WO2025050076A1 - Breast cup with integrated pressure source and uses thereof - Google Patents

Breast cup with integrated pressure source and uses thereof Download PDF

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Publication number
WO2025050076A1
WO2025050076A1 PCT/US2024/044913 US2024044913W WO2025050076A1 WO 2025050076 A1 WO2025050076 A1 WO 2025050076A1 US 2024044913 W US2024044913 W US 2024044913W WO 2025050076 A1 WO2025050076 A1 WO 2025050076A1
Authority
WO
WIPO (PCT)
Prior art keywords
mmhg
breast
milk
breast cup
pressure
Prior art date
Application number
PCT/US2024/044913
Other languages
French (fr)
Inventor
Laura Haft
William C. Brody
Heath STEPHENSON
Original Assignee
Nooshee Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nooshee Inc. filed Critical Nooshee Inc.
Publication of WO2025050076A1 publication Critical patent/WO2025050076A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/06—Milking pumps
    • A61M1/062—Pump accessories
    • A61M1/064—Suction cups
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/06—Milking pumps
    • A61M1/062—Pump accessories
    • A61M1/067—Pump accessories with means for hands-free operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/80—Suction pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/80—Suction pumps
    • A61M1/82—Membrane pumps, e.g. bulbs

Definitions

  • Breast pumps systems draw breast milk from a breast of a user and may be used to pump breast milk for later consumption by an infant, to stimulate lactation in users with low milk supply, or to relieve engorgement.
  • Breast pumps may be manually operated, for example by squeezing a handle or operation of a foot pedal.
  • Breast pumps may also be electrically driven by a drive unit.
  • portable breast pumps may also include on-body milk collection, which requires a user to remove the breast cups in order to access the milk, and many of these pumps also have a large breast cup and/or milk collection profile.
  • Breast cup removal and large breast cup profiles do not allow for discreet public pumping.
  • the present disclosure provides improved breast cups having integrated pressure sources, components thereof, and methods of use thereof that address these and other problems of traditional breast pumps.
  • the breast cup includes a housing including an outlet configured to be fluidly coupled to an external reservoir.
  • the breast cup further includes a breast shield configured to be attached to a human breast.
  • the breast cup further includes a diaphragm disposed between the housing and the breast shield, wherein the diaphragm is disposed between a pressure chamber and a milk chamber.
  • the breast cup further includes a pressure source in fluidic communication with the pressure chamber, the pressure source configured to apply pressure to the pressure chamber to induce lactation from the human breast and pull milk from the human breast into the milk chamber.
  • the outlet when fluidly coupled to the external reservoir, allows the milk to flow from the milk chamber to the external reservoir.
  • the breast pump system includes a reservoir configured to store milk.
  • the breast pump system further includes a breast cup configured to be attached to a human breast.
  • the breast cup includes a housing including an outlet configured to be fluidly coupled to the reservoir.
  • the breast cup further includes a diaphragm disposed within the housing between a pressure chamber and a milk chamber.
  • the breast cup further includes a pressure source in fluidic communication with the pressure chamber, the pressure source configured to apply pressure to the pressure chamber to induce lactation from the human breast and pull milk from the human breast into the milk chamber.
  • the breast pump system further includes a fluid conduit fluidly coupling the outlet to the reservoir. The outlet allows the milk to flow from the milk chamber, through the fluid conduit, to the reservoir.
  • Another embodiment relates to a method of breast pumping.
  • the method includes attaching a breast cup to a human breast of a subject, the breast cup including an internal pressure source and a pressure chamber.
  • the method further includes applying pressure to the pressure chamber using the internal pressure source to pump milk from the human breast and into an external reservoir fluidly coupled to the breast cup via a fluid conduit.
  • the disclosure provides a breast cup including a housing, a breast shield, a milk outlet, and a pressure source disposed to alter pressure within the breast cup to express milk, wherein the breast cup is configured so that milk is collected external to the breast cup.
  • the breast cup further includes a fluid conduit connected to the milk outlet and a reservoir.
  • the breast cup further includes a power source operatively connected to the pressure source.
  • the disclosure provides a breast cup including (a) a housing; (b) a breast shield; (c) a diaphragm disposed between the housing and the breast shield; (d) a pressure source; and (e) optionally a power source.
  • the diaphragm is disposed between a pressure chamber and a milk chamber, and the pressure source is in fluidic communication with the pressure chamber.
  • the breast shield includes a wide portion and a nipple tunnel.
  • the breast cup further includes a milk chamber wall disposed between the diaphragm and the breast shield.
  • the diaphragm and the milk chamber wall define the milk chamber.
  • the milk chamber includes an inlet from the breast shield, and the diaphragm releasably seals the inlet.
  • the inlet includes a valve, e.g., a mechanical valve, an umbrella valve, a butterfly valve, a disk valve, or a duckbill valve.
  • the inlet comprises a plurality of orifices. In some embodiments, the plurality of orifices is circumferentially arranged at a nipple tunnel of the breast shield.
  • the milk chamber includes an inlet from the breast shield, e.g., wherein the diaphragm releasably contacts the inlet. In some embodiments, the diaphragm releasably seals the inlet.
  • the inlet includes a valve.
  • the valve is mechanical valve, an umbrella valve, a butterfly valve, a disk valve, or a duckbill valve.
  • the breast cup or component thereof e.g., the breast shield
  • the breast cup or component thereof is polymeric.
  • the housing includes polyethylene terephthalate (PET), polypropylene (PP), polytetrafluoroethylene (PTFE) (e.g., Teflon), polyethylene, high-density polyethylene (HDPE), low-density polyethylene (LDPE), copolyester (e.g., Tritan EX401), polycarbonate (PC), nylon, poly vinylidene fluoride (PVDF), silicone, polyester, cotton, linen, satin, organdy, rayon, taffeta, broad cloth, poplin, velour, gauze, canvas, shirting, muslin, tweed, georgette, crepe, wool, twill, gabardine, denim, or drill.
  • PET polyethylene terephthalate
  • PP polypropylene
  • PTFE polytetrafluoroethylene
  • HDPE high-density polyethylene
  • the breast cup or component thereof e.g., the breast shield, include ridges, bumps or dimples.
  • the breast cup includes a toroidal ridge.
  • the diaphragm includes a flexible material. In some embodiments, the diaphragm includes a polymeric material.
  • the diaphragm includes a material having a Shore hardness from A10 to A80. In some embodiments, the diaphragm includes a material having a Shore hardness from A10 to A80 and a second Shore hardness from A10 to A80 or being rigid, wherein the material includes the second Shore hardness or is rigid where the diaphragm contacts the inlet. In some embodiments, the diaphragm includes a first material, e.g., having a Shore hardness from A10 to A80, and a second material, e.g., having a different Shore hardness from A10 to A80 or being rigid. In some embodiments, either the first or second material may have a Shore hardness from DIO to D80. The second material may be more rigid than the first material and contact the inlet.
  • the diaphragm includes a thickness from about 1 mm to about 10 mm (e.g., about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 5 mm, about 2 mm to about 7 mm, about 4 mm to about 6 mm, about 5 mm to about 7.5 mm, about 5 mm to about 10 mm, or about 7.5 mm to about 10 mm).
  • a thickness from about 1 mm to about 10 mm (e.g., about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 5 mm, about 2 mm to about 7 mm, about 4 mm to about 6 mm, about 5 mm to about 7.5 mm, about 5 mm to about 10 mm, or about 7.5 mm to about 10 mm).
  • the diaphragm includes a first thickness from about 1 mm to about 10 mm (e.g., about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 5 mm, about 2 mm to about 7 mm, about 4 mm to about 6 mm, about 5 mm to about 7.5 mm, about 5 mm to about 10 mm, or about 7.5 mm to about 10 mm), and a second thickness from about 1 mm to about 10 mm (e.g., about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 5 mm, about 2 mm to about 7 mm, about 4 mm to about 6 mm, about 5 mm to about 7.5 mm, about 5 mm to about 10 mm, or about 7.5 mm to about 10 mm), wherein the diaphragm includes the second thickness where the diaphragm contacts the inlet.
  • the thickness of the diaphragm may be non
  • the diaphragm includes a plurality of layers. In some embodiments, the diaphragm includes a plurality of layers wherein the diaphragm contacts the inlet. In some embodiments, the diaphragm is shaped to conform to the shape of breast shield or the milk chamber wall. In some embodiments, the diaphragm includes a curved shape.
  • the pressure chamber further includes a valve to the ambient atmosphere.
  • a volume of the pressure chamber may be set with the valve.
  • the valve is an inflation valve.
  • All or portions of the breast cup may be clear, e.g., to allow for visualization of the nipple during placement of the breast cup.
  • a portion, e.g., a portion of the diaphragm, may also include a lens to magnify the nipple for alignment.
  • Breast cups with clear portions may include a flap or other opaque covering to hide the clear portions after alignment. References to “clear” material should be understood to encompass transparent material and certain translucent material.
  • the milk chamber further comprises an outlet.
  • the breast cup further includes a one directional valve configured to allow fluid flow from the milk chamber to a reservoir.
  • the one directional valve is disposed in the outlet.
  • the breast cup further includes a positive pressure source, wherein the positive pressure source is in fluidic communication with the pressure chamber.
  • the positive pressure source is a vacuum pump.
  • the pressure source includes a negative pressure source and a positive pressure source.
  • the negative pressure source is a vacuum pump.
  • the breast shield is configured to permit a slow leak to the ambient atmosphere.
  • the breast shield includes a wide portion and a nipple tunnel.
  • the nipple tunnel has a length from about 5 mm to about 75 mm (e.g., about 5 mm to about 25 mm, about 10 mm to about 30 mm, about 25 mm to about 50 mm, about 30 mm to about 60 mm, or about 50 mm to about 75 mm).
  • the nipple tunnel has a minimum diameter from about 10 mm to about 130 mm (e.g., about 10 mm to about 50 mm, about 25 mm to about 75 mm, about 50 mm to about 100 mm, about 75 mm to about 100 mm, or about 100 mm to about 130 mm).
  • the nipple tunnel has a maximum diameter from about 10 mm to about 130 mm (e.g., about 10 mm to about 50 mm, about 25 mm to about 75 mm, about 50 mm to about 100 mm, about 75 mm to about 100 mm, or about 100 mm to about 130 mm). In some embodiments, the diameter of the nipple tunnel is between about 20 and about 40 mm. In some embodiments, the breast shield is funneled.
  • the milk chamber includes a volume from about 1 mL to about 150 mL (e.g., about 1 mL to about 10 mL, about 1 mL to about 50 mL, about 10 mL to about 50 mL, about 25 mL to about 50 mL, about 30 mL to about 60 mL, about 50 mL to about 100 mL, about 50 mL to about 150 mL, about 75 mL to about 125 mL or about 100 mL to about 150 mL).
  • about 1 mL to about 150 mL e.g., about 1 mL to about 10 mL, about 1 mL to about 50 mL, about 10 mL to about 50 mL, about 25 mL to about 50 mL, about 30 mL to about 60 mL, about 50 mL to about 100 mL, about 50 mL to about 150 mL, about 75 mL to about 125 mL or about 100 m
  • the pressure chamber includes a volume from about 1 mL to about 150 mL (e.g., about 1 mL to about 10 mL, about 1 mL to about 50 mL, about 10 mL to about 50 mL, about 25 mL to about 50 mL, about 30 mL to about 60 mL, about 50 mL to about 100 mL, about 50 mL to about 150 mL, about 75 mL to about 125 mL or about 100 mL to about 150 mL).
  • mL to about 150 mL e.g., about 1 mL to about 10 mL, about 1 mL to about 50 mL, about 10 mL to about 50 mL, about 25 mL to about 50 mL, about 30 mL to about 60 mL, about 50 mL to about 100 mL, about 50 mL to about 150 mL, about 75 mL to about 125 mL or about 100 mL to
  • the breast cup further includes a first fluid conduit providing fluidic communication between the milk chamber and the reservoir.
  • the first fluid conduit is releasably connected to the milk chamber and/or the reservoir.
  • the first fluid conduit includes a movement element.
  • the movement element includes a swivel fitting or a rotating fitting.
  • the movement element includes a ball bearing.
  • the first fluid conduit is movably connected to the milk chamber.
  • the first fluid conduit is rotatable with respect to the breast cup.
  • the breast cup further includes a second breast cup as described herein.
  • the present disclosure provides a breast cup system including: (a) a breast cup as described herein and (b) a reservoir in fluidic communication with the milk chamber via a fluid conduit.
  • the breast pump system further includes a first fluid conduit providing fluidic communication between the milk chamber and the reservoir.
  • the first fluid conduit is releasably connected to the milk chamber and/or the reservoir.
  • the first fluid conduit includes a movement element.
  • the movement element includes a swivel fitting or a rotating fitting.
  • the movement element includes a ball bearing.
  • the first fluid conduit is movably connected to the milk chamber.
  • the first fluid conduit is rotatable with respect to the breast cup.
  • the breast pump system further includes a control valve.
  • the breast pump system further includes a one directional valve configured to allow fluid flow from the milk chamber to the reservoir.
  • the one directional valve is disposed in the first fluid conduit.
  • the outlet includes the one directional valve.
  • the one directional valve is disposed in the diaphragm.
  • the breast pump system further includes two breast cups, wherein the two breast cups each include a housing, a breast shield, and a diaphragm as described herein.
  • the breast cup further includes a drive unit operatively connected to the pressure source.
  • the drive unit includes the control unit.
  • the breast cup is connected to a power source.
  • the breast cup further includes the power source.
  • the power source may or may not be disposed in the breast cup, e.g., it may be connected via wire and worn separately or disposed with or adjacent to the reservoir.
  • the breast cup further includes a button, display, timer, alarm, and/or power switch.
  • one or more interactive components e.g., button, display, timer, alarm, and/or a power switch, may be disposed on the breast cup, e.g., on the housing.
  • the breast cup may be remotely controlled, e.g., by a remote or mobile device app.
  • the breast cup further includes a sensor selected from the group consisting of a weight sensor, a load cell, a temperature sensor, a pressure sensor, an optical sensor, a flow sensor, a volume sensor, a pH sensor, and a viscosity sensor.
  • a sensor selected from the group consisting of a weight sensor, a load cell, a temperature sensor, a pressure sensor, an optical sensor, a flow sensor, a volume sensor, a pH sensor, and a viscosity sensor.
  • the breast cup system further includes a garment, and the breast cup is releasably secured to the garment.
  • the garment is a bra or shirt.
  • the coefficient of friction between the garment and the housing is less than 0.4 (e.g., 0.3, 0.2, 0.1, or 0.5).
  • the present disclosure provides a method of breast pumping including providing the breast cup of the present disclosure, wherein a reservoir is in fluidic communication with the breast cup; contacting a breast of a subject with the breast cup; and pumping milk from the breast to the reservoir by alternating reducing and increasing pressure in the pressure chamber.
  • the subject is moving, resting, or sleeping. In some embodiments, the subject is moving, reclining, resting, or sleeping.
  • the method further includes connecting the first fluid conduit to the breast cup and the reservoir. In some embodiments, the method further includes contacting the breast with the wide portion of the breast cup. In some embodiments, the method further includes contacting the breast with the wide portion of the breast shield. In some embodiments, a nipple of the breast is placed in the nipple tunnel of the breast cup. In some embodiments, the method further includes contacting two breasts with the two breast cups.
  • the method further includes applying negative pressure to the pressure chamber with the pressure source. In some embodiments, the method further includes deforming the diaphragm away from the breast shield. In some embodiments, the method further includes deforming the diaphragm away from the inlet. In some embodiments, the milk chamber comprises an inlet, and the diaphragm pulls away from the inlet to provide fluidic communication between the milk chamber and the breast shield when pressure in the pressure chamber is reduced. In some embodiments, the method further includes unsealing the inlet. In some embodiments, the method further includes expanding the milk chamber. In some embodiments, the method further includes contracting the pressure chamber. In some embodiments, the method further includes providing negative pressure to elongate the nipple. In some embodiments, the method further includes drawing milk from the nipple. In some embodiments, the method further includes drawing milk from the nipple tunnel into the milk chamber. In some embodiments, the method further includes drawing milk through the inlet into the milk chamber.
  • the method further includes opening the control valve and depressurizing the pressure chamber. In some embodiments, the method further includes returning the diaphragm to a nominal position. In some embodiments, the method further includes closing the control valve.
  • the method further includes applying positive pressure to the pressure chamber with a positive pressure source. In some embodiments, the method further includes allowing the nipple to contract. In some embodiments, the method further includes deforming the diaphragm towards the breast shield. In some embodiments, the method includes allowing the diaphragm to return to a nominal position. In some embodiments, the method further includes sealing the inlet with the diaphragm. In some embodiments, the diaphragm seals the inlet when pressure in the pressure chamber increases. In some embodiments, the method further includes sealing orifices in the inlet with the diaphragm. In some embodiments, the method further includes contracting the milk chamber. In some embodiments, the method further includes expanding the pressure chamber. In some embodiments, the method further includes transporting milk from the milk chamber through the first fluid conduit to the reservoir. In some embodiments, the method further includes transporting milk through the outlet. In some embodiments, the method further includes transporting milk through the one directional valve.
  • the method further includes applying negative pressure to a fluid conduit attached to an outlet of the milk chamber.
  • the negative pressure is applied via a vacuum pump.
  • the fluid conduit comprises an air inlet.
  • the method further includes removing the reservoir from fluidic communication with the breast cup without removing the breast cup from the user.
  • the method further includes waiting at least 30 minutes after the pumping step and repeating the pumping step to a provide a first and second breast pumping session. In some embodiments, the method further includes pumping milk from the human breast twice, wherein there is at least about 30 minutes (e.g., about 45 minutes, about 60 minutes, about 75 minutes, about 90 minutes, about 120 minutes, about 150 minutes, about 180 minutes, about 210 minutes, or about 240 minutes) between a first breast pumping session to a second breast pumping session.
  • 30 minutes e.g., about 45 minutes, about 60 minutes, about 75 minutes, about 90 minutes, about 120 minutes, about 150 minutes, about 180 minutes, about 210 minutes, or about 240 minutes
  • milk from the first breast pumping session is transported to a first reservoir
  • milk from the second breast pumping session is transported to a second reservoir.
  • the method further includes taking a weight, a temperature, a pressure, an optical, a flow rate, a pH, or a viscosity measurement of the milk with the sensor. In some embodiments, the method further includes alerting a user of the temperature, pressure, optical, flow rate, volume, pH, or viscosity measurement. In some embodiments, the method further includes changing at least one of the first pressure or second pressure based on the temperature, pressure, or flow rate measurement. In some embodiments, the method further includes measuring the weight of a reservoir containing the pumped milk.
  • the method further includes securing the breast cup to the garment and donning the garment. In some embodiments, the method further includes donning the garment and securing the breast cup to the garment.
  • the method further includes pumping milk from the breast at least twice without removing the breast cup from the breast. In some embodiments, the method further includes removing the reservoir from fluidic communication with the breast cup without removing the breast cup. In some embodiments, the method includes replacing the reservoir between the first and second breast pumping sessions. In some embodiments, a subject including the human breast is moving, reclining, resting, or sleeping.
  • fluidically connected refers to a direct connection between at least two device elements, e.g., a channel, reservoir, etc., that allows for fluid to move between such device elements without passing through an intervening element.
  • fluidically disconnected refers to the absence of a connection in which fluid, e.g., a liquid, can flow between elements in a fluid path.
  • food contact substance refers to a substance or material that is intended for use as a component in manufacturing, packing, packaging, transporting, or holding food in which such use is not intended to have any technical effect in such food.
  • fluid communication refers to a connection between at least two device elements, e.g., a channel, reservoir, etc., that allows for fluid to move between such device elements with or without passing through one or more intervening device elements.
  • valve refers to an element which regulates, directs or controls the flow of a fluid by opening, closing, or partially obstructing a fluid pathway.
  • positive pressure refers to an application of pressure from a pressure source (e.g., a pump) that tends to increase a pressure within a given component or space.
  • a pressure source e.g., a pump
  • negative pressure refers to an application of pressure from a pressure source (e.g., a pump) that tends to decrease a pressure within a given component or space.
  • a pressure source e.g., a pump
  • FIG. 1 shows a schematic drawing of a breast cup, including a pressure source, according to an example embodiment.
  • FIG. 2 shows a schematic of a breast cup including a wide portion and a nipple tunnel, according to an example embodiment.
  • FIG. 3 shows a schematic drawing of a breast cup connected to a reservoir, according to an example embodiment.
  • FIG. 4 shows a schematic drawing of breast cup, including housing, diaphragm, breast shield, pressure chamber, milk chamber, outlet, and sealing point, according to an example embodiment.
  • FIG. 5 shows a schematic drawing of breast cup, including housing, diaphragm, breast shield, pressure chamber, milk chamber, outlet, and valve, according to an example embodiment.
  • FIG. 6 shows a schematic drawing of breast cup, including housing, diaphragm, breast shield, pressure chamber, milk chamber, outlet, sealing point, and orifices, according to an example embodiment.
  • FIG. 7 shows a schematic drawing of breast cup, including housing, diaphragm, breast shield, pressure chamber, milk chamber, outlet, sealing point, and milk chamber wall, according to an example embodiment.
  • FIG. 8 A and FIG. 8B show schematic drawings of breast shield having a protrusion on the inner surface of breast shield, wherein the inner surface of breast shield is configured to contact the breast of a user, according to example embodiments.
  • FIG. 8A shows a schematic drawing of breast shield having a toroidal ridge on the inner surface of breast shield, according to an example embodiment.
  • FIG. 8B shows a schematic drawing of breast shield having a curved toroidal ridge on the inner surface of breast shield, according to an example embodiment.
  • FIG. 9A-9D show views of a breast cup including housing, diaphragm, breast shield, pressure chamber, milk chamber, milk chamber wall, ports, and a one directional valve, according to example embodiments.
  • FIG. 10 shows a perspective view of another breast cup, according to an example embodiment.
  • FIG. 11 shows a section view of the breast cup of FIG. 10, taken along section line 11-11, according to an example embodiment.
  • FIG. 12 shows a top view of the breast cup of FIG. 10, shown without an upper housing, according to an example embodiment.
  • FIG. 13 shows a section view of the breast cup of FIG. 12, taken along section line
  • FIG. 14 shows a section view of the breast cup of FIG. 12, taken along section line
  • the present disclosure provides a breast cup, components thereof, and methods of use thereof.
  • the present breast cups are particularly advantageous for navigating daily activities, resting, reclining, sleeping, and for removing a reservoir without removal of a breast cup.
  • the present disclosure provides a breast cup.
  • the breast cup is advantageous in that it comfortably allows for pumping in any position, such as lying reclined, flat, or on the side; allows for pumping without assembly at the time of use; allows for discrete public pumping; and/or allows for removal of a reservoir without necessitating removal of the breast cup after a pumping session.
  • An exemplary scheme for a breast cup of the disclosure is shown in FIG. 1.
  • the breast cup may include a housing, a breast shield, a milk outlet, and a pressure source disposed to alter pressure within the breast cup to express milk. Milk is collected external to the breast cup, e.g., via a fluid conduit connected to the milk outlet.
  • the breast cup may include (a) a housing (e.g., including an upper housing 17 and a lower housing or milk chamber wall 26); (b) a breast shield 19; (c) a diaphragm 18 disposed between the upper housing 17 and the breast shield 19 (and also between the upper housing 17 and/or the lower housing or milk chamber wall 26); and (d) a pressure source 9.
  • the diaphragm may be disposed further between a pressure chamber and a milk chamber.
  • the breast cup 2 may include at least one breast cup 2 in fluidic communication with a separate reservoir 3 via a fluid conduit.
  • FIG. 3 shows a schematic of a breast cup 2, including two breast cups 2 in fluidic communication with the pressure source 9 and a reservoir 3.
  • the breast cup 2 can include a breast cup 2 having a housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), a breast shield 19, and a diaphragm 18 disposed between the upper housing 17 and the breast shield 19 (and also between the upper housing 17 and/or the lower housing or milk chamber wall 26).
  • the diaphragm 18 can separate the pressure chamber 20 from the milk chamber 21.
  • the diaphragm provides numerous advantages including improved breast pumping in reclined positions.
  • the pressure source 9 may be a negative pressure source and/or a positive pressure source in fluidic communication with the pressure chamber 20, and the reservoir 3 can be in fluidic communication with the milk chamber 21.
  • the breast cup 2 can include a food contact substance, e.g., for surfaces that contact milk and the breast. Alternatively, or in addition, the breast cup 2 can include an infant grade material.
  • the breast cup 2, including any element therein, can include a polymer (e.g., polyvinyl chloride (PVC), polyethylene terephthalate (PET), polypropylene (PP), polytetrafluoroethylene (PTFE), polyethylene, high-density polyethylene (HDPE), low- density polyethylene (LDPE), copolyester (e.g., Tritan EX401), polystyrene, a thermoplastic elastomer, thermoplastic polyurethane, nylon, polyvinylidene fluoride (PVDF), silicone, or polycarbonate (PC)).
  • a polymer e.g., polyvinyl chloride (PVC), polyethylene terephthalate (PET), polypropylene (PP), polytetrafluoroethylene (PTFE), polyethylene, high-density polyethylene (HDPE), low- density polyethylene (LDPE), copolyester (e.g., Tritan EX401), polystyrene,
  • the reservoir 3, the reservoir enclosure 4, the fluid conduit 5, or the breast cup 2, including the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), breast shield 19, and diaphragm 18 can include a polymer.
  • the breast cup, including any element therein may be substantially free of bisphenol A (BP A) and/or polyfluoroalkyl substances (PFAS).
  • BP A bisphenol A
  • PFAS polyfluoroalkyl substances
  • the breast cup, including any element therein and/or any components thereof is manufactured absent of any intentionally added BP A and/or PFAS.
  • breast cup 2 can include a fabric (e.g., polyester, cotton, linen, satin, organdy, rayon, taffeta, broad cloth, poplin, velour, gauze, canvas, shirting, muslin, tweed, georgette, crepe, wool, twill, gabardine, denim, or drill).
  • a fabric e.g., polyester, cotton, linen, satin, organdy, rayon, taffeta, broad cloth, poplin, velour, gauze, canvas, shirting, muslin, tweed, georgette, crepe, wool, twill, gabardine, denim, or drill.
  • the reservoir 3 or the breast cup 2 including the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) and the breast shield 19, can include a fabric.
  • the breast cup 2 includes a foam, e.g., an open cell foam.
  • the reservoir 3 or the breast cup 2, including the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) and the breast shield 19, can include a foam.
  • the breast cup 2 includes a pressure source 9, e.g., a negative pressure source and/or a positive pressure source.
  • the pressure source 9 may be a single pressure source comprising both a negative pressure source and a positive pressure source.
  • the pressure source is configured to be used to move fluids, such as air, water, milk, and/or cleaning fluid, in the breast cup 2.
  • the breast cup 2 includes a plurality of pressure sources (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10).
  • at least one pressure source is a vacuum pump, e.g., which is capable of producing negative and positive pressure.
  • the breast cup 2 includes a pressure source 9 that provides negative pressure to the breast cup 2, and thus the nipple of the breast in order to express milk.
  • the pressure source 9 may be configured transport milk in the breast cup 2, e.g., to expand and/or compress the pressure chamber 20 and/or the milk chamber 21.
  • the pressure source 9 is pneumatic.
  • the pressure source 9 is a vacuum pump, such as a small vacuum pump, a micro vacuum pump, a piezo pump, an air powered vacuum pump, a positive displacement pump, or a scroll pump sized to attach to the breast cup.
  • the pressure source 9 is mechanical. In some embodiments, the mechanical pressure source 9 may be attached to the diaphragm.
  • the mechanical pressure source 9 may not be attached to the diaphragm.
  • the mechanical pressure source 9 includes a plunger, screw, chain, a rope, a pulley, a wire, an articulating arm, a rotating cam, or any other suitable mechanical actuator sized to attach to the breast cup.
  • the breast cup 2 includes a positive pressure source that provides positive pressure to the breast cup 2, e.g., to aid in transportation of milk, e.g., to expand and/or compress the pressure chamber 20 and/or the milk chamber 21.
  • the positive pressure source is pneumatic.
  • the positive pressure source is a pressure pump, a manually compressible chamber, a vacuum pump, a small vacuum pump, a micro vacuum pump, a piezo pump, an air powered vacuum pump, a positive displacement pump, a scroll pump, a peristaltic pump, or a valve to the ambient atmosphere sized to attach to the breast cup.
  • the positive pressure source is mechanical.
  • the mechanical pressure source 9 may be attached to the diaphragm. In some embodiments, the mechanical pressure source 9 may not be attached to the diaphragm. In some embodiments, the mechanical pressure source 9 includes a plunger, screw, chain, a rope, a pulley, a wire, an articulating arm, a rotating cam, or any other suitable mechanical actuator sized to attach to the breast cup.
  • the pressure source may include features configured to reduce noise and/or vibrations.
  • the pressure source may include a brushless motor.
  • pressure applied to the breast cup 2 varies. In some embodiments, the pressure source applies pressure to the breast cup 2 for 1 to 20 cycles (e.g.,
  • a first cycle may apply a maximum negative pressure of 0 mmHg to about 400 mmHg and/or a maximum positive pressure of about 0 mmHg to about 400 mmHg of positive pressure.
  • a second cycle may apply a maximum negative pressure of about 0 mmHg to about 400 mmHg and/or a maximum positive pressure of about 0 mmHg to about 400 mmHg of positive pressure.
  • a third, fourth, fifth, etc., cycle may apply a maximum negative pressure of about 0 mmHg to about 400 mmHg and/or a maximum positive pressure of about 0 mmHg to about 400 mmHg of positive pressure.
  • the pressure source 9 may provide a negative pressure from about 0 mmHg to about 400 mmHg (e.g., about 0 mmHg to about 10 mmHg, about 0 mmHg to about 20 mmHg, about 0 mmHg to about 30 mmHg, about 0 mmHg to about 40 mmHg, about 0 mmHg to about 50 mmHg, about 0 mmHg to about 60 mmHg, about 0 mmHg to about 70 mmHg, about 0 mmHg to about 80 mmHg, about 0 mmHg to about 90 mmHg, about 0 to about 100 mmHg, about 0 mmHg to about 110 mmHg, about 0 mmHg to about 120 mmHg, about 0 mmHg to about 130 mmHg, about 0 to about 140 mmHg, about 0 mmHg to about 150 mmHg, about 0 to about 1
  • the positive pressure source can provide a positive pressure from about 0 mmHg to about 400 mmHg (e.g., about 0 mmHg to about 10 mmHg, about 0 mmHg to about 20 mmHg, about 0 mmHg to about 30 mmHg, about 0 mmHg to about 40 mmHg, about 0 mmHg to about 50 mmHg, about 0 mmHg to about 60 mmHg, about 0 mmHg to about 70 mmHg, about 0 mmHg to about 80 mmHg, about 0 mmHg to about 90 mmHg, about 0 to about 100 mmHg, about 0 mmHg to about 110 mmHg, about 0 mmHg to about 120 mmHg, about 0 mmHg to about 130 mmHg, about 0 to about 140 mmHg, about 0 mmHg to about 150 mmHg, about 0 to about 1
  • pressure applied to the breast cup 2 may change, e.g., from about every 0.1 seconds to about every 120 seconds (e.g., about every 0.1 seconds to about every 1 second, about every 0.1 seconds to about every 2 seconds, about every 0.1 seconds to about every 3 seconds, about every 0.1 seconds to about every 4 seconds, about every 0.1 seconds to about every 5 seconds, about every 0.1 seconds to about every 6 seconds, about every 0.1 seconds to about every 7 seconds, about every 0.1 seconds to about every 8 seconds, about every 0.1 seconds to about every 9 seconds, about every 0.1 seconds to about every 10 seconds, about every 0.1 seconds to about every 11 seconds, about every 0.1 seconds to about every 12 seconds, about every 0.1 seconds to about every 13 seconds, about every 0.1 seconds to about every 14 seconds, about every 0.1 seconds to about every 15 seconds, about every 0.1 seconds to about every 20 seconds, about every 0.1 seconds to about every 30 seconds, about every 0.1 seconds to about every 45 seconds, about every 0.1 seconds to about every 60 seconds, about every 0.1 seconds to about every 60 seconds, about
  • pressure applied to the breast cup 2 changes gradually. In some embodiments, pressure applied to the breast cup 2 changes at different rates, e.g., in a first cycle the pressure applied to the breast cup 2 changes over about 0.1 seconds to about 120 seconds (e.g., about 1 second), and in a second cycle the pressure applied to the breast cup 2 changes over about 0.1 seconds to about 120 seconds (e.g., about 5 seconds).
  • Pressure within the breast cup 2 can provide a pulsating or massaging sensation.
  • the speed and pressure of the pulsation or massage may be selected by the user.
  • alternating pressure mimics the action of suckling.
  • the pressure source 9 is disposed in the breast cup 2.
  • the housing may cover the pressure source and the connection between the pressure source and the pressure chamber.
  • the pressure source may be attached to the exterior of the housing or breast cup, e.g., with the housing mating around the exterior of the pressure source.
  • the pressure source 9 may integrate seamlessly with another component of the breast cup 2, e.g., the breast cup upper housing 17, such that when fit together, the breast cup 2 as a whole presents an overall minimal and/or unobtrusive profile and/or natural shape, e.g., breast shaped.
  • a breast cup 2 with an unobtrusive profile may minimize visibility of the device while in use under a garment.
  • the pressure source 9 may be releasably or non- releasably attached to another component of the breast cup 2.
  • the pressure source 9 may be attached in any suitable manner, e.g., a connector, snap-fit, recess and groove, fastener, or magnet.
  • the breast cup 2 may include various components, including a control valve 10, a drive unit 11, and/or a power source 12.
  • the pressure source 9 is electrically connected to various components including a control valve 10, a drive unit 11, and/or a power source 12.
  • the control valve 10, drive unit 11, and/or power source 12 may be included in the breast cup 2 or external to the breast cup 2.
  • the present disclosure may include a first breast cup and a second breast cup.
  • the first breast cup may include a first pressure source 9.
  • the second breast cup may include a second pressure source 9.
  • the first breast cup and the second breast cup may be fluidically connected such that one pressure source 9 may provide positive and/or negative pressure to both the first breast cup and the second breast cup.
  • the first breast cup may include a pressure source 9, and/or the second breast cup may include various components including a control valve 10, a drive unit 11, and/or a power source 12.
  • the first breast cup and the second breast cup may be fluidically and electrically connected such that components in the first breast cup may affect both the first breast cup and the second breast cup, and/or components in the second breast cup may affect both the second breast cup and the first breast cup, e.g., a power source in the second breast cup may provide power to both breast cups.
  • the breast cup may include a pressure source 9, a housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), a breast shield 19, and a diaphragm 18 disposed between the upper housing 17 and the breast shield 19 (and also between the upper housing 17 and/or the lower housing or milk chamber wall 26), such that the diaphragm 18 separates a pressure chamber 20 from a milk chamber 21.
  • a pressure source 9 e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26
  • a breast shield 19 e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26
  • the breast cup 2 includes a milk chamber wall 26, e.g., as shown in FIG. 7.
  • the milk chamber wall 26 can be disposed between the diaphragm 18 and the breast shield 19, thereby defining the milk chamber 21 between the diaphragm 18 and the milk chamber wall 26. Pressurization and/or depressurization of the pressure chamber 20 deforms the diaphragm 18, and thereby expands or compresses the milk chamber 21.
  • the pressure chamber is not fluidically connected to the milk chamber or breast shield. In some embodiments, the pressure chamber is not in fluidic communication with the milk chamber or breast shield.
  • the pressure chamber 20 and/or the milk chamber 21 are distinct reservoirs, as opposed to chambers formed from the space between other components (e.g., the upper housing 17, the diaphragm 18, the milk chamber wall 26, and/or the breast shield 19, and may be reversibly attached to the breast cup 2).
  • the milk chamber 21 may be removed from the breast cup 2 to be cleaned or replaced.
  • At least one of the upper housing 17, the diaphragm 18, the breast shield 19, and/or the milk chamber wall 26 can include a protrusion and/or a recess, such as a groove.
  • a protrusion on at least one of the upper housing 17, the diaphragm 18, the breast shield 19, and/or the milk chamber wall 26 is configured to mate with a recess, such as a groove, on at least one of the upper housing 17, the diaphragm 18, the breast shield 19, and/or the milk chamber wall 26. Mating between a protrusion and a recess, e.g., groove, allows two components to be snapped, slid, or friction-fit together.
  • FIG. 7 shows an embodiment of the breast cup 2, in which the upper housing 17, the diaphragm 18, the breast shield 19, and/or the milk chamber wall 26 are attached together at least partially using protrusions and recesses, e.g., grooves.
  • FIGS. 9A- 9D show an embodiment of the breast cup 2, in which the upper housing 17, the diaphragm 18, the breast shield 19, and/or the milk chamber wall 26 are attached together at least partially using a fastener.
  • the breast cup 2 e.g., via the breast shield 19, contacts the breast of the user and can provide a seal during breast pumping, such that milk does not leak.
  • the breast cup 2, the breast shield 19, and/or the housing e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26
  • the interior of the breast cup 2, e.g., the breast shield 19, may conform to the breast and/or the nipple of the user.
  • the breast cup 2, the breast shield 19, and/or the housing may be in a shape for improved conformance to the breast, e.g., a funnel, a cone, or a dome.
  • the exterior of the breast cup 2 may be rounded.
  • a rounded breast cup 2 may appear breast-like, e.g., to be worn discreetly under clothing.
  • the breast cup 2, the breast shield 19, and/or the housing may be toroidal, e.g., forming a ring, with the breast cup 2, the breast shield 19, and/or the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) covering the breast.
  • the breast cup 2 is funneled.
  • the breast cup 2 may include a wide portion 8 and a nipple tunnel 13, e.g., as shown in FIG. 2, in which the wide portion 8, e.g., of the breast cup 2, initially contacts the breast, and the nipple tunnel 13, e.g., of the breast cup 2, is configured to receive the nipple.
  • the wide portion 8 of the breast cup 2 may have a largest diameter from about 50 mm to about 250 mm (e.g., about 50 mm to about 75 mm, about 50 mm to about 100 mm, about 50 mm to about 125 mm, about 50 mm to about 150 mm, about 50 mm to about 75 mm, about 75 mm to about 100 mm, about 75 mm to about 125 mm, about 75 mm to about 150 mm, about 75 mm to about 175 mm, about 75 mm to about 200 mm, about 100 mm to about 125 mm, about 100 mm to about 150 mm, about 100 mm to about 175 mm, about 100 mm to about 200 mm, about 125 mm to about 150 mm, about 125 mm to about 175 mm, about 125 mm to about 200 mm, about 150 mm to about 175 mm, about 150 mm to about 200 mm, about 150 mm to about 175 mm, about 150 mm to about 200 mm, about 150
  • the nipple tunnel 13 of the breast cup 2 may have a largest diameter greater than 25 mm (e.g., greater than 50 mm, 75 mm, 100 mm, 125 mm, 150 mm, 175 mm, 200 mm, 225 mm, or 250 mm).
  • the breast cup 2, the breast shield 19, and/or the housing may include a gel such that it allows better conformance to the breast.
  • the breast cup 2 conforms to the breast and supports the weight of the breast cup 2 and fluid conduits extending from the breast cup 2 without additional adhesives, gels, straps, or bras.
  • the breast cup 2 secures to a garment, such as a bra or shirt.
  • the breast cup 2, the breast shield 19, and/or the housing may include a food contact substance. Additionally, or alternatively, the breast cup 2, the breast shield 19, and/or the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) may include an infant grade material.
  • the breast cup 2, the breast shield 19, and/or the housing may include a flexible material, e.g., formed from a polymeric material such as silicone.
  • the breast cup 2, the breast shield 19, and/or the housing may include a rigid material.
  • the breast cup 2, the breast shield 19, and/or the housing may include PET, PVC, PTFE, polyethylene, HDPE, LDPE, copolyester (e.g., Tritan EX401), PP, polystyrene, a thermoplastic elastomer, thermoplastic polyurethane, PC, nylon, PVDF, or silicone.
  • breast cup 2, the breast shield 19, and/or the housing can include a fabric (e.g., polyester, cotton, linen, satin, organdy, rayon, taffeta, broad cloth, poplin, velour, gauze, canvas, shirting, muslin, tweed, georgette, crepe, wool, twill, gabardine, denim, or drill).
  • a fabric e.g., polyester, cotton, linen, satin, organdy, rayon, taffeta, broad cloth, poplin, velour, gauze, canvas, shirting, muslin, tweed, georgette, crepe, wool, twill, gabardine, denim, or drill).
  • the breast cup 2 may have a first fluidic conduit providing fluidic communication between the breast cup 2 and a reservoir 3 or manifold 29.
  • the first fluidic conduit is releasably connected to the breast cup 2 via a first outlet on the breast cup 2, e.g., from the milk chamber.
  • the second fluidic conduit is releasably connected to the breast cup 2 via an inlet to the breast cup 2, e.g., in the pressure chamber.
  • the first fluidic conduit is releasably connected to the breast cup 2 via a connector.
  • the breast cup 2 allows for the extension of the nipple when negative pressure is supplied, e.g., by negative pressure from pressure source 9 e.g., at a first pressure, in order to express milk.
  • negative pressure supplied by a control valve 10 and/or a positive pressure from a pressure source, e.g., at a second pressure
  • the nipple contracts, and reduces or stops milk flow until a higher negative pressure is supplied.
  • the interior of the breast cup 2, e.g., the interior of the breast shield 19, includes an open area, e.g., the nipple tunnel 13, dimensioned to allow for clearance and space in front of the nipple to permit milk to exit the nipple even when the nipple is pulled forward by suction.
  • an open area e.g., the nipple tunnel 13, dimensioned to allow for clearance and space in front of the nipple to permit milk to exit the nipple even when the nipple is pulled forward by suction.
  • the breast pump system 1 includes two breast cups 2, e.g., one for each breast.
  • the two breast cups 2 can each include a housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), a breast shield 19, and a diaphragm 18.
  • a user can use both of the breast cups 2 at the same time, or just one of the two at any given time.
  • One or more components of the breast cup may be clear to allow for visualization of the nipple, e.g., for alignment, during placement.
  • the breast cup may also include an opaque cover or flat to make the nipple not visible after placement of the breast cup.
  • the breast cup may also include a lens to magnify the nipple to aid in alignment.
  • the breast cup 2 can include a breast shield 19, e.g., as shown in FIGS. 9A-9D.
  • the breast shield 19 contacts the breast of the user and can provide an airtight seal during breast pumping, such that milk does not leak from the breast cup 2.
  • the breast shield 19 is configured to conform to the breast comfortably for frequent and/or long periods of wear, such that the breast is not irritated.
  • the breast shield 19 can include a wide portion and a nipple tunnel, in which the wide portion initially contacts the breast, and the nipple tunnel is configured to receive the nipple.
  • the breast shield 19 can conform to the breast and provide space for the nipple, e.g., in the nipple tunnel.
  • the nipple tunnel has a length from about 5 mm to about 75 mm (e.g., about 5 mm to about 10 mm, about 5 mm to about 20 mm, about 5 mm to about 30 mm, about 5 mm to about 40 mm, about 5 mm to about 50 mm, about 10 mm to about 20 mm, about 10 mm to about 30 mm, about 10 mm to about 40 mm, about 10 mm to about 50 mm, about 10 mm to about 60 mm, about 10 mm to about 70 mm, about 25 mm to about 50 mm, about 25 mm to about 75 mm, about 50 mm to about 75 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21
  • the nipple tunnel has a minimum diameter from about 10 mm to about 130 mm (e.g., about 10 mm to about 20 mm, about 10 mm to about 30 mm, about 10 mm to about 40 mm, about 10 mm to about 50 mm, about 10 mm to about 60 mm, about 10 mm to about 70 mm, about 10 mm to about 100 mm, about 25 mm to about 50 mm, about 25 mm to about 75 mm, about 30 mm to about 130 mm, about 50 mm to about 75 mm, about 50 mm to about 130 mm, about 70 mm to about 130 mm, about 100 mm to about 130 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26
  • the nipple tunnel has a maximum diameter from about 10 mm to about 130 mm (e.g., about 10 mm to about 20 mm, about 10 mm to about 30 mm, about 10 mm to about 40 mm, about 10 mm to about 50 mm, about 10 mm to about 60 mm, about 10 mm to about 70 mm, about 10 mm to about 100 mm, about 25 mm to about 50 mm, about 30 mm to about 130 mm, about 25 mm to about 75 mm, from about 50 mm to about 75 mm, about 50 mm to about 130 mm, about 70 mm to about 130 mm, about 100 mm to about 130 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about
  • the breast shield 19 can be in a shape for improved conformance to the breast, e.g., a funnel, a cone, or a dome.
  • the breast shield 19 can be rounded or toroidal, e.g., forming a ring.
  • the breast shield 19 can include an inlet to the milk chamber 21, such that milk may enter the milk chamber 21 once expressed from the nipple.
  • the diaphragm 18 releasably contacts the inlet, e.g., at a sealing point 23, providing a seal when negative pressure is not applied to the pressure chamber.
  • the diaphragm 18 releasably seals the inlet. The releasable sealing of the inlet to the milk chamber 21 is shown in FIG. 4.
  • the inlet includes a valve, e.g., an umbrella valve 24, e.g., as shown in FIG. 5, or a non-drip valve.
  • the valve is a mechanical valve, an umbrella valve 24, a butterfly valve, a disk valve, or a duckbill valve.
  • the inlet includes at least one orifice 25, e.g., as shown in FIG. 6.
  • the inlet includes a plurality of orifices 25.
  • the plurality of orifices 25 is circumferentially arranged at the nipple tunnel of the breast shield 19, e.g., as shown in FIG. 6.
  • the diaphragm 18 releasably contacts at least one of the orifices 25, e.g., at sealing point 23, providing a seal when negative pressure is not applied to the pressure chamber 20.
  • the diaphragm 18 contacts the plurality of orifices 25.
  • the diaphragm 18 releasably seals at least one orifice, e.g., at sealing point 23.
  • the diaphragm 18 seals the plurality of orifices 25, e.g., at sealing point 23.
  • the diaphragm 18 releasably contacts the breast shield 19 at a point as to separate the at least one orifice 25 from the milk chamber 21.
  • the orifice 25 can have a diameter from about 0.5 mm to about 10 mm (e.g., about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 0.5 mm to about 2 mm, about 0.5 mm to about 5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 1 mm to about 6 mm, about 1 mm to about 7 mm, about 1 mm to about 8 mm, about 1 mm to about 9 mm, about 1 mm to about 10 mm, about 3 mm to about 7 mm, about 5 mm to about 10 mm, about 8 mm to about 10 mm, about 1mm, about 2mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, or about 10 mm).
  • about 10 mm e.g., about
  • the diaphragm 18 is not configured to contact the inlet, e.g., at sealing point 23.
  • the breast cup 2, e.g., the breast shield 19 includes a fitting which may seal the inlet from the milk chamber 21.
  • the fitting is a plug or a cover.
  • the wide portion of the breast shield 19 can seal to the breast, while the nipple tunnel provides room for the nipple to be expanded to express milk. In some embodiments, the wide portion of the breast shield 19 seals to the breast, e.g., around the base of nipple. In some embodiments, the breast shield 19 is sealed to the breast before a breast pumping session commences.
  • a positive or negative pressure may be applied to the breast cup 2 prior to a breast pumping session to contract the breast shield 19, e.g., the wide portion of the breast shield 19, such that the breast shield 19 may be sealed to the breast.
  • a positive or negative pressure may be applied to the breast cup 2 such that the breast cup 2, e.g., the wide portion of the breast shield 19, may be unsealed from the breast.
  • the edge of the wide portion of the breast shield 19 solely contacts the breast before application of negative pressure. Following application of negative pressure to the breast cup 2, substantially all of the wide portion of the breast shield 19 may contact the breast.
  • Negative pressure can be applied to the breast cup 2 for sealing of the breast cup 2 to the breast from the pressure source 9, or from force applied manually from the user to the breast cup 2, e.g., to the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26).
  • the user may push on the breast cup 2, e.g., the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), to provide negative pressure to the breast shield 19 and seal the breast cup 2 to the breast.
  • Positive pressure can be applied to the breast cup 2 to unseal the breast cup 2 from the breast from a pressure source, from a valve to the ambient atmosphere, from a slow leak, or from force manually applied from the user to the breast cup 2.
  • a user may pull on the breast cup 2, e.g., the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), to provide positive pressure to the breast shield 19 and unseal the breast cup 2 from the breast.
  • the breast cup 2 includes an air pocket, to which negative or positive pressure can be applied to seal or unseal the breast cup 2 to the breast.
  • the inside of the breast shield 19 can include at least one protrusion 27 to improve sealing of the breast shield 19 to the breast.
  • FIG. 8 A and FIG. 8B show embodiments of the breast shield 19 having protrusions 27.
  • the protrusion 27 is a toroidal ridge, see, e.g., FIG. 8A.
  • the protrusion 27 is a curved toroidal ridge, see, e.g., FIG. 8B.
  • the outer surface of the breast shield 19 includes an indent to form the protrusion 27 on the inner surface of the breast shield 19, see, e.g., FIG. 8A.
  • Sealing of the breast shield 19 to the breast may keep milk from leaking around the breast and improve security of the breast shield 19 to the breast during breast pumping. Unsealing of the breast shield 19 from the breast when a breast pumping session is not ongoing, e.g., to allow air flow, may improve comfort, reduce skin temperature, and reduce sweat build-up. Furthermore, expansion and contraction of breast shield 19 allows for the breast shield 19 to fit breasts of a plurality of sizes, e.g., AA cup, A cup, B cup, C cup, D cup, DD cup, DDD cup, E cup, F cup, etc.
  • the ability to expand and contract the nipple tunnel of the breast shield 19, mechanically or using pressure, may be advantageous in setting up the breast cup 2 for breast pumping.
  • the internal diameter of the nipple tunnel of breast shield 19 is reduced slowly while moving the breast shield 19 into position, such that the user may be able to center the breast shield 19 on their nipple via touch and feel without the need for line of sight.
  • the housing e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26
  • diaphragm 18 may be or may include a clear material, such that the user may additionally use line of sight to center the breast shield 19 on their nipple.
  • the breast shield 19 and/or the housing include ridges, bumps, and/or dimples.
  • an internal surface of the breast shield 19 and/or the housing include ridges, bumps, or dimples. Ridges, bumps, and/or dimples may aid in aligning the breast cup 2 to the breast, adherence of the breast cup 2 to skin, reduction of heat build-up, and may provide further comfort when a user is wearing the breast cup.
  • the ridges, bumps, and/or dimples include foam.
  • the ridge includes a straight ridge, a curved ridge, a zig-zag ridge, an undulating ridge, a spiral ridge, a continuous ridge, or a broken ridge.
  • the breast shield 19 can include a plurality of ridges.
  • the ridges are from about 1 mm to about 100 mm apart (e.g., about 1 mm to about 2 mm, about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 1 mm to about 25 mm, about 1 mm to about 50 mm, about 5 mm to about 10 mm, about 10 mm to about 25 mm, about 10 mm to about 50 mm, about 25 mm to about 75 mm, about 50 mm to about 100 mm, about 1 mm, about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 40 mm, about 50 mm, about 60 mm, about 70 mm, about 75 mm, about 80 mm, about 90 mm, or about 100 mm).
  • about 1 mm to about 100 mm apart e.g., about 1 mm to about 2 mm, about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 1 mm to about 25
  • Air may flow between the ridges, bumps, and/or dimples where the surface of the breast shield 19 does not contact the breast.
  • the ridges, bumps, and/or dimples extend from an edge of the breast shield 19 to an inner point of the inner surface of the breast shield 19.
  • the ridges, bumps, and/or dimples may form an air passage from the ambient atmosphere to the inner surface of the breast shield 19.
  • the breast shield 19 includes a fluid conduit, wherein the fluid conduit may be defined by the (i) ridges, bumps, and/dimples, (ii) the skin of the breast, and (iii) the inner surface of the breast shield 19.
  • the fluid conduit may create a chimney effect resulting in the advantage of improved air circulation in the breast shield 19.
  • the breast cup 2 may be manually pressed in order to expel air from the breast shield 19. Following release of the breast cup 2, fresh air may flow back into the breast shield 19.
  • this method of circulating air in the breast shield 19 may be accomplished before or following a breast pumping session.
  • a spiral ridge on the inner surface of the breast shield 19 may form a fluid conduit with the skin of the breast.
  • air inside the breast shield 19 may be transported around the spiral to the ambient atmosphere.
  • fresh air may be transported around the spiral back into the breast shield 19.
  • Ridges, bumps, and/or dimples may also reduce the peeling effect when removing the breast cup 2.
  • a reduction in peeling effect can improve comfort, especially for those users with sensitive skin.
  • the breast shield 19 may include a material which becomes soft by heating and further conforms to the geometry of the body.
  • the breast shield 19 can include one or more formable chambers, which aid in conforming the breast shield 19 to the breast of the user.
  • the formable chambers include a fluid, e.g., a gas or liquid.
  • the breast shield 19 includes flexible, gel-like materials such as cross-linked silicone.
  • the breast shield 19 includes one or more thixotropic fluids.
  • breast shield 19 includes a material which may store heat for improved comfort. In some embodiments, the breast shield 19 includes a material which may expel heat into the ambient environment. In some embodiments, the breast shield 19 includes regions of material which may store heat, and regions of material which may expel heat. In some embodiments, the regions of material which may expel heat include regions having ridges, bumps, and/or dimples.
  • the breast shield 19 can include a food contact substance. Alternatively, or additionally, the breast shield 19 can include an infant grade material.
  • the breast shield 19 can include polyvinyl chloride (PVC), polyethylene, PP, polystyrene, a thermoplastic elastomer, thermoplastic polyurethane, PC, nylon, polyvinylidene fluoride (PVDF), or silicone.
  • the breast shield 19 can include a flexible material, e.g., formed from a polymeric material such as silicone.
  • the breast shield may be substantially free of Bisphenol A (BP A) and/or polyfluoroalkyl substances (PF AS).
  • the breast shield may be manufactured absent of any intentionally added BPA and/or PFAS.
  • the breast shield 19 can include a rigid material.
  • the breast shield 19 includes a water-resistant or a sweat-resistant material.
  • two human breasts are contacted with two breast shields 19 to pump milk from both breasts.
  • the breast cup 2 may include a housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26).
  • the housing e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26
  • the upper housing 17 may form a portion of the outer surface of the pressure chamber 20 or be a separate component.
  • the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) may be disposed around the wide portion 8 of the breast shield 19, e.g., the first point of contact with the breast.
  • the lower housing 26 may conform to the breast.
  • the lower housing 26 may include a gel such that it conforms to the breast.
  • the lower housing 26 conforms to the breast and supports the weight of the breast cup 2, the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), and fluid conduits 5 extending from the breast cup 2 without additional adhesives, gels, straps, or bras.
  • the lower housing 26 does not conform to the breast.
  • the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) may secure to a garment, such as a bra or shirt.
  • the housing may interact with the pressure source 9.
  • the pressure source 9 may be releasably attached to the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26).
  • the pressure source 9 may further attach at any point to the outer or inner surface of the housing.
  • the housing may serve a plurality of additional purposes including improved conformance of the breast cup 2 to the breast, improved comfort of the breast cup 2, attachment of the pressure source 9, releasable attachment of the breast cup 2 to a garment, and/or blocking the breast from view while using the breast cup 2.
  • the housing can include a food contact substance.
  • the housing e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26
  • the housing can include a flexible material, e.g., formed from a polymeric material such as silicone.
  • the housing e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26
  • a rigid material e.g., a polymeric material such as silicone.
  • the housing e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26
  • a fabric e.g., polyester, cotton, linen, satin, organdy, rayon, taffeta, broad cloth, poplin, velour, gauze, canvas, shirting, muslin, tweed, georgette, crepe, wool, twill, gabardine, denim, or drill).
  • the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) can include polyvinyl chloride (PVC), PTFE (e.g., Teflon), polyethylene, HDPE, LDPE, copolyester (e.g., Tritan EX401), PP, polystyrene, a thermoplastic elastomer, thermoplastic polyurethane, PC, nylon, poly vinylidene fluoride (PVDF), or silicone.
  • the housing e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26
  • the breast cup 2 may include a diaphragm 18.
  • the diaphragm 18 may separate the pressure chamber 20 from the milk chamber 21.
  • the diaphragm 18 is configured to deform, i.e., expand, contract, or balloon, under pressure. Upon application of negative pressure to the pressure chamber 20, the diaphragm 18 may deform away from the inlet to the milk chamber 21, opening the inlet to the milk chamber 21.
  • the breast cup 2 including the diaphragm 18 is advantageous in that the configuration may aid in providing fluid flow under pressure, as opposed to exclusively relying on gravity, such that a subject may breast pump in a reclined position.
  • the diaphragm 18 includes a flexible material that may stretch upon depressurization and pressurization of the pressure chamber.
  • the diaphragm 18 includes a folded, or otherwise shaped, material, which may unfold and refold upon depressurization and pressurization of pressure chamber 20.
  • the diaphragm 18 includes from 1 to 10 folds (e.g., 1 to 2, 1 to 3, 1 to 4, 1 to 5, 1 to 6, 1 to 7, 1 to 8, 1 to 9, 2 to 3, 2 to 4, 2 to 5, 2 to 6, 2 to 8, 3 to 4, 3 to 5, 3 to 7, 4 to 5, 4 to 6, 4 to 10, 5 to 8, 5 to 10, 8 to 10, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10).
  • the folded, or otherwise shaped, material is toroidal. In some embodiments, the folded, or otherwise shaped, material may unfold in either direction. In other embodiments, the folded, or otherwise shaped, material may unfold only towards the pressure chamber 20 or milk chamber 21. Flexible and/or folded diaphragms are advantageous in that they allow for expansion with smaller footprints.
  • the diaphragm 18 includes a patterned material, such as including a plurality of indents or grooves.
  • a diaphragm including a patterned material may be advantageous in optimizing interaction with the pressure chamber 20 and/or the milk chamber 21.
  • a first portion of the diaphragm 18 includes a plurality of indents and/or grooves.
  • the first portion of the diaphragm 18, which includes the plurality of indents and/or grooves can deform more than a second portion of the diaphragm 18 which does not include a plurality of indents and/or grooves.
  • the diaphragm 18 includes a material having a Shore hardness from A10 to A80 (e.g., A10, A20, A30, A40, A50, A60, A70, or A80). In some embodiments, the diaphragm 18 includes a material having a Shore hardness from D10 to D80 (e.g., D10, D20, D30, D40, D50, D60, D70, or D80).
  • the diaphragm 18 includes a thickness from about 0.5 mm to about 10 mm (e.g., about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 0.5 mm to about 2 mm, about 0.5 mm to about 2.5 mm, about 0.5 mm to about 5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 1 mm to about 6 mm, about 1 mm to about 7 mm, about 1 mm to about 8 mm, about 1 mm to about 9 mm, about 5 mm to about 10 mm, about 0.5 mm, about 1mm, about 1.5 mm, about 2mm, about 2.5 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, or about 10 mm).
  • the diaphragm may have a non-
  • the diaphragm 18 is configured to seal the inlet to the milk chamber 21 at sealing point 23. Sealing between the diaphragm 18 and the inlet may be improved through optimization of the Shore hardness, rigidity, thickness, material, surface conditions, and shape of the diaphragm 18.
  • the diaphragm 18 varies in thickness and/or Shore hardness.
  • the diaphragm 18 may include a higher thickness and/or higher Shore hardness in the portion of the diaphragm 18 which overlaps with the inlet of the milk chamber 21, e.g., at sealing point 23.
  • the diaphragm 18 includes a first thickness from about 0.5 mm to about 10 mm (e.g., about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 0.5 mm to about 2 mm, about 0.5 mm to about 2.5 mm, about 0.5 mm to about 5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 1 mm to about 6 mm, about 1 mm to about 7 mm, about 1 mm to about 8 mm, about 1 mm to about 9 mm, about 1 mm to about 10 mm, about 1 mm to about
  • 1 mm to about 4 mm about 1 mm to about 5 mm, about 1 mm to about 6 mm, about 1 mm to about 7 mm, about 1 mm to about 8 mm, about 1 mm to about 9 mm, about 1 mm to about 10 mm, about 1 mm to about 12 mm, about 1 mm to about 15 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 5 mm to about 20 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 20 mm, about 0.5 mm, about 1mm, about 1.5 mm, about 2mm, about 2.5 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about
  • diaphragm 18 includes the second thickness where diaphragm 18 contacts the inlet, e.g., at sealing point 23.
  • the diaphragm 18 includes a material having a first Shore hardness from A10 to A80 (e.g., A10, A20, A30, A40, A50, A60, A70, or A80) and a second Shore hardness, different from the first, from A10 to A80 (e.g., A10, A20, A30, A40, A50, A60, A70, or A80) or being rigid, in which the material includes the second Shore hardness where diaphragm 18 contacts the inlet, e.g., at sealing point 23.
  • the second Shore hardness may further range from DIO to D80 (e.g., DIO, D20, D30, D40, D50, D60, D70, or D80) or be rigid.
  • the diaphragm 18 includes a curved shape, such that the surface of the diaphragm 18 curves over and around the inlet to the milk chamber 21. In some embodiments, the diaphragm 18 includes a parabolic shape on the side of the diaphragm that contacts the inlet. In some embodiments, the diaphragm 18 may have a cup or cone shape.
  • the diaphragm 18 includes a plurality of layers, e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10. In some embodiments, the diaphragm 18 includes a plurality of layers in which the diaphragm 18 contacts the inlet, e.g., at sealing point 23. In some embodiments, a second layer is over molded over a first layer of the diaphragm 18.
  • the first layer and/or second layer may be a flexible or rigid material. In some embodiments, the first layer is a rigid material, and the second layer is a flexible material. This embodiment may be advantageous in sealing the inlet, such that the rigid material maintains coverage of the entire inlet, while the flexible material aids in sealing the sealing point 23.
  • the first layer may be a disk and/or may include a ring or lip to aid in sealing.
  • the first layer may be a cup or cone shaped layer over molded or embedded into the diaphragm 18.
  • the cup or cone shaped layer is configured to cap the inlet to the milk chamber 21, e.g., at sealing point 23.
  • a plurality of layers may aid decreasing deflection and improving sealing performance at the point where the diaphragm 18 contacts the inlet of the milk chamber, e.g., at sealing point 23.
  • all or a portion of the diaphragm may be clear.
  • a clear portion may be configured to seal the inlet to the milk chamber 21, e.g., at the sealing point, and may provide a visual line of sight from the outside of the diaphragm 18 to the nipple tunnel 13.
  • the clear portion may contain a lens, wherein the lens allows for magnification.
  • a visual line of sight to the nipple chamber may aid the user in centering the breast shield 19 on the nipple during a pumping session.
  • the diaphragm 18 is shaped to conform to the shape of the breast shield 19, e.g., upon compression of the milk chamber 21. In some embodiments, the diaphragm 18 is not configured to contact the inlet, e.g., at sealing point 23. In some embodiments, the fitting is a plug or a cover. In some embodiments, the diaphragm 18 is configured to actuate a valve 24.
  • the diaphragm 18 can include a food contact substance.
  • the diaphragm 18 can include polyvinyl chloride (PVC), polyethylene, PP, polystyrene, a thermoplastic elastomer, thermoplastic polyurethane, PC, nylon, polyvinylidene fluoride (PVDF), or silicone.
  • PVC polyvinyl chloride
  • the diaphragm 18 can include a flexible material, e.g., formed from a polymeric material such as silicone.
  • the diaphragm 18 can include a rigid material.
  • the breast cup 2 can include the milk chamber 21, which is configured to temporarily hold a volume of milk that is expressed from a nipple before it is pumped to an external reservoir.
  • the milk chamber 21 includes an inlet and an outlet 22.
  • the milk chamber 21 is reversibly attached to the breast cup 2. In some embodiments, the milk chamber 21 is reversibly attached to the breast cup 2, such that smaller or larger milk chambers 21 may be reversibly attached to the breast cup 2.
  • the milk chamber 21 can have a volume, nominal or expanded, from about 1 mL to about 150 mL (e.g., about 1 mL to about 10 mL, about 1 mL to about 25 mL, about 1 mL to about 50 mL, about 1 mL to about 75 mL, about 1 mL to about 100 mL, about 25 mL to about 50 mL, about 25 mL to about 100 mL, about 50 mL to about 150 mL, about 100 mL to about 150 mL, about 1 mL, about 5 mL, about 10 mL, about 15 mL, about 20 mL, about 25 mL, about 30 mL, about 40 mL, about 50 mL, about 60 mL, about 70 mL, about 75 mL, about 80 mL, about 90 mL, about 100 mL, about 125 mL, or about 150 mL).
  • the milk chamber 21 can have a maximum volume, nominal or expanded, from about 1 mL to about 150 mL (e.g., about 1 mL to about 10 mL, about 1 mL to about 25 mL, about 1 mL to about 50 mL, about 1 mL to about 75 mL, about 1 mL to about 100 mL, about 25 mL to about 50 mL, about 25 mL to about 100 mL, about 50 mL to about 150 mL, about 100 mL to about 150 mL, about 1 mL, about 5 mL, about 10 mL, about 15 mL, about 20 mL, about 25 mL, about 30 mL, about 40 mL, about 50 mL, about 60 mL, about 70 mL, about 75 mL, about 80 mL, about 90 mL, about 100 mL, about 125 mL, or about 150 mL).
  • the milk chamber 21 has a nominal volume of less than about 10 mL (e.g., less than about 5 mL, less than about 4.5 mL, less than about 4 mL, less than about 3.5 mL, less than about 3 mL, less than about 2.5 mL, less than about 2 mL, less than about 1.5 mL, less than about 1 mL, less than about 0.5 mL, or less than about 0.1 mL). In some embodiments, the milk chamber has a nominal volume of about 30 mL.
  • the diaphragm 18 seals the inlet to the milk chamber 21 before positive pressure, e.g., at ambient pressure, is applied to pressure chamber 20 and the milk chamber 21 is compressed, e.g., at sealing point 23.
  • the seal between the diaphragm 18 and the inlet to the milk chamber 21 has greater sealing pressure than that resistance of one directional valve on the outlet of the milk chamber 21.
  • the milk chamber may be formed by the space between the breast shield and the diaphragm or between one or more additional layers between the diaphragm and the breast shield.
  • the milk chamber includes an outlet.
  • the outlet may include a one directional valve, e.g., to prevent air or expressed milk from being drawn back into the milk chamber during milk expression.
  • the valve opens to allow milk to flow out of the milk chamber.
  • the one directional valve is passively actuated by pressure changes in the milk chamber.
  • the milk chamber may also include an inlet, e.g., as a vent or to allow additional fluids, e.g., cleaning fluids or positive pressure to enter.
  • the breast cup 2 may include a milk chamber wall 26.
  • the milk chamber wall 26 can include a curved shape or a cupshape.
  • the milk chamber wall 26 is removably attached to the breast cup 2. In some embodiments, the milk chamber wall 26 is snapped into the breast cup 2. In some embodiments, the milk chamber wall 26 can be inserted into the breast cup 2 to reduce the volume of the milk chamber 21.
  • the milk chamber wall 26 includes an orifice for outlet 22.
  • the milk chamber wall 26 can include polyethylene terephthalate (PET), polypropylene (PP), polyethylene, high-density polyethylene (HDPE), low-density polyethylene (LDPE), or polycarbonate (PC).
  • PET polyethylene terephthalate
  • PP polypropylene
  • HDPE high-density polyethylene
  • LDPE low-density polyethylene
  • PC polycarbonate
  • the milk chamber wall may include a clear material.
  • the breast cup 2 can include the pressure chamber 20, which is configured to expand and compress the diaphragm 18 in order to express milk from a nipple.
  • the pressure chamber 20 is reversibly attached to the breast cup 2.
  • the pressure chamber 20 can have a maximum volume from about 1 mL to about 150 mL (e.g., about 1 mL to about 10 mL, about 1 mL to about 15 mL, about 1 mL to about 20 mL, about 1 mL to about 25 mL, about 1 mL to about 50 mL, about 1 mL to about 75 mL, about 1 mL to about 100 mL, about 5 mL to about 10 mL, about 5 mL to about 15 mL, about 5 mL to about 20 mL, about 5 mL to about 25 mL, about 5 mL to about 50 mL, about 10 mL to about 15 mL, about 10 mL to about 20 mL, about 10 mL to about 25 mL, about 10 mL to about 30 mL, about 10 mL to about 50 mL, about 15 mL to about 20 mL, about 15 mL to about 25 m
  • the pressure chamber 20 limits the shape of the diaphragm 18 at the maximum deflection of the diaphragm 18, thus restricting the maximum negative pressure that can be applied to the nipple.
  • the diaphragm 18 upon application of positive pressure, the diaphragm 18 moves towards its nominal position and extends past it under pressure to conform to the shape of the milk chamber 21, thus transporting all liquid through the outlet 22.
  • the pressure chamber 20 further includes a valve to the ambient atmosphere.
  • the valve is an inflation valve.
  • volume of the pressure chamber 20 may be set with the inflation valve.
  • the valve is a relief valve. The relief valve may be configured to release pressure from the pressure chamber 20 if the positive pressure exceeds a maximum positive pressure, or if the negative pressure exceeds a maximum negative pressure.
  • the volume of the pressure chamber 20 may be set with an inflation valve, the volume of the pressure chamber 20 may be set in a variety of manners.
  • the pressure chamber 20 is reversibly attached to the breast cup 2, such that smaller or larger pressure chambers 20 may be reversibly attached to the breast cup 2.
  • the breast cup includes a plug, which may be configured to be inserted into the pressure chamber 20 to reduce the volume.
  • the volume of the pressure chamber 20 may be adjusted manually by the user such that it sits further or closer to the chest of the user.
  • the pressure chamber 20 can be returned to ambient pressure following a breast pumping session.
  • the pressure chamber 20 is connected to the pressure source via an inlet.
  • the connection may be direct between the outlet of the pressure source and the inlet of the pressure chamber, and there may be a fluid path in the breast cup to connect the pressure source to the inlet.
  • a fluid path may be molded or otherwise manufactured in the components of the breast cup, e.g., the housing and/or diaphragm.
  • a short fluid conduit may be employed in the breast cup to connect the pressure source with the pressure chamber.
  • the pressure chamber or housing may include a limiter that controls the maximum volume of the pressure chamber, e.g., to determine the pressure limit.
  • the breast shield may include a bladder or other element that can be filled with air or other fluid, e.g., water, and disposed to reduce the volume available for expansion of the pressure chamber.
  • the reservoir 3 is a collection container for the milk, such as a bottle or bag. Any commercially available reservoir may be used to collect milk pumped from a breast cup of this disclosure.
  • the reservoir 3 may be polymeric or fabric.
  • the reservoir 3 may be in fluidic communication with the pressure source 9, such that fluid is moved from the breast to the reservoir 3.
  • the reservoir 3 may be releasably connected to a fluid conduit 5, such as a tube.
  • the reservoir 3 may be configured for ease of cleaning.
  • the reservoir 3 may be placed in a dishwasher, refrigerator, and/or freezer.
  • the reservoir 3 is insulated, e.g., with foam or a reflective material. Reservoirs 3 are removable from the system, e.g., to feed an infant.
  • the reservoir includes a volume from about 50 mL to about 1500 mL (e.g., about 50 mL to about 100 mL, about 50 mL to about 150 mL, about 50 mL to about 200 mL, about 50 mL to about 250 mL, about 50 mL to about 300 mL, about 50 mL to about 400 mL, about 50 mL to about 500 mL, about 50 mL to about 600 mL, about 50 mL to about 700 mL, about 50 mL to about 700 mL, about 50 mL to about 750 mL, about 50 mL to about 800 mL, about 50 mL to about 900 mL, about 50 mL to about 1000 mL, about 50 mL to about 1100 mL, about 50 mL to about 1200 mL, about 50 mL to about 1300 mL, about 50 mL to about 1400 mL, about 100 mL to about 1500
  • a reservoir may be disposed in a reservoir enclosure 4 external to the breast cup.
  • the reservoir enclosure 4 may include a cooling element.
  • the reservoir enclosure may be attached or secured to the user, e.g., by a belt, clip, strap or other fastener or attachment mechanism.
  • each reservoir 3 includes a lid, wherein lid includes the pressure outlet, the inlet of the reservoir 3, and/or the valve of the reservoir 3.
  • the lid can be integral to or attached to the reservoir 3.
  • the lid is releasably attached to the reservoir 3.
  • the lid is screwed or snapped onto the reservoir 3.
  • the reservoir 3 may include external threads
  • the lid may include internal threads
  • the internal threads and the external threads may provide releasable attachment of the reservoir 3 and lid.
  • the lid is attached with a magnet, e.g., an electromagnet.
  • the lid is configured to be opened and/or closed with the electromagnet.
  • the lid is configured to be opened and/or closed with pressure, e.g., air pressure.
  • the lid of the reservoir can have a substantially flat or rounded top surface.
  • the reservoir 3, e.g., the lid of the reservoir 3, includes a pressure outlet.
  • the pressure outlet may or may not include a valve 24.
  • the pressure outlet is a breather tube.
  • the pressure outlet is an orifice, e.g., the reservoir 3 or the lid of the reservoir 3 may include an orifice.
  • a pressure outlet is advantageous in allowing excess pressure to vent as the reservoir 3 is being filled with milk.
  • the pressure outlet is solely open as the reservoir 3 is being filled, and the pressure outlet is otherwise nominally closed.
  • An outlet may be connected to a pressure source and a vent, e.g., to remove warm air to aid in cooling or to provide suction for milk flow.
  • the breast cup 2 may include a drive unit 11.
  • the drive unit 11 provides power to the elements of the breast cup 2.
  • the drive unit 11 is a brushless motor, a stepper motor or a linear actuator.
  • the linear actuator is an electric linear actuator, a hydraulic linear actuator, or a pneumatic linear actuator.
  • the drive unit is a stepper motor.
  • the drive unit is a brushless motor.
  • the drive unit 11 may be electrically connected to the pressure source 9 (e.g., negative pressure source and/or positive pressure source) and the control valve 10.
  • the pressure source 9 e.g., negative pressure source and/or positive pressure source
  • the breast cup 2 may include a control unit.
  • the drive unit 11 may include a control unit.
  • the control unit provides instructions to the drive unit 11, e.g., pre-programmed instructions or instructions provided by an external computer.
  • the preprogrammed instructions or instructions provided by an external computer may be pumping instructions, time instructions, etc.
  • the control unit can be configured to send a signal to the pressure source to being a pumping session.
  • the breast cup 2 may include at least one fluid conduit 5 to provide movement of milk and other fluids, e.g., air.
  • the fluid conduits 5 may include tubing.
  • the fluid conduit 5 may include a food contact substance or infant grade material.
  • the fluid conduit 5 may include an infant grade material.
  • the fluid conduit 5 may include polyacetal, polyoxymethylene (POM), chlorinated polyvinyl chloride (CPVC), ethylene tetrafluoroethylene (ETFE), ethylene-vinyl acetate (EVA), fluorinated ethylene propylene (FEP), nylon, polyether ether ketone (PEEK), perfluoroalkoxy alkane (PF A), PC, polyethylene, PP, PTFE (e.g., Teflon), PVC, PVDF, thermoplastic elastomer (TPE), fluorosilicone, gum, latex, neoprene, polyurethane, rubber, rubber particles encapsulated in a PP matrix (e.g., Santoprene), or silicone.
  • fluid conduit may be substantially free of Bisphenol A (BPA) and/or poly
  • the fluid conduit 5 includes an outer diameter (OD) from about 0.5 mm to about 50 mm (e.g., about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 0.5 mm to about 2 mm, about 0.5 mm to about 2.5 mm, about 0.5 mm to about 3 mm, about 0.5 mm to about 3.5 mm, about 0.5 mm to about 4 mm, about 0.5 mm to about 4.5 mm, about 0.5 mm to about 5 mm, about 0.5 mm to about 5.5 mm, about 0.5 mm to about 6 mm, about 0.5 mm to about 6.5 mm, about 0.5 mm to about 7 mm, about 0.5 mm to about 7.5 mm, about 0.5 mm to about 10 mm, about 1 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 2.5 mm, about 1 mm to about 3 mm, about 1 mm to about 3.5 mm, about 0.5 mm
  • the breast cup 2 may be configured such that the user may roll during rest and/or sleep.
  • Currently available breast pump systems are not designed to be utilized while resting, reclining, or sleeping.
  • the fluid conduit 5 may be selected to have a desired durometer to provide the preferred amount of flexibility for allowance of movement.
  • the fluid conduit 5 may have a durometer from about 25 Shore A scale and about 100 Shore D scale, including 25A, 30A, 35A, 40A, 45A, 50A, 55A, 60A, 65A, 70A, 75A, 80A, 85A, 90A, 95 A, 100A, 10D, 25D, 30D, 35D, 40D, 45D, 50D, 55D, 60D, 65D, 70D, 75D, 80D, 85D, 90D, 95D, 100D, or any durometer therebetween.
  • the fluid conduit 5 may be disposed in the center of the breast cup 2, e.g., in line with a nipple. In some embodiments, the fluid conduit 5 may be disposed at the base of breast cup 2, such that milk is expressed to the side. In some embodiments, the fluid conduit 5 may be disposed at the side of the breast cup 2.
  • the breast cup 2 may include any number of fluid conduits 5, e.g., one, two, three, four, five, six, seven, eight, nine, ten, etc.
  • the breast cup 2 includes a first fluid conduit 5 providing fluidic communication between the milk chamber 21 and the reservoir 3.
  • Additional fluid conduits 5 may transport milk from a second breast.
  • a first breast cup 2 is connected to a first fluid conduit 5
  • a second breast cup 2 is connected to a second fluid conduit 5.
  • the first fluid conduit 5 and the second fluid conduit 5 merge into a third fluid conduit 5.
  • the third fluid conduit 5 connects to a reservoir 3.
  • the breast cup 2 and fluid conduits 5 may move with the user. Independent movement of the breast cup 2 and fluid conduits 5 allow the user to have a better range of motion, and further when the user moves the breast cup 2 does not experience force that might remove it from the breast during pumping.
  • the breast cup 2 includes a movement element.
  • the movement element may be positioned at the nipple tunnel of the breast cup 2 or at the side of the breast cup 2.
  • the first fluid conduit 5 is movably connected to the breast cup 2.
  • the first fluid conduit 5 is rotatable with respect to breast cup 2.
  • the first fluid conduit 5 is movably connected to the milk chamber 21.
  • the movement element may be a swivel fitting or a rotating fitting.
  • the movement element includes a ball bearing.
  • the movement element may allow the fluid conduit 5 to rotate around the breast cup 2 from about 0° to about 360°, e.g., from about 0° to about 30°, from about 0° to about 60°, about 0° to about 90°, about 0° to about 120°, about 0° to about 150°, about 0° to about 180°, about 0° to about 210°, about 0° to about 240°, about 0° to about 300°, about 30° to about 120°, about 30° to about 180°, about 30° to about 240°, about 30° to about 360°, about 60° to about 120°, about 60° to about 180°, about 60° to about 240°, about 60° to about 360°, about 90° to about 180°, about 90° to about 360°, about 120° to about 240°, about 120° to about 360°, about 150° to about 240°, about 150° to about 360°, about 180° to about 240°, about 180° to about 360°, about 180° to
  • the movement element may allow the fluid conduit 5 to pivot from the center of the breast cup 2 from about 0° to about 90°, e.g., from about 0° to about 5°, about 0° to about 10°, about 0° to about 15°, about 0° to about 20°, about 0° to about 25°, about 0° to about
  • a fluid conduit may have any appropriate connector at each end for connection to the breast cup 2 or reservoir 3.
  • connectors include Luer connectors, threaded connectors, and slip fit connectors.
  • the breast cup 2 may include one or more valves.
  • the valve is a control valve, an open-close valve, a one directional valve, a relief valve, a quick-release valve, an inflation valve, or a slow-leak valve.
  • the valve is a mechanical valve, an inflation valve, an umbrella valve, a butterfly valve, a disk valve, a nondrip valve, a duckbill valve, a ball valve, a batch dispensing valve, a diaphragm valve, a gate valve, a diverting valve, a pinch valve, a piston valve, a plug valve, a saddle valve, a solenoid valve, a stem valve, a stop cock valve, or a three-way valve.
  • the breast cup 2 may include a control valve 10.
  • the control valve 10 may be in fluidic communication with the breast cup 2 and the pressure source 9.
  • the control valve 10 may provide positive pressure to the breast cup 2 and/or the pressure source 9 in order to decrease negative pressure, and reduce or stop milk flow, e.g., by depressurizing the nipple.
  • the positive pressure provided by the control valve 10 may be between 0 mmHg to 400 mmHg, e.g., about 25 mmHg. In some embodiments, the positive pressure is 0 mmHg, e.g., open atmospheric pressure. In some embodiments, the pressure source 9 and control valve 10 are contained within the same feature.
  • the breast cup 2 may include an open-close valve.
  • the control valve includes an open-close valve.
  • the open-close valve may be configured to open and close fluidic communication between a first element and a second element.
  • the first element can include a reservoir 3, fluid conduit 5, a pressure chamber 20, a milk chamber 21, a manifold, or the ambient atmosphere.
  • the second element can include a reservoir 3, fluid conduit 5, a pressure chamber 20, a milk chamber 21, a manifold, or the ambient atmosphere.
  • the breast cup 2 may include one or more one directional valves 15 or anti -backflow valves, e.g., a plurality of one directional valves 15.
  • the one directional valve 15 may be a duckbill valve or other type of one directional valve.
  • the one directional valve 15 may be placed in a fluid conduit 5, e.g., to prevent backflow of milk. In some embodiments, the one directional valve 15 is configured to allow fluid flow from the milk chamber 21 to the reservoir 3. In some embodiments, the one directional valve 15 is disposed in the first fluid conduit 5. In some embodiments, the one directional valve 15 is disposed at the outlet 22 of the milk chamber 21, e.g., FIG. 9D. In some embodiments, the one directional valve 15 is disposed in the diaphragm 18. In some embodiments, the one directional valve 15 may prevent air from entering the first fluid conduit 5, thereby maintaining negative pressure to move the milk.
  • the one directional valve 15 is configured to allow fluid flow from the control valve 10 to the breast cup 2 or pressure source 9. In other embodiments, the one directional valve 15 may allow air to flow to the first fluid conduit from the control valve 10, such that negative pressure from the pressure source 9 fluctuates to express milk from the breast. Thus, in some embodiments, the one directional valve 15 follows the control valve 10 in a fluid conduit 5, e.g., in the third fluid conduit 5. In some embodiments, the one directional valve 15 is between the breast cup 2 and the reservoir 3, such that milk cannot backflow from the reservoir 3.
  • the inlet to the milk chamber 21 includes a one directional valve, e.g., as shown in FIG. 5.
  • the one directional valve is a duckbill valve.
  • the powered breast cup may further include at least one relief valve.
  • at least one fluid conduit 5 includes a relief valve.
  • the breast cup 2 includes a relief valve. If vacuum at the breast becomes too strong the relief valve may provide a release of negative pressure to prevent discomfort for the user.
  • a relief valve may be placed such that if a predetermined maximum vacuum level is exceeded in a fluid conduit 5, such as greater than 250 mmHg vacuum (-250 mmHg pressure), the relief valve is able to provide positive pressure.
  • the relief valve can be in the form of a spring and ball, pin and O-ring, or other equivalent mechanical means of providing pressure relief.
  • the user may activate the release valve.
  • a user may twist a relief valve to lower or shut off suction.
  • the breast cup 2 includes one or more quick-release valves.
  • the outlet of breast cup 2 e.g., the outlet 22 of the milk chamber 21, includes a quick-release valve such that a fluid conduit 5 may be easily connected to the milk chamber 21.
  • the breast cup 2 is configured to permit a slow leak of pressure.
  • the slow leak of pressure may be to the ambient atmosphere.
  • a slow leak aids in slowly venting pressure during breast pumping.
  • the breast cup 2 is configured to permit a slow leak of pressure.
  • the breast shield 19 is configured to permit a slow leak of pressure.
  • the breast shield 19 includes an imperfect seal configured to provide a slow leak.
  • the breast shield 19 includes an orifice to provide a slow leak.
  • the slow leak includes a leak rate that would not decrease the maximum negative pressure of a pressure cycle by more than 10% (e.g., 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, or 1%).
  • the slow leak provides a positive pressure to the breast cup 2 that is equivalent to the maximum applied negative pressure over a period of time from about 0.5 minutes to about 60 minutes (e.g., about 0.5 minutes to about 1 minute, about 0.5 minutes to about 5 minutes, about 0.5 minutes to about 10 minutes, about 0.5 minutes to about 15 minutes, about 0.5 minutes to about 30 minutes, about 1 minute to about 5 minutes, about 2 minutes to about 8 minutes, about 3 minutes to about 7 minutes, about 5 minutes to about 10 minutes, about 5 minutes to about 15 minutes, about 5 minutes to about 30 minutes, about 10 minutes to about 15 minutes, about 10 minutes to about 20 minutes, about 15 minutes to about 30 minutes, about 15 minutes to about 45 minutes, about 30 minutes to about 45 minutes, about 30 minutes to about 60 minutes or about 45 minutes to about 60 minutes).
  • about 0.5 minutes to about 60 minutes e.g., about 0.5 minutes to about 1 minute, about 0.5 minutes to about 5 minutes, about 0.5 minutes to about 10 minutes, about 0.5 minutes to about 15 minutes, about 0.5 minutes to about 30 minutes, about
  • a slow leak valve may be configured to provide the slow leak of pressure. For example, if a maximum pressure of 100 mmHg is applied to the breast cup 2, e.g., the nipple tunnel of the breast shield 19, the slow leak may provide 10 mmHg of positive pressure every minute for 10 minutes.
  • the breast cup 2 includes a slow leak valve.
  • the slow leak valve may be configured to provide a slow leak of pressure to the ambient atmosphere.
  • the slow leak valve includes a leak rate that would not decrease the maximum negative pressure of a pressure cycle by more than 10% (e.g., 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, or 1%) when negative pressure is being applied to the breast cup 2.
  • the breast cup 2 may also include at least one sensor. At least one sensor may detect a baseline value, e.g., an initial pressure in the breast cup 2. Throughout breast pumping the sensor may continue detecting. Data are compared throughout breast pumping to the initially detected baseline. Sensors include weight sensors, load cells, temperature sensors, pressure sensors, pH sensors, flow sensors, viscosity sensors, volume sensors, etc. Sensors may be in the breast cup 2, at least one fluid conduit 5, in the pressure source, or on an external surface of the breast cup.
  • the breast cup 2 includes at least one temperature sensor, e.g., a thermocouple.
  • the breast pump includes a plurality of temperature sensors. Temperature sensors may provide time history data. Using the circadian baseline, deviations from baseline may be identified.
  • the breast cup 2 may include at least one pressure sensor.
  • the breast cup includes a plurality of pressure sensors.
  • Pressure sensors may include diaphragms, strain gauges, piezoresistive pressure sensors, capacitive pressure sensors, or electromagnetic sensors.
  • Pressure sensors may be used to measure the pressure in the breast cup 2, e.g., in the pressure chamber 20, milk chamber 21, and/or breast shield 19. Data from the pressure sensor may be used to determine the pressure used to express milk from the nipple. Pressure sensors are also advantageous in that they may detect high pressure levels which may cause discomfort for the user.
  • the breast cup 2 includes a pressure sensor.
  • the breast cup 2 may include at least one pH sensor.
  • the breast cup includes a plurality of pH sensors.
  • the pH sensor is an ion sensitive glass electrode.
  • the breast cup 2 may include at least one flow sensor.
  • the breast cup includes a plurality of flow sensors.
  • a fluid conduit 5 includes a flow sensor.
  • a flow sensor may detect the rate of fluid flow in the fluid conduit 5.
  • the breast cup 2 may include at least one volume sensor.
  • the breast pump includes a plurality of volume sensors.
  • the breast cup 2 may include at least one optical sensor.
  • the breast pump includes a plurality of optical sensors.
  • the optical sensor may include a light source, e.g., a light source made of one or more light emitting diodes (LEDs), and associated photodetector.
  • the light source in one example emits light at different wavelengths within the visible spectrum, including a violet light, a blue light, a green light, a yellow light, an orange light and a red light.
  • the optical sensor includes a singular light source or a plurality of light sources, similarly the photodetector may include a single photodetector or a plurality of photodetectors.
  • the optical sensor may sense movement of the breast cup 2 on the breast. Sensing the movement of the breast cup 2 on the breast is advantageous in that it may measure how much the breast cup 2 moves during use, e.g., such as through the night. In some embodiments, the breast cup 2 can alert the user if it becomes unaligned or loose. In some embodiments, the optical sensor is in view of a portion of the skin of the user. In some embodiments, the breast cup 2, e.g., an outer surface of breast cup 2, e.g., the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), includes the optical sensor. In some embodiments, the optical sensor is mounted on the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26).
  • the breast cup 2 may include at least one viscometer. In some embodiments, the breast cup 2 includes a plurality of viscometers.
  • the breast cup 2 includes a Hall effect sensor.
  • a Hall effect sensor is a sensor which detects the presence and magnitude of a magnetic field using the Hall effect.
  • a Hall effect sensor is advantageous in that it may allow the breast cup 2 to collect information on whether the system completes actions. The information collected by the Hall effect sensor may be used to provide assurance and aid in diagnosing any errors.
  • the breast cup 2 includes a heating system (a heater).
  • a heating system is advantageous in that the breast cup 2 may be heated prior to or during breast pumping for improved comfort.
  • the heating system is disposed in the breast shield 19.
  • the heating system includes insulation, an insertion heater, a resistive heater, a thermoelectric heater, a heating film, a heating pad, a heating wire, or a pneumatic heating tube.
  • the breast cup 2 includes a pressure outlet.
  • the pressure outlet may or may not include a valve 24.
  • each pressure outlet includes a valve 24.
  • the pressure outlet is a breather tube.
  • the pressure outlet is an orifice.
  • the breast cup 2 may include an anti-bacterial coating, e.g., in the fluid conduits 5 or on one or more other surfaces.
  • the breast cup 2 may include a power source 12.
  • the power source 12 may be a battery and/or an AC power source.
  • the power source 12 may be electrically connected to the control unit and the pressure source.
  • the breast cup 2 may include or be utilized with a display.
  • the display may be disposed on the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), an electrically connected remote, or an external computing device with an appropriate software application, e.g., a mobile device.
  • the display may be a screen. In some embodiments, the screen is a touchscreen.
  • the breast cup 2 may include or be utilized with a timer.
  • the drive unit 11 and/or control unit may include the timer.
  • the timer may be disposed on the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), an electrically connected remote, or an external computing device with an appropriate software application, e.g., a mobile device .
  • the breast cup 2 may include or be utilized with an alarm.
  • the alarm may be disposed on the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), an electrically connected remote, or an external computing device with an appropriate software application, e.g., a mobile device.
  • the alarm may be a light, a vibration element, or a sound element.
  • the alarm may be configured to sound in the event of an error (e.g., the pumping system is improperly assembled), the ending of a pumping session, a temperature increase in the milk in the reservoir 3, a full reservoir 3, and/or the start of an upcoming preprogrammed pumping session.
  • the breast cup 2 may include a power switch 14 or button.
  • the power switch 14 or button may enable a user to power on or off the breast cup 2.
  • the power switch 14 or button may be disposed on the outside of the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26). Alternatively, or in addition, the power switch 14 or button may be disposed on the breast cup 2. However, in some embodiments, the user may power on or off the breast cup 2 remotely, such as through an application on an external computer, e.g., a mobile device.
  • the breast cup 2 may include or be utilized with a garment to secure the breast cup 2 to the user.
  • the garment may secure the breast cup 2 in place, and/or stabilize breast cup 2 for milk expression.
  • the breast cup 2 is inserted into the garment.
  • the garment may be a bra, a bustier, a sports bra, a shirt, a tank top, a bandeau, a strap, a dress, a nightgown, or a nursing bra that provides support to a wearer and/or at least a portion of a breast cup 2.
  • the garment includes polyester, cotton, linen, satin, organdy, rayon, taffeta, broad cloth, poplin, velour, gauze, canvas, shirting, muslin, tweed, georgette, crepe, wool, twill, gabardine, denim, or drill.
  • the garment is machine washable.
  • the breast cup 2 is held in place by compression provided by the garment.
  • the garment may provide a level of compression of the breast cup 2 to the breast such that the subject may move, rest, and/or sleep with the breast cup continuing to be secured to the breast. Securement of the breast cup 2 to the breast during movement improves safety and reduces milk leakage.
  • the garment may include a flexible or stretch material, e.g., nylon, elastic, or spandex.
  • the garment may include portions of varying compression, e.g., high compression portions and low compression portions.
  • the material of the garment contacting the breast cup may include a high compression portion.
  • the garment may apply a compression of at least 5 mmHg, e.g., at least 10 mmHg, 15 mmHg, 20 mmHg, 25 mmHg, 30 mmHg, 35 mmHg, 40 mmHg, 45 mmHg, 50 mmHg, 55 mmHg, 60 mmHg, 65 mmHg, 70 mmHg, 75 mmHg, 80 mmHg, 85 mmHg, 90 mmHg, 95 mmHg, 100 mmHg, 125 mmHg, or 150 mmHg.
  • a compression of at least 5 mmHg e.g., at least 10 mmHg, 15 mmHg, 20 mmHg, 25 mmHg, 30 mmHg, 35 mmHg, 40 mmHg, 45 mmHg, 50 mmHg, 55 mmHg, 60 mmHg, 65 mmHg, 70 mmHg, 75 mm
  • the garment may apply a compression from about 5 mmHg to about 100 mmHg, e.g., about 5 mmHg to about 10 mmHg, about 5 mmHg to about 15 mmHg, about 10 mmHg, to about 20 mmHg, about 5 mmHg to about 25 mmHg, about 5 mmHg to about 30 mmHg, about 5 mmHg to about 35 mmHg, about 5 mmHg to about 40 mmHg, about 5 mmHg to about 45 mmHg, about 5 mmHg to about 50 mmHg, about 5 mmHg to about 60 mmHg, about 5 mmHg to about 70 mmHg, about 5 mmHg to about 80 mmHg, about 5 mmHg to about 90 mmHg, about 5 mmHg to about 100 mmHg, about 10 mmHg to about 20 mmHg, about 10 mmHg to about 30 mm
  • the garment provides access to at least one breast to facilitate breastfeeding and/or pumping.
  • the user may pull the garment away from their skin, and insert the breast cup 2 underneath the garment from below or above the garment.
  • the garment may have openings formed or defined in the material that makes up the garment to provide an opening for access to at least one of the wearer’s breasts.
  • the opening in the garment has a smaller diameter than the largest diameter of the breast cup 2.
  • the breast cup 2 and/or housing are inserted into at least one opening formed in the material of the garment, and compression of the material secures it to the breast.
  • This configuration is advantageous such that the breast cup 2 may not be pulled out from the garment unintentionally.
  • the nipple tunnel 13 of the breast cup 2 may be inserted through the opening in the garment such that the wide portion 8 of the breast cup 2 may contact the garment, but not pass through.
  • the nipple tunnel 13 of the breast cup may then be releasably connected to a fluid conduit 5.
  • the opening in the garment may have a diameter from about 5 mm to about 250 mm, e.g., from about 5 mm to about 10 mm, about 5 mm to about 20 mm, about 5 mm to about 25 mm, about 5 mm to about 30 mm, about 5 mm to about 40 mm, about 5 mm to about 50 mm, about 5 mm to about 75 mm, about 5 mm to about 100 mm, about 10 mm to about 20 mm, about 10 mm to about 25 mm, about 10 mm to about 30 mm, about 10 mm to about 40 mm, about 10 mm to about 50 mm, about 20 mm to about 25 mm, about 20 mm to about 30 mm, about 20 mm to about 40 mm, about 20 mm to about 50 mm, about 25 mm to about 50 mm, about 25 mm to about 75 mm, about 30 mm to about 40 mm, about 30 mm to about 50 mm, about 30 mm to about 50 mm, about 30 mm to about
  • the opening may have a diameter less than 100 mm, e.g., less than 90 mm, 80 mm, 70 mm, 60 mm, 50 mm, 40 mm, 30 mm, 25 mm, 20 mm, 10 mm or 5 mm.
  • the garment may include at least one layer, e.g., two layers. The two layers may overlap such that they may be pulled apart to reveal at least one breast.
  • the garment includes at least two layers, and the breast cup 2 and/or housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) are secured to the breast by positioning between at least two layers.
  • the garment may include snaps, buttons, or a zipper which may be opened to provide access to at least one breast.
  • the breast cup 2 may include a fastener for securing the breast cup 2 and/or housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) to the garment.
  • the breast cup 2 may also include a fastener for securing the fluid conduit 5.
  • the fastener may be used to route the fluid conduit 5 to an advantageous location (e.g., under the arm, or under the garment), such that the fluid conduit does not impede the user’s freedom of motion.
  • the breast cup 2 may also include a fastener system for the reservoir 3 and/or reservoir enclosure 4.
  • the fastener may attach the reservoir 3 and/or reservoir enclosure 4 to the user, such that they are able to conduct their daily activities while breast pumping.
  • the fastener may include a clip, a strap, a hook, a zipper, a magnet, a pin, a button, a snap, a hook and loop fastener (e.g., VELCRO®), or a combination thereof.
  • the fastener may fasten the reservoir 3 and/or reservoir enclosure 4 to the user in such a way that they may have freedom of motion, e.g., fasten the reservoir 3 and/or reservoir enclosure 4 to the waist of
  • the breast cup 2 may be reversibly connected to the garment before or after the garment is donned.
  • the breast cup 2 and/or housing e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26
  • the garment is donned, and then the breast cup 2 and/or housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) are reversibly secured to the garment.
  • the breast cup 2 and/or housing e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26
  • the fluid conduit 5 is reversibly secured to the breast cup 2 after the garment is donned.
  • the fluid conduit 5 is reversibly secured to the breast cup 2 prior to the garment being donned.
  • the outer surface of breast cup 2 has a lower coefficient of friction than the inner surface of the garment to allow freedom of movement. Without wishing to be bound to theory, if there is a lower coefficient of friction between the breast cup 2 and the garment than between the breast cup 2 and the breast, then relative movement of the garment is less likely to move the breast cup 2 out of position. In some embodiments, the coefficient of friction between the outer surface of the breast cup 2, e.g., the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), and the garment is less than 0.4 (e.g., 0.35, 0.3, 0.25, 0.2, 0.15, 0.1, or 0.05).
  • the outer surface of the breast cup 2, e.g., the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), can include a smooth material.
  • the outer surface of the breast cup 2, e.g., the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) can include a smooth plastic or fabric.
  • the outer surface of the breast cup 2, e.g., the upper housing 17, the breast shield 19, and/or the lower housing or milk chamber wall 26, can include PET, PP, PTFE, polyethylene, HDPE, LDPE, PC, nylon, acetal, PEEK, PPS, or polyester.
  • the outer surface of the breast cup 2 e.g., the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), can include cotton, linen, satin, organdy, rayon, taffeta, broad cloth, poplin, velour, gauze, canvas, shirting, muslin, tweed, georgette, crepe, wool, twill, gabardine, denim or drill.
  • the housing e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26
  • the outer surface of the breast cup 2 can include cotton, linen, satin, organdy, rayon, taffeta, broad cloth, poplin, velour, gauze, canvas, shirting, muslin, tweed, georgette, crepe, wool, twill, gabardine, denim or drill.
  • the breast cup 2 may include controls that are operable by a user to select or modify at least one of: pumping program or mode, frequency of pumping cycle, maximum suction pressure achieved during a pumping cycle, latch suction pressure achieved during the pumping cycle, volume of the pressure chamber 20, pumping force, and pumping session time.
  • the controls may be present on the surface of the breast cup 2, or an external remote, e.g., on the display. Alternatively, or in addition, the controls may be present in an application on an external computer, e.g., a mobile device. Alternatively, the breast cup 2 is solely controlled through an application on an external computer, e.g., a mobile device. Control of the breast cup 2 through an application on an external computer is advantageous in that a user may control the device in any position.
  • the breast cup 2 can have a wait time set, e.g., through the display or an application on an external computer, such that the user has time to contact the breast cup 2 to their breast before the breast cup 2 begins pumping.
  • Control of the breast cup 2 may be customized.
  • the customized pump functions include modifications to at least one of: maximum suction pressure level, latch suction pressure level, suction pressure waveform over a pumping cycle, phases of extraction or feeding times, rest times, heating temperatures and times, vibration frequency and duration, and pumping session time.
  • the user may input at least one pump program into the breast cup 2, e.g., through the display or application on an external computer. For example, the user may set the number of minutes that the breast cup 2 will run before shutting off automatically and/or the user may set a time for the breast cup 2 to engage during the night.
  • Custom pump programming is advantageous in that user may control how long they pump for so that they may go about their daily activities, resting, or sleeping, without the worry that the pump will continue endlessly.
  • the pumping frequency may be programmed to slow down gradually during operation, e.g., towards the end of a preprogrammed pumping time.
  • the control unit may be configured to send signals to and receive signals from an external computer, e.g., a mobile device.
  • the control unit may include a transmission element, e.g., a wireless transmission element, and receiver element for wirelessly sending signal to and receiving signals from the external computer.
  • a transmission element e.g., a wireless transmission element
  • the transmission element is a BLUETOOTH® transmission element.
  • the external computer may include a processor and instructions, which when executed, cause the processor to customize pump functions and send customized pump functions to the control unit.
  • the custom pump functions are based on the signals received from the control unit, such as measurements taken by sensors.
  • the user is able to program different custom pump programs, e.g., a daytime program and a nighttime program.
  • the external computer may include a processor and instructions, which when executed, cause the processor to calculate volume of milk extracted and track expression efficiency and monitor it over time.
  • the calculation of milk extracted, and expression efficiency are based on signals received from the control unit, such as measurements taken by the sensors.
  • the external computer may include a processor and instructions, which when executed, cause the processor to track of inventory of previous pumping sessions, including tracking at least one of dates of the previous pumping sessions, volumes pumped in the previous pumping sessions, and specific tracking numbers for specific milk collection containers into which milk has been pumped in the previous pumping sessions.
  • the external computer may include a processor and instructions, which when executed, cause the processor to one or more of monitor remaining battery power of the battery and output a warning when the battery reaches a predetermined low level of charge.
  • the external computer may include a processor and instructions, which when executed, cause the processor to display in the application screen or on display of the breast cup 2 the time left in the pumping session, measurements taken by the at least one sensor, and/or one or more photos of the user’s choosing on the display.
  • the present disclosure provides improved methods of breast pumping.
  • the present disclosure provides a method of breast pumping by: (i) providing a breast cup 2 of the disclosure; (ii) providing a reservoir 3 in fluidic communication with the breast cup; (iii) contacting a human breast with the breast cup; and (vi) applying an alternating first pressure and second pressure such that milk is moved from the human breast to the reservoir 3, in which the first pressure and the second pressure are functions of a negative pressure and a positive pressure.
  • the breast cup 2 includes a wide portion and a nipple tunnel, and the method includes contacting the human breast with the wide portion of the breast cup 2.
  • the method includes positioning the nipple in the nipple tunnel of the breast cup 2.
  • the method includes contacting two human breasts with the two breast cups 2.
  • the method includes applying negative pressure to the pressure chamber 20 with the pressure source 9. Pressure around the nipple is reduced to below atmospheric pressure.
  • the method includes deforming the diaphragm 18 away from the breast cup. In some embodiments, the method includes deforming the diaphragm 18 away from the inlet. In some embodiments, the method includes unsealing the inlet. Deformation of the diaphragm 18 away from the inlet allows milk to flow from the nipple to the milk chamber 21. In some embodiments, the method includes expanding the milk chamber 21. In some embodiments, the method includes providing negative pressure to elongate the nipple. In some embodiments, the method includes drawing milk from the nipple. In some embodiments, the method includes drawing milk from the nipple tunnel 13 into the milk chamber 21. In some embodiments, the method includes drawing milk through the inlet.
  • the method includes opening the control valve 10 and depressurizing the pressure chamber 20. In some embodiments, the method includes returning the diaphragm 18 to a nominal position. In some embodiments, the method includes closing the control valve 10.
  • the method includes applying positive pressure to the pressure chamber 20 with the positive pressure source. In some embodiments, the method includes allowing the nipple to contract. In some embodiments, the method includes deforming the diaphragm 18 towards the breast shield 19. In some embodiments, the method includes allowing the diaphragm 18 to return to a nominal position. In some embodiments, the method includes sealing the inlet with the diaphragm 18. Deformation of the diaphragm 18 towards the breast shield seals the inlet such that the nipple is allowed to contract. In some embodiments, the method includes sealing the orifices with diaphragm 18. In some embodiments, the method includes contracting the milk chamber 21. Contraction of the milk chamber acts to pump milk out of the breast cup.
  • the method includes transporting milk from the milk chamber 21 to the reservoir 3. In some embodiments, the method includes transporting milk through the first fluid conduit. In some embodiments, the method includes transporting milk through the outlet. In some embodiments, the method includes transporting milk through the one directional valve. In some embodiments, the method includes applying a negative pressure to the milk chamber 21 at the end of the pumping session. In this embodiment, the negative pressure transports any residual milk from the milk chamber 21 and fluid conduit 5 into the reservoir 3.
  • the pressure source is a peristaltic pump, e.g., on a first conduit or downstream component connected thereto. Positive pressure may also be introduced into the milk chamber, e.g., via a separate inlet, to aid in transport of milk or cleaning. The clearing of milk from the fluid conduit and/or milk chamber may occur only once at the end of a breast pumping cycle.
  • the time between one breast pumping session and another breast pumping session is from about 30 minutes to about 240 minutes (e.g., about 30 minutes to about 45 minutes, about 30 minutes to about 60 minutes, about 30 minutes to about 90 minutes, about 30 minutes to about 120 minutes, about 30 minutes to about 180 minutes, about 45 minutes to about 60 minutes, about 45 minutes to about 90 minutes, about 45 minutes to about 120 minutes, about 60 minutes to about 90 minutes, about 60 minutes to about 120 minutes, about 50 minutes to about 180 minutes, about 60 minutes to about 210 minutes, about 90 minutes to about 120 minutes, about 90 minutes to about 180 minutes, about 90 minutes to about 210 minutes, about 90 minutes to about 240 minutes, about 120 minutes to about 180 minutes, about 120 minutes to about 210 minutes, about 120 minutes to about 210 minutes, about 120 minutes to about 210 minutes, about 120 minutes to about 240 minutes, about 180 minutes to about 180 minutes, about 120 minutes to about 180 minutes, about 120 minutes to about 210 minutes, about 120 minutes to about 210 minutes, about 120 minutes to about 240 minutes, about 180 minutes to about 180
  • milk from the first breast pumping session is transported to a first reservoir, and milk from the second breast pumping session is transported to a second reservoir. Once full, a reservoir may be removed and replaced with an empty reservoir.
  • the method may further include assembling the breast cup 2.
  • the method includes releasably connecting at least one fluid conduit 5 to the pressure source 9.
  • the method further includes releasably connecting at least one fluid conduit to the breast cup 2.
  • the method includes releasably connecting at least one fluid conduit to the reservoir 3.
  • the method includes connecting the first fluid conduit 5 to the milk chamber 21 and the reservoir 3.
  • Releasable connections between the breast cup 2 are advantageous for ease of cleaning.
  • the breast cup 2 is advantageous in that the user may be able to breast pump a plurality of times following a one-time assembly. Prior to the first use, the user may secure the breast cup to a breast and/or garment to their body. Then, in some embodiments, the user does not need to remove the breast cup 2 and/or garment between a plurality of breast pumping sessions, e.g., two, three, four, five, six, seven, eight, nine, or ten breast pumping sessions. In this embodiment, the user may be able to remove the full reservoir after a pumping session without removing the breast cup 2.
  • the breast cup 2 is further advantageous in that the user may be able to breast pump in a reclined position.
  • the method further includes turning on the breast cup 2.
  • the breast cup 2 may be turned on after the breast cup 2 is contacted to the human breast.
  • the breast cup 2 may be turned on before the breast cup 2 is contacted to the human breast, e.g., the negative pressure is applied after the human breast is contacted, or the human breast is contacted during a waiting period before the negative pressure is applied.
  • breast cup 2 is turned on with the power switch 14.
  • the breast cup 2 is turned on remotely.
  • the breast cup 2 is turned on automatically according to a pre-programmed schedule.
  • the breast cup 2 is turned on automatically according to a pre-programmed schedule a plurality of times.
  • the method further includes turning on a pressure source.
  • a pressure source may be turned on after the breast cup 2 contacts the human breast.
  • the pressure source is turned on with the power switch 14.
  • the pressure source is turned on remotely.
  • the pressure source is turned on automatically according to a pre-programmed schedule.
  • the pressure source is turned on automatically according to a pre-programmed schedule a plurality of times.
  • the pressure source 9 may be a negative pressure source or a positive pressure source.
  • the method further includes turning on the pressure source 9.
  • the pressure source 9 may be turned on after the breast cup 2 is contacted to the human breast.
  • pressure source 9 is turned on with the power switch 14.
  • the pressure source 9 is turned on remotely.
  • the pressure source 9 is turned on automatically according to a pre-programmed schedule.
  • the pressure source 9 is turned on automatically according to a preprogrammed schedule a plurality of times.
  • the first pressure or second pressure may be between about 0 mmHg to about 250 mmHg, e.g., about 0 mmHg to about 10 mmHg, about 0 mmHg to about 20 mmHg, about 0 mmHg to about 30 mmHg, about 0 mmHg to about 40 mmHg, about 0 mmHg to about 50 mmHg, about 0 mmHg to about 60 mmHg, about 0 mmHg to about 70 mmHg, about 0 mmHg to about 80 mmHg, about 0 mmHg to about 90 mmHg, about 0 to about 100 mmHg, about 0 mmHg to about 110 mmHg, about 0 mmHg to about 120 mmHg, about 0 mmHg to about 130 mmHg, about 0 to about 140 mmHg, about 0 mmHg to about 150 mmHg, about 0 to about 175
  • the breast cup 2 may pump from about 1 second to about 2 hours, about e.g., about 30 seconds to about 1 minute, about 30 seconds to about 2 minutes, about 30 seconds to about 3 minutes, about 30 seconds to about 4 minutes, about 30 seconds to about 5 minutes, about 30 seconds to about 10 minutes, about 30 seconds to about 15 minutes, about 30 seconds to about 30 minutes, about 30 seconds to about 5 minutes, about 5 minutes to about 10 minutes, about 5 minutes to about 15 minutes, about 5 minutes to about 20 minutes, about 5 minutes to about 25 minutes, about 5 minutes to about 30 minutes, about 5 minutes to about 35 minutes, about 5 minutes to about 40 minutes, about 5 minutes to about 1 hour, about 10 minutes to about 15 minutes, about 10 minutes to about 20 minutes, about 10 minutes to about 25 minutes, about 10 minutes to about 30 minutes, about 10 minutes to about 40 minutes, about 10 minutes to about 50 minutes, about 10 minutes to about 1 hour, about 15 minutes to about 30 minutes, about 15 minutes to about 45 minutes, about 15 minutes to about 1 hour, about 15 minutes to about 1.25 hours, about 15 minutes to about 1.5 hours
  • the method further includes turning on a positive pressure source.
  • a positive pressure source may be turned on after the breast cup 2 contacts the human breast.
  • the positive pressure source is turned on with the power switch 14.
  • the positive pressure source is turned on remotely.
  • the positive pressure source is turned on automatically according to a preprogrammed schedule.
  • the positive pressure source is turned on automatically according to a pre-programmed schedule a plurality of times.
  • the method further includes turning off the breast cup 2.
  • the breast cup 2 is turned off with the power switch 14. In some embodiments, the breast cup 2 is turned off remotely. In some embodiments, the breast cup 2 is turned off automatically according to a pre-programmed schedule. In some embodiments, the breast cup 2 is turned off automatically according to a pre-programmed schedule a plurality of times.
  • the breast cup 2 may include at least one sensor.
  • the method may further include the taking of a weight, temperature, pressure, pH, viscosity, optical, volume, or flow measurement.
  • the method may further include alerting a user of a sensor measurement.
  • the method may further include changing at least one of the first pressure or second pressure based on the temperature, weight, pressure, or flow measurement.
  • the present disclosure provides methods of breast pumping while the user is in motion. Further, the present disclosure allows for methods to allow a mother or other care provider to carry out pumping in accordance with lifestyle preferences.
  • the present disclosure provides a breast cup 2 which may be used while the user is in motion, such that the user may consistently breast pump while carrying out other activities (e.g., travel to and from work) associated with their daily routine.
  • the present disclosure further provides a breast cup 2 which may be used while the user is working.
  • the breast cup 2 may be used while the user is moving, reclining, resting, or sleeping.
  • the breast pumping system may be used comfortably during sleep with reduced interruption of sleep.
  • Kits may include two or more unconnected components of a breast cup.
  • a kit may include a breast cup or components thereof and one or more fluidic conduits.
  • a kit may include two breast cups or components thereof and two or more fluidic conduits.
  • the fluidic conduits e.g., for the milk chamber, may be branched to allow connection to both breast cups with a single connection to the reservoir.
  • a kit including components of a breast cup may include at least two of the following components, e.g., all: the pressure source 9, the upper housing 17, the diaphragm 18, the breast shield 19, the milk chamber wall 26, and a power source.
  • a user may assemble the breast cup from the kit.
  • a kit may include two or more components for use with the breast cup, e.g., one or more breast cups, a reservoir, and/or a garment.
  • the breast cup 102 includes an integrated pressure source 109 configured to selectively apply negative and/or positive pressure to a pressure chamber 120 within the breast cup 102 to selectively move a diaphragm 118 to expand and/or contract a milk chamber 121 to induce lactation and force or otherwise provide induced milk out of the breast cup 102 into an off- body reservoir (e.g., one of the reservoirs 3).
  • an integrated pressure source 109 configured to selectively apply negative and/or positive pressure to a pressure chamber 120 within the breast cup 102 to selectively move a diaphragm 118 to expand and/or contract a milk chamber 121 to induce lactation and force or otherwise provide induced milk out of the breast cup 102 into an off- body reservoir (e.g., one of the reservoirs 3).
  • the breast cup 102 may include similar and/or the same components and/or functionalities of the breast cup 2 and may similarly be used in any of the methods described above to induce lactation and force or otherwise provide induced milk out of the breast cup 102 into an off-body reservoir.
  • the pressure source 109 may be the same as or similar to the pressure source 9 and/or function similarly to or in the same way as the pressure source 9 discussed above.
  • any of the various components and/or functionalities of the breast cup 102 described below may be applied to or otherwise incorporated into the breast cup 2 described above. Each of these variations is contemplated herein and is within the scope of the present disclosure.
  • the breast cup 102 includes a housing formed by an upper housing component 117 and a lower housing component 126.
  • the upper housing component 117 includes a cap or cover portion 130 coupled to a pressure chamber wall portion 132.
  • the cap or cover portion 130 and the pressure chamber wall portion 132 collectively form an internal cavity within the upper housing component 117 that houses or otherwise envelopes a plurality of additional components of the breast cup 102.
  • the cap or cover portion 130 and the pressure chamber wall portion 132 may be coupled together via a snap-fit connection, a latch-type connection, a threaded fastener connection, an adhesive coupling, or any other suitable coupling method.
  • the internal cavity of the upper housing component 117 houses the integrated pressure source 109, which is configured to produce or otherwise generate pressure to be delivered or applied to the pressure chamber 120.
  • the integrated pressure source 109 is coupled to the pressure chamber 120 via a manifold 134 having a plurality of solenoid valves 136.
  • the plurality of solenoid valves 136 is configured to selectively direct positive pressure and negative pressure from the integrated pressure source 109 through an internal fluid channel or conduit of the manifold 134 and into the pressure chamber 120 via a pressure chamber inlet 137 (shown in FIG. 14).
  • the integrated pressure source 109 is a vacuum pump or a similar pressure source that is configured to continuously generate both positive pressure and negative pressure (e.g., out of separate pressure ports) when activated, and the plurality of solenoid valves 136 are configured to be actuated to selectively direct the positive pressure or the negative pressure into the pressure chamber 120.
  • the plurality of solenoid valves 136 include three three-way solenoid valves. In other instances, the plurality of solenoid valves 136 include more or less solenoid valves of varying types.
  • the integrated pressure source 109 and the various solenoid valves 136 are each electronically coupled to and receive power from a power source 138.
  • the power source 138 may be a battery, such as a rechargeable battery or a disposable battery.
  • the cap or cover portion 130 of the upper housing component 117 may be removed to provide access to the power source 138 to allow for a user to recharge or replace the power source 138.
  • the integrated pressure source 109 and the various solenoid valves 136 may be communicatively coupled to and controlled by a processing circuit or controller 140.
  • the processing circuit or controller 140 is configured to selectively power the integrated pressure source 109 via the power source 138.
  • the processing circuit or controller 140 is additionally configured to selectively actuate the various solenoid valves 136 to direct the positive pressure or negative pressure generated by the integrated pressure source 109 into the pressure chamber 120.
  • the processing circuit or controller 140 may include one or more processors and one or more memories storing instructions thereon that, when executed by the one or more processors, cause the one or more processing circuits to perform the various functions described herein. In some instances, the processing circuit or controller 140 may further include one or more communication interfaces configured to allow the processing circuit or controller 140 to communicate with other devices over a communications network (e.g., Bluetooth, Wi-Fi, near-field communication, etc.).
  • a communications network e.g., Bluetooth, Wi-Fi, near-field communication, etc.
  • the processing circuit or controller 140 may include or be communicatively coupled to one or more input/output (VO) devices 142 (shown in FIG. 10) configured to allow a user to selectively operate the breast cup 102 and/or modify functionality parameters of the breast cup 102.
  • the one or more I/O devices may include a display, one or more buttons (e.g., a power button, a pumping session start/stop button), a touchscreen, an audio speaker, a timer, an alarm, a power switch, and/or any other suitable I/O devices.
  • the I/O devices may allow for a user to initiate, end, and/or modify a pumping session using the breast cup 102, as will be described further below.
  • the diaphragm 118 is disposed between the pressure chamber wall portion 132 of the upper housing component 117 and the lower housing component 126.
  • the diaphragm 118 is further coupled between the upper housing component 117 and the lower housing component 126 around an outer periphery of the diaphragm 118.
  • the diaphragm 118 is disposed between and separates the pressure chamber 120 and the milk chamber 121.
  • the diaphragm 118 is pulled into an expanded position (illustrated by dashed lines 118’ shown in FIG. 11).
  • the diaphragm 118 returns to and/or is forced back into a contracted position (e.g., the position of the diaphragm 118 shown in FIGS. 11, 13, and 14).
  • the lower housing component 126 is coupled to the upper housing component 117 and the breast shield 119 and forms a lower milk chamber wall. As shown in FIG. 11, the lower housing component 126 includes a seal interface surface 144 configured to contact a lip 146 of the diaphragm 118 to create a seal therebetween when the diaphragm is in the contracted position. The seal interface surface 144 and the lip 146 are further configured to move out of contact with one another when the diaphragm 118 is pulled into the expanded position, thereby breaking the seal and creating a milk chamber inlet therebetween.
  • the breast shield 119 is coupled to the lower housing component 126 and is configured to contact and couple to a human breast of a subject.
  • the breast shield 119 comprises a conical shape configured to receive a human breast
  • a nipple tunnel 113 is formed by the breast shield 119 (e.g., alone or in combination with a rounded upper surface 148 of the diaphragm 118) within which a nipple of the human breast is configured to pass into and sit during a pumping session, as will be described further below.
  • the breast cup 102 may initially be attached to a breast of a subject by placing the breast shield onto the breast with the nipple of the breast arranged within the nipple tunnel 113. With the breast cup 102 attached to the breast of the subject, negative pressure from the pressure source 109 is applied (e.g., directed by the various solenoid valves 136 as controlled by the controller 140) to the pressure chamber 120 via the pressure chamber inlet 137.
  • negative pressure from the pressure source 109 is applied (e.g., directed by the various solenoid valves 136 as controlled by the controller 140) to the pressure chamber 120 via the pressure chamber inlet 137.
  • the diaphragm 118 As the negative pressure is applied to the pressure chamber 120, the diaphragm 118 is moved into the expanded position shown in FIG. 11 (or in some instances is pulled farther into the pressure chamber 120 than illustrated), and negative pressure is induced within the milk chamber 121 and the nipple tunnel 113, thereby inducing lactation from the nipple. The lactated milk is then able to flow from the nipple tunnel 113 and into the milk chamber 121 through the milk chamber inlet formed between the seal interface surface 144 of the lower housing component 126 and the lip 146 of the diaphragm 118. In some instances, the rounded upper surface 148 of the diaphragm 118 allows for lactated milk that contacts the diaphragm 118 to more easily drip down through the milk chamber inlet into the milk chamber 121.
  • the diaphragm 118 is allowed to return to the nominal position shown in FIGS. 11, 13, and 14 by discontinuing the application of the negative pressure and allowing the pressure chamber 120 to return to an initial pressurization level (e.g., the solenoid valves 136 and/or the pressure source 109 may be configured to return the pressure chamber 120 to atmospheric pressure).
  • an initial pressurization level e.g., the solenoid valves 136 and/or the pressure source 109 may be configured to return the pressure chamber 120 to atmospheric pressure.
  • the seal interface surface 144 of the lower housing component 126 and the lip 146 of the diaphragm 118 come back into contact with each other, thereby recreating the seal therebetween and preventing milk and positive pressure from flowing from the milk chamber 121 back into the nipple tunnel 113 (which would otherwise lower efficiency of the pumping and/or cause the breast cup 102 to detach from the breast of the subject).
  • the diaphragm 118 returning to the nominal position collapses the milk chamber 121 and forces milk out of the milk chamber 121 through an outlet 150 extending from the milk chamber 121, through the lower housing component 126, and out of the breast cup 102.
  • the outlet 150 may be fluidly coupled (e.g., via fluid conduit 5) to one or more external reservoirs (e.g., reservoirs 3) configured to receive, store, and provide later access to the pumped milk.
  • positive pressure is applied (e.g., directed by the various solenoid valves 136 as controlled by the controller 140) to the pressure chamber 120 via the pressure chamber inlet 137 to further collapse the milk chamber 121 and force the milk out of the milk chamber 121 through the outlet.
  • the breast cup 102 may be utilized in a variety of pumping scenarios similar to those discussed above, with respect to the breast cup 2.
  • the breast cup 102 may be utilized to perform multiple pumping sessions.
  • a subject may wait at least 30 minutes between breast pumping sessions.
  • the breast cup 102 may not be removed between breast pumping sessions.
  • a first external reservoir may be replaced with a second external reservoir between consecutive pumping sessions.
  • an external manifold may be configured to direct milk to different external reservoirs between pumping sessions.
  • An example breast cup includes a pressure source, a diaphragm, a breast shield, a pressure chamber, a milk chamber, an outlet, and a sealing point.
  • a control valve may be opened to return the pressure of breast shield to atmospheric pressure, allowing the nipple to return to a nominal length, and allowing the diaphragm to return to a position sealing the inlet to milk chamber at sealing point.
  • diaphragm When positive pressure is applied to pressure chamber, diaphragm deforms towards sealing point, sealing the inlet to milk chamber at sealing point. Diaphragm further deforms towards milk chamber, transporting milk through outlet of milk chamber, and into a fluid conduit. Milk then flows towards a reservoir.
  • the breast cup includes controls that are operable by a user to select or modify at least one of pumping program or mode, frequency of pumping cycle, maximum suction pressure achieved during a pumping cycle, latch suction pressure achieved during the pumping cycle, pumping force and pumping session time.
  • the controls are present in an application on an external computer.
  • the breast cup has two phases: a stimulation phase and an expression phase.
  • the stimulation phase is typically characterized by a rapid initial stage, e.g., 100 cycles per minute, at a low to moderate vacuum strength. The initial rapid stage induces the letdown of milk and mimics the initial quick suckling motion of an infant.
  • the system or the user typically switches the breast cup into the expression phase.
  • Expression is typically characterized by slower cycles per minute, e.g., 38 cycles per minute, at moderate to high vacuum strength.
  • the expression phase mimics an infant’s behavior at breast with slower and deeper suckling. It is possible for the user to cycle between these two phases more than one time per session. Once a user has completed the initial stimulation and expression phase, the user may switch back to stimulation mode to produce another let down of milk and then begin another expression cycle.
  • the terms “approximately,” “about,” “substantially,” and similar terms generally mean ⁇ 5% or 10% of the disclosed values, unless specified otherwise.
  • the terms “approximately,” “about,” “substantially,” and similar terms are meant to cover minor variations in structure that can 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.
  • connection 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 coupled with one another, or with the two members coupled to each other using an intervening member that is integrally formed as a single unitary body with one of the two members.

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Abstract

A breast cup includes a housing including an outlet configured to be fluidly coupled to an external reservoir. The breast cup further includes a breast shield configured to be attached to a human breast. The breast cup further includes a diaphragm disposed between the housing and the breast shield, wherein the diaphragm is disposed between a pressure chamber and a milk chamber. The breast cup further includes a pressure source in fluidic communication with the pressure chamber, the pressure source configured to apply pressure to the pressure chamber to induce lactation from the human breast and pull milk from the human breast into the milk chamber. The outlet, when fluidly coupled to the external reservoir, allows the milk to flow from the milk chamber to the external reservoir.

Description

BREAST CUP WITH INTEGRATED PRESSURE SOURCE AND USES THEREOF
CROSS-REFERENCE TO RELATED APPLICATION
This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63/535,866, filed on August 31, 2023, which is incorporated herein by reference in its entirety.
BACKGROUND
New mothers use breast pumps post-birth in order to achieve milk feeding and milk expression. Breast pumps systems draw breast milk from a breast of a user and may be used to pump breast milk for later consumption by an infant, to stimulate lactation in users with low milk supply, or to relieve engorgement. Breast pumps may be manually operated, for example by squeezing a handle or operation of a foot pedal. Breast pumps may also be electrically driven by a drive unit.
On average, new mothers feed their infants more than 12 times per day, with newborn infants often needing to be fed every two to three hours. Mothers or other care providers may spend more than four hours each day breastfeeding, on average spending 20 minutes out of every two hours breastfeeding, interrupting work, social, and sleep schedules.
SUMMARY
Traditional breast pumps require mothers to be stationary and near an outlet to draw power to express milk. Consequently, portable breast pumps are often less powerful and are unable to fully express milk. Not fully emptying breasts during pumping sessions can contribute to reduced milk supply and clogged milk ducts, which can lead to mastitis.
Commercially available portable breast pumps may also include on-body milk collection, which requires a user to remove the breast cups in order to access the milk, and many of these pumps also have a large breast cup and/or milk collection profile. Breast cup removal and large breast cup profiles do not allow for discreet public pumping. Thus, there is a need for discreet, wearable, portable breast pump systems that provide the power of traditional breast pumps, and permit access to pumped milk without necessitating breast cup removal, while allowing the user the mobility to pump while navigating daily activities or traveling. The present disclosure provides improved breast cups having integrated pressure sources, components thereof, and methods of use thereof that address these and other problems of traditional breast pumps.
One embodiment relates to a breast cup. The breast cup includes a housing including an outlet configured to be fluidly coupled to an external reservoir. The breast cup further includes a breast shield configured to be attached to a human breast. The breast cup further includes a diaphragm disposed between the housing and the breast shield, wherein the diaphragm is disposed between a pressure chamber and a milk chamber. The breast cup further includes a pressure source in fluidic communication with the pressure chamber, the pressure source configured to apply pressure to the pressure chamber to induce lactation from the human breast and pull milk from the human breast into the milk chamber. The outlet, when fluidly coupled to the external reservoir, allows the milk to flow from the milk chamber to the external reservoir.
Another embodiment relates to a breast pump system. The breast pump system includes a reservoir configured to store milk. The breast pump system further includes a breast cup configured to be attached to a human breast. The breast cup includes a housing including an outlet configured to be fluidly coupled to the reservoir. The breast cup further includes a diaphragm disposed within the housing between a pressure chamber and a milk chamber. The breast cup further includes a pressure source in fluidic communication with the pressure chamber, the pressure source configured to apply pressure to the pressure chamber to induce lactation from the human breast and pull milk from the human breast into the milk chamber. The breast pump system further includes a fluid conduit fluidly coupling the outlet to the reservoir. The outlet allows the milk to flow from the milk chamber, through the fluid conduit, to the reservoir.
Another embodiment relates to a method of breast pumping. The method includes attaching a breast cup to a human breast of a subject, the breast cup including an internal pressure source and a pressure chamber. The method further includes applying pressure to the pressure chamber using the internal pressure source to pump milk from the human breast and into an external reservoir fluidly coupled to the breast cup via a fluid conduit.
In one aspect, the disclosure provides a breast cup including a housing, a breast shield, a milk outlet, and a pressure source disposed to alter pressure within the breast cup to express milk, wherein the breast cup is configured so that milk is collected external to the breast cup. In some embodiments, the breast cup further includes a fluid conduit connected to the milk outlet and a reservoir. In some embodiments, the breast cup further includes a power source operatively connected to the pressure source.
In one aspect, the disclosure provides a breast cup including (a) a housing; (b) a breast shield; (c) a diaphragm disposed between the housing and the breast shield; (d) a pressure source; and (e) optionally a power source. The diaphragm is disposed between a pressure chamber and a milk chamber, and the pressure source is in fluidic communication with the pressure chamber.
In some embodiments, the breast shield includes a wide portion and a nipple tunnel.
In some embodiments, the breast cup further includes a milk chamber wall disposed between the diaphragm and the breast shield. The diaphragm and the milk chamber wall define the milk chamber.
In some embodiments, the milk chamber includes an inlet from the breast shield, and the diaphragm releasably seals the inlet. In some embodiments, the inlet includes a valve, e.g., a mechanical valve, an umbrella valve, a butterfly valve, a disk valve, or a duckbill valve. In some embodiments, the inlet comprises a plurality of orifices. In some embodiments, the plurality of orifices is circumferentially arranged at a nipple tunnel of the breast shield.
In some embodiments, the milk chamber includes an inlet from the breast shield, e.g., wherein the diaphragm releasably contacts the inlet. In some embodiments, the diaphragm releasably seals the inlet.
In some embodiments, the inlet includes a valve. In some embodiments, the valve is mechanical valve, an umbrella valve, a butterfly valve, a disk valve, or a duckbill valve.
In some embodiments, the inlet includes a plurality of orifices. In some embodiments, the plurality of orifices is circumferentially arranged at the nipple tunnel of the breast shield. In some embodiments, each of the plurality of orifices has a diameter from about 0.5 mm to about 10 mm (e.g., about 0.5 mm to about 1 mm, about 0.5 mm to about 2.5 mm, about 1 mm to about 5 mm, about 2 mm to about 7 mm, about 4 mm to about 6 mm, about 5 mm to about 7.5 mm, about 5 mm to about 10 mm, or about 7.5 mm to about 10 mm).
In some embodiments, the breast cup or component thereof, e.g., the breast shield, includes a flexible material. In some embodiments, the breast cup or component thereof, e.g., the breast shield, is polymeric. In some embodiments, the housing includes polyethylene terephthalate (PET), polypropylene (PP), polytetrafluoroethylene (PTFE) (e.g., Teflon), polyethylene, high-density polyethylene (HDPE), low-density polyethylene (LDPE), copolyester (e.g., Tritan EX401), polycarbonate (PC), nylon, poly vinylidene fluoride (PVDF), silicone, polyester, cotton, linen, satin, organdy, rayon, taffeta, broad cloth, poplin, velour, gauze, canvas, shirting, muslin, tweed, georgette, crepe, wool, twill, gabardine, denim, or drill.
In some embodiments, the breast cup or component thereof, e.g., the breast shield, include ridges, bumps or dimples. In some embodiments, the breast cup includes a toroidal ridge.
In some embodiments, the diaphragm includes a flexible material. In some embodiments, the diaphragm includes a polymeric material.
In some embodiments, the diaphragm includes a material having a Shore hardness from A10 to A80. In some embodiments, the diaphragm includes a material having a Shore hardness from A10 to A80 and a second Shore hardness from A10 to A80 or being rigid, wherein the material includes the second Shore hardness or is rigid where the diaphragm contacts the inlet. In some embodiments, the diaphragm includes a first material, e.g., having a Shore hardness from A10 to A80, and a second material, e.g., having a different Shore hardness from A10 to A80 or being rigid. In some embodiments, either the first or second material may have a Shore hardness from DIO to D80. The second material may be more rigid than the first material and contact the inlet.
In some embodiments, the diaphragm includes a thickness from about 1 mm to about 10 mm (e.g., about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 5 mm, about 2 mm to about 7 mm, about 4 mm to about 6 mm, about 5 mm to about 7.5 mm, about 5 mm to about 10 mm, or about 7.5 mm to about 10 mm). In some embodiments, the diaphragm includes a first thickness from about 1 mm to about 10 mm (e.g., about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 5 mm, about 2 mm to about 7 mm, about 4 mm to about 6 mm, about 5 mm to about 7.5 mm, about 5 mm to about 10 mm, or about 7.5 mm to about 10 mm), and a second thickness from about 1 mm to about 10 mm (e.g., about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 5 mm, about 2 mm to about 7 mm, about 4 mm to about 6 mm, about 5 mm to about 7.5 mm, about 5 mm to about 10 mm, or about 7.5 mm to about 10 mm), wherein the diaphragm includes the second thickness where the diaphragm contacts the inlet. The thickness of the diaphragm may be non-uniform. For example, portions at the edge or contacting the inlet may be thicker or thinner than other portions.
In some embodiments, the diaphragm includes a plurality of layers. In some embodiments, the diaphragm includes a plurality of layers wherein the diaphragm contacts the inlet. In some embodiments, the diaphragm is shaped to conform to the shape of breast shield or the milk chamber wall. In some embodiments, the diaphragm includes a curved shape.
In some embodiments, the pressure chamber further includes a valve to the ambient atmosphere. In some embodiments, a volume of the pressure chamber may be set with the valve. In some embodiments, the valve is an inflation valve.
All or portions of the breast cup may be clear, e.g., to allow for visualization of the nipple during placement of the breast cup. A portion, e.g., a portion of the diaphragm, may also include a lens to magnify the nipple for alignment. Breast cups with clear portions may include a flap or other opaque covering to hide the clear portions after alignment. References to “clear” material should be understood to encompass transparent material and certain translucent material.
In some embodiments, the milk chamber further comprises an outlet.
In some embodiments, the breast cup further includes a one directional valve configured to allow fluid flow from the milk chamber to a reservoir. In some embodiments, the one directional valve is disposed in the outlet.
In some embodiments, the breast cup further includes a positive pressure source, wherein the positive pressure source is in fluidic communication with the pressure chamber. In some embodiments, the positive pressure source is a vacuum pump. In some embodiments, the pressure source includes a negative pressure source and a positive pressure source. In some embodiments, the negative pressure source is a vacuum pump.
In some embodiments, the breast shield is configured to permit a slow leak to the ambient atmosphere.
In some embodiments, the breast shield includes a wide portion and a nipple tunnel. In some embodiments, the nipple tunnel has a length from about 5 mm to about 75 mm (e.g., about 5 mm to about 25 mm, about 10 mm to about 30 mm, about 25 mm to about 50 mm, about 30 mm to about 60 mm, or about 50 mm to about 75 mm). In some embodiments, the nipple tunnel has a minimum diameter from about 10 mm to about 130 mm (e.g., about 10 mm to about 50 mm, about 25 mm to about 75 mm, about 50 mm to about 100 mm, about 75 mm to about 100 mm, or about 100 mm to about 130 mm). In some embodiments, the nipple tunnel has a maximum diameter from about 10 mm to about 130 mm (e.g., about 10 mm to about 50 mm, about 25 mm to about 75 mm, about 50 mm to about 100 mm, about 75 mm to about 100 mm, or about 100 mm to about 130 mm). In some embodiments, the diameter of the nipple tunnel is between about 20 and about 40 mm. In some embodiments, the breast shield is funneled.
In some embodiments, the milk chamber includes a volume from about 1 mL to about 150 mL (e.g., about 1 mL to about 10 mL, about 1 mL to about 50 mL, about 10 mL to about 50 mL, about 25 mL to about 50 mL, about 30 mL to about 60 mL, about 50 mL to about 100 mL, about 50 mL to about 150 mL, about 75 mL to about 125 mL or about 100 mL to about 150 mL). In some embodiments, the pressure chamber includes a volume from about 1 mL to about 150 mL (e.g., about 1 mL to about 10 mL, about 1 mL to about 50 mL, about 10 mL to about 50 mL, about 25 mL to about 50 mL, about 30 mL to about 60 mL, about 50 mL to about 100 mL, about 50 mL to about 150 mL, about 75 mL to about 125 mL or about 100 mL to about 150 mL).
In some embodiments, the breast cup further includes a first fluid conduit providing fluidic communication between the milk chamber and the reservoir. In some embodiments, the first fluid conduit is releasably connected to the milk chamber and/or the reservoir. In some embodiments, the first fluid conduit includes a movement element. In some embodiments, the movement element includes a swivel fitting or a rotating fitting. In some embodiments, the movement element includes a ball bearing. In some embodiments, the first fluid conduit is movably connected to the milk chamber. In some embodiments, the first fluid conduit is rotatable with respect to the breast cup.
In some embodiments, the breast cup further includes a second breast cup as described herein.
In another aspect, the present disclosure provides a breast cup system including: (a) a breast cup as described herein and (b) a reservoir in fluidic communication with the milk chamber via a fluid conduit.
In some embodiments, the breast pump system further includes a first fluid conduit providing fluidic communication between the milk chamber and the reservoir. In some embodiments, the first fluid conduit is releasably connected to the milk chamber and/or the reservoir. In some embodiments, the first fluid conduit includes a movement element. In some embodiments, the movement element includes a swivel fitting or a rotating fitting. In some embodiments, the movement element includes a ball bearing. In some embodiments, the first fluid conduit is movably connected to the milk chamber. In some embodiments, the first fluid conduit is rotatable with respect to the breast cup.
In some embodiments, the breast pump system further includes a control valve.
In some embodiments, the breast pump system further includes a one directional valve configured to allow fluid flow from the milk chamber to the reservoir. In some embodiments, the one directional valve is disposed in the first fluid conduit. In some embodiments, the outlet includes the one directional valve. In some embodiments, the one directional valve is disposed in the diaphragm.
In some embodiments, the breast pump system further includes two breast cups, wherein the two breast cups each include a housing, a breast shield, and a diaphragm as described herein.
In some embodiments, the breast cup further includes a drive unit operatively connected to the pressure source. In some embodiments, the drive unit includes the control unit.
In some embodiments, the breast cup is connected to a power source. In some embodiments, the breast cup further includes the power source. The power source may or may not be disposed in the breast cup, e.g., it may be connected via wire and worn separately or disposed with or adjacent to the reservoir.
In some embodiments, the breast cup further includes a button, display, timer, alarm, and/or power switch. In some embodiments, one or more interactive components, e.g., button, display, timer, alarm, and/or a power switch, may be disposed on the breast cup, e.g., on the housing. In some embodiments, the breast cup may be remotely controlled, e.g., by a remote or mobile device app.
In some embodiments, the breast cup further includes a sensor selected from the group consisting of a weight sensor, a load cell, a temperature sensor, a pressure sensor, an optical sensor, a flow sensor, a volume sensor, a pH sensor, and a viscosity sensor.
In some embodiments, the breast cup system further includes a garment, and the breast cup is releasably secured to the garment. In some embodiments, the garment is a bra or shirt. In some embodiments, the coefficient of friction between the garment and the housing is less than 0.4 (e.g., 0.3, 0.2, 0.1, or 0.5).
The present disclosure provides a method of breast pumping including providing the breast cup of the present disclosure, wherein a reservoir is in fluidic communication with the breast cup; contacting a breast of a subject with the breast cup; and pumping milk from the breast to the reservoir by alternating reducing and increasing pressure in the pressure chamber.
In some embodiments, the subject is moving, resting, or sleeping. In some embodiments, the subject is moving, reclining, resting, or sleeping.
In some embodiments, the method further includes connecting the first fluid conduit to the breast cup and the reservoir. In some embodiments, the method further includes contacting the breast with the wide portion of the breast cup. In some embodiments, the method further includes contacting the breast with the wide portion of the breast shield. In some embodiments, a nipple of the breast is placed in the nipple tunnel of the breast cup. In some embodiments, the method further includes contacting two breasts with the two breast cups.
In some embodiments, the method further includes applying negative pressure to the pressure chamber with the pressure source. In some embodiments, the method further includes deforming the diaphragm away from the breast shield. In some embodiments, the method further includes deforming the diaphragm away from the inlet. In some embodiments, the milk chamber comprises an inlet, and the diaphragm pulls away from the inlet to provide fluidic communication between the milk chamber and the breast shield when pressure in the pressure chamber is reduced. In some embodiments, the method further includes unsealing the inlet. In some embodiments, the method further includes expanding the milk chamber. In some embodiments, the method further includes contracting the pressure chamber. In some embodiments, the method further includes providing negative pressure to elongate the nipple. In some embodiments, the method further includes drawing milk from the nipple. In some embodiments, the method further includes drawing milk from the nipple tunnel into the milk chamber. In some embodiments, the method further includes drawing milk through the inlet into the milk chamber.
In some embodiments, the method further includes opening the control valve and depressurizing the pressure chamber. In some embodiments, the method further includes returning the diaphragm to a nominal position. In some embodiments, the method further includes closing the control valve.
In some embodiments, the method further includes applying positive pressure to the pressure chamber with a positive pressure source. In some embodiments, the method further includes allowing the nipple to contract. In some embodiments, the method further includes deforming the diaphragm towards the breast shield. In some embodiments, the method includes allowing the diaphragm to return to a nominal position. In some embodiments, the method further includes sealing the inlet with the diaphragm. In some embodiments, the diaphragm seals the inlet when pressure in the pressure chamber increases. In some embodiments, the method further includes sealing orifices in the inlet with the diaphragm. In some embodiments, the method further includes contracting the milk chamber. In some embodiments, the method further includes expanding the pressure chamber. In some embodiments, the method further includes transporting milk from the milk chamber through the first fluid conduit to the reservoir. In some embodiments, the method further includes transporting milk through the outlet. In some embodiments, the method further includes transporting milk through the one directional valve.
In some embodiments, the method further includes applying negative pressure to a fluid conduit attached to an outlet of the milk chamber. In some embodiments, the negative pressure is applied via a vacuum pump. In some embodiments, the fluid conduit comprises an air inlet.
In some embodiments, the method further includes removing the reservoir from fluidic communication with the breast cup without removing the breast cup from the user.
In some embodiments, the method further includes waiting at least 30 minutes after the pumping step and repeating the pumping step to a provide a first and second breast pumping session. In some embodiments, the method further includes pumping milk from the human breast twice, wherein there is at least about 30 minutes (e.g., about 45 minutes, about 60 minutes, about 75 minutes, about 90 minutes, about 120 minutes, about 150 minutes, about 180 minutes, about 210 minutes, or about 240 minutes) between a first breast pumping session to a second breast pumping session.
In some embodiments, milk from the first breast pumping session is transported to a first reservoir, and milk from the second breast pumping session is transported to a second reservoir.
In some embodiments, the method further includes taking a weight, a temperature, a pressure, an optical, a flow rate, a pH, or a viscosity measurement of the milk with the sensor. In some embodiments, the method further includes alerting a user of the temperature, pressure, optical, flow rate, volume, pH, or viscosity measurement. In some embodiments, the method further includes changing at least one of the first pressure or second pressure based on the temperature, pressure, or flow rate measurement. In some embodiments, the method further includes measuring the weight of a reservoir containing the pumped milk.
In some embodiments, the method further includes securing the breast cup to the garment and donning the garment. In some embodiments, the method further includes donning the garment and securing the breast cup to the garment.
In some embodiments, the method further includes pumping milk from the breast at least twice without removing the breast cup from the breast. In some embodiments, the method further includes removing the reservoir from fluidic communication with the breast cup without removing the breast cup. In some embodiments, the method includes replacing the reservoir between the first and second breast pumping sessions. In some embodiments, a subject including the human breast is moving, reclining, resting, or sleeping.
Definitions
To facilitate the understanding of this disclosure, a number of terms are defined below and throughout the disclosure. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. The terminology herein is used to describe specific embodiments of the disclosure, but their usage does not limit the disclosure, except as outlined in the claims.
Terms such as "a", "an," and "the" are not intended to refer to only a singular entity but include the general class of which a specific example may be used for illustration.
The term “fluidically connected,” as used herein, refers to a direct connection between at least two device elements, e.g., a channel, reservoir, etc., that allows for fluid to move between such device elements without passing through an intervening element.
The term “fluidically disconnected,” as used herein refers to the absence of a connection in which fluid, e.g., a liquid, can flow between elements in a fluid path.
The term “food contact substance,” as used herein, refers to a substance or material that is intended for use as a component in manufacturing, packing, packaging, transporting, or holding food in which such use is not intended to have any technical effect in such food.
The term “fluidic communication,” as used herein, refers to a connection between at least two device elements, e.g., a channel, reservoir, etc., that allows for fluid to move between such device elements with or without passing through one or more intervening device elements.
The term “valve,” as used herein, refers to an element which regulates, directs or controls the flow of a fluid by opening, closing, or partially obstructing a fluid pathway.
The term “positive pressure,” as used herein, refers to an application of pressure from a pressure source (e.g., a pump) that tends to increase a pressure within a given component or space.
The term “negative pressure,” as used herein, refers to an application of pressure from a pressure source (e.g., a pump) that tends to decrease a pressure within a given component or space.
BRIEF DESCRIPTION OF THE DRAWINGS The following detailed description of the embodiments of the disclosure will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the disclosure, there are shown in the drawing embodiments, which are presently exemplified. It should be understood, however, that the disclosure is not limited to the precise arrangement and instrumentalities of the embodiments shown in the drawings.
FIG. 1 shows a schematic drawing of a breast cup, including a pressure source, according to an example embodiment.
FIG. 2 shows a schematic of a breast cup including a wide portion and a nipple tunnel, according to an example embodiment.
FIG. 3 shows a schematic drawing of a breast cup connected to a reservoir, according to an example embodiment.
FIG. 4 shows a schematic drawing of breast cup, including housing, diaphragm, breast shield, pressure chamber, milk chamber, outlet, and sealing point, according to an example embodiment.
FIG. 5 shows a schematic drawing of breast cup, including housing, diaphragm, breast shield, pressure chamber, milk chamber, outlet, and valve, according to an example embodiment.
FIG. 6 shows a schematic drawing of breast cup, including housing, diaphragm, breast shield, pressure chamber, milk chamber, outlet, sealing point, and orifices, according to an example embodiment.
FIG. 7 shows a schematic drawing of breast cup, including housing, diaphragm, breast shield, pressure chamber, milk chamber, outlet, sealing point, and milk chamber wall, according to an example embodiment.
FIG. 8 A and FIG. 8B show schematic drawings of breast shield having a protrusion on the inner surface of breast shield, wherein the inner surface of breast shield is configured to contact the breast of a user, according to example embodiments. FIG. 8A shows a schematic drawing of breast shield having a toroidal ridge on the inner surface of breast shield, according to an example embodiment. FIG. 8B shows a schematic drawing of breast shield having a curved toroidal ridge on the inner surface of breast shield, according to an example embodiment.
FIG. 9A-9D show views of a breast cup including housing, diaphragm, breast shield, pressure chamber, milk chamber, milk chamber wall, ports, and a one directional valve, according to example embodiments. FIG. 10 shows a perspective view of another breast cup, according to an example embodiment.
FIG. 11 shows a section view of the breast cup of FIG. 10, taken along section line 11-11, according to an example embodiment.
FIG. 12 shows a top view of the breast cup of FIG. 10, shown without an upper housing, according to an example embodiment.
FIG. 13 shows a section view of the breast cup of FIG. 12, taken along section line
13-13, according to an example embodiment.
FIG. 14 shows a section view of the breast cup of FIG. 12, taken along section line
14-14, according to an example embodiment.
DETAILED DESCRIPTION
The present disclosure provides a breast cup, components thereof, and methods of use thereof. The present breast cups are particularly advantageous for navigating daily activities, resting, reclining, sleeping, and for removing a reservoir without removal of a breast cup.
Breast Cup
The present disclosure provides a breast cup. The breast cup is advantageous in that it comfortably allows for pumping in any position, such as lying reclined, flat, or on the side; allows for pumping without assembly at the time of use; allows for discrete public pumping; and/or allows for removal of a reservoir without necessitating removal of the breast cup after a pumping session. An exemplary scheme for a breast cup of the disclosure is shown in FIG. 1.
The breast cup may include a housing, a breast shield, a milk outlet, and a pressure source disposed to alter pressure within the breast cup to express milk. Milk is collected external to the breast cup, e.g., via a fluid conduit connected to the milk outlet. In one embodiment, the breast cup may include (a) a housing (e.g., including an upper housing 17 and a lower housing or milk chamber wall 26); (b) a breast shield 19; (c) a diaphragm 18 disposed between the upper housing 17 and the breast shield 19 (and also between the upper housing 17 and/or the lower housing or milk chamber wall 26); and (d) a pressure source 9. The diaphragm may be disposed further between a pressure chamber and a milk chamber.
The breast cup 2 may include at least one breast cup 2 in fluidic communication with a separate reservoir 3 via a fluid conduit. FIG. 3 shows a schematic of a breast cup 2, including two breast cups 2 in fluidic communication with the pressure source 9 and a reservoir 3.
As shown in, e.g., FIG. 4, the breast cup 2 can include a breast cup 2 having a housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), a breast shield 19, and a diaphragm 18 disposed between the upper housing 17 and the breast shield 19 (and also between the upper housing 17 and/or the lower housing or milk chamber wall 26). The diaphragm 18 can separate the pressure chamber 20 from the milk chamber 21. The diaphragm provides numerous advantages including improved breast pumping in reclined positions. The pressure source 9 may be a negative pressure source and/or a positive pressure source in fluidic communication with the pressure chamber 20, and the reservoir 3 can be in fluidic communication with the milk chamber 21.
The breast cup 2 can include a food contact substance, e.g., for surfaces that contact milk and the breast. Alternatively, or in addition, the breast cup 2 can include an infant grade material.
The breast cup 2, including any element therein, can include a polymer (e.g., polyvinyl chloride (PVC), polyethylene terephthalate (PET), polypropylene (PP), polytetrafluoroethylene (PTFE), polyethylene, high-density polyethylene (HDPE), low- density polyethylene (LDPE), copolyester (e.g., Tritan EX401), polystyrene, a thermoplastic elastomer, thermoplastic polyurethane, nylon, polyvinylidene fluoride (PVDF), silicone, or polycarbonate (PC)). For example, the reservoir 3, the reservoir enclosure 4, the fluid conduit 5, or the breast cup 2, including the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), breast shield 19, and diaphragm 18 can include a polymer. In some embodiments, the breast cup, including any element therein, may be substantially free of bisphenol A (BP A) and/or polyfluoroalkyl substances (PFAS). In some embodiments, the breast cup, including any element therein and/or any components thereof, is manufactured absent of any intentionally added BP A and/or PFAS.
In some embodiments, breast cup 2 can include a fabric (e.g., polyester, cotton, linen, satin, organdy, rayon, taffeta, broad cloth, poplin, velour, gauze, canvas, shirting, muslin, tweed, georgette, crepe, wool, twill, gabardine, denim, or drill). For example, the reservoir 3 or the breast cup 2, including the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) and the breast shield 19, can include a fabric.
In some embodiments, the breast cup 2 includes a foam, e.g., an open cell foam. For example, the reservoir 3 or the breast cup 2, including the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) and the breast shield 19, can include a foam.
Pressure Source
The breast cup 2 includes a pressure source 9, e.g., a negative pressure source and/or a positive pressure source. The pressure source 9 may be a single pressure source comprising both a negative pressure source and a positive pressure source. Specifically, the pressure source is configured to be used to move fluids, such as air, water, milk, and/or cleaning fluid, in the breast cup 2. In some embodiments, the breast cup 2 includes a plurality of pressure sources (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10). In some embodiments, at least one pressure source is a vacuum pump, e.g., which is capable of producing negative and positive pressure.
In some embodiments, the breast cup 2 includes a pressure source 9 that provides negative pressure to the breast cup 2, and thus the nipple of the breast in order to express milk. Additionally, the pressure source 9 may be configured transport milk in the breast cup 2, e.g., to expand and/or compress the pressure chamber 20 and/or the milk chamber 21. In some embodiments, the pressure source 9 is pneumatic. In some embodiments, the pressure source 9 is a vacuum pump, such as a small vacuum pump, a micro vacuum pump, a piezo pump, an air powered vacuum pump, a positive displacement pump, or a scroll pump sized to attach to the breast cup. In some embodiments, the pressure source 9 is mechanical. In some embodiments, the mechanical pressure source 9 may be attached to the diaphragm. In some embodiments, the mechanical pressure source 9 may not be attached to the diaphragm. In some embodiments, the mechanical pressure source 9 includes a plunger, screw, chain, a rope, a pulley, a wire, an articulating arm, a rotating cam, or any other suitable mechanical actuator sized to attach to the breast cup.
In some embodiments, the breast cup 2 includes a positive pressure source that provides positive pressure to the breast cup 2, e.g., to aid in transportation of milk, e.g., to expand and/or compress the pressure chamber 20 and/or the milk chamber 21. In some embodiments, the positive pressure source is pneumatic. In some embodiments, the positive pressure source is a pressure pump, a manually compressible chamber, a vacuum pump, a small vacuum pump, a micro vacuum pump, a piezo pump, an air powered vacuum pump, a positive displacement pump, a scroll pump, a peristaltic pump, or a valve to the ambient atmosphere sized to attach to the breast cup. In some embodiments, the positive pressure source is mechanical. In some embodiments, the mechanical pressure source 9 may be attached to the diaphragm. In some embodiments, the mechanical pressure source 9 may not be attached to the diaphragm. In some embodiments, the mechanical pressure source 9 includes a plunger, screw, chain, a rope, a pulley, a wire, an articulating arm, a rotating cam, or any other suitable mechanical actuator sized to attach to the breast cup.
In some embodiments, the pressure source may include features configured to reduce noise and/or vibrations. In some embodiments, the pressure source may include a brushless motor.
In some embodiments, pressure applied to the breast cup 2 varies. In some embodiments, the pressure source applies pressure to the breast cup 2 for 1 to 20 cycles (e.g.,
I to 2 cycles, 1 to 3 cycles, 1 to 4 cycles, 1 to 5 cycles, 1 to 6 cycles, 1 to 7 cycles, 1 to 8 cycles, 1 to 9 cycles, 1 to 10 cycles, 1 to 15 cycles, 2 to 3 cycles, 2 to 4 cycles, 2 to 5 cycles, 3 to 7 cycles, 4 to 6 cycles, 5 to 10 cycles, 5 to 15 cycles, 10 to 15 cycles, 15 to 20 cycles, 1 cycle, 2 cycles, 3 cycles, 4 cycles, 5 cycles, 6 cycles, 7 cycles, 8 cycles, 9 cycles, 10 cycles,
I I cycles, 12 cycles, 13 cycles, 14 cycles, 15 cycles, 16 cycles, 17 cycles, 18 cycles, 19 cycles, or 20 cycles). A first cycle may apply a maximum negative pressure of 0 mmHg to about 400 mmHg and/or a maximum positive pressure of about 0 mmHg to about 400 mmHg of positive pressure. A second cycle may apply a maximum negative pressure of about 0 mmHg to about 400 mmHg and/or a maximum positive pressure of about 0 mmHg to about 400 mmHg of positive pressure. Likewise, a third, fourth, fifth, etc., cycle, may apply a maximum negative pressure of about 0 mmHg to about 400 mmHg and/or a maximum positive pressure of about 0 mmHg to about 400 mmHg of positive pressure.
The pressure source 9 may provide a negative pressure from about 0 mmHg to about 400 mmHg (e.g., about 0 mmHg to about 10 mmHg, about 0 mmHg to about 20 mmHg, about 0 mmHg to about 30 mmHg, about 0 mmHg to about 40 mmHg, about 0 mmHg to about 50 mmHg, about 0 mmHg to about 60 mmHg, about 0 mmHg to about 70 mmHg, about 0 mmHg to about 80 mmHg, about 0 mmHg to about 90 mmHg, about 0 to about 100 mmHg, about 0 mmHg to about 110 mmHg, about 0 mmHg to about 120 mmHg, about 0 mmHg to about 130 mmHg, about 0 to about 140 mmHg, about 0 mmHg to about 150 mmHg, about 0 to about 175 mmHg, about 0 mmHg to about 200 mmHg, about 0 mmHg to about 225 mmHg, about 0 mmHg to about 250 mmHg, about 0 mmHg to about 275 mmHg, about 0 mmHg to about 300 mmHg, about 0 to about 350 mmHg, about 0 mmHg to about 400 mmHg, about 10 mmHg to about 20 mmHg, about 10 mmHg to about 30 mmHg, about 10 mmHg to about 40 mmHg, about 10 mmHg to about 50 mmHg, about 10 mmHg to about 60 mmHg, about 10 mmHg to about 70 mmHg, about 10 mmHg to about 80 mmHg, about 10 mmHg to about 90 mmHg, about 10 mmHg to about 100 mmHg, about 10 mmHg to about 110 mmHg, about 10 mmHg to about 120 mmHg, about 10 mmHg to about 130 mmHg, about 10 mmHg to about 140 mmHg, about 10 mmHg to about 150 mmHg, about 10 mmHg to about 175 mmHg, about 10 mmHg to about 200 mmHg, about 10 mmHg to about 225 mmHg, about 10 mmHg to about 250 mmHg, about 10 mmHg to about 300 mmHg, about 10 to about 350 mmHg, about 10 mmHg to about 400 mmHg, about 20 mmHg to about 30 mmHg, about 20 mmHg to about 40 mmHg, about 20 mmHg to about 50 mmHg, about 20 mmHg to about 60 mmHg, about 20 mmHg to about 70 mmHg, about 20 mmHg to about 80 mmHg, about 20 mmHg to about 90 mmHg, about 20 mmHg to about 100 mmHg, about 20 mmHg to about 110 mmHg, about 20 mmHg to about 120 mmHg, about 20 mmHg to about 130 mmHg, about 20 mmHg to about 140 mmHg, about 20 mmHg to about 150 mmHg, about 20 mmHg to about 175 mmHg, about 20 mmHg to about 200 mmHg, about 20 mmHg to about 225 mmHg, about 20 mmHg to about 250 mmHg, about 20 mmHg to about 300 mmHg, about 20 to about 350 mmHg, about 20 mmHg to about 400 mmHg, about 25 mmHg to about 50 mmHg, about 25 mmHg to about 75 mmHg, about 25 mmHg to about 100 mmHg, about 30 mmHg to about 40 mmHg, about 30 mmHg to about 50 mmHg, about 30 mmHg to about 60 mmHg, about 30 mmHg to about 70 mmHg, about 30 mmHg to about 80 mmHg, about 30 mmHg to about 90 mmHg, about 30 mmHg to about 100 mmHg, about 30 mmHg to about 110 mmHg, about 30 mmHg to about 120 mmHg, about 30 mmHg to about 130 mmHg, about 30 mmHg to about 140 mmHg, about 30 mmHg to about 150 mmHg, about 30 mmHg to about 175 mmHg, about 30 mmHg to about 200 mmHg, about 30 mmHg to about 225 mmHg, about 30 mmHg to about 250 mmHg, about 30 mmHg to about 300 mmHg, about 30 to about 350 mmHg, about 30 mmHg to about 400 mmHg, about 40 mmHg to about 50 mmHg, about 40 mmHg to about 60 mmHg, about 40 mmHg to about 70 mmHg, about 40 mmHg to about 80 mmHg, about 40 mmHg to about 90 mmHg, about 40 mmHg to about 100 mmHg, about 40 mmHg to about 110 mmHg, about 40 mmHg to about 120 mmHg, about 40 mmHg to about 130 mmHg, about 40 mmHg to about 140 mmHg, about 40 mmHg to about 150 mmHg, about 40 mmHg to about 175 mmHg, about 40 mmHg to about 200 mmHg, about 40 mmHg to about 225 mmHg, about 40 mmHg to about 250 mmHg, about 40 mmHg to about 300 mmHg, about 40 to about 350 mmHg, about 40 mmHg to about 400 mmHg, about 50 mmHg to about 60 mmHg, about 50 mmHg to about 70 mmHg, about 50 mmHg to about 75 mmHg, about 50 mmHg to about 80 mmHg, about 50 mmHg to about 90 mmHg, about 50 mmHg to about 100 mmHg, about 50 mmHg to about 110 mmHg, about 50 mmHg to about 120 mmHg, about 50 mmHg to about 130 mmHg, about mmHg 50 to about 140 mmHg, about 50 mmHg to about 150 mmHg, about 50 mmHg to about 175 mmHg, about 50 mmHg to about 200 mmHg, about 50 mmHg to about 225 mmHg, about 50 mmHg to about 250 mmHg, about 50 mmHg to about 300 mmHg, about 50 to about 350 mmHg, about 50 mmHg to about 400 mmHg, about 60 mmHg to about 70 mmHg, about 60 mmHg to about 80 mmHg, about 60 mmHg to about 90 mmHg, about 60 mmHg to about 100 mmHg, about 60 mmHg to about 110 mmHg, about 60 mmHg to about 120 mmHg, about 60 mmHg to about 130 mmHg, about 60 mmHg to about 140 mmHg, about 60 mmHg to about 150 mmHg, about 60 mmHg to about 175 mmHg, about 60 mmHg to about 200 mmHg, about 60 mmHg to about 225 mmHg, about 60 mmHg to about 250 mmHg, about 60 mmHg to about 300 mmHg, about 60 to about 350 mmHg, about 60 mmHg to about 400 mmHg, about 70 mmHg to about 80 mmHg, about 70 mmHg to about 90 mmHg, about 70 mmHg to about 100 mmHg, about 70 mmHg to about 110 mmHg, about 70 mmHg to about 120 mmHg, about 70 mmHg to about 130 mmHg, about 70 mmHg to about 140 mmHg, about 70 mmHg to about 150 mmHg, about 70 mmHg to about 175 mmHg, about 70 mmHg to about 200 mmHg, about 70 mmHg to about 225 mmHg, about 70 mmHg to about 250 mmHg, about 70 mmHg to about 300 mmHg, about 70 to about 350 mmHg, about 70 mmHg to about 400 mmHg, about 75 mmHg to about 100 mmHg, about 75 mmHg to about 125 mmHg, about 80 mmHg to about 90 mmHg, about 80 mmHg to about 100 mmHg, about 80 mmHg to about 110 mmHg, about 80 mmHg to about 120 mmHg, about 80 mmHg to about 130 mmHg, about 80 mmHg to about 140 mmHg, about 80 mmHg to about 150 mmHg, about 80 mmHg to about 175 mmHg, about 80 mmHg to about 200 mmHg, about 80 mmHg to about 225 mmHg, about 80 mmHg to about 250 mmHg, about 80 mmHg to about 300 mmHg, about 80 to about 350 mmHg, about 80 mmHg to about 400 mmHg, about 90 mmHg to about 100 mmHg, about 90 mmHg to about 110 mmHg, about 90 mmHg to about 120 mmHg, about 90 mmHg to about 130 mmHg, about 90 mmHg to about 140 mmHg, about 90 mmHg to about 150 mmHg, about 90 mmHg to about 175 mmHg, about 90 mmHg to about 200 mmHg, about 90 mmHg to about 225 mmHg, about 90 mmHg to about 250 mmHg, about 90 mmHg to about 300 mmHg, about 90 to about 350 mmHg, about 90 mmHg to about 400 mmHg, about 100 mmHg to about 110 mmHg, about 100 mmHg to about 120 mmHg, about 100 mmHg to about 130 mmHg, about 100 mmHg to about 140 mmHg, about 100 mmHg to about 150 mmHg, about 100 mmHg to about 175 mmHg, about 100 mmHg to about 200 mmHg, about 100 mmHg to about 225 mmHg, about 100 mmHg to about 250 mmHg, about 100 mmHg to about 300 mmHg, about 100 to about 350 mmHg, about 100 mmHg to about 400 mmHg, about 110 mmHg to about 120 mmHg, about 110 mmHg to about 130 mmHg, about 110 mmHg to about 140 mmHg, about 110 mmHg to about 150 mmHg, about 110 mmHg to about 175 mmHg, about 110 mmHg to about 200 mmHg, about 110 mmHg to about 225 mmHg, about 110 mmHg to about 250 mmHg, about 110 mmHg to about 300 mmHg, about 110 to about 350 mmHg, about 110 mmHg to about 400 mmHg, about 120 mmHg to about 130 mmHg, about 120 mmHg to about 140 mmHg, about 120 mmHg to about 150 mmHg, about 120 mmHg to about 175 mmHg, about 120 mmHg to about 200 mmHg, about 120 mmHg to about 225 mmHg, about 120 mmHg to about 250 mmHg, about 120 mmHg to about 300 mmHg, about 120 to about 350 mmHg, about 120 mmHg to about 400 mmHg, about 130 mmHg to about 140 mmHg, about 130 mmHg to about 150 mmHg, about 130 mmHg to about 175 mmHg, about 130 mmHg to about 200 mmHg, about 130 mmHg to about 225 mmHg, about 130 mmHg to about 250 mmHg, about 130 mmHg to about 300 mmHg, about 130 to about 350 mmHg, about 130 mmHg to about 400 mmHg, about 140 mmHg to about 150 mmHg, about 140 mmHg to about 175 mmHg, about 140 mmHg to about 200 mmHg, about 140 mmHg to about 225 mmHg, about 140 mmHg to about 250 mmHg, about 140 mmHg to about 300 mmHg, about 140 to about 350 mmHg, about 140 mmHg to about 400 mmHg, about 150 mmHg to about 175 mmHg, about 150 mmHg to about 200 mmHg, about 150 mmHg to about 225 mmHg, about 150 mmHg to about 250 mmHg, about 150 mmHg to about 300 mmHg, about 150 to about 350 mmHg, about 150 mmHg to about 400 mmHg, about 175 mmHg to about 200 mmHg, about 175 mmHg to about 225 mmHg, about 175 mmHg to about 250 mmHg, about 175 mmHg to about 300 mmHg, about 175 to about 350 mmHg, about 175 mmHg to about 400 mmHg, about 200 mmHg to about 225 mmHg, about 200 mmHg to about 250 mmHg, about 200 mmHg to about 300 mmHg, about 200 to about 350 mmHg, about 200 mmHg to about 400 mmHg, about 225 mmHg to about 250 mmHg, about 225 mmHg to about 300 mmHg, about 225 to about 350 mmHg, about 225 mmHg to about 400 mmHg, about 275 mmHg to about 300 mmHg, about 275 to about 350 mmHg, about 275 mmHg to about 400 mmHg, about 300 mmHg to about 325 mmHg, about 300 to about 350 mmHg, about 300 mmHg to about 400 mmHg, about 325 mmHg to about 350 mmHg, about 325 to about 375 mmHg, about 325 mmHg to about 400 mmHg, about 350 mmHg to about 375 mmHg, about 350 to about 400 mmHg, or about 375 mmHg to about 400 mmHg.
The positive pressure source can provide a positive pressure from about 0 mmHg to about 400 mmHg (e.g., about 0 mmHg to about 10 mmHg, about 0 mmHg to about 20 mmHg, about 0 mmHg to about 30 mmHg, about 0 mmHg to about 40 mmHg, about 0 mmHg to about 50 mmHg, about 0 mmHg to about 60 mmHg, about 0 mmHg to about 70 mmHg, about 0 mmHg to about 80 mmHg, about 0 mmHg to about 90 mmHg, about 0 to about 100 mmHg, about 0 mmHg to about 110 mmHg, about 0 mmHg to about 120 mmHg, about 0 mmHg to about 130 mmHg, about 0 to about 140 mmHg, about 0 mmHg to about 150 mmHg, about 0 to about 175 mmHg, about 0 mmHg to about 200 mmHg, about 0 mmHg to about 225 mmHg, about 0 mmHg to about 250 mmHg, about 0 mmHg to about 275 mmHg, about 0 mmHg to about 300 mmHg, about 0 to about 350 mmHg, about 0 mmHg to about 400 mmHg, about 10 mmHg to about 20 mmHg, about 10 mmHg to about 30 mmHg, about 10 mmHg to about 40 mmHg, about 10 mmHg to about 50 mmHg, about 10 mmHg to about 60 mmHg, about 10 mmHg to about 70 mmHg, about 10 mmHg to about 80 mmHg, about 10 mmHg to about 90 mmHg, about 10 mmHg to about 100 mmHg, about 10 mmHg to about 110 mmHg, about 10 mmHg to about 120 mmHg, about 10 mmHg to about 130 mmHg, about 10 mmHg to about 140 mmHg, about 10 mmHg to about 150 mmHg, about 10 mmHg to about 175 mmHg, about 10 mmHg to about 200 mmHg, about 10 mmHg to about 225 mmHg, about 10 mmHg to about 250 mmHg, about 10 mmHg to about 300 mmHg, about 10 to about 350 mmHg, about 10 mmHg to about 400 mmHg, about 20 mmHg to about 30 mmHg, about 20 mmHg to about 40 mmHg, about 20 mmHg to about 50 mmHg, about 20 mmHg to about 60 mmHg, about 20 mmHg to about 70 mmHg, about 20 mmHg to about 80 mmHg, about 20 mmHg to about 90 mmHg, about 20 mmHg to about 100 mmHg, about 20 mmHg to about 110 mmHg, about 20 mmHg to about 120 mmHg, about 20 mmHg to about 130 mmHg, about 20 mmHg to about 140 mmHg, about 20 mmHg to about 150 mmHg, about 20 mmHg to about 175 mmHg, about 20 mmHg to about 200 mmHg, about 20 mmHg to about 225 mmHg, about 20 mmHg to about 250 mmHg, about 20 mmHg to about 300 mmHg, about 20 to about 350 mmHg, about 20 mmHg to about 400 mmHg, about 25 mmHg to about 50 mmHg, about 25 mmHg to about 75 mmHg, about 25 mmHg to about 100 mmHg, about 30 mmHg to about 40 mmHg, about 30 mmHg to about 50 mmHg, about 30 mmHg to about 60 mmHg, about 30 mmHg to about 70 mmHg, about 30 mmHg to about 80 mmHg, about 30 mmHg to about 90 mmHg, about 30 mmHg to about 100 mmHg, about 30 mmHg to about 110 mmHg, about 30 mmHg to about 120 mmHg, about 30 mmHg to about 130 mmHg, about 30 mmHg to about 140 mmHg, about 30 mmHg to about 150 mmHg, about 30 mmHg to about 175 mmHg, about 30 mmHg to about 200 mmHg, about 30 mmHg to about 225 mmHg, about 30 mmHg to about 250 mmHg, about 30 mmHg to about 300 mmHg, about 30 to about 350 mmHg, about 30 mmHg to about 400 mmHg, about 40 mmHg to about 50 mmHg, about 40 mmHg to about 60 mmHg, about 40 mmHg to about 70 mmHg, about 40 mmHg to about 80 mmHg, about 40 mmHg to about 90 mmHg, about 40 mmHg to about 100 mmHg, about 40 mmHg to about 110 mmHg, about 40 mmHg to about 120 mmHg, about 40 mmHg to about 130 mmHg, about 40 mmHg to about 140 mmHg, about 40 mmHg to about 150 mmHg, about 40 mmHg to about 175 mmHg, about 40 mmHg to about 200 mmHg, about 40 mmHg to about 225 mmHg, about 40 mmHg to about 250 mmHg, about 40 mmHg to about 300 mmHg, about 40 to about 350 mmHg, about 40 mmHg to about 400 mmHg, about 50 mmHg to about 60 mmHg, about 50 mmHg to about 70 mmHg, about 50 mmHg to about 75 mmHg, about 50 mmHg to about 80 mmHg, about 50 mmHg to about 90 mmHg, about 50 mmHg to about 100 mmHg, about 50 mmHg to about 110 mmHg, about 50 mmHg to about 120 mmHg, about 50 mmHg to about 130 mmHg, about mmHg 50 to about 140 mmHg, about 50 mmHg to about 150 mmHg, about 50 mmHg to about 175 mmHg, about 50 mmHg to about 200 mmHg, about 50 mmHg to about 225 mmHg, about 50 mmHg to about 250 mmHg, about 50 mmHg to about 300 mmHg, about 50 to about 350 mmHg, about 50 mmHg to about 400 mmHg, about 60 mmHg to about 70 mmHg, about 60 mmHg to about 80 mmHg, about 60 mmHg to about 90 mmHg, about 60 mmHg to about 100 mmHg, about 60 mmHg to about 110 mmHg, about 60 mmHg to about 120 mmHg, about 60 mmHg to about 130 mmHg, about 60 mmHg to about 140 mmHg, about 60 mmHg to about 150 mmHg, about 60 mmHg to about 175 mmHg, about 60 mmHg to about 200 mmHg, about 60 mmHg to about 225 mmHg, about 60 mmHg to about 250 mmHg, about 60 mmHg to about 300 mmHg, about 60 to about 350 mmHg, about 60 mmHg to about 400 mmHg, about 70 mmHg to about 80 mmHg, about 70 mmHg to about 90 mmHg, about 70 mmHg to about 100 mmHg, about 70 mmHg to about 110 mmHg, about 70 mmHg to about 120 mmHg, about 70 mmHg to about 130 mmHg, about 70 mmHg to about 140 mmHg, about 70 mmHg to about 150 mmHg, about 70 mmHg to about 175 mmHg, about 70 mmHg to about 200 mmHg, about 70 mmHg to about 225 mmHg, about 70 mmHg to about 250 mmHg, about 70 mmHg to about 300 mmHg, about 70 to about 350 mmHg, about 70 mmHg to about 400 mmHg, about 75 mmHg to about 100 mmHg, about 75 mmHg to about 125 mmHg, about 80 mmHg to about 90 mmHg, about 80 mmHg to about 100 mmHg, about 80 mmHg to about 110 mmHg, about 80 mmHg to about 120 mmHg, about 80 mmHg to about 130 mmHg, about 80 mmHg to about 140 mmHg, about 80 mmHg to about 150 mmHg, about 80 mmHg to about 175 mmHg, about 80 mmHg to about 200 mmHg, about 80 mmHg to about 225 mmHg, about 80 mmHg to about 250 mmHg, about 80 mmHg to about 300 mmHg, about 80 to about 350 mmHg, about 80 mmHg to about 400 mmHg, about 90 mmHg to about 100 mmHg, about 90 mmHg to about 110 mmHg, about 90 mmHg to about 120 mmHg, about 90 mmHg to about 130 mmHg, about 90 mmHg to about 140 mmHg, about 90 mmHg to about 150 mmHg, about 90 mmHg to about 175 mmHg, about 90 mmHg to about 200 mmHg, about 90 mmHg to about 225 mmHg, about 90 mmHg to about 250 mmHg, about 90 mmHg to about 300 mmHg, about 90 to about 350 mmHg, about 90 mmHg to about 400 mmHg, about 100 mmHg to about 110 mmHg, about 100 mmHg to about 120 mmHg, about 100 mmHg to about 130 mmHg, about 100 mmHg to about 140 mmHg, about 100 mmHg to about 150 mmHg, about 100 mmHg to about 175 mmHg, about 100 mmHg to about 200 mmHg, about 100 mmHg to about 225 mmHg, about 100 mmHg to about 250 mmHg, about 100 mmHg to about 300 mmHg, about 100 to about 350 mmHg, about 100 mmHg to about 400 mmHg, about 110 mmHg to about 120 mmHg, about 110 mmHg to about 130 mmHg, about 110 mmHg to about 140 mmHg, about 110 mmHg to about 150 mmHg, about 110 mmHg to about 175 mmHg, about 110 mmHg to about 200 mmHg, about 110 mmHg to about 225 mmHg, about 110 mmHg to about 250 mmHg, about 110 mmHg to about 300 mmHg, about 110 to about 350 mmHg, about 110 mmHg to about 400 mmHg, about 120 mmHg to about 130 mmHg, about 120 mmHg to about 140 mmHg, about 120 mmHg to about 150 mmHg, about 120 mmHg to about 175 mmHg, about 120 mmHg to about 200 mmHg, about 120 mmHg to about 225 mmHg, about 120 mmHg to about 250 mmHg, about 120 mmHg to about 300 mmHg, about 120 to about 350 mmHg, about 120 mmHg to about 400 mmHg, about 130 mmHg to about 140 mmHg, about 130 mmHg to about 150 mmHg, about 130 mmHg to about 175 mmHg, about 130 mmHg to about 200 mmHg, about 130 mmHg to about 225 mmHg, about 130 mmHg to about 250 mmHg, about 130 mmHg to about 300 mmHg, about 130 to about 350 mmHg, about 130 mmHg to about 400 mmHg, about 140 mmHg to about 150 mmHg, about 140 mmHg to about 175 mmHg, about 140 mmHg to about 200 mmHg, about 140 mmHg to about 225 mmHg, about 140 mmHg to about 250 mmHg, about 140 mmHg to about 300 mmHg, about 140 to about 350 mmHg, about 140 mmHg to about 400 mmHg, about 150 mmHg to about 175 mmHg, about 150 mmHg to about 200 mmHg, about 150 mmHg to about 225 mmHg, about 150 mmHg to about 250 mmHg, about 150 mmHg to about 300 mmHg, about 150 to about 350 mmHg, about 150 mmHg to about 400 mmHg, about 175 mmHg to about 200 mmHg, about 175 mmHg to about 225 mmHg, about 175 mmHg to about 250 mmHg, about 175 mmHg to about 300 mmHg, about 175 to about 350 mmHg, about 175 mmHg to about 400 mmHg, about 200 mmHg to about 225 mmHg, about 200 mmHg to about 250 mmHg, about 200 mmHg to about 300 mmHg, about 200 to about 350 mmHg, about 200 mmHg to about 400 mmHg, about 225 mmHg to about 250 mmHg, about 225 mmHg to about 300 mmHg, about 225 to about 350 mmHg, about 225 mmHg to about 400 mmHg, about 275 mmHg to about 300 mmHg, about 275 to about 350 mmHg, about 275 mmHg to about 400 mmHg, about 300 mmHg to about 325 mmHg, about 300 to about 350 mmHg, about 300 mmHg to about 400 mmHg, about 325 mmHg to about 350 mmHg, about 325 to about 375 mmHg, about 325 mmHg to about 400 mmHg, about 350 mmHg to about 375 mmHg, about 350 to about 400 mmHg, or about 375 mmHg to about 400 mmHg.
In some embodiments, pressure applied to the breast cup 2 may change, e.g., from about every 0.1 seconds to about every 120 seconds (e.g., about every 0.1 seconds to about every 1 second, about every 0.1 seconds to about every 2 seconds, about every 0.1 seconds to about every 3 seconds, about every 0.1 seconds to about every 4 seconds, about every 0.1 seconds to about every 5 seconds, about every 0.1 seconds to about every 6 seconds, about every 0.1 seconds to about every 7 seconds, about every 0.1 seconds to about every 8 seconds, about every 0.1 seconds to about every 9 seconds, about every 0.1 seconds to about every 10 seconds, about every 0.1 seconds to about every 11 seconds, about every 0.1 seconds to about every 12 seconds, about every 0.1 seconds to about every 13 seconds, about every 0.1 seconds to about every 14 seconds, about every 0.1 seconds to about every 15 seconds, about every 0.1 seconds to about every 20 seconds, about every 0.1 seconds to about every 30 seconds, about every 0.1 seconds to about every 45 seconds, about every 0.1 seconds to about every 60 seconds, about every 0.1 seconds to about every 90 seconds, about every 1 second to about every 2 seconds, about every 1 second to about every 3 seconds, about every 1 second to about every 4 seconds, about every 1 second to about every 5 seconds, about every 1 second to about every 6 seconds, about every 1 second to about every 7 seconds, about every 1 second to about every 8 seconds, about every 1 second to about every 9 seconds, about every 1 second to about every 10 seconds, about every 2 second to about every 5 seconds, about every 3 second to about every 7 seconds, about every 4 second to about every 5 seconds, about every 5 second to about every 10 seconds, about every 10 second to about every 15 seconds, about every 15 second to about every 30 seconds, about every 0.1 seconds, about every 0.2 seconds, about every 0.3 seconds, about every 0.4 seconds, about every 0.5 seconds, about every 0.6 seconds, about every 0.7 seconds, about every 0.8 seconds, about every 0.9 seconds, about every 1 second, about every 1.5 seconds, about every 2 seconds, about every 3 seconds, about every 4 seconds, about every 5 seconds, about every 6 seconds, about every 7 seconds, about every 8 seconds, about every 9 seconds, about every 10 seconds, about every 11 seconds, about every 12 seconds, about every 13 seconds, about every 14 seconds, about every 15 seconds, about every 20 seconds, about every 30 seconds, about every 45 seconds, about every 60 seconds, about every 75 seconds, about every 90 seconds, about every 105 seconds, or about every 120 seconds). In some embodiments, pressure applied to the breast cup 2 changes gradually. In some embodiments, pressure applied to the breast cup 2 changes at different rates, e.g., in a first cycle the pressure applied to the breast cup 2 changes over about 0.1 seconds to about 120 seconds (e.g., about 1 second), and in a second cycle the pressure applied to the breast cup 2 changes over about 0.1 seconds to about 120 seconds (e.g., about 5 seconds).
Pressure within the breast cup 2 can provide a pulsating or massaging sensation. In some embodiments, the speed and pressure of the pulsation or massage may be selected by the user. In some embodiments, alternating pressure mimics the action of suckling.
In the present disclosure, the pressure source 9 is disposed in the breast cup 2. The housing may cover the pressure source and the connection between the pressure source and the pressure chamber. Alternatively, the pressure source may be attached to the exterior of the housing or breast cup, e.g., with the housing mating around the exterior of the pressure source. The pressure source 9 may integrate seamlessly with another component of the breast cup 2, e.g., the breast cup upper housing 17, such that when fit together, the breast cup 2 as a whole presents an overall minimal and/or unobtrusive profile and/or natural shape, e.g., breast shaped. A breast cup 2 with an unobtrusive profile may minimize visibility of the device while in use under a garment. The pressure source 9 may be releasably or non- releasably attached to another component of the breast cup 2. The pressure source 9 may be attached in any suitable manner, e.g., a connector, snap-fit, recess and groove, fastener, or magnet.
In addition to the pressure source 9, the breast cup 2 may include various components, including a control valve 10, a drive unit 11, and/or a power source 12. In some embodiments, the pressure source 9 is electrically connected to various components including a control valve 10, a drive unit 11, and/or a power source 12. In this embodiment, the control valve 10, drive unit 11, and/or power source 12 may be included in the breast cup 2 or external to the breast cup 2.
In some embodiments, the present disclosure may include a first breast cup and a second breast cup. In some embodiments, the first breast cup may include a first pressure source 9. In some embodiments, the second breast cup may include a second pressure source 9. In some embodiments, the first breast cup and the second breast cup may be fluidically connected such that one pressure source 9 may provide positive and/or negative pressure to both the first breast cup and the second breast cup. In some embodiments, the first breast cup may include a pressure source 9, and/or the second breast cup may include various components including a control valve 10, a drive unit 11, and/or a power source 12. The first breast cup and the second breast cup may be fluidically and electrically connected such that components in the first breast cup may affect both the first breast cup and the second breast cup, and/or components in the second breast cup may affect both the second breast cup and the first breast cup, e.g., a power source in the second breast cup may provide power to both breast cups.
Breast cup architecture
Any breast cup that allows for milk collection external to the cup, e.g., in a reservoir connected to the cup via a fluid conduit, may be employed. The breast cup may include a pressure source 9, a housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), a breast shield 19, and a diaphragm 18 disposed between the upper housing 17 and the breast shield 19 (and also between the upper housing 17 and/or the lower housing or milk chamber wall 26), such that the diaphragm 18 separates a pressure chamber 20 from a milk chamber 21. An exemplary breast cup 2 is shown in FIG. 2 without the integrated pressure source. In some embodiments, the breast cup 2 includes a milk chamber wall 26, e.g., as shown in FIG. 7. The milk chamber wall 26 can be disposed between the diaphragm 18 and the breast shield 19, thereby defining the milk chamber 21 between the diaphragm 18 and the milk chamber wall 26. Pressurization and/or depressurization of the pressure chamber 20 deforms the diaphragm 18, and thereby expands or compresses the milk chamber 21. The pressure chamber is not fluidically connected to the milk chamber or breast shield. In some embodiments, the pressure chamber is not in fluidic communication with the milk chamber or breast shield.
One or more of the components of the breast cup 2, including the upper housing 17, the diaphragm 18, the breast shield 19, and/or the milk chamber wall 26 may be removably attached to the breast cup 2. In some embodiments, the pressure chamber 20 and/or the milk chamber 21 are distinct reservoirs, as opposed to chambers formed from the space between other components (e.g., the upper housing 17, the diaphragm 18, the milk chamber wall 26, and/or the breast shield 19, and may be reversibly attached to the breast cup 2). For example, the milk chamber 21 may be removed from the breast cup 2 to be cleaned or replaced.
In some embodiments, at least one of the upper housing 17, the diaphragm 18, the breast shield 19, and/or the milk chamber wall 26 can include a protrusion and/or a recess, such as a groove. In some embodiments, a protrusion on at least one of the upper housing 17, the diaphragm 18, the breast shield 19, and/or the milk chamber wall 26 is configured to mate with a recess, such as a groove, on at least one of the upper housing 17, the diaphragm 18, the breast shield 19, and/or the milk chamber wall 26. Mating between a protrusion and a recess, e.g., groove, allows two components to be snapped, slid, or friction-fit together. FIG. 7 shows an embodiment of the breast cup 2, in which the upper housing 17, the diaphragm 18, the breast shield 19, and/or the milk chamber wall 26 are attached together at least partially using protrusions and recesses, e.g., grooves.
Alternatively, or in addition, at least one of the upper housing 17, the diaphragm 18, the breast shield 19, and/or the milk chamber wall 26 can be attached together using any other suitable connector, e.g., an adhesive (e.g., glue) or a fastener (e.g., a screw). FIGS. 9A- 9D show an embodiment of the breast cup 2, in which the upper housing 17, the diaphragm 18, the breast shield 19, and/or the milk chamber wall 26 are attached together at least partially using a fastener.
The breast cup 2, e.g., via the breast shield 19, contacts the breast of the user and can provide a seal during breast pumping, such that milk does not leak. The breast cup 2, the breast shield 19, and/or the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) are configured to conform to the breast comfortably for frequent and/or long periods of wear, such that the breast is not irritated. For example, the interior of the breast cup 2, e.g., the breast shield 19, may conform to the breast and/or the nipple of the user.
The breast cup 2, the breast shield 19, and/or the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) may be in a shape for improved conformance to the breast, e.g., a funnel, a cone, or a dome. The exterior of the breast cup 2 may be rounded. A rounded breast cup 2 may appear breast-like, e.g., to be worn discreetly under clothing. The breast cup 2, the breast shield 19, and/or the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) may be toroidal, e.g., forming a ring, with the breast cup 2, the breast shield 19, and/or the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) covering the breast.
In some embodiments, the breast cup 2 is funneled. The breast cup 2 may include a wide portion 8 and a nipple tunnel 13, e.g., as shown in FIG. 2, in which the wide portion 8, e.g., of the breast cup 2, initially contacts the breast, and the nipple tunnel 13, e.g., of the breast cup 2, is configured to receive the nipple.
The wide portion 8 of the breast cup 2 may have a largest diameter from about 50 mm to about 250 mm (e.g., about 50 mm to about 75 mm, about 50 mm to about 100 mm, about 50 mm to about 125 mm, about 50 mm to about 150 mm, about 50 mm to about 75 mm, about 75 mm to about 100 mm, about 75 mm to about 125 mm, about 75 mm to about 150 mm, about 75 mm to about 175 mm, about 75 mm to about 200 mm, about 100 mm to about 125 mm, about 100 mm to about 150 mm, about 100 mm to about 175 mm, about 100 mm to about 200 mm, about 125 mm to about 150 mm, about 125 mm to about 175 mm, about 125 mm to about 200 mm, about 150 mm to about 175 mm, about 150 mm to about 200 mm, about 150 mm to about 250 mm, or about 200 mm to about 250 mm). The nipple tunnel 13 of the breast cup 2 may have a largest diameter greater than 25 mm (e.g., greater than 50 mm, 75 mm, 100 mm, 125 mm, 150 mm, 175 mm, 200 mm, 225 mm, or 250 mm).
The breast cup 2, the breast shield 19, and/or the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) may include a gel such that it allows better conformance to the breast. In some embodiments, the breast cup 2 conforms to the breast and supports the weight of the breast cup 2 and fluid conduits extending from the breast cup 2 without additional adhesives, gels, straps, or bras. In some embodiments, the breast cup 2 secures to a garment, such as a bra or shirt.
The breast cup 2, the breast shield 19, and/or the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) may include a food contact substance. Additionally, or alternatively, the breast cup 2, the breast shield 19, and/or the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) may include an infant grade material. The breast cup 2, the breast shield 19, and/or the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) may include a flexible material, e.g., formed from a polymeric material such as silicone. The breast cup 2, the breast shield 19, and/or the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) may include a rigid material. The breast cup 2, the breast shield 19, and/or the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) may include PET, PVC, PTFE, polyethylene, HDPE, LDPE, copolyester (e.g., Tritan EX401), PP, polystyrene, a thermoplastic elastomer, thermoplastic polyurethane, PC, nylon, PVDF, or silicone. In some embodiments, breast cup 2, the breast shield 19, and/or the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) can include a fabric (e.g., polyester, cotton, linen, satin, organdy, rayon, taffeta, broad cloth, poplin, velour, gauze, canvas, shirting, muslin, tweed, georgette, crepe, wool, twill, gabardine, denim, or drill).
In some embodiments, the breast cup 2 may have a first fluidic conduit providing fluidic communication between the breast cup 2 and a reservoir 3 or manifold 29. In some embodiments the first fluidic conduit is releasably connected to the breast cup 2 via a first outlet on the breast cup 2, e.g., from the milk chamber. In some embodiments, the second fluidic conduit is releasably connected to the breast cup 2 via an inlet to the breast cup 2, e.g., in the pressure chamber. In some embodiments, the first fluidic conduit is releasably connected to the breast cup 2 via a connector.
In some embodiments, the breast cup 2 allows for the extension of the nipple when negative pressure is supplied, e.g., by negative pressure from pressure source 9 e.g., at a first pressure, in order to express milk. When positive pressure is supplied by a control valve 10 and/or a positive pressure from a pressure source, e.g., at a second pressure, the nipple contracts, and reduces or stops milk flow until a higher negative pressure is supplied.
In some embodiments, the interior of the breast cup 2, e.g., the interior of the breast shield 19, includes an open area, e.g., the nipple tunnel 13, dimensioned to allow for clearance and space in front of the nipple to permit milk to exit the nipple even when the nipple is pulled forward by suction.
In some embodiments, the breast pump system 1 includes two breast cups 2, e.g., one for each breast. In embodiments in which the breast pump system includes two breast cups 2, the two breast cups 2 can each include a housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), a breast shield 19, and a diaphragm 18. A user can use both of the breast cups 2 at the same time, or just one of the two at any given time.
One or more components of the breast cup may be clear to allow for visualization of the nipple, e.g., for alignment, during placement. The breast cup may also include an opaque cover or flat to make the nipple not visible after placement of the breast cup. The breast cup may also include a lens to magnify the nipple to aid in alignment.
Breast Shield
The breast cup 2 can include a breast shield 19, e.g., as shown in FIGS. 9A-9D. The breast shield 19 contacts the breast of the user and can provide an airtight seal during breast pumping, such that milk does not leak from the breast cup 2. The breast shield 19 is configured to conform to the breast comfortably for frequent and/or long periods of wear, such that the breast is not irritated. The breast shield 19 can include a wide portion and a nipple tunnel, in which the wide portion initially contacts the breast, and the nipple tunnel is configured to receive the nipple. For example, the breast shield 19 can conform to the breast and provide space for the nipple, e.g., in the nipple tunnel.
In some embodiments, the nipple tunnel has a length from about 5 mm to about 75 mm (e.g., about 5 mm to about 10 mm, about 5 mm to about 20 mm, about 5 mm to about 30 mm, about 5 mm to about 40 mm, about 5 mm to about 50 mm, about 10 mm to about 20 mm, about 10 mm to about 30 mm, about 10 mm to about 40 mm, about 10 mm to about 50 mm, about 10 mm to about 60 mm, about 10 mm to about 70 mm, about 25 mm to about 50 mm, about 25 mm to about 75 mm, about 50 mm to about 75 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, 35 mm, about 40 mm, about 45 mm, about 50 mm, about 55 mm, about 60 mm, about 65 mm, about 70 mm, or about 75 mm).
In some embodiments, the nipple tunnel has a minimum diameter from about 10 mm to about 130 mm (e.g., about 10 mm to about 20 mm, about 10 mm to about 30 mm, about 10 mm to about 40 mm, about 10 mm to about 50 mm, about 10 mm to about 60 mm, about 10 mm to about 70 mm, about 10 mm to about 100 mm, about 25 mm to about 50 mm, about 25 mm to about 75 mm, about 30 mm to about 130 mm, about 50 mm to about 75 mm, about 50 mm to about 130 mm, about 70 mm to about 130 mm, about 100 mm to about 130 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, 35 mm, about 40 mm, about 45 mm, about 50 mm, about 55 mm, about 60 mm, about 65 mm, about 70 mm, about 75 mm, about 80 mm, about 90 mm, about 100 mm, about 110 mm, about 120 mm, about 125 mm, or about 130 mm). In some embodiments, the diameter of the nipple tunnel is between about 20 and about 40 mm.
In some embodiments, the nipple tunnel has a maximum diameter from about 10 mm to about 130 mm (e.g., about 10 mm to about 20 mm, about 10 mm to about 30 mm, about 10 mm to about 40 mm, about 10 mm to about 50 mm, about 10 mm to about 60 mm, about 10 mm to about 70 mm, about 10 mm to about 100 mm, about 25 mm to about 50 mm, about 30 mm to about 130 mm, about 25 mm to about 75 mm, from about 50 mm to about 75 mm, about 50 mm to about 130 mm, about 70 mm to about 130 mm, about 100 mm to about 130 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, 35 mm, about 40 mm, about 45 mm, about 50 mm, about 55 mm, about 60 mm, about 65 mm, about 70 mm, about 75 mm, about 80 mm, about 90 mm, about 100 mm, about 110 mm, about 120 mm, about 125 mm, or about 130 mm). In some embodiments, the diameter of the nipple tunnel is between about 11 and 30 mm.
The breast shield 19 can be in a shape for improved conformance to the breast, e.g., a funnel, a cone, or a dome. The breast shield 19 can be rounded or toroidal, e.g., forming a ring.
The breast shield 19 can include an inlet to the milk chamber 21, such that milk may enter the milk chamber 21 once expressed from the nipple. In some embodiments, the diaphragm 18 releasably contacts the inlet, e.g., at a sealing point 23, providing a seal when negative pressure is not applied to the pressure chamber. Thus, in some embodiments, the diaphragm 18 releasably seals the inlet. The releasable sealing of the inlet to the milk chamber 21 is shown in FIG. 4.
In some embodiments, the inlet includes a valve, e.g., an umbrella valve 24, e.g., as shown in FIG. 5, or a non-drip valve. In some embodiments, the valve is a mechanical valve, an umbrella valve 24, a butterfly valve, a disk valve, or a duckbill valve.
In some embodiments, the inlet includes at least one orifice 25, e.g., as shown in FIG. 6. In some embodiments, the inlet includes a plurality of orifices 25. In some embodiments, the plurality of orifices 25 is circumferentially arranged at the nipple tunnel of the breast shield 19, e.g., as shown in FIG. 6. In some embodiments, the diaphragm 18 releasably contacts at least one of the orifices 25, e.g., at sealing point 23, providing a seal when negative pressure is not applied to the pressure chamber 20. In some embodiments, the diaphragm 18 contacts the plurality of orifices 25. Thus, in some embodiments, the diaphragm 18 releasably seals at least one orifice, e.g., at sealing point 23. In some embodiments, the diaphragm 18 seals the plurality of orifices 25, e.g., at sealing point 23. In some embodiments, the diaphragm 18 releasably contacts the breast shield 19 at a point as to separate the at least one orifice 25 from the milk chamber 21.
In some embodiments, the orifice 25 can have a diameter from about 0.5 mm to about 10 mm (e.g., about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 0.5 mm to about 2 mm, about 0.5 mm to about 5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 1 mm to about 6 mm, about 1 mm to about 7 mm, about 1 mm to about 8 mm, about 1 mm to about 9 mm, about 1 mm to about 10 mm, about 3 mm to about 7 mm, about 5 mm to about 10 mm, about 8 mm to about 10 mm, about 1mm, about 2mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, or about 10 mm). In some embodiments, the diaphragm 18 is not configured to contact the inlet, e.g., at sealing point 23. In some embodiments, the breast cup 2, e.g., the breast shield 19 includes a fitting which may seal the inlet from the milk chamber 21. In some embodiments, the fitting is a plug or a cover.
The wide portion of the breast shield 19 can seal to the breast, while the nipple tunnel provides room for the nipple to be expanded to express milk. In some embodiments, the wide portion of the breast shield 19 seals to the breast, e.g., around the base of nipple. In some embodiments, the breast shield 19 is sealed to the breast before a breast pumping session commences.
In some embodiments, a positive or negative pressure may be applied to the breast cup 2 prior to a breast pumping session to contract the breast shield 19, e.g., the wide portion of the breast shield 19, such that the breast shield 19 may be sealed to the breast. Following a breast pumping session, a positive or negative pressure may be applied to the breast cup 2 such that the breast cup 2, e.g., the wide portion of the breast shield 19, may be unsealed from the breast. In some embodiments, the edge of the wide portion of the breast shield 19 solely contacts the breast before application of negative pressure. Following application of negative pressure to the breast cup 2, substantially all of the wide portion of the breast shield 19 may contact the breast.
Negative pressure can be applied to the breast cup 2 for sealing of the breast cup 2 to the breast from the pressure source 9, or from force applied manually from the user to the breast cup 2, e.g., to the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26). For example, the user may push on the breast cup 2, e.g., the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), to provide negative pressure to the breast shield 19 and seal the breast cup 2 to the breast. Positive pressure can be applied to the breast cup 2 to unseal the breast cup 2 from the breast from a pressure source, from a valve to the ambient atmosphere, from a slow leak, or from force manually applied from the user to the breast cup 2. For example, a user may pull on the breast cup 2, e.g., the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), to provide positive pressure to the breast shield 19 and unseal the breast cup 2 from the breast. In some embodiments, the breast cup 2 includes an air pocket, to which negative or positive pressure can be applied to seal or unseal the breast cup 2 to the breast.
The inside of the breast shield 19 can include at least one protrusion 27 to improve sealing of the breast shield 19 to the breast. FIG. 8 A and FIG. 8B show embodiments of the breast shield 19 having protrusions 27. In some embodiments, the protrusion 27 is a toroidal ridge, see, e.g., FIG. 8A. In some embodiments, the protrusion 27 is a curved toroidal ridge, see, e.g., FIG. 8B. In some embodiments, the outer surface of the breast shield 19 includes an indent to form the protrusion 27 on the inner surface of the breast shield 19, see, e.g., FIG. 8A.
Sealing of the breast shield 19 to the breast may keep milk from leaking around the breast and improve security of the breast shield 19 to the breast during breast pumping. Unsealing of the breast shield 19 from the breast when a breast pumping session is not ongoing, e.g., to allow air flow, may improve comfort, reduce skin temperature, and reduce sweat build-up. Furthermore, expansion and contraction of breast shield 19 allows for the breast shield 19 to fit breasts of a plurality of sizes, e.g., AA cup, A cup, B cup, C cup, D cup, DD cup, DDD cup, E cup, F cup, etc.
The ability to expand and contract the nipple tunnel of the breast shield 19, mechanically or using pressure, may be advantageous in setting up the breast cup 2 for breast pumping. In some embodiments, the internal diameter of the nipple tunnel of breast shield 19 is reduced slowly while moving the breast shield 19 into position, such that the user may be able to center the breast shield 19 on their nipple via touch and feel without the need for line of sight. In some embodiments, the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) and diaphragm 18 may be or may include a clear material, such that the user may additionally use line of sight to center the breast shield 19 on their nipple.
In some embodiments, the breast shield 19 and/or the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) include ridges, bumps, and/or dimples. In some embodiments, an internal surface of the breast shield 19 and/or the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) include ridges, bumps, or dimples. Ridges, bumps, and/or dimples may aid in aligning the breast cup 2 to the breast, adherence of the breast cup 2 to skin, reduction of heat build-up, and may provide further comfort when a user is wearing the breast cup. In some embodiments, the ridges, bumps, and/or dimples include foam.
In some embodiments, the ridge includes a straight ridge, a curved ridge, a zig-zag ridge, an undulating ridge, a spiral ridge, a continuous ridge, or a broken ridge. The breast shield 19 can include a plurality of ridges. In some embodiments, the ridges are from about 1 mm to about 100 mm apart (e.g., about 1 mm to about 2 mm, about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 1 mm to about 25 mm, about 1 mm to about 50 mm, about 5 mm to about 10 mm, about 10 mm to about 25 mm, about 10 mm to about 50 mm, about 25 mm to about 75 mm, about 50 mm to about 100 mm, about 1 mm, about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 40 mm, about 50 mm, about 60 mm, about 70 mm, about 75 mm, about 80 mm, about 90 mm, or about 100 mm).
Air may flow between the ridges, bumps, and/or dimples where the surface of the breast shield 19 does not contact the breast. In some embodiments, the ridges, bumps, and/or dimples extend from an edge of the breast shield 19 to an inner point of the inner surface of the breast shield 19. In this regard, the ridges, bumps, and/or dimples may form an air passage from the ambient atmosphere to the inner surface of the breast shield 19. Thus, in some embodiments, the breast shield 19 includes a fluid conduit, wherein the fluid conduit may be defined by the (i) ridges, bumps, and/dimples, (ii) the skin of the breast, and (iii) the inner surface of the breast shield 19. The fluid conduit may create a chimney effect resulting in the advantage of improved air circulation in the breast shield 19.
Alternatively, or additionally, the breast cup 2 may be manually pressed in order to expel air from the breast shield 19. Following release of the breast cup 2, fresh air may flow back into the breast shield 19. In some embodiments, this method of circulating air in the breast shield 19 may be accomplished before or following a breast pumping session. For example, a spiral ridge on the inner surface of the breast shield 19 may form a fluid conduit with the skin of the breast. When the breast cup 2 is pressed, air inside the breast shield 19 may be transported around the spiral to the ambient atmosphere. When the pressure is removed from the breast cup 2, fresh air may be transported around the spiral back into the breast shield 19.
Ridges, bumps, and/or dimples may also reduce the peeling effect when removing the breast cup 2. A reduction in peeling effect can improve comfort, especially for those users with sensitive skin.
The breast shield 19 may include a material which becomes soft by heating and further conforms to the geometry of the body. The breast shield 19 can include one or more formable chambers, which aid in conforming the breast shield 19 to the breast of the user. In some embodiments, the formable chambers include a fluid, e.g., a gas or liquid. In some embodiments, the breast shield 19 includes flexible, gel-like materials such as cross-linked silicone. In some embodiments, the breast shield 19 includes one or more thixotropic fluids.
In some embodiments, breast shield 19 includes a material which may store heat for improved comfort. In some embodiments, the breast shield 19 includes a material which may expel heat into the ambient environment. In some embodiments, the breast shield 19 includes regions of material which may store heat, and regions of material which may expel heat. In some embodiments, the regions of material which may expel heat include regions having ridges, bumps, and/or dimples.
The breast shield 19 can include a food contact substance. Alternatively, or additionally, the breast shield 19 can include an infant grade material. The breast shield 19 can include polyvinyl chloride (PVC), polyethylene, PP, polystyrene, a thermoplastic elastomer, thermoplastic polyurethane, PC, nylon, polyvinylidene fluoride (PVDF), or silicone. The breast shield 19 can include a flexible material, e.g., formed from a polymeric material such as silicone. In some embodiments, the breast shield may be substantially free of Bisphenol A (BP A) and/or polyfluoroalkyl substances (PF AS). In some embodiments, the breast shield, may be manufactured absent of any intentionally added BPA and/or PFAS. The breast shield 19 can include a rigid material. In some embodiments, the breast shield 19 includes a water-resistant or a sweat-resistant material.
In some embodiments, two human breasts are contacted with two breast shields 19 to pump milk from both breasts.
Housing
The breast cup 2 may include a housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26). The housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) may be disposed on the exterior of breast cup 2, e.g., around the breast cup 2, e.g., be outward facing. The upper housing 17 may form a portion of the outer surface of the pressure chamber 20 or be a separate component.
In some embodiments, the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) may be disposed around the wide portion 8 of the breast shield 19, e.g., the first point of contact with the breast. The lower housing 26 may conform to the breast. The lower housing 26 may include a gel such that it conforms to the breast. In some embodiments, the lower housing 26 conforms to the breast and supports the weight of the breast cup 2, the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), and fluid conduits 5 extending from the breast cup 2 without additional adhesives, gels, straps, or bras. In some embodiments, the lower housing 26 does not conform to the breast. The housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) may secure to a garment, such as a bra or shirt.
In some embodiments, the housing may interact with the pressure source 9. In this embodiment, the pressure source 9 may be releasably attached to the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26). The pressure source 9 may further attach at any point to the outer or inner surface of the housing.
The housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) may serve a plurality of additional purposes including improved conformance of the breast cup 2 to the breast, improved comfort of the breast cup 2, attachment of the pressure source 9, releasable attachment of the breast cup 2 to a garment, and/or blocking the breast from view while using the breast cup 2.
The housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) can include a food contact substance. In some embodiments, the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) can include a flexible material, e.g., formed from a polymeric material such as silicone. In some embodiments, the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) can include a rigid material. In some embodiments, the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) can include a fabric (e.g., polyester, cotton, linen, satin, organdy, rayon, taffeta, broad cloth, poplin, velour, gauze, canvas, shirting, muslin, tweed, georgette, crepe, wool, twill, gabardine, denim, or drill). The housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) can include polyvinyl chloride (PVC), PTFE (e.g., Teflon), polyethylene, HDPE, LDPE, copolyester (e.g., Tritan EX401), PP, polystyrene, a thermoplastic elastomer, thermoplastic polyurethane, PC, nylon, poly vinylidene fluoride (PVDF), or silicone. In some embodiments, the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) can include a clear material.
Diaphragm
The breast cup 2 may include a diaphragm 18. The diaphragm 18 may separate the pressure chamber 20 from the milk chamber 21.
The diaphragm 18 is configured to deform, i.e., expand, contract, or balloon, under pressure. Upon application of negative pressure to the pressure chamber 20, the diaphragm 18 may deform away from the inlet to the milk chamber 21, opening the inlet to the milk chamber 21. The breast cup 2 including the diaphragm 18 is advantageous in that the configuration may aid in providing fluid flow under pressure, as opposed to exclusively relying on gravity, such that a subject may breast pump in a reclined position.
In some embodiments, the diaphragm 18 includes a flexible material that may stretch upon depressurization and pressurization of the pressure chamber. Alternatively, the diaphragm 18 includes a folded, or otherwise shaped, material, which may unfold and refold upon depressurization and pressurization of pressure chamber 20. In some embodiments, the diaphragm 18 includes from 1 to 10 folds (e.g., 1 to 2, 1 to 3, 1 to 4, 1 to 5, 1 to 6, 1 to 7, 1 to 8, 1 to 9, 2 to 3, 2 to 4, 2 to 5, 2 to 6, 2 to 8, 3 to 4, 3 to 5, 3 to 7, 4 to 5, 4 to 6, 4 to 10, 5 to 8, 5 to 10, 8 to 10, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10). In some embodiments, the folded, or otherwise shaped, material is toroidal. In some embodiments, the folded, or otherwise shaped, material may unfold in either direction. In other embodiments, the folded, or otherwise shaped, material may unfold only towards the pressure chamber 20 or milk chamber 21. Flexible and/or folded diaphragms are advantageous in that they allow for expansion with smaller footprints.
In some embodiments, the diaphragm 18 includes a patterned material, such as including a plurality of indents or grooves. A diaphragm including a patterned material may be advantageous in optimizing interaction with the pressure chamber 20 and/or the milk chamber 21. In some embodiments, a first portion of the diaphragm 18 includes a plurality of indents and/or grooves. In some embodiments, the first portion of the diaphragm 18, which includes the plurality of indents and/or grooves, can deform more than a second portion of the diaphragm 18 which does not include a plurality of indents and/or grooves.
In some embodiments, the diaphragm 18 includes a material having a Shore hardness from A10 to A80 (e.g., A10, A20, A30, A40, A50, A60, A70, or A80). In some embodiments, the diaphragm 18 includes a material having a Shore hardness from D10 to D80 (e.g., D10, D20, D30, D40, D50, D60, D70, or D80).
In some embodiments, the diaphragm 18 includes a thickness from about 0.5 mm to about 10 mm (e.g., about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 0.5 mm to about 2 mm, about 0.5 mm to about 2.5 mm, about 0.5 mm to about 5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 1 mm to about 6 mm, about 1 mm to about 7 mm, about 1 mm to about 8 mm, about 1 mm to about 9 mm, about 5 mm to about 10 mm, about 0.5 mm, about 1mm, about 1.5 mm, about 2mm, about 2.5 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, or about 10 mm). The diaphragm may have a non-uniform thickness, e.g., with a thicker portion to seal an inlet or at the edge to seal to other components.
In some embodiments, the diaphragm 18 is configured to seal the inlet to the milk chamber 21 at sealing point 23. Sealing between the diaphragm 18 and the inlet may be improved through optimization of the Shore hardness, rigidity, thickness, material, surface conditions, and shape of the diaphragm 18.
In some embodiments, the diaphragm 18 varies in thickness and/or Shore hardness. The diaphragm 18 may include a higher thickness and/or higher Shore hardness in the portion of the diaphragm 18 which overlaps with the inlet of the milk chamber 21, e.g., at sealing point 23. In some embodiments, the diaphragm 18 includes a first thickness from about 0.5 mm to about 10 mm (e.g., about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 0.5 mm to about 2 mm, about 0.5 mm to about 2.5 mm, about 0.5 mm to about 5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 1 mm to about 6 mm, about 1 mm to about 7 mm, about 1 mm to about 8 mm, about 1 mm to about 9 mm, about 1 mm to about 10 mm, about 1 mm to about
12 mm, about 1 mm to about 15 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 5 mm to about 20 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 20 mm, about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm), and a second thickness from about 0.5 mm to about 10 mm (e.g., about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 0.5 mm to about 2 mm, about 0.5 mm to about 2.5 mm, about 0.5 mm to about 5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about
1 mm to about 4 mm, about 1 mm to about 5 mm, about 1 mm to about 6 mm, about 1 mm to about 7 mm, about 1 mm to about 8 mm, about 1 mm to about 9 mm, about 1 mm to about 10 mm, about 1 mm to about 12 mm, about 1 mm to about 15 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 5 mm to about 20 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 20 mm, about 0.5 mm, about 1mm, about 1.5 mm, about 2mm, about 2.5 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about
13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm), in which diaphragm 18 includes the second thickness where diaphragm 18 contacts the inlet, e.g., at sealing point 23. In some embodiments, the diaphragm 18 includes a material having a first Shore hardness from A10 to A80 (e.g., A10, A20, A30, A40, A50, A60, A70, or A80) and a second Shore hardness, different from the first, from A10 to A80 (e.g., A10, A20, A30, A40, A50, A60, A70, or A80) or being rigid, in which the material includes the second Shore hardness where diaphragm 18 contacts the inlet, e.g., at sealing point 23. In this embodiment, the second Shore hardness may further range from DIO to D80 (e.g., DIO, D20, D30, D40, D50, D60, D70, or D80) or be rigid.
In some embodiments, the diaphragm 18 includes a curved shape, such that the surface of the diaphragm 18 curves over and around the inlet to the milk chamber 21. In some embodiments, the diaphragm 18 includes a parabolic shape on the side of the diaphragm that contacts the inlet. In some embodiments, the diaphragm 18 may have a cup or cone shape.
In some embodiments, the diaphragm 18 includes a plurality of layers, e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10. In some embodiments, the diaphragm 18 includes a plurality of layers in which the diaphragm 18 contacts the inlet, e.g., at sealing point 23. In some embodiments, a second layer is over molded over a first layer of the diaphragm 18. The first layer and/or second layer may be a flexible or rigid material. In some embodiments, the first layer is a rigid material, and the second layer is a flexible material. This embodiment may be advantageous in sealing the inlet, such that the rigid material maintains coverage of the entire inlet, while the flexible material aids in sealing the sealing point 23. The first layer may be a disk and/or may include a ring or lip to aid in sealing. Alternatively, the first layer may be a cup or cone shaped layer over molded or embedded into the diaphragm 18. In some embodiments, the cup or cone shaped layer is configured to cap the inlet to the milk chamber 21, e.g., at sealing point 23. A plurality of layers may aid decreasing deflection and improving sealing performance at the point where the diaphragm 18 contacts the inlet of the milk chamber, e.g., at sealing point 23. In some embodiments, all or a portion of the diaphragm may be clear. In some embodiments, a clear portion may be configured to seal the inlet to the milk chamber 21, e.g., at the sealing point, and may provide a visual line of sight from the outside of the diaphragm 18 to the nipple tunnel 13. In this embodiment, the clear portion may contain a lens, wherein the lens allows for magnification. A visual line of sight to the nipple chamber may aid the user in centering the breast shield 19 on the nipple during a pumping session.
In some embodiments, the diaphragm 18 is shaped to conform to the shape of the breast shield 19, e.g., upon compression of the milk chamber 21. In some embodiments, the diaphragm 18 is not configured to contact the inlet, e.g., at sealing point 23. In some embodiments, the fitting is a plug or a cover. In some embodiments, the diaphragm 18 is configured to actuate a valve 24.
The diaphragm 18 can include a food contact substance. The diaphragm 18 can include polyvinyl chloride (PVC), polyethylene, PP, polystyrene, a thermoplastic elastomer, thermoplastic polyurethane, PC, nylon, polyvinylidene fluoride (PVDF), or silicone. The diaphragm 18 can include a flexible material, e.g., formed from a polymeric material such as silicone. The diaphragm 18 can include a rigid material.
Milk Chamber
The breast cup 2 can include the milk chamber 21, which is configured to temporarily hold a volume of milk that is expressed from a nipple before it is pumped to an external reservoir. The milk chamber 21 includes an inlet and an outlet 22.
In some embodiments, the milk chamber 21 is reversibly attached to the breast cup 2. In some embodiments, the milk chamber 21 is reversibly attached to the breast cup 2, such that smaller or larger milk chambers 21 may be reversibly attached to the breast cup 2.
The milk chamber 21 can have a volume, nominal or expanded, from about 1 mL to about 150 mL (e.g., about 1 mL to about 10 mL, about 1 mL to about 25 mL, about 1 mL to about 50 mL, about 1 mL to about 75 mL, about 1 mL to about 100 mL, about 25 mL to about 50 mL, about 25 mL to about 100 mL, about 50 mL to about 150 mL, about 100 mL to about 150 mL, about 1 mL, about 5 mL, about 10 mL, about 15 mL, about 20 mL, about 25 mL, about 30 mL, about 40 mL, about 50 mL, about 60 mL, about 70 mL, about 75 mL, about 80 mL, about 90 mL, about 100 mL, about 125 mL, or about 150 mL). The milk chamber 21 can have a maximum volume, nominal or expanded, from about 1 mL to about 150 mL (e.g., about 1 mL to about 10 mL, about 1 mL to about 25 mL, about 1 mL to about 50 mL, about 1 mL to about 75 mL, about 1 mL to about 100 mL, about 25 mL to about 50 mL, about 25 mL to about 100 mL, about 50 mL to about 150 mL, about 100 mL to about 150 mL, about 1 mL, about 5 mL, about 10 mL, about 15 mL, about 20 mL, about 25 mL, about 30 mL, about 40 mL, about 50 mL, about 60 mL, about 70 mL, about 75 mL, about 80 mL, about 90 mL, about 100 mL, about 125 mL, or about 150 mL). In some embodiments, the milk chamber 21 has a nominal volume of less than about 10 mL (e.g., less than about 5 mL, less than about 4.5 mL, less than about 4 mL, less than about 3.5 mL, less than about 3 mL, less than about 2.5 mL, less than about 2 mL, less than about 1.5 mL, less than about 1 mL, less than about 0.5 mL, or less than about 0.1 mL). In some embodiments, the milk chamber has a nominal volume of about 30 mL.
In some embodiments, the diaphragm 18 seals the inlet to the milk chamber 21 before positive pressure, e.g., at ambient pressure, is applied to pressure chamber 20 and the milk chamber 21 is compressed, e.g., at sealing point 23. In some embodiments, the seal between the diaphragm 18 and the inlet to the milk chamber 21 has greater sealing pressure than that resistance of one directional valve on the outlet of the milk chamber 21. As described herein, the milk chamber may be formed by the space between the breast shield and the diaphragm or between one or more additional layers between the diaphragm and the breast shield.
The milk chamber includes an outlet. The outlet may include a one directional valve, e.g., to prevent air or expressed milk from being drawn back into the milk chamber during milk expression. The valve opens to allow milk to flow out of the milk chamber. In some embodiments, the one directional valve is passively actuated by pressure changes in the milk chamber. The milk chamber may also include an inlet, e.g., as a vent or to allow additional fluids, e.g., cleaning fluids or positive pressure to enter.
Milk Chamber Wall
The breast cup 2 may include a milk chamber wall 26.
While in some embodiments, the milk chamber 21 is defined between the diaphragm 18 and the breast shield 19, the milk chamber 21 can alternatively be defined between the diaphragm 18 and the milk chamber wall 26, e.g., as shown in FIG. 7. Thus, in some embodiments, the milk chamber wall 26 is disposed between the diaphragm 18 and the breast shield 19, thereby defining the milk chamber 21 between the diaphragm 18 and the milk chamber wall 26. The milk chamber wall is advantageous, in that it can provide additional structural stability to the milk chamber.
In some embodiments, the milk chamber wall 26 can include a curved shape or a cupshape.
In some embodiments, the milk chamber wall 26 is removably attached to the breast cup 2. In some embodiments, the milk chamber wall 26 is snapped into the breast cup 2. In some embodiments, the milk chamber wall 26 can be inserted into the breast cup 2 to reduce the volume of the milk chamber 21.
In some embodiments, the milk chamber wall 26 includes an orifice for outlet 22.
In some embodiments, the milk chamber wall 26 can include polyethylene terephthalate (PET), polypropylene (PP), polyethylene, high-density polyethylene (HDPE), low-density polyethylene (LDPE), or polycarbonate (PC). The milk chamber wall may include a clear material.
Pressure Chamber
The breast cup 2 can include the pressure chamber 20, which is configured to expand and compress the diaphragm 18 in order to express milk from a nipple. In some embodiments, the pressure chamber 20 is reversibly attached to the breast cup 2.
The pressure chamber 20 can have a maximum volume from about 1 mL to about 150 mL (e.g., about 1 mL to about 10 mL, about 1 mL to about 15 mL, about 1 mL to about 20 mL, about 1 mL to about 25 mL, about 1 mL to about 50 mL, about 1 mL to about 75 mL, about 1 mL to about 100 mL, about 5 mL to about 10 mL, about 5 mL to about 15 mL, about 5 mL to about 20 mL, about 5 mL to about 25 mL, about 5 mL to about 50 mL, about 10 mL to about 15 mL, about 10 mL to about 20 mL, about 10 mL to about 25 mL, about 10 mL to about 30 mL, about 10 mL to about 50 mL, about 15 mL to about 20 mL, about 15 mL to about 25 mL, about 15 mL to about 30 mL, about 15 mL to about 50 mL, about 20 mL to about 25 mL, about 20 mL to about 30 mL, about 20 mL to about 50 mL, about 25 mL to about 50 mL, from about 25 mL to about 100 mL, from about 50 mL to about 150 mL, from about 100 mL to about 150 mL, about 1 mL, about 5 mL, about 6 mL, about 7 mL, about 8 mL, about 9 mL, about 10 mL, about 11 mL, about 12 mL, about 13 mL, about 14 mL, about 15 mL, about 16 mL, about 17 mL, about 18 mL, about 19 mL, about 20 mL, about 25 mL, about 30 mL, about 40 mL, about 50 mL, about 60 mL, about 70 mL, about 75 mL, about 80 mL, about 90 mL, about 100 mL, about 125 mL, or about 150 mL). The pressure chamber may have a maximum volume of about 45 mL.
In some embodiments, the pressure chamber 20 limits the shape of the diaphragm 18 at the maximum deflection of the diaphragm 18, thus restricting the maximum negative pressure that can be applied to the nipple.
In some embodiments, upon application of positive pressure, the diaphragm 18 moves towards its nominal position and extends past it under pressure to conform to the shape of the milk chamber 21, thus transporting all liquid through the outlet 22.
In some embodiments, the pressure chamber 20 further includes a valve to the ambient atmosphere. In some embodiments, the valve is an inflation valve. In some embodiments, volume of the pressure chamber 20 may be set with the inflation valve. In some embodiments, the valve is a relief valve. The relief valve may be configured to release pressure from the pressure chamber 20 if the positive pressure exceeds a maximum positive pressure, or if the negative pressure exceeds a maximum negative pressure.
While in some embodiments, the volume of the pressure chamber 20 may be set with an inflation valve, the volume of the pressure chamber 20 may be set in a variety of manners. In some embodiments, the pressure chamber 20 is reversibly attached to the breast cup 2, such that smaller or larger pressure chambers 20 may be reversibly attached to the breast cup 2. In some embodiments, the breast cup includes a plug, which may be configured to be inserted into the pressure chamber 20 to reduce the volume. In some embodiments, the volume of the pressure chamber 20 may be adjusted manually by the user such that it sits further or closer to the chest of the user.
The pressure chamber 20 can be returned to ambient pressure following a breast pumping session.
The pressure chamber 20 is connected to the pressure source via an inlet. The connection may be direct between the outlet of the pressure source and the inlet of the pressure chamber, and there may be a fluid path in the breast cup to connect the pressure source to the inlet. Such a fluid path may be molded or otherwise manufactured in the components of the breast cup, e.g., the housing and/or diaphragm. Alternatively, a short fluid conduit may be employed in the breast cup to connect the pressure source with the pressure chamber.
The pressure chamber or housing may include a limiter that controls the maximum volume of the pressure chamber, e.g., to determine the pressure limit. For example, the breast shield may include a bladder or other element that can be filled with air or other fluid, e.g., water, and disposed to reduce the volume available for expansion of the pressure chamber.
Reservoir
The reservoir 3 is a collection container for the milk, such as a bottle or bag. Any commercially available reservoir may be used to collect milk pumped from a breast cup of this disclosure. The reservoir 3 may be polymeric or fabric. The reservoir 3 may be in fluidic communication with the pressure source 9, such that fluid is moved from the breast to the reservoir 3. The reservoir 3 may be releasably connected to a fluid conduit 5, such as a tube. The reservoir 3 may be configured for ease of cleaning. The reservoir 3 may be placed in a dishwasher, refrigerator, and/or freezer. In some embodiments, the reservoir 3 is insulated, e.g., with foam or a reflective material. Reservoirs 3 are removable from the system, e.g., to feed an infant.
In some embodiments, the reservoir includes a volume from about 50 mL to about 1500 mL (e.g., about 50 mL to about 100 mL, about 50 mL to about 150 mL, about 50 mL to about 200 mL, about 50 mL to about 250 mL, about 50 mL to about 300 mL, about 50 mL to about 400 mL, about 50 mL to about 500 mL, about 50 mL to about 600 mL, about 50 mL to about 700 mL, about 50 mL to about 700 mL, about 50 mL to about 750 mL, about 50 mL to about 800 mL, about 50 mL to about 900 mL, about 50 mL to about 1000 mL, about 50 mL to about 1100 mL, about 50 mL to about 1200 mL, about 50 mL to about 1300 mL, about 50 mL to about 1400 mL, about 100 mL to about 250 mL, about 100 mL to about 500 mL, about 100 mL to about 750 mL, about 100 mL to about 1000 mL, about 100 mL to about 1250 mL, about 250 mL to about 500 mL, about 250 mL to about 750 mL, about 250 mL to about 1000 mL, about 250 mL to about 1250 mL, about 250 mL to about 1500 mL, about 500 mL to about 750 mL, about 500 mL to about 1000 mL, about 500 mL to about 1250 mL, about 500 mL to about 1500 mL, about 750 mL to about 1000 mL, about 750 mL to about 1250 mL, about 750 mL to about 1500 mL, about 1000 mL to about 1250 mL, about 1250 mL to about 1500 mL, about 50 mL, about 100 mL to about 150 mL, about 200 mL, about 250 mL, about 300 mL, about 350 mL, about 400 mL, about 450 mL, about 500 mL, about 55 mL, about 600 mL, about 650 mL, about 700 mL, about 750 mL, about 800 mL, about 850 mL, about 900 mL, about 950 mL, about 1000 mL, about 1050 mL, about 1100 mL, about 1150 mL, about 1200 mL, about 1250 mL, about 1300 mL, about 1350 mL, about 1400 mL, about 1450 mL, or about 1500 mL).
In some embodiments, a reservoir may be disposed in a reservoir enclosure 4 external to the breast cup. In some embodiments, the reservoir enclosure 4 may include a cooling element. The reservoir enclosure may be attached or secured to the user, e.g., by a belt, clip, strap or other fastener or attachment mechanism.
In some embodiments, each reservoir 3 includes a lid, wherein lid includes the pressure outlet, the inlet of the reservoir 3, and/or the valve of the reservoir 3. The lid can be integral to or attached to the reservoir 3. In some embodiments, the lid is releasably attached to the reservoir 3. In some embodiments, the lid is screwed or snapped onto the reservoir 3. In particular, the reservoir 3 may include external threads, the lid may include internal threads, and the internal threads and the external threads may provide releasable attachment of the reservoir 3 and lid. In some embodiments, the lid is attached with a magnet, e.g., an electromagnet. In some embodiments, the lid is configured to be opened and/or closed with the electromagnet. In some embodiment, the lid is configured to be opened and/or closed with pressure, e.g., air pressure.
The lid of the reservoir can have a substantially flat or rounded top surface.
In some embodiments, the reservoir 3, e.g., the lid of the reservoir 3, includes a pressure outlet. The pressure outlet may or may not include a valve 24. In some embodiments, the pressure outlet is a breather tube. In some embodiments, the pressure outlet is an orifice, e.g., the reservoir 3 or the lid of the reservoir 3 may include an orifice. A pressure outlet is advantageous in allowing excess pressure to vent as the reservoir 3 is being filled with milk. In some embodiments, the pressure outlet is solely open as the reservoir 3 is being filled, and the pressure outlet is otherwise nominally closed. An outlet may be connected to a pressure source and a vent, e.g., to remove warm air to aid in cooling or to provide suction for milk flow.
Drive Unit and Control Unit
The breast cup 2 may include a drive unit 11. The drive unit 11 provides power to the elements of the breast cup 2.
In some embodiments, the drive unit 11 is a brushless motor, a stepper motor or a linear actuator. In some embodiments, the linear actuator is an electric linear actuator, a hydraulic linear actuator, or a pneumatic linear actuator. In some embodiments, the drive unit is a stepper motor. In some embodiments, the drive unit is a brushless motor.
The drive unit 11 may be electrically connected to the pressure source 9 (e.g., negative pressure source and/or positive pressure source) and the control valve 10.
In some embodiments, the breast cup 2 may include a control unit. The drive unit 11 may include a control unit. The control unit provides instructions to the drive unit 11, e.g., pre-programmed instructions or instructions provided by an external computer. The preprogrammed instructions or instructions provided by an external computer may be pumping instructions, time instructions, etc. For example, the control unit can be configured to send a signal to the pressure source to being a pumping session.
Fluid Conduit
The breast cup 2 may include at least one fluid conduit 5 to provide movement of milk and other fluids, e.g., air.
The fluid conduits 5 may include tubing. The fluid conduit 5 may include a food contact substance or infant grade material. The fluid conduit 5 may include an infant grade material. The fluid conduit 5 may include polyacetal, polyoxymethylene (POM), chlorinated polyvinyl chloride (CPVC), ethylene tetrafluoroethylene (ETFE), ethylene-vinyl acetate (EVA), fluorinated ethylene propylene (FEP), nylon, polyether ether ketone (PEEK), perfluoroalkoxy alkane (PF A), PC, polyethylene, PP, PTFE (e.g., Teflon), PVC, PVDF, thermoplastic elastomer (TPE), fluorosilicone, gum, latex, neoprene, polyurethane, rubber, rubber particles encapsulated in a PP matrix (e.g., Santoprene), or silicone. In some embodiments, fluid conduit may be substantially free of Bisphenol A (BPA) and/or polyfluoroalkyl substances (PF AS). In some embodiments, the fluid conduit may be manufactured absent of any intentionally added BPA and/or PF AS.
In some embodiments, the fluid conduit 5 includes an internal diameter (ID) from about 0.5 mm to about 50 mm (e.g., about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 0.5 mm to about 2 mm, about 0.5 mm to about 2.5 mm, about 0.5 mm to about 3 mm, about 0.5 mm to about 3.5 mm, about 0.5 mm to about 4 mm, about 0.5 mm to about 4.5 mm, about 0.5 mm to about 5 mm, about 0.5 mm to about 5.5 mm, about 0.5 mm to about 6 mm, about 0.5 mm to about 6.5 mm, about 0.5 mm to about 7 mm, about 0.5 mm to about 7.5 mm, about 0.5 mm to about 10 mm, about 1 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 2.5 mm, about 1 mm to about 3 mm, about 1 mm to about 3.5 mm, about 1 mm to about 4 mm, about 1 mm to about 4.5 mm, about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 1 mm to about 25 mm, about 1 mm to about 30 mm, about 1 mm to about 40 mm, about 2 mm to about 2.5 mm, about 2 mm to about 3 mm, about 2 mm to about 3.5 mm, about 2 mm to about 4 mm, about 2 mm to about 4.5 mm, about 2 mm to about 5 mm, about 3 mm to about 4 mm, about 3 mm to about 5 mm, about 4 mm to about 5 mm, about 4 mm to about 6 mm, about 5 mm to about 8 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 5 mm to about 25 mm, about 5 mm to about 50 mm, about 10 mm to about 25 mm, about 20 mm to about 30 mm, about 25 mm to about 50 mm, about 30 mm to about 40 mm, about 30 mm to about 50 mm, or about 40 mm to about 50 mm).
In some embodiments, the fluid conduit 5 includes an outer diameter (OD) from about 0.5 mm to about 50 mm (e.g., about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 0.5 mm to about 2 mm, about 0.5 mm to about 2.5 mm, about 0.5 mm to about 3 mm, about 0.5 mm to about 3.5 mm, about 0.5 mm to about 4 mm, about 0.5 mm to about 4.5 mm, about 0.5 mm to about 5 mm, about 0.5 mm to about 5.5 mm, about 0.5 mm to about 6 mm, about 0.5 mm to about 6.5 mm, about 0.5 mm to about 7 mm, about 0.5 mm to about 7.5 mm, about 0.5 mm to about 10 mm, about 1 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 2.5 mm, about 1 mm to about 3 mm, about 1 mm to about 3.5 mm, about 1 mm to about 4 mm, about 1 mm to about 4.5 mm, about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 1 mm to about 25 mm, about 1 mm to about 30 mm, about 1 mm to about 40 mm, about 2 mm to about 2.5 mm, about 2 mm to about 3 mm, about 2 mm to about 3.5 mm, about 2 mm to about 4 mm, about 2 mm to about 4.5 mm, about 2 mm to about 5 mm, about 3 mm to about 4 mm, about 3 mm to about 5 mm, about 4 mm to about 5 mm, about 4 mm to about 6 mm, about 5 mm to about 8 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 5 mm to about 25 mm, about 5 mm to about 50 mm, about 10 mm to about 25 mm, about 20 mm to about 30 mm, about 25 mm to about 50 mm, about 30 mm to about 40 mm, about 30 mm to about 50 mm, or about 40 mm to about 50 mm).
The breast cup 2 may be configured such that the user may roll during rest and/or sleep. Currently available breast pump systems are not designed to be utilized while resting, reclining, or sleeping.
The fluid conduit 5 may be selected to have a desired durometer to provide the preferred amount of flexibility for allowance of movement. For example, the fluid conduit 5 may have a durometer from about 25 Shore A scale and about 100 Shore D scale, including 25A, 30A, 35A, 40A, 45A, 50A, 55A, 60A, 65A, 70A, 75A, 80A, 85A, 90A, 95 A, 100A, 10D, 25D, 30D, 35D, 40D, 45D, 50D, 55D, 60D, 65D, 70D, 75D, 80D, 85D, 90D, 95D, 100D, or any durometer therebetween.
In some embodiments, the fluid conduit 5 may be disposed in the center of the breast cup 2, e.g., in line with a nipple. In some embodiments, the fluid conduit 5 may be disposed at the base of breast cup 2, such that milk is expressed to the side. In some embodiments, the fluid conduit 5 may be disposed at the side of the breast cup 2.
The breast cup 2 may include any number of fluid conduits 5, e.g., one, two, three, four, five, six, seven, eight, nine, ten, etc.
In some embodiments, the breast cup 2 includes a first fluid conduit 5 providing fluidic communication between the milk chamber 21 and the reservoir 3.
Additional fluid conduits 5 may transport milk from a second breast. In some embodiments, a first breast cup 2 is connected to a first fluid conduit 5, and a second breast cup 2 is connected to a second fluid conduit 5. In some embodiments, the first fluid conduit 5 and the second fluid conduit 5 merge into a third fluid conduit 5. In some embodiments, the third fluid conduit 5 connects to a reservoir 3.
To facilitate better movement, the breast cup 2 and fluid conduits 5 may move with the user. Independent movement of the breast cup 2 and fluid conduits 5 allow the user to have a better range of motion, and further when the user moves the breast cup 2 does not experience force that might remove it from the breast during pumping. In some embodiments, the breast cup 2 includes a movement element. The movement element may be positioned at the nipple tunnel of the breast cup 2 or at the side of the breast cup 2. In some embodiments, the first fluid conduit 5 is movably connected to the breast cup 2. In some embodiments, the first fluid conduit 5 is rotatable with respect to breast cup 2. In some embodiments, the first fluid conduit 5 is movably connected to the milk chamber 21. The movement element may be a swivel fitting or a rotating fitting. In some embodiments, the movement element includes a ball bearing.
The movement element may allow the fluid conduit 5 to rotate around the breast cup 2 from about 0° to about 360°, e.g., from about 0° to about 30°, from about 0° to about 60°, about 0° to about 90°, about 0° to about 120°, about 0° to about 150°, about 0° to about 180°, about 0° to about 210°, about 0° to about 240°, about 0° to about 300°, about 30° to about 120°, about 30° to about 180°, about 30° to about 240°, about 30° to about 360°, about 60° to about 120°, about 60° to about 180°, about 60° to about 240°, about 60° to about 360°, about 90° to about 180°, about 90° to about 360°, about 120° to about 240°, about 120° to about 360°, about 150° to about 240°, about 150° to about 360°, about 180° to about 240°, about 180° to about 360°, about 210° to about 360°, about 240° to about 360°, about 270° to about 360°, or about 300° to about 360°.
The movement element may allow the fluid conduit 5 to pivot from the center of the breast cup 2 from about 0° to about 90°, e.g., from about 0° to about 5°, about 0° to about 10°, about 0° to about 15°, about 0° to about 20°, about 0° to about 25°, about 0° to about
30°, about 0° to about 45°, about 0° to about 60°, about 0° to about 75°, about 5° to about
10°, about 5° to about 15°, about 5° to about 20°, about 5° to about 25°, about 5° to about
30°, about 5° to about 45°, about 5° to about 60°, about 5° to about 90°, about 10° to about
15°, about 10° to about 30°, about 10° to about 45°, about 10° to about 60°, about 10° to about 90°, about 30° to about 45°, about 30° to about 60°, about 30° to about 90°, about 45° to about 60°, about 45° to about 90°, or about 60° to about 90°.
A fluid conduit may have any appropriate connector at each end for connection to the breast cup 2 or reservoir 3. Examples of connectors include Luer connectors, threaded connectors, and slip fit connectors.
Valves
The breast cup 2 may include one or more valves. In some embodiments, the valve is a control valve, an open-close valve, a one directional valve, a relief valve, a quick-release valve, an inflation valve, or a slow-leak valve. In some embodiments, the valve is a mechanical valve, an inflation valve, an umbrella valve, a butterfly valve, a disk valve, a nondrip valve, a duckbill valve, a ball valve, a batch dispensing valve, a diaphragm valve, a gate valve, a diverting valve, a pinch valve, a piston valve, a plug valve, a saddle valve, a solenoid valve, a stem valve, a stop cock valve, or a three-way valve. The breast cup 2 may include a control valve 10. The control valve 10 may be in fluidic communication with the breast cup 2 and the pressure source 9. The control valve 10 may provide positive pressure to the breast cup 2 and/or the pressure source 9 in order to decrease negative pressure, and reduce or stop milk flow, e.g., by depressurizing the nipple.
The positive pressure provided by the control valve 10 may be between 0 mmHg to 400 mmHg, e.g., about 25 mmHg. In some embodiments, the positive pressure is 0 mmHg, e.g., open atmospheric pressure. In some embodiments, the pressure source 9 and control valve 10 are contained within the same feature.
In some embodiments, the breast cup 2 may include an open-close valve. In some embodiments, the control valve includes an open-close valve. The open-close valve may be configured to open and close fluidic communication between a first element and a second element. In some embodiments, the first element can include a reservoir 3, fluid conduit 5, a pressure chamber 20, a milk chamber 21, a manifold, or the ambient atmosphere. In some embodiments, the second element can include a reservoir 3, fluid conduit 5, a pressure chamber 20, a milk chamber 21, a manifold, or the ambient atmosphere.
The breast cup 2 may include one or more one directional valves 15 or anti -backflow valves, e.g., a plurality of one directional valves 15.
The one directional valve 15 may be a duckbill valve or other type of one directional valve.
In some embodiment, the one directional valve 15 may be placed in a fluid conduit 5, e.g., to prevent backflow of milk. In some embodiments, the one directional valve 15 is configured to allow fluid flow from the milk chamber 21 to the reservoir 3. In some embodiments, the one directional valve 15 is disposed in the first fluid conduit 5. In some embodiments, the one directional valve 15 is disposed at the outlet 22 of the milk chamber 21, e.g., FIG. 9D. In some embodiments, the one directional valve 15 is disposed in the diaphragm 18. In some embodiments, the one directional valve 15 may prevent air from entering the first fluid conduit 5, thereby maintaining negative pressure to move the milk.
In some embodiments, the one directional valve 15 is configured to allow fluid flow from the control valve 10 to the breast cup 2 or pressure source 9. In other embodiments, the one directional valve 15 may allow air to flow to the first fluid conduit from the control valve 10, such that negative pressure from the pressure source 9 fluctuates to express milk from the breast. Thus, in some embodiments, the one directional valve 15 follows the control valve 10 in a fluid conduit 5, e.g., in the third fluid conduit 5. In some embodiments, the one directional valve 15 is between the breast cup 2 and the reservoir 3, such that milk cannot backflow from the reservoir 3.
In some embodiments, the inlet to the milk chamber 21 includes a one directional valve, e.g., as shown in FIG. 5. In some embodiments, the one directional valve is a duckbill valve.
The powered breast cup may further include at least one relief valve. In some embodiments, at least one fluid conduit 5 includes a relief valve. In some embodiments, the breast cup 2 includes a relief valve. If vacuum at the breast becomes too strong the relief valve may provide a release of negative pressure to prevent discomfort for the user. A relief valve may be placed such that if a predetermined maximum vacuum level is exceeded in a fluid conduit 5, such as greater than 250 mmHg vacuum (-250 mmHg pressure), the relief valve is able to provide positive pressure. The relief valve can be in the form of a spring and ball, pin and O-ring, or other equivalent mechanical means of providing pressure relief. In some embodiments, the user may activate the release valve. In some embodiments, a user may twist a relief valve to lower or shut off suction. In some embodiments, the breast cup 2 includes one or more quick-release valves. In some embodiments, the outlet of breast cup 2, e.g., the outlet 22 of the milk chamber 21, includes a quick-release valve such that a fluid conduit 5 may be easily connected to the milk chamber 21.
In some embodiments, the breast cup 2 is configured to permit a slow leak of pressure. The slow leak of pressure may be to the ambient atmosphere. A slow leak aids in slowly venting pressure during breast pumping. In some embodiments, the breast cup 2 is configured to permit a slow leak of pressure. In some embodiments, the breast shield 19 is configured to permit a slow leak of pressure. In some embodiments, the breast shield 19 includes an imperfect seal configured to provide a slow leak. In some embodiments, the breast shield 19 includes an orifice to provide a slow leak. In some embodiments, the slow leak includes a leak rate that would not decrease the maximum negative pressure of a pressure cycle by more than 10% (e.g., 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, or 1%). In some embodiments, the slow leak provides a positive pressure to the breast cup 2 that is equivalent to the maximum applied negative pressure over a period of time from about 0.5 minutes to about 60 minutes (e.g., about 0.5 minutes to about 1 minute, about 0.5 minutes to about 5 minutes, about 0.5 minutes to about 10 minutes, about 0.5 minutes to about 15 minutes, about 0.5 minutes to about 30 minutes, about 1 minute to about 5 minutes, about 2 minutes to about 8 minutes, about 3 minutes to about 7 minutes, about 5 minutes to about 10 minutes, about 5 minutes to about 15 minutes, about 5 minutes to about 30 minutes, about 10 minutes to about 15 minutes, about 10 minutes to about 20 minutes, about 15 minutes to about 30 minutes, about 15 minutes to about 45 minutes, about 30 minutes to about 45 minutes, about 30 minutes to about 60 minutes or about 45 minutes to about 60 minutes). A slow leak valve may be configured to provide the slow leak of pressure. For example, if a maximum pressure of 100 mmHg is applied to the breast cup 2, e.g., the nipple tunnel of the breast shield 19, the slow leak may provide 10 mmHg of positive pressure every minute for 10 minutes.
In some embodiments, the breast cup 2 includes a slow leak valve. The slow leak valve may be configured to provide a slow leak of pressure to the ambient atmosphere. In some embodiments, the slow leak valve includes a leak rate that would not decrease the maximum negative pressure of a pressure cycle by more than 10% (e.g., 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, or 1%) when negative pressure is being applied to the breast cup 2.
Sensors
The breast cup 2 may also include at least one sensor. At least one sensor may detect a baseline value, e.g., an initial pressure in the breast cup 2. Throughout breast pumping the sensor may continue detecting. Data are compared throughout breast pumping to the initially detected baseline. Sensors include weight sensors, load cells, temperature sensors, pressure sensors, pH sensors, flow sensors, viscosity sensors, volume sensors, etc. Sensors may be in the breast cup 2, at least one fluid conduit 5, in the pressure source, or on an external surface of the breast cup.
In some embodiments, the breast cup 2 includes at least one temperature sensor, e.g., a thermocouple. In some embodiments, the breast pump includes a plurality of temperature sensors. Temperature sensors may provide time history data. Using the circadian baseline, deviations from baseline may be identified.
The breast cup 2 may include at least one pressure sensor. In some embodiments, the breast cup includes a plurality of pressure sensors. Pressure sensors may include diaphragms, strain gauges, piezoresistive pressure sensors, capacitive pressure sensors, or electromagnetic sensors. Pressure sensors may be used to measure the pressure in the breast cup 2, e.g., in the pressure chamber 20, milk chamber 21, and/or breast shield 19. Data from the pressure sensor may be used to determine the pressure used to express milk from the nipple. Pressure sensors are also advantageous in that they may detect high pressure levels which may cause discomfort for the user. In some embodiments, the breast cup 2 includes a pressure sensor. The breast cup 2 may include at least one pH sensor. In some embodiments, the breast cup includes a plurality of pH sensors. In some embodiments, the pH sensor is an ion sensitive glass electrode.
The breast cup 2 may include at least one flow sensor. In some embodiments, the breast cup includes a plurality of flow sensors. In some embodiments, a fluid conduit 5 includes a flow sensor. A flow sensor may detect the rate of fluid flow in the fluid conduit 5.
The breast cup 2 may include at least one volume sensor. In some embodiments, the breast pump includes a plurality of volume sensors.
The breast cup 2 may include at least one optical sensor. In some embodiments, the breast pump includes a plurality of optical sensors. The optical sensor may include a light source, e.g., a light source made of one or more light emitting diodes (LEDs), and associated photodetector. The light source in one example emits light at different wavelengths within the visible spectrum, including a violet light, a blue light, a green light, a yellow light, an orange light and a red light. In various embodiments, the optical sensor includes a singular light source or a plurality of light sources, similarly the photodetector may include a single photodetector or a plurality of photodetectors.
In some embodiments, the optical sensor may sense movement of the breast cup 2 on the breast. Sensing the movement of the breast cup 2 on the breast is advantageous in that it may measure how much the breast cup 2 moves during use, e.g., such as through the night. In some embodiments, the breast cup 2 can alert the user if it becomes unaligned or loose. In some embodiments, the optical sensor is in view of a portion of the skin of the user. In some embodiments, the breast cup 2, e.g., an outer surface of breast cup 2, e.g., the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), includes the optical sensor. In some embodiments, the optical sensor is mounted on the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26).
The breast cup 2 may include at least one viscometer. In some embodiments, the breast cup 2 includes a plurality of viscometers.
In some embodiments, the breast cup 2 includes a Hall effect sensor. A Hall effect sensor is a sensor which detects the presence and magnitude of a magnetic field using the Hall effect. A Hall effect sensor is advantageous in that it may allow the breast cup 2 to collect information on whether the system completes actions. The information collected by the Hall effect sensor may be used to provide assurance and aid in diagnosing any errors.
Additional Components In some embodiments, the breast cup 2 includes a heating system (a heater). A heating system is advantageous in that the breast cup 2 may be heated prior to or during breast pumping for improved comfort. In some embodiments, the heating system is disposed in the breast shield 19. In some embodiments, the heating system includes insulation, an insertion heater, a resistive heater, a thermoelectric heater, a heating film, a heating pad, a heating wire, or a pneumatic heating tube.
In some embodiments, the breast cup 2 includes a pressure outlet. The pressure outlet may or may not include a valve 24. In some embodiments, each pressure outlet includes a valve 24. In some embodiments, the pressure outlet is a breather tube. In some embodiments, the pressure outlet is an orifice.
In some embodiments, the breast cup 2 may include an anti-bacterial coating, e.g., in the fluid conduits 5 or on one or more other surfaces.
The breast cup 2 may include a power source 12. The power source 12 may be a battery and/or an AC power source. The power source 12 may be electrically connected to the control unit and the pressure source.
The breast cup 2 may include or be utilized with a display. The display may be disposed on the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), an electrically connected remote, or an external computing device with an appropriate software application, e.g., a mobile device. The display may be a screen. In some embodiments, the screen is a touchscreen.
The breast cup 2 may include or be utilized with a timer. The drive unit 11 and/or control unit may include the timer. The timer may be disposed on the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), an electrically connected remote, or an external computing device with an appropriate software application, e.g., a mobile device .
The breast cup 2 may include or be utilized with an alarm. The alarm may be disposed on the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), an electrically connected remote, or an external computing device with an appropriate software application, e.g., a mobile device. The alarm may be a light, a vibration element, or a sound element. The alarm may be configured to sound in the event of an error (e.g., the pumping system is improperly assembled), the ending of a pumping session, a temperature increase in the milk in the reservoir 3, a full reservoir 3, and/or the start of an upcoming preprogrammed pumping session. The breast cup 2 may include a power switch 14 or button. The power switch 14 or button may enable a user to power on or off the breast cup 2. The power switch 14 or button may be disposed on the outside of the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26). Alternatively, or in addition, the power switch 14 or button may be disposed on the breast cup 2. However, in some embodiments, the user may power on or off the breast cup 2 remotely, such as through an application on an external computer, e.g., a mobile device.
Wearability
The breast cup 2 may include or be utilized with a garment to secure the breast cup 2 to the user. The garment may secure the breast cup 2 in place, and/or stabilize breast cup 2 for milk expression. In some embodiments, the breast cup 2 is inserted into the garment.
The garment may be a bra, a bustier, a sports bra, a shirt, a tank top, a bandeau, a strap, a dress, a nightgown, or a nursing bra that provides support to a wearer and/or at least a portion of a breast cup 2. In some embodiments, the garment includes polyester, cotton, linen, satin, organdy, rayon, taffeta, broad cloth, poplin, velour, gauze, canvas, shirting, muslin, tweed, georgette, crepe, wool, twill, gabardine, denim, or drill. In some embodiments, the garment is machine washable.
In some embodiments, the breast cup 2 is held in place by compression provided by the garment. The garment may provide a level of compression of the breast cup 2 to the breast such that the subject may move, rest, and/or sleep with the breast cup continuing to be secured to the breast. Securement of the breast cup 2 to the breast during movement improves safety and reduces milk leakage. The garment may include a flexible or stretch material, e.g., nylon, elastic, or spandex. The garment may include portions of varying compression, e.g., high compression portions and low compression portions. For example, the material of the garment contacting the breast cup may include a high compression portion. The garment may apply a compression of at least 5 mmHg, e.g., at least 10 mmHg, 15 mmHg, 20 mmHg, 25 mmHg, 30 mmHg, 35 mmHg, 40 mmHg, 45 mmHg, 50 mmHg, 55 mmHg, 60 mmHg, 65 mmHg, 70 mmHg, 75 mmHg, 80 mmHg, 85 mmHg, 90 mmHg, 95 mmHg, 100 mmHg, 125 mmHg, or 150 mmHg. In other embodiments, the garment may apply a compression from about 5 mmHg to about 100 mmHg, e.g., about 5 mmHg to about 10 mmHg, about 5 mmHg to about 15 mmHg, about 10 mmHg, to about 20 mmHg, about 5 mmHg to about 25 mmHg, about 5 mmHg to about 30 mmHg, about 5 mmHg to about 35 mmHg, about 5 mmHg to about 40 mmHg, about 5 mmHg to about 45 mmHg, about 5 mmHg to about 50 mmHg, about 5 mmHg to about 60 mmHg, about 5 mmHg to about 70 mmHg, about 5 mmHg to about 80 mmHg, about 5 mmHg to about 90 mmHg, about 5 mmHg to about 100 mmHg, about 10 mmHg to about 20 mmHg, about 10 mmHg to about 30 mmHg, about 10 mmHg to about 40 mmHg, about 10 mmHg to about 50 mmHg, about 10 mmHg to about 75 mmHg, about 10 mmHg to about 100 mmHg, about 20 mmHg to about 30 mmHg , about 20 mmHg to about 40 mmHg, about 20 mmHg to about 50 mmHg, about 25 mmHg to about 50 mmHg, about 25 mmHg to about 75 mmHg, about 25 mmHg to about 100 mmHg, about 40 mmHg to about 50 mmHg, about 40 mmHg to about 60 mmHg, about 40 mmHg to about 70 mmHg, about 40 mmHg to about 80 mmHg, about 40 mmHg to about 90 mmHg, about 40 mmHg to about 100 mmHg, about 50 mmHg to about 60 mmHg, about 50 mmHg to about 60 mmHg, about 50 mmHg to about 70 mmHg, about 50 mmHg to about 80 mmHg, about 50 mmHg to about 100 mmHg, about 60 mmHg to about 70 mmHg, about 60 mmHg to about 80 mmHg, about 60 mmHg to about 70 mmHg, about 60 mmHg to about 80 mmHg, about 60 mmHg to about 90 mmHg, about 60 mmHg to about 100 mmHg, about 70 mmHg to about 80 mmHg, about 70 mmHg to about 90 mmHg, about 70 mmHg to about 100 mmHg, about 80 mmHg to about 90 mmHg, about 80 mmHg to about 100 mmHg, or about 90 mmHg to about 100 mmHg.
The garment provides access to at least one breast to facilitate breastfeeding and/or pumping. Several embodiments are described to provide access to at least one breast. In some embodiments, the user may pull the garment away from their skin, and insert the breast cup 2 underneath the garment from below or above the garment. In some embodiments, the garment may have openings formed or defined in the material that makes up the garment to provide an opening for access to at least one of the wearer’s breasts. In some embodiments, the opening in the garment has a smaller diameter than the largest diameter of the breast cup 2. In some embodiments, the breast cup 2 and/or housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) are inserted into at least one opening formed in the material of the garment, and compression of the material secures it to the breast. This configuration is advantageous such that the breast cup 2 may not be pulled out from the garment unintentionally. For example, the nipple tunnel 13 of the breast cup 2 may be inserted through the opening in the garment such that the wide portion 8 of the breast cup 2 may contact the garment, but not pass through. The nipple tunnel 13 of the breast cup may then be releasably connected to a fluid conduit 5.
The opening in the garment may have a diameter from about 5 mm to about 250 mm, e.g., from about 5 mm to about 10 mm, about 5 mm to about 20 mm, about 5 mm to about 25 mm, about 5 mm to about 30 mm, about 5 mm to about 40 mm, about 5 mm to about 50 mm, about 5 mm to about 75 mm, about 5 mm to about 100 mm, about 10 mm to about 20 mm, about 10 mm to about 25 mm, about 10 mm to about 30 mm, about 10 mm to about 40 mm, about 10 mm to about 50 mm, about 20 mm to about 25 mm, about 20 mm to about 30 mm, about 20 mm to about 40 mm, about 20 mm to about 50 mm, about 25 mm to about 50 mm, about 25 mm to about 75 mm, about 30 mm to about 40 mm, about 30 mm to about 50 mm, about 40 mm to about 50 mm, about 50 mm to about 75 mm, about 50 mm to about 100 mm, about 50 mm to about 125 mm, about 50 mm to about 150 mm, about 50 mm to about 75 mm, about 75 mm to about 100 mm, about 75 mm to about 125 mm, about 75 mm to about 150 mm, about 75 mm to about 175 mm, about 75 mm to about 200 mm, about 100 mm to about 125 mm, about 100 mm to about 150 mm, about 100 mm to about 175 mm, about 100 mm to about 200 mm, about 125 mm to about 150 mm, about 125 mm to about 175 mm, about 125 mm to about 200 mm, about 150 mm to about 175 mm, about 150 mm to about 200 mm, about 150 mm to about 250 mm, or about 200 mm to about 250 mm. The opening may have a diameter less than 100 mm, e.g., less than 90 mm, 80 mm, 70 mm, 60 mm, 50 mm, 40 mm, 30 mm, 25 mm, 20 mm, 10 mm or 5 mm.
The garment may include at least one layer, e.g., two layers. The two layers may overlap such that they may be pulled apart to reveal at least one breast. In some embodiments, the garment includes at least two layers, and the breast cup 2 and/or housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) are secured to the breast by positioning between at least two layers. Alternatively, or additionally, the garment may include snaps, buttons, or a zipper which may be opened to provide access to at least one breast. In addition to providing access to at least one breast, the breast cup 2 may include a fastener for securing the breast cup 2 and/or housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) to the garment. The breast cup 2 may also include a fastener for securing the fluid conduit 5. The fastener may be used to route the fluid conduit 5 to an advantageous location (e.g., under the arm, or under the garment), such that the fluid conduit does not impede the user’s freedom of motion. The breast cup 2 may also include a fastener system for the reservoir 3 and/or reservoir enclosure 4. The fastener may attach the reservoir 3 and/or reservoir enclosure 4 to the user, such that they are able to conduct their daily activities while breast pumping. The fastener may include a clip, a strap, a hook, a zipper, a magnet, a pin, a button, a snap, a hook and loop fastener (e.g., VELCRO®), or a combination thereof. The fastener may fasten the reservoir 3 and/or reservoir enclosure 4 to the user in such a way that they may have freedom of motion, e.g., fasten the reservoir 3 and/or reservoir enclosure 4 to the waist of the user.
Securement to the breast may be further improved by negative pressure provided by the pressure source 9.
The breast cup 2 may be reversibly connected to the garment before or after the garment is donned. In some embodiments, the breast cup 2 and/or housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) are reversibly secured to the garment and then the garment is donned. In some embodiments, the garment is donned, and then the breast cup 2 and/or housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) are reversibly secured to the garment. In some embodiments, the breast cup 2 and/or housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26) are irreversibly secured to the garment. In some embodiments, the fluid conduit 5 is reversibly secured to the breast cup 2 after the garment is donned. In some embodiments, the fluid conduit 5 is reversibly secured to the breast cup 2 prior to the garment being donned.
In some embodiments, the outer surface of breast cup 2 has a lower coefficient of friction than the inner surface of the garment to allow freedom of movement. Without wishing to be bound to theory, if there is a lower coefficient of friction between the breast cup 2 and the garment than between the breast cup 2 and the breast, then relative movement of the garment is less likely to move the breast cup 2 out of position. In some embodiments, the coefficient of friction between the outer surface of the breast cup 2, e.g., the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), and the garment is less than 0.4 (e.g., 0.35, 0.3, 0.25, 0.2, 0.15, 0.1, or 0.05). In some embodiments, the outer surface of the breast cup 2, e.g., the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), can include a smooth material. In some embodiments, the outer surface of the breast cup 2, e.g., the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), can include a smooth plastic or fabric. In some embodiments, the outer surface of the breast cup 2, e.g., the upper housing 17, the breast shield 19, and/or the lower housing or milk chamber wall 26, can include PET, PP, PTFE, polyethylene, HDPE, LDPE, PC, nylon, acetal, PEEK, PPS, or polyester. In some embodiments, the outer surface of the breast cup 2, e.g., the housing (e.g., the upper housing 17 and/or the lower housing or milk chamber wall 26), can include cotton, linen, satin, organdy, rayon, taffeta, broad cloth, poplin, velour, gauze, canvas, shirting, muslin, tweed, georgette, crepe, wool, twill, gabardine, denim or drill. Breast Cup Control
The breast cup 2 may include controls that are operable by a user to select or modify at least one of: pumping program or mode, frequency of pumping cycle, maximum suction pressure achieved during a pumping cycle, latch suction pressure achieved during the pumping cycle, volume of the pressure chamber 20, pumping force, and pumping session time. The controls may be present on the surface of the breast cup 2, or an external remote, e.g., on the display. Alternatively, or in addition, the controls may be present in an application on an external computer, e.g., a mobile device. Alternatively, the breast cup 2 is solely controlled through an application on an external computer, e.g., a mobile device. Control of the breast cup 2 through an application on an external computer is advantageous in that a user may control the device in any position.
In some embodiments, the breast cup 2 can have a wait time set, e.g., through the display or an application on an external computer, such that the user has time to contact the breast cup 2 to their breast before the breast cup 2 begins pumping.
Control of the breast cup 2 may be customized. The customized pump functions include modifications to at least one of: maximum suction pressure level, latch suction pressure level, suction pressure waveform over a pumping cycle, phases of extraction or feeding times, rest times, heating temperatures and times, vibration frequency and duration, and pumping session time. The user may input at least one pump program into the breast cup 2, e.g., through the display or application on an external computer. For example, the user may set the number of minutes that the breast cup 2 will run before shutting off automatically and/or the user may set a time for the breast cup 2 to engage during the night. Custom pump programming is advantageous in that user may control how long they pump for so that they may go about their daily activities, resting, or sleeping, without the worry that the pump will continue endlessly. In some embodiments, the pumping frequency may be programmed to slow down gradually during operation, e.g., towards the end of a preprogrammed pumping time.
Wireless Control
The control unit may be configured to send signals to and receive signals from an external computer, e.g., a mobile device.
The control unit may include a transmission element, e.g., a wireless transmission element, and receiver element for wirelessly sending signal to and receiving signals from the external computer. In some embodiments, the transmission element is a BLUETOOTH® transmission element.
The external computer may include a processor and instructions, which when executed, cause the processor to customize pump functions and send customized pump functions to the control unit. In some embodiments, the custom pump functions are based on the signals received from the control unit, such as measurements taken by sensors. In some embodiments, the user is able to program different custom pump programs, e.g., a daytime program and a nighttime program.
The external computer may include a processor and instructions, which when executed, cause the processor to calculate volume of milk extracted and track expression efficiency and monitor it over time. In some embodiments, the calculation of milk extracted, and expression efficiency are based on signals received from the control unit, such as measurements taken by the sensors.
The external computer may include a processor and instructions, which when executed, cause the processor to track of inventory of previous pumping sessions, including tracking at least one of dates of the previous pumping sessions, volumes pumped in the previous pumping sessions, and specific tracking numbers for specific milk collection containers into which milk has been pumped in the previous pumping sessions.
The external computer may include a processor and instructions, which when executed, cause the processor to one or more of monitor remaining battery power of the battery and output a warning when the battery reaches a predetermined low level of charge.
The external computer may include a processor and instructions, which when executed, cause the processor to display in the application screen or on display of the breast cup 2 the time left in the pumping session, measurements taken by the at least one sensor, and/or one or more photos of the user’s choosing on the display.
Methods of Use
The present disclosure provides improved methods of breast pumping.
The present disclosure provides a method of breast pumping by: (i) providing a breast cup 2 of the disclosure; (ii) providing a reservoir 3 in fluidic communication with the breast cup; (iii) contacting a human breast with the breast cup; and (vi) applying an alternating first pressure and second pressure such that milk is moved from the human breast to the reservoir 3, in which the first pressure and the second pressure are functions of a negative pressure and a positive pressure. In some embodiments, the breast cup 2 includes a wide portion and a nipple tunnel, and the method includes contacting the human breast with the wide portion of the breast cup 2. In some embodiments, the method includes positioning the nipple in the nipple tunnel of the breast cup 2. In some embodiments, the method includes contacting two human breasts with the two breast cups 2.
In some embodiments, the method includes applying negative pressure to the pressure chamber 20 with the pressure source 9. Pressure around the nipple is reduced to below atmospheric pressure.
In some embodiments, the method includes deforming the diaphragm 18 away from the breast cup. In some embodiments, the method includes deforming the diaphragm 18 away from the inlet. In some embodiments, the method includes unsealing the inlet. Deformation of the diaphragm 18 away from the inlet allows milk to flow from the nipple to the milk chamber 21. In some embodiments, the method includes expanding the milk chamber 21. In some embodiments, the method includes providing negative pressure to elongate the nipple. In some embodiments, the method includes drawing milk from the nipple. In some embodiments, the method includes drawing milk from the nipple tunnel 13 into the milk chamber 21. In some embodiments, the method includes drawing milk through the inlet.
In some embodiments, the method includes opening the control valve 10 and depressurizing the pressure chamber 20. In some embodiments, the method includes returning the diaphragm 18 to a nominal position. In some embodiments, the method includes closing the control valve 10.
In some embodiments, the method includes applying positive pressure to the pressure chamber 20 with the positive pressure source. In some embodiments, the method includes allowing the nipple to contract. In some embodiments, the method includes deforming the diaphragm 18 towards the breast shield 19. In some embodiments, the method includes allowing the diaphragm 18 to return to a nominal position. In some embodiments, the method includes sealing the inlet with the diaphragm 18. Deformation of the diaphragm 18 towards the breast shield seals the inlet such that the nipple is allowed to contract. In some embodiments, the method includes sealing the orifices with diaphragm 18. In some embodiments, the method includes contracting the milk chamber 21. Contraction of the milk chamber acts to pump milk out of the breast cup.
In some embodiments, the method includes transporting milk from the milk chamber 21 to the reservoir 3. In some embodiments, the method includes transporting milk through the first fluid conduit. In some embodiments, the method includes transporting milk through the outlet. In some embodiments, the method includes transporting milk through the one directional valve. In some embodiments, the method includes applying a negative pressure to the milk chamber 21 at the end of the pumping session. In this embodiment, the negative pressure transports any residual milk from the milk chamber 21 and fluid conduit 5 into the reservoir 3. In some embodiments, the pressure source is a peristaltic pump, e.g., on a first conduit or downstream component connected thereto. Positive pressure may also be introduced into the milk chamber, e.g., via a separate inlet, to aid in transport of milk or cleaning. The clearing of milk from the fluid conduit and/or milk chamber may occur only once at the end of a breast pumping cycle.
In some embodiments, the time between one breast pumping session and another breast pumping session (e.g., between a first breast pumping session and a second breast pumping session, a second breast pumping session and a third breast pumping session, a third breast pumping session and a fourth breast pumping session, etc.) is from about 30 minutes to about 240 minutes (e.g., about 30 minutes to about 45 minutes, about 30 minutes to about 60 minutes, about 30 minutes to about 90 minutes, about 30 minutes to about 120 minutes, about 30 minutes to about 180 minutes, about 45 minutes to about 60 minutes, about 45 minutes to about 90 minutes, about 45 minutes to about 120 minutes, about 60 minutes to about 90 minutes, about 60 minutes to about 120 minutes, about 50 minutes to about 180 minutes, about 60 minutes to about 210 minutes, about 90 minutes to about 120 minutes, about 90 minutes to about 180 minutes, about 90 minutes to about 210 minutes, about 90 minutes to about 240 minutes, about 120 minutes to about 180 minutes, about 120 minutes to about 210 minutes, about 120 minutes to about 240 minutes, about 180 minutes to about 210 minutes, about 180 minutes to about 240 minutes, about 210 minutes to about 240 minutes, about 30 minutes, about 45 minutes, about 60 minutes, about 85 minutes, about 90 minutes, about 105 minutes, about 120 minutes, about 135 minutes, about 150 minutes, about 165 minutes, about 180 minutes, about 195 minutes, about 210 minutes, about 225 minutes, or about 240 minutes). In some embodiments, the breast cup 2 may enter a waiting phase between breast pumping sessions where the breast cup 2 is not in fluidic communication with any reservoir 3.
In some embodiments, milk from the first breast pumping session is transported to a first reservoir, and milk from the second breast pumping session is transported to a second reservoir. Once full, a reservoir may be removed and replaced with an empty reservoir.
The method may further include assembling the breast cup 2. In some embodiments, the method includes releasably connecting at least one fluid conduit 5 to the pressure source 9. In some embodiments, the method further includes releasably connecting at least one fluid conduit to the breast cup 2. In some embodiments, the method includes releasably connecting at least one fluid conduit to the reservoir 3. In some embodiments, the method includes connecting the first fluid conduit 5 to the milk chamber 21 and the reservoir 3.
Releasable connections between the breast cup 2 are advantageous for ease of cleaning.
The breast cup 2 is advantageous in that the user may be able to breast pump a plurality of times following a one-time assembly. Prior to the first use, the user may secure the breast cup to a breast and/or garment to their body. Then, in some embodiments, the user does not need to remove the breast cup 2 and/or garment between a plurality of breast pumping sessions, e.g., two, three, four, five, six, seven, eight, nine, or ten breast pumping sessions. In this embodiment, the user may be able to remove the full reservoir after a pumping session without removing the breast cup 2. The breast cup 2 is further advantageous in that the user may be able to breast pump in a reclined position.
In some embodiments, the method further includes turning on the breast cup 2. The breast cup 2 may be turned on after the breast cup 2 is contacted to the human breast. In some embodiments, the breast cup 2 may be turned on before the breast cup 2 is contacted to the human breast, e.g., the negative pressure is applied after the human breast is contacted, or the human breast is contacted during a waiting period before the negative pressure is applied. In some embodiments, breast cup 2 is turned on with the power switch 14. In some embodiments, the breast cup 2 is turned on remotely. In some embodiments, the breast cup 2 is turned on automatically according to a pre-programmed schedule. In some embodiments, the breast cup 2 is turned on automatically according to a pre-programmed schedule a plurality of times.
In some embodiments, the method further includes turning on a pressure source. A pressure source may be turned on after the breast cup 2 contacts the human breast. In some embodiments, the pressure source is turned on with the power switch 14. In some embodiments, the pressure source is turned on remotely. In some embodiments, the pressure source is turned on automatically according to a pre-programmed schedule. In some embodiments, the pressure source is turned on automatically according to a pre-programmed schedule a plurality of times. The pressure source 9 may be a negative pressure source or a positive pressure source.
In some embodiments, the method further includes turning on the pressure source 9. The pressure source 9 may be turned on after the breast cup 2 is contacted to the human breast. In some embodiments, pressure source 9 is turned on with the power switch 14. In some embodiments, the pressure source 9 is turned on remotely. In some embodiments, the pressure source 9 is turned on automatically according to a pre-programmed schedule. In some embodiments, the pressure source 9 is turned on automatically according to a preprogrammed schedule a plurality of times.
The first pressure or second pressure may be between about 0 mmHg to about 250 mmHg, e.g., about 0 mmHg to about 10 mmHg, about 0 mmHg to about 20 mmHg, about 0 mmHg to about 30 mmHg, about 0 mmHg to about 40 mmHg, about 0 mmHg to about 50 mmHg, about 0 mmHg to about 60 mmHg, about 0 mmHg to about 70 mmHg, about 0 mmHg to about 80 mmHg, about 0 mmHg to about 90 mmHg, about 0 to about 100 mmHg, about 0 mmHg to about 110 mmHg, about 0 mmHg to about 120 mmHg, about 0 mmHg to about 130 mmHg, about 0 to about 140 mmHg, about 0 mmHg to about 150 mmHg, about 0 to about 175 mmHg, about 0 mmHg to about 200 mmHg, about 0 mmHg to about 225 mmHg, about 0 mmHg to about 250 mmHg, about 0 mmHg to about 275 mmHg, about 0 mmHg to about 300 mmHg, about 0 to about 350 mmHg, about 0 mmHg to about 400 mmHg, about 10 mmHg to about 20 mmHg, about 10 mmHg to about 30 mmHg, about 10 mmHg to about 40 mmHg, about 10 mmHg to about 50 mmHg, about 10 mmHg to about 60 mmHg, about 10 mmHg to about 70 mmHg, about 10 mmHg to about 80 mmHg, about 10 mmHg to about 90 mmHg, about 10 mmHg to about 100 mmHg, about 10 mmHg to about 110 mmHg, about 10 mmHg to about 120 mmHg, about 10 mmHg to about 130 mmHg, about 10 mmHg to about 140 mmHg, about 10 mmHg to about 150 mmHg, about 10 mmHg to about 175 mmHg, about 10 mmHg to about 200 mmHg, about 10 mmHg to about 225 mmHg, about 10 mmHg to about 250 mmHg, about 10 mmHg to about 300 mmHg, about 10 to about 350 mmHg, about 10 mmHg to about 400 mmHg, about 20 mmHg to about 30 mmHg, about 20 mmHg to about 40 mmHg, about 20 mmHg to about 50 mmHg, about 20 mmHg to about 60 mmHg, about 20 mmHg to about 70 mmHg, about 20 mmHg to about 80 mmHg, about 20 mmHg to about 90 mmHg, about 20 mmHg to about 100 mmHg, about 20 mmHg to about 110 mmHg, about 20 mmHg to about 120 mmHg, about 20 mmHg to about 130 mmHg, about 20 mmHg to about 140 mmHg, about 20 mmHg to about 150 mmHg, about 20 mmHg to about 175 mmHg, about 20 mmHg to about 200 mmHg, about 20 mmHg to about 225 mmHg, about 20 mmHg to about 250 mmHg, about 20 mmHg to about 300 mmHg, about 20 to about 350 mmHg, about 20 mmHg to about 400 mmHg, about 25 mmHg to about 50 mmHg, about 25 mmHg to about 75 mmHg, about 25 mmHg to about 100 mmHg, about 30 mmHg to about 40 mmHg, about 30 mmHg to about 50 mmHg, about 30 mmHg to about 60 mmHg, about 30 mmHg to about 70 mmHg, about 30 mmHg to about 80 mmHg, about 30 mmHg to about 90 mmHg, about 30 mmHg to about 100 mmHg, about 30 mmHg to about 110 mmHg, about 30 mmHg to about 120 mmHg, about 30 mmHg to about 130 mmHg, about 30 mmHg to about 140 mmHg, about 30 mmHg to about 150 mmHg, about 30 mmHg to about 175 mmHg, about 30 mmHg to about 200 mmHg, about 30 mmHg to about 225 mmHg, about 30 mmHg to about 250 mmHg, about 30 mmHg to about 300 mmHg, about 30 to about 350 mmHg, about 30 mmHg to about 400 mmHg, about 40 mmHg to about 50 mmHg, about 40 mmHg to about 60 mmHg, about 40 mmHg to about 70 mmHg, about 40 mmHg to about 80 mmHg, about 40 mmHg to about 90 mmHg, about 40 mmHg to about 100 mmHg, about 40 mmHg to about 110 mmHg, about 40 mmHg to about 120 mmHg, about 40 mmHg to about 130 mmHg, about 40 mmHg to about 140 mmHg, about 40 mmHg to about 150 mmHg, about 40 mmHg to about 175 mmHg, about 40 mmHg to about 200 mmHg, about 40 mmHg to about 225 mmHg, about 40 mmHg to about 250 mmHg, about 40 mmHg to about 300 mmHg, about 40 to about 350 mmHg, about 40 mmHg to about 400 mmHg, about 50 mmHg to about 60 mmHg, about 50 mmHg to about 70 mmHg, about 50 mmHg to about 75 mmHg, about 50 mmHg to about 80 mmHg, about 50 mmHg to about 90 mmHg, about 50 mmHg to about 100 mmHg, about 50 mmHg to about 110 mmHg, about 50 mmHg to about 120 mmHg, about 50 mmHg to about 130 mmHg, about mmHg 50 to about 140 mmHg, about 50 mmHg to about 150 mmHg, about 50 mmHg to about 175 mmHg, about 50 mmHg to about 200 mmHg, about 50 mmHg to about 225 mmHg, about 50 mmHg to about 250 mmHg, about 50 mmHg to about 300 mmHg, about 50 to about 350 mmHg, about 50 mmHg to about 400 mmHg, about 60 mmHg to about 70 mmHg, about 60 mmHg to about 80 mmHg, about 60 mmHg to about 90 mmHg, about 60 mmHg to about 100 mmHg, about 60 mmHg to about 110 mmHg, about 60 mmHg to about 120 mmHg, about 60 mmHg to about 130 mmHg, about 60 mmHg to about 140 mmHg, about 60 mmHg to about 150 mmHg, about 60 mmHg to about 175 mmHg, about 60 mmHg to about 200 mmHg, about 60 mmHg to about 225 mmHg, about 60 mmHg to about 250 mmHg, about 60 mmHg to about 300 mmHg, about 60 to about 350 mmHg, about 60 mmHg to about 400 mmHg, about 70 mmHg to about 80 mmHg, about 70 mmHg to about 90 mmHg, about 70 mmHg to about 100 mmHg, about 70 mmHg to about 110 mmHg, about 70 mmHg to about 120 mmHg, about 70 mmHg to about 130 mmHg, about 70 mmHg to about 140 mmHg, about 70 mmHg to about 150 mmHg, about 70 mmHg to about 175 mmHg, about 70 mmHg to about 200 mmHg, about 70 mmHg to about 225 mmHg, about 70 mmHg to about 250 mmHg, about 70 mmHg to about 300 mmHg, about 70 to about 350 mmHg, about 70 mmHg to about 400 mmHg, about 75 mmHg to about 100 mmHg, about 75 mmHg to about 125 mmHg, about 80 mmHg to about 90 mmHg, about 80 mmHg to about 100 mmHg, about 80 mmHg to about 110 mmHg, about 80 mmHg to about 120 mmHg, about 80 mmHg to about 130 mmHg, about 80 mmHg to about 140 mmHg, about 80 mmHg to about 150 mmHg, about 80 mmHg to about 175 mmHg, about 80 mmHg to about 200 mmHg, about 80 mmHg to about 225 mmHg, about 80 mmHg to about 250 mmHg, about 80 mmHg to about 300 mmHg, about 80 to about 350 mmHg, about 80 mmHg to about 400 mmHg, about 90 mmHg to about 100 mmHg, about 90 mmHg to about 110 mmHg, about 90 mmHg to about 120 mmHg, about 90 mmHg to about 130 mmHg, about 90 mmHg to about 140 mmHg, about 90 mmHg to about 150 mmHg, about 90 mmHg to about 175 mmHg, about 90 mmHg to about 200 mmHg, about 90 mmHg to about 225 mmHg, about 90 mmHg to about 250 mmHg, about 90 mmHg to about 300 mmHg, about 90 to about 350 mmHg, about 90 mmHg to about 400 mmHg, about 100 mmHg to about 110 mmHg, about 100 mmHg to about 120 mmHg, about 100 mmHg to about 130 mmHg, about 100 mmHg to about 140 mmHg, about 100 mmHg to about 150 mmHg, about 100 mmHg to about 175 mmHg, about 100 mmHg to about 200 mmHg, about 100 mmHg to about 225 mmHg, about 100 mmHg to about 250 mmHg, about 100 mmHg to about 300 mmHg, about 100 to about 350 mmHg, about 100 mmHg to about 400 mmHg, about 110 mmHg to about 120 mmHg, about 110 mmHg to about 130 mmHg, about 110 mmHg to about 140 mmHg, about 110 mmHg to about 150 mmHg, about 110 mmHg to about 175 mmHg, about 110 mmHg to about 200 mmHg, about 110 mmHg to about 225 mmHg, about 110 mmHg to about 250 mmHg, about 110 mmHg to about 300 mmHg, about 110 to about 350 mmHg, about 110 mmHg to about 400 mmHg, about 120 mmHg to about 130 mmHg, about 120 mmHg to about 140 mmHg, about 120 mmHg to about 150 mmHg, about 120 mmHg to about 175 mmHg, about 120 mmHg to about 200 mmHg, about 120 mmHg to about 225 mmHg, about 120 mmHg to about 250 mmHg, about 120 mmHg to about 300 mmHg, about 120 to about 350 mmHg, about 120 mmHg to about 400 mmHg, about 130 mmHg to about 140 mmHg, about 130 mmHg to about 150 mmHg, about 130 mmHg to about 175 mmHg, about 130 mmHg to about 200 mmHg, about 130 mmHg to about 225 mmHg, about 130 mmHg to about 250 mmHg, about 130 mmHg to about 300 mmHg, about 130 to about 350 mmHg, about 130 mmHg to about 400 mmHg, about 140 mmHg to about 150 mmHg, about 140 mmHg to about 175 mmHg, about 140 mmHg to about 200 mmHg, about 140 mmHg to about 225 mmHg, about 140 mmHg to about 250 mmHg, about 140 mmHg to about 300 mmHg, about 140 to about 350 mmHg, about 140 mmHg to about 400 mmHg, about 150 mmHg to about 175 mmHg, about 150 mmHg to about 200 mmHg, about 150 mmHg to about 225 mmHg, about 150 mmHg to about 250 mmHg, about 150 mmHg to about 300 mmHg, about 150 to about 350 mmHg, about 150 mmHg to about 400 mmHg, about 175 mmHg to about 200 mmHg, about 175 mmHg to about 225 mmHg, about 175 mmHg to about 250 mmHg, about 175 mmHg to about 300 mmHg, about 175 to about 350 mmHg, about 175 mmHg to about 400 mmHg, about 200 mmHg to about 225 mmHg, about 200 mmHg to about 250 mmHg, about 200 mmHg to about 300 mmHg, about 200 to about 350 mmHg, about 200 mmHg to about 400 mmHg, about 225 mmHg to about 250 mmHg, about 225 mmHg to about 300 mmHg, about 225 to about 350 mmHg, about 225 mmHg to about 400 mmHg, about 275 mmHg to about 300 mmHg, about 275 to about 350 mmHg, about 275 mmHg to about 400 mmHg, about 300 mmHg to about 325 mmHg, about 300 to about 350 mmHg, about 300 mmHg to about 400 mmHg, about 325 mmHg to about 350 mmHg, about 325 to about 375 mmHg, about 325 mmHg to about 400 mmHg, about 350 mmHg to about 375 mmHg, about 350 to about 400 mmHg, or about 375 mmHg to about 400 mmHg.
The breast cup 2 may pump from about 1 second to about 2 hours, about e.g., about 30 seconds to about 1 minute, about 30 seconds to about 2 minutes, about 30 seconds to about 3 minutes, about 30 seconds to about 4 minutes, about 30 seconds to about 5 minutes, about 30 seconds to about 10 minutes, about 30 seconds to about 15 minutes, about 30 seconds to about 30 minutes, about 30 seconds to about 5 minutes, about 5 minutes to about 10 minutes, about 5 minutes to about 15 minutes, about 5 minutes to about 20 minutes, about 5 minutes to about 25 minutes, about 5 minutes to about 30 minutes, about 5 minutes to about 35 minutes, about 5 minutes to about 40 minutes, about 5 minutes to about 1 hour, about 10 minutes to about 15 minutes, about 10 minutes to about 20 minutes, about 10 minutes to about 25 minutes, about 10 minutes to about 30 minutes, about 10 minutes to about 40 minutes, about 10 minutes to about 50 minutes, about 10 minutes to about 1 hour, about 15 minutes to about 30 minutes, about 15 minutes to about 45 minutes, about 15 minutes to about 1 hour, about 15 minutes to about 1.25 hours, about 15 minutes to about 1.5 hours, about 15 minutes to about 1.75 hours, about 15 minutes to about 2 hours, about 20 minutes to about 30 minutes, about 20 minutes to about 40 minutes, about 20 minutes to about 50 minutes, about 30 minutes to about 45 minutes, about 30 minutes to about 1 hour, about 30 minutes to about 1.25 hours, about 30 minutes to about 1.5 hours, about 30 minutes to about 1.75 hours, about 30 minutes to about 2 hours, about 45 minutes to about 1 hour, about 45 minutes to about 1.25 hours, about 45 minutes to about 1.5 hours, about 45 minutes to about 1.75 hours, about 45 minutes to about 2 hours, about 1 hour to about 1.25 hours, about 1 hour to about 1.5 hours, about 1 hour to about 1.75 hours, about 1 hour to about 2 hours, about 1.25 hours to about 1.5 hours, about 1.25 hours to about 1.75 hours, about 1.25 hours to about 2 hours, about 1.5 hours to about 1.75 hours, about 1.5 hours to about 2 hours, or about 1.75 hours to about 2 hours. The user may input a pump program from about 1 second to about 2 hours, and, e.g., set the program before the start of an activity, rest, or sleep.
In some embodiments, the method further includes turning on a positive pressure source. A positive pressure source may be turned on after the breast cup 2 contacts the human breast. In some embodiments, the positive pressure source is turned on with the power switch 14. In some embodiments, the positive pressure source is turned on remotely. In some embodiments, the positive pressure source is turned on automatically according to a preprogrammed schedule. In some embodiments, the positive pressure source is turned on automatically according to a pre-programmed schedule a plurality of times.
In some embodiments, the method further includes turning off the breast cup 2. In some embodiments, the breast cup 2 is turned off with the power switch 14. In some embodiments, the breast cup 2 is turned off remotely. In some embodiments, the breast cup 2 is turned off automatically according to a pre-programmed schedule. In some embodiments, the breast cup 2 is turned off automatically according to a pre-programmed schedule a plurality of times.
In some embodiments, the method further includes turning off the pressure source 9. In some embodiments, the pressure source 9 is turned off with the power switch 14. In some embodiments, the pressure source 9 is turned off remotely. In some embodiments, the pressure source 9 is turned off automatically according to a pre-programmed schedule. In some embodiments, the pressure source 9 is turned off automatically according to a preprogrammed schedule a plurality of times.
The method may include alternating between a first pressure to extend the nipple and express milk, and a second pressure to contact the nipple and slow or stop milk expression. Additionally, the method may include pumping at from two to ten pressures, e.g., one, two, three, four, five, six, seven, eight, nine, or ten pressures. The pressures applied to the breast may increase or decrease throughout the pumping.
As discussed above, the breast cup 2 may include at least one sensor. The method may further include the taking of a weight, temperature, pressure, pH, viscosity, optical, volume, or flow measurement. The method may further include alerting a user of a sensor measurement. The method may further include changing at least one of the first pressure or second pressure based on the temperature, weight, pressure, or flow measurement. As noted, the present disclosure provides methods of breast pumping while the user is in motion. Further, the present disclosure allows for methods to allow a mother or other care provider to carry out pumping in accordance with lifestyle preferences.
For example, speaking generally, if a new mother or other care provider wishes to resume or undertake activities requiring travel (e.g., to work), the possibility of not initiating or prematurely ending the breastfeeding period may increase. The present disclosure provides a breast cup 2 which may be used while the user is in motion, such that the user may consistently breast pump while carrying out other activities (e.g., travel to and from work) associated with their daily routine. The present disclosure further provides a breast cup 2 which may be used while the user is working.
In some embodiments, the breast cup 2 may be used while the user is moving, reclining, resting, or sleeping. The breast pumping system may be used comfortably during sleep with reduced interruption of sleep.
KITS
In another aspect, the disclosure provides kits. Kits may include two or more unconnected components of a breast cup. A kit may include a breast cup or components thereof and one or more fluidic conduits. For example, a kit may include two breast cups or components thereof and two or more fluidic conduits. The fluidic conduits, e.g., for the milk chamber, may be branched to allow connection to both breast cups with a single connection to the reservoir. A kit including components of a breast cup may include at least two of the following components, e.g., all: the pressure source 9, the upper housing 17, the diaphragm 18, the breast shield 19, the milk chamber wall 26, and a power source. A user may assemble the breast cup from the kit. A kit may include two or more components for use with the breast cup, e.g., one or more breast cups, a reservoir, and/or a garment.
Alternative Breast Cup
Referring now to FIGS. 10-14, an alternative breast cup 102 for use with the breast pump system 1 is shown, according to an example embodiment. As will be described below, the breast cup 102 includes an integrated pressure source 109 configured to selectively apply negative and/or positive pressure to a pressure chamber 120 within the breast cup 102 to selectively move a diaphragm 118 to expand and/or contract a milk chamber 121 to induce lactation and force or otherwise provide induced milk out of the breast cup 102 into an off- body reservoir (e.g., one of the reservoirs 3). It should be appreciated that, in some instances, the breast cup 102 may include similar and/or the same components and/or functionalities of the breast cup 2 and may similarly be used in any of the methods described above to induce lactation and force or otherwise provide induced milk out of the breast cup 102 into an off-body reservoir. For example, in some instances, the pressure source 109 may be the same as or similar to the pressure source 9 and/or function similarly to or in the same way as the pressure source 9 discussed above. Similarly, any of the various components and/or functionalities of the breast cup 102 described below may be applied to or otherwise incorporated into the breast cup 2 described above. Each of these variations is contemplated herein and is within the scope of the present disclosure.
As best illustrated in FIGS. 10 and 11, the breast cup 102 includes a housing formed by an upper housing component 117 and a lower housing component 126. The upper housing component 117 includes a cap or cover portion 130 coupled to a pressure chamber wall portion 132. The cap or cover portion 130 and the pressure chamber wall portion 132 collectively form an internal cavity within the upper housing component 117 that houses or otherwise envelopes a plurality of additional components of the breast cup 102. In some instances, the cap or cover portion 130 and the pressure chamber wall portion 132 may be coupled together via a snap-fit connection, a latch-type connection, a threaded fastener connection, an adhesive coupling, or any other suitable coupling method.
For example, as best illustrated in FIG. 12, the internal cavity of the upper housing component 117 houses the integrated pressure source 109, which is configured to produce or otherwise generate pressure to be delivered or applied to the pressure chamber 120. The integrated pressure source 109 is coupled to the pressure chamber 120 via a manifold 134 having a plurality of solenoid valves 136. The plurality of solenoid valves 136 is configured to selectively direct positive pressure and negative pressure from the integrated pressure source 109 through an internal fluid channel or conduit of the manifold 134 and into the pressure chamber 120 via a pressure chamber inlet 137 (shown in FIG. 14). For example, in some instances, the integrated pressure source 109 is a vacuum pump or a similar pressure source that is configured to continuously generate both positive pressure and negative pressure (e.g., out of separate pressure ports) when activated, and the plurality of solenoid valves 136 are configured to be actuated to selectively direct the positive pressure or the negative pressure into the pressure chamber 120. In some instances, the plurality of solenoid valves 136 include three three-way solenoid valves. In other instances, the plurality of solenoid valves 136 include more or less solenoid valves of varying types. In some instances, the integrated pressure source 109 and the various solenoid valves 136 are each electronically coupled to and receive power from a power source 138. For example, in some instances, the power source 138 may be a battery, such as a rechargeable battery or a disposable battery. In some instances, the cap or cover portion 130 of the upper housing component 117 may be removed to provide access to the power source 138 to allow for a user to recharge or replace the power source 138.
In some instances, the integrated pressure source 109 and the various solenoid valves 136 may be communicatively coupled to and controlled by a processing circuit or controller 140. For example, in some instances, the processing circuit or controller 140 is configured to selectively power the integrated pressure source 109 via the power source 138. In some instances, the processing circuit or controller 140 is additionally configured to selectively actuate the various solenoid valves 136 to direct the positive pressure or negative pressure generated by the integrated pressure source 109 into the pressure chamber 120.
In some instances, the processing circuit or controller 140 may include one or more processors and one or more memories storing instructions thereon that, when executed by the one or more processors, cause the one or more processing circuits to perform the various functions described herein. In some instances, the processing circuit or controller 140 may further include one or more communication interfaces configured to allow the processing circuit or controller 140 to communicate with other devices over a communications network (e.g., Bluetooth, Wi-Fi, near-field communication, etc.).
Additionally, in some instances, the processing circuit or controller 140 may include or be communicatively coupled to one or more input/output (VO) devices 142 (shown in FIG. 10) configured to allow a user to selectively operate the breast cup 102 and/or modify functionality parameters of the breast cup 102. For example, the one or more I/O devices may include a display, one or more buttons (e.g., a power button, a pumping session start/stop button), a touchscreen, an audio speaker, a timer, an alarm, a power switch, and/or any other suitable I/O devices. In some instances, the I/O devices may allow for a user to initiate, end, and/or modify a pumping session using the breast cup 102, as will be described further below.
As best shown in FIGS. 11, 13, and 14, the diaphragm 118 is disposed between the pressure chamber wall portion 132 of the upper housing component 117 and the lower housing component 126. The diaphragm 118 is further coupled between the upper housing component 117 and the lower housing component 126 around an outer periphery of the diaphragm 118. As shown, the diaphragm 118 is disposed between and separates the pressure chamber 120 and the milk chamber 121. As described further below, as negative pressure is applied to the pressure chamber 120 by the pressure source 109, the diaphragm 118 is pulled into an expanded position (illustrated by dashed lines 118’ shown in FIG. 11). As the negative pressure is released and/or the positive pressure is applied to the pressure chamber 120 by the pressure source 109, the diaphragm 118 returns to and/or is forced back into a contracted position (e.g., the position of the diaphragm 118 shown in FIGS. 11, 13, and 14).
The lower housing component 126 is coupled to the upper housing component 117 and the breast shield 119 and forms a lower milk chamber wall. As shown in FIG. 11, the lower housing component 126 includes a seal interface surface 144 configured to contact a lip 146 of the diaphragm 118 to create a seal therebetween when the diaphragm is in the contracted position. The seal interface surface 144 and the lip 146 are further configured to move out of contact with one another when the diaphragm 118 is pulled into the expanded position, thereby breaking the seal and creating a milk chamber inlet therebetween.
The breast shield 119 is coupled to the lower housing component 126 and is configured to contact and couple to a human breast of a subject. For example, as shown in FIGS. 11, 13, and 14, the breast shield 119 comprises a conical shape configured to receive a human breast A nipple tunnel 113 is formed by the breast shield 119 (e.g., alone or in combination with a rounded upper surface 148 of the diaphragm 118) within which a nipple of the human breast is configured to pass into and sit during a pumping session, as will be described further below.
Now that the general structure of the breast cup 102 has been described above, a method of operating the breast cup 102 will be provided below. It should be appreciated that the following method is provided as an illustrative example and is not meant to be limiting.
During operation, the breast cup 102 may initially be attached to a breast of a subject by placing the breast shield onto the breast with the nipple of the breast arranged within the nipple tunnel 113. With the breast cup 102 attached to the breast of the subject, negative pressure from the pressure source 109 is applied (e.g., directed by the various solenoid valves 136 as controlled by the controller 140) to the pressure chamber 120 via the pressure chamber inlet 137.
As the negative pressure is applied to the pressure chamber 120, the diaphragm 118 is moved into the expanded position shown in FIG. 11 (or in some instances is pulled farther into the pressure chamber 120 than illustrated), and negative pressure is induced within the milk chamber 121 and the nipple tunnel 113, thereby inducing lactation from the nipple. The lactated milk is then able to flow from the nipple tunnel 113 and into the milk chamber 121 through the milk chamber inlet formed between the seal interface surface 144 of the lower housing component 126 and the lip 146 of the diaphragm 118. In some instances, the rounded upper surface 148 of the diaphragm 118 allows for lactated milk that contacts the diaphragm 118 to more easily drip down through the milk chamber inlet into the milk chamber 121.
After the negative pressure is applied to the pressure chamber 120, the diaphragm 118 is allowed to return to the nominal position shown in FIGS. 11, 13, and 14 by discontinuing the application of the negative pressure and allowing the pressure chamber 120 to return to an initial pressurization level (e.g., the solenoid valves 136 and/or the pressure source 109 may be configured to return the pressure chamber 120 to atmospheric pressure). As the diaphragm 118 returns to the nominal position, the seal interface surface 144 of the lower housing component 126 and the lip 146 of the diaphragm 118 come back into contact with each other, thereby recreating the seal therebetween and preventing milk and positive pressure from flowing from the milk chamber 121 back into the nipple tunnel 113 (which would otherwise lower efficiency of the pumping and/or cause the breast cup 102 to detach from the breast of the subject).
Further, with the seal created between the seal interface surface 144 and the lip 146, the diaphragm 118 returning to the nominal position collapses the milk chamber 121 and forces milk out of the milk chamber 121 through an outlet 150 extending from the milk chamber 121, through the lower housing component 126, and out of the breast cup 102. The outlet 150 may be fluidly coupled (e.g., via fluid conduit 5) to one or more external reservoirs (e.g., reservoirs 3) configured to receive, store, and provide later access to the pumped milk.
In some instances, to ensure complete evacuation of the milk chamber 121 and/or to allow for breast pumping while the subject is in any position (e.g., leaning back, laying down, reclining), positive pressure is applied (e.g., directed by the various solenoid valves 136 as controlled by the controller 140) to the pressure chamber 120 via the pressure chamber inlet 137 to further collapse the milk chamber 121 and force the milk out of the milk chamber 121 through the outlet.
It should be appreciated that the breast cup 102 may be utilized in a variety of pumping scenarios similar to those discussed above, with respect to the breast cup 2. For example, in some instances, the breast cup 102 may be utilized to perform multiple pumping sessions. In some instances, a subject may wait at least 30 minutes between breast pumping sessions. In some instances, the breast cup 102 may not be removed between breast pumping sessions. In some instances, a first external reservoir may be replaced with a second external reservoir between consecutive pumping sessions. In some instances, an external manifold may be configured to direct milk to different external reservoirs between pumping sessions.
The foregoing and following examples are provided to be illustrative and are not meant to be limiting.
EXAMPLES
Example 1: Breast Cup
An example breast cup includes a pressure source, a diaphragm, a breast shield, a pressure chamber, a milk chamber, an outlet, and a sealing point.
When negative pressure from the pressure source is applied to pressure chamber, diaphragm deforms away sealing point, opening the inlet to milk chamber. As negative pressure is applied to the nipple, the nipple expands, and milk is expressed. The expressed milk enters milk chamber through the opened inlet, expanding the volume of milk chamber.
Optionally, a control valve may be opened to return the pressure of breast shield to atmospheric pressure, allowing the nipple to return to a nominal length, and allowing the diaphragm to return to a position sealing the inlet to milk chamber at sealing point.
When positive pressure is applied to pressure chamber, diaphragm deforms towards sealing point, sealing the inlet to milk chamber at sealing point. Diaphragm further deforms towards milk chamber, transporting milk through outlet of milk chamber, and into a fluid conduit. Milk then flows towards a reservoir.
The breast cup includes controls that are operable by a user to select or modify at least one of pumping program or mode, frequency of pumping cycle, maximum suction pressure achieved during a pumping cycle, latch suction pressure achieved during the pumping cycle, pumping force and pumping session time. The controls are present in an application on an external computer.
In the application, the user is able to set the pump programing including pumping length, cycle speed(s), vacuum level(s), and pump start time(s). The breast cup has two phases: a stimulation phase and an expression phase. The stimulation phase is typically characterized by a rapid initial stage, e.g., 100 cycles per minute, at a low to moderate vacuum strength. The initial rapid stage induces the letdown of milk and mimics the initial quick suckling motion of an infant. Once milk begins flowing, the system or the user typically switches the breast cup into the expression phase. Expression is typically characterized by slower cycles per minute, e.g., 38 cycles per minute, at moderate to high vacuum strength. The expression phase mimics an infant’s behavior at breast with slower and deeper suckling. It is possible for the user to cycle between these two phases more than one time per session. Once a user has completed the initial stimulation and expression phase, the user may switch back to stimulation mode to produce another let down of milk and then begin another expression cycle.
As utilized herein with respect to numerical ranges, the terms “approximately,” “about,” “substantially,” and similar terms generally mean ± 5% or 10% of the disclosed values, unless specified otherwise. As utilized herein with respect to structural features (e.g., to describe shape, size, orientation, direction, relative position, etc.), the terms “approximately,” “about,” “substantially,” and similar terms are meant to cover minor variations in structure that can 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.
It should be noted that the term “exemplary” and variations thereof, as used 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).
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 can differ according to other exemplary embodiments, and that such variations are intended to be encompassed by the present disclosure.
Additionally, the terms “connected” or “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 coupled with one another, or with the two members coupled to each other using an intervening member that is integrally formed as a single unitary body with one of the two 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.
It is important to note that any element disclosed in one embodiment may be incorporated or utilized with any other embodiment disclosed herein. The systems and methods described herein may be embodied in other specific forms without departing from the characteristics thereof. The foregoing implementations are illustrative rather than limiting of the described devices and methods. The scope of the devices and methods described herein is thus indicated by the appended claims, and changes that come within the meaning and range of equivalency of the claims are embraced therein.

Claims

1. A breast cup comprising: a housing including an outlet configured to be fluidly coupled to an external reservoir; a breast shield configured to be attached to a human breast; a diaphragm disposed between the housing and the breast shield, wherein the diaphragm is disposed between a pressure chamber and a milk chamber; and a pressure source in fluidic communication with the pressure chamber, the pressure source configured to apply pressure to the pressure chamber to induce lactation from the human breast and pull milk from the human breast into the milk chamber, wherein the outlet, when fluidly coupled to the external reservoir, allows the milk to flow from the milk chamber to the external reservoir.
2. The breast cup of claim 1, wherein the pressure source is configured to apply negative pressure to the pressure chamber to induce the lactation and pull the milk into the milk chamber and to apply positive pressure to the pressure chamber to force the milk out of the breast cup.
3. The breast cup of claim 2, wherein the milk is pulled into the milk chamber from a nipple tunnel of the breast shield through a milk chamber inlet.
4. The breast cup of claim 3, wherein, when the pressure source applies the positive pressure to the pressure chamber to force the milk out of the breast cup, the diaphragm is configured to seal the milk chamber inlet to prevent the positive pressure from being transferred to the nipple tunnel.
5. The breast cup of claim 3, wherein the diaphragm includes a sealing lip configured to allow the milk to travel from the nipple tunnel into the milk chamber and to prevent the milk from traveling from the milk chamber into the nipple tunnel.
6. The breast cup of claim 1, wherein the pressure source is disposed within the housing.
7. The breast cup of claim 1, further comprising a manifold configured to selectively alternate the pressure applied from the pressure source to the pressure chamber between positive pressure and negative pressure.
8. The breast cup of claim 1, wherein the housing is formed by an upper housing component and a lower housing component.
9. The breast cup of claim 8, wherein the lower housing component includes the outlet.
10. The breast cup of claim 1, wherein one or more of the housing, the diaphragm, or the breast shield comprises a clear material.
11. The breast cup of claim 1, wherein the outlet comprises a one directional valve configured to allow the milk to flow from the milk chamber to the external reservoir.
12. The breast cup of claim 1, wherein the pressure source comprises both a positive pressure source and a negative pressure source.
13. The breast cup of claim 1, wherein the pressure source is a vacuum pump.
14. The breast cup of claim 1, wherein the pressure source is operatively connected to a power source.
15. The breast cup of claim 14, wherein the breast cup further comprises the power source.
16. The breast cup of claim 14, wherein the power source is external to the breast cup.
17. The breast cup of claim 1, further comprising one or more of a display, a timer, an alarm, or a power switch.
18. A breast pump system comprising: a reservoir configured to store milk; a breast cup configured to be attached to a human breast, the breast cup comprising: a housing including an outlet configured to be fluidly coupled to the reservoir; a diaphragm disposed within the housing between a pressure chamber and a milk chamber; and a pressure source in fluidic communication with the pressure chamber, the pressure source configured to apply pressure to the pressure chamber to induce lactation from the human breast and pull milk from the human breast into the milk chamber; and a fluid conduit fluidly coupling the outlet to the reservoir, wherein the outlet allows the milk to flow from the milk chamber, through the fluid conduit, to the reservoir.
19. The breast pump system of claim 18, wherein first fluid conduit is releasably connected to one or more of the outlet or the reservoir.
20. The breast pump system of claim 18, wherein the breast cup is a first breast cup, the breast pump system further comprising a second breast cup.
21. A method of breast pumping compri sing : attaching a breast cup to a human breast of a subject, the breast cup including an internal pressure source and a pressure chamber; and applying pressure to the pressure chamber using the internal pressure source to pump milk from the human breast and into an external reservoir fluidly coupled to the breast cup via a fluid conduit.
22. The method of claim 21, wherein the breast cup further includes a diaphragm disposed within a housing of the breast cup between the pressure chamber and a milk chamber.
23. The method of claim 22, wherein applying the pressure to the pressure chamber comprises applying alternating negative pressure and positive pressure to pull the milk from the human breast into the milk chamber and to force the milk out of the milk chamber to the external reservoir via the fluid conduit.
24. The method of claim 23, wherein the milk is pulled from the human breast into the milk chamber from a nipple tunnel and, when the positive pressure is applied to the pressure chamber, a sealing lip of the diaphragm prevents the milk from passing from the milk chamber back into the nipple tunnel.
25. The method of claim 24, wherein the milk chamber comprises an inlet and the diaphragm pulls away from the inlet to provide fluidic communication between the milk chamber and the nipple tunnel when pressure in the pressure chamber is reduced.
26. The method of claim 21, wherein the subject is one of moving, reclining, resting, or sleeping while the milk is pumped.
27. The method of claim 21, further comprising: subsequent to pumping the milk from the human breast and into the external reservoir, removing fluidic communication between the external reservoir and the breast cup without removing the breast cup from the human breast of the subject.
PCT/US2024/044913 2023-08-31 2024-08-30 Breast cup with integrated pressure source and uses thereof WO2025050076A1 (en)

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US63/535,866 2023-08-31

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5542921A (en) * 1994-11-04 1996-08-06 Gerber Products Company Electric breast pump
US20130023821A1 (en) * 2011-07-18 2013-01-24 Medela Holding Ag Breastshield unit
US20150328380A1 (en) * 2012-12-18 2015-11-19 Medela Holding Ag Breast shield unit with media separation
US20180104395A1 (en) * 2015-04-01 2018-04-19 Koninklijke Philips N.V. Pump unit for a breast pump
US20200139026A1 (en) * 2017-06-15 2020-05-07 Chiaro Technology Limited Breast pump system
US20230110029A1 (en) * 2020-12-07 2023-04-13 Willow Innovations, Inc. Breast pump systems and methods
US20230111110A1 (en) * 2020-03-26 2023-04-13 Chiaro Technology Limited Wearable breast pump system

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5542921A (en) * 1994-11-04 1996-08-06 Gerber Products Company Electric breast pump
US20130023821A1 (en) * 2011-07-18 2013-01-24 Medela Holding Ag Breastshield unit
US20150328380A1 (en) * 2012-12-18 2015-11-19 Medela Holding Ag Breast shield unit with media separation
US20180104395A1 (en) * 2015-04-01 2018-04-19 Koninklijke Philips N.V. Pump unit for a breast pump
US20200139026A1 (en) * 2017-06-15 2020-05-07 Chiaro Technology Limited Breast pump system
US20230111110A1 (en) * 2020-03-26 2023-04-13 Chiaro Technology Limited Wearable breast pump system
US20230110029A1 (en) * 2020-12-07 2023-04-13 Willow Innovations, Inc. Breast pump systems and methods

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