Recent Developments in Active Implants · Implantable leadless cardiac pacing device for treatment...

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Recent Developments in Active Implants

Innovation of interconnections for Active Implant Applications

Valtronic’s Overview

1) Introduction of Valtronic:

from Micro-technology to Medtech

2) Active Implants:

application of miniaturized assembly technologies

3) From industry to Medtech:

adaptation to specific constrains

30 Years in Micro Technology

1990 Electronic Module for Discovery Space Shuttle

1995 Chip for Formula One race

2000 World's smallest hearing aid

2006 World's smallest implantable pulse generator

2006 Retinal Implant for the Blind

2009 "Smart Pill" Wireless Motility Capsule

What Do We Mean By Smart?

An implant that is able to provide in-vivo diagnostic biofeedback

and/or treat a patient according to specific conditions

Smart Implants

Microsystem measuring and transmitting

diagnostic data during or after implantation

Needs to function in an autonomous way

during the lifespan of a product which

varies from six months to over fifty years

Monitoring Diabetics

Minimal Power Consumption – no battery

Tiny antenna and extreme miniaturization (COC, COB and 01005 SMD)

Assembled in a RF transparent, bio-compatible material housing

Measures 4mm thick x 17 mm diameter

Acquires, processes and analyzes brain activity

Implantable EEG Recorder

Allows ophthalmologists to observe the behavior of intraocular

pressure continuously, particularly during while sleeping

Treating Glaucoma

Built-in flexible electronics, silicone,

ultrasonic flip-chip process and clean

manufacturing

Preventing Heart Failure

Implantable leadless cardiac pacing

device for treatment of heart rhythm

management

Six-layer flex board, 2mil lines and

spaces, ENEPIG process.

Stimulate/pace the heart through wireless transmission of energy

Smart Implant Challenges

Reliable Processes

& Technology

Powering & Autonomy

Detection & Sensing

Interaction Communication Memory

&

Packaging / enclosure

Design Constraint Trends in Stimulation Field

More specific stimulation features:

More electrodes & leads

Innovative electrode design

Channel modulation

Device as minimally invasive as possible:

Smaller Implant size

Smaller and reliable interconnections

Application of micro-technology assembly

to Active implant device

• Long term reliability of assembly

• Extreme miniaturization

• High computation power at low power

Wire-bonding with over molding

Ultrasonic Flip-Chip

Miniaturization of micro-elecronics

Chip on Board

1.- Glue on substrate (FR4, Flex, G10 etc.)

2.- Die attach

3.- Wire bonding & testing

4.- Coating & testing

Miniaturization - Wire-Bonding with Over Molding

Internal electronic of a

cochlear implant

Chip-on-board assembly with 0201

components

Product lifetime 75 years!

.

Miniaturization - Ultrasonic Flip Chip Bonding

Assembly of flexible electronics in a silicone rubber lens

Clean manufacturing

10x faster than glued flip-chip

Lowest total cost of ownership

Allows ophthalmologists to observe the

behavior of intraocular pressure during

sleep.

PCB

PCB

DIE

DIE

PCB

PCB track

Ultrasonic Flip Chip

Underfill of non-conductive adhesive

PCB

Temperature + Pressure + Ultrasonic Power

DIE

High Density Ultra-Sonic Flip-Chip Process

Gold Bumping Ultrasonic Flip-Chip Dispensing

Applied to active Implant interconnection lead

High density Ultra-Sonic Flip-Chip Process Process Characteristics:

High Density Ultra-Sonic Flip-Chip Process

High Density Ultra-Sonic Flip-Chip

process

Reducing the required volume for the implants

Allowing innovative electrodes design

Ensuring the liability for long term implantation

Innovative Interconnection Technology means:

• Apply and adapt known technologies to “new” fields

• Adaptation to constrains :

• QA structure (ISO13485)

• EU/US regulation and norms application

• Clean Manufacturing

• Verified and validated processes

• Culture change

• Organization and business model adaptation

• Develop bridging technologies

How to get from Industry to Medtech?

Valtronic Core Competencies Contract Manufacturing & Engineering service for Medtechs’

SMT Fine pitch to 01005

3D chip-scale Wire bonding to 55µ density

Flip-chip <100µ pitch, HDI flex circuitry

5 axis CNC Machining, thread cutting, HSM

PEEK, Titanium, Pe-Hd, Chrome Cobalt, POM…

World-wide Supply Chain

DFM & DOE

Final packaging, sterilization & labeling

Project management

Valtronic at a Glance Today

Valtronic is a full-service provider of Engineering, Design and Contract

Manufacturing services.

We provide solutions ranging from micro-electronic and mechanical

parts to the design for manufacturing of complete devices.

Engineering Staff 70

Production Staff 480

Manufacturing Area 13’000 m2 of which 540 m2 clean room

(Class ISO 7 & 10K)

Served Markets Medical Devices (70%) and Select Industrial

No. of Class 3 Projects

(active implant) 22 projects in development, clinical trials or production

Dr. Peter Ruppersberg, CEO

The initial core competences in “Ultra-miniaturized”

assembly technologies are adapted to be the driver

bringing a high added-value to the Medtec world.

In conclusion

Route de Bonport 2 ~ 1343 Les Charbonnières ~ Switzerland ~ www.valtronic.com ~ +41 21 841 01 11

Thank you for your attention