Near infrared spectroscopy device with reusable portion

• US 7,706,853 B2
• Filed: 02/07/2006
• Issued: 04/27/2010
• Est. Priority Date: 02/10/2005
• Status: Expired due to Fees

• Current Assignee: Terumo Cardiovascular Systems Corporation (Terumo Corporation)
• Original Assignee: Terumo Cardiovascular Systems Corporation (Terumo Corporation)
• Inventors: Allen, Brent William, Hacker, Thomas G.
• Primary Examiner(s): Winakur; Eric F
• Assistant Examiner(s): Berhanu; Etsub D
• Application Number:
  US11/349,477
• Publication Number:
  US 20060189860A1
• Time in Patent Office: 1,540 Days
• Field of Search: 600/310, 600/340, 600/344, 600/473, 600/476, 600/322, 600/323
• US Class Current: 600/344
• CPC Class Codes: A61B 2562/222 Electrical cables or leads therefor, e.g. coaxial cables or ribbon cables
• CPC Class Codes: A61B 2562/223 Optical cables therefor
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/14553 specially adapted for cerebral tissue
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: G01N 21/359 using near infrared light
• CPC Class Codes: G01N 21/4738 Diffuse reflection precedence is given to G01N21/55 - G01N21/57 if specular component is taken into consideration, e.g. also for testing fluids, fibrous materials

Abstract

A NIRS sensor device for brain monitoring is small in size, provides reliable attachment to a patient, blocks ambient light, is easy to use, is hygienic, and supports data integration with surgical and monitoring systems. The sensor device is coupled to a remote near infrared light source via a hybrid cable. Since the light source is remotely located, a source adapted for providing high energy, short pulses can easily be used so that there is less chance of interference by superficial non-brain tissues and less interference from ambient light. In addition, the remote location avoids changes in output of local light sources experienced in the prior art during hypothermia procedures (e.g., bandwidth shifts in LEDs as a result of lowered temperature). The higher energy may be achieved by the use of laser diodes as opposed to locally-mounted LEDs typically used in the prior art. The sensor device is a two-piece design comprising a reusable portion containing the photodetector(s) and a disposable portion that receives the light from the reusable portion and bends it to direct the light into the brain.

Claims

1. A near infrared spectroscopy system for monitoring an oxygenation-related parameter beneath a body surface of a patient, comprising:

a reusable probe portion comprising a ferrule member mounted to a hybrid cable for conveying near infrared light from a remote source, said reusable probe portion further comprising a pair of photodetectors, said ferrule member having a termination spaced from said pair of photodetectors; and

a disposable coupler portion comprising a flexible housing with a receiving slot into which said reusable probe portion is releasably inserted, wherein said disposable coupler portion further comprises a light channel member adapted to be selectively coupled to said termination of said ferrule member for directing said near infrared light toward said body surface, wherein said flexible housing further comprises an adhesive layer for temporarily attaching said disposable coupler portion to said body surface, and wherein said flexible housing includes a window disposed in alignment with said pair of infrared detectors for admitting reflected near infrared light from said patient when said disposable coupler portion is releasably connected with said reusable probe portion, whereby only said disposable coupler portion is configured to adhere to said body surface.

2. The system of claim 1 wherein said light channel member comprises a light bender having a reflective surface for directing said near infrared light in a direction substantially perpendicular to said body surface.

3. The system of claim 2 wherein said flexible housing comprises a substantially opaque overmold including soft rubber.

4. The system of claim 1 wherein said reusable probe portion further comprises:

an elongated flexible printed circuit board mounted to said ferrule member at a first end and connected to said pair of photodetectors at a second end, wherein said flexible printed circuit board includes conductive traces for interconnecting said photodetectors to said hybrid cable.

5. The system of claim 4 further comprising:

an EMI cover mounted at said second end;

a rigid housing containing said photodetectors and said EMI cover; and

an overmolded body covering said flexible printed circuit board.

6. The system of claim 5 wherein said overmolded body of said reusable probe portion and said flexible housing of said disposable coupler portion include respective locking features for positively retaining said disposable coupler portion and said reusable probe portion when connected for use.

7. The system of claim 6 wherein said photodetectors are respectively spaced at predetermined distances from said light channel member when connected for use.

8. A sensor device for a brain monitoring system using near infrared spectroscopy, comprising:

a reusable portion; and

a disposable portion;

wherein said reusable portion comprises a ferrule member for coupling to a near infrared light source, a flexible circuit board, a photodetector mounted to said flexible circuit board at a distal end opposite said ferrule member, an EMI shield disposed around a portion of said photodetector, and an overmold that covers at least said flexible circuit board; and

wherein said disposable portion comprises a light bending optical channel, electronic connecting pins for interfacing to said flexible circuit board, an electronic memory chip for storing data, and a flexible housing overmold having a patient contact adhesive layer and having a receiving slot into which said reusable probe portion is releasably inserted so that only said disposable coupler portion configured to adhere to a patient.

9. The sensor device of claim 8 wherein said flexible housing overmold is substantially opaque for blocking ambient light from said photodetector.

10. The sensor device of claim 8 wherein said data stored in said memory chip relates to a patient and is encrypted.

11. The sensor device of claim 8 wherein said reusable portion further comprises a hybrid cable for conveying near infrared light from a remote light source and for electrically connecting said sensor device to a monitor controller.

12. A method of measuring an oxygenation-related parameter during surgery of a patient using a monitoring system having a remote near infrared light source and a controller and using a sensor device having a reusable portion and a disposable portion, said method comprising the steps of:

mating said reusable portion and said disposable portion to conduct near infrared light from said source through said mated portions and projecting out of an exit from said disposable portion, wherein said disposable portion includes a receiving slot into which said reusable probe portion is releasably inserted, and as a result of said mating, a photodetector in said reusable portion is disposed in a window formed in said disposable portion at a predetermined distance from said exit, said reusable portion having a ferrule member mounted to a hybrid cable for conveying near infrared light from said remote near infrared light source, and said disposable portion having a light channel member adapted to be selectively coupled to said ferrule member for directing said near infrared light out of said exit;

attaching said disposable portion to a skin surface of said patient over an area of interest so that said reusable portion does not contact said skin surface;

illuminating said area of interest with said near infrared light;

detecting reflected light with said photodetector as a measure of said oxygenation-related parameter;

removing said disposable portion from said skin surface after completion of said surgery;

unmating said reusable portion from said disposable portion; and

mating said reusable portion to a second disposable portion to measure an oxygenation-related parameter of a second patient during a second surgery.

13. A near infrared spectroscopy system for monitoring an oxygenation-related parameter beneath a body surface of a patient, comprising:

a reusable probe portion comprising a ferrule member mounted to a hybrid cable for conveying near infrared light from a remote source, said reusable probe portion further comprising a pair of photodetectors, said ferrule member having a termination spaced from said pair of photodetectors; and

a disposable coupler portion comprising a flexible housing with a receiving slot into which said reusable probe portion is releasably inserted, wherein said disposable coupler portion further comprises a light channel member adapted to be selectively coupled to said termination of said ferrule member for directing said near infrared light toward said body surface, wherein said flexible housing further comprises an adhesive layer for temporarily attaching said disposable coupler portion to said body surface, wherein said flexible housing includes a window disposed in alignment with said pair of infrared detectors for admitting reflected near infrared light from said patient when said disposable coupler portion is releasably connected with said reusable probe portion, wherein said disposable coupler portion further comprises an electronic memory, wherein said near infrared spectroscopy system is adapted to be coupled to a monitor controller via said hybrid cable, and wherein said reusable probe portion includes a data circuit for coupling with said electronic memory to transmit information between said electronic memory and said monitor controller via said hybrid cable.

14. The system of claim 13 wherein said electronic memory comprises an integrated circuit having connection pins and wherein said disposable coupler portion further comprises pin members mounted to said light channel member for receiving said connection pins at one end thereof and for projecting from said disposable coupler portion at the other end thereof to join with said hybrid cable.

15. The system of claim 13 wherein said information stored in said electronic memory is associated with a patient, and wherein said patient information is accessible to said monitor controller.

16. A near infrared spectroscopy system for monitoring an oxygenation-related parameter beneath a body surface of a patient, comprising:

a reusable probe portion comprising a ferrule member mounted to a hybrid cable for conveying near infrared light from a remote source, said reusable probe portion further comprising a pair of photodetectors, said ferrule member having a termination spaced from said pair of photodetectors; and

a disposable coupler portion comprising a flexible housing with a receiving slot into which said reusable probe portion is releasably inserted, wherein said disposable coupler portion further comprises a light channel member adapted to be selectively coupled to said termination of said ferrule member for directing said near infrared light toward said body surface, wherein said flexible housing further comprises an adhesive layer for temporarily attaching said disposable coupler portion to said body surface, wherein said flexible housing includes a window disposed in alignment with said pair of infrared detectors for admitting reflected near infrared light from said patient when said disposable coupler portion is releasably connected with said reusable probe portion;

wherein said reusable probe portion further comprises a light generator mounted to said ferrule member for generating a visible emission when receiving electrical power from said hybrid cable; and

wherein said disposable coupler portion further comprises a lens receiving said visible emission and radiating said visible emission outside said disposable coupler portion to indicate that said electrical power is being received.