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
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
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.
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
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)
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
-Complex fractures -Custom Implants
-Cranioplasties -Aneurysms
-post-Cancer prostheses -Implants
-HO -Prostheses Design
-Facial fixation & reconstructions
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
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
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
•Mandibular discontinuity •Substantial Missing bone •Articular surface missing or damaged
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
Hand bent in Operating Theater Approximate fit Inexpensive & readily available
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
Sub-periosteal implants Custom abutments for maxillary prostheses
after hemi-maxillectomy Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
Complex fractures
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
•Hemi-pelvectomy repair or implant •Custom Acetabular implant integration
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
Failed total hip implant
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
• 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
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
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.
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
•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
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
• 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.
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
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
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
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!
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
Dr. Stephen Rouse Independent Consultant in Medical Applications
of Additive Manufacturing Cell: +1(703) 568-4779 [email protected]
Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing