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?
âĒ Mechanical Engineer / Physics
âĒ Started at the Cleveland Clinic within BME working on Aortic
Replacement Devices in 2002.
âĒ Patented 12 Endovascular Aortic Devices
âĒ These devices are placed Minimally Invasively using
Fluoroscopy (x-Rays)
âĒ Started 3D printing patient specific anatomical models to better
understand the complex aortic geometries
âĒ Roy Greenberg MD, battle with cancer.
âĒ Invented an new imaging technology without ionizing radiation
âĒ Presented Idea / Prototype to Physician and Innovations Group
âĒ In 2014, the Start-Up called Centerline Biomedical was created
3. September 9, 2016 3
The ProblemâĶ
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 ExposureâĶRadiation ExposureâĶ
âĒ Average fluoro time (N=369) is 86 minutesAverage fluoro time (N=369) is 86 minutes
âĒ Effective dose of 106 mSvEffective dose of 106 mSv
âĒ How does that relate to other modalities,How does that relate to other modalities,
like CT scans?like CT scans?
73715 DAP ï 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
8. Intra Operative Positioning System (IOPS)
Fluoroscopy
Similar to GPS (Global Positioning System)
technology, electromagnetic navigation creates a
three-dimensional virtual âroadmapâ from the
patientâs 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.
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
âĒ Surgical plan based on patient CT scanSurgical plan based on patient CT scan
âĒ Surgical plan information captured in patientSurgical plan information captured in patient
specific SmartBonespecific SmartBone
âĒ Instrumentation to transfer from SmartBone toInstrumentation to transfer from SmartBone to
patient (Intelligent Reusable Instrument = IRI)patient (Intelligent Reusable Instrument = IRI)
âĒ 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
âĒ Extremely difficult to prototype for a show-and-
tell session without the 3D models
âĒ Modifications to design in a short period of time
allowing the company to show investors âQuick
Forward Progressâ.
âĒ Patient specific models for training prior to
surgery.
âĒ We would be 2+ years behind without the 3D
printer along with increased development costs
Editor's Notes
Medical Device Solutions at Cleveland Clinic Lerner Research Institute:
Serve as a âCore Serviceâ 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.
Medical Device Solutions at Cleveland Clinic Lerner Research Institute:
Serve as a âCore Serviceâ 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.
All of that was background information
Letâs now shift gears and really focus on medicine and related applications
All of that was background information
Letâs now shift gears and really focus on medicine and related applications
All of that was background information
Letâs now shift gears and really focus on medicine and related applications
All of that was background information
Letâs now shift gears and really focus on medicine and related applications
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.