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ARTIFICIAL ORGAN AND PROSTHESIS-any instrument, apparatus, appliance, software, material o, Summaries of Organic Chemistry

ARTIFICIAL ORGAN AND PROSTHESIS- any instrument, apparatus, appliance, software, material or another article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for: • diagnosis, prevention, monitoring, treatment or alleviation of disease, • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, • Investigation, replacement or modification of the anatomy or a physiological process, • Control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means; Devices that interact with the body directly, i.e. have an interface with the biological environment A biomaterial is a systemical

Typology: Summaries

2022/2023

Uploaded on 08/15/2023

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Introduction
Artificial Organs and Prosthesis
08/03/2021
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Introduction

Artificial Organs and Prosthesis 08/03/

Medical Device

2 some definitions… According to Article 1 of Council Directive 93/42/EEC ‘medical device’ means: any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment , alleviation of or compensation for an injury or handicap,
  • investigation, replacement or modification of the anatomy or of a physiological process,
  • control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

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Biomaterials

Few definitions

A biomaterial is a systemically, pharmacologically inert substance designed for implantation within or incorporation with a living system. Annual International Biomaterials Symposium 1974 Any substance (other than a drug) or combination of substances, synthetic or natural in origin, which can be used for any period of time, as a whole or as a part of a system which treats , augments or replaces any tissue, organ or function of the body. Consensus Development Conference on the Clinical Applications of Biomaterials 1982 Non-living substance, used in the manufacture of a medical device that has interfaces with a living tissue. European Society of Biomaterials 1986 A biomaterial is any substance that has been engineered to interact with biological systems for a medical purpose - either a therapeutic (treat, augment, repair or replace a tissue function of the body) or a diagnostic one Definitions in Biomaterials, Proceedings of a Consensus Conference of the European Society for Biomaterials 2004

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Biomaterials

Some historical examples

  • 1829 : H.S. Levert studies canine responses to implanted metals
  • 1886 : German doctor H. Hansmann is the first surgeon to use metal plates
for internal fixation
  • 1931 : Boston surgeon Smith Peterson develops a metal cup for partial hip
implants
  • 1939 – 1945 : WWII spurs the development of many new materials and
orthopaedic surgical techniques
  • Up until ~1950, mostly metals were used because very few plastics existed
  • 1947 : first paper on polyethylene as a synthetic implant material
  • 1949 : paper published about plastics “sweating out” additives, resulting in
a strong (negative) biological reaction
  • Cellophane, Lucite and nylon

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  • After WWII, materials that had been rationed were now available and surgeons did not collaborate with scientists or engineers
  • Surgeon hero – dentists/doctors would invent devices “on the fly” when patients’ lives or functionality were at stake by using materials “ off-the-shelf
  • Also, minimal government/regulatory activity was ongoing at this time:
    • Prior to 1938, Cosmetics and medical devices were overseen by the Post Office Department and Federal Trade Commission
    • The FDA took over in 1938 Dealt with increasing medical device “quackery” and the proliferation of medical technologies after WWII
  • The advancements in recent decades, enabled by increasingly better laboratory technologies (e.g., fluorescence microscopy), is the understanding of biocompatibility on a cellular and molecular level
    • Definitions vary, but biocompatibility can be described as the capacity of a material or device to not induce toxic or injurious effects on biological systems (i.e., to subvert the wound healing response mentioned earlier)
    • Before 1950, this lack of understanding translated to a very low implant success rate due to rejection by the immune system

Biomaterials

Some historical examples

Biomaterial-host interaction

In many circumstances, materials properties do not affect cell behaviour directly, but rather the adsorption of proteins present in the environment

  • hydrophylicity/hydrophobicity
  • surface roughness/topography
  • charge