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Bioabsorbable Extrusion: Revolutionizing the Next Generation of Medical Devices

 

Development of Bioabsorbable Polymers
Bioabsorbable polymers are capable of safely existing in the body and eventually absorbing without causing harm or adverse interactions. The ability to safely remain in the body for controlled lengths of time makes bioabsorbable polymers particularly suitable for various medical applications, presenting an alternative to traditional polymers or metal components.

Several families of bioabsorbable polymers are known which include polyesters, poly(amino acids), polyanhydrides, polyorthoesters, polyurethanes, and polycarbonates. Most of the commercially available bioabsorbable devices are composed of polyesters, primarily homopolymers and copolymers of poly(lactic acid) and poly(glycolic acid). Copolyesters of ε-caprolactone, trimethylene carbonate, and para-dioxanone have also been commercialized.

The Zeus Advantage: Technology and Capabilities
Our bioabsorbable material processing capabilities and formulations are the most advanced in the industry. Zeus is able to extrude these biomaterials into high precision tubular geometries and perform full polymer characterization to provide necessary data to meet regulatory requirements. Our capabilities include tight tolerance extrusion, formulations, customization, sophisticated materials science, multiple combinations of the product, and degradation profiles.

The Role of Bioabsorbables in Typical Medical Applications
Zeus’ biomaterials platform is targeted for the development of a wide variety of medical products for both preventive care and the treatment of disease. With steady growth in the field of bioabsorbables, typical applications are ever-evolving and expanding. Current typical applications include:

bullet Orthopedic – fracture fixation plates, pins and screws, bone augmentation, nails (scaffolding)
bullet Dental – Packing, dry socket treatment, scaffolding
bullet Surgical – Ligament repair, wound closure (sutures, suture anchors, skin staples, & adhesives), adhesion barriers, drug delivery, antineoplastic delivery, ligating clips, hemostasis clips, temporary RO markers
bullet Stents – vascular, coronary, biliary, ureteral, esophageal, etc.
bullet Tissue engineering – 3-D structures, electrospinning, molded, extruded
bullet Vascular graft with scaffolding
bullet Bowel anastamosis and ureteral anastamosis
bullet Guided nerve regeneration
bullet Percutaneous devices with limited ingrowth
bullet Tissue engineering scaffolds
bullet Vehicles for controlled drug and therapeutic agent delivery
bullet Catheters
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Key Properties:
bullet Modulated degradation rates
bullet Varying strengths and stiffness
bullet Multiple extrusion forms
bullet FDA-approved for medical devices
bullet Tailored to customer’s specifications

Features:
bullet Capable of safely existing and being absorbed in the body
bullet Finite functionality
bullet Absence of stress shielding associated with long term permanent implants
bullet Controlled/gradual rate of bioabsorption or degradation

Benefits:
bullet No second surgery for explantation
bullet Controlled load transfer
bullet Promotion and temporary support for tissue in-growth for tissue engineering
bullet Ability to match degradation profile with healing profile leading to optimal tissue differentiation
bullet No undesirable interactions with the body as associated with corrosion of metals
bullet Enables long term drug release
bullet Provides Novel and Alternate IP position
bullet Controlled rate of drug delivery or therapeutic agent
bullet Cost effective as compared to metal equivalents
 
Capabilities
bullet Tight tolerance extrusion
bullet Sophisticated materials science
bullet Advanced processing and development
bullet Multiple combinations of the product

  Tg (C) Tm (C) E (Gpa) σ (MPa) Mass Loss (months)*
PLA 60 180-190 2.7-4.1 65 18-36
PdLA 55 amorph 1.0-3.0 40 5-6
PGA 40 215-225 6.0-7.0 95 4-6
L/G(10/90) 42 202-210 3.0-6.0 45 3-4
PL/dL(80/20) 60 115-130 2.0-4.0 50 12-18
PL/G(85/15) 55 140-150 3.3-3.5 65 12-18
PCL -60 55-65 0.2-0.4 25 24-36

Approximate values for a small selection of absorbable materials processed by Zeus


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Information reprinted with permission from Victrex PLC

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