Integrated Sensing Systems (ISSYS) The First Annual Unither Nanomedical and Telemedical Technology...
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Integrated Sensing Systems (ISSYS) Integrated Sensing Systems (ISSYS) The First Annual Unither Nanomedical and The First Annual Unither Nanomedical and Telemedical Technology Conference Telemedical Technology Conference April 3, 2008 April 3, 2008 Novel Wireless, Batteryless, Implantable Novel Wireless, Batteryless, Implantable Sensors Sensors for Chronic Disease Management for Chronic Disease Management Implantable Sensor Implantable Sensor Pressure sensor Pressure sensor for the implant on for the implant on a penny a penny
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Transcript of Integrated Sensing Systems (ISSYS) The First Annual Unither Nanomedical and Telemedical Technology...
Integrated Sensing Systems (ISSYS)Integrated Sensing Systems (ISSYS)
The First Annual Unither Nanomedical and Telemedical The First Annual Unither Nanomedical and Telemedical Technology Conference Technology Conference
April 3, 2008April 3, 2008
Novel Wireless, Batteryless, Implantable Sensors Novel Wireless, Batteryless, Implantable Sensors for Chronic Disease Managementfor Chronic Disease Management
Implantable SensorImplantable Sensor
Pressure sensor for the Pressure sensor for the implant on a pennyimplant on a penny
Integrated Sensing Systems (ISSYS)Integrated Sensing Systems (ISSYS)o ISSYS was established in January 1995.ISSYS was established in January 1995.
o One of the oldest independent MEMS companies in the U.S.One of the oldest independent MEMS companies in the U.S.
o Vertically Integrated Technical CompanyVertically Integrated Technical Companyo Entire sensing system Entire sensing system
o Sensor, circuit, software, package, delivery, …Sensor, circuit, software, package, delivery, …
o Full Bio-MEMS Manufacturing FacilityFull Bio-MEMS Manufacturing Facility
o High Quality ManufacturingHigh Quality Manufacturingo ISO 9001: 2000 CertificationISO 9001: 2000 Certification
o ISO 13485-2003 Compliance (FDA)ISO 13485-2003 Compliance (FDA)
o First FDA 510(k) Granted 2006First FDA 510(k) Granted 2006
Slide Slide 22
ISSYS Core TechnologiesISSYS Core Technologieso Wireless, batteryless, implantable pressure Wireless, batteryless, implantable pressure
sensorssensorso Tremendous market potential in many Tremendous market potential in many
emerging medial fields.emerging medial fields.
o Resonating micro-tubesResonating micro-tubes
o Comprehensive analysis of fluidic Comprehensive analysis of fluidic properties (density, concentration, properties (density, concentration, viscosity, mass flow, and temperature). viscosity, mass flow, and temperature).
o Unprecedented advantages in Unprecedented advantages in functionality, performance, size, and functionality, performance, size, and cost.cost.
ISSYS Flow Sensor ChipISSYS Flow Sensor Chip
ISSYS Wireless BioPressure ISSYS Wireless BioPressure SensorsSensors
Slide Slide 33
ISSYS Goal:ISSYS Goal:To Greatly Improve Disease TreatmentTo Greatly Improve Disease Treatment
We believe that the treatment of many diseases can be greatly We believe that the treatment of many diseases can be greatly
improved by dynamically tailoring the medication via monitoring improved by dynamically tailoring the medication via monitoring
through frequent and non-invasive measurements using ISSYS’ through frequent and non-invasive measurements using ISSYS’
products.products.
Slide Slide 44
Slide Slide 55
Wireless Sensing SystemWireless Sensing System
o Two system components:Two system components:o Implantable pressure sensor(s)Implantable pressure sensor(s)
o External handheld readout unitExternal handheld readout unit
o The components communicate using RF The components communicate using RF telemetry.telemetry.
Slide Slide 66
Congestive Heart Failure Congestive Heart Failure (CHF)(CHF)
Many experts consider CHF to be the Many experts consider CHF to be the largest emerging medical marketlargest emerging medical market
Slide Slide 77
ISSYS Goal:ISSYS Goal:To Greatly Improve CHF TreatmentTo Greatly Improve CHF Treatment
o Improve patient outcomes and lower cost of careImprove patient outcomes and lower cost of care
o Dynamically tailor medication over timeDynamically tailor medication over time
o Modify patient behaviorModify patient behavior
Slide Slide 88
Left Atrium PressureLeft Atrium Pressure
o Today there are other companies that are developing Today there are other companies that are developing
miniature wireless implant products for monitoring miniature wireless implant products for monitoring
pulmonary artery pressures.pulmonary artery pressures.
o While PA pressure is beneficial, compared to no input, it is While PA pressure is beneficial, compared to no input, it is
not the most useful waveform for CHF.not the most useful waveform for CHF.
o The left atrium pressure is the holly grail for the treatment The left atrium pressure is the holly grail for the treatment
of CHF.of CHF.
o Today, ISSYS offers the only viable technology for Today, ISSYS offers the only viable technology for
miniature wireless monitoring of the left atrium pressure.miniature wireless monitoring of the left atrium pressure.
Slide Slide 99
Left Atrium PressureLeft Atrium Pressureo ISSYS left atrium implant platform:ISSYS left atrium implant platform:
o Minimum protrusion inside the left heart (extremely important)Minimum protrusion inside the left heart (extremely important)
o A practical anchorA practical anchor
o Catheter delivery (similar to current transcatheter patch atrial Catheter delivery (similar to current transcatheter patch atrial septal defect (ASD) occlusion implants)septal defect (ASD) occlusion implants)
o Outpatient procedureOutpatient procedure
Left Atrium
Atrial Septum
Pressure Sensor
Anchor
Right Atrium
Slide Slide 1010
o Application:Application: Tailored treatment of congestive heart Tailored treatment of congestive heart failure (CHF) failure (CHF)
o Implantation Locations:Implantation Locations: o Left atriumLeft atrium
o Atrial SeptumAtrial Septum
o Delivery and Anchoring:Delivery and Anchoring:o Outpatient procedureOutpatient procedure
o Catheter basedCatheter based
o Similar to the current cardiac procedures Similar to the current cardiac procedures
o Small Catheter Size: < 16 French (ideally <14 French)Small Catheter Size: < 16 French (ideally <14 French)
Cardiac Implant Specifications:Cardiac Implant Specifications:
Slide Slide 1111
o Monitored Pressure Waveforms:Monitored Pressure Waveforms:o Look the same as the current catheterization waveformsLook the same as the current catheterization waveforms
o No new training requiredNo new training required
o Complete waveformComplete waveform
o Real timeReal time
o ContinuousContinuous
o Chronic use (over the patients’ life)Chronic use (over the patients’ life)
o Ability to read wide range of cardiac pressuresAbility to read wide range of cardiac pressureso -100 to +300 mmHg-100 to +300 mmHg
o DetailedDetailedo High-fidelity data with sensitivity of ± 0.3 mmHg and accuracy of High-fidelity data with sensitivity of ± 0.3 mmHg and accuracy of
±1mmHg,±1mmHg,
o Fast (200+ samples/second) data gatheringFast (200+ samples/second) data gathering
Cardiac Implant Specifications:Cardiac Implant Specifications:
Slide Slide 1212
Cardiac Implant Specifications:Cardiac Implant Specifications:
o Communication:Communication:o Tele-communication distance over 10 cm (15 cm desirable)Tele-communication distance over 10 cm (15 cm desirable)o Tele-powering distance over 10 cm (15 cm desirable)Tele-powering distance over 10 cm (15 cm desirable)o RobustRobusto FDA & FCC compliantFDA & FCC compliant
o Handheld Readout UnitHandheld Readout Unito Small sizeSmall size
o In particular for home monitoring applications by patientsIn particular for home monitoring applications by patientso Easy to useEasy to use
o Minimal trainingMinimal trainingo Antenna working with a wide angle relative to the implant locationAntenna working with a wide angle relative to the implant location
ISSYS vs. Millar Catheterization ComparisonLeft Ventricle
56 days explant
0
20
40
60
80
100
120
0.0 1.0 2.0 3.0 4.0 5.0
Time (sec)
Pre
ssu
re (
mm
Hg
)
ISSYSMillar
ISSYS Mean = 43.5Millar Mean = 43.9HR~108 bpm
ISSYS Wireless Probe vs Millar Catheter: ISSYS Wireless Probe vs Millar Catheter: Left Ventricle Left Ventricle
Slide Slide 1313
ISSYS Wireless Probe vs Lumen Filled Catheter: ISSYS Wireless Probe vs Lumen Filled Catheter: Right Ventricle Right Ventricle
Implantable SensorImplantable Sensor
Slide Slide 1414
ISSYS Wireless Pressure Probe vs Lumen Filled Reference Sensor Right Ventricle
Implantable SensorImplantable Sensor
Slide Slide 1515
Sensor Placed in RV Outflow Tract After 78 days of implant in the right ventricle, there was no After 78 days of implant in the right ventricle, there was no
measurable cell growth on top of the MEMS pressure sensor.measurable cell growth on top of the MEMS pressure sensor.
Slide Slide 1616
Histology Tests o Wayne State University has been Wayne State University has been
performing comprehensive histology performing comprehensive histology tests on ISSYS’ implants at different tests on ISSYS’ implants at different cardiovascular locations.cardiovascular locations.
o All the histology tests up to now have All the histology tests up to now have shown outstanding results.shown outstanding results.
External
Implant Sensor Area
Implant Sensor Area
Implant Sensor Area
10x 20x 40x
External Area
Internal Area
Cardiac Muscle Tissue
Enlarged Area Below
Slide Slide 1717
Enabling PlatformEnabling Platformo ISSYS has intentionally created a flexible platform for the ISSYS has intentionally created a flexible platform for the
design, prototyping, and manufacturing of new design, prototyping, and manufacturing of new implantable products.implantable products.
o ISSYS implantable products include an electronics chip ISSYS implantable products include an electronics chip As a result, the modification of the implant to include As a result, the modification of the implant to include other sensors (or functionalities) can be easily other sensors (or functionalities) can be easily accomplished by redesigning this electronics chip.accomplished by redesigning this electronics chip.
o Proprietary, biocompatible, hermetic sealing technique Proprietary, biocompatible, hermetic sealing technique that ISSYS has developed allows the integration of other that ISSYS has developed allows the integration of other components into the implantable device.components into the implantable device.
o ISSYS implantable products can be easily modified to ISSYS implantable products can be easily modified to measure other parameters than pressure.measure other parameters than pressure.
Slide Slide 1818
Slide Slide 1919
Other Applications
Intracranial Pressure MonitorsIntracranial Pressure Monitors
Bladder Pressure MonitorsBladder Pressure Monitorsfor Incontinencefor Incontinence Wireless Orthopedic Wireless Orthopedic
Monitoring ConceptsMonitoring Concepts
Implication and Future DirectionsImplication and Future Directions
o Closed LoopsClosed Loopso Pacemaker OptimizationPacemaker Optimization
o Drug deliveryDrug delivery
o Home MonitoringHome Monitoring
o Other Parameters:Other Parameters:o FlowFlow
o TempTemp
o PhPh
o COCO22
o Oxygen SaturationOxygen Saturation
Slide Slide 2020
