Compounding assembly for nutritional fluids

Fluent material handling – with receiver or receiver coacting mea – With signal – indicator – recorder – inspection means or exhibitor

Reexamination Certificate

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Details

C141S104000

Reexamination Certificate

active

06202711

ABSTRACT:

BACKGROUND OF THE INVENTION
This application contains Microfiche Appendix consisting of four (4) slides and 341 pages.
The present invention relates to assemblies for transferring a plurality of individual fluids from multiple source containers into a collecting container, and specifically relates to such an assembly which controllably transfers the individual fluids to a collecting container in at least partial dependence on a determination of the type of the transferred fluids.
In many instances, an individual must be fed by administration of a nutritional solution to that patient. For example, such feeding may be accomplished by administration of a nutritional solution directly to a patent's digestive system or by administration of a solution into a patients intravenous system. Frequently, the desired solution to be administered will vary between individuals, and in many settings, such as hospitals or other care giving facilities, there may be a sizable number of individuals needing such solutions. Therefore, it is desirable that these solutions are prepared in a safe, efficient and accurate manner.
There are several devices which are designed to compound a desired nutritional solution in a collection container by varying the amount of each of a number of nutritional components which are added to the container. One such exemplary device is the Automix® compounder sold by Baxter Healthcare Corporation of Deerfield, Ill.
In one method of utilizing such devices, a pharmacist or nutritional caregiver will determine the nutritional solution which is to be administered and specify the desired quantity of each of the nutritional components which are needed to form the desired solution. This information will then be utilized to compound the desired solution. A number of source containers of the various individual nutritional components may be clustered about and connected to the collection container for the nutritional solution. A desired quantity of one or more of the components is then transferred from the source containers to the collection container in a controlled manner. Upon completion the collection container is disconnected and eventually transported to the individual for administration.
As can be appreciated, it is highly desirable that the compounding method add the nutritional components to the collection container in an accurate manner. In one example, the method may utilize a compounder which transfers, in a controlled manner, the desired quantities of the nutritional components to the collection container. Although the compounder may be properly instructed to make the nutritional solution, an accurate determination of the quantity and the type of component being added to the container during the transferring process is also desirable.
To promote sterility of the nutritional solution, surfaces which come into contact with any of the nutritional fluids must be kept clean. To implement this requirement, compounding devices frequently utilize a sterile disposable apparatus or transfer set for connecting the containers housing the sterile nutritional components to the collection container. At appropriate times, the transfer set will be replaced, with the replaced set properly disposed of.
These transfer sets, however, may make it difficult to use fluid sensors which must contact a fluid to distinguish the different types of fluids in the compounding method. Thus, typically if transfer sets are used, it is highly desirable that the compounding apparatus be operable without utilizing sensors which require contact with the fluid to function properly.
Generally, in compounding solutions such as nutritional solutions, the type of source solution in a particular container is one of the inputs to the compounder. However, in some instances, there may be a possibility that the type of solution is input incorrectly. It would be highly desirable to have a compounder that independently verifies the type of solution which flows from a particular container so that any errors may be detected.
One type of sensing system which may find use in compounding methods is disclosed in published European Patent Application No. EP 721,103 entitled “APPARATUS FOR IDENTIFYING CONTAINER COMPONENTS USING ELECTRICAL CONDUCTIVITY”. However, it has been found that with such a system distinguishing between two or more of the fluids which are typically used in nutritional compounding methods may be difficult. Thus other types of sensing systems or processes may be desirable.
It is therefore an object of the present invention to provide an assembly for transferring component fluids from a plurality of individual source containers to a receiving or collection container. A related object is to provide such an assembly which controllably transfers desired volumes of the component fluids and compounds a desired nutritional solution in a collection container in at least partial dependence on a determination of the type of the fluids being transferred.
Another object of the present invention is to provide an assembly for individually transferring and compounding a number of predetermined nutritional solutions in a collection container in an efficient and accurate manner.
A further object of the present invention is to provide an assembly for transferring a plurality of component fluids and compounding a desired solution by adding in a controlled manner the components to a collection container to form the desired solution. A related object is to provide as an input to such a compounding process, the type and amount of components which have been transferred to the collection container.
Yet another object of the present invention is to provide an assembly for transferring component fluids with the assembly adapted to utilize a disposable transfer set to connect source component containers to a receiving or collection container. A related object is to provide such an assembly having sensors uniquely suited to operate with such a set and without requiring contact with fluids during the compounding process.
A still further object of the present invention is to provide an assembly for transferring component fluids and compounding a desired solution, with the assembly having the ability to check the type of component fluid being transferred during the compounding process. A related object is to provide such an assembly where the types of component fluids being transferred are input into the system and the compounding assembly independently checks the type of component solutions during the compounding process.
SUMMARY OF THE INVENTION
The present invention provides an assembly which controllably transfers component fluids from a plurality of individual source containers through a transfer set to form or compound a desired mixture in a collection container while determining or sensing the type of fluid being transferred. The identified component fluid type may then be compared with the desired fluid type to verify that the fluid being transferred matches the desired fluid.
To this end, the transferring assembly of the present invention includes a sensing assembly which is in sensory contact with the component fluid as the fluid flows through the transfer set and provides a distinguishing characteristic of the solution being transferred.
In an embodiment, the sensing assembly is in noninvasive sensory contact with the component fluid during flow. The distinguishing characteristic provided by the sensing assembly accurately identifies at least one of the component fluids without the necessity of further input. In a further embodiment, the transferring assembly identifies a distinguishing characteristic which may correspond to a plurality of fluid types. Then, if the distinguishing characteristic is insufficient to identify the particular fluid, the transferring assembly examines an additional input characteristic of at least one of the component solution types and identifies the component fluid with the desired accuracy.
In an embodiment the mixing assembly includes a pump operatively acting on at least one of the comp

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