In-vitro measurement of catamenial tampon systems

Abstract

An apparatus for testing of medical products such as a feminine hygiene product, is presented. The apparatus includes a body, a pump and a vaginal canal assembly. The body includes an internal chamber and a bottom surface having a bore open to the internal chamber. The pump provides a fluid to the body. In one embodiment, the fluid is a menses simulant. The vaginal canal assembly includes an interior canal accepting the product. The vaginal canal assembly includes a passage providing the fluid to the interior canal. The apparatus includes a pressure regulator controlling pressure exerted on the vaginal canal assembly from a volume of air within the internal chamber. The apparatus includes a stand. The stand includes a retaining device and a locking device. The locking device cooperates with the retaining device to selectively secure the body in at least one of a rotational position and an angular position.

1 . A method for forming a vaginal canal assembly of an in-vitro testing apparatus, the method comprising the steps of:
 measuring a vaginal cavity of a subject human female;   modeling the measured vaginal cavity in three-dimensional space; and   molding the vaginal canal assembly from the three-dimensional model.   
     
     
         2 . The method of  claim 1 , wherein the measuring step includes imaging the subject human female's pelvic cavity. 
     
     
         3 . The method of  claim 2 , wherein the modeling step includes analyzing the imaging data by segmenting the pelvic cavity to identify the vaginal cavity and surrounding tissues and organs, and generating object boundaries in three-dimensional space for the vaginal cavity and the surrounding tissues and organs. 
     
     
         4 . The method of  claim 3 , wherein the molding step includes developing a mold assembly design from the generated object boundaries of the subject human female's pelvic cavity. 
     
     
         5 . The method of  claim 1 , wherein the steps of measuring, modeling and molding are performed for a plurality of subject human females. 
     
     
         6 . The method of  claim 5 , wherein the plurality of subject human females include females of varying ages including young adult, adult and senior citizens, and varying sizes including short, average and tall in height, and slim, average and heavy in weight.