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SPINE ASSIST Mitul Shah 11715595 Medical Robotics ECE S 690 / 490

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Page 1: Spine Assist

SPINE ASSIST

Mitul Shah 11715595Medical Robotics ECE S 690 / 490

Page 2: Spine Assist

Outline

The intended application of this system

Architecture and Components Working Mechanism The Company and Competition An Engineering Perspective References

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

Page 3: Spine Assist

The Intended Application of the System

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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The Older Approach

Spinal fusion, also known as spondylodesis or spondylosyndesis, is a surgical technique used to combine two or more vertebrae using a screw like implant.

With the help of multiple fluoroscopy images the surgeon continuously monitors the placement of the pedicle in the spinous process.

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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Medical Robotics ECE S 690 / 490Mitul Shah 11715595

2004199519651850

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The Older Approach Drawbacks

Intricate, delicate and long surgery 10% risk of implant misplacement, out of which

5% have clinical consequences. 30% of implants could have been better

placed, though they do not require revision surgery

Radiation Exposure

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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What SpineAssist Brings to the Table

Enabling precise and efficient Minimal Invasive access procedures.

Short MIS procedure time while Significantly reduce exposure to Fluro radiation

(2 shots only). Operated with no dedicated personal in the room. No need to maintain Line of Sight during

operation Training:

2 hours saw bone.5 cases supported by clinical instructor.

Set up: Nurse / Radiology technician based 3 minutes set up time

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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Some important Statistics

2008, the total U.S. spinal implant market was valued at $4.75 billion(1), coupled with a dynamic market growth of 10.7% annually, and is projected to reach more than $3.8 billion in the year 2009.

Aimed to increase the accuracy of implantation during surgeries

Minimally invasive spinal fusion systems are estimated to grow at a compound annual rate of nearly 15%, from an estimated $107 million in 2004 to more than $200 million in 2009.

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

Page 9: Spine Assist

Architecture and Components

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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Medical Robotics ECE S 690 / 490Mitul Shah 11715595

The Workstation

Miniature Robot Device

The T- Frame

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Workstation And Software Software allows surgeons to perform pre-operative planning

on a PC at their own convenience. A virtual catalogue of surgical implants allows visualizing the

placement of the implants in 3 planes for each vertebra. The software allows for a step by step review of the planning

and simulation of correction intended by the procedure. The software supports a range of measurements including

Cobb angle, lordosis and kyphosis. The software also calculates rod length and curvature.

The workstation connects to a fluoroscopic C-Arm and performs automatic CT-to-fluoroscopy image registration based upon 2 fluoroscopic images. The workstation is used to control the precise motion of the miniature device to the preplanned position

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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Miniature device A miniature, high precision hexapod with 6 DOF is used as

guidance assistance for spinal surgery. The hexapod robot measures 50 mm (2 in) in diameter and 80

mm (3.15in) in height for a weight of 250 g (0.5 lb). The working volume is several cubic centimeters depending on

the guide arm used. Six of Faulhaber’s DC brushless smoovy® gear motors with

custom drive electronics drive the linear actuators based on a high precision, miniature lead screw design.

Accurate and absolute displacement measurement is assured by seven LVDT sensors, one for each actuator and the seventh tracking the performance of the others. The miniature drive measuring only 5 mm in diameter and has a custom M2.5 thread lead screw.

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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Platform

Hover-T™ for minimally invasive, percutaneous procedures or 3+ level cases

Clamp and Bridge for open procedures and scoliosis/deformity cases

Bed Mount for VCF, biopsy and single level approaches

Bilateral Bed Mount Hover T for Cervical and GO-LIF cases.

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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Working Mechanism

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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The Procedure

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

The video can be found here

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Mazor Surgical Technologies

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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The Company Established in 2001and sponsored by the Technion (Israel

Institute of Technology). Pioneered the development of miniature Semi robotic bone

mounted positioning systems Mazor is a leading provider of SpineAssist, a highly

accurate, minimally invasive, easy-to-use, miniature surgical assistance system for a wide range of spine procedures

Strong IP position with 8 patents submitted (main patent has been accepted).

The company’s offices are located in Caesarea, Israel and Atlanta, USA (Mazor Surgical Technologies Inc.) and employs 32 individuals.

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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Current Status The product and its MIS platform, the “Hover-

T” has been approved by the FDA and CE for marketing and use within the US and Europe.

The system is used clinically in US, German, Israeli and Korean hospitals.

Over 150 cases have been preformed with the SpineAssist since mid 05.

The SpineAssist device supports the wide range of surgical procedures

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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The Cost First financial round (USD8.5M ) took place

as of Q1/2003. Investors includes: Johnson & Johnson DC (USA), Shalom EF (USA), DOR Ventures (Belgium), MBVC (Italy).

Second financial round (USD12M) been closed as of May 2005. Investors includes existing share holders together with IHCV.

Manual Spinal Fusion Surgery can cost an average of $ 62,000 solely for the operation.

The spine assist robot cost $ 100,000 per installation and an additional $ 900 per operation towards disposable patient specific clamps.

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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The Market

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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Over 150 cases have been preformed with the SpineAssist between Jan – Jun 06

Helios – Germany

LA: UCLACCDH

USMD – Dallas

HSS – New York

Naval Medical Center – Virginia

Cleveland Clinic – Cleveland

Israel: Tel hashomerHadassah

Korea – all hospitals

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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Total Available MarketAnalysis Assumption:Number of Spine Centers: 2,200 Average Lumbar fusion cases per annum per center 240 Average Disposable kit cost 1,000$ Average SpineAssist End User Price 100,000$ Average Annually Service Price 10%Market (# of Lumbar Procedures) annually growth 9%

Capital Related MarketTotal Capital Equipment Available Market 220,000,000$ Total SpineAssist Service Available Market 22,000,000$

Total SpineAssist US based Capital Available Market 242,000,000$

Total SpineAssist ANNUALLY Disposable Kits Available Market 528,000,000$

4 Years SpineAssist Available Market CalculationTotal Capital Equipment Available Market 220,000,000$ Total SpineAssist Service Available Market 22,000,000$ SpineAssist Disposable kits Available market 2,981,260,360$

4 Years horizon SpineAssist TAM: 3,223,260,360$

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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The Competition

Stealth Station: Manufactured by Medtronic Sofamor Danek Inc.

Many more navigational platforms being developed namely

BrainLAB, which sells the VectorVision platform for orthopedic surgical navigation

CBYON, a Mountain View, Calif.-based firm that also sells visualization tools for use in spine surgery.

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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Regulations Has been issued a 510 K regulatory approval on 23rd August

2007. 510(k) Number K063607 FDA has classified Stereotactic devices as a Class II medical

device, with product code HAW and 21 CFR classification code 882.4560. Review by the General & Plastic Surgery Devices Panel.

9 performance tests were performed on the system Software Validation (IEC 60601-1-4 & FDA Guidelines) Biocompatibility Testing (ISO 10993) Osteoid Osteoma Case Study Thoracic Hover-T Case Study General Spinal Accuracy Test New Imaging and Lateral to 30 degree Accuracy Test Use of Prisms in Tranislaminar Facet Cases Study Hover-T Accuracy Test Results Report Hover-T Stability Test Results Report Vertebroplasty Summary Report

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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Medical Robotics ECE S 690 / 490Mitul Shah 11715595

Misplaced Pedicle screw Revision

Spine (Multi Level) Fixation with Pedicle

Screws

The Task

Application

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Clamping Techniques

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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Medical Robotics ECE S 690 / 490Mitul Shah 11715595

Single Level Clamping

Multi – Level Bridges

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Medical Robotics ECE S 690 / 490Mitul Shah 11715595

Rigidly Mounted to the Bony Anatomy

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Medical Robotics ECE S 690 / 490Mitul Shah 11715595

Hover-T MIS Bridge (with lateral capabilities)

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An Engineering Perspective

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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Advantages The high precision software guiding system and an

accurate computer to calculate the rotation and displacement transformations , the overall system accuracy and repeatability is less than 100 microns and 10 microns respectively.

With highly accurate and durable Faulhaber’s DC brushless smoovy® gear motors supported with custom drive electronics drive the 6 linear actuators and a miniature lead screw design the motion control accuracy is of 10 microns.

The displacement of the linear actuators is constantly measured in a feedback mechanism by 7 Lvdt’s.

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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Advantages When you take into account human influence and the

CT- and fluoroscopic-image distortion, the system accuracy in placing an implant with respect to the preoperative plan is of less than 1.5 mm.

The computerized simulations and pre-operative procedures supported by the automatic image registration has reduced the number of fluroscopy images required per operation by a factor of 3 hence less radiation exposure time .

Less pain, smaller incisions, fewer complications and a more rapid return to normal activity

The surgeon drills and places the desired implant with 2.5 times more accuracy than with freehand, and with 51 times less radiation exposure. (2)

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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Disadvantages

One has to attach a bridge to the tool for advanced entry into the spinous process as shown in the video.

The T- frame limits the range of motion for the robotic device. One cannot have multiple insertions if they are at a distance greater than the length of the T-frame.

Doctors require many hours of training before they can use the SpineAssist since they need to understand the software and pre-operative procedures in great detail before operating with the system

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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Critical Review Limited range of motion is by far the only

major drawback for this system. Consider the given system. The optimal robot position is the calculated

that aligns the robot and image coordinate frames Timage

robot is computed by matching three points, Pi

robot i =1,2,3, along the X,Y,Z axes at unit distance from the robot origin Pbase

robot with Horn’s closed-form solution. Then, the planned trajectory computed in

robot coordinates, and the closest point to the robot guide is obtained with t

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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Critical Review The L shaped tool arm attached to

the soda can type miniature robot (hexapod) does not offer any degree of freedom to the operator.

Computational and development cost may have propelled this decision but ..

One could suggest the inclusion of 2 rotational joints as circled in the picture alongside

This would definitely complicate the computation of the transformation but would lead to much a more flexible robot

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

2 rotational joints

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Critical Review

Another significant drawback of the SpineAssist is the T – frame.

With the T – frame one has to make 3 incisions to just place the foundation and then make actual operating incision

If we could develop a guide wire type of system, where the miniature robot would hover over the patient’s body. The system would be truly minimally invasive.

Medical Robotics ECE S 690 / 490Mitul Shah 11715595

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References1. Spine Assist Website

2. Research and Markets

3. SpineAssist: Miniature Robotic Guidance for Spinal Surgery Cadaveric Efficacy Study for Time, Accuracy and Radiation Exposure. Jan 2007.

4. Image-guided system with miniature robot for precise positioning and targeting in keyhole neurosurgery: L. JOSKOWICZ, R. SHAMIR, et al.

5. Hospital Buyer

6. Micro Motors Information

7. Venture Wire

8. FDA approval website

9. Medical Tourism

Medical Robotics ECE S 690 / 490Mitul Shah 11715595