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Fueling Start-Up MedicalFueling Start-Up Medical
Companies through 3DCompanies through 3D
ModelingModeling
Karl West, MSKarl West, MS
Lerner Research / BMELerner Research / BME
September 9, 2016 1
September 9, 2016 2
Background?
â€Ē Mechanical Engineer / Physics
â€Ē Started at the Cleveland Clinic within BME working on Aortic
Replacement Devices in 2002.
â€Ē Patented 12 Endovascular Aortic Devices
â€Ē These devices are placed Minimally Invasively using
Fluoroscopy (x-Rays)
â€Ē Started 3D printing patient specific anatomical models to better
understand the complex aortic geometries
â€Ē Roy Greenberg MD, battle with cancer.
â€Ē Invented an new imaging technology without ionizing radiation
â€Ē Presented Idea / Prototype to Physician and Innovations Group
â€Ē In 2014, the Start-Up called Centerline Biomedical was created
September 9, 2016 3
The Problemâ€Ķ
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 Exposureâ€ĶRadiation Exposureâ€Ķ
â€Ē Average fluoro time (N=369) is 86 minutesAverage fluoro time (N=369) is 86 minutes
â€Ē Effective dose of 106 mSvEffective dose of 106 mSv
â€Ē 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.
Frequency of Peak Skin Dose During Fenestrated Stent Graft
Implantation
What Prolonged Radiation Exposure CanWhat Prolonged Radiation Exposure Can
Look LikeLook Like
Redness
Hair Loss
Ulceration
Skin Loss
300 min
~21 gray
Solutionâ€ĶSolutionâ€Ķ
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 ModelsPatient-Specific, Pre-operative Models
Arterial
Pre-operative
Axial Images
from 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 System3D 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) ProductCustom Orthopedic Solution (COS) Product
SummarySummary
â€Ē Surgical plan based on patient CT scanSurgical plan based on patient CT scan
â€Ē Surgical plan information captured in patientSurgical plan information captured in patient
specific SmartBonespecific SmartBone
â€Ē Instrumentation to transfer from SmartBone toInstrumentation to transfer from SmartBone to
patient (Intelligent Reusable Instrument = IRI)patient (Intelligent Reusable Instrument = IRI)
â€Ē Advantages:Advantages:
- Improved procedure visualizationImproved procedure visualization
- Able to accommodate real-time adjustmentsAble to accommodate real-time adjustments
17
18
Smartbone DefinedSmartbone Defined
19
Smartbone PrintedSmartbone Printed
20
COS in the Clinical SettingCOS in the Clinical Setting
3D Educational3D 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
Left Anterior
Descending
Artery
XX Image Correlation HistologyXX
Cardiac Module
Pathophysiology Contemporary Topic
September 9, 2016 22
In Conclusion
â€Ē Extremely difficult to prototype for a show-and-
tell session without the 3D models
â€Ē Modifications to design in a short period of time
allowing the company to show investors “Quick
Forward Progress”.
â€Ē Patient specific models for training prior to
surgery.
â€Ē We would be 2+ years behind without the 3D
printer along with increased development costs

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Fueling Start-Up Medical Companies through 3D Modeling

  • 1. Fueling Start-Up MedicalFueling Start-Up Medical Companies through 3DCompanies through 3D ModelingModeling Karl West, MSKarl West, MS Lerner Research / BMELerner Research / BME September 9, 2016 1
  • 2. September 9, 2016 2 Background? â€Ē Mechanical Engineer / Physics â€Ē Started at the Cleveland Clinic within BME working on Aortic Replacement Devices in 2002. â€Ē Patented 12 Endovascular Aortic Devices â€Ē These devices are placed Minimally Invasively using Fluoroscopy (x-Rays) â€Ē Started 3D printing patient specific anatomical models to better understand the complex aortic geometries â€Ē Roy Greenberg MD, battle with cancer. â€Ē Invented an new imaging technology without ionizing radiation â€Ē Presented Idea / Prototype to Physician and Innovations Group â€Ē In 2014, the Start-Up called Centerline Biomedical was created
  • 3. September 9, 2016 3 The Problemâ€Ķ Placing a device within the aorta using x-ray imaging system
  • 4. September 9, 2016 4 The Whole Problem! Radiation Dose to the Patient and Caregivers in the Room
  • 5. Radiation Exposureâ€ĶRadiation Exposureâ€Ķ â€Ē Average fluoro time (N=369) is 86 minutesAverage fluoro time (N=369) is 86 minutes â€Ē Effective dose of 106 mSvEffective dose of 106 mSv â€Ē 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.
  • 6. Frequency of Peak Skin Dose During Fenestrated Stent Graft Implantation What Prolonged Radiation Exposure CanWhat Prolonged Radiation Exposure Can Look LikeLook Like Redness Hair Loss Ulceration Skin Loss 300 min ~21 gray
  • 7. Solutionâ€ĶSolutionâ€Ķ September 9, 2016 7 Intra-Operative Positioning System or IOPS Vascular Algorithm Electro-Magnetic Tracking Innovation
  • 8. 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
  • 9. Patient-Specific, Pre-operative ModelsPatient-Specific, Pre-operative Models Arterial Pre-operative Axial Images from MDCT Bone Patient-specific arterial and bone models are used to intra-procedurally track the catheter position in the IOPS display.
  • 10. IOPS Components & Set-up IOPS Cart Sensor Enabled Catheter Dual Modality Registration Markers Window Field Generator
  • 11. September 9, 2016 11 How 3D Models Made it Possible!!
  • 12. September 9, 2016 12 Patient Tracking Pad 3D Printed EM Tracking Markers
  • 13. September 9, 2016 13 Generator Mounts for OR Table 3D Printed EM Generator Table Mount
  • 14. IOPS in OR 76IOPS in OR 76
  • 15. 3D Printed Patient Specific Training System3D Printed Patient Specific Training System September 9, 2016 15 CAD Model 3D Printed Model
  • 16. Another Start-Up with Close Ties to 3D PrintingAnother Start-Up with Close Ties to 3D Printing Custom Orthopedic Solutions or COS
  • 17. Custom Orthopedic Solution (COS) ProductCustom Orthopedic Solution (COS) Product SummarySummary â€Ē Surgical plan based on patient CT scanSurgical plan based on patient CT scan â€Ē Surgical plan information captured in patientSurgical plan information captured in patient specific SmartBonespecific SmartBone â€Ē Instrumentation to transfer from SmartBone toInstrumentation to transfer from SmartBone to patient (Intelligent Reusable Instrument = IRI)patient (Intelligent Reusable Instrument = IRI) â€Ē Advantages:Advantages: - Improved procedure visualizationImproved procedure visualization - Able to accommodate real-time adjustmentsAble to accommodate real-time adjustments 17
  • 20. 20 COS in the Clinical SettingCOS in the Clinical Setting
  • 21. 3D Educational3D 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 Left Anterior Descending Artery XX Image Correlation HistologyXX Cardiac Module Pathophysiology Contemporary Topic
  • 22. September 9, 2016 22 In Conclusion â€Ē Extremely difficult to prototype for a show-and- tell session without the 3D models â€Ē Modifications to design in a short period of time allowing the company to show investors “Quick Forward Progress”. â€Ē Patient specific models for training prior to surgery. â€Ē We would be 2+ years behind without the 3D printer along with increased development costs

Editor's Notes

  1. Medical Device Solutions at Cleveland Clinic Lerner Research Institute: Serve as a “Core Service” for both the research institute and the clinical institutions My team is the mechanical design & engineering wing of the MDS dept Help surgeons, cardiologists, other clinicians with new device ideas, improvements to existing devices, etc. Other teams in MDS include electrical design, polymer fabrication, full service machine shop, robotics testing and a dedicated FEA group.
  2. Medical Device Solutions at Cleveland Clinic Lerner Research Institute: Serve as a “Core Service” for both the research institute and the clinical institutions My team is the mechanical design & engineering wing of the MDS dept Help surgeons, cardiologists, other clinicians with new device ideas, improvements to existing devices, etc. Other teams in MDS include electrical design, polymer fabrication, full service machine shop, robotics testing and a dedicated FEA group.
  3. All of that was background information Let’s now shift gears and really focus on medicine and related applications
  4. All of that was background information Let’s now shift gears and really focus on medicine and related applications
  5. All of that was background information Let’s now shift gears and really focus on medicine and related applications
  6. All of that was background information Let’s now shift gears and really focus on medicine and related applications
  7. This technology combines a computer-information system, navigation-recognition technology, and 3D printed anatomical models to provide an interactive, haptic/tactile, visual/auditory learning experience As students select and identify anatomical structures with a tracked stylus on a 3D printed model (based on de-identified medical imaging data), the system displays a wide range of integrated information, programming and formats across the medical curriculum (see diagram). Note: Could also be optical tracking system, etc.