Technology Challenges for Active Cardiac Implantable Devices

Alain Ripart – Senior VP and CSO

Heart rhythm disorders and associated therapy devices

Bradycardia

Atrial Arrhythmias

Ventricular arrhythmias

Congestive Heart Failure

Pacemaker

Pacemaker

ICD

CRT-D2

Smart, Powerful, Small

CRT-D

PMMarket value

2 844 2 890

211 190

2 7614 372

1 814

3 120

2007 2012

M€ 7,629

M€ 10,573

Heart Failure

Tachycardia

Bradycardia

11,5

9,6

0,2

CAGR, 2004-09 (%)

CRT-D

ICD

Total 6,7%

PM

CRT-P

3

Active Cardiac Implantable Devices

RFcommunication

Low powerCPU

Analog sensing & pacing

RAM ROM

MEMSSensors

High voltageDefibrillation

Wireless RemoteMonitoring

Programming System

Titaniumpackage

Hermeticpackage 4

Requirements for an implantable sensor

Physiologic but simple

Miniature

Integration

Low current consumption

Reliable Hermetically sealed

Biocompatible

Leadless / Wireless

5

1D Accelerometer

Accéléromètre

Batterie

What's inside the package?

Feedthrough with ground wire and capacitor filters

Hybrid circuit encompasses only components automatically managed by "Pick & Place" machine

Flex circuit provide high density interconnection and cancels complex & risky feedthrough wire bending

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What’s inside? Hybrid circuit

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Shock circuits

9

1 sec.1 sec.

20 J, T/N.20 J, T/N.DDD, 90 bpmDDD, 90 bpmV: 4.8 V, 0.37 msV: 4.8 V, 0.37 ms

LAE DALAE DA

Défibrillation

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What’s inside? Ovatio defibrillator

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Defibrillator downsizing

0

20

40

60

80

100

120

140

1993 1994 1995 1996 1997 1998 1999 2000

VVIDDD

cc

2001

010

2030

40

5060

7080

78 c

c

49 c

c

39 c

c

29 c

c

Mechanics & interconnexionConnectorElectronicsCapacitorsrsBattery

2002 2003

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PoP and WDoD package

Innovations from : IPEDIAIntegration of passive components in silicon

3D

Adapted from NXP

PN532

3DCS

P5CN072

PN532

3DCS

P5CN072

3DCS3DCS

A technical challenge in CRM : circuit & package miniaturization

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Hybrid Platform

1 2 3

4 5 6

8 7 9

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Detailed views of DIAMOND stack process

Hybrid

Heart failure

2005: up to 14 million Europeans currently suffer from heart failure.

2020: increasing to 30 million.

Over 3.6 million new cases of heart failure are reported each year in Europe.

First cause of cardiovascular mortality in Europe.

Heart Failure is the most common cause of hospital admission in people over 65.

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HF heart status change over time• CRT settings must be repeatedly tailored

to the individual patient

Self-adjustment of CRT parameters • Cardiac resynchronization is permanently

tailored to the patient• Replaces time-consuming echocardiographic assessment required with

conventional CRT devices require

Monitoring of the patient’s status

Optimal Management of Heart Failure

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Heart failure sensor

Distal End, with accelerometer inside

Pacing Tip

Proximal end; connector fits into pacemaker receptacle

Lead body (length=60cm)

Lead Connections

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Capteur SonR

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What does the signal look like?

PEA I

PEA II

0 1 2

0

100

200

-0.5

0

0.5

EA (g)

PHONO

BP (mmHg)

ECG

t (s)

Isovolumic Contraction Phase Isovolumic Relaxation Phase

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Clinical Efficacy of CRT continuous optimization with SonR versus standard clinical practice.

Heart Rhythm 2010 ;7(5s):AB27_4

.L.Padeletti et al

The future: exercise adaptive & monitoring of resynchronization

Neuronal Co-Processor

Micro-controller

Hemodynamic sensors

RA lead

RV lead

LV lead CRT / CRT-D Device

PulseGenerator,

Sense Amps

Real time AV and VV intervals optimization during exercise

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Monitoring of implanted patients for detectionof

Cardiac Decompensation

(early detection of pulmonary oedema condition)

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Ventilation measurement

ela

Injection (I)

Measure (dV)

Bonnet JL, Ritter P, Pioger G et al. Measurement of minute ventilation with different DDDR pacemaker electrode configurationsPacing And Clinical Electrophysiol 1998; 21 ; 1 [Pt I] : 4-10

ΔZ=ΔV/I and VE=k.ΔZ

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Clinical case: True positive

Alarm by the RestRule first thenthe Activity rule

Patient hospitalized for CHF at the end of the 3-month FU phase D88).An alarm was delivered 1 month before at D58.

ALARMS

Rese

arch

softw

are

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CRT system with multielectrodeslead

AMICA ASICs

Electrodes

Lead

Multiple distributed & communicating hemodynamicsensors for diagnosis and treatment of HF

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Biocompatible packaging with ASIC substrate and sensor

0.3mm

2 mm1mm

0.8 mm

0.9 mm

0.9 mm

chip

MEMSAccelerometer

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Evolution of implanted devices

S

S

SA

A

A

S S

FROM

A device with one, simple sensor on one lead

A device with- multiple, complex sensors- multiple, complex actuators- wired and wireless

TO

S S

S S

A

A

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RESEARCH in FP7: Leadless pacemakerIC Device 1 (Technology 1)

MetallisationSystem 1

IC Device 2 (Technology 2) with TSV

MetallisationSystem 2

IC Device 2 (Technology 2) with TSV

MetallisationSystem 2Metallisation

MEMS/NEMS Device possibly with TSV

Cap -Chip (Wafer)

MEMS/NEMS Device possibly with TSV

Cap -Chip (Wafer)

MEMS/NEMS Device possibly with TSV

Cap -Chip (Wafer)

e-BRAINS

25mm

Diameter: 6 mmLength: 26 mm

Leadless pacing system

Heart beat

Energy scavenger

Leadless pacemaker

Communication Synchronization

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RESEARCH in FP7: Leadless pacemakerIC Device 1 (Technology 1)

MetallisationSystem 1

IC Device 2 (Technology 2) with TSV

MetallisationSystem 2

IC Device 2 (Technology 2) with TSV

MetallisationSystem 2Metallisation

MEMS/NEMS Device possibly with TSV

Cap -Chip (Wafer)

MEMS/NEMS Device possibly with TSV

Cap -Chip (Wafer)

MEMS/NEMS Device possibly with TSV

Cap -Chip (Wafer)

e-BRAINS

24mm*15mm*5mm

8 cc

1CC

Remote Follow-upof implanted

Cardiac active devices

Telemedecine… was born

a long time ago !

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non emergencymonitoring of device

and patient

Homemonitor

CRMpatient

IMD

Clinician access

home monitor inventoryHome Monitors and ICD

deliveries

Helpdesk

Orange hosting centre Orange application service

Sorin remote monitoring :a global solution

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Hearing aids

Cardiac implants

Cochlear implants

Insulin pumps

2.4GHzmW‐level

<4x4x1 mm3

WBAN

RF+IF+LF MEMS 

RF & DSP SoC

RADIO IC65nm CMOS

RF & LF MEMS

WiserBAN microsystem

Heterogenous SiP

Miniature antenna

Smart miniature low-power wirelessmicrosystem for Body Area Networks

Smart Systems for CRM What do we need ?

Ultra miniature micro-systems including

High density sub micron technology chips.

Large capacity static RAM

Sensors : accélérometers, pressure, impédance to measure activity,workloadposition,contractility,volume,minute-ventilation ,left side pressures etc…

RF transmission : antennas, Baw filters ,RF Mems for switches or sensors.

HV switches and storage capacitors.

Low leakage Hi energy density battery ,efficient energy scavengers

Micro-encapsulation, micro-connectors

Low current consumption

Reliability and Biocompatibility: Blood tightness.

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THANK YOU FOR YOUR ATTENTION

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Biocompatible packaging with glass substrate• ENCAPSULATION STEPS

(1): silicon case cover                                 (2) : gold connection pad(3): borosilicate substrate                         (4) : cavity for the ASIC(5): ASIC de‐multiplexers  integration    (6) : gold interconnections 

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