Seminar Report
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Medical Plastics :
Materials, Applications And Processing
For Medical Devices And
Pharmaceuticals Industries |
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MEDICAL PLASTICS : PRECLINICAL
EVALUATION
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Muraleedharan C V
Division of Artifical Organs, Biomedical
Technology Wing
Sree Chitra Tirunal Institute for Medical Sciences & Technology
Thiruvananthapuram - 695012, INDIA |
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Introduction
Shri Murlidharan C V did his B. Tech in
Electrical Engineering and M. Tech in Control System & Instrumentation
University of Bombay form REC, Calicut in 1983 & 1987 respectively.
He has worked as a Lecturer in Dept. of
Electrical Engg., Rec Calicut from 1984 to 1985. In 1985 he joined
SCTIMST and since then working in BMT Wing. He is having more than 18
years of research experience in medical device development covering
design, evaluation, pilot production and technology transfer.
Associated with the following product development/ applied research
activities at SCTIMST.
He has received 3 awards 1. ISTE -
L&T National Award, ISTE, New Delhi -1997, 2. FIE Foundation Award
for Development of Chitra Heart Valve, 1995 3. NRDC Award‑94
from NRDC, New Delhi for development of Chitra Heart Valve, 1994. He has more than
18 Journals Articles and 12 Conference Proceedings and holds 6 Indian,
1
USA & 1 European patents.
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Programme |
Role (s) |
Project Status |
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Heart Valve Prosthesis
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Process Development, Product
Evaluation, Pilot Production |
In commercial production since 1994 by
M/s. TTK Healthcare Ltd, Chennai |
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Humidifier |
Product Design, Process Development,
Product Evaluation |
Technology Transferred to M/s.
Peninsula Polymers, Thiruvananthapuram |
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Hydrocephalus Shunt System |
Product Design, Process Development,
Product Evaluation |
In commercial production since 1993 by
M/s. Hindustan Latex Limited, Thiruvananthapuram |
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Prosthetic Vascular Graft |
Process Standardization, Product
Evaluation |
Multicentric clinical evaluation and
technology transfer in progress |
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Membrane Oxygenate |
Product Design, Design Validation,
Product Evaluation |
Undergoing Multicentric Clinical
Evaluation |
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Evaluation of DLC for Biomedical
Applications |
Engineering Evaluation , Application
Development |
Completed |
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Implementation of Quality System (ISO
17025) |
Calibration and setting up of
calibration cell |
Accredited by COFRAC, France, 2003
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Agenda
- Polymers in medical devices
- Biocompatibility & Biomaterials
- Material Responses
- Test Methods
- Standards - ISO 10993
- Selection of tests
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Indian Scenario
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SCTIMST
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Testing services
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How to approach
Biocompatibility
The ability of a material to perform with an appropriate hoist response in a specific situation
- Host response : The local and systemic response, other than the intended therapeutic response, of living systems to the material
- Material response : The response of the material to living system
Biomaterials
A nonviable material used in a medical device, intended to interact with the biological system.
- Metals and alloys
- Ceramics
- Polymers
- Composites
Classes of Biomaterials
- Inert Biomaterials: Implantable materials that elicit little or no host response
- Interactive Biomaterials : Implantable materials designed to elicit specific, beneficial responses, such as tissue in growth, adhesion etc
- Viable Biomaterials : Implantable materials, incorporating or attracting live cells at implantation, that are treated by the host as normal tissue matrices and are actively resorbed or remodeled
- Replant Biomaterials : Implantable materials consisting of native tissue, cultured in vitro from cells obtained previously from specific patient.
Polymers as Biomaterials
- Polymers are attractive in medical applications because of their
- Wide range in properties
- Ease of manufacturing
- Low cost
- Polymers used in medical applications falls into the category of interactive biomaterials
- Both host response as well as material response need to be taken into consideration while selecting a polymer material for a specific application
Material Responses
- Swelling and leaching
- Corrosion and dissolution
- Friction and wear
- Deformation and failure
- Effect of surface morphology
- Effect of degradation products
ISO 10993 - Philosophy
- Testing shall be performed on the final product / material
- The selection of tests shall take the end use into consideration
- If extracts are used for testing, the extraction vehicle should be appropriate to the nature of exposure
- Positive and negative controls shall be used where ever applicable
ISO 10993 - Selection of tests
The choice of the test procedure shall take into account
- The nature, degree, duration, frequency and conditions of exposure to the device
- The chemical and physical nature of the final product
- The toxicological activity of the chemical elements / compounds in the formulation of the final product
- The relationship of the device surface area to the recipient's body size
- Existing information based on the literature / experience
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