Fueling Start-Up Medical Fueling Start-Up Medical Companies through 3D Companies through 3D
ModelingModeling
Karl West, MSKarl West, MSLerner Research / BMELerner Research / BME
September 9, 2016 1
September 9, 2016 2
Background?
• Mechanical Engineer / Physics• Started at the Cleveland Clinic within BME working on Aortic
Replacement Devices in 2002.• Patented 12 Endovascular Aortic Devices
• These devices are placed Minimally Invasively using Fluoroscopy (x-Rays)
• Started 3D printing patient specific anatomical models to better understand the complex aortic geometries
• Roy Greenberg MD, battle with cancer.• Invented an new imaging technology without ionizing radiation• Presented Idea / Prototype to Physician and Innovations Group • In 2014, the Start-Up called Centerline Biomedical was created
September 9, 2016 3
The Problem…Placing a device within the aorta using x-ray imaging system
September 9, 2016 4
The Whole Problem!
Radiation Dose to the Patient and Caregivers in the Room
Radiation Exposure…Radiation Exposure…
• Average fluoro time (N=369) is 86 minutesAverage fluoro time (N=369) is 86 minutes• Effective dose of 106 mSvEffective dose of 106 mSv• How does that relate to other modalities, How does that relate to other modalities,
like CT scans?like CT scans?
73715 DAP 86 mins * 60000 DAP / 70 mins 106 mSv = 73715 * 0.145 mSv / (total DAP) avg. conv. Factor from Panuccio et. al
Frequency of Peak Skin Dose During Fenestrated Stent Graft Implantation
What Prolonged Radiation Exposure Can What Prolonged Radiation Exposure Can Look LikeLook Like
Redness
Hair Loss
Ulceration
Skin Loss
300 min~21 gray
Solution…Solution…
September 9, 2016 7
Intra-Operative Positioning System or
IOPS
Vascular Algorithm
Electro-Magnetic Tracking
Innovation
Intra Operative Positioning System (IOPS)Fluoroscopy
Similar to GPS (Global Positioning System) technology, electromagnetic navigation creates a three-dimensional virtual “roadmap” from the patient’s CT-Scan that enables the physician to steer a unique set of catheters through the vasculature to reach the targeted areas in a minimally invasive manner.
Same patient Same moment
IOPS
Patient-Specific, Pre-operative Models Patient-Specific, Pre-operative Models
Arterial
Pre-operative Axial Imagesfrom MDCT
Bone
Patient-specific arterial and bone models are used to intra-procedurally track the catheter position in the IOPS display.
IOPS Components & Set-up
IOPS Cart
Sensor Enabled Catheter
Dual Modality Registration Markers
Window Field Generator
September 9, 2016 11
How 3D Models Made it Possible!!
September 9, 2016 12
Patient Tracking Pad
3D Printed EM Tracking Markers
September 9, 2016 13
Generator Mounts for OR Table
3D Printed EM Generator Table
Mount
IOPS in OR 76IOPS in OR 76
3D Printed Patient Specific Training System 3D Printed Patient Specific Training System
September 9, 2016 15
CAD Model
3D Printed Model
Another Start-Up with Close Ties to 3D PrintingAnother Start-Up with Close Ties to 3D Printing
Custom Orthopedic Solutions or COS
Custom Orthopedic Solution (COS) Product Custom Orthopedic Solution (COS) Product SummarySummary
• Surgical plan based on patient CT scanSurgical plan based on patient CT scan• Surgical plan information captured in patient Surgical plan information captured in patient
specific SmartBonespecific SmartBone• Instrumentation to transfer from SmartBone to Instrumentation to transfer from SmartBone to
patient (Intelligent Reusable Instrument = IRI)patient (Intelligent Reusable Instrument = IRI)• Advantages:Advantages:
- Improved procedure visualizationImproved procedure visualization- Able to accommodate real-time adjustmentsAble to accommodate real-time adjustments
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Smartbone DefinedSmartbone Defined
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Smartbone PrintedSmartbone Printed
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COS in the Clinical SettingCOS in the Clinical Setting
3D Educational 3D Educational
Case No. 2015-117
Anatomy Identification Mode (User selects locations)
3D Printed Model
Tracking System
Virtual Practical Exam ModeTask Augmentation Mode
Coord(x,y,z)
Display
3D Coordinate (x,y,z)
Left Anterior Descending Artery
X Image Correlation HistologyX
Cardiac Module
Pathophysiology Contemporary Topic
September 9, 2016 22
In Conclusion• Extremely difficult to prototype for a show-and-
tell session without the 3D models• Modifications to design in a short period of time
allowing the company to show investors “Quick Forward Progress”.
• Patient specific models for training prior to surgery.
• We would be 2+ years behind without the 3D printer along with increased development costs