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Title:
FUNNEL FOR A BREAST PUMP, BREAST PUMP AND METHOD FOR OPERATION OF A BREAST PUMP
Document Type and Number:
WIPO Patent Application WO/2018/115234
Kind Code:
A1
Abstract:
The present invention relates to a funnel (1) for a breast pump (11), said funnel comprising a funnel body (2) configured to receive a breast (3) therein, and a resilient element (4) arranged in the funnel body (2) to have contact with the nipple (5) of the breast (3) and configured to exert a movement to the nipple (5), in particular a peristaltic movement by alternatingly deforming and releasing the resilient element (4), wherein the resilient element (4) is connected with its first end (6) to the funnel body (2) at or in vicinity of a neck (7) of the funnel body (2).

Inventors:
BOURQUIN YANNYK PARULIAN JULIAN (NL)
BROCKHUIS LILI-MARJAN (NL)
Application Number:
PCT/EP2017/084006
Publication Date:
June 28, 2018
Filing Date:
December 21, 2017
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
KONINKLIJKE PHILIPS NV (NL)
International Classes:
A61M1/06
Domestic Patent References:
WO2010146501A12010-12-23
WO2016033107A12016-03-03
WO2010146501A12010-12-23
WO2016033107A12016-03-03
Foreign References:
EP2687246A12014-01-22
US20060106334A12006-05-18
US20110190695A12011-08-04
EP2687246A12014-01-22
US20110190695A12011-08-04
US20060106334A12006-05-18
Attorney, Agent or Firm:
ROCHE, Denis et al. (FR)
Download PDF:
Claims:
CLAIMS:

1. Funnel (1) for a breast pump (11), said funnel comprising:

a funnel body (2) configured to receive a breast (3) therein and having a neck

(7), and

- a resilient element (4) arranged in the funnel body (2) to have contact with the nipple (5) of the breast (3) and configured to exert a movement to the nipple (5), wherein the resilient element (4) is connected with a first end (6) to the funnel body (2) at or in vicinity of the neck (7) of the funnel body (2),

wherein the resilient element (4) is bendable, wherein cavities (10) are arranged in the resilient element (4), wherein the cavities (10) are expandable and/or contractible by applying and/or extracting a gas or a liquid, wherein the cavities (10) are connected to an external pressure source (12) wherein a free second end (16) of the resilient element (4) opposite the first fixed end (6) is slidable along a surface of the funnel body (2) when the cavities are expanded or contracted.

2. Funnel (1) according to claim 2, wherein the resilient element (4) has a curved shape having a maximum vertical displacement of the resilient element (4) in the range of 1 to 10 mm. 3. Funnel (1) according to one of the preceding claims, wherein the resilient element (4) comprises a first component (8) and a second component (9), the first and second components (8, 9) having different properties with regard to resilience and stretchability.

4. Funnel (1) according to claim 3, wherein the first and/or second component (8, 9) is made of a polymeric material, in particular polydimethylsiloxane, rubber, polyurethane, and silicone.

5. Funnel (1) according to one of the preceding claims, wherein the resilient element (4) is configured to exert a peristaltic movement to the nipple (5) by alternatingly deforming and releasing the resilient element (4). 6. Funnel (1) according to one of the preceding claims, wherein the resilient element (4) is integrally formed with the funnel body (2) or arranged removably in the funnel body (2).

7. Breast pump (11) comprising

- a funnel (1) according to one of the preceding claims, and

a pressure source (12) connected to the funnel (1) and configured to apply positive or negative pressure to the resilient element (4).

8. Breast pump (11) according to claim 7, wherein the pressure source (12) is configured to operate the breast pump (11) and the resilient element (4) separately or in a combined manner, in particular by starting a peristaltic movement when the vacuum profile is at the peak.

9. Breast pump (11) according to claim 7 or 8, further comprising a control unit (13) configured for controlling the amount of positive or negative pressure applied to the resilient element (4).

10. Method for operating a breast pump (11) according to one of claims 7 to 9, said method comprising:

- applying a positive or negative pressure to the resilient element (4) thereby deforming the resilient element (4) to have a curved shape, and

repeating the step of deformation of the resilient element (4) at a frequency in the range of 0.5 to 3 Hz, in particular in the range of 1 to 2 Hz,

wherein the positive or negative pressure is applied to move the second free end (16) of the resilient element (4) with increasing pressure towards the fixed first end (6) of the resilient element (4) so that the maximum curvature of the resilient element (4) moves along the nipple (5).

Description:
Funnel for a breast pump, breast pump and method for operation of a breast pump

FIELD OF THE INVENTION

The present invention relates to the field of health care, especially to the field of mother and child care, and more specific to the field of breast pumps for extracting milk from a female breast.

BACKGROUND OF THE INVENTION

Breastfeeding is the natural way of feeding a baby. The WHO recommends exclusively breastfeeding an infant for six months and then continuing breastfeeding for at least up to the age of two years. If a mother is not able to feed her infant directly, e.g. because of medical problems or because of absence, the use of a breast pump allows to express milk and to feed the breast milk to the infant through other means, e.g. by a bottle.

An infant sucks by making a peristaltic motion with the tongue, creating a double effect by pushing the milk out and creating a vacuum. Also, the tactile stimulation from the tongue on the nipple will trigger the milk ejection reflex, causing the milk to eject from the breast.

Current breast pumps are based on vacuum only to express milk. Women often complain about the "mechanical" feel and discomfort it causes. In fact, the nipple is elongated in the funnel of the breast pump via the pulling effect of the vacuum causing friction between the skin and the funnel. On the other hand, the absence of the mechanical stimulus caused by the infant's tongue hinders the expression of milk.

WO 2010/ 146501 A 1 discloses an insert for a breast-receiving funnel of a breast pump comprising an elongate inflatable bladder which defines a pressure chamber, the elongate inflatable bladder being adapted to fit in a teat receiving space of said breast receiv ing funnel so that the bladder extends from an inner end of said funnel towards an outer end of said funnel, and lie between a user's teat and the funnel when a breast is inserted in the funnel, such that the elongate inflatable bladder is configured to deform towards a user's teat located in the teat receiving space in a predetermined manner when a pressure difference is applied between the teat receiving space and the pressure chamber such that a peristaltic action is applied to said user's teat, to aid the expression of milk therefrom. EP 2 687 246 Al discloses a funnel with a funnel body and a resilient element which can be pressurized.

US 2011/0190695 Al discloses a breast receiving funnel which has an extendable layer. The breast receiving funnel swells towards the user's breast to apply a positive pressure thereto and to aid an extraction of milk.

WO 2016/033107 Al discloses a funnel with a resilient element which can be pressurized.

US 2006/0106334 Al discloses a funnel for breast extraction. The funnel has a resilient element which can be pressurized to enable a milk extraction.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide an improved funnel for a breast pump and a respective breast pump which offer a more natural stimulation of the nipple, thus allowing an efficient expression session, preferably at reduced vacuum and less painful deformation of the breast and the nipple.

In a first aspect of the present invention a funnel for a breast pump is presented which comprises a funnel body configured to receive a breast therein, and a resilient element arranged in the funnel body to have contact with the nipple of the breast and configured to exert a movement to the nipple, wherein the resilient element is connected with its first end to the funnel body at or in vicinity of a neck of the funnel body.

A free second end of the resilient element opposite the first end is slidable along a surface of the funnel body. The slidable end allows free movement of the resilient element in the desired direction, thus improving the natural feeling during expression.

Cavities are arranged in the resilient element. The cavities allow loading with a positive or negative pressure, thus inflating and deflating accordingly and actuating the resilient element. The cavities are expandable and/or contractible by applying and/or extracting a gas, in particular air, or a liquid, in particular water.

The cavities are connected to an external pressure source. The pressure source allows filling end emptying of the cavities in the desired frequency and extent.

In a further aspect of the present invention a breast pump is presented which comprises a funnel and a pressure source connected to the funnel and configured to apply positive or negative pressure to the resilient element.

In yet a further aspect of the present invention a method for operating a breast pump is presented, said method comprising the steps of applying a positive or negative pressure to the resilient element thereby deforming the resilient element to have a curved shape, and repeating the step of deformation of the resilient element at a frequency in the range of 0.5 to 3 Hz, in particular 1 to 2 Hz. Thereby, it may be distinguished between the stimulating phase and the expression phase. Typically, the stimulating phase is about 2 Hz and the expression phase is about 1 Hz in a baby. Hence, both phases may be distinguished and two respective ranges of frequency may be applied, e.g. for stimulation 1-3 Hz preferably 2 Hz, and for expression 0.5 to 2 Hz preferably 1 Hz).

The method for operating a breast pump does not relate to a therapeutic procedure and is thus non-therapeutic.

Preferred embodiments of the invention are defined in the dependent claims. It shall be understood that the claim method has similar and/or identical preferred embodiments as the claimed device and as defined in the dependent claims.

The disclosed funnel, breast pump and method for operation allow a very effective stimulus of the nipple by way of a resilient element which mimics the natural movement of an infant's tongue during suction. Since natural impressions exerted by an infant yield the best results of breast milk for a lactating woman, the efforts in improving current breast pumps are mainly directed to allow a feeling during use which is as naturalistic as possible. The natural feeling of the infant's tongue during suction are the most effective way to stimulate the release of oxytocin which for its part is responsible for the so-called let down reflex (or milk ejection reflex) which triggers the release of breast milk. The movement of the tongue is simulated by a resilient element arranged in the funnel of the breast pump.

The resilient element is actuated in a way which resembles as close as possible this tongue movement. For instance, by deformation in the shape of an arc the resilient element performs a movement which is directed upwards and away from the body of the user along the areola towards the nipple. The movement is repeated cyclically at a frequency resembling the natural sucking frequency of an infant. The impression of the lactating woman when using a breast pump according to the invention thus can be made more comfortable, less painful and more satisfactory. The use of the inventive breast pump thus allows an effective expression session.

In a preferred embodiment the resilient element is configured to exert a peristaltic movement to the nipple by alternatingly deforming and releasing the resilient element. This provides for a good mimic of the baby's sucking during the expression phase. The disclosed funnel and breast pump may, however, also be used also to only stimulate the nipple to induce the milk ejection reflex in a stimulation phase. In that case a peristaltic movement is not required.

The disclosed funnel and breast pump may further allow increasing the vacuum while keeping the same comfort. The vacuum level is known to have an impact on the amount of milk extracted. Higher vacuum are however generally not used due to comfort issue.

Preferably the resilient element is bendable, in particular to have a curved shape having a maximum vertical displacement of the resilient element in the range of 1 to 10 mm, in particular 3 to 5 mm. This range correlates to the natural movement of an infant's tongue and thus helps to keep the use of the breast pump pain free and comfortable.

According to an advantageous embodiment of the invention the resilient element comprises a first component and a second component, the first and second components having different properties with regard to resilience and stretchability. When actuated, the two components will be subject to a different deformation and thus support the correct movement of the resilient element for a near-natural impression.

Advantageously the first and/or second component is made of a polymeric material, in particular polydimethylsiloxane, rubber, polyurethane, and silicone. Polymeric materials are soft, easy to process and cheap. They can be formed to arbitrary shapes, event to the form of an infant's tongue.

According to advantageous embodiments of the invention the cavities are connected to each other or separated from each other. Connected cavities can be easily actuated and allow a bigger range of motion, while separate cavities can be separately actuated, thus allowing structured movement, e.g. only in the front or back part or on the outer edges of the resilient element.

According to advantageous embodiments the resilient element is integrally formed with the funnel body or arranged removably in the funnel body. The integral arrangement allows reliable positioning without the danger of involuntary

displacement. The removable arrangement is preferred for easier cleaning. For funnels which e.g. comprise a liner which itself can be removed for cleaning purposes the same

arrangements can be applied. The resilient element can be integrated in the liner or be removable for easier cleaning. In a preferred embodiment of the breast pump the pressure source is configured to operate the breast pump and the resilient element separately or in a combined manner, in particular by starting a peristaltic movement when the vacuum profile is at the peak. In this way, there is no need for an additional pressure source which would make the breast pump bigger, heavier and more expensive.

Preferably a control unit configured for controlling the amount of positive or negative pressure applied to the resilient element is present. The control unit can be manually operated or comprise pre-programmed schemes to be chosen by the user.

In an advantageous embodiment of the method, the positive or negative pressure is applied to move a second free end of the resilient element with increasing pressure towards the first end of the resilient element so that the maximum curvature of the resilient element moves along the nipple, thus improving the near-natural feeling of the expression.

In a further embodiment, several separated resilient elements or one large resilient element are used to cover a larger part of the funnel. This further increases the stimulated surface of the nipple. Thus, the disclosed breast pump can not only mimic the baby's tongue, but may also extrapolate the tongue movement to the entire nipple, increasing the stimulating effect. BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects of the invention will be apparent from and elucidated with reference to the embodiment(s) described hereinafter. In the following drawings

Fig. 1 shows a schematic view of a breast pump according to the invention, Fig. 2A-B show schematic views of a first embodiment of a funnel according to the invention in a state of deactivation and in a state of activation,

Fig. 3A-B show schematic views of a cross section of the resilient element of the first embodiment of the invention in a state of deactivation and in a state of activation,

Fig. 4 shows a diagrammatic view of the bend of the resilient element depending on the exerted pressure, and

Fig. 5 shows a schematic view of a second embodiment of a resilient element according to the invention. DETAILED DESCRIPTION OF THE INVENTION

Fig. 1 shows a schematic view of a breast pump 11 which is suitable for application of the inventive features described further below. The breast pump 11 comprises an expression kit 14 with a bottle 15 connected thereto for receiving the expressed breast milk. Further, a funnel 1 is arranged on the expression kit 14, wherein the funnel 1 is suitable to receive a female breast 3 therein. Preferably, the funnel 1 comprises a funnel body 2 which has the shape of a truncated cone, and a neck 7 extending from the narrow end of the cone into the expression kit 14. In the funnel body 2 a resilient element 4 is accommodated which will be described in more detail below. A breast 3 is shown schematically positioned in the funnel 1.

The breast pump 11 further comprises a pressure source 12 for generating a positive or negative pressure and a control unit 13 with a vacuum control button 17 and a control button 18 for the resilient element 4 and other functions of the breast pump 11 as described further below.

The breast pump 11 can be designed in a conventional manner except from the inventive features described in the following. Therefore a detailed description of e.g. the bottle 15 or the expression kit 14 can be omitted.

As mentioned above, the use of a breast pump 11 often is felt being

uncomfortable and even painful by women using a breast pump 11 , because the negative pressure or vacuum which is exerted to the breast 3 and especially to the nipple 5 is quite strong and thus elongates the respective parts of the breast 3 under influence of the vacuum. Lactating women often suffer from pain in the breasts and nipples even without using a breast pump 11 , thus the expression of milk using the breast pump 11 is perceived as a painful and discomforting experience. This makes the process of use of the breast pump 11 even more frustrating since the result of the expression session, i.e. the yield of breast milk, is known be lower in case of stress.

To overcome these problems, a soft resilient element 4 that mimics the stimulus of the tongue of an infant is implemented into the funnel 1 of the breast pump 11. The nipple 5 will not be elongated as much as by the conventional vacuum, thus making the inventive breast pump 11 more comfortable to use. The tactile stimulation of the nipple 5 will make the expression session more efficient. The milk will start to flow from the breast sooner and more milk will be expressed.

The resilient element 4 and its function are now described in more detail with reference to Figs. 2A and 2B. Fig. 2A shows in a very schematic manner the upper part of an expression kit 14 with a funnel 1 in which the resilient element 4 is arranged. The funnel 1 is connected to the expression kit 14 at the neck 7. The bottle 15 for collection of breast milk is partly visible. The resilient element 4 of the embodiment shown in Fig. 2A and 2B is arranged in the lower part of the funnel body 2 in the vicinity to the neck 7. The arrangement of the element 4 in the lower part of the funnel 1 resembles the aspect that during

breastfeeding the infant's tongue will act on the nipple 5 from below. Alternatively and not shown in the figures, the resilient element 4 can be arranged in other suitable positions in the funnel body 2.

The resilient element 4 is fixed to the funnel body 2 at a first end 6. The connection to the funnel body 2 can be permanent or removable. The permanent connection has the advantage of secure positioning, while the removable connection allows easier cleaning. Besides, the resilient element 4 can be removed if it is not always necessary.

A second end 16, which is opposite to the first end 6, is free and can move relative to the first end 6 as described hereinafter.

Fig. 2A shows the resilient element 4 in a non-activated state. In this state, the resilient element 4 lies flat against a surface of the funnel body 2. If the resilient element 4 is activated as shown in Fig. 2B, an arc shaped deformation of the resilient element 4 takes place, and pressure will be applied to the breast 3 progressing from the aureola towards the nipple 5, with the maximum point of the arc moving forward to the tip of the nipple 5, similar to the tongue movement of a sucking infant.

As can be seen in Fig. 3, the strength of the deformation of the resilient element 4 increases the more pressure is applied to the resilient element 4. Since the resilient element 4 is fixed to the funnel body 2 at its first end 6 and the opposing second end 16 of the resilient element 4 is free to move, the second end 16 slides along the surface of the funnel body 2 during activation of the resilient element 4. Thus a small deformation will occur at a low pressure PI and a high deformation at a maximum pressure Pmax. The second end 16 is sliding towards the fixed first end 6 with increasing pressure. The higher the pressure the closer the free second end 16 will approach the fixed first end 6.

The maximum of the arc thus will also move in direction to the fixed first end 6 of the element 4, thus resulting in the peristaltic actuation on the breast 3 and the nipple 5 of the user. If the pressure is released, the resilient element 4 will flatten and thus return to the non-activated state of Fig. 2A. Then the next cycle can start. As a consequence, the shifting maximum of the arc is moving forwards and backwards cyclically resembling the touch of a tongue of an infant sucking on the breast 3. The maximum deformation or displacement of the element 4 can be at about 1 to 10 mm, preferably 3 to 5 mm, which is in the range of an infant's tongue movement.

With reference to Figs. 4A and 4B as well as Fig. 5, two embodiments of the invention are described in more detail. In Fig. 4A and 4A a first embodiment of the resilient element 4 is shown. The resilient element 4 comprises a first component 8 and second component 9 which have different properties with regard to resilience and stretchability. Especially, the first and second components 8, 9 can be made of different materials with different material properties, or alternatively the components 8, 9 can be made of the same material but e.g. in different material thickness to vary the reaction on the activation of the resilient element 4. Preferable materials for the components can comprise, but are not restricted to, polymers like polydimethylsiloxane, rubber, polyurethane, and silicone.

As can be seen in Fig. 4A, which shows the resilient element 4 in a sectional view along the length of the resilient element 4 between the first end 6 and the second end 16, the first component 8 is block-shaped with recesses or cavities 10 arranged therein. The second component 9 covers the cavities 10 thus closing them to the environment.

The cavities 10 are connected to a pressure source, which is not shown in Figs. 4A and 4B, but which can for example be the pressure source 12 shown in Fig. 1 which also actuates the breast pump 11 itself. Alternatively, the resilient element 4 can be activated by a separate pressure source.

When the pressure source 12 is connected to the cavities 10, activation of the pressure source 12 by applying a positive pressure results in inflation of the cavities 10 as shown in Fig. 4B. Since the material itself or e.g. the material thickness or another parameter of the second component 9 is different to the material or material thickness of the first component 8, the first component 8 is bent by the widening of the cavities 10, whereas the second component 9 with a lower stretchability or higher stiffness generally retains its shape. Due to stretching of the first component 8 and a significantly smaller stretching of the second component 9 the resilient element 4 is deformed to the shape of an arc with the free second end 16 moving towards the fixed first end 6.

As described with reference to Fig. 3, the deformation of the resilient element 4 will be the higher, the higher the pressure applied to the cavities 10 is. If the positive pressure applied to the cavities 10 is released, the resilient element 4 returns due to the restoring force to its original shape as shown in Fig. 4A. The next cycle can restart again with the application of pressure to the cavities 10. In the embodiment according to Fig. 4A and 4B, the second component 9 is arranged on the side of the resilient element 4 which is adjacent to the surface of the funnel body 2.

In Fig. 5 a second embodiment of the invention is shown in similar perspective as in Fig. 4B. In this embodiment however the resilient element 4 is deformed in the opposite direction by not applying a positive pressure which is widening the cavities, but by a negative pressure which evacuates the cavities 10 and thus leads to a contraction of the cavities 10 and to the deformation of the element 4 against the stiff second component 9. In this case, the second component 9 is arranged on the upper side of the resilient element 4, and the first component 8 is arranged adjacent to the surface of the funnel body 2. Again, the components 8 and 9 can differ in terms of material or in terms of material thickness.

The negative pressure or vacuum exerted to the cavities 10 can also be generated by the pressure source 12 of the breast pump 11, since switching between positive or negative pressure is a technical feature which can be incorporated easily in any pressure source 12 for a breast pump 1 1.

The cavities 10 for both embodiments according to Figs. 4 A and 4B and 5 can be connected to each other or can be separated from each other to be activated separately. Separate activation of the cavities allows modulation of the movement of the maximum of the arc, thus allowing the user to activate the element 4 in a personally suitable and convenient manner. The breast pump according to Fig. 1 can be equipped with respective control buttons 17 and 18 to control the pressure source 12 for activation of the breast pump 11 itself and for activation of the resilient element 4. The buttons 17 and 18 can be arranged in the breast pump 11 itself, for example on the pressure source 12, or alternatively on a remote control or via an app on a mobile phone which is not shown in Fig. 1.

The breast pump 11 can be operated in different modes, for example only by use of the negative pressure applied to the nipple 5 to extract milk without further stimulation or by stimulation by the resilient element 4 only. In the latter case, the pressure source 12 is operated to deform the element 4 without further negative pressure being applied to the breast 3. In yet another mode, both functions of the breast pump 11 can be combined and a stimulus by the resilient element 4 and a negative pressure can be exerted simultaneously to the breast 3 to extract breast milk.

To make the resilient element 4 variable with respect to the amount of deformation, the distance between the cavities 10, the thickness of the walls, of the first and/or second component 8, 9 etc. can vary in order to obtain different types of pressure curvatures.

In another embodiment, the resilient element 4 can apply the pressure from two opposite sides of the resilient element 4, e.g. from bottom and top or from left and right side, such that the vertical displacement of the resilient element 4 can be half on each side compared to a resilient element 4 with peristaltic movement from one side only.

In Fig. 2A and 2B the resilient element 4 is arranged in the bottom part of the funnel body 2. This position is preferred, since it resembles the natural position of an infant's tongue during suction. Alternatively, the resilient element 4 can be cone-shaped like the funnel body 2 and cover the whole surface of the funnel body 2. Thus, pressure from all sides can be applied to the nipple 5. The vertical displacement of the resilient element 4 can in this case be smaller compared to the displacement of the resilient element of Fig. 2A and 2B. The displacement can for example be up to 1 mm only. In this embodiment, the activation of single cavities 10 would lead to even more possibilities to apply pressure where convenient. The activation of single cavities 10 can for example be achieved by activation or deactivation of valves which are arranged accordingly but which are not shown in the drawings.

The movement of the resilient element 4 and the vacuum of the breast pump 11 are preferably synchronized as shown by an infant, having the vacuum peak just before the lower jaw moves upward, which is the start of the peristaltic tongue movement. The natural frequency of sucking of an infant is around 1 to 2 Hz. The resilient element 4 can be configured to work at similar frequencies. In an embodiment different frequencies may be applied in the stimulating phase and the expression phase, e.g. for stimulation 1-3 Hz preferably 2 Hz, and for expression 0.5 to 2 Hz preferably 1 Hz. Further, in the stimulation phase only the resilient element may be moved without applying any vacuum.

While the invention has been described with respect to activation of the resilient element 4 by applying positive or negative air pressure to the cavities 10, alternatively the same activation principle can be realized by use of a liquid like water. The water could be warmed up before it is introduced into the cavities, thus making the expression session even more naturalistic.

While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive; the invention is not limited to the disclosed embodiments. Other 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. A single element or other unit may fulfill the functions of several items recited in the claims. 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.

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