THE NEXT GENERATION OF SMART IMPLANTS -

THE NEXT GENERATION OF

SMART IMPLANTS

Glass Encapsulation

By

Donald Styblo

Vice President of Technology

Valtronic Technologies (USA), Inc.

Active Implants Overview

Cylindrical Glass Encapsulation CGE

Planar Glass Encapsulation PGE

Future Platform for Innovative Implantable Devices

OUTLINE

9/21/2013 The Next Generation of Smart Implants - Glass

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ACTIVE IMPLANTS OVERVIEW

What Do We Mean By Active?

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

treat a patient according to specific conditions

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 6 months to over 50 years

ACTIVE IMPLANTS


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Increased safety of patient: resistant, long term stable,

biocompatible

Longer autonomy: ultra-low power electronic, transfer and

storage

Patient “on-line” information:

Data computing and front-end data treatment

Accessible real time data (mobile applications)

Minimally invasive:

Miniaturization, functionalization of encapsulation

More interaction with biological elements:

More accurate measurement and stimulation

ACTIVE IMPLANTS INDUSTRY TRENDS


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• )


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WIRELESS PACEMAKER Wireless Pacemaker with rechargeable battery

SMART IMPLANT CHALLENGES AND EXAMPLES


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Reliable Processes

& Technology

Powering & Autonomy

Detection & Sensing

Interaction Communication Memory

&

Packaging / Encapsulation

Substrate design with specific metallization

Die attach with specific materials

COB with fine Ag or Al wire

Chip on Chip

Ultra fine pitch Wire Bonding

Ultra Sonic Flip Chip

High Precision SMT (01x005)

3DCSP

MINIATURIZATION TECHNOLOGIES


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External RF link Non self powered implant

Compatible with reduced dimensions

Rechargeable Battery Size non-compatible with highly integrated device

External device is needed for the patient

Permanent Battery Non-compatible with highly integrated device

Battery needs to be replaced after a defined period

“Harvesting” Energy concepts Bio-Fuels

Wireless Pacemaker rechargeable batteries

POWERING CONCEPTS


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Smart Pill

External link

Bi-Directional link

Continuous Monitoring (100%/24/7)

Duty cycling of measurements and data creation

Power storage

COMMUNICATION & MEMORY


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ENCAPSULATION APPLICATION CLASSIFICATION


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Short term human contact (24-48 hr)

Silicone encapsulation

Medium term human contact (30 days – 6 month)

Epoxy / multilayer encapsulation:

Long term implantation (1 – 5 – 10 Years)

Titanium housing

Long term implantation (1 – 5 – 10 – 15+ Years)

Glass encapsulation (cylindrical or planar) no battery


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GLASS ENCAPSULATION OVERVIEW

9/21/2013 The Next Generation of Smart Implants -

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ADVANTAGES OF THIS GLASS

WELDING PROCESS

Our scientists and research partners have

developed a room-temperature pulsed laser welding process specifically for sealing Cylindrical Glass Encapsulation (CGE) & Planar Glass Encapsulation (PGE)

CGE and PGE implants under special

environmental conditions The temperature inside the implant’s cavity

remains at less than 80°C throughout the sealing process, which eliminates the potential for heat damage to the encapsulated circuitry.



ENCAPSULATION PROCESS

No auxiliary materials such as intermediate layers or

adhesives are involved in the encapsulation process, which

helps to maintain glass’s high biocompatibility.

The process also ensures the implant’s high hermeticity,

preserving the integrity of embedded elements by protecting

them from moisture, the condition of being hermetic (airtight).

Hermeticity is the desired result in glass sealing. A prime

example of hermetic seals are in light bulbs, in which metal

conducting wires are sealed through glass in order to

maintain integrity.



TESTING

Our scientists and research partners have confirmed this high level of hermeticity through extensive tritium leakage tests, steam tests in autoclaves, and direct helium leakage testing.

Shear, pressure, tensile vibration and de-bonding energy tests were used to characterize the mechanical stability of the complete implant package.

High hermeticity protects patients from the effects of the breakdown of components and material inside the implant.

GLASS ENCAPSULATION TYPES


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Figure 1. CGE implants can be small enough to be injected in a patient with a

hypodermic needle.

Figure 2. Compact planar glass encapsulated (PGE) implants.


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CYLINDRICAL GLASS ENCAPSULATION (CGE)

Process Equipment

CGE / PGE Equipment

All Main Process Functions Integrated

Dedicated Process Software

Automated Processing

Dedicated Formulations

LASER WELDING PROCESS


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Low temperature process!

Preserves integrity of embedded elements

CGE Capability Today Glass Types: Boroscilicates, AR, KOVAR,

Quartz, Bio glass

Dout: 4/6/8 mm [2…12mm<4 weeks]

Wall Thickness: 0.4 – 0.6 mm [other< 4 weeks]

Length: 12…50 mm [<12: on request]

CGE Bio-compatibility According to ISO 10993-1 (the procedure for the assessment

of medical devices and their constituent materials with regard

to their potential to produce irritation and skin sensitization).

CGE Tightness >10 years (electronics protected against

breakdown by moisture proved by tritium tests complete)

TOP LEVEL SPECIFICATIONS


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Swiss Military Watch

Commander model with

tritium-illuminated face

http://en.wikipedia.org/wiki/Swiss_Military_Watch

APPLICATION: INJECTABLE GLUCOSE

MEASUREMENT SYSTEM


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The miniaturized sensor is designed to

measure glucose in the interstitial fluid


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GI-PILL: (FOR CHILDREN), 6MM X 18MM

Challenge:

• < 80oC for the Electronics

GI-PILL: (FOR ADULTS), 8MM X 24MM


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Challenge:

< 80oC for the Electronics

Internal coating and Glued/Bonded

Electronics

IMPLANTS CGE ---- PGE

Challenge (for CGE):

< 80oC for the electronics

13 mm long (today‘s minimum)

Membrane fixed outside of the

glass




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PLANAR GLASS ENCAPSULATION (PGE)

Glass encapsulant itself may perform a function other than

simply encapsulation, such as actually monitoring

pressures (blood or intracranial)

PGE assembly process supports a high level of feature

(leads) density in extremely small implants and has a high

level of hermeticity

PLANAR GLASS ENCAPSULATION (PGE)


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Laser Glass – Glass Joining Process Parameter

optimization

First test of mechanical stability (seam)

(shear resistance/binding energies)

ASSEMBLY PROCESS


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Test Devices 2nd Generation

Big cavities to meet requirement of product with and without

Total Glass Vacuum (TGV) for helium leakage test and

tritium tightness tests.

HERMETICITY


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Proven long term hermeticity!


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PROCESS FOR PLANAR IMPLANT

ENCAPSULATION

Process Step One :

Provision of cover glass → metallization (inside/outside)


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Process Step Two: Incoming inspection of the electronic device (IC) →

Contacting Electronic Device (inside) → Testing → Quality Control (QC) →

Curing Process


ENCAPSULATION


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Process Step Three: Provision of raw material (glass compartment with

cavity) → Combining with cover glass/preparation for sealing → Joining by

laser welding (at room temperature and under special environmental

conditions) → Hermeticity QC → Packaging (sterilization upon request,

depending on further processes required for finishing implants).


ENCAPSULATION

GOLD PLATING OF TUNGSTEN VIAS


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Enable micro-assembly

interconnection technologies!

Processing Contact Layer (Au) on Glass and Tungsten Vias

as pads and as circuit paths

Contacting Sensors direct on Tungsten Vias and direct on

circuit paths

CONNECTIVITY AND HOUSING FUNCTION


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MICROSTRUCTURE INSIDE THE

HERMETIC CAVITY


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CONNECTING TO BIO

(HIGH DENSITY FEED-THROUGH)


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First electrical contacting

Direct contacting platinum-iridium on Tungsten Vias by

laser

Classical Platinum versus Titanium Nitride (TiN) or

Iridium Oxide) (IrOx) with surface enhancement

CONNECTING TO BIO AND LEADS


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COATINGS Titanium Nitride (TiN)

TiN coating improves stimulation and sensing capabilities, enabling better device

performance. The impedance value (at 1 Hz) for Medical TiN coated electrodes is found

to be on the order of 102 - 103 times lower than that of uncoated metallic electrodes.

Greatbatch Medical has engineered low polarization titanium nitride (TiN) coatings to

meet the modern implantable electrode requirements for CRM applications. Millions of

Greatbatch Medical TiN coated electrodes have been implanted worldwide

Iridium Oxide) (IrOx)

The electrochemically active surface area of the electrode can be increased by

coating the electrode with electro-active coatings such as IrOx. IrOx coatings are

biocompatible with neural and cardiac tissue and require a lower thickness of coating.

Additionally, this coating optimizes the stimulation electrode design by reducing the

size and utilizes less battery power to drive the implantable device.


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PLATFORM FOR INNOVATIVE

IMPLANTABLE DEVICE WITH HIGH

I/O COUNT

INNOVATIVE DESIGN APPROACH

With High I/O Connections

Elements

Silicone jacket

Microns

600

Enclosure Top thikness 300

Cavity for electonic's 1'000

Enclosure Bottom

thickness 300

FC Interconnect 50

Lead thickness 300

Total Thickness 2'550 Microns

2.55 mm


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Electrode lead Gold stud bumps Underfill

Silicone jacket

Enclosure ASIC/MEM’s/SiP

Wire bonded

/ FC

interconnecti

on

To

tal T

hic

kn

ess

Side View

Interconnec

-

tions

n

Rows n

Col Casing +

inner

space

Dim

Row (L)

microns

Dim Col

(l)

microns

72 1 72 1'500 1'750 19'500

2 36 2'000 10'500

3 24 2'250 7'500

4 18 2'500 6'000

5 15 2'750 5'250

6 12 3'000 4'500

7 11 3'250 4'250

8 9 3'500 3'750

9 8 3'750 3'500

10 8 4'000 3'500

Enclosure P

itch

25

0 u

m

L

l

INTERCONNECTION SIZE EVALUATION:

Please note that this only considers the interconnections

spaces and not include the real volume needed to

encapsulate the electronic components.

Surface reduction compare to

feed through technology: over 70%

INNOVATIVE DESIGN APPROACH


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Bottom View

Thank you for your attention.

Questions?

Donald Styblo

Vice President of Technology

Valtronic Technologies (USA), Inc.

Documents

THE NEXT GENERATION OF SMART IMPLANTS -