Syringe Filling Device

12 December 2018

Team: Holly Chen, Lindsay Epstein, Ellen O'Connell, Julia Sokol, Jiani Zeng
Mentors: Nevan Hanumara, Julian Chacon-Castano, Galit Frydman
Proposers: Richard Gyory, Bo Yang Yu (Becton Dickinson)
Mission Statement
To develop an assistive device to enable diabetic patients with low dexterity and
vision to easily fill a syringe.

Type II Diabetics

Late adopter

Vision Impairment

Dexterity Impairment

Difficult and Stressful

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Source: https://www.cdc.gov/diabetes/data/statistics/statistics-report.html
Persona
Treatments (Daily):
1. Breakfast dose
2. Lunch dose
3. Dinner dose
4. Basal dose

Pain Points:
❏ Can’t read the syringe marks without a magnifier

Susan Jones ❏ Can’t align the needle to the insulin bottle

“I try to live independently, but sometimes it can be tough.”
❏ Can’t hold and draw the syringe steadily

AGE: 71 ❏ My daughter lives 50 miles away and comes by every

DIAGNOSIS: Type II Diabetes
Sunday to fill up my 30 syringes and label them, but she has
ONSET AGE: 64
OCCUPATION: Retired kids and work, I feel like I am a burden.
FAMILY: Daughter and grandkids

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Prior Art market gap for product that addresses dexterity and vision impairments

Aids Impaired Aids Impaired Insulin Pen Alternative

Vision Dexterity

● Insul-eze Syringe Magnifier ● Insul -Cap ● NovoPen Echo

● Syringe Magnifier ● Injection safety guard

Does NOT Aid Does NOT Aid Expensive and Does

Impaired Dexterity Impaired Vision NOT Use Standard
Supplies

Impaired Vision and Impaired Dexterity Tend to go Hand-in-Hand with Type 2 Diabetes
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Functional Requirements Design Parameters
Useable by low-vision and dexterity patients Human factors testing

Accommodates standard vials and syringes Syringes (Ø 5.1-6.6 mm, 80.3-97.0 mm long),
needles (6-12 mm), vials (51.5-53.7 mm height)
Provides adjustable fill volume 0.01 - 1 mL

Provides accurate dosing (ISO 11608-1) ±1 unit below 20 units, ±5% above 20 units

Portable < 1 kg, < 30x10x10 cm

Safe

Costs within consumer price range

Maintains sterility
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Design Overview a simple, semi-automated system

Automated plunger movement

Manual syringe-vial joining with slider
Portable form factor
Simple user interface 6
Mechanical Design addresses accuracy and adjustability

- Plunger motion actuated by lead screw - Spring loaded clips for adjustability
- Manually actuated vial - Geometry accommodates standard vials
- Guide rods for alignment and BD U-100, U-50 syringes

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UI/UX & Electronics address low vision and low dexterity

Microcontroller and Sensors

Simple Interface
- Arduino
- Large buttons and pre set doses
- Limit Switches
- Screen with clear instructions
- Accelerometer
- Visual window to syringe 8
- Reed Switch
Analysis: Key Calculations
- Motor specification for plunger motion (torque, linear resolution)
xunit
Fplunger Motor Torque: 4.8 mN*m
Linear Resolution: 0.58mm

- Cavitation calculations for bubble formation (linear speed)

Vplunger ΔP
Patm

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Analysis: Key Calculations
- Battery specification (power, current, voltage, operating time)

P = imotorVmotor + iarduinoVarduino+ iscreenVscreenBattery life: 28-35 syringes (week’s supply)

- Accuracy requirements (structural loop, sources of error)

D
d

Ɛ = Ɛflange1+Ɛflange2+ (D-d)/t t
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Demonstration

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Accuracy and Bubble Testing

Tested with U-100 syringes

- Filled with 10-90 units in 10-unit increments (n=5)
- Error recorded from visual checks and syringe mass
- 41 out of 45 draws (91%) met ISO 11608-1 Standard
- Largest dose errors due to
“dome bubbles” in the vial
- Draw never exceed dose

Cavitation Testing
- Maximum speed of draw without
the formation of bubbles
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Risks
Countermeasures
● Lower dose of insulin due to presence of ● Add bubble detection features
bubbles ● Notify the user to remove vial, adjust insulin
● Redrawing the dose does not break the levels and reset
bubbles ● Only an issue when pre-filling 20+ syringes at
● Motor heats up insulin one time; add temperature sensor or insulate
motor
● Liquid spills on electronics ● Integrate a protective layer separating the
electronics

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Revisiting Functional Requirements
Functional Requirement Prototype Next Steps

1. Low vision and low dexterity X Continue to refine design

2. Standard vials and syringes X Accommodate U-30 syringes

3. Adjustable fill volume X

4. Accurate dosing X Avoid “dome bubble” formation

5. Portable X Condense electronics with SMT

Add carry case for syringes, disinfectant

6. Consumer cost X Reduced cost at scale

7. Safe X Add more sensors for safety

8. Maintain sterility X
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Future Work and Commercialization

- Detailed User Testing

- Design Variants
- Connectivity
- Regulatory
- DFMA
- Cost Analysis
- Channels

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Questions and Feedback?

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prototype evolution
Appendices

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 FRDPARRC
Functional Design Parameters Analysis References Risks Countermeasures
Requirements

1. Useable by patients Characterize low dexterity/low vision -Injection force of NovoPen is 8-16 -NovoPen injection force
with low vision and Steadiness, Strength, Aiming, Line Tracking N, depending on speed (patients -Accuracy and preference for pre-filled
dexterity issues prefer low force) pens
-Age Lab at MIT

2. Accommodate See tables below Dimensions: hand measure with -BD syringes Vial or syringe manufacturers Make holders adjustable within
standard vials and calipers -Insulin types modify design in the future certain range
syringes Pulling & pushing force: -BD’s guide to insulin
measure with force gauge

3. Provide adjustable fill Range: 0 - 1 mL (0 - 100 units) -- Communication with BD -Extreme health risk if -Prevent any possibility of
volume Increment: 0.01 mL (1 unit) overdosing overdosing; err on side of
-Filling mechanism may underdosing if necessary
break/get stuck -Enable manual override or
-Patient may forget dose removal of syringe
amount -Pre-programmed dosing?

4. Provide accurate Dosing accuracy from ISO standard Will depend on design concept -ISO 11608-1:2014 -Hand-filled syringes much less -Use precise electrical or
dosing Accuracy includes bubble avoidance -Arch Dis Child 1998;79:59–62 accurate at low doses (1U) than mechanical dose setting
pens

5. Maintain sterility Components that contact insulin must be sanitizable -- -ISO 11608-1:2014 User may not follow best Incorporate container with hand
-Mayo Clinic insulin delivery practices for hand hygiene, not sanitizer & alcohol wipes to make
recommendations reusing syringes, wiping vial it easier?
-MedlinePlus guide with alcohol
-Good insulin injection practices

6. Safe Follow safety requirements of ISO 11608-1 -- -ISO 11608-1:2014 Failure to identify hypothetical -Address all safety risks identified
standard risks during design
-Do user testing

7. Portable / mobile Maximum size: 30x10x10 cm (11”x4”x4”) -- -- -Device may be damaged when -Provide case to protect from
Maximum weight: 1 kg carried damage
Conveniently packable -Do user testing

8. Cost within consumer Maximum $100, ideally <$70 (price of closest -- -Count-a-Dose price -Unintended maintenance or -Do accelerated life testing to
price range manual-assist device, Count-a-Dose) -- depends on -Total healthcare cost of pre-filled pens repair costs check for failures
lifetime of device vs syringes 18
Cost Estimate

Component Prototype Commercial

Motor and lead screw $146 $40
Microcontroller board $35 $10
Screen, buttons, sensors $37 $10
Plastic parts $500 $3
Metal hardware $28 $10
(rods, screws, springs, etc)
Assembly - $10
Total cost (estimated) $746 $83

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State Machine

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 Motor & Energy Analysis
Calculated using pulling force Measured using prototype motor

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Cavitation Analysis
Pressure in syringe should not fall below saturated vapor pressure
minimum pressure in syringe

Calculated max plunger

Based on narrowest, speed:
longest needle 2.2 mm/sec
(31 gauge, 12 mm)

saturated vapor pressure

Measured max plunger
Possible reasons: pressure inspeed:
vial below 0.8 mm/sec
atmospheric,
unaccounted for pressure losses

Vplunger ⃤ P
Patm

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Structural Loop & Error Analysis

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Standard vials

Cap
diameter

Vial manufacturer Novo Nordisk Lilly Neck

Insulin trade name Novolog*, Novolin, Levemir Humalog*, Humulin, diameter
Basaglar
Vial volume (mL) 10 10
Neck diameter (mm) Cap height
10.77 +- 0.02 10.81 +- 0.01
Neck height (mm) Neck height
4.63 +- 0.23 3.85 +- 0.01
Cap diameter (mm)
13.87 +- 0.05 13.74 +- 0.04
Cap height (mm)
6.69 +- 0.05 6.55 +- 0.21
Vial diameter (mm)
22.83 +- 0.03 22.82 +- 0.04 Vial
Vial height (mm) height
51.48 +- 0.11 53.65 +- 0.21

__log = rapid-acting
__lin R = regular or short-acting
__lin N = intermediate-acting
Lantus, Levemir, Basaglar = long-acting (basal)

* = vial measured
Vial diameter
Standard syringes and needles

BD Ultra-Fine Syringes
Syringe volume 0.3 mL 0.5 mL 1.0 mL
(U-100 concentration) (30 units) (50 units) (100 units)
Body diameter (mm) 5.08 +- 0.04 5.56 +- 0.02 6.63 +- 0.01
Total length (w/o needle) (mm) 80.27 +- 0.68 88.54 +- 1.43 97.03 +- 0.20
Plunger max extension (mm) 64.83 +- 0.17 58.05 +- 0.14 64.05 +- 0.23
Plunger extension for 10 units
Plunger extension for 10 units (mm) 13.43 +- 0.05 9.99 +- 0.01 5.77 +- 0.00
Plunger max extension

Total length

Needle options
Needle lengths (mm) 6 mm 8 mm 12.7 mm
Needle diameters (mm) 28 gauge 30 gauge 31 gauge
0.36 mm OD 0.31 mm OD 0.26 mm OD
0.18 mm ID 0.16 mm ID 0.12 mm ID