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February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published,
or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United
States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party.
Cardiac Devices
• Manage and monitor pacing,
assist with ventricular pumping,
and defibrillate the heart
through the use of electrical
pulses
 Implantable cardioverter-
defibrillator (ICD)
 Pacemaker
 Ventricular Assist Device (VAD)
Source:BlausenMedical
Communications,Inc.
Source:GregoryMarcus,M.D.,MAS,FACC
Source: Biotronik, Inc.
Source:Medtronic,Inc.
Slide 3
February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published,
or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United
States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party.
The Role of The Interconnect
• A.K.A “connector block,” or “header
assembly” – it’s the area where lead
meets electronics, power source
 Consists of contact components and seals,
fixed connections
• Designs must support strict standards
for implantables (IS-1, IS-4 or DF-4),
and VAD requirements
• Represents as much as 30% of device
size
• Can help designers reduce device scale
for current and future therapies
 Shrink the interconnect, shrink the device
Slide 4
February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published,
or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United
States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party.
What’s Inside: The Electrical Contact
• Transfers current along
lead with high efficiency
• Must be ultra-reliable,
consistent, proven, easy
to integrate
• Contact materials must
be biocompatible
• Compact size
(influenced by lead
diameters & standards)
• Directly impacts
interconnect bulk
Common electrical
contact types for cardiac
Spring-based
Contact
Wire BasketLouver/Leaf
Spring
Slide 5
February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published,
or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United
States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party.
Contact Performance Factors
• Biocompatibility
 Can be ensured with selection of proven
materials:
 MP35N®
 Platinum iridium
 Titanium
 Stainless steel
• Conductivity
 Ultra-low contact resistance (<100 mΩ) can
ensure better signal integrity, longer device life
• Force
 Can be minimized by using technology that
offers precise control of contact features (i.e.,
wire/louver angles)
• Reliability
 Can be optimized by employing:
 Technology that ensures maximum contact
point redundancy
 100% force verification
Slide 6
February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published,
or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United
States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party.
Power Efficiency: A Closer Look
• In cardiac devices,
contacts must offer
uncompromising electrical
conductivity, enabling
reliable transmission of
power from the battery
and electronics to the
lead, and providing
consistent connectivity
and power efficiency
Slide 7
February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published,
or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United
States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party.
Low Insertion Force: A Closer Look
• Designers of cardiac devices
typically work with a
predetermined force budget,
and must allocate most of that
force to sealing components in
the header. The more force a
contact requires, the less
effective sealing may be. The
ideal contact requires minimum
insertion force, so that optimal
sealing and conducting can be
achieved
Slide 8
February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published,
or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United
States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party.
Spring-based Contact Technology
• Consists of spring in metal
housing
 Leverages mechanical and
electrical properties of canted
coil spring
 Multiple coils provide built-in
connection redundancy
 The compact axial length
allows more room for electrical
isolation in allowable window
 Example: Bal Conn®
electrical
contact
Bal Conn® electrical contact,
featuring Bal Spring® canted coil
spring technology
Slide 9
February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published,
or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United
States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party.
Bal Conn® Electrical Contacts
• Engineered for active
implantables & cardiac devices
• 20+ years of proven reliability
 Enabling therapy delivery in millions
of devices worldwide
• Consist of precision-engineered
metal housings with Bal Spring®
elements
 Family also includes:
 SYGNUS®
implantable contact system
 Combines Bal Conn electrical contacts and silicone
seals
Slide 10
February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published,
or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United
States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party.
Bal Conn® Electrical Contact Design
• In IS-4/DF-4/VAD
applications:
 Creates consistent force
during insertion and
removal by limiting spring
movement
 Reduces contact resistance
with more points of contact
 Meets ISO 27186
requirements for force and
contact resistance
Slide 11
February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published,
or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United
States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party.
Bal Conn® Electrical Contact Design
• In IS-1 applications:
 Proven to work with IS-1
seal elements
 Features axial spring design
enables low contact
resistance without noble
metals
 Potential replacement for
screw set to reduce duration
of surgery and eliminate
leak path
Slide 12
February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published,
or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United
States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party.
Bal Conn® Electrical Contact:
Application Examples
VAD In-line Connections Rhythm Management VAD Header Connections
Slide 13
February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published,
or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United
States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party.
Bal Conn® Electrical Contact: Materials
• Implantable-grade,
biocompatible materials
 Housing
 MP35N®
 Medical grade titanium
 Stainless steel
 Platinum iridium
 Spring
 MP35N®
 Platinum iridium
Slide 14
February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published,
or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United
States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party.
Summary & Recommendations
• To eliminate costly mistakes and delays,
consider electrical contact requirements
as part of overall system design
• In early design stages, collaborate with
Bal Seal Engineering to:
 Custom design components to meet all your
system/application requirements, not just
some
 Produce high-quality prototypes
 Perform testing to verify performance
 Force (spring)
 Conductivity (spring/housing)
 Transition successful prototype to full
production; 100 to 1M+ units
Slide 15
February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published,
or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United
States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party.
Resources & Contact Information
Mark Russell
Sr. Global Market Manager, Medical Electronics
Bal Seal Engineering
mrussell@balseal.com
+1 630.765.7255
solutions@balseal.com www.balseal.com +1 949.460.2100 Design request form
Improving the Performance of Cardiac Devices with Electrical Contacts

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Improving the Performance of Cardiac Devices with Electrical Contacts

  • 1.
  • 2. Slide 2 February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Cardiac Devices • Manage and monitor pacing, assist with ventricular pumping, and defibrillate the heart through the use of electrical pulses  Implantable cardioverter- defibrillator (ICD)  Pacemaker  Ventricular Assist Device (VAD) Source:BlausenMedical Communications,Inc. Source:GregoryMarcus,M.D.,MAS,FACC Source: Biotronik, Inc. Source:Medtronic,Inc.
  • 3. Slide 3 February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. The Role of The Interconnect • A.K.A “connector block,” or “header assembly” – it’s the area where lead meets electronics, power source  Consists of contact components and seals, fixed connections • Designs must support strict standards for implantables (IS-1, IS-4 or DF-4), and VAD requirements • Represents as much as 30% of device size • Can help designers reduce device scale for current and future therapies  Shrink the interconnect, shrink the device
  • 4. Slide 4 February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. What’s Inside: The Electrical Contact • Transfers current along lead with high efficiency • Must be ultra-reliable, consistent, proven, easy to integrate • Contact materials must be biocompatible • Compact size (influenced by lead diameters & standards) • Directly impacts interconnect bulk Common electrical contact types for cardiac Spring-based Contact Wire BasketLouver/Leaf Spring
  • 5. Slide 5 February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Contact Performance Factors • Biocompatibility  Can be ensured with selection of proven materials:  MP35N®  Platinum iridium  Titanium  Stainless steel • Conductivity  Ultra-low contact resistance (<100 mΩ) can ensure better signal integrity, longer device life • Force  Can be minimized by using technology that offers precise control of contact features (i.e., wire/louver angles) • Reliability  Can be optimized by employing:  Technology that ensures maximum contact point redundancy  100% force verification
  • 6. Slide 6 February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Power Efficiency: A Closer Look • In cardiac devices, contacts must offer uncompromising electrical conductivity, enabling reliable transmission of power from the battery and electronics to the lead, and providing consistent connectivity and power efficiency
  • 7. Slide 7 February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Low Insertion Force: A Closer Look • Designers of cardiac devices typically work with a predetermined force budget, and must allocate most of that force to sealing components in the header. The more force a contact requires, the less effective sealing may be. The ideal contact requires minimum insertion force, so that optimal sealing and conducting can be achieved
  • 8. Slide 8 February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Spring-based Contact Technology • Consists of spring in metal housing  Leverages mechanical and electrical properties of canted coil spring  Multiple coils provide built-in connection redundancy  The compact axial length allows more room for electrical isolation in allowable window  Example: Bal Conn® electrical contact Bal Conn® electrical contact, featuring Bal Spring® canted coil spring technology
  • 9. Slide 9 February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Bal Conn® Electrical Contacts • Engineered for active implantables & cardiac devices • 20+ years of proven reliability  Enabling therapy delivery in millions of devices worldwide • Consist of precision-engineered metal housings with Bal Spring® elements  Family also includes:  SYGNUS® implantable contact system  Combines Bal Conn electrical contacts and silicone seals
  • 10. Slide 10 February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Bal Conn® Electrical Contact Design • In IS-4/DF-4/VAD applications:  Creates consistent force during insertion and removal by limiting spring movement  Reduces contact resistance with more points of contact  Meets ISO 27186 requirements for force and contact resistance
  • 11. Slide 11 February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Bal Conn® Electrical Contact Design • In IS-1 applications:  Proven to work with IS-1 seal elements  Features axial spring design enables low contact resistance without noble metals  Potential replacement for screw set to reduce duration of surgery and eliminate leak path
  • 12. Slide 12 February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Bal Conn® Electrical Contact: Application Examples VAD In-line Connections Rhythm Management VAD Header Connections
  • 13. Slide 13 February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Bal Conn® Electrical Contact: Materials • Implantable-grade, biocompatible materials  Housing  MP35N®  Medical grade titanium  Stainless steel  Platinum iridium  Spring  MP35N®  Platinum iridium
  • 14. Slide 14 February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Summary & Recommendations • To eliminate costly mistakes and delays, consider electrical contact requirements as part of overall system design • In early design stages, collaborate with Bal Seal Engineering to:  Custom design components to meet all your system/application requirements, not just some  Produce high-quality prototypes  Perform testing to verify performance  Force (spring)  Conductivity (spring/housing)  Transition successful prototype to full production; 100 to 1M+ units
  • 15. Slide 15 February 20 © Copyright, Bal Seal Engineering, LLC. This document contains and/or refers to information that is PROPRIETARY to Bal Seal Engineering, LLC, and may not be reproduced, copied, published, or distributed in any form or disclosed to a third party, in whole or in part, without the written authorization of an officer of Bal Seal Engineering, LLC. Products are the subject of issued or pending United States and foreign patents. Products of Bal Seal Engineering, LLC and this document are PROPRIETARY and products may not be manufactured, or caused to be manufactured, by any other party. Resources & Contact Information Mark Russell Sr. Global Market Manager, Medical Electronics Bal Seal Engineering mrussell@balseal.com +1 630.765.7255 solutions@balseal.com www.balseal.com +1 949.460.2100 Design request form