SPINE ASSIST
Mitul Shah 11715595Medical Robotics ECE S 690 / 490
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
The Intended Application of the System
Medical Robotics ECE S 690 / 490Mitul Shah 11715595
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
Medical Robotics ECE S 690 / 490Mitul Shah 11715595
2004199519651850
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
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
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
Architecture and Components
Medical Robotics ECE S 690 / 490Mitul Shah 11715595
Medical Robotics ECE S 690 / 490Mitul Shah 11715595
The Workstation
Miniature Robot Device
The T- Frame
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
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
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
Working Mechanism
Medical Robotics ECE S 690 / 490Mitul Shah 11715595
The Procedure
Medical Robotics ECE S 690 / 490Mitul Shah 11715595
The video can be found here
Mazor Surgical Technologies
Medical Robotics ECE S 690 / 490Mitul Shah 11715595
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
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
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
The Market
Medical Robotics ECE S 690 / 490Mitul Shah 11715595
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
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
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
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
Medical Robotics ECE S 690 / 490Mitul Shah 11715595
Misplaced Pedicle screw Revision
Spine (Multi Level) Fixation with Pedicle
Screws
The Task
Application
Clamping Techniques
Medical Robotics ECE S 690 / 490Mitul Shah 11715595
Medical Robotics ECE S 690 / 490Mitul Shah 11715595
Single Level Clamping
Multi – Level Bridges
Medical Robotics ECE S 690 / 490Mitul Shah 11715595
Rigidly Mounted to the Bony Anatomy
Medical Robotics ECE S 690 / 490Mitul Shah 11715595
Hover-T MIS Bridge (with lateral capabilities)
An Engineering Perspective
Medical Robotics ECE S 690 / 490Mitul Shah 11715595
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
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
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
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
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
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
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
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