Wearable Breast Pump System

Abstract

The breast pump system includes at least one wearable milk collection hub connected to a combined external air pump and control unit via an air line, wherein each milk collection hub includes (a) a breastshield comprising a breast flange and a nipple hole, (b) a flexible diaphragm configured to prevent milk from reaching the external air pump, (c) an outer shell configured to be removably attached to the breastshield such that, when attached, the breastshield and outer shell form a receptacle for collecting milk, and (d) a diaphragm cap configured to be secured over the diaphragm, forming a portion of the front surface of the outer shell and including a port connected to the air line.

Description

[Technical field]

[0001] The field of the invention relates to wearable breast pump systems. [Background technology]

[0002] Breast pump systems are mechanical or electromechanical devices that extract milk from the breasts of a lactating woman.

[0003] Most portable breast pump solutions that include discreet designs are not readily available to most parents. There is a need for a wearable breast pump system design that has not only a low price point but also a stylish and discreet design.

[0004] A fully integrated wearable breast pump system is described in WO2018229504A1. The wearable breast pump system includes a housing molded to fit inside a bra. The housing includes an air pump that drives a diaphragm to generate negative air pressure. The diaphragm is attached to a diaphragm holder that is positioned away from the side of a breast shield flange.

[0005] A compact, hands-free human breast milk collection device that fits into the mother's existing nursing or standard bra is shown in the system of US20080262420A1. The hands-free collection device connects to an external standard pump via a vacuum hose that is also configured to apply vacuum pressure to the interior volume of the collection device. The vacuum hose is attached to a shaft that is located at a fixed position on the top exterior surface of the collection device. The position of the shaft is selected so that the pump does not draw breast milk into the external pump. Because it is inconvenient and difficult to connect the vacuum hose to the shaft located at the top of the device after the device is attached to the breast, the vacuum hose must be properly connected to the shaft before the milk collection device is attached to the breast.

[0006] A breast milk collection device is also shown in the system of US20180008758A1. The collection device is attached to a vacuum tube through an opening that is also located at a fixed position on the rim of the outer surface of the collection device. The opening communicates with an internal chamber that contains an inflatable / deflated flexible barrier that allows for the application of vacuum pressure to the breast. A flexible barrier housing that surrounds the flexible barrier has an elliptical cone-like shape and is located at the top of the collection device. Unfortunately, the location of the flexible barrier blocks a line of sight to the interior of the collection device and to the nipple.

[0007] Wearable hands-free breast pumps such as the Freemie Cup system have entered the market. The Freemie Cup includes a flexible barrier located at the top of the cup, thereby blocking the view of the interior of the cup and the nipple. Additionally, the cup is also made from a fairly opaque material, making it difficult to have a clear view of the interior of the device and the nipple, as well as to achieve correct nipple alignment.

[0008] In view of the above, there is a need for an improved method for providing an easy and flexible connection between a suction tube and a wearable milk collection device, and a need for providing an unobstructed view of the interior chamber of the wearable milk collection device to achieve correct nipple alignment as milk enters the interior of the device and to ensure that the system is operating properly. Summary of the Invention

[0009] The present invention is a breast pump system comprising at least one wearable milk collection hub connected via an air line to a combined external air pump and control unit, each milk collection hub comprising a breastshield comprised of a breast flange and a nipple hole, a flexible diaphragm configured to prevent milk from reaching the external air pump, a diaphragm cap configured to be removably attached to the breastshield and secured over the diaphragm, forming part of a front or front end facing portion of the and including a port connected to the air line, the diaphragm cap ... configured to be removably attached to the breastshield and secured over the diaphragm, such that the front surface of the outer shell includes a curved portion when the breastshield and the diaphragm cap form a container for collecting milk when the breastshield and the diaphragm cap form a part of a front or front end facing portion of the and including a port connected to the air line.

[0010] This configuration allows the air lines to be connected to the front of the outer shell of the milk collecting hub, whereas prior art devices position the diaphragm and air lines on the top of the milk collecting hub which obscures the user's view down into the device which in turn makes correct nipple positioning difficult.By having the diaphragm cap forming part of the front of the outer shell, the user's view into the device is not obscured by the diaphragm seating on the nipple, making it easier to achieve correct nipple positioning.

[0011] In one embodiment, the diaphragm cap can be rotated relative to the outer shell to adjust the position of the air port, and thus the position and orientation of the port and the air line connected to the port, allowing the user to easily adjust the position of the air line to remain comfortable under a bra or other clothing. The diaphragm cap may also be removable from the outer shell, thus allowing the user to place the hub on the breast without the diaphragm cap and without the inconvenience of an air line connected to the air port. Once proper nipple alignment is achieved, the diaphragm cap and connected air line can be easily attached back to the outer shell of the milk collection hub. [Brief description of the drawings]

[0012] Aspects of the present invention will now be described, by way of example only, with reference to the following figures, each of which illustrates features of a wearable breast pump system embodying the invention:

[0013] [Figure 1A] A wearable breast pump system is shown, consisting of a pair of milk collection hubs, air lines, and a separate control and air pump combination unit external to the milk collection hubs. [Figure 1B] 1 shows a wearable breast pump system having a milk collection hub connected to a combination control and air pump unit via an air line. [Diagram 2] FIG. 2 shows a perspective front view of the milk collection hub. [Diagram 3] FIG. 2 shows a rear perspective view of the milk collection hub. [Figure 4] A rear view of the milk collection hub is shown. [Diagram 5] 1 shows a perspective view of a milk collection hub without the outer shell and without the diaphragm. [Figure 6] 1 shows an exploded view of the milk collection hub. [Figure 7] The diaphragm is shown. [Figure 8] 1 shows a cross section of the milk collection hub in a relaxed state. [Figure 9] 1 shows a cross section of the milk collection hub, showing the diaphragm under maximum negative pressure. [Figure 10] FIG. 1 shows a perspective view of a removable diaphragm cap without an air tube. [Figure 11] FIG. 2 shows a front view of a removable diaphragm cap connected to an air tube. [Figure 12] 1 shows a perspective view of a removable diaphragm cap including a rigid pressure portion. [Figure 13A] 13A-13C show other cross-sectional views of the milk collection hub in a relaxed state, at midpoint, and under maximum negative pressure. [Figure 13B] 13A-13C show other cross-sectional views of the milk collection hub, including the milk port in a relaxed state, at the midpoint, and under maximum negative pressure. [Figure 14]FIG. 1 shows a perspective view of the outer shell without the removable diaphragm cap. [Figure 15] FIG. 2 shows a side view of the milk collection hub. [Figure 16] FIG. 1 shows a top view of a control and air pump unit for a breast pump system. [Figure 17] FIG. 2 is a top view of the control and air pump unit with the upper case of the unit removed. [Figure 18] An exploded view of the control / air pump unit is shown. [Figure 19] 1 shows components of the pump unit subsystem. [Figure 20] 1 shows a cross section of the airflow block inside the control unit. [Figure 21] 1 shows a cross section of the airflow block inside the control unit. [Figure 22] 1 shows a cross section of the airflow block inside the control unit. [Figure 23] Shown is a sound valve. [Figure 24] 1 shows a plot of a pumping cycle. [Diagram 25] FIG. 2 shows a schematic diagram of the pump unit subsystem illustrating the pump cycle. [Figure 26] 1 shows a cross section of a control unit including a pump unit subsystem illustrating a pump cycle. [Figure 27] 1 shows a cross section of a control unit including a pump unit subsystem. [Figure 28] A table showing various examples of vacuum levels is provided. [Figure 29] 1 shows a diagram of a control unit including a multi-function mount. [Diagram 30] 1 shows a diagram of a control unit including an accessory. [Diagram 31] 1 shows a diagram of a control unit including a multi-function mount. [Diagram 32] Shows tubing connections.

[0014] Index 1 air line leading to the milk collection hub Air lines leading to the milk collection hub2 Air line 3 from the control and air pump combination unit Milk Collection Hub 10 Control and air pump combined unit 11 Air tube connection parts 12 Control and user interface on air pump unit 13 Air port or hole 14 on control and air pump unit Diaphragm cap air port or hole 15 Milk collection hub outer shell 20 Breast Shield 21 Diaphragm Cap 22 Breast opening cover 23 Milk volume scale on shell 24 Finger grip mechanism 30 Breast shield nipple hole 31 Breast shield flange 32 Guidelines on Breast Shields 33 Nipple hole 41 Breast check valve 51 2nd breast hole 52 Diaphragm Housing 53 Diaphragm housing, annular rear wall 54 Diaphragm housing, cylindrical outer wall 55 Diaphragm housing, cylindrical inner wall 56 Diaphragm housing, front wall 57 Diaphragm 61 Seal 62 between the breast shield and the outer shell Diaphragm, annular rear wall 63 Diaphragm, cylindrical outer wall 64 Diaphragm, cylindrical inner wall 65 Diaphragm, front wall 66 Central axis passing through the nipple hole 81 Pressure chamber 82 in relaxed state Maximum negative pressure in pressure chamber 83 Chamber in diaphragm cap vs. 84 Diagram 85 of the end user's breast area Rigid pressure chamber section 91 Ball Bearing 100 Relaxed state cross section 101 Section at point 102 Maximum pressure cross-sectional area 103 Milk spout 111 Diaphragm cap flat 120 Dual Function Pump / Pause Button 130 Power On / Off Button 131 Button 132 for switching pumping profiles Pressure reduction button 133 Pressure increase button 134 Pressure Level Visual LED135 Pump Profile Visual Indicator LED136 Battery Status LED137 USB-C charging socket 138 Chassis 140 Uppercase 151 Lowercase 152 PCB153 Air Pump Unit Subsystem 154 Rechargeable Battery 155 Pump unit 161 Solenoid Air Bleed Valve 162 Sound-reducing motor mount 163 Airflow Block 164 Solenoid Foam Cap 165 Sound Valve 166 Sound valve cap 167 Solenoid valve inlet 171 Solenoid valve outlet 172 Seal material 173 Motor exhaust 181 Tube Wrap Accessories 241 Battery Accessories242 Breasts drawn into chamber from nipples 251 Removable waistband clip 261 Tube Splitter 261 Plug or stopper in tube splitter 262 O-ring 290 Control unit and o-ring 291 in longitudinal mode Control unit and o-ring 292 in lateral mode First stage of the pumping cycle (pumping time) P Second stage of pump cycle (bleed time) B DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] An implementation of the present invention is a breast pump system for extracting and collecting breast milk. The system includes a pair of milk collection hubs 10, a combined control and air pump unit 11, and an air tube connection component 12, as shown in Figure 1A. In normal use, air tubes 1, 2 connect each milk collection hub 10 to the air tube connection component 12, which in turn connects the air tubes 1, 2 to a single air tube 3, which in turn connects to the control and air pump unit 11, as shown in Figure 1B.

[0016] The milk collection hub may also be connected to any external control and air pump unit, including any external standard electric or manual control and air pump unit.

[0017] An example application involves a user placing either one or two milk collection hubs 10 on their breasts and connecting one or both collection hubs to a combined control and air pump unit 11 via air tubes 1, 2 and 3 and tube connection components 12.

[0018] A user controls the device using a user interface 13 located on the control unit 11. Activation of the breast pump system activates an air suction pump in the control and air pump unit 11 (also referred to as the control unit) via the user interface 13. An air port or hole 14 in the control and air pump unit 11 connects to a tube 3 that splits into two tubes 1, 2 via a tube splitter in an air tube connection component 12, and then delivers suction to the milk collection hubs 10 via air ports or holes 15 in each milk collection hub 10. When the pump in the unit 11 is activated, a negative air pressure is created between the control unit 11 and the milk collection hubs 10, thereby applying a negative pressure to the nipples, drawing milk from the breasts and collecting it in the milk collection hubs 10.

[0019] The breast pump system can be operated using either one (single pumping) or two (dual pumping) milk collection hubs 10. The breast pump system can generate pressures ranging from 150 to 350 mmHg, depending on the level of stimulation selected by the user.

[0020] 2 and 3 show perspective views of the milk collection hub. Both milk collection hubs 10 are identical and are configured to be held comfortably inside a bra in an unobtrusive manner, with an outer shell 20 having a curved shape configured to contact the inner surface of the bra. The outer shell 20 fits or hooks onto a breast shield 21 which forms the underside of the hub 10. The breast shield 21 is comprised of a breast flange 32 and a nipple hole 31, with the interior volume between the outer shell 20 and the breast shield 21 defining a chamber in which milk is collected. The breast flange 32 contacts the user's breast. The outer shell 20 is directly removable from the breast shield during normal use or normal disassembly to allow cleaning of the interior volume in which milk is collected.

[0021] The outer shell 20 also includes a removable diaphragm cap 22 that covers and seals a diaphragm located inside the milk collection hub. The diaphragm cap 22 is located at the front of the outer shell 20 and forms a central area at the front of the outer shell 20. The diaphragm cap 22 includes an air port or hole 15 that provides an air connection via a tube to the control unit 11. Because the diaphragm cap 22 is located at the front of the outer shell 20, it does not obstruct the user's view into the interior of the milk collection hub through the transparent outer shell 20, thus allowing the user to see whether the collection hub 10 is correctly positioned on the breast and whether milk is being successfully expressed into the collection hub 10.

[0022] The diaphragm cap 22 is easily removable from the hub outer shell 20 with one hand during normal use or normal disassembly. The air lines 1, 2 are connected to the air holes 15 in the diaphragm cap 22, and removing the diaphragm cap 22 from the outer shell 20 provides a robust, easy and quick release of the suction connection between the hub 10 and the control unit 11, as well as a robust, easy and quick installation of the suction connection between the hub 10 and the control unit 11. In general, because the air lines 1, 2 remain secured to their respective diaphragm caps 22, the user does not need to worry about the potentially difficult process of attaching air lines to the air ports 15 in each collection hub 10.

[0023] The removable diaphragm cap 22 can be rotated relative to the outer shell 20 to adjust the location of the air ports on the outer shell, and therefore the location and orientation of the air lines 1, 2, allowing a user to easily adjust the position of the air lines 1, 2 to remain comfortable under a bra or other garment. A user can place the hub 10 on the breast without the diaphragm cap and without the inconvenience of air tubes 1, 2 connected to the air ports 15. Once proper nipple alignment is achieved, the diaphragm cap 22 and connected tubes can be easily attached to the hub 10.

[0024] In Figure 3, breastshield 21 includes nipple hole 31 shaped to receive a nipple, and flange 32. Preferably, breastshield 21, including flange 32 and nipple hole 31, is a single piece made from a single molding having a single smooth inner surface. There are no joints along the nipple hole; joints can aggravate delicate nipple tissue as the nipple expands and contracts during pumping.

[0025] The breast shield 21 can be configured to slide onto the outer shell using a single push action. The breast shield 21 and outer shell 20 can also be attached using magnets.

[0026] Preferably, the breast shield 21, and outer shell 20, and diaphragm cap 22 are all substantially rigid and are optically clear or substantially transparent, for example, to provide an unobstructed view of the nipple and the interior of the hub 10. The breast shield 21, diaphragm cap 22, and outer shell 20 may be substantially made of a transparent, rigid, dishwasher-compatible material, for example, polypropylene, or polycarbonate, or a copolyester such as Tritan®, or may include a section of material sufficient to allow the user to clearly see the interior of the milk collection hub 10. Dishwasher-compatible is important because it allows all of these components to be easily cleaned in a normal dishwashing cycle. This also allows the different components of the wearable breast pump system to be easily cleaned and / or sterilized. This rigidity and transparency helps achieve correct nipple alignment when placing the entire milk collection hub 10 on the breast, as well as allowing the user to easily check if alignment is being maintained during pumping. A milk collection hub made of silicone, which is very flexible, may be more difficult to position correctly on the breast. Additionally, the nipple hole is clearly visible to the user through the substantially transparent wall of the hub 10, further ensuring that the spacing between the nipple and the side wall of the nipple hole 31 is properly maintained during pumping.

[0027] During a pumping session, the user can also view the interior of the milk collection hub 10, see milk being expressed inside the hub 10, and get an indication of the level of milk collected inside the hub. Graduations 24 located on the outer shell 20 indicate the volume of milk within the hub 10.

[0028] The breast shield 21 may also include guidelines 33 running parallel to the sides of the breast shield to aid in nipple alignment; these guidelines 33 are positioned generally horizontally when in use and are designed to be easily seen by the user when looking down at the breast shield 21 when positioned on the breast, the lines allowing the user to properly position the breast shield 21 so that the nipple is positioned generally along a centerline passing through the nipple orifice (e.g., central axis 81 shown in FIG. 8 ).

[0029] The outer shell also includes a milk spout that can be closed using a removable portion 23 to cover the milk spout during pumping and general handling.

[0030] The breast shield 21 and / or outer shell 20 may be made from a substantially rigid polypropylene material, or a polycarbonate or copolyester material, such as a Tritan material that is optically clear and dishwasher safe. The material may be selected as a balance between cost and acceptable achievable transparency, among other things.

[0031] A rear view of the milk collection hub is shown in Figure 4. As shown, the nipple hole 31 includes a milk hole 41 through which expressed milk flows onto the milk collection hub. The guide line 33 is located above and not aligned with the central axis of the nipple hole 31, which compensates for the slight parallax that occurs when viewing the guide line 33 and the nipple from above.

[0032] 5 shows a perspective view of the one-piece rigid breastshield 21, but without the outer shell and without the diaphragm. The breastshield 21 includes an annular diaphragm 53 having a roughly cylindrical outer wall 55 generally parallel to the nipple orifice 31 and a generally concentric cylindrical inner wall 56 which forms the outer wall of the nipple orifice 31. The diaphragm housing 53 has a front wall 57 which forms the end of the nipple orifice, and also has an annular rear wall 54 which joins the concentric inner wall 56 and the outer wall 55.

[0033] Figure 8 provides a cross section illustrating these features. Flexible membrane 61 (see Figures 6-9 and Figures 13A and 13B) lies flush with these walls of annular diaphragm housing 53 in a relaxed state (i.e., when no negative air pressure is applied) and therefore has a similar shape, with a generally cylindrical outer membrane wall 64 lying flush with housing outer cylindrical wall 55, a concentric inner membrane wall 65 lying flush with housing inner cylindrical wall 56, a front wall 66 lying on the end of housing front wall 57 which forms the end of the nipple hole, and an annular rear wall 63 lying flush with diaphragm housing rear wall 54.

[0034] The diaphragm cap 22 is located on the flexible diaphragm or membrane 61, and thus a negative pressure chamber is formed between the diaphragm cap 22 and one side of the flexible diaphragm 61. Thus, the diaphragm 61 moves in an air pump chamber formed on one side by the diaphragm housing 53 and on the other side by the diaphragm cap 22, and the flexible diaphragm 61 moves through this negative pressure chamber when it is pulled forward along the direction of the central axis 81 and suction is applied. When the flexible diaphragm 61 is pulled forward, a low air pressure area is formed on the other side of the flexible diaphragm 61, i.e., the side between the flexible diaphragm 61 and the diaphragm housing 53. This causes a decrease in the air pressure in the nipple hole 31, since the milk hole 41 in the nipple hole 31 ensures air pressure equivalence between the hole in the nipple hole 31 and the hole in the diaphragm housing 53, and this pressure decrease causes the nipple to be pulled forward and milk to be squeezed out of the nipple. Milk passes through the nipple hole 41 of the nipple hole 31, then through a second nipple hole or opening 52 located on the diaphragm housing 53, and then through a check valve 51 mounted on the second nipple hole or opening 52, into the collection hub. The check valve allows milk to pass in one direction into the milk container. Note that the diaphragm 53, and therefore the diaphragm 61, are positioned toward the end of the nipple hole 31, away from the breast shield 21. The diaphragm 61 actually extends over the end of the nipple hole 31. This configuration has the advantage of giving the user a clearer view through the nipple hole 31 when positioning the nipple inside the nipple hole 31. If the diaphragm housing 53 were closer to the breast shield 21, that view might be blocked. A disadvantage, however, is that the milk collection hub 10 is not compact in the direction of the nipple hole, but is shaped to fit inside the inner portion of the bra.

[0035] Preferably the check valve is removable for easy cleaning.

[0036] When the outer shell 20 is attached to the breastshield 21, the collection hub forms a container in which milk is collected after passing through the check valve and has a capacity to collect approximately 5 fluid ounces (148 ml).

[0037] The hub also includes a vent hole located, for example, at the top of the outer shell so that atmospheric pressure is maintained inside the container even during negative pressure cycles.

[0038] 6 shows an exploded view of the milk collection hub 10. In this example, the wearable milk collection hub 10 comprises the following user-removable parts: a breastshield 21, an outer shell 20, a diaphragm 61, and a diaphragm cap 22. The diaphragm cap 22 fits over the flexible diaphragm 61 with an airtight seal. An airtight seal between the breastshield 21 and the outer shell 20 is provided by a removable seal member 62.

[0039] The flexible diaphragm 61 may be completely removable from the hub 10, or may form an integral part of the outer shell 20. When it is removable, it is press-fit into the outer shell 20 to form an air-tight and liquid-tight seal. When it is an integral part of the outer shell, the flexible diaphragm 61 is typically laser welded at its single outer circular edge to a single circular edge in the outer shell 20.

[0040] As noted above, the breastshield 21 includes a diaphragm housing portion 53 within which a flexible diaphragm 61 can move in and out when assembled. The diaphragm housing portion 53 has an air hole that transmits negative pressure to the nipple orifice 31, which may be the breast orifice 41 of the nipple orifice 31 or may be another hole (not shown). The diaphragm 61 flexes when negative air pressure is applied to it by an external air pump unit subsystem located in the control unit, transmitting negative air pressure to pull the breast and / or nipple against the breastshield and apply suction to the nipple to express milk.

[0041] 7 shows a side view and a perspective view of the diaphragm 61. The diaphragm 61 is configured to prevent milk from reaching the pump unit housed inside the control unit 11.

[0042] The overall dimensions of the diaphragm are approximately 77.3 mm in diameter and 24 mm in height (i.e., depth along the major axis 81 of the nipple hole). At maximum suction, the diaphragm has a displacement of approximately 17550 mm. 3 Typical variations may have dimensions that are ±25% of these dimensions.

[0043] The shape of the diaphragm 61 is not a substantially flat or raised convex membrane as found, for example, in the Elvie Pump. Instead, it has a roughly cylindrical outer wall 64 that is generally parallel to the nipple hole 31, and a roughly cylindrical inner wall 65 that is also generally parallel to the nipple hole 31. The diaphragm 61 has a front wall 66 that covers the inner wall 65 and overlies the end of the nipple hole 31. It also has an annular rear wall 63 that joins the outer wall 64 and the inner wall 65.

[0044] 8 is a cross-sectional view of a breast 85 inserted in a relaxed state inside the milk collection hub, showing the diaphragm 61 relative to the axes of the nipple hole 81, the milk port 41, and the pressure chamber 82. The flexible diaphragm 61 includes an outer wall 64 and an inner wall 65 that extend substantially parallel to the central axis of the nipple hole 81, and a portion that extends substantially perpendicular to the central axis of the nipple hole 81. As shown, the diaphragm 61 includes an inner annular wall 63 and an end cap wall 66 that are perpendicular to the central axis 81. A majority of the flexible diaphragm 61 is above the milk port 41, as well as to the right of the milk port 41 (i.e., away from the breast). Thus, the milk collection hub 10 is not designed to be compact in the direction of the axis of the nipple hole 81. Furthermore, inside the nipple hole, the entire volume or space to the right of the nipple and breast is exposed to negative pressure, therefore the negative pressure zone begins at the skin / air boundary and therefore the flexible diaphragm 61 is completely to the right of the negative pressure zone adjacent to the breast (i.e. away from the breast). Furthermore, this leads to the milk collection hub 10 not being compressed in the direction of the axis of the nipple hole 81. However, that compromise is necessary to give the user a clear view through the transparent material of the nipple and 20 of the breastshield 21 so that the nipple can be correctly positioned within the nipple hole 31. Correct positioning is very important for comfort and effective milk expression.

[0045] 9 is a cross-sectional view of a breast 85 inserted inside the milk collection hub, showing the diaphragm 61 under maximum negative pressure. During the negative air pressure phase, the flexible diaphragm 61 bends and moves towards the right, even moving the rear wall 63 past the milk port 41. The central portion 66 of the diaphragm 61 is always located substantially to the right of (i.e., extends beyond) the end of the nipple hole 31. During suction, the central portion 66 also moves forward into a pair of chambers 84 in the diaphragm cap 22, and this additional movement of the diaphragm 61 contributes significantly to the suction achieved in the nipple hole, and therefore to milk pumping efficiency.

[0046] The diaphragm 61 and associated diaphragm cap 22 are also located at the front of the hub 10 so as not to obstruct the mother's view of the nipple when the collection hub 10 is placed on the breast.

[0047] 10 shows a perspective view of the removable diaphragm cap 22. The diaphragm cap 22 includes a pair of hollow or concave finger grip features 30, allowing it to be easily handled using only two fingers. The diaphragm cap 22 is easily rotated to adjust the position of the air port 15, and therefore the position of the air tubes 1, 2 (not shown) that are connected to the air port 15.

[0048] FIG. 11 shows a front view of the removable diaphragm cap 22 connected to the air tube 1. The air tube 1 can pass through a passage located in the center of the diaphragm cap 22, providing additional protection to the air tube 1 so that it is not easily pulled out during use and so that the orientation of the tube 1 coincides with the surface of the inner bra. The diaphragm cap 22 may also be configured to be attached to the outer shell 20 by means of a latching system. The diaphragm cap 22 can be latched into the outer shell when a spring plunger, such as a ball bearing 100 in the diaphragm cap, is located in a small recess in the outer shell 20. Audible and / or tactile feedback can confirm that the removable diaphragm cap 22 and the air tube 1 are properly assembled.

[0049] 12 shows a side view of the removable diaphragm cap 22 including an additional rigid part 91. The additional part 91 is removable from the diaphragm cap 22 and is shown separately. Alternatively, the additional part 91 may be an integral part of the diaphragm cap 22. The additional part 91 reduces the volume of the pump chamber and therefore leads to improved pumping efficiency.

[0050] FIG. 13A shows a cross section of a breast 85 inserted into the milk collection hub 10, including the additional rigid portion 91 located within the pressure chamber. FIG. 13B shows a similar cross section of the milk collection hub, but without the nipple. It is noted that the nipple sizes are approximate and that there is considerable variation in nipple size and how they stretch when suctioned. It is also noted that these device cross sections are only exemplary and commercially available devices may differ. The diaphragm 61 is located over the end of the nipple hole 31 and extends beyond the milk port 41 in the direction of the axis 81 for the reasons given above, i.e., to provide a clear view of the nipple within the transparent nipple hole 31. The cross section shows the movement of the diaphragm 61 from a relaxed state 101 to a midpoint 102 and down to a final maximum suction force 103. The diaphragm 61 is shown in a relaxed state relative to the axes of the nipple hole 81, milk port 41, and pressure chamber. The rigid pressure chamber portion 91 reduces the volume of air in the pressure chamber by restricting the movement of the diaphragm 61 under negative pressure, for example by blocking a pair of chambers 84 in the diaphragm cap 22. The central portion 66 of the diaphragm 61 is always located substantially to the right of (i.e., extends beyond) the end of the nipple hole 31. When suction is applied, the member 61 moves forward through the negative pressure chamber along the direction of the central axis 81 of the wearable hub, as shown in midpoint diagram 102. When the diaphragm 61 is fully displaced under maximum negative pressure, it is flush with the rear surface of the rigid pressure chamber portion 91.

[0051] In this configuration, faster response times and faster cycle times are achieved for single and double pumping and greater peak negative pressures by minimizing the volume of air in the pressure chamber. In one embodiment, using single pumping, the minimum pressure is 50 mmHg at a cycle time of 75 cycles / min and the maximum pressure is 350 mmHg at a cycle time of 30 cycles / min. Using double pumping, the minimum pressure is 30 mmHg at a cycle time of 75 cycles / min and the maximum pressure is 280 mmHg at a cycle time of 30 cycles / min.

[0052] FIG. 14 shows a perspective view of the outer shell 20 including the milk spout 111 .

[0053] 15 shows a side view of the milk collection hub. The overall width dimension of the milk collection hub 10 along the central axis of the nipple bore is approximately 5.7 cm and is not designed to be particularly thin or compact in the direction of the axial arrow, having a width dimension similar to or greater than previous breast collection hubs such as Playtex Embrace®. The milk collection hub 10 includes a flat portion 120 that sits on the diaphragm cap 22 so that the entire milk collection hub 10 can rest on a flat surface with the breastshield 21 uppermost.

[0054] Alternatively, the milk collection hub 10 may also include a flat portion on the base of the outer shell 20 so that the entire milk collection hub 10 can rest on a flat surface with the milk opening 111 uppermost.

[0055] Control Unit The control unit 11 is configured to generate negative air pressure for the breast pump system. The control unit 11 has a low-profile shape and is shaped to fit comfortably in the palm of the hand and be easily grasped in one hand.

[0056] The control unit 11 is shaped to fit within a pocket (or bra). Preferably the control unit is less than 120mm in length, less than 70mm in width and less than 45mm in height. Preferably the control unit weighs less than 0.2kg.

[0057] The user interface 13 provided on the control unit 11 may include buttons, tactile feedback, sliders, any form of display, lights, or any other components necessary to control and direct the use of the breast pump system. The user interface is configured to be intuitive and easy to use.

[0058] A specific example of the user interface 13 is provided in FIG. 16, which shows a top view of the control unit 11. A power on / off button 131 powers the breast pump system on or off. One button 132 switches between pumping profiles, such as between stimulation or pumping modes. Buttons 133 and 134 adjust the pressure generated by the pump and therefore the vacuum pressure applied to the user's breasts. A dual function pump / pause button 130 is also provided for the user to interrupt the pumping process without turning off the device.

[0059] The visual indicators include a series of LEDs 135 that change appearance as more LEDs are lit as pressure produced by the pump increases. Other visual indicators include LEDs 136 that change appearance when changing pumping profiles. For example, one color indicates stimulation and another color indicates expression. As another example, an LED is turned off to indicate stimulation and turned on to indicate expression. Other visual indicators include LEDs 137 that indicate battery status. For example, red indicates low battery, amber indicates the battery is charging, and green indicates the battery is fully charged.

[0060] The battery is a rechargeable battery that is rechargeable via USB, and therefore the control unit includes a USB charging socket 138 for transferring power to a power charging circuit contained within the control unit.

[0061] Information provided via the user interface may be supplemented by haptic feedback, or alternatively may be conveyed solely via haptic feedback. The user interface may also take the form of a touch screen.

[0062] The control unit is shown with the top case removed in Figure 17. Visual indicators 135, 136 and 137, including LEDs, are mounted or attached to the chassis 140.

[0063] 18 shows an exploded view of control unit 11 with some of the main internal elements. The exterior of the control unit is made up of an upper case 151 and a lower case 152, which when assembled are adapted to contain, hold and protect the internal components of control unit 11.

[0064] The control unit 11 houses the air pump unit subsystem 154 for generating negative pressure in the milk collection hub, as well as the control electronics on the battery 155 and PCB 153. The chassis 140 holds the main components in place, such as the air pump unit 154, battery 155, and PCB 153. The chassis also contains the actuators between the user interface and the PCB switches.

[0065] The breast pump system is configured for quiet operation during normal use. In particular, the control unit is configured to reduce motor vibrations and dampen sound from the pump unit subsystem 154.

[0066] Components of the pump unit subsystem 154 are shown in Figure 19. Pump unit 161, which includes a pump driven from a motor, is configured to generate negative air pressure. Pump unit 161 is connected to a bleed valve, such as a solenoid valve 162, configured to reset the system to ambient pressure when the motor stops.

[0067] Reduced motor vibration and sound dampening The breast pump system is designed to be less obtrusive in terms of noise volume and sharpness compared to available solutions by one or more of reducing the sound generated by the pump unit 161, soundproofing the control unit 11, reducing the power of the pump unit 161, reducing bleed noise by slowing down the air velocity during the rapid return to ambient air pressure after each pumping cycle, and absorbing vibrations of the pump motor within the pump unit subsystem 154.

[0068] Motor vibration is reduced by holding the pump unit 161 in place between two silicone parts: a sound reducing motor mount 163 and an air flow block 164. The sound reducing motor mount 163 holds the back of the pump motor and absorbs some of the pump motor vibration. The air flow block 164 contains air ports or holes to allow air flow from the pump unit 161 to the tube connector 14 and also absorbs some of the pump unit vibration. By using two silicone parts, the vibration transmitted to the hard plastic casing 151, 152 is significantly reduced and therefore this unit is much quieter than other pumping units, which is a major advantage when discretion is required and for reducing disturbance to the baby.

[0069] Both the sound reducing motor mount 163 and the air flow block 164 are one piece made from either compression molded or ISR molded silicone.

[0070] 20-22 provide a cross section of the airflow block showing the air paths inside the airflow block. Airflow block 164 is a multi-function block as follows. · Route or direct the air flow from the tube connector 14 or inlet to the pump unit 161 (see FIG. 20). · Air from the motor exhaust 181 is directed to atmosphere through a simple straight hollow tube with an exit passage at one end (see FIG. 21). Provide for mounting solenoid valve inlet 171 and outlet 172 (see Figures 20 and 22). Provides an isolation barrier against motor vibration.

[0071] Thus, the airflow block 164 is configured to both attenuate sound and reduce motor vibration.

[0072] Several components may be used to further reduce the sound generated by the pump unit subsystems, including but not limited to the following: Solenoid foam cap 165 to reduce bleed flow and bleed noise. Located at the bottom of the case 152 is a sound valve 166 (also shown in FIG. 23). The sound valve 166 allows the internal pressure of the control unit 11 to be maintained at ambient pressure without allowing high levels of sound to escape from the control unit 11. A sound valve cap 167 is also used to protect the sound valve 166 from the outside environment. · Further seal the control unit 11 to attenuate sound. For example, by providing a seal member 173 (see FIG. 23) between the upper part 151 and the lower part 152 of the case and arranging it around the control unit 11, it is possible to prevent air from escaping from the control unit 11 and reduce sound from the pump part 161 escaping to the outside of the control unit 11. Optionally, the airflow block 164 may also be integrated with a part of the seal member 173. Mufflers or silencers may also be used to reduce airborne sound emitted from the air inlet and / or exhaust. One silencer may be connected to the solenoid 162 and the other to the pump motor.

[0073] 19 and 23 show the sound valve 166 located in the bottom 152 of the case. The sound valve 166 is a silicone part that is configured to deform under pressure, thus allowing air to pass in and out of the control unit 11 while greatly reducing motor and pump noise from escaping the control unit 11. The sound valve 166 also ensures that the inside of the control unit 11 remains at ambient pressure and that the pump unit 161 is operating properly.

[0074] The sound valve may include a small cross-sectional cut.

[0075] The pumping cycle is shown in Figures 24 to 26.

[0076] When the system is activated, a pumping cycle begins and the pneumatic pump turns on and creates negative air pressure during a first phase of the pumping cycle, referred to as pumping time (P). When negative air pressure is applied to the milk collection hub 10, the flexible diaphragm 61 deflects and the negative air pressure is conveyed inside the nipple hole 31, pulling on the breast and / or nipple, thus drawing milk 251 from the nipple. During this first phase of the pumping cycle (P), the pneumatic pump 161 is configured to be on for a predetermined time to provide the target negative air pressure. During this first phase, the solenoid valve 162 is configured to be turned off.

[0077] After the target negative pressure is reached, the air pressure pump 161 is turned off and air is bled into the system via the solenoid valve 162 during the second phase of the pumping cycle, called the bleed time (B). Thus, at the end of the bleed time, the system is reset to ambient pressure.

[0078] During this second phase of the pumping cycle, the solenoid valve 162 opens to reset the pressure in the milk collection hub 10 to ambient, which causes an inrush of air into the solenoid valve 162, producing a sound, such as a sharp high frequency tone. As described above, the use of a solenoid foam cap 165, as shown in FIG. 27, reduces the inrush of air entering the solenoid valve 162, and therefore reduces the overall sound produced by the solenoid valve 162. The solenoid foam cap 165 includes one or more small openings or holes configured to reduce and control the velocity of the air as it enters the solenoid valve 162. The solenoid foam cap 165 may be a one-piece piece made of plastic.

[0079] The pumping cycles can be programmed to follow different modes, such as stimulation and milking modes, by controlling the pump time and bleed time. The pumping cycles and / or modes may also be programmed to reach different vacuum levels.

[0080] The stimulation mode is configured to promote milk flow and the expression mode is configured to maximize pumping efficiency. Each mode includes a number of different vacuum levels, such as ten different vacuum levels, which can be selected via a user interface on the control unit.

[0081] Figure 28 lists examples of 10 different vacuum levels for stimulation and milking modes, as well as single and double pumping. This is only an example, and commercially available devices may vary. Regulating the power delivered to the pump motor also reduces the sound produced by the system.

[0082] Thus, the desired vacuum level and sound for a particular mode can be achieved by controlling the time of both phases of the pumping cycle and the power supplied to the pump motor.

[0083] The perimeter of the control unit has an integral seal 173 (see FIG. 23) that dramatically reduces the airborne sound emanating from the unit. This seal creates a significantly quieter product for the user.

[0084] Overall, during operation, the noise level is less than 50 dB, preferably less than 45 dB.

[0085] To improve the user experience, several removable accessories can be used that are attached to the control unit 11. These include, for example: A removable auxiliary battery pack that allows users to pump longer between charges. A tube wrap device that clips onto the back of the control unit, allowing users to neatly store their tubes by wrapping them around it. This also allows users to customize the length of the tube when in use. Belt clip, which allows the user to attach the control unit to clothing and wear it around the waist etc. A lanyard that clips onto the control unit and allows the user to wear the control unit by hanging it around their neck.

[0086] The accessory attachment method may include O-ring type loops that extend over the control unit in multiple positions, allowing the control unit to be mounted in either portrait or landscape orientation.

[0087] Control Unit Accessories The control unit can also include many accessories that are easily removable.

[0088] 29 shows a diagram of the control unit 11 including a multi-function mount, such as an O-ring 290. The multi-function mount allows the control unit 11 to be easily held by a user's fingers in different modes, such as portrait 291 or landscape mode 292.

[0089] FIG. 30 shows a diagram of a control unit 11 including a tube wrap accessory 241 located under the bottom case of the control unit 11, and a control unit including a battery accessory 242, such as a battery pack, located under the bottom case of the control unit 11.

[0090] 31 shows a view of the control unit 11 including an o-ring 290 mount that extends around the periphery of the control unit 11. The mount includes a removable waistband clip 261 to allow the control unit to be clipped to, for example, a belt or pants.

[0091] Tube Connections FIG. 32 shows the tube connections 12 including a tube splitter 261. The tube splitter 12 actually splits the air line 3 coming from the combined control and air pump unit 11 into two separate air lines 1, 2 which are attached to the two milk collection hubs 10. The tube splitter 12 is attached to one end of the air lines 1, 2 which are connected at the other end to the air ports 14 of each milk collection hub 10. The tube splitter is attached to one end of the air line 3 which is connected at its other end to the combined control and air pump unit 11. The tube splitter 12 can include a rotatable plug or stopper 262 to configure the breast pump system for single or double pumping by leading from the air line 3 to either the left air line 1 or the right air line 2 to create an air path that operates only the left hub or the right hub respectively, or can lead from the air line 3 to both the left air line 1 and the right air line 2 to create an air path for double pumping.

[0092] Applications running on connected devices Pump system related data may be transmitted by the system to a connected smartphone or other computing device. The data may be further analyzed by a data analysis subsystem. The data may also be displayed on an application running on the computing device.

[0093] An application may provide one or more of the following features: Discrete / remote control of devices, including play / pause, mode change, brightness setting change, etc. -Battery life display. - Track session times and dates. ·Milk yield tracking. Integration with other devices such as other breast pump systems.

[0094] Appendix 1 The primary features of breast pump systems are currently generalized into the following categories: A. User Experience: Nipple visibility B. Cost Engineering: Simplicity C. User experience: Low noise D. User Experience: Product Handling

[0095] It is noted that any feature may be combined with any one or more of the other features. However, the invention is defined in the appended claims. Furthermore, while the above implementations are breast pump systems with one or two inbra-wearable milk collection hubs, each connected to an external air pump, it is noted that it is possible to integrate the air pump mechanism, rechargeable battery, and control electronics inside each milk collection hub in much the same way that the Elvie pump (see WO 2018 / 229504) integrates the air pump, rechargeable battery, and control electronics into an inbra-wearable unit that includes a user-wearable milk collection container. The following features, unless otherwise stated, should be interpreted expansively to cover breast pump systems that do not require an external air pump, but may utilize an external or internal air pump. Similarly, while the above implementation is a breast pump system having a closed-loop air pump (i.e., the pump is protected from potential milk contamination via the flexible membrane), the following features do not require a closed-loop air pump unless otherwise specified and should be interpreted expansively to cover breast pump systems that are both closed-loop and open-loop.

[0096] A. User Experience Innovation: Nipple Visibility Feature 1: Nipple visibility One embodiment of the present invention contemplates a wearable milk collection hub for a breast pump system that provides a clear, unobstructed view of the nipple to facilitate nipple alignment. This ensures that correct alignment is maintained during pumping. Both the breast shield and the outer shell are substantially transparent, providing a clear, unobstructed view of the nipple when the assembled system is placed on the breast. This further allows the user to verify proper nipple suction when the breast pump system is placed on the breast and while pumping.

[0097] A generalized embodiment is a wearable milk collection hub for a breast pump system, comprising: (a) a breast shield consisting of a breast flange and a nipple hole; (b) a flexible diaphragm configured to prevent milk from reaching an external air pump subsystem; and (c) an outer shell configured to be removably attached to the breastshield such that the breastshield and the outer shell form a container for collecting milk; The breast shield and outer shell are substantially transparent, providing a clear, unobstructed view of the nipple to the mother placing the collection hub on her breast, facilitating proper alignment of the nipple.

[0098] Feature 2: Visibility of nipple and flexible diaphragm In addition to a clear, unobstructed view of the nipple, the system also provides a clear, unobstructed view of the diaphragm inside the hub. The user can see any movement of the diaphragm while pumping and can verify that the system is operating correctly. The diaphragm is positioned to provide an unobstructed line of sight to the nipple, thus providing a view of both the nipple and the flexible diaphragm.

[0099] A generalized embodiment is a wearable milk collection hub for a breast pump system, comprising: (a) a breast shield consisting of a breast flange and a nipple hole; (b) a flexible diaphragm configured to prevent milk from reaching an external air pump subsystem; and (c) an outer shell configured to be removably attached to the breastshield such that the breastshield and the outer shell form a container for collecting milk; The breast shield and outer shell are substantially transparent, simultaneously providing the mother placing the collection hub on her breast with (i) a clear, unobstructed view of the nipple to facilitate proper alignment of the nipple, and (ii) a view of the diaphragm to confirm that the breast pump system is operating properly.

[0100] Feature 3: Visibility of a large part of the nipple and nipple hole The system can also provide an unobstructed view of the nipple hole for easy nipple alignment when the system is placed on the breast and during pumping, which further confirms that the spacing between the nipple and the nipple hole sidewalls is correctly positioned and maintained during pumping.

[0101] A generalized embodiment is a wearable milk collection hub for a breast pump system, comprising: (a) a breast shield consisting of a breast flange and a nipple hole; (b) a flexible diaphragm configured to prevent milk from reaching an external air pump subsystem; and (c) an outer shell configured to be removably attached to the breastshield such that the breastshield and the outer shell form a container for collecting milk; The breast shield and outer shell are substantially transparent and provide a mother placing the collection hub on her breast with (i) a clear, unobstructed view of the nipple to facilitate correct alignment of the nipple, and (ii) a clear, unobstructed view of a substantial portion of the nipple orifice.

[0102] Feature 4: The diaphragm is removably attached. The wearable milk collection hub also includes a removable diaphragm that is configured to separate the air pump side from the milk side located within the hub, thus preventing any contamination of the air pump unit with any milk. The diaphragm is shaped to include a portion that is substantially parallel to the central axis of the nipple orifice or substantially perpendicular to the central axis of the nipple orifice.

[0103] A generalized embodiment is a wearable milk collection hub for a breast pump system, comprising: (a) a substantially transparent breast shield comprising a breast flange and a nipple hole; (b) a flexible diaphragm configured to prevent milk from reaching an external air pump subsystem; and (c) a substantially transparent outer shell configured to be removably attached to the breastshield such that the breastshield and the outer shell form a container for collecting milk; The diaphragm is removably attached to the breastshield and / or the outer shell, the diaphragm including a portion that is positioned over an end or tip of the nipple hole.

[0104] Feature 5: Specific shape and position of the diaphragm The diaphragm is also positioned so as not to obstruct the mother's view of the nipple when the collection hub is placed on the breast, therefore allowing the mother to see any movement of the diaphragm when the air pump is activated, thereby further ensuring proper functioning of the breast pump system.

[0105] A generalized embodiment is a wearable milk collection hub for a breast pump system, comprising: (a) a breast shield consisting of a breast flange and a nipple hole; (b) a flexible diaphragm configured to prevent milk from reaching an external air pump subsystem; and (c) an outer shell configured to be removably attached to the breastshield such that the breastshield and the outer shell form a container for collecting milk; The diaphragm is removably mounted on the breast shield and / or outer shell and is located behind a diaphragm cap that forms a front or part of a front portion of the outer shell so as not to obstruct the mother's view of the nipple when the collection hub is placed on the breast.

[0106] B. Cost Engineering Innovation: Simplicity Feature 6: Removable diaphragm cap The wearable milk collection hub includes a removable diaphragm cap configured to cover and seal the diaphragm, the diaphragm cap being easily removable or attachable with a single push action when the collection hub is placed on the breast, and the diaphragm cap includes an air port or hole for connecting tubing between the milk collection hub and an external control unit that houses the pump unit subsystem.

[0107] Thus, the mother can initially place the collection hub on the breast without the diaphragm cap and without the inconvenience of a tube connected to an air port. Once the milk collection hub is properly positioned on the breast, the mother can easily attach the diaphragm cap together with the tube with a single pushing action.

[0108] A generalized embodiment is a wearable milk collection hub for a breast pump system, comprising: (a) a breast shield consisting of a breast flange and a nipple hole; (b) a flexible diaphragm configured to prevent milk from reaching an external air pump subsystem; and (c) an outer shell configured to be removably attached to the breastshield such that the breastshield and the outer shell form a container for collecting milk; The outer shell includes a removable diaphragm cap that covers and seals the diaphragm, the diaphragm cap forming part of a front surface or front portion of the outer shell and including an air port configured to transfer negative air pressure from an external air pump subsystem to the diaphragm.

[0109] Feature 7: Removable diaphragm cap is omnidirectional An additional benefit of the diaphragm cap is that it is omnidirectional and can be easily rotated on the underside of the outer shell, thus providing the user with the ability to change or rotate the location of the air ports on the diaphragm cap. This also aids the user in changing the placement of the tubes connected to the diaphragm cap. This feature also provides additional versatility and / or flexibility to be used by different users and body shapes with different garments to achieve comfort and / or discretion.

[0110] A generalized embodiment is a wearable milk collection hub for a breast pump system, comprising: (a) a breast shield consisting of a breast flange and a nipple hole; (b) a flexible diaphragm configured to prevent milk from reaching an external air pump subsystem; and (c) an outer shell configured to be removably attached to the breastshield such that the breastshield and the outer shell form a container for collecting milk; The outer shell includes a removable diaphragm cap that covers and seals the diaphragm, the diaphragm cap forming part of the front or front-facing portion of the outer shell and including an air port configured to transfer negative air pressure from the external air pump subsystem to the diaphragm, the removable diaphragm cap configured to rotate to allow the position of the air port on the outer shell to be adjusted by a user.

[0111] Feature 8: Three user-removable parts from the breast shield A generalized embodiment is a wearable milk collection hub for a breast pump system, comprising: (a) a breast shield consisting of a breast flange and a nipple hole; (b) a flexible diaphragm configured to prevent milk from reaching an external air pump subsystem; and (c) an outer shell configured to be removably attached to the breastshield such that the breastshield and the outer shell form a container for collecting milk; (d) a diaphragm cap forming a part of a front surface or front portion of the outer shell; The only items that the user can remove from the breastshield during normal use or normal disassembly are the outer shell, the diaphragm, and the diaphragm cap.

[0112] C. User Experience Innovation: Low Noise Feature 9: Airflow block What can be generalized is a control unit for generating negative air pressure for a breast pump system, the control unit comprising: (a) a rechargeable battery; (b) a power charging circuit for controlling charging of the rechargeable battery; (c) control electronics powered by a rechargeable battery; and (d) a pump powered by a rechargeable battery to generate negative air pressure; (e) a motor for driving the pump; and (f) a casing; The control unit further includes an airflow block configured to transfer suction from the pump to a suction or air port on the control unit, and is further configured to attenuate sound from the pump and / or motor from reaching the casing.

[0113] Feature 10: Sound valve What can be generalized is a control unit for generating negative air pressure for a breast pump system, the control unit comprising: (a) a rechargeable battery; (b) a power charging circuit for controlling charging of the rechargeable battery; (c) control electronics powered by a rechargeable battery; and (d) a pump powered by a rechargeable battery to generate negative air pressure; (e) a motor for driving the pump; The control unit also includes a sound valve configured to allow sufficient air into and out of the control unit for pressure equalization between the interior and exterior of the control unit, while minimizing sound from the pump and / or motor leaking from the control unit.

[0114] Feature 11: Solenoid foam cap What can be generalized is a control unit for generating negative air pressure for a breast pump system, the control unit comprising: (a) a rechargeable battery; (b) a power charging circuit for controlling charging of the rechargeable battery; (c) control electronics powered by a rechargeable battery; and (d) a pump powered by a rechargeable battery to generate negative air pressure; (e) a motor for driving the pump; and (f) a solenoid valve for controlling the generated negative pressure; The control unit also includes a cap or other structure configured to reduce the velocity of air entering the solenoid valve when the solenoid valve opens to ambient air pressure.

[0115] D. User Experience Innovation: Product Handling Feature 12: Multi-function mount What can be generalized is a control unit for generating negative air pressure for a breast pump system, the control unit comprising: (a) a rechargeable battery; (b) a power charging circuit for controlling charging of the rechargeable battery; (c) control electronics powered by a rechargeable battery; and (d) a pump powered by a rechargeable battery to generate negative air pressure; (e) a motor for driving the pump; The control unit also includes a removable multi-function mount configured to be attached to the control unit in at least two different positions such that the control unit can be held in either an upright / portrait or a length / landscape mode.

[0116] Feature 13: Tube management features What can be generalized is a control unit for generating negative air pressure for a breast pump system, the control unit comprising: (a) a rechargeable battery; (b) a power charging circuit for controlling charging of the rechargeable battery; (c) control electronics powered by a rechargeable battery; and (d) a pump powered by a rechargeable battery to generate negative air pressure; (e) a motor for driving the pump; The control unit may also include a tube management structure configured to allow an air tube attachable to the control unit to be wrapped around the tube management structure or may be removably attached to the tube management structure.

[0117] Generally applicable optional features may be combined with any one or more of the above features and may themselves be combined with each other.

[0118] Breast shield Breast shields are rigid or semi-rigid. The breast shield comprises a breast flange and a nipple hole, the nipple hole being configured to receive a nipple. The breast shields come in different sizes, each configured to be attached to the same outer shell. · Different sizes of breast shields each provide a different spacing of the nipple from the sidewall of the nipple cavity when the breast shield is positioned on the breast. · The breast shield integrates the breast flange and nipple hole as a single, integral piece with no joints. The nipple hole contains a milk hole through which expressed milk flows through a check valve into a milk collecting hub. The breast shield includes a diaphragm housing having a side parallel to the nipple hole. The diaphragm housing contains an air hole that transmits negative air pressure to the nipple hole. The air pump chamber is a substantially annular chamber having walls parallel to the longitudinal or central axis of the nipple orifice, the parallel walls positioning the area of ​​the nipple orifice which is subjected to negative air pressure in use. The diaphragm housing has a generally cylindrical outer wall generally parallel to the nipple orifice and a generally cylindrical inner wall generally parallel to the nipple orifice. The diaphragm has a front wall which forms the end of the nipple hole. The diaphragm housing has an annular rear wall joining the outer and inner walls, the annular rear wall overlying the area of ​​the nipple hole which is exposed to negative air pressure in use. The diaphragm moves within an air pump chamber formed on one side by a diaphragm housing with walls parallel to the long or central axis of the nipple hole, and on the other side by a diaphragm cap. The breastshield is integrated with the diaphragm housing portion as a single, one-piece molded piece. The breastshield includes a removable perimeter seal that provides an airtight seal between the outer edge of the breastshield and the outer shell. · The breast shield is a clear or optically clear, dishwasher compatible polypropylene, polycarbonate or copolyester, such as Trita® breast shield.

[0119] Outer shell The outer shell is rigid. The outer shell removably attaches, latches or fits onto the breastshield so that the breastshield provides a rear surface that contacts the breast. The outer shell can be attached to the breast shield with a single push action. The outer shell is attached to the breast shield using magnets. The outer shell includes air openings or vents so that atmospheric pressure is maintained inside the milk collection hub. The outer shell is directly removable from the breast shield during normal use or normal disassembly The outer shell is removable from the breastshield, with the flexible diaphragm permanently or removably attached to the outer shell. The outer shell is an integral part of the breast shield. The outer shell includes a diaphragm cap that sits over the diaphragm. The outer shell and diaphragm are a single piece. The outer shell includes a spout that can be closed for transport of the milk collecting hub. The outer shell fits inside the bra and has a curved front surface to contact the inner surface of the bra. · The outer shell is a clear or optically clear dishwasher safe polypropylene, polycarbonate or copolyester, such as Tritan® outer shell. The outer shell is a self-contained milk collection hub, therefore the breastshield does not provide a surface that comes into contact with milk.

[0120] Diaphragm The diaphragm is flexible and deforms to create negative pressure. The diaphragm is not flexible enough to deform to create negative pressure, but instead simply acts to prevent milk from passing through it and filling the air lines or reaching the motor. The diaphragm is substantially rigid and instead serves to prevent milk from passing through it and filling the air lines or reaching the motor. The diaphragm includes an inner wall and an outer wall that are substantially parallel to the central axis of the nipple orifice. The diaphragm includes substantially cylindrical inner and outer walls substantially parallel to the central axis of the nipple orifice. · When the diaphragm is under negative pressure it moves through the milk opening of the nipple orifice towards the end or tip of the nipple orifice. The diaphragm includes a portion that is substantially parallel to a central axis of the nipple orifice and a portion that is substantially perpendicular to the central axis of the nipple orifice. The diaphragm is molded flush with a diaphragm housing having a roughly cylindrical outer wall generally parallel to the nipple hole and a roughly cylindrical concentric inner wall generally parallel to the nipple hole. The diaphragm deflects when negative air pressure is applied to it by the air pump subsystem, transmitting the negative air pressure to pull the breast and / or nipple against the breastshield, causing milk to be expressed. The diaphragm is positioned so as not to obstruct the mother's view of a significant portion of the nipple orifice when the collection hub is placed on the mother's breast The diaphragm is molded as part of or otherwise attached to the outer shell. The outer shell and diaphragm are formed or joined together to form a unitary item. The diaphragm includes a portion that extends substantially parallel to a central axis of the nipple orifice. The diaphragm is a single flexible membrane molded to include substantially cylindrical inner and outer walls generally parallel to the central axis of the nipple orifice. The diaphragm includes a portion that faces away from the breast and is positioned over the tip of the nipple opening. The diaphragm is removably attached to the outer shell. The diaphragm is removable from the outer shell for cleaning. The diaphragm is configured to self-seal under negative air pressure against a diaphragm holder that is part of the breast shield. The diaphragm is a one-piece unit with no holes or openings. The diaphragm is permanently fixed to the outer shell. The diaphragm is a single flexible membrane formed to include substantially cylindrical inner and outer walls generally parallel to the central axis of the nipple hole, an annular wall joining the substantially cylindrical inner and outer walls, and an end wall located over an end of the nipple hole.

[0121] Diaphragm Cap The diaphragm cap is removable. The diaphragm cap forms the front of the outer shell. The diaphragm cap includes an air port configured to deliver air pressure to the milk collection hub. The diaphragm cap is configured to latch or fit onto the outer shell with a single push action. The diaphragm cap includes recesses or features configured to be grasped by the fingers of one hand. The diaphragm cap includes a pair of recesses configured to allow for one-handed gripping and removal from and installation onto the outer shell. The diaphragm cap is rotatable within the outer shell to adjust the position of the air port on the diaphragm cap. The diaphragm cap contains a passage for the air tube. The diaphragm cap includes a flat portion so that the milk collection hub can rest on a flat surface located on the flat portion. The diaphragm cap is molded to fit the inner part of the bra. The diaphragm cap is a clear or optically clear, dishwasher safe polypropylene, polycarbonate or copolyester, such as a Tritan® diaphragm cap.

[0122] Overall System The system is a closed system. The system has a capacity of approximately 5 fluid ounces (148 ml). The width of the milk collection hub is approximately 5.7cm in the direction of the central axis of the nipple hole. Each milk collection hub is shaped to be fitted, in use, to a bra, for example to be fitted inside a maternity bra. The motor should generate noise levels of 50dB or less at maximum output, and preferably 45dB or less.

[0123] Control Unit The control unit is configured to control suction delivered to the one or two wearable milk collection hubs. The control unit houses an air pump subsystem configured to generate negative air pressure and transmit the negative air pressure to the wearable milk collection hub. The control unit does not house the air pump subsystem and controls an air pump that is external to the control unit. The air pump subsystem is held in place between a sound-attenuating motor mount and an airflow block, each configured to absorb vibrations from the pump unit. The control unit includes a wireless data communication system powered by a rechargeable battery. The control unit includes one or more buttons configured to control the at least one wearable collection hub. The control unit includes a visual and / or tactile indicator that shows whether milk is flowing to the hub. The control unit includes visual and / or tactile indicators that indicate the pumping profile or pattern that has been activated. The control unit includes a visual and / or tactile indicator that indicates the status of the rechargeable battery. The control unit includes a USB charging socket connected to the power charging circuit The multi-function mount is an O-ring.

[0124] Air flow block The airflow block is configured to transmit air or suction from the pump unit and also absorb vibrations from the pump unit. Airflow blocks are made from compression molded silicone. The airflow block is connected directly to the outlet of the air pump subsystem. The air flow block is located near the solenoid valve. The air flow block is a single piece. The control unit is sealed to further attenuate sound. The control unit includes a housing having a top and a bottom. · The bottom and top are sealed together using a seal perimeter. The airflow block is integrated into part of the seal perimeter. The air flow block is connected to an air port or hole for a tube that delivers air to the wearable milk collection hub.

[0125] Sound valve The sound valve is configured to regulate the pressure inside the control unit so that the inside of the control unit remains at ambient pressure and also to attenuate noise from the pump unit leaking from inside the control unit. The sound valve is located at the bottom of the control unit. The sound valve includes a small cut that is configured to deform under pressure. The sound valve is made of silicone.

[0126] Foam Cap The solenoid foam cap is configured to reduce the velocity of air entering the solenoid valve when the solenoid valve opens to ambient air pressure, thus reducing the sound of air entering the solenoid valve. The solenoid foam cap is a one-piece plastic component. The foam cap contains one or more small openings or holes. The control unit also includes two mufflers (or mufflers), one muffler connected to the solenoid valve and the other muffler connected to the motor.

[0127] Note It is to be understood that the above-described arrangements are merely illustrative of the application of the principles of the present invention. Numerous modifications and alternative arrangements can be devised without departing from the spirit and scope of the invention. While the invention has been illustrated in the drawings and fully described in detail and with reference to what are presently considered to be the most practical and preferred embodiments of the invention, it will be apparent to those skilled in the art that numerous modifications can be made without departing from the principles and concepts of the invention as set forth herein.

[0128] A portion of the disclosure of this patent document contains material that is subject to copyright protection. As the patent document or patent disclosure is in the Patent and Trademark Office patent files or records, the copyright owner has no objection to its facsimile reproduction, but otherwise reserves all copyright rights whatsoever.

Claims

1. 1. A breast pump system comprising at least one wearable milk collection hub connected via an air line to an associated external air pump and control unit, each of said milk collection hubs comprising: (a) a breast shield consisting of a breast flange and a nipple hole; (b) a flexible diaphragm configured to prevent milk from reaching the external air pump; (c) an outer shell configured to be removably attached to the breastshield such that when attached, the breastshield and outer shell form a receptacle for collecting milk, the front surface of the outer shell including a curved portion; (d) a diaphragm cap configured to be secured over the flexible diaphragm in use, forming part of a front or forward-facing portion of the outer shell, the diaphragm cap including an air port connected to the air line; Equipped with the diaphragm cap is removable from the outer shell. Breast pump system comprising:

2. 10. The breast pump system of claim 1, wherein said diaphragm cap is rotatable within said outer shell to adjust the position of said air port.

3. 3. The breast pump system of claim 1 or 2, wherein the diaphragm cap includes a pair of recesses configured to enable the cap to be grasped and removed from the outer shell with one hand and installed within the outer shell.

4. 4. The breast pump system of claim 1, wherein the diaphragm cap includes a flat portion, the milk collecting hub being capable of resting on a flat surface located on the flat portion.

5. 5. The breast pump system of claim 1, wherein the diaphragm cap has a passage through which the air line passes, and the air line extends in a direction that coincides with the surface of the bra.

6. 6. The breast pump system of claim 1, wherein the diaphragm cap is made from a transparent or optically clear, dishwasher-safe polypropylene, polycarbonate, or copolyester material.

7. 7. The breast pump system of claim 1, wherein the outer shell comprises or is made from transparent or optically clear, dishwasher safe polypropylene, polycarbonate, or copolyester.

8. 8. The breast pump system of claim 1, wherein the breastshield is a transparent or optically clear, dishwasher safe, polypropylene, polycarbonate or copolyester breastshield.

9. 9. The breast pump system of claim 1, wherein the breastshield comprises a diaphragm housing having a side parallel to the nipple orifice.

10. 10. The breast pump system of claim 9, wherein the diaphragm housing comprises a generally cylindrical outer wall generally parallel to the nipple orifice and a generally cylindrical inner wall generally parallel to the nipple orifice.

11. 11. The breast pump system of claim 9 or 10, wherein the diaphragm housing has a front wall that defines an end of the nipple hole.

12. 12. The breast pump system of claim 9, wherein the diaphragm housing has an annular rear wall.

13. 13. The breast pump system of claim 9, wherein the diaphragm is flexible and (i) includes a wall formed by the diaphragm housing on one side, the flexible diaphragm being parallel to a longitudinal or central axis of the nipple orifice, and (ii) moves within an air pump chamber formed by the diaphragm cap on the opposite side.

14. 14. The breast pump system of any one of claims 9 to 13, wherein the breastshield is integrated with the diaphragm housing portion as a single, unitary piece.

15. 15. The breast pump system of claim 1, wherein the outer shell is a transparent or optically clear, dishwasher safe, polypropylene, polycarbonate or copolyester outer shell.

16. 16. The breast pump system of claim 1, wherein the diaphragm is located at an end of the nipple hole.

17. 17. The breast pump system of claim 1, wherein the diaphragm is a single flexible membrane molded with substantially cylindrical inner and outer walls generally parallel to a central axis of the nipple orifice.

18. 18. The breast pump system of claim 1, wherein the diaphragm is molded to be flush with a diaphragm housing having a roughly cylindrical outer wall generally parallel to the nipple orifice and a roughly cylindrical concentric inner wall also generally parallel to the nipple orifice.

19. 19. The breast pump system of claim 1, wherein the diaphragm includes a portion that extends substantially parallel to a central axis of the nipple orifice.

20. 20. The breast pump system of claim 1, wherein the diaphragm includes a portion that faces away from the breast and overlies an end of the nipple hole.

21. 21. The breast pump system of claim 1, wherein the diaphragm is a single flexible membrane molded to include substantially cylindrical inner and outer walls generally parallel to a central axis of the nipple hole, an annular wall joining the substantially cylindrical outer and inner walls, and an end wall located over an end of the nipple hole.

22. 22. The breast pump system of any one of claims 1 to 21, wherein the control unit is configured to control suction delivered to at least one of the wearable milk collection hubs, and the control unit houses an air pump subsystem configured to generate negative air pressure and transmit negative air pressure to the wearable milk collection hub.

23. 23. The breast pump system of claim 22, wherein the air pump subsystem is held in place between two blocks, each configured to absorb vibrations from the pump unit.

24. 24. The breast pump system of claim 1, further comprising an airflow block within the control unit, the airflow block configured to transmit air or suction from the pump unit and to absorb vibrations from the pump unit.

25. 25. The breast pump system of claim 1, wherein a sound valve in the control unit is configured to adjust the pressure in the control unit so that the interior of the control unit remains at ambient pressure, and the sound valve is configured to attenuate noise from the pump unit that leaks from the interior of the control unit.

26. 26. The breast pump system of claim 25, wherein the sound valve includes small cuts configured to deform under pressure.

27. 27. The breast pump system of any one of claims 1 to 26, wherein the control unit comprises a solenoid valve for resetting the pressure in the wearable milk collection hub to ambient pressure and a solenoid foam cap, the solenoid foam cap in the control unit configured to reduce the velocity of air entering the solenoid valve when the solenoid valve opens to ambient pressure, thus reducing the sound of air entering the solenoid valve.

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