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.

Revision #: 3CUSTOMER NEEDS Customer Need # ImportanceDescriptionComments/Status Signal Transmission CN15 Eliminate as many wires as possible from position sensors (HESA) to XPC Control Target CN25 Eliminate as many wires as possible from XPC Control Target to Active Magnetic Bearings (AMB) CN35 Eliminate as many wires as possible from from the XPC Control Target to the LVAD Motor CN45The interior and exterior transceivers must have a power supply. Safety CN55Signals transmitted through the dermis are safe to human tissue. CN65 Packaging, materials, and connections of the inner transceiver are safe to implant in a human body. CN75Heat generated by the inner transceiver does not cause tissue damage. CN85 Inner and outer transceivers must be protected from the surrounding environment of human tissue and outside forces. CN95Protocols are comliant with IEEE, FDA, and FCC standards. Functionality CN104The device must be reliable.Heart pump functions 20 years. CN114The device must function continuously. CN124The device must function without user interventions. CN135The device should work with the currently established system components. CN143 The wireless technology functions in accordance with Project #10021 (miniaturization senior design team). Size CN155The interior transceiver's must fit within the human body cavity. CN165The exterior transceiver's must be small enough to wear on a belt. CN175The exterior transceiver's must be light enough to wear on a belt. Cost CN182The cost should be affordable. CN190Optional: 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

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

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

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

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

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

Wired Signal 8 PWM currents 3 phase currents Miniaturization Project Control XPc Target Motor Controller PWM Amps 4 Total Exterior Electronics (Proposed) 1:8 Multiplexer Wire- “Less” Proposal (EXT) Clock4-bit Counter 11:1 Multiplexer Counter Requires 4 Wires 15 V Line Ground Line 2 Signal Wire Wired Signal Differential/Summing Amps 6 Total 12-bit A/D 6 Total 8 position signals

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

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

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

P10022 Transcutaneous Wireless Signal TransmissionStep #1 Screening ABC ZarlinkBluetoothZigbee 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+0+ Sum + 's Sum 0's Sum -'s134 Net Score Rank123 Continue?Yes No Concept Screening – Wireless Technology

Step #1 Screening Concepts Stainless SteelTitanium Gold, Silver, Platinum ZirconiaPolyethyleneSilicone Selection Criteria Machinability FDA Approved Similar Applications + Low Cost+ + Avalability+++- Thermal Conductance Wireless Interference Weight Strength Durability Susceptibility to Corrosion Sum + 's Sum 0's Sum -'s Net Score Rank21 Continue?Yes Concept Screening – Packaging

Concepts Selection A B C Stainless SteelTitaniumSilicone Selection CriteriaWeightRatingNotesWtdRatingNotesWtdRatingNotesWtd Machinability5% 0.00 FDA Approved25% Similar Applications25% Low Cost0% Availability5% Thermal Conductance10% Wireless Interference15% Weight5% Durability15% Susceptibility to Corrosion0% Total Score Rank Continue?