Biomedical Fiber Optic Sensors Applications & Markets

Biomedical Fiber Optic Sensors Applications & Markets

Optical fibers and fiber-optic sensors (FOS) have been attracting attention in the healthcare industry in recent years, leading to a wave of research activity and development of new products. Given their EM immunity, intrinsic safety, small size and weight, autoclave compatibility, and capability to perform multi-point and multi-parameter sensing remotely, fiber-optic-based sensors are ideally suited for a broad variety of applications — invasive and non-invasive — in life sciences, clinical research, medical monitoring, and diagnostics, ranging from laser delivery systems, to disposable blood gas sensors, to intra-aortic pressure probes.

Optical fibers have a variety of different uses in the medical industry, including endoscopes, illumination systems, fiber laser delivery probes, imaging systems (such as Optical Coherence Tomography — OCT), and of course, sensors. At present, the market share of this global market by fiber-optic sensors is relatively small — estimated to be at around $250 million in 2020 and growing at double-digit CAGR. However, the potential is tremendous, and fiber-optic biomedical sensors provide capabilities and features that cannot be attained with other technologies.

This report reviews the advantages of using optical fibers and fiber sensors and discusses what makes them such an attractive, flexible, reliable, and unique solution for the healthcare and life sciences industries. Present industry trends, commercial and technical drivers, as well as the various biomedical fiber sensor types and associated applications, are reviewed. The report also presents a market analysis on the future opportunities for optical fiber sensors in biomedical applications, with market forecasts out to 2025. Key industry trends are identified, along with relevant commercial opportunities and associated regulatory approval hurdles and technical challenges.


1. Introduction & Health Care Industry Trends
1.1. Healthcare Sector Trends
1.1.1. Global Population Issues
1.1.2. Aging Global Population
1.1.3. Chronic Diseases
1.2. Healthcare Industry Trends
1.2.1. Patient Instrumentation & Monitoring
1.2.2. Advanced Operating Rooms
1.2.3. Technical Innovations and Needs
1.2.3.1. Drive towards minimally invasive surgery (MIS)
1.2.3.2. Miniaturization, Automation & Robotics
1.2.3.3. Sensors Compatible with MRI, CT, PET, RF & microwave
1.2.3.4. Increased use of Lasers à Need for fiber delivery devices
1.2.3.5. Increased use of optical imaging and scanning techniques
1.2.4. Minimally Invasive Robotic Surgery (MIRS)
1.2.5. MIRS - The Need for Sensors
1.2.6. Need for faster Biochemical Analysis
1.3. Key Takeaway: The Healthcare Industry is being revolutionized by Technology Innovation & Increased global demand
2. Biomedical Uses of Optical Fibers
2.1.The Impact of Light in Medicine
2.2. Why Fiber Optic Sensors for Medical Applications?
2.3. Biomedical Applications of Optical Fibers
2.4. Medical Application Areas for Fiber Optic Devices & Sensors
2.5. Fiber Illumination
2.6. Biomedical Uses of Optical Fibers: Lighting & Illumination
2.7. Surgical Illumination
2.8. Surgical Instrument Lighting
2.9. Medical Fiberscopes
2.10. Fiber Laser Delivery: Bio-Medical Applications
2.11. Laser Delivery: Sculpted Fiber Tips
2.12. Laser Delivery: Commercial Fiber Probe Examples
2.13. Fiber Optic Fused Tapers & Faceplates: Digital X-Rays
3. Biomedical Sensor Fundamentals
3.1. What is a Bio-Medical Sensor?
3.2. Biomedical Sensor Requirements
3.3. Biomedical Sensing
3.3.1. Classification by location: In-Vivo, In-Vitro
3.3.2. Cells, Tissues & Organs
3.3.3. A Matter of Scale
3.3.4. Sources of Biomedical Signals
3.3.5. Basic Transducing Principle
3.4. Basic Biomedical Instrument System
3.5. Biomedical FO Sensors: Measurable Parameters & Applications
3.6. Biomedical Sensing: Vital Signs
3.7. Biomedical Sensing: Application Areas
3.7.1. Medical
3.7.2. Healthcare
3.7.3. Research
3.7.4. Veterinary Medicine
3.8. Biomedical Sensing: Sterilization Techniques
3.9. ISO 10993 Biocompatibility of Materials & Devices
4. Biomedical Fiber Optic Sensors & Types
4.1. Biosensor Technologies
4.2. Advantages of Fiber Optic Sensors
4.3. Fiber Optic Sensor
4.3.1. Basic Configuration
4.3.2. Classification by Type, Principle & Application
4.3.3. Intrinsic Type
4.3.4. Intrinsic Fiber Optic Sensors Classification Table
4.3.5. Extrinsic Type
4.3.6. Extrinsic Fiber Optic Sensors Classification Table
4.3.7. Classification by Technique
4.4. Fiber Optic Bio/Chem Sensors Sensing Mechanisms
4.5. Biomedical Applications: Key Specialty Fiber/Cable Considerations
5. Applications and Sensor Examples
5.1. Spectroscopy: FO Probes
5.1.1. Optrodes
5.1.2. FO Optrode Sensing Principle
5.1.3. Typical Extrinsic Optrode Configurations
5.1.4. FO Sensor with Porous Microsphere
5.1.5. pH Optrode Sensor
5.1.6. Glucose Optrode
5.1.7. pHOptica™
5.1.8. pH Optrode Sensors: Dye indicators
5.1.9. Optrode Advantages and Drawbacks
5.2. Evanescent Wave Sensors
5.2.1. Evanescent Field Sensors
5.2.2. Evanescent-Wave Sensor Principle
5.3. Optical Fiber Pressure Sensors: Operating Principles
5.3.1. Etalon (Fabry-Perot) Based Fiber Sensors
5.3.2. Fiber Bragg Gratings (FBG): Operating Principle
5.4. Temperature Sensors
5.4.1. Typical Applications
5.4.2. Magnetic Resonance Imaging (MRI): Patient Monitoring
5.4.3. RF Ablation
5.4.4. FO Temperature Probe: GaAs Etalon
5.4.5. FO Fluorescent Sensor: Luxtron Temperature Sensor
5.5. Pressure Sensors
5.5.1. Medical Applications for Pressure Sensing
5.5.2. Fabry-Perot Sensors: Some Examples
5.5.3. Intensity FO Sensor: Intra-cranial Pressure
5.5.4. Fabry-Perot Sensor: Intra-aortic Pressure
5.5.5. Fabry-Perot Sensor: Intra-aortic Balloon (IAB) Catheter
5.5.6. Pressure Monitoring: Fractional Flow Reserve (FFR)
5.5.7. Pressure Monitoring: OptoWire
5.5.8. Fluid Pressure Probe
5.5.9. FO Microphone/Pressure Sensor
5.5.10. Bragg Grating Sensors: Biomedical Pressure/Strain Sensors
5.5.11. Gastro-Intestinal Manometer Catheter
5.5.12. Multi-Point Pressure Monitoring: FBG Manometry – Operating Principle
5.5.13. Gastro-Intestinal Manometer Catheter
5.5.14. Multi-Point Pressure Monitoring: FBG Manometry Sensor Array
5.5.15. FBG Pressure Array: Patient Sleep & Bedsore Sensor
5.5.16. FBG Pressure Array: Patient Heart Rate & Respiration Sensor
5.5.17. FBG Pressure Sensor: Bandage Pressure Monitoring
5.5.18. FBG Pressure Sensor: Prosthetics Design Improvement
5.5.19. FBG Pressure Array: Orthopedic Applications
5.6. Strain, Force, Position, Shape Sensors
5.6.1. Cardiac Force Probe: FBG Intra-Cardiac Sensor
5.6.2. Fiber Optic Force Sensing in Ablation Catheter
5.6.3. Retinal Microsurgery Tool: FBG Force Sensor
5.6.4. FBG Pressure Probe: Spinal Disc Pressure Monitoring
5.6.5. Deflection and Force Sensing of Biopsy Needles
5.6.6. FBG Shape Sensing
5.6.7. Needle Tip Position & Force Sensing
5.6.8. FBG Respiration Sensor: MRI Environment
5.6.9. Smart Fabrics: Patient MonitoringàOFSETH Project
5.6.10. FBG Kinematics Sensor
5.6.11. Polymer Optical Fibers (POF) & Fabrics: Photoplethysmograph (PPG)
5.6.12. FBG Array Sensor: Femur Prosthesis Testing
5.6.13. FBG Array Sensor: Dental Prosthesis Testing
5.6.14. FBG Tendon & Ligament Testing
5.7. Flow Sensors
5.7.1. Fiber Optic Laser Doppler Velocimetry (FOLD-V)
5.7.2. Blood Perfusion Monitoring
5.8. Gas Sensors
5.8.1. Fiber Optic Pulse Oximeter
5.8.2. FO Near IR Oxymeter
5.8.3. Fiber Optic Blood Gas Sensor
5.9. Bio-chemical Sensors
5.9.1. FO Biosensors: Basic Types
5.9.2. Sensing System Approach
5.9.3. Optical Fiber Approach
5.9.4. Sensing Platforms & Techniques
5.9.5. Type II Biosensors: Biologically-Based Sensors
5.9.6. Biochemical Recognition Elements
5.9.7. Biomolecule Immobilization Techniques
5.9.8. Fiber Optic Immunosensor: Evanescent Field
5.10. Fiber Optic Imaging
5.10.1. Biomedical Imaging: Types of FO Probes
5.10.2. Optical Coherence Tomography (OCT): A FO Interferometric Sensor
5.10.3. Standard vs. Long Range OCT
5.10.4. Standard-Range, High Resolution OCT
5.10.5. Long range OCT: Scanning Probe
5.10.6. Side-Imaging OCT Probe
5.10.7. Intravascular Imaging: Coronary Lipid Scanner
5.10.8. Optical Needle Probes
6. Market Overview
6.1. Market Opportunity
6.2. Fiber Optic Biomedical Market Product Categories
6.2.1. Specialty Fibers (large core, high-power, metal-coated, etc.)
6.2.2. Fiber Bundles (incoherent & Coherent)
6.2.3. Fiber Cables
6.2.4. Lensed Fibers
6.2.5. Fiber Assemblies
6.2.6. Probes (Sensing & Imaging)
6.2.7. Fused Tapers & Faceplates (Digital X-Rays)
6.3. Global Fiber Optic Biomedical Market Forecast
6.4. Biomedical Market: Segmentation by Application (2015)
6.5. Global Fiber Optic Biomedical Sensor Market Forecast
6.6. Fiber Optic Biomedical Sensor Companies
6.7. From Research Lab to Hospital: Pathway to Commercialization
6.8. FDA Requirements for Medical Devices
6.8.1. Class I Devices
6.8.2. Class II Devices
6.8.3. Class III Devices
6.8.4. 510(k) Premarketing
6.8.5. Premarket Approval (PMA)
6.8.6. Investigational Device Exemption (IDE)
6.9. European Union Medical Directive
6.9.1. Class I
6.9.2. Class IIa
6.9.3. Class IIb
6.9.4. Class III
6.10. Future R&D Opportunities
6.10.1. Custom-tailored specialty fibers
6.10.2. Active fiber coatings
6.10.3. Holey and hollow-core fiber based sensors
6.10.4. Fiber arrays
6.10.5. Plastic fiber sensors & FBGs
6.11. Future Opportunities/Trends: Lab-on-a-Fiber
7. Conclusions
Author’s Bio
Recommended Bibliography
Appendix:
Company Overviews of Select Biomedical Fiber Optic Sensor Suppliers
ADInstruments Ltd
ADInstruments Inc.
AFL / Verrillon
Verrillon Optical Fiber
Coherent, Inc./ Nufern
Endosense SA
Fibercore
FISO Technologies Inc.
Fujikura Ltd.
Hansen Medical, Inc.
Infraredx, Inc.
Intuitive Surgical, Inc.
Intelligent Fiber Optic Systems (IFOS)
Intelligent Optical Systems, Inc.
ISS, Inc.
LEONI Fiber Optics GmbH
LEONI Fiber Optics Inc.
LumaSense Technologies, Inc.
Maquet Getinge Group
Micronor Sensors, Inc.
Neoptix, Inc.
Nonin Medical Inc.
OFS
OmniGuide, Inc.
Opsens Inc.
RJC Enterprises, LLC
Samba Sensors
Technobis Group

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