Needle dislodgement detection

• US 7,147,615 B2
• Filed: 06/22/2001
• Issued: 12/12/2006
• Est. Priority Date: 06/22/2001
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Caro, Hector, Cameron, Norm, Wariar, Ramesh, Hartranft, Thomas P., Lasso, Angel
• Primary Examiner(s): Bianco, Patricia
• Application Number:
  US09/888,154
• Publication Number:
  US 20020198483A1
• Time in Patent Office: 1,999 Days
• Field of Search: 128/886, 128/DIG.26, 604 401- 606, 604 65- 67, 604174-180, 604/168.01, 604/900, 604/19, 604 27- 29, 604/31, 600/390, 600391-395, 600/371, 600/547, 600/437, 600/459, 600/462, 600/464, 600/309, 600/362, 600/363, 600/365, 600368- 71, 600/382, 600/384, 600/386, 340/573.5, 340/605, 422/44, 422/68.1, 422/82.01, 422/82.02, 422/105, 422/108, 422/110, 422/111, 494/1, 494/10, 494/36, 494/37
• US Class Current: 604/6.16
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• 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 5/15087 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 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 2005/1588 having means for monitoring, controlling or visual inspection, e.g. for patency check, avoiding extravasation
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• 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: G01N 27/121 for determining moisture content, e.g. humidity, of the fluid moisture content of the tested material G01N27/048
• CPC Class Codes: G01N 27/223 for determining moisture content, e.g. humidity rain detectors on vehicle windows B60S1/0825

Abstract

An apparatus for detecting dislodgement of a needle inserted into a patient includes a sensor for detecting wetness due to blood and a sensor holder to secure the sensor to the patient such that the sensor detects wetness due to blood loss from the patient upon dislodgement of the needle. Methods and apparatuses for detecting, monitoring and/or controlling blood loss from a patient due to needle dislodgement are also provided.

Claims

1. An apparatus for detecting dislodgement of a needle inserted into a patient comprising:

a sensor having a capacitive sensor, the capacitive sensor configured to detect wetness due to blood; and

a barrier pad capable of absorbing blood lost from the patient due to the dislodgment of the needle; and

a sensor holder configured to secure the sensor and the barrier pad adjacent to the needle, wherein the sensor holder secures the barrier pad between the sensor and the needle such that the sensor detects blood absorbed within the barrier pad.

2. The apparatus of claim 1 wherein the capacitive sensor includes one or more electrodes.

3. The apparatus of claim 1 wherein the capacitive sensor is located within the sensor holder such that the sensor detects wetness due to blood loss in the barrier pad.

4. The apparatus of claim 1 wherein the sensor produces a signal upon detection of blood loss.

5. The apparatus of claim 4 further comprising a control device adapted to receive the signal for monitoring and controlling blood loss due to the dislodgement of the needle during hemodialysis.

6. The apparatus of claim 5 wherein the control device is attached to the patient.

7. The apparatus of claim 1 wherein the needle comprises a venous needle.

8. An apparatus for detecting needle dislodgement during hemodialysis comprising:

a sensor holder having a cavity;

a barrier pad configured to absorb blood lost from the patient due to the dislodgment of the needle; and

a capacitive sensor comprising an electrode enclosed within the cavity of the sensor holder such that the capacitive sensor is positioned to detect wetness absorbed within the barrier pad from blood due to needle dislodgement during hemodialysis such that the capacitive sensor detects blood absorbed within the barrier pad.

9. The apparatus of claim 8 wherein the electrode comprises a single plate electrode.

10. The apparatus of claim 8 wherein the barrier pad overlies a vascular access region of a venous needle.

11. The apparatus of claim 10 wherein the sensor holder comprises a flexible material that adaptably conforms to the vascular access region such that the capacitive sensor is capable of detecting blood loss due to needle dislodgement.

12. An apparatus for controlling blood loss from a patient during hemodialysis comprising:

a barrier pad configured to absorb blood lost from the patient due to the dislodgment of the needle;

a capacitive sensor configured to detect wetness due to blood;

a sensor holder configured to secure the sensor and the barrier pad adjacent to the patient such that the sensor produces a signal indicative of wetness detected within the barrier due to blood loss from the patient upon dislodgement of a venous needle inserted into the patient wherein the capacitive sensor detects blood absorbed within the barrier pad; and

a controller capable of processing the signal to prevent blood flow through the venous needle such that blood loss from the patient due to dislodgement of the venous needle is minimized.

13. The apparatus of claim 12 wherein the sensor holder comprises a pad configuration overlying an access region of the venous needle.

14. The apparatus of claim 12 wherein the barrier pad overlies an access region of the venous needle.

15. The apparatus of claim 14 wherein the sensor detects a change in a dielectric constant of the barrier pad.

16. The apparatus of claim 14 wherein the sensor is located inside of the sensor holder such that the sensor does not contact the sterile pad upon detecting wetness therein.

17. The apparatus of claim 12 wherein the controller is in communication with a hemodialysis machine via an electrical communication cable or a cordless interface to minimize blood loss due to venous needle dislodgement.

18. The apparatus of claim 17 wherein the controller is adapted to monitor one or more hemodialysis treatment parameters including wetness due to blood loss, change in blood flow and detection of arterial air bubbles during hemodialysis.

19. The apparatus of claim 18 wherein the controller is attached to the patient for electrical connection to the sensor.

20. The apparatus of claim 18 wherein the controller comprises a display for monitoring each of the parameters.

21. A method of detecting needle dislodgement comprising the steps of:

providing a barrier pad to absorb blood lost from the patient due to the dislodgment of the needle; and

providing a capacitive sensor configured to detect wetness due to blood wherein the sensor detects blood absorbed within the barrier pad;

inserting a needle into a patient; and

securing the sensor and the barrier pad to the patient such that the sensor detects blood absorbed within the barrier pad on the patient upon dislodgement of the needle.

22. The method of claim 21 wherein the needle comprises a venous needle inserted into the patient for hemodialysis.

23. A method of controlling blood loss from a patient due to needle dislodgement comprising the steps of:

providing a capacitive sensor configured to detect wetness due to blood;

providing a barrier pad to absorb blood lost from the patient due to the dislodgment of the needle; and

inserting a needle into the patient;

securing the sensor and the barrier pad adjacent to the patient such that the sensor produces a signal indicative of wetness within the barrier pad due to blood loss from the patient upon dislodgement of the needle and detects blood absorbed within the barrier pad; and

processing the signal to prevent blood flow through the venous needle such that blood loss from the patient due to needle dislodgement is minimized.

24. The method of claim 23 wherein the needle comprises a venous needle inserted into the patient for hemodialysis.

25. The method of claim 24 wherein the signal is processed for communicating with a hemodialysis machine to minimize blood loss to the patient due to needle dislodgement.

26. The method of claim 25 wherein the signal is processed to shut-off a blood pump of the hemodialysis machine.

27. The method of claim 25 wherein the signal is processed to activate a venous line clamp for preventing blood flow via the venous needle.

28. A method of providing dialysis to a patient comprising the steps of:

providing a barrier pad;

providing a capacitive sensor to detect wetness due to blood wherein the sensor does not contact blood upon detection thereof;

inserting a venous needle into the patient;

securing the sensor and the barrier pad in juxtaposition to the venous needle;

passing blood through the venous needle via a hemodialysis machine; and

detecting wetness within the barrier pad indicative of blood loss from the patient upon dislodgement of the venous needle such that the sensor detects blood absorbed within the barrier pad.

29. The method of claim 28 wherein blood flow through the venous needle is stopped upon detecting dislodgement of the venous needle such that blood loss from the patient is minimized.