Method and apparatus for making fluid delivery device

Abstract

A method and apparatus for the high volume manufacture of fluid infusion devices which embody a self-contained, stored-energy source for expelling fluids from the reservoir of the device into an ambulatory patient at precisely controlled rates over extended periods of time. In accordance with the method of the invention, the base and cover infusion components of the devices of the invention are manufactured in injection molded arrays which comprise a cover array which is superimposed over and connected to a base array with the elastomeric membrane being captured therebetween. The elastomeric membrane material, which forms the stored-energy source of the infusion devices, is continuously unrolled from a large roll of film-backed membrane material which is rotatably mounted on a turret assembly upon which a second back-up roll of elastomeric membrane material is also mounted. After being unrolled, the film backing is separated from the membrane and the membrane is introduced into a novel tenter apparatus which controllably, biaxially stretches the membrane material. Following the stretching step, the membrane is automatically cut and then sealed between the cover components and base components of the cover and base arrays. The finished, individual infusion devices are then separated from the arrays and automatically packaged for shipping.

I claim:  
     
         1 . An array comprising: 
 (a) a base array comprising a plurality of adjacent base components, each said base component being interconnected with an adjacent base component and each having an upper surface;    (b) an elastomeric membrane covering said upper surface of each said base component; and    (c) a cover array comprising a plurality of adjacent cover components, each said cover component being interconnected with an adjacent cover component, said cover array being interconnected with said base array to form a plurality of sealably interconnected together base components and cover components each having an elastomeric membrane captured therebetween.    
     
     
         2 . An array as defined in    claim 1    in which said sealably interconnected base components and cover components are interconnected together by bonding.  
     
     
         3 . An array as defined in    claim 1    in which each said base component includes an outwardly extending cannula having a fluid inlet and a fluid outlet and a cannula body portion disposed between said fluid inlet and said fluid outlet.  
     
     
         4 . An array as defined in    claim 3    in which each said base component includes a base having a cavity formed therein and in which said body portion of said cannula is disposed within said cavity.  
     
     
         5 . An array as defined in    claim 4    in which each said cannula is generally spiral shaped.