Compounding assembly for nutritional fluids

• US 6,199,603 B1
• Filed: 08/11/1999
• Issued: 03/13/2001
• Est. Priority Date: 08/14/1998
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Pierce, Richard S., Hitchcock, James R., DiGianfilippo, Aleandro
• Primary Examiner(s): MAUST, TIMOTHY LEWIS
• Application Number:
  US09/372,284
• Time in Patent Office: 580 Days
• Field of Search: 141/9, 141/83, 141/94, 141/100, 141/104, 222/52, 73/614.3, 73/614.4, 73/616.1
• US Class Current: 141/83
• CPC Class Codes: A61J 3/002 Compounding apparatus specially for enteral or parenteral nutritive solutions bottling liquids B67C
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus

Abstract

A mixing assembly which transfers a number of nutritional fluids from individual source containers into a collection container while noninvasively sensing the type of fluid being transferred is provided. The mixing assembly utilizes a transfer set to establish fluid communication between the source containers and the collection container. A sensing assembly is configured to noninvasively sense a number of the types of fluid flowing through the transfer set to help to prevent improper mixing. For other fluids for which the sensing assembly alone may not be able to distinguish with the desired accuracy, the mixing device utilizes a method to approximate the flow rate of that fluid with the flow rate also providing an indication of that type of fluid. By combining the output of the sensing assembly with the flow rate determination, additional fluids can be identified.

The assembly includes a controller that executes a number of routines that minimize the occurrence of false alarms, while insuring accurate and reliable compounding of prescriptions.

Claims

1. An assembly for controllably transferring fluids from a plurality of individual source containers through a transfer set of the type which has a plurality of conduits through which fluid can pass to form a desired mixture in a receiving container, each conduit of the set being adapted to place one of the source containers in fluid communication with the receiving container, the assembly comprising:

a pump assembly being adapted to operatively act on fluid in at least one conduit to force a flow of said fluid therethrough, the rate of the flow varying in at least partial dependence on a characteristic of said fluid, said pump assembly operating responsive to predetermined signals being applied thereto;

a first sensor adapted to be in operative contact with the receiving container adapted to generate a signal that is indicative of the weight of the receiving container and its contents;

a second sensor being adapted to be positioned in close proximity to said at least one conduit when properly installed, said second sensor being in noninvasive sensory contact with fluid present in said at least one conduit, and adapted to sense and selectively determine the absence of said at least one conduit, the absence of fluid in said at least one properly installed conduit, and a characteristic of the fluid present in said at least one conduit and generate signals that are indicative of such determination;

a controller for controlling the operation of said apparatus, including said pump assembly and for processing said signals from said first and second sensor and being adapted to generate preselected alarm signals in response to predetermined conditions; and

,

an alarm indicator operatively connected to said controller for providing preselected alarm indications in response to preselected alarm signals being generated by said controller.

2. An assembly as defined in claim 1 wherein said controller generates one of said preselected alarm signals in response to said second sensor sensing the absence of said conduit.

3. An assembly as defined in claim 2 wherein said alarm indicator includes a display operatively connected to said controller for providing a visual display of said preselected alarms.

4. An assembly as defined in claim 2 wherein said alarm means includes an audible alarm operatively connected to said controller for providing an audible indication of said preselected alarms.

5. An assembly as defined in claim 1 wherein said first sensor includes an extension on which the receiving container is adapted to be removably connected, said controller generating one of said preselected alarm signals in the event said first sensor senses an increase in the weight of the receiving container subsequent to said controller terminating operation of said pump assembly.

6. An assembly as defined in claim 1 wherein said alarm indicator is adapted to provide a no flow alarm indication responsive to said controller generating a no flow alarm signal, and an incorrect solution alarm indication responsive to said controller generating an incorrect solution alarm signal, said controller processing said weight signals and said fluid characteristic signals during operation of said pump assembly and initially generating a no flow alarm signal when said weight signals indicate a less than expected weight change and said fluid characteristic signals are sufficient to generate an incorrect solution alarm signal.

7. An assembly as defined in claim 6 wherein said controller is operative to delay a predetermined time period before said weight signals are processed after initiating operation of said pump assembly.

8. An assembly as defined in claim 1 wherein said pump assembly comprises at least two pumps, each having a pump motor for driving the same, said controller being adapted to control the operation of each pump motor by selectively controlling a main power switch and a pump motor select switch, both of which must be in an operating state to operate a pump motor, said switches being actuated responsive to said controller selectively generating signals for placing said switches in said operating state, said controller placing said main power switch and said pump motor select switch in a nonoperating state in response to said preselected alarm signals being generated.

9. An assembly as defined in claim 8 wherein said controller is adapted to be placed in an idle mode wherein all of said pump motors are not operating and a user of the assembly can input operating and information data into the assembly, said controller placing said main power switch and said pump motor select switch in a nonoperating state in response to said controller being in said idle condition.

10. An assembly as defined in claim 1 wherein said controller is adapted to determine the flow rate of fluid into the receiving container by determining the change in weight of the receiving container per unit of time during operation of said pump assembly.

11. An assembly for controllably transferring fluids from a plurality of individual source containers through a transfer set of the type which has a plurality of conduits through which fluid can pass to form a desired mixture in a receiving container, each conduit of the set being adapted to place one of the source containers in fluid communication with the receiving container, the assembly comprising:

a pump assembly being adapted to operatively act on fluid in at least one conduit to force a flow of said fluid therethrough, the rate of the flow varying in at least partial dependence on a characteristic of said fluid, said pump assembly operating responsive to predetermined signals being applied thereto;

a first sensor adapted to be in operative contact with the receiving container adapted to generate a signal that is indicative of the weight of the receiving container and its contents;

a second sensor being adapted to be positioned in close proximity to said at least one conduit when properly installed, said second sensor being in noninvasive sensory contact with fluid present in said at least one conduit, and adapted to sense and selectively determine a characteristic at least partially identifying the fluid present in said at least one conduit and generate signals that are indicative of such determined characteristic and to sense and selectively determine the absence of fluid in said at least one properly installed conduit and generate signals that are indicative of an empty conduit;

a controller for controlling the operation of said apparatus, including said pump assembly and for processing said signals from said first and second sensor and being adapted to generate preselected alarm signals in response to predetermined conditions, said controller including a memory having data that identifies at least one fluid in said at least one conduit; and

,

an alarm indicator operatively connected to said controller for providing preselected alarm indications in response to preselected alarm signals being generated by said controller, said alarm indicator being adapted to provide a no flow alarm indication responsive to said controller generating a no flow alarm signal and an incorrect solution alarm indication responsive to said controller generating an incorrect solution alarm signal;

said controller being adapted to begin acquiring a predetermined plurality of said fluid characteristic signals during operation of said pump assembly and compare each of said plurality with said fluid identifying data in said memory and generate an incorrect solution alarm signal when said comparison indicates an incorrect solution;

said controller being adapted to immediately begin acquiring another plurality of characteristic signals in response to said second sensor selectively determining the absence of fluid in said at least one properly installed conduit, thereby precluding completion of said comparison of said earlier acquired characteristic signals and possible generation of an incorrect solution alarm signal.

12. An assembly as defined in claim 11 wherein said plurality comprises 10 successive signals, and said controller generates an incorrect solution signal when 10 successive signals do not correctly compare.

13. An assembly as defined in claim 11 wherein said controller is adapted to generate a no flow alarm signal when a plurality of said weight signals over successive approximately ½

second intervals indicate a less than expected weight change and preclude the generation of an incorrect solution alarm signal.

14. An assembly as defined in claim 11 wherein said pump assembly is adapted to selectively operate at a high speed and a low speed, said controller being precluded from immediately beginning the acquisition of another plurality of characteristic signals in response to said second sensor selectively determining the absence of fluid in said at least one properly installed conduit when said pump assembly is operating at said low speed.

15. An assembly as defined in claim 14 wherein during high speed operation of said pump assembly, said controller delays the acquiring of a predetermined plurality of said fluid characteristic signals during operation of said pump assembly until a predetermined quantity of fluid has been pumped after starting operation of said pump assembly.

16. An assembly for controllably transferring fluids from a plurality of individual source containers through a transfer set of the type which has a plurality of conduits through which fluid can pass to form a desired mixture in a receiving container, each conduit of the set being adapted to place one of the source containers in fluid communication with the receiving container, the assembly comprising:

a pump assembly being adapted to operatively act on fluid in at least one conduit to force a flow of said fluid therethrough, the rate of the flow varying in at least partial dependence on a characteristic of said fluid, said pump assembly operating responsive to predetermined signals being applied thereto;

a first sensor adapted to be in operative contact with the receiving container adapted to generate a signal that is indicative of the weight of the receiving container and its contents;

a second sensor being adapted to be positioned in close proximity to said at least one conduit when properly installed, said second sensor being in noninvasive sensory contact with fluid present in said at least one conduit, and adapted to sense and selectively determine a characteristic at least partially identifying the fluid present in said at least one conduit and generate signals that are indicative of such determined characteristic and to sense and selectively determine the absence of fluid in said at least one properly installed conduit and generate signals that are indicative of an empty conduit;

a controller for controlling the operation of said apparatus, including said pump assembly and for processing said signals from said first and second sensor and being adapted to generate preselected alarm signals in response to predetermined conditions, said controller including memory having data that specifies the weight and identity of fluid in said conduit; and

,

an alarm indicator operatively connected to said controller for providing preselected alarm indications in response to preselected alarm signals being generated by said controller, said alarm indicator being adapted to provide a no flow alarm indication responsive to said controller generating a no flow alarm signal and an incorrect solution alarm indication responsive to said controller generating an incorrect solution alarm signal;

said controller being adapted to begin acquiring a predetermined plurality of said fluid characteristic signals during operation of said pump assembly and compare each of said plurality with fluid identifying data in said memory and generate an incorrect solution alarm signal when said comparison indicates an incorrect solution;

said controller being adapted to preclude generation of said incorrect solution alarm signal if said weight signal indicates the weight of said receiving container and its contents is within a predetermined amount of said weight of fluids in the receiving container that is indicated by said data in said memory, and the last sensed characteristic corresponded to the identity of the fluid in said at least one conduit that was specified for said conduit in said memory.

17. An assembly for controllably transferring fluids from a plurality of individual source containers through a transfer set of the type which has a plurality of conduits through which fluid can pass to form a desired mixture in a receiving container, each conduit of the set being adapted to place one of the source containers in fluid communication with the receiving container, the assembly comprising:

a pump assembly being adapted to operatively act on fluid in at least one conduit to force a flow of said fluid therethrough, the rate of the flow varying in at least partial dependence on a characteristic of said fluid, said pump assembly operating responsive to predetermined signals being applied thereto;

a first sensor adapted to be in operative contact with the receiving container adapted to generate a signal that is indicative of the weight of the receiving container and its contents;

a second sensor being adapted to be positioned in close proximity to said at least one conduit when properly installed, said second sensor being in noninvasive sensory contact with fluid present in said at least one conduit, and adapted to sense and selectively determine a characteristic at least partially identifying the fluid present in said at least one conduit and generate signals that are indicative of such determined characteristic and to sense and selectively determine the absence of fluid in said at least one properly installed conduit and generate signals that are indicative of an empty conduit;

a controller for controlling the operation of said apparatus, including said pump assembly and for processing said signals from said first and second sensor and being adapted to generate preselected alarm signals in response to predetermined conditions, said controller including memory having data that specifies the weight and identity of fluid in said conduit; and

,

an alarm indicator operatively connected to said controller for providing preselected alarm indications in response to preselected alarm signals being generated by said controller, said alarm indicator being adapted to provide a no flow alarm indication responsive to said controller generating a no flow alarm signal and an incorrect solution alarm indication responsive to said controller generating an incorrect solution alarm signal;

said controller processing said weight signals during operation of said pump assembly and generating a no flow alarm signal when said weight signals indicate a less than expected weight change;

said controller acquiring a predetermined plurality of said fluid characteristic signals during operation of said pump assembly and comparing each of said plurality with fluid identifying data in said memory and being adapted to generate an incorrect solution alarm signal when said comparison indicates an incorrect solution unless precluded from doing so;

said controller being adapted to preclude generation of said incorrect solution alarm signal if said weight signal indicates the weight of fluid within a portion of said conduit that is located between said receiving container and said second sensor is within a predetermined amount of said specified weight of fluids in the receiving container that is indicated by said data in said memory, and the sensed characteristic approximately corresponding to the fluid immediately before the no flow alarm signal was generated indicated that the fluid was a correct solution, and sensed characteristics since said no flow alarm signal was generated indicated that said conduit is empty, said controller then operating said pump assembly to pump said fluid in said portion of said conduit into the receiving container.

18. An assembly for selectively transferring fluids from one or more source containers to form a desired mixture in a receiving container, the assembly comprising:

a pump assembly being adapted to force fluid through each conduit responsive to applied drive signals;

a first sensor assembly for generating a signal that is indicative of the weight of the receiving container;

a second sensor assembly in noninvasive sensory contact with fluid present in a portion of a conduit extending between the source container and the receiving container, the second sensor being adapted to selectively determine the absence of a conduit, the presence of an empty conduit, and a characteristic of the fluid present in the conduit and to generate signals that are indicative of such determinations;

a controller for controlling the pump assembly, for processing the signals from the sensor assemblies, and for selectively generating alarm signals; and

,

an alarm indicator connected to the controller for providing alarms when alarm signals are received from the controller.

19. An assembly for selectively transferring fluids from one or more source containers to form a desired mixture and goal weight in a receiving container, the assembly comprising:

a pump assembly being adapted to force fluid through each conduit responsive to applied drive signals;

a first sensor assembly for generating a signal that is indicative of the weight of the receiving container and its contents;

a second sensor assembly in noninvasive sensory contact with fluid present in a portion of a conduit extending between the source container and the receiving container, the second sensor being adapted to selectively determine the absence of a conduit, the presence of an empty conduit, and a characteristic of the fluid at least partially identifying the fluid present in the conduit and to generate signals that are indicative of such determinations;

a controller for controlling the pump assembly, for processing the signals from the sensor assemblies, and for selectively generating alarm signals, the controller also including a memory having data that specifies the identity of predetermined fluids that may be in the conduit; and

,

an alarm indicator connected to the controller for providing preselected alarms when preselected alarm signals are received from the controller, the alarm indicator being adapted to provide a no flow alarm indication when a no flow alarm signal is received from the controller and an incorrect solution alarm indication when an incorrect solution alarm signal is received from controller;

the controller acquiring a number of fluid characteristic signals during operation of the pump assembly and comparing each of them with fluid identifying data in the memory and generating an incorrect solution alarm signal when the comparison indicates an incorrect solution, unless the weight signal indicates the weight of the receiving container is within a small amount of the goal weight, and the last sensed characteristic corresponded to the identity of the fluid in the conduit that was specified for the conduit.

20. An assembly for selectively transferring fluids from one or more source containers through respective conduits to form a desired mixture in a receiving container having a goal weight, the assembly comprising:

a pump assembly being adapted to force fluid through each conduit responsive to applied drive signals;

a first sensor assembly for generating a signal that is indicative of the weight of the receiving container and its contents;

a second sensor assembly in noninvasive sensory contact with fluid present in a portion of a conduit extending between the source container and the receiving container, the second sensor being adapted to selectively determine the absence of a conduit, the presence of an empty conduit, and a characteristic of the fluid at least partially identifying the fluid present in the conduit and to generate signals that are indicative of such determinations;

a controller for controlling the pump assembly, for processing the signals from the sensor assemblies, and for selectively generating alarm signals, the controller also including a memory having data that specifies the identity of predetermined fluids that may be in the conduit; and

,

an alarm indicator connected to the controller for providing preselected alarms when preselected alarm signals are received from the controller, the alarm indicator being adapted to provide a no flow alarm indication when a no flow alarm signal is received from the controller and an incorrect solution alarm indication when an incorrect solution alarm signal is received from controller;

the controller acquiring a number of fluid characteristic signals during operation of the pump assembly and comparing each of them with fluid identifying data in the memory and generating an incorrect solution alarm signal when the comparison indicates an incorrect solution, unless the weight signal indicates the weight of fluid within a portion of the conduit that is located between the receiving container and the second sensor is within a predetermined amount of said specified weight of fluids in the receiving container that is indicated by said data in said memory, and the sensed characteristic approximately corresponding to the fluid immediately before the no flow alarm signal was generated indicated that the fluid was a correct solution, and sensed characteristics since said no flow alarm signal was generated indicated that the conduit is empty, the controller then operating the pump assembly to pump the fluid in the portion of the conduit into the receiving container.

21. An assembly for controllably transferring fluids from a plurality of individual source containers through a transfer set of the type which has a plurality of conduits through which fluid can pass to form a desired mixture in a receiving container, each conduit of the set being adapted to place one of the source containers in fluid communication with a manifold junction that is in fluid communication to the receiving container via a manifold transfer conduit, the assembly comprising:

a pump assembly being adapted to operatively act on fluid in at least one conduit to force a flow of said fluid therethrough, the rate of the flow varying in at least partial dependence on a characteristic of said fluid, said pump assembly operating responsive to predetermined signals being applied thereto;

a first sensor adapted to be in operative contact with the receiving container adapted to generate a signal that is indicative of the weight of the receiving container and its contents;

a second sensor being adapted to be positioned in close proximity to said junction transfer conduit or one of said transfer set conduits, said second sensor being in noninvasive sensory contact with fluid present in said conduit, and adapted to sense and selectively determine the absence of said at least one conduit, the absence of fluid in said conduit, and a characteristic of the fluid present in said conduit and generate signals that are indicative of such determination;

a controller for controlling the operation of said apparatus, including said pump assembly and for processing said signals from said first and second sensor and being adapted to generate preselected alarm signals in response to predetermined conditions; and

,

an alarm indicator operatively connected to said controller for providing preselected alarm indications in response to preselected alarm signals being generated by said controller.

22. An assembly for selectively transferring fluids from one or more source containers to form a desired mixture in a receiving container, the assembly comprising:

a pump assembly being adapted to force fluid through each conduit responsive to applied drive signals;

a first sensor assembly for generating a signal that is indicative of the weight of the receiving container;

a second sensor assembly in noninvasive sensory contact with fluid present in a portion of a conduit extending between the source container and the receiving container, the second sensor being adapted to selectively determine the absence of a conduit, the presence of an empty conduit, and a characteristic of the fluid present in the conduit and to generate signals that are indicative of such determinations;

a controller for controlling the pump assembly, for processing the signals from the sensor assemblies, and for selectively generating alarm signals; and

,

an alarm indicator connected to the controller for providing alarms when alarm signals are received from the controller;

said controller monitoring said first sensor assembly signals and data relating to the desired mixture being formed in the receiving container, and determining whether weight gain is occurring after completion of compounding of the desired mixture when said pump assembly is not operating, said controller inhibiting generation of an alarm signal for a predetermined time period after receiving signals from said first sensor assembly indicating a weight gain have been received, said controller receiving signals from said first sensor assembly to determine if the container weight returns to the completed weight that existed before said signals were received indicating a weight gain had occurred, and generating an alarm signal in the event the completed weight is not returned.

23. An assembly as defined in claim 22 wherein said predetermined time period is within the range of about 5 to about 20 seconds.