Laminated patient infusion device

Abstract

A device for delivering fluid to a patient including an exit port assembly adapted to connect to a transcutaneous patient access tool, and a dispenser including at least two laminated layers of material defining a passageway connected to the exit port assembly, and an expandable accumulator in fluid communication with the passageway for controlling fluid flow from a reservoir to the exit port assembly. The laminated construction provides many benefits including simplifying the design and manufacturing of the device, in order to further reduce the size, complexity and costs of the device so that the device lends itself to being small and disposable in nature.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application is related to U.S. patent application Ser. No. 09 / 943,992, filed on Aug. 31, 2001, which is assigned to the assignee of the present application and incorporated herein by reference.FIELD OF THE INVENTION [0002] The present invention relates generally to medical devices, systems and methods, and more particularly to small, low cost, portable infusion devices and methods that are useable to achieve precise, sophisticated, and programmable flow patterns for the delivery of therapeutic liquids to a mammalian patient. BACKGROUND OF THE INVENTION [0003] Today, there are numerous diseases and other physical ailments that are treated by various medicines including pharmaceuticals, nutritional formulas, biologically derived or active agents, hormonal and gene based material and other substances in both solid or liquid form. In the delivery of these medicines, it is often desirable to bypass the digestive system of a mamma...

AI Technical Summary

Benefits of technology

[0012] In response, the present invention provides a device for delivering fluid to a patient, including an exit port assembly adapted to connect to a transcutaneous patient access tool, and a dispenser including at least two laminated layers of material defining a passageway connected to the exit port assembly, and an expandable accumulator in fluid communication with the passageway for controlling fluid flow from a reservoir to the exit port assembly. The laminated construction provides many benefits including, but not limited to, simplifying the design and manufacturing of the device, and further reducing the size, complexity and costs of the device. The device of the present invention, therefore, lends itself to being small and disposable in nature.

[0014] According to another aspect, one of the second and the third layers defines a recess receiving the diaphragm, and wherein the recess has a depth about equal to a thickness of the diaphragm such that the diaphragm is secured in a substantially fluid-tight manner between the second and the third layers. Preferably, a length and a width of the recess are greater than a length and a width of the diaphragm in order to decrease required manufacturing tolerances of the dispenser.

Problems solved by technology

Bolus injections often imperfectly match the clinical needs of the patient, and usually require larger individual doses than are desired at the specific time they are given.

Continuous delivery of medicine through gravity feed systems compromise the patient's mobility and lifestyle, and limit the therapy to simplistic flow rates and profiles.

Transdermal patches have special requirements of the medicine being delivered, particularly as it relates to the molecular structure, and similar to gravity feed systems, the control of the drug administration is severely limited.

Currently available ambulatory infusion devices are expensive, difficult to program and prepare for infusion, and tend to be bulky, heavy and very fragile.

Filling these devices can be difficult and require the patient to carry both the intended medication as well as filling accessories.

Due to the high cost of existing devices, healthcare providers limit the patient populations approved to use the devices and therapies for which the devices can be used.

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