learner research - 3d printing for personalized medicine

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3D Printing for Personalized Medicine In the New Healthcare EraRyan Klatte, BSBMEPrincipal Research EngineerLerner Research InstituteJeff Yanof, Ph.D.Senior Principal Research EngineerLerner Research Institute

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September 8, 2016Tri-C R3D 20162Introduction

A little bit of background about myself:Engineer at the Cleveland Clinics Lerner Research InstituteStarted there in 2002 with a blood pump development team; worked on both pulsatile and rotary blood pump devicesTransitioned to my current team in 2007 Medical Device Solutions


http://mds.clevelandclinic.org

Ryan Klatte:

Medical Device Solutions at Cleveland Clinic Lerner Research Institute:Serve as a Core Service for both the research institute and the clinical institutionsMy team is the mechanical design & engineering wing of the MDS deptHelp 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.


Jeff Yanof:

Presently: The West-Greenberg Endovascular Devices and Imaging Lab.* at CCF (3 years) Over 25 years developing highly advancedbiomedicaltech in NE Ohio Pt. time Adjunct Faculty at Tri-C (Statistics)

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September 8, 2016Tri-C R3D 20165

BackgroundMedical ImagingAdditive ManufacturingPatient-BasedAnatomical Model

So, that is a little bit about who we are. We'd like to give some background about why we're presenting on the topic of patient-based 3D printed models.

What are these and Why are they so compelling?

These are made possible by two key technologies, Medical Imaging and 3D Printing.5

September 8, 2016Tri-C R3D 20166Background 3D Printing TechnologiesMainstream Additive Manufacturing Technologies

Stereolithography

Fused Deposition Modeling(Fused Filament Fabrication)

Binder Jetting

Selective Laser Sintering

Polyjet(multi-material jetting)

Selective Laser Melting(Electron Beam, Direct Metal Laser Sintering)

Continuous Light Interface Production

MultiJet Fusion

This is conference is focused on the topic of 3D Printing, so we don't need to speak too much about the power of 3D Printing.

Variety of Additive Manufacturing technologies; this slides illustrates some of the mainstream printer technologies. These make parts using a variety of techniques andVariety of materials; ranging from polymers to metals to ceramics. These have a variety of accuracies, ranging from mediocre to very good and a variety of costs, from affordable to very expensive.

Choose a technology to fit your application.

September 8, 2016Tri-C R3D 20167Background 3D Printing Features(nearly) Unlimited Geometry

Nearly any geometry can be produced.

The limitations:

Build size of a platform, i.e. how big the part can be, Minimum feature size a printer can resolve.

Between these two constraints, in theory any shape can be produced.

Variety of industries have used 3D Printing - automotive, aerospace, fashion, home decor, entertainment.

So, in one hand we have a tool that can fabricate just about any geometry.


Background Medical Imaging, Ultrasound, PET, SPECTCT, MRI,

The other key technology is Medical Imaging

CTMRIUltrasoundPETSPECT

Going to focus on CT and MRI based applications.8

September 8, 2016Tri-C R3D 20169Background Medical Imaging

CT & MRI Visualization

Both CT and MRI capture a number of cross-sectional images going from bottom top or top bottom.

The first graphic illustrates how a series of these might look, this example being a CT scan of a patients skull region. (should I add a graphic showing as a vertical stack. While that is useful in and of itself (transition to next)

most modern software can perform both a multi-planar reformatting, i.e. displaying the images in the other planar orientations; as well as performing a 3D volume rendering with pseudo-realism. This allows a healthcare practitioner to visualize that internal geometry more easily. (transition to final image)

and by changing the range of greyscale values from the original 2D images, we can alter our view of the anatomy.

There is a lot more to discuss in medical imaging but that could easily be the topic of a workshop or even a semester-long course. The key takeaway is that these provide a means of digitizing real-world geometry, in this case - patient specific anatomy. This lets us see not only the external features of a person, like a white light or laser scanner can, but also and more importantly, the inside.

This is quite powerful because we all have different geometry, don't we? We all have different shapes and sizes and Medical Imaging is a tool that provides the means to a digital model.

So, in the other hand, we have a tool that can digitize just about any geometry.

September 8, 2016Tri-C R3D 201610Background Medical ImagingApplications

Who can benefit from this? We think that we're still only beginning to tap the various applications in healthcare. But based on our experience at the Cleveland Clinic, and we're going to keep our focus there for this presentation, we see the following applications.

Medical Education, Surgical/Procedure Planning, Device Development and/or implants10


Background ApplicationsMedical EducationTextbook GraphicsVideoCatalog ModelCadaver Labs

Med Ed:

Medical Students, A&P students, even residents and fellows

e.g. if we were in med school and our current teaching section is on the liver

Textbook (text, graphics)VideoCadaver based labs, instructionCatalog models

All these have limitations. A personalized or patient-based model would solve that. Enter a patient-specific 3D printed liver model

Real-world anatomy (better that catalog model and text book images)Can be held in your hand (better than cadaver or video)No special storage (better than cadaver)Can add in features to disassemble, be transparent, etc

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Background ApplicationsMedical Education

and of course, we can have an entire collections.

Include both healthy and diseased patient-based models12


Background ApplicationsSurgical PlanningTumorResectionRemnant

For a surgeon planning a tumor resection (cutting the tumor and any diseased tissue out), a 3D Printed patient specific model is a valuable aide

Real liver is opaque, model (digital and physical) is transparent, allows surgeon to clearly see how close the tumor is to other important structures (Hepatic vein, IVC, and others).

Can be a planning tool or even an intra-operative reference.

Useful to a variety of clinicians in a variety of disciplines13

September 8, 2016Tri-C R3D 201614Background ApplicationsMedical Devices

EndoscopeCatheter | GuidewirePancreatic DuctBile Duct

Image credit link: http://patients.gi.org/topics/ercp-a-patients-guide/

Medical device designers, engineers can benefit from patient-based models as well.

To stick with the liver-them, imagine you are designing a catheter that needs to access the Bile Duct, perhaps to treat a gallstone. The catheter needs to access the Major Duodenal Papilla, and it can be difficult to access; a specialized endoscope helps to navigate there, but still difficult.

Obviously to test a new design, you would need a test fixture. If youre modeling one from scratch, you might consult a textbook, create a relatively simple model and could print it.

But Bile Duct anatomy has a lot of variety, even in healthy patients, so having a number of Bile Duct models to aid design and use in testing would be really helpful.14

September 8, 2016Tri-C R3D 201615Medical Applications Patient Specific ModelsCT/MR Imaging3D ReconstructionDigital Preparation3D PrintingPost Processing

Very basic flow chart of how one can go from the clinical imaging, be it CT or MR to a Final Model

1) CT/MR data exported as slides or DICOM images2) These images have spatial orientation so that can be Reconstructed to make a 3D representation. With some further effort, a 3D model representing an end organ can be exported.3) Well take that model and do some additional digital preparation to get it ready for the 3D printer.4) Then well run it on the 3D printer5) Finally, the 3D printed part needs to be cleaned at a minimum, but really needs some additional post-processing work to be presentable.

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September 8, 2016Tri-C R3D 2016163D Printed Model

Post Processing

Medical Applications Anatomical ModelsTraining & Education

3D printed models can be used for training and educational purposes.

One application of this is for anesthesiology residents. *They need to learn how to intubate and scope patients airways. *Simulation rooms have trainer models for this purpose. *This first image shows the existing airway model they have these are just after the first bifurcation off of the trachea*These models omit a lot of details and this becomes very obvious once viewed with an endoscope

One anesthesiologist asked if we could make 3D printed airways*Here is an example of one of them:*Based on a patients CT scan and 3D reconstructed*We took the airway itself and added a 1-2mm wall thickness*Digitally we could see a lot of detail but how would the physical model compare when it was scoped?

September 8, 2016Tri-C R3D 2016173D Printed ModelReal Anatomy

Viewed through airway endoscopeMedical Applications Anatomical ModelsTraining & Education

Here is a couple images showing a snapshot from the endoscope for the 3D printed model and the real anatomy.These are blurry but you can see that they are very similar.

This is very useful for training purposes and its more accurateAlso, we can print more than just normal anatomy, we can print diseased anatomy or just abnormal but healthy anatomyOne e.g. was a patient who had a tracheal bronchus -

September 8, 2016Tri-C R3D 2016183D ReconstructionDigital Preparation3D Printed ModelDescending AortaMedical Applications Anatomical ModelsIntrasvascular Device TestingCommon IliacExternal Iliac

Another area where medical Imaging and anatomy models has been valuable is for device testing.A couple years ago approached by a medical device company developing an intravascular device. They wanted 50 sets of patient specific data for the region of the descending aorta splits or bifurcates into the left and right common iliacs and subsequently into the external & internal iliac arteries. They had some criteria for which patient data as well.At Cleveland Clinic we have many many thousands of CT sets as well as the personnel to perform the measurements they wanted, to reconstruct the CT into a digital model, and finally to print & clean the models.


Medical Applications Anatomical ModelsDevice TestingeasyTortuousCalcificationsDiameter changes

The printed models were very useful to them because they could test the function of their device in real-world actual geometry. The one extra model we have left-over from that project (left image) is pretty tame but some of the data sets we had showed some very tortuous anatomy (right image)Would have been difficult to replicate such shapes in tubing.They could bench test their device in 50 unique, real-world test fixtures.

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September 8, 2016Tri-C R3D 201620Medical Applications Surgical Planning Case StudyAortic Arch AneurysmCase History:

Previous open heart surgery Aortic Arch Aneurysm graft Aortic value replacement

Present: Kink in existing Aortic Graft

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September 8, 2016Tri-C R3D 201621Medical Applications Surgical Planning Case Study

Aortic Arch AneurysmOpen Repair vs. Endovascular Approach ?

Discuss trade-offs. Stent graft may migrate intra-operatively (explantation required) 21

September 8, 2016Tri-C R3D 201622Step 1 - ImagingMedical Applications Arch Aneurysm Surgical Planning

September 8, 2016Tri-C R3D 201623Step 2 Image SegmentationMedical Applications Arch Aneurysm Surgical Planning

September 8, 2016Tri-C R3D 201624Step 2 Segmentation PreviewMedical Applications Arch Aneurysm Surgical Planning

September 8, 2016Tri-C R3D 201625Step 2 Mesh PreviewMedical Applications Arch Aneurysm Surgical Planning

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September 8, 2016Tri-C R3D 201626Step 2 Mesh PreviewMedical Applications Arch Aneurysm Surgical Planning

3d pdf for review with pre-print review with surgeons. 3d pdf can be rotated. Cut to decrease material required for print. 26

September 8, 2016Tri-C R3D 201627Step 2 Segmentation RefinementMedical Applications Arch Aneurysm Surgical Planning

aortic valvegraft kinkaneurysmRt. coronaryfocal calcifin

September 8, 2016Tri-C R3D 201628Step 3 Digital PreparationMedical Applications Arch Aneurysm Surgical Planning

September 8, 2016Tri-C R3D 201629Step 4 3D PrintingMedical Applications Arch Aneurysm Surgical Planning

September 8, 2016Tri-C R3D 201630Step 5 Post Processing (Cleaning)Medical Applications Arch Aneurysm Surgical Planning

September 8, 2016Tri-C R3D 201631Clinical ReviewMedical Applications Arch Aneurysm Surgical Planning

Open Repairvs.Intravascular(minimally invasive)?


Total Shoulder ArthroplastyMedical Applications Patient Specific DevicesSurgical Planning & Intraoperative Tools

At Cleveland Clinic one area where surgical planning led to the use of surgical templates was with Total Shoulder Arthroplasty or a shoulder joint replacement.Looks pretty straightforward as you can see with the graphic on the left the native humerus and glenoid are replacement with implants.But as the image on the right shows the surgical field and access is limitedTypically, an x-ray was used to pre-operatively evaluate the patientThis only shows a collapsed planeOne thing they need to do is drill a hole that will determine the position and orientation of the glenoid implant, so its critical to be accurately placed.The conventional approach has been to eyeball it basically

Image Links: http://morphopedics.wikidot.com/total-shoulder-replacement

September 8, 2016Tri-C R3D 201633Joseph P Iannottiet al, Comparison of Patient-Specific Instruments with Standard Surgical Instruments in Determining Glenoid Component Position, 2012 Journal of Bone and Joint Surgery Vol 94-ADigital Surgical PlanningMedical Applications Patient Specific DevicesSurgical Planning & Intraoperative Tools

Dr. Iannotti is a expert in these surgeriesHe recognized the need to utilize CT imaging in the surgical planning stage.His team developed some custom software that performed the 3D reconstruction and also allowed the user to virtually place the implant. Furthermore, it could export a template digital model that can be 3D printed.The template fits to the patients actual glenoid anatomy and has the drill hole locations and orientations already set, so it removes a lot of the guesswork from the surgery.

Images from the journal: Joseph P Iannottiet al, Comparison of Patient-Specific Instruments with Standard Surgical Instruments in Determining Glenoid Component Position, 2012 Journal of Bone and Joint Surgery Vol 94-A

September 8, 2016Tri-C R3D 201634Joseph P Iannottiet al, Comparison of Patient-Specific Instruments with Standard Surgical Instruments in Determining Glenoid Component Position, 2012 Journal of Bone and Joint Surgery Vol 94-APublished Trial ResultsOutcomes measuredStandard Surgical Group (n=16)Glenoid Positioning System Group (n=15)P ValueNonoptimal implant type used during surgery10 (63%)1 (7%)< 0.001Malposition occurrences (version and/or inclination)14 (44%)4 (13%)