Access disconnect detection using glucose

• US 8,083,677 B2
• Filed: 09/24/2007
• Issued: 12/27/2011
• Est. Priority Date: 09/24/2007
• Status: Expired due to Fees

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Rohde, Justin B.
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US11/860,071
• Publication Number:
  US 20090082653A1
• Time in Patent Office: 1,555 Days
• Field of Search: 600/345, 600/347, 600/365, 600/371, 604/4.01
• US Class Current: 600/371
• CPC Class Codes: A61B 5/02042 Determining blood loss or bleeding, e.g. during a surgical procedure
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/16836 by sensing tissue properties at the infusion site, e.g. for detecting infiltration detecting tissue temperature for diagnostic purposes A61M39/0247

Abstract

An access disconnect sensor for a patient undergoing extracorporeal blood processing includes an electrochemical fuel cell or sensor to detect blood leakage. The fuel cell includes circuitry for oxidizing glucose in the blood. The sensor also includes a transmitter to send a signal to a remote receiver that the sensor indicates the presence of blood. The circuitry may include a battery or may use electricity generated by the sensor to send a signal indicating a leak of blood or disconnection of the access needle.

Claims

1. An access disconnect detector, comprising:

a fuel cell having an anode and a cathode, the fuel cell configured to generate electrical signals and receive only blood for power;

a control circuit connected to the fuel cell, the control circuit configured to receive the electrical signals generated by the fuel cell and compare the electrical signals to predetermined values, wherein the control circuit includes a memory storing the predetermined values;

a communications circuit connected to the fuel cell; and

a mount suitable for mounting the fuel cell and the communications circuit near an access site of a patient, wherein the fuel cell is configured for receiving blood leaking from the access site and producing electrical power upon receiving the leaking blood, thus causing the communications circuit to send a signal, indicating an access disconnection.

2. The access disconnect detector of claim 1, wherein the anode is configured for oxidizing at least one of glucose and glucose oxidase.

3. The access disconnect detector of claim 1, wherein the cathode is configured for reducing potassium hexacyanoferrate.

4. The access disconnect detector of claim 1, wherein the communications circuit is in operable communication with a hemodialysis machine, and further comprising the hemodialysis machine.

5. The access disconnect detector of claim 1, further comprising a local output device to alert a person or to sound an alarm.

6. The access disconnect detector of claim 1, wherein the cathode is permeable and is configured to wick blood into an inside of the fuel cell.

7. The access disconnect detector of claim 1, wherein the fuel cell is a glucose detector.

8. An access disconnect detector, comprising:

a glucose detector having an anode and a cathode, the anode comprising an anode electrolysis layer suitable for oxidation of glucose and the cathode comprising a cathode electrolysis layer, the glucose detector being powered exclusively by blood;

a control circuit connected to the glucose detector, the control circuit configured to receive electrical signals generated by the glucose detector and compare the electrical signals to predetermined values, wherein the control circuit includes a memory for storing the predetermined values;

a communications circuit connected to the glucose detector; and

a mount suitable for mounting the glucose detector and the communications circuit near an access site of a patient, wherein the glucose detector is configured for receiving blood leaking from the access site and generating electrical power upon receiving the leaking blood, the power causing the communications circuit to send a signal upon detecting the leaking blood, indicating an access disconnection.

9. The access disconnect detector of claim 8, wherein the anode electrolysis layer comprises an anode enzyme and an anode redox polymer.

10. The access disconnect detector of claim 9, wherein the anode enzyme is selected from the group consisting of glucose oxidase, pyrroloquinoline quinone glucose dehydrogenase, galactose oxidase, pyrroloquinoline quinone fructose dehydrogenase, quinohemoprotein alcohol dehydrogenase, pyranose oxidase, oligosaccharide dehydrogenase, and lactate oxidase.

11. The access disconnect detector of claim 8, wherein the cathode electrolysis layer comprises a cathode enzyme and a cathode redox polymer.

12. The access disconnect detector of claim 11, wherein the cathode enzyme is selected from the group consisting of a peroxidase, tyrosinase, horseradish peroxidase, soybean peroxidase, a laccase, and cytochrome C peroxidases.

13. The access disconnect detector of claim 8, wherein the mount is a flexible pad, and further comprising an absorbent layer adjacent the glucose detector.

14. The access disconnect detector of claim 8, further comprising a battery connected to the glucose detector and the communications circuit.

15. The access disconnect detector of claim 8, wherein the glucose detector causes oxidation of glucose in the blood detected.