Method for forming and sterilizing catheters

Abstract

Abstract A catheter for insertion into the human body and made of a thermoplastic tubing, is preformed to a desired shape by heating it above its free form temperature and allowing it to cool while held in that shape. To hold the catheter in position for such forming, a forming board having a catheter receiving groove of the desired shape is used. The cross-sectional shape of this groove is wider at the bottom and narrower at the open top where it becomes a part of the board so as to hold the catheter in place during the forming and storage and to allow the catheter to be easily removed thereafter. This forming board is made by vacuum forming a sheet of thermosetting plastic over a solid, non-heat responsive, master representation of the exact longitudinal shape of the final preformed catheter. The crosssectional shape of the master is the negative of the desired cross-section of the final forming board groove. When the catheter has been so preformed, it and its forming board are packaged in a sealed plastic bag which is, like the catheter and the forming board, permeable to sterilizing gas. The resulting package is gas claved and stored in this sealed condition until ready for use. The catheter is removed from the sealed package and the forming board immediately before insertion into the body. When it has served its purpose, it is removed from the body, cleaned, positioned back into the forming board, preformed with heat when necessary, placed in another sealed film container, and resterilized for storage until it is again needed.

Inventors

• 👤 K Amplatz

Bibliographic Details