The present invention relates to a breastshield unit of a breast pump for expressing human breastmilk, to a sensor unit of a breast pump, and to a method for determining at least one property of human breastmilk during the expression process.
In order to express human breastmilk, a breastshield is placed onto the mother's breast, said breastshield being connected to a vacuum pump in order to apply a varying negative pressure to the breast. The negative pressure preferably varies cyclically or according to a predefined or empirically evaluated suction curve.
From the breastshield, the expressed milk passes through a milk channel into a milk collection container. In order to keep the dead volume as small as possible during the expression process, a milk channel running from the breastshield to the milk collection container is usually provided with a check valve which opens in order to admit the expressed milk into the milk collection container. This check valve is preferably arranged at a breastshield adapter which connects the breastshield to the milk collection container and also, usually, the breastshield to the vacuum pump or to a vacuum tube leading to the vacuum pump. The check valve can be arranged on a valve head which is connected in a secure or detachable manner to the breastshield adapter, the latter also being referred to as coupling part. Breastshield and adapter are usually two separate components. However, they can also be formed together in one piece.
A device of this kind is known from WO 2014/161099 A1, for example. The breastshield unit described there has a throughflow sensor which detects the change of a valve flap of the check valve, such that conclusions can be drawn regarding the throughflow of the milk from the breastshield into the milk collection container.
US 2016/0220743 A1 discloses an adapter with sensors for detecting the individual drops of the expressed milk. The sensors are arranged upstream from the check valve in the direction of flow of the milk.
US 2015/0283311 A1 describes various sensors which are arranged in the neck or in the bottom of the breastmilk bottle.
US 2017/0021068 A1 discloses a fluid sensor which is connected to the milk collection container.
Measurements by sensors arranged in the milk flow are often too imprecise since, depending on the mother and on the expression phase, the milk flows only in drops or flows more abundantly. Moreover, the milk is mixed with different quantities of air, which likewise adversely affects the accuracy of the measurement of a throughflow quantity of milk.
Sensors that measure the milk quantity already received in the milk collection container are usually unsuitable for the measurement of small quantities of milk, e.g. quantities of up to 30 ml.
A further factor preventing precise measurements of the flow of milk, or of the expressed quantity of milk, is the media separation membrane. A media separation membrane is used to protect the breast pump from contamination. It separates the region in which the vacuum is generated from the region in which the milk flows, wherein it transmits the vacuum generated by the breast pump into the interior of the breastshield. In particular, sensors located on flaps or check valves are influenced by these media separation membranes, since the behaviour of the check valve is influenced by the movement of the media separation membrane.
Devices for measuring quantities of urine are also known which use a siphon arrangement. Such devices are described in DE 41 06 995 A1, DE 41 14 933 A1, U.S. Pat. Nos. 3,641,818, 3,919,455, 5,656,027, GB 2 031 158 and WO 2010/149708 A1.
It is an object of the invention to provide a breastshield unit of a breast pump for expressing human breastmilk, which permits optimization of the measurement of the expressed milk.
This object is achieved by a breastshield unit having the features of Patent claim 1, by a sensor unit of a breast pump according to claim 15, and by a method according to claim 16 for determining at least one property of human breastmilk.
The breastshield unit, according to the invention, of a breast pump for expressing human breastmilk comprises a breastshield for placing onto a human breast, a milk collection container for receiving expressed breastmilk, a breastshield adapter for connecting the breastshield to the milk collection container, and at least one sensor for detecting the breastmilk. A milk channel extends from the breastshield through the breastshield adapter into the milk collection container. The milk channel defines a direction of flow of the breastmilk. According to the invention, a siphon is arranged in the milk channel, and the at least one sensor for detecting the breastmilk is arranged downstream from the siphon in the direction of flow of the breastmilk.
A siphon within the meaning of this application also comprises loops and other geometries that lead to a section of the milk channel being emptied in batches, i.e. in a pulsed manner.
By virtue of its damming region, the siphon arrangement has a settling effect on the irregular inflow of milk. The siphon arrangement additionally has the advantage that only the milk collects in the damming region, and therefore the air/milk mixture that has a disruptive effect on the measurement in other systems is separated out.
It is moreover advantageous that individual columns of milk pass the at least one downstream sensor in batches. In this way, a clear separation layer between air and milk is discernible and detectable. The column of milk is also called the milk volume or milk batch.
The detection of the air/milk separation layer at the start of the milk column passing the sensor and the detection of the milk/air separation layer at the end of the milk column passing the sensor, and the evaluation of the signals thereby obtained as a function of time, provide information on the milk throughflow quantity and milk throughflow rate during a defined time interval. The total number of the milk columns provides information on the milk quantity. The number of milk columns during a defined time interval provides information on the expressed quantity of milk during this defined time. It is thus possible to determine the quantity of milk and the throughflow rate during the entire duration of pumping, likewise the quantity of milk and the throughflow rate during individual pump phases.
The flow behaviour of the milk can likewise be detected by virtue of the clear separation of milk and air. This flow behaviour provides information, for example, on the viscosity and thus the composition of the milk. It is thus possible to draw conclusions concerning the macronutrient content of the milk, for example the fat content, proteins and lactose and/or combined forms thereof.
A valve is preferably present which closes and opens the milk channel during the expression of the breastmilk. The siphon is preferably arranged downstream from the valve in the direction of flow of the breastmilk.
This breastshield unit permits a measurement of the quantity of milk in a manner that is not adversely affected by the changing negative pressure applied or by the vacuum applied. The valve, which is preferably a one-way valve or a check valve, separates the expression region from the measurement region.
Moreover, any media separation membrane that is present does not therefore influence the measurement, since it influences only the expression region.
Depending on the property of the milk that is to be measured, one sensor is present, or two or more sensors are needed. If two or more sensors are present, they are preferably arranged in succession in the direction of flow.
In a preferred embodiment, the breastshield unit comprises a signal evaluation module for evaluating signals of the at least one sensor. The signal evaluation module supplies a profile of the signals as a function of time, as a result of which at least one of the following variables can be determined: throughflow quantity, throughflow rate, throughflow velocity, macronutrients, fat content. The signal evaluation module can be arranged in the region of the breastshield, of the breastshield adapter, of the milk collection container or of another component located in this region. However, it can also be arranged spaced apart from these components, for example inside a housing that also accommodates the breast pump assembly and/or the control of the breast pump.
In a preferred embodiment, the milk channel comprises a widened region between valve and siphon. This widened region serves for settling the milk flowing in through the valve, i.e. for the first separation of the air/milk mixture and for the avoidance of eddies. The widened region is preferably a funnel narrowing in the direction of flow.
The milk channel preferably has a constant diameter along the length of the siphon.
Instead of a single lumen of the milk channel, it is also possible to use two or more lumens, i.e. the milk can also flos in a divided form through different lumens. This is advantageous, for example, when different sensors are arranged in the individual lumens and detect different properties of the breastmilk. In this way, the measurements do not influence each other.
The sensor and the siphon can be arranged in the region of the breastshield, of the breastshield adapter or of the milk collection container. In preferred embodiments, however, a sensor unit is present which is preferably arranged between the breastshield adapter and the milk collection container, wherein the sensor unit comprises the siphon of the milk channel and the at least one sensor. The sensor unit is preferably a separate component which is connectable to the breastshield adapter and to the milk collection container preferably in such a way as to be releasable therefrom without destruction. In other embodiments, however, it is preferably connected in part or as a whole component fixedly to the breastshield adapter and/or to the milk collection container.
The milk channel can be formed by a hose or a tube at least in the region of the siphon.
In preferred embodiments, however, the sensor unit has a main body with a surface and with a cover tightly closing this surface. At least the siphon of the milk channel is formed by a groove which is configured in the surface and/or in the cover and which, by the cooperation of the surface with the cover, is tightly closed except for an inlet and an outlet. Such arrangements can be optimally cleaned, since in particular the siphon region is easily accessible over its entire length.
In preferred embodiments, the surface is a radially outwardly oriented surface of the main body. The cover is in this case preferably a lid, which can be placed onto the jacket of the main body, or a sleeve, which can be engaged over the main body.
In other preferred embodiments, the sensor unit has an interior which is open at the top and in which the surface is formed in an undulating shape. The cover is in this case preferably configured as an undulating counterpart.
The sensor unit can be made extremely compact and robust if the main body has a cavity for receiving an electronics unit. The electronics unit preferably has the signal evaluation module. The electronics unit preferably has waterproof protection, such that the main body can be rinsed with water or washed in a wash basin in order to clean the milk channel and in particular the siphon.
The sensor unit preferably has a substantially rotationally symmetrical configuration. It preferably has the shape of a circular cylinder or the shape of a truncated cone. In this way, it can be formed flush with the other components of the breastshield unit and it can be connected to these via thread connections or bayonet connections.
In preferred embodiments, the at least one sensor is at least one optical sensor. However, it is also possible to use other types of sensors, e.g. capacitive sensors, calorimetric sensors, electrochemical or inductive sensors, ultrasound sensors, temperature sensors, sensors for measuring resistance, impedance meters, running time meters, radar and optical sensors such as CCD cameras. In preferred embodiments, more than one sensor is present. Preferably, different types of sensors are present. If a position sensor is present which determines the rotation position of the breastshield unit in space, measured values can be corrected according to the measured position.
The sensor unit according to the invention is part of a breast pump for expressing human breastmilk, wherein the breast pump comprises a breastshield for placing onto a human breast, a milk collection container for receiving expressed breastmilk, a milk channel extending from the breastshield to the milk collection container, and at least one sensor for detecting the breastmilk, wherein the milk channel defines a direction of flow of the breastmilk. The sensor unit comprises a part of the milk channel, wherein this part of the milk channel forms a siphon. Downstream from the siphon in the direction of flow of the breastmilk, the sensor unit comprises the at least one sensor for detecting the breastmilk. A valve is preferably present which closes and opens the milk channel during the expression process.
This sensor unit is preferably arranged in the region of the breastshield and of the milk collection container. However, if breastshield and milk collection container lie far apart from each other, it is preferably arranged either in the region of the breastshield or in the region of the milk collection container. However, it can also be arranged in a region therebetween, i.e. spaced apart from the breastshield and milk collection container, for example in the region of the breast pump housing of the pump assembly.
The method according to the invention for determining at least one property of human breastmilk takes place during expression of the human breastmilk, wherein the breastmilk is expressed by application of a changing negative pressure. The method comprises the following steps, which are carried out in succession, but not necessarily directly after each other:
The breastmilk is preferably conveyed first through a valve, in particular a check valve, and only then is it collected in the damming region of the siphon region.
Further embodiments are set forth in the dependent claims.
Preferred embodiments of the invention are described below with reference to the drawings, which serve only for explanatory purposes and are not to be interpreted as limiting the invention. In the drawings:
The breastshield 1 preferably has a funnel-shaped shield 10, which is to be placed sealingly onto a human breast, and an adjoining tubular connector 11. Shield 10 and connector 11 are preferably formed together in one piece. However, they can also be configured as separate components, each composed of one piece or of several pieces. Such breastshields 1 are known in a wide variety of embodiments in the prior art.
The breastshield adapter 2 in this example is formed in one piece with the breastshield 1. However, it is preferably a separate component that can be connected to the breastshield 1 in a releasable manner.
It preferably has a main body 20 with a port (not visible here) for connection to a vacuum source. Depending on the embodiment, the port is a connection element for connection to a suction hose, of which the second end is connected to a housing of a pump assembly of the breast pump. However, the pump assembly of the breast pump can also be arranged directly on the breastshield adapter 2. The pump assembly can be operated manually. However, it is preferably a pump assembly driven by an electric motor. All of these variants are well known from the prior art.
In the breastshield adapter 2, depending on the embodiment, a media separation membrane is arranged between breastshield 1 and the port leading to the vacuum source. Such media separation membranes are likewise very well known, and they are therefore not discussed in any more detail here.
A valve 22 is moreover arranged in the breastshield adapter 2. This valve 22 is preferably a one-way valve, in particular a check valve. In preferred embodiments, it is a flap articulated at one side, a duckbill valve or a centrally suspended valve. The valve 22 divides the inner region of the breastshield unit into an expression region 12 and a measurement region. In the expression region 12, the changing vacuum is applied to the human breast. The measurement region is not directly exposed to these pressure changes. The measurement region is described in more detail below.
The breastshield adapter 2 moreover has an attachment 21 for connecting to a further component, here the sensor unit 3. The connection is preferably releasable without destruction, for the purpose of cleaning the individual components, and is therefore able to be re-established. The connection is preferably effected via a thread or a bayonet catch. For this purpose, the sensor unit 3 has an upper attachment part 31.
The sensor unit 3 is also preferably connected to the milk collection container 4 in such a way as to be releasable from the latter without destruction. Here too, the connection is preferably effected via a thread or via a bayonet catch. The thread on a lower attachment part 32 of the sensor unit 3 is provided with reference sign 320 in
The described components preferably have a substantially rotationally symmetrical design. The sensor unit 3 preferably has a main body 30 having the shape of a truncated cone or of a circular cylinder.
This main body 30 is covered by a cover 34 at least over part of its jacket, in this example over its entire circumference. This can be seen clearly in
The main body 30 of the sensor unit 3 preferably has a central cavity 38, which is preferably closed off tightly from the outside, at least in a liquid-tight manner. This can be clearly seen in
The device is preferably switched to an energy-saving mode as soon as the sensor unit 3 is released from the breastshield adapter 2 and/or from the milk collection container 4. For this purpose, a reed switch 51 is preferably present which separates or switches off the current supply as soon as the cover 34 is removed from the main body 30. A holder for a reed switch magnet is provided with reference sign 33 in
Moreover, the electronics unit 5 preferably has a TOF sensor (time-of-flight sensor), which is not visible here. It is preferably located on the underside of the electronics unit and faces towards the interior of the milk collection container 4. By means of this TOF sensor, the filling level of the milk collection container 4 can be measured continuously. This measurement is preferably combined with a measurement of the throughflow, e.g. of the throughflow rate, the throughflow volume or the throughflow quantity.
Sensors are moreover connected to the printed circuit board 53. In this example, a first light barrier 6 and a second light barrier 7 are present, and also an acceleration sensor 54. By means of these or other sensors, said properties of the breastmilk are preferably detected, in particular measured.
A milk channel extends through the entire breastshield unit. The channel extends from the breastshield 1, into which milk is expressed from the human breast, as far as the interior of the main body 40 of the milk collection container 4. The channel is thus formed by the cavities connected to one another in the breastshield unit and leads through the valve 22. In the region of the sensor unit 3, the milk channel, as can be seen clearly in
As can be seen in
As can be seen in
This milk channel section 36, the inlet 35 with the funnel on the inlet side having the inclined surface 302, and the two light barriers 6, 7 are shown schematically once again in
In
The milk column M3 forms two clear separation lines T1, T2 between air and milk. These separation lines T1, T2 can be detected very precisely by means of sensors, for example by means of optical sensors and in particular by means of the light barriers 6, 7 shown here. The signals thus obtained can be processed by means of the signal evaluation module of the electronics system, and various measurements can be performed.
The velocity vi of a column is then:
vi=(distance between the two light barriers): ci
The volume V is obtained from:
Vi=vi*(cross-sectional area of milk channel section)*di
The total volume V, i.e. the total quantity of expressed breastmilk, is obtained from:
Vtotal=Σ Vi
It is also possible to determine the number of milk columns M3 that have passed through during a time interval. The frequency of the throughflow of the milk columns can also be determined. Moreover, other methods are possible for determining the viscosity of the milk columns and therefore the macronutrient value.
In the illustrative embodiment according to
In the embodiment according to
In the illustrative embodiment according to
In these examples, the groove of the milk channel section 36 is always arranged on the outer surface of the main body. It can also be arranged additionally or alternatively in the cover.
In the illustrative embodiment according to
All of these illustrative embodiments permit optimal placement of the sensors and of the electronics unit and, by virtue of the groove-like siphon and the removable cover, they permit simple and thorough cleaning.
The breastshield unit according to the invention permits optimal measurement of properties of the expressed breastmilk.
Number | Date | Country | Kind |
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18160184.0 | Mar 2018 | EP | regional |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2019/055240 | 3/4/2019 | WO | 00 |