3D Imaging and Printing models for Pre Operative planning

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1 3D Imaging and Printing models for Pre Operative planning Dr.Jayanthi Parthasarathy B.D.S., M.S., PhD. Director Biomedical Engineering MedCAD Dallas. TX Innovations in 3D Printing Houston 10/14/15

2 IDOR - MFS Dallas TX USA AU FRG ICC

3 What does the surgeon see?

4 Imaging decision support - To name some

5 What can the surgeon do with the images? See images to define pathology understand anatomy relate the existing pathology to the anatomy plan surgery in 2 dimensions What can the surgeon not do with the images? Rotate, Relate to the structure in 3D, Simulate surgery in 3D, Analyze what if situations Have a tactile sensation of the anatomy and pathology

6 Surgeons needs Reduce operative time Look at a virtual model that he can move, rotate, scale and highlight pathology and simulate surgery Evaluate what if situations for best treatment outcomes Transfer virtual surgical planning to the OR Create templates for the specific surgery Have physical reference models that he an cut in rehearse surgery Have a tactile sensation of the existing situation Create patient specific implants Predictable performance Repeatable fabrication Affordable cost

7 What can we provide? Virtual Physical 3D Models Surgical planning Non Implantable Implantable Design Implant Design Guides Template models Guides Patient Specific Implant Generic Devices

8 Advantages of patient specific devices Reduce operative time Look at a virtual model that he can move, rotate, scale and highlight pathology and simulate surgery Evaluate what if situations for best treatment outcomes Transfer virtual surgical planning to the OR Create templates for the specific surgery Have physical reference models that he an cut in rehearse surgery Have a tactile sensation of the existing situation Patient specific implants with predictable performance, repeatable fabrication Affordable cost

9 Why Additive Manufacturing is the solution for Patient Specific Medical Devices? Design Material Freedom Manufacturing processes Mechanical properties

10 Geometric freedom & reproduction of complex shapes Murr et al Phil. Trans. R. Soc. A (2010) Parthasarathy et al J. Mech Beh. Biomed Materials (2009 )

11 Material freedom - Biomedical Applications AM Polymers Photopolymers Visijet and Projet group of materials from 3D systems Epoxies, Acrylate epoxies Objet Digital material Resins VeroGlaze VeroDent Thermoplastics ABS ABS-M30i ULTEM 9085 Nylon Organic materials Chitosan Hydrogels Alginate Gelatin Fibrin Alginate Polymers PCL PLLA PLGA PEG PEGDA PEKK Pre Alloyed metal elements Titanium and its alloys Co-Cr Ceramic Matrix HA and TCP combined with Epoxy

12 FDM Extrusion BOTS Cubify Biopolymers AM Processes Liquid based SLA Polyjet Starch Powder based EBM,DMLS,SLM, Laser sintering Cell Based Bioplotting

13 Design phase is common to both implantable and Non Implantable devices User needs Regulatory compliance Data Input Cost Design Mfg. Process Post processing Engineering material properties

14 User needs - Non implantable patient specific devices Anatomical models Physical evaluation models Surgical rehearsals Check prosthesis fitting Team interaction Patient education Teaching Accuracy, Easy deciphering of normal anatomy and pathology, Sturdy and withstand handling, Non toxic, Cut and plan surgery with usually available tools, Not warp or change shape at room temperature, replication of thin walled structures in certain situations.

15 Process flow for Design and manufacturing of patient specific devices with AM Design phase and manufacturing of templates Manufacturing of implants 15

16 Data input CT/ CT Angiography MRI Ultrasound 3D scanning Typically any imaging output that has X,Y and Z data derived from routine diagnostic processes

17 Software MIMICS 3D Doctor Biobuild Amira Invesalius Geomagic design studio Geomagic Touch

18 Imaging protocols

19 Design Phase - Reconstruction External Geometry MIMICS Data acquisition from CT scans 3D Doctor Biobuild Amira Invesalius Med. Image processingthresholding 3D reconstruction Region of Interest

20 Design Phase - Implant Design Process Haptic devices Geomagics touch Out put. STL file

21 Creation of precise geometry of the ROI depends on Input data CT/ MRI protocol Image processing Software itself Thresholding Identification of structures and personnel training Creating a 3D Model Data points connecting algorithms Data transfer Image processing.stl to 3D Modeling Cleaning up of the 3D Model Haptic devices based or other softwares Design of Guides Data transfer final digital model for AM

22 Pre op Surgical planning Web conference

23 AccuPlan app

24 Clinical cases template Models

25 Template models for plate bending

26 Mandible resection and reconstruction Pre Op Tumor Reconstruction plan

27 Template models QC Check for Devices

28 Spine Model

29 Design for conjoined twins Requirements Model to be sturdy to be handled by the team of surgeons Upright stand alone models that can be easily put together to visualize current situation Some part of the visceral anatomy to be in soft material Vasculature to be visualized distinctly

30 Design for conjoined twins

31 Cardiology Stratasys.com Courtesy Abiomed Inc. and

32 Surgical Guides Precise fitting to anatomy Simple to use Not break during use Made of biocompatible material that can be in short term contact with body tissue and blood Not abrade during use Cutting guides Sterilizable

33 Distraction vector planning Marking guide

34 Surgical Guides Plan 1 21 mm Final Bandeau device

35 Craniotomy Marking Guide

36 Guides

37 Mandible resection and reconstruction Pre op Mandible resection plan Marking Guide PEEK Filler for resected mandible

38 Resection plan and marking guide

39 Virtual surgical planning and surgical guides Virtual - models Surgical planning Guides Physical models and guides that translate VR to the OR

40 Dental Implant Guides

41 Orthopedic Hearing aid

42 Aortic Aneurysm (Michigan Childrens Hospital) Soft material for fluid flow studies

43 Implantable Devices Patient specific Generic devices Non resorbable Resorbable Non resorbable Resorbable

44 Engineering Mechanical properties -Functionally Graded Implants Functionally Graded design Design of internal architecture Solid filled structures Creation of voids Reduce weight Reduce density Increase surface area for better cell adhesion Load bearing Joints smooth finish Prevention of abrasion and friction 44

45 Design of internal architecture Periodic cellular lattice structures Combination of struts of routine mathematically represented geometric shapes Repeated Interconnected pores in X,Y and Z directions Cell size tens of micrometers to tens of millimeters Mechanical properties varied by altering the size of the struts and cells Mechanical properties more predictable Starly et al

46 Creation of lattice structures Boolean operation With CAD Software- ProE TM, SW TM, Freeform TM and MIMICS Netfabb TM 46

47 Functionally graded designs Mandible Hip implant Parthasarathy et al 2010 Dongmei et al 2005 Layerwise.com Harryson et al

48 Functionally Graded BioMaterials (FGBM) Stochastic structures

49 Patient specific porous titanium implant - EBM

50 Orthopedic applications Devices has EU approval Not approved by FDA 50

51 Orthopedic applications

52 AM Orthopedic devices - China

53 Custom Designed Spinal Fusion cage and Vertebra tatic/managed/876/493/6603dspine3.jpg?ve= 1&tl=1

54 3DP Knee implant hip-and-knee-implants jpg

55 Laser Sintering PEKK Implantable Polymer Oxford performance materials

56 Tracheal Stent Resorbable stents Cardiac devices Resorbable stents Emergency approval by FDA University of Michigan

57 The Art to Part Process Additive manufacturing Non implantable Devices

58 Metal Additive Manufacturing EBM SLM DMLS EBM Photo courtesy SLM Solutions GmbH EOS

59 Printers for tissue engineered resorbable devices

60 MedCAD Dallas Texas

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