Catheter manufacturing process and Regulatory consulting

PUNE, India - Jan. 2, 2021 - PRLog -- Catheter manufacturing nowadays is specialized into various designs. A catheter is a flexible tube made of latex, silicone, or Teflon that can be inserted into the body creating a channel for the passage of fluid or the entry of a medical device. For many years, the epidermal catheters used were plain tubes made of available industrial compounds, catheter manufacturing and design was largely based on current need. For example, specific catheter designs allow catheters to be used in pulmonary, cardiac (vascular), neonatal, central nervous system, and epidural tissues. Catheters are designed to perform tissue ablation (tissue removal) and even serve as conduits for thermal, optics, and various medical devices.

The catheter manufacturing requires only 1200 units of side arms before they can get the breakeven point. Catheters manufacturing are also being designed with safety features to prevent needles tick injuries along with Silver/Hydro gel-Coated Foley catheters to resist bacterial infection. The fastest growing segment of the catheter manufacturing industry, the coronary catheter market, is expected to reach four billion dollars by 2003, growing at 11.2% annually.

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The catheter Manufacturing Process

The first step in the manufacturing of a Foley catheter is the production of the long, thin tube that will be inserted into the bladder. The liquid rubber silicone is poured into a room temperature vulcanization (RTV) rubber mold. The mold is shaped like the desired catheter with either two or three outputs.

The silicone is then heat cured. This procedure can take anywhere from 0.5 to 40 hours. Once cooled, the tube is withdrawn from the mold. A small opening is then punched in the distal end of the tube furthest away from the two outputs.

A thin band of cured latex is slipped over the tube by hand to form a sheath around the tube. It is positioned so that the latex covers the opening that has been punched in the tube.

To form the balloon, the entire length of the tube is dipped in latex, which creates an overcoat layer and bonds the band to the tube proximate to the distal and proximal ends of the band, forming the balloon. This A Foley catheter.