The document discusses the role of additive manufacturing in trauma and reconstructive surgery based on lessons learned at the 3D Medical Applications Center. It summarizes that over 2600 pre- and post-surgical models and 400 cranioplasty plates were produced between 2003-2012. Challenges with existing solutions and benefits of custom designs for complex cases are outlined. The transition from PMMA to Ti6Al4V cranial plates is described, noting reduced challenges and improved outcomes. Requirements for ensuring quality and collaborating closely with surgeons are emphasized.

1. LESSONS LEARNED IN THE ROLE OF ADDITIVE
MANUFACTURING IN TRAUMA AND RECONSTRUCTIVE
SURGERY
Dr. Stephen Rouse
Former Director of Operations and Research
3D Medical Applications Center
Walter Reed Army Medical Center, Washington, DC

2. Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

3.  Statements made during this presentation do
not reflect official policy of the US Army
 All photos of individuals are shown with the
patient’s consent
 No duplication or publishing of these materials
may be made outside of this conference
without written permission.
Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

4.  Established October 2002 with initial investment of
2.3 million dollars
 First model was produced October 2003
 Since then produced more than 2600 pre and post-
surgical models and 400 cranioplasty plates
(PMMA & Ti6Al4V) (2003-2012)
Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

5. -Complex fractures
-Custom Implants
-Facial fixation & reconstructions
-Cranioplasties
-Aneurysms
-post-Cancer prostheses
-Implants
-HO
-Prostheses Design
Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

6.  Design cannot be milled, stamped, or cast
 Internal geometry
 Where it reduces cost significantly
 Variable material properties required
 No “off-the-shelf” solution exists
 Custom design reduces surgery time
 Custom design improves outcome
 Custom design reduces repetitive surgery to
correct same problem
Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

7. •Mandibular
discontinuity
•Substantial Missing
bone
•Articular surface
missing or damaged
Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

8. Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

9. Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

10.  Hand bent in Operating Theater
 Approximate fit
 Inexpensive & readily available
Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

11. Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

12. Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

13.  Sub-periostealimplants
 Custom abutments for maxillary prostheses
after hemi-maxillectomy
Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

14.  Complex fractures
Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

15. •Hemi-pelvectomy repair or
implant
•Custom Acetabular implant
integration
Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

16.  Failed total hip
implant
Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

17. • Dec 2003 – June 2008 165 Cranial PMMA implants
• Multi-piece PMMA implants present challenges to
surgeon
• Unknown number of PMMA plates removed due to
infection
• Stimulated search for new material/method
• 100+ 3-dimensional EBM built Ti6Al4V cranial plates
implanted to replace PMMA
• Surgeon driven need
Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

18.  Methods & Materials:
• Computed Tomography (CT) scans are obtained
relevant bony structures segmented using Mimics
(Materialise NV).
• The implant is designed using 3Matic (Materialise NV)
or Freeform Plus (Sensable Technologies)
• Built in an ARCAM A-1, using Electron Beam Melting of
Ti6Al4V, medical grade titanium alloy.
• The resultant three dimensional mesh is 3-4mm in
thickness, and has fixation plates integrated.
• Sterilizable using standard steam autoclave
techniques.
Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

19. •PMMA easily modified intraoperatively and
inexpensive
•Requires EtO sterilization
•No tissue ingrowth
•Time consuming to process with significant
man-hour requirements
•Limited contour complexity capable
Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

20. Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

21. Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

22. Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

23. Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

24. Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

25. Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

26. Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

27. • 100+ porous mesh implants placed since
November 2007
• First implant – primary, subsequent primary, or
followed multiple PMMA failures
• 1 implant removed due to free flap necrosis with
infection
• 1 Implant removed 12 days post op due to
immediate recurrent infection
• 1 additional resolved infection
• 3 patients tested positive for infection
perioperatively.
Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

28.  Know the limitations of your material and
equipment
 Regular factory preventive maintenance and
calibration
 NEVER neglect recommended maintenance
 Keep all records of maintenance, calibration,
material batch info, materials testing
 Document-document-document
 Participate actively in AMUG and vendor user
groups
Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

29.  Work closely with the surgical team
 Be very comfortable with radiographic
anatomy as well as the anatomy of the area
where you are working
 Get feedback from the surgeon
 Educate—educate—educate both yourself and
your customers
 Every solution doesn’t fit every patient
 Experiment in house—NOT on the surgeon!
Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013

30. Dr. Stephen Rouse
Independent Consultant in Medical Applications
of Additive Manufacturing
Cell: +1(703) 568-4779
Stephen.L.Rouse@gmail.com
Masterclass: Biomedical applications of Additive Manufacturing Organized by SIRRIS the 12th of March 2013