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    Bioactive Polymers

    INTRODUCTION

    Bioactive polymer made of synthetic or artificial polymers

    substituted with specific chemical functional groups carried by the

    macromolecular chain are designed to develop specific interactions with living

    systems.

    When a polymeric material is exposed to a biological environment,

    there is a natural tendency to induce different reactions such as blood coagulation,

    complement activation and cell interactions.

    Polymer scientists have synthesized a large number of polymers andhave evaluate their behavior when they are in contact with biomolecules, viruses,

    bacteria, body fluids, cells and whole organisms.

    Bioactive polymers are used to repair, restore or replace damaged or

    diseased tissue or to interface with the physiological environment.

    They are basically three main types of polymers used in a biological

    environment.

    Polymer used as bio materials, e.g. in organ replacement and bone surgery.

    Polymers serve as matrices in devices that permit control release of an

    active substance over along period of time.

    Soluble polymers: synthetic polymers that themselves display biological

    activities.

    Uses of bioactive polymers:

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    Bioactive Polymers

    Bioactive polymers in medicines and surgery are currently widely

    used and include intracorporeal, paracorporeal and extracorporeal (inside,

    interfacing or outside the body, respectively) Applications are given below:

    Intracorporeal Materials

    Temporary devices:

    Surgical dressings

    Sutures

    Adhesives

    Polymeric intermedulary nails

    Polymer - fiber composite bone plates

    Simple semipermanent devices:

    Tendons

    Reinforcing meshes

    Heart valves

    Joint reconstruction & bone cement

    Tubular devices

    Soft-tissue replacement materials for cosmetic reconstruction

    Drug delivery implants.

    Complex devices simulating physiological processes:

    Artificial kidney/Blood dialysis

    Artificial lung/Blood oxygenator

    Artificial pancreas/Insulin delivery system

    Artificial heart

    According to a soon-to-be-released updated report from Business

    Communications Company, Inc. the U.S. biocompatible materials market is

    C.O.E.& T., Akola 2

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    Bioactive Polymers

    estimated at $8.2 billion in sales at the manufacturer's sales level in 2003.

    Fueled by greater demand from the aging population and the relatively

    short medical device product life cycles (as compared to other medical

    products) this market is forecast to grow at a 7.7% AAGR (average annualgrowth rate) through 2008 reaching nearly $1.9 billion.

    The biocompatible materials market is a niche market comprised of

    polymers, metals, advanced ceramics, natural materials, pyrolytic carbon,

    composites and coatings. The industry requires superior grade materials in

    relatively small volumes when compared to the volume of these materials

    consumed in other industries.

    PVC accounts for 80% of polymer consumption; other polymers commonly

    consumed are silicone, polyurethane, polycarbonates, polyester and

    polyethylene. Emerging polymer applications include biodegradable

    polymers, bioactive polymers (polypeptides), hydrogels, molecular

    imprinted polymers, conductive polymers and biopolymers. Many of these

    are being applied to meshes, foams, sponges or hydrogels to stimulate

    tissue growth.

    MARKET DATA

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    Bioactive Polymers

    U.S. Market Size for Biocompatible Materials in Medical Devices,

    through 2008 ($ Millions)

    Materials 2003 2008AAGR %

    2003-2008

    Polymer 7,200 10,500 7.8Metals 162.5 212.8 5.5

    Other materials * 834.5 1,178.4 7.1

    Total 8,197.0 11,891.2 7.7

    Medical Device market using

    biocompatible materials38,000.0 57,380.0 8.6

    * Includes advanced ceramics, natural materials, pyrolytic carbon, natural materials,

    companies and coatings. Source: BCC, Inc.

    U.S. Market Size for Biocompatible Materials

    in Medical Devices, through 2008

    ($ Millions)

    C.O.E.& T., Akola 4

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    Bioactive Polymers

    FEATURES OF BIOACTIVE POLYMERS

    Some of important properties should be required for bioactive polymers are as

    follows.

    Biocompatibility.

    Mechanical, Physical and Chemical Properties.

    Purity.

    Fabrication.

    Stability.

    Tolerability.

    Sterilizability.

    Foreign body reaction.

    Biocompatibility:

    Acceptance of an artificial important by the surrounding tissue and by the

    body as a whole.

    Physical, Chemical & Mechanical Properties:

    These must be capable with the proposed and for eg.. in the design of

    heart , the flexing characteristics of the polymer have often been overlooked.

    Polymer Purity :

    Industrial reins are highly variable in nature from manufacture to

    manufacturer. A variety of other materials incidental to the polymer process such

    as residual initiators, initiator fragments, solvents, plasticizers, trapped free

    radicals, inhibitors, lubricants, heat sand light stabilizers, fillers, parting agents,

    anti oxidants, degradation products, curing agents, residual monomers and allow

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    Bioactive Polymers

    molecular weight oligomers may be present. There may be variations in the

    molecular weight and in the mol. Wt. distribution, as well linkages and branching.

    Ease of fabrication:

    The desired device should be capable of fabrication without damages in

    properties, surface characteristics, crystallinity, surface oxidation, or

    contamination by processing aids such as oils, solvents or like that.

    Stability:

    Bioactive polymers should not be adversely affected by the normal

    physiological environment. No biodegradation that could compromise function

    over the short or long term should occur, and no process should release toxic to the

    environment.

    Tolerability:

    Bioactive polymers should not exhibit toxic or irritant qualities, or elicit

    adverse physiological responses locally or systemically. Toxicity can also be

    affected by the rate of release of the substance and the biological processing and

    removal of the substance.

    Sterilizability:

    The physical, chemical, mechanical and biochemical characteristics of the

    device or material must not undergo any change during sterilization. This is often

    not as easy as it may seem. Light, heat, radiation, or chemical treatment may be

    used during this process.

    Foreign body reaction:

    The polymer should cause only minimal, if any, foreign body interaction,inflammation, encapsulation or cell change response in the surrounding tissue. It

    also should not cause tissue or other reaction rmote from the site of implantation

    and should be free of response.

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    Bioactive Polymers

    Materials used as bioactive polymers

    The following materials using as bioactive polymers.

    PEUUs [Poly(ether urhane urea )s]

    Silicons

    TFE polymers

    PVC

    Polyolefins

    Polycarbonate

    PMMA

    Polyesters

    Cellulose

    Polyvinyl alcohol

    Epoxy resins

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    Bioactive Polymers

    Comparison with Other Materials

    PROPERTIES Glass Metal plastics

    Flexibility Poor Poor Excellent

    Clarity Excellent Poor Good

    Design Versatility poor poor Excellent

    Barrier Properties Excellent Excellent Good

    Chemical Resistance

    Excellent Poor Good

    Saleability Poor Good Excellent

    Performance weight/vol.

    Ratio

    Poor Poor Excellent

    Cost/ Performance

    RatioPoor Poor Excellent

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    Bioactive Polymers

    Application of bioactive polymer

    Application of bioactive polymers in artificial heart.

    Numerous polymeric systems have been explored for use in cardiovascular

    systems. For example the materials used in artificial heart studies include

    Polyvinyl Chloride (PVC), silicone rubber (silatic), Polyurethane, Biomer and

    polyolefin rubber. However among polyurethanes the most promising materials

    appear to be some of the polyether urethane ureas.

    Yourheart is the engine inside your body that keeps everything running. Basically,

    the heart is a muscular pump that maintains oxygen andblood circulation through

    your lungs and body. In a day, your heart pumps about 2,000 gallons of blood.

    Like any engine, if the heart is not well taken care of it can break down and pump

    less efficiently, a condition called heart failure.

    The AbioCor is the first artificial heart to be used in nearly two

    decades.

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