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Slide 2
June 23 © 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.
Heart Assist Devices
• Help the heart circulate
blood throughout the
body
• Typically consist of a
pump and a power
source/controller
 VAD
• Increasingly targeting
longer-term use –
destination vs. bridge
therapies
Source:
Blausen
Medical
Communications,
Inc.
Slide 3
June 23 © 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 Interconnect: A Critical Link
• Safely and reliably conducts current
from the battery and electronics
through the lead
• Can be incorporated into the device
header, or in the driveline that
connects to an external power
source
Slide 4
June 23 © 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.
Interconnect Operating Requirements
• Interconnect designs must:
 Contribute minimal heat to
protect against tissue
damage
 Use biocompatible
materials that minimize
corrosion in the human
body
 Deliver uninterrupted
current to the pump motor
– typically 5 amps or less
 Function reliably for life of
device (from transplant
bridge to destination
therapy)
 Support both external
power and fully
implantable systems
Image source: Cirtec Medical, Inc. For illustration purposes only
Image
source:
Corvion,
Inc.
For
illustration
purposes
only.
Slide 5
June 23 © 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.
Interconnect Engineering Challenges
• Reduce contact resistance
 Generates heat, which can
compromise patient comfort
and safety
 Impacts device power
efficiency, leading to reduced
battery life, device
performance and reliability
issues
• Minimize corrosion
 Causes device malfunction over
time
 Can require explant and/or
device replacement in some
cases
 Could compromise regulatory
compliance
mΩ
Image
source:
https://www.researchgate.net/profile/Lillian-
Hughes
For
illustration
purposes
only.
Slide 6
June 23 © 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.
Inside The Interconnect:
Contacts & Contact Systems
• These components can efficiently deliver
power to heart assist devices IF they meet
these requirements:
Requirement Success factor
Compact size Short axial length to reduce interconnect size
Reliability Technology that ensures maximum contact point
redundancy, and offers 100% force verification
Corrosion resistance Platinum-iridium for both housing and contact element
Power efficiency Ultra-low contact resistance (<10 mΩ) for optimal signal
integrity, longer device life
Force Contact technology that offers ability to precisely control
contact features and minimize force
Scalability & flexibility Option to “stack” contacts in a serial configuration with
seals for electrical isolation
Slide 7
June 23 © 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
• Consists of precision-engineered
metal housing w/Bal Spring®
element
 Leverages mechanical and
electrical properties of canted
coil spring
 Multiple coils provide built-in
connection redundancy
 Compact axial length allows more
room for electrical isolation in
allowable window
 20+ years of proven reliability, at
work in millions of devices
worldwide
 Core of the SYGNUS®
implantable
contact system, which combines
Bal Conn w/silicone seals
Slide 8
June 23 © 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 VAD applications:
 Creates consistent force
during insertion and
removal by limiting spring
movement
 Reduces contact
resistance with more
points of contact
 Meets requirements for
force and contact
resistance
Slide 9
June 23 © 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.
SYGNUS® Implantable Contact System
• Combines proven contact
and seal into a “stackable”
serial configuration
• Eliminates need for
separate component
development & testing
• Can improve speed to
market
• Turnkey solution that
accommodates “standard”
& custom lead sizes
 .9mm, 1.3mm & 3.2mm
 Custom pitch capable
Slide 10
June 23 © 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® and SYGNUS® : Application Examples
VAD In-line Connections VAD Header Connections
Slide 11
June 23 © 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 12
June 23 © 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.co
om
www.balseal.com +1 949.460.2100 Design request form

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Electrical Contact Selection for Heart Assist Device Design

  • 1.
  • 2. Slide 2 June 23 © 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. Heart Assist Devices • Help the heart circulate blood throughout the body • Typically consist of a pump and a power source/controller  VAD • Increasingly targeting longer-term use – destination vs. bridge therapies Source: Blausen Medical Communications, Inc.
  • 3. Slide 3 June 23 © 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 Interconnect: A Critical Link • Safely and reliably conducts current from the battery and electronics through the lead • Can be incorporated into the device header, or in the driveline that connects to an external power source
  • 4. Slide 4 June 23 © 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. Interconnect Operating Requirements • Interconnect designs must:  Contribute minimal heat to protect against tissue damage  Use biocompatible materials that minimize corrosion in the human body  Deliver uninterrupted current to the pump motor – typically 5 amps or less  Function reliably for life of device (from transplant bridge to destination therapy)  Support both external power and fully implantable systems Image source: Cirtec Medical, Inc. For illustration purposes only Image source: Corvion, Inc. For illustration purposes only.
  • 5. Slide 5 June 23 © 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. Interconnect Engineering Challenges • Reduce contact resistance  Generates heat, which can compromise patient comfort and safety  Impacts device power efficiency, leading to reduced battery life, device performance and reliability issues • Minimize corrosion  Causes device malfunction over time  Can require explant and/or device replacement in some cases  Could compromise regulatory compliance mΩ Image source: https://www.researchgate.net/profile/Lillian- Hughes For illustration purposes only.
  • 6. Slide 6 June 23 © 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. Inside The Interconnect: Contacts & Contact Systems • These components can efficiently deliver power to heart assist devices IF they meet these requirements: Requirement Success factor Compact size Short axial length to reduce interconnect size Reliability Technology that ensures maximum contact point redundancy, and offers 100% force verification Corrosion resistance Platinum-iridium for both housing and contact element Power efficiency Ultra-low contact resistance (<10 mΩ) for optimal signal integrity, longer device life Force Contact technology that offers ability to precisely control contact features and minimize force Scalability & flexibility Option to “stack” contacts in a serial configuration with seals for electrical isolation
  • 7. Slide 7 June 23 © 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 • Consists of precision-engineered metal housing w/Bal Spring® element  Leverages mechanical and electrical properties of canted coil spring  Multiple coils provide built-in connection redundancy  Compact axial length allows more room for electrical isolation in allowable window  20+ years of proven reliability, at work in millions of devices worldwide  Core of the SYGNUS® implantable contact system, which combines Bal Conn w/silicone seals
  • 8. Slide 8 June 23 © 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 VAD applications:  Creates consistent force during insertion and removal by limiting spring movement  Reduces contact resistance with more points of contact  Meets requirements for force and contact resistance
  • 9. Slide 9 June 23 © 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. SYGNUS® Implantable Contact System • Combines proven contact and seal into a “stackable” serial configuration • Eliminates need for separate component development & testing • Can improve speed to market • Turnkey solution that accommodates “standard” & custom lead sizes  .9mm, 1.3mm & 3.2mm  Custom pitch capable
  • 10. Slide 10 June 23 © 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® and SYGNUS® : Application Examples VAD In-line Connections VAD Header Connections
  • 11. Slide 11 June 23 © 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
  • 12. Slide 12 June 23 © 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.co om www.balseal.com +1 949.460.2100 Design request form