Medical Device Coatings April Innoplast 2015
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Transcript of Medical Device Coatings April Innoplast 2015
Considerations for Medical Device Coatings
Keith Edwards, President
Biocoat, Inc.
Devices that benefit from a coating:Guide wires
PTCA catheters
IOL insertion cartridges
Micro-catheters
Clot retrieval wires
Delivery Sheaths
Stent delivery systems
Embolic delivery
Implant delivery
Endoscopes
Why have a coating?
• Common device substrates are not lubricious on their own.
– Nylon
– Pebax
– Urethanes
– Metals: SS, Pt, Ni, Ti
– Nitinol
– Silicones– Plasma treatment may be required
Ability to navigate complex vasculature
Improved patient comfort
Lubricity and durability
Guide wire example:
Multiple passes
Rotational tracking
Biocompatibility
Low particle counts
Regulatory Considerations
• Design Inputs should include several options that meet your design requirements:
Lubricity
Durability
Biocompatibility – ISO 10993
• Cytotoxicity (MEM Elution)
• Hemolysis (Direct Contact Method)
• Irritation (Intracutaneous Reactivity)
• Systemic Toxicity (Systemic Injection)
• Partial Thromboplastin Time (PTT)
• USP 788 - Particulates
Thickness
Test method: is the test environment reflective of the use?
Technical Coating Considerations
• Will my coating stick?
• What particle counts may I anticipate?
• Verification of coating presence
• QA/QC testing & sampling
• PVP vs. HA
• Surface Energy
• Contact angle
• Unreacted monomers
• Plasticizers & bloom
• Humidity
• Sterilization methods
• Heat cure vs. UV cure
6
HA Coating Platform
Covalent bondsIsocyanate linkage
Mechanical AdhesionAdsorption
ElectrostaticMechanical interlock
PVP – A matrix of cross-linked polymers of various molecular weights
Hydrophilic Coating Flow chart
Catheterswith coating
mandrels
Top coat cure
Apply Base coat
Apply Top coat
Base coat Dry
Base coat formulation
Inspection and QC testing
Packaging
Enemies of Adhesion
Surface preparation & Fixturing
Unclean surface . Too fast cure . Substrate contact angle too high
Performance: Pinch Friction test
• Pinch testing on 10 uncoated and 10 coated tubes to evaluate frictional forces. Pinch testing parameters:
– Load : 470 grams
– Number of cycles: 30
– Pinch pad material: Delrin or Silicone
– Phosphate Buffered Saline (PBS) bath at 37C
• Trackability testing on 10 coated tubes to measure insertion and pulling forces
• Design team to define friction specification and failure mode• Comment: Delrin pads harder on coating; display better lubricity. Silicone pads
softer on coating; display higher friction.
Other tests: Bound top coat,Swelling ratios &
rotational tracking
-40
-20
0
20
40
60
80
-0.5 0 0.5 1 1.5 2 2.5 3 3.5
Friction, gram_force
Distance, inch
PETG T67 pbs-1 pinch force 770 gram __TRACES
0
10
20
30
40
50
60
70
0 5 10 15 20 25 30 35
Friction, gram_force
Cycle
PETG T67 pbs-1 pinch force 770 gram __Pulling Stage
Dyn.
Static
Peak
-150
-100
-50
0
50
100
150
200
-0.5 0 0.5 1 1.5 2 2.5 3 3.5
Friction, gram_force
Distance, inch
PETG T70/B23 E-12w-1 pinch force 770 gram __TRACES
0
20
40
60
80
100
120
140
160
180
0 5 10 15 20 25 30 35
Friction, gram_force
Cycle
PETG T70/B23 E-12w-1 pinch force 770 gram __Pulling Stage
Dyn.
Static
Peak
Got Slick?Hydration is part of the procedure.
Biocoat Research: Dry pinch test protocol
• Immerse coated guide wire into DI H2O (or PBS) for 1min. Note
humidity.
• Remove GW from water and test lubricity of the wetted GW
imminently (initial point) by pulling through the pinch tester pads
(using silicone pads or delrin pads and 470G load)
• Test lubricity after kept the GW out of DIW at room temperature for 1,
2, 3, 4, 5 min. or until the coating shows high friction
• Immerse the tested GW into PBS or DI H2O for 1min
• Test the lubricity (Re-hydrate)
0
50
100
150
200
0 1 2 3
Pu
llin
g St
age
Fric
tio
n (
g)
Distance (inch)
A-14: Delrin-pads & 470G
Initial
1min
2min
3min
4min
5min
Re-hydrate
0
50
100
150
200
0 1 2 3P
ulli
ng
Stag
e Fr
icti
on
(g)
Distance (inch)
A-14: Silicone-pads & 470G
Initial
1min
2min
3min
4min
5min
Re-hydrate
Open air Time Pinch Test
Humidity: 66.5-67% & Temp.: 21-22oC
DIW H2O Hydrated
0
50
100
150
200
0 1 2 3
Pu
llin
g St
age
Fric
tio
n (
g)
Distance (inch)
A-14: PBS Hydrated
initial
1min
2min
3min
Re-hydrate
0
50
100
150
200
0 1 2 3
Pu
llin
g St
age
Fric
tio
n (
g)
Distance (inch)
A-14: DIW Hydrated
initial
1min
2min
3min
4min
5min
Re-hydrate
Open air Pinch Test: Delrin-pads & 470g
Humidity: 53-55% & Temp: 21-21.5oC
Weight gained after soaking in PBS for 1 min.:
0.007g
After 3min.: 0.002g remained
(4” length GW: 0.0323” OD)
Weight gained after soaking in DIW for 1min.:
0.0077g
After 5min.: 0.0016g remained
(4” length GW : 0.0323” OD)
Coating Business Models
• Cost of Reagents
• Royalty & rate
• Tiered or flat rates
• Term and amount
• Quarterly minimums
• License fee
• One time or for each device?
• Cost per device
• Batch size/throughput per shift
• Waste
• Equipment
• Service agreements