Surgery – Container for blood or body treating material – or means used... – Materials mixed within container
Reexamination Certificate
1997-07-15
2001-07-31
Stright, Jr., Ronald (Department: 3762)
Surgery
Container for blood or body treating material, or means used...
Materials mixed within container
C604S082000, C604S087000
Reexamination Certificate
active
06267753
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to automated dispensing apparatus in general, and to machines for preparing pharmaceutical solutions for intravenous injection and ophthalmic application in particular.
BACKGROUND OF THE INVENTION
Typically, bags of solutions for intravenous injection of patients are prepared manually by pharmacists or pharmacist's aides. Each solution must be tailored to the particular need of the patient with respect to composition, quantity and type of medicament, and pH level. Variations from required levels can have deleterious, even fatal, consequences for the patient. Pharmacists and their assistants are highly trained and conscientious professionals. Nonetheless, under the pressures of time and environment, these professionals can make errors. In addition, the need to keep the final preparation sterile requires costly and time-consuming measures on the part of those who prepare the solutions.
Heat sterilization of solutions for intravenous injection, for example as part of a total parenteral nutrition system can lead to carmelization of the injectable sugars, which can have enormously negative consequences for the health of the patient. In my prior U.S. Pat. No. 4,906,103 I disclosed a system for the cold sterilization of solutions which completely avoids the hazards of heat sterilization. In my prior U.S. Pat. No. 5,196,001 I disclosed a preparation assembly and unit dose medicament containers for use in a cold sterilization system which permitted controlled pre-preparation dosing of medicaments.
Great strides have been made in automatic dispensing of solid pills and powders by way of computer controlled robotic assemblies. With greater attention to costs at all levels of the health care system, efforts have been made to limit the direct intervention of doctors and pharmacists in dispensing of medications, while at the same time maintaining adequate control by these professionals. Solid pills and capsules are by their nature suited to dispensing in unit doses, but the remotely operated drawers and dispensers which are adequate for pills are not effective for the preparation of individualized injectable solutions. Furthermore, robotic devices for dispensing liquids from a storage vessel of liquid present serious concerns in the preparation of solutions for administration to humans. Typically an aliquot of liquid would be dispensed by a micropump. Yet pumps are subject to malfunctions, and great care needs to be taken to quality check whether the desired quantity of liquid has actually been dispensed. In any event, no physical record remains to verify the amount and type of liquid dispensed. What is needed is a consistent and effective apparatus for preparing and dispensing liquid medicament solutions.
SUMMARY OF THE INVENTION
The apparatus of this invention employs robotic manipulation of three-part plastic preparation assemblies to automatically produce IV solutions which conform to the pharmacist's input specifications. The assemblies are stored in a magazine, and are extracted automatically one by one for preparation of individual prescriptions. A supply bag is prefilled with U.S.P. water and is connected through a valve to a transparent plastic mixing bag. Unit dose holders containing various medicaments and pH adjusting chemistries are dispensed into the mixing bag through an inlet. The unit dose holders are broken open by manipulation of the bag, and the U.S.P. water is introduced into the bag through the inlet. The contents of the unit dose holders and the water is mixed within the mixing bag by rotation of a magnetic mixing bar. The mixing bag is connected by a second valve through a filter to an administration bag. Negative pressure is applied to the administration bag to draw the solution through the filter. The administration bag is then heat sealed and severed from the filter for delivery to the patient. For ophthalmic solutions, a plurality of pre-capped containers are formed on the administration bag, and liquid from the administration bag is drawn into the individual ophthalmic solution containers, which are then heat sealed and severed from the administration bag.
The assembly of this invention is well suited to remote preparation of solutions, or to automated preparation of solutions, both under the supervision of a pharmacist. Furthermore, the exhausted mixing bag for each prepared solution may be stored, or an image of it may be stored, for later analysis of a particular solution should questions arise about its content after it has been administered to a patient. The assembly may be used for telerobotic preparation of solutions aboard spacecraft, where a licensed pharmacist will usually not be on site.
It is an object of the present invention to provide an apparatus for formulating solutions for intravenous injections without significant human intervention.
It is an additional object of the present invention to provide an apparatus for automatically and reliably preparing intravenous solutions.
It is another object of the present invention to provide a injectable solution system which displays visual markers to validate the prescribed contents of the solution.
It is a further object of the present invention to provide an apparatus for preparing human injectable solutions which may be operated in space by an earthbound pharmacist.
It is a still further object of the present invention to provide an apparatus for automatically preparing solutions for ophthalmic application.
Further objects, features and advantages of the invention will be apparent from the following detailed description when taken in conjunction with the accompanying drawings.
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Lathrop & Clark LLP
Stright, Jr. Ronald
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