Tissue Expander. Tissue Expander is an implantable medical device used in plastic surgery for the development of tissue flaps or reconstruction of tissue defects and deficiencies
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- Tissue Expander is an implantable medical device used in plastic surgery for the development of tissue flaps or reconstruction of tissue defects and deficiencies
- The device is placed subcutaneously and implanted periodically with sterile isotonic saline until the tissue is fully developed.
- The device is removed once the expansion is over(6 weeks)
DEVELOPMENT OF AN
AND ECONOMICALLY VIABLE
Need for Development
- Extremely high cost
- Reusing tendency
Expanders are used in:
- Tattoo removal
- Treatment for scar revision
- Correction of an under developed breast
- Post mastectomy reconstruction
- Reconstruction of donor site defects
- Aiding generation of tissue with properties similar to donor tissue like color, hair density
Tissue expander parts
Stages of Evaluation
- Material Evaluation
- Biocompatibility, analytical, mechanical, others
- Invitro Evaluation
- Results found OK, device is safe.
- Clinical Trails
- Proven materials used and encouraging Invitro test followed a very limited clinical trial under the close supervision of investigating surgeon
Raw Materials Used
- Silicone Rubber
- Liquid Silicon Rubber
- Silicone Rubber tubing
- Silicone Adhesive
- Reinforced Silicon Sheet
- Polyacetal rods
Raw Material Screening
All basic raw materials which are to be used in the fabrication of an implantable device should not cause any toxic response in the host, undue inflammation of the tissues with which it is in contact or migration of any bi-products from the device to vital organs.
Raw Material Screening contd.
- The material should be free of all heavy metal impurities.
- The material should have stable mechanical properties so that the variation in the performance of the device is minimized.
- Each batch of material has to undergo all the specified test
Biocompatibility Test(as per USP)
- Systemic Toxicity test
- Intracutaneous Irritation test
- Invitro Haemolysis test
- Intra muscular Implantation test
Analytical and Mechanical Test(as per ASTM standards)
- IR Spectrum
- Volatile Matter
- Vacuum volatiles
- Total extractables
- Tensile Strength
- Elongation at break
- Trace Element Analysis
- Antimony, Arsenic, Bismuth, copper, Lead, Mercury, Tin, Iron should be less than/equal to 10ppm
- Silicone tubing ID, OD and concentricity
IN PROCESS TESTING(AS PER ASTM F 1441-92)
- Shell(Pouch) * Tensile test * breaking force* Tear resistance.
- Tube Shell Junction
- Injection port competence
- Over Expansion
- Tubing Length adapter strength.
- Needle stop penetration.
- Fused or Adhered joints
- Two Roll Mill
- Compression Moulding machine
- Injection Moulding machine
- Ultrasonic cleaner
- Laminar Flow Benches
- Adhesive Dispenser
- Curing Oven
- Mini Lathe
- Blister packing Machine
- ETO sterilizer
- Compounding of Silicon Rubber
- Compression Moulding
- Injection moulding
- Flash cutting
- Connector machining
- Ultra sonic cleaning
- Drying of components
- Assembly of pouch and dome
- In process Testing
- Blister packing
Features of HLL Tissue Expander
- Developed using biocompatible material suitable for long term implantation.
- Absence of any metallic part enable trouble free CT or MRI scan for the patients
- Muscles of the patient are bound to less strain due to the ability of the expander to expand differentially