(19)
(11)EP 2 575 920 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
27.07.2022 Bulletin 2022/30

(21)Application number: 11790450.8

(22)Date of filing:  03.06.2011
(51)International Patent Classification (IPC): 
A61M 1/06(2006.01)
(52)Cooperative Patent Classification (CPC):
A61M 1/06; A61M 2205/273; A61M 1/062
(86)International application number:
PCT/US2011/039033
(87)International publication number:
WO 2011/153412 (08.12.2011 Gazette  2011/49)

(54)

ONE TIME USE BREASTPUMP ASSEMBLY

EINWEG-BRUSTPUMPENANORDNUNG

ENSEMBLE TIRE-LAIT JETABLE APRÈS USAGE


(84)Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

(30)Priority: 04.06.2010 US 794317

(43)Date of publication of application:
10.04.2013 Bulletin 2013/15

(73)Proprietor: Medela Holding AG
6340 Baar (CH)

(72)Inventors:
  • WACH, Joseph
    Ingleside, IL 60041 (US)
  • AVANZINO, Paul
    Crystal Lake, IL 60014 (US)
  • BAUER, Ryan
    Fox River Grove, IL 60021 (US)

(74)Representative: Clerc, Natalia 
Isler & Pedrazzini AG Giesshübelstrasse 45 Postfach 1772
8027 Zürich
8027 Zürich (CH)


(56)References cited: : 
WO-A1-2009/055949
DE-U1-202009 017 571
US-A- 2 040 356
US-A- 5 918 854
US-A1- 2007 173 756
WO-A2-2008/038054
US-A- 2 016 200
US-A- 5 918 854
US-A1- 2007 173 756
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description

    FIELD OF THE INVENTION



    [0001] This invention relates to a breastpump assembly for drawing breastmilk, and particularly to a breastpump assembly having a mechanism that prevents the breastpump from re-use, e.g., a disposable breastpump asssembly.

    BACKGROUND OF THE INVENTION



    [0002] Current breastpumping technologies require a pumping kit that functions as the milk collection interface to the mother from the vacuum generating breastpump. Currently, these kits are designed to be re-useable in that they can be disassembled, cleaned, and used for multiple pumping sessions.

    [0003] In the hospital, mothers are provided with sterile kits for their personal use. Once a mother uses a kit, it is no longer sterile and it is generally incumbent upon the mother to clean the kit for subsequent uses. Cleaning typically involves hand washing, boiling, microsteaming, or placing in the dishwasher. In some cases the hospital may be involved in the cleaning process during the mother's stay, such as when autoclaving is employed. Hospitals may also provide sinks and cleaning agents for the mother's convenience. Cleaning practices vary widely from hospital to hospital and from mother to mother. Hospitals frequently provide mothers with disposable sterile bottles to pump into, but the kit, which most of the milk must pass through, is no longer sterile after the first use.

    [0004] Improperly cleaned kits can easily become contaminated with undesirable microbes, mold, mildew, dirt, etc. For some hospitals and mothers it is desirable to have a freshly sterilized kit available for each pumping session, especially for hospitals with contaminated water supplies, and for high-risk infant patients such as those staying in the Neonatal Intensive Care Unit (NICU). In order to ensure that the pumping kits can only be used in their sterile form, it is desirable to provide a kit that ceases to function after the kit is used for the first time.

    [0005] Separately, there are pumping mothers that would simply desire a hygienic, ready-to-use kit that would suffice for a single use where convenience outweighs the cost benefits of cleaning and using a re-usable kit. Cleaning facilities are not always available or practical.

    [0006] Accordingly, it would be desirable to provide a breastpump assembly that only works during the first pumping session that the mother employs the assembly. Preferably, the kit (breastpump assembly and perhaps tubing and other collateral optional elements) would employ tamper resistant features that prevent the mother from bypassing the function that limits the single use. Additionally, the kit would preferably be able to be supplied in a sterile form as desired for hospital markets. Elements of the kit would not require the durability features required to meet the rigors of re-use conditions such as exposure to steam, boiling, and autoclaving.

    [0007] US 2007/0173756 A1 discloses a disposable breast cup set which comprises a coupling element to be coupled to a milk collection container and a breast cup connecting element to be coupled to a breast cup funnel. The coupling element and the breast cup connecting element are interlinked via a tamper-evident element. This connection is destroyed when the milk collection container is removed for the first time, preventing re-use of the breast cup set.

    [0008] WO 2009/055949 A1 shows a suction hose connector of a breast pump assembly, wherein the connector can not be removed without destroying the connector or some other parts of the connection.

    SUMMARY OF THE INVENTION



    [0009] The invention is defined by the features of independent claim 1.

    [0010] The present application discloses a disposable breast pump assembly including a breast shield having a first end for placement on a breast and a second end for connection to a collection container, a conduit structure communicating with the breast shield, the conduit structure being in connection with a vacuum source, and a valve mechanism connected to the second end of the breast shield, the valve mechanism disabling the vacuum function after the disposable breast pump assembly has been used.

    BRIEF DESCRIPTION OF THE DRAWINGS



    [0011] These and other features and advantages of the present invention will be further understood and appreciated when considered in relation to the following detailed description of embodiments of the invention, taken in conjunction with the drawings, in which:

    Figure 1 is an exploded view of an embodiment of a breastpump assembly according to certain aspects of the present invention;

    Figure 2 is a rear view partly in section of the breastpump assembly of Figure 1 (assembled) with the valve mechanism in the functional (closed) position;

    Figure 3 is a similar view of the breastpump assembly shown in Figure 2 with the valve mechanism in the non-functional (open) position; and

    Figure 4 is a similar view of the breastpump assembly as shown in Figure 2 showing an alternate embodiment of the valve mechanism.


    DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION



    [0012] One embodiment of the invention is shown in a breastpump assembly of Figures 1 through 3. This type of breastpump assembly is simply illustrative, and not intended to be limiting of the invention.

    [0013] The breastpump assembly 100 includes a breast shield 102, for receiving a breast. The breast shield 102 is attached to a conduit structure 104. The conduit structure 104 may include a connection port 110 that attaches to a vacuum source 200 through a tube or hose 202. The vacuum source 200 may be an electric pump, such as the pumps disclosed in U.S. Patent Nos. 6,547,756 or 6,257,847each of which can be referred to for details of the breastpumping equipment in general. Alternatively, the breastpump assembly 100 may be used with a manual pump, which is also well known in the art. The nature of the source of vacuum is not significant to the invention.

    [0014] The conduit structure 104 transmits vacuum generated in the vacuum source 200 to the breast shield 102, and moves expressed breastmilk from the breast shield 102 through a check valve assembly 106 to an attached container 108. The container 108 may include a lip 109. The container 108, such as a standard baby bottle, communicates with ambient air when the breastpump assembly 100 is in use, as by a pathway provided via the threaded engagement or a vent hole (not shown) in a cap-part 123 of the conduit structure 104. Again, these common details can be gleaned from art well known in the breastpumping business.

    [0015] The breast shield 102 has a generally funnel shaped portion 112 at a first end, and is sized for being received onto a breast. The breast shield 102 extends into a sleeve 114 downstream from the funnel shaped portion 112 at a second end. The sleeve, or nipple tunnel, 114 conducts expressed milk into the conduit structure 104. For purposes of the instant invention, the shape of the breast shield 102 and its formation with the conduit structure 104 are generally incidental to the invention; again, the particular arrangement and details of these elements is in no way limiting.

    [0016] The conduit structure 104 is attachable to the breast shield 102 through a shield mount 116 sized and shaped to receive the sleeve 114. The conduit structure 104 may also include an orifice 105 which may be closed to air ingress to maintain a vacuum within the conduit structure. The conduit structure 104 is generally a housing (base) that interconnects and permits fluid communication between parts of the breastpump assembly 100 that includes not only milk flow, but also pressure (e.g., vacuum) communication. Here, the conduit structure 104 connects to the sleeve 114, by way of the shield mount 116 at an upstream end, and terminates with a check valve assembly 106 at a container attachment end 118. The container attachment end 118 may include threads 120 (Figures 2 and 3) or any suitable mechanism for releasable attachment to container 108, which may be in the form of a milk bottle or the like.

    [0017] Provided in the conduit structure 104 is a valve mechanism 122 for closing the pathway 107 in the orifice 105. The valve mechanism 122 may comprise a one-time valve, pop-up valve, or flap valve for example. The valve mechanism 122 here is mechanically attached to the orifice 105. It should be understood that the valve mechanism 122 may take alternate forms, such as any type of closure that prevents ambient air from entering the conduit structure 104, but is then opened by removal of some part of the breastpump assembly 100. This valve mechanism 122 comprises a tube being folded upon itself in a first, pinched position, to close the valve and thereby the orifice 105. The valve mechanism 122 is held in the first, pinched position by the lip 109 of the container 108. As will be understood, the valve mechanism 122 may be located elsewhere to communicate with the conduit structure 104, and may be held in the first position by another structure, which when moved (as for cleaning, emptying, etc.), opens the valve or opening.

    [0018] The valve mechanism 122 is surrounded by a valve cover 124, which is part of the cap-part 123. The valve cover 124 communicates with ambient air, at least when the valve mechanism 122 is open. In the first, pinched position, the valve mechanism 122 closes an air pathway 107 located in the orifice 105. The valve mechanism 122 is made of a flexible material, such as thermoplastic elastomer, rubber, or silicone rubber, for example.

    [0019] The check valve assembly 106 includes a rigid wall or base 128 and a thin flexible membrane 130 (or flap), made of rubber or silicone rubber; such is detailed in U.S. Patent 4,929,229. The wall 128 is circular (disk-like) in shape, and can either be removably engaged or integrated with the conduit structure 104. The wall 128 includes a plurality of openings.

    [0020] In operation, the breastpump assembly 100 is provided in the condition shown in Figure 2. The container 108 collects milk during a pumping session. Typically, the container 108 may be a bottle or a bag. During pumping, the conduit structure 104 is closed to air ingress from the container 108 under a negative pressure applied within the conduit structure 104 in a first position where the valve mechanism 122 is closed and held in a pinched position by the container 108, as shown in Figure 2. When the valve mechanism 122 is in the closed, pinched position, the pathway 107 in the orifice 105 is closed, and a vacuum is maintainable in the breastpump assembly 100.

    [0021] After pumping, the container 108 is separated from the rest of the breastpump assembly 100 to be placed in storage for later delivery to the infant. When the container 108 is removed from the conduit structure 104, however, the valve mechanism 122 automatically opens into a second, uncompressed position within the valve cover 124, since it is no longer pinched by the container 108, as shown in Figure 3. In this second position, the pathway 107 is opened and ambient air may pass into the breastpump assembly 100. Alternatively, removal of a portion of the breastpump assembly, such as the check valve or tubing, may free the valve mechanism 122 from the first pinched position into the second position.

    [0022] When a mother attempts to attach the container 108 or a new container (not shown) to the conduit structure 104, the valve mechanism 122 remains in the open position, thereby allowing air ingress from the container when a container is reattached to the conduit structure 104. Vacuum is leaked out of (not maintained in) the breastpump assembly 100 through the valve mechanism 122, rendering the assembly substantially or completely non-functional. Thus, the breastpump assembly 100 is substantially disabled and cannot be re-used once the container 108 is removed.

    [0023] In yet another embodiment, a breakaway tab or collar may be used to free the container 108 from the conduit structure, thereby preventing the container 108 from being reattached to the conduit structure 104. This might be a frangible member or a stopper 130, as shown in Figure 4, which covers the pathway 107 in orifice 105 in the first, closed position, and which is attached to the container 108. Rotation or removal of the container 108 mechanically moves the frangible member or stopper 130 from the closed position.

    [0024] In yet another embodiment, the breastpump assembly 100 may be comprised of materials that cannot withstand heat and/or moisture commonly seen in cleaning processes. Such materials may include polyethylene or polystyrene, for example. These materials would be designed to warp or otherwise degrade under heat. In yet another embodiment, the breastpump assembly 100 may include parts that fatigue and cease to function upon repeated use.


    Claims

    1. A one-time use breastpump assembly comprising:

    a breast shield (102) within which a woman's breast is received, a container (108) for expressed milk, and conduit structure (104) between said breast shield (122) and said container (108); and

    a closure (122) in an opening (105) to said breastpump assembly, said closure (122) preventing ingress of ambient air when the breastpump assembly is initially provided to a user, said closure (122) being in mechanical connection to a part (108) of said breastpump assembly and caused to open and thereby allow ambient air to pass into said breastpump assembly through removal of said part (108) from said breastpump assembly, so as to substantially disable the breast pump assembly, characterized in that said closure (122) includes a valve mechanism,

    wherein the valve mechanism is a flexible member interposed and compressed between a container lip (109) of said container (108) and a part of said conduit structure (104) when in said first position and thereby closing an orifice (105) to said conduit structure (104) for air ingress, said flexible member (122) moving to a an uncompressed position when said container (108) is removed and opening said orifice (105), said flexible member (122) further remaining in said uncompressed position when said container (108) is reattached.


     
    2. The one-time use breastpump assembly of claim 1 wherein said conduit structure (104) is closed to air ingress from ambient air under a negative pressure applied within said conduit structure (104) in a first position where said closure (122) is closed.
     
    3. The one-time use breastpump assembly of claim 1 wherein said valve mechanism (122) is a tube, said tube being folded upon itself in said first position to thereby close said tube and said orifice (105), said tube being attached to said orifice (105).
     
    4. The one-time use breastpump assembly of claim 1 wherein said valve mechanism (122) is a cover, said cover closing an opening to said conduit structure (104) in said first position to thereby close said opening (105), said cover being attached to said container (108) such that when said container (108) is removed, said cover opens said opening (105).
     
    5. The one-time use breastpump assembly of claim 1 wherein the valve mechanism (122) is automatically opened when said part (108) is removed from said conduit structure (104).
     
    6. The one-time use breastpump assembly of claim 1 wherein said valve mechanism (122) is opened when a structure (108) in direct communication with the valve mechanism (122) is removed from the breastpump assembly.
     
    7. The one-time use breastpump assembly of claim 1 wherein said valve mechanism (122) is opened when said container (108) is removed from the breastpump assembly.
     
    8. The one-time use breastpump assembly of claim 1 wherein the valve mechanism (122) is a pop-up valve mechanism.
     
    9. A breastpump with a breastpump assembly according to one of claims 1 to 8.
     


    Ansprüche

    1. Eine Brustpumpenanordnung zum einmaligen Gebrauch, umfassend:

    eine Brusthaube (102), in der eine Brust einer Frau aufgenommen ist, einen Behälter (108) für abgepumpte Milch und eine Leitungsstruktur (104) zwischen der Brusthaube (122) und dem Behälter (108); und

    einen Verschluss (122) in einer Öffnung (105) zur Brustpumpenanordnung, wobei der Verschluss (122) das Eindringen von Umgebungsluft verhindert, wenn die Brustpumpenanordnung erstmals einer Benutzerin zur Verfügung gestellt wird, wobei der Verschluss (122) in mechanischer Verbindung mit einem Teil (108) der Brustpumpenanordnung steht und zum Öffnen gebracht wird und dadurch Umgebungsluft in die Brustpumpenanordnung eindringen zu lassen, indem das Teil (108) von der Brustpumpenanordnung entfernt wird, um die Brustpumpenanordnung im Wesentlichen ausser Betrieb zu setzen, dadurch gekennzeichnet, dass der Verschluss (122) einen Ventilmechanismus aufweist, wobei der Ventilmechanismus ein flexibles Element ist, das zwischen einer Behälterlippe (109) des Behälters (108) und einem Teil der Leitungsstruktur (104) angeordnet und zusammengedrückt ist, wenn es sich in der ersten Position befindet, und dadurch eine Öffnung (105) zur Leitungsstruktur (104) gegen Eindringen von Luft verschliesst, wobei sich das flexible Element (122) in eine nicht zusammengedrückte Position bewegt, wenn der Behälter (108) entfernt wird, und die Öffnung (105) öffnet, wobei das flexible Element (122) weiterhin in der nicht zusammengedrückten Position verbleibt, wenn der Behälter (108) wieder angebracht wird.


     
    2. Die Brustpumpenanordnung zum einmaligen Gebrauch nach Anspruch 1, wobei die Leitungsstruktur (104) in einer ersten Position, in der der Verschluss (122) geschlossen ist, gegen das Eindringen von Umgebungsluft bei einem in der Leitungsstruktur (104) angelegten Unterdruck verschlossen ist.
     
    3. Die Brustpumpenanordnung zum einmaligen Gebrauch nach Anspruch 1, wobei der Ventilmechanismus (122) ein Schlauch ist, wobei der Schlauch in der ersten Position auf sich selbst gefaltet ist, um dadurch den Schlauch und die Öffnung (105) zu schliessen, wobei der Schlauch an der Öffnung (105) befestigt ist.
     
    4. Die Brustpumpenanordnung zum einmaligen Gebrauch nach Anspruch 1, wobei der Ventilmechanismus (122) eine Abdeckung ist, wobei die Abdeckung in der ersten Position eine Öffnung zu der Leitungsstruktur (104) verschliesst, um dadurch die Öffnung (105) zu schliessn, wobei die Abdeckung an dem Behälter (108) so angebracht ist, dass die Abdeckung die Öffnung (105) öffnet, wenn der Behälter (108) entfernt wird.
     
    5. Die Brustpumpenanordnung zum einmaligen Gebrauch nach Anspruch 1, wobei der Ventilmechanismus (122) automatisch geöffnet wird, wenn das Teil (108) von der Leitungsstruktur (104) entfernt wird.
     
    6. Die Brustpumpenanordnung zum einmaligen Gebrauch nach Anspruch 1, wobei der Ventilmechanismus (122) geöffnet wird, wenn eine Struktur (108), die in direkter Verbindung mit dem Ventilmechanismus (122) steht, von der Brustpumpenanordnung entfernt wird.
     
    7. Die Brustpumpenanordnung zum einmaligen Gebrauch nach Anspruch 1, wobei der Ventilmechanismus (122) geöffnet wird, wenn der Behälter (108) von der Brustpumpenanordnung entfernt wird.
     
    8. Die Brustpumpenanordnung zum einmaligen Gebrauch nach Anspruch 1, wobei der Ventilmechanismus (122) ein Pop-up-Ventilmechanismus ist.
     
    9. Eine Brustpumpe mit einer Brustpumpenanordnung nach einem der Ansprüche 1 bis 8.
     


    Revendications

    1. Ensemble tire-lait à usage unique comprenant :

    une téterelle (102) à l'intérieur de laquelle est reçu le sein d'une femme, un récipient (108) pour le lait exprimé, et une structure de conduit (104) entre ladite téterelle (122) et ledit récipient (108) ; et

    une fermeture (122) dans une ouverture (105) dudit ensemble tire-lait, ladite fermeture (122) empêchant l'entrée de l'air ambiant lorsque l'ensemble tire-lait est initialement fourni à un utilisateur, ladite fermeture (122) étant en liaison mécanique avec une partie (108) dudit ensemble tire-lait et amenée à s'ouvrir et à permettre de ce fait que l'air ambiant passe dans ledit tire-lait par le biais du retrait de ladite partie (108) dudit ensemble tire-lait, de façon à sensiblement désactiver l'ensemble tire-lait, caractérisé en ce que ladite fermeture (122) comprend un mécanisme de soupape, dans lequel le mécanisme de soupape est un élément flexible interposé et comprimé entre une lèvre de récipient (109) dudit récipient (108) et une partie de ladite structure de conduit (104) lorsqu'il est dans ladite première position et fermant de ce fait un orifice (105) vers ladite structure de conduit (104) pour l'entrée d'air, ledit élément flexible (122) se déplaçant vers une position non comprimée lorsque ledit récipient (108) est retiré et ouvrant ledit orifice (105), ledit élément flexible (122) restant en outre dans ladite position non comprimée lorsque ledit récipient (108) est à nouveau fixé.


     
    2. Ensemble tire-lait à usage unique selon la revendication 1 dans lequel ladite structure de conduit (104) est fermée à l'entrée d'air provenant de l'air ambiant sous une pression négative appliquée à l'intérieur de ladite structure de conduit (104) dans une première position où ladite fermeture (122) est fermée.
     
    3. Ensemble tire-lait à usage unique selon la revendication 1 dans lequel ledit mécanisme de soupape (122) est un tuyau, ledit tuyau étant replié sur lui-même dans ladite première position pour fermer de ce fait ledit tuyau et ledit orifice (105), ledit tuyau étant fixé audit orifice (105).
     
    4. Ensemble tire-lait à usage unique selon la revendication 1 dans lequel ledit mécanisme de soupape (122) est un couvercle, ledit couvercle fermant une ouverture de ladite structure de conduit (104) dans ladite première position pour fermer de ce fait ladite ouverture (105), ledit couvercle étant fixé audit récipient (108) de telle sorte que lorsque ledit récipient (108) est retiré, ledit couvercle ouvre ladite ouverture (105).
     
    5. Ensemble tire-lait à usage unique selon la revendication 1 dans lequel le mécanisme de soupape (122) est automatiquement ouvert lorsque ladite partie (108) est retirée de ladite structure de conduit (104).
     
    6. Ensemble tire-lait à usage unique selon la revendication 1 dans lequel ledit mécanisme de soupape (122) est ouvert lorsqu'une structure (108) en communication directe avec le mécanisme de soupape (122) est retirée de l'ensemble tire-lait.
     
    7. Ensemble tire-lait à usage unique selon la revendication 1 dans lequel ledit mécanisme de soupape (122) est ouvert lorsque ledit récipient (108) est retiré de l'ensemble tire-lait.
     
    8. Ensemble tire-lait à usage unique selon la revendication 1 dans lequel le mécanisme de soupape (122) est un mécanisme de soupape rétractable.
     
    9. Tire-lait doté d'un ensemble tire-lait selon l'une des revendications 1 à 8.
     




    Drawing














    Cited references

    REFERENCES CITED IN THE DESCRIPTION



    This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

    Patent documents cited in the description