1. 11022 Transcutaneous Signal Transmission for LVAD October 8, 2010 Yevgeniy Popovskiy, Vince Antonicelli, Craig LaMendola, Chrystal Andreozzi

2.  Project Background  Project Scope and Objective  Project Schedule  Customer Requirements  Engineering specifications  Work Breakdown  System Concept Generation, Scoring and Selection  Case  Insulation/ wire  Electrical System  Risks Assessment  Project Budget  Next Steps  Questions and discussion System Level Design Review Agenda

3.  The primary objective of this project is to design a transmission system to safely and affectively transfer power and control signal from the external power supply and control to the Left Ventricular Assist Device(LVAD). Project Background

4. MSD I  Objectives  Concept Generation and Selection  Detailed Design  Ready for Construction  Deliverables  Finalizes design  Order parts  Finalize Test specification Project Objectives MSD II  Objectives  Assumable system  Troubleshoot design  Testing equipment  Deliverables  Working System  Test data to support design

5. Senior Design I Schedule

6. System Signal Transmission Vince Antonicelli Design Electrical Hardware Debug Yevgeniy Popovskiy Program Chip Debug Case, Packaging, Material Craig LaMendola Case Material Dimensions and Design Wire Port Seal Material Products Chrystal Andreozzi Insulation Heat sink Material Wire Flexibility Material Work Breakdown

7.  The device must be reliable (Must produce a continuous power and control signs)  The number of wires needs to be reduced  The cable diameter needs to be reduced  The cable needs to be more flexible  Meet FDA standards or be able to be modified to meet FDA standards Customer Needs THE SYSTEM NEEDS TO WORK!!!!

8.  Reliable Operation 6 hours  Cable Size ~3mm  Improve Cable Flexibility200%  Internal/ External Volume 450 cm 3  Eternal Weight 0.9 kg  Costbelow $3500 Engineering Specification

9. System Overview

10. Outer Protection Protective outer layers Wire port sealing Material/productBenefitsPossible Risks Sealcon Cord Grips With/without strain relief Removable Adjustable Proven to work Bulky size Heat shrink boot Permanent Installation Long lead time On failed 10022 Adhesive heat shrinkProven to workLess robust Material/productBenefitsPossible Risks Locktite 5248BiocompatibleOn failed 10022 Master Bond Jacket Biocompatible Encapsulates components More Robust 1 st Line of Defense

11. Sealing Methods Types of O-rings O-ring grooves Material/productBenefitsPossible Risks Parker O-ringno break or seam Case designed for available O-ring PAI X-ringdouble seal unreliable when bent O-ring cordCustom sizing Break or Seam On failed 10022 Install methodBenefitsPossible Risks Square groove O-ring unsecured Dove tail grooveSecure install 2 nd Line of Defense

12. Protective Case Case Structural material Material/productBenefitsPossible Risks Titanium Biocompatible Electrical shielding Stainless Steel Biocompatible Electrical shielding May corrode AluminumElectrical shielding Least robust metal May corrode ABS plastic printingMade at RIT On failed 10022 Not water tight

13. Product Cost ($) Reliability Availability Bio- compatible Key Risk associated with selection process Selected Design Outer Layer of Protection Locktite 5248In Lab355Failed last team Master Bond Jacket$650-$800435 ? Wire Port sealing Sealcon cord grip$4/$14 each531Bulky size Heat shrink boot$10 each411Permanent installation Adhesive heat shrink$15/ In Lab43/51Durability O-rings Parker O-ring$13531Design case for O-ring sizes PAI X-ring$0 Sample321Unreliable when bent O-ring cord$2331Has seam O-Rin g Groove Square grooveIncluded43-Less secure installation Dove tail groove (AL/SS/Ti)+65/100/15051-Expense/ production time Structural Material Titanium$470515Expense/ production time Stainless Steel$420525Expense/ production time Aluminum$300431Least robust metal ABS plastic printing$200241No shielding/ Porous Case Concept Selection

14. Insulation.  Heatsink paste/grease  Pasted applied directly to component  Heatsink Pad  Remain sold at room temperature and then soften at heatsink operating temperature

15. Electrical Potting  Epoxy  Stable material (hard)  Resistance to temp. up to 200 oC  Very good resistance to chemicals  Cracks easily Insulation Cont.

16.  Wire Types  Calmont Wire and Cable  Stranded Single-Conductor (P10022)  Thoratec Corporation (HeartMate II) Wire

17. Insulation and Wire Concept Selection Cost ($) Flexibility Reliability Availability Bio-compatible Risk associated with selection Selected Design Insulation (Heat sinks) Heat Sink Pad<$20n/a25No Heat Sink Paste/ grease <$5n/a45No Electrical Potting$20- $50 n/a55No May break Wire Calmont Wire and Cable ?451YesTime(product is custom made) Stranded Single- Conductor <$5135yesWire does not have max flexibility

18. System Overview

19. Transmit digital signal WiredWirelessThrough power Transmit analog signal MultiplexConvert to DigitalMultiplex through power Chip Technology MicrocontrollerFPGA Clock InternalWired Protocol Use ExistingInvent One Major Electrical Choices

20. Current Layout Skin Main Controller + A/D + Battery Pump Motor Control Linear Amplifier Blood Pump SA MCC MCO LADS LAOP LAOG MCP SP LAP

21. Senior Design P10021-P10022 Layout MCP Main Controller + A/D + Battery Skin SA MCC MCO PADS PAOP PAP+MCP+SP SP Motor Control SA PWM Gen. Blood Pump PAP PADS MCC NSD Chip + Elect. Chip + Elect.

22. Option 1 Main Controller + A/D + Battery Pump Motor Control Linear Amplifier Blood Pump SA MCC MCO LADS LAOP LAOG MCP SP LAP SA Micro. + Elect. Micro. + Elect. SP Skin NSD SP

23. Option 1 Details

24. Option 2 Main Controller + A/D + Battery Skin SA SP SA NSD Micro. + Elect. Motor Control MCC MCO MCP PAOP LAP PADS Blood Pump Micro. + Elect. PADS LAP Linear Amp.

25. Option 2 Details

26. Option 3 Main Controller + A/D + Battery Skin SA SP SA NSD Micro. + Elect. Motor Control MCC MCO MCP PAOP PAP PADS Blood Pump Micro. + Elect. PADS PAP PWM Gen.

27. Option 3 Details

28. Option 4 Main Controller + A/D + Battery Linear Amplifier LADS LAOP LAOG LAP Skin MCP SA MCC MCO SP Motor Control SA MCC NSD Micro. + Elect. Micro. + Elect. Blood Pump MCP

29. Option 4 Details

30. Option 5 MCP Main Controller + A/D + Battery Skin SA MCC MCO LADS LAOP PAP+MCP+SP SP Motor Control SA Linear Amp. Blood Pump PAP LADS MCC NSD Micro. + Elect. Micro. + Elect. LAOG

31. Option 5 Details

32. Option 6 MCP Main Controller + A/D + Battery Skin SA MCC MCO PADS PAOP PAP+MCP+SP SP Motor Control SA PWM Gen. Blood Pump PAP PADS MCC NSD Micro. + Elect. Micro. + Elect.

33. Option 6 Details

34. Design Evaluation

35. Selected Design

36. Risk Assessment

37.  Yevgeniy Popovskiy  Select Chip  Component Pricing  Vince Antonicelli  Circuit Design  Component Pricing  Craig LaMendola  Determine Case Dimensions  Create Case Drawings  Material Selection with customer  Chrystal Andreozzi  Identify Wire in the Cable  Electrical Reliability Testing  Team  Contact manufactures and get pricing  Verify that different components will assumable Next Steps