1. Field of the Invention
The present invention relates generally to fluid delivery devices. More particularly, the invention concerns an improved multi-channel apparatus for infusing various medicinal agents into an ambulatory patient at specific rates of flow over extended periods of time. The apparatus includes a novel energy source, a novel fill means for filling the reservoirs of the apparatus and a unique adjustable, multi-channel flow rate control means for precisely adjustably controlling the rate of fluid flow from individual reservoirs of the device toward the patient.
2. Discussion of the Prior Art
A number of different types of medicament dispensers for dispensing medicaments to ambulatory patients have been suggested. Many of the devices seek either to improve or lo replace the traditional gravity flow and hypodermic syringe methods, which have been the standard for delivery of liquid medicaments for many years.
The prior art gravity flow methods typically involve the use of intravenous administration sets and the familiar flexible solution bag suspended above the patient. Such gravametric methods are cumbersome, imprecise and require bed confinement of the patient. Periodic monitoring of the apparatus by the nurse or doctor is required to detect malfunctions of the infusion apparatus.
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 the liver. The use of more potent medications at elevated concentrations has also increased the need for accuracy in controlling the delivery of such drugs. The delivery device, while not an active pharmacologic agent, may enhance the activity of the drug by mediating its therapeutic effectiveness. 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 can result in a toxic reaction.
For those patients that require frequent injections of the same or different amounts of medicament, the use of the hypodermic syringe method of delivery is common. However for each injection, it is necessary to first draw the injection dose into the syringe, then check the dose and, after making certain that all air has been expelled from the syringe, finally, inject the dose either under bolus or slow push protocol. This cumbersome and tedious procedure creates an unacceptable probability of debilitating complications, particularly for the elderly and the infirm.
As will be appreciated from the discussion, which follows, the apparatus of the present invention is uniquely suited to provide precise, multi-channel fluid delivery management in those cases where a variety of precise dosage schemes are of utmost importance. An important aspect of the apparatus of the present invention is the provision of novel fill means for filling the reservoirs of the device using a plurality of conventional medicament vials, each having a pierceable septum. Another unique feature of the apparatus of the present invention is an embedded microcapillary multi-channel flow rate control means, which enables precise control of the rate of fluid flow of the medicament to the patient. More particularly, the apparatus of the present invention, includes a unique, adjustable fluid flow rate mechanism which enables the fluid contained within the various reservoirs of the device to be precisely dispensed at selected rates.
The apparatus of the present invention can be used with minimal professional assistance in an alternate health care environment, such as the home. By way of example, devices of the invention are readily portable and can be used for the continuous infusion of injectable anti-infectives, hormones, steroids, blood clotting agents, analgesics and like medicinal agents. Similarly, the devices oft the invention can be used for most I-V chemotherapy and can accurately deliver fluids to the patient in precisely the collect quantities and at extended micro fusion rates over time.
By way of summary, the apparatus of the present invention uniquely overcomes the drawbacks of the prior art by providing a novel, disposable dispenser of simple but highly reliable construction. A particularly important aspect of the apparatus of the present invention resides in the provision of a novel, self-contained energy source in the form of a substantially constant-force compressible, expandable or retractable member that provides the force necessary to uniformly and precisely dispense various solutions, including medicament mixtures from a plurality of standard, prefilled vial containers that can be conveniently loaded into the apparatus. Because of the simplicity of construction of the apparatus of the invention, and the straightforward nature of the energy source, the apparatus can be manufactured at low cost without in any way sacrificing accuracy and reliability.
With regard to the prior art, one of the most versatile and unique fluid delivery apparatus developed in recent years is that developed by the present inventor and described in. U.S. Pat. No. 5,205,820. The components of this novel fluid delivery apparatus generally include: a base assembly, an elastomeric membrane serving as a stored energy means, fluid flow channels for filling and delivery, flow control means, a cover, and an ullage which comprises a part of the base assembly.
Another prior art patent issued to the present applicant, namely U.S. Pat. No. 5,743,879) discloses an injectable medicament dispenser for use in controllably dispensing fluid medicaments from a prefilled container at a uniform rate. The dispenser, which is quite dissimilar in construction and operation from that of the present invention, includes a stored energy source in the form of a compressively deformable, polymeric elastomeric member that provides the force necessary to controllably discharge the medicament from a prefilled container which is housed within the body of the device. After having been deformed, the polymeric, elastomeric member will return to its starting configuration in a highly predictable manner.
Another important prior art fluid delivery device is described in the U.S. Pat. No. 6,063,059 also issued to the present inventor. This device, while being of a completely different construction embodies a compressible-expandable stored energy source somewhat similar to that used in the apparatus of the present invention.
Still another prior art fluid delivery device, in which the present invention is also named as an inventor, is described in U.S. Pat. No. 6,086,561. This latter patent incorporates a fill system that makes use of conventional vials and cartridge medicament containers.