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.

Description

[0001] This is a Divisional Application of co-pending application Ser. No. 09 / 250,034 which is a Divisional of application Ser. No. 08 / 769,654, now U.S. Pat. No. 5,906,703.[0002] 1. Field of the Invention[0003] The present invention relates generally to methods and apparatus for making fluid delivery devices for infusing medicinal agents into an ambulatory patient at specific rates over extended periods of time. More particularly, the invention concerns a novel method and apparatus for the large volume manufacture of small, disposable fluid delivery devices for infusion of medicinal agents into a ambulatory patient.[0004] 2. Discussion of the Prior Art[0005] Many medicinal agents require an intravenous route for administration thus bypassing the digestive system and precluding degradation by the catalytic enzymes in the digestive tract and liver. The use of more potent medications at elevated concentrations has also increased the need for accuracy in controlling the delivery of such...

AI Technical Summary

Benefits of technology

These devices provide precise, controlled fluid delivery at low cost and in large quantities, suitable for ambulatory patients, overcoming the limitations of previous methods by ensuring accurate dosing and reducing the risk of toxic reactions.

Problems solved by technology

Certain classes of new pharmacologic agents possess a very narrow range of therapeutic effectiveness, for instance, too small a dose results in no effect, while too great a dose results in toxic reaction.

Such methods are cumbersome, imprecise and require bed confinement of the patient.

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