Analyte-controlled liquid delivery device and analyte monitor

• US 5,807,375 A
• Filed: 11/02/1995
• Issued: 09/15/1998
• Est. Priority Date: 11/04/1994
• Status: Expired due to Fees

• Current Assignee: Elan Corporation PLC (Perrigo Company PLC)
• Original Assignee: Elan Medical Technologies (Ireland) Ltd. (Perrigo Company PLC)
• Inventors: Gross, Joseph, Kelly, John Gerard
• Primary Examiner(s): Bockelman, Mark
• Assistant Examiner(s): NGUYEN, ANH TUAN TUONG
• Application Number:
  US08/556,744
• Time in Patent Office: 1,048 Days
• Field of Search: 604/65, 604/66, 604/67, 604/131, 604/132, 604/133, 604/890.1, 604/892.1, 128/632, 128/635, 128/642, 128/DIG. 12, 128/DIG. 13
• 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 device for monitoring the concentration of an analyte in a subject, comprising:

a housing having a lower surface for application to the skin of the subject;

means for holding the housing in position with the lower surface against the subject'"'"'s skin;

an electrical detection circuit comprising a power source connected across two electrodes mounted on said lower surface and switching means, the circuit being completed upon application of the lower surface to the skin of the subject, one of said electrodes being a sensor needle for penetrating through the epidermis and into the dermis when the lower surface is applied to the skin and having an enzyme associated therewith, said enzyme being specific to the analyte to be detected, and the switching means allowing the current through the circuit to flow intermittently to the sensor needle; and

a communication circuit comprising means for measuring the current through said electrical detection circuit, means for calculating the concentration of the analyte from the measured current and communicating means for communicating the calculated concentration to the subject.

2. A device according to claim 1, wherein the enzyme is glucose oxidase and the analyte to be measured is glucose.

3. A device according to claim 1, wherein the sensor needle is a working electrode and the other of said two electrodes is a counter electrode in the form of a platinum surface for contact with the subject'"'"'s skin.

4. A device according to claim 1, wherein the electrical detection circuit also comprises a reference electrode on the lower surface of the housing, in the form of a silver/silver chloride surface for contact with the subject'"'"'s skin, and a potentiostat having an operational amplifier which drives a current between the working electrode and the counter electrode.

5. A device according to claim 4, wherein the power source and the sensor needle are connected in series with the positive input of the amplifier and wherein a resistor and the delivery needle are connected in series with the amplifier output, the reference electrode being connected to the negative input of the amplifier.

6. A device according to claim 5, wherein the current through the circuit is determined by measuring the voltage drop across said resistor.

7. A device according to claim 6, wherein a voltmeter connected across said resistor provides a signal determined by the magnitude of the voltage drop and the signal is amplified and supplied to the communicating means.

8. A device according to claim 1, wherein the switching means comprises means for intermittently applying a voltage to the sensor needle.

9. A device according to claim 8, further comprising means for comparing the current at different times.

10. A device according to claim 9, wherein the means for comparing the current at different times is integral with the means for controlling the rate of active discharge.

11. A device according to claim 1, wherein the sensor needle is provided with a conduit permitting communication between the inner skin-contacting end and a source of oxygen.

12. A device according to claim 11, wherein the source of oxygen is the atmosphere.

13. A device according to claim 1, wherein the housing comprises a first part and a second part, the first part comprising the lower surface and the electrodes and the second part comprising the power source and the communication circuit.

14. A device according to claim 13, wherein the first part is detachably mounted on the second part, such that the first part can be disposed of and replaced and the second part can be reused a number of times.

15. A device according to claim 1, wherein the communicating means is activated when the calculated analyte concentration falls outside a predetermined range.

16. A device according to claim 1, wherein the communicating means comprises an audible alarm.

17. A device according to claim 1, wherein the communicating means operates continuously to provide a constant indication of the subject'"'"'s analyte concentration.

18. A device according to claim 1, wherein the communicating means comprises a visible display of the analyte concentration.

19. A device according to claim 18, wherein the visible display is in the form of a liquid crystal display for indicating the analyte concentration as a numerical value.

20. The device of claim 1 wherein the concentration is communicated to the subject.

21. The device of claim 1 wherein the concentration is communicated to a microprocessor.

22. The device of claim 1 wherein the microprocessor is in communication with a liquid drug delivery device for delivering drug to the subject via the subject'"'"'s skin, the device containing a liquid drug, whereby the microprocessor controls the rate of discharge of drug via the subject'"'"'s skin in response to the communication thereto.