IMAGIN.

Biomaterials Overview

Biomaterials is a sub-discipline of biomedical engineering which revolves around the study and application of various substances and materials for biomedical uses. This includes the utilization of metals and compounds to replace bones or bodily structures. As an example, the use of titanium in orthopedics was a product of biomaterial innovation.

 

Biomaterial- a biological or synthetic substance that can be introduced into body tissues as part of a medical device or used to replace an organ or bodily function. This means any creation or innovation that is used to work in conjunction with the human body. This means a drug would not be considered a biomaterial.

 

• Current innovations in Biomaterial include:

  • Stents

  • Heart Valves

  • Hip replacements

  • Bone plates

  • Scaffolding for tissue culture

  • Dissolvable Stitches

• "A biomaterial is a nonviable material used in a medical device, intended to interact with biological systems"

  • Williams, 1987

• "Biomaterials Science" is the study of materials with special reference to their interaction with the biological environment

• Subjects Integral to Biomaterial Science

  • Toxicology

    • Biomaterial should not cause any adverse responses in the host or recipients body (non-toxic)

  • Biocompatibility

    • The action or idea of a material having the ability to co-existence with human tissue without any negative responses

  • Inflammation and healing

    • When foreign bodies are present in human tissue they can cause foreign body or immunological reactions including inflammation and healing.

  • Functional Tissue Structure and Pathobiology

  • Dependence on Specific Anatomical Sites of Implantation

    • Medical devices and biomaterials are limited in terms of implantation in the human body. A prosthetic hip is limited to only being able to exist in the hip space. Intravenous Catheters are limited to only being able to be inside vessels. This means that it must not conflict with the systems or functions of surrounding tissue

  • Mechanical Requirements and Physical Performance Requirements

    • Mechanical Performance

      • Does the material have the necessary qualification to do what it is intended to do?

    • Mechanical Durability

      • Can the material withstand trauma for the period of time which it must be used?

    • Physical Properties

      • Do the physical aspects of the material support its performance in a positive way?

  • Industrial Movement

  • Risk-Benefit and Corporate Realities

    • Do the risk factors and potential risks of the material invalidate its use?

  • Ethics

    • Does the testing or creation of the material create any ethical concerns?

    • Potential Ethical Concerns:

      • Animals

        • Is the animal model relevant to human physiology?

        • Will the potential results of the data justify experimentation on animals?

      • Human Subjects

        • How should human testing be conducted in order to create the most accurate and useful data?

        • How should we best ensure informed consent?

      • Industrial Involvement

      • Researchers

        • Researchers have the most involvement and influence in the creation of the material

          • How can investigator bias be minimized?

      • Patients

        • At what point does prolonging life interfere with the quality of life?

          •  For example, a person is alive due to life support, they are alive but have poor qualities of life

        • Does the device or material support quality of life as well as supporting and relieving the needs of the patient?

      • Regulatory Agencies

        • Do government regulatory agencies have sufficient information to define adequate tests for material and devices and to properly regulate biomaterials?

• Regulation

  • Is the cost of regulation inflating the cost of healthcare and preventing improved devices from reaching those who need them?

 

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