Medicine

and Engineering Intersection

– Personalization of Airway Stents
George Cheng MD PhD
Duke University
Interventional Pulmonology
11/16/2017
 Disclaimers
• Consultant to Boston Scientific, Medtronic,
Auris
• Research Funding from IntuitSurgical
• Co-Founder and Consultant for Additive
Device Inc.
• Previous Funding Sources:
• CIMIT and BBIC
 Outline
• Clinical Problem
• 3D printing overview
• Initial Explorations
• Current Progress
• Future Directions
Clinical Problem of Central Airway Obstruction
- Current Solutions
- Current Problems
Courtesy of Dr. Thomas Gildea, Cleveland Clinic
 Ideal Stent
• Biocompatible
• Biostable
• Perfect fit based on patient’s anatomy
• Minimal interruption to clearance of secretions
• Resistant to biofilm formation
• Easily placed and removed
• Eliminate migration
• Inexpensive to make

Adapted from Dr. Thomas Gildea, Cleveland Clinic

Modifying Stents

Courtesy of Dr. Thomas Gildea, Cleveland Clinic

A quick word on 3D Printing.
Charles Hull – Father of 3D Printing
 Background – The Beginning
• Charles “Chuck” Hull coined
stereolithography (STL/SLA) in the
early 1980s
• Experimentation with photopolymers
to create plastic objects
o Liquid acrylic-based materials
that harden when exposed to UV
light
• Stereolithography Apparatus was
created in 1984
• First object ever 3D printed: a cup
for eyewashers about 5 centimeters
tall (took months to produce)
• 3D Systems was created in 1986
SLA-250, 1988
• First commercial 3-D printer: cost
$100,000, hit the market in 1988
Common Modes of 3D Printing

A. B. C.

A. Stereolithography (SLA): resin based

B. Fused deposition modeling (FDM): ABS (acrylonitrile butadiene styrene) and

polylactic acid polymers (PLA)

C. Selective laser sintering (SLS): uses powdered materials (such as nylon, titanium,
aluminum, polystyrene, and glass)
3D Printing: Pros and Cons

Advantages Disadvantages
• Complexity is free • Slow build rates
• Variety is free • Considerable effort in
• No assembly required application design and
setting process
• Little lead time parameters
• Little-skill • Requires post-processing
manufacturing
• Discontinuous production
• Less waste process, preventing
• Infinite materials economics of scale.
• Limited component
size/small build volume
 1988:
1984: Charles 2005: 2007: 2009: 2011: 2015:
1st commerical
Hull (STL) RepRap Fab@Home Makerbot Formlab Carbon3D
3D Printer

1986: 2006: 2009: 2014:

1994: STL patent FDM patent SLS patent
STL patent
SLS patent expired expired expired
3D systems

1989:
FDM patent
Stratasys
A Couple of Cases
Prove of principle
Prove that ideas do not exist in isolation
CASE 1:

68-year-old male with history of POD 5

medullary thyroid cancer status post
resection and radiation

- Found to have recurrent medullary

thyroid cancer
- Underwent tracheal resection and
reconstruction
- Anastomotic dehiscence c/b carotid
artery rupture POD 10
- AlloDerm patch then T-tube after 3
weeks
 A B

C D

4 weeks follow up
CASE 2
Patient with GPA:
– On Rituximab, Prednisone
in clinical remission.
– Many airway procedures
over 10 years.
– In the prior year, every 42
days for stent revision.
– Could not tolerate being
stent free.
– Complex customization
attempted several times
with some improvement.

Courtesy of Dr. Thomas Gildea, Cleveland Clinic

Courtesy of Dr. Thomas Gildea, Cleveland Clinic
 Custom Left Main Bronchus “Y” stent

Y Stent Design and final product Implant in situ

Courtesy of Dr. Thomas Gildea, Cleveland Clinic

 Follow-up at 13 months

• No procedures required in
the prior 7 months
• Complained of symptoms
in the right chest - Tiny granulation
conventional stent in the
BI.
• FDA - granted
compassionate use to
make new left sided stent
and place new right sided
stent.

Courtesy of Dr. Thomas Gildea, Cleveland Clinic

French Experience

Guibert et al. AJRCCM 195:7, e31–e33, Apr 1, 2017

French Experience

Guibert et al. AJRCCM 195:7, e31–e33, Apr 1, 2017

 Current Clinical Trials
• NCT02889029: Management of Complex
Airway Stenoses With Dedicated Tailored
Stents Wrought by 3D Computer-assisted
Conception (DASCAS)
• NCT03111888: Evaluating the Clinical
Effectiveness of 3D Printing for a Patient-
specific Silicone Stent Airway Implant

https://clinicaltrials.gov
 Process of inverse 3D printing
Advantages:
Personalized airway prosthesis
No migration
Minimal granulation
Permit improved airflow and decreased infection/mucus clearance

Disadvantages:
Require mold generation
Need silicone as the material
Not able to achieve full freedom of design

Major Question: Can we direct 3D print stents for the airway?

Challenge of Materials
• 3D printable in high quality
• Biocompatible
• Biostable
• Mechanically desirable
• Soft and liable with shape memory
• Able to tolerate repeat compression
• Sterilization
• Cheap and accessible material
 Duke Engineering Group

Kenneth Gall PhD Andrew Miller PhD Catherine Wood

 Promising Material: EPU

Elastomeric Polyurethane Stent

EPU Stents
Future Considerations:
• Evaluation of EPU stents
• Comparison studies to current silicone stents
• Animal testing to evaluate in vivo behavior
• Drug eluting or biodegradable stents
• Streamline design, manufacturing, sterilization
• Freedom of design
• Freedom of complexity
• Single step in manufacturing
• FDA regulations
Thank you to all my advisors/collaborators!

BIDMC-MGH Personalized Stent Designers

- Adnan Majid - Noah Garcia
- Sidhu Gangadharan - Robert Brik
- Erik Folch - Adam Wilson
- Colleen Channick
- Colleen Keyes Everyone at CIMIT, B-BIC, and
- Jennifer Wilson NHLBI.
- Daniel Alape
- Alejandro Folch CCF
- Sebastian Ochoa - Thomas Gildea
- IP group
BWH – LMI (3D slicer)
- Ron Kikinis
Duke School of Engineering :
• Ken Gall
• Andrew Miller
• Catherine Wood

Duke Interventional Pulmonary

Research Group:
• Momen Wahidi
• Scott Shofer
• Kamran Mahmood