BREAST SHIELD FOR A BREAST PUMP

Abstract

A breast shield for a breast pump comprises a first (inner) cavity for placing over the nipple and having a first pressure control port for controlling milk expression. A second (outer) cavity is radially outward of the first cavity and is coupled to a second pressure control port for providing a sealing or positioning and then holding function. Thus, a positioning/holding function and a milk expression function may be optimized independently.

Claims

1. A breast shield for a breast pump, comprising: a first cavity for placing over a first portion of the breast surface including the nipple of a breast, the first cavity coupled to a first pressure control port for controlling milk expression; and a second cavity positioned radially outwardly from the first cavity, the second cavity coupled to a second pressure control port for providing a sealing, or positioning function, wherein the second cavity is for applying a pressure to a second portion of the breast surface radially outward from the first portion.

2. The breast shield of claim 1, wherein the second cavity extends at least partially around the outside of the first cavity.

3. The breast shield of claim 1, wherein the second cavity comprises: a closed shape around the first cavity; or an open shape extending partially around the first cavity.

4. The breast shield of claim 3, wherein the first cavity has a milk output channel and the ring has an interruption located at the milk output channel.

5. The breast shield of claim 1, wherein the second cavity has a covering membrane.

6. The breast shield of claim 1, wherein the second cavity is separated into segments, wherein each segment has its own pressure control port.

7. The breast shield of claim 1, wherein: the second cavity is rigidly mounted to the first cavity; or the second cavity is elastically non-rigidly mounted to the first cavity.

8. The breast shield of claim 1, further comprising at least one further cavity positioned radially outwardly of the second cavity

9. The breast shield of claim 1, wherein the second cavity is non-circular with a greater height than width.

10. A breast pump comprising: a vacuum pump system; an expression kit which comprises the breast shield of claim 1 coupled to the vacuum pump system; and a controller for controlling the vacuum pump system.

11. The breast pump system of claim 10, wherein the vacuum pump system comprises a vacuum pump, and a regulator system for controlling the pressure applied from the vacuum pump to the first and second cavities.

12. The breast pump system of claim 10, wherein the vacuum pump system comprises a first vacuum pump for the first cavity and a second vacuum pump for the second cavity.

13. The breast pump system of claim 10, wherein the controller is adapted to apply a holding under-pressure to the second cavity which adapts over time from an intermittent application of a particular under-pressure level to a constant application of under-pressure when the breast shield is first positioned.

14. The breast pump system of claim 10, wherein the controller is adapted to apply a massage pressure profile to the second cavity during milk expression using the first cavity.

15. The breast pump system of claim 10, comprising a user interface to allow a user to select pressure characteristics for the first and second cavities.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0043] For a better understanding of the invention, and to show more clearly how it may be carried into effect, reference will now be made, by way of example only, to the accompanying drawings, in which:

[0044] FIG. 1 shows a known breast pump system;

[0045] FIG. 2 shows a first example of a breast shield;

[0046] FIG. 3 shows a first implementation of the example of FIG. 2;

[0047] FIG. 4 shows a second implementation of the example of FIG. 2;

[0048] FIG. 5 shows a second example of a breast shield;

[0049] FIG. 6 shows a third example of a breast shield;

[0050] FIG. 7 shows a fourth example of a breast shield;

[0051] FIG. 8 shows two designs with additional outer cavities;

[0052] FIG. 9 shows a fifth example of a breast shield;

[0053] FIG. 10 shows an example of an intermittent application of under-pressure; and

[0054] FIG. 11 shows a design for the seal provided between the first and second cavities.

DETAILED DESCRIPTION OF THE EMBODIMENTS

[0055] The invention will be described with reference to the Figures.

[0056] It should be understood that the detailed description and specific examples, while indicating exemplary embodiments of the apparatus, systems and methods, are intended for purposes of illustration only and are not intended to limit the scope of the invention. These and other features, aspects, and advantages of the apparatus, systems and methods of the present invention will become better understood from the following description, appended claims, and accompanying drawings. It should be understood that the Figures are merely schematic and are not drawn to scale. It should also be understood that the same reference numerals are used throughout the Figures to indicate the same or similar parts.

[0057] The invention provides a breast shield for a breast pump, which comprises a first cavity for placing over the nipple and having a first pressure control port for controlling milk expression. A second cavity is radially outwardly positioned relative to first cavity (e.g. around or partially around the first cavity) and is coupled to a second pressure control port for providing a sealing or positioning function. Thus, a positioning/holding function and a milk expression function may be optimized independently.

[0058] FIG. 1 shows a known breast pump system 1, comprising an expression unit 2 and a pump arrangement 3 which are connected via a tube 4. The pump arrangement includes various components in addition to the pump, so may be considered to be a general operating unit.

[0059] The expression unit 2 is formed with a main body 7, a funnel 5 for receiving a breast of a user and a receptacle 6 for collecting the expressed milk. The funnel 5 is commonly known as a breast shield. The breast shield 5 and the receptacle 6 are connected to the main body 7. The main body 7 comprises a vacuum chamber, i.e. a chamber to which any desired under-pressure may be applied. A flexible membrane or diaphragm is located in the vacuum chamber, and this membrane prevents expressed milk from flowing into the tube 4 leading to the pump arrangement unit 3.

[0060] The pump arrangement 3 may instead be directly mounted and connected to the main body 7. In this case, the membrane prevents expressed milk from flowing directly into the pump arrangement 3.

[0061] The pump arrangement 3 comprises a controller 10, a power source 12, a motor 14 and a vacuum pump 16. The controller controls 10 the operation of the power source 12, motor 14 and vacuum pump 16. The vacuum pump delivers an under-pressure at one side and an over-pressure at an opposite side (relative to a middle reference pressure, which may be the atmospheric pressure). The pump arrangement 3 further comprises a solenoid valve 18.

[0062] In use, the vacuum pump applies an under-pressure to the membrane located in the main body 7 so that it deforms. The membrane deforms to create an under-pressure in the breast shield 5 which in turns applies an under-pressure to the breast which enables milk to be expressed.

[0063] Although the breast pump system 1 is described as comprising a membrane such that the under-pressure is applied indirectly to the breast, it should be understood that in an alternative embodiment, the under-pressure is applied directly to the breast of a user. In this case, the breast pump system does not comprise a membrane and the under-pressure created by the vacuum pump is applied directly to the breast.

[0064] The under-pressure is applied to the breast at intervals. That is, a pressure differential is applied on a cyclic basis. After an under-pressure has been established, the pressure from the vacuum pump is released by the use of the solenoid valve which is temporarily opened. The solenoid valve is an electromechanically operated valve configured to open and close an air passage that connects to the vacuum side of the vacuum pump to ambient air such that when the solenoid valve is closed, the vacuum pump generates an under-pressure in the expression unit which enables milk to be expressed from the breast of a user. When the solenoid valve is opened, the under-pressure generated by the vacuum pump is released as ambient air flows towards the vacuum or negative pressure created by the vacuum pump such that the pressure exerted on the breast of a user is partially or completely reduced.

[0065] This is a basic description of the known operation of a standard breast pump system.

[0066] The invention relates in particular to the breast shield 5. The breast shield needs to be correctly aligned on the breast and it also needs to remain in place during milk expression. In conventional systems, these functions all have to be achieved by the pressure profile applied to the single area of the breast within the breast shield.

[0067] FIG. 2 shows a first example of a breast shield 5 in accordance with the invention. The breast shield 5 has a first cavity 20 for placing over the nipple. This will be termed a first portion of the breast surface. It has a closed shape such as circle around the nipple. It will be described as an inner cavity in the following description. The inner cavity is coupled to a first pressure control port 22 for applying a first pressure profile to the first cavity, in particular for controlling the milk expression. This first pressure profile is thus applied to the nipple.

[0068] A second cavity 24 extends at least partially around the outside of the inner cavity 20. It will be described as an outer cavity in the following description. The outer cavity is coupled to a second pressure control port 26 for applying a second pressure profile to the outer cavity, in particular for providing a sealing, or positioning function. The outer cavity interfaces with a second portion of the breast surface which extends at least partially around the first portion. This second portion is typically a ring of breast tissue outside the area of the areole.

[0069] The first pressure profile may be considered to implement the basic functionality of the breast pump and the second pressure profile may be considered to implement supporting functions. The two functions may be operated independently, in space and time. Inside the breast shield, the basic functionality focuses on efficient milk extraction e.g. the pumping profile and baseline under-pressure. The supporting functions are for example ensuring a good seal to provide leakage prevention, and to provide attachment of the breast shield and optionally a separate hold and assist function during initial placement of the breast shield.

[0070] In one example, the inner cavity has an inner diameter d1 such as to fit an average range of nipple/teat sizes while the outer diameter d2 is similar to the existing diameters of the breast shield.

[0071] The inner diameter d1 for example may range from 20 mm to 35 mm and the outer diameter 2d may range from 10 cm to 15 cm.

[0072] The surface area between d1 and d2 is proportional to the force exerted by the cup due to the applied under-pressure.

[0073] Alternatively, the inner diameter may be the same as the existing diameter of a breast shield, and the second cavity results in an increased size.

[0074] The diameter ratio and pressure ratio between the cavities can differ in relation to the amount of desired under-pressure.

[0075] While the physical separation into two compartments mainly concerns the basic and support functions for the under-pressure, atmospheric pressure and over pressure, a separation in time enables additional user interface and user experience (UI/UX) functionality.

[0076] For example, the independent control of the two pressure profiles enables personalization and adjustability based on user preferences but also allows adjusting the pressure profiles independently of each other. For example, there may be the option to have direct attachment using the second cavity without applying a baseline vacuum to the nipple and areola. Alternatively, the holding function may, as in conventional breast pump, be implemented by the inner cavity.

[0077] The attachment force for holding the breast shield on the breast is achieved using a minimum baseline under-pressure in the second cavity, intended to mimic the baseline vacuum naturally created by the baby's mouth between the tongue and palate for attachment.

[0078] The contact area and level of negative pressure determine the force required to balance the weight of the breast shield and any connected components, and hold it in place. Ideally, the second cavity is able to support the full weight of the device alone and/or in combination with the first, internal cavity. This may be achieved with different vacuum levels in the two compartments.

[0079] As mentioned above, the user may choose not to use the option of direct attachment using the second cavity.

[0080] FIG. 3 shows a first implementation of the example of FIG. 2 in which the outer cavity 24 comprises a closed shape around the inner cavity.

[0081] FIG. 4 shows a second implementation of the example of FIG. 2 in which the outer cavity 24 comprises a shape only partially around the inner cavity.

[0082] The second cavity is thus open, having a C-shape. This enables connections to the first cavity bypassing the direct attachment of the outer compartment. For example, a milk transport passage may extend from the first cavity towards the bottle through the interruption 30. The inner cavity 22 then has a milk output channel 32 and the outer cavity has an interruption 30 located at the milk output channel.

[0083] The outer cavity may be smaller and hence located at one location around the outer periphery of the inner cavity, e.g. at the top

[0084] FIG. 5 shows an example in which the outer cavity has a covering membrane

[0085] The example of FIGS. 2 to 4 are open systems, meaning the under-pressure or other pressure is in direct contact with the skin. This might be undesirable when there is a rapid application of under-pressure or if there is a risk of milk being sucked into the vacuum system. The membrane 40 functions as an active suction cup to create an attachment on the breast.

[0086] FIG. 6 shows an example in which the outer cavity is separated into segments 50, wherein each segment has its own pressure control port (not shown). The segments may be controlled individually or in groups. Thus, each segment has a pressure control port so that a pressure may be applied to the chamber formed by the segment.

[0087] A single covering membrane as shown in FIG. 5 may cover the set of separated segments of the design of FIG. 6.

[0088] Having multiple segments for example enables the use of over pressure in one or more segments while the other segments secure the breast shield by an applied under-pressure. By having a balance between the under-pressure of some segments and the over pressure of other segments, a number of over pressure profiles can provide massaging, by circular motion or within a specific target area, to improve the milk extraction while the remaining segments still hold the breast shield secure to the breast.

[0089] A massage function for example requires a difference in pressure between different points, which varies over time. The massage function may use an over-pressure or an under-pressure or a combination.

[0090] By changing the actuation of the segments, the over pressure and massage function can move around the outer diameter of the breast. There may again be a membrane between the applied pressure and the skin.

[0091] The examples above all form the two cavities using a single integrated molded component so that the outer cavity is rigidly mounted to the inner cavity.

[0092] FIG. 7 shows an example in which the outer cavity 24 is elastically non-rigidly mounted to the inner cavity 22 by means of an elastic ring 60. This elastic ring may form part of the tubing of the breast shield. This reduces the attachment to the remainder of the breast shield and provides a suspension. This makes the outer cavity at least partially mechanically independent from the central body of the breast shield, so that movement can be supported between the two cavities to allow a best fit to the breast.

[0093] The examples above have a single inner cavity and a single outer cavity. There may instead be multiple outer cavities.

[0094] FIG. 8 shows in the top image two concentric outer cavities 24a, 24b around the inner cavity. FIG. 8 shows in the bottom image three concentric outer cavities 24a, 24b, 24c around the inner cavity.

[0095] By switching the application of under-pressure between the multiple outer cavities, it can be ensured that there is a constantly present under-pressure to hold the breast pump while there is no constant under-pressure all of the tissue. This avoid bruises that can occur when an under-pressure is constantly applied to one location of the skin. The pressures could for example follow a sinusoidal pattern, with opposite phase between the two outer cavities 24a,24b, or a three phase approach for three outer cavities.

[0096] The positioning of the breast shield needs to overcome the force of gravity.

[0097] FIG. 9 shows an example in which at least the outer cavity is non-circular with a greater height than width. This means that the force component exerted by the second cavity in the vertical direction (parallel to gravity) is stronger than the horizontal component. An oval or rectangular shape may be used. This gives the advantage that in the vertical direction more force is available, avoiding unintended movement, while horizontal movements, which are less influenced by gravity, are facilitated for improved comfort and fit.

[0098] The sum of the forces resulting from the under-pressure levels applied to the first and second cavities preferably remains at least at a level sufficient to hold the expression kit to the breast, thereby counteracting gravity.

[0099] The oval design may be combined with any of the previous examples. When the inner and outer cavities are concentric, they will both have the same non-circular shape.

[0100] In order to provide different under-pressure levels and/or profiles to the two cavities (or indeed the multiple segments for a segmented second cavity), a single vacuum pump may be used but with a regulator system which controls the pressure applied to first cavity and the second cavity. A buffer and valve system may be used to regulate the pressures in the cavities from a share vacuum pump. For example, EP 2 598 183 discloses a vacuum pump and a variable volume buffer volume, in which the buffer volume may be used to control a negative pressure generated. This type of system may be used for each of the cavities.

[0101] Alternatively, there may be a first vacuum pump for the first cavity and a second vacuum pump for second cavity.

[0102] As explained above, the second cavity may have the function of providing a holding force. A holding vacuum may be applied to the outer cavity which adapts over time from an intermittent application of under-pressure to a constant application of under-pressure when the breast shield is first positioned.

[0103] Placing a breast shield with a fixed pre-established constant vacuum results in a quick positioning of the device on the breast. However, a constant baseline vacuum is not optimal for repositioning, as the user needs to break the vacuum seal before repositioning into the desired position. The use of an intermittent short holding (vacuum) and a release pressure (a lower vacuum, or atmospheric pressure or even an over pressure) means the user can reposition gradually until she feels that the positon is optimal. The rhythm or pace of the intermitting pressure and release changes to a full vacuum suitable for holding and operating the device hands-free.

[0104] FIG. 10 shows the intermittent application of under-pressure as pressure (relative to atmospheric pressure) versus time. The intermittent pressure enables repositioning by the user until the correct alignment is found.

[0105] The switch to a constant vacuum may be after a fixed time, or user specified time, or when an input command is received from the user, the pressure can convert to a fixed baseline pressure.

[0106] The controller may also apply a massage pressure profile to the outer cavity during milk expression using the first cavity.

[0107] A user interface may allow a user to select pressure characteristics for the first and second cavities as mentioned above. This provides personalization and adjustment to user preferences. Direct attachment using the second cavity means that the pumping vacuum profile does not need the conventional baseline vacuum on the nipple and areola.

[0108] In the examples above, there is an annular ridge between the cavities, and this ridge is held against the skin by the under-pressure in one or both of the cavities on each side. This ridge may be adapted to ensure the best possible comfort for the wearer. For example, instead of a flat surface with a sharp edges leading into the cavities on each side, a curved shape may be formed, with a soft low friction surface where there will be contact with the skin. By providing a curved shape for the wall between the cavities, sharp edges can be avoided.

[0109] FIG. 11 shows an example of a design of the interface between the inner and outer cavities. The ridge 70 has a smooth curved surface. In addition, it can deflect as represented by the arrow so that it can move in response to movement of the skin surface 72 for example induced by the different pressures applied to the cavities. In this way, the ridge can remain in contact with the same area of skin and does not need to slide relative to the skin surface when there are small movements in the skin surface. The ridge can move with the skin.

[0110] A curved shape may be formed by an integrated molded shape feature, but it may instead be an externally applied pad which is mounted over the front face of the breast shield.

[0111] The curved shape between the cavities may be formed by a flexible wall portion which defines the transition between adjacent cavities. It may then define a soft sealing ring which separates a first cavity from a second cavity.

[0112] The invention has been described above with reference to a conventional vacuum pump (motor and impeller) and solenoid. However, there are other options for creating the desired under-pressure, such as hydraulic-driven systems, ultrasonic motors, and peristaltic pumps. Any of these different ways of producing an under-pressure may be used for the inner and/or outer cavities.

[0113] Variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, the disclosure and the appended claims. In the claims, the word comprising does not exclude other elements or steps, and the indefinite article a or an does not exclude a plurality.

[0114] The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage.

[0115] If the term adapted to is used in the claims or description, it is noted the term adapted to is intended to be equivalent to the term configured to.

[0116] Any reference signs in the claims should not be construed as limiting the scope.