Technique for remanufacturing a BIS sensor

• US 9,220,436 B2
• Filed: 09/26/2011
• Issued: 12/29/2015
• Est. Priority Date: 09/26/2011
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Sandmore, Donald R., Besko, David P.
• Primary Examiner(s): Dvorak, Linda
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US13/245,040
• Publication Number:
  US 20130079618A1
• Time in Patent Office: 1,555 Days
• Field of Search: 600/372, 600391-393, 600/396, 600/554, 600/382, 600/383, 600/544, 600/545, 294/020.1, 298/25, 295/921
• US Class Current: 1/1
• 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;

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

a second foam layer disposed on at least a portion of the first foam layer;

a first adhesive layer configured to secure the first foam layer to the second foam layer; and

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

wherein at least a portion of one of the first, second, and third electrodes and at least a portion of the backing layer are from a used medical sensor, and the second adhesive layer is new.

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

3. The remanufactured BIS sensor of claim 1, comprising a plurality of conductors printed in the 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, comprising the connector, wherein the connector comprises a memory unit storing information relating to the remanufactured BIS sensor that enables a BIS monitor to use the BIS sensor to perform BIS measurements on the patient using at least the first, second, and third electrodes as a ground electrode, a reference electrode, and a signal electrode, respectively.

5. The remanufactured BIS 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 BIS 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 by simulating an output of the original memory unit based on an analysis of the output of the original memory unit.

7. The remanufactured BIS sensor of claim 4, wherein the memory unit comprises code configured to cause the remanufactured BIS sensor to become non-functional after a predetermined number of uses or after a predetermined period of time.

8. The remanufactured BIS sensor of claim 4, comprising an adaptor coupled to the connector, wherein the adaptor is configured to manipulate data transmitted to or from the memory unit to enable continued operation of the remanufactured BIS sensor.

9. The remanufactured BIS sensor of claim 8, wherein the adaptor is configured to manipulate data transmitted to the memory unit such that the memory unit receives data indicative of a reduced number of connections, a reduced operation time, a reduced number of uses, or a combination thereof.

10. The remanufactured BIS sensor of claim 1, wherein the first and second foam layers each comprise 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.

11. The remanufactured BIS sensor of claim 10, 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.

12. The remanufactured BIS sensor of claim 11, wherein each of the preparation surfaces are coupled to a gel support structure holding a conductive gel, the conductive gel is configured to enable electrical contact between the patient and the first, second, and third electrodes, and wherein the preparation surfaces, the gel support structures, and the conductive gel are new.

13. The remanufactured BIS 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.

14. The remanufactured BIS sensor of claim 1, wherein the first foam layer is a remnant foam layer from the used medical sensor.

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

a BIS sensor, comprising;

a backing layer, wherein the backing layer is non-elastomeric; and

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

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

a new base layer disposed on the backing layer on a side that is opposite from a side on which the first, second, and third electrodes are disposed, wherein the new base layer is elastomeric; and

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

wherein the backing layer has a periphery trimmed to fit within a periphery of the new base layer, wherein the backing layer comprises a first backing portion on which the first electrode is disposed, a second backing portion on which the second electrode is disposed, and a first bridge coupling the first and second backing portions, wherein the new base layer comprises a first base portion disposed on the first backing portion, and a second base portion disposed on the second backing portion, and a second bridge coupling the first and second base portions, wherein the second bridge is stretchable to enable a distance between the first and second electrodes to vary and the first bridge is folded to enable the distance between the first and second electrodes to vary, and wherein the second bridge comprises one or more notches to enable rotational movement of the first electrode with respect to the second electrode.

16. The remanufactured BIS sensor of claim 15, wherein the new base layer is a different shape than the backing layer.