2013 03-12-masterclass-biomedical-applications-of-am clinical-support-requirements-rouse
DESCRIPTION
Additive manufacturing (AM) offers a few major benefits to biomedical applications. To improve the knowledge on AM possibilities, Sirris is organizing two different masterclasses. The first will address the technology, materials used and applications, with experts in the matter explaining all relevant aspects.TRANSCRIPT
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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
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Organized by SIRRIS the 12th of March 2013 Masterclass: Biomedical applications of Additive Manufacturing
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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.
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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)
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-Complex fractures -Custom Implants
-Cranioplasties -Aneurysms
-post-Cancer prostheses -Implants
-HO -Prostheses Design
-Facial fixation & reconstructions
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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
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•Mandibular discontinuity •Substantial Missing bone •Articular surface missing or damaged
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Hand bent in Operating Theater Approximate fit Inexpensive & readily available
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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
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Complex fractures
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•Hemi-pelvectomy repair or implant •Custom Acetabular implant integration
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Failed total hip implant
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• 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
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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.
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•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
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• 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.
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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
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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!
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Dr. Stephen Rouse Independent Consultant in Medical Applications
of Additive Manufacturing Cell: +1(703) 568-4779 [email protected]
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