CN118178759A - Breast shield assembly, adjustment device and method - Google Patents

Abstract

The invention relates to a breastshield assembly, an adjustment device and a method. A breastshield assembly (112) is provided for use in a breast procedure, such as a milk expression and/or a breast massaging procedure. The breastshield assembly includes a cavity for receiving at least a portion of the breast, the cavity being at least partially defined by a surface (100) that faces the breast when at least a portion of the breast is received in the cavity. The surface is arranged such that relative movement of the surface and the breast during a breast procedure causes the breast to be contactable by at least one location (111A, 111B) of the surface. The adjustment means (110) enables changing one or more of the at least one position such that different discrete areas of the breast can be contacted by the surface. Also provided are the adjustment device itself, a breast pump assembly comprising a breast shield assembly and a breast pump for moving a surface during a breast procedure, and a method of engaging a breast with a surface of such a breast shield assembly.

Description

Breast shield assembly, adjustment device and method

Technical Field

The present invention relates to a breast shield assembly, a breast pump assembly comprising a breast shield assembly, and a method of engaging a breast with a surface of such a breast shield assembly. The invention also relates to an adjustment device for a breastshield.

Background

Women in lactation often suffer from nipple pain and catheter blockage: 69% suffered from catheter blockage, 97% suffered from nipple pain, 20% suffered from mastitis. In breast feeding, the mother would be advised to choose alternate positions to change the latch. Different locks cause different mouth orientations, resulting in different interactions with the breast/nipple. This different interaction can open the "closed" catheter and avoid nipple pain. Both methods can reduce mastitis.

Another cause of nipple pain and catheter blockage arises from the use of breast funnels and breast pumps to express milk. Meanwhile, designs are known which aim to mimic the mouth of an infant by providing a collapsible breast funnel that contacts the nipple. Typically, not all milk tubes are emptied. Furthermore, repeated movement of the breast funnel against the nipple may create stress points on the nipple skin.

WO2022/129291A1 discloses a breast pump with a breast shield, wherein a stimulation unit is used to apply a physical stimulus to a nipple and/or a part of the breast to stimulate the lactation reflex.

EP4000661A1 discloses a breast shield for a breast pump comprising: a first lumen having a first pressure control port for controlling milk expression; and a second outer chamber having a second pressure control port for providing sealing, positioning and retaining functions.

US2019/336661A1 discloses a breast pump device having a pump body comprising an actuator element, wherein deformation of the actuator element changes at least one of the shape and size of the pump volume.

US2004/181205A1 discloses a method of noninvasively obtaining an intraductal fluid from a patient. The method includes contacting the patient with a fluid-in-tube sampling device, providing compression, and transferring heat to the patient according to a predetermined cycle characteristic.

DE102012018903 discloses a breast shield designed such that manual milk discharge pressure producing milk can be applied to the nipple and its vicinity.

Disclosure of Invention

The invention is defined by the claims.

According to an example of an aspect of the present invention, there is provided a breastshield assembly for use during a breast procedure, the breastshield assembly comprising: a cavity for receiving at least a portion of a breast, the cavity being at least partially defined by a surface that faces the breast during use, wherein the surface is arranged such that relative movement of the surface and the breast during a breast procedure causes the breast to be contactable by at least one location of the surface; and an adjustment device configured to enable one or more of the at least one position to be changed such that different discrete areas of the breast can be contacted by the surface.

Despite the advantages associated with milk expression associated with discrete region(s) (e.g., nipple and/or areola) of the breast being contacted at different location(s) of the surface, repeated contact of the same discrete region(s) during milk expression may be undesirable because it may cause only certain milk tube(s) to be stimulated, in other words, only milk tube(s) at or near the discrete region(s) to be stimulated, while other milk tubes are not. There is a risk of blockage of the milk tube that is not stimulated, and the same discrete area(s) that are repeatedly contacted by the surface may be exposed to more friction. The latter may be one of the causes of nipple pain.

To alleviate one or more of these problems, the configuration of the adjustment means enables a variation between different positions of the surface that may be in contact with the breast. In this way, different discrete areas of the breast may be contacted by the surface.

This can alleviate nipple pain associated with repeated contact of the same discrete region(s) of the surface and can reduce the risk of obstruction of the milk tube(s) because modulation can cause different milk tubes to be stimulated.

Furthermore, since this is achieved via the adjustment means comprised in the breastshield assembly, the orientation of one or more components of the breastshield assembly with respect to the breast can be maintained regardless of the change in at least one position. The ability to maintain this orientation may have various advantages.

In embodiments where the breast shield assembly comprises a milk receiving assembly for receiving milk during milk expression, the orientation of the milk receiving assembly during milk expression may be independent of a change in position(s) of the surface that may be in contact with the breast.

Thus, the change in the position(s) of the surface that may be in contact with the breast may not interfere with receiving expressed milk via the milk receiving assembly, e.g. collecting milk in a collection container comprised by the milk receiving assembly. This may be particularly advantageous in case the orientation of the milk receiving assembly is such that the expressed milk can be received partly by gravity.

The adjustment means may be configured in any suitable way as long as the position(s) of the surface in contact with the breast can be changed such that different discrete areas of the breast can be contacted by the surface.

In some embodiments, the adjustment device is configured to enable a change in one or more of the at least one positions by moving the position(s) of the surface towards and/or away from the breast. Such movement may include, for example, radial movement of the location(s) toward and/or away from a central axis extending through an open mouth of the cavity in which the breast may be received by movement along the central axis.

In some embodiments, the breastshield assembly includes a wall having a wall surface that at least partially defines a cavity.

In a first set of embodiments, the wall is a rigid wall. In such embodiments, the breast may be moved toward and away from the rigid wall by providing a variable pressure in the cavity.

When the wall is such a rigid wall, the breastshield assembly may comprise an insert that is movably (e.g., rotatably) mounted within the cavity, wherein movement (e.g., rotation) of the insert is such that the insert may contact different areas of the breast when the breast is moved within the cavity, e.g., due to the variable pressure described above.

Thus, in such embodiments, the position(s) of the surface comprise(s) the breast-facing surface(s) of the insert (e.g. defined by the breast-facing surface(s) of the insert), wherein the adjustment means comprises a mechanism, such as a pivotal coupling mechanism, which allows the breast-facing surface(s) to be moved such that different areas of the breast can contact the breast-facing surface(s).

In a second set of embodiments, the surface is at least partially comprised in a deformable wall, wherein the surface is movable by deformation of the wall and shape recovery of the wall after deformation.

In such embodiments, the adjustment means may be configured to enable a change in one or more of the at least one positions by changing at least one axis along which the wall is deformed or restored.

In some embodiments, the cavity has a non-rotationally symmetrical shape when the surface is not moved, wherein the adjustment means is configured to change the position and/or orientation of at least a portion of a wall that translates and/or rotates the non-rotationally symmetrical cavity.

In some embodiments, and whether the wall is deformable or not, the adjustment means is provided at one or more of the following positions: around the wall; an outer surface of the wall, the outer surface facing away from the breast during use; the inner side of the wall; on the surface (the location(s) of which may be in contact with the breast); and within the cavity.

In some embodiments, the mechanical properties of one or more portions of the deformable wall are variable.

For example, the stiffness of the deformable wall may be variable.

In such embodiments, the adjustment means may be considered to comprise a buckling mechanism, such as a fluid or mechanical buckling mechanism, for effecting said change of position(s) of the surface contactable with the breast.

For example, the buckling mechanism may be configured to cause deformation/bending of the wall, which changes in successive pumping cycles such that the first location(s) of the surface are in contact with the first discrete region(s) of the breast, followed by the second location(s) of the surface are in contact with the second discrete region(s) of the breast, the second discrete region being different from the first discrete region.

In some embodiments, the adjustment means comprises one or more springs, for example in the form of one or more springs, arranged such that applying a stress to the springs flexes the springs towards the outer surface of the deformable wall and thereby causes a pressure to be applied by the surface to the breast.

In other embodiments, the adjustment device comprises a piezoelectric buckling mechanism, for example in the form of a piezoelectric buckling mechanism, having a stack of at least two piezoelectric elements connected together.

In such embodiments, a smaller piezoelectric displacement may result in a larger buckling displacement.

In some embodiments, the adjustment device is at least partially defined by a wall comprising one or more non-newtonian fluid portions comprising a non-newtonian fluid, such as rubber, that moves in response to the frequency of pressure changes provided by operation of the breast pump. In such embodiments, the pump frequency may be adjusted to enable a change in the position(s) of the surface that may be in contact with the breast.

In some embodiments, the conditioning device comprises at least one tube filled with a non-newtonian fluid, for example in the form of at least one tube filled with a non-newtonian fluid. The at least one tube is attached to the flexible/deformable wall, but may be disposed around only a portion of the deformable wall, for example, around about one third of the circumference of the deformable wall. When a lower pumping frequency is used, the tube(s) may deform together with the rest of the deformable wall so that the location(s) of the surface of the deformable wall is in contact with the breast. When high frequencies are applied, the tube(s) may exhibit greater rigidity than the deformable wall and deform the deformable wall in a different manner.

Alternatively or additionally, the adjustment means may comprise one or more inflatable cushions, inflation and/or deflation of the one or more inflatable cushions enabling selection of discrete region(s) of the breast contacted by the surface.

Alternatively or additionally, the adjustment means may comprise an electroactive polymer assembly, the electroactive polymer(s) of which are deformable to enable a change in position(s) of the surface that can be brought into contact with the breast.

By varying the voltage across the electrodes (with the electroactive polymer(s) disposed between them), the shape of the electroactive polymer assembly can be varied while adjusting the position(s) of the surface that can contact the breast.

In such embodiments, the surface may be at least partially included in the electroactive polymer(s).

Alternatively or additionally, the adjustment means may comprise a thermal change material assembly configured such that the surface is movable in response to thermal stimulation to change the position(s) of the surface that are contactable with the breast.

In summary, the adjustment means may comprise at least one of the following: an electroactive polymer assembly, at least one inflatable and/or deflatable air chamber, a piezoelectric buckling mechanism; a heat-altered material assembly; and one or more non-newtonian fluid portions of the wall.

Alternatively or additionally, the adjustment means comprises a wall surrounding member configured to engage the wall such that the at least one position is contactable with the breast, the wall surrounding member being movable relative to the wall to enable said change of one or more of the at least one position.

In such embodiments, engagement of the wall surrounding member with the outer surface of the wall may determine the shape of the surface.

This shaping of the surface may provide more locations for the wall surrounding members to bend (e.g., be collapsed inward) than other areas. The greater flexing of the former may mean that it is easier than the latter to flex, e.g. collapse inwardly, in response to the variable pressure provided by operation of the breast pump. Thus, the more curved (e.g., inwardly collapsed) position(s) may correspond to the position(s) that may be in contact with the breast during a breast procedure.

In an alternative embodiment, the wall surrounding member may cooperate with the deformable wall to control the resting state of the wall without impeding the expansion of the cavity upon application of a vacuum. In such embodiments, the breastshield assembly may include a support structure comprising a rigid base to which a deformable wall (e.g., an edge of the deformable wall) is secured; and a rigid wall surrounding member disposed adjacent the rigid base. Because the rigid wall surrounding member is proximate to the rigid base, expansion of the cavity may be unobstructed or may be only minimally obstructed by the wall surrounding member.

Thus, the wall surrounding member may enable a change in the position and/or orientation of at least a portion of the wall that translates and/or rotates the non-rotationally symmetric cavity.

In some embodiments, the wall surrounding member is rotatable relative to the wall to allow for a change in one or more of the at least one position. Since the milk ducts are arranged radially around the nipple, such rotation of the wall surrounding member relative to the wall may enable direct stimulation of the different milk ducts.

In some embodiments, the adjustment means may be manually operable by a user to enable said change of one or more of the at least one positions.

Such manual operability of the adjustment device may provide a relatively simple and low cost way for the user to control the breastshield assembly to increase comfort and/or improve milk expression.

In some embodiments, the adjustment device may be manually operated by the user when performing a breast procedure (e.g., milk expression). Alternatively or additionally, the adjustment means may be manually operated by the user to enable a change in one or more of the at least one positions prior to performing a breast operation procedure (e.g. milk expression).

In some embodiments, the adjustment device (e.g., wall surrounding member) includes a user-accessible portion configured to enable a user to manually move the adjustment device (e.g., wall surrounding member) to enable a change in one or more of the at least one positions.

The user-accessible portion may be of any suitable type. In some embodiments, the user accessible portion includes a finger grip portion disposed about an outer surface of the wall surrounding member, the outer surface facing away from the surface.

In embodiments where the adjustment means (e.g. the wall surrounding member) is rotatable, the user accessible portion (e.g. the finger grip portion) may facilitate manual rotation of the adjustment means to allow for a change in one or more of the at least one position.

Alternatively or in addition to the user adjustment of the adjustment device described above, the adjustment device may comprise a power device which may be controlled to effect a change in one or more of the at least one positions.

The power means may be of any suitable type. In some embodiments, the power device includes one or more actuators, such as electroactive polymer assemblies described above that are configured to move a surface in response to an electrical signal, and/or heat-altered material assemblies described above that are configured to move a surface in response to a thermal stimulus.

In some embodiments, the adjustment device includes an automatic adjustment system configured to effect a change in one or more of the at least one positions.

Such an automatic adjustment system may automatically effect the change, e.g., based on a preselected or predetermined timing of the different discrete areas being contacted by the surface, and/or based on milk collection data collected, e.g., via one or more sensors.

These milk collection data may indicate when it may be beneficial to effect a change in one or more of the at least one location, for example, as milk is collected at a slower rate.

The automatic adjustment system may, for example, include one or more processors configured to control the power plant, and optionally configured to receive milk collection data from the one or more sensors and to control the power plant based on the received milk collection data.

According to another aspect, there is provided a breast pump assembly comprising: a breastshield assembly according to any of the embodiments described herein; and a breast pump for providing a variable pressure that causes relative movement of the surface and the breast during a breast procedure.

In some embodiments, the breast pump is a wearable breast pump.

In such embodiments, the orientation of the wearable breast pump during milk expression may be independent of a change in one or more of the at least one position.

Thus, the change of one or more of the at least one position may not interfere with the orientation of the wearable breast pump, and thus the wearable breast pump may continue to be worn in the same manner during the change of one or more of the at least one position.

According to a further aspect, there is provided an adjustment device for a breastshield, the breast receiving cavity of the breastshield being at least partially defined by a surface, the surface and the breast being movable relative to each other during a breast operation such that the breast is contactable by at least one position of the surface, wherein the adjustment device is engageable with the surface and is configured to enable one or more of the at least one position to be changed such that different discrete areas of the breast are contactable by the surface.

In some embodiments, the adjustment device (e.g., an adjustment device comprising a wall surrounding member) may be retrofittable to the breastshield.

Where the adjustment means comprises a wall surrounding member (e.g. a wall surrounding member), the wall surrounding member may be a ring for disposition around the deformable wall. Such a ring may, for example, comprise two (or more) ring portions that may be positioned around the wall and coupled to one another to define a wall encircling member.

According to another aspect, there is provided a method of engaging a breast with a surface of a breastshield assembly adapted for use during a breast operation, the breast being contactable by at least one position of the surface as the surface and the breast move relative to one another during the breast operation, the breastshield assembly further comprising adjustment means, the method comprising using the adjustment means to alter one or more of the at least one positions such that different discrete areas of the breast are contactable by the surface.

The breastshield assembly may be a breastshield assembly according to any of the embodiments described herein.

In some embodiments, the method does not include a breast procedure, such as not including expressing milk from a breast engaged with a surface.

The method may set the breastshield assembly to the following states: the surface engages the breast and the at least one (or more) locations are selected to contact the breast, thereby allowing a subsequent breast procedure (e.g., milk expression) to be performed, but the claimed method does not include a breast procedure (e.g., milk expression).

These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter.

Drawings

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

FIG. 1 provides a partial perspective view of a breastshield assembly according to one example;

Figures 2A-2E provide various views of a breastshield assembly according to one example;

FIG. 3 illustrates a first example of an adjustment device of a breastshield assembly;

fig. 4 shows a second example of an adjustment means of the breastshield assembly;

fig. 5 shows a third example of an adjustment means of the breastshield assembly;

FIG. 6 illustrates a breastshield assembly according to another example; and

Fig. 7A and 7B depict two positions of the adjustment device included in the breastshield assembly shown in fig. 6.

Detailed Description

The present invention will be described below with reference to the accompanying drawings.

It should be understood that the detailed description and specific examples, while indicating exemplary embodiments of the apparatus, system, and method, 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, system, and method of the present invention will become better understood with regard to 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 drawings to designate the same or similar components.

A breastshield assembly is provided for use in a breast procedure, such as a milk expression and/or breast massage procedure. The breastshield assembly includes a cavity for receiving at least a portion of the breast, the cavity being at least partially defined by a surface that faces the breast when at least a portion of the breast is received in the cavity. The surface is arranged such that relative movement of the surface and the breast during a breast procedure causes the breast to be contactable by at least one location of the surface. The adjustment means enables one or more of the at least one position to be changed such that different discrete areas of the breast can be contacted by the surface. Also provided are an adjustment device per se, a breast pump assembly comprising a breast shield assembly and a breast pump for moving a surface during a breast operation procedure, and a method of engaging a breast with a surface of such a breast shield assembly.

Fig. 1 shows a breast shield having a wall 101, the surface 100 of which (see fig. 2B, 2C and 2E) at least partially defines a cavity for receiving at least a portion of a breast, such as a breast including a nipple area (not visible in fig. 1 and 2A-2E). The surface 100, together with at least a portion of the breast, may at least partially define a chamber in which a variable pressure may be provided during a breast procedure, such as a breast procedure including milk expression from the breast and/or a breast massaging procedure.

Such variable pressure may be provided by operating a breast pump (not visible).

In some embodiments, as shown in fig. 1, the surface 100 is included in a wall 101, such as a deformable wall 101 defining a flexible funnel in which a nipple-including region of the breast may be received. The term "flexible" may be considered to mean that the flexible funnel is elastically deformable.

The surface 100 may be defined at least in part by an inner surface of the flexible funnel that faces the breast in use.

In such embodiments, the flexible funnel may define an open mouth 102 for receiving at least a nipple of a breast.

The open mouth 102 may be defined by an edge 104 of the flexible funnel that extends at least partially around a nipple-containing region of the breast.

The deformation/bending of the flexible funnel or the recovery of the flexible funnel after deformation/bending may generate a mechanical pressure applied to the breast including the nipple area, as will be explained in more detail below.

In some embodiments, this bending and recovery of the flexible funnel also creates a variable vacuum within the chamber, thereby facilitating expression of milk from the breast.

The wall 101 may be formed of any suitable material. In embodiments where the wall 101 is deformable, the wall 101 is made of a flexible (i.e., elastically deformable) material.

In some embodiments, the wall 101 (e.g., flexible funnel) is formed of an elastomeric material such as silicone rubber.

In some embodiments, as shown in fig. 1, the flexible funnel is supported by a support structure 106. Such support structures 106 may support the flexible funnel during bending and subsequent recovery of the flexible funnel.

The support structure 106 may have any suitable design as long as the support structure 106 is capable of supporting the flexible funnel during bending and recovery of the flexible funnel.

In some embodiments, and as shown in fig. 1, the support structure 106 includes a mouth support portion 108A that extends at least partially around the open mouth 102 of the flexible funnel and supports the open mouth 102; and a base support portion 108B, the base support portion 108B extending at least partially around a base 109 of the funnel-shaped wall 101, the base 109 being opposite the open mouth 102.

In such embodiments, support structure 106 may include one or more support ribs 108C, 108D extending between mouth support portion 108A and base support portion 108B. Although two support ribs 108C, 108D are visible in fig. 1, in this non-limiting example, the support structure 106 includes a third support rib 108E, which third support rib 108E can be seen, for example, in fig. 2D and 2E.

More generally, and with reference to fig. 2A-2E, the breastshield assembly 112 includes an adjustment device 110, the adjustment device 110 enabling a change in the position(s) 111A, 111B of the surface 100 that contact the breast during a breast operation, such that different discrete areas of the breast may be contacted by the surface 100.

For example, the adjustment device 110 may cooperate with the surface 100 to effect a change in the position(s) 111A, 111B of the surface 100 in contact with the breast.

While the different (e.g., discrete) location(s) 111A, 111B of the surface 100 contact the discrete region(s) (e.g., nipple and/or areola) of the breast has some advantages related to milk expression, repeated contact with the same discrete region(s) during a breast procedure (e.g., milk expression) may be undesirable because it may cause only certain tube(s) to be stimulated, in other words, only tube(s) at or near the discrete region(s), which other tubes may not receive. There is no risk of blockage of the stimulated milk tube, and the same discrete region(s) repeatedly contacted by the surface 100 may be exposed to more friction. The latter may be one of the causes of nipple pain.

To alleviate these problems, the adjustment device 110 enables changing (e.g., changing) between different positions 111A, 111B where the surface 100 may be in contact with the breast. In this way, different discrete areas of the breast may be contacted by the surface 100.

This can alleviate nipple pain associated with repeated contact of the same discrete region(s) with the surface 100 and can reduce the risk of obstruction of the milk tube(s) because the adjustment can cause different milk tubes to be stimulated.

Furthermore, since this is achieved via the adjustment means 110 comprised in the breastshield assembly, the orientation of one or more components of the breastshield assembly 112 (such as the flexible funnel) with respect to the breast can be maintained during this change. The ability to maintain this orientation may have various advantages.

In some embodiments, the edge 104 of the wall 101 (e.g. flexible funnel) extends at least partially around at least a portion of the breast and the positioning arranged against the breast, e.g. in use, may be independent of the change.

Thus, the positioning of the wall 101 (e.g., flexible funnel) against the breast need not be changed by adjustment, thereby making the breastshield assembly 112 more convenient to use.

Alternatively or additionally, in embodiments where the breastshield assembly 112 includes a milk receiving assembly (not visible) for receiving milk during milk expression, the orientation of the milk receiving assembly during milk expression may be independent of a change in one or more of the at least one positions 111A, 111B.

Thus, a change in one or more of the at least one locations 111A, 111B may not interfere with receiving expressed milk via the milk receiving assembly, e.g., collecting milk in a collection container comprised by the milk receiving assembly. This may be particularly advantageous in case the orientation of the milk receiving assembly is such that the expressed milk can be received partly by gravity.

Alternatively or additionally, in embodiments where the breastshield assembly 112 includes a support structure 106 for supporting the wall 101 (e.g., a flexible funnel) during deformation of the wall 101, the orientation of the support structure 106 relative to the breast may be independent of a change in one or more of the at least one positions 111A, 111B.

The adjustment means 110 may be configured in any suitable way as long as the position(s) 111A, 111B of the surface 100 in contact with the breast can be changed such that different discrete areas of the breast can be contacted by the surface 100.

In some embodiments, such as shown in fig. 2A-2E, the adjustment device 110 is configured to enable a change in one or more of the at least one locations 111A, 111B by moving the location(s) of the surface 100 toward and/or away from the breast. Such movement may include, for example, radially moving the position(s) 111A, 111B toward and/or away from a central axis 114 extending through the open mouth 102 of the cavity in which the breast may be accommodated by movement along the central axis 114.

In some embodiments, the adjustment device 110 comprises a buckling mechanism, such as a fluid or mechanical buckling mechanism, that effects the described change in position(s) 111A, 111B of the surface 100 that can be in contact with the breast.

In such embodiments, the buckling mechanism may be configured to cause bending of the flexible funnel that varies over the continuous pumping cycle such that the first location(s) 111A are in contact with the first discrete region(s) of the breast, followed by the second location(s) 111B being in contact with the second discrete region(s) of the breast, the second discrete region being different from the first discrete region.

In some embodiments, the adjustment means 110 comprises one or more springs, for example in the form of one or more springs, arranged such that applying a stress on the springs causes the spring(s) to flex towards the outer surface of the deformable wall 101, thereby causing a pressure to be applied by the surface 100 to the breast.

In other embodiments, the adjustment device comprises a piezoelectric buckling mechanism, for example in the form of a piezoelectric buckling mechanism, having a stack of at least two piezoelectric elements connected together.

In such embodiments, smaller piezoelectric displacements may result in larger buckling displacements.

In some embodiments, the regulating device 110 is at least partially defined by a wall 101, the wall 101 including one or more non-newtonian fluid portions having a non-newtonian fluid (e.g., rubber) that moves in response to a frequency of pressure change provided by operation of the breast pump. In such embodiments, the pump frequency may be adjusted to enable a change in the location(s) 111A, 111B of the surface 100 that may be in contact with the breast.

For example, the regulating device 110 comprises a non-newtonian fluid, such as rubber, that moves in response to the frequency of pressure change provided by operation of the breast pump. In such embodiments, the pump frequency may be adjusted so as to be switchable between a first position(s) 111A that may be in contact with the first discrete region(s) of the breast and a second position(s) 111B that may be in contact with the second discrete region(s) of the breast.

In some embodiments, the conditioning device 110 includes at least one tube filled with a non-newtonian fluid, for example in the form of at least one tube filled with a non-newtonian fluid. The at least one tube is attached to the flexible/deformable wall 101, but may be disposed around only a portion of the deformable wall 101, for example, around about one third of the circumference of the deformable wall 101. When a lower pumping frequency is used, the tube(s) may deform together with the rest of the deformable wall 101 to bring the location(s) 111A, 111B of the surface 100 of the deformable wall 101 into contact with the breast. When high frequencies are applied, the tube(s) may exhibit greater rigidity than the deformable wall 101 and deform the deformable wall in a different manner.

Alternatively or additionally, the adjustment means 110 may comprise one or more inflatable cushions, the inflation and/or deflation of which enables selection of the discrete region(s) of the breast contacted by the surface 100.

Alternatively or additionally, the adjustment device 110 may comprise an electroactive polymer assembly, the electroactive polymer(s) of which is deformable to enable a change in position(s) 111A, 111B of the surface 100 that can be in contact with the breast.

By varying the voltage across the electrodes (with the electroactive polymer(s) disposed therebetween), the shape of the electroactive polymer assembly can be varied and, at the same time, the position(s) 111A, 111B of the surface 100 that can contact the breast can be adjusted.

In such embodiments, the surface 100 may be at least partially included in the electroactive polymer(s).

Alternatively or additionally, the adjustment device 110 may comprise a thermal change material assembly configured to enable the surface 100 to move in response to thermal stimulation, thereby changing the position(s) 111A, 111B of the surface 100 that may be in contact with the breast.

In some embodiments, and referring again to fig. 2A-2E, the wall 101 (e.g., flexible funnel) and the adjustment device 110 are configured to cooperate such that bending of the wall 101 causes the first location(s) 111A or the second location(s) 111B of the surface 100 to contact the respective discrete region(s) of the breast.

The adjustment means 110 may control the deformation, e.g. collapse, of the wall 101 to cause or force the surface 100 to deform, thereby enabling a change of the position(s) 111A, 111B of the surface 100 that may be in contact with the breast.

In some embodiments, such as shown in fig. 2A-2E, the adjustment device 110 is configured to enable changing, for example, the selection of at least one axis along which the wall 101 (e.g., flexible funnel) is deformed, e.g., collapsed, toward the nipple of the breast.

In some embodiments, the adjustment device 110 is movable relative to the surface 100 to enable a change in the position(s) 111A, 111B of the surface 100 that can be in contact with the breast.

This may provide a relatively straightforward and viable way for selecting the region(s) of the breast that may be contacted by the surface 100.

In some embodiments, such as shown in fig. 2A-2E, the adjustment device 110 is rotatable about the surface 100 to enable a change in the position(s) 111A, 111B of the surface 100 that can be in contact with the breast.

In such embodiments, at least a portion of the adjustment device 110 may be rotatable about a central axis 114 of the breastshield assembly 112, the central axis 112 extending away from the nipple of the breast in use.

Since the milk ducts are arranged radially around the nipple, a direct stimulation of the different milk ducts can be achieved.

In some embodiments, such as shown in fig. 2A-2E, the adjustment device 110 includes a wall surrounding member configured to engage the wall 101, e.g., an outer surface of the wall 101 that faces away from a breast received in the cavity in use. Such engagement may cause at least one location 111A, 111B to be contactable with the breast.

In such embodiments, the engagement of the wall surrounding member with the outer surface of the deformation wall 101 (e.g., flexible funnel) may determine the shape of the surface 100 of the wall (e.g., flexible funnel).

This shaping of the surface of the wall 101 (e.g., flexible funnel) may provide more portions that are bent (e.g., inwardly collapsed) by the wall surrounding members than other portions. The greater flexing of the former may mean that it is easier than the latter to flex, e.g. collapse inwardly, in response to the variable pressure provided by operation of the breast pump.

Thus, depending on the fit adjustment between the adjustment means 110 (in particular the wall surrounding member) and the surface 100, the more curved (e.g. inwardly collapsed) portion may correspond to the first position(s) 111A or the second position(s) 111B.

In some embodiments, such as shown in fig. 2A-2E, the wall surrounding member included in the adjustment device 110 is rotatable relative to the wall 101 (e.g., flexible funnel) to allow for a change in the position(s) 111A, 111B of the surface 100 that can be in contact with the breast. Thus, rotation of the wall surrounding member may enable switching between at least one first position 111A contactable with the first discrete region(s) of the breast and at least one second position 111B contactable with the second discrete region(s) of the breast. Since the milk ducts are arranged radially around the nipple, such rotation of the wall surrounding member relative to the wall 101 (e.g. flexible funnel) may enable direct stimulation of the different milk ducts.

While the above embodiments refer to deformable wall 101 (e.g., defining a flexible funnel), this is not intended to be limiting and in other embodiments, wall 101 may also be a rigid wall 101. In such embodiments, the breast may be moved toward and away from the rigid wall 101 by a variable pressure provided in the cavity (e.g., a variable pressure provided by a breast pump).

When the wall 101 is such a rigid wall 101, the breastshield assembly 112 may include an insert that is movably (e.g., rotatably) mounted within the cavity, wherein movement (e.g., rotation) of the insert enables the insert to contact different areas of the breast as the breast moves within the cavity, e.g., due to the variable pressure described above.

Thus, in such embodiments, the location(s) 111A, 111B of the surface 100 comprise, e.g. are defined by, the breast-facing surface(s) of the insert, wherein the adjustment means comprises a mechanism, e.g. a pivot coupling mechanism, allowing the breast-facing surface(s) to move such that different areas of the breast can contact the breast-facing surface(s).

More generally, the adjustment device 110 may be manually operated by a user to enable a change in the position(s) 111A, 111B of the surface 100 that may be in contact with the breast.

Such manual operability of the adjustment device 110 may provide a relatively simple and low cost way for the user to control the breastshield assembly 112 to increase comfort and/or improve milk expression.

This may involve, for example, manually operating the adjustment device 110, thereby switching to contacting the surface 100 with one or more discrete areas in the vicinity of the less irritating tube(s) and/or avoiding one or more discrete areas corresponding to painful areas of the breast during a previous breast operation procedure (e.g., a pumping procedure).

In some embodiments, the adjustment device 110 may be manually operated by a user while performing a breast procedure (e.g., milk expression).

Alternatively or additionally, the adjustment device 110 may be manually operated by a user to select one or more discrete areas contacted by the surface 100 prior to milk expression.

In some embodiments, as shown in fig. 2A-2E and 3-5, the adjustment device 110 (e.g., wall surrounding member) includes a user-accessible portion 116, the user-accessible portion 116 configured to enable a user to manually move the adjustment device 110 (e.g., wall surrounding member) to cause a change in the position(s) 111A, 111B of the surface 100 that are contactable with the breast.

The user-accessible portion 116 may be of any suitable type. In some embodiments, the user accessible portion 116 includes a finger grip portion that is disposed about an outer surface of the adjustment device 110, such as about an outer surface of a wall surrounding member, the outer surface of the wall surrounding member facing away from the surface 100.

In embodiments where the adjustment device 110 (e.g., wall surrounding member) is rotatable, the user-accessible portion 116 (e.g., finger grip portion) may facilitate manual rotation of the adjustment device 110, thereby allowing for a change in the position(s) 111A, 111B of the surface 100 that may be in contact with the breast.

Fig. 3 to 5 show various designs of the adjusting device 110, in particular of the wall surrounding member. In the design shown in fig. 3, the wall surrounding member may cooperate with the wall 101 (in this case a flexible funnel) such that each of the different positions 111A, 111B has 3 defined positions, respectively, which may be in contact with the breast. This is a three-lobed epitrochoidal shape by means of a wall encircling member aperture 118 engaging the outer surface of wall 101.

In the design shown in fig. 4, the wall surrounding member may cooperate with the wall 101 (in this case a flexible funnel) such that each of the different positions 111A, 111B has 2 defined positions, respectively, which may be in contact with the breast. This is by means of the elliptical or oval shape of the wall surrounding the aperture 118 of the member engaging the outer surface of the wall 101.

In the design shown in fig. 5, the wall surrounding member may cooperate with the wall 101 (in this case a flexible funnel) such that each of the different positions 111A, 111B has 4 defined positions, respectively, that may be in contact with the breast. This is a four-lobed epitrochoidal shape by means of a wall encircling member aperture 118 engaging the outer surface of wall 101.

More generally, any number of defined positions that can be contacted by the breast, such as 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10, are contemplated for each of the selectable different positions 111A, 111B.

In a specific non-limiting example, the adjustment device 110 comprises a wall surrounding member, such as an adjustment ring, having an oblong hole (see fig. 4) through which a portion of the wall 101 in the form of a flexible funnel passes. In this illustrative example, the elliptical shape of the aperture slightly changes the resting state of the flexible funnel and forces the flexible funnel to collapse along a particular axis, such as a particular radial axis toward the central axis 114. By rotating the wall surrounding member relative to the flexible funnel, the particular axis along which the funnel collapses can be controlled (i.e., selected). In this way, the design enables a change in one or more of the at least one locations 111A, 111B such that different discrete areas of the breast can be contacted by the surface 100.

A prototype according to this particular non-limiting example was constructed and tested in the following manner: the flexible funnel was placed over the false breast and video of the flexible funnel collapsing from the inside of the flexible funnel was recorded.

In this case, the resting state of the flexible funnel already has an oval shape, due to the shape created by the wall surrounding member being slightly pressed against the flexible funnel. Collapse of the flexible membrane is only observed at the two corners defined by the wall surrounding members. When the wall surrounding member is rotated relative to the flexible funnel, the corner positions are offset and thus collapse occurs with both corners in the offset position.

In this way, a cooperative adjustment between the wall surrounding member and the flexible funnel is observed, such that a switching between two first positions 111A, which are contactable with two first discrete areas of the breast respectively, and two second positions 111B, which are contactable with two second discrete areas of the breast respectively, is achieved.

For comparison, a similar video was made for a flexible funnel without any adjustment means 110 (see fig. 1). In this case, the flexible funnel collapses such that the four corners of the flexible funnel come into contact with the nipple of the breast prosthesis and return to the rounded state after the vacuum is released. The collapse of the membrane always occurs in the same way throughout the video, with the four corners in the same position. This illustrates the repeated contact of the same discrete region(s) during a breast procedure (e.g. milk expression) as mentioned above.

In some embodiments, such as shown in fig. 6, 7A, and 7B, when the surface 100 is not moved, the cavity has a non-rotationally symmetric shape, wherein the adjustment device 110 is configured to change the position and/or orientation of at least a portion of the wall 101 (e.g., flexible funnel) that translates and/or rotates the non-rotationally symmetric cavity.

In such embodiments, the deformable wall 101 (e.g., flexible funnel) and the adjustment device 110 may be configured to cooperate such that recovery of the wall 101 after bending causes at least one location 111A, 111B to contact the breast 120.

In such embodiments, the deformable wall 101 (e.g., flexible funnel) may be considered to be in a collapsed, resting state when no vacuum is applied, and may expand when a vacuum is applied.

Thus, the adjustment device 110 may cooperate with the flexible funnel to control the resting state of the flexible funnel without impeding the expansion of the flexible funnel upon application of a vacuum.

To this end, the breastshield assembly 112 may include a support structure 106, the support structure 106 including a rigid base to which a flexible funnel (e.g., flexible funnel rim 104) is secured; and an adjustment device 110, the adjustment device 110 comprising a rigid wall surrounding member arranged near the rigid base. Because the rigid wall surrounding member is close to the rigid base, expansion of the flexible funnel may be unimpeded by the wall surrounding member, or may be impeded only minimally by the wall surrounding member. The rigid wall surrounding member may be rotatable to obtain different deformations of the flexible funnel, as shown in fig. 7A and 7B.

Another possibility is to arrange the wall surrounding member to cover the nipple portion of the flexible funnel and to manufacture the wall surrounding member from a flexible material that is sufficiently rigid to deform the flexible funnel but sufficiently flexible to expand during expansion of the flexible funnel.

More generally, in such embodiments, the adjustment device 110 is adjustable to allow selection of at least one axis along which the deformable wall 101 (e.g., flexible funnel) is restored toward the nipple 122 of the breast 120.

The selection of at least one axis may allow for a change in the location(s) 111A, 111B of the surface 100 that may be in contact with the breast 120, as previously described with respect to the embodiments shown in fig. 2A-5.

Fig. 6 illustrates an embodiment in which breastshield assembly 112 includes a milk receiving assembly 124 for receiving milk during milk expression. In such embodiments, as previously described, the orientation of the milk receiving assembly during milk expression may be independent of the configuration of the adjustment device 110 for changing the position(s) 111A, 111B of the surface 100 that may be in contact with the breast 120.

In some embodiments, such as the embodiments shown in fig. 2A-2E, 6, 7A, and 7B, the adjustment device 110 may be manually operated by a user to change the position(s) 111A, 111B of the surface 100 that may be in contact with the breast 120. Thus, the user may manually adjust the adjustment means 110 according to his own preferences, in particular in order to increase comfort and/or improve milk expression by stimulating different milk ducts.

Alternatively or in addition to the user adjustment of the adjustment device 110 described above, the adjustment device 110 may comprise a power device (not visible) which may be controlled to enable a change of the position(s) 111A, 111B of the surface 100 which may be in contact with the breast 120.

The power means may be of any suitable type. In some embodiments, the power device includes one or more actuators, such as electroactive polymer assemblies described above that are configured to move the surface 100 in response to an electrical signal, and/or heat-altered material assemblies described above that are configured to move the surface 100 in response to a thermal stimulus.

Alternatively or additionally, the adjustment device 110, e.g. a power device comprised in the adjustment device 110, may comprise an inflation device which may be controlled to inflate and/or deflate one or more inflatable cushions as described above, the inflation and/or deflation of the cushions enabling a change of the position(s) 111A, 111B of the surface 100 which may be in contact with the breast 120.

More generally, in some embodiments, the adjustment device 110 includes an automatic adjustment system configured to enable a change in one or more of the at least one locations 111A, 111B.

Such an automatic adjustment system may automatically effect the change, e.g., based on a preselected or predetermined timing of the different discrete areas being contacted by the surface 100, and/or based on milk collection data collected, e.g., via one or more sensors.

These milk collection data may indicate when it may be beneficial to effect a change in one or more of the at least one locations 111A, 111B, for example, as milk is collected at a slower rate.

The automatic adjustment system may, for example, include one or more processors configured to control the power plant, and optionally configured to receive milk collection data from the one or more sensors and to control the power plant based on the received milk collection data.

There is also provided a breast pump assembly comprising: a breastshield assembly 112 according to any of the embodiments described herein; and a breast pump for providing a variable pressure that causes relative movement of the surface 100 and the breast 120 during a breast procedure.

Thus, the main elements of the present aspect may be a breast pump (e.g. a breast shield assembly 112 comprising a wall 101, the wall 101 being e.g. a collapsible material funnel) and an adjustment device 110.

For example, the adjustment device 110 may include a controllable funnel collapse portion that allows control of the collapsible funnel, and optionally a user interface, such as a user-accessible portion 116, to allow a user to control the controllable funnel collapse portion.

In some embodiments, the breast pump is a wearable breast pump.

In such embodiments, the orientation of the wearable breast pump during milk expression may be independent of a change in one or more of the at least one locations 111A, 111B.

Thus, the change of one or more of the at least one positions 111A, 111B may not interfere with the orientation of the wearable breast pump, and thus the wearable breast pump may continue to be worn in the same manner during the change of one or more of the at least one positions 111A, 111B.

There is also provided an adjustment device 110 for a breast shield, the breast receiving cavity of which is at least partially defined by a surface 100, the surface 100 and the breast 120 being movable relative to each other during a breast operation such that the breast 120 is contactable by at least one location 111A, 111B of the surface 100, wherein the adjustment device 110 is cooperable with the surface 100 (e.g. by cooperable with a deformable wall 101 comprising at least a portion of the surface 100) and is configured to enable one or more of the at least one location 111A, 111B to be changed such that different discrete areas of the breast 120 are contactable by the surface 100.

In some embodiments, the adjustment device 110 (e.g., the adjustment device 110 including the wall surrounding member) may be retrofittable to the breastshield.

Where the adjustment means 110 comprises a wall surrounding member (e.g. a wall surrounding member), the wall surrounding member may be a ring arranged around the deformable wall 101 of the breast shield. Such a ring may, for example, comprise two (or more) ring portions that may be positioned around the wall 101 and coupled to each other to define a wall encircling member.

Such a joinable ring portion may enable retrofitting of a wall surrounding member despite the inclusion of support ribs 108C, 108D, 108E described above with respect to fig. 1 and 2A-2E.

The joint between the ring parts, where the ring parts (in this case the two half-ring parts) can be coupled to each other, can be seen clearly in fig. 3 to 5.

A method of engaging a breast 120 with a surface 100 of a breastshield assembly 112 suitable for use during a breast procedure is also provided. As the surface 100 and the breast 120 move relative to one another during a breast procedure, the breast 120 may be contacted by at least one location 111A, 111B of the surface 100. The breastshield assembly 112 also includes an adjustment device 110. The breastshield assembly 112 may be a breastshield assembly according to any of the embodiments described herein.

The method includes changing one or more of the at least one locations 111A, 111B using the adjustment device 110 such that different discrete areas of the breast can be contacted by the surface 100.

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.

The functions implemented by a processor may be implemented by a single processor or by a plurality of separate processing units, which may be regarded as together constituting a "processor". In some cases, the processing units may be remote from each other and communicate with each other in a wired or wireless manner.

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.

A computer program may be stored/distributed on a suitable medium, such as an optical storage medium or a solid-state medium supplied together with or as part of other hardware, but may also be distributed in other forms, such as via the Internet or other wired or wireless telecommunication systems.

If the term "adapted" is used in the claims or specification, it should be noted that the term "adapted" is intended to be equivalent to the term "configured to". If the term "device" is used in the claims or specification, it should be noted that the term "device" is intended to be equivalent to the term "system" and vice versa.

Any reference signs in the claims shall not be construed as limiting the scope.

Claims (15)

1. A breastshield assembly (112) for use during breast operation, the breastshield assembly comprising:

A cavity for receiving at least a portion of a breast, the cavity being at least partially defined by a surface (100) facing the breast during use, wherein the surface is arranged such that relative movement of the surface and the breast during the breast procedure causes the breast to be contactable by at least one location (111A, 111B) of the surface; and

An adjustment device (110) configured to enable one or more of the at least one position to be changed such that different discrete areas of the breast can be contacted by the surface.

2. The breastshield assembly (112) according to claim 1, wherein the adjustment device (110) is configured to enable the change of one or more of the at least one positions (111A, 111B) by moving the position of the surface (100) towards the breast and/or by moving the position of the surface away from the breast.

3. The breastshield assembly (112) according to claim 1 or 2, comprising a wall (101), the wall (101) comprising at least a portion of the surface (100), the wall being deformable, the surface being movable by deformation of the wall and shape recovery of the wall after the deformation.

4. A breastshield assembly (112) according to claim 3, wherein the adjustment means (110) is configured to enable said change of one or more of the at least one positions (111A, 111B) by changing at least one axis along which the wall (101) is deformed or restored.

5. The breastshield assembly (112) according to claim 3 or 4, wherein the cavity has a non-rotationally symmetrical shape when the surface (100) is not moved, the adjustment device (110) being configured to change a position and/or orientation of at least a portion of the wall (101), the wall (101) translating and/or rotating the cavity that is non-rotationally symmetrical.

6. The breastshield assembly (112) according to any of claims 3 to 5, wherein the adjustment device (110) is provided at one or more of the following positions:

-the circumference of the wall (101);

An outer surface of the wall, the outer surface facing away from the breast during use;

The inner side of the wall;

-on said surface (100); and

The cavity is internally provided.

7. The breastshield assembly (112) of any of claims 3 to 6, wherein mechanical properties of one or more portions of the wall (101) are variable.

8. The breastshield assembly (112) of any of claims 3 to 7, wherein the adjustment device (110) comprises at least one of: an electroactive polymer assembly, at least one inflatable and/or deflatable air chamber, a piezoelectric buckling mechanism; a heat-altered material assembly; and one or more non-newtonian fluid portions of the wall (101).

9. The breastshield assembly (112) according to any of claims 3 to 8, wherein the adjustment device (110) comprises a wall surrounding member configured to engage the wall (101) to cause the at least one position (111A, 111B) to be contactable with the breast, the wall surrounding member being movable relative to the wall to enable the change in one or more of the at least one position.

10. The breastshield assembly (112) of claim 9, wherein the wall surrounding member is rotatable relative to the wall (101) to enable the change in one or more of the at least one positions (111A, 111B).

11. The breastshield assembly (112) according to any of claims 1 to 10, wherein the adjustment device (110) is manually operable by a user to enable the change of one or more of the at least one positions (111A, 111B).

12. The breastshield assembly (112) according to any of claims 1 to 11, wherein the adjustment device (110) comprises a power device that can be controlled to effect the change of one or more of the at least one positions (111A, 111B).

13. A breast pump assembly for use during breast operation, the breast pump assembly comprising:

the breastshield assembly (112) of any of claims 1 to 12; and

A breast pump for providing a variable pressure that causes relative movement of the surface (100) and the breast during the breast operation procedure.

14. An adjustment device (110) for a breast shield, a breast receiving cavity of the breast shield being at least partially defined by a surface, the surface and the breast being movable relative to each other during the breast operation such that the breast is contactable by at least one position of the surface, wherein the adjustment device is cooperable with the surface and is configured such that one or more of the at least one position can be changed such that different discrete areas of the breast are contactable by the surface.

15. A method of engaging a breast with a surface (100) of a breastshield assembly (112) adapted for use during a breast operation, the breast being contactable by at least one position of the surface during relative movement of the surface and the breast during the breast operation, the breastshield assembly further comprising adjustment means (110), the method comprising using the adjustment means to alter one or more of the at least one positions such that different discrete areas of the breast are contactable by the surface, wherein the method does not comprise effecting the breast operation with the breastshield assembly after using the adjustment means and engaging the breast with the surface of the breastshield assembly.