

• Current Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Original Assignee: Elan Medical Technologies (Ireland) Ltd. (Perrigo Company PLC)
• Inventors: Gross, Joseph, Kelly, John Gerard
• Primary Examiner(s): McDermott, Corrine M.
• Assistant Examiner(s): NGUYEN, ANH TUAN TUONG
• Application Number:
  US08/769,212
• Time in Patent Office: 664 Days
• Field of Search: 422/63, 422/68.1, 422/82.1, 422/82.2, 422/82.3, 204/280, 204/292, 435/4, 435/14, 435/287.1, 435/287.9, 600/308, 600/345, 600/347, 600/368, 600/372, 600/373, 600/382, 600/386, 600/395, 600/316, 600/322, 600/377, 604/890.1, 604/892.1
• US Class Current: 604/890.1
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61K 9/7023 Transdermal patches and similar drug-containing composite devices, e.g. cataplasms galenical aspects of iontophoretic devices A61K9/0009; microneedle arrays A61K9/0021; buccal patches A61K9/006
• CPC Class Codes: A61M 2005/14204 with gas-producing electrochemical cell
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: C07C 253/34 Separation; Purification
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

A liquid delivery device comprising a housing having a lower surface for application to the skin of a subject and having a reservoir and a gas generation chamber therein separated by a displaceable membrane. Gas generated by an electrolytic cell under the control of a microprocessor causes the gas generation chamber to expand and the reservoir to contract, thereby discharging a liquid drug, such as insulin, from the reservoir via a hollow delivery needle extending from the lower surface. The delivery needle and a sensor needle both extend from the lower surface a sufficient distance so as to penetrate through the epidermis and into the dermis when the housing is pressed against the skin. The sensor needle has an enzymatic coating for the detection of an analyte, such as glucose in the subject'"'"'s plasma. The delivery needle is made of platinum-iridium, and a current passes between the needles and a potentiostat circuit according to the amount of glucose detected. A reference electrode (silver/silver chloride) which rests against the subject'"'"'s skin increases the accuracy of the glucose measurement. The current through the potentiostat circuit is measured by a voltmeter and a signal from the voltmeter is amplified and communicated to the microprocessor which determines the correct rate of delivery of the drug on the basis of the level of analyte detected in the subject'"'"'s plasma.

Claims

1. A method of measuring concentration of an analyte comprising the steps of:

a) penetrating epidermis with an enzymatic sensor which forms part of an electrical circuit, wherein current through the circuit is dependent on the presence of a species produced by the enzymatic reaction with the analyte;

b) supplying a periodic potential to the enzymatic sensor such that current only flows through the electric circuit intermittently; and

c) measuring the current shortly after it begins to flow.

2. A method according to claim 1, wherein the potential is supplied intermittently as a periodic stepped potential, providing a disconnect period and a connect period, thereby giving rise to a peak current at the beginning of the connect period, falling away towards a steady state current level.

3. A method according to claim 2, wherein the disconnect period is at least one second long and the connect period is at least 20 microseconds long.

4. A method according to claim 2, wherein the connect period is in the range 20-400 microseconds.

5. A method according to claim 2, wherein the disconnect period is in the range 1-15 seconds.

6. A method according to claim 2, wherein the current is measured in the first 15 microseconds of the connect period.

7. A method according to claim 6, wherein the current is measured between 0.5 and 10 microseconds after the beginning of the connect period.

8. A method according to claim 8, further comprising the steps of measuring the current a second time during the connect period, calculating a ratio between the two measured values, and comparing this ratio to a memorised value or range of values to determine whether the sensor is performing normally.

9. A method according to claim 8, further comprising the step of providing an indication that the sensor is defective if the calculated ratio is different to the memorised value or range of values.