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11022 Transcutaneous Signal Transmission for LVAD
November 5 , 2010Yevgeniy Popovskiy, Vince Antonicelli, Craig
LaMendola , Chrystal Andreozzi
Determine if our Team is on Track New Ideas Meeting Customer Needs To Ensure our Proposed Solution is Feasible To Ensure that our Team has Developed that
Ideal Solution to the Problem at Hand
Detailed Design Review
Project Summary Customer Needs Engineering Specifications
Schedule Project 10022 Failures High Level Schematics Electrical Detailed Design Case Design Heat Transfer Analysis Cable Design Bill of Material Test Plan Questions, Concerns, Ideas Action Items Review
Detailed Design Review Agenda
The Left Ventricular Assist Device (LVAD) is a electro mechanical circulatory device designed to assist a patient with a failing heart. Typically, a patient will receive one for temporary use after a heart attack or major heat surgery.
Eliminate as many transcutaneous wires as possible running from the external battery and controller to the LVAD.
Project Background
The device must be reliable
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
Customer Needs and Engineering Specifications
THE SYSTEM NEEDS TO WORK!!!! Must Operate
Reliably for 6 hours Cable Size Reduced
to 3mm Improve Cable
Flexibility by 200% Internal Volume
must be less then 450 cm3
MSD I Schedule
MSD II Schedule
Failure What Happen? How we are going to fix it?
Chip Specification
Programming the Chip
Case was not Water tight
Wire was not flexible
Not enough Time for Debugging the System
Too Much Responsibility on One Member
Project 10022 Failures
Big Picture
“Big Black Box”
LVAD
Skin
ICs
ICs
Motor Controller
Amplifiers
External Case
Internal Case
Electronics Function
SKINThe Big
Black Box
MCC + MCTMotor Controller
Amplifiers
Sensors
PAAS=>PADS
3
1
2
SA
Current Schematic
Main
Controller+
A/D
+
Battery
Pump
Motor
Control
Skin
Linear Amplifier
BloodPump
SA
MCC MC
O
LADS LAOP
LAOG
MCP
SP
LAP
(Sensor Analog)
8 Wires
(Sensor Power)
2 Wires
2 Wires
(Mot. Cont. Out)
2 Wires
(Mot. Cont. Control)
(Linear Amplifier Output)
4 Wires4 Wires
2 Wires
(Mot. Cont. Pwr)
2 Wires
(Linear Amplifier Input)
(Linear Amplifier Output Return)
1 Wires
(Linear Amplifier Power)
Project 11022 Schematic
MCP
Main
Controller+
A/D
Skin
SA
MCC
MCO
PAAS
PAOP
PAP+MCP+SP
SP
Motor
Control
PWM
Gen.
BloodPump
MCC
NSD
Chip
+
Elect.
Chip
+
Elect.
(Sensor Analog)
8 Wires
(Mot. Cont. Control)
3 Wires
(New Signal Digital)
SA
(Sensor Analog)
8 Wires
(Sensor Power)
2 Wires
(Mot. Cont. Cont)
(Mot. Cont. Pwr)
2 Wires
(Mot. Cont. Out)
2 Wires
(PWM Analog Signal)
4 Wires
(PWM Mot Cont Sen Pwr)
2 Wires
(PWM Output)
8 Wires
PADS(PWM Signal)
4 Wires
PAP(PWM AMPLIFIER POWER)
Electronic Details
DAC
ADC
ADC
DN CNT
POR
COUNTERCOUNTER
SKININIT LOGIC
SA
PAAS
MCC
MCT
SA
PADS
MCC
MCT
CLR
INIT LOGICMUX
MUX
FLIP FLOP
External Internal1
3
2
Wire Diagram 1
Wire Diagram 2 (PADS)
Failure What Happen? How we are going to fix it?
Chip Specification • Wrong Number for Bandwidth and clock speed
• Chip did not fit in initial PCB
• Double check calculations• Plan on obtain all chips before
ordering breadboard
Programming the Chip • Underestimated the time required to program chip
• Using integrated circuit design, instead of a microcontroller
Case was not Water tight
Wire was not flexible
Not enough Time for Debugging the System
Too Much Responsibility on One Member
Project 10022 Failures
Internal Case *Design not finalized
Titanium 2 shielded compartments 3 piece design with 2 equally sized halves and shielding plate Main compartment to hold electronics provided by Customer Second smaller compartment to house our new electronics
• Main Compartment: 5.25” x 2.25” x 1.25”
• Second Compartment: 4.5” x 2.15” x 0.5”
• Outer Dimensions: 6.63” x 2.63” x 2.25”
External Case *Design not finalized
Aluminum One compartment Will accommodate 2” x 2” x 0.5”
board Outer Dim. 2.37” x 3.13” x 0.87”
Case Similarities
• Cord grips screw into case• Same 1/16” O-ring • Same square O-ring grooves• Sharp corners and edges eliminated• Adhesive board and cable mounts• Board will be grounded to case• Will be quoted by multiple local shops
Hardware on Cases
Cord Grips: Sealcon products Pressure tested
O-rings: Silicone 1/16” McMaster Additional sealing:
Loctite silicone sealant on O-ring seal Water tight thread tape on cord grip
threads, in addition to stock O-ring Screws: All Stainless Steel from
McMaster No lead time problems expected on
Hardware
Failure What Happen? How we are going to fix it?
Chip Specification • Wrong Number for Bandwidth and clock speed
• Chip did not fit in initial PCB
• Double check calculations• Plan on obtain all chips before
ordering breadboard
Programming the Chip • Underestimated the time required to program chip
• Using integrated circuit design, instead of a microcontroller
Case was not Water tight • Two cable exciting one round port
• Screw entering the case inside the O-ring seal
• ABS Material Not Waterproof
• More reliable materials• Corrected design flaws• Cord grips are guaranteed
Wire was not flexible
Not enough Time for Debugging the System
Too Much Responsibility on One Member
Project 10022 Failures
Intersection Point Temperature(oC)
Center 73.09 66.6955.0
9
Air-Titanium 53.91 47.5135.9
1
Titanium-Air 47.43 41.0329.4
3Tissue 43.00 36.60 25
Heat Transfer Analysis Internal Case
0 0.0020.0040.0060.008 0.01 0.0120.0140.0160.0180.00
10.00
20.00
30.00
40.00
50.00
60.00
70.00
80.00
Tissue
43 °C
36.6°C
25°C
Distance(m)
Tem
pera
ture
(oC
)
𝑞𝑥=(𝑇 ∞−𝑇 𝑖 )∑ 𝑅
Heat Transfer Analysis External Case
𝑞𝑥=(𝑇 ∞−𝑇 𝑖 )∑ 𝑅
0 0.002 0.004 0.006 0.008 0.01 0.012 0.014 0.016 0.01820.00
25.00
30.00
35.00
40.00
45.00
Tissue
43 °C 36.6°C 25°C
Distance(m)
Tem
pera
ture
(oC
)
Intersection Point Temperature(oC)
Center 43.33 36.93 25.33
Air-Aluminum 43.12 36.72 25.12
Aluminum-Air 43.05 36.65 25.05
Tissue 43.00 36.60 25.00
Reduce Cable Diameter Flexibility: the ability to bend a cable through
its full-range of required motion Bend Radius: is the minimum inside radius one
can bend a cable Stiffness: is the resistance of elastic body to
deformation by an applied force along a given degree of freedom
Cable
Cable
Cable Current Cable Designed Cable
Cable Diameter 8 mm 3 mm
Number of Wires
~40 8
Heat Shrink Tubing
Thickness 0.38 mm
36 Gage, 0 A
0.3 mm
22 Gage, 6
A1 mm
22 Gage, 6
A1 mm
Copper Shielding
3 mm
Make cable at RIT Custom cable Manufactures
Coast Wire & Plastic Tech., Inc. Calmont Wire & Cable Merit Cable Carroi’s Medical Cable American Biosurgical
Cable Choices
Failure What Happen? How we are going to fix it?
Chip Specification • Wrong Number for Bandwidth and clock speed
• Chip did not fit in initial PCB
• Double check calculations• Plan on obtain all chips before
ordering breadboard
Programming the Chip • Underestimated the time required to program chip
• Using integrated circuit design, instead of a microcontroller
Case was not Water tight • Two cable exciting one round port
• Screw entering the case inside the O-ring seal
• ABS Material Not Waterproof
• More reliable materials• Corrected design flaws• Cord grips are guaranteed
Wire was not flexible • Wire binding in many places • Quoting cable with professional harness engineering company
Not enough Time for Debugging the System
• Team ran out of time to debug the system
• Plan on ordering components and assemble early, giving us 3 weeks to debug.
Too Much Responsibility on One Member
• To much responsibility on one member of the team
• Design is completed in a manor that allow multiple people to complete the work independently
Project 10022 Failures
Bill of Material# System Part Name
Critical Characteristics/Functions Part Number Manufacturer
Cost per part
Quantity ordered
Shipping Cost
Total Cost
Lead Time
1Cable 22 Gage Wire
Power Wire, Continuous-Flex Miniature Wire 22 Awg, .052" OD, 600 VAC, Red 7071K623 McMASTER-CARR $1.86/ FT 25 FT ? 46.5
1 week
2Cable 36 Gage Wire
Signal Wire, 392 Degree F HI-Flex Miniature Wire 36 Awg, .012" OD, 30 VAC/VDC, Green 9487T112 McMASTER-CARR $0.54/ FT 25 FT ? 13.5
1 week
3Cable Copper sheilding
Copper Foil Tape W/Conductive Adhesive, 3/4" Wide X 6 Yards
Long 76555A713 McMASTER-CARR$14.39/roll 1 roll ? 14.39
1 week
4cable Cable Jacket
Flexible Polyolefin Heat-Shrink Tubing 1/8" ID Before, 1/16" ID After, 25' L, White McMASTER-CARR
0.3756/FT 25 FT 9.39
1 week
5Cable Cable Cable between the body CWPT-Q10-0848Coast Wire and Plastic Tech., Inc. 13.52/ft 100 ft 1352
6 weeks
6Connector connectors lemo Connectors
FGG.2K.326.CLAC80Z PEI-GENESIS 136.64 1 136.64
2 week
7Insulations Heat sink Paste
Zalman ZMSTG1 Super Thermal Grease Model:ZM-STG1 Catalog #: 55020842 55020842Radio Shack
$9.95 per container 1 n/a 9.951 Day
8Inner case Large cord grip CD16MA-BR Sealcon 2
9Inner case Small cord grip CD12MR-BR Sealcon 3.94 2 7.46 (a) 24.18
10Inner case Outer screws 10-32 SS cap screws Mc Master Carr
11Inner case Inner screws 90585A225 Mc Master Carr 5.52 1
12Inner case Titanium Case *******
Laurel Tool and Die 1
13Outer Case Aluminum Case *******
Laurel Tool and Die 1
14Outer Case Outer screws 8-32 SS cap screws Mc Master Carr
15Outer Case Outer cover 9109k72 Mc Master Carr 21.48 1
16Both Thread Tape 6802k11 Mc Master Carr 1.95 1
17Both O ring 96505k21 Mc Master Carr 0.24 10
Bill of Material
# System Part NameCritical Characteristics/Functions Part Number Manufacturer
Cost per part
Quantity ordered
Shipping Cost
Total Cost Lead Time
18Electric
alResistor 10M Keeps sig at a stable value inside 10mqbk-nd ? 5 1 WEEK
19Electric
alAnalog Mux Demux
Converts data from p to s and s to p
both ? 4
20Electric
alCounter (74163) Splits time for sigaling both 74HC4040 $0.63 4 1 WEEK
21Electric
alAdr Latch (74259) Memory inside 7400 Series ? 2
22Electric
alNOR 4 Gate Chip IC to control counter to latch inside 7401 Series ? 2
23Electric
alPower on Reset chip Provides Clr Signal outside 1
24Electric
alTerminal Blocks holds wire both ? 8
25Electric
alPWB Holds IC components inside ? 2
26Electric
alPWB Holds IC components outside ? 2
27Electric
alA/D Converter Main part - converts signal inside
TLC2578IPWG4-ND
$15.95 2 1 WEEK
28Electric
alD/A Converter Main part - converts signal ouside TLV563 ? 2
29Electric
alDC to DC 5v
converterConverts 15v to 5v both ? 4
30Electric
alDC to DC 3.3v
converterConverts 15v to 3.3v inside ? 1
31Electric
alClock clock (20Mhz) ouside ? 1
32Electric
alAdheasive back
stand offHolds the pwba down both 10971.00 18 1 WEEK
33Electric
al10pF Capacitors
Needed for decoupling bet. REFP & REFM on ADC
34Electric
al.1pF Capacitors
Needed for decoupling bet. REFP & REFM on ADC
35Electric
alParellel load 8 bit
shift regNeede to shift data to carry internal 74AC16652DLG4 $11.70 2 1 week
36Electric
al8 BIT SYNC BINUP DOWN COUNTER
both 74HC40103PW,112
$1.19 2 1 WEEK
37Electric
alOR GATE both 74AC32D $0.57 1 1WEEK
38Electric
alNOR 4 Gate Chip INSIDE CD74AC02M96 $0.77 1 1WEEK
39Electric
alINVERTS INSIDE
SN74AC240DWR$0.77 1 1WEEK
40Electric
alD FLIP FLOP both
SN74AC74DR$0.55 1 1WEEK
41Electric
alAnalog Mux Demux both
74HC4051PW,118$0.58 2 1WEEK
42Electric
alDual 4 bit binary both
74HC4520DB,112$1.11 2 1WEEK
LVAD Simulation Signal Test Electronics Functionality Test Leak and Pressure Test Drop Test Heat Transfer Test Flexibility Testing
Bend Radius Stiffness
Test Plan
Before connecting to LVAD and Dr. Days Equipment we will be preforming a simulation by monitoring the signals coming in and out using Function Generator and Oscilloscope.
LVAD Simulation Signal Test
They System Must operate Continuously for 6 hours.
Test: 3 one hour test 3 one hour test in Water(dependent on
leak test) 1 six hour test
Electronics Functionality Test
Test fully assembled cases with no electronics inside O-rings will be installed with Loctite silicon
sealant Place cases in water 1 meter deep for 15
minutes Case will experience 10 kPa of pressure Cases will contain a test material to absorb
water Cases will be opened up to ensure success
Leak and Pressure Test
Test fully assembled cases with no electronics inside
Cases will be dropped from height of 1.5 meters Internal case will be dropped onto carpet to
protect surface from marking External case will be dropped onto concrete to
simulate worst case scenario We will inspect the cases to ensure full
structural integrity was maintained Secondary leak test
Drop Test
For feasibility reasons will be preforming the test in Water
Heat Transfer Test
0 0.002 0.004 0.006 0.008 0.01 0.012 0.014 0.016 0.0180.00
10.00
20.00
30.00
40.00
50.00
60.00
70.00
80.00
90.00
100.00Temperature
AirWaterTissue
Distance(m)
Tem
pera
ture
(oC
)
Flexibility Test: Bend Radius
Determine the Stiffness of the individual cables by apply 3 different applied Force.
Flexibility Test: Stiffness
C-Clamp
Cable
δ= Deflection
Applied Force
Spring Scale
RiskID Risk Item Effect Cause
Likelihood
Severity
Importance
Action to Minimize Risk Owner
1Electrics Produce too much heating
Failure of project
Not enough heat dispersion. Electronics heat production not
calculated correctly3 5 15
Research best heat sink options and apply to design.
Chrystal Andreozzi
2 Wire BreaksFailure of project
Too much stress and ware on the wire connects. Not enough analyzing of wire fatigue.
2 5 10Research best Wire fatigue
optionsChrystal
Andreozzi
3 Cass LeaksFailure of project
Case Design fails 2 3 6Research best case options and
leak testCraig
LaMendola
4 Parts arrive lateSchedule is
delayedUnreliable vendor, out of stock part 3 4 12
Constant communication with vendor, use reliable vendors, have
backup parts selectedTeam
5Longevity of component
Failure of project
Manufacture of components 3 3 9Look for quality components Make
Dr. Day are of failure possibility
Yevgeniy Popovskiy and
Vince Antonicelli
6Chips can’t handle
signal speedFailure of project
Poor IC family choice 3 3 9Make sure IC family can handle
the clock rate
Yevgeniy Popovskiy and
Vince Antonicelli
8Miswire of
componentsFailure of project
Rush thru work 1 3 3 Lay out on bread board first Yevgeniy
Popovskiy and Vince Antonicelli
9Electrical
component don’t fit in boxes
Failure of project
Poor design 2 3 6Communicate expected space
needsTeam
10
Unacceptably long time delay is
introduced by signal transmission
Poor LVAD function /
project failure
Poor research, important considerations overlooked,
calculations errors1 4 4
Calculate speed and tolerance needed, analyze alternatives
Yevgeniy Popovskiy and
Vince Antonicelli
11Design more
complicated than needed
Team does excess work,
excesses recourses
consumed
Poor consideration of design alternatives
3 2 6 Review each other’s workYevgeniy
Popovskiy and Vince Antonicelli
12 Project Failure Project FailureOur team does NOT fully understand the mistakes that team 10022 made
and we make the same mistake Research to the best of our ability Team
?