DETECTING ACCESS DISCONNECT USING NEEDLE SLEEVE

• US 20090082647A1
• Filed: 09/24/2007
• Published: 03/26/2009
• Est. Priority Date: 09/24/2007
• 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: Busby, Donald
• Granted Patent: US 7,874,999 B2
• Time in Patent Office: Days
• US Class Current: 600/309
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150396 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150633 Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
• CPC Class Codes: A61B 5/15074 Needle sets comprising wings, e.g. butterfly type, for ease of handling
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150961 Means for the detection of the presence or absence of a module, a component or an abnormal condition; detection of leaks
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• 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

Abstract

An access needle for extracorporeal therapy is equipped with a mount and a sleeve having a metal or magnetic component at its distal end. The mount includes a sensor for detecting when the distal end is pressed against the mount. The sensor is a hall-effect sensor or a proximity sensor. When therapy is begun, the sleeve is rolled up and urged against the mount, exposing the needle for use with the patient. While the sleeve, and the piece of metal or magnet, remains in contact with the sensor, the needle has not been dislodged and therapy may continue. If the needle is dislodged, the sleeve pushes away from mount, moving the metal or magnet away from the sensor. The sensor notes the dislodgement and sends a signal to alert the patient or a caregiver.

Claims

1. A method of detecting a needle disconnection, the method comprising:

providing a needle having a mount with a sensor and a sleeve with a metallic target, the sensor configured for detecting the metallic target;

placing the needle into an extracorporeal blood processing access site;

urging the sleeve against the mount, thereby placing at least a portion of the metallic target near the sensor;

taking a reading of the sensor after the metallic target is urged against the mount;

monitoring the access site by taking additional readings of the sensor during an extracorporeal blood processing therapy; and

sending a signal if a reading consistent with absence of the target from the sensor is detected, thereby indicating dislodgement of the needle.

2. The method of claim 1, further comprising taking a baseline reading of the sensor before the step of urging the sleeve against the mount.

3. The method of claim 1, wherein the signal is sent to a local output device to alert a person or to sound an alarm.

4. The method of claim 1, wherein the sensor is a hall-effect sensor or a proximity sensor.

5. A method for detecting needle disconnection at an access site, the method comprising:

providing an access needle with an electroactive sleeve and a sensor on a mount of the access needle, wherein the sensor is configured to detect metal or a magnet on the sleeve;

mounting the access needle on the access site of a patient and pressing the sleeve toward the mount;

taking a reading of the sensor with the pressed sleeve;

monitoring the access site during a therapy procedure by taking additional readings with the sensor; and

sending a signal if a reading indicative of needle dislodgement is taken.

6. The method of claim 5, further comprising taking a first baseline reading of the sensor and the sleeve while the sleeve covers the needle, and saving data of the first baseline reading for comparison with the baseline reading.

7. The method of claim 5, further comprising sending a local alert as a result of sending the signal.

8. The method of claim 5, further comprising saving data of the reading.

9. A system for detecting needle dislodgement, the system comprising:

an access needle suitable for mounting near an access site for extracorporeal therapeutic blood processing, the access needle including a mount;

a sleeve having an electromagnetic target, the sleeve positioned over the needle and adjacent the mount;

a sensor on the mount for detecting the electromagnetic element; and

a communications circuit in communication with the sensor, wherein the needle is configured for placing into the access site, the sleeve is configured for pressing against the mount, the sensor is configured for detecting the electromagnetic element, and the communications circuit is configured for sending data indicative of a position of the electromagnetic element with respect to the sensor.

10. The system according to claim 9, wherein the electromagnetic target is selected from the group consisting of magnet or a piece of metal placed on a distal end of the sleeve, and metallic or magnet wire embedded within the sleeve.

11. The system according to claim 9, wherein the sensor is selected from the group consisting of a hall-effect sensor, a proximity sensor, and a magnetic sensor.

12. The system according to claim 9, wherein the sleeve has a shape of a thin tube or bellows.

13. A system for detecting needle dislodgement, the system comprising:

a needle with a mount suitable for mounting near an access site for an extracorporeal blood therapy;

a sleeve having a metallic or magnetic target, the sleeve positioned over the needle and adjacent the mount;

a sensor on the mount for detecting the metallic or magnetic target; and

a control circuit connected to the sensor, wherein the needle is configured for placing into the access site, the sleeve is configured for pressing against the mount, and the control circuit is configured for taking readings of the sensor indicative of a position of the metallic or magnetic target with respect to the sensor.

14. The system according to claim 13, further comprising a local output device selected from the group consisting of a video screen and a speaker.

15. The system according to claim 13, further comprising a hemodialysis machine for providing the extracorporeal therapy.

16. The system according to claim 13, wherein the sleeve comprises a bellows made from a thin plastic or elastomeric material.

17. The system according to claim 13, wherein the metallic or magnetic target is positioned near a distal end of the sleeve.

18. The system according to claim 13, wherein a shape of the metallic or magnetic target is selected from the group consisting of a thin cylinder or an arc.

19. The system according to claim 13, wherein the sensor is a hall-effect sensor, a capacitance sensor, an inductance sensor, or a magnet sensor.