Technique for remanufacturing a medical sensor

• US 10,098,577 B2
• Filed: 10/07/2015
• Issued: 10/16/2018
• Est. Priority Date: 09/07/2011
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Besko, David P., Sandmore, Donald R.
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US14/877,671
• Publication Number:
  US 20160022184A1
• Time in Patent Office: 1,105 Days
• Field of Search: None
• CPC Class Codes: A61B 2560/028 Arrangements to prevent overuse, e.g. by counting the number of uses
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2560/0475 Special features of memory means, e.g. removable memory cards
• CPC Class Codes: A61B 2562/0233 Special features of optical sensors or probes classified in A61B5/00
• CPC Class Codes: A61B 2562/0238 Optical sensor arrangements for performing transmission measurements on body tissue
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 2562/222 Electrical cables or leads therefor, e.g. coaxial cables or ribbon cables
• CPC Class Codes: A61B 2562/242 Packaging, i.e. for packaging the sensor or apparatus before use
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/68335 including release sheets or liners
• CPC Class Codes: Y10T 29/4973 Replacing of defective part

Abstract

Remanufactured medical sensors and methods for remanufacturing used medical sensors are provided. Such a remanufactured sensor may include certain components from a used medical sensor and certain new components. For example, a remanufactured regional oximetry sensor may include a padding layer, an emitter and a pair of detectors, a flexible circuit coupled to the emitter and detectors, and a patient-contacting adhesive layer. The flexible circuit, the emitter, the first detector, the second detector, or any combination thereof, are from a used medical sensor, and the padding layer, the patient-contacting adhesive layer, or a combination thereof, are new.

Claims

1. A remanufactured medical sensor, comprising:

a padding layer;

a flexible circuit secured to the padding layer and comprising a plurality of conductors disposed on a flexible substrate;

an emitter electrically coupled to the flexible circuit and adapted to transmit light into a patient tissue;

a first detector coupled to the flexible circuit and configured to detect a first portion of light passing through the patient tissue;

a second detector coupled to the flexible circuit and configured to detect a second portion of light passing through the patient tissue; and

a patient-contacting adhesive layer configured to secure the remanufactured medical sensor to the patient tissue;

wherein the padding layer is a trimmed padding layer from a used medical sensor, and wherein the patient-contacting adhesive layer is a new patient-contacting adhesive layer that is disposed directly on a used patient-contacting adhesive layer of the used medical sensor, and wherein the used patient-contacting adhesive layer is trimmed such that a perimeter of the used patient-contacting adhesive layer fits within extents of the new patient-contacting adhesive layer.

2. The remanufactured medical sensor of claim 1, wherein the flexible circuit tapers at one end into a first sensor cable, and the first sensor cable is coupled to a second sensor cable comprising one or more conductors disposed within an insulating material.

3. The remanufactured medical sensor of claim 1, wherein the flexible circuit is coupled to a sensor cable comprising one or more conductors disposed within an insulating material, and the sensor cable is coupled to a connector comprising a memory unit, wherein the connector is adapted to couple the remanufactured medical sensor to a patient monitor.

4. The remanufactured medical sensor of claim 3, wherein the connector, the memory unit, the sensor cable, or any combination thereof, are from the used medical sensor.

5. The remanufactured medical sensor of claim 3, wherein the memory unit is from the used medical sensor and has been re-programmed to enable continued operation of the emitter, the first detector, and the second detector.

6. The remanufactured medical sensor of claim 3, wherein the memory unit comprises an erasable programmable read-only memory (EPROM) unit.

7. The remanufactured medical sensor of claim 3, wherein the memory unit is a replacement memory unit configured to emulate an original memory unit of the used medical sensor.

8. The remanufactured medical sensor of claim 1, comprising an inner foam layer secured to the flexible circuit and the patient-contacting adhesive layer, wherein the flexible circuit is disposed between the inner foam layer and the padding layer, the padding layer comprises an exterior foam layer, the inner foam layer comprises first, second, and third optical windows corresponding to the position of the emitter, the first detector, and the second detector, respectively.

9. The remanufactured medical sensor of claim 1, wherein the patient-contacting adhesive layer is laminated over a used patient-contacting adhesive layer.

10. The remanufactured medical sensor of claim 1, wherein the patient-contacting adhesive layer covers the emitter and the first and second detectors, and is transparent with respect to the wavelengths of light transmitted through the patient tissue.

11. The remanufactured medical sensor of claim 1, wherein the patient-contacting adhesive layer comprises first, second, and third windows corresponding to the emitter and the first and second detectors, respectively.

12. The remanufactured medical sensor of claim 1, wherein the medical sensor comprises a regional oximeter.

13. A patient monitoring system, comprising:

a remanufactured regional oximetry sensor, comprising;

a padding layer;

a flexible circuit secured to the padding layer and comprising a plurality of conductors disposed on a flexible substrate;

an emitter electrically coupled to the flexible circuit and adapted to transmit light into a patient tissue;

a first detector coupled to the flexible circuit and configured to detect a first portion of light passing through the patient tissue;

a second detector coupled to the flexible circuit and configured to detect a second portion of light passing through the patient tissue;

a patient-contacting adhesive layer configured to secure the remanufactured regional oximetry sensor to the patient tissue, wherein the padding layer is a trimmed padding layer from a used regional oximetry sensor, wherein the patient-contacting adhesive layer is a new patient-contacting adhesive layer that is disposed directly on a used patient-contacting adhesive layer of the used regional oximetry sensor, and wherein the used patient-contacting adhesive layer is trimmed such that a perimeter of the used patient-contacting adhesive layer fits within extents of the new patient-contacting adhesive layer; and

a patient monitor adapted to couple with a connector of the remanufactured regional oximetry sensor and operable to monitor signals indicative of the first portion of light received by the first detector and the second portion of light received by the second detector to estimate a blood oxygen saturation level of hemoglobin in a region underlying the patient tissue.

14. The patient monitoring system of claim 13, wherein the remanufactured regional oximetry sensor comprises a sensor cable coupling the flexible circuit with the connector comprising a memory unit, wherein the connector, the memory unit, the sensor cable, or any combination thereof, are from the used regional oximetry sensor.

15. A remanufactured medical sensor, comprising:

a padding layer;

a flexible circuit secured to the padding layer and comprising a plurality of conductors disposed on a flexible substrate;

an emitter electrically coupled to the flexible circuit and adapted to transmit light into a patient tissue;

a first detector coupled to the flexible circuit and configured to detect a first portion of light passing through the patient tissue;

a second detector coupled to the flexible circuit and configured to detect a second portion of light passing through the patient tissue; and

a patient-contacting adhesive layer configured to secure the remanufactured medical sensor to the patient tissue;

wherein the padding layer is a trimmed padding layer from a used medical sensor, wherein the trimmed padding layer comprises a used interior foam layer with a portion of the used interior foam layer trimmed away, and wherein the patient-contacting adhesive layer is a new patient-contacting adhesive layer that is disposed on an additional foam layer secured directly to the trimmed padding layer.