ACCESS DISCONNECT SYSTEM WITH OPTICAL AND OTHER SENSORS

• US 20090082649A1
• Filed: 09/21/2007
• Published: 03/26/2009
• Est. Priority Date: 09/21/2007
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Chan, William W., Beehner, Luke, Yardimci, Atif, Slepicka, James S., Muller, Matthew R.
• Granted Patent: US 8,187,184 B2
• Time in Patent Office: Days
• US Class Current: 600/310
• 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 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• 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 optical access disconnect system is useful for detecting the presence of blood. The optical access disconnect system includes one or more optical sensors placed near an access site of a patient, the optical sensors suitable for detecting the presence of blood, especially by detecting a difference in light reflected or absorbed by blood. The optical access disconnect system may also be used as an interlock to assure compliance. A detector may be placed adjacent the access site to detect the access needle, or an object or mark on the access needle or fluid line. A therapy machine, such as a dialysis machine, may be programmed not to start or continue operation unless the needle or fluid line is detected. The detector may be one of the optical sensors, calibrated or adjusted to detect a mark on the needle or access line, or may be another type of detector.

Claims

1. An optical access disconnect system, comprising:

at least one first optical detector;

a mount suitable for mounting the at least one first optical detector;

signal processing circuitry, the circuitry operably connected to the at least one first optical detector; and

a communications circuit connected to the signal processing circuitry,

wherein the mount and the at least one first optical detector are configured for positioning adjacent a dialysis access site for detecting a presence of blood of a patient.

2. The system of claim 1, wherein the communications circuit comprises a wired or wireless connection to a controller.

3. The system of claim 1, further comprising at least one light source connected to the signal processing circuitry and configured to emit light for detection by the at least one first optical detector.

4. The system of claim 1, wherein the at least one first optical detector comprises at least two optical detectors, and further comprising at least one light source configured to emit light for detection by the at least two optical detectors.

5. The system of claim 1, wherein the at least one first optical detector comprises at least two optical detectors, and further comprising at least two light sources of different wavelengths connected to the signal processing circuitry and configured to emit light for detection by the at least two optical detectors, wherein one of the light sources optionally emits light with a wavelength of about 425 nm.

6. The system of claim 1, wherein the signal processing circuitry further comprises an analog-to-digital converter for converting analog signals from the at least first optical detector into digital signals for further data processing by a local or remote controller.

7. The system of claim 1, further comprising an output device operably connected to the signal processing circuitry or a controller for the signal module for sending a signal if the optical detector detects blood leakage.

8. The system of claim 1, wherein the signal processing circuitry comprises at least one of signal ADC processing, signal data conversion, and additional data processing.

9. The system of claim 1, further comprising a detector for detecting a mark or an object on a venous needle adjacent the detector, or on tubing connected to the needle, the detector operably connected to the signal processing circuitry.

10. The system of claim 9, wherein the detector is selected from the group consisting of a second optical detector, a hall-effect sensor, a magnetic detector, and a electrical detector.

11. An optical access disconnect system, comprising:

at least one optical sensor;

a mount suitable for mounting the at least one optical sensor on a patient, wherein the mount and the at least one optical sensor are configured for positioning adjacent an access site for detecting a presence of blood;

signal processing circuitry operably connected to the at least one optical sensor;

a communications circuit connected to the signal processing circuitry; and

an output device connected to the communications circuit or to the signal processing circuitry, the output device configured for sending a signal if blood is detected.

12. The optical access disconnect system of claim 11, wherein the access site is a dialysis access site.

13. The optical access disconnect system of claim 11, wherein the mount comprises a flexible pad.

15. The optical access disconnect system of claim 11, wherein the pad further comprises an absorbent material adjacent the plurality of optical sensors.

16. The optical access disconnect system of claim 11, further comprising:

a detector for detecting an access needle or tubing connected to the access needle, the detector configured for mounting on the access site, wherein the detector is selected from the group consisting of an optical sensor, a proximity detector and a hall-effect sensor, wherein the access needle or the tubing comprises a detectable feature, the feature selected from the group consisting of a mark, a metal piece, and a magnet.

14. The access disconnect system of claim 14, wherein the signal processing circuitry is mounted in a housing separate from the at least one optical sensor.

17. An optical access disconnect system, comprising:

at least one optical sensor;

a mount suitable for mounting the at least one optical sensor, wherein the mount and the at least one optical sensor are configured for positioning adjacent a dialysis access site on a patient for detecting a presence of blood;

signal processing circuitry operably connected to the at least one optical sensor;

a detector for detecting a presence of a needle adjacent the access site, the detector operably connected to the signal processing circuitry or a control circuit in communication with the signal processing circuitry; and

a communications circuit connected to the signal processing circuitry.

18. The optical access disconnect system according to claim 17, further comprising an output device for raising an alarm or ceasing dialysis if blood is detected or if the needle is dislodged.

19. The optical access disconnect system according to claim 17, wherein the detector is an optical detector, a hall-effect sensor, or a proximity sensor.

20. The optical access disconnect system according to claim 17, further comprising an optical filter.

21. A method for detecting a presence of blood, the method comprising:

furnishing an optical access disconnect detecting system, the system comprising one or more optical sensors;

mounting one or more optical sensors near an access site of a patient;

initiating a medical therapeutic procedure at the access site;

operating the one or more optical sensors to detect a presence of blood; and

sending a signal if the presence of blood is detected.

22. The method of claim 21, further comprising furnishing a detector for detecting a presence of a needle adjacent the access site and connecting the detector to the optical access disconnect detecting system.

23. The method of claim 21, further comprising furnishing a detector for detecting a presence of a needle adjacent the access site, and wherein the procedure cannot be initiated until the detector has located the needle and satisfied an interlock.

24. A method for detecting an access needle, the method comprising:

furnishing a detector mounted on a patient near an access site, the detector suitable for detecting a feature on an access needle or on tubing for the access needle, the feature selected from the group consisting of a mark, a metal object, and a magnet;

attaching the access needle and the tubing to the access site;

detecting the feature with the detector;

initiating a therapeutic procedure at the access site;

monitoring a presence of the feature with the detector; and

sending a signal if the feature ceases to be detected.

25. The method of claim 24, wherein sending the signal causes an alarm to be sent or causes therapy to be ceased.