Synthetic Polyisoprene Dip Molded Medical Device Components

A synthetic polyisoprene latex material has been developed by Apex Medical Technologies, Inc.  in response to customers' requests for a synthetic material with properties similar to those of natural rubber latex, such that it could be used as a direct replacement for natural rubber.  With this material, customers need not be concerned with the biocompatibility/protein issues associated with natural rubber latex.  Dip molded components made from synthetic polyisoprene materials have a set of distinctive properties normally associated only with natural rubber latex - low modulus, low tensile set properties, high resiliency and high ultimate elongation.  Apex works individually with each customer to custom tailor a material which best matches the need at hand.  Apex believes it is currently the only commercial source of synthetic polyisoprene latex dip molded components.

The desirable aspects of using Synthetic polyisoprene in dip molded medical device components are as follows:

Biocompatibility Issues:

- The chemical structure of the synthetic polyisoprene is nearly identical to that produced naturally by rubber trees, but does not contain any proteins, thus preventing Type I allergies completely. -The lack of proteins allows for components to be produced without the possibility of forming nitrosamines. - For certain critical applications, it is possible to formulate polyisoprene such that it is free of traditional rubber curative chemicals which have been implicated in Type IV latex allergies.

Physical Properties:

- Ultimate elongation between 700% and 1300%   100% tensile modulus between 50 and 100 psi   Ultimate tensile strength up to about 3000+ psi   Tensile set values as low as 1% or less   Note: Not all combinations of properties are possible - The physical properties of dip molded components made from these materials are very similar to those made from natural rubber latex.  Many different compounding techniques can be used to tailor the properties of the polyisoprene to those needed for a given application. - Completely clear and/or powder free products can be produced from certain compounding formulations.

The synthetic polyisoprene material is processed by conventional dip molding processes, allowing for a wide range of component geometries and thichnesses to be accommodated.

Apex Medical Technologies, Inc., 10064 Mesa Ridge Court, Suite 202, San Diego, CA 92121. Tel: 858-535-0165; Fax: 858-535-9715.