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Integrated Sensing Systems (ISSYS)

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Implantable Sensor Integrated Sensing Systems (ISSYS) Novel Wireless, Batteryless, Implantable Sensors for Chronic Disease Management The First Annual Unither ... – PowerPoint PPT presentation

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Title: Integrated Sensing Systems (ISSYS)


1
Integrated Sensing Systems (ISSYS)
Novel Wireless, Batteryless, Implantable Sensors
for Chronic Disease Management
The First Annual Unither Nanomedical and
Telemedical Technology Conference April 3, 2008
2
Integrated Sensing Systems (ISSYS)
  • ISSYS was established in January 1995.
  • One of the oldest independent MEMS companies in
    the U.S.
  • Vertically Integrated Technical Company
  • Entire sensing system
  • Sensor, circuit, software, package, delivery,
  • Full Bio-MEMS Manufacturing Facility
  • High Quality Manufacturing
  • ISO 9001 2000 Certification
  • ISO 13485-2003 Compliance (FDA)
  • First FDA 510(k) Granted 2006

Slide 2
3
ISSYS Core Technologies
  • Wireless, batteryless, implantable pressure
    sensors
  • Tremendous market potential in many emerging
    medial fields.
  • Resonating micro-tubes
  • Comprehensive analysis of fluidic properties
    (density, concentration, viscosity, mass flow,
    and temperature).
  • Unprecedented advantages in functionality,
    performance, size, and cost.

Slide 3
4
ISSYS GoalTo Greatly Improve Disease Treatment
We believe that the treatment of many diseases
can be greatly improved by dynamically tailoring
the medication via monitoring through frequent
and non-invasive measurements using ISSYS
products.
Slide 4
5
Wireless Sensing System
  • Two system components
  • Implantable pressure sensor(s)
  • External handheld readout unit
  • The components communicate using RF telemetry.

Slide 5
6
Congestive Heart Failure (CHF)
Many experts consider CHF to be the largest
emerging medical market
Slide 6
7
ISSYS GoalTo Greatly Improve CHF Treatment
  • Improve patient outcomes and lower cost of care
  • Dynamically tailor medication over time
  • Modify patient behavior

Slide 7
8
Left Atrium Pressure
  • Today there are other companies that are
    developing miniature wireless implant products
    for monitoring pulmonary artery pressures.
  • While PA pressure is beneficial, compared to no
    input, it is not the most useful waveform for
    CHF.
  • The left atrium pressure is the holly grail for
    the treatment of CHF.
  • Today, ISSYS offers the only viable technology
    for miniature wireless monitoring of the left
    atrium pressure.

Slide 8
9
Left Atrium Pressure
  • ISSYS left atrium implant platform
  • Minimum protrusion inside the left heart
    (extremely important)
  • A practical anchor
  • Catheter delivery (similar to current
    transcatheter patch atrial septal defect (ASD)
    occlusion implants)
  • Outpatient procedure

Anchor
Atrial Septum
Pressure Sensor
Right Atrium
Left Atrium
Slide 9
10
Cardiac Implant Specifications
  • Application Tailored treatment of congestive
    heart failure (CHF)
  • Implantation Locations
  • Left atrium
  • Atrial Septum
  • Delivery and Anchoring
  • Outpatient procedure
  • Catheter based
  • Similar to the current cardiac procedures
  • Small Catheter Size lt 16 French (ideally lt14
    French)

Slide 10
11
Cardiac Implant Specifications
  • Monitored Pressure Waveforms
  • Look the same as the current catheterization
    waveforms
  • No new training required
  • Complete waveform
  • Real time
  • Continuous
  • Chronic use (over the patients life)
  • Ability to read wide range of cardiac pressures
  • -100 to 300 mmHg
  • Detailed
  • High-fidelity data with sensitivity of 0.3 mmHg
    and accuracy of 1mmHg,
  • Fast (200 samples/second) data gathering

Slide 11
12
Cardiac Implant Specifications
  • Communication
  • Tele-communication distance over 10 cm (15 cm
    desirable)
  • Tele-powering distance over 10 cm (15 cm
    desirable)
  • Robust
  • FDA FCC compliant
  • Handheld Readout Unit
  • Small size
  • In particular for home monitoring applications by
    patients
  • Easy to use
  • Minimal training
  • Antenna working with a wide angle relative to the
    implant location

Slide 12
13
ISSYS Wireless Probe vs Millar Catheter Left
Ventricle
Slide 13
14
ISSYS Wireless Probe vs Lumen Filled Catheter
Right Ventricle
Slide 14
15
ISSYS Wireless Pressure Probe vs Lumen Filled
Reference Sensor Right Ventricle
Slide 15
16
Sensor Placed in RV Outflow Tract
After 78 days of implant in the right ventricle,
there was no measurable cell growth on top of the
MEMS pressure sensor.
Slide 16
17
Histology Tests
External Area
Enlarged Area Below
  • Wayne State University has been performing
    comprehensive histology tests on ISSYS implants
    at different cardiovascular locations.
  • All the histology tests up to now have shown
    outstanding results.

Cardiac Muscle Tissue
Internal Area
Slide 17
18
Enabling Platform
  • ISSYS has intentionally created a flexible
    platform for the design, prototyping, and
    manufacturing of new implantable products.
  • ISSYS implantable products include an electronics
    chip As a result, the modification of the implant
    to include other sensors (or functionalities) can
    be easily accomplished by redesigning this
    electronics chip.
  • Proprietary, biocompatible, hermetic sealing
    technique that ISSYS has developed allows the
    integration of other components into the
    implantable device.
  • ISSYS implantable products can be easily modified
    to measure other parameters than pressure.

Slide 18
19
Other Applications
Intracranial Pressure Monitors
Bladder Pressure Monitors for Incontinence
Wireless Orthopedic Monitoring Concepts
Slide 19
20
Implication and Future Directions
  • Closed Loops
  • Pacemaker Optimization
  • Drug delivery
  • Home Monitoring
  • Other Parameters
  • Flow
  • Temp
  • Ph
  • CO2
  • Oxygen Saturation

Slide 20
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