Lactation aids and breast tissue treatment devices

Abstract

A lactation aid is disclosed having an outer layer defining a cavity and a core material located in the cavity, the core material being adapted to perform one or more of: heating and cooling. The lactation aid is adapted to be manually rolled over a breast. The lactation aid may include a protrusion, which may be hollow so that the core material extends at least partially into the protrusion. A temperature indicator may also be present. The lactation aid may combine three therapeutic components: application of temperature (heating or cooling), movement, and compression to breast tissue.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of Australian Provisional Patent Application No. 2018902800 filed on 1 August 2018, the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates to promoting lactation and / or treating conditions associated with lactation and affecting breast tissue. Background Art

[0004] During normal lactation, milk is secreted through the mammary glands located within the breast tissue. The milk then flows through the lactiferous ducts (milk ducts) and the nipple pores to the nursing baby through the action of smooth muscle contractions. However, there are many problems associated with lactation that can occur.

[0005] Problems may include edema (breast swelling), blocked milk ducts (caused by stagnant breast milk), breast infections, insufficient milk production or drainage, and serious medical problems such as mastitis, breast abscesses and cysts. Mastodynia (breast pain) is often associated with an affected area of ​​the breast. Contributing factors may include a busy lifestyle, fatigue, allergies, stress, restrictive clothing and a predisposing body.

[0006] Many problems associated with lactation can be prevented or alleviated by effectively draining breast milk on a regular basis. However, in situations where this is not possible or does not resolve the problem, alternative solutions are needed.

[0007] Any discussion of documents, acts, materials, devices, articles of manufacture or the like included in this specification is not to be taken as an admission that any or all of these matters formed part of the prior art base or were common general knowledge in the field relevant to the present disclosure as they existed before the priority date of each claim of this application. Summary of the invention

[0008] In one aspect, the present disclosure provides a lactation aid, comprising:

[0009] an outer layer defining a cavity; and

[0010] a core material located in the cavity, the core material being suitable for one or more of: heating and cooling;

[0011] The lactation aid is adapted to be manually rolled over the breast.

[0012] In another aspect, the present disclosure provides a method for assisting lactation, the method comprising:

[0013] The lactation aid is manually rolled toward the breast, the lactation aid comprising:

[0014] an outer layer defining a cavity; and

[0015] A core material is located in the cavity, the core material being suitable for one or more of: heating and cooling.

[0016] During rolling of the lactation aid on the breast, the lactation aid may be pressed between the surface of the breast and the user's hand during application. The lactation aid may be rolled on different areas of the breast in one or more random directions and / or in different directions as desired. However, application of the lactation aid need not be limited to only a rolling motion. For example, the lactation aid may additionally or alternatively be pressed, twisted or rubbed against the breast. When applied to the breast, heat may be transferred to or from the breast tissue, lateral motion may be applied to the breast tissue and compression may be applied to the breast tissue.

[0017] The lactation aid may combine three key therapeutic components: application of temperature (heating or cooling), movement, and compression to breast tissue. As a result, the lactation aid may be used, for example, to stimulate milk production and flow, aiding the let-down reflex; help unclog blocked milk ducts; help resolve excessive milk secretion and fullness; reduce swelling and pain associated with breastfeeding or lactation; help fight infection and prevent escalation of breast swelling (assisting milk ducts to open and flow); and / or improve the quality of milk by increasing total solids, lipid and casein concentrations, and total energy. The treatment may be further enhanced by one or more of the features described below.

[0018] In one embodiment, the outer layer of the lactation aid comprises a plurality of protrusions extending radially outward from the outer surface of the outer layer. The protrusions may be distributed on the outer surface of the outer layer in a regular or irregular pattern. During use, the protrusions may be pressed into breast tissue to provide enhanced movement and / or compression to the breast tissue. The protrusions may be spikes, ridges or bulges or a combination thereof. The protrusions may have a circular shape without sharp edges. The protrusions may, for example, be integrally formed with the outer surface of the outer layer. The protrusions may have a height of at least 1 mm, at least 2 mm, or at least 3 mm. The protrusions may have a height of less than 10 mm, less than 8 mm, or less than 6 mm. For example, the protrusions may have a height of about 2 mm, 3 mm, 4 mm, 5 mm, or other values.

[0019] One or more of the protrusions may be hollow. The cavity defined by the outer layer may reach into the protrusion. Thus, the core material may extend at least partially into the hollow protrusion. The hollow protrusion may enable the heated or cooled core material to be as close as possible to the breast tissue, for example instead of being separated from the breast tissue by the protrusion. Furthermore, it may be ensured that the outer layer maintains substantially the same thickness around its entire (three-dimensional) circumference, even at locations where the protrusions are provided. The outer layer may have substantially the same thickness in areas where the protrusions are formed and in areas where there are no protrusions. Thus, the outer layer may have a more uniform flexibility and / or compressibility over its surface.

[0020] The outer layer may include different parts (e.g., one-half, one-third, or one-quarter of the outer layer) having configurations and / or properties that are different from each other. For example, projections of different numbers, sizes, and / or distribution patterns may be present at different parts of the outer layer. Additionally or alternatively, different parts of the outer layer may be formed by materials having different properties (e.g., hardness properties). In some embodiments, different parts may be formed separately and connected together to form the outer layer and the cavity. By providing different configurations and / or properties to different parts, the lactation aid may provide different therapeutic benefits; different parts may provide different temperature, motion, and / or compression properties. Different benefits may be experienced during a single use of the lactation aid, for example, by successively rolling different parts on the breast, or by selectively experiencing different benefits by applying only one or a selected group of parts to the breast instead of one or more other parts.

[0021] In one embodiment, the outer layer comprises a first portion and a second portion. The projections of the first subset are distributed at the first portion, and the projections of the second subset are distributed at the second portion. The projections of the first subset may each have a first height, and the projections of the second group may each have a second height different from the first height. The difference between the first height and the second height may be, for example, at least 0.5 mm, at least 1 mm, or at least 1.5 mm. The first portion and the second portion may be the first half and the second half of the outer layer, respectively.

[0022] Before applying the lactation aid to the breast, the core material may be placed in a heated or cooled state. When the core material is in a heated or cooled state, the lactation aid may be applied to the breast tissue.

[0023] For example, the core material can be heated to a desired treatment temperature that is substantially above the ambient room or atmospheric temperature, such as at least 5° C., at least 10° C., at least 15° C., at least 20° C., at least 30° C., at least 40° C., at least 50° C., or at least 60° C. above the room or atmospheric temperature. For example, the core material can be heated to a desired temperature of at least 25° C., at least 30° C., at least 35° C., at least 40° C., at least 50° C., at least 60° C., at least 70° C., or at least 80° C. Heating the core material to the desired temperature can include heating using an electrical heating device (such as a microwave or other type of oven), heating by immersion in a hot fluid such as hot water, or heating in other ways.

[0024] As another example, the core material can be cooled to a desired treatment temperature substantially below the ambient room or atmospheric temperature, such as at least 5°C, at least 10°C, at least 15°C, or at least 20°C below the room or atmospheric temperature. For example, the core material can be cooled to a desired temperature below 15°C, below 10°C, below 5°C, or below 0°C. In some embodiments, the core material can be frozen. Cooling the core material to the desired temperature can include cooling using an electrical refrigeration device (e.g., placing the aid in a refrigerator or freezer), cooling by immersion in a cold fluid such as cold water, or cooling in other ways.

[0025] However, in some embodiments, the core material may have "instant" heating or cooling properties. For example, the lactation aid may be configured so that an exothermic or endothermic reaction can be triggered to cause instant heating or instant cooling of the core material. In this regard, the lactation aid may include core materials and / or additional triggering elements common to "instant heating bags" or "instant cooling bags" known in the art. In addition, in some embodiments, the use of the lactation aid at room temperature is not excluded.

[0026] In some embodiments, the lactation aid can be used with a customized heating or cooling device that can have a chamber specifically designed to receive the lactation aid. The chamber can be surrounded by a wall of high thermal density that can maintain the heated or cooled state for a long period of time. The lactation aid can be repeatedly placed in the chamber to reheat or recool.

[0027] The outer layer can be thermally conductive so that it can be directly cooled or heated at least partially by the same method as the core material and / or so that heat is transferred or lost from the core material to the core material. The core material can have a relatively high thermal density or a high specific heat capacity so that it can be kept at or near the desired temperature for a relatively long period of time. The core material can be suitable for one or more of the following: repeated heating and repeated cooling. For example, if the lactation aid returns to room temperature / atmospheric temperature, it can be reheated or recooled. Therefore, the lactation aid can be reusable.

[0028] The core material can be a liquid or fluid. For example, the core material can be water, a saline solution, or a gel. In some embodiments, the core material can include propylene glycol, calcium chloride, magnesium sulfate, ammonium nitrate, or a combination thereof.

[0029] The lactation aid may be spherical. The shape of the lactation aid as defined by the outer surface of the outer layer may be substantially spherical, for example, shaped as a prolate spheroid, an oblate spheroid, or a sphere. However, in some embodiments, the lactation aid may not be substantially spherical or spherical. For example, it may have a substantially cylindrical shape, an elongated shape, an oval or egg-shaped shape, a regular or irregular shape, or other shapes. The inclusion of protrusions at the outer surface, although potentially irregular in nature, may not obscure the overall shape of the lactation aid. The shape of the lactation aid may make it particularly suitable for rolling on the breast.

[0030] The maximum diameter of the lactation aid as defined by the outer layer can be, for example, between about 20 mm and 60 mm, between about 40 mm and 60 mm, between about 45 mm and 55 mm, or about 45 mm, about 50 mm, or about 55 mm. Thus, the lactation aid can be relatively small, for example, its diameter can be similar to a standard golf ball (about 43 mm), but significantly smaller than a standard tennis ball (about 67 mm). For example, the size of the lactation aid can make it particularly suitable for rolling on the breast, and also suitable for application to hard-to-reach areas (such as mammalian folds). When performing other activities at the same time (such as holding a baby, breastfeeding, pumping, or showering, etc.), the relatively small size can reduce the risk of the lactation aid interfering with those activities.

[0031] The outer layer of the lactation aid may be soft and / or elastically flexible. The outer layer may be formed of silicone, rubber, polyethylene, nylon, thermoplastic polyamide, phthalate-free vinyl chloride or a combination thereof. The outer layer may have a Shore 00 hardness, for example, between 15 and 80, between 20 and 65, between 20 and 50 or between 2 and 40. The outer layer may have a hardness, for example, between Shore 00 of 20 and Shore A of 20. The outer layer may be relatively thin, for example, by having a thickness of less than 3 mm, less than 2 mm or less than 1 mm in depth.

[0032] The flexibility of the outer layer of the lactation aid and the choice of a core material such as a gel or other fluid / liquid can provide a "gel-like" property to the lactation aid. The entire lactation aid can be substantially soft and relatively easily compressed or deformed. The lactation aid can be considered "squishy" or "soft and squishy." The core material may not fill the cavity of the outer layer under high pressure. At room temperature, the core material can be substantially at atmospheric pressure. The core material can fill the cavity to a maximum diameter as defined by the natural shape and size of the outer layer without expanding the outer layer by stretching the outer layer.

[0033] In some embodiments, the elastic modulus of the lactation aid can substantially match the perceived / desired elastic modulus of the breast / breast tissue. For example, the elastic modulus of the lactation aid can be between 0.5 kPa (lower levels for adipose tissue) and 3,000 kPa (higher levels for skin). For example, the elastic modulus of the lactation aid can be less than 3,000 kPa, less than 2,500 kPa, less than 1,000 kPa, less than 500 kPa, less than 100 kPa, less than 50 kPa, less than 25 kPa, less than 10 kPa, or other values.

[0034] In some embodiments, the stiffness of the outer layer can vary, and in addition to the properties of the core material, this can allow the lactation aid to have a "maximum pressure" that it can apply to the breast tissue no matter how hard the ball is pressed against the tissue by allowing for a relaxed expansion of the outer layer when the recognized maximum pressure is reached. This can be used to reduce the possibility of applying harmful pressure to the breast tissue.

[0035] In some methods of the present disclosure, an instrument version (or calibrated version) of the lactation aid can be used in conjunction with a therapeutic version to measure breast tissue compliance and guide the proper selection of parameters for outer layer, core material, and temperature settings, as described herein. This instrument version can be reusable and covered by a sanitary cover for use in a commercial or clinical setting.

[0036] In some embodiments, the core material may have variable elastic properties. These non-linear properties may be thixotropic (to achieve a softening and broadening of the force applied to the breast, where excessive force may be painful or harmful - this is similar to the material properties of toothpaste, for example); non-Newtonian, where increasing applied deformation serves to stiffen the material (much as cornmeal and water behave) and in this way can "boost" or increase the effective applied force (much as may be needed to eliminate a blockage); or a combination of these properties, where the material behaves elastically and then becomes either thixotropic or non-Newtonian or both at different application rates.

[0037] The core material may be thermoplastic and thus may be set to different elasticities at different temperatures. This accounts for the fact that different breasts have different moduli; that there may be regions of variable stiffness within any one breast; and that there may be various disease states and normal physiological changes (which occur during lactation) that require different therapeutic elasticities. These different elastic states may be represented by different temperature measurement properties, which may be observable with the aid of a temperature indicator / color change, as discussed further below.

[0038] In some embodiments, the lactation aid may further include a vibrating element configured to vibrate at least the outer layer.

[0039] In some embodiments, the lactation aid may include a temperature indicator suitable for indicating the temperature of all or part of the lactation aid. The temperature indicator may form part of the outer layer or be located in the cavity, for example by forming part of the core material. The outer layer of the lactation aid may be at least partially transparent, and the temperature indicator may be at least partially visible through the outer layer. The temperature indicator may include a thermochromic substance that can change temperature, such as a thermochromic dye. The dye may be selected to change color at a threshold temperature. At temperatures above the threshold temperature, breast tissue discomfort and / or damage to breast tissue may occur. The threshold temperature may, for example, be between 60°C and 85°C.

[0040] In one aspect of the present disclosure, there is provided a lactation device comprising: a lactation aid; and a handle, the lactation aid being rollably mounted to the handle. A passage may extend at least partially through the lactation aid, and at least a portion of the handle may extend into the passage, but other mounting arrangements are possible. The lactation aid may be removably mounted to the handle so that the lactation aid may be heated or cooled when removed from the handle.

[0041] As described herein, lactation aids may be provided with hot / cold massage and compression capabilities that are manually applied directly to the breasts of lactating women (including women who are or may soon be breastfeeding, pumping breast milk, and / or expressing breast milk) and are designed to assist lactation in a variety of ways. Key applications and benefits of lactation aids include, for example, the ability to: stimulate / reduce milk production (as desired); and / or assist in unclogging milk ducts; and / or reduce and relieve symptoms of mastitis.

[0042] Although lactation aids are primarily intended for use with respect to lactation, lactation aids may also help prevent and alleviate other breast-related problems (including lymphedema). Lactation aids have the ability to assist lactation due to: the quality and physical design of the lactation aid (including, for example, the protrusions (which may be spikes / ridges / bumps) of the lactation aid; and / or the heat / cool capabilities of the lactation aid; and / or the manual application of the lactation aid directly to the breast (including massage and / or compression, which may be achieved by moving the lactation aid over the breast); and / or the ability of the lactation aid to provide one or more of the above benefits while breastfeeding / expressing / pumping breast milk.

[0043] Lactation aids have the potential to achieve the uses / benefits of all of these factors simultaneously, which can cumulatively enhance the benefits and effects.

[0044] Throughout the present specification, the word "comprise" or variations such as "comprises" or "comprising" will be understood to imply the inclusion of stated elements, integers or steps, or groups of elements, integers or steps but not the exclusion of any other elements, integers or steps, or groups of elements, integers or steps. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Embodiments will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0046] Figure 1 is a front view of a lactation aid according to one embodiment of the present disclosure;

[0047] Figure 2 yes Figure 1 A front view of a diameter cross section of a lactation aid;

[0048] Figure 3 Is applied to the breast Figure 1 illustrative views of a lactation aid according to the method of the present disclosure;

[0049] Figure 4 is Figure 3 An illustrative view showing a process of heating a lactation aid prior to applying the lactation aid to a breast;

[0050] Figure 5 is a front view of a lactation apparatus according to one embodiment of the present disclosure;

[0051] Figure 6 is a front view of a lactation aid according to one embodiment of the present disclosure;

[0052] Figure 7 yes Figure 6 A front view of a cross-sectional diameter of a lactation aid; and

[0053] Figure 8 is another front view of a lactation aid according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0054] Figure 1 and Figure 2 A front view and a cross-sectional view of a lactation aid 10 according to an embodiment of the present disclosure are shown. The lactation aid 10 includes an outer layer 12 having an outer surface 13 and defining a cavity 16. A core material 15 (and more specifically, a gel in this embodiment) is located in the cavity 16. The core material 15 is suitable for one or more of: heating and cooling.

[0055] In this embodiment, the outer layer 12 seals the cavity 16 so that the core material 15 is securely and permanently contained therein. In addition, a plurality of protrusions 14 are provided at the outer surface of the outer layer 12. In this embodiment, the protrusions 14 are shown as protrusions, but may generally be spikes, ridges, protrusions, or a combination thereof. The protrusions 14 extend radially outward from the outer surface 13 of the outer layer 12. In this embodiment, the protrusions are integrally formed with the outer layer 12, are circular, and are evenly distributed across the outer surface 13.

[0056] In this embodiment, the lactation aid 10 is spherical. The spherical shape of the lactation aid is defined by the outer surface 13 of the outer layer. The inclusion of protrusions on the outer surface, although irregular in nature, does not obscure the overall spherical shape of the lactation aid.

[0057] exist Figure 3 , a method of using a lactation aid 10 according to an embodiment of the present disclosure is shown. The lactation aid 10 is applied to the breast 101 by the user pressing the lactation aid 10 between the surface 102 of the breast 101 and the user's hand 103. The user rolls the lactation aid 10 on the surface of the breast 101 in one or more random directions and / or different directions as desired. The user may also press, twist, or rub the lactation aid 10 against the breast 101 if desired or necessary.

[0058] In this embodiment, the user places the core material 15 in a heated state before applying the lactation aid 10 to the breast 101 (although in alternative embodiments, the user may place the core material 15 in a cooled state, and further, use of lactation at room temperature is not excluded). For example, the user may heat the core material 15 by using an electric heating device (such as Figure 4 The microwave oven 104 is shown to heat the core material 15 to a desired temperature.

[0059] When the lactation aid 10 is applied to the breast 101, heat can be transferred to or from the breast tissue, lateral motion can be applied to the breast tissue, and compression can be applied to the breast tissue. Thus, the lactation aid 10 can combine three key therapeutic components: (i) applying temperature (heating or cooling) to the breast tissue; (ii) applying motion to the breast tissue; and (iii) applying compression to the breast tissue. As a result, the lactation aid 10 can be used, for example, to stimulate milk production and flow, assist with the let-down reflex; help unclog blocked milk ducts; help resolve excessive milk secretion and engorgement; reduce swelling and pain associated with breastfeeding or lactation; help fight infection and prevent escalation of breast swelling (assisting milk ducts to open and flow); and / or improve the quality of milk by increasing total solids, lipid and casein concentrations, and total energy.

[0060] refer to Figure 5 , provides a lactation device according to an embodiment of the present disclosure, wherein a lactation aid 20 is mounted to a handle 30. The lactation aid 20 is rollably mounted to the handle 30. The lactation aid 20 is similar to the above reference Figures 1 to 4 The lactation aid 10 described is substantially the same, except that the passage 21 extends through the lactation aid 20 approximately across the central diameter of the lactation aid 20. The handle 30 includes a grip portion 31 and two opposing arms 32a, 32b extending distally from the grip portion 31. The arms 32a, 32b are elastically flexible and are configured so that they can be pried apart from each other. When pried apart, the ends of the arms 32a, 32b can be inserted into the opposite ends of the passage 21 to enable the lactation aid 20 to be rolled onto the handle 30 or to be removed from the handle 30. The lactation aid 20 can be removed from the handle for heating or cooling or other purposes. When in use, instead of directly pressing the lactation aid 20 between the user's hand and the breast, the user can hold the handle 30 to manually apply / roll the lactation aid 20 on the breast.

[0061] refer to Figures 6 to 8 , a lactation aid 40 according to another embodiment of the present disclosure is now described. The lactation aid 40 also includes an outer layer 42 having an outer surface 43 and defining a cavity 46. A core material 45 is located in the cavity 46. The core material 45 is suitable for performing one or more of the following: heating and cooling. In addition, a plurality of protrusions 14 are also provided at the outer surface 43 of the outer layer 42. In this embodiment, the protrusions 44 are shown as protrusions, but may generally be spurs, ridges, protrusions, or a combination thereof. The protrusions 44 extend radially outward from the outer surface 43 of the outer layer 42. In this embodiment, the protrusions are integrally formed with the outer layer 42, are circular, and are distributed across the outer surface 13.

[0062] In this embodiment, the cavity 46 is filled with the core material 45 through an opening 47 in the outer layer 42. The opening 47 is provided at the bottom end of a recess 48 in the outer layer and is sealed using a plug 49.

[0063] In this embodiment, if Figure 7 As can be seen, the protrusions 44 are hollow. The cavity 46 defined by the outer layer 42 reaches into the protrusions 44, and the core material 45 therefore extends into the protrusions 44. The hollow protrusions 44 enable the heated or cooled core material 45 to be closer to the breast tissue during use, rather than being separated from the breast tissue by the height of the protrusions. Moreover, at least in this embodiment, the hollow protrusions enable the outer layer 42 to have substantially the same thickness around its entire circumference, even at locations where the protrusions 44 are provided. In this way, the outer layer 42 as a whole has relatively uniform flexibility and / or compressibility.

[0064] In this embodiment, the maximum diameter D of the lactation aid 40 as defined by the outer layer 12 is about 50 mm, which is similar in size to a standard golf ball.

[0065] In this embodiment, outer layer 42 is formed by different parts with different configurations. Different parts are specifically first half 42a and second half 42b of outer layer 42. First half 42a includes first subgroup 44a of projection, and second half 42b includes second subgroup 44b of projection. Projection 44b of first subgroup has first height separately, and projection 44b of second subgroup has second height different from first height separately. In this embodiment, projection 44a of first subgroup 44a has height h1 of about 2mm separately, and projection of second subgroup has height h2 of about 4mm separately. Projection 44,44a,44b can have height of at least 1mm, at least 2mm or at least 3mm. Projection 44,44a,44b can have height less than 10mm, less than 8mm or less than 6mm. In this embodiment, height difference Δh (h2-h1) is, for example, about 0.5mm, 1mm or 1.5mm.

[0066] In some embodiments, in addition to or as an alternative to having projections 44, 44a, 44b with different configurations, different portions 42a, 42b of the outer layer 42 can be formed of materials having different properties (e.g., hardness properties). By providing configurations and / or properties to different portions, the lactation aid 40 can provide different therapeutic benefits; different portions can provide different temperature, motion, and / or compression characteristics. Different benefits 40 can be experienced during a single use of the lactation aid 40, for example, by rolling different portions 42a, 42b successively on the breast, or by selectively experiencing different benefits by applying only one or a selected group of portions to the breast instead of one or more other portions.

[0067] In this embodiment, the first half 42a and the second half 42b are formed separately and joined together at the joining area 42c to form the outer layer 42 and the cavity 46. However, in alternative embodiments, the halves 42a, 42b may be integrally formed.

[0068] In this embodiment, the lactation aid 40 includes a temperature indicator that is suitable for indicating the temperature of all or part of the lactation aid. The temperature indicator is provided by a thermochromic dye mixed into the core material 45. The outer layer 42 is at least partially transparent so that the user can see the color change of the thermochromic dye within the cavity 46. The dye can be selected to change color at a threshold temperature. At temperatures above the threshold temperature, breast tissue discomfort and / or damage to breast tissue may occur. The threshold temperature can be, for example, between 60°C and 85°C. In alternative embodiments, the temperature indicator can be provided on the outer surface or other location of the lactation aid.

[0069] Although not shown, in some embodiments, the lactation aid may further include a vibrating element configured to vibrate at least the outer layer.

[0070] shape

[0071] The shape of the lactation aid according to the present disclosure affects the surface area of ​​the lactation aid in contact with the breast, which in turn affects the resulting pressure on the breast. In addition, the shape affects the maneuverability of the lactation aid. It should be possible to roll the lactation aid in random and different directions on different areas of the breast (including near the armpit and on lumps, etc.) as needed.

[0072] The shape of the lactation aid 10, 20, 40 as described in the previous embodiments is an irregular spherical or spherical shape. However, other rollable shapes can be used. The lactation aid can be spherical. The lactation aid can be substantially spherical, for example, shaped as a prolate spheroid, an oblate spheroid or a sphere. The lactation aid can be substantially cylindrical, elongated, oval or egg-shaped, regular or irregular, or other shapes.

[0073] Some shapes may be better suited for different areas or purposes of a lactation aid. For example, a cylindrical shape may be better suited to encourage milk to flow from the top of the breast to the nipple. For example, an oval shape may be better suited to reaching under the breast or under the arm.

[0074] size

[0075] The lactation aid may be of a size that enables it to be easily handled. In fact, it is intended that the application of the lactation aid to the breast is simple, especially for hard-to-reach areas, and it is also expected that it can often be applied in conjunction with other activities (holding a baby, breastfeeding, pumping, showering, etc.).

[0076] Preferably, the lactation aid should be able to fit comfortably in a typical female adult hand. However, ideally, it is large enough to be easily manipulated, apply a practical amount of pressure on the breast tissue, and cover the breast tissue in a reasonable time frame. The amount of surface area of ​​the lactation aid that contacts the breast will also affect the amount of breast tissue that can be acted upon in a certain time frame.

[0077] Thus, at a basic level, the lactation aid can be smaller than a tennis ball but larger than a marble to ensure appropriate maneuverability, pressure application, and area coverage. For example, the maximum diameter of the lactation aids, as defined by their outer layers, can be, for example, between about 20 mm and 60 mm, between about 40 mm and 60 mm, between about 45 mm and 55 mm, or about 45 mm, about 50 mm, or about 55 mm. As described above, the diameter of the lactation aid can be more similar to a standard golf ball (about 43 mm) than a standard tennis ball (about 67 mm).

[0078] Due to its size, the lactation aid may advantageously be compact and lightweight, enabling it to be easily portable and easily stored.

[0079] The size and shape of the lactation aid together may mean that, unlike a static nursing garment or heating pack, the lactation aid is adapted to fit all breast sizes and shapes. However, it is envisaged that a user may be provided with and select a lactation aid of a different size and / or shape.

[0080] Material

[0081] The outer layer of the lactation aid 10, 20, 40 may include a soft elastomeric material. The outer layer may include silicone, rubber, polyethylene, nylon, thermoplastic polyamide, phthalate-free vinyl chloride, or a combination thereof.

[0082] The outer layer may be thermally conductive such that it may be directly cooled or heated, at least in part, by the same process as the core material and / or such that heat is transferred from or lost to the core material.

[0083] The outer layer of the lactation aid may be formed of a waterproof material. Thus, the lactation aid may be waterproof / watertight. Thus, the lactation aid may be heated or cooled in a liquid and may be easily washed or sterilized, such as by high temperature or chemical sterilization.

[0084] In addition, the waterproof configuration can also be used in the bath or shower and can be used in combination with a cream, water-based gel or oil. Using a cream, gel or oil in combination with a lactation aid can mimic the feeling of a baby's mouth, which can improve the let-down reflex.

[0085] The core material can be a liquid or fluid suitable for heating / cooling or reheating / cooling. The core material can have a relatively high thermal density or a high specific heat capacity so that it can remain at or near the desired temperature over a relatively long period of time. For example, the core material can be water, a saline solution, or a gel as described above. In some embodiments, the core material can include propylene glycol, calcium chloride, magnesium sulfate, ammonium nitrate, or a combination thereof.

[0086] The thickness of the outer layer depends on the choice of material and its ability to accommodate the gel inner core. Typically, the outer layer can be relatively thin, for example by having a thickness of less than 3 mm, less than 2 mm or less than 1 mm in depth.

[0087] Advantageously, the lactation aid may require no power or assembly by the user and may not have any mechanical, electrical and / or replacing parts.

[0088] hardness

[0089] The hardness of the lactation aid 10, 20, 40 may affect its performance. It is desirable that the hardness of the lactation aid is within a specific range. If the lactation aid is too soft (e.g., a sponge), it is unlikely that there will be a noticeable effect on the breast tissue. If the lactation aid is too hard (e.g., a cricket ball), the lactation aid may cause damage to the breast tissue.

[0090] The outer layer may have a Shore 00 hardness of, for example, between 15 and 80, between 20 and 65, between 20 and 50, or between 2 and 40. The outer layer may have a hardness of, for example, between Shore 00 of 20 and Shore A of 20. The outer layer may be relatively thin, for example less than 3 mm, less than 2 mm, or less than 1 mm in depth. The flexibility of the outer layer of the lactation aid and the choice of the core material may provide the lactation aid with a 'jelly-like' quality.

[0091] The lactation aids 10, 20, 40 may be substantially soft and relatively easily compressed or deformed. Each lactation aid may be considered "jelly-like," "squishy," or "soft and crushable," particularly by using, for example, a flexible polymer outer layer and a liquid or gel core material. The core material may not fill the cavity of the outer layer under high pressure. At room temperature, the core material may be substantially at atmospheric pressure. The core material may not expand the outer layer by stretching the outer layer, but rather fill the cavity to a maximum fixed diameter as defined by the outer layer.

[0092] The elastic modulus of the lactation aid can substantially match the perceived / desired elastic modulus of the breast / breast tissue. For example, the elastic modulus of the lactation aid can be between 0.5 kPa and 3,000 kPa. For example, the elastic modulus of the lactation aid can be less than 3,000 kPa, less than 2,500 kPa, less than 1,000 kPa, less than 500 kPa, less than 100 kPa, less than 50 kPa, less than 25 kPa, less than 10 kPa, or other values.

[0093] The stiffness of the outer layer can be varied, and in addition to the properties of the core material, this can allow the lactation aid to have a "maximum pressure" that it can exert on the breast tissue no matter how hard the ball is pressed against the tissue, by allowing the outer layer to relax and expand when the recognized maximum pressure is reached. This can be used to reduce the possibility of applying harmful pressure to the breast tissue.

[0094] The core material may have variable elastic properties. These non-linear properties may be thixotropic (to achieve a softening and broadening of the force applied to the breast, where excessive force may be painful or harmful - this is similar to the material properties of toothpaste, for example); non-Newtonian, where increasing applied deformation serves to stiffen the material (much as cornmeal and water behave) and in this way can "boost" or increase the effective applied force (much as may be needed to remove a blockage); or a combination of these properties, where the material behaves elastically and then becomes either thixotropic or non-Newtonian or both at different application rates.

[0095] The core material may be thermoplastic and therefore may be set to different elasticities at different temperatures. This accounts for the fact that different breasts have different moduli; that there may be regions of variable stiffness within any one breast; and that there may be various disease states and normal physiological changes (which occur during lactation) that require different therapeutic elasticities. These different elastic states may be represented by different temperature measurement properties, which may be observable with the aid of a temperature indicator / color change.

[0096] Protrusion

[0097] The plurality of protrusions at the outer surface of the outer layer of the lactation aid 10, 20, 40 may be in the form of rounded spikes or flatter protrusions or a combination thereof. The protrusions may not be so sharp that they may damage breast tissue, but are sharp enough to effectively reach deep enough in the breast tissue to transmit temperature and pressure to the milk ducts.

[0098] The shape and size of the protrusions, their thickness and arrangement may vary, and the illustrations are merely examples.

[0099] temperature

[0100] When the lactation aid 10, 20, 40 is applied to the breast, the desired heat or cold can actually be transferred from the core material to the breast tissue.

[0101] The core material may be heated to a desired treatment temperature substantially above the ambient room temperature or atmospheric temperature, for example, at least 5°C, at least 10°C, at least 15°C, at least 20°C, at least 30°C, at least 40°C, at least 50°C, or at least 60°C above the ambient room temperature or atmospheric temperature. For example, the core material may be heated to a desired temperature of at least 25°C, at least 30°C, at least 35°C, at least 40°C, at least 50°C, at least 60°C, at least 70°C, or at least 80°C. As another example, the core material may be cooled to a desired treatment temperature substantially below the ambient room temperature or atmospheric temperature, for example, at least 5°C, at least 10°C, at least 15°C, or at least 20°C below the ambient room temperature or atmospheric temperature. For example, the core material may be cooled to a desired temperature of less than 15°C, less than 10°C, less than 5°C, or less than 0°C. In some embodiments, the core material may be frozen. However, the use of the lactation aid when the core material is at room temperature is not excluded.

[0102] In some embodiments, heat / cold can be delivered to deeper locations in the breast tissue through the protrusions (including by using hollow protrusions). This can enable temperature to be delivered more effectively and directly to the mammary glands, milk ducts, milk plugs, and the lymphatic system.

[0103] Heating the core material to a desired temperature may include heating using an electrical heating device (such as a microwave or other type of oven), heating by immersion in a hot fluid such as hot water, or otherwise. Cooling the core material to a desired temperature may include cooling using an electrical refrigeration device (e.g., placing the aid in a refrigerator or freezer), cooling by immersion in a cold fluid such as cold water, or otherwise. However, in some embodiments, the core material may have "instant" heating or cooling properties. For example, the lactation aid may be configured so that an exothermic or endothermic reaction can be triggered to cause instant heating or instant cooling of the core material. In this regard, the lactation aid may include a core material and / or additional triggering elements common to "instant heating bags" or "instant cooling bags" known in the art.

[0104] In some embodiments, the lactation aid can be used with a customized heating or cooling device that can have a chamber specifically designed to receive the lactation aid. The chamber can be surrounded by a wall of high thermal density that can maintain the heated or cooled state for a long period of time. The lactation aid can be repeatedly placed in the chamber to reheat or recool.

[0105] Heated lactation aids can be applied to breast tissue to help relieve pain, eliminate or reduce blockages in milk ducts, and promote milk secretion. Heat also improves blood flow to the tissue, which can aid in milk secretion and also helps the immune system fight local infections. Heat can also be used to prevent or treat Raynaud's phenomenon (vasospasm) of the nipple.

[0106] For lactating women, it may be desirable to apply heat prior to breastfeeding or expressing milk and to continue applying heat to the breast tissue while breastfeeding or expressing milk. It may then be desirable to use cold therapy for milk reabsorption and to reduce swelling and pain.

[0107] Oppression and movement

[0108] The lactation aid 10, 20, 40 is manually applied to the skin of the breast, which selectively compresses the breast tissue as needed. Alternatively, the lactation aid can be used over clothing or garments (such as maternity bras). The user can apply increased pressure by hand as needed to increase localized pressure to desired areas of the breast.

[0109] Localized pressure mimics hand massage or infant breastfeeding and provides physical stimulation for the let-down reflex. In addition, localized pressure assists the smooth muscle tissue in moving milk from the mammary gland through the milk ducts to the nipple. Localized pressure can also reduce or eliminate blockages in the milk ducts and promote blood circulation and fluid flow in the desired area.

[0110] The multiple protrusions apply additional pressure and reach deeper into the breast tissue closer to the milk ducts.

[0111] The lactation aid may be applied to the desired area in a random or patterned manner. Preferably, milk flow is encouraged to the nipple. This may include deep rhythmic "kneading", rolling or comb-like dragging motions toward the nipple, or concentric circular motions toward the nipple or over the affected area. Rhythm, rate, and pressure may be varied as desired.

[0112] The compression provided by the lactation aid helps move the hindmilk, which has lots of fat globules, toward the nipple, which is important for infant nutrition.

[0113] Combined Effect

[0114] The lactation aid 10, 20, 40 can promote lactation in a number of ways. First, the lactation aid can improve the let-down reflex. The lactation aid achieves this by tactile stimulation of the breast tissue and mimicking the movement, temperature, and feel of a baby's breastfeeding. The let-down reflex is also improved when a lactating woman relaxes. Application of the lactation aid can also help relax the user. Physical and visual contact with the baby also helps the let-down reflex, so the property of being able to apply the device with one hand is ideal if the user is also holding the baby.

[0115] The combined application of heat and manual compression can increase milk flow to the nipple and also aid in the movement of milk clots and bulk fat globules.

[0116] Such application may increase the volume and quality of milk, such as the concentration of solids, lipids, casein and total energy.

[0117] Using a lactation aid on breast tissue may help revitalize the skin and improve breast skin tone. Lactation aids may be used in conjunction with creams, gels, or oils known to help skin tone and / or reduce the visibility of stretch marks.

Claims

1. A lactation aid, comprising: an outer layer defining a generally spherical cavity, the outer layer being formed of a soft elastomeric material having a Shore 00 hardness of between 15 and 80, wherein the outer layer comprises a plurality of protrusions extending radially outward from an outer surface of the outer layer, the plurality of protrusions comprising: a first subset of protrusions each having a first height and a second subset of protrusions each having a second height different from the first height, wherein one or more of the plurality of protrusions are hollow and the remaining protrusions are non-hollow; and a core material that fills the entire cavity and contacts the inner surface of the outer layer, the core material being a liquid or gel and being substantially at atmospheric pressure when at room temperature, the core material being suitable for one or more of: heating and cooling, wherein the core material at least partially extends into the hollow protrusion, The lactation aid is a single spherical device. wherein the lactation aid is adapted to be manually rolled over the breast, and The soft outer layer and the liquid or gel core material provide the lactation aid with a jelly-like property, the stiffness of the outer layer is variable, and the relaxation and expansion of the outer layer is allowed so that the lactation aid has a maximum pressure that can be applied to the breast tissue.

2. The lactation aid of claim 1, wherein the plurality of protrusions are spikes, ridges, or a combination thereof.

3. The lactation aid of claim 1, wherein the plurality of protrusions are integrally formed with the outer surface of the outer layer.

4. A lactation aid as claimed in claim 1, wherein the outer layer has substantially the same thickness in the area where the protrusions are formed and in the area where there are no protrusions.

5. The lactation aid of claim 1, wherein the protrusion has: a height of at least 1 mm, at least 2 mm or at least 3 mm; and / or Less than 10 mm, less than 8 mm or less than 6 mm in height.

6. The lactation aid of claim 1, wherein the difference between the first height and the second height is at least 0.5 mm, at least 1 mm, or at least 1.5 mm.

7. A lactation aid as claimed in claim 1, wherein the first subset of protrusions is distributed at a first portion of the outer layer and the second subset of protrusions is distributed at a second portion of the outer layer.

8. A lactation aid as claimed in claim 7, wherein the first part and the second part are formed separately and connected together to form the cavity.

9. The lactation aid of claim 7, wherein the first portion and the second portion are first and second halves of the outer layer, respectively.

10. A lactation aid as claimed in any one of the preceding claims 1 to 9, wherein the core material is suitable for heating to at least 50°C.

11. A lactation aid as claimed in any one of the preceding claims 1 to 9, wherein the core material is suitable for cooling to 5°C or below.

12. A lactation aid as claimed in any one of the preceding claims 1 to 9, wherein the core material is suitable for at least one of: repeated heating and repeated cooling.

13. A lactation aid as claimed in any one of the preceding claims 1 to 9, wherein the core material comprises water, gel, salt or a combination thereof.

14. A lactation aid as claimed in any one of the preceding claims 1 to 9, wherein the core material comprises propylene glycol, calcium chloride, magnesium sulphate, ammonium nitrate or a combination thereof.

15. A lactation aid as claimed in any one of the preceding claims 1 to 9, wherein the shape of the lactation aid as defined by the outer surface of the outer layer is substantially spherical.

16. The lactation aid according to any one of the preceding claims 1 to 9, wherein the maximum diameter of the lactation aid as defined by the outer layer is between 20 mm and 60 mm.

17. The lactation aid of any one of the preceding claims 1 to 9, wherein the maximum diameter of the lactation aid as defined by the outer layer is between 45 mm and 55 mm.

18. The lactation aid according to any one of the preceding claims 1 to 9, wherein the diameter of the lactation aid as defined by the outer layer is 50 mm.

19. A lactation aid as claimed in any one of the preceding claims 1 to 9, wherein the outer layer is formed from silicone, rubber, polyethylene, nylon, thermoplastic polyamide, phthalate-free vinyl chloride or a combination thereof.

20. A lactation aid as claimed in any one of the preceding claims 1 to 9, wherein the outer layer has a Shore 00 hardness of between 20 and 65.

21. A lactation aid as claimed in any one of the preceding claims 1 to 9, wherein the outer layer has a hardness between 20 Shore 00 and 20 Shore A.

22. The lactation aid of any one of the preceding claims 1 to 9, wherein the elastic modulus of the lactation aid is between 0.5 kPa and 3,000 kPa.

23. A lactation aid according to any one of claims 1 to 9, comprising: A temperature indicator adapted to indicate the temperature of all or part of a lactation aid.

24. A lactation aid as claimed in claim 23, wherein the temperature indicator is located in the cavity.

25. A lactation aid as claimed in claim 24, wherein the temperature indicating agent forms part of the core material.

26. A lactation aid as claimed in claim 24, wherein the outer layer is transparent and the temperature indicating agent is at least partially visible through the outer layer.

27. The lactation aid of claim 23, wherein the temperature indicating agent is a thermochromic substance.

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