Feed-fortify enteral feeding and related methods therefor

A pump set for use with a pumping apparatus to deliver nutrition to an infant is disclosed. The pump set can have a first container configured to receiving breast milk; a second container configured to receive fortifier; tubing extending from the first container and from the second container; and a valve mechanism connected to the first and second containers by the tubing and configured to selectively pass liquid from the first container and the second container.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a nonprovisional application of U.S. Serial No. 62/036,194, filed Aug. 12, 2014, the entire contents of which is incorporated herein by reference.

BACKGROUND

The present disclosure generally relates to an enteral feeding of breast milk and fortifier to an infant. Administering fluids containing medicine or nutrition to a patient is generally known in the art. Typically, fluid is delivered to the patient by a pump set received by a flow control apparatus, such as a pump, connected to a source of fluid which delivers fluid to a patient.

Currently, delivering breast milk and fortifier (e.g., formula) to an infant in a clinical setting requires a clinician to thaw a container of breast milk, measure a selected amount of fortifier based on a desired ratio to the amount of breast milk, then manually mix the breast milk and fortifier. This process can waste amounts of breast milk because the ratio of breast milk to fortifier desired may change before the mixture is used up. Because the breast milk is pre-mixed with the fortifier, the mixture may not be suitable for subsequent feedings. Further, the measurement process can be very time consuming. Additionally, this process can be messy since the mixture is prepared by hand, and the process also has the potential to transmit disease to the clinician since breast milk is known to carry blood borne pathogens.

SUMMARY

There is disclosed a method of delivering breast milk and fortifier to an infant using a pumping apparatus that acts on a pump set attached to the pumping apparatus to produce fluid flow through the pump set for delivery of the breast milk and fortifier to the infant. The method, in some cases, comprises receiving input into the pumping apparatus of a predetermined volume of breast milk to be delivered through the pump set to the infant; receiving input into the pumping apparatus of a predetermined volume of fortifier to be delivered through the pump set to the infant; operating the pumping apparatus according to the received input to deliver the predetermined volume of breast milk through the pump set at the selected breast milk flow rate; and operating the pumping apparatus according to the received input to deliver the predetermined volume of fortifier through the pump set at the selected fortifier flow rate.

There is also disclosed a pumping apparatus for use with a pump set to deliver breast milk and fortifier through the pump set to an infant. The pumping apparatus in some cases comprises a pumping device capable of acting on the pump set to produce a fluid flow within the pump set; and a controller in communication with the pumping device for controlling operation of the pumping device in a breast milk delivery configuration for producing a flow of breast milk in the pump set, and in a fortifier delivery configuration for producing a flow of fortifier in the pump set, the controller including a processor and a memory, the controller including a memory adapted to store a value representing amount of breast milk to be delivered through the pump set and a value representing an amount of fortifier to be delivered through pump set.

There is further disclosed a pump set for use with a pumping apparatus to deliver nutrition to an infant. The pump set can comprise a first container configured to receiving breast milk; a second container configured to receive fortifier; tubing extending from the first container and from the second container; and a valve mechanism connected to the first and second containers by the tubing and configured to selectively pass liquid from the first container and the second container. The first and second containers can be formed, in some cases, integrally with each other.

DETAILED DESCRIPTION

Referring now to the exemplary embodiment schematically illustrated inFIGS. 1, 2, and 3, an enteral feeding pump (broadly, “a flow control apparatus”) is generally indicated at1. The pump1may comprise a housing3that is constructed to allow an administration feeding set5(broadly, “a pump set”) to be mounted to the housing. The housing3may comprise a recess7(FIG. 3) for receiving a cassette9of the feeding set5to load the feeding set on the pump. The feeding set5can comprise tubing indicated generally at11that provides a fluidic pathway between a first source of a first liquid such as a container or bag12of nutritional liquid (e.g., breast milk) and an infant (FIG. 1). The tubing11may also provide a fluidic pathway between a second source of a second liquid such as a container or bag13of fortifier (e.g., formula) and the infant. The fortifier can be a pre-mixed powdered formula mixed with water or a liquid fortifier. The cassette9may mount the tubing11for engaging the tubing with the pump1when the cassette is received in the recess7. It will be understood that a pump set may have a construction other than shown herein without departing from the scope of the present disclosure. For example, a pump set (not shown) may not include a cassette9as illustrated herein.

The bags12,13are shown schematically inFIG. 1. In an embodiment, the bags12,13may be rigid containers. For instance,FIG. 1Aexemplarily shows a rigid container12′ including a flared top14′ and a lid15′ configured to snap on to the top of the container. The flared top14′ facilitates easy pouring of a liquid in the container12′ and the lid15′ seals the liquid in the container. The lid15′ may allow the container12′ and/or13′ to function as a storage container for the first and second liquids, such as breast milk and/or fortifier. One or both of the bags12,13could be replaced with containers12′. InFIG. 1Athe bags12,13are individually replaced with the rigid containers12′,13′. In yet another embodiment, an integrated source of the first and second liquids can be utilized. Thus as illustrated, a bifurcated container12″ can be used to hold both the milk and fortifier (FIG. 1B). The bifurcated container12″ may also have a flared top14″ and snap on lid15″. Further, a dual lumen tubing11″ may connect outlets of the bifurcated container12″ to the pump1.

The bag or container holding the breast milk may in one embodiment also be the same container used to collect the breast milk. This potentially eliminates s step involving a transfer of the breast milk between containers prior to delivery to the infant. As a result, the chance for contamination of the milk and/or exposure to the clinician of blood borne pathogens is reduced. This is extremely beneficial in neonatal intensive care units.

As used herein, the feeding set5being “received” by the pump1means that the tubing11is engaged with the pump1so that the feeding set is ready for operation with the pump to deliver liquid to a patient. The term “housing,” as used herein, may include many forms of supporting structures including, without limitation, multi-part structures and structures that do not enclose or house the working components of the pump1.

Referring back toFIGS. 1, 2, and 3, the pump1may include a user interface19with a display screen indicated at21on the front of the housing3that is capable of displaying information about the status and operation of the pump. The pump1can further comprise buttons23and light emitting diodes25on the housing3for use with the display screen21to facilitate exchanging information, such as providing and obtaining information, between the pump1and a user. Various user interfaces for displaying information to the user and receiving user input may be implemented. Any of the various configurations of the user interface can involve utilizing one or more graphical display subcomponents. As an example, the display screen21may be a graphical user interface having a touch screen by which the user can provide the input information. In other embodiments (not shown), the user interface can be a tethered component that can be used to provide input information, provide operating information pertaining to the flow control apparatus, or both.

Referring toFIGS. 2-4, the pump1may include a pump motor27(FIG. 4) located in the housing3. A pump rotor29may be mounted on a rotatable shaft31and rotated by the motor27. In one embodiment, the pump rotor29includes an inner disk39, an outer disk41, and preferably a plurality of rollers43mounted between the inner and outer disks rotatable about their longitudinal axes relative to the disks. The motor27may also be connected to a valve shaft45(FIG. 3). It will be understood that the valve shaft45could be omitted, or a separate motor (not shown) could be provided to operate the valve shaft. The rollers43may engage the administration feeding set5for moving fluid, e.g., liquid, through the feeding set. In the illustrated embodiment, the pump motor27, rotatable shaft31, rotor29, and valve shaft45may broadly be considered “a pumping device”. It will be understood that peristaltic pumps that use mechanisms other than rollers may fall within the scope of the present disclosure. For example, a linear peristaltic pump could be used within the scope of the present disclosure. It is also envisioned that non-peristaltic pumps may be employed. Non-limiting examples of the cassette, apparatus, and controller therefor that may be utilized to implement one or more aspects disclosed herein include the systems and apparatus as disclosed in any of U.S. patent application Ser. No. 14/021,567, titled FEEDING SET WITH CASSETTE AND RELATED METHODS THEREFOR; U.S. patent application Ser. No. 14/472,521, based on U.S. patent application No. 61/871,944, titled FEEDING RATE COMPENSATED PUMP AND RELATED METHODS THEREFOR, and published as U.S. Patent Application Publication No. 2015/0065988 A1; U.S. patent application Ser. No. 14/807,495, based on U.S. patent application Ser. No. 62/028970, titled FLOW DETECTION SYSTEM FOR FLOW CONTROL APPARATUS, each of which is incorporated herein by reference for all purposes including, at least, utilizing for feeding, including operation and control, of the disclosed cassette, pump apparatus, and control system or controller.

Referring now toFIGS. 1, 2 and 4, the tubing11of the administration feeding set5provides a fluidic pathway for two liquid sources, bags12and13, to communicate with an infant. A first inlet tube section47is connected at an inlet of the tubing11to bag12of breast milk and to valve mechanism49(FIG. 4). The valve mechanism may be a stopcock49″ (FIGS. 1A and 1B) or any other suitable mechanism for selectively switching between fluid sources. Operation of the valve mechanism49may be controlled by the pump device by way of connection of the valve mechanism49to the valve shaft45.

A second inlet tube section51is connected at an inlet of the tubing11to bag13of fortifier and to the valve mechanism. The valve mechanism49is operable to selectively permit flow of breast milk from bag12or fortifier from bag13, or prevent any fluid flow communication from the bags12,13past the valve mechanism. Thus, the valve mechanism49can be turned to three positions. A first position closes off all liquid flow from the inlet tube sections47,51past the valve mechanism49. A second position allows breast milk to flow from bag12past the valve mechanism. A third position allows fortifier to flow from bag13past the valve mechanism. Alternatively, the pump1may simultaneously deliver a mixture of breast milk and fortifier from the bags12,13. In this embodiment, the valve mechanism49,49″ could be configured to permit liquid flow from both bags12,13at the same time. Moreover, a mixing device (not shown) could be incorporated into the feeding set to achieve mixing of the breast milk and fortifier. The mixing device can be a static mixer disposed at tubing11downstream from the pump, before introduction of the liquid to the infant. In use, the breast milk bag12and fortifier bag13can be suspended from a suitable support, such as an IV pole (not shown).

The pump1can be programmed or otherwise controlled for operation in a desired manner. For instance, the pump1can begin operation to provide breast milk from bag12to the infant or fortifier from bag13to the infant. The caregiver may select (for example) the amount of breast milk/fortifier to be delivered and the flow rate of the breast milk/fortifier. The pump1may have a controller77(FIG. 4) including a microprocessor79that allows it to accept programming and/or to include pre-programmed operational routines that can be initiated by the care giver. The controller77may also be connected to the pump motor27for controlling its operation to actuate the rotor29and to actuate the valve shaft45for actuating the valve mechanism49. The pump motor27can operate the valve mechanism49and rotor29independently of each other.

If the pump1is to deliver breast milk from the bag12to the infant, the valve shaft45is rotated so that the valve mechanism49is moved to the second position in which fluid communication from the breast milk bag12past the valve mechanism is open and fluid communication from the fortifier bag13past the valve mechanism is closed. The pump1may be programmed or the care giver may select (for example) the amount of breast milk to be delivered to the infant and the flow rate at which the breast milk is to be delivered. The amount of breast milk that is delivered to the infant is controlled by the number of rotations of the rotor29(in a counterclockwise direction as viewed inFIG. 2).

In the illustrated embodiment, the rotor29may include the three rollers43so that each one-third of a rotation delivers one aliquot of liquid to the patient. As each roller43first engages the tubing11, it pinches off the tubing thereby closing off an amount of liquid forward (i.e., toward the patient) from the liquid portion coming from the feeding fluid bag12. The roller43continues to the right, pushing liquid forward of the roller toward the patient. Finally, the roller43releases engagement with the tubing11at about the same time the trailing roller engages the tubing for pinching it off for delivering the next aliquot of fluid. Thus, when the microprocessor79receives a command to deliver a selected fluid flow rate, it calculates the number of rotations within a given period of time that will deliver a number of aliquots producing the desired flow rate. It is to be understood that other ways of changing rotor operation could be used to maintain a constant flow rate. The selected flow rate may be a rate that is selected by the doctor, nurse or other care giver, or may be a default feeding rate pre-programmed into the pump1.

If the pump1is to deliver fortifier from the bag13to the infant, the valve shaft45is rotated so that the valve mechanism49is moved to the third position in which fluid communication from the fortifier bag13past the valve mechanism is open and fluid communication from the breast milk bag12past the valve mechanism is closed. The amount of fortifier that is delivered through the tubing11is also controlled by the number of rotations of the rotor29. The pump1may be programmed or the care giver may select (for example) the amount of fortifier to be delivered through the tubing and the rate at which the fortifier is to be delivered. A fortifier delivery cycle may operate at the programmed or selected interval after the breast milk delivery cycle is initiated/concluded. Additionally, a number of pre-set breast milk/fortifier ratios may be programmed into the microprocessor79to direct the amount breast milk and fortifier delivered to the infant.

As an example, if breast milk to fortifier ratio of 2:1 is selected, the pump will deliver a first volume of breast milk to the infant and a second volume of fortifier to the infant so that the overall delivery of nutritional liquid to the infant is in a 2:1 ratio. The microprocessor79may first instruct the valve shaft45to rotate the valve mechanism49to the second position to deliver breast milk from the breast milk bag12. The pump1will deliver breast milk to the infant at the selected flow rate until the first volume of breast milk is delivered. The microprocessor79may then instruct the valve shaft45to rotate the valve mechanism49to the third position to deliver fortifier to the infant at the selected flow rate until the second volume of fortifier is delivered. At a ratio of 2:1, the pump1will deliver twice as much breast milk as fortifier to the infant. Other ratios are envisioned, including delivering only breast milk or only fortifier. Alternatively, the pump1may deliver the second volume of fortifier before the first volume of breast milk is delivered. The ratios may be based on a selected type and/or brand of fortifier.

It will also be understood that the pump1could be used as a feed/flush pump. In this configuration, bag13can be filled with water as the flushing liquid.

Accordingly, the controller77may comprise a memory area84for storing delivery ratios. The ratios may be pre-programmed into the pump memory area84or could be wirelessly or otherwise downloaded to the pump1. The controller77may be programmed to deliver nutrition and different times in different ratios of breast milk to fortifier. Selection of the particular ratio of first liquid to second liquid may be based on several factors including but not limited to the hourly, daily, or weekly caloric requirements to be delivered to the patient, e.g., neonate, the fat requirements to be delivered, the time of delivery of the liquids, as well as requirements for specific nutritional components. For example, if a specified daily amount of calories may be set for a neonate to supplement the daily breast milk intake, then the ratio of the breast milk to the daily calorie target may be based on the amount of available breast milk relative to the caloric density of the supplemental second liquid, e.g., the fortifier.

Various aspects and embodiments disclosed herein may be described in the general context of computer-executable instructions, such as program modules, executed by one or more computers or other devices. The computer-executable instructions may be organized into one or more computer-executable components or modules including, but not limited to, routines, programs, objects, components, and data structures that perform particular tasks or implement particular abstract data types. Any of the various aspects may be implemented with any number and organization of such components or modules. For example, some disclosed aspects are not limited to the specific computer-executable instructions or the specific components or modules illustrated in the figures and described herein. Other embodiments and aspects may include different computer-executable instructions or components having more or less functionality than illustrated and described.

Further, the order of execution or performance of the operations exemplarily illustrated and described herein is not essential, unless otherwise specified. That is, the operations may be performed in any order, unless otherwise specified, and any of the disclosed embodiments may include additional or fewer operations than those disclosed herein. For example, it is contemplated that executing or performing a particular operation before, contemporaneously with, or after another operation is within the scope of aspects of the disclosure.

In operation, the microprocessor79executes computer-executable instructions to implement any of the various herein disclosed aspects. Any of the various aspects may also be practiced in distributed computing environments where tasks are performed by remote processing devices linked through a communications network. In a distributed computing environment, program modules may be located in both local and remote computer storage media including memory storage devices.

Having described the aspects and features in detail, it will be apparent that modifications and variations are possible without departing from the scope defined in the appended claims.

In view of the above, it will be seen that the several objects are achieved and other advantageous results attained.