Mitul Shah 11715595

deadmancrossingraceAI and Robotics

Nov 13, 2013 (3 years and 10 months ago)

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Mitul Shah

11715595

Medical 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 / 490

Mitul Shah

11715595

Medical Robotics ECE S 690 / 490

Mitul 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 / 490

Mitul Shah

11715595

Medical Robotics ECE S 690 / 490

Mitul Shah

11715595

2004

1995

1965

1850

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

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

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

Medical Robotics ECE S 690 / 490

Mitul Shah

11715595

Medical Robotics ECE S 690 / 490

Mitul 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 / 490

Mitul 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 / 490

Mitul 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 / 490

Mitul Shah

11715595

Medical Robotics ECE S 690 / 490

Mitul Shah

11715595

The Procedure

Medical Robotics ECE S 690 / 490

Mitul Shah

11715595


The video can be found
here

Medical Robotics ECE S 690 / 490

Mitul 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 / 490

Mitul 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 / 490

Mitul 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 / 490

Mitul Shah

11715595

The Market

Medical Robotics ECE S 690 / 490

Mitul Shah

11715595

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

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

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

Regulations


Has been issued a 510 K regulatory approval on 23
rd

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

Medical Robotics ECE S 690 / 490

Mitul Shah

11715595

Misplaced Pedicle screw

Revision

Spine (Multi Level)
Fixation with Pedicle
Screws

The Task


Medical Robotics ECE S 690 / 490

Mitul Shah

11715595

Medical Robotics ECE S 690 / 490

Mitul Shah

11715595

Single Level Clamping

Multi


Level Bridges

Medical Robotics ECE S 690 / 490

Mitul Shah

11715595

Rigidly Mounted to the Bony Anatomy

Medical Robotics ECE S 690 / 490

Mitul Shah

11715595

Hover
-
T MIS Bridge
(with lateral capabilities)


Medical Robotics ECE S 690 / 490

Mitul 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 / 490

Mitul 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 / 490

Mitul 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 / 490

Mitul 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
T
image

robot

is computed by matching
three points,
P
i
robot


i

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

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

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

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

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