Breast expression device

Abstract

Breast expression device, comprising a body made of an elastically deformable material, defining a breast shield and a vacuum chamber communicating with the breast shield, the device having an opening communicating with a colostrum collection cavity, the breast shield having a flared wall, shaped to apply at its distal end hermetically over the entire circumference of the breast behind the nipple, so as to allow the formation of a vacuum near the nipple and the retention of the device on the breast by suction effect, the breast shield defining behind its distal end a deformable compression zone, allowing the breast's lactiferous ducts to be compressed by applying pressure on the outer surface of said zone, one or more ridges being present on the inner face of the compression zone to prevent it from adhering to the breast during use.Figure for the abbreviation: Figure 1.

Description

Title of the invention: Breast expression device technical field

[0001] The present invention relates to the extraction of colostrum in women.

[0002] The invention relates more particularly to breast expression devices using compression (or positive pressure), particularly manual or mechanized, of the milk ducts of the breast, as opposed to those based solely on negative pressure. Previous technique

[0003] Colostrum is the very first breast milk, secreted by women during the third trimester of pregnancy and up to a few days after childbirth. It is a thick, yellow-orange substance, extremely rich in proteins and antibodies essential for the immunization of the newborn.

[0004] Colostrum is much less abundant than conventional, or "mature," breast milk and has a different texture and composition. It is much more viscous, making it difficult to express, particularly through the valves commonly found in conventional manual breast pumps and breast pumps. Extracting colostrum using these methods is therefore a challenging task.

[0005] In addition, manual pumps and breast pumps are not designed to adhere to the breast and must be held during use. It is then necessary to hold them manually or with the help of bras against the chest.

[0006] Furthermore, many breast pumps rely entirely on generating strong negative pressure to promote milk flow, with little or no positive pressure on the breast. The predominance of negative pressure can cause pain for women, while also not promoting optimal milk expression.

[0007] DE102012018903 describes a breast pump into which a woman can apply a positive pressure precisely measured using her fingers on an area surrounding the nipple.

[0008] WO2019038255 discloses a baby mouth simulator for the breast of a woman, based on manual compression of the breast using a double sleeve, one sleeve ensuring the device is airtight while the other sleeve helps to keep the device in place.

[0009] WO2020220574 describes a breast pump device comprising two surfaces sealing elements joining at a non-zero angle to more effectively hold the device on the breast during use.

[0010] The breast pump presented in application CN213789193 has a greater thickness of material in the middle of the body of the milk collection container to improve its hold on the breast when it is compressed and a negative pressure is generated, causing the flow of milk.

[0011] The breast fluid expression device of US patent 9498565B2 generates a negative pressure gradient, which is the origin of the expression of breast fluid.

[0012] US 11116880B2 discloses a manual breast pump based on compression, or positive pressure, of the lactiferous ducts of the breast but whose design is nevertheless complex.

[0013] There is therefore a need for a breast expression device that operates by positive pressure on the breast, is simple to produce and inexpensive, allows for the efficient and painless extraction of colostrum, while remaining easily in position on the breast without the need for manual support. Summary of the invention

[0014] The invention aims to meet this need and, according to one of its aspects, relates to a breast expression device, comprising a body made of an elastically deformable material, defining a teat cup and a vacuum chamber communicating with the teat cup, the device having an opening communicating with a colostrum collection cavity, the breast shield having a flared wall, preferably generally conical, shaped to apply at its distal end hermetically over the entire circumference of the breast behind the nipple, so as to allow the formation of a vacuum near the nipple and the retention of the device on the breast by suction effect, the breast shield defining behind its distal end a deformable compression zone, allowing the breast's milk ducts to be compressed by applying pressure to the outer surface of said zone, one or more reliefs being present on the inner face of the compression zone to prevent it from adhering to the breast during use.

[0015] Advantageously, the device according to the invention allows, by compressing the milk ducts, the application of positive pressure to the breast, similar to that generated by an infant during suckling. This positive pressure, inspired by biomimicry and repeated numerous times, in combination with a vacuum oscillation created near the nipple, stimulates milk production and empties the breast more effectively than negative pressure or suction alone. The vacuum created near the nipple notably helps to dilate the milk ducts and facilitate the flow of colostrum. Body

[0016] By “body” is meant the main part of the device.

[0017] The body of the device can extend along a longitudinal axis X.

[0018] The body may have a length along the X axis of between 60 and 100 mm, preferably of the order of 70 mm.

[0019] It defines the breast shield and the vacuum chamber, the breast shield and the vacuum chamber joining along the X axis and communicating with each other.

[0020] The body may be in one piece, for example being injection molded from a thermoplastic or thermosetting material.

[0021] The body may have an annular constriction at the junction of the teat and the vacuum chamber. This makes it possible to prevent or limit a reflux of colostrum from the vacuum chamber towards the teat.

[0022] The body may be made of an elastically deformable material, for example a silicone or a flexible plastic, preferably a silicone.

[0023] The material can have a hardness between 30 and 70 Shore A. This choice of hardness allows for a material that is flexible enough to allow compression but rigid enough to ensure the device remains in place on the breast by suction. The choice of a flexible material also allows the device, which is preferably one-size-fits-all, to adapt to most breast shapes.

[0024] Preferably, the body is made of a transparent or translucent material to facilitate installation and control of position during use.

[0025] The body of the device may require relatively little material, which makes its production easy and quick and makes it an inexpensive solution. Nipple shield

[0026] By "tetherelle", we mean a cup having a flared wall, preferably generally conical, open at its distal end and connected by its proximal end to the vacuum chamber.

[0027] The inclination of the generally conical wall of the nipple can be measured by an angle G at the apex, preferably with G of the order of 90°.

[0028] The section of the distal end of the teat in a transverse plane perpendicular to the X axis can have a circular shape, measured by its diameter d.

[0029] The diameter d can be between 5 and 10 cm, preferably between 6 and 8 cm.

[0030] The compression zone can be compressed manually. Alternatively, it can be compressed automatically.

[0031] By "compression zone" is meant the part of the breast shield located behind its distal end, arranged to be situated near the nipple, on the outer surface of which, in the case of manual compression, one or more fingers They can be positioned to perform repetitive compression movements to compress the milk ducts of the breast. In the case of automatic compression, one or more actuators can compress the compression area.

[0032] In the case of manual compression, the nipple shield may have at least one indentation for receiving one or more fingers on the compression area.

[0033] Preferably, the teat cup has a single recess for receiving one or more fingers extending over the entire circumference of the teat cup to allow compression in all directions.

[0034] It may have several receiving recesses for one or more fingers, for example two receiving recesses for one or more fingers, these two recesses being diametrically opposed.

[0035] The recess or recesses help guide and facilitate the positioning of the fingers on the device to ensure optimal compression of the breast's milk ducts. A longitudinal section of the recess may have a generally rounded shape.

[0036] By "relief," we mean any irregularity on the internal surface of the nipple and more specifically on the compression zone. The relief(s) on the internal face of the compression zone may be bumps, grooves, ribs, preferably grooves, particularly oriented longitudinally along the X-axis.

[0037] The relief(s) may be located at a distance from the distal end of the teat, at a distance of between 3 and 15 mm, preferably between 5 and 10 mm.

[0038] The relief(s) may have a length along the X axis of between 5 and 20 mm, preferably between 10 and 15 mm.

[0039] The presence of one or more reliefs on the inner face of the compression zone ensures the passage of air and thus prevents the compression zone from adhering to the breast during compression movements, and thereby preventing a shift of the suction effect towards the nipple, disrupting its use, in particular risking the device falling off.

[0040] The compression zone may have on its inner surface a raised area extending around its entire circumference or several raised areas distributed around its entire circumference. Preferably, the compression zone has one or more raised areas only on the top and sides of its wall, when the device is viewed in the position of use, the bottom of the compression zone having no raised areas. The absence of raised areas on the bottom of the compression zone helps to prevent or limit colostrum leakage.

[0041] The teat can have a wall of constant thickness.

[0042] Alternatively, the teat cup may have an annular ridge at its distal end. The annular ridge may have a thickness of between 3 and 5 mm, preferably between 3.5 and 4 mm.

[0043] The presence of an annular ridge, inducing a thickening of the wall of the teat, ensures the rigidity of the distal end of the teat, necessary to maintain the suction effect during compression movements.

[0044] The distal end may have a smooth internal surface to provide an airtight seal when positioned on the breast.

[0045] The wall of the breast shield may also thicken towards the rear in a portion of the compression zone. The thickness may be between 2 and 6 mm.

[0046] The greater wall thickness in part of the compression zone reduces play, allows for more precise movement, and enables greater forceful compression of the breast's milk ducts, thus promoting colostrum expression, while also facilitating compression and making it less tiring. Vacuum chamber

[0047] The vacuum chamber has a side wall and a bottom wall. When viewed in longitudinal section, the side wall and / or the bottom wall may exhibit an outwardly bulging shape. This outward bulge of the side and / or bottom wall helps to better maintain the air gap and limit wall collapse during compression movements.

[0048] The bottom wall can be smooth, the vacuum being created by compressing the vacuum chamber before positioning the device on the breast. Alternatively, the vacuum chamber can have a recess, arranged to allow the insertion of a tube connected to a vacuum pump, mechanically creating a vacuum in the vacuum chamber.

[0049] The side wall and the bottom wall may have an identical thickness, preferably constant, between 2 and 6 mm, better between 2.5 and 4 mm.

[0050] The thickness of the walls of the vacuum chamber and their dimensions can be chosen so that the maximum negative pressure in the vacuum chamber is between 40 and 200 mmHg, preferably between 60 and 100 mmHg.

[0051] The pain threshold in women is in the range of 200 to 250 mmHg. By configuring the vacuum chamber to limit negative pressure, it is possible to improve user comfort. The challenge lies in finding the right balance between a vacuum sufficient to hold the device in place and one that is not so high as to cause pain. Alternatively, the deformation resistance of the side wall and / or the bottom wall can be adjusted so that the walls remain deformed after the initial compression of the vacuum chamber when the device is positioned on the breast, thus preventing critical negative pressure from developing.

[0052] The opening of the device communicating with a colostrum collection cavity can be disposed in the side wall of the vacuum chamber.

[0053] The vacuum chamber may have a slope and / or a recess to channel and guide the colostrum towards the opening communicating with a collection cavity of the colostrum.

[0054] This recess may be in the form of a channel. It may extend from the distal end of the vacuum chamber to the opening communicating with a colostrum collection cavity. Opening

[0055] The opening of the device may communicate with a colostrum collection cavity formed as a single unit with the vacuum chamber. Alternatively, the opening may be arranged to allow the insertion of a colostrum collection container.

[0056] The opening allowing the insertion of a container can be defined by a nozzle comprising at its end a clamping lip oriented radially inwards, the nozzle preferably communicating with the interior of the vacuum chamber by at least one orifice passing through the side wall of the chamber, of smaller section than that defined by the free edge of the clamping lip.

[0057] The colostrum collection container can be a tube. Preferably, it is a so-called "standard" 10 mL analysis tube, with an outside diameter of about 15 mm, fitted with a thread to receive a screw cap, with a height of about 5 mm.

[0058] Alternatively, the colostrum collection container can also be used to administer colostrum to the infant. Preferably, this is a colostrum syringe or pipette.

[0059] The tip can be made of the same elastically deformable material as the body of the device.

[0060] The tip can be formed as a single piece with the body of the device.

[0061] The nozzle can extend vertically along a Z axis from the bottom of the side wall of the vacuum chamber, when the device is observed in the operating position.

[0062] The tip can have a height h along the Z axis of between 8 and 12 mm.

[0063] A section of the edge of the clamping lip along a plane transverse to the Z axis can to have a circular shape, with a diameter of d2

[0064] d2 can be on the order of 12 mm.

[0065] When the container is a tube with a thread for receiving a screw cap, the height h of the nozzle may be greater than the height of the thread, and the inner diameter d2dc of the clamping lip may be smaller than the outer diameter of the tube, so that inserting the tube into the nozzle causes the nozzle opening to expand. The nozzle is preferably made of the same elastically deformable material as the body of the device, as mentioned above. Once the tube is inserted into the nozzle, the free edge of the clamping lip is positioned hermetically under the thread of the tube to hold it in place and ensure a seal.

[0066] The orifice passing through the side wall of the vacuum chamber may have a shape circular, with diameter d3.

[0067] <7;pcut be of the order of 10 mm.

[0068] The diameter d3 of the orifice passing through the side wall may be smaller than the internal diameter d2 of the clamping lip, so as to prevent colostrum leaks and to serve as a stop at the end of insertion of the tube serving as a container.

[0069] In another embodiment, the insertion opening of the container can be simply defined by a single orifice passing through the side wall of the chamber.

[0070] In another embodiment, the opening may be arranged to allow a conventional breast milk collection container, preferably a bottle, to be inserted therein.

[0071] In another embodiment, the opening may be arranged to allow a collection container of the syringe or pipette type, preferably a colostrum syringe or pipette, to be inserted therein. Together

[0072] According to another aspect of it, the invention relates to a breast expression set comprising the device as defined above and a colostrum collection container arranged to fit into it.

[0073] The colostrum collection container is preferably a so-called analysis tube “standard,” as mentioned above. Alternatively, the colostrum collection container can be a colostrum syringe or pipette.

[0074] In another embodiment, the breast expression assembly comprises the device as defined above and a conventional breast milk collection container, arranged to fit into it.

[0075] The conventional breast milk collection container is preferably a bottle. Extraction process

[0076] According to another aspect of the invention, the invention relates to a method for extracting colostrum using the mammary expression system as defined above, comprising the following steps: a. Insert a collection container into the opening of the device provided for this purpose, b. compress the wall of the vacuum chamber to reduce its internal volume, c. Position the breast shield on the breast, centered over the nipple, then release the vacuum chamber, so that the device adheres to the breast by suction effect, d. Place your fingers on the compression area, preferably on the indentation designed to receive one or more fingers, e. perform repetitive compression movements on it to compress the milk ducts of the breast, and collect the colostrum in the container.

[0077] The invention further relates to a method of extracting colostrum incorporating the above steps except for step a), using the device according to the invention comprising a colostrum collection cavity formed in one piece with the vacuum chamber.

[0078] The invention further relates to a method for extracting colostrum as defined above with the exception of step d), the compression being done automatically on the compression zone.

[0079] The invention also relates to a method for extracting colostrum using the mammary expression system as defined above, comprising the following steps: a. Insert a collection container into the opening of the device provided for this purpose, b. Position the breast shield on the breast, centered over the nipple, c. create a vacuum using a vacuum pump so that the device adheres by suction effect on the breast, d. Place your fingers on the compression area, preferably on the indentation designed to receive one or more fingers, e. perform repetitive compression movements on it to compress the milk ducts of the breast, and collect the colostrum in the container.

[0080] The invention further relates to a method of extracting colostrum incorporating the above steps except for step a), using the device according to the invention comprising a colostrum collection cavity formed in one piece with the vacuum chamber.

[0081] In another embodiment, the invention relates to a method for extracting colostrum as defined above with the exception of step d), the compression being done automatically on the compression zone.

[0082] In another embodiment, the invention relates to a method for extracting conventional breast milk, based on the model of the method for extracting colostrum previously defined. Brief description of the drawings

[0083] The invention may be better understood by reading the following description, non-limiting examples of implementation of the invention, and by examining the attached drawing, in which:

[0084] [Fig-1] [Fig.1] is a profile view of the device positioned on the breast,

[0085] [Fig.2] [Fig.2] is a perspective view of the device,

[0086] [Fig.3] [Fig.3] is a longitudinal cross-sectional view of the device,

[0087] [Fig.4] [Fig.4] is a view in another longitudinal section perpendicular to the axis Z of the device,

[0088] [Fig.5] The figure is a bottom view of the device,

[0089] [Fig.6] [Fig.6] is a top view of the device,

[0090] [Fig.7] [Fig.7] represents a detail of [Fig.3] in another embodiment,

[0091] [Fig.8] [Fig.8] illustrates another embodiment of the device according to the same view that the [Fig.3],

[0092] [Fig.9] [Fig.9] represents another embodiment of the device according to the same given that [Fig.4],

[0093] [Fig. 10] [Fig. 10] illustrates another embodiment of the device according to the same given that [Fig.3] Detailed description

[0094] A set of breast expression according to the invention is illustrated in [Fig.1].

[0095] The breast expression assembly includes a device 1 according to the invention in which a collection container is inserted, which in this case is in the form of a so-called "standard" analysis tube 2. The device 1 comprises a body 100 defining a breast shield 101 and a vacuum chamber 102 communicating with the breast shield 101. The breast shield 101 is intended to be applied hermetically over the entire circumference of the breast behind the nipple.

[0096] The body 100 extends along a longitudinal axis X which is substantially horizontal during use. It has a length along the X axis of 78 mm, for example.

[0097] The body 100, preferably formed in one piece, is for example made of transparent silicone with a hardness of 40 Shore A

[0098] Device 1 is shown in isolation in Figures 2 to 10.

[0099] The body 100 may present at the junction of the nipple 101 and the vacuum chamber 102 an annular constriction 103, as seen in [Fig.4].

[0100] The section of the distal end 104 of the teat 101, in a transverse cutting plane perpendicular to the axis X, preferably has a circular shape, with a diameter d of 7 cm for example, as shown in figures 3 and 6.

[0101] The angle 9 at the top defining the inclination of the generally conical wall of the teat is for example equal to 90°.

[0102] The teat 101 has a compression zone 105, located behind its distal end 104, as illustrated in Figures 2 and 3.

[0103] The teat 101 may have a recess 106 for receiving a finger on the compression zone 105, visible in figures 3 and 4.

[0104] The inner face of the compression zone 105 has grooves 107, visible in figures 3 to 5, oriented longitudinally along the X axis. These grooves have a length along the X axis of 15 mm for example.

[0105] An internal annular ridge 108, visible in figures 3 and 4, with a thickness of 3.7 mm for example, is present at the distal end 104 of the teat 101.

[0106] The wall of the teat 101 thickens towards the rear of the compression zone 105 in a zone 109, shown in [Fig.4].

[0107] The vacuum chamber comprises a side wall 110 and a bottom wall 111, the latter preferably having a convex shape outwards when viewed as in [Fig.3] in longitudinal section.

[0108] Fig. 8 illustrates another embodiment in which the side wall 110 has in longitudinal section a shape generally convex outwards, like the bottom wall 111.

[0109] Fig. 10 illustrates another embodiment in which the bottom wall has a recess 117, arranged to allow the insertion of a tube connected to a vacuum pump, mechanically creating a vacuum in the vacuum chamber.

[0110] The side wall and the bottom wall have, for example, an identical and constant thickness of the order of 3 mm.

[0111] The opening of the device communicating with a colostrum collection cavity is arranged to allow the insertion of the collection container 2. Preferably, as illustrated in Figures 2 and 3, it is defined by an end piece 112, formed in one piece and made of the same material as the body 100 of the device 1. The end piece 112 has at its tip a clamping lip 113 oriented radially inwards. The end piece 112 communicates with the vacuum chamber 102 via an orifice 114, shown in Figures 3 and 4, passing through the side wall 110.

[0112] The tip 112 has a height h along the Z axis of the order of 10 mm for example.

[0113] The clamping lip 113 has an inner diameter d2dc of the order of 12 mm for example.

[0114] The orifice 114 has a circular shape with a diameter d3 of approximately 10 mm, for example.

[0115] To use the device, the user inserts, for example, an analysis tube called The "standard" 2 is inserted into the nozzle 112 by exploiting the latter's ability to deform. The free edge of the clamping lip 113 is hermetically sealed under the threads of the tube 2, which is thus held securely to the device. The user then compresses the side wall 110 of the vacuum chamber 102, positions the breast shield 101 on the breast, centering it over the nipple, and then releases the vacuum chamber 102. A suction effect is created, which keeps the device 1 in place on the breast without manual support, as illustrated in [Fig. 1].

[0116] In order to extract the colostrum, the user places one or more fingers on the receiving recess(es) 106 and performs repetitive compression movements. which compress the milk ducts of the breast. Combined with the vacuum created at the nipple, this compression leads to the expression of colostrum. This flows into the breast shield 101, then into the vacuum chamber 102, through the bottom of the lateral wall 110, towards the orifice 114 and into the tube 2.

[0117] In some embodiments, a slight slope 115, as shown in [Fig.7], extends from the junction 103 to the orifice 114, to guide the colostrum more efficiently towards the tube 2. Alternatively or in addition to this slope 115, a channel 116, as illustrated in [Fig.9], can help to channel and guide the colostrum.

[0118] The invention is not limited to the illustrated example.

[0119] For example, in another embodiment, the opening is arranged to allow the insertion of a collection container other than a tube, such as a bottle, a syringe or a pipette.

[0120] The insertion opening may be simply defined by a single orifice passing through the side wall of the chamber.

[0121] The relief(s) 107 present on the internal face of the breast shield 101 in the compression zone may have other shapes. These are, for example, bosses or ribs.

[0122] This may consist of a single ridge extending around the entire inner circumference of the nipple in the compression zone, or of several ridges distributed periodically around the circumference. Alternatively, the ridge(s) may be absent from the bottom of the compression zone and confined to the top and sides of the nipple.

[0123] In another embodiment, the compression is automated.

Claims

Claims

1. Breast expression device (1), comprising a body (100) made of an elastically deformable material, defining a breast shield (101) and a vacuum chamber (102) communicating with the breast shield (101), the device (1) having an opening communicating with a colostrum collection cavity, the breast shield (101) having a wall of flared shape, preferably generally conical, shaped to be applied at its distal end (104) in a hermetic manner over the entire circumference of the breast behind the nipple, so as to allow the formation of a vacuum near the nipple and the holding by suction effect of the device on the breast, the breast shield (101) defining behind its distal end (104) a deformable compression zone (105), making it possible to compress the milk ducts of the breast by applying pressure to the outer surface of said zone,one or more reliefs (107) being present on the internal face of the compression zone (105) in order to prevent it from adhering to the breast during use.,

2. Device (1) according to the preceding claim, the opening being arranged to allow the insertion of a container (2) for collecting colostrum.

3. Device (1) according to one of the preceding claims, the body (100) of the device extending along a longitudinal axis X, the relief(s) (107) on the internal face of the compression zone being grooves or ribs, preferably grooves, in particular oriented longitudinally along the axis X.

4. Device (1) according to any one of the preceding claims, the teat (101) having at its distal end (104) an annular bead (108).

5. Device (1) according to any one of the preceding claims, the wall of the teat (101) thickening towards the rear in a part (109) of the compression zone (105).

6. Device (1) according to any one of the preceding claims, the vacuum chamber (102) having a slope (115) and / or a recess (116) for channeling and guiding the colostrum towards the opening communicating with a colostrum collection cavity.

7. Device (1) according to any one of the preceding claims, the vacuum chamber (102) comprising a side wall (110) and a bottom wall (111), the side wall and / or the bottom wall having, when observed in longitudinal section, an outwardly curved shape.

8. Device (1) according to any one of the preceding claims, the body (100) having at the junction of the teat (101) and the vacuum chamber (102) an annular constriction (103).

9. Device (1) according to any attachment to claim 2, the opening allowing the insertion of the container (2) being defined by a nozzle (112) comprising at its end a clamping lip (113) oriented radially inwards, the nozzle (112) preferably communicating with the interior of the vacuum chamber (102) by at least one orifice (114) passing through the side wall (110) of the chamber (102), of smaller section than that defined by the free edge of the clamping lip (113).

10. Device (1) according to any one of the preceding claims, the body (100) being made of a material, in particular a silicone, with a hardness of between 30 and 70 Shore A.

11. Device (100) according to any one of the preceding claims, the teat (101) having at least one receiving recess (106) for one or more fingers on the compression zone (105).

12. A breast expression assembly comprising a device (1) according to any attachment to claim 2 and a colostrum collection container (2), arranged to be inserted therein, the container (2) preferably being a so-called "standard" analysis tube.

13. Method for extracting colostrum using the breast expression assembly according to the preceding claim, comprising the following steps: a. inserting a collection container (2) into the opening of the device (1) provided for this purpose, b. compressing the wall (110) of the vacuum chamber (102) to reduce its internal volume, c. positioning the breast shield (101) on the breast, centered on the nipple, then releasing the vacuum chamber (102), so that the device (1) adheres by suction effect to the breast, d. placing one's fingers on the compression zone (105), preferably on the receiving recess (106) of one or more fingers, e. perform repetitive compression movements on it to compress the milk ducts of the breast, and collect the colostrum in the container (2).

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