Transcript Document

Making of new sapphire hip endoprosthesis.
From science to business
on October, 10 – 12, 2006
Kiev
Doctor of medicine Vladimir Tankut
Tel.: 8 (057) 704-14-66
E-mail: [email protected]
Sytenko Institute of Spine and Joint
Pathology
Ukrainian Academy of Medical
Sciences
Kharkov
1
What is needed in the market?
The creation of biologically inactive, wear-proof,
inexpensive pair of friction in the hinge of
endoprosthesis of joint hip is topical.
Prevention of high concentrations formation of tension
and increasing of operating reliability are the advantages
of the offered construction.
2
Brief technology description.
The technology of endoprosthesis creation is
based on the synthesis of scaffolding with
following “raising” of sapphire crystal in
laboratory conditions and it’s processing in
order to create the spheres into hinge of
artificial joint.
3
Stage of development.
Development
types of hip
endoprosthesis
with sapphirechirulene pair of
friction are
created, their
preclinical
appraisal was
performed with
positive results.
4
In two years after operation
Who needs it & how many will they need?
The necessity in
new working-out is
very high. Patients
with I1I-IV grade
of hip arthrosis
require operations
of hip replacement.
The amount of
these operations is
equal to 50 000 in
Ukraine annually,
whereas about 1
million
in
the
whole world per
year.
400 000
400 000
350 000
300 000
250 000
250 000
200 000
150 000
120 000
100 000
50 000
50 000
0
USA
Europe
Canada
Ukraine
It is annually executed
operations of hip replacement
5
What is my unique technology
advantage?
The complete process of product
manufacturing (from the raw mining to the
outlet of end product) is set up; there are
customers for its forth putting.
6
Competitive matrix.
The cheapness (comparing with existing analogues),
overstability and durability of material (sapphire),
low coefficient of friction, biochemical inactivity
and biocompatibility with human organism.
7
How will I beat the competition?
Plainness, cheapness, originality of
endoprosthesis manufacturing.
Opportunity for joint work.
The work requires the participation of
technologists and medical staff, for further
improvement of endoprosthesiss workingout and their clinical appraisal.
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Proprietary information statement
• The technology material presented in this talk is
available for licensing or joint product development.
• None of the slides contain any confidential or
proprietary information which would prevent patenting
the technology.
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Problem Description & Market Need
66
Hip arthrosis is a severe
chronic
progressive
disease of hip joint,
which leads to severe
disability in 70-80 %
cases. The incidence of
this disease among
working population has
increased on 40-60 %
for the last 20 years.
70
60
50
%
40
30
18
20
10
0
1986
2006
year
Dynamics of increase of coxarthrosis
10
Problem Description & Market Need
Hip replacement is an
effective and progressive
method for the treatment of
coxarthrosis. The pairs of
friction in the hinge knot are
imperfect in the existing
constructions
of
endoprosthesiss, which lead
to severe complication in
25% cases 10-12 years after
joint
replacement
and
require repeated revision
operations.
100
90
80
70
60
% 50
40
30
20
10
0
97
82
73
54
50
45
15
0
0
5
10
15
years after the operation
complication results of operation
Long-Term Clinical 11
Results Arthroplasty of the Hip
Problem Description & Market Need
The destruction of polymer in the knot of endoprosthesis friction
factor of destruction
Total wear-out
of Teflon socket after 3 years
J.Charnley
“Low Friction Arthroplasty of the Hip” 1979.
Total wear-out
of Chirulen socket after 3 years
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Sytenko institute of spine and joint pathology
2003
Brief technology description
Advantages
On a level with the highest world standards the new
technologies of the production of pure furnace charge for the
growing of crystals, optimal technologies for the processing of
spheres and acetabulum of artificial joint made from sapphire, for
the production of friction pair with minimal coefficient of friction in
hinge will be worked out.
New unique design of hip endoprosthesis using sapphiresapphire friction pair in hinge will be worked out and the technique
of operation will be improved.
New pathogeneticaly grounded approach to the carrying out of
clinical roentgenological and laboratory investigation of patients
with hip pathology will be worked out: new criteria for the updating
of indications for operation and rehabilitation period will be
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designed.
Experimental results
The change of coefficient friction for
different connections of materials
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Stage of development (clinical tests if medical) and
international patents
Pre-productions models of hip endoprosthesiss with
sapphire head and acetabulum are manufactured,
pre-clinical trials are carried out.
Clinical approbation of endoprosthesis with sapphire
head was carried out on 5 patients, 5 years follow-up
after first operation, the results are good. There 4
Declarative Patents of Ukraine, no international
patents.
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Targeted Market Segment
Patients with coxarthrosis of III-1V grade require
hip replacement. Among these people are
middle aged and able to work citizens who has
the pathology of hip due to its disease or injury.
About 15 000 of hip replacement are performed
in Ukraine per year, and about 1million all over
the world. The price of our endoprosthesis
construction is about 1 000 Euro, whereas
existent construction – 1500 - 2500 Euro.
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Competition
Our
competitors
are
firms
that
produce
endoprosthesis (1 in Ukraine and about 30 all over
the world). On the background of great experience
in sapphire production, carrying out about 5 000
operations of primary and repeated joint
replacement
using
different
design
of
endoprosthesiss (including 5 with a sapphire head),
presence of experienced highly qualified specialists
we will work out an endoprosthesis with sapphire
friction pair, that will be cheaper, more safety, solid
and unsophisticated in manufacture in comparison
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with the analogues existing nowadays.
Competitive Matrix
Sytenko Institute of
Spine and Joint
Pathology
Ukrainian Academy of
Medical Sciences
Kharkov
DePuy
USA
Zimmer
USA
Endurance
Saphire/saphire
0,02% per year
Metal/polymer
2% per year
Metal/polymer
2-3% per year
Coefficient of
friction
Saphire/saphire
0,001
Metal/polymer
0,058
Ceramics/polymer
0,080
Biocompatibility
Absolute
Cost (euro)
1000
Important
product or
technology
characteristics
Incomplete from formation of toxic
particles of friction of materials
1800-3000
1500-2500
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Opportunities
The necessity to create a modern hightechnology
manufacture
of
hip
endoprosthesis with new design and
sapphire friction pair in hinge.
Carrying out of the design of endoprosthesis
in order to get the European and world level.
Approximate cost of project is equal
to 300 – 400 thousands Euro.
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Contact information
Doctor of medicine Vladimir
Tankut
Tel.: 8 (057) 704-14-66
Mob. Tel.: +38(066) 112-45-79
E-mail: [email protected]
Sytenko Institute
of Spine and Joint Pathology
Ukrainian Academy of Medical
Sciences
Kharkov
new sapphire
hip endoprosthesis
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