2013 03-12-masterclass-biomedical-applications-of-am clinical-support-requirements-rouse

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.


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)


-Complex fractures -Custom Implants

-Cranioplasties -Aneurysms

-post-Cancer prostheses -Implants

-HO -Prostheses Design

-Facial fixation & reconstructions


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


•Mandibular discontinuity •Substantial Missing bone •Articular surface missing or damaged


Hand bent in Operating Theater Approximate fit Inexpensive & readily available


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


•Hemi-pelvectomy repair or implant •Custom Acetabular implant integration


Failed total hip implant


• 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


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.


•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


• 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.


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


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!


Dr. Stephen Rouse Independent Consultant in Medical Applications

of Additive Manufacturing Cell: +1(703) 568-4779 [email protected]


2013 03-12-masterclass-biomedical-applications-of-am clinical-support-requirements-rouse

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