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L. Heinrich Курзина И., Хейнрих Л.
Medical TechnologyМедицинская технология
- Basics, Materials, System Solutions -- основы, материалы, системные решения -
MT _WS_2008_K1+K2 1TSU_lecture 1_indroduction
Tomsk State UniversitySeptember/October 2015
L. Heinrich Курзина И., Хейнрих Л.
Preliminary scheduleпредварительный план продолжиться
6 7 lectures each of 90 minutes in the morning & afternoon• 6 … 7 lectures each of 90 minutes, in the morning & afternoon6 … 7 лекций (90 минут), утром и после полудня
• exercises to the lecturesупражнения о лекциях
• written test on the content of the lectures on Monday afternoon (October 5th)письменный тест о содержании лекций в понедельник после полудня (5 октябрь)
MT _WS_2008_K1+K2 2TSU_lecture 1_indroduction
• final and closing discussion and handing over the certifications on the successful participation in the course on Medical Technology on Tuesday morning (October 6th)финал и заключительное обсуждение и передача сертификатов успешного участия в курсе о Медицинской Технологии во вторник утром (6 октябрь)
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L. Heinrich Курзина И., Хейнрих Л.
Literature & Links
Medical technology:
• Standard literatur such as
Basic medical literature(e.g. on physiology)is highly recommended• Standard literatur such as
- overviews on modern technologiesare not available on the internationalbook market!
Reasons:- huge varieties of materials, techniques andclinical applications
- huge dynamic of technological solutionsand innovative efforts (huge competion)
is highly recommendedas supplement
MT _WS_2008_K1+K2 3TSU_lecture 1_indroduction
Useful links:www.rosminzdrav.ru/ (Министерсиво здравоохранения Руссийской Федерации),www.uspto.gov/patft/index.html (patent search at the US patent office)www.fda.gov (US Food and Drug Administration, e.g. status reports on medical devices, approvals etc.)www1.fips.ru/wps/wcm/connect/content_ru/ru/inform_resources/inform_retrieval_system/ (Russian patent office ----> search in the this data sources as “guest”)
L. Heinrich Курзина И., Хейнрих Л.
Content
presently under preparation !p y p p
MT _WS_2008_K1+K2 4TSU_lecture 1_indroduction
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L. Heinrich Курзина И., Хейнрих Л.
Medical technology in retrospective view
anesthesia equipment
MT _WS_2008_K1+K2 5TSU_lecture 1_indroduction
brain surgery
amputation of a leg
surgeoncase
L. Heinrich Курзина И., Хейнрих Л.
New materials and technologies improve healt care
artifical heart valves
imaging techniques (e.g. MRT, CT) for diagnostics
heart pace maker
minimal invasive surgery
MT _WS_2008_K1+K2 6TSU_lecture 1_indroduction
artificial heart incubators and monitoring systems using specific sensors
biomolecular analytics for diagnostics
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L. Heinrich Курзина И., Хейнрих Л.
Further examples of modern medical technology
electron linear accelerator generating X rays
implanted chip (retina implant)
navigation and computer aidedsurgery
MT _WS_2008_K1+K2 7TSU_lecture 1_indroduction
artifial heart cochlea implantat microarray for molecular biological
screenings & diagnostics
L. Heinrich Курзина И., Хейнрих Л.
World market: ca. 200 bill. US$1. Medical device market
growth: ca 5 8% per year
USA34%
EU2513%
JapanAsia10%
others36%
Regions US$ mill.
USA ca. 80.000EU27 >30.000Japan 17.300China 2.400Russia (2013) 7 600
growth: ca. 5…8% per year
MT _WS_2008_K1+K2 8TSU_lecture 1_indroduction
13%7%10%Russia (2013) 7.600
Source:The World Medical Market Fact Book 2009,EPISCOM BUSINESS INTELLIGENCE Publications,Chichester, UK
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L. Heinrich Курзина И., Хейнрих Л.
Russia
Population (2014): 143 7 mill (74% are living in urban regions)Population (2014): 143,7 mill (74% are living in urban regions)growth rate (2013): +0,02 % (РОССТАТ), -0,04% (WORLD FACTBOOK)GDP (purchase power parity): 3.565 bill US$ (2014, WORLD FACTBOOK)
(USA: 17.420 bill US$, Germany: 3.722 bill US$, EU: 18.010 US$)
Exports: 530,3 bill US$Imports: 323,9 bill US$
Expenditures for health care: 6,5% of GDP
MT _WS_2008_K1+K2 9TSU_lecture 1_indroduction
pExpenditures for education: 4,1% of GDP
Life expectancy : male: 63, female: 75 Sources:Федеральная служба государственной статистики (РОССТАТ): www.gks.ruCIA The World Factbook: www.cia.gov/library/publications/the-world-factbook/
L. Heinrich Курзина И., Хейнрих Л.
2050: 120.896.000 (-17%)2010: 143.617.000
Population structure in the Russian Federation
MT _WS_2008_K1+K2 10TSU_lecture 1_indroduction
Source: http://populationpyramid.net/russian-federation/
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L. Heinrich Курзина И., Хейнрих Л.
предсказанный рост российского рынка
Health care system and medical device market in Russia
медицинского устройства
MT _WS_2008_K1+K2 11TSU_lecture 1_indroduction
- free basic healthcare through the Mandatory Medical Insurance law,Russian healthcare system changes from a highly centralized to a decentralized one, divided on a federal, regional and municipal level. Apart from a guaranteed package of free services covered by the government, - Voluntary Medical Insurance (ДМС = Добровольное медицинское страхование )
covers additional services- out-of-pocket expenditures are rather high
L. Heinrich Курзина И., Хейнрих Л.
Russian market situation:
imported medical devices valued at USD
leading international companies
Johnson & JohnsonG l El t i4,468.5 mn in 2014
(decline is expected)
examples of Russian medical deviceCompanies (> 2.500 manufacturers):
- ЗДРАВМЕДТЕХ (www.zmt.ru/)- ЭФА group (www.efa.ru/)- ЗАО "МЕДПРОМ" (http://medprom.spb.ru/)- JSC Elamed (www elamed com)
General ElectricBaxter InternationalAbbott3MBoston ScientificBraun MelsungFresenius medicalSiemens medical
MT _WS_2008_K1+K2 12TSU_lecture 1_indroduction
- JSC Elamed (www.elamed.com)[Елатомский приборный завод]
- Яртек Медикал "Медицинские катетеры", (http://yamik.org/ru/ )
search on companies in Russia. http://medprom.ru/medpromwww.orgpage.ru/
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L. Heinrich Курзина И., Хейнрих Л.
Fragmented market (large number of small i )
Characteristics of the medical device market
companies)
Only several internationally dominant companies (also present in Russia)
No player can totally contol the market
Consolidation (=mergers of small companies)
Causes :
Technology driven high innovation activities
Different market needs, manifold core compenties and product linies
L i l/ ti l diff i
MT _WS_2008_K1+K2 13TSU_lecture 1_indroduction
(Vmarkt05 p
(=mergers of small companies)
Global growth: about 5% per year
Large regional/national differences in
- regulations (registration, permission)- financing the health care systems- national socio-economic performance
Cost pressure especially for basic medicalDevices (disposals, bandages etc)
L. Heinrich Курзина И., Хейнрих Л.
Scientific and engineering disciplines involved in medical technology
MT _WS_2008_K1+K2 14TSU_lecture 1_indroduction
• molecular biology(e.g. diagnostics)
• stem cell therapies • nanotechnologynano-medicine
• translational medicine
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L. Heinrich Курзина И., Хейнрих Л.
Typical life cycles of technologies and products
MT _WS_2008_K1+K2 15TSU_lecture 1_indroduction
Examples:ORStem: organ replacement on the base of pluripotent adult stem cellsCaidNS: computer aided navigation in surgeryRContr: remote contol of risk patients, telemetry, telematicLASIK: laser-assisted in situ keratomileusis; refractive eye surgery at corneaHeartPM: heart pace makers, also implanted defibrillators
L. Heinrich Курзина И., Хейнрих Л.
2. Rough functional classification of medical devices(1/2)
• Implants (soft ... hard; active <---> passive)p ( p )
• Drug delivery systems
• disposals such ascatheters, sensors, drainages, tubings, connectors, valves, syringes etc.
• filter and membrane systems
i l d i d t l
MT _WS_2008_K1+K2 16TSU_lecture 1_indroduction
• surgical devices and tools
• wound management systems, hygienic products
• orthopedic products, orthesis, fixatives
• diagnostic systems (e.g. microchips, biomelecular kits, PCR, DNA micro-arrays)
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L. Heinrich Курзина И., Хейнрих Л.
complexe devices and data management (2/2)• functional (electro-)diagnostic devices⇒ cardiovascular, pulmonary and neurologic measurments
• imaging systems⇒ ultra sound, endoscopy, angiography, röntgen diagnosis,
tomography (MRT, CT …); alpha-, beta- & gamma scanning techniques
• therpeutic devices⇒ artificial respiration, heart-lung machine, heart pace maker, defibrillators,
radiotherapy, infusion pumps, dialysis, oxygenators, temperature management
• patient monitoring
MT _WS_2008_K1+K2 17TSU_lecture 1_indroduction
• patient monitoring⇒ cardiovascular, respiration, cerebral and fetal
monotoring systems
• electronic data processing and management⇒ (on-line) data collecting & analysis, data networks, electronic expert systems,
telemetry, remote control (e.g. clinic and patient within home care,global patient monitoring & control systems
L. Heinrich Курзина И., Хейнрих Л.
• in Russiaregistration at Ministry of Health of Russia and certification as medical device
3. Legal requirements to market medical devices
(GOST R certification) ---> http://medexpert.ru/document/registration/61/ [valid over a period of three years]
• in the EU:only products labeled with the CE tag are permited to access the market= CE certification ! (§ 6 (1) und § 7 MPG = EU guideline 93/42/EWG)
document of conformity permits the use of the CE label fixed on the product= “passport for supply” within the EU countries
MT _WS_2008_K1+K2 18TSU_lecture 1_indroduction
• in US:certification according the FDA rules is necessary (www.fda.gov)
Supplying any medical devices in foreign countries:The national legal requirements must be fulfilled: registration + certification
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L. Heinrich Курзина И., Хейнрих Л.
3.1. Classification of medical devices according the potential risks(GOST R 51609-2000 Medical devices) = similar to EU(GOST R 51609 2000 Medical devices) similar to EU
class 1 class 2a class 2b class 3
• low risks• minal contact to skin• non-invasive• short application
Examples:
• average risks• low level ofinvasion
• timely limitedapplication (≤ 30days)
• increased risks• long time application≥ 30 Tage
• systemic effectsExamples:
anesthesia
• high degree of risks • apllications at heart,central cardiovascularsystem or centralnervous system
Examples:
MT _WS_2008_K1+K2 19TSU_lecture 1_indroduction
Examples:- surgery clothes,- bandages without
direct skin contact- some surgical
equipments
y )Examples:- Ultrasound devices
for diagnostics- short time catheters
(not near the heart)
- anesthesia machines
- PCR catheters- condoms- administration of
drugs
p- heart pace makers- invasive
contraconceptiva- stents- artificial heart
valves
L. Heinrich Курзина И., Хейнрих Л.
3.3. Safety concept for medical devices
MT _WS_2008_K1+K2 20TSU_lecture 1_indroduction
GMP = Good Manufacturing Practice (DIN EN ISO 9000 ff, Guidelines EU)GLP = Good Laboratory PracticeGCP = Good Clinical Practice (Richtlinie: 2001/20/EC)
standardization, regulations and laws are under steady changes!
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L. Heinrich Курзина И., Хейнрих Л.
4. Biomaterials, biocompatibility
rawmaterials
Upgradingto achieve
MT _WS_2008_K1+K2 21TSU_lecture 1_indroduction
Biocompatibilityis the ability of a material
to perform with an appropriate hostresponse in a specific application
(European Society for Biomaterials, 1986)
L. Heinrich Курзина И., Хейнрих Л.
Requirements of Biocompatibility
structural biocompatibilityp y• fitted design• mechanical performance• anisotropy/isotropy• structural mimicry• morphology/texture
• weight & force transfer• tribology
biofunctionalitysignal transmission in subretinal implants(Hopkins Univ.; Bio World 4/1999, p. 14)
surface biocompatibility
MT _WS_2008_K1+K2 22TSU_lecture 1_indroduction
• tribology• resistance to wear• optical & acoustic transmission• bioresistance/controlled
biodegradation
• controlled interactionwith the biological system
• hemocompatibility• minor immune response• no cell activation• no release of remaining mono-
mers or additives
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L. Heinrich Курзина И., Хейнрих Л.
5. Materials in Medical Technology
5.1. metals (+ alloys)5.2 ceramics, glass
5.3. polymers(synthetic, natural;
MT _WS_2008_K1+K2 23TSU_lecture 1_indroduction
bioresistent, biodegradable)
L. Heinrich Курзина И., Хейнрих Л.
5.1. Metallic devices (examples)
Knee, hip and shoulder prosthesis, fixation elements tostabilize fractures, stents (e.g. vascular), screws and wires( g )
Stents
MT _WS_2008_K1+K2 24TSU_lecture 1_indroduction
artificial hip jointbone plates andscrews
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L. Heinrich Курзина И., Хейнрих Л.
stainless/alloyed steel,CoCr(Mo) alloys AuAg alloys
Implantable metals
- mechanical strength- resistant against corrosion- biokompatibility- non-allergene
CoCr(Mo) alloys, AuAg alloys,cp (commercially pure) titanium and titanium alloys (e.g. TiAl6V4)
requirements:
MT _WS_2008_K1+K2 25TSU_lecture 1_indroduction
risks:- corrosion (after distroy of passive layers),pitting corrosion and stress cracking
- wear- material fatigue- loosening of prosthesis (aseptic/septic loosening)
L. Heinrich Курзина И., Хейнрих Л.
metallic materials applications (examples)
316, 316L,ll d t l
bone fixation (bone fractures)joint replacementalloyed steel joint replacementspinal implantsstentssurgical instruments/tools
titanium, mostly used as alloyssuch as TiAl4V6, TiNb13Zr13
bone and joint replacementdental implants
CoCr(MO) alloys bone and joint replacement
MT _WS_2008_K1+K2 26TSU_lecture 1_indroduction
dental implantsartifial heart valvesstents
Au alloys,Au, Pt
heart valves, middle ear implants,dental technology (e.g. crowns, inlays),sensors
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L. Heinrich Курзина И., Хейнрих Л.
Corrosion & adverse effects
Me Me n+ + n e -
O + 4 e - + 2 H O 4 OH - broken f h ftO2 + 4 e + 2 H2O 4 OH
4 H + + 4 OH - 4 H2O
caused by local electrochemical elements• between different metals• intercrystalline electrochemisty
femour shaft(hip jont implant)
• corrosion caused crack growth --> break,ibl t i ff t t i ti
MT _WS_2008_K1+K2 27TSU_lecture 1_indroduction
broken metallic fixture of a heart valve
possibly toxic effects, mutagenic reaction,or allergic effects (e.g. Ni sensivity)
• wear ---> reduced tribology, particlescause inflammation and/or osteolysis,implant loosening
• fatigue ---> break
L. Heinrich Курзина И., Хейнрих Л.
Titaniumcp Titan: unalloyed commercially pure titanium = α-titanium,
hexagonal close-packing of spheres, crystal positionsffcan be exchanged with different metals; low strength
TiAI6V4 : cubic centered crystal structur = β−titanium alloy,applied as crystalline mixed phase: „α−β−titanium“enlarged strength, improved stability against fatigue
thermaltreatment
MT _WS_2008_K1+K2 28TSU_lecture 1_indroduction
dental implant;rough texture improvesthe osseointegration(coatings with Ca apatiteare also used)
titanium implantsof individually adjusted geometry(cranial plates)
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L. Heinrich Курзина И., Хейнрих Л.
5.2. Biocompatible ceramic materials
Bioceramics:mainly Al and Zr oxides glass ceramics as artificial teeth (adjusted colors)mainly Al and Zr oxides, glass ceramics as artificial teeth (adjusted colors),Ca phosphate (Ca5(PO4)3OH = HAP) as coatingson implants or in bone repair products
MT _WS_2008_K1+K2 29TSU_lecture 1_indroduction
joint components for hip and prosthesis dental implantsmade from ZrO2
L. Heinrich Курзина И., Хейнрих Л.
Corrosion effects on ceramic materials• “baked” ceramics (treated at < 800 °C) and glass
= surface corrosion by partial dissolutiond b id d OHcaused by acids and OH-
surface destruction, increasing roughnessand pore formation ---> increasing wear
• high temperature treated ceramics ---->biologically intert of different porosities,improved fracture and crack resistance
• hydrothermally produced and high pressure-thermally
jont replacement by ceramics
MT _WS_2008_K1+K2 30TSU_lecture 1_indroduction
hydrothermally produced and high pressure thermally manufactured glass ceramics---> no pores, stronly closed ultrastrukture
chemically resistantstrong scratch resistanthigh pressure, crack and fracture resistance
glass ceramics manufacturedfor dental crowns
Risks: wear (inflammation), over-loading induced breaks (focal failures)