Apparatus, systems and methods for minimizing fat loss in collection and feeding of human breast milk
The fluid containment and dispensing system addresses the challenge of minimizing fat loss in human breast milk collection and feeding by using a variable-volume container with a movable floor and a filter, achieving efficient fat transfer to neonates.
Patent Information
- Application Number
- PCT/US2024/047862
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-03-08
- Filing Date
- 2024-09-20
- Publication Date
- 2025-03-27
AI Technical Summary
Existing systems for collecting and feeding human breast milk face challenges in minimizing fat loss during collection, transfer, and feeding, particularly in neonatal intensive care units where preterm infants require specialized nutrition.
A fluid containment and dispensing system featuring a variable-volume container with a movable floor and a breast shield lactation pump head, designed to minimize fat loss by adjusting the contained volume and using a filter to separate lipids from the remainder of the fluid.
The system effectively minimizes fat loss during breast milk collection and feeding, ensuring that up to 96% of the fat in breast milk is successfully transferred to the neonate, compared to conventional systems which achieve only about 70% fat transfer.
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Abstract
Description
APPARATUS, SYSTEMS AND METHODS FOR MINIMIZING FAT LOSS INCOLLECTION AND FEEDING OF HUMAN BREAST MILKCROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of and priority to U.S. Provisional Patent Application Serial No. 63 / 583,881, filed September 20, 2023, and claims the benefit of and priority to U.S. Provisional Patent Application Serial No. 63 / 562,812, filed March 8, 2024, the entire contents of which are hereby incorporated herein by reference.BACKGROUND
[0002] The present disclosure relates generally to medical devices and more particularly the present disclosure relates to apparatuses, systems and / or methods for minimizing nutrition loss during collection, transfer and feeding of human breast milk.
[0003] The Neonatal Intensive Care Unit (NICU) is a hospital nursery where infants receive specialized care as a result of preterm birth defined as less than 37 weeks of gestation, low birth weight, or health conditions that require continuous care. Out of the 140 million infants that are bom each year worldwide, 15 million are born preterm, increasing their susceptibility to health challenges as a consequence of hindered intrauterine development.SUMMARY
[0004] In some implementations, the techniques described herein relate to a fluid containment and dispensing system, including: a variable-volume container, including: an elongate body spanning between a first end and a second end and defining an internal volume therebetween; a cover coupled to the second end and including a fluid port; and a movable floor slidably mounted within the internal volume.
[0005] In some implementations, the techniques described herein relate to a fluid containment and dispensing system, including: a first variable- volume container including: a first elongate body having a first bore between a first end and a second end; a first floor slidably mounted within the first bore and providing a seal defining a first contained volume on a first side thereof, and an uncontained volume on a second side opposite the first side; and a removablecover coupled to the second end of the first elongate body; a breast shield of a lactation pump head configured to couple to the second end of the first elongate body and to direct lactated nutrition into the contained volume of the first variable-volume container; and a plunger stem configured to engage the first floor and move the first floor within the first elongate body to thereby adjust the contained volume.
[0006] In some implementations, the techniques described herein relate to a variable-volume container, including: an elongate body spanning between a first end and a second end and defining an internal volume therebetween; a cover coupled to the second end; and a floor slidably mounted within the internal volume, the floor including at least one of a gasket or a wiper, and a skirt around a perimeter of the floor.
[0007] In some implementations, the techniques described herein relate to a method for administering nutrient to a recipient, including: expressing a volume of nutrient into a collection container having a variable containment volume and a movable floor; attaching a cover to a second end of the collection container; inserting a plunger stem into a first end of the collection container opposite the second end of the collection container; attaching the plunger stem to the movable floor; moving, via the plunger stem, the movable floor toward the cover to eject gas from the contained volume; and ejecting the nutrition from the contained volume.
[0008] In some implementations, the techniques described herein relate to a fluid containment and dispensing system including: a collection container including an interior wall defining an interior volume of the collection container; and a spatula sized and configured to be received within the interior volume of the collection container, the spatula including: an elongated body including a central lumen extending therethrough, and a wing extending radially from the elongated body for wiping the interior wall of the collection container.
[0009] In some implementations, the techniques described herein relate to a device for removing the contents from the interior of container, the device including: a spatula sized and configured to be received within the interior volume of a collection container, the spatula including: an elongated body including a central lumen extending therethrough, a first wing and a second wing extending radially from the elongated body, the first wing extending from an opposite side of the elongated body from the second wing, where the wing is located adjacent a distal end of the elongated body a coupling mechanism at a proximal end of theelongated body, the coupling mechanism configured to removably couple the spatula 30 to a collection device
[0010] In some implementations, the techniques described herein relate to a method removing the contents from the interior of a container including: providing a collection container including an interior wall defining an interior volume, and an opening provided at the first end 18 of the collection container; inserting a spatula into the opening of the collection container and into the interior volume, the spatula including: an elongated body including a central lumen extending therethrough, and a wing extending radially from the elongated body; and moving the spatula rotationally and / or axially within the interior volume of the collection container such that the wing contacts the interior wall of the collection container and contents of the collection container adhered to the interior wall are dislodged from the interior wall.
[0011] In some implementations, the techniques described herein relate to a nutrition containment and dispensing system, including: a barrel spanning between a first end and a second end and defining an internal volume therebetween, the barrel having a first opening at the first end and a second opening at the second end; a filter slidably mounted within the internal volume and dividing the internal volume into a first chamber and a second chamber, the filter including a filter media configured to prevent solids and semisolids from passing therethrough; a filter plunger stem configured to engage the filter and move the filter within the internal volume to thereby adjust a volume of the first chamber and a volume of the second chamber.
[0012] In some implementations, the techniques described herein relate to a method for preparing and providing nutrition to a recipient, including: providing a flow of lactated nutrient through a barrel including a lipid filter slidably mounted within a bore of the barrel; accumulating lipids contained within the flow of lactated nutrients within a first chamber of the bore of the barrel; providing the accumulated lipids to a recipient.
[0013] In some implementations, the techniques described herein relate to a kit including: a barrel having a bore between a first opening at a first end and a second opening at a second end; a filter configured to be slidably mounted within the bore of the barrel; and a collection container configured to couple with the second opening at the second end of the barrel.BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIGS. 1-2 are perspective views of a collection system including a collection container, according to an exemplary implementation;
[0015] FIGS. 3-4 are perspective views of the collection container and a transfer syringe, according to some implementations;
[0016] FIGS. 5-8 are perspective views of the transfer syringe and a secondary collection container, according to some implementations;
[0017] FIG. 9 is a perspective view of collection containers and a secondary collection container, according to some implementations;
[0018] FIG. 10 is a perspective view of the collection container being aspirated, according to some implementations;
[0019] FIG. 11 is a perspective view of the collection container and a transfer syringe, according to some implementations;
[0020] FIG. 12 is a front top right perspective view of a collection container, according to some implementations;
[0021] FIG. 13 is a top view of the collection container of FIG. 12, according to some implementations;
[0022] FIG. 14 is a bottom view of the collection container of FIG. 12, according to some implementations;
[0023] FIG. 15 is a section view of the collection container taken along the line A- A of FIGS. 13 and 14, according to some implementations;
[0024] FIG. 16 is a section view of the collection container with a plunger stem engaging a floor of the collection container, according to some implementations;
[0025] FIG. 17 is a section view of the collection container with the floor pressed against the cover, according to some implementations;
[0026] FIG. 18 is a perspective view of the plunger ram of FIGS. 16 and 17, according to some implementations;
[0027] FIG. 19 is a perspective view of a plunger ram, according to some implementations;
[0028] FIGS. 20-21 are perspective views of the plunger stem of FIG. 19 engaging the floor of the collection container, according to some implementations;
[0029] FIG. 22 is a perspective view of a cover, according to some implementations;
[0030] FIGS. 23-24 are detail section views of the cover and a barrel, according to some implementations;
[0031] FIGS. 25 is a perspective view of the floor, according to some implementations;
[0032] FIGS. 26-27 are section views of the floor and barrel, according to some implementations;
[0033] FIG. 28 is a perspective view of a base flange of the barrel, according to some implementations;
[0034] FIGS. 29-30 are perspective views of a floor, according to an exemplary implementation;
[0035] FIGS. 31-32 are section views of the floor and barrel, according to some implementations;
[0036] FIGS. 33-34 are perspective views of a floor, according to an exemplary implementation;
[0037] FIG. 35 is a perspective view of a seal, according to some implementations;
[0038] FIG. 36 is a perspective view of a plunger stem, according to an exemplary implementation;
[0039] FIG. 37 is a perspective view of the floor and the plunger stem of FIGS. 33-36, according to some implementations;
[0040] FIG. 38 is a section view of the floor and the plunger stem of FIG. 37, according to some implementations;
[0041] FIG. 39 is a perspective view of a floor, according to an exemplary implementation;
[0042] FIGS. 40-41 are section views of the floor of FIG. 39 in a barrel, according to some implementations;
[0043] FIG. 42 is a perspective view of a floor, according to an exemplary implementation;
[0044] FIGS. 43-44 are section views of the floor of FIG. 42 in a barrel, according to some implementations;
[0045] FIG. 45 is a perspective view of a floor, according to an exemplary implementation;
[0046] FIGS. 46-47 are section views of the floor of FIG. 45 in a barrel, according to some implementations;
[0047] FIG. 48 is a perspective view of a floor, according to an exemplary implementation;
[0048] FIGS. 49-50 are section views of the floor of FIG. 48 in a barrel, according to some implementations;
[0049] FIG. 51 is a perspective view of a floor, according to an exemplary implementation;
[0050] FIGS. 52-53 are section views of the floor of FIG. 51 in a barrel, according to some implementations;
[0051] FIG. 54 is a perspective view of a floor, according to an exemplary implementation;
[0052] FIG. 55 is a perspective view of a floor, according to an exemplary implementation;
[0053] FIG. 56-59 are flow diagrams for using a nutrition collection system, according to some implementations;
[0054] FIG. 60 is a table of test data, according to some implementations;
[0055] FIGS. 61 and 62 are side elevation view of an example collection container;
[0056] FIG. 63 is a perspective view of an example spatula;
[0057] FIG. 64 is a side perspective view of an example nutrition containment and dispensing system;
[0058] FIG. 65 is a partial side view of the nutrition containment and dispensing system of FIG. 64;
[0059] FIG. 66 is a partial side view of the nutrition containment and dispensing system of FIG. 64;
[0060] FIG. 67 is a flow diagram for using a nutrition containment and dispensing system according to FIGS. 61-66.
[0061] FIG. 68 is a perspective view of a nutrition collection system, according to some implementations;
[0062] FIG. 69 is a perspective view of a filter, according to some implementations.
[0063] FIG. 70 is a perspective view of a nutrition collection system filtering a flow of nutrition, according to some implementations;
[0064] FIG. 71 is a perspective view of a nutrition collection system having an accumulation in the first chamber, according to some implementations;
[0065] FIG. 72 is a perspective view of a collection container and a collection device 134;
[0066] FIG. 73-74 are perspective views of a nutrition collection system including a nipple attachment and a plunger stem, according to some implementations;
[0067] FIG. 75 is a perspective view of a nutrition collection system including a plunger stem and an enteral feeding tube, according to some implementations;
[0068] FIG. 76 is a perspective view of a nutrition collection system delivering nutrition to a neonate, according to some implementations;
[0069] FIG. 77 is a perspective view of a nutrition collection system and a collection device, according to some implementations;
[0070] FIG. 78 is a flow diagram using a nutrition collection system, according to some implementations; and
[0071] FIG. 79 is a flow diagram using a nutrition collection system, according to some implementations.DETAILED DESCRIPTION
[0072] Before turning to the figures, which illustrate the exemplary implementations in detail, it should be understood that the present application is not limited to the details or methodology set forth in the description or illustrated in the figures. It should also be understood that the terminology is for the purpose of description only. Like reference numerals in the figures may represent and refer to the same or similar element, feature, or function.
[0073] Described in detail herein are systems and methods for improved nutrition savings in fluid containment and dispensing systems. Collecting, containing, and dispensing liquids such as lactated nutrition (e.g., human milk), poses many technical challenges and can be difficult and burdensome. For example, the nutrition profile of human breast milk is composed of several beneficial macromolecules including lipids, proteins, and carbohydrates. Of these, the largest potential for ensuring nutritional uptake from HBM is lipids. While lipids make up only 5% of human milk volume, they account for 50% of infants’ daily energy intake. Premature babies can absorb 95% of human milk fat; however, on average only 5% of HBM is fat and fat-soluble components, including many vitamins. These fat and fat-soluble components constitute the majority of the calories in HBM, so it is desirable to maximize lipid (i.e. fat) delivery.
[0074] Studies have shown that due to its molecular properties, the fat in HBM has a tendency to adhere to the vessels it passes through during collection, preparation, handling, and delivery. Moreover, many neonatal patients are unable to be directly breastfed HBM due to factors such as an underdeveloped digestive system, the presence of ventilators, or an overall lack of physical strength. In some situations, providing nutrition via enteral feeding can be necessary. Ensuring proper nutrition for patients allows for normal growth and organ development and overcoming preterm health conditions. Often, HBM is uniquely suited to an infant’s nutritional needs and is a live substance with unparalleled immunological and anti-inflammatory properties that may protect against a host of illnesses and diseases for both mothers and babies.
[0075] The nutrition saving containment system and method described herein provides solutions to these and other technical problems through an improved apparatus, e.g., collection container, and / or accessories to be used therewith to improve nutrition (e.g., HBM nutrition)savings during a feeding process such as enteral feeding. For example, the collection container and plunger stem provides a user the flexibility to selectively sweep and aspirate one or more containers that may be implemented in the collection, preparation, storing, and / or delivery of liquid nutrition. Advantageously, the systems and methods described herein provide improved nutrition savings and ergonomics.
[0076] Referring now to FIGS. 1-4 and 12-17, a nutrition collection system 10 includes a collection container 100, e.g., collection bottle, having a variable containment volume, according to some implementations. The collection container 100 may have an elongate body 112 extending along a longitudinal axis 111 between a first end 114 (e.g., base end) and a second end 116 (e.g., top end) and defining an internal volume 118 between the first end 114 and the second end 116. For example, the elongate body 112 may be a barrel having a bore. In some implementations, the sidewall 120 of the elongate body 112 has an inward facing surface, shown as inner surface 122, and an outward facing surface, shown as outer surface 124. One of the first end 114 and the second end 116, e.g., the second end 116, is an open end configured to receive a cover 130 to seal the collection container 100 and / or couple with a lactation pump head 132 of a breastmilk collection device 134 such as a funnel or breast shield 136 coupled to a pump 138. In some implementations, the first end 114 of the collection container 100 can be coupled to an adapter to facilitate coupling a different sized collection container 100 (e.g., a larger collection container) to the lactation pump head 132 / breast shield 136. Coupling to an adapter allows the user to customize the size of the nutrition collection system 100 and / or lactation pump head 132 used to accommodate their needs. In some implementations, the open end 116 may include an engagement feature 140 such as a threaded portion (e.g., male threads) that are configured to engage a corresponding engagement portion 142 such as a corresponding threaded portion (e.g., female threads) of the cover 130 and / or the lactation pump head 132 of the breastmilk collection device 134. The other of the first end 114 and the second end 116, e.g., the first end 114, may have a floor 152 (e.g., piston) forming an opposite end of the contained volume 150 within the internal volume 118 of the elongate body 112. In some implementations, the collection container 100 is graduated and / or the sidewall 120 comprises a plurality of markings 156 regarding the volume of the contained volume 150 of the collection container 100 relative to the position of the floor 152 along the longitudinal axis 111.
[0077] In some implementations, the movable floor 16 has a substantially identical shape as a cross-sectional shape of the elongate body 12 such that the movable floor 152 can seal the end of the elongate body 112. In some implementations, the movable floor 152 is slidably mounted within the bore of the elongate body 112.
[0078] In some implementations, the movable floor 152 may have a seal portion 160 configured to maintain sealing contact between the floor 152. For example, the seal portion 160 may include a gasket 162 (see, e.g., FIGS. 29-46) surrounding an outer perimeter edge thereof, shown as outer edge 302. In some implementations, the gasket 162 may be inserted within a channel 164 (e.g. , groove, compression ring groove, o-ring slot, etc.) about a periphery of the movable floor 152. In some implementations, the gasket 162 is provided by a seal material coupled to and / or integrally formed with the movable floor 152. For example, the gasket 162 can include a seal material (e.g., silicone) overmolded onto the movable floor 152. The gasket 162 may form a fluid-tight seal between the movable floor 152 and the elongate body 112. For example, the outer diameter of the gasket 162 may maintain sealing contact with the inner surface 122 of the sidewall 120 as the movable floor 152 translates along the longitudinal axis 111 within the internal volume 118. In some implementations, the movable floor 152 may include one or more gaskets 162, such as two or more gaskets 162, e.g., axially spaced apart. See, e.g., FIGS. 33-38. The gaskets 162 may have differing functions, for instance, a gasket 162 for sealing and a gasket 162 for redundancy or stability of the movable floor 152 within the elongate body 112. In some implementations, the inner diameter of the gasket 162 is about equal to or slightly smaller than the diameter of the channels 164 of the seal portion 160, thereby providing secure retention of the gaskets 162 on the seal portion 164. The outer diameter of the gaskets 162 when installed in tension onto the seal portion 160 is slightly greater than the inside diameter (e.g., bore diameter) of the elongate body 112, such that flexure and compression of the gasket 162 allows the floor 152 to slide smoothly in continuous sealing contact along the length of the elongate body 112. In some implementations, movable floor 152 does not include a separate gasket 162. Instead, the gasket 162 function is provided by the structure of the movable floor 152. For example, the movable floor 152 can include a wiper or other interference feature for providing a seal between the movable floor 152 and the elongate body 112.
[0079] In some implementations, a gasket 162 nearer to the top surface 168 of the floor 152 may he provided to sweep nutrition up the sides of the elongate body 112. For example, whenthe floor 152 slides along the longitudinal axis 111, the gasket 162 may dislodge solids and semi-solids (e.g., milk fat) on the inner surface 122, and carry and / or slide the dislodged solids and semi-solids toward the open end 116. In some implementations, the solids and semi-solids may be or include milk-fat, formula, debris, or combinations thereof. In some implementations, multiple gaskets 152 may have differing cross-sectional shapes. A gasket 152 nearer to the sloped surface 168 may have a generally flat profile on an upper surface to prevent liquid from pooling on top of the gasket 152 between the sloped surface 168 and the elongate body 112. In some aspects, a gasket 152 nearer to the recess 153 may include a vent, e.g., between the gasket 18 and the channel 19, to prevent a vacuum from forming between the two gaskets 18.
[0080] Referring to FIGS. 1-2, and 9, the movable floor 152 may be disposed at the first end 114 of the elongate body 1 12 during a nutrition collection process (e.g., a milk collection process). For example, a mother or other mammal may transfer or express a nutrient (e.g., milk) into the collection container 100 via, e.g., the collection device 134. Referring now to FIGS. 3-4, the collection container 100 may be coupled with a syringe 186 (e.g., an enteral feeding syringe) or other transfer device to transfer the collected nutrient (e.g., human breast milk (HBM)) from the contained volume 150 of the collection container 100, according to some implementations. For instance, the cover 130 may provide a coupler 183 configured to fluidly couple a syringe body 190 to the contained volume 150 of the collection container 100. Referring to FIG. 4, as a syringe plunger 192 is withdrawn (e.g., in direction 194) to create a vacuum within the syringe body 190 to transfer HBM from the container 100 into the syringe body 190, the suction pressure of the syringe 186 further initiates sufficient suction to move the movable floor 152 of the container 100 upward toward the first end of the elongate body 12 (e.g., in direction 196). In doing so, the gasket 162 can sweep the interior walls of the elongate body 112 to force any nutrition stuck to the inner surface 122 of the interior walls in the direction 196 (e.g., upward, toward the cover 130 and into the coupler 183). Advantageously, by sweeping the interior walls with the seal portion 160 as the movable floor 152 is moved upwards by suction, nutrition savings can be improved, as little to no nutrition may be left stuck to the interior walls of the elongate body 112 below a present location of the movable floor 152, according to some implementations.
[0081] Referring to FIGS. 5-6, the nutrition collection system 10 includes a second variablevolume container 300, according to some implementations. The second variable volume container 300 may include some or all of the features and functions of the collection container100. For example, the second variable volume container 300 may include a floor 352 slidably mounted within an internal volume 318 of a second elongate member 312. In some embodiments, the second variable volume container 300 is a reservoir configured to a greater volume than the volume of the collection container 100. For example, the second variable volume container 300 may store nutrition from multiple milking sessions. In some implementations, the floor 352 of the second variable volume container 300 may initially be near the open end 316. Referring to FIG. 6, when the syringe 186 is coupled to the cover 330 of the second variable volume container 300, and the plunger 192 is actuated (e.g., pushed in a direction 198 opposite direction 194) to force the contents of the syringe body 190 into the contained volume 350 of the second variable volume container 300, the second floor 352 is pushed toward the first end 314 of the second elongate body 312.
[0082] Referring to FIGS. 7-9, the syringe 186 may be coupled to the second variable volume container and draw up a quantity of nutrient from the second variable volume container 300. In some implementations, the nutrient is drawn into the syringe 186 in a similar manner as shown and described with reference to FIG. 4. In some implementations, the syringe 186 containing collected nutrition is configured to be coupled to an enteral feeding pump and the collected nutrient is ejected from the syringe 186 into an enteral feeding tube. In some implementations, the nutrition collection system 10 may include multiple collection containers 100. The collection container 100 may deposit liquid nutrition directly into the secondary variable volume container 300. In some implementations, the floor 152 is initially proximate the first end 114. A plunger stem 170 may be inserted into the internal volume 118 and engage the floor 152 and slide the floor 152 in a direction 171 toward the cover 130. In some implementations, the direction 171 is parallel to the longitudinal axis 111.
[0083] Referring to FIGS. 10-11, the container 100 may be situated on a supportive surface (e.g., a table, a countertop, a flat surface, the ground, etc.). A user may grasp the syringe body 190 of the syringe 186 and draw the syringe plunger 192 in a direction away from the contained volume 150 and thereby draw the contents of the contained volume 150 into the syringe body 190. In some implementations, the collection container 100 may be positioned to elevate the cover 130 gravitationally above the contained volume 150. In some implementations, the plunger stem 170 may slide the floor 152 toward the cover 130 and cause the collection container to eject gasses trapped within the contained volume 150 through a fluid port 131 of the cover 130.
[0084] Referring to FIGS. 16-18, the plunger stem 170 is configured to engage the floor 152 and slide the floor 152 in a direction 171 towards the cover 130. The plunger stem 170 includes a body 172 spanning between a distal end 173 and a proximal end 174. The distal end 173 may be compatible with a receiver 153 (e.g., recessed portion, pocket, blind hole, tapped hole, etc.) provided on the floor 152. In some implementations, the proximal end 174 includes a handle or knob 175 that is graspable by a user. The body 172 may include a hollow portion (e.g., a hollow cylinder portion) spanning at least a portion of the length of the body 172. In some implementations, the proximal end 174 has a first opening 176, and the distal end 173 has a second opening 177. In some implementations, the first opening 176 is in fluid communication with the second opening 177. In some implementations, the body 172 includes multiple thumbholds 178 (e.g., pockets, recesses, ledges, etc.) providing surfaces on which a user may apply force in the direction 171 to push the plunger stem and slide the floor 152 along the longitudinal axis 111 of the elongate member 112. In some implementations, the body 172 has multiple apertures 179 circumferentially spaced around a longitudinal axis of the plunger stem 170. In some implementations, the multiple apertures are in fluid communication with the first opening 176 and / or the second opening 177.
[0085] In some implementations, the plunger stem 170 may be provided for use with the collection container 100. The plunger stem 170 may be adapted to mate with an external-facing surface of the movable floor 152, e.g., to push the movable floor 152 toward the cover 130 without using suction as described above. For instance, the plunger stem 170 may have a contact face at the distal end 173 that is adapted to mate with the movable floor 152. The movable floor 152 may have a recess 153 or opening on an external facing surface thereof that is configured to receive the contact face of the plunger stem 170. When the distal end 173 of the ram 170 is inserted into the recess 153, a user may push the plunger stem 170 in a direction towards the second end 166 of the elongate body 112 so that the movable floor 152 moves towards the second end 116. In some implementations, the contact face of the distal end 173 may have a diameter slightly smaller than a diameter of the movable floor 16, e.g., from about 50% to about 100% of a diameter of the movable floor 152.
[0086] In some implementations, the plunger stem 170 may easily be inserted into the recess 153 and may provide enhanced stability of the movable floor 152 when pushing through the elongate body 112, e.g., by evenly pushing the movable floor 152 along the longitudinal axis 111 rather than unevenly pushing one radial side of the movable floor 152 ahead, which alsomay be referred to as “tilting” of the movable floor 152. Furthermore, having a contact face at the distal end 173 approximately the same size as the movable floor 152 may also prevent tilt by preventing the plunger stem 170 from moving side to side. The present inventors have found that tilting of the movable floor 152 may increase leakage of fluid from the container 100 between the elongate body 112 and the movable floor 152. Moreover, tilting of the movable floor 152 may cause increased friction when the movable floor 152 is pushed toward the cover 130, increasing the difficulty of use for a user and potentially causing frustration and misuse by a user.
[0087] Referring to FIGS. 20-21, a user may grasp a flange or lip 115 provided at the first end 114 of the elongate body 112 and apply a pinching or clamping force between the lip 115 and a first pair of thumb holds 178, shown as thumb-holds 178A. Referring to FIG. 21 , the floor 165 has moved (e.g., slid) within the internal volume 118 and a user may apply a pinching or clamping force between the lip 115 and a second pair of thumb holds 178B . The pairs of thumb holds 178 may be on opposite sides of the plunger stem 170 at similar points along the length of the plunger stem 170. In some implementations, a user may apply a pinching or clamping force between the lip 115 and the knob 175 to slide the floor 152 along the longitudinal axis 111 and into contact with the cover 130. Referring now to FIGS. 19-21, the plunger stem 270 includes a knob 175 having an outer diameter and recesses 272 extending circumferentially on the peripheral edge of the knob 175. The plunger stem 270 may include some or all of the features and functions of the plunger stem 170. Likewise, the plunger stem 270 may include some or all of the features and functions of the plunger stem 170. In some implementations, the knob includes defines multiple recesses 272 having a radius of curvature less than an overall outer diameter of the knob 175.
[0088] Referring to FIGS. 15 and 23-4, the cover 130 may have a sloped profile 135 that is sloped or angled downward from the fluid port 131 and coupler 183 to the elongate body coupler 142. FIG. 17 illustrates a cross sectional view of the cover 130 and a side view of the elongate body 112 having the movable floor 152 drawn up to the first end thereof 114. In some implementations, the cover 130 provides a fluid port 131 and a cap 133 configured to selectively seal the fluid port 131, according to some implementations. The fluid port 131 may be or include a coupler portion 183. For example, the coupler portion 183 may facilitate a fluid connection between the contained volume 150 and the syringe 186 via a reverse luer lock (e.g., ENfit™ Connecter) or slip lock coupler. In some implementations, the cover 1 0 may have asloped surface 135, and may provide a ceiling to the contained volume 150. In some implementations, the shape of the sloped surface 135 may be conical. In some implementations, the fluid port 131 may provide a flow path between the internal volume 118 and the exterior of the container 100 and allows for flow of the contents of the contents of the elongate body 112 through the cover 130.
[0089] Referring to FIGS. 15-17, the movable floor 152 may have an interior-facing surface 168 disposed within the elongate body 112 that defines a floor of the contained volume 150. The interior-facing surface 168 may have a convex profile (see FIGS. 27 and 31) to reduce or eliminate the “dead-space” between the interior- facing surface 168 and the sloped surface 135 of the cover 130. For instance, an angle or pitch of the interior-facing surface 168 may be approximately equal to an angle or pitch of the sloped surface 135, i.e., equal or within about 1-2 degrees of the angle of the sloped surface 135. Similarly, any surface profile features of the sloped surface 135 can be complementarily matched by the interior- facing surface 168 to further reduce deadspace. The present inventors have found that, by matching or substantially matching the pitch of the interior- facing surface 168 and the sloped surface 135, the quantity of HBM lost during transfer from the elongate body 112 to a syringe 186 or other vessel can be minimized or nearly eliminated, thereby improving the efficiency of transferring HBM to improve the amount of HBM able to be fed to a patient. The angle of the sloped surface 135 and the angle of the interior-facing surface 168 may be in a range from about 1 degree to about 5 degrees, such as from about 2 degrees to about 4 degrees, for instance, about 3 degrees. In some implementations, the angle of the interior-facing surface 168 is grater than 5 degrees. The present inventors have found that an angle of about 3 degrees may result in superior reduction of volume of fluid, e.g., breastmilk (fluid having both water and lipid properties), left behind in the container. See Table 1 below for comparative data between prototype bottles having 3 degree, 5 degree, and 7 degree slopes on both the interior facing surface 168 and the sloped surface 135.Table 1 - Comparative Data Between Containers Having Various Slope Angles
[0090] In some aspects of the present invention, the sloped surface 135 of the cover 130 may have a smooth surface finish to reduce lipid adhesion onto the surfaces of the syringe. For instance, an A2 polish surface finish may be used. Similarly, the sloped surface 62 of the movable floor 16 may be provided with a surface finish configured to reduce lipid adhesion, such as an A2 polish surface finish.
[0091] The present inventors have found that an A2 polish surface finish shows reduced nutrition loss and adhesion between nutrition and the sloped surface 62 as compared to other surface finishes. Table 2 below demonstrates data from testing of various surface finishes and the average amount of nutrition loss, measured in grams. The following surface finishes on polypropylene were tested: A2, A3, B2, B3, Tl, and T2. The nutrition sampled was milk. Each sample was repeated ten times.Table 2 - Comparative Data of Containers Having Various Surface Finishes
[0092] In a further example of testing the container having a 3 degree slope on both the interiorfacing surface 168 and the sloped surface 135, ten samples were tested for volume left behindin the container, as shown in Table 3. The mean volume left behind in the container over the ten samples was 0.45 mL. The median volume left behind in the container over the ten samples was 0.45 mL.Table 3 - Comparison of Volume Left Behind
[0093] The container 100 was further tested in comparison to a competitor container in a process of transferring nutrition fluid out of the container using a syringe. The container 100 had a sloped surface 168 at an angle of about 3 degrees and a movable floor 152 having two gaskets 164. The competitor container included an 8 ounce polypropylene bottle having a flat screw cap. Ten test samples were performed for each of the container 10 and the competitor’s product. The results are shown in FIG. 60.
[0094] Overall, the comparative testing showed that the mean volume left behind in the container 100 was 0.23 mL, while the mean volume left behind in the competitor’s container was about 0.78 mL. In other words, the competitor’s container left behind three times as muchnutrition in the container compared to the container of the present invention. Stated differently, the container of the present invention shows a 200% improvement in reduction of nutrition left behind in a container.
[0095] Referring to FIGS. 25-26, 48-55, the floor 152 includes a seal portion 160 having a wiper 141 (e.g., a wiper lip, a wiper flange, a wiper blade, etc.) extending circumferentially around a side of the floor 152, according to some implementations. In some implementations, the wiper 141 is edge leading when the floor is slid from the first end 114 to the second end 116 of the elongate body 112. For example, the distahnost portion of the wiper 141 may extend radially outward and toward the surface 168. In some implementations, the floor 152 is a unitary body.
[0096] Referring to FIGS. 25-27, 29-32, and 39-55, the floor 152 includes a skirt 180, according to some implementations. In some implementations, the skirt 180 has axial ribs 155. The axial ribs 155 may protrude radially from a peripheral surface 157 of the skirt 180 and extend in an axial direction. The skirt 180 may also include multiple legs 159. The legs 159 may be annular. For example, the multiple legs 159 may define an inner diameter and an outer diameter. In some implementations, the multiple legs 159 may be spaced circumferentially around a central axis 161 of the floor 152. In some implementations, the skirt 180 provides a thrust face for centering and / or aligning the floor 152 within the internal volume 118 when an axial force is applied to the receiver 153 by the plunger stem 170. This helps to prevent torquing or pivoting movement of the floor 152 within the interval volume 118 with respect to the longitudinal axis 111 of the container 100. In some implementations, the skirt 180 includes multiple cutouts 238 between the legs 159. In some implementations, the bottom edge 232 of the legs 159 define the bottom-most edge of the skirt 80. In some implementations, at least a portion of the inner and outer surface of the legs 159 are aligned with the outer surface of the skirt 80. In some implementations, the legs 159 include a foot portion 240.
[0097] Referring to FIGS. 23-24, the inner surface 122 of the opening 202 at the second end 116 features a chamfer or bevel 137. The cover 130 may include a boss 139 protruding from the sloped surface 135. In some implementations, the boss 139 may extend into the opening at the second end 116 of the elongate member 112. In some implementations, the boss 139 may occupy a space 117 defined between the floor 152 and the inner wall 122 when the floor 152 is in contact with the cover 130. In some implementations, the boss 139 may cover the bevel 137 when the cover 130 is coupled to the second end 116 of the elongate member 112.
[0098] Referring to FIG. 28, the first end 116 of the elongate body 212 may include a flange or lip 115 extending circumferentially from a bottom side of the elongate body 112. The flange or lip 115 may be generally flat, e.g., to provide a surface to stand or rest and / or to provide an ergonomic surface for a user to engage one or more fingers with while depressing the plunger stem 170. The flange or lip 115 may be generally round or circular shaped, with a flat section 119 to prevent the container 100 from rolling if tipped over. In some aspects, more than one flat section 119 may be provided about a circumference of the flange or lip 115. In some implementations, the profile of the flange or lip 115 is polygonal (e.g., hexagonal, octagonal, pentagonal, etc.). In some implementations, a groove 121 may be provided along a bottom surface 123 of the flange or lip 115, e.g., on a surface upon which the elongate body 112 may stand. The groove 121 may function as a vent in order to prevent formation of a vacuum or suction between the flange or lip 115 and a surface upon which the elongate body 112 stands. The groove 121 may be provided in a radial direction at any point about the flange 115, for instance, along a portion of the flat section 119, as shown in FIG. 28. Referring to FIG. 17, in some implementations, lip 115 extends radially inward from an inner surface of the elongate body 112 and into the internal volume 118. An inner edge 206 of the lip 115 may define an opening 214. A portion 210 of the inner edge 206 of the lip 115 extends axially into the internal volume 118 forming a shoulder 212 such that a recess 216 is formed between the shoulder 212 and the inner surface 122 of the elongate body 112. The recess 216 may extend circumferentially around the elongate body 112. In some implementations, a portion of the bottom surface 230 and / or edge 232 of the floor 152 is received within the recess 216 when the floor 152 is in a bottom-most position.
[0099] Referring to FIGS. 33-35, the gasket 162 may have an undulating side profile. For instance, the gasket 162 may be an X-style gasket having a double ridged side profile with upper and lower convex portions or “ridges” and a concave portion between. However, it is to be understood that the gasket 162 may have any geometry, e.g., surface profile, that provides a seal between the movable floor 152 and the elongate body 112 and sweeps nutrition up along the elongate body 112 while minimizing frictional interference between the movable floor 152 and elongate body 112. Each gasket 162 may be formed from a resilient material that is configured to be compressed between the movable floor 152 and the elongate body 112. In this manner, any nutrition adhered or stuck along the elongate body 112 may be swept off the sides of the container and toward the fluid port 131 and coupler 183 by the gasket(s) 162 and the movable floor 152. By providing multiple gaskets 162 axially spaced along the movablefloor 152, e.g., two gaskets as shown in FIGS. 33-35, may provide increased surface area of contact between the elongate body 112 and the movable floor 152 to enhance sweeping nutrition up toward the cover 130 and coupler 183 as the plunger stem 170 is compressed and enables smooth movement of the movable floor 152 in a direction of the longitudinal axis 111 of the elongate body 112.
[0100] Referring to FIGS. 34-38, the recess 153 of the movable floor 152 may have an alignment feature 163 extending from the recess 153. Moreover, the distal end 173 of the plunger stem 370 may have a complementary alignment feature 165. For instance, the alignment feature 163 may include a protruding structure, e.g., a peg, protruding from the recess 153. The protruding structure may be substantially centered about a central axis 161 of the movable floor 152. The complementary alignment feature 165 of the plunger stem 370 may be a recess or other concave structure in the contact face of the distal end 173 that is configured to receive the protruding structure. The complementary alignment feature 165 of the plunger stem 370 may be substantially centered around a central axis 161 of the plunger stem 370. In this manner, the alignment features 163 and 165 may improve axial alignment of the movable floor 352 and the plunger stem 370 along a common longitudinal axis when the distal end 173 of the plunger stem 370 is inserted within the recess 153 of the movable floor 152.
[0101] Referring to FIGS. 36-38, the plunger stem 370 may have an elongate plunger body 172 having ergonomic surface features. For instance, one or more concave depressions 181 may be formed about a circumference of the elongate plunger body 172. The concave depressions 181 may have a curved surface configured to receive a user’s finger, e.g., a user’s thumb, therein. The elongate plunger body 80 may have a plurality of concave depressions 181 about a circumference of the plunger body 80. For instance, in some aspects four concave depressions 181 may be provided about the circumference of the elongate plunger body 172. Additionally or alternatively, the elongate plunger body 172 may include a plurality of concave depressions 181 along a length of the plunger body 172. For instance, at least two concave depressions 181 may be provided adjacent to each other along a length of the elongate body 172. The curved concave depressions 181 may enhance the ergonomics of a user depressing the plunger 370 into the elongate body 112 of the container 100. Moreover, by providing a plurality of curved concave depressions 181 about the circumference and / or length of theplunger body 172, a user may ergonomically position their fingers at a most comfortable and ergonomic position about the circumference and length of the plunger body 172.
[0102] As shown in FIG. 22, the cover 130 may include a coupler 183. In some implementations, the coupler 183 is an enteral connector configured to be coupled with a complementary adapter for transferring fluid. The connector may optionally include male connecting feature extending upward from the lid. In some implementations, the cap 133 is configured to seal the adaptor when not in use. The cap 133 may be hingedly coupled with the cover 130 and may have a snap-fit to close and seal the coupler 183. However, it is to be understood that any suitable coupling arrangement may be used.
[0103] Referring to FIG. 56, a process 5600 for preparing and providing nutrition to a recipient is shown, according to some implementations. The process 5600 can be performed using the nutrition collection and distribution system 10 according to some implementations. In some implementations, the process 5600 begins with a step 5602.
[0104] In a step 5602, the process 5600 includes expressing nutrient into a collection container, according to some implementations. For example, a mammal may express a quantity of milk into a containment volume 150 of the container 100. In some implementations, a mammal may pump or otherwise provide HBM into the containment volume 150 directly. In some implementations, the expressed nutrient is extracted or received by a lactation pump head 132 coupled to the containment volume 150. In some implementations, the expressed nutrient may be provided through a barrel 500 having a filter 520 between the lactation pump head 132 and the contained volume 150 of the collection container 100. In some implementations, the process 5600 continues with a step 5604.
[0105] In a step 5604, the process 5600 may include attaching a cover to collection container, according to some implementations. For example, a user may couple the cover 130 with the second end 116 of the collection container 100. In some implementations, a user may first remove the lactation pump head 132 from the second end 116, and subsequently couple the cover to the second end 116 of the collection container. In some implementations, the process 5600 continues with a step 5604.
[0106] In a step 5606, the process 5600 may include attaching a transfer syringe to the cover, according to some implementations. For example, a user may couple a syringe 186 to the cover 130 of the containment system 100. In some implementations, the syringe 186 is configuredto couple with an enteral feeding pump or syringe pump. In some implementations, the syringe may draw up some or all of the nutrition from the contained volume 150 of the collection container 100. In some implementations, the moveable floor 152 may move from the first end 114 to the second end 116 within the internal volume 118. In some implementations, the process 5600 continues with a step 5608.
[0107] In a step 5608, the process 5600 may include transferring nutrition from a transfer syringe to a second container, according to some implementations. For example, a user may transfer nutrition from the transfer syringe 186 to the second variable volume container 300. In some implementations, the nutrient may be stored within the second variable volume container 300. In some implementations, the process 5600 continues with a step 5610.
[0108] In a step 5610, the process 5600 may include batching nutrition into one or more transfer syringes, according to some implementations. For example, a user may draw nutrition from the second container 300 into one or more syringes 186.
[0109] In a step 5612, the process 5600 may include administering the nutrition to a patient, according to some implementations. For example, a user may administer nutrition to a patient directly (e.g., by ejecting nutrient directly into a mouth or other orifice of a patient) or via an enteral feeding device or apparatus. In some implementations, administering nutrition to a patient.
[0110] Referring to FIG. 57, a process 5700 for preparing and providing nutrition to a recipient is shown, according to some implementations. The process 5700 can be performed using the nutrition collection and distribution system 10, according to some implementations. In some implementations, the process 5700 begins with a step 5702.
[0111] In a step 5702, the process 5700 includes removing a cover from a batch container and / or opening a cap on a collection container, according to some implementations. For example, a user may remove the cover 330 from the second variable volume container 300, and unseal the fluid port 131. For example, a user may remove the cap 133 to expose the fluid port 131. In some implementations, the process 5700 continues with a step 5702.
[0112] In a step 5704, the process 5700 includes attaching a plunger stem to the movable floor and pushing milk into a batch container, according to some implementations. For example, a user may insert a plunger stem 170 into the receiver 153 and apply a pressure to one or moreof the plurality of concave depressions 181, thumb-holds 178, and knob 175. In some implementations, a user may engage with pairs of thumb-holds 178A and / or 178B and move the floor 152 in the direction 171 towards the cover 130. See, e.g., FIG. 20-21. In some implementations, the process 5700 continues with a step 5706.
[0113] In a step 5706, the process 5700 includes fortifying the nutrition, according to some implementations. In some implementations, the process 5700 continues with a re-attaching the cover, closing the fluid port, and agitating the container (Step 5708), aspirating the container of gasses via the plunger tool (Step 5710), drawing up a quantity of nutrition into a syringe (Step 5712), placing the syringe in an enteral feeding pump (Step 5714), and / or administering nutrition to a recipient (5716).
[0114] Referring to FIG. 58, a process 5800 for preparing and providing nutrition to a recipient is shown, according to some implementations. The process 5800 can be performed using the nutrition collection and distribution system 10, according to some implementations. In some implementations, the process 5800 includes opening a cap (Step 5802), keeping a container on a flat surface (Step 5804), aspirating the container with a syringe (Step 5806), drawing up a desired quantity of nutrition (Step 5808), replacing the cap (Step 5810), and / or administering the syringe contents (Step 5812), according to some implementations.
[0115] Referring to FIG. 59, a process 5900 for preparing and providing nutrition to a recipient is shown, according to some implementations. The process 5900 can be performed using the nutrition collection and distribution system 10, according to some implementations. In some implementations, the process 5900 begins with a mother pumping milk into a bottle (Step 5902), transporting bottle to a hospital per hospital protocol (Step 5904), attaching a plunger tool to bottom of floor and push up to activate the movable floor and remove gasses (e.g., air) from container (Step 5906), determining whether to batch together the fluid into a batch container (Step 5908). If yes in step 5918, the process 5900 may continue with opening lid and attaching a syringe (Step 5918), drawing out a desired amount of nutrition into the syringe (Step 5920), and / or administering the syringe contents (Step 5922). In some implementations, if no in step 5918, the process 5900 continues with removing lid from batch container and opening cap on collection chamber (Step 5910), using a plunger tool to push milk into batch container from collection container (Step 5912), fortifying the nutrition by mixing in a quantity of a fortifier (e.g., formula) (Step 5914), and / or aspirating the batch container by opening the tip and using the syringe to pull out air via the fluid port in the cover, or by attaching a plungertool to the bottom of the movable floor and pushing the movable floor toward the cover to drive gasses out of the contained volume of the container (Step 5916), according to some implementations.
[0116] FIGS. 61-67 provide another example nutrition collection system 10. As described in more detail herein, the example nutrition collection system 10 utilizes a scraping tool for releasing liquids and solids from the interior surface of the collection container. The nutrition collection system 10 of FIGS. 67-67 is similar to other collection systems illustrated herein in reference to FIGS. 1-60 and 68-79. Thus, similar reference numbers as those used for the implementation shown in FIGS. 1-60 and 68-79 are used in reference to the implementation provided in FIGS. 61-67. It is contemplated that features in any other implementations disclosed herein can be included in the implementation disclosed in FIGS. 61 -67.
[0117] FIGS. 61 and 62 provide side views of an example collection container 400. Similar to the collection containers described herein, collection container 400 includes an elongate body 412 extending between a first end 414 (bottom) and a second end 416 (top) of the collection container 400. As provided in FIGS. 61 and 62, the first end 414 of the collection container 400 can be an open or openable end of the collection container 400 to allow the transfer nutrition contained within the interior volume 418 of the collection container 400. In some implementations, the first end 414 is configured to receive a cap or cover to seal or otherwise close the collection container 400. In some implementations, the first end 414 of the collection container 400 includes a coupling feature for coupling the first end 414 of the collection container 400 with a cap or nutrition collection device (e.g., breastmilk collection device). For example, in some implementations, the first end 414 of the collection container 400 can be configured to couple to a breast flange coupled to a breast pump for the collection of human breast milk. The coupling feature can include a threaded surface, a snap fit, a press fit, lock, clip, or other feature for coupling the first end 414 with a cover and / or nutrition collection device.
[0118] As provided in FIGS. 61 and 62, the collection container 400 includes an interior wall 420 defining the interior contained volume 418 of the collection container 400. As described here, in some implementations, the interior contained volume 418 is configured for maintaining nutrition (e.g., HBM).
[0119] FIG. 61 provides a side elevation view of the collection container 400 with a volume of nutrition contained within the interior volume 418. As provided in FIG. 62, and described herein, in some implementations, when the contained nutrition is dispensed from the collection container 400, liquid and solid portions of the nutrition can adhere to the interior wall 420 of the collection container 400. It is important that these remnant portions of the nutrition are collected as often the nutrition solids (e.g., lipids contained in human breast milk) will adhere to the interior wall of the collection container 400. As described herein, a scraping device such as spatula 450 can be used to dislodge the adhered portions of the nutrition from the interior wall 420 of the container 400, helping to ensure that as much of the nutrition, including the often times most nutrient dense nutrition solids, is removed from the container and provided to the patient as possible.
[0120] FIG. 63 provides a side perspective view of an example spatula 450. The spatula 450 is sized and configured to be received and movable within the interior volume 418 of the collection container 400. As illustrated in FIG. 63, the spatula 450 includes an elongated body 452 having a central lumen 454 extending therethrough. The spatula 450 includes a wing 480 extending radially from the elongated body 452 for wiping or scraping the interior wall 420 of the collection container 400 to remove the adhered nutrition.
[0121] In some implementations, rotational and / or longitudinal movement of the spatula 450 within the interior volume 418 of the collection container 400 causes the wing 480 contact the interior wall 420 and dislodge nutrition contents, both fluids and solids, adhered to the interior wall 420 of the collection container 400. As a result, the nutrition contents of the collection container 400, including the dislodged nutrition components, can be collected from the collection container 400. This minimizes nutrition loss, as little to no nutrition may be left adhered to the interior wall 420 of the collection container 400 and can be successfully removed.
[0122] As provided in FIG. 63, the elongated body 452 of the spatula 450 extends between a proximal end 456 and a distal end 458. In some implementations, as illustrated in FIG. 63, the wing 480 is located adjacent the distal end 458 of the elongated body 452. It is contemplated that the wing 480 can be positioned at any location along and around the elongated body 452 to facilitate clearing the interior wall 420 of the collection container 400 of nutrition.
[0123] As illustrated in FIG. 63, in some implementations, the spatula 450 includes two wings 480 that extend radially from the elongated body 452. As provided in FIG. 63, where each of the wings 480 extend from opposite sides of the elongated body 452. In some implementations, the spatula 450 can include more than two wings 480 extending radially from the elongated body 452 of the spatula 450, spaced circumferentially around the elongated body 452. In some implementations, the spatula 450 includes a plurality of wings 480 spaced symmetrically around the elongated body 452. While in some implementations, the spatula 450 includes a plurality of wings 480 spaced asymmetrically around the elongated body 452. Tn some implementations, the wings 480 are arranged around the elongated body 452 to have a complimentary opposing wing 480. In some implementations, as provided in FIG. 63, the wings 480 are longitudinally aligned along the elongated body 452. In other implementations, the wings 480 can be offset or longitudinally spaced from an adjacent wing 480 along the elongated body 452.
[0124] As illustrated in FIG. 63, in some implementations, each of the wings 480 have a corresponding size and shape. While in some implementations, the size, shape, and location of the wings 480 can vary around and along the elongated body 452. In some implementations, when the spatula 450 includes more than one wing 480, when the spatula 450 is received within the interior volume 418 of the collection container 400, the elongated body 452 is centered within the interior volume of the collection container 400.
[0125] As shown in FIG. 63, the wings 480 include a side edge 482, where the distance (DI) between the side edge 482 of the wing 480 and the elongated body 452 (e.g., the outer surface of the elongated body 452) corresponds with the distance between the elongated body 452 (e.g., outer surface of the elongated body 452) and the interior wall 420 of the collection container 400 when the spatula 450 is received within the interior volume 418 of the collection container 400. In some implementations, the distance (DI) between the side edge 482 of the wing 480 and the elongated body 452 is greater than the distance between elongated body 452 and the interior wall 420 of the collection container 400. As a result, the wings 480 are compressed against the interior wall 420 of the collection container 400 when the spatula 450 is received within the interior volume 418. With the wings 480 compressed against the interior wall 420 of the collection container 400, interference between the side edge 482 of the wing 480 and the interior wall 420 dislodges any nutrition, including solids, adhered to the interior wall 420 of the collection container 400. In some implementations, interference between the wings 480 andthe interior wall 420 causes the wings 480 to bend / flex such that the front surface 490 and / or opposing back surface 492 of the wings 480 contacts the interior wall 420. As a result, the front surface 490 and opposing back surface 492 of the wings are also used to dislodge nutrition adhered to the interior wall 420 of the collection container 400.
[0126] As illustrated in FIG. 63, the wings 480 include a bottom edge 484 extending between an outer surface of the elongated body 452 and the side edge 482. In some implementations, the bottom edge 484 extends at an acute angle between the outer surface of the elongated body 452 towards the proximal end 456 of the spatula 450. In some implementations, the bottom edge 484 has a shape corresponding with the shape of the bottom interior wall 420 of the collection container 400. As such, the bottom edge 484 of the wing 480 is able to dislodge any nutrition adhered to the bottom interior wall 420 of the collection container 400. As provided in FIG. 63, the bottom edge 484 is aligned with the bottom surface 460 of the elongated body 452. This allows the entire bottom edge / surface of the spatula 450 to align with the bottom interior wall 420 of the collection container 400, maximizing nutrition dislodgement.
[0127] In some implementations, the wings 480 include a top edge 486 extending from / between the side edge 482 of the wing 480 and the outer surface of elongated the 452. In some implementations, the top edge 486 extends at an acute angle between the outer surface of the elongated body 452 towards the distal end 458 of the spatula 450. In some implementations, as illustrated in FIG. 63, the axial length of the top edge 486 (measured along the elongated body 452 / longitudinal axis of the spatula 450) is greater than the axial length of the bottom edge 484. Alternatively, the axial length of the bottom edge 484 can be greater than the axial length of the top edge 48.
[0128] As provided in FIG. 63, the wing 480 includes an end surface 488 defining the edge of the wing 480. The end surface 488 can define the circumferential and / or outer perimeter or surface of the wing 480. In some implementations, at least a portion of the end surface 488 abuts interior wall 420 of the collection container 400 when the spatula 450 is positioned within the collection container 400. In some implementations, the end surface 488 of the wing 480 extends perpendicular to a front surface 490 and / or an opposing back surface 492 of the wing 480. In some implementations, the end surface 488 of the wings 480 extends at an angle relative front surface 490 and opposing back surface 492 of the wing 480.
[0129] In some implementations, the end surface 488 of the wing 480 includes a groove or other surface treatment providing a contact surface that increases the friction between the wing 480 and interior wall 420 of the collection container 400 as the spatula 450 is moved within the collection container 400. This groove or surface treatment helps to dislodge the contents of the collection container 400 from the interior wall 420.
[0130] In some implementations, the wings 480 and / or elongated body 452 of the spatula 450 are formed from a material capable of withstanding a sterilization procedure. For example, the wings 480 can be formed from silicone or any other suitable material capable of being sterilized. For example, in some implementations, the spatula 450 can be sterilized for contact with HBM, and prevent contamination of the HBM prior to feeding a neonate.
[0131] In some implementations, the spatula 450 includes a coupling mechanism 455 at the proximal end 456 of the elongated body 452 as shown in FIGS. 64 and 66. The coupling mechanism 455 is configured to removably couple the spatula 450 to a collection device. The coupling mechanism 455 can include a threaded coupling, a snap fit, a press fit, luer connection, or any other coupling known in the art for creating a liquid tight seal / coupling between the spatula 450 and a collection device for withdrawing the nutrition from the collection container 400 through the spatula 450. As described herein, the collection device is suitable to withdraw / suction the contents from the collection container 400 through the spatula 450. In some implementations, as illustrated in FIGS. 64 and 66, the collection device includes a syringe 20. The syringe 20 can be removably coupled to the coupling mechanism 455 and used to draw the contents of the collection container 400, including nutrition dislodged (e.g., HBM and corresponding lipids) from the interior wall 420 of the collection container 400 and into the barrel 22 of the syringe 20. For example, as the syringe 20 plunger 24 is withdrawn within the syringe 20, a vacuum is created within the barrel 22 drawing the nutrition from the collection container 400, through the central lumen 454 of the spatula 450, and into the barrel 22 of the syringe 20. In some implementations, as illustrated in FIG. 65, the nutrition can also be poured through the open 414 of the collection container 400.
[0132] Referring to FIG. 67, a method of using the spatula 450 to remove the contents from the interior of a collection container 400 is provided (4000). A collection container 400 including contents (e.g., nutrition) is provided. For example, in some implementations, HBM is pumped directly into the collection container 400 (step 4002). A cover can be attached to the coupling mechanism provided at the first end 414 of the collection container 400 securing thecontents of the collection container 400 for transport and / or prevent contamination (step 4004). When the user is ready to dispense the nutrition from the collection container 400 the cover is removed providing an open first end 414 of the collection container 400 (step 4006).
[0133] The spatula 450 is then inserted into the open first end 414 of a collection container 400 containing nutrition (step 4008). In some implementations, a shield is provided around the elongated body 452 if the spatula 450 and / or proximate the open first end 414 of the collection container 400 to prevent the accidental spilling or contamination of the nutrition contained within the interior volume 418.
[0134] The spatula 450 is then moved rotationally and / or axially within the interior volume 418 of the collection container 400 such that the wing 480 contacts the interior wall 420 of the collection container 400 (step 4010). Interference between the wing 480 and the interior wall 420 of the collection container 400 dislodges any nutrition and / or contents adhered to the interior wall 420 of the collection container 400. In some implementations, the spatula 450 is rotated less than 360° within the interior volume 418 of the collection container 400. In some implementations, the spatula 450 is rotated more than 360° within the interior volume 418 of the collection container 400. In some implementations, the spatula 450 is rotated in only one direction. While in some implementations, the spatula 450 is rotated in both a clockwise and counterclockwise direction.
[0135] The nutrition, including the dislodged components of the nutrition, are then withdrawn from the collection container 400 (step 4012). In some implementations, the nutrition is withdrawn by pouring the nutrition out the open first end 414 of the collection container 400 as illustrated in FIG. 65. In some implementations, the nutrition is alternatively or additionally withdrawn through the central lumen 454 of the spatula 450. For example, a collection device (e.g., syringe 20) is coupled to the coupling mechanism 455 provided at the proximal end 456 of the elongated body 452 of the spatula 450. A suction or vacuum is then applied to the central lumen 454 of the spatula 450 via the coupling mechanism 455 such that the contents of the collection container 400, including any contents dislodged from the interior wall 420, are withdrawn through the central lumen 454 of the spatula 450 and into the collection device. It is contemplated that the nutrition can be removed from the collection container 400 by both pouring through the open first end 414 and suction through the central lumen 454 of the spatula 450 with either removal method occurring first and / or repeated.
[0136] The nutrition is then provided to a feeding device for providing the nutrition to a patient (step 4014). In some implementations, the collection device also functions as the feeding device. The nutrition is then provided to the patient (step 4016).
[0137] Referring to FIGS. 68-77, a nutrition containment and dispensing system 50 may further include a collection and / or transfer device such as a collection bottle or syringe that is capable of separating or filtering lipids (i.e., fat) from the remainder of the fluid in human breast milk in order to concentrate the lipid content for feeding to a neonate.
[0138] Referring to FIGS. 68-77, the nutrition containment and dispensing system 50 may include a barrel 500 spanning between a first end 502 and a second end 504 and defining an internal volume 506 therebetween. The barrel 500 may have a first opening 508 at the first end 504 and a second opening 510 at the second end 504.
[0139] In some implementations, a movable filter 520 is slidably mounted within the internal volume 506 of the barrel 500. For example, the movable filter 520 may slide along a longitudinal axis of the internal volume 506. In some implementations, the filter 520 divides the internal volume 506 into a first chamber 522 and a second chamber 524.
[0140] Referring to FIG. 69, the filter 520 may include a seal portion 160 configured to maintain a seal with the internal wall of the barrel 500. For example, the seal portion 160 may include a gasket 162. In some implementations, the filter 520 includes a filter media 526 configured to prevent solids and semisolids from passing through. For example, the filter media 526 may be a lipid filter. In some implementations, the filter plunger stem 530 is configured to engage the filter 520 and move the filter 520 within the internal volume 506 to thereby adjust a volume of the first chamber 522 and a volume of the second chamber 524.
[0141] Referring to FIGS. 68 and 70-71, a collection container 100 may be coupled to the second end 504 of the barrel 500. For example, the collection container 100 may include a cover configured to fluidly couple the internal volume 506 of the barrel 500 to a containment volume 150 of the collection container 100. In some implementations, the collection container 100 further includes a lactation pump head 132 coupled to the first end of the barrel 500. Referring to FIG. 70, a flow of nutrition 542 may be directed in the direction of arrows 544. A filtered fluid 546 (e.g., filtered milk) may be collected in the collection container 100.
[0142] Referring to FIGS. 70-71, the barrel 100 may receive and at least partially pass a fluid between the first opening 508 and the second opening 510. For example, when a flow of nutrition, (e.g., nutritional material, HBM, milk, lactated nutrition, etc.) is directed through the first opening 508 of the barrel 500, the movable filter 520 may prevent the flow of solids and semisolids within the flow of nutrition from passing therethrough and into the second chamber 524. In some implementations, when a flow of lactated nutrition is directed through the first opening 508 of the barrel 40, the filter 520 prevents the flow of lipids into the second chamber 524 such that lipids contained within the flow of lactated nutrition are accumulated within the first chamber 522. For example, the solids and semisolids may be or include lipids. In operation, the first chamber 522 may accumulate a quantity of lipids, illustrated as accumulation 540. The accumulation of 540 may occupy at least a portion of the volume of the first chamber 524.
[0143] Referring to FIGS. 73-76, the nutrition containment and dispensing system 50 may include a plunger stem 530. In some implementations, the plunger stem 530 is configured to be received by the second opening 510. For example, a distal end 524 of the plunger stem 530 may pass through the opening 510 and engage the filter 520. In some implementations, the plunger stem 530 is configured to engage the filter 520 to move the filter 520 toward the first end 502 of the barrel 500. In implementations, the plunger stem 530 includes a thumb rest 532 on a proximal end 534 of the plunger stem 530.
[0144] Referring to FIGS. 73-74 and 76, the nutrition containment and dispensing system 50 may include a nipple attachment 536 coupled to the first end 504 of the barrel 500. In some implementations, when the plunger stem 530 slides the filter 520 within the barrel 500 toward the first end 508, the contents of the first chamber 522 are ejected from the barrel 500 and into a nipple attachment 536 or an enteral feeding tube 538 coupled to the first end 502 of the barrel 500.
[0145] Referring to FIG. 78, a process 7800 for preparing and providing nutrition to a recipient is shown, according to some implementations. In some implementations, the process 7800 includes providing a flow of nutrition through a filter (e.g., lipid filter) slidably mounted within a bore of a barrel (Step 7802), accumulating lipids of the flow of nutrition within a first chamber of the barrel (Step 7804), collecting a liquid nutrient (e.g., filtered milk) of the flow of nutrient in a container coupled to a second end of the barrel (Step 7806), Fortifying the collected liquid nutrient (Step 7808), Ejecting the accumulated lipids from the first volume by sliding the lipidfilter within barrel (Step 7810), Ejecting the accumulated lipids into an enteral feeding tube or a nipple attachment (Step 7812), Providing the accumulated lipids to a recipient (Step 7814), and / or Providing liquid nutrient to a recipient (Step 7816).
[0146] Referring to FIG. 79, a process 7900 for preparing and providing nutrition to a recipient is shown, according to some implementations. In some implementations, the process 7800 includes Connecting a barrel with internal filter directly to breast shield to collect fat and filter milk into collection bottle (Step 7902), Orally feeding fat into recipient or feeding into feeding tube when plunger is inserted (Step 7904), and / or Administering liquid nutrition collected in bottle to recipient (Step 7906).
[0147] In some implementations, a method (e.g., method 7800) for preparing and providing nutrition to a recipient may include includes providing a flow of lactated nutrient through a barrel including a lipid filter slidably mounted within a bore of the barrel; accumulating lipids contained within the flow of lactated nutrients within a first volume of the bore of the barrel; and or providing the accumulated lipids to a recipient. In some implementations, the method includes collecting a liquid nutrient of the flow of lactated nutrient in a container coupled to a second end of the barrel. In some implementations, the method includes fortifying the liquid nutrient and providing the fortified liquid nutrient to the recipient.
[0148] For instance, a syringe body or barrel 500 may have an open first end and an open second end. Between the first end and the second end, a filter 42 may be disposed within the syringe body 40. The filter is configured to separate lipids in human breast milk from the remainder of the fluid such that lipids do not pass through the filter. In this arrangement, lipids may be collected and contained within the syringe body 500 while the remainder of the fluid of the human breast milk passes through the filter 520. In this manner, lipids may be concentrated and collected to feed directly to a neonate, thereby ensuring a high-calorie nutrient feed. The syringe body 500 can be sized to contain and collect a fluid volume of up to 5 mL or 10 mL between the first end and the filter 520. However, a syringe body 500 may be formed from any desirable size to collect larger or smaller volumes of lipids from human breast milk.
[0149] The filter 520 can be a filter disk having an outer perimeter shape that generally matches a cross-sectional shape of the syringe body 40 such that the filter disk is fully seated within the syringe body 500. The filter 520 can separate the lipids from the remainder of the liquid in HBM, e.g., by microfiltration or any other suitable means. For instance, the filter 520 canseparate particles by size, whereby the larger lipid molecules (also known as fat globules) cannot pass through pores of the filter and are thereby contained within the syringe body 500 between the first end of the syringe body 500 and the filter 520.
[0150] In one configuration, illustrated in FIGS. 68-71, the syringe body 40 may be coupled with a breast milk collection apparatus 134 such as a flange of a pump at the first end, and may be coupled with a collection container (e.g., bottle) 100 at the second end, such that breast milk may pass through the syringe body 500 during a breast milk collection process. In another configuration, a syringe plunger 530 may be coupled to the second end of the syringe body 500, and the first end of the syringe body 500 may be coupled with an enteral feeding system 538, a bottle nipple 536 for directly feeding a neonate, or other feeding coupler. For instance, FIGS. 74-75 each illustrates the syringe body 500 coupled with a syringe plunger 530 at the second end 502. FIG. 76 illustrates a bottle nipple 136 coupled at the first end 502 of the syringe body 40 to feed a neonate directly. FIG. 75 illustrates the syringe body 40 coupled with an enteral feeding extension set to provide nutrition from the syringe body 40 to a neonate via enteral feeding.
[0151] Collection containers, e.g., the collection container 100 described above, are contemplated to contain any suitable volume. For instance, the container 10 can be a bottle configured to contain a volume of 1 ounce (oz.), 2 oz., 4 oz., 8 oz., or any other suitable volume. For instance, when measuring using the metric system, FIGS. 1A-1E illustrate embodiments of the container 10 having a measured volume of up to about 60 mL or 120 mL
[0152] By using any one or more of the disclosed embodiments to collect and deliver HBM to a neonate, fat loss in the HBM may be minimized such that up to or exceeding approximately 96% of the fat (lipids) in the HBM collected in the collection container may be successfully transferred to the neonate. In contrast, when using a conventional system which requires transferring HBM from a collection container to a syringe, and possibly including transferring HBM to a measuring cup prior to transferring to a syringe, only about 70% of fat (lipids) in the HBM collected in the collection container are successfully transferred to the neonate. Without intending to be bound by theory, the present inventors believe that the decrease in number of vessels that the HBM is transferred between during the feeding process, and the ability to sweep lipid or fat globules from the sides of the interior walls of the collection containers using the embodiments disclosed herein, may result in the significant increase in fat (lipid) content delivered to the neonate using the system of the present invention (over 25% more fat (lipids)delivered to the neonate). Moreover, reducing the number of vessels required for the enteral feeding process using the system of the present invention directly increases the ease of use for nurses, milk technicians, and other care providers in the enteral feeding process.
[0153] As utilized herein with respect to numerical ranges, the terms “approximately,” “about,” “substantially,” and similar terms generally mean + / - 10% of the disclosed values. When the terms “approximately,” “about,” “substantially,” and similar terms are applied to a structural feature (e.g., to describe its shape, size, orientation, direction, etc.), these terms are meant to cover minor variations in structure that may result from, for example, the manufacturing or assembly process and are intended to have a broad meaning in harmony with the common and accepted usage by those of ordinary skill in the art to which the subject matter of this disclosure pertains. Accordingly, these terms should be interpreted as indicating that insubstantial or inconsequential modifications or alterations of the subject matter described and claimed are considered to be within the scope of the disclosure as recited in the appended claims.
[0154] It should be noted that the term “exemplary” and variations thereof, as utilized herein to describe various embodiments, are intended to indicate that such embodiments are possible examples, representations, or illustrations of possible embodiments (and such terms are not intended to connote that such embodiments are necessarily extraordinary or superlative examples).
[0155] The term “coupled” and variations thereof, as used herein, means the joining of two members directly or indirectly to one another. Such joining may be stationary (e.g., permanent or fixed) or moveable (e.g., removable or releasable). Such joining may be achieved with the two members coupled directly to each other, with the two members coupled to each other using a separate intervening member and any additional intermediate members. If “coupled” or variations thereof are modified by an additional term (e.g., directly coupled), the generic definition of “coupled” provided above is modified by the plain language meaning of the additional term (e.g., “directly coupled” means the joining of two members without any separate intervening member), resulting in a narrower definition than the generic definition of “coupled” provided above. Such coupling may be mechanical, electrical, or fluidic.
[0156] References herein to the positions of elements (e.g., “top,” “bottom,” “above,” “below”) are merely used to describe the orientation of various elements in the FIGURES. It should be noted that the orientation of various elements may differ according to other exemplaryembodiments, and that such variations are intended to be encompassed by the present disclosure.
[0157] Although the figures and description may illustrate a specific order of method steps, the order of such steps may differ from what is depicted and described, unless specified differently above. Also, two or more steps may be performed concurrently or with partial concurrence, unless specified differently above. Such variation may depend, for example, on the software and hardware systems chosen and on designer choice. All such variations are within the scope of the disclosure. Likewise, software implementations of the described methods could be accomplished with standard programming techniques with rule-based logic and other logic to accomplish the various connection steps, processing steps, comparison steps, and decision steps.
[0158] It is important to note that the construction and arrangement of the system 100 as shown in the various exemplary implementations is illustrative only. Additionally, any element disclosed in one implementation may be incorporated or utilized with any other implementation disclosed herein.
[0159] Exemplary Aspects
[0160] In view of the described processes and compositions, hereinbelow are described certain more particularly described aspects of the disclosure. These particularly recited aspects should not, however, be interpreted to have any limiting effect on any different claims containing different or more general teachings described herein, or that the “particular” aspects are somehow limited in some way other than the inherent meanings of the language and formulas literally used therein.
[0161] Example 1. A fluid containment and dispensing system, comprising: a variablevolume container, comprising: an elongate body spanning between a first end and a second end and defining an internal volume therebetween; a cover coupled to the second end and comprising a fluid port; and a movable floor slidably mounted within the internal volume.
[0162] Example 2. The fluid containment and dispensing system according to any example herein, particularly example 1, further including: a plunger stem configured to engage the floor and move the floor in an axial direction within the internal volume, wherein the plunger stem comprises a body spanning between a distal end and a proximal end, and where thebody comprises a plurality of thumb-holds provided between the distal end and the proximal end.
[0163] Example 3. The fluid containment and dispensing system according to any example herein, particularly example 2, wherein the plunger stem comprises a hollow portion and where at least one of the plurality of thumb-holds includes an opening in a wall of the hollow portion.
[0164] Example 4. The fluid containment and dispensing system according to any example herein, particularly examples 1-2, further including a plunger stem configured to engage the floor and move the floor in an axial direction within the internal volume, wherein the plunger stem comprises a knob at a proximal end thereof.
[0165] Example 5. The fluid containment and dispensing system according to any example herein, particularly examples 1-4, wherein the first end of the elongate body comprises a lip extending radially outward from an outer surface of the elongate body.
[0166] Example 6. The fluid containment and dispensing system according to any example herein, particularly example 5, wherein the lip comprises a groove extending in a radial direction along a bottom surface of the elongate body about the lip.
[0167] Example 7. The fluid containment and dispensing system according to any example herein, particularly examples 1-6, further including a plunger stem configured to engage the floor and move the floor in an axial direction within the internal volume, wherein the first end of the elongate body provides an opening having a diameter less than a diameter of the internal volume, and wherein a portion of the plunger stem is received by the opening when the plunger stem engages the floor.
[0168] Example 8. The fluid containment and dispensing system according to any example herein, particularly examples 1-7, wherein the cover comprises a fluid port and a cap configured to seal the fluid port.
[0169] Example 9. The fluid containment and dispensing system according to any example herein, particularly examples 1-8, wherein an interior surface of the cover comprises a sloped surface and the upper surface of the floor comprises a correspondingly shaped second sloped surface, wherein when the floor is moved into contact with the cover, the sloped surface and the second sloped surface are flush.
[0170] Example 10. The fluid containment and dispensing system according to any example herein, particularly example 1. wherein the floor comprises: a seal portion on a first side; a receiver provided on a second side; and a skirt provided on the first side of the floor distal to the seal portion and surrounding the receiver.
[0171] Example 11. The fluid containment and dispensing system according to any example herein, particularly example 10, wherein the seal portion comprises a circumferential recess and a gasket provided therein.
[0172] Example 12. The fluid containment and dispensing system according to any example herein, particularly examples 10-11, wherein the seal portion comprises a wiper extending radially from the first side of the floor and continuously around a circumference of the floor.
[0173] Example 13. The fluid containment and dispensing system according to any example herein, particularly examples 1-12, wherein the floor is a unitary body and the wiper edge is oriented toward an interior- facing surface of the floor when the floor is moved from a location proximate the first end of the elongate body toward a location proximate the second end of the elongate body.
[0174] Example 14. The fluid containment and dispensing system according to any example herein, particularly examples 10-13, wherein the skirt comprises a plurality of axial ribs protruding radially from a peripheral surface of the skirt.
[0175] Example 15. The fluid containment and dispensing system according to any example herein, particularly examples 10-14, wherein the skirt comprises a plurality of legs spaced circumferentially around a central axis of the floor and extending in a distal direction from a bottom of the skirt.
[0176] Example 16. The fluid containment and dispensing system according to any example herein, particularly example 15, wherein the plurality of legs are define an arcuate outermost surface.
[0177] Example 17. The fluid containment and dispensing system according to any example herein, particularly examples 10-16, wherein the cover includes an interior sloped surface and includes one or more protrusions that extend distally from the sloped surface, when the floor is moved into contact with the cover the protrusions occupy a gap provided between the floor and the elongate body.
[0178] Example 18. A fluid containment and dispensing system, comprising: a first variablevolume container comprising: a first elongate body having a first bore between a first end and a second end; a first floor slidably mounted within the first bore and providing a seal defining a first contained volume on a first side thereof, and an uncontained volume on a second side opposite the first side; and a removable cover coupled to the second end of the first elongate body; a breast shield of a lactation pump head configured to couple to the second end of the first elongate body and to direct lactated nutrition into the contained volume of the first variable-volume container; and a plunger stem configured to engage the first floor and move the first floor within the first elongate body to thereby adjust the contained volume.
[0179] Example 19. The fluid containment and dispensing system according to any example herein, particularly example 18, further comprising a second variable-volume container comprising: a second elongate body having a second bore; and a second floor slidably mounted within the second bore and defining a second contained volume; wherein the plunger stem is configured to engage the second floor and move the second floor within the second elongate body to thereby adjust the second contained volume.
[0180] Example 20. A variable-volume container, comprising: an elongate body spanning between a first end and a second end and defining an internal volume therebetween; a cover coupled to the second end; and a floor slidably mounted within the internal volume, the floor including at least one of a gasket or a wiper, and a skirt around a perimeter of the floor.
[0181] Example 21. A method for administering nutrient to a recipient, comprising: expressing a volume of nutrient into a collection container having a variable containment volume and a movable floor; attaching a cover to a second end of the collection container; inserting a plunger stem into a first end of the collection container opposite the second end of the collection container; attaching the plunger stem to the movable floor; moving, via the plunger stem, the movable floor toward the cover to eject gas from the contained volume; and ejecting the nutrition from the contained volume.
[0182] Example 22. The method for administering nutrient to a recipient according to any example herein, particularly example 21, further comprising, fortifying the nutrition within the collection container.
[0183] Example 23. The method for administering nutrient to a recipient according to any example herein, particularly example 21, further comprising, transferring the nutrition to a second container having a second variable containment volume; inserting the plunger steminto a third end of the second collection container; attaching the plunger stem to a second movable floor of the second collection container; moving, via the plunger stem, the second movable floor toward a second cover of the second container to eject gas from the second contained volume; batching the nutrition from the second containment volume into one or more syringes; and administering, via the one or more syringes, the nutrition to a recipient.
[0184] Example 24. A fluid containment and dispensing system comprising: a collection container including an interior wall defining an interior volume of the collection container; and a spatula sized and configured to be received within the interior volume of the collection container, the spatula including: an elongated body including a central lumen extending therethrough, and a wing extending radially from the elongated body for wiping the interior wall of the collection container.
[0185] Example 25. The fluid containment and dispensing system according to any example herein, particularly example 24, wherein the elongated body of the spatula extends between a proximal end and a distal end, where the wing is located adjacent the distal end of the elongated body, wherein the spatula includes a coupling mechanism at the proximal end of the elongated body of the spatula, the coupling mechanism configured to removably couple the spatula to a collection device.
[0186] Example 26. The fluid containment and dispensing system according to any example herein, particularly examples 24-25, wherein the spatula includes two wings extending radially from the elongated body, where each of the wings extend from opposite sides of the elongated body.
[0187] Example 27. The fluid containment and dispensing system according to any example herein, particularly examples 24-26, wherein the wing includes a side edge, the distance between the side edge of the wing and the elongated body corresponds with the distance between the elongated body and the interior wall of the collection container when the spatula is received within the interior volume of the collection container.
[0188] Example 28. The fluid containment and dispensing system according to any example herein, particularly example 27, wherein the wings include a bottom edge extending between an outer surface of the elongated body and the side edge, the bottom edge extending at an acute angle between the outer surface of the elongated body towards the proximal end of the spatula.
[0189] Example 29. The fluid containment and dispensing system according to any example herein, particularly example 28, wherein the bottom edge has a shape corresponding with a shape of a bottom interior wall of the collection container.
[0190] Example 30. The fluid containment and dispensing system according to any example herein, particularly examples 24-30, wherein the wings include a top edge extending from the side edge and the outer surface of elongated the, the top edge extending at an acute angle between the outer surface of the elongated body towards the distal end of the spatula.
[0191] Example 31. The fluid containment and dispensing system according to any example herein, particularly examples 24-30, wherein an end surface of the wing extends perpendicular to a front surface and / or an opposing back surface of the wing.
[0192] Example 32. The fluid containment and dispensing system according to any example herein, particularly examples 24-31, wherein the wings are formed from a material capable of withstanding a sterilization procedure.
[0193] Example 33. The fluid containment and dispensing system according to any example herein, particularly examples 24-32, wherein the collection container includes a body portion extending from a first, open, end to a second, closed, end and configured to form the interior volume between the first end and the second end, wherein the first end is configured to receive a cap to seal the collection container and / or couple with a breastmilk collection device.
[0194] Example 34. A device for removing the contents from the interior of container, the device comprising: a spatula sized and configured to be received within the interior volume of a collection container, the spatula including: an elongated body including a central lumen extending therethrough, a first wing and a second wing extending radially from the elongated body, the first wing extending from an opposite side of the elongated body from the second wing, where the wing is located adjacent a distal end of the elongated body a coupling mechanism at a proximal end of the elongated body, the coupling mechanism configured to removably couple the spatula 30 to a collection device
[0195] Example 35. The device for removing the contents from the interior of container according to any example herein, particularly example 34, wherein spatula includes a plurality of wings more than two wings, wherein each of the plurality of wings extend radially from the elongated body of the spatula, wherein each of the plurality of wings are spaced evenly around the elongated body.
[0196] Example 36. The device for removing the contents from the interior of container according to any example herein, particularly examples 34-35, wherein each of the wings has a corresponding size, shape, and location around and along the elongated body to another one of the wings.
[0197] Example 37. The device for removing the contents from the interior of container according to any example herein, particularly examples 34-36, wherein the first and second wings each include a side edge, where the distance between the side edge of the first and / or second wing and the elongated body corresponds with the distance between the elongated body and an interior wall of a target collection container when the spatula is received within the interior volume of the collection container.
[0198] Examples 38. The device for removing the contents from the interior of container according to any example herein, particularly example 37, wherein each of the first and second wings include a bottom edge extending between an outer surface of the elongated body and the side edge, the bottom edge extending at an acute angle between the outer surface of the elongated body towards the proximal end of the spatula.
[0199] Example 39. The device for removing the contents from the interior of container according to any example herein, particularly example 38, wherein the bottom edge of each of the first and second wings is aligned with the bottom surface of the elongated body.
[0200] Example 40. The device for removing the contents from the interior of container according to any example herein, particularly examples 34-39, wherein each of the first and second wings include a top edge extending from the side edge and the outer surface of the elongated body, the top edge of each of the first and second wings extends at an acute angle between the outer surface of the elongated body towards the distal end of the spatula.
[0201] Example 41. The device for removing the contents from the interior of container according to any example herein, particularly examples 34-40, wherein an end surface of at least one of the first or second wings extends perpendicular to a front surface and / or an opposing back surface of the corresponding wing.
[0202] Example 42. The device for removing the contents from the interior of container according to any example herein, particularly examples 34-41, wherein the first wing and / or second wing are formed from a material capable of withstanding a sterilization procedure.
[0203] Example 43. A method removing the contents from the interior of a container comprising: providing a collection container including an interior wall defining an interiorvolume, and an opening provided at the first end 18 of the collection container; inserting a spatula into the opening of the collection container and into the interior volume, the spatula including: an elongated body including a central lumen extending therethrough, and a wing extending radially from the elongated body; and moving the spatula rotationally and / or axially within the interior volume of the collection container such that the wing contacts the interior wall of the collection container and contents of the collection container adhered to the interior wall are dislodged from the interior wall.
[0204] Example 44. The method removing the contents from the interior of a container according to any example herein, particularly example 43, wherein the interference between the wing and contents adhered to the interior wall of the collection container causes the adhered contents to dislodge from the interior wall.
[0205] Example 45. The method removing the contents from the interior of a container according to any example herein, particularly examples 43-44, further comprising: withdrawing the contents of the collection container through the central lumen of the spatula.
[0206] Example 46. The method removing the contents from the interior of a container according to any example herein, particularly example 45, further comprising: coupling a collection device to a coupling mechanism provided at a proximal end of the elongated body of the spatula; the coupling mechanism providing a suction / vacuum to the central lumen of the spatula such that the contents of the collection container, including any contents dislodged from the interior wall of the collection container, are withdrawn through the central lumen of the spatula and into the collection device.
[0207] Example 47. The method removing the contents from the interior of a container according to any example herein, particularly examples 43-46, further comprising: pouring the contents of the collection container, including any contents dislodged from the interior wall of the collection container, into a feeding device.
[0208] Example 48. The method removing the contents from the interior of a container according to any example herein, particularly examples 43-47, further comprising: transferring the collected contents from the collection device to a feeding device for providing nutrition to a patient.
[0209] Example 49. The method removing the contents from the interior of a container according to any example herein, particularly examples 43-48, wherein moving the spatula rotationally and / or axially within the interior volume of the collection container includes,rotating the spatula rotationally less than 360° within the interior volume of the collection container.
[0210] Example 50. The method removing the contents from the interior of a container according to any example herein, particularly examples 43-49, wherein moving the spatula rotationally and / or axially within the interior volume of the collection container includes, rotating the spatula rotationally at least 360° within the interior volume of the collection container.
[0211] Example 51. A nutrition containment and dispensing system, comprising: a barrel spanning between a first end and a second end and defining an internal volume therebetween, the barrel having a first opening at the first end and a second opening at the second end; a filter slidably mounted within the internal volume and dividing the internal volume into a first chamber and a second chamber, the filter comprising a filter media configured to prevent solids and semisolids from passing therethrough; a filter plunger stem configured to engage the filter and move the filter within the internal volume to thereby adjust a volume of the first chamber and a volume of the second chamber.
[0212] Example 52. The nutrition containment and dispensing system according to any example herein, particularly example 48, further comprising a collection container coupled to the second end of the barrel.
[0213] Example 53. The nutrition containment and dispensing system according to any example herein, particularly examples 48-49, further comprising a lactation pump head coupled to the first end of the barrel.
[0214] Example 54. The nutrition containment and dispensing system according to any example herein, particularly examples 48-50, wherein when a flow of nutrition is directed through the first opening of the barrel, the movable filter prevents the flow of solids and semisolids within the flow of nutrition from passing therethrough and into the second chamber.
[0215] Example 55. The nutrition containment and dispensing system according to any example herein, particularly example 51, wherein the plunger stem passes through the second opening and is configured to engage the filter to move the filter toward the first end of the barrel.
[0216] Example 56. The nutrition containment and dispensing system according to any example herein, particularly examples 48-52, wherein the filter plunger stem comprises a thumb rest on a proximal end thereof.
[0217] Example 57. The nutrition containment and dispensing system according to any example herein, particularly examples 48-53, further comprising a nipple attachment coupled to the first end of the barrel.
[0218] Example 58. The nutrition and dispensing system according to any example herein, particularly examples 48-54, wherein when the plunger stem slides the filter within the barrel, the contents of the first chamber are ejected from the barrel and into a nipple attachment or an enteral feeding tube coupled to the first end of the barrel.
[0219] Example 59. A method for preparing and providing nutrition to a recipient, comprising: providing a flow of lactated nutrient through a barrel comprising a lipid filter slidably mounted within a bore of the barrel; accumulating lipids contained within the flow of lactated nutrients within a first chamber of the bore of the barrel; providing the accumulated lipids to a recipient.
[0220] Example 60. The method for preparing and providing nutrition to a recipient according to any example herein, particularly example 56, further comprising collecting a liquid nutrient of the flow of lactated nutrient in a container coupled to a second end of the barrel.
[0221] Example 61. The method for preparing and providing nutrition to a recipient according to any example herein, particularly example 57, further comprising fortifying the liquid nutrient and providing the fortified liquid nutrient to the recipient.
[0222] Example 62. The method for preparing and providing nutrition to a recipient according to any example herein, particularly examples 56-58, wherein the lactated nutrient is milk.
[0223] Example 63. The method for preparing and providing nutrition to a recipient according to any example herein, particularly examples 56-59, further comprising ejecting the accumulated lipids from the first chamber by sliding the lipid filter within the bore of the barrel.
[0224] Example 64. The method for preparing and providing nutrition to a recipient according to any example herein, particularly examples 56-60, wherein providing theaccumulated lipids to a recipient comprises ejecting the accumulated lipids from the first chamber into an enteral feeding tube or a nipple attachment.
[0225] Example 65. A kit comprising: a barrel having a bore between a first opening at a first end and a second opening at a second end: a filter configured to be slidably mounted within the bore of the barrel: and a collection container configured to couple with the second opening at the second end of the barrel.
[0226] Example 66. The kit according to any example herein, particularly example 62, further comprising a filter plunger stem configured to extend through the second opening and to engage the filter and move the filter within the bore of the barrel.
[0227] Example 67. The kit according to any example herein, particularly examples 62-63, further comprising a lactation pump head configured to couple with the first opening at the first end of the barrel.
[0228] Example 68. The kit according to any example herein, particularly examples 62-64, further comprising a nipple attachment configured to couple with the first opening at the first end of the barrel.
[0229] Example 69. The kit according to any example herein, particularly examples 62-65, wherein the collection container is a variable volume container.
[0230] Example 70. The kit according to any example herein, particularly examples 62-66, wherein the bore has an internal diameter that is larger than a diameter of the first opening and a diameter of the second opening.
[0231] Additional advantages may be learned by practice. The advantages will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that the description and are exemplary and explanatory only and are not restrictive, as claimed.
Claims
WHAT IS CLAIMED IS:
1. A fluid containment and dispensing system, comprising: a variable-volume container, comprising: an elongate body spanning between a first end and a second end and defining an internal volume therebetween; a cover coupled to the second end and comprising a fluid port; and a movable floor slidably mounted within the internal volume.
2. The fluid containment and dispensing system of claim 1, further including: a plunger stem configured to engage the floor and move the floor in an axial direction within the internal volume, wherein the plunger stem comprises a body spanning between a distal end and a proximal end, and where the body comprises a plurality of thumb-holds provided between the distal end and the proximal end.
3. The fluid containment and dispensing system of claim 2, wherein the plunger stem comprises a hollow portion and where at least one of the plurality of thumb-holds includes an opening in a wall of the hollow portion.
4. The fluid containment and dispensing system of claim 1 , further including a plunger stem configured to engage the floor and move the floor in an axial direction within the internal volume, wherein the plunger stem comprises a knob at a proximal end thereof.
5. The fluid containment and dispensing system of claim 2, wherein the first end of the elongate body comprises a lip extending radially outward from an outer surface of the elongate body.
6. The fluid containment and dispensing system of claim 5, wherein the lip comprises a groove extending in a radial direction along a bottom surface of the elongate body about the lip.
7. The fluid containment and dispensing system of claim 1, further including: a plunger stem configured to engage the floor and move the floor in an axial direction within the internal volume, wherein the first end of the elongate body provides an opening having a diameter lessthan a diameter of the internal volume, and wherein a portion of the plunger stem is received by the opening when the plunger stem engages the floor.
8. The fluid containment and dispensing system of claim 2, wherein the cover comprises a fluid port and a cap configured to seal the fluid port.
9. The fluid containment and dispensing system of claim 1 , wherein an interior surface of the cover comprises a sloped surface and the upper surface of the floor comprises a correspondingly shaped second sloped surface, wherein when the floor is moved into contact with the cover, the sloped surface and the second sloped surface are flush.
10. The fluid containment and dispensing system of claim 1, wherein the floor comprises: a seal portion on a first side; a receiver provided on a second side; and a skirt provided on the first side of the floor distal to the seal portion and surrounding the receiver.
11. The fluid containment and dispensing system of claim 10, wherein the seal portion comprises a circumferential recess and a gasket provided therein.
12. The fluid containment and dispensing system of claim 10, wherein the seal portion comprises a wiper extending radially from the first side of the floor and continuously around a circumference of the floor.
13. The fluid containment and dispensing system of claim 2, wherein the floor is a unitary body and the wiper edge is oriented toward an interior-facing surface of the floor when the floor is moved from a location proximate the first end of the elongate body toward a location proximate the second end of the elongate body.
14. The fluid containment and dispensing system of claim 10, wherein the skirt comprises a plurality of axial ribs protruding radially from a peripheral surface of the skirt.
15. The fluid containment and dispensing system of claim 10, wherein the skirt comprises a plurality of legs spaced circumferentially around a central axis of the floor and extending in a distal direction from a bottom of the skirt.
16. The fluid containment and dispensing system of claim 15, wherein the plurality of legs are define an arcuate outermost surface.
17. The fluid containment and dispensing system of claim 10, wherein the cover includes an interior sloped surface and includes one or more protrusions that extend distally from the sloped surface, when the floor is moved into contact with the cover the protrusions occupy a gap provided between the floor and the elongate body.
18. A fluid containment and dispensing system, comprising: a first variable-volume container comprising: a first elongate body having a first bore between a first end and a second end; a first floor slidably mounted within the first bore and providing a seal defining a first contained volume on a first side thereof, and an uncontained volume on a second side opposite the first side; and a removable cover coupled to the second end of the first elongate body; a breast shield of a lactation pump head configured to couple to the second end of the first elongate body and to direct lactated nutrition into the contained volume of the first variable- volume container; and a plunger stem configured to engage the first floor and move the first floor within the first elongate body to thereby adjust the contained volume.
19. The fluid containment and dispensing system of claim 18, further comprising a second variable-volume container comprising: a second elongate body having a second bore; and a second floor slidably mounted within the second bore and defining a second contained volume; wherein the plunger stem is configured to engage the second floor and move the second floor within the second elongate body to thereby adjust the second contained volume.
20. A variable-volume container, comprising: an elongate body spanning between a first end and a second end and defining an internal volume therebetween; a cover coupled to the second end; and a floor slidably mounted within the internal volume, the floor including at least one of a gasket or a wiper, and a skirt around a perimeter of the floor.
21. A method for administering nutrient to a recipient, comprising: expressing a volume of nutrient into a collection container having a variable containment volume and a movable floor; attaching a cover to a second end of the collection container; inserting a plunger stem into a first end of the collection container opposite the second end of the collection container; attaching the plunger stem to the movable floor; moving, via the plunger stem, the movable floor toward the cover to eject gas from the contained volume; and ejecting the nutrition from the contained volume.
22. The method of claim 21 , further comprising, fortifying the nutrition within the collection container.
23. The method of claim 21, further comprising, transferring the nutrition to a second container having a second variable containment volume; inserting the plunger stem into a third end of the second collection container; attaching the plunger stem to a second movable floor of the second collection container; moving, via the plunger stem, the second movable floor toward a second cover of the second container to eject gas from the second contained volume; batching the nutrition from the second containment volume into one or more syringes; and administering, via the one or more syringes, the nutrition to a recipient.
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