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