KGCOE MSD Technical Review Agenda
P10044 – Smart LAP-BAND Phase 3
Meeting Purpose: Detailed Design Review of P10044- Fluid Smart Lap-band. The objectives of this are to present and receive feedback on our final design, researched items and Bill of Materials.
Meeting Date:
Meeting Location:
Meeting time:
Timeline
Meeting Timeline /Duration / Topic of Review / Required Attendees /
15 min / Introduction, Review / All attendees
20 min / Materials
- encapsulation, reservoir, tubing & sealing / Dr. Lamkin-Kennard, Dr. Day
15 min / Test Stand / Dr. Lamkin-Kennard, Dr. Day, Prof. Wellin
30 min / Pump/Motor
- research status, recommendations / Dr. Lyshevski, Dr. Borkholder, Prof. Slack
10 min / Wrap Up / All attendees
Materials to be Reviewed / Page
Project Description / 3
Block Diagram / 4
System CAD Drawing / 5
ME Risk Assessment / 6
ME Engineering Specifications - Detailed Design phase / 7
Bill of Materials / 8
Motor/ Pump Analysis / 9
Drawings/Schematics
1. System
2. Pump
3. Reservoir / 10
11
12
Feasibility Analysis / 13-14
MSD 2 Preliminary Schedule / 15
Appendix
1. Vesta Quote
2. Albright Technologies Quote
3. Risk Assessment / A1
A2
A3
KGCOE MSD Page 1 Detailed Design Review
Project Description
KGCOE MSD Page 3 Detailed Design Review
Project Background:
The LAP-BAND Adjustable Gastric Banding System is a gastric banding system that helps patients gradually lose and control their weight by reducing the amount of food their stomach can hold at one time. The name “LAP-BAND” comes from the minimally invasive surgical technique (laparoscopy) and the silicone gastric band placed around the top of the upper part of their stomach. The LAP-BAND System uses soft, pre-curved, 360 degree inflation area that distributes pressure evenly on the stomach. The system also has a fill volume so the surgeon can adjust after installation.
Problem Statement:
To reduce the size so the Smart LAP-BAND is safe to be fully placed within the body as well as developing proper wireless communication. This will allow the Smart LAP-BAND to be completely internal and reduce the patients discomfort during adjustments.
Objectives/Scope:
· Find a pump/electronics that is expectable in size while still meeting required parameters.
· Setup wireless communication between internal unit and remote controlled user interface.
· Ensure that the new hardware will be safe for the patient.
· Ensure there is no interference with existing port and use the port as a mechanical backup.
Deliverables:
· Improved concept selection of pump/motor to meet the customer needs.
· New schemes for mechanical and electrical diagrams and layout of designs.
· A functioning prototype.
Expected Project Benefits:
· Decrease discomfort of patient during adjustments
· Improve current design
· Make the design easy to use for doctor and surgeon
Core Team Members:
· Gabrielle Bartlett (ME) – Project Manager
· Oyuna Myagmar (ME) – Lead Mechanical
· Yonathan Tulu (EE) – Lead Electrical
· Joesph Sisson (EE)
· Albert Sze (CE)
· Adam Clark (ISE)
· Jimmy Mounnarat (ME)
Strategy & Approach
Assumptions & Constraints:
· Work achieved by previous team will accurately simulate banding needs
· Meeting difficult customer needs
· Transmitting certain signals may be a constraint
· Previous design can be miniaturized and wireless communication can be used to control the system
Issues & Risks:
· Understanding of project
o Customer Needs (Meeting specs)
o Design space for system
· System Requirements
o Safety considerations
o Long-term sustainability
o Meeting required parameters
· Available Resources
o Parts Availability
o Testing/Lab Ti
Block Diagram
KGCOE MSD Page 4 Technical Review Agenda
System CAD Drawing
ME Risk Assessment – Detailed Design phase
ID / Risk Item / Effect / Cause / Likelihood / Severity / Importance / Action to Minimize Risk / Owner1 / Can not build (reservoir, enclosure) / Can not meet project needs / Materials are expensive or not available / 1 / 2 / 2 / Eliminate from project needs / ME
2 / Unable to enclose/coat the electronics / Failure to implant / Incompatible with electronics, lack of experience with materials / 2 / 3 / 6 / Research more about alternative methods to enclose electronics / ME
3 / Sensor Failure / Cannot accurately adjust system, may be dangerous / Hardware Damage
Software/Interface failure / 1 / 3 / 3 / Testing / ME
4 / System Leak / Removal of entire system / Reservoir corrosion
Tubing/attachments leaking / 2 / 3 / 6 / Select appropriate material
Check sealing before installation / ME
5 / Materials Used Not Safe / Harm to the patient’s body, may reject system / Materials not accepted by body / 2 / 3 / 6 / Use safe materials
Follow Biomedical Industry Standards / ME
KGCOE MSD Page 6 Technical Review Agenda
Engineering Specifications - Detailed Design phase
KGCOE MSD Page 7 Technical Review Agenda
Bill of Materials
Existing Hardware
Researched Hardware
KGCOE MSD Page 8 Technical Review Agenda
Motor/Pump Analysis
KGCOE MSD Page 9 Technical Review Agenda
KGCOE Page 10 Detailed Design Review
Motor/ Pump
The LAP-BAND Phase 2 pump from Willamson is being used as a generic device to create an electro-mechanical load to enable testing of Phase 3 project functions. There will not be any feasibility analysis since this pump works. If the customer chooses to pursue an opportunity to advance a pump device, the team recommends New Scale Technologies.
Reservoir
- Primary design interest is to fabricate a reservoir from raw materials.
- Not feasible due to design constraints and cost.
Biomaterials/ Encapsulation
We found a biomedical grade elastomer (SILASTIC(R) MDX4-4210 ) which was published in two medical research papers stating that this can be used in long term implantable medical devices. This is the material we propose to be used to encapsulate the electronics and the battery. Also this could be the material used to seal connection between the tubing and the different components. As note that the company (Applied Silicone) that supplies the biomedical elastomer offers an adhesive (RTV Adhesives) that also could be used. However, additional funds would be required to purchase this item. Below is the initial detailed process of how the team would implement the encapsulation
1. Covering the electronics in plastic wrap
2. Creating a mold using for example Plaster of Paris (optional)
3. Re-assemble the mold (POP) to from the shape of the electronics
4. Coat the mold with the biomedical grade elastomer
5. Allow elastomer to cure
6. Peel off elastomer encapsulation and insert electronics
KGCOE MSD Page 11 Detailed Design Review
MSD II Preliminary Schedule (Mechanical)
Week 2 / Finalize BOM and finish ordersInventory of received purchases and Plan for rest of the quarter
Assemble all components
Preliminary testing
Full Testing
Formally document and analyze results
Make appropriate adjustments and retest
Final system layout
Create final report
Display functional system
KGCOE MSD Page 12 Detailed Design Review
KGCOE MSD Technical Review Agenda
Reservoir Company Contact Information:
Vesta Contact information / Albright Contact informationRay Pellerin
Northeast Sales Manager
Vesta/ExtruMed
NH Office: 603.489.1599
/ Alan Frechette
Quality Assurance Manager
Albright Technologies
Tel. 978 466-5870
Fax 978 466-5901
Vesta –please see following pages. / Albright – please see following pages.
KGCOE MSD A1 Technical Review Agenda
A1 - Quote from Vesta
KGCOE MSD A2 Detailed Design Review
A2 - Quote from Albright Technologies
KGCOE MSD A3 Detailed Design Review
Risk Assessment
ID / Risk Item / Effect / Cause / Likelihood / Severity / Importance / Action to Minimize Risk / Owner1 / Power loss / Fatal system failure / Battery doesn't last long enough
Battery failure
Short-circuit / 2 / 3 / P*R / Design for reliability and redundancy
Reliable battery
Backup battery / TBD
2 / Signal interference / Wireless Communication Failure / External Signals
Unable to communicate through body tissue / 2 / 3 / R*A / Shielding
Filters
Selecting proper frequencies / TBD
3 / Possible shock / Harm to patient (esp strong enough and reaches heart)
Damage Hardware / Inappropriate shielding/enclosing material
Static buildup
Short-circuit / 2 / 3 / P*R / Design for reliability and redundancy
Ground
Follow Biomedical Industry Standards / TBD
4 / Materials Used Not Safe / Harm to the patient’s body, may reject system / Materials not accepted by body / 2 / 3 / P*R / Use safe materials
Follow Biomedical Industry Standards / TBD
5 / Warning system fails / Don’t know of any possible dangers / Sensor failure
Hardware/Software failure / 2 / 3 / P*R / Design for reliability and redundancy
Follow Biomedical Industry Standards / TBD
6 / UI is hard to use / Difficult to adjust system / Poor UI Design
Lack of customer feedback / 2 / 1 / R / Customer feedback / TBD
7 / Wireless/Manual overrides failure / System cannot turn off in case of emergency, posing grave danger to patient / Overall System Failure / 2 / 3 / P*R / Design for reliability and redundancy
Follow Biomedical Industry Standards / TBD
8 / Wireless cannot communicate to UI / Cannot adjust system / Signal interference
Power loss
Overall wireless failure / 2 / 3 / P*R / Design for reliability and redundancy / TBD
9 / RF Range is too small / Cannot adjust system
Wireless communication failure / Communications module/Hardware failure
Reduced power
Critical Research Failure / 1 / 3 / P*R / Testing and Research
Reliable and redundant power / TBD
ID / Risk Item / Effect / Cause / Likelihood / Severity / Importance / Action to Minimize Risk / Owner
10 / Unable to meet size constraints/pump specs / Customer Needs failure / Design Failure
Customer Needs too severe / 3 / 2 / P*R / Customer Feedback
Design Processes / TBD
11 / Wireless Communication Failure
(umbrella risk) / Cannot adjust system / (Many) / 2 / 3 / P*R / Design for reliability and redundancy / TBD
12 / Sensor Failure / Cannot accurately adjust system, may be dangerous / Hardware Damage
Software/Interface failure / 1 / 3 / P*R / Testing / TBD
13 / Microcontroller Failure / Cannot adjust system
Wireless Communication failure / Chip damage
Electrical Behavior Anomalies / 2 / 3 / P*R / Select hardy microcontroller / TBD
14 / Software Failure / Overall System Failure / Software Bugs
Microcontroller failure / 2 / 3 / P*R / Software testing and reliability processes / TBD
15 / System Leak / Removal of entire system / Reservoir corrosion
Tubing/attachments leaking / 2 / 3 / P*R / Select appropriate material
Check sealing before installation / TBD
16 / Possible Burn to Tissue / Harm to patient / Short-Circuit generating high amount of heat, not dissipating heat from system properly / 2 / 3 / P*R / Implement protection circuit and use heat dissipating material / TBD
17 / Internal Integration Failure / Non-functional deliverable / Racial change in the pump / 2 / 3 / T*A / Communication with ME sub-team / TBD
18 / Integration/Interfacing failure / Non-functional deliverable / Components not compatible with each other / 2 / 3 / P*R / Research / TBD
19 / Packets Dropping / Delayed Communication
Higher latency / High bit error rate
Signal Interference
Low Signal to Noise ratio / 2 / 1 / P*R / Boost the signal
Design a better antenna / TBD
20 / Huge Drain on Battery (remote control) / Short/ Inconvenient battery life
High heat generation / High power components / 2 / 1 / P*R / Redundant batteries / TBD
KGCOE MSD A5 Detailed Design Review
KGCOE MSD A4 Technical Review Agenda
Drawings/Schematics
1. System
KGCOE MSD A6 Technical Review Agenda
2. Pump
KGCOE MSD A7 Detailed Design Review
3. Reservoir
KGCOE MSD A8 Detailed Design Review