Abstract:
A breastshield unit for use with a breastpump for expressing human breastmilk using underpressure has a dimensionally stable breastshield and a flexible breastshield insert for placing in the breastshield. The breastshield has a first, open breastshield end for placing on a mother&#39;s breast. The breastshield insert has a first insert end and a second insert end which define a longitudinal direction, the first, open breastshield end having a peripheral edge on which the breastshield insert is securable with the first insert end. In the assembled state, the breastshield insert extends from this first insert end through the inside of the breastshield to the second insert end, wherein the breastshield insert, between the first and second insert ends, extends substantially spaced apart from the breastshield. In the assembled state of the breastshield insert, the second insert end is displaceable in the longitudinal direction relative to the breastshield. The breastshield unit adapts optimally to the shape of the mother&#39;s breast and optimizes the bearing force.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    The present application is the US national phase of International Patent Application No. PCT/CH2013/000219, filed Dec. 12, 2013, which application claims priority to Switzerland Application No. CH 2840/12, filed Dec. 18, 2012. The priority application, CH 2840/12, is hereby incorporated by reference. 
     
    
     TECHNICAL FIELD 
       [0002]    The present invention relates to a breastshield unit and to a breastshield insert. 
       PRIOR ART 
       [0003]    Breastpumps for expressing human breastmilk by means of underpressure are well known. Manually operated breastpumps and motor-driven breastpumps are commercially available. They are connected to a breastshield either directly or via a vacuum line. The breastshield is placed onto the mother&#39;s breast from which milk is to be expressed, in such a way that at least the nipple, and in most cases also the areola and the surrounding tissue of the mother&#39;s breast, are sealingly enclosed. The breastshield is usually connected to a milk collection container, either directly or via a milk line, such that expressed milk can flow directly into this container. 
         [0004]    The known breastshields are substantially rigid funnels, and therefore another funnel has to be chosen according to the size of the breast. Moreover, these breastshields are often used with flexible and soft breastshield inserts in order to enhance the mother&#39;s comfort. Some of these inserts have a massaging effect on the breast, in order to promote the flow of milk. 
         [0005]    U.S. Pat. No. 5,571,084 discloses a breastshield unit with a hemispherical, stiff shell, and with a flexible breastshield insert arranged in the latter. The breastshield insert has a funnel-shaped main body and a tubular stub formed integrally on the latter. The main body has a peripheral collar turned back over a flange of the shell. The stub is held fixedly in a tubular holder of the shell. 
         [0006]    WO 2011/007140 discloses a breastshield unit with a stiff outer breastshield and with a flexible breastshield insert. This insert is also funnel-shaped, with a tubular stub formed integrally thereon, and it is secured at both ends on the breastshield. 
         [0007]    WO 2011/037841 describes a breastshield insert on which a duckbill valve is arranged. 
       DISCLOSURE OF THE INVENTION 
       [0008]    It is an object of the invention to make available a breastshield unit and a breastshield insert that are optimally adaptable to the particular shape of the mother&#39;s breast and that load or stress the latter as uniformly as possible. 
         [0009]    The breastshield unit according to the invention, for use with a breastpump for expressing human breastmilk, has a dimensionally stable breastshield and a flexible breastshield insert for placing in the breastshield. The breastshield has a first, open breastshield end for placing on a mother&#39;s breast. The breastshield insert has a first insert end and a second insert end, which define a longitudinal direction, wherein the first, open breastshield end has a peripheral edge, on which the breastshield insert is or can be secured with the first insert end. The breastshield insert, in the assembled state, extends from this first insert end through the inside of the breastshield to the second insert end. The breastshield insert, between the first and second insert ends, extends substantially spaced apart from the breastshield. According to the invention, the second insert end, in the assembled state of the breastshield insert, is displaceable in the longitudinal direction relative to the breastshield. 
         [0010]    By virtue of the end of the breastshield insert being displaceable in the longitudinal direction, this breastshield unit conforms optimally to the mother&#39;s breast. This adaptation can be further improved by the flexibility and thinness of the breastshield insert. Concerned that the breastshield is not placed tightly enough on the breast, mothers usually press the breastshield too firmly against the breast. Not only is this uncomfortable and painful over a period of time, it also adversely affects the flow of milk. Pressing the breastshield on too tightly is prevented by the breastshield unit according to the invention. The bearing pressure on the breast and the distribution of the bearing pressure are also optimized. 
         [0011]    A further advantage is that, by virtue of the adaptability of the breastshield insert, the same shape and size of the breastshield unit and of the breastshield insert is suitable for use within a wide range of different shapes and sizes of breasts. This makes the choice of breastshield unit easier for the mother and reduces the manufacturing costs. 
         [0012]    This adaptability to the mother&#39;s breast can be enhanced by suitable selection of a breast pad which adjoins the first insert end of the breastshield insert and which has a bearing surface for placing on the mother&#39;s breast. For example, this breast pad can be stretched or pretensioned. In addition or alternatively, this breast pad can extend approximately perpendicularly with respect to the longitudinal direction. 
         [0013]    The breastshield insert according to the invention preferably has a tubular stub which forms the second insert end. This insert can be produced inexpensively. It is easy to clean thanks to its simple design. 
         [0014]    In a preferred embodiment, the breastshield insert according to the invention has a first insert end and, lying opposite the first insert end, a second insert end, which insert ends together define a longitudinal direction. A bearing area for placing on the mother&#39;s breast is formed adjacent to the first insert end. A tubular stub for receiving the nipple of the mother&#39;s breast is provided. It is formed integrally on the bearing area and extends as far as the second insert end. According to the invention, the bearing surface of the bearing area is approximately flat. The length of the breastshield insert in said longitudinal direction is a multiple of the length of the bearing area in this longitudinal direction. 
         [0015]    This breastshield insert is used optimally when its second free end is held displaceably with respect to the breastshield. However, it can also be clamped in place or secured with both ends. The approximately flat bearing surface, particularly if pretensioned in the assembled state, also permits optimized adaptation to different breast sizes and, by virtue of its shape, prevents excessive pressing. This is disclosed here as a further invention. 
         [0016]    The second, rear insert end can also be connected non-displaceably to a housing, which is held displaceably in the breastshield. If a housing is present, the latter can be easily moved by hand and helps when placing the unit on the mother&#39;s breast. 
         [0017]    In a preferred embodiment, a media separation device is also present, which transfers an externally applied vacuum into the interior of the breastshield insert, but which at the same time prevents expressed milk from reaching the vacuum source or passing into any vacuum lines. In this case, the second insert end of the breastshield insert, which forms the abovementioned housing, is preferably connected to the media separation device. 
         [0018]    Preferably, the media separation device as a whole is arranged to be movable relative to the breastshield in the longitudinal direction. This too is an independent invention which can also be used in other breastshields without breastshield insert, or without breastshield insert with displaceable second end. 
         [0019]    Preferably, the media separation device is suspended on the housing by means of the flexible breast pad. In a preferred embodiment, this suspension is achieved by means of a peripheral securing collar of the breast pad being turned back over a flange of the breastshield. 
         [0020]    In a preferred embodiment, the breastshield has guide slits which extend in a longitudinal direction and along which the media separation device as a whole is movable. The movement is guided and limited in this way. 
         [0021]    Preferably, the media separation device has a dimensionally stable housing, and a media separation membrane arranged movably therein. 
         [0022]    In a preferred embodiment, the breastshield has a rear opening at its second end directed away from the first end, as a result of which the second end of the breastshield insert, and therefore the entire breastshield insert, is manually displaceable in the longitudinal direction towards the mother&#39;s breast by access through this rear opening. This makes it easier to apply and adapt the breastshield unit to the mother&#39;s breast. The breast pad of the breastshield insert can be pressed forwards out of the breastshield. It can also be turned inside out depending on its shape. If this breast pad is now applied to the breast, it automatically assumes the shape of the breast. Depending on the shape, it then turns back into this shape adapted to the breast. 
         [0023]    If a media separation device is present and if the second end of the breastshield insert is connected to this media separation device, then the media separation device can preferably be pressed in or is displaceable manually by access through the open second end of the breastshield. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0024]    Preferred embodiments of the invention are described below with reference to the drawings, which are provided only for explanatory purposes and are not to be interpreted as limiting the invention. In the drawings: 
           [0025]      FIG. 1  shows a longitudinal section through a breastshield unit according to the invention, mounted on a milk collection container, in a first embodiment; 
           [0026]      FIG. 2  shows the breastshield unit with milk collection container according to  FIG. 1  when placed on a mother&#39;s breast; 
           [0027]      FIG. 3  shows a longitudinal section through a breastshield insert according to the invention; 
           [0028]      FIG. 4  shows a perspective view of the breastshield insert according to  FIG. 3  from the front; 
           [0029]      FIG. 5  shows a perspective view of the breastshield insert according to  FIG. 3  from the back; 
           [0030]      FIG. 6  shows a longitudinal section through a breastshield unit according to the invention, mounted on a milk collection container, in a second embodiment; 
           [0031]      FIG. 7  shows the breastshield unit according to  FIG. 6  in an enlarged view; 
           [0032]      FIG. 8  shows a perspective view of the breastshield unit according to  FIG. 6  in a first position; 
           [0033]      FIG. 9  shows the breastshield unit according to  FIG. 7  being placed on a mother&#39;s breast; 
           [0034]      FIG. 10  shows a perspective view of the breastshield unit in the position according to  FIG. 9 ; 
           [0035]      FIG. 11  shows the breastshield unit according to  FIG. 7  when placed on a mother&#39;s breast; and 
           [0036]      FIG. 12  shows the breastshield unit according to  FIG. 7  in an inclined position. 
       
    
    
     DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0037]      FIGS. 1 and 2  show a first example of a breastshield unit according to the invention. It has a breastshield  2  and a breastshield insert  3 . 
         [0038]    The breastshield  2  has a funnel body  20 , for receiving a mother&#39;s breast B, and a tubular stub  21  preferably formed integrally on said funnel body  20 . The breast-side end of the breastshield  2  directed away from the stub  21  is provided with a peripheral and outwardly protruding flange  22 . The breastshield  2  is preferably stiff or at least dimensionally stable. It is preferably made of plastic. 
         [0039]    The breastshield  2  is held in a coupling part  1 . The coupling part  1  has a preferably stiff main body  10  with a tubular holder for the stub  21  of the breastshield  2 . A vacuum connector  11  serves for the attachment of a manually driven or motor-driven vacuum pump. Alternatively or in addition, the connector  11  serves for the insertion of a vacuum line, which provides a connection to an external vacuum pump. The vacuum connector  11  can have an inner thread  110  or some other design. 
         [0040]    At an angle to this vacuum connector  11 , a container attachment part  12  with a milk outlet opening  14  is present and serves for connection to a milk collection container  5 . This attachment part  12  also has a connection stub  120  or other suitable connection means. In the interior of the coupling part  1 , here in the hollow space of the connection stub  120 , a valve is preferably arranged in order to limit the dead volume when expressing milk and in order to prevent a return flow of the expressed milk. In this example, a neck  13  is for this purpose formed integrally on the coupling part  1 , on which neck  13  a valve unit  4  with a valve body  40  and a valve membrane  42  can be secured. 
         [0041]    The coupling part  1  and the milk collection container  5  can also have a different design. The coupling part  1  can also be a component of the breastshield  2 , as is shown, for example, in the example described further below. Here, a one-part or multi-part unit of coupling part  1  and breastshield  2  can be formed. 
         [0042]    The breastshield insert  3  is made from a soft, elastic and flexible material, preferably from silicone. It has a breast pad  30  with a receiving opening  33  for bearing on the mother&#39;s breast B, and a stub  32  formed integrally on said breast pad  30 . The receiving opening  33  leads from the breast-side end of the insert  3 , by way of a channel through the stub  32 , to the end of the insert  3  directed away from the breast. This defines a longitudinal direction a, which is indicated in  FIG. 3 . 
         [0043]    On a breast-side, first insert end  34  of the insert  3  directed away from the stub  32 , a securing collar  31  is integrally formed, which can be turned back over the flange  22  of the breastshield  2 . In this way, the breastshield insert  3  can be secured on the breastshield  2 . 
         [0044]    The stub  32  of the breastshield insert  3  is pushed into the stub  21  of the breastshield  2 . However, its external diameter is such that it slides inside this stub  21  and is therefore not fixed. The stub  32  of the breastshield insert  3  thus forms a second insert end, which is held displaceably with respect to the breastshield  2 . 
         [0045]    In  FIG. 1 , the breastshield unit is shown in the assembled state, but before use or when not currently in use. In this state, a peripheral hollow space  6  is present between breastshield  2  and breastshield insert  3 , i.e. the breastshield insert  3 , or at least the breast pad  30  and the uninserted part of the stub  32 , extends at a distance from the inner wall of the breastshield  2 . The breast pad  30  is approximately flat, or it has a funnel shape with a relatively large opening angle α of 100 to 150°. The breast pad  30  is preferably stretched or pretensioned in the breastshield  2 . That is to say, in the unassembled state it preferably has an opening angle α of 120° to 180°, and in the assembled state it is approximately flat or is stretched or pretensioned as far as the abovementioned opening angle. 
         [0046]    In  FIG. 2 , the breastshield unit is shown in the state when in use. The breast pad  30  is placed on a mother&#39;s breast B, with the nipple protruding into the receiving opening  33 . By pressing the breastshield unit onto the breast B, the breast pad  30  deforms and adapts to the shape of the breast B. It adopts in particular, but not exclusively, a funnel shape and/or a concave shape. If the pressure is too great, the breastshield insert  3  moves rearwards, i.e. away from the breast B, by means of the stub  32  moving relative to the breastshield  2 , and therefore to the front fastening of the insert  3  in the breastshield  2 , and approaching a rear end  26  of the breastshield  2 . The tight bearing of the insert  3  on the breast B is still ensured even when the bearing pressure is reduced. 
         [0047]    A breastshield insert  3  of this kind is shown in  FIGS. 3 to 5 . It corresponds substantially to the one shown in  FIGS. 1 and 2 , but its stub  32  is shorter. Moreover, the breast pad  30  has a lesser wall thickness than the stub  32 . The stub  32  is preferably more or less dimensionally stable, and the breast pad  30  is like a membrane and therefore more flexible and more elastic than the stub  32 . The breast pad  30  and the receiving opening  33  are preferably circular. The breast pad  30  is preferably completely flat, and its rear face, i.e. the face directed away from the breast, also preferably has no elevations or depressions. The breast pad  30  has a length L A , which is many times shorter than the length L B  of the whole insert  3 . 
         [0048]      FIGS. 6 to 12  show another illustrative embodiment. Identical parts are provided with the same reference signs as in the first example. 
         [0049]    In this embodiment, the breastshield  2  has a housing-shaped main body  25 . The breastshield  2  serves to bear on the mother&#39;s breast B, but also at the same time to connect to the milk collection container  5 . For this purpose, it has a milk attachment part  28  with which it can be connected to the milk collection container  5 . The breastshield  2  is preferably stiff or dimensionally stable and is in particular made of plastic. 
         [0050]    The main body  25  accommodates a media separation device  7 , which here serves for media separation and for connection to the breastshield insert  3  and to the vacuum pump (not shown). Media separation devices for breastpumps are known from the prior art. They serve to protect the vacuum pump from being contaminated by milk. 
         [0051]    The media separation device  7  according to  FIGS. 6 to 12  has a housing  70 , which is preferably stiff or dimensionally stable and is in particular made of plastic. In the rear area directed away from the breast B, a vacuum connector  71  is present for connection to a vacuum pump or to a vacuum line. 
         [0052]    A milk outlet opening  77 , which is provided with a nonreturn valve  8 , leads into the milk collection container  5  by way of a through-opening  29  of the main body  25 . 
         [0053]    A breastshield insert holder  74  is formed integrally on the housing  70  of the media separation device  7  and forms a receiving stub for the stub  32  of the insert  3 . The stub  32  of the insert  3  is held non-displaceably in this holder  74  during use. It is held with an interference fit, for example, and can be removed for cleaning or replacement. However, it can also be connected to the media separation device  7  such that it cannot be released without destruction. The first insert end  34  of the insert  3  is once again turned back over the flange  22  of the main body  25  of the breastshield  2 . The insert  3  is preferably designed according to the illustrative embodiment shown in  FIGS. 3 to 5  or in the above-described sense according to the invention. In all of the illustrative embodiments, the insert  3  preferably has a maximum external diameter that is slightly smaller than the maximum external diameter of the breastshield  2 . The securing collar  31  preferably has a smaller diameter than the flange  22  of the breastshield  2 . In this way, the insert  3  is stretched when secured on the breastshield  2 . 
         [0054]    For the purpose of media separation, the media separation device  7  has a media separation membrane  9 . The latter is held movably in the housing  70 . It forms a pump chamber  90  with the rear wall of the housing  70 . When an underpressure is conveyed cyclically into the pump chamber via the vacuum connector  71 , the media separation membrane  9  moves synchronously with this and transfers the underpressure into the hollow space formed by the breastshield insert  3  and the mother&#39;s breast B. Milk is expressed. The media separation membrane  9  prevents expressed milk from passing into the pump chamber  90  and from there to the vacuum source. Instead, the milk flows through the milk outlet opening  77 , arranged before the membrane  9 , into the milk collection container  5 . 
         [0055]    The media separation membrane  9  is preferably located, at least in the undeflected starting state, in the bearing area of the nipple. This optimally minimizes the dead volume T. As can be seen in  FIG. 9 , the media separation membrane  9 , even in the undeflected state, reaches approximately or exactly as far as the end of the stub  32  of the insert  3 . It will be seen in  FIG. 11  that the stub  32  is dimensioned in such a way that, with a breast and nipple of a size in the normal range, it is filled along its entire length by the nipple. However, during the expression of milk, the media separation membrane  9  preferably does not touch the nipple, and instead they move synchronously in the same direction.  FIG. 12  shows an inclined position, which can be obtained by suitably shaped guide slits  24 . 
         [0056]    According to the invention, the media separation device  7  is movable, in particular displaceable in the main body  25  of the breastshield  2 . For this purpose, the main body  25  has guide slits  24 , in which guide lugs  76  of the housing  70  engage. This can be seen in  FIG. 8 , for example. The media separation device  7  is displaceable along these slits  24 . The slits  24  can be rectilinear or curved. They are rectilinear in this example. The valve  8  and the milk outlet opening  77  lead into the milk collection container  5  in all positions of the media separation device  7  relative to the main body  25 , since the through-opening  29  is larger than the valve  8  and the milk outlet opening  77 . The through-opening  29  is preferably designed as an oblong hole. 
         [0057]    The rear end of the main body  25 , directed away from the breast, is open. The media separation device  7  is manually movable via this rear opening  23 , specifically displaceable in this case along the slits  24 . 
         [0058]    In  FIGS. 7 and 8 , the breastshield unit is shown in the state before use or when not currently in use. The media separation device  7  protrudes through the rear opening  23  or is located at least in a rear area. The breast pad  30  of the insert  3  is relaxed and is slightly funnel-shaped in this example. 
         [0059]    In order to use the breastshield unit, the media separation device  7  is pushed forwards by hand, as is shown in  FIGS. 9 and 10 . The breast pad  30  of the insert  3  is prestressed, being pushed out to the front, according to requirements, towards the mother&#39;s breast B. The nipple can be received optimally in the receiving opening  33 . If the manual pressure on the housing  70  is now stopped, but the main body  25  is held as before on the breast by hand, in a bra or another holding device, the housing  70  slides back along the slits  24  and the insert  3  lies sealingly, but without excessive or unevenly distributed pressure, on the breast B. This is shown in  FIG. 11 . Expressing milk can now begin. 
         [0060]    In this example too, the second insert end is therefore displaceable relative to the breastshield  2 , this displacement taking place together with the media separation device  7 . Instead of the media separation device, the second insert end can also be held in another part that is displaceable relative to the breastshield. For example, the housing  70  can be designed in the same way as described above, or similarly, and be held in the breastshield  2 , but have no media separation membrane  9 . 
         [0061]    The breastshield unit according to the invention adapts optimally to the shape of the mother&#39;s breast and optimizes the bearing force.