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									Senior Design Project Data Sheet




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
             Pump/Motor                                         Dr. Lyshevski, Dr. Borkholder,
  30 min
              - research status, recommendations                Dr. Day, Prof. Slack
  10 min     Wrap Up                                            All attendees
Materials to be Reviewed                        Page

       Project Description                       3

       Block Diagram                             4

       System CAD Drawing                        5

       Motor/ Pump Analysis                      6-7

Appendix
              Reservoir Contact Information      A1
              1. Vesta Quote                     A2
              2. Albright Technologies Quote     A3
              3.Risk Assessment                 A4-A6

Engineering Specifications                       A7
Bill of Materials                                A8
Motor/Pump Reservoir Analysis                    A9
MSD II Preliminary Schedule                     A10
Drawings/Schematics
               1. System                        A11
               2. Pump                          A12
               3. Reservoir                     A13
Motor/Pump Data Sheets                         A14-A20
    Project #              Project Name                           Project Track                      Project Family
    P10044         Smart LAP-BAND Phase 3                     Biomedical Systems &                 Assistive Devices
                                                                  Technologies
Start Term                  Team Guide                           Project Sponsor                     Doc. Revision
     20092              Prof. George Slack                    QUANTUM Technology
                                                                Associates, Inc.




        Project Description
                                                                              Improve current design
                                                                              Make the design easy to use for doctor and
Project Background:                                                            surgeon
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             Core Team Members:
food their stomach can hold at one time. The name                             Gabrielle Bartlett (ME) – Project Manager
“LAP-BAND” comes from the minimally invasive                                  Oyuna Myagmar (ME) – Lead Mechanical
surgical technique (laparoscopy) and the silicone                             Yonathan Tulu (EE) – Lead Electrical
gastric band placed around the top of the upper part of                       Joesph Sisson (EE)
their stomach. The LAP-BAND System uses soft, pre-                            Albert Sze (CE)
curved, 360 degree inflation area that distributes
                                                                              Adam Clark (ISE)
pressure evenly on the stomach. The system also has
                                                                              Jimmy Mounnarat (ME)
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
                                                                          Strategy &
developing proper wireless communication. This
will allow the Smart LAP-BAND to be completely
internal and reduce the patients discomfort during
                                                                          Approach
adjustments.
                                                                    Assumptions & Constraints:
Objectives/Scope:                                                             Work achieved by previous team will
            Find     a       pump/electronics  that    is                     accurately simulate banding needs
             expectable in size while still meeting                           Meeting difficult customer needs
             required parameters.                                             Transmitting certain signals may be a
            Setup wireless communication between                              constraint
             internal unit and remote controlled user                         Previous design can be miniaturized and
             interface.                                                        wireless communication can be used to
            Ensure that the new hardware will be    safe                      control the system
             for the patient.
            Ensure there is no interference with                   Issues & Risks:
             existing port and use the port as a
             mechanical backup.                                               Understanding of project
                                                                           o             Customer Needs (Meeting specs)
                                                                           o             Design space for system
 Deliverables:                                                                System Requirements
            Improved       concept       selection     of                 o             Safety considerations
             pump/motor      to    meet    the    customer                 o             Long-term sustainability
             needs.                                                        o             Meeting required parameters
            New      schemes     for    mechanical    and                    Available Resources
             electrical   diagrams      and    layout   of                 o             Parts Availability
             designs.                                                      o             Testing/Lab Ti
            A functioning prototype.


Expected Project Benefits:
            Decrease discomfort      of   patient   during
             adjustments


KGCOE MSD                                      Page 3 of 28                             Detailed Design Review
                           Block Diagram




KGCOE MSD   Page 4 of 28            Detailed Design Review
                           1. System CAD Drawing




KGCOE MSD   Page 5 of 28               Detailed Design Review
                         Motor/Pump Analysis

                                     MaxFlow
            Image   Pump Manf          Rate      Power Pressure          Size
                                      mL/min     Watts    psi       (l x w x h) cm



                     Takasago
                                       0.45       0.12   7.25        3 x 1.2 x 1.4
                      Electric




                      Thermo
                                        43        27      37       10.7 x 5.4 x 3.8
                     Scientific




                      Namiki            180       2.28   10.1       5.56 x 2 x 3.91




                    Instech Labs        10        1.5     40         6.8x2.7x3.2




KGCOE MSD                         Page 6 of 28                    Detailed Design Review
     key: RED = Specification Not M et                                                                                   P10044 LapBand III
     revision: 2/3/2010
                                                                                                                         Motor/ Pump Screening
                                                                                          Concepts

                                                                                                                                        New Scale
                                       Dr. Kwon's         LapBand II                          P625 Peristaltic                          Squiggle
                                      Specifications                             Namiki                                    Takasago
                                                          Peristaltic                        (Recommended)                             Micro Pump
                                                                                                                                        (not available)
     Selection Criteria
     Motor/ Pump Length (cm)                 7                    5               5.56                 6.8                     3                2.8
     Motor/ Pump Diameter (cm)              1.4                   4                 2                  2.7                    1.2               0.6

     Size Ratio                                                  1:6               1:8                 1:6                    1:4             1:2.5
     Total Volume (cc)                    18.00                 100               147                  99                     63                42
     Motor/ Pump volume (cc)               10.78                62.8               17.5               58.8                    3.4              0.8
     Reservoir volume (cc)                 10 cc                10.00             10.00               10.00                  10.00            10.00
                                                                                             Included in motor/pump
                                                                  10               10                                         10                 6
     Motor controller volume (cc)      Included in the                                               volume
     Battary Volume (cc)             motor/pump volume            20              100                   20                    20                20
     rf communications Volume (cc)                                10              10                    10                    10                5

     Flow rate (cc/min)                    0.25                 40.00            180.00               10.00                  0.45              0.24
     Pressure (psi)                         10                  12.00            10.10                40.00                  0.01             37.00
     Power while moving (W)                N/A                  1.10              2.28                0.90                   0.12              2.50
     Hold Position                        design                 yes              yes                  yes                    No               yes
     Device Control Life (yrs)               3                    5                 3                   3                      3                 3
     Device Implanted Life (yrs)           100                   100              N/A                  N/A                   N/A               N/A
     Flow resolution (cc)                  0.10                 0.10              N/A                 0.05                   N/A             0.8x10-6
     Meets Specifications?                                       no               no                   no                    no                no
     Motor/ Pump Cost                       $$                  $45              $450                 $640                   N/A               N/A
                                                                                                                                       No. Pump does not
                                                          No. Does not meet
                                                                                                                                      meet any of the critical
                                                         volume but meets all                Yes. Does not meet volume
                                       continuation                                                                                   specifications. Pump
                                                         other specifications.     No.           but meets all other          No
                                     recommendation       Requires extensive                       specifications.
                                                                                                                                         is currently not
                                                                                                                                        available by New
                                                              machining.
                                                                                                                                              Scale.




KGCOE MSD                                  Page 7 of 28                            Detailed Design Review
            Appendix




KGCOE MSD              Detailed Design Review
Reservoir Company Contact Information:


            Vesta Contact information                Albright Contact information



                  Ray Pellerin                              Alan Frechette
                  Northeast Sales Manager                   Quality Assurance Manager

                  Vesta/ExtruMed                            Albright Technologies
                  NH Office:                                Tel. 978 466-5870
                  603.489.1599
                                                            Fax 978 466-5901
                  rpellerin@vestainc.com
                                                            alan@albright1.com

           Vesta –please see following pages.         Albright – please see following pages.




KGCOE MSD                                       A1                            Detailed Design Review
Quote from Vesta




KGCOE MSD          A2   Detailed Design Review
A2 - Quote from Albright Technologies




KGCOE MSD                               A6   Detailed Design Review
                                                ME Risk Assessment – Detailed Design phase




                                                                                                            Importance
                                                                                    Likelihood

                                                                                                 Severity
 ID   Risk Item            Effect                      Cause                                                             Action to Minimize Risk                      Owner
      Can not build
                           Can not meet project        Materials are expensive or
 1    (reservoir,                                                                   1            2          2            Eliminate from project needs                 ME
                           needs                       not available
      enclosure)

      Unable to                                        Incompatible with
                                                                                                                         Research more about alternative methods to
 2    enclose/coat the     Failure to implant          electronics, lack of         2            3          6                                                         ME
                                                                                                                         enclose electronics
      electronics                                      experience with materials

                           Cannot accurately adjust
                                                       Hardware Damage
 3    Sensor Failure       system, may be                                           1            3          3            Testing                                      ME
                                                       Software/Interface failure
                           dangerous
                                                       Reservoir corrosion
                                                                                                                         Select appropriate material
 4    System Leak          Removal of entire system                                 2            3          6                                                         ME
                                                                                                                         Check sealing before installation
                                                       Tubing/attachments leaking

      Materials Used Not   Harm to the patient’s       Materials not accepted by                                         Use safe materials
 5                                                                                  2            3          6                                                         ME
      Safe                 body, may reject system     body                                                              Follow Biomedical Industry Standards




KGCOE MSD                                             A4                                Detailed Design Review
                                                                          Risk Assessment




                                                                                                                                     Importance
                                                                                                     Likelihood

                                                                                                                      Severity
I
D   Risk Item                 Effect                     Cause                                                                                    Action to Minimize Risk                 Owner
                                                         Battery doesn't last long enough                                                         Design for reliability and redundancy
1   Power loss                Fatal system failure       Battery failure                         2                3              P*R              Reliable battery                        TBD
                                                         Short-circuit                                                                            Backup battery
                                                         External Signals
                                                                                                                                                  Shielding
                              Wireless                                                                                           R*
2   Signal interference                                                                          2                3                               Filters                                 TBD
                              Communication Failure      Unable to communicate through body                                      A
                                                                                                                                                  Selecting proper frequencies
                                                         tissue
                                                         Inappropriate shielding/enclosing
                              Harm to patient (esp
                                                         material
                              strong enough and                                                                                                   Design for reliability and redundancy
                                                                                                                                 P*
3   Possible shock            reaches heart)                                                     2                3                               Ground                                  TBD
                                                         Static buildup                                                          R
                                                                                                                                                  Follow Biomedical Industry Standards
                              Damage Hardware
                                                         Short-circuit
                              Harm to the patient’s                                                                              P*               Use safe materials
4   Materials Used Not Safe                              Materials not accepted by body          2                3                                                                       TBD
                              body, may reject system                                                                            R                Follow Biomedical Industry Standards
                                                                                                                                                  Design for reliability and redundancy
                              Don’t know of any          Sensor failure                                                          P*
5   Warning system fails                                                                         2                3                                                                       TBD
                              possible dangers           Hardware/Software failure                                               R                Follow Biomedical Industry Standards
                              Difficult to adjust        Poor UI Design
6   UI is hard to use                                                                            2                1              R                Customer feedback                       TBD
                              system                     Lack of customer feedback
                              System cannot turn off
                                                                                                                                                  Design for reliability and redundancy
    Wireless/Manual           in case of emergency,                                                                              P*
                                                                                                                                                  Follow Biomedical Industry Standards
7                                                        Overall System Failure                  2                3                                                                       TBD
    overrides failure         posing grave danger to                                                                             R
                              patient
                                                         Signal interference
    Wireless cannot                                                                                                              P*               Design for reliability and redundancy
8                             Cannot adjust system       Power loss                              2                3                                                                       TBD
    communicate to UI                                                                                                            R
                                                         Overall wireless failure
                              Cannot adjust system       Communications module/Hardware
                                                                                                                                                  Testing and Research
                                                         failure                                                                 P*
9   RF Range is too small                                                                        1                3                                                                       TBD
                              Wireless communication     Reduced power                                                           R
                                                                                                                                                  Reliable and redundant power
                              failure                    Critical Research Failure




KGCOE MSD                                               A5                                  Detailed Design Review
                                                                                                                              Importance
                                                                                                      Likelihood

                                                                                                                   Severity
I
     Risk Item                 Effect                      Cause                                                                           Action to Minimize Risk                 Owner
D


                                                                                                                                           Customer Feedback
     Unable to meet size                                   Design Failure                                                     P*
10                             Customer Needs failure                                             3                2                                                               TBD
     constraints/pump specs                                Customer Needs too severe                                          R
                                                                                                                                           Design Processes
     Wireless Communication
                                                                                                                              P*           Design for reliability and redundancy
11   Failure                   Cannot adjust system        (Many)                                 2                3                                                               TBD
                                                                                                                              R
     (umbrella risk)
                               Cannot accurately adjust
                                                           Hardware Damage                                                    P*
12   Sensor Failure            system, may be                                                     1                3                       Testing                                 TBD
                                                           Software/Interface failure                                         R
                               dangerous
                               Cannot adjust system
                                                           Chip damage                                                        P*
13   Microcontroller Failure                                                                      2                3                       Select hardy microcontroller            TBD
                               Wireless                    Electrical Behavior Anomalies                                      R
                               Communication failure
                                                           Software Bugs                                                      P*           Software testing and reliability
14   Software Failure          Overall System Failure                                             2                3                                                               TBD
                                                           Microcontroller failure                                            R            processes
                                                           Reservoir corrosion                                                             Select appropriate material
                               Removal of entire                                                                              P*
15   System Leak                                                                                  2                3                                                               TBD
                               system                                                                                         R
                                                           Tubing/attachments leaking                                                      Check sealing before installation
                                                           Short-Circuit generating high amount
                                                                                                                              P*           Implement protection circuit and use
16   Possible Burn to Tissue   Harm to patient             of heat, not dissipating heat from     2                3                                                               TBD
                                                                                                                              R            heat dissipating material
                                                           system properly
     Internal Integration      Non-functional                                                                                 T*
17                                                         Racial change in the pump              2                3                       Communication with ME sub-team          TBD
     Failure                   deliverable                                                                                    A
     Integration/Interfacing   Non-functional              Components not compatible with                                     P*
18                                                                                                2                3                       Research                                TBD
     failure                   deliverable                 each other                                                         R
                                                           High bit error rate
                               Delayed Communication                                                                          P*           Boost the signal
19   Packets Dropping                                      Signal Interference                    2                1                                                               TBD
                               Higher latency                                                                                 R            Design a better antenna
                                                           Low Signal to Noise ratio
                               Short/ Inconvenient
     Huge Drain on Battery                                                                                                    P*
20                             battery life                High power components                  2                1                       Redundant batteries                     TBD
     (remote control)                                                                                                         R
                               High heat generation




KGCOE MSD                                                 A6                                Detailed Design Review
                                        Engineering Specifications - Detailed Design phase
  Revision #:           7
  Engr. Spec.                                                                Unit of    Marginal
              Importance    Source            Specification (description)                        Ideal Value                   Comments/Status
       #                                                                    Measure      Value
                                                                                                               Values per adjustment specs; ideal rechargeable
     ES1          2          CN9     Battery life                            Years          5        100
                                                                                                               battery
                                                                                                               Heat coming off of the components, based on
     ES2          3          CN3     Heat dissipation                          C           0-3         0
                                                                                                               maximum temperature human body can take
                                                                                                               Longevity of design/enclosure; ideal value is
     ES3          2          CN9     Longevity                               Years          5        100
                                                                                                               lifetime of patient
     ES4          1         CN13     Wireless Range > reach outside body      cm           0.5       200       Transmitter placed under skin

     ES5          3          CN3     Pump fail safe                           Kpa       62.05-68.9   62.05     Above a certain pressure it shuts off the pump
     ES6          1          CN4     Biocompatibility                       Yes/No                   Yes       FDA/IEEE regulations
     ES7          2         CN10     Reservoir volume                         cc           4-7        10       Volume not included overall size dimensions
     ES8          2         CN15     Time constraint                        cc/min        0.25        10
                                                                                                               Number of adjustments the LAP-BAND goes
     ES9          2          CN9     Number of adjustments                     --           6         10
                                                                                                               through
    ES10          2         CN15     CC's per adjustment                      cc          .25-1      0.25      Increments
    ES11          3          CN3     Moisture contamination                  g/m3
                                                                                                               Check pressure sensors in both lap-band and
    ES12          1          CN8     Leakage fail safe                      pascal
                                                                                                               pump




KGCOE MSD                                             A7                            Detailed Design Review
                                                                                         Bill of Materials

                                                                                      102-1212-                                                            SENSOR FORCE
  Mechanical
  Subsystem



               New Pressure Sensor Purchasing    CUI Inc      IESF-R-5      DigiKey                 1      0   0   1    $8.12        $8.12     1 week
                                                                                         ND                                                               1.5KGF DIA FLEX


               SILASTIC(R) MDX4-       Kit       Applied       40072        Applied    40072        2      0   0   -   $250.00      $500.00    1 week       A kit to make
                 4210 Biomedical                 Silicone                   Silicon                                                                        “home-made”
                 grade elasomer                                                                                                                          elastomer to coat
                                                                                                                                                             electronics




Existing Hardware
                                                Williamson    100-070- Williamson 100-070-                                                                4 Roller Peristaltic
                     Pump          Purchased                                                       1       0   0   0    $39.71      $39.71     0 weeks
                                                 Pumps         006-016   Pumps     006-016                                                                       Pump
                                                              2619 006             2619 006
                                                                                                                                                         33:1 Gearbox 6 VDC
                  Pump Motor       Purchased       FTB       SR 33:1 IE-   FTB    SR 33:1 IE-      1                    $74.40      $74.40     0 weeks
                                                                                                                                                                Motor
                                                                  16                  16
                                                                                                                                                            0-15 Pressure
                Pressure Sensors   Purchased     OMEGA       PX40-15G5V OMEGA PX40-15G5V           2                    $15.99      $31.98     0 weeks
                                                                                                                                                               Senosr




Researched Hardware
                                                                                                                                                          Custom made to
                     Reservoir       Molding       Vesta                     Vesta                  1                  $5,000.00   $5,000.00   1 week      meet spec ific
                                                                                                                                                            parameters
                                                                                                                                                          Custom made to
                     Couplers        Molding                                                      2 to 4                Quoting     Quoting    1 week      meet spec ific
                                                                                                                                                            parameters
                                                                                                                                                          Custom made to
                    Extra tubing     Molding                                                                            Quoting     Quoting    1 week      meet spec ific
                                                                                                                                                            parameters




                    Legend
                                                    Ready to order
                                             Know what needs to be done
                                               and have XX hrs of work
                                               Do not know all info. and
                                                estimate time is XX hrs.




KGCOE MSD                                                              A8                                                    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.




KGCOE MSD                                       A9                                                           Detailed Design Review
                         MSD II Preliminary Schedule (Mechanical)

            Week 11 (SD1) Finalize BOM and finish orders


            Week 1         Inventory of received purchases and Plan for rest of the quarter


            Week 2 -3      Assemble all components


            Week 4         Preliminary testing


            Week 5-6       Full Testing


            Week 7         Formally document and analyze results


            Week 8         Make appropriate adjustments and retest


            Week 9         Final system layout


            Week 10        Create final report


            Week 11        Display functional system




KGCOE MSD                    A10                                                              Detailed Design Review
                  Drawings/Schematics
                         1. System




KGCOE MSD   A11                         Detailed Design Review
                  2. Pump




KGCOE MSD   A12         Detailed Design Review
                  3. Reservoir




KGCOE MSD   A13                  Detailed Design Review
KGCOE MSD   A14   Detailed Design Review
KGCOE MSD   A15   Detailed Design Review
KGCOE MSD   A16   Detailed Design Review
KGCOE MSD   A17   Detailed Design Review
KGCOE MSD   A18   Detailed Design Review
KGCOE MSD   A19   Detailed Design Review
KGCOE MSD   A20   Detailed Design Review

								
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