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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5361_Библиотеки_им_академика_М_И_Перельмана.pdf
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- •Aim and Scope
- •Preface
- •Acknowledgments
- •Contents
- •Contributors
- •About the Editors
- •1.1 Introduction
- •1.2.1 Friction
- •1.2.1.3 Friction Under Lubricated Conditions
- •1.7.1 Joint Tribology
- •1.7.2 Skin Tribology
- •1.7.3 Oral Tribology
- •1.8 Summary
- •References
- •2.1 Introduction
- •2.3.1 Fluid Pressurization/Fluid-Film Lubrication
- •2.3.2 Boundary Lubrication
- •2.3.3 Hydrodynamic Lubrication
- •2.3.4 Squeeze-Film Lubrication
- •2.3.5 Synovial Fluid
- •2.3.6 Hydration Lubrication
- •2.5.2 Scaffolds
- •2.5.3 Synthetic Polymer
- •2.5.4 Polyacrylamide
- •2.5.5 PEG Hydrogel
- •2.5.6 PVA Hydrogel
- •2.5.7 Double Network Hydrogel
- •2.5.8 Triple Network Hydrogel
- •2.6.1 Polyacrylamide
- •2.6.2 PEG Hydrogel
- •2.6.3 PVA Hydrogel
- •2.6.4 Double Network Hydrogel
- •2.6.5 Triple Network Hydrogel
- •2.7.1 Mechanical Properties
- •2.7.2 Structural Properties
- •2.8 Conclusion
- •References
- •3.1 Introduction
- •3.3.1 Label-Based Biosensors
- •3.3.2 Label-Free Biosensors
- •3.4 Different Nanobiosensing Techniques
- •3.4.1 Optical Sensing
- •3.4.2 Electrochemical/Electrical Sensing
- •3.4.3 Magnetic Sensing
- •3.4.4 Mass-Based Sensing
- •3.6.2 Neurodegenerative Diseases
- •3.6.3 Infectious Diseases
- •3.6.4 Metabolic Diseases
- •References
- •4.1 Introduction
- •4.2.1 Surface Functionalization
- •4.2.2 Bioconjugation
- •4.3 Synthesis Approach
- •4.3.1 Hydrothermal Method
- •4.3.2 Chemical Vapor Deposition (CVD)
- •4.3.3 Wet Chemical Method
- •4.4 Plasmonic Black Bodies (PBBs)
- •4.4.1 Gold NP (AuNPs)-Based PBB
- •4.4.2 Silver NPs (Ag NPs)-Based PBB
- •4.4.3 Platinum NPs (Pt NPs)-Based PBB
- •4.5 Biomimetic NP
- •4.6 Upconverting NP (UCNP)
- •4.6.1 Synthesis
- •4.7 Inorganic NP
- •4.7.1 Synthesis
- •4.8 Photothermal Therapy (PTT)
- •4.9 Conclusion
- •References
- •5.1 Introduction
- •5.2 Human Skin
- •5.10 Future Scope
- •5.11 Conclusion
- •References
- •6.1 Introduction
- •6.1.1 Class 1
- •6.1.2 Class 2
- •6.1.3 Class 3
- •6.4.1.1 Surface Patterning
- •6.4.1.2 Direct-Write Patterning
- •6.4.1.5 Dip-Pen Nanotechnology
- •6.4.1.7 Composing Using Beams
- •6.4.1.8 Direct Write Photolithography (DWP)
- •6.4.1.9 Light-Beam Lithography Electron
- •6.4.1.10 Focused Ion Beam Lithography
- •6.4.2 Fabrication Techniques
- •6.4.2.4 Non-invasive Glucose Monitoring Devices Technique
- •6.4.2.6 Cost-Effective Electrochemical Voltametric Sensors Techniques
- •6.4.2.7 Three-Dimensional (3D) Printing Techniques
- •6.4.2.8 UV-LED Stereolithography Printer Technique
- •6.4.2.9 4D Printing Techniques
- •6.4.2.10 Advanced Biomedical Techniques Involving Biorobots
- •References
- •7.1 Introduction
- •7.6 Mechanical Biocompatibility Challenges
- •7.7 Poor Bio-Printing Resolution
- •7.9 Limited Biomaterial Selection
- •7.11 Conclusion
- •8.2 Animal Tribology
- •8.2.1 Joint
- •8.2.3 Integumentary Change
- •References
- •8.1 Introduction
- •8.3.1 Nanotribology
- •8.4 Green Tribology
- •8.5 Conclusion
- •References
- •9.1 Introduction
- •9.2 Bio-Tribological Issues
- •9.3.2 Bone Fracture Fixation
- •9.3.4 Cardiovascular Devices
- •9.3.5 Minimal Invasive Surgical Devices
- •References
- •10.1 Introduction
- •10.2.2.1 Structural Integrity
- •10.2.2.2 Controlled Release Properties
- •10.2.2.3 Enhanced Drug Loading Capacity
- •10.2.2.4 Tailored Material Properties
- •10.2.3.1 Biocompatibility
- •10.2.3.3 Mechanical Properties
- •10.2.3.4 Drug Compatibility
- •10.2.3.5 Fabrication Compatibility
- •10.3.1 Matrix Material Properties
- •10.3.4 Biocompatibility Assessment
- •10.3.4.1 In Vitro Cell Culture Studies
- •10.3.4.2 Hemocompatibility Studies
- •10.3.4.3 In Vivo Animal Studies
- •10.3.4.4 Histological Analysis
- •10.3.4.5 Immune Response Evaluation
- •10.3.4.6 Biodegradation Assessment
- •10.4 Surface Engineering Considerations
- •10.4.2.1 Surface Coatings
- •10.4.2.2 Plasma Treatment
- •10.4.2.3 Surface Grafting
- •10.4.2.4 Dip Coating
- •10.4.2.5 Spray Coating System
- •10.4.2.6 Electrotreated Coating
- •10.4.2.9 Microfabrication Techniques
- •10.4.2.10 Surface Roughness Control
- •10.5.1.2 Mechanical Properties
- •10.5.1.3 Surface Characteristics
- •10.5.1.4 Release Kinetics Analysis
- •10.5.1.5 Biological Compatibility
- •10.5.1.7 Other Analyses
- •10.6 Advanced Fabrication Techniques
- •10.8 Conclusion
- •References
- •11.1 Introduction
- •11.2 Shape Memory Alloys (SMA)
- •11.3 Shape Memory Polymers
- •11.3.1 Heat
- •11.3.2 Light
- •11.3.3 Magnetic Field
- •11.4 Shape-Changing Hydrogels
- •11.5 Biomedical Applications
- •11.6 Conclusion
- •References
- •12.1 Introduction
- •12.3 Bioresorbable Orthopedic Implants
- •12.4.1 Polylactides
- •12.4.2 Poly (Ortho Esters)
- •12.4.3 Polyphosphoesters
- •12.4.4 Polyphosphazenes
- •12.4.5 Polycaprolactone
- •12.4.6 Polyurethanes
- •12.4.7 Polycarbonates
- •12.5.1 Compression Molding
- •12.5.2 Transfer Molding
- •12.5.3 Injection Molding
- •12.5.4 Extrusion
- •12.5.5 Blow Molding
- •12.5.6 Calendering Process
- •12.5.7 Fiber Spinning
- •12.5.8 Thermoforming
- •12.5.9 Polymer Foaming
- •12.7 Challenges
- •12.8 Conclusion
- •References
- •13.1 Introduction
- •13.3.1.1 Total Hip Replacement (THR)
- •13.3.2 Resurfacing Hip Replacement (RHR)
- •13.5.1 Adhesive Wear
- •13.5.2 Abrasive Wear
- •13.5.3 Fatigue Wear
- •13.5.4 Corrosion/Oxidative Wear
- •13.5.5 Surface Cracking
- •13.6.1 Metallic Implants
- •13.6.1.1 Stainless Steel
- •13.6.1.2 Co-Cr Alloys
- •13.6.1.3 Ti-Alloy
- •13.6.2 Ceramic Implants
- •13.6.3 Polymer Implants
- •13.6.4 Composite Implants
- •13.6.5.2 Surface Coatings
- •13.7.2.1 Hydrodynamic Lubrication
- •13.7.2.2 Boundary Lubrication
- •13.7.2.3 Elastohydrodynamic Lubrication
- •13.7.3 Biomimetic Lubrication Approaches
- •13.7.3.1 Replicating Natural Lubrication Mechanisms
- •13.7.4.1 Implant Wear
- •13.7.4.3 Synovial Fluid Degradation
- •13.8.1 Hydroxyapatite Coatings
- •13.8.1.1 Bone Integration
- •13.8.1.2 Implant Stability
- •13.8.1.4 Biocompatibility
- •13.8.2 Diamond-Like Carbon Coatings
- •13.8.3 Metal Nitride Coatings
- •13.8.4 Polymeric Coatings
- •13.8.5 Nanocomposite Coatings
- •13.9.1 Pin-on-Disk Testing
- •13.9.2 Hip Joint Simulators
- •13.9.3 Knee Joint Simulators
- •13.9.4 Tribo-Corrosion Testing
- •13.9.5 Wear Debris Analysis Techniques
- •13.9.5.1 Scanning Electron Microscopy (SEM)
- •13.9.5.2 Energy-Dispersive X-Ray Spectroscopy (EDS)
- •13.10.1.1 Tailored Geometries
- •13.10.1.2 Improved Wear Characteristics
- •13.10.1.3 Accelerated Innovation
- •13.10.2.1 Real-Time Wear Monitoring
- •13.10.2.2 Functionality Assessment
- •13.10.2.3 Implant Status Monitoring
- •13.10.2.4 Patient-Centric Healthcare
- •13.10.3.1 Advanced Biomaterials
- •13.10.3.4 Multidisciplinary Approaches
- •13.10.4.1 Wear Data Analysis
- •13.10.4.2 Predictive Wear Patterns
- •13.10.4.3 Early Intervention Strategies
- •13.10.4.4 Personalized Treatment Plans
- •13.11 Conclusion
- •References
- •14.1 Introduction
- •14.2.1 Powder Bed Fusion (PBF)
- •14.2.2 Directed Energy Deposition
- •14.3.1 Extrusion-Based AM
- •14.5 Biomanufacturing
- •14.5.1 Tissue Engineering
- •14.5.2 Organ-on-a-Chip Models
- •14.6 Conclusion
- •References
- •Index

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A. Pal et al.
5.11 Conclusion
The topic of human skin interface behaviour is extensively researched in both industry and academia due to its signicance for the functional performance of many
items. People with varying age groups, genders, ethnicities, and skin types have
diverse skin qualities. Furthermore, the features of the skin vary based on the part of
the body and can be affected by lifestyle choices and body mass index. Even though
the skin’s primary function is to act as a barrier, some substances can nevertheless
be absorbed. A large portion of the underlying fundamental physical mechanisms
are still unknown due to the complexity of skin interactions. Gaining more insight
into skin tribology will require targeted, in-depth experimental studies.
References
1. Adams, M.J., Briscoe, B.J., & Johnson, S.A. (2007). Friction and lubrication of human skin.
Tribology letters, 26, 239–253.
2. Boer, M., Duchnik, E., Maleszka, R., & Marchlewicz, M. (2016). Structural and biophysical
characteristics of human skin in maintaining proper epidermal barrier function. Advances in
Dermatology and Allergology/Postępy Dermatologii i Alergologii, 33(1), 1–5.
3. Bragazzi, N.L., Sellami, M., Salem, I., Conic, R., Kimak, M., Pigatto, P.D. M., & Damiani,
G. (2019). Fasting and its impact on skin anatomy, physiology, and physiopathology: A comprehensive review of the literature. Nutrients, 11(2), 249.
4. Chen, C.Y., Yu, C.A., Hong, T.F., Chung, Y.L., & Li, W.L. (2015). Contact and frictional
properties of stratum corneum of human skin. Biosurface and Biotribology, 1(1), 62–70.
5. Czichos, H., Klaffke, D., Santner, E., & Woydt, M. (1995). Advances in tribology: the materials point of view. Wear, 190(2), 155–161.
6. D’Souza, B., Kasar, A.K., Jones, J., Skeete, A., Rader, L., Kumar, P., & Menezes, P.L. (2022).
A brief review on factors affecting the tribological interaction between human skin and different textile materials. Materials, 15(6), 2184.
7. Dąbrowska, A.K., Spano, F., Derler, S., Adlhart, C., Spencer, N.D., & Rossi, R.M. (2018).
The relationship between skin function, barrier properties, and body-dependent factors. Skin
Research and Technology, 24(2), 165–174.
8. Darden, M.A., & Schwartz, C.J. (2009). Investigation of skin tribology and its effects on the
tactile attributes of polymer fabrics. Wear, 267(5–8), 1289–1294.
9. DeBois, I. J., Agarwal, E., Kapoor, A., & Mathur, K. (2022). Tribology of the sock-skin
Interface–the inuence of different fabric parameters on sock friction. Journal of Foot and
Ankle Research, 15(1), 1–11.
10. Derler, S., & Gerhardt, L.C. (2012). Tribology of skin: review and analysis of experimental
results for the friction coefcient of human skin. Tribology Letters, 45, 1–27.
11. Derler, S., Rossi, R.M., & Rotaru, G.M. (2015). Understanding the variation of friction coefcients of human skin as a function of skin hydration and interfacial water lms. Proceedings
of the Institution of Mechanical Engineers, Part J: Journal of Engineering Tribology, 229(3),
285–293.
12. Gitis, N., & Sivamani, R. (2004). Tribometrology of skin. Tribology Transactions, 47(4), 461.
13. Graça, A., Runo, I., Martins, A. M., Raposo, S., Ribeiro, H. M., & Marto, J. (2023).
Prevention of skin lesions caused by the use of protective face masks by an innovative gelatinbased hydrogel patch: Design and invitro studies. International Journal of Pharmaceutics,
638, 122941.

5 Tribological Measurements ofHuman Skin
14. Greenaway, R.E. (2010). Psychorheology of skin cream (Doctoral dissertation, University of
Nottingham).
15. Hendriks, C.P., & Franklin, S.E. (2010a). Inuence of surface roughness, material and climate conditions on the friction of human skin. Tribology Letters, 37, 361–373.
16. Hendriks, C.P., & Franklin, S.E. (2010b). Inuence of surface roughness, material and climate conditions on the friction of human skin. Tribology Letters, 37, 361–373.
17. Hoath, S.B., & Leahy, D.G. (2003). The organization of human epidermis: functional epidermal units and phi proportionality. Journal of Investigative Dermatology, 121(6), 1440–1446.
18. Kalra, A., Lowe, A., & Al-Jumaily, A.M. (2016). Mechanical behaviour of skin: a review.
J.Mater. Sci. Eng, 5(4), 1000254.
19. MacFarlane, M.J., & Theobald, P. (2021). Skin tribology in sport. Biosurface and Biotribology,
7(3), 113–118.
20. Masen, M.A., Veijgen, N., & Klaassen, M. (2019). Experimental tribology of human skin.
Skin Biophysics: From Experimental Characterization to Advanced Modeling, 281–295.
21. Meng, Y., Xu, J., Jin, Z., Prakash, B., & Hu, Y. (2020). A review of recent advances in tribology. Friction, 8, 221–300.
22. Meng, Y., Xu, J., Ma, L., Jin, Z., Prakash, B., Ma, T., & Wang, W. (2022). A review of advances
in tribology in 2020–2021. Friction, 10(10), 1443–1595.
23. Mohammadpour, M., Johns-Rahnejat, P. M., Rahnejat, H., & Gohar, R. (2014). Boundary
conditions for elastohydrodynamics of circular point contacts. Tribology Letters, 53, 107–118.
24. Sivamani, R.K., & Maibach, H.I. (2006). Tribology of skin. Proceedings of the Institution of
Mechanical Engineers, Part J: Journal of Engineering Tribology, 220(8), 729–737.
25. Thieulin, C., Pailler-Mattei, C., Abdouni, A., Djaghloul, M., & Zahouani, H. (2020). Mechanical
and topographical anisotropy for human skin: Ageing effect. journal of the mechanical behav-
ior of biomedical materials, 103, 103551.
26. Tudor, A., Călin, A., Stoica, N., & Subhi, K. (2023). The stick-slip phenomenon occurring
between human skin and other surfaces. Journal of Research & Innovation for Sustainable
Society (JRISS), 5(1).
27. Van Kuilenburg, J., Masen, M.A., & Van Der Heide, E. (2013). Contact modelling of human
skin: What value to use for the modulus of elasticity?. Proceedings of the institution of
mechanical engineers, Part J: Journal of Engineering Tribology, 227(4), 349–361.
28. Xiao, H., Ariyasinghe, N., He, X., & Liang, H. (2014). Tribological evaluation of porcine skin.
Colloids and Surfaces B: Biointerfaces, 116, 734–738.
29. Xu, F., & Lu, T. (2011). Introduction to skin biothermomechanics and thermal pain (Vol. 21).
NewYork: Science Press.
30. Zahouani, H., Boyer, G., Pailler-Mattei, C., Tkaya, M.B., & Vargiolu, R. (2011). Effect of
human ageing on skin rheology and tribology. Wear, 271(9–10), 2364–2369.
31. Zhang, S. (2018a). Modelling non-uniform deformation of human skin in multi-asperity contact. Microsystem Technologies, 24(8), 3381–3388.
32. Zhang, S. (2018b). Modelling non-uniform deformation of human skin in multi-asperity contact. Microsystem Technologies, 24(8), 3381–3388.
33. Zhou, X., Masen, M.A., Mo, J., Shi, X., He, Y., & Jin, Z. (2023). Investigation of Experimental
Devices for Finger Active and Passive Tactile Friction Analysis. Chinese Journal of Mechanical
Engineering, 36(1), 38.
34. Zhou, Z.R., & Jin, Z.M. (2015). Biotribology: recent progresses and future perspectives.
Biosurface and biotribology, 1(1), 3–24.
165

Chapter 6
Tribological Hurdles inBiomedical
Manufacturing: AComprehensive
Examination
AvinashKumar , PradiptaGajjar, KavithaSharanappaGudadur,
AbhishekKumar , AshishKumarGupta , AmitChoudhari ,
NusratChowdhury , andAshwaniKumar
Abstract Manufacturing of biomedical device involves in-depth understanding of
tribology and biology, biotribology. The word “tribology,” comes from ancient
Greek. In this chapter, the focus is on challenges and future scopes of biotribology
in the eld of biomedical devices. Some of the problems while designing a
A. Kumar (*)
Indian Institute of Information Technology Design & Manufacturing (IIITDM),
Kancheepuram, Chennai, Tamil Nadu, India
Department of Mechanical Engineering, Stanford University, Stanford, CA, USA
e-mail: avikr@iiitdm.ac.in
P. Gajjar · K. S. Gudadur
Indian Institute of Information Technology Design & Manufacturing (IIITDM),
Kancheepuram, Chennai, Tamil Nadu, India
A. Kumar
J.Mike Walker ’66 Department of Mechanical Engineering, Texas A&M University,
College Station, TX, USA
Department of Mechanical Engineering, University of California, Merced, CA, USA
e-mail: akumar71@tamu.edu
A. K. Gupta
School of Mechanical and Aerospace Engineering, Oklahoma State University,
Stillwater, OK, USA
e-mail: ashish.gupta10@okstate.edu
A. Choudhari
Mechanical Engineering Department, Cleveland State University, Cleveland, OH, USA
e-mail: a.choudhari@vikes.csuohio.edu
N. Chowdhury
University of Illinois Urbana-Champaign, Urbana, IL, USA
e-mail: nusratc2@illinois.edu
A. Kumar
Department of Mechanical Engineering, Technical Education Department Uttar Pradesh
(under Government of Uttar Pradesh), Kanpur, Uttar Pradesh, India
A. Kumar etal. (eds.), Applications of Biotribology in Biomedical Systems,
https://doi.org/10.1007/978-3-031-58327-8_6
167© The Author(s), under exclusive license to Springer Nature Switzerland AG 2024

168
A. Kumar etal.
biomedical device involve making the device nano, large-scale production of the
device, inconsistency of quality of the device, use of chips in human organs(brain),
high- cost manufacturing, mechanical biocompatibility, poor bioprinting mechanism, cell damage rate(high), the device user’s ability, etc. Here the discussion is
about how to target each one of them with highly advanced techniques like using
combination of 3D and 4D printing techniques, biomedical gadgets which incorporate gecko’s skin, bionic ears/eyes, biosensors, and microgels, biorobots, shark skin
properties, biomimetic watery oil applications, lotus leaf surface, creepy crawly
silk, and catsh skin bodily uid, they are highly advance application and still lacking in understanding of their organic working and strategy of manufacture. Human
factors engineering (HFE), role of voltametric sensors, internet of things (IoT) in
healthcare, and binder jetting-based 3D printing also have contribution to biomedical device’s future. Using software like Autodock, Discovery studio, and Pyrx will
help inrecognizing the material (protein or ligand) in silico. Italso helps in estimatingthe interaction that is taking place,such as bond types (protein-ligand interaction proler)and their negative delta G prediction in nature (mimicking). Hence,
minimizing theuncertainty of desired results. To target these future scopes variousadvanced techniqueshas been discussed in this chapter. The most commonly
usedtechniques arebiocompatible lm technology, cost-effective techniques for
CKD biodevice, non-invasive glucose monitoring devices technique, biosensing
device techniques involving volumetric glucose sensors, optical or spectroscopy
techniques for other detection purposes, cost-effective electrochemical voltametric
sensors techniques, non-invasive glucose monitoring devices technique, threedimensional (3D) printing techniques, ultraviolet light-emitting diode (UV-LED)
stereolithography printer technique, four-dimensional (4D) printing techniques,
fabrication(techniques) of hollow self-folding 4D vascular tubes having shape
memory by direct-ink-writing (DIW) printing techniques, technique for directwrite printing (DWP) of a vascular 4D scaffold by shape memory nanocomposites
(SMNCs: Iron oxide (Fe3O4)), shape memory polymers (SMPs: PLA ink), and
advanced biomedical techniques involving biorobots.
Keywords Biomedical devices · Tribology · Biofabrication · Biomedical systems
· Manufacturing technologies
6.1 Introduction
In biomedical systems with intriguing designs, biomechanics, biomaterials, bioinstrumentation, and framework scienceplay important role in developing a building
block and integration of various parts of system. These biomedical system design

6 Tribological Hurdles inBiomedical Manufacturing: AComprehensive Examination
169
have a widespread usethat varies from designing and creating prosthetics and articial organs to creating biomaterials for the delivery of medications. Scientic
models are used to improve healthcare systems, and machine learning is used to
advance microscopy and restorative imaging. Medical devices include any tool,
equipment, apparatus, implant, or invitro reagent that isn’t a medication used for
human or animal diagnostic or therapeutic purposes, according to the Food and
Drug Administration (FDA) of the United States (US). On the other hand, any tool,
apparatus, machine, appliance, or other item that the manufacturer has invented to
be used for biomedical purposes and whose main function is not accomplished by
means of metabolic, immunological, or pharmacological means is classied as a
medical device by the World Health Organization (WHO) [1]. In the US, the FDA
is in charge of regulating the security and effectiveness of medical equipment.
Medical device regulation, both before and after they are put on sale in the US, is
primarily the responsibility of the FDA’s Centre for Devices and Radiological
Health (CDRH). In terms of regulatory regulation, Class I, II, and III are the higher
classications of medical equipment. The device categorization regulations set forth
the legal requirements for a wide range of devices. Class II devices must have premarket notice, Class III devices must have premarket approval (PMA), while the
majority of Class I devices are exempt from FDA notication. Humanitarian Use
Devices (HUDs) are marketed for a certain demographic under a totally separate
approach known as Humanitarian Device Exemptions (HDEs). CDRH evaluates the
majority of medical devices in compliance with premarket notication [2]. In biomedical system any device, appliance, machine, implant, invitro reagent or calibrator, software, material, or other similar or related article that the manufacturer
intends to be used, either alone or in combination.one or more of the specic purposes of disease prevention, diagnosis, treatment, monitoring, or harm reduction.It
also helps to achieve investigation, replacement, alteration, or support of the anatomy or a physiological process; life support or control; or sterilization of medical
equipment; or providing data for medical or diagnostic purposes through invitro
examination of human specimens [1]. Figure6.1 explains the classication in owchart. Figure6.1 simplies the imagination of sub-classication of all the medical
devices according to FDA.
6.1.1 Class 1
Technologies classied as class I apparatuses don’t raise the risk of absurd patient
injury or disease. Class I devices (lowest risk) are subject to general controls, which
are generally accepted guidelines for labeling, manufacturing, post-market surveillance, and reporting. Devices are classied as class I when there is a reasonable
certainty that general controls alone will be sufcient to guarantee safety and efcacy [3]. 95% of medical devices are exempt from regulation under the FDA’s

170
Fig. 6.1 US FDA medical device classication
A. Kumar etal.
classication standards found in 21 CFR (Code of Federal Regulations), which
apply to about 47% of devices [1]. As an illustration, consider surgical sponges,
reusable scalpels, masks for surgery, bandages, wraps, oxygen masks, tongue
depressors, exam gowns, hospital beds, and electric toothbrushes [1, 4, 5].
6.1.2 Class 2
Medium-risk devices belong to a single class, unlike the medical device regulation
of the European Union, that are subdivided into Class IIa (medium-risk devices) and
Class IIb (medium-to-higher-risk devices) [6]. Examples of common items used in
medical procedures include surgical masks, wheelchairs, catheters, surgical drapes,
blood pressure cuffs, blood transfusion kits, magnetic resonance imaging (MRI)
machines, contact lenses, pregnancy test kits, electrocardiogram (ECG) monitors,
diagnostic endoscopes, and colonoscopes [1, 4, 7].

6 Tribological Hurdles inBiomedical Manufacturing: AComprehensive Examination
Table 6.1 Classication of biomedical devices
Classication Examples
Class 1 Hospital beds, exam gowns, reusable surgical scalpels, surgical bed and masks,
tongue depressors, bandages, crutches, electric toothbrushes wraps, oxygen
masks, scissors
Class 2
(A and B)
Class 3 Wearable automated external debrillators, silicone implants, bone and
Contact lenses, hypodermic needles, blood pressure cuffs; pregnancy test kits;
ECG monitors, diagnostic endoscopes, blood bags, colonoscopes, and syringes;
surgical drapes; catheters; surgical masks; X-ray and MRI machines; blood
transfusion kits; and so on
implants, implanted prostheses, implanted pacemakers, implanted heart valves,
and high-frequency ventilators
171
6.1.3 Class 3
Several general and particular controls are applied to the most dangerous equipment
in order to ensure their efcacy and safety. Ten percent of the medical gadgets under
FDA regulation fall into this group. Body orice, surgically invasive, and implanted
entities make up the bulk of these device groups, all of which are intrusive. Class III
devices need to go through premarket approval (PMA) and other required processes
before they may get a license. Examples include silicone implants, implanted pacemakers, wearable automated external debrillators, implanted prostheses, bone and
hip implants, and high-frequency ventilators [1, 8]. A summary of each class’s
examples may be found in Table6.1.
6.2 Types ofBiomedical Devices
It is a broad-spectrum eld that includes regenerative medicine and biomaterials;
systems and engineered biology; neuro sensory and rehab designing; and sensors,
nano/microsystems, and instrumentation. Courses cover embryonic development
principle and tissue building, numerical modeling in cell and molecular biology,
natural and restorative imaging, omic innovations, biomechanics and rehabilitation
designing, physiological control systems, and computational biology. These systems can be divided further, biomedical systems for arthropathy, biomedical systems for dermatology, buccal cavity, human and animal organ system, and
therapeutics (cancer and immunotherapy). Tables 6.2 and 6.3 have information
about different types of biomedical devices, while Fig.6.2 explains the types of
biomedical systems (Fig.6.3).

172
A. Kumar etal.
Pain, swelling, and
redness can all result
from surgical methods.
Bruising at the surgical
site is also a possibility
implants are composed
of plastic, ceramic,
metal, or other materials,
others are made of skin,
bone, or other bodily
tissues
Human organs While the majority of
Automatically applies
medication by heating
tiny needles that are
soaked into the skin
The interval between
tissue and blood glucose
levels
Tears, saliva, sweat,
mucus in the
airways, or the
subcutaneous tissue’s
Skin piercing
To create a voltametric
interstitial uid
Biouids include
O
2
glucose sensor that is
bearable, Cu
nano-clusters were used
as the touchy fabric and
drop cast on the nest
part of the working
anode
interstitial uid,
saliva, tears, and
perspiration
Biomedical
Table 6.2 Types of medical devices with their mode of action, location they are used in, requirements for the devices and tribology involved with them [9–15]
If a medical device is inserted
entirely or partially into the human
body after surgery or other
restorative procedures and is
expected to stay there indenitely,
then it is considered implantable
(ETT), urine catheters
(UC), central venous
catheters (CVC), breast,
craniofacial, and dental,
cochlear implants,
metal-on-metal bone and
hip implants, etc.
system Type of device used Mode of action Location of device Requirements Tribology
Invasive device Endotracheal tubes
A non-invasive gadget is any
symptomatic device or gadget that
does not incorporate the opening of
the skin into the body
An SVM classication
algorithm and a pulse
radar sensor comprise the
Vascular Wall motion
Non-invasive
device
Make strides the consolation level
of patients, particularly those
inuenced with diabetes and in
some cases incessant wounds.
(VWM) monitoring
system
Biosensors, biochemical
markers, non-invasive
electronic skin patch,
skin chip
Biosensing
device
Evaluate genuine-time interstitial
liquid glucose levels; in any case,
they don’t do this without
depending on skin piercing, rely on
optical or spectroscopy strategies

6 Tribological Hurdles inBiomedical Manufacturing: AComprehensive Examination
nanoparticles
4
O
Biomimicking
implants with
characteristics akin to
those of real bone
Metal 3D-printing
strategy empowers the
fabricating of
biomimicking to embed
gadgets with comparative
properties compared to
Application of
craniofacial embeds
tailored to each
patient for the
replication of the
cranium and
normal bone,
3D-printing advances too
incorporate coordinate-
type in strategies such as
inkjet printing with
skeleton, facial
titanium bone, hip
and mandibular
prostheses, and a
platform for tissue
distinctive bio- materials
engineering,
implants, external
prostheses, and
3
Form memory-4D,
Fe
that allowed for
nanoparticles, an
4
O
3
Fe
UV-LED
stereolithography printer
automation
remotely controlled
and structure-
magnetically directed
behavior were on
display for biomedical
devices
173
Fabric is put consecutively in a
layer-by-layer design to construct
The osteofab craniofacial
patient-specic stability
Biomedical
system Type of device used Mode of action Location of device Requirements Tribology
3D-printed
bio-medical
the utilitarian 3D objects, strategy
gives adaptability in terms of
customized patient-specic
gadgets, plan opportunity, and
complex inner structures
device, the DENTCA
three-dimensionally
printed polymer dentures,
the TirboLOX-L titanium
lumbar cages for spinal
stabilization, and the
trachea-bronchial splint
(TBS)
device
development
4D printing is the ability to
transform 3D things instantly off
the print bed from one shape to
another. Therapeutic devices can
benet from a range of thermo-
mechanical qualities that can be
engineered into shape memory
thermosets
−1
Tracheal stents, vascular
regeneration and stents,
4D printing of stent
vascular graft devices,
and magnetic eld-
triggered 4D stents are
examples of materials
with a mol. wt of
10,000gol
4D printing of
biomedical
devices

174
A. Kumar etal.
[15–20]
Skull and face skeleton reconstruction,
tissue engineering, scaffolding
Targeted areas for device
implementation Application References
Joints (mimicking cartilage-
bone to bone joints), elbows,
hips, spine
[1]
perspiration and automatically delivers
Skin epidermis, middle layer Detection of too much glucose in
[1, 20]
medication by heating tiny needles that
are absorbed into the skin
biosensor to identify chronic uropathy,
and the possibility of continuously and
accurately measuring biochemical
indicators in biouids such as sweat, tears,
Dental cavities, saliva Salivary conductivity is employed as a
saliva, and interstitial uid has been
produced
[2, 21–24]
Such as retinal prostheses that are
implanted in the human eye, has been
created to access ow failure in
arteriovenous stulas (AVF), identifying
chronic kidney disease (CKD), spine
stabilization made by captiva spine,
vascular regeneration, 4D-printed
constructions, because these materials’
tubular structure may be readily achieved
by 4D rolling or stretching, self-expanding
biocompatible polymer stents
Trachea, ureter, veins,
arteries, vascular walls,
heart, spine, stula, kidney
manufactured by 4D printing for
minimally invasive heart valve
replacement
Direct write techniques including inkjet
printing with various biomaterials,
metal 3D printing, titanium hip and
mandibular prosthesis, 3D printing
technologies
An electronic skin patch, osteofab
craniofacial patient-specic stability
device
Biomedical system Device and system
Biomedical systems for
Table 6.3 Types of biomedical systems, the devices included in them with their system
arthropathy
Biomedical systems for
dermatology
Biosensors. Chronic uropathy,
DENTCA three-dimensionally printed
polymer dentures
Biomedical systems for
buccal cavity
Silicon chip covers that are bioinert or
biocompatible, urine catheters (UC),
central venous catheters (CVC), and
endotracheal tubes (ETT). A support
vector machine (SVM) classication
Biomedical systems for
human and animal organ
system
algorithm and a pulse radar sensor
make up this non-invasive vascular wall
motion (VWM) monitoring device.
Affordable biosensor, magnetic
eld-triggered 4D stent, TirboLOX-L
titanium lumbar cages, 4D-printed
vascular stents, and 4D-printed heart
valves
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