Materials for Medical Application

638 Pages·2020·11.815 MB·English

by  Robert B. Heimann (ed.)

RobertB.Heimann(Ed.)
MaterialsforMedicalApplication
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Materials for
Medical
Application
Edited by Robert B. Heimann
Editor
Prof.em.Dr.RobertB.Heimann
AmStadtpark2A
D-02826Görlitz,Germany
[email protected]
ISBN978-3-11-061919-5
e-ISBN(PDF)978-3-11-061924-9
e-ISBN(EPUB)978-3-11-061931-7
LibraryofCongressControlNumber:2020934825
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Preface
During the past several decades, research into biomaterials has emerged as a hot
topicamongmaterialscientistsandmedicalresearchersalike.Virtually10,000sof
papersonmoreorlessnovelorimprovedbiomaterialsandbiomedicaldevicescan
now be found in relevant scientific journals, textbooks, the patent literature, and
ontheInternet.Attemptingtotreatthisvastfieldofcurrentendeavorinanencyclo-
pedic fashion is clearly impossible as new contributions are being published daily
withever-increasingspeedandregularity.Hence,tryingtokeepabreastwiththese
developmentsisakintoshootingataveryfastmovingtarget.Thebestonecando
istoprovidesnapshotsofcurrentlyavailablesalientinformationpertainingtobio-
materials and biomedical devices and attempt to chart a course of their future de-
velopment.Forthose readerswho desire todelve moredeeplyinto thefinedetails
of biomaterials science, many comprehensive specialist accounts are available. A
collection of recent treatises on biomaterials science and bioengineering can be
foundinthereferencesection.
To say it clearly: it is not our intention to compete with these excellent and
comprehensive texts. This would indeed be a tough act to follow. So, why do we
write another text on biomaterials science? What is so special about it and which
aspects does it cover that are not adequately treated or even missing in previous
accounts?Manytextbooksonbiomaterialsandbiomedicaldevicesaremerecollec-
tionsofreviewsthatappeardisjointed,andthus,donotconveyfullappreciationof
thehighlyinterdisciplinarynatureofthesubjectmatterowingtotheirlackofcohe-
sion.Astheyfrequentlydwellonspecialcases,theydonotallowacomprehensive
view atthe wholecomplex and variegatedlandscape of biomaterial science. Other
accountsaremerelycollatedresultsofconferencepresentationsandsymposiapro-
ceedings that lack substance since they frequently discuss isolated peculiarities of
the research portfolio of the authors involved, and thus, fail to convey the bigger
picture.
Whatarewestartingwith,then?Werealizethatmanymetallic,ceramic,poly-
meric, and composite materials today are being used successfully in the clinical
practice to alleviate many health-related problems. A very substantial part of this
effortrelatestoimplantsdesignedtorepaircongenitaldefects,replacediseasedor
missing body parts, or attempt to restore lost body functions. These applications
rangefromartificialdentalroots,toalveolarridge,iliaccrestandcheekaugmenta-
tion, to spinal implants, to scaffolds for tissue engineering, and to restorative hip
and knee endoprostheses to repair the compromised ambulatory knee–hip kine-
matic. Applications also include bone replacement parts in cranial and maxillary-
mandibularareas,ocularimplants,theossicularchainoftheinnerear,periodontal
pocket obliteration, osteosynthetic musculoskeletal fixation devices for improved
bone healing, heart pacemakers, and cardiovascular stents to prevent occlusion
andstenosisofbloodvessels.Muchresearchisbeingperformedondrugandgene
https://doi.org/10.1515/9783110619249-202
VI Preface
deliveryvehiclestofindnontoxic,biocompatible,nonimmunogenic,biodegradable
materialcombinationsthatavoidrecognitionbythehost’sdefensemechanismsby
targetingtheverylocusofdiseaseratherthanprovidingasystemictherapy.Inad-
dition,increasinglyapplicationsemergethatusebiomaterialsinthemedicaldevice
industryas diverseas percutaneousaccessdevices, intramedullarynails andbone
screws, antibacterial coatings for surgical instruments and clinical equipment, as
well as medical textiles. In the future, the so-called fourth-generation biomaterials
basedonintegratingelectronicsystemswiththehumanbodyarepoisedtomanipu-
late and monitor cellular bioelectrical responses for tissue regeneration aimed to
communicatingwiththehosttissue.
In the preface of Brian Love’s 2017 book on Biomaterials: A Systems Approach
toEngineeringConcepts,heoutlinedsuccinctlytheproblemsatextonbiomaterials
facesasfollows:“Manybelievethatitisimpossibletowriteabookrelatingtomate-
rials used in medicine. There are several reasons for this dilemma. Books that em-
phasize the materials’ concepts are founded on volumetric replacement and
biological response and less on a mechanical or other analysis of the design envi-
ronment .. . Other monographs that are focused on tissue engineering are also
hardtogauge,becausethereissomuchdetailneededtodefineascaffoldstructure,
optimize the culturing environment, identify an implantation protocol, test in ap-
propriateanimalmodels,toestablishwhenandhowtoassay,andtoconfirmasuc-
cessfuloutcome. ..Theclinicalbooksarealsofocusedmorecloselyontheaspects
ofbiocompatibilityandthesubtletiesassociatedwithmaterials,compositionalvar-
iations,or/andendmechanicalfunctionaresometimeslacking.”
Indeed,theseareseriousaspectstoconsider.However,inspiteofthosewarn-
ings,theauthorsofthisbookhaveendeavoredtotakeupthechallengetoaddtheir
own account on biomaterials to the existing literature by attempting to discuss is-
suesofsignificanceofthehistory,structure,andmechanical,chemical,andbiolog-
ical behavior of materials used in medical applications, and their interaction with
living tissue by reviewing clinical applications in joint replacement, bone grafts,
dentistry, and tissue engineering. Information has been appended on existing and
emerging markets including sales forecasts as well as standard specifications and
regulatory affairs of biomaterials and biomedical devices that underscore the im-
portant economic aspect of today’s health-related research and development. This
forayintotheworldofeconomicsaddsaunique viewpointthatismissinginmost
competing texts available today. Finally, a host of future developments and chal-
lengeshavebeenoutlinedthatneedtobeaddressedintheyearstocome.Suchde-
velopments range from biomimetically designed drug and gene delivery vehicles,
bioinspired computers based on DNA, biosensors, and hybrid inorganic/organic
nanocomposites to 3D-printed scaffolds for regenerative medicine to novel biode-
gradablemetals,bioceramicsandcarbonmaterialstosurface-activebioglassesand
hydrogels,andtothenewclassoffourth-generationbiomaterialsbasedonintegrat-
ing electronic systems with the human body to provide powerful diagnostic and
Preface VII
therapeutic tools for basic research and clinical use. Salient aspects of the role of
artificialintelligenceinthefieldofresearchanddevelopmentofnovelbiomaterials
andbiomedicaldeviceshavebeenbrieflyoutlined.
Alas, this textbook is not designed to satisfy the curiosity of the specialist by
disseminatingveryspecificinformationbut,instead,attemptstoprovideabasicac-
count on the present state of biomaterials for students of materials science and
medicineaswellasyoungprofessionalsofbothdisjointeddisciplinesatthebegin-
ningoftheircareer.Hence,thetextispredominantlyaimedtothosestudentswho
maywanttoinformthemselvesquicklyonthegeneralsubjectofbiomaterials,their
properties, synthesis and preparation technologies, analytical characterization, in
vitro and in vivo behavior as well as clinical uses, and standardization and regula-
tory affairs. The authors are hopeful that their treatise will provide information
soughtbythosestudentswithoutrequiringthemtodelveintotheabyssofspecialized
literaturethatthreatenstooverwhelmeventhemostpatientreader.Consequently,stu-
dentsmaybenefitfromourconciseandcondensedapproachinasmuchasitwillre-
lieve them from plowing through piles of original papers scattered over scores of
scientificjournals.Further,wehopethatreaderstrainedintherealmsofmedicaland
biological sciences will appreciate the materials science aspects of biomaterials
whereas those educated and trained in materials science may find the rather chal-
lengingmedicalcontentofthebookenlighteninganduseful.Weholditevidentthat
our potential audience in their perception of the biomaterials’ world is akin to the
much quoted Snowian concept of the “two cultures,” here of materials science and
themedicalprofession.Satisfyingtheexpectationsoftheseverydiversegroupsisin-
trinsically difficult. Should we have failed here and there in this endeavor, we are
beggingthegentlereaderforpardon.
RobertB.Heimann,editor
Görlitz,Germany

Contents
Preface V
Contributingauthors XIV
ListofAbbreviations XVII
Chapter1 Biomaterials–characteristics,history,applications 1
RobertB.Heimann
1.1 Biomaterialsandtheconceptofbiocompatibility 2
1.1.1 Roleofbiomaterials 2
1.1.2 Auniverseofbiomaterials 2
1.1.3 Hybridnanocomposites 5
1.1.4 Fourgenerationsofbiomaterials 8
1.1.5 Biocompatibility 9
1.1.6 Osseointegration 12
1.1.7 Medicaldevicesandmedicalequipment:definitions 16
1.1.8 Bioinspiredmaterials 17
1.2 Abriefhistoryofbiomaterials 18
1.2.1 Metallicbiomaterials 19
1.2.2 Ceramics 28
1.2.3 Polymers 38
1.3 Selectedtypesandapplicationsofmedicaldevices 47
1.3.1 Externallywornbiomimeticdevices 49
1.3.2 Implantabledeviceswithphysicalreplacementfunction 50
1.3.3 Mechanicallyactivedevices 53
1.3.4 Biologicallyinteractingdevices 60
1.3.5 Electricallyactivedevices 62
1.3.6 Drugandgenedeliveryvehicles 69
1.3.7 Three-dimensional-printedscaffoldsfortissueengineering 72
Chapter2 Typesandpropertiesofbiomaterials 75
RobertB.Heimann,MitsuoNiinomi,MatthiasSchnabelrauch
2.1 Metals(RobertB.Heimann,MitsuoNiinomi) 75
2.1.1 Corrosion-resistantmetals 75
2.1.2 Biodegradablemetals 124
2.2 Ceramics(RobertB.Heimann) 132
2.2.1 Bioinert/biotolerantceramics 133
2.2.2 Bioactiveceramics 165
2.3 Polymers(MatthiasSchnabelrauch) 212
2.3.1 Introduction 212
X Contents
2.3.2 Classificationofpolymers 213
2.3.3 Molecularstructure 213
2.3.4 Molecularmassandmolecularmassdistribution 215
2.3.5 Solidstateofpolymers 216
2.3.6 Thermalandmechanicalbehavior 217
2.3.7 Biostabilityandbiodegradability 218
2.3.8 Naturalpolymers 222
2.3.9 Syntheticpolymers 236
Chapter3 Synthesisandprocesstechnologyofbiomaterials 251
RobertB.Heimann,MitsuoNiinomi,MatthiasSchnabelrauch
3.1 Metals(RobertB.Heimann,MitsuoNiinomi) 251
3.1.1 Stainlesssteels 251
3.1.2 CoCralloys 254
3.1.3 Titaniumandtitaniumalloys 257
3.1.4 Magnesium 283
3.2 Ceramics(RobertB.Heimann) 291
3.2.1 Generalpropertiesofadvancedceramics 291
3.2.2 Manufacturingofceramicpowdersandtheirconsolidation 293
3.2.3 Sintering 294
3.2.4 Alumina 298
3.2.5 Zirconia 304
3.2.6 Carbon 310
3.2.7 Calciumphosphates 312
3.2.8 Bioglasses 334
3.3 Polymers(MatthiasSchnabelrauch) 337
3.3.1 Generalsynthesisprinciplesforpolymers 337
3.3.2 Polymerprocessing 342
3.4 Surfacefunctionalization(RobertB.Heimann) 359
3.4.1 Physicalfunctionalization 360
3.4.2 Chemicalfunctionalization 360
3.4.3 Biologicalfunctionalization 362
3.4.4 Radiativefunctionalization 365
Chapter4 Invitroandinvivoperformanceofbiomaterialsandbiomedical
devices 369
ChristineKnabe,DoaaAdel-Khattab,ChristianMüller-Mai,Barbara
Nebe,MichaelSchlosser,RobertB.Heimann,Hans-JürgenKock
4.1 Biologicalperformanceofbiomaterialsandbiomedicaldevices
(ChristineKnabe,DoaaAdel-Khattab,ChristianMüller-Mai) 369
4.1.1 Principlesofhowtotestnewbiomaterialsandmedicaldevices 369
4.1.2 Tissueandhostresponseandclassificationofbiomaterials 371