P09043 Fluid Smart Lap Band MSD I

Transcription

1 P0903 FluidSmartLap Band MSDI BrianSmits JohnGriffith MarkOzimek BrooksPrzybylek

2 KGCOE MSD Technical Review Agenda Meeting Purpose: To review the detailed design choices for project P0903. Materials to be reviewed: Feedback from first design review System level design Customer Needs Specifications Device Features Engineering Analysis and Design of specific subsystems o Mechanical Pumping System o Mechanical Enclosures o Micro-Processor and Pseudo Code o Driver Logic Risk Assessment and Mitigation Bill of Materials (B.O.M.) Meeting Date: Friday February 13th, 2009 Meeting Location: (Video Conference Room) Meeting time: 12:00 pm :00 pm (Small shorter meetings) Timeline: Start time Duration 12:00 PM 30 Minutes 2:00 PM 20 Minutes 2:20 AM 30 Minutes Meeting Timeline Topic of Review Introduction New Pumping System Overall size of Mechanical Enclosure Placement of Enclosure and Parts Material for Enclosure Risk Analysis Mechanical Review of New System Level Designs Demonstration of system mock-up Review of System Level Block Diagram Review of Customer Needs, Specifications and device features Mechanical Risk Assessment and Mitigation Pumping System o Concept Pictures o Drawings o Data Sheets Enclosure o Feasibility / Materials Required Attendees Dr. Doolittle Mechanical Prof Mechanical Prof KGCOE MSD Page 1 of 2 Technical Review Agenda

3 Start time Duration 3:30 PM 10 Minutes 3:0 AM 20 Minutes Meeting Timeline Topic of Review Electrical Review of New System Level Designs Demonstration of system mock-up Review of System Level Block Diagram Pseudo Code Review of Customer Needs, Specifications and device features Driver Circuitry Risk Assessment and Mitigation Schematics and Analysis of chosen amplifier circuitry o Gear Motor Driver o Optical Encoder Driver o 2-Way Valve Driver Feasibility o Parts in house Bill of Materials Required Attendees Dr. Borkholder Prof Slack Jay KGCOE MSD Page 2 of 2 Technical Review Agenda

4 Senior Design Project Data Sheet Project # Project Name Project Track Project Family P0903 Fluid Smart Lap-Band Bioengineering Bioengineering Start Term Team Guide Project Sponsor Doc. Revision Prof. George Slack Winter 2008 Project Description QUANTUM Technology Associates, Inc. B 12/12/2008 Project Background: The current method of adjusting the lap-band Adjustable Gastric Banding System is an invasive and possibly painful procedure for the patient. This project aims to design a lap-band which will be adjustable via non-invasive means. Some major goals of this project are to design a suitable pumping system, devise a closed loop control scheme, and create fail-safes to insure patient safety. Problem Statement: The primary objective of this project is to automate the process by which fluid is added to the system. This will be done using some type of pumping method in order to adjust stomach constriction per doctor requirements. In doing so, fail-safe mechanisms must also be devised to deal with unexpected device failures. A power system for the device must also be designed which will be able to power the device reliably and without doctor intervention. Objectives/Scope: 1. Adjustable gastric banding fluid schemes 2. Fail-safes signal processing 3. Power requirements Deliverables: Adjustment scheme Device Monitoring method Device power supply requirements Expected Project Benefits: Design for a safe, non-invasive lap-band adjustment system Testing Data from human or similar stomach Improvement on existing product Testable components & methods for future senior designs Core Team Members: Brian Smits - IE - Project Manager John Griffith - EE Mark Ozimek - ME Brooks Przybylek - ME Strategy & Approach Assumptions & Constraints: Lap-band system can be automated Work achieved by previous team will accurately simulate banding needs Issues & Risks: Project Understanding By Team o Adjustment needs o Design space for system System Requirements o Safety considerations o Long-term sustainability Available Resources o Parts Availability o Testing Data o Lead Time

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6 Lap-Band Controller Pressure Sensor Control Valve Peristaltic Pump Motor Reservoir Component Fluid Signal Mechanical

7 Lap-Band Controller Pressure Sensor Control Valve Peristaltic Pump Motor Reservoir Component Fluid Signal Mechanical

8 A-A 11. SECTION A-A-A-A SCALE A-A RIT Fluid Smart Lap-Band Project P0903

9 ProjectP0903:FluidSmartLap Band BillofMaterials Item QTY Price Unit Vendor Part# Comments Website MechancialComponents Pump 1 $ WilliamsonPumps RollerPeristalticPump PumpMotor 1 Quoting 1 FTB SR33:1IE :1Gearbox6VDCMotor ControlValve 1 Quoting 1 Humphrey VA20 7 ManifoldMountOn/OffValve products.com Acrylic 1 $ Mcmaster Carr 860K321 CustomManifoldMaterial ElectricalComponents Controller 1 $3.9 1 SparkFunElectronics DEV DevelopmentBoard PressureSensor 1 $ OMEGA PX0 1GV 0 1psiPressureSensor Total $90.6 note: Awaitingpriceforpumpmotorandcontrolvalve.

10 Human Stomach Test (out of body) February 6, 2009 forward reverse averages cc in band PSI cc in band psi cc in band psi Pressure (psi) Pressure vs. Volume Volume in band (cc)

11 Upwards Downwards CC(insyringe) 1lbVolt 2lbVolt Pressure 1lbVolt 2lbVolt Pressure 1lbVolt 2lbVolt Pressure 1lbVolt 2lbVolt Pressure 1lbVolt 2lbVolt Pressure 1lbVolt 2lbVolt Pressure lbVolt 1lbVolt 1lbVolt 1lbVolt 1lbVolt 1lbVolt lbVolt lbVolt lbVolt Pressure lbVolt Pressure

12 Revision #: 1 Customer Need # Importance Description Comments/Status Overall System CN1 1 Implantable inside the human body CN2 1 Durable CN3 1 Safe CN 2 Low Cost CN 2 Compact CN6 2 Longevity Pump System CN7 1 Able to fill lap-band to specified volume CN8 1 Long life cycle CN9 1 Easy to use CN10 1 Safe for patient CN11 3 Bi-directional (tentative) CN12 1 Automated CN13 1 Maintain static pressure CN1 2 Resivor CN1 1 Flow control valve CN16 2 Knowledge of how much saline is being pumped Pressure Sensors CN17 1 Monitor pressure exerted by stomach on lap-band CN18 1 Monitor internal pressure CN19 1 Precise reading of current pressure Micocontroller CN20 1 Input signals CN21 1 Display pressure CN22 1 Turn pupm on in forward direction CN23 2 Turn pump on in reverse direction CN2 2 Power source Cust. Need #: enables cross-referencing (traceability) with specifications Importance: Sample scale (1=must have, 2=nice to have, 3=preference only), or see Ulrich exhibit -8. Description: organize as primary and secondary needs (hierarchy) -- Ulrich exhibit.8 Comment/Status: allows tracking of questions, proposed changes, etc; indicate if you are meeting the need ("met") or not ("not met")

13 Revision #: 1 Engr. Spec. Unit of Design Importance Source Specification (description) # Measure Value Ideal Value Comments/Status ES1 CN Total Cost $ ~300 TBD Still waiting for pump and valve quotes, cost is estimated. ES2 CN1, CN3, CN, CN6, CN2 System displacement cc <100 Need exact LabBand and tubing discplacement (neither included in figure), assumes 1 cc reservoir. ES3 CN1, CN2, CN3, CN Total system weight (not including power supply) g 89 <100 Need exact LabBandand tubing weight, does not include those or controller. Assumes 1 cc reservoir filled with water ES CN2, CN6, CN8 Expected device lifespan years TBD 0 Lapband should last the lifespan of patient without corrosion, failure of parts, or draining the battery ES CN1, CN, CN6, CN8, CN22, CN23, CN2 Pump power draw W 1.10 <1 Max motor power quoted in spec sheet, will be less than this during normal operation ES6 CN9, CN13, CN16, CN19 Pump speed cc/min 28 Flow rate decreases with voltage and increased pressure. Decreasing supplied voltage will reduce flow rate, as well as maximum pressure. ES7 CN7, CN9, CN16, CN19 Pump Pressure capacity psi >10 20 Pressure limited by motor torque, manufacturer indicated that this amount of pressure is possible with torque created by selected motor ES8 CN1, CN2, CN7, CN1 Reservior capacity cc TBD 1 Lap band holds 7-13cc, we will fabricate our own reservior ES9 CN8, CN1 Solenoid power draw W 0.-1 <1 Spec sheet quotes range, suspect power spike upon actuation ES10 CN2, CN3, CN10, CN13, CN1 Solenoid/One way valve max fluid pressure psi 100 Higher pressure values with smaller orfice sizes leading to decreased flow. Pressure within system should never exceed 10 psi ES11 CN11, CN13, CN1 Solenoid positions # 2 2 Used 2-position, 2-way valve to maintain constant volume in LapBand when inactive ES12 CN, CN6, CN2 Microcontroller power draw W TBD <1 Consider standby/power-off mode during inactivity ES13 CN12, CN20 Microcontroller Inputs # 2 6 Input from pressure sensor and control from doctor ES13 CN12, CN20 Microcontroller Outputs # 2 2 Outputs to control valves and pump ES1 CN7, CN16, CN17, CN18, CN19 Pressure sensor precision psi TDB <0.1 Pressure sensor data sheet vauge, but output is analog, accuracy limited by precision in reading voltage. Engr. Spec. #: enables cross-referencing (traceability) and allows mapping to lower level specs within separate documents Source: Customer need #, regulatory standard (eg. EN 60601), and/or "implied" (must exist but doesn't have an associated customer need) Description: quantitative, measureable, testable details *This table can be expanded to document test results