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

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

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:

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.

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.

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

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

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.

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")

Customer Specifications

Risk Assessment

Project Plan Uploaded to Edge 74 Tasks

Work Breakdown Structure

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

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

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

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

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

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

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

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

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

Concept Screening – Wireless Technology P10022 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

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

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?