AU2020203701A1 - Pump apparatus and methods for expression of human breast milk - Google Patents

Abstract

PUMP APPARATUS AND METHODS FOR EXPRESSION OF HUMAN BREAST MILK Improved devices, systems and methods for the expression of milk from a breast are disclosed herein. A device for expression of milk may comprise a peristaltic pump configured to move a fluid to or from a breast interface, so as to apply pressure at the breast interface and thereby express milk from the breast. The peristaltic pump can be removably coupled to a tube carrying the fluid, so as to maintain a separation between the peristaltic pump and the fluidly coupled components of the device. A device for expressing breast milk may further comprise an adjustable breast interface configured to engage and fluidly seal against the human breast. The adjustable breast interface may be manually or automatically adjustable to fluidly seal against a plurality of sizes or shapes of human breasts.

Description

PUMP APPARATUS AND METHODS FOR EXPRESSION OF HUMAN BREAST MILK

CROSS-REFERENCE

[0001] This application claims the benefit of U.S. Provisional Application No. 62/021,601, filed July 7, 2014 [Attorney Docket No. 44936-705.101] and U.S. Provisional Application No. 62/028,219, filed July 23, 2014 [Attorney Docket No. 44936-708.101], the full disclosures of which are incorporated herein by reference. This is a divisional application of Australian Patent Application No. 2015287926, the entire contents of which being incorporated herein by reference.

[0002] This application is related to U.S. Patent Application No. 14/221,113, filed on March 20, 2014 [Attorney Docket No. 44936-703.201], U.S. Patent Application No. 14/616,557, filed on February 6, 2015 [Attorney Docket No. 44936-704.201], U.S. Provisional Application No. 62/021,597, filed on July 7, 2014 [Attorney Docket No. 44936-706.101], and U.S. Provisional Application No. 62/021,604, filed July 7, 2014 [Attorney Docket No. 44936-707.101] , the full disclosures of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

[0003] 1. Field of the Invention. The present invention generally relates to medical devices and methods, and more particularly relates to devices and methods for expression and collection of human breast milk.

[0004] The exemplary embodiments disclosed herein are preferably directed at expression of breast milk, but one of skill in the art will appreciate that this is not intended to be limiting and that the devices, systems and methods disclosed herein may be used for other treatments requiring application of a differential pressure. The devices, systems and methods disclosed herein may be used for treatments requiring application of a differential pressure to a patient or work surface, with a device having an adjustable flange that can accommodate varying patient anatomy or varying work surfaces.

[0005] Breast pumps are commonly used to collect breast milk in order to allow mothers to continue breastfeeding while apart from their children. Currently, there are two primary types

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2020203701 04 Jun 2020 of breast pumps: manually-actuated devices, which are small, but inefficient and tiring to use; and electrically-powered devices, which are efficient, but large and bulky. Therefore, it would be desirable to provide improved breast pumps that are small and highly efficient for expression and collection of breast milk. Additionally, current and proposed pump systems may only actuate a single breast pump, and therefore it may be advantageous to provide a pump that can actuate two breast pumps simultaneously.

[0006] Further, currently existing or proposed breast pumps may only provide breast interfaces of limited, fixed sizes, which can result in users having to purchase and return multiple parts as well as contend with poor fit and inefficient pumping. Breast pump users comprise a population with a wide range of size and shape requirements, which may also change over the course of use of the breast pump due to the effects of sustained use of the pump or due to natural changes in user anatomies throughout the course of breastfeeding. Therefore, it would be desirable for a breast pump to provide a breast interface that is adjustable in size or shape. At least some of these objectives will be satisfied by the devices and methods disclosed below.

[0007] 2, Description of the Background Art, The following US patents are related to expression and collection of human breast milk: U.S. Pat. Nos.: 6,673,036; 6,749,582; 6,840,918; 6,887,210; 7,875,000; 8,118,772; and 8,216,179. U.S. Patent Publication No. 2014/0121593 also relates to expression and collection of breast milk.

SUMMARY OF THE INVENTION

[0008] The present invention generally relates to medical devices, systems and methods, and more particularly relates to devices, systems and methods for expression and collection of human breast milk.

[0009] Disclosed herein are small and highly efficient apparatuses and methods of use for expression and collection of breast milk. An apparatus for expression of milk as described herein may comprise a hydraulic system, wherein movement of a fluid to or from a breast interface can apply pressure at the breast interface and thereby express milk from the breast engaged thereto. The apparatus may comprise a peristaltic pump that is removably coupled to a tube carrying the fluid, so as to move the fluid to or from the breast interface while maintaining a separation between the peristaltic pump and the fluidly coupled components of the apparatus.

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[0010] Also disclosed herein are methods and apparatus for providing an adjustable breast interface to accommodate a range of size and shape requirements of the users. The adjustable breast interface may comprise an adjustable flange configured to engage and seal against the breast, wherein the adjustable flange may be adjusted in one or both of the frustoconical portion and the inner diameter of the tubular flange neck. Alternatively or in combination, the adjustable breast interface may comprise an adjustable expression area, whose size and/or shape may be adjusted by adjusting a volume of an expression reservoir of the breast interface. For example, the expression reservoir may be fluidly coupled to an adjustable reservoir and an actuatable assembly, wherein a volume of the adjustable reservoir may be manually or automatically adjusted to adjust the volume of the expression reservoir and hence the size of the expression area.

[0011] An aspect of the present invention provides a device for expressing breast milk from a breast, said device comprising:

a breast interface comprising a flange configured to engage and fluidly seal against the breast, and an expression area where milk is expressed from the breast;

wherein the breast interface is manually or automatically adjustable to fluidly seal against a plurality of sizes or shapes of breasts.

[0012] Disclosed herein is a device for expression and collection of breast milk comprises a breast interface configured to engage a breast and fluidly seal thereagainst, the breast interface having a movable member disposed within at least a portion thereof. The device further comprises a tube filled with fluid and fluidly coupled with the breast interface, and a peristaltic pump coupled with the tube, wherein actuation of the peristaltic pump moves the fluid in a first direction or a second direction opposite the first direction. Movement of the fluid in the first direction moves the movable member in the breast interface in the first direction and thereby causes the breast interface to apply vacuum pressure at the breast to express milk therefrom. Movement of the fluid in the second direction moves the movable member in the breast interface in the second direction and thereby applies pressure at the breast interface. The peristaltic pump may be removably coupled with the tube.

[0013] The movable member of the breast interface may comprise one or more of a flexible membrane, a deformable portion of a sealing element coupled to a flexible membrane, or an expandable membrane, configured to move in response to actuation of the peristaltic pump. Movement of the movable member in the second direction may return the breast interface to

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2020203701 04 Jun 2020 atmospheric pressure, thereby allowing the expressed milk to drain into a collection vessel coupled to the breast interface. The device may further comprise a collection vessel fluidly coupled to the breast interface, and movement of the movable member in the second direction may apply positive pressure at breast interface, thereby forcing the expressed milk out of breast interface into the collection vessel.

[0014] The device may further comprise a collection vessel fluidly coupled to the breast interface, and the breast interface may comprises a first breast interface configured to engage a first breast and a second breast interface configured to engage a second breast. Actuation of the peristaltic pump may simultaneously cause the first breast interface to express milk from the first breast and the second breast interface to collect expressed milk from the second breast into the collection vessel.

[0015] The tube may comprise a central compliant region configured to engage the peristaltic pump. The tube may further comprise a less compliant region that is less compliant relative to the central compliant region and disposed adjacent to the central compliant region. The central compliant region may compress in response to actuation of the peristaltic pump, while the less compliant region may transmit pressure along the tube to the breast interface.

[0016] In another aspect, a method for expressing milk from a breast comprises engaging and fluidly sealing a breast interface with the breast, actuating a peristaltic pump, and expressing milk from the breast. The peristaltic pump may be coupled with a tube filled with a fluid and fluidly coupled to the breast interface, such that actuation of the peristaltic pump can apply vacuum pressure at the breast to express milk from the breast.

[0017] Actuating a peristaltic pump may comprise actuating the peristaltic pump so as to move the fluid in a first direction or in a second direction opposite the first direction. Moving the fluid in the first direction may cause a movable member within the breast interface to move away from the breast and thereby apply vacuum pressure at the breast to express milk therefrom.

Moving the fluid in the second direction may cause the movable member to move toward the breast and thereby cause the expressed milk to drain into a collection vessel fluidly coupled to the breast interface. Moving the fluid in the second direction may return the breast interface to atmospheric pressure, thereby allowing the expressed milk to drain into the collection vessel. Alternatively or in combination, moving the fluid in the second direction may apply a positive

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2020203701 04 Jun 2020 pressure at breast interface, thereby forcing the expressed milk out of the breast interface into the collection vessel.

[0018] The breast interface may comprise a first breast interface configured to engage a first breast and a second breast interface configured to engage a second breast. Actuating a peristaltic pump may comprise simultaneously moving the fluid away from the first breast interface to express milk from the first breast, and moving the fluid toward the second breast interface to collect expressed milk from the second breast into a collection vessel fluidly coupled to the second breast interface.

[0019] In another aspect, a device for expressing breast milk from a breast comprises a breast interface comprising a flange configured to engage and fluidly seal against the breast, and an expression area where milk is expressed from the breast. The breast interface is manually or automatically adjustable to fluidly seal against a plurality of sizes or shapes of breasts.

[0020] The flange may comprise one or more resilient materials conformable to the breast and adapted to fluidly seal against the plurality of sizes or shapes of breasts. The flange may further comprise a pocket fillable with a filling material, wherein addition of filling material to, or removal of the filling material from the pocket adjusts a size of the flange. The filling material may comprise a plurality of bead-like elements, wherein application of a vacuum to the pocket substantially locks the plurality of bead-like elements and the flange into a fixed configuration for fluidly sealing against a particular size or shape of human breast. Alternatively or in combination, the filling material may comprise a fluid. The breast interface may further comprise a fluid pump fluidly coupled to the pocket, the fluid pump configured to add or remove the fluid from the pocket.

[0021] The device may further comprise an actuatable assembly operatively coupled to the breast interface, an expression reservoir disposed within the breast interface, and an adjustable reservoir fluidly coupled to the expression reservoir and operatively coupled to the actuatable assembly. The actuatable assembly may be configured to deliver fluid from the adjustable reservoir to the expression reservoir or remove fluid from the expression reservoir and return the fluid to the adjustable reservoir. The adjustable reservoir may comprise a mechanism to adjust a volume thereof, so as to adjust a volume of the expression reservoir and thereby adjust a size of the expression area to fluidly seal against a particular size or shape of breast.

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[0022] The mechanism may be manually adjustable. Alternatively or in combination, the mechanism may be automatically adjustable, to adjust the volume of the adjustable reservoir in response to a feedback from the actuatable assembly indicating a degree of fluid seal between the breast interface and the breast. The feedback may comprise a current produced by the actuatable assembly as the volume of the adjustable reservoir is adjusted, wherein an increase in the current indicates an increased degree of fluid seal between the breast interface and the breast. The adjustable reservoir may be integrated with the actuatable assembly, such that the volume of the adjustable reservoir may be adjusted by changing a setting of the actuatable assembly. For example, the actuatable assembly may comprise a piston assembly, and the adjustable reservoir may comprise a reservoir of the piston assembly, such that changing a resting position of the piston assembly adjusts the volume of fluid in the adjustable reservoir.

[0023] In another aspect, a method for expressing breast milk from a breast comprises providing a device for expressing breast milk comprising an adjustable breast interface having a flange and an expression area. The method further comprises engaging the adjustable breast interface with the breast, adjusting a size of the adjustable breast interface, fluidly sealing the breast interface against the breast, and expressing milk from the breast.

[0024] Adjusting the size of the adjustable breast interface may comprise adding a fluid to or removing the fluid from a pocket disposed within the flange. Alternatively or in combination, adjusting the size of the adjustable breast interface may comprise providing a plurality of beadlike elements disposed in a pocket in the flange. The method may further comprise molding the plurality of bead-like elements against the human breast, applying a vacuum to the pocket, and locking the flange into a particular size or shape.

[0025] The breast interface may comprise an expression reservoir fluidly coupled with an actuatable assembly and an adjustable reservoir. Adjusting the size of the adjustable breast interface may comprise actuating the actuatable assembly, thereby delivering a fluid from the adjustable reservoir to the expression reservoir or removing the fluid from the expression reservoir and returning the fluid to the adjustable reservoir. The method may further comprise adjusting a volume of the adjustable reservoir so as to adjust a volume of the expression reservoir, thereby adjusting a size of the expression area. Adjusting a volume of the adjustable reservoir may comprise manually adjusting the volume of the adjustable reservoir. Alternatively or in combination, adjusting a volume of the adjustable reservoir may comprise automatically

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2020203701 04 Jun 2020 adjusting the volume of the adjustable reservoir in response to a feedback from the actuatable assembly indicating a degree of fluid seal between the breast interface and the breast. The adjustable reservoir may be integrated with the actuatable assembly, and automatically adjusting the volume of the adjustable reservoir may comprise changing a setting of the actuatable assembly. For example, the actuatable assembly may comprise a piston assembly and the adjustable reservoir may comprise a reservoir of the piston assembly, wherein automatically adjusting the volume of the adjustable reservoir comprises changing a resting position of the piston assembly.

[0026] These and other embodiments are described in further detail in the following description related to the appended drawing figures.

INCORPORATION BY REFERENCE

[0027] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

[0029] FIG. 1 is a perspective view of an exemplary embodiment of a pumping device.

[0030] FIG. 2 is a perspective view of an exemplary embodiment of a pumping device.

[0031] FIG. 3 A is a cross-section of an exemplary embodiment of a pumping device.

[0032] FIG. 3B is a cross-section of an exemplary embodiment of a pumping device.

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[0033] FIG. 4 illustrates an exemplary embodiment of an actuatable assembly coupled to a driving mechanism.

[0034] FIGS. 5A-5B illustrate an exemplary embodiment of an actuatable assembly coupled to a pendant unit.

[0035] FIG. 6 is a cross-sectional view of an exemplary embodiment of a breast interface.

[0036] FIG. 7 is a cross-sectional view of another exemplary embodiment of a breast interface.

[0037] FIG. 8A is a cross-sectional view of an exemplary embodiment of an integrated valve in an open position.

[0038] FIG. 8B is a cross-sectional view of an exemplary embodiment of an integrated valve in a closed position.

[0039] FIG. 9A is a cross-sectional view of an exemplary embodiment of integrated sensors within a breast interface.

[0040] FIG. 9B is a cross-sectional view of another exemplary embodiment of integrated sensors within a breast interface.

[0041] FIG. 10 illustrates an exemplary embodiment of a pendant unit and a mobile device.

[0042] FIG. 11 illustrates an exemplary embodiment of a pendant unit in communication with a mobile device.

[0043] FIG. 12 is a cross-sectional view of an exemplary embodiment of a breast interface with a mechanical deformable member.

[0044] FIG. 13 is a cross-sectional view of an exemplary embodiment of a mechanical driver for a mechanical deformable member.

[0045] FIG. 14 is a graph illustrating the pump performance of an exemplary embodiment compared to a commercial device.

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[0046] FIG. 15 is a graph illustrating the pumping efficiency of an exemplary embodiment compared to a commercial device.

[0047] FIG. 16 illustrates an exemplary pump.

[0048] FIG. 17 illustrates a cross-section of the pump in FIG. 16.

[0049] FIG. 18 illustrates an alternative embodiment of a pump system.

[0050] FIG. 19A is a cross-sectional view of an exemplary embodiment of an adjustable flange 1600.

[0051] FIGS. 19B and 19C illustrate exemplary embodiments of adjustable flanges of different sizes.

[0052] FIGS. 20A and 20B are perspective views of an exemplary embodiment of an adjustable flange with a sizing element.

[0053] FIGS. 21A, 21B, and 21C are cross-sectional views of an exemplary embodiment of an adjustable flange with a sizing element.

[0054] FIGS. 22A, 22B, and 22C illustrate exemplary embodiments of an adjustable flange that comprises a fillable pocket.

[0055] FIG. 22D is a cross-sectional view of an exemplary embodiment of an adjustable flange with a pocket filled with a fluid.

[0056] FIG. 22E is a cross-sectional view of an exemplary embodiment of an adjustable flange with a pocket filled with a plurality of bead-like elements.

[0057] FIG. 23A and 23B illustrate an exemplary embodiment of an adjustable flange that comprises a fillable pocket.

[0058] FIGS. 24A and 24B illustrate an exemplary embodiment of a device for expressing breast milk comprising an adjustable expression area.

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[0059] FIG. 25 illustrates an exemplary embodiment of an automatically adjustable system for adjusting the size of the expression area.

DETAILED DESCRIPTION OF THE INVENTION

[0060] Specific embodiments of the disclosed devices and methods will now be described with reference to the drawings. Nothing in this detailed description is intended to imply that any particular component, feature, or step is essential to the invention. One of skill in the art will appreciate that various features or steps may be substituted or combined with one another.

[0061] The present invention will be described in relation to the expression and collection of breast milk. However, one of skill in the art will appreciate that this is not intended to be limiting, and the devices and methods disclosed herein may be used in other applications involving the creation and transmission of a pressure differential, such as in the treatment of sleep apnea, wound compression, and/or other remote pressure needs, and where it would be desirable to provide an adjustable flange that can fluidly seal against a variety of anatomical shapes and sizes or any other varying work surface.

[0062] FIG. 1 illustrates an exemplary embodiment of a breast pump. Pumping device 100 includes breast interfaces 105, a tube 110, and a controller or pendant unit 115 operatively coupled to breast interfaces 105 through tube 110. Breast interfaces 105 include resilient and conformable flanges 120, for engaging and creating a fluid seal against the breasts, and collection vessels 125. The device may optionally only have a single breast interface. Pendant unit 115 houses the power source and drive mechanism for pumping device 100, and also contains hardware for various functions, such as controlling pumping device 100, milk production quantification and content analysis, and communication with other devices. Tube 110 transmits suitable energy inputs, such as mechanical energy inputs, from pendant unit 115 over a long distance to breast interfaces 105. Breast interfaces 105 convert the energy inputs into vacuum pressure against the breasts in a highly efficient manner, resulting in the expression of milk into collection vessels 125.

[0063] One of skill in the art will appreciate that components and features of this exemplary embodiment can be combined or substituted with components and features of any of the embodiments of the present invention as described below. Similarly, components and features of other embodiments disclosed herein may be substituted or combined with one another.

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Hydraulic pumping device

[0064] Hydraulic systems can reduce pumping force requirements, and therefore also reduce the size of the pumping device, while maintaining high pumping efficiency. In a preferred embodiment, the pumping device can utilize a hydraulic pumping device to generate a pressure differential against the breast for the expression and collection of milk.

[0065] Exemplary hydraulic pumping devices are depicted in FIGS. 2 and 3. FIG. 2 illustrates a pumping device 150 with a syringe 155 fluidly coupled to breast interface 160 by tube 165.

Syringe 155 is coupled to tube 165 through a three-way valve 170. Breast interface 160 contains an exit port 175. The syringe 155 drives a fluid 180 contained within tube 165 against or away from an expandable member contained within breast interface 160 to create the pressure differential necessary for milk expression from the breast.

[0066] FIG. 3A illustrates another embodiment of a pumping device 200. The actuatable assembly 205 includes an assembly housing 210, a driving element 215, radial seals 220, and a shaft 222. Driving element 215 is operatively coupled to a pendant unit, such as pendant unit 115, through shaft 222. The tube 225 contains a fluid 230 and is fluidly coupled to the actuatable assembly 205 and the breast interface 235. The breast interface 235 consists of an interface housing 240, a flexible membrane 245, a reservoir 250, a sealing element 255, an expression area 260, and a drain port 265. The sealing element 255 includes deformable portion 270. The drain port 265 is coupled to a collection vessel 275 and includes a one-way valve 280 which may be a flap, duckbill, or ball valve.

[0067] Actuatable assembly 205 displaces fluid 230 contained within tube 225, which can be a flexible line. Fluid 230 occupies reservoir 250 within breast interface 235 and is coupled with flexible membrane 245. Flexible membrane 245 transmits vacuum pressure from fluid 230 to the deformable portion 270 of sealing element 255. The flexible membrane 245 and deformable portion 270 are movable so as to move toward and away from the breast as the actuatable element 215 is actuated. When a breast is engaged into and fluidly sealed with breast interface 235 by sealing element 255, displacement of the actuatable element 215 in the outward direction away from the breast produces substantial vacuum pressure against the breast through flexible membrane 245 and deformable portion 270, resulting in the expression of breast milk into expression area 260. The expressed milk drains through drain port 265 into collection vessel

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275. Drain port 265 is configured with a one-way valve 280 to provide passage of milk while maintaining vacuum pressure in expression area 260.

[0068] FIG. 3B illustrates another exemplary embodiment of a pumping device 200a. The actuatable assembly 205 includes an assembly housing 210, a driving element 215, radial seals 220, and a shaft 222. Driving element 215 is operatively coupled to a pendant unit, such as pendant unit 115, through shaft 222. The tube 225 contains a fluid 230 and is fluidly coupled to the actuatable assembly 205 and the breast interface 235 a. The breast interface 235 a comprises a flange 236, an interface housing 240, an expandable membrane 245a, an expression reservoir 250, an expression area 260, and a drain port 265. The flange 236 comprises a frustoconical portion 237 and a tubular flange neck 238. The flange neck connects to the expression area through the expression mouth 261. The drain port 265 is coupled to a collection vessel 275 and includes a one-way valve 280.

[0069] Actuatable assembly 205 displaces fluid 230 contained within tube 225, which can be a flexible line. Fluid 230 occupies expression reservoir 250 within breast interface 235a and is coupled with expandable membrane 245a. The expandable membrane 245 a is movable so as to move toward and away from the breast as the actuatable element 215 is actuated. When a breast is engaged into and fluidly sealed with breast interface 235a by the flange 236, displacement of the actuatable element 215 in the outward direction away from the breast produces substantial vacuum pressure against the breast through expandable membrane 245a, resulting in the expression of breast milk into expression area 260. The expressed milk drains through drain port 265 into collection vessel 275. Drain port 265 is configured with a one-way valve 280 to provide passage of milk while maintaining vacuum pressure in expression area 260.

[0070] The fluid for the hydraulic pumping device can be any suitable fluid, such as an incompressible fluid. In many embodiments, the incompressible fluid can be water or oil. Alternatively, the fluid can be any suitable gas, such as air. Suitable incompressible fluids and gases for hydraulic systems are known to those of skill in the art.

[0071] One of skill in the art will appreciate that components and features of any of the exemplary embodiments of the hydraulic pumping device can be combined or substituted with components and features of any of the embodiments of the present invention as described herein.

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Peristaltic Pump

[0072] In previous hydraulic pump embodiments, the hydraulic fluid in the pumping mechanism is often the same fluid used in the transmission lines and also in the breast interface. It can be advantageous to separate the fluids to prevent contamination, so that various components of the system may be more easily separated from one another, and also to avoid having to prime the pump or other components with fluid prior to use. An alternative embodiment of a pumping device that addresses some of these challenges uses a peristaltic pump device to move fluid to or from the breast interface device.

[0073] FIG. 16 illustrates an exemplary embodiment of a peristaltic pump system 1602 for expression of breast milk. The system 1602 preferably includes two breast interfaces 1612, a transmission line or tubing 1608 and a peristaltic pump 1604. The breast interfaces 1612 may be any of the embodiments disclosed herein or known in the art. A transmission line or tubing 1608 is coupled to both breast interfaces. A preferably incompressible fluid 1610 is disposed in tubing 1608. This embodiment illustrates two breast interfaces 1612, however one of skill in the art will appreciate that a single breast interface or multiple breast interfaces may be used. The peristaltic pump includes one or more rollers 1614 that engage tubing 1608. When the rollers move in a first direction, fluid 1610 is moved in a first direction toward one of the two breast interfaces and away from the remaining breast interface. This results in actuation of the flexible membrane in the breast interfaces. One membrane is displaced outwardly thereby creating a vacuum in the breast interface and allowing expression of breast milk. The other membrane is displaced inwardly thereby either returning pressure to normal pressure such as atmospheric pressure in the breast interface, or a positive pressure may be applied in the breast interface.

When normal atmospheric pressure exists in the breast interface, the expressed milk can then be collected as previously described. Or when a positive pressure is applied, the expressed milk may be forced out of the breast interface into a collection container. One advantage of using a peristaltic pump with two breast interfaces is that while one side is expressing milk, the other side is collecting the milk in a container. The pump 1604 may include any of the display features or communication features 1606 described elsewhere in this application.

[0074] FIG. 17 illustrates a partial cross-section of the peristaltic pump in FIG. 16. Tubing 1608 is positioned in a tight channel between the rollers 1614 and an outer rim 1710 of pump 1604. As drive wheel 1708 rotates, rollers 1614 compress tubing 1608 thereby displacing fluid

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1610 in the direction of rotation. Thus, in the embodiment of FIG. 17, the drive wheel 1708 is rotating in a clock-wise direction and thus fluid 1610 will be displaced from left to right side of the tubing and positive pressure will be formed in breast interface 1612a and expandable membrane 1706 will be pushed outward toward the breast. Fluid 1608 will move away from breast interface 1612b thereby creating a vacuum and membrane 1704 will move inward toward the back of the breast interface. The negative pressure will then permit expression of breast milk. The drive wheel 1708 may be a full circular wheel as indicated in phantom, or it may be a partial circle. One or more rollers 1614 maybe coupled to the wheel.

[0075] FIG. 18 illustrates another exemplary embodiment of a peristaltic pump 1604 with the tubing uncoupled from the rollers 1614. This embodiment of a pump system 1802 is substantially the same as the previous embodiment in FIGS. 16-17 with the major difference being that the tubing 1610 has varying compliance regions. Tubing 1610 may have a central compliant region 1806 designed for engagement with the rollers 1614 and stiffer, less compliant regions 1804 on either side of the compliant region 1806. The compliant region 1804 allows the tubing to be compressed an easily inserted into engagement with the rollers 1614. Additionally, when the rollers roll over the complaint region, the tubing conforms to the rollers and this facilitates transmission of the fluid 1610 along the tubing. The other portions 1804 are more rigid in order to transmit the pressure along the tubing.

Actuation mechanism

[0076] Many actuation mechanisms known to those of skill in the art can be utilized for the actuatable assembly 205. Actuatable assembly 205 can be a piston assembly, a pump such as a diaphragm pump, or any other suitable actuation mechanism. The optimal configuration for actuatable assembly 205 can depend on a number of factors, such as: vacuum requirements; size, power, and other needs of the pumping device 200; and the properties of the fluid 230, such as viscosity, biocompatibility, and fluid life requirements.

[0077] FIGS. 3A and 3B illustrate exemplary embodiments in which actuatable assembly 205 is a piston assembly and driving element 215 is a piston. Actuatable assembly 205 includes radial seals 220, such as O-rings, sealing against assembly housing 210 to prevent undesired egress of fluid 230 and to enable driving of fluid 230.

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[0078] FIG. 4 illustrates another exemplary embodiment of an actuatable assembly 300 including a pair of pistons 305.

[0079] In preferred embodiments, the actuatable assembly includes a driving element powered by a suitable driving mechanism, such as a driving mechanism residing in pendant unit 115. Many driving mechanisms are known to those of skill in the art. For instance, the driving element, such as driving element 215, may be actuated electromechanically by a motor, or manually by a suitable user-operated interface, such as a lever. Various drive modalities known to those of skill in the art can be used. In particular, implementation of the exemplary hydraulic pumping devices as described herein enables the use of suitable drive modalities such as direct drive and solenoids, owing to the reduced force requirements of hydraulic systems.

[0080] Referring now to the exemplary embodiment of FIG. 4, the pistons 305 include couplings 310 to a crankshaft 315. The crankshaft 315 is operatively coupled to a motor 320 through a belt drive 325. The crankshaft 315 drives the pair of pistons 305 with the same stroke timing in order to apply vacuum pressure against both breasts simultaneously, a feature desirable for increased milk production. Alternatively, the crankshaft 315 can drive the pair of pistons 305 with any suitable stroke timing, such as alternating or offset stroke cycles.

[0081] The driving mechanism can be powered by any suitable power source, such as a local battery or an AC adaptor. The driving mechanism can be controlled by hardware, such as onboard electronics located within pendant unit 115.

[0082] FIGS. 5A-5B illustrate an exemplary embodiment of an actuatable assembly 350 that includes releasable coupling 355. FIG. 5 A is a perspective view of the embodiment, and FIG. 5B is a cross-sectional view of the embodiment. Preferably, actuatable assembly 350 is releasably coupled to a pendant unit 360 and the driving mechanism housed therein. The coupling can be a mechanical coupling or any suitable quick release mechanism known to those of skill in the art. The releasably coupled design allows for flexibility in the configuration and use of the pumping device. For instance, user comfort can be improved through the use of differently sized breast interfaces for compatibility with various breast sizes. Additionally, this feature enables a common pumping device to be used with interchangeable breast interfaces, thus reducing the risk of spreading pathogens. Furthermore, the releasable coupling enables easy replacement of individual parts of the pumping device.

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[0083] One of skill in the art will appreciate that components and features of any of the exemplary embodiments of the actuation mechanism can be combined or substituted with components and features of any of the embodiments of the present invention as described herein.

Expandable membrane

[0084] In many embodiments such as the embodiment depicted in FIG. 3B, the expandable membrane 245a is located within breast interface 235 a and disposed over at least a portion thereof, forming expression reservoir 250 between the interface housing 240 and the expandable membrane 245a. Preferably, the expandable membrane 245a comprises a resilient material that deforms substantially or a more rigid material that is displaced when subject to the negative pressures created when the fluid 230 is displaced from expression reservoir 250 by actuatable assembly 205. The expandable membrane returns to an unbiased position when the negative pressures subside. The amount of deformation of the expandable membrane 245a can be controlled by many factors, (e.g., wall thickness, durometer, surface area) and can be optimized based on the pumping device (e.g., pump power, vacuum requirements).

[0085] FIG. 6 illustrates an exemplary expandable membrane 370 with a specified thickness and durometer.

[0086] FIG. 7 illustrates another embodiment of expandable membrane 375 with corrugated features 380 for increased surface area. Other configurations of the expandable membrane which may be used in any of the embodiments of breast pumps described herein are disclosed in US Patent Provisional Application No. 62/021,597 (Attorney Docket No. 44936-706.101) filed July 7, 2014; the entire contents of which are incorporated herein by reference.

[0087] Suitable materials for the expandable membrane are known to those of skill in the art. In many embodiments, the expandable membrane can be made of a material designed to expand and contract when subject to pressures from the coupling fluid such as silicone, polyether block amides such as PEBAX, and polychloroprenes such as neoprene. Alternatively, the expandable membrane can be fabricated from a substantially rigid material, such as stainless steel, nitinol, high durometer polymer, or high durometer elastomer. In these embodiments, the rigid material would be designed with stress and/or strain distribution elements to enable the substantial deformation of the expandable membrane without surpassing the yield point of the material.

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[0088] FIGS. 8A and 8B illustrate preferred embodiments of a breast interface 400 in which an exit valve 405 is integrated into the expandable membrane 410 to control the flow of expressed milk through exit port 415. The exit valve 405 is opened to allow fluid flow when the expandable membrane 410 is relaxed, as shown in FIG. 8A, and is closed to prevent fluid flow when the expandable membrane 410 is deformed, as shown in FIG. 8B. The exit valve 405 enables substantial vacuum pressure to be present in expression area 420 during extraction, while allowing milk to drain during the rest phase of the pump stroke. While many conventional breast pump valves function on pressure differentials alone, the exit valve 405 can preferably be configured to also function on the mechanical movement of expandable membrane 410. Incorporation of an integrated exit valve 405 with mechanical functionality as described herein can improve the sealing of the breast interface 400 during vacuum creation. Furthermore, the implementation of an exit valve integrally formed within the expandable membrane 410 such as exit valve 405 reduces the number of parts to be cleaned.

[0089] One of skill in the art will appreciate that components and features of any of the exemplary embodiments of the expandable membrane can be combined or substituted with components and features of any of the embodiments of the present invention as described herein.

Milk collection and quantification system

[0090] With reference to FIG. 3B, expressed milk drains through exit port 265 in expandable membrane 245a into a collection vessel 275. Collection vessel 275 can be any suitable container, such as a bottle or a bag. In many embodiments, collection vessel 275 is removably coupled to expandable membrane 245a. Collection vessel 275 can be coupled directly or remotely via any suitable device such as extension tubing.

[0091] In many instances, it can be desirable to track various data related to milk expression and collection, such as the amount of milk production or the chemical and nutritional content of the produced milk. Currently, the tracking of milk production is commonly accomplished by manual measurements and record-keeping. Exemplary embodiments of the device described herein may provide digital-based means to automatically measure and track milk production for improved convenience, efficiency, and accuracy.

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[0092] FIGS. 9A and 9B illustrate exemplary embodiments of a breast interface 450 with one or more integrated sensors 455. Sensors 455 are preferably located in flap valve 460, but may also be located in exit valve 465, or any other suitable location for monitoring fluid flow. In a preferred embodiment, at least one sensor 455 is integrated into a valve that is opened by fluid flow and detects the length of time that the valve is opened. The sensor signal can be interrogated to quantify the fluid flow. Suitable sensors are known to those of skill in the art, such as accelerometers, Hall effect sensors, and photodiode/LED sensors. The breast interface can include a single sensor or multiple sensors to quantify milk production.

[0093] FIG. 10 illustrates an exemplary embodiment of pendant unit 500 in which milk expression data is shown on a display screen 505. In many embodiments, the pendant unit 500 collects, processes, stores, and displays data related to milk expression. Preferably, the pendant unit 500 can transmit the data to a second device, such as a mobile phone 510.

[0094] FIG. 11 illustrates data transmission 515 between pendant unit 500 and a mobile phone 510. Suitable methods for communication and data transmission between devices are known to those of skill in the art, such as Bluetooth or near field communication.

[0095] In exemplary embodiments, the pendant unit 500 communicates with a mobile phone 510 to transmit milk expression data, such as expression volume, duration, and date. The mobile phone 510 includes a mobile application to collect and aggregate the expression data and display it in an interactive format. Preferably, the mobile application includes additional features that allow the user to overlay information such as lifestyle choices, diet, and strategies for increasing milk production, in order to facilitate the comparison of such information with milk production statistics. The mobile application can also include features that allow the user to control aspects of the pump, such as pump power and pump states (e.g., let-down and stimulate modes), adjust expression pressure and speed, and adjust the size of the breast interface 235a or others described herein, where the breast interface is automatically adjustable. The application may also have resources for breastfeeding moms, such as advice or connection to advice, social aspects such as peer comparisons, and an accessory store for acquiring accessories for the pump. Additionally, the pendant unit 500 can send information about the times of pump usage to the mobile phone 510 so that the mobile application can identify when pumping has occurred and set reminders at desired pumping times. Such reminders can help

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2020203701 04 Jun 2020 avoid missed pumping sessions, and thus reduce the incidence of associated complications such as mastitis.

[0096] One of skill in the art will appreciate that components and features of any of the exemplary embodiments of the milk collection and quantification system can be combined or substituted with components and features of any of the embodiments of the present invention as described herein.

Mechanical pumping device

[0097] FIG. 12 illustrates an alternative embodiment of a breast interface 600 in which a mechanical deformable member 605 can be used in place of a flexible membrane 245 or expandable membrane 245a. The mechanical deformable member 605 can be constructed from similar techniques as those used for the flexible or expandable membrane as described herein. The mechanical deformable member 605 is coupled to a tensile element 610. In some instances, tensile element 610 is disposed within an axial load absorbing member 615. The axial load absorbing member 615 is disposed within tube 620. Preferably, tensile element 610 is concentrically disposed within axial load absorbing member 615 and axial load absorbing member 615 is concentrically disposed within tube 620. Alternative arrangements of tensile element 610, axial load absorbing member 615, and tube 620 can also be used.

[0098] FIG. 13 illustrates the tensile element 610 coupled to driving element 625 of an actuatable assembly 630 within an assembly housing 635. Driving element 625 is operatively coupled to a driving mechanism, such as a driving mechanism housed within a pendant unit, through shaft 640. Axial load absorbing member 615 within tube 620 is fixedly coupled to the assembly housing 635. Displacement of the driving element 625 transmits tensile force through tensile element 610 to the mechanical deforming member 605 to create vacuum pressure against the breast.

[0099] The tensile element 610 can be any suitable device, such as a wire, coil, or rope, and can be made from any suitable material, such as metals, polymers, or elastomers. Axial load absorbing member 615 can be made from any suitable axially stiff materials, such as metals or polymers, and can be configured into any suitable axially stiff geometry, such as a tube or coil.

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[00100] One of skill in the art will appreciate that components and features of any of the exemplary embodiments of the mechanical pumping device can be combined or substituted with components and features of any of the embodiments of the present invention as described herein.

Adjustable breast interface

[00101] Referring to the exemplary embodiment of FIG. 3B, the breast interface 235a or any other embodiment described herein may be adjustable in size or shape to fluidly seal against and perform efficiently with a plurality of sizes or shapes of human breast. In some embodiments, the flange 236 may be adjustable in one or both of the frustoconical portion 237 and the inner diameter of the tubular flange neck 238, so as to adjust the size or shape of the breast interface. In some embodiments, the expression area 260 may be adjustable in size or shape, including in the size of the expression mouth 261, so as to adjust the size or shape of the breast interface and improve the efficiency of milk expression. Yet other embodiments may comprise a combination of an adjustable flange and an adjustable expression area.

[00102] FIG. 19A is a cross-sectional view of an exemplary embodiment of an adjustable flange 1900. A flange includes a tapered or frustoconical portion 1905 that engages the breast, and a tubular flange neck 1915 on the opposite end that transitions into expression area 1920 of the breast interface 1910 through the expression mouth 1921. The flange has an exterior surface 1925 and an interior surface 1930 with a wall 1935 defined therebetween. Physical properties and construction of the wall 1935 may vary in different embodiments, allowing the thickness of the wall to be adjusted so as to adjust the size of the flange 1910 to fit a particular size or shape of breast. The flange 1910 may be sized fixedly or adjustably, and flanges of various fixed or adjusted sizes may be detachable from or integrated with the breast interface 1910. The thickness of the wall 1935 may vary in different embodiments.

[00103] FIGS. 19B and 19C illustrate exemplary embodiments of adjustable flanges 1901 and 1902 of different sizes. Whereas the flange 1900 in FIG. 19A has a wall 1935 of a thickness such that the inner diameter of flange neck 1915 is about 30mm, the flange 1901 in FIG. 19B has a wall 1936 thicker than wall 1935 such that the inner diameter of the flange neck 1906 is about 27mm. The flange 1907 in FIG. 19C has a wall 1937 thicker yet than wall 1936, such that

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2020203701 04 Jun 2020 the inner diameter of the flange neck 1907 is about 24mm. One of skill in the art will appreciate that these dimensions are not limiting, and that any size is possible.

[00104] FIGS. 20A and 20B are perspective views of an exemplary embodiment of an adjustable flange 2000 with a sizing element 2005. The sizing element 2005 may be a fully closed ring or a partial ring, which encircles the engagement region 2010 disposed on the flange neck 2015, thereby decreasing or increasing the inner diameter of flange neck. The sizing element 2005 may be releasably coupled to the engagement region 2010 by any one of several mechanisms well-known in the art, such as a snap fit, press fit, or magnetic engagement mechanism. The sizing element 2005 may be provided in various sizes, all of which are releasably coupleable to the engagement region 2010 in the same manner. The sizing element 2005 can be coupled to and released from the engagement region 2010 repeatedly, so as to allow the flange 2000 to be adjustable in size throughout the course of a user’s use of the breast milk expression device. FIG. 20A shows the sizing element 2005 coupled to the flange 2000, while FIG. 20B shows the sizing element 2005 released from the flange 2000.

[00105] FIGS. 21A, 21B, and 21C are cross-sectional views of an exemplary embodiment of an adjustable flange 2100 with a sizing element. Sizing elements 2105 and 2106 can be releasably coupled to the engagement region 2110, which may comprise a compliant material that is reversibly deformed when a sizing element 2105 or 2106 is coupled. The deformation of the engagement region 2110 can result in the narrowing of the flange neck 2115 so as to adjust the size of the flange 2100 to fluidly seal against a particular size or shape of human breast. The release of a coupled sizing element 2105 or 2106 can reverse the deformation of the engagement region 2110, resulting in the widening of the flange neck 2115. FIG. 21A shows the adjustable flange 2100 with no coupled sizing element, having a flange neck 2115 with an inner diameter of about 30mm. FIG. 21B shows the flange 2100 with sizing element 2105 coupled to the engagement region 2110, resulting in the narrowing of the flange neck 2115 such that the inner diameter of the flange neck decreases to about 27mm. FIG. 21C shows the flange 2100 with sizing element 2106 coupled to the engagement region 2110, resulting in the further narrowing of the flange neck 2115 such that the inner diameter of the flange neck decreases to about 24mm. The sizing element may be a ring, split ring, or other clip such as those previously described.

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[00106] FIGS. 22A, 22B, and 22C illustrate exemplary embodiments of an adjustable flange 2200 that comprises a tillable pocket 2205. The pocket 2205 may be disposed between the interior surface 2206 and exterior surface 2207 of the flange 2200 or the pocket may be a discrete reservoir on an interior or exterior surface of the flange. The pocket 2205 comprises a material that prevents any filling material from leaking out. Filling of the pocket 2205 with a filling material displaces the interior surface of the flange 2200 towards the breast to better seal against the surface of the breast and also to narrow the flange neck 2210. The filling of the pocket 2205 can be reversible, such that the removal of a filling material from a filled pocket 2205 results in the widening of the flange neck 2210. Preferably, the pocket 2205 may be filled or emptied repeatedly, so as to allow the flange 2200 to be adjustable in size throughout the course of a user’s use of the breast milk expression device. The pocket 2205, whether filled or emptied, does not obstruct the flange 2200 from forming a fluid seal against the breast.

[00107] The pocket 2205 can be accessed for filling with a filling material by various means, depending on the physical and chemical properties of the filling material. As shown in FIG. 22B, the pocket 2205 may comprise a flexible material 2215 that can be punctured without being permanently deformed, such as a butyl rubber or other elastomer, thereby allowing the addition or removal of a filling material through a sharp apparatus such as a needle 2220. Alternatively, as shown in FIG. 22C, the pocket 2205 may comprise an access port 2225 such as a cap 2230 that can be opened or closed mechanically, disposed on the surface of the pocket 2205, through which the filling material may be added or removed.

[00108] FIG. 22D is a cross-sectional view of an exemplary embodiment of an adjustable flange 2250 with a pocket 2255 filled with a fluid 2260. Filling of the pocket 2255 with the fluid 2260 displaces the interior surface 1956 of the flange 2250 towards the breast to better seal against the surface of the breast and also to narrow the flange neck 2210. The fluid 2260 may comprise any suitable material, such as a saline solution or other fluids including gases. Adding the fluid 2260 to or removing the fluid from the pocket 2255 can adjust the size of the flange 2250 to fit a particular size or shape of human breast.

[00109] FIG. 22E is a cross-sectional view of an exemplary embodiment of an adjustable flange 2280 with a pocket 2285 filled with a plurality of bead-like elements 2290. The plurality of bead-like elements 2290 may comprise any suitable material, such as polystyrene beads or silica nanoparticles. The pocket 2285 can be filled with the plurality of bead-like elements 2290, then

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2020203701 04 Jun 2020 molded against the user’s breast. Once the pocket 2285 with the bead-like elements 2290 is disposed against the breast and molded therearound, application of a vacuum to the filled pocket 2285 can lock the plurality of bead-like elements 2290 into a fixed configuration for fluidly sealing against a particular size or shape of human breast. This concept is well known in the art and is sometimes referred to as dilatancy.

[00110] FIG. 23 A and 23B illustrate another exemplary embodiment of an adjustable flange 2300 comprising a fillable pocket 2305. The pocket 2305 is fluidly coupled to the air pump 2310 and the exhaust valve 2315. The air pump comprises a vault 2320 having an integrated valve, such that the valve closes when the vault is compressed and opens when the vault expands. The air pump also comprises an inlet valve 2325 which fluidly couples the vault 2320 with the pocket 2305. When vault 2320 is depressed, air flows from the vault into the pocket 2305 through the inlet valve 2325. Inlet valve 2325 is a check valve, such as a duckbill valve, that allows air to flow in one direction only, from the vault to the pocket. A secondary relief valve, separate from or integrated with valve 2325, may be configured to release excessive pressure in the pocket 2305. The exhaust valve 2315 is configured to be in a closed position by default, for example by means of a spring mechanism. When depressed, the exhaust valve opens, allowing air to flow out from the pocket 2305, through the exhaust valve. FIG. 23A shows the pocket 2305 in the empty configuration, while FIG. 23B shows the pocket filled with air, whereby the interior surface 2330 of the flange is displaced towards the breast and the flange neck 2335 is narrowed. Adding air to or removing air from the pocket 2305 can adjust the size of the flange 2300 to fit a particular size or shape of human breast.

[00111] FIGS. 24A and 24B illustrate an exemplary embodiment of a device 2400 for expressing breast milk comprising an adjustable expression area 2402. The device further comprises an adjustable reservoir 2405 in fluid communication with an actuatable assembly 2410, which is operatively coupled by tube 2415 to the breast interface 2420. The breast interface comprises an expandable membrane 2425 and an expression reservoir 2440, which is fluidly coupled by tube 2415 to the adjustable reservoir 2405 and the actuatable assembly 2410.

[00112] The actuation of the actuatable assembly 2410 delivers the fluid 2435 from the adjustable reservoir 2405 through the tube 2415 to the expression reservoir 2440, and returns the fluid 2435 from the expression reservoir through the tube to the adjustable reservoir. The change in the volume of fluid in the expression reservoir causes the expandable membrane 2425

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2020203701 04 Jun 2020 to expand or collapse, thereby adjusting the size of the expression area 2402. The volume of fluid 2435 in the adjustable reservoir can be adjusted so as to adjust the volume of the fluid in the expression reservoir. When the volume of fluid in the expression reservoir decreases, the expandable membrane 2425 expands and moves closer to the interface housing 2421, thereby increasing the size of the expression area 2402. FIG. 24A shows the device whereby the adjustable reservoir 2405 contains a small volume of fluid and the expression reservoir 2440 contains a corresponding larger volume of fluid, thereby resulting in a smaller expression area 2402. FIG. 24B shows the device whereby the adjustable reservoir 2405 contains a large volume of fluid and the expression reservoir 2440 contains a corresponding smaller volume of fluid, thereby resulting in a larger expression area 2402. Adjusting the size of the expression area 2402 can adjust the size of the breast interface 2420 to fluidly seal against a particular size or shape of human breast.

[00113] The volume of fluid in the adjustable reservoir 2405 may be adjusted manually by various means. For example, the adjustable reservoir 2405 may comprise threaded walls 2406 and a threadably engaged plug 2407, such that turning the plug increases or decreases the volume of fluid in the adjustable reservoir.

[00114] The volume of fluid in the adjustable reservoir 2405 may also be adjusted automatically, whereby the device 2400 comprises a closed-loop system that is capable of sensing the engagement of the breast interface with the breast and accordingly adjusting the volume of fluid in the adjustable reservoir to adjust the size of the expression area 2402. FIG. 25 illustrates an exemplary embodiment of an automatically adjustable system for adjusting the size of the expression area. A mobile phone 2500 may be in communication with a pendant unit 2501 that controls the breast milk expression device. The device may operate in several different states, such as pumping state 2502 and adjustment state 2503. The phone can put the pendant unit into an adjustment state, which drives the motor 2505, disposed within the actuatable assembly, for adjustment of the volume of fluid in the expression reservoir 2510. The adjustable reservoir 2515 may be integrated with and in fluid communication with the actuatable assembly, such that the volume of fluid in the expression reservoir may be adjusted by changing a setting of the actuatable assembly. For example, the actuatable assembly may comprise a piston assembly in fluid communication with the expression reservoir, and the piston may be set at a preset resting position so as to result in a preset volume of fluid in the expression reservoir. Changing the resting position of the piston can accordingly increase or decrease the volume of

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2020203701 04 Jun 2020 fluid the expression reservoir. An adjustable reservoir integrated with the actual assembly in this manner, compared to a separate adjustable reservoir, can reduce the number of parts in the system as well as simplify the adjustment operation. The motor may steadily increase the volume of fluid in the expression reservoir, providing motor current feedback to the pendant unit. The motor current feedback may be used to determine when the breast interface has fluidly sealed against the breast, by sensing the timepoint at which the motor current begins to rise in response to greater resistance in the system. When the pendant unit receives feedback that the breast interface has sealed against the breast, it may end the adjustment state.

Preferably, the volume of fluid in the adjustable reservoir may be reset to an initial default value at any point, so that a user may readjust the size of the expression area as necessary.

[00115] One of skill in the art will appreciate that components and features of any of the exemplary embodiments of the adjustable breast interface can be combined or substituted with components and features of any of the embodiments of the present invention as described herein.

Experimental data

[00116] FIGS. 14 and 15 illustrate experimental pumping data obtained from a commercial breast pump device and an exemplary embodiment of the present invention. The exemplary embodiment utilized an incompressible fluid for pumping and had a maximum hydraulic fluid volume of 4 cc, while the commercial device utilized air for pumping and had a maximum volume of 114 cc.

[00117] FIG. 14 illustrates a graph of the pump performance as quantified by vacuum pressure generated per run. For the exemplary embodiment, pressure measurements were taken for 1 cc, 2 cc, 3 cc, and 4 cc of fluid volume displaced by the pump, with the run number corresponding to the volume in cc. For the commercial device, measurements were taken with the pump set to one of seven equally incremented positions along the vacuum adjustment gauge representing 46 cc, 57 cc, 68 cc, 80 cc, 91 cc, 103 cc, and 114 cc of fluid volume displaced by the pump, respectively, with the run number corresponding to the position number. Curve 700 corresponds to the exemplary embodiment and curve 705 corresponds to the commercial device. The exemplary embodiment generated higher levels of vacuum pressure per displacement volume

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2020203701 04 Jun 2020 compared to the commercial device, with maximum vacuum pressures of -240.5 mmHg and 177.9 mmHg, respectively.

[00118] FIG. 15 illustrates a graph of the pump efficiency as measured by the maximum vacuum pressure per maximum volume of fluid displaced, with bar 710 corresponding to the exemplary embodiment and bar 715 corresponding to the commercial device. The exemplary embodiment demonstrated a 42-fold increase in pumping efficiency compared to the commercial device, with efficiencies of -71.1 mmHg/cc and -1.7 mmHg/cc, respectively.

[00119] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims (20)

1. CLAIMS:

   1. A device for expressing breast milk from a breast, said device comprising:

   a breast interface comprising a flange configured to engage and fluidly seal against the breast, and an expression area where milk is expressed from the breast;

   wherein the breast interface is manually or automatically adjustable to fluidly seal against a plurality of sizes or shapes of breasts.
2. 2. The device of claim 1, wherein the flange comprises one or more resilient materials conformable to the breast and adapted to fluidly seal against the plurality of sizes or shapes of breasts.
3. 3. A device as in any one of claims 1 or 2, wherein the flange comprises a pocket fillable with a filling material, and wherein addition of filling material to, or removal of the filling material from the pocket adjusts a size of the flange.
4. 4. The device of claim 3, wherein the filling material comprises a plurality of bead-like elements, and wherein application of a vacuum to the pocket substantially locks the plurality of bead-like elements and the flange into a fixed configuration for fluidly sealing against a particular size or shape of human breast.
5. 5. A device as in any one of claims 3 or 4, wherein the filling material comprises a fluid.
6. 6. The device of claim 5, wherein the breast interface further comprises a fluid pump fluidly coupled to the pocket, the fluid pump configured to add or remove the fluid from the pocket.
7. 7. A device as in any one of claims 1, 2, 3, 4, 5 or 6, wherein the device further comprises an actuatable assembly operatively coupled to the breast interface;

   an expression reservoir disposed within the breast interface; and an adjustable reservoir fluidly coupled to the expression reservoir and operatively coupled to the actuatable assembly;

   wherein the actuatable assembly is configured to deliver fluid from the adjustable reservoir to the expression reservoir or remove fluid from the expression reservoir and return the fluid to the adjustable reservoir, and

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   2020203701 04 Jun 2020 wherein the adjustable reservoir comprises a mechanism to adjust a volume thereof, so as to adjust a volume of the expression reservoir and thereby adjust a size of the expression area to fluidly seal against a particular size or shape of breast.
8. 8. The device of claim 7, wherein the mechanism is manually adjustable.
9. 9. A device as in any one of claims 7 or 8, wherein the mechanism is automatically adjustable to adjust the volume of the adjustable reservoir in response to a feedback from the actuatable assembly indicating a degree of fluid seal between the breast interface and the breast.
10. 10. The device of claim 9, wherein the feedback comprises a current produced by the actuatable assembly as the volume of the adjustable reservoir is adjusted, wherein an increase in the current indicates an increased degree of fluid seal between the breast interface and the breast.
11. 11. A device as in any one of claims 9 or 10, wherein the adjustable reservoir is integrated with the actuatable assembly, such that the volume of the adjustable reservoir may be adjusted by changing a setting of the actuatable assembly.
12. 12. The device of claim 11, wherein the actuatable assembly comprises a piston assembly and wherein the adjustable reservoir comprises a reservoir of the piston assembly, such that changing a resting position of the piston assembly adjusts the volume of fluid in the adjustable reservoir.
13. 13. A method for expressing breast milk from a breast, said method comprising: providing a device for expressing breast milk comprising an adjustable breast interface having a flange and an expression area;

    engaging the adjustable breast interface with the breast;

    adjusting a size of the adjustable breast interface;

    fluidly sealing the breast interface against the breast; and expressing milk from the breast.
14. 14. The method of claim 13, wherein adjusting the size of the adjustable breast interface comprises adding a fluid to or removing the fluid from a pocket disposed within the flange.

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15. 15. A method as in any of claims 13 or 14, wherein adjusting the size of the adjustable breast interface comprises:

    providing a plurality of bead-like elements disposed in a pocket in the flange;

    molding the plurality of bead-like elements against the human breast;

    applying a vacuum to the pocket; and locking the flange into a particular size or shape.
16. 16. A method as in any of claims 13, 14 or 15, wherein the breast interface comprises an expression reservoir fluidly coupled with an actuatable assembly and an adjustable reservoir, and wherein adjusting the size of the adjustable breast interface comprises:

    actuating the actuatable assembly, thereby delivering a fluid from the adjustable reservoir to the expression reservoir or removing the fluid from the expression reservoir and returning the fluid to the adjustable reservoir; and adjusting a volume of the adjustable reservoir so as to adjust a volume of the expression reservoir, thereby adjusting a size of the expression area.
17. 17. The method of claim 16, wherein adjusting a volume of the adjustable reservoir comprises manually adjusting the volume of the adjustable reservoir.
18. 18. A method as in any of claims 16 or 17, wherein adjusting a volume of the adjustable reservoir comprises automatically adjusting the volume of the adjustable reservoir in response to a feedback from the actuatable assembly indicating a degree of fluid seal between the breast interface and the breast.
19. 19. The method of claim 18, wherein the adjustable reservoir is integrated with the actuatable assembly, and wherein automatically adjusting the volume of the adjustable reservoir comprises changing a setting of the actuatable assembly.
20. 20. The method of claim 19, wherein the actuatable assembly comprises a piston assembly and wherein the adjustable reservoir comprises a reservoir of the piston assembly, and wherein automatically adjusting the volume of the adjustable reservoir comprises changing a resting position of the piston assembly.