a breakthrough of vr for surgical training greenlight sim project a breakthrough of vr for surgical...

The Greenlight Sim Project

A Breakthrough of VR for Surgical Training

Robert Sweet, MD, FACSAssociate Professor, Departments of Urology and Surgery

William L Anderson Endowed ChairDirector of Medical School Simulation Programs

Panelists

• Mike Kujak, Vice President and General Manager Prostate Health, American Medical Systems an Endohealth solution

• Yunhe Shen, PhD Assistant Professor SimPORTALUniversity of Minnesota

Medicine Meets Virtual Reality 2014

Lower GU anatomy

• Prostate

Epidemiology

• 5.6 million currently in U.S. complain of moderate or severe lower urinary tract symptoms (LUTS).

• Approximately 11.2 million by the year 2025

• Incidence of moderate to severe LUTS in men:– 40s- 18%– 50s- 29%– 60s- 40%– 70s- 56% (Roehrborn, Campbell’s Urology 2002)

BPH Trends• Urology residency training is unlikely to mimic the increased utilization

of office-based BPH therapies seen nationwide. Such a gap in education should be addressed in any redesign of the residency curriculum.

• New Tools are needed to promote proper training

7

• Elliott, SP, and Sweet, RM. Contemporary surgical management of benign prostatic hyperplasia: What do recent trends imply for urology training? Current Prostate Reports. Issue Volume 7, Number 1 / February, 2009pp. 19-24

Full Procedural trainer

VR TURP Trainer (2002)

VALIDATION

DEVELOPMENT

ASSESSMENT/TRAINING

Specific aim

• To build a trainer using our advanced virtual reality modeling capabilities for the purposes of training green-light PVP.

Financial challenge?

• VR is expensive. . . . . But so is faculty time!

Medical-VR RESEARCHERS

AMS – A Medical Device Company’s Interest in VR Simulation

Mike KujakGeneral Manager, AMS Prostate Health

©2012 American Medical Systems, Inc. All rights reserved. 13


$507 M

$3B Revenue in 2012

Endo Health Solutions and Its Companies

Branded products that address unmet patient needs in pain, urology, oncology and endocrinology.

Affordable, high‐quality generic and over‐the‐counter pharmaceuticals with a current portfolio exceeding 600 products.

$212 M$633 M$1.7BProvides the most advanced technology and premiere support systems to urologists, hospitals, surgery centers and clinics across the US.

Unrivaled Leadership in Serving Pelvic Health Needs

15©2012 American Medical Systems, Inc. All rights reserved.

Over 40 years of innovation in pelvic health

#1 market share position in male sexual dysfunction, male continence, female SUI, female PFR and BPH Laser procedures

More than 315,000 patients treated annually

1,100 team members in 9 countries

Presence and distribution in over 67 countries

Full Portfolio of Urology Devices and Services

Men’s Health

Women’s Health

ProstateHealth

GreenLight PV®

Laser Therapy (80W)

Launched GreenLight HPS®

Laser Therapy (120W) & 2090 Fiber (275kJ)

MoXy® Fiber (650kJ) &

GreenLight SIM®

Laser Therapy

Sparc®

Sling System

Straight-In™ Sacralcolpopexy

System

Monarc®

Subfascial Hammock

BioArc®

System

Elevate® Anterior & Posterior

Prolapse Repair Systems

MiniArc®

Single-Incision Sling

System

MiniArc Precise™

Single-Incision Sling System

MiniArc®

Pro Single-Incision Sling

System

AMS 800®

Urinary Control System

AMS Conceal®

Flat Reservoir

AdVance®

Male Sling System

InhibiZone®

Antibiotic Surface Treatment

Parylene Coating

StoneLight®Laser Therapy & SureFlex™ Fiber

Spectra®

Concealable Penile

Prosthesis

*Some of the products displayed are in development and are subject to FDA approval or clearance. © 2012 Endo Pharmaceuticals Inc. All rights reserved 16

A History of Innovation Firsts. A Commitment to Advancement.

AMS Ambicor®

Penile Prosthesis

AMS700®

Inflatable Penile Prosthesis

CRYOCARE CS®

Surgical System

MoJo® Software for GreenLight HPS®

Laser Therapy(400kJ), GreenLight XPS®

Laser Therapy (180W) & MoXy® Fiber

(400kJ)

GreenLight Laser Therapy

18

AMS Interest in Simulation Technology

Consistent, standardized, modular training approach to performing GreenLight Laser Therapy by using a virtual reality simulator to develop the users’ skill to achieve rapid clinical proficiency leading to excellent clinical outcomes

19

Framework of Collaboration

Sponsored Research with the University of Minnesota to develop a GreenLight Simulator

– PI: Robert M. Sweet, MD– Software and Hardware development completed by University of

Minnesota– Exclusive rights for non-commercial usage with ability to move into

commercial applications– Deployment options are independent of design and development

process

GreenLight Training Modalities pre-GreenLight SIM

COE

Preceptor

Wet Lab

Format

1.5d program w/ live cases, mini-lectures, panel & hands-on training

Program Size

< 20

Program focused on bull prostate;

also includes didactic session

~10

1d program w/ live case, didactic

and hands-on training

< 4

21

Benefits of GreenLight Simulator

– Portable training platform for beginning and advanced skills– Physicians

– Residents– New Users– Competitive Users

– Distributors – AMS personnel

– Upgradeable– Sales and marketing demo platform– Potential for CME accreditation– International clinical training needs can be more easily met– Enhancement / optimization of learning curve prior to clinical use– Further develop non-users and further increase user base– Cost-effective– Comprehensive training at multiple skill levels

“Backwards Design Principles”Step 1: Define intent and desired outcomes Step 2: Define specific learning objectives, which learning domain(s) predominate? Step 3: Define what we want to assess and metricsStep 4: Define safety and efficiency and “proficiency”Step 5: Task deconstructionStep 6: Define condition and what senses need to be simulated Step 7: Design format, exercises and anticipate possible threats to Step 8: Engineering designStep 9: Define standards on and refine instrument (verification and early validation)Step 10: Collect data on experts and establish inter-rater reliabilityStep 11: Formal validation

Intent and desired OutcomesSimulator will serve all of these areas

• Build Fundamentals

• Allow consistent training on new modality regardless of attending skill or preference

• Assessments will be aimed at driving RRC

• Skill level independent learning

• Ability to add advanced topics after developing core skills

• Easier access to training

• Advantage over competing modalities in the area of training

• Assessment capabilities and realism will entice

• Advanced techniques can be tried on GL Simulator

• Ability to spark product development discussions versus debate over current modalities

• Supplement Current learning

• Training will be the same as what is being presented to physicians

• Higher level of surgical / coaching readiness

Residents New Users Competitive User AMS Personnel

Methods• A clinical advisory panel

– 4 key opinion leaders for PVP– Defined learning objectives and

performance metrics. – Conceptualized exercises

• 6 core prostatic anatomic full cases• Part-task training exercises for training proper

sweep speed, tissue distance, coagulation, power setting management and landmark identification.

Learning objectives• Demonstrate safe and efficient GL technique• Demonstrate proper endoscopic anatomy

identification• Demonstrate proper fiber sweep speed, distance and

angle• Demonstrate proper usage of power settings• Demonstrate ability to approach classic anatomy

variations• Demonstrate how to properly deal with bleeding

vessels• Demonstrate proper error avoidance, recognition and

recovery

University of Washington Grand Rounds

Metrics and Errors• Case Metrics (units)

• Avg Sweep Speed • Avg Laser Dist • Gram vaporized (GRAMS)• Energy Delivered/GRAM• Capsule Perforation (sq

mm)• SPHINCTER INJURED vs

Trial No• Ureteral orifice injury• Bladder neck undermining• Injury of rectum• Injury of dorsal vein• Blood loss• Coagulation/pause/vaporiz

ation time

• Scope damage• Lens damage• Fiber damage• Time

Fidelity and resources

• Requirements dictated a high fidelity simulator

• Virtual reality approach critical given the desire for objective metrics assessment and the presence of complex features such as bleeding.

• Haptic requirement minimal

University of Washington Grand Rounds

Overview

Validation• Our group (AUA

meetings and MMVR proceedings)

• External Construct Validation– Herlemann et al

European Urology 64 (2013)

– 4 abstracts AUA 2014

The Greenlight Sim Project:Needs-Driven Research and Development

Yunhe Shen, PhDR&D Lead, Co-PI

The Drivers

Business-Driven

Needs-Driven

Consumer-Driven

Market-Driven

Data-Driven

Model-Driven

Competition-Competition-Driven

Technology-Driven

Technology-Driven vs. Needs-Driven

• Technology-driven

ApplicationsNeeds*Solutions *Technologies*Problems *Needs

Problems

Solutions

Application

• Needs-driven

Understand the Needs

• Defined by users not developers• Prioritize specific R&D aims and key

elements accordingly– Must have– Nice to have– Future work

Previous work as candidate solutionsCREST 2006-2009

Interdisciplinary Team

• Clinical advisory board• Collaborative R&D

– UMN, ADS, KDI, AMS• QA/QC• Technology transfer• User support

Collaborative R&D• Algorithms: VR simulation, graphics, visualization• Computational mechanics• VR interface: haptics, motion tracking• Computer art design, video & audio• Web/database – learning management• Wet lab/animal model• Hardware manufacturing, system assembly

System Overview

Framework Interface layersFramework Interface layers

Instrument-tissueinteractive modelingDeformation,Collision

Detection & Response, Ablation

VR Interfacescope, pedals,

display…Motion tracking Haptic device

Graphic rendering,

special effects

Framework integration & interface layer

Curriculum, training modulesDatabase/LMP connector

Files I/O

Learning management

serverCurriculum database

Installer,License manager

VR Interface Motion Tracking Haptic modeling

Simulation System Architecture and Functional Modules

Instrument-TissueInteractions

DeformationCollision Detection &

Response

Tissue Destruction

AblationVaporization

CuttingBlunt dissection

VisualizationGraphics Engine

RenderingSpecial Effects

PropertiesTissue propertiesInstrument profiles

Environments

GUI

Real Time VR Simulation FrameworkSynchronization - Threading, Timing, Communication

DisplaysHuman-MachineVR peripherals

CurriculaScenarios, Metrics,

Scores

Anatomy ModelsSlices/Scans

MeshesTextures

MultimediaDataset

Audios Videos Animations

Database Server

Database Connector

Web Server

Learning Management Platform

“To Err is Human”

• Underestimated the unknowns• Overestimated the knowns

Challenges

Frame rates•Haptic•Graphic

Integration•Time consuming•Debug

VR-Interface: Motion tracking and haptics•Cost-efficient, compact, portable, reliable

High resolution, intensive computation•¼ to ½ millions elements going through vaporization, deformation, collision detection, graphic and haptic rendering…

Robustness & reliability

Must sustain arbitrary

user input

Vaporization and Visualization

• Boundary surface model– Less elements in prostate model– Computation concentrates on surfaces– Easy to render– Arbitrary and constant topology editing problem– Robustness and speed concerns

• Volumetric model– Explicit mesh editing / implicit isovalue operators– Handle topological complexity well– Much more elements– Speed concern– Isosurface texturing

Constructive solid geometry• Volumetric CSG difference operator between the laser

beam and the tissue

• Level Set - Implicit isosurface model

Methods: Vaporization

Prostate tissue

Ablation boundarydh

WD Laser beam

http://en.wikipedia.org/wiki/Constructive_solid_geometry

Boolean difference

Boolean union

Boolean intersection

Vaporization and Coagulation• Better level set method

implemented in GLSIM v1 (2010).– Model both vaporization zone

and coagulation zone– Allow tissue property

changes, e.g., “hardening” effect

– Applicable to relatively lower resolution models

• Can reduce the min. tetrahedral resolution to a quarter-million per prostate model

HPS5 mm

H. Kang, D. Jebens, R. Malek, et. al. Laser vaporization of bovine prostate: A quantitative comparison of potassium-titanyl-phosphate and lithium triborate lasers. J. Urology, 180, pages 2675-2680, 2008.

Experimental Data

• Tissue ablation rate as a function of multi-variables– Laser power – Treatment distance– Sweep speed

0.000

0.050

0.100

0.150

0.200

0.250

0 2 4 6

Vapo

rization Vo

lume (m

l)

Working Distance (mm)

HPS 120W (Kanget. al.,2008)HPS 80W (Kang et.al., 2008)

0.000

0.020

0.040

0.060

0.080

0.100

0.120

0 2 4 6 8 10

Volume pe

r Ene

rgy (m

l/KJ)

Treatment Speed (mm/s)

Experiment (Kang et. al., 2008) Present Model

Learning Management PlatformLMP Client LMP Server

VR surgery application

Database connector

Database connector wrapper

Client-Server framework for LMP

Client network agent

SQL data transfer

Network protocol (Socket)

Web browser

https://

Server network agent

Web application & server

SQL database application & server

Launch GLSIM V1 as an Interactive Simulation System

System integrated and demonstrated 2009-2010• AUA, San Francisco, CA

• IEEE Visualization, Salt Lake City, UT

Multi-institutional validation studies

started 2010

Resolve robustness issues in the following year• Large deformation challenges collision detection/contact modeling

• Random memory error• Hardware assembly issues

Revises and maintenance• Feature changes• Bug fixes• Minimal on site maintenance – Robust and Reliable

Results

Ongoing and future work

• New tracking/navigation• New graphics• GPU• Patient specific

GreenLight SIM Curriculum

Mike KujakGeneral Manager, AMS Prostate Health


Skills Enhancement to Drive Outcomes

– Comprehensive training for all experience levels

– Best-in-class training technology, including innovative simulators and leading cadaver lab

– Educating the next generation of pelvic surgeons through residency and fellowship programs

52

In 2012, we trained more than 1,400 physicians, fellows and residents in

around the world

©2012 American Medical Systems, Inc. All rights reserved.

AMS GLOBAL TRAININGF. BRANTLEY SCOTT PHYSICIAN

ACADEMY®

Physician Education & Training Process

• Support Needed- Hospital- Clinic- AMS

• Patients Available

• New orAugmented Skills

• Peer Discussion• Preceptor• Online Programs- Surgical Video

•Product Demonstration- Hands-On

• Pre-work

• COE• Proctor WithChecklist• Training Records

• Advanced Training

• Case Support• Follow-up• On-Going Education

Identify Understand Commitment Learn ApplyQualifiedand FullyCommitted

E-Learning AMS Rep* Completed Training Record**

• 1 visit• 3 cases optimal

Prostate Health Training Pathways


Non-XPS Users: TURP, Former or Current HPS, No/Minimal Experience with Lasers

11-20 CasesTotal 10 Cases

Training Event (COE)

Preceptor(Current HPS

user only)

Proctor

• Faculty Led• Skill Modules • 1 SIM Case

GreenLight Simulator

(SIM)

Case Observation Forms required for minimum # cases (AMS Rep)*AMS Rep must pass PEAK Phase 2 to sign off on cases 1-10,

PEAK Phase 4 to sign off on case 11+** Interim Training Record may be issued at request of hospital

***And/Or***

***And/Or***

(Optional for current HPS user)



Dabblers: Competitive Laser Users



Recommended 10 Cases

Training Event (Advanced COE)

Proctor(Optional based on experience)

AMS Rep* Completed Training Record**


• Faculty Led• Skill Modules • 1 SIM Case


(SIM)

***And/Or***

5 Cases Minimum





Believers: Advanced Users

21-30 CasesRecommended 10 Cases

Training Event (Advanced COE)

Proctor

AMS Rep* Completed Training Record**



(SIM)• Faculty Led• Skill Modules • 1 SIM Case

5 Cases Minimum

***And/Or***

***And/Or***

SIM Target Customers

Prospective Users

New Users Competitive Users

Existing GL Users

Objective Get commitment to become new users

Complete 10 cases

Get commitment to become new users

Enhance GL skills to

become super users

SIM Exposure X XSIM Basic X XSIM Advanced X

2013 International GL SIM Use

Simulator Workshops 2013

Dec-13 Total 2013DACH 5 71WE 0 12Iberica 0 17France & Belgium 0 63 (338 physicians)Japan 3 30Distributor Markets 0 3 (45 physicians)Australia 0 12 (50 physicians)Malaysia X 3Brazil 2 25Thailand X 20Mexico X 3Peru X 4India X 3China 2 11Total APLA (limited availability in some markets) 4 69Total International 12 277


“In our view the SIM is our current main training and marketing tool. Since the introduction of the SIM, the learning curve for GL has been significantly reduced for the most users. This results by the possible big numbers of cases made on the SIM...AMS German Sales rep”

“The use of SIM to referring physicians or patient events is invaluable. Firstly, it is an eye-catcher, on the other hand, the participants have a realistic assessment of the procedure…French physician.”

“SIM made the learning fun AND more efficient and effective. Without SIM this technique could not have been done, in such an efficient and effective fashion…German physician”

Post Mortem: SIM Update


Residency programs with SIM integrated: Columbia, Cornell, Southern Illinois University, University of Toledo, Stanford, Mayo – Florida

SIM appears cost-effective versus other training programs

90 days prior 90 days post Difference % change

YTD Fiber Unit Volume of 68 SIM trained physicians 116 265 149 129%

SIM impact on Physician Competency

Program TypePhysicians Trained

YTD TotalAvg training

cost/physicianTotal Training

Cost YTDCOE 25 $3,948 $98,692PH Advanced 38 $2,878 $109,377Preceptor 29 $1,878 $54,468Proctor 27 $3,668 $99,031SIM-Faculty 212 $297 $62,873Wetlab 17 $723 $12,289

US EMEA APLAC GET TOTAL

TOTAL 55 33 35 5 128

Total Deployed YTD

2013 GL SIM Metrics: COE Physician Feedback


8.809.07

8.478.91

8.608.91

8.338.86

0.00

1.00

2.00

3.00

4.00

5.00

6.00

7.00

8.00

9.00

10.00

New User Advanced New User Advanced New User Advanced New User Advanced

Usefulness of GreenLight SIM inhelping communicate proper

technique?

Effectiveness of hands-onexperience with SIM in providing

realistic experience of lasersystem?

How beneficial was experiencewith SIM in helping you better

understand how to use GL lasertechnology?

Impact of SIM in perparing you toperform an effective GreenLight

procedure?

Displayed data is for US only

The GreenLight Pathway


Excitement

Confidence

Predictable Outcomes

Thank you!

• www.simportal.umn.edu• [email protected]• [email protected]• [email protected]

a breakthrough of vr for surgical training greenlight sim project a breakthrough of vr for surgical...

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