Objective. DEVELOPMENT OF AN INDIGENOUS CLINICALLY, TECHNICALLY AND ECONOMICALLY VIABLE TISSUE EXPANDER. . Need for Development. Extremely high cost Non-availabilityReusing tendency. Expanders are used in:. Tattoo removalTreatment for scar revisionCorrection of an under developed breastPost mastectomy reconstructionReconstruction of donor site defectsAiding generation of tissue with properties similar to donor tissue like color, hair density.
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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
Expanders are used in:
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
Biocompatibility, analytical, mechanical, others
Results found OK, device is safe.
Proven materials used and encouraging Invitro test followed a very limited clinical trial under the close supervision of investigating surgeon
Raw Materials Used
Liquid Silicon Rubber
Silicone Rubber tubing
Reinforced Silicon Sheet
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)
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
Tubing Length adapter strength.
Needle stop penetration.
Fused or Adhered joints
Two Roll Mill
Compression Moulding machine
Injection Moulding machine
Laminar Flow Benches
Blister packing Machine
Compounding of Silicon Rubber
Ultra sonic cleaning
Drying of components
Assembly of pouch and dome
In process Testing
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