System and method for continuous non-invasive glucose monitoring

• US 7,963,917 B2
• Filed: 12/05/2005
• Issued: 06/21/2011
• Est. Priority Date: 12/05/2005
• Status: Expired due to Fees

• Current Assignee: Echo Therapeutics Incorporated
• Original Assignee: Echo Therapeutics Incorporated
• Inventors: Barman, Shikha, Chuang, Han, Kellogg, Scott, Warner, Nick
• Primary Examiner(s): Marmor, II; Charles A
• Assistant Examiner(s): Natnithithadha; Navin
• Application Number:
  US11/275,038
• Publication Number:
  US 20070129621A1
• Time in Patent Office: 2,024 Days
• Field of Search: 600/300, 600/309, 600345-366
• US Class Current: 600/365
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A system and method for continuous non-invasive glucose monitoring is disclosed. According to one embodiment of the present invention, the method includes the steps of (1) contacting a remote device to an area of biological membrane having a permeability level, the remote device comprising a sensor and a transmitter; (2) extracting the at least one analyte through and out of the area of biological membrane and into the sensor; (3) generating an electrical signal representative of a level of the at least one analyte; (4) transmitting the electrical signal to a base device; (5) processing the electrical signal to determine the level of the at least one analyte; and (6) displaying the level of the at least one analyte in real time. The system includes a remote device that includes a sensor that generates an electrical signal representative of the concentration of the at least one analyte; and a transmitter that transmits the electrical signal. The system further includes a base device that includes a receiver that receives the electrical signal; a processor that processes the electrical signal; and a display that displays the processed signal in real time.

Claims

1. A method for real time remote monitoring and display of a level of at least one analyte in a body fluid of a subject, comprising:

contacting a remote device to an area of biological membrane having a permeability level, the remote device comprising a sensor and a transmitter;

extracting the analyte through and out of the area of biological membrane and into the sensor;

generating an electrical signal representative of a level of the analyte;

transmitting the electrical signal to a base device;

processing the electrical signal to determine the level of the analyte and the rate of change of the level of analyte, wherein the one or more future analyte level(s) are calculated based on the determined level of analyte and an average of the determined rate of change of the level of analyte;

displaying the level of the at least one analyte in real time; and

triggering an alarm if (1) one or more determinations of the level of analyte is/are below a hypoglycemic preset limit or above a hyperglycemic preset limit and (2) the determined rate of change of the level of analyte predicts that one or more future analyte level(s) will be below the hypoglycemic preset limit or above the hyperglycemic preset limit within a period of time.

2. The method of claim 1, wherein the at least one analyte is glucose.

3. The method of claim 1, further comprising the step of:

increasing the permeability level of the area of biological membrane.

4. The method of claim 1, wherein the step of contacting a remote device to an area of biological membrane having a permeability level comprises:

affixing the remote device to the area of biological membrane with an adhesive.

5. The method of claim 1, wherein the step of transmitting the signal to a base device comprises:

converting the electrical signal representative of the level of the at least one analyte to a digital signal; and

transmitting the digitized signal, an identification number of the remote device, and a time stamp to the base device.

6. The method of claim 1, wherein the step of transmitting the signal to a monitoring device is performed periodically.

7. The method of claim 1, wherein step of the transmitting the electrical signal to a base device comprises:

transmitting the signal to the base device by at least one of a wireless application protocol link, a general packet radio service link, a Bluetooth radio link, an IEEE 802.11-based radio frequency link, a RS-232 serial connection, an IEEE-1394 (Firewire) connection, a fibre channel connection, an infrared (IrDA) port, a small Computer Systems Interface (SCSI) connection, and a Universal Serial Bus (USB) connection.

8. The method of claim 1, further comprising the step of:

periodically determining an amount of a drug to be injected in response to the analyte level; and

automatically providing the determined amount of the drug to the subject.

9. The method of claim 8, wherein the drug is insulin.

10. The method of claim 1, wherein the analyte level is displayed graphically.

11. The method of claim 10, wherein the analyte level is displayed in relative to time.

12. The method of claim 1, wherein the alarm is triggered if (1) two consecutive determinations of the level of analyte are below the hypoglycemic preset limit or above the hyperglycemic preset limit and (2) the determined rate of change of the level of analyte predicts that two consecutive future analyte levels will be below the hypoglycemic preset limit or above the hyperglycemic preset limit within a period of time.

13. The method of claim 12, wherein the average is a five-minute average and the period of time is ten minutes.