Spine Assist

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  • The history of the Spine operations. Back in the mid 1800’s we had the surgeons cutting the back wide open and then evaluating the extend of surgery required as there was no pre-operative planning tools available.
    Moving to the late 1900’s pre-operative procedure tools were made available and surgeries were less painful and more accurate.
    Coming to this decade, with the Spine Assist the spine surgeries are more effective and minimally invasive.
  • The workstation is the brains for the miniature robot housing the imaging software for pre-operative surgical planning, the trajectory planning and execution for the miniature robot.
  • The video in this slide can be found at
    This video explains the step by step the use of the Spine-Assist in the spinal surgery.
  • The companies and products described are not real competitors for Spine Assist, but are the nearest competitors. Spine Assist is like having a cab service to get from point A to B, while the other products are like having a GPS to get from A to B.
  • The Table shows the average recovery time spent by individuals with spinal surgeries. The other images are some applications of the Spine Assist.
  • Spine Assist

    1. 1. Mitul Shah 11715595Medical Robotics ECE S 690 / 490
    2. 2. 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 / 490 Mitul Shah 11715595
    3. 3. Medical Robotics ECE S 690 / 490 Mitul Shah 11715595
    4. 4. 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 / 490 Mitul Shah 11715595
    5. 5. Medical Robotics ECE S 690 / 490 Mitul Shah 11715595 2004199519651850
    6. 6. 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 / 490 Mitul Shah 11715595
    7. 7. 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 / 490 Mitul Shah 11715595
    8. 8. 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 / 490 Mitul Shah 11715595
    9. 9. Medical Robotics ECE S 690 / 490 Mitul Shah 11715595
    10. 10. Medical Robotics ECE S 690 / 490 Mitul Shah 11715595 The Workstation Miniature Robot Device The T- Frame
    11. 11. 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 / 490 Mitul Shah 11715595
    12. 12. 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 / 490 Mitul Shah 11715595
    13. 13. 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 / 490 Mitul Shah 11715595
    14. 14. Medical Robotics ECE S 690 / 490 Mitul Shah 11715595
    15. 15. The Procedure Medical Robotics ECE S 690 / 490 Mitul Shah 11715595  The video can be found here
    16. 16. Medical Robotics ECE S 690 / 490 Mitul Shah 11715595
    17. 17. 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 / 490 Mitul Shah 11715595
    18. 18. 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 / 490 Mitul Shah 11715595
    19. 19. 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 / 490 Mitul Shah 11715595
    20. 20. The Market Medical Robotics ECE S 690 / 490 Mitul Shah 11715595
    21. 21. Over 150 cases have been preformed with the SpineAssist between Jan – Jun 06 Helios – Germany LA: UCLA CCDH USMD – Dallas HSS – New York Naval Medical Center – Virginia Cleveland Clinic – Cleveland Israel: Tel hashomer Hadassah Korea – all hospitals Medical Robotics ECE S 690 / 490 Mitul Shah 11715595
    22. 22. Total Available Market Analysis 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 Market Total 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 Calculation Total 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 / 490 Mitul Shah 11715595
    23. 23. 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 / 490 Mitul Shah 11715595
    24. 24. 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 / 490 Mitul Shah 11715595
    25. 25. Medical Robotics ECE S 690 / 490 Mitul Shah 11715595 Misplaced Pedicle screw Revision Spine (Multi Level) Fixation with Pedicle Screws The Task
    26. 26. Medical Robotics ECE S 690 / 490 Mitul Shah 11715595
    27. 27. Medical Robotics ECE S 690 / 490 Mitul Shah 11715595 Single Level Clamping Multi – Level Bridges
    28. 28. Medical Robotics ECE S 690 / 490 Mitul Shah 11715595 Rigidly Mounted to the Bony Anatomy
    29. 29. Medical Robotics ECE S 690 / 490 Mitul Shah 11715595 Hover-T MIS Bridge (with lateral capabilities)
    30. 30. Medical Robotics ECE S 690 / 490 Mitul Shah 11715595
    31. 31. 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 / 490 Mitul Shah 11715595
    32. 32. 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 / 490 Mitul Shah 11715595
    33. 33. 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 / 490 Mitul Shah 11715595
    34. 34. 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 / 490 Mitul Shah 11715595
    35. 35. 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 / 490 Mitul Shah 11715595 2 rotational joints
    36. 36. 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 / 490 Mitul Shah 11715595
    37. 37. References 1. 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 / 490 Mitul Shah 11715595

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