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Advancing Neuromodulation Device
Development with Turnkey Implantable
Connector Systems
Mark Russell
Sr. Global Category Manager
Bal Seal Engineering
• Active medical implantables that deliver
life-improving therapies, including:
 Cochlear/middle ear
 Cortical
 Deep brain (DBS)
 Vagus nerve (VNS)
 Functional electrical stimulation (FES)
 Peripheral nerve stimulation (PNS)
 Spinal cord (SCS)
 Sacral nerve (SNS)
• Increasingly employ closed-loop systems
 Adjust stimulation parameters in real time to
optimize effectiveness
DEFINING NEUROMODULATION DEVICES
2
B A L S E A L . C O M
• Need to focus limited resources on
therapy advancement, NOT
component development & testing
• Pressure to get to market faster
w/devices requiring greater
functionality (i.e., closed loop)
• Desire to integrate only proven
technology (risk averse)
• Patient/surgeon demand for smaller
devices
NEUROMODULATION DEVICE CHALLENGES
3
B A L S E A L . C O M
• Header
 Where lead meets electronics &
power source
 Represents as much as 30% of device
size
• Interconnect
 Consists of connector components
and seals, fixed connections
 Area of primary focus for device
functionality (connection count) & size
reduction
FOCUS ON THE DEVICE HEADER & INTERCONNECT
4
B A L S E A L . C O M
INTERCONNECT ECONOMICS
5
B A L S E A L . C O M
Vertical
integration
Outsourcing
• Complete control of
production process
• Ownership of designs
& IP
• Large capital investment
• Limited speed to market
• Resource drain
• Quick access to proven, pre-
tested solutions
• Increased speed to market
• Engineering assistance
• Consolidation
• Ability to focus on
development, not components
• Reduced control of
production process
• Turnkey alternative to vertical
integration, they can eliminate need for
internal component development
• Consist of compact, biocompatible
electrical connectors & seals for electrical
isolation, protection from fluid ingress
• Leverage proven, high-performance
components
 Example: Bal Seal Engineering’s SYGNUS
implantable connector system
A SOLUTION: IMPLANTABLE CONNECTOR SYSTEMS
B A L S E A L . C O M 6
• To deliver optimal performance, these compact systems of serially-
configured connectors & seals should have these features:
CONNECTOR SYSTEM PERFORMANCE INDICATORS
7
B A L S E A L . C O M
Small pitch to conserve header or inline
interconnect space & provide greater
connector density for more device
functionality
Implantable-grade silicone seals for fluid
sealing & electrical isolation
Spring contact element for reduced failure risk
Ultra-low contact resistance (<100 mΩ) for
better signal integrity and longer device life
2mm
• Biocompatibility
 Can be ensured with selection of proven materials,
such as:
▸ MP35N®
▸ Platinum iridium
▸ Titanium
▸ Stainless/stainless
• Insertion force
 Can be minimized by using a connector that offers
customizable control of lead insertion/removal
requirements
• Reliability
 Can be optimized by employing:
▸ 100% force verification
▸ Heat lot material control
CONNECTOR SYSTEM DESIGN CONSIDERATIONS
8
B A L S E A L . C O M
• Male interface diameter and
tolerance
• Materials that will interact with
the contact
• Space availability for contact OD
• Force contribution of contact and
fluid seals
• Electrical resistance requirements
CONNECTOR SYSTEM DESIGN CONSIDERATIONS
B A L S E A L . C O M 9
• To maintain focus on therapy advancement,
reduce neuro device size AND boost connection
density, consider integrating proven a
implantable electrical connector system, such as
Bal Seal Engineering’s SYGNUS
• Consider connector system requirements as part
of your overall device design
• In early design stages, collaborate with Bal Seal
Engineering to:
 Get consultative engineering advice
▸ Lead interface design
▸ Integration methods
▸ Industry practices
▸ Performance and design impact discussion
▸ Recommendations for integration partners
SUMMARY & RECOMMENDATIONS
10
B A L S E A L . C O M
RESOURCES & CONTACT INFORMATION
Mark Russell
Sr. Global Category Manager, Medical Implantables
Bal Seal Engineering
mrussell@balseal.com
+1 612.590.2187
marketing@balseal.com www.balseal.com +1 949.460.2100 Design request form
B A L S E A L . C O M 11

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Advancing Neuromodulation Device Development with Turnkey Implantable Connector Systems

  • 1. Advancing Neuromodulation Device Development with Turnkey Implantable Connector Systems Mark Russell Sr. Global Category Manager Bal Seal Engineering
  • 2. • Active medical implantables that deliver life-improving therapies, including:  Cochlear/middle ear  Cortical  Deep brain (DBS)  Vagus nerve (VNS)  Functional electrical stimulation (FES)  Peripheral nerve stimulation (PNS)  Spinal cord (SCS)  Sacral nerve (SNS) • Increasingly employ closed-loop systems  Adjust stimulation parameters in real time to optimize effectiveness DEFINING NEUROMODULATION DEVICES 2 B A L S E A L . C O M
  • 3. • Need to focus limited resources on therapy advancement, NOT component development & testing • Pressure to get to market faster w/devices requiring greater functionality (i.e., closed loop) • Desire to integrate only proven technology (risk averse) • Patient/surgeon demand for smaller devices NEUROMODULATION DEVICE CHALLENGES 3 B A L S E A L . C O M
  • 4. • Header  Where lead meets electronics & power source  Represents as much as 30% of device size • Interconnect  Consists of connector components and seals, fixed connections  Area of primary focus for device functionality (connection count) & size reduction FOCUS ON THE DEVICE HEADER & INTERCONNECT 4 B A L S E A L . C O M
  • 5. INTERCONNECT ECONOMICS 5 B A L S E A L . C O M Vertical integration Outsourcing • Complete control of production process • Ownership of designs & IP • Large capital investment • Limited speed to market • Resource drain • Quick access to proven, pre- tested solutions • Increased speed to market • Engineering assistance • Consolidation • Ability to focus on development, not components • Reduced control of production process
  • 6. • Turnkey alternative to vertical integration, they can eliminate need for internal component development • Consist of compact, biocompatible electrical connectors & seals for electrical isolation, protection from fluid ingress • Leverage proven, high-performance components  Example: Bal Seal Engineering’s SYGNUS implantable connector system A SOLUTION: IMPLANTABLE CONNECTOR SYSTEMS B A L S E A L . C O M 6
  • 7. • To deliver optimal performance, these compact systems of serially- configured connectors & seals should have these features: CONNECTOR SYSTEM PERFORMANCE INDICATORS 7 B A L S E A L . C O M Small pitch to conserve header or inline interconnect space & provide greater connector density for more device functionality Implantable-grade silicone seals for fluid sealing & electrical isolation Spring contact element for reduced failure risk Ultra-low contact resistance (<100 mΩ) for better signal integrity and longer device life 2mm
  • 8. • Biocompatibility  Can be ensured with selection of proven materials, such as: ▸ MP35N® ▸ Platinum iridium ▸ Titanium ▸ Stainless/stainless • Insertion force  Can be minimized by using a connector that offers customizable control of lead insertion/removal requirements • Reliability  Can be optimized by employing: ▸ 100% force verification ▸ Heat lot material control CONNECTOR SYSTEM DESIGN CONSIDERATIONS 8 B A L S E A L . C O M
  • 9. • Male interface diameter and tolerance • Materials that will interact with the contact • Space availability for contact OD • Force contribution of contact and fluid seals • Electrical resistance requirements CONNECTOR SYSTEM DESIGN CONSIDERATIONS B A L S E A L . C O M 9
  • 10. • To maintain focus on therapy advancement, reduce neuro device size AND boost connection density, consider integrating proven a implantable electrical connector system, such as Bal Seal Engineering’s SYGNUS • Consider connector system requirements as part of your overall device design • In early design stages, collaborate with Bal Seal Engineering to:  Get consultative engineering advice ▸ Lead interface design ▸ Integration methods ▸ Industry practices ▸ Performance and design impact discussion ▸ Recommendations for integration partners SUMMARY & RECOMMENDATIONS 10 B A L S E A L . C O M
  • 11. RESOURCES & CONTACT INFORMATION Mark Russell Sr. Global Category Manager, Medical Implantables Bal Seal Engineering mrussell@balseal.com +1 612.590.2187 marketing@balseal.com www.balseal.com +1 949.460.2100 Design request form B A L S E A L . C O M 11