Nipple stimulation device, milk squeezing system, breast pump and milk collection system

Abstract

Embodiments of the present disclosure relate to a nipple stimulation device for promoting milk squeezing. It includes a teat contact device for contacting a teat having one or more flexible arms, each flexible arm having a distal end configured to point to the teat in use. A respective vibrating element is mounted along each of the flexible arms for delivering vibrations to the distal ends of the flexible arms.

Description

Technical Field

[0001] The utility model relates to nipple stimulation, for example for use as part of a breast pump or other milk collecting device. Background Art

[0002] Breast pumps are used by breastfeeding women to extract milk from their breasts so that the extracted milk can later be fed to their babies.

[0003] It is well known that the best nutrition for infants is breast milk. The World Health Organization (WHO) recommends breastfeeding infants for at least one year, preferably longer. However, mothers often return to work after only a few weeks or months. Then, in order to provide the best nutrition for their infants, mothers can express breast milk using a breast pump. The expressed milk can be stored and fed to the infant at a later stage and / or by someone else.

[0004] To use a breast pump, the breast is typically placed in a funnel-shaped cup and a vacuum is applied so that milk is extracted. Electric breast pumps typically have two modes of operation, namely, a stimulation mode and an extraction mode. The operation of a typical breast pump utilizes a cyclic pressure waveform, usually negative pressure or vacuum, which is applied to the breast and nipple within a breast shield (or a pair of breast shields) to draw milk from the nipple into a collection container. The typical pressure profile oscillates between maximum negative pressures and then returns to atmospheric pressure at the end of each cycle.

[0005] During stimulation mode, the milk ejection reflex is stimulated. This uses, for example, a relatively high frequency cyclic pressure waveform, such as 2 Hz. Once milk is flowing out of the breast, it is recommended to switch to extraction mode, which has a lower frequency (usually around 1 Hz) and higher intensity pumping (ie, lower pressure) for more effective milk extraction.

[0006] When the breast pump is activated, a pressure source inside the breast pump (e.g. a vacuum pump) creates a vacuum and the stimulation mode can begin. The vacuum pump is usually driven by an electric motor. For portable breast pumps, these motors are powered by battery power. There are also breast pumps that use a manually driven mechanical pump.

[0007] Recently, there has been a trend towards wearable breast pumps. These devices typically have a small form factor and can be worn entirely on the user's body, allowing the user to move freely. Some of these breast pumps are small enough to fit into a user's bra. For example, the motor, battery, and milk container are integrated together to form a single device.

[0008] In addition, there are passive milk collectors that can be placed on the breast and usually allow the user to apply static pressure to keep the device in place and help extract milk. For example, these collectors are intended to be used to collect milk from a non-breastfeeding breast while breastfeeding. The stimulation provided by the baby produces a milk ejection reflex on both breasts, and a simple passive vacuum is usually sufficient to extract (some) milk.

[0009] Unfortunately, because stimulation from the baby is required to produce the milk ejection reflex (MER) to initiate milk flow, these milk collectors cannot be used at other times when the baby is not around.

[0010] Nipple stimulation based on mechanical means including vibrations to stimulate MER is known in the art, for example it is known to apply vibrations to promote MER, for example as disclosed in EP 4 029 540. Producing MER by stimulation in the absence of an infant results in additional milk being collected with a milk collector at any suitable time.

[0011] However, stimulation requires good contact with the nipple for effective stimulation. The shape and size of the nipple varies from person to person, as well as dynamically changing during milk expression. These differences in nipple size lead to inconsistent and unreliable nipple stimulation.

[0012] Therefore, there is a need for nipple stimulation that can accommodate different sizes and shapes to ensure good contact during milk expression.

[0013] WO 2021 / 186006 A1 discloses a biomechanical breast pump mechanism for expressing breast milk, which includes a bionic funnel, at least two active actuation zones and a static zone on the funnel, the active actuation zone being actuated by a drive mechanism or multiple drive mechanisms and being configured to replicate the complex functions of an infant's tongue during sucking, namely physical stimulation of the areola / nipple; nipple positioning: generating and maintaining a low level baseline vacuum to create an air seal on the breast: generating a sub-atmospheric pressure inside the funnel; generating and maintaining a near-zero air environment in the funnel; and independently or simultaneously coordinating negative and positive actuation of one or two actuation zones to control vacuum oscillations within a predefined range.

[0014] US2021 / 0361837A1 discloses a breast pump with an areola stimulation assembly. The breast pump may include a breast cup. The breast pump may also include a vacuum component connected to the breast cup. In addition, the breast pump may include an areola stimulation assembly contained in the breast pump, the areola stimulation assembly including an upper plate; a lower plate; and a mechanism for moving the lower plate relative to the upper plate.

[0015] US2018 / 0126052A1 discloses a system for hands-free nursing and breast pumping, which includes a breast compression system that uses a plastic cavity filled with air in the cup of a nursing bra or attached to the flange of a breast pump to apply pressure and massage mode to the breast when using a breast pump. The compression or pressure is applied radially on the surface of the breast, and its rhythm and intensity can be adjusted by the user by using a controller to mimic the best practices of manual compression. These bra cups with compression devices have openings on the nipples so that the breast pump flange can be inserted through them and used in a typical manner to extract breast milk, thereby increasing the amount of milk squeezed. Utility Model Content

[0016] The utility model is defined by the claims.

[0017] According to an embodiment of one aspect of the utility model, there is provided a nipple stimulation device for promoting milk expression, comprising:

[0018] a nipple contact device for contacting a nipple, the nipple contact device comprising a collection of one or more flexible arms, each flexible arm having a distal end, configured to be directed towards the nipple in use so that the nipple contact device can contact a range of nipple sizes; and

[0019] A vibration system includes a set of one or more vibration elements, wherein a respective vibration element is mounted along each of the flexible arms for delivering vibrations to the distal ends of the flexible arms.

[0020] The nipple contact device transmits vibrations to the nipple by means of a vibrating element mounted along at least one flexible arm. The design of the flexible arm or arms creates a bias towards the nipple when the nipple has been bent. In particular, deformation of the flexible arm or arms away from a default resting state creates a restoring force. For example, the nipple contact device is used to contact the sides and base of the nipple. This provides effective stimulation without blocking the milk duct outlet.

[0021] The system provides a cost-effective, small and quiet way of inducing the milk ejection reflex by applying mechanical oscillations or vibrations to the nipple / areola area.

[0022] The vibration element of each flexible arm is preferably located at the distal end of the flexible arm.Therefore, the vibration element is located at the position where the flexible arm or multiple flexible arms contact the nipple.

[0023] For example, a nipple stimulation device comprises a set of at least three flexible arms, wherein the distal ends of the flexible arms are located in a closed-shaped path that is configured to be positioned around a nipple in use, wherein the flexible arms bias the path inwardly (if they have previously been deformed outwardly from a resting state).

[0024] Thus, the closed path surrounds the nipple and can be sized to contact a range of possible nipple sizes. For example, the path can be configured to form a ring having a range of diameters including a range of 12 mm to 18 mm. For example, when no nipple is present, the path is a circle with a 4 mm diameter, and the path opens to accommodate an inserted nipple to a size that matches the size (diameter) of the nipple. A restoring force (pushing the ring back to its 4 mm diameter) is then applied to the nipple.

[0025] The distal end of the flexible arm includes a spherical, elliptical, bean-shaped or U-shaped body. For example, the distal end is a spherical shape with a diameter of 8 mm.

[0026] The nipple stimulation device may include a frame for coupling the proximal ends of the collection of flexible arms together. The frame serves as a mounting feature. For example, it mounts the nipple contact device and the vibration system to the milk collection chamber.

[0027] For example, the vibration elements each include:

[0028] Electric actuator; or

[0029] Piezoelectric actuator; or

[0030] Mechanical actuator.

[0031] The electric actuator may include a motor with an eccentric rotating mass, a motor actuating a planetary gear, or a motor with a cam or similar device for applying a varying contact depth or intermittent contact and release. For example, a linear resonant actuator may be used.

[0032] The motor in the above examples may be replaced by a manually actuated rotary device. A mechanical actuator in the form of a spring powered mechanism may be used.

[0033] The vibration frequency of the vibration system may be in the range of 1 Hz to 250 Hz.

[0034] When multiple arms are present, they can vibrate synchronously, thus following the same pattern at the same time, or they can vibrate sequentially, thus following the pattern one after another, or they can be driven with independent patterns in terms of frequency and amplitude.

[0035] For example, the vibration amplitude of the vibration system is less than 2 mm. This has been found to be sufficient to provide the desired stimulation to promote the milk ejection reflex.

[0036] The stiffness of the collection of flexible arms can be adjustable. The stiffness then determines the restoring force applied. This can be achieved with electroactive polymers, or with the help of pressure chambers, or based on temperature changes. Thus, the pressure applied on the figure can be controllable.

[0037] The nipple stimulation device may also include a contact pressure sensor. This monitors the applied pressure and enables a feedback loop to be provided for controlling the adjustable firmness.

[0038] The utility model also provides a milk squeezing system, comprising:

[0039] Nipple stimulation devices as defined above;

[0040] A milk collection chamber is positioned above the nipple and is used to collect expressed milk.

[0041] Thus, the expression system stimulates milk expression and provides collection of milk.The nipple stimulation device is preferably inside the milk collection chamber.

[0042] The milk expression system may further comprise a pressure source for generating a pressure in the milk collection chamber which is lower than atmospheric pressure. This (static) negative pressure may be delivered to the chamber directly or indirectly via a membrane. The reduced pressure further stimulates milk expression.

[0043] The utility model also provides a breast pump combined with a milk squeezing system, and also provides a milk collecting system combined with the milk squeezing system. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] In order to better understand the present invention, and to more clearly show how it may be put into practice, reference will now be made, by way of example only, to the accompanying drawings, in which:

[0045] Figure 1 A known breast pump system is shown;

[0046] Figure 2 A wearable breast pump is shown;

[0047] Figure 3 The nipple stimulation device according to the utility model is shown, which is applied to a milk collector;

[0048] Figure 4 A perspective view of one example of a nipple stimulation device is shown. DETAILED DESCRIPTION

[0049] The present invention will be described with reference to the accompanying drawings.

[0050] It should be understood that the detailed description and specific examples, although indicating exemplary embodiments of the device, system and method, are intended to be used for illustrative purposes only and are not intended to limit the scope of the present invention. These and other features, aspects and advantages of the device, system and method of the present invention will become better understood from the following description, the appended claims and the accompanying drawings. It should be understood that these drawings are only schematic and not drawn to scale. It should also be understood that the same reference numerals are used throughout the drawings to indicate the same or similar parts.

[0051] The utility model provides a nipple stimulation device for promoting milk expression. The nipple stimulation device comprises a nipple contact device for contacting a nipple, wherein the nipple contact device has one or more flexible arms, each of which has a distal end configured to point toward the nipple during use. A corresponding vibration element is installed along each of the flexible arms to deliver vibration to the distal end of the flexible arm.

[0052] Figure 1 A known breast pump system 1 is shown, comprising an expression device 2 and a drive arrangement for controlling the expression function of the breast pump.

[0053] In the example shown, the drive device comprises an electric pump device 3, which is connected to the extrusion device 2 via a pipe 4. Apart from the pump impeller and the pump motor, the pump device comprises various components, so that the pump device can be regarded as a universal operating device.

[0054] The expressing device 2 is formed by a body 7, a funnel 5 (called a breast shield) for accommodating the user's breast, and a milk collection container 6 for collecting expressed milk. The funnel 5 and the container 6 are connected to the body 7. The body 7 includes a vacuum chamber. A flexible membrane called a diaphragm is located in the vacuum chamber. The diaphragm prevents the expressed milk from flowing into the tube 4 leading to the pump device 3.

[0055] The operating device comprising the pump means 3 may alternatively be directly mounted and connected to the body 7. In this case, the diaphragm prevents the expressed milk from flowing directly into the pump means 3.

[0056] The pump device 3 includes a controller 10, a power source 12, a motor 14 and a vacuum pump 16 (i.e., an impeller driven by the motor 14). A diaphragm pump (displacement pump) may be used instead. The controller 10 controls the operation of the power source 12, the motor 14 and the vacuum pump 16. The pump device 3 also includes a solenoid valve 18.

[0057] In use, the vacuum pump 16 applies a vacuum to the diaphragm located in the body 7, causing it to deform. When the funnel 5 is sealed to the breast, the diaphragm deforms to create a vacuum in the funnel 5, which in turn applies a vacuum to the breast, enabling milk to be expressed.

[0058] At intervals, a vacuum is applied to the breast. That is, a pressure differential is applied on a cyclic basis. After the vacuum has been established, the pressure from the vacuum is released by using a temporarily opened solenoid valve. The solenoid valve is an electromechanically operated valve configured to open and close an air passage connecting the vacuum side of the vacuum pump to ambient air, so that when the solenoid valve is closed, the vacuum pump creates a vacuum in the expression device, which enables milk to be expressed from the user's breast. When the solenoid valve is opened, the vacuum created by the vacuum pump is released due to the flow of ambient air towards the vacuum or negative pressure created by the vacuum pump, so that the pressure applied to the user's breast is partially or completely reduced.

[0059] This is a basic description of the known operation of a standard breast pump system.

[0060] There are also wearable breast pumps, for example, which are intended to be mounted inside a nursing bra. All the drive train components described above are then formed inside an enclosure that is fixed to the breast. The top part contains the drive train (pump, motor, controller) and the bottom part forms the collection container. This allows the breast pump to perform more independently and leaves both hands free to do other things.

[0061] There are also other types of wearable breast pumps whereby the expression device is secured to the breast and the pump device and / or milk collection container are located elsewhere on the user's body.

[0062] Figure 2 A wearable breast pump is shown comprising an expression kit 30 attached to a corresponding milk collection container 31 .

[0063] The utility model relates to stimulating the nipple to promote the milk ejection reflex. The stimulation can be used to avoid the need for a specific cyclic pressure waveform. For example, a static negative pressure can be applied. This then avoids the need for components such as vacuum pumps, motors, valves and large batteries. Therefore, the nipple stimulation device can be used as part of a device (breast pump or milk collector), which avoids the problems of large cost, size, weight and noise level. The nipple stimulation device can be part of a milk collection system or a simple breast pump without the need for a cyclic pressure waveform. However, the nipple stimulation method can also be used with an ordinary breast pump (with a cyclic pressure waveform).

[0064] Figure 3 A nipple stimulation device for use within a milk collection apparatus 50 is shown.

[0065] The milk collection device 50 is designed to provide a secure and effective mechanical stimulation of different nipple sizes and shapes. The device 50 is used as a vibration stimulation device for providing contact with the nipple 54 and applying mechanical vibrations for stimulating the MER.

[0066] The nipple stimulation device has a nipple contact means for contacting the nipple. The nipple contact means comprises a collection of one or more flexible arms 60, 61, each flexible arm 60, 61 having a distal end 58, configured to be directed towards the nipple 54 in use so that the nipple contact means can contact a range of nipple sizes.

[0067] The one or more arms 60, 61 have a default resting configuration and the presence of the nipple causes the one or more arms to bend away from the resting position. The inherent elasticity of the one or more arms 60, 61 causes the nipple to be exerted with a restoring force. Thus, the arms are flexible but elastically deformable.

[0068] The distal ends of the flexible arms have a smooth surface for contacting the nipple. For example, they may include a spherical, elliptical, bean-shaped or U-shaped body.

[0069] The vibration system includes a collection of vibration elements, with a respective vibration element 64 mounted along each of the flexible arms for delivering vibrations to the distal end of the flexible arms. The vibration elements can produce reciprocating motion in one or more directions relative to the nipple. Each vibration element can include a single actuator or it can include multiple actuators that are differently oriented and controlled in unison or independently.

[0070] The vibration may have an axis of vibration in the transverse or longitudinal direction (relative to the nipple axis), or a combination of both. The vibration may be applied in a continuous mode or in a pulsed mode (where each pulse comprises a collection of vibrations). When high frequency vibrations are used, the pulsed mode may be perceived as more comfortable.

[0071] The distal end 58 preferably contacts the sides and base of the nipple and areola. The distal end is made of a material that conducts mechanical vibrations from the vibrating element 64 to the nipple. The vibrating element 64 is mounted on or embedded in the flexible arm.

[0072] In the example shown, there is an upper flexible arm 60 and a lower flexible arm 61. As a minimum, there may be a single flexible arm. The space between the arm and the fixed support may then be adjusted by the flexibility and deformation of the flexible arm. With two flexible arms as shown, the space between them is adjusted by the flexibility and deformation of the flexible arms so that the nipple is clamped between them.

[0073] There may be a set of three or more arms. In this way, the distal ends of the flexible arms may form a path configured to be positioned around the nipple in use. For example, the path is a circle, but it may be any closed shape. In practice, the set of three points may be considered to be located on a circle or to define a triangle. In a preferred example, the distal ends are evenly angularly spaced around the circle. The biasing of the flexible arms (back to their resting state) causes the annular path to contact the nipple inwardly. For example, the diameter range of such annular path may be configured to include a range of 12 mm to 18 mm.

[0074] The arm structure of at least three arms then surrounds an effective nipple opening 62, wherein the nipple opening 62 is configured so that the distal end 58 contacts the side or base of the nipple, or areola rather than the tip where the opening of the milk duct may be blocked. The flexibility of the flexible arms ensures that the nipple opening 62 can be resized to accommodate a wide range of nipple diameters.

[0075] The vibration device 64 generates vibrations by electrical means such as a piezoelectric actuator, a vibration motor, etc., or by mechanical means such as a wound spring motor or by vibrations induced by the movement of a spring-loaded ring;

[0076] The frame 66 holds the proximal ends of the flexible arms 60, 61 together and serves as a support for the arm assembly.

[0077] A milk collection device 56 covers the nipple stimulation device for collecting milk.

[0078] The distal end is formed of a material that is soft enough for nipple contact, and the one or more arms 60, 61 are flexible enough to deflect toward the nipple, but when contact is made, the pressure is not so high as to cause pain and block the milk ducts.

[0079] Each vibrating element 64, when in use and in contact with the nipple, provides vibrations to the nipple, for example at a frequency in the range of 1 Hz to 250 Hz and an amplitude of less than 2 mm. Stimulation of the nipple to promote milk expression is affected by several aspects, such as vibration frequency, vibration amplitude, and the location of stimulation (e.g., the side of the nipple, the areola, the top of the nipple, as long as it does not interfere with the milk outflow ducts).

[0080] In one example, a micromechanical vibrator may be embedded in the distal ends of three arms, and a spherical nipple of the contact element is formed at the distal end. For example, the arms have a length in the range of 10 mm to 20 mm (e.g., 15 mm), and the spherical nipple of the contact element has a diameter in the range of 5 mm to 10 mm (e.g., 8 mm). The minimum nipple opening diameter is, for example, 4 mm, and the flexible arms allow opening to up to 18 mm after insertion of the nipple length. This configuration allows insertion of nipples of a typical range of nipple lengths (e.g., 7 mm to 14 mm).

[0081] The volume of the milk collection chamber may be provided with a negative pressure (ie below atmospheric pressure). This may be a static negative pressure, which is therefore easier to produce than a cyclic pressure waveform.

[0082] By static pressure is meant that only a single pressure level is applied and there is no active pressure modulation over time. The pressure may however vary over time due to pressure leaks or filling of the milk container but in this example there is no active modulation of the applied pressure.

[0083] The negative pressure source 68 for this purpose may comprise a pump (electrical or mechanical), or it may be a compressible chamber for manually generating negative pressure, or it may even be implemented by the milk collection container 50 itself.

[0084] The distal end of each flexible arm may be integral with the arm, or it may be a separate element.

[0085] In an example, the stiffness of the flexible arm's device can be adjusted, for example, using electroactive polymers, pressure chambers, or based on temperature changes. The stiffness can be adjusted by other means, such as by blowing air or fluid into the flexible arm's cavity, thereby changing its elasticity.

[0086] Another option is to provide an actuator for active movement of the arm rather than purely passive movement, or to manually change the position of the flexible arm (and thus the distance to the nipple) by the user, such as using a screw-like mechanism. For example, an alternative mechanical adjustment is to adjust the size of the frame 66, such as by making the frame deformable or inflatable, to adjust the nipple opening.

[0087] The pressure exerted on the nipple by the arrangement of flexible arms may be controllable in these different ways.

[0088] Contact pressure sensors 70 may also be integrated into the distal end of one or more of the arms, or pressure or strain sensors may be integrated into the arms or provided at the frame to monitor the applied pressure and provide a feedback loop.

[0089] For example, the arm has a stiffness of about 0.005 N / mm (eg, in the range of 0.015-0.02 N / mm). The choice of arm stiffness, size, and configuration determines the mechanical properties of the arm arrangement.

[0090] Figure 4 One example of a nipple stimulation device is shown in a perspective view.

[0091] The nipple stimulation device comprises an arrangement of three arms 80 with a spherical distal end 58. The arms 80 are overmolded over the vibrating elements and wire connections 82 connected to the vibrating elements. These wire connections extend around the frame 66 and along the arms to reach the vibrating elements. Thus, the vibrating elements are embedded in the spherical distal end.

[0092] For example, Figure 4 The relaxed state is shown with a 4 mm opening defined between the distal ends 58. When the device is applied to a breast such that a nipple is present, the arms deflect to increase the size of the nipple. Figure 3 The size of the opening shown.

[0093] For example, each arm comprises a pair of parallel arm portions with a slot therebetween for the wire connection member. The slot is located at the neutral plane so that the wire does not contribute significantly to the stiffness of the arm.

[0094] By studying the drawings, the disclosure and the appended claims, other variations of the disclosed embodiments can be understood and implemented by those skilled in the art when practicing the utility model for which protection is claimed. In the claims, the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality.

[0095] The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage.

[0096] If the term "adapted to" is used in the claims or the specification, it should be noted that the term "adapted to" is intended to be equivalent to the term "configured to".

[0097] Any reference signs in the claims should not be construed as limiting the scope.

Claims

1. A nipple stimulation device comprising: A nipple contact device for contacting a nipple, characterised in that the nipple contact device comprises a collection of one or more flexible arms, each flexible arm having a distal end, the distal end being configured to point towards the nipple in use so that the nipple contact device can contact a range of nipple sizes; and A vibration system includes a set of one or more vibration elements, wherein a respective vibration element is mounted along each of the flexible arms for delivering vibrations to the distal ends of the flexible arms.

2. The nipple stimulation device according to claim 1, characterized in that The vibrating element of each flexible arm is located at the distal end of the flexible arm.

3. The nipple stimulation device according to claim 1 or 2, characterized in that A set of at least three flexible arms is included, wherein the distal ends of the flexible arms are located on a path of a closed shape, the closed shape being configured to be positioned around the nipple in use, wherein the flexible arms bias the path inwardly.

4. The nipple stimulation device according to claim 3, characterized in that The path can be configured to form a loop having a diameter ranging from 12 mm to 18 mm.

5. The nipple stimulation device according to any one of claims 1 to 4, characterized in that The distal end of the flexible arm includes a spherical, elliptical, bean-shaped or U-shaped body.

6. The nipple stimulation device according to any one of claims 1 to 5, characterized in that A frame is included for coupling together the proximal ends of the collection of flexible arms.

7. The nipple stimulation device according to any one of claims 1 to 6, characterized in that Each of the vibration elements comprises: Electric actuator; or Piezoelectric actuator; or Mechanical actuator.

8. The nipple stimulation device according to any one of claims 1 to 7, characterized in that The vibration frequency of the vibration system is in the range of 1 to 250 Hz.

9. The nipple stimulation device according to any one of claims 1 to 8, characterized in that The vibration amplitude of the vibration system is less than 2 mm.

10. The nipple stimulation device according to any one of claims 1 to 9, characterized in that The stiffness of the set of flexible arms is adjustable.

11. The nipple stimulation device according to claim 10, characterized in that A contact pressure sensor is also included.

12. A milk expression system, characterized in that: include: A nipple stimulation device according to any one of claims 1 to 11; as well as A milk collection chamber is positioned above the nipple and is used to collect expressed milk.

13. The milk expression system according to claim 12, characterized in that: Also included is a pressure source for generating a subatmospheric pressure in the milk collection chamber.

14. A breast pump, characterized in that: The breast pump comprises a milk expression system according to claim 12 or 13.

15. A milk collection system, characterized in that: The milk collection system comprises a milk expression system according to claim 12 or 13.

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