TECHNIQUE FOR REMANUFACTURING A BIS SENSOR

• US 20130079618A1
• Filed: 09/26/2011
• Published: 03/28/2013
• Est. Priority Date: 09/26/2011
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Nellcor Puritan Bennett LLC (Medtronic Plc)
• Inventors: Sandmore, Donald R., Besko, David P.
• Granted Patent: US 9,220,436 B2
• Time in Patent Office: Days
• US Class Current: 600/393
• CPC Class Codes: A61B 2560/0475 Special features of memory means, e.g. removable memory cards
• CPC Class Codes: A61B 2562/0215 Silver or silver chloride containing
• CPC Class Codes: A61B 2562/0217 Electrolyte containing
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: A61B 5/6839 Anchoring means, e.g. barbs
• CPC Class Codes: Y10T 29/4973 Replacing of defective part
• CPC Class Codes: Y10T 29/49732 by attaching repair preform, e.g., remaking, restoring, or patching

Abstract

Remanufactured BIS sensors and methods for remanufacturing used BIS sensors are provided. Such a remanufactured sensor may include certain components from a used medical sensor and certain new components. For example, a remanufactured BIS sensor may include a backing layer and at least first, second, and third electrodes disposed on the backing layer having a conductive ink. The first, second, and third electrodes are adapted to be in electrical contact with a patient to perform BIS measurements. A foam layer may be disposed on at least a portion of the backing layer, and an adhesive may be attached to the foam layer and is configured to secure the remanufactured BIS sensor to the patient. The first electrode, the second electrode, the third electrode, the backing layer, or a combination thereof, may be new and the foam layer, the adhesive, or a combination thereof, may be from a used medical sensor.

Claims

1. A remanufactured bispectral index (BIS) sensor, comprising:

a backing layer;

first, second, and third electrodes disposed on the backing layer and comprising a conductive ink, wherein the first, second, and third electrodes are adapted to be in electrical contact with a patient to perform BIS measurements, and the first, second, and third electrodes are configured to act as a ground electrode, a reference electrode, and a signal electrode, respectively;

a foam layer disposed on at least a portion of the backing layer; and

an adhesive attached to the foam layer and configured to secure the remanufactured BIS sensor to the patient;

wherein at least one of the first, second, and third electrodes, the backing layer, or any combination thereof, are from a used medical sensor, and at least one of the foam layer, the adhesive, or a combination thereof, are new.

2. The remanufactured medical sensor of claim 1, wherein the first, second, and third electrodes comprise a silver/silver chloride ink printed on the backing layer and are positioned between the backing layer and the foam layer.

3. The remanufactured medical sensor of claim 1, comprising a plurality of conductors printed in conductive ink on the backing layer, wherein the conductors connect the first, second, and third electrodes to a tail region of the backing layer, and the tail region is configured to attach to a connector.

4. The remanufactured medical sensor of claim 3, wherein the connector comprises a memory unit.

5. The remanufactured medical sensor of claim 4, wherein the memory unit is from the used medical sensor and has been re-programmed to enable continued operation of the remanufactured BIS sensor.

6. The remanufactured medical sensor of claim 4, wherein the memory unit comprises a replacement memory unit configured to emulate an original memory unit of the used medical sensor.

7. The remanufactured medical sensor of claim 1, wherein the foam layer comprises first, second, and third openings corresponding to the respective positions of the first, second, and third electrodes, and the first, second, and third openings and the backing layer form first, second, and third electrode wells.

8. The remanufactured medical sensor of claim 7, wherein each of the first, second, and third electrodes are coupled to a respective preparation surface configured to prepare the skin of the patient for monitoring.

9. The remanufactured medical sensor of claim 8, wherein each of the preparation surfaces are coupled to a gel support structure configured to hold a conductive gel, the conductive gel is configured to enable electrical contact between the patient and the first, second, and third electrodes, and at least one of the preparation surfaces or the gel support structure is from the used medical sensor, and the conductive gel is new.

10. The remanufactured medical sensor of claim 1, comprising a fourth electrode comprising the conductive ink disposed on the backing layer, wherein the fourth electrode is adapted to enable the remanufactured BIS sensor to monitor motion artifacts resulting from eye movement.

11. A remanufactured bispectral index (BIS) sensor, comprising:

a backing layer;

first, second, and third electrodes disposed on the backing layer and comprising a conductive ink, wherein the first electrode is adapted to be placed in electrical contact with a patient'"'"'s temple and the second and third electrodes are adapted to be placed in electrical contact with the patient'"'"'s forehead to enable the sensor to perform BIS measurements;

a flexible base material surrounding at least a portion of the backing layer; and

an adhesive attached to the base material and configured to secure the remanufactured BIS sensor to the patient;

wherein the first electrode, the second electrode, the third electrode, the backing layer, or any combination thereof, are from a used medical sensor, and the base material, the adhesive, or a combination thereof, are new.

12. The sensor of claim 11, comprising a plurality of conductors printed in conductive ink on the backing layer, wherein the conductors connect the first, second, and third electrodes to a tail region of the backing layer, and the tail region is configured to attach to a connector.

13. The sensor of claim 12, comprising a memory unit disposed on the connector configured to store sensor-related data or patient historical data, or any combination thereof, and the connector, or the memory unit, or both, are from the used medical sensor or another used medical sensor.

14. The sensor of claim 13, wherein the base material comprises a bridge portion disposed at a location on the base material corresponding to a position between the first and second electrodes, and the bridge portion is adapted to enable a distance between the first and second electrodes to change to accommodate a range of patient head sizes.

15. A method of remanufacturing a used BIS sensor, comprising:

obtaining the used BIS sensor, the used BIS sensor comprising;

a backing layer;

first, second, and third electrodes disposed on the backing layer, wherein the first, second, and third electrodes are adapted to be in electrical contact with a patient to perform BIS measurements; and

a foam layer disposed on the backing layer and comprising a used adhesive configured to secure the BIS sensor to the patient;

wherein the foam layer comprises first, second, and third holes corresponding to respective positions of the first, second, and third electrodes, and the first, second, and third holes and the backing layer form first, second, and third electrode wells;

retaining the backing layer, the first, second, and third electrodes, or any combination thereof, in a remanufactured BIS sensor; and

replacing the used adhesive, the foam layer, or a combination thereof, with a new adhesive, a new foam layer, or a combination thereof.

16. The method of claim 15, comprising exposing at least a portion of the first, second, and third electrodes and replenishing the first, second, and third electrodes with conductive ink.

17. The method of claim 16, wherein replenishing the conductive ink of the first, second, and third electrodes comprises disposing a new conductive ink over the conductive ink or re-ionizing the conductive ink.

18. The method of claim 16, wherein replenishing the conductive ink of the first, second, and third electrodes comprises disposing a metallic ink over the over the conductive ink and ionizing a metal contained within the metallic ink to form a new conductive ink.

19. The method of claim 15, comprising:

removing the foam layer from the backing layer to remove the foam layer and the used adhesive;

disposing the new foam layer on the backing layer; and

disposing the new adhesive on the new foam layer.

20. The method of claim 15, comprising:

removing a portion of the foam layer comprising the used adhesive to leave a remaining portion of the foam layer on the backing layer;

disposing the new foam layer on the remaining portion of the foam layer; and

disposing the new adhesive on the new foam layer.

21. The method of claim 15, comprising:

providing a flexible base material comprising an adhesive;

re-sizing the backing layer to conform to a size and shape of the flexible base material; and

securing the backing layer to the flexible base material.

22. The method of claim 15, comprising replacing a conductive gel disposed within the first, second, and third electrode wells.

23. The method of claim 15, comprising replacing at least a portion of first, second, and third electrode well structures disposed within each of the first, second, and third electrode wells, wherein each of the first, second, and third electrode well structures comprise a gel support configured to hold a conductive gel, a preparation surface configured to prepare the patient'"'"'s skin for monitoring, and an adhesive dot configured to secure the preparation surface to its respective electrode.

24. The method of claim 15, comprising cleaning first, second, and third electrode well structures disposed within each of the first, second, and third electrode wells, wherein each of the first, second, and third electrode well structures comprise a gel support configured to hold a conductive gel, a preparation surface configured to prepare the patient'"'"'s skin for monitoring, and an adhesive dot configured to secure the preparation surface to its respective electrode.

25. The method of claim 15, comprising re-programming a used memory unit of the used BIS sensor to enable continued operation of the used BIS sensor.