1. Transcutaneous Signal Transmission to the LVAD
Sara Carr
Keith Lesser
Robert MacGregor
Carl Hoge
Oxana Petritchenko

2. Team Organization Sara Carr – Lead Engineer Carl Hoge– EDGE expert
Robert MacGregor – Project Plan
Keith Lesser – Building of the prototype and testing
Oxana Petritchenko – Project Manager
Mechanical Design: Carl Hoge and Oxana Petritchenko
Electrical Design: Sara Carr, Robert MacGregor, and Keith Lesser

3. Team Norms and Values Respect for all group members in any situation
Raise concerns and share to each other as soon as they arise
Communicate with Dr. Day promptly if any needs or questions arise
Be honest and realistic in reporting progress
Be proactive and take initiative in order to achieve design/prototype completion
Do not take things personally
Promptness in communication and deadlines
Take responsibility for personal actions
Be meticulous in recording everything as it arises and in completing project tasks
Each team member will abide by these principles
Phone calls: call anytime except after 12 am. All Verizon customers.
Meet Tuesday mornings as needed for updates.
Reply to messages and requests at your earliest convenience.
Be present and prepared each Friday. All MyCourses information read as needed. If absent, notify group members ahead of time.
If need extra help, address the issue immediately to team members.
Team Members Electronic Signature:

4. Problem Statement
Eliminate as many wires as possible going through the dermis of the patient to the Left Ventricular Assist Device (LVAD) blood pump, and design wireless signal transmission based on accepted wireless protocols allowing the LVAD to function effectively.

5. Benefits of the Project
The current design uses 26 wires leading from the control unit to the LVAD blood pump, entering through the skin and into the body of the patient.
This design is associated with many health risks to the patient because the exposure of the tissue to the wires causes many infections which often lead to death of the patient.
The benefits of our project proposal are elimination of most, if not all, of the wires leading to the LVAD heart pump, therefore, reducing or eliminating most infections and health risks.

6. Objectives Transmit all signals wirelessly.
Functions of the LVAD are not constricted.
Wireless signals are safe for human tissue.
Packaging of internal and external components provides environment protection.
Anti-shock protection
Thermal management to avoid damaging tissue or electronics
The proposed design follows IEEE, FDA and FCC standards.
Power transmission is optional. If time allows, a rechargeable battery by inductive coupling may be considered in the proposed design

7. Assumptions and Constraints
The required wireless signals can be safely transmitted through tissue
The proposed design is accurate in receiving and transmitting signals
The 3 phase power can be transmitted from the Motor Controller to spin the rotor wirelessly

8. Issues and Risks
The greatest challenge will be the design of the reception, interpretation, and transmission of signals.
LVAD function is impaired by poor wireless transmission.
Wireless signals damage human tissue.
Packaging of electronics and heat generated by them causes tissue damage.
Electronics are damaged by body tissue.

9. Description: organize as primary and secondary needs (hierarchy).
Revision #: 3
CUSTOMER NEEDS
Customer Need #
Importance
Description
Comments/Status
Signal Transmission
CN1 5
Eliminate as many wires as possible from position sensors (HESA) to XPC Control Target
CN2
Eliminate as many wires as possible from XPC Control Target to Active Magnetic Bearings (AMB)
CN3
Eliminate as many wires as possible from from the XPC Control Target to the LVAD Motor
CN4
The interior and exterior transceivers must have a power supply.
Safety
CN5
Signals transmitted through the dermis are safe to human tissue.
CN6
Packaging, materials, and connections of the inner transceiver are safe to implant in a human body.
CN7
Heat generated by the inner transceiver does not cause tissue damage.
CN8
Inner and outer transceivers must be protected from the surrounding environment of human tissue and outside forces.
CN9
Protocols are comliant with IEEE, FDA, and FCC standards.
Functionality
CN10 4
The device must be reliable.
Heart pump functions 20 years.
CN11
The device must function continuously.
CN12
The device must function without user interventions.
CN13
The device should work with the currently established system components.
CN14 3
The wireless technology functions in accordance with Project #10021 (miniaturization senior design team).
Size
CN15
The interior transceiver's must fit within the human body cavity.
CN16
The exterior transceiver's must be small enough to wear on a belt.
CN17
The exterior transceiver's must be light enough to wear on a belt.
Cost
CN18 2
The cost should be affordable.
CN19
Optional: Power transmission through the human skin and biological tissues.
Transcutaneous power transmission coils. Currently 2 wires enter the body.
Cust. Need #: enables cross-referencing (traceability) with specifications
Importance: Sample scale (5=must have, 3=nice to have, 1=preference only).
Description: organize as primary and secondary needs (hierarchy).
Comment/Status: allows tracking of questions, proposed changes, etc; indicate if you are meeting the need ("met") or not ("not met")

10. Customer Specifications

11. Risk Assessment

12. Project Plan
Uploaded to Edge
74 Tasks

13. Work Breakdown Structure

14. Ideal Proposal (INT) 12-bit A/D FPGA Clock Transmitter Receiver HESA
Interior Electronics
(Proposed)
Pump
Transmitter
12-bit A/D
6 Total
72 bits
72 bits
6 signals
HESA
Hall Effect
Sensor Array
2 Total
Differential/Summing
Amps
6 Total 5V
8 signals
3 currents
Receiver
Motor
Controller
PWM
Amps
4 or 8 Total
Motor
12V
5 bits
8 currents
AMB
Active Magnetic Bearing
2 Total
15V
Clock
FPGA
For Signal Processing

15. Miniaturization Project
Ideal Proposal (EXT)
Miniaturization Project
Exterior Electronics
(Proposed)
Control
XPc
Target
6 signals
FPGA
For Signal Processing
Receiver
72 bits
72 bits
Motor Control
Signal
PWM Control
4 Signals
5 bits
Transmitter
5 bits
Clock
Requires 2 Wires
15 V Line
Ground Line

16. Compromise Proposal (INT)
Interior Electronics
(Proposed)
Pump
Transmitter
12-bit A/D
6 Total
72 bits
72 bits
6 signals
HESA
Hall Effect
Sensor Array
2 Total
Differential/Summing
Amps
6 Total 5V
8 signals
Motor
3 currents
12V
1:11 Multiplexer
Wired Signal
8 currents
AMB
Active Magnetic Bearing
2 Total
15V
Clock
FPGA
For Signal Processing

17. Miniaturization Project
Compromise Proposal (EXT)
Miniaturization Project
Exterior Electronics
(Proposed)
72 bits
Control
XPc
Target
6 position
signals
Receiver
Motor
Controller
FPGA
Clock
3 phase
currents
PWM
Amps
4 Total
Counter
Wired
Signal
11:1 Multiplexer
8 PWM currents
Requires 3 Wires
15 V Line
Ground Line
Signal Wire

18. Wire- “Less” Proposal (INT)
Interior Electronics
(Proposed)
Pump
HESA
Hall Effect
Sensor Array
2 Total
8:1 Multiplexer 5V
Wired Signal
8 signals
Motor
3 currents
12V
1:11 Multiplexer
Wired Signal
8 currents
AMB
Active Magnetic Bearing
2 Total
15V
Clock
4-bit Counter

19. Miniaturization Project
Wire- “Less” Proposal (EXT)
Miniaturization Project
Exterior Electronics
(Proposed)
8 position
signals
Wired
Signal
Control
XPc
Target
12-bit A/D
6 Total
1:8 Multiplexer
Differential/Summing
Amps
6 Total
3 phase
currents
4-bit Counter
Clock
Motor
Controller
Counter
Wired
Signal
PWM
Amps
4 Total
11:1 Multiplexer
8 PWM currents
Requires 4 Wires
15 V Line
Ground Line
2 Signal Wire

20. High-Level Schematic 4 signals Multipurpose DAQ Input DAQ
Control XPc Target
Intermediate Electronics
Pump
Input DAQ
A/D
10 signals
Differential Amplifier
HESA (Hall Effect Sensor Array)
with 5V
and Gnd
Output DAQ
Digital Counter
1 Relay (5V)
Motor Controller
3 Phase-Currents
Motor
Rotor
1 Speed
Command
(50Hz PWM)
PWM (Pulse Width Modulation) Amplifier
AMB (Active Magnetic Bearing)
4 AMB-Currents
1 Relay(5V)
4 AMB Current
Command
(20K Hz PWM)
Pump I/O
Signal
Power Box
Force/Field
Power 20
Current

21. Proposed High-Level Schematic (INT)
Interior Electronics
(Proposed)
72 bits
Differential/Summing
Amps
6 Total
12-bit A/D
Digital Data
Communication
System
(Transmit)
6 signals
x bits
(Receive)
Current
Regulation
X-bit DAC
7 Total
7 signals
Pump
72 bits
HESA
Hall Effect
Sensor Array
2 Total 5V
8 signals
Motor
12V
3 currents
x bits
4 currents
AMB
Active Magnetic Bearing
2 Total
15V

22. Miniaturization Project
Proposed High-Level Schematic (EXT)
Miniaturization Project
Exterior Electronics
(Proposed)
Digital Data
Communication
System
(Receive)
(Transmit)
Control
XPc
Target
72 bits
72 bits
Motor
Controller ?
PWM
Amps
4 Total ?
x bits

23. Concept Screening – Wireless Technology
P Transcutaneous Wireless Signal Transmission
Step #1 Screening A B C
Zarlink
Bluetooth
Zigbee
Selection Criteria
Low Interference + -
Small Size
High Data Rate (min 385kbps)
Low Power (less than 1mW)
Penetrates skin and some tissue
Available for implementation within 10 weeks
Follows FCC Regulations
Designed for Implantable Devices
Sum + 's
7.00
4.00
Sum 0's
0.00
1.00
Sum -'s 1 3 4
Net Score
Rank 2
Continue?
Yes No

25. Concept Screening – Packaging
Step #1 Screening
Concepts
Stainless Steel
Titanium
Gold, Silver, Platinum
Zirconia
Polyethylene
Silicone
Selection Criteria
Machinability + -
FDA Approved
Similar Applications
Low Cost
Avalability
Thermal Conductance
Wireless Interference
Weight
Strength
Durability
Susceptibility to Corrosion
Sum + 's
7.00
8.00
4.00
Sum 0's
1.00
0.00
3.00
Sum -'s 2 3 1
Net Score
5.00
6.00
Rank
Continue?
Yes

26. Concepts Selection A B C
Stainless Steel
Titanium
Silicone
Selection Criteria
Weight
Rating
Notes
Wtd
Machinability 5%
0.00
FDA Approved
25% 3
0.75 2
0.50
Similar Applications 1
0.25
Low Cost 0%
Availability
0.15
Thermal Conductance
10%
0.30
0.20
Wireless Interference
15%
0.45
0.05
0.10
Durability
Susceptibility to Corrosion
Total Score
2.35
2.60
1.80
Rank
Continue?