Clinical Impact of Smart Orthopaedic Implants - The human body - an untapped data source, no more - FDA

Clinical Impact of Smart
  Orthopaedic Implants
  The human body – an untapped data source, no more

               Aenor Sawyer, MD, MS             @ASawyerMD
               HITO (Health Innovation & Technology in Ortho)
5/10/2018
               UCSF Department Orthoapedic Surgery

Disclosures
     Associate Editor, Nature Journal of Digital Medicine
     External Advisory Board, Scripps CTSI
     Chair, Global Advisory Board, MCRI, Royal Childrens Hospital
     Advisor: Open Placement, BabyScripts, Kenzen,Tagnos, Ouva, IDEO
     Editor/Author: Bone Health Assessment in Pediatrics – Springer

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Precision Medicine = Person + Population Health

                                5/10/2018

Ubiquitous data sources

Panome

                          Cell 157, March 27, 2014

Patient-generated health data
    in their Life Flow
 Supplement the existing clinical data, more
comprehensive picture of ongoing patient health.
     • Provide important information about how patients are doing between medical
       visits… in their Real World settings
     • Gather information on an ongoing basis, rather than only at artificial intervals
     • Provide information relevant to preventive and chronic care management
 Essential for Targeted treatment, Value-based care, Post market
  surveillance
     • NEED TO MOVE BEYOND PROs
6    • MUST include Qualitative AND Quantitative Data

Patient Generated
  Health Data
  Patient Generated Data
  ONC - Building Data Infrastructure to Support Patient Centered Outcomes
    Research (PCOR)
  The policy framework will consider how PGHD can be collected in a way that:
  • protects the patient and the integrity of the patient record,
  • maximizes the provider-patient relationship,
  • builds confidence among providers and researchers to use these data, and
  • encourages individuals to donate their health data for research.
https://www.healthit.gov/policy-researchers-implementers/patient-generated-health-data

                                                                                5/10/2018

The Individual remains an untapped source for
        physiologic, biomechanical, biometric data
    • What about wearables?
        •       Not well validated
        •       Not measuring all that would be useful
    •   Some patients have engaged w/ wearables
            •    But > 50% stop w/in 6 months
            •    Require active collection from
                 fragmented sources and typically not
                 well contextualized, poor battery life
            •    Not achieved ideal VNR
                 (Value/Nuisance Ratio)                   https://www.nature.com/articles/nbt.3222

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3 Generations: Moving from
Wearable Sensors to Smart Implants –
             To Pervasive and Personalized Healthcare

 Andreu-PereFrom Wearable Sensors to Smart Implants – Towards Pervasive and Personalised Healthcarez J., Leff D., Ip H., & Yang, G.-Z.. IEEE Transactions on
 Biomedical Engineering. 2015

Evolution: Allied technologies for pervasive and personalized   healthcare

                                                                      2004
                                                                       to
                                                                      2015
                                                                     Andreu-Perez,
                                                                     Javier,
                                                                     et al. IEEE
                                                                     2015

                                                                    From Wearable
                                                                    Sensors to Smart
                                                                    Implants –
                                                                    Towards Pervasive
                                                                    and Personalised
                                                                    Healthcarez J.,
                                                                    Leff D., Ip H., &
                                                                    Yang, G.-Z.. IEEE
                                                                    Transactions on
                                                                    Biomedical
                                                                    Engineering. 2015

Human Implantables - Microchips
      The Food and Drug Administration approved a Radio Frequency chip (RFID)
       for implant in 2004 as a way to relay medical information quickly to doctors.
      In June 2007, the American Medical Association declared that "implantable
       radio frequency identification (RFID) devices may help to identify patients,
       thereby improving the safety and efficiency of patient care, and may be used
       to enable secure access to patient clinical information",[37]
      "American Medical Association CEJA Report 5-A-07“

      In 2007 reports surfaced associating chips in animals with tumors
      More recently, in 2014, the FDA said that while it was not aware of any
       adverse events associated with having an RFID chip in your body, the
       government agency said it was studying to address "concerns" about the
       potential effects of RIFD chips "on medical devices," like pacemakers and
       defibrillators.
11                                                           5/10/2018

Human Microchips

     A tiny chip from Biohax International will be
     embedded into employee at a Wisconsin
     firm (Photo: Biohax International)

12                                                   5/10/2018

Human micro-implants
     3,000 Sweden residents are walking around with
      microchips in their hands.
     Sweden in 2015 the national rail company planned to
      offer hand scanning instead of tickets to board
      Are embedded microchips dangerous? Ask the Swedes — and pets
     Jefferson Graham, USA TODAYPublished 1:51 p.m. ET July 25, 2017
      | Updated 5:03 p.m. ET July 25, 2017

13                                                   5/10/2018

Humans with microchips implanted in them
     By CHRIS STEIN CBS NEWS June 22, 2016, 3:57 PM

                                                                   Typically in
                                                                    finger tip or
                                                                    web space
                                                                   Glass bead,
                                                                    rice size or
                                                                    slightly bigger
                                                                   Open house
                                                                    door
                                                                   Control phone
                                                                   Work ID

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Overview of smart medical implants or
devices
• Smart medical devices share many features and basic
  components –
     • Signal detection, processing, transfer,
     • Power requirements,
     • Biocompatibility, safety, longevity, reliability, precision
• Bi-directional data
  - can be Active and used in ”closed loop” fashion
• Smart devices allow detection of problems early and provide
  minimally invasive management

[Andreu-Perez, Javier, et al. IEEE 2015]
Smart implants in recent years

SENSIMED Triggerfish
• Soft contact lens with strain gauges that record changes in intraocular
  pressure (for glaucoma management) by sensing changes in curvature
  and circumference of the corneoscleral area
• Data is transmitted through a cable to a portable recorder
• Originated from Swiss Federal Institute of Tech (EPFL)
• Status: Used in clinics in over 30 countries but not USA

                                                             http://www.sensimed.ch/en/

Other smart contact lenses
     • Google is developing contact lenses
       that sense glucose levels in tears
     • Sony and Samsung are both
       developing contact lenses with built-
       in cameras
                 • Used for augmented reality
                   with a more “natural”
                   experience than smart glasses
     • Status: All three are patented and in
       development stages

Google: http://www.healthline.com/hlcmsresource/images/diabetesmine/wp-content/uploads/2014/01/Google-Smart-Contacts-One-Pager.pdf
Samsung: http://www.sciencealert.com/samsung-just-patented-smart-contact-lenses-with-a-built-in-camera
Sony: http://petapixel.com/2016/04/28/sony-patents-contact-lens-camera-joins-google-samsung/

ACTIVE or CLOSED LOOP:
      Cochlear Implants that
       self adjust

                                 Pacemaker and
                                 Implanted
                                   Defibrillators

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ACTIVE or CLOSED LOOP: Medtronic SmartGuard

• Pump system that detects sugar levels and regulates insulin delivery
  accordingly
• Status: Used in patients

                         http://www.medtronicdiabetes.com/products/smartguard-technology

CLOSED LOOP:                   RNS System (NeuroPace)
• Monitors electrical activity under the skull and sends targeted pulse within
  milliseconds to stop a seizure before it begins
• Status: In clinics. Hundreds have been installed since FDA approval in 2013

                                                             http://www.neuropace.com

Orthopaedic Implant Market
      Projected to increase from 29.2 billion USD in 2012 to
                                                     41.2 billion USD in 2019
        http://www.transparencymarketresearch.com/pressrelease/global-orthopedicdevices-
        market.htm

      Total knee replacement (or arthroplasty) over 600,000/yr in US
      Most arthroplasy implants fail after15 years - often due to
         • wear, loosening, and misalignment
      Other complications with implants include infection and peri-prosthetic
       fracture or adjacent tissue failure
 Wireless Sensors for Smart Orthopedic Implants Cody O’Connor1, Asimina Kiourti1
 J Bio Tribo Corros (2017) 3:20 DOI 10.1007/s40735-017-0078-z Springer International Publishing Switzerland 2017

23   Presentation Title and/or Sub Brand Name Here                                           5/10/2018

Potential of Smart Orthopaedic Implants
      The ability to unobtrusively monitor the implant’s performance in real time in
       real world settings could offer unprecedented capabilities to
      Analyze signs of and causes of failures
      Develop of predictive models and clinical decision support
      Detect early abnormalities or early warning of impending complications or
       likely failure and extend implant life
      Create opportunity for early intervention
      Develop closed Loop processes where possible (actionable insightst sent to
       patient)
 Wireless Sensors for Smart Orthopedic Implants Cody O’Connor1, Asimina Kiourti1
 J Bio Tribo Corros (2017) 3:20 DOI 10.1007/s40735-017-0078-z Springer International Publishing Switzerland 2017

25   Presentation Title and/or Sub Brand Name Here                             5/10/2018

Instrumented implant
                   Hip III with one 9-channel transmitter

                                                  Implant Hip III
        This new design of a instrumented hip implant was
     developed to measure contact forces and the friction
             at the joint in vivo. A clinical proven hip implant
      ('Spotorno' design) was modified in the neck area. 6
        strain gauges and antennas were embedded in the
                                         neck and via telemetry
          three contact forces acting onto the implant head
         center and three friction moments acting between
               the gliding partners can be measured in vivo.

           Since April 2010 ten instrumented hip joints (Hip
      III) were implanted in ten patients to monitor forces
                                             and moments.

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OrthoLoad

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OrthoLoad Database for Hip joint, shoulder
      joint, knee joint, vertebral body replacement and
      internal spinal fixator.
     A coil for the inductive power supply is arranged
     around the implant and the antenna is placed close
     to it. The data received is at first controlled in
     regard to transmission errors and then led to a
     notebook where the forces and moments are
     calculated and displayed in real time. The images of
     the patients' exercises and the synchronous data
     stream are both recorded on the same video tape.
     On a monitor or using a video beamer, the forces
     and moments can be controlled immediately. This
     allows one to detect unexpected loading situations
     and immediately modify the way an exercise is
     performed.

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eKnee
• Total knee arthroplasty tibial component with internal sensing to
  report impact of knee from activities
• Status: Developed by Scripps and has been used in select subjects
  to gain load information for improving implant design

                                  http://jbjs.org/content/jbjsam/83/2_suppl_1/S62.full.pdf

Balancing of Ligaments in Total Knee Arthroplasty

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TECHNOLOGY BEHIND
     SENSOR-ASSISTED DEVICE

     OrthoSensor’s Verasense
      technology makes use of smart
      technological devices, such as
      those developed and miniaturized
      for smartphones. Some examples
      of this technology include
      integrated circuits, digital signal
      processors, RFID and embedded
      biosensors.
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SImOS
      TKA System:
      Implanted
       sensors
      External
       sensors,
       electronics
      Remote
       device

                     5/10/2018
32

Smart knee prosthesis
• Detects abnormal forces and kinematics
• Magnets/magnetic sensor measure knee kinematics, and strain
  gauge measure forces
• Status: In development at EPFL

                                                 [Arash+ IEEE 2013] – click link

Hip Loosening by US, Hip Temperature

 Wireless Sensors for Smart Orthopedic Implants Cody O’Connor1,          Bergmann G, Graichen F, Dymke J, Rohlmann A, Duda GN,
 Asimina Kiourti1                                                        Damm P (2012) High-tech hip implant for wireless temperature
 J Bio Tribo Corros (2017) 3:20 DOI 10.1007/s40735-017-0078-z Springer   measurements in vivo. PLoS One 7:1–7
34   Presentation Title and/or Sub Brand Name Here                                5/10/2018
 International   Publishing Switzerland 2017

Smart Hip
• Network of sensors and actuators on hip implants that that detect
  bone loosening to determine need for revision surgery
• Uses acoustic method where implants are excited externally and
  the resulting frequencies are analyzed for levels of loosening
• Information is sent via Bluetooth
• Status: In development (came out of Universidade do Porto)

                                                     http://www.smarthip.eu

SHOULDER

 Contact forces
  and moments
 Guide design,
  fixation,
  activity
  parameters
 complication
  detection

      Westerhoff P, Graichen F, Bender A, Rohlmann A, Bergmann G (2009) An instrumented implant for in vivo measurement of
     contact forces and contact moments in the shoulder. Med. Eng.Phys. 31:207–213

36   Presentation Title and/or Sub Brand Name Here                                                  5/10/2018

Spine rod strain sensors
• Two versions:
      • LOADPROTM Intraoperative Rod Strain
        Sensor: Single-use device that allows
        spine surgeons to balance strains on
        implanted fusion rods during operation
      • ACCUVISTATM Postoperative Rod Strain
        Sensor: Permanent device that allows
        rod strains to be tracked after spine
        fusion
• Status: In development (came out of University
  of Louisville)

                                                   http://www.intellirodspine.com

Ortho-tag
• Wireless chip attached to any
  implant
• Handheld receiver is waved over
  implant and gives physicians
  information about the patient, the
  implant, and the procedure
• Sensors in chip also gauge pressure
  on implant, chemical balance and
  temperature of tissue, and presence
  of harmful organisms
• Status: In development
                                        http://www.ortho-tag.com

eDisc by Theken Disc
• Lumbar total disc replacement with electronic sensing capabilities
• User wears device that beeps when they exceed recommended
  loads
• Status: Acquired by Integra Lifesciences, but no news since 2008.

                                   http://www.businesswire.com/news/home/2004102600608
                                          0/en/Theken-Design-Artificial-Spinal-Disc-Embedded-
                                                                               Microelectronics

Smart Implant Clinical Impact
      Detection of Loosening for Hip Implants
      Force Measurements in Knee Implants
      Bone Healing Assessment
      Wireless Correction of Orthopedic Structural Deformities
      Wireless Temperature Measurements in Hip Implants
      Measurement of Contact Forces and Moments in the Shoulder Joint
      Diagnosing Orthopedic Implant Failures
      Spinal Fusion Monitoring
      Investigation of Tribocorrosion of Metallic Implant Materials
 Wireless Sensors for Smart Orthopedic Implants Cody O’Connor1, Asimina Kiourti1
 J Bio Tribo Corros (2017) 3:20 DOI 10.1007/s40735-017-0078-z Springer International Publishing Switzerland 2017
41   Presentation Title and/or Sub Brand Name Here                             5/10/2018

Affordable? - Coil sensor
• Simple coil that senses force,
  pressure, temperature, pH
  and presence of antigens at
  orthopaedic implant sites
• No battery, no external power, no
  electronics
• Excite coil with RF energy (sensor is
  simple; external electronics are
  complex)
• Status: In development at Rensselaer
  Polytechnic Institute

 [Wachs RA+ Adv Bioens Biolectron 2013] and http://news.rpi.edu/luwakkey/2997

Important criteria for smart devices moving forward
•   Low power consumption/ battery life
•   High reliability
•   Safety monitoring features
•   Simplicity and miniaturization
      • Overly complex systems of the past never made it to clinical
        phases due to size and cost
• Intersection with other data sources to create
  associations and contextualize the information to
  make it actionable

Consumer Health

                  Confidential & Proprietary © 2015 UCSF All Rights Reserved
                                Confidential & Proprietary © 2015 UCSF All Rights Reserved

Multiparametric
and biometric
Technologies:

- “SWEAT is the
new BLOOD”

    45

Remote Health Monitoring
 Digital
 Health
 Apps
 IOT
Wearables -
 Consumer

Medical
 Grade - in
 clinics and remote

                           5/10/2018

Medical Monitors, Devices

        Confidential & Proprietary © 2015 UCSF All Rights Reserved

Traditional
                                                  Device
                                                  companies
                                                  interested

     Ultimate linkage between
     external and internal sensors

48     Proprietary and Confidential   5/10/2018

To realize the
    Power of Health Information
Health Data         Actionable Information
 Must be Contextualized and Accessible
      INTEROPERABILITY
    Aggregation, Analytics, Algorithms, AI, Availability

INFORMED HEALTH
           RIGHT INFO @ RIGHT INSTANT = RIGHT OUTCOME

Conf
 iden
   tial
     &
Prop
rieta
ry ©
  201
      5
UCS
    F-
  CD
    HI
    All
Righ
     ts
  Res
 erve
      d

Sensors, Smart devices could create a
paradigm shift from:
  • Reliance on subjective, secondary or late
    signs of problems
  • Missed opportunity for understanding loads,
    responses in real life settings
  • Episodic and fragmented monitoring
  • Shift to as needed sensing contextualized
    into actionable insights
 Proprietary and Confidential

CLINICIANS…If you are putting
      something on or in a patient - what
     information might you want know to
       optimize that patient across time?

     FDA – integrate discussions on these
      media/modalities into ‘use driven’
                   topics
52                            5/10/2018

Thank you
 Conference Chairs at FDA and CDMI
 UCSF Department of Orthopaedic Surgery
 Britta Berg-Johansen, Brian Mayershon