A breast pump is a mechanical device that lactating women use to extract milk from one or both of their breasts. Reasons that a woman would use a breast pump include periodically being separated from, and needing another person to feed breast milk to, her breastfeeding infant at feeding time (e.g., while the woman is at work), maintaining or increasing her breast-milk production, and building a reserve supply of breast milk for use when her breasts do not produce enough breast milk for her infant at feeding time. Additionally, many women use breast pumps to donate breastmilk to others in need, for example, to mothers who cannot breastfeed their children.
A breast pump can be a manual device powered from hand or foot movements or an electric device powered from batteries or from electricity via a power outlet. An electric breast pump includes a fluid pump that is powered by a motor to generate, produce, provide, or supply a suction through plastic tubing to a flange that fits over the nipple of a woman's breast. In more detail, the pump achieves a letdown of breast milk by using suction to pull the nipple into the tunnel of a breast shield or flange during a high-suction portion of a milking cycle, and then by releasing the suction, and, therefore, the nipple, during a low-suction portion of the milking cycle; the pump is configured to cycle the high-suction and low-suction portions in a manner that mimics the suckling of an infant. This high-to-low-and-low-to-high suction milking cycle is repeated, for example, approximately 30-60 times per minute, or approximately one time every 1-2 seconds.
The portions of the breast-pump that come into direct contact with the expressed milk and nipple typically must be cleaned after every use to prevent contamination of breastmilk pumped during a subsequent breast-milk pumping session.
For example, the Center for Disease Control (CDC) issued guidelines in 2017 for how to wash such breast-pump components. The process includes using a separate, dedicated wash basin, warm soapy water, sterile drying towels, and sanitizing the components at least once daily (e.g., in a boiling water bath).
It follows, therefore, that lactating mothers in the workplace and elsewhere would save time, would reduce the risk of contaminating their breast milk, and, therefore, would reduce the risk of their breast-feeding infants becoming ill due to contaminated breast milk, if there were a breast-milk collection system that required little or no clean-up yet ensured a sterile collection of breast milk every time.
Therefore, a need exists for a partially or fully disposable single-use breastmilk-collection assembly that requires no washing of the assembly components or parts of the breast pump before or after pumping breast milk.
The details of one or more embodiments are set forth in the description below. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Thus, any of the various embodiments described herein can be combined to provide further embodiments. Aspects of the embodiments can be modified, if necessary to employ concepts of the various patents, applications and publications as identified herein to provide yet further embodiments.
In one embodiment, a breastmilk-extraction-assembly kit is provided. The kit includes a flange configured to collapse for packaging, to expand in response to being unpackaged, and to form a seal with a human breast while expanded; a hub having an output port and configured for coupling to the flange; and a check valve configured to allow breastmilk to flow out of the hub through the output port during a low-suction portion of a pump cycle, and to impede breastmilk from flowing out of the hub through the output port during a high-suction portion of the pump cycle.
Exemplary features of the present disclosure, its nature and various advantages will be apparent from the accompanying drawings and the following detailed description of various embodiments. Non-limiting and non-exhaustive embodiments are described with reference to the accompanying drawings, wherein like labels or reference numbers refer to like parts throughout the various views unless otherwise specified. The sizes and relative positions of elements in the drawings are not necessarily drawn to scale. For example, the shapes of various elements are selected, enlarged, and positioned to improve drawing legibility. The particular shapes of the elements as drawn have been selected for ease of recognition in the drawings. One or more embodiments are described hereinafter with reference to the accompanying drawings as briefly described below, in which:
In accordance with common practice, the various described features are not drawn to scale but are drawn to emphasize specific features relevant to the exemplary embodiments.
In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which is shown by way of illustration specific illustrative embodiments. However, it is to be understood that other embodiments may be utilized and that logical, mechanical, and electrical changes may be made. Furthermore, the method presented in the drawing figures and the specification is not to be construed as limiting the order in which the individual steps may be performed. The following detailed description is, therefore, not to be taken in a limiting sense.
Conventional breast-pump assemblies typically require the user to clean (and sometimes even to sterilize) multiple reusable pump components after each use. The recommendations issued by the Center for Disease Control for cleaning breast-pump components are often laborious (e.g., sterilizing by immersing components in boiling water) even in the home, and are also often impractical outside the home.
Consequently, an embodiment of a breastmilk collection device disclosed herein allows lactating women to pump breast milk with no need to wash reusable pump components. This can be a major convenience, especially in workplaces, restaurants, sports venues, and other public locations where the facilities for breast pumping are inadequate (if they even exist at all). The breastmilk collection device provides for sterile pump components every use without the inconvenience of washing or sterilizing components, and potentially with a reduced risk of bacterial and other contamination of expressed milk as compared to conventional breast-milk collection devices. An embodiment of the breast-milk collection device can provide a reduced risk of contamination as compared to conventional breast-milk collection devices due to inadequate cleaning and sterilization of such conventional collection devices. And such a reduced risk of contamination is a significant advance in breast-milk collection devices and systems because such contamination can be harmful or even fatal to infants.
Reusable vacuum tubing typically is a component of the user's own breast pump assembly and is used in conjunction with embodiments of a breastmilk-extraction system disclosed herein. However, an alternative embodiment of the breast pump kit comes with a length of vacuum tubing to be used in conjunction with the user's own breast pump assembly. Like the breastmilk-extraction device itself, the vacuum tubing can be disposed of after a single use, thus further reducing both the time needed to clean and prepare the user's breast-pump assembly while also reducing the risk of dangerous contaminants in reusable assemblies. Additionally, the breastmilk collection device can be compactly packaged and easily assembled and disassembled, which allows the user to easily carry one or multiple disposable devices at a time.
Although the embodiments described below illustrate a breastmilk collection device as applied to a human breast, the techniques described herein may apply to other mammalian breasts where applicable.
In some embodiments, the single-use breastmilk collection device 100 is used in conjunction with a breast pump that utilized vacuum tubing 104, according to an embodiment. The breastmilk collection device 100 attaches to the vacuum tubing 104 of a breast pump 106. The breastmilk collection device 100 is held over the nipple of the breast by the user's hand, or may be secured in place by a specially purposed brassiere or other hands-free device, such that the device forms a fluid-tight seal over the nipple of breast. After the pumping of breastmilk is completed, a container 108 is sealed with a screw closure or alternative closure (e.g., a snapping closure seal) and the upper portion of breastmilk collection device 100, including the check valve, hub, and flange, are disposed of in the garbage or recycled. The container 108 containing the extracted breastmilk can then be sealed and stored flat or upright for later use. When container 108 is filled with breastmilk it can be stored upright or, alternatively, the breastmilk can be transferred to another container for storage and container 108 can be disposed of in the garbage or recycling.
To disassemble the device (as shown in
The flange 302 is unique in that it is configured to be used once and then disposed of. The flange 302 is made from a flexible material, such as plastic, that can be collapsed before packaging to take up less space for packaging. In an embodiment, the flange 302 is made of flexible, clear polyvinyl chloride. The user (not shown in
Also, the components can be arranged within the enclosure 401 in a compact fashion to render the package to have a suitably small size for transport and storing as inventory, on a store shelf, and in a home.
In one embodiment, one dimension of the packaged kit 400 is approximately equal to the diameter of the flange 402 in a packaged (compressed) form. Additionally, or alternatively, another dimension of the packaged kit 400 is approximately equal to the width of the container 410. And the depth (thickness) of the packaged kit 400 can be about as thick as a widest thickness of the hub 404. Thus, in one embodiment, the dimensions of the packaged kit 400 are approximately 4.0 inches by 3.0 inches by 0.5 inches, and the volume of the packaged kit is about 6.0 cubic inches.
Achieving, for the packaged kit 400, dimensions that are suitably compact depends, at least in part, on the materials of the breast-milk-extraction-assembly components and how they are arranged in the packaging enclosure 401.
Still referring to
In some embodiments, the hub 404 can be positioned adjacent to the flange 402 in the packaging enclosure 401. A portion of flange 402 can rest over the hub 404 to increase the compactness of the packaging enclosure 401. Additionally, the hub 404 and flange 402 can rest on a container 410, which is flattened in packaging enclosure 401. The container 410 can also be folded one or more times while packaged. The female container screw cap 414 is also included in the packaging enclosure, where it can be positioned, for example, under a portion of the flange 402. Thus, in one embodiment, the conical portion of the flange 402 is positioned on top of the hub 404 and both the hub 404 and the flange 402 are positioned on top of the folded container 410 in the packaging 401. The female container screw cap 414 can also be positioned on top of the folded container 410 in the packaging 401. However, the components can be arranged in other ways as well.
Still referring to
Container 500 is made of a flexible material, e.g., a plastic or plastic polymer material, that is easily foldable without losing structural integrity. The male fitment 511 is fused with the container 500 to create a spouted plastic pouch. In an embodiment, the container 500 is unscrewed from the upper portion of the device (e.g., the hub and the check valve of
In some embodiments, the container 500 can include a perforated section, as shown in
Referring back to
The hub 604 also includes an interior baffle 620 that terminates just above the hub base, which deflects the extracted breastmilk and directs it downward into the check valve 608. The hub 604 may include a plastic structural support 630 on the exterior of the vacuum chamber 632 for additional structural integrity to the vacuum chamber 632 and input port 605. The vacuum chamber 632 acts as a vent to equalize interior pressure within the container 610 with atmospheric pressure in order to prevent build-up of pressure within the container 610.
During a low-suction portion of the pump cycle, the breast pump 650 reduces the amount of suction through tubing 670 that is applied to hub 604, though even in this stage the breast pump 650 still creates sufficient suction to maintain the seal between the flange 602 and breast 601. In this phase, if there is any extracted breastmilk, then the extracted breastmilk can still flow through the hub 604 to the hub base, albeit perhaps at a slower flow rate. Once the breastmilk reaches the hub base it comes into contact with check valve 608. Check valve 608 is a one-way valve that allows the breastmilk to collect in the container 610, and also reduces or prevents the backflow of breastmilk up through the hub 604, particularly during the high suction portion of a pump cycle. When in the high suction portion of a pump cycle, the check valve 608 closes to maintain suction within the hub 604 and the flange 602. When suction is relaxed during the low-suction portion of the pump cycle, the breastmilk is able to flow downward through the check valve 608 and into the container 610. This high-low suction cycle is repeated, for example, approximately 30-60 times per minute, or approximately one time every 1-2 seconds, to stimulate a child's suckling. The user holds the device to the breast 601 (or the pump suction alone may be sufficient to maintain the flange 602 against the breast in both the high-suction and low-suction phases of the pump cycle) for the desired length of time, for example 5-20 minutes, or until a desired volume of milk has been expressed, for example, 6 fluid ounces.
As shown in
The cylindrical-shaped first portion 902 acts as a sleeve that fits snugly over the output port of the hub base. The duckbill-shaped second portion 904 includes an opening 906, in the form of a slit, which enables breastmilk to flow from the cylindrical-shaped first portion 902 out of the duckbill-shaped second portion 904 during a low-suction portion of a pumping cycle, and which prevents breastmilk form flowing out of the container and toward or into the breast pump during a high-suction portion of the pumping cycle.
Other mechanical vacuum or gravity regulated one-way valves may be used in alternative embodiments of the check valve, such as that described in
During operation of the breastmilk collection device, breastmilk flows from the cylindrical-shaped first portion 1002 down to the elongated second portion 1004, which includes an output port 1005, and which the elongated second portion 1004 is further coupled to flap 1006. In some embodiments, the flap 1006 can have a length v of approximately 21.75 mm. During a high-suction portion of a pump cycle, a suction (e.g., a negative-pressure gradient) within the check valve 1000 causes the flap 1006 to press against the output port 1005 and create a seal, thereby preventing breastmilk from dripping out of outport port 1005 and into a container (as described above, breastmilk coating the sealing surfaces of the output port and the flap may enhance the seal formed by the check valve). When the pump cycle enters a low-suction portion (e.g., a lower negative pressure, zero pressure, or slightly positive pressure), the seal between the flap 1006 and the output port 1005 opens (even ever so slightly), thus enabling breastmilk to flow out of the check-valve output port 1005 and into the container.
The flap 1006 can be made out of a Silicon polymer or other Silicon-based material. In some embodiments the flap forms a teardrop shape as shown in
The terms “about” or “approximately” mean that the value or parameter specified may be somewhat altered, as long as the alteration does not result in nonconformance of the process or structure to the illustrated embodiment from the perspective of one having ordinary skill in the art. For instance, unless otherwise indicated, a numerical quantity modified by the term “approximately” can be altered to within ±20% of the specified value. Finally, the term “exemplary” merely indicates the accompanying description is used as an example, rather than implying an ideal, essential, or preferable feature of the invention.
Example 1 includes a breastmilk-extraction-assembly kit, comprising: a flange configured to collapse for packaging, to expand in response to being unpackaged, and to form a seal with a human breast while expanded; a hub having an output port and configured for coupling to the flange; and a check valve configured to allow breastmilk to flow out of the hub through the output port during a low-suction portion of a pump cycle, and to impede breastmilk from flowing out of the hub through the output port during a high-suction portion of the pump cycle.
Example 2 includes the kit of Example 1, comprising a container configured to couple to the hub, composed of a flexible material, and configurable to be flat.
Example 3 includes the kit of Example 2, wherein the container: is perforated around a perimeter of the container; and comprises a closing seal around the perimeter.
Example 4 includes the kit of any of Examples 2-3, wherein the container comprises measurement gradations etched along the perimeter.
Example 5 includes the kit of any of Examples 1-4, wherein the flange is composed of polyvinyl chloride.
Example 6 includes the kit of any of Examples 1-5, wherein the hub comprises: an interior baffle configured to deflect the breastmilk towards the check valve; a hub base configured to mechanically couple the hub to a container; and a vacuum chamber configured to equalize pressure inside and outside of the container.
Example 7 includes the kit of any of Examples 1-6, wherein the check valve comprises: a cylindrical-shaped portion configured to mechanically couple with the hub; and a duckbill-shaped portion configured to transfer the breastmilk to the container.
Example 8 includes the kit of any of Examples 1-7, wherein the check valve comprises: a cylindrical-shaped first portion configured to mechanically couple with the hub; and a second portion comprising: a second valve configured to receive the breastmilk from the cylindrical-shaped portion, and a flap coupled to the second valve and configured to: separate from the second valve during the low-suction portion of the pumping cycle, and seal with the second valve during the high-suction phase of the pumping cycle.
Example 9 includes the kit of any of Examples 1-8, wherein the check valve comprises a flexible Silicon-based material.
Example 10 includes a system, comprising: a flange configured to collapse for packaging, to expand in response to being unpackaged, and to form a seal with a breast while expanded; a hub configured for coupling to the flange to a container; and a check valve configured to allow breastmilk to flow from the hub to the container during a low-suction portion of a pump cycle, and to form a seal between the hub and the container during a high-suction portion of a pump cycle.
Example 11 includes the system of Example 10, comprising a breast pump coupled to the hub and configured: to produce increased suction to the flange during the high-suction portion of the pumping cycle; and to produce decreased suction to the flange during the low-suction portion of the pumping cycle.
Example 12 includes the system of any of Examples 10-11, further comprising: the container configured to couple to the hub; and wherein the container is composed of a flexible material and is configurable to be flat.
Example 13 includes the system of any of Examples 11-12, further comprising a tubing configured for connecting to the breast pump and the hub and to transfer suction between the breast pump and the hub.
Example 14 includes the system of any of Examples 10-13, wherein the container is perforated around a perimeter of the container, and wherein the container comprises an interlocking closure seal around the perimeter.
Example 15 includes a packaged breastmilk-extraction assembly, comprising: a package; a collapsed flange disposed in the package, configured to expand in response to being unpackaged, and configured to form a seal with a human breast while expanded; a hub disposed in the package adjacent to the collapsed flange, the hub having an output port and configured for coupling to the flange; and a check valve disposed in the package, connected to the hub, and configured to allow breastmilk to flow out of the hub through the output port during a low-suction portion of a pump cycle, and to impede breastmilk from flowing out of the hub through the output port during a high-suction portion of the pump cycle.
Example 16 includes the packaged breastmilk-extraction assembly of Example 15, further comprising a container disposed in the package beneath the collapsed flange and the hub and configured to couple to the hub; and where the container is composed of a flexible material and is flat while enclosed in the packaging film, and is configured to expand in response to being unpackaged.
Example 17 includes the packaged breastmilk-extraction assembly of Example 16, wherein the container: is perforated around a perimeter of the container; and comprises an interlocking closing seal around the perimeter.
Example 18 includes the packaged breastmilk-extraction assembly of any of Examples 15-17, wherein a portion of the collapsed flange is placed over the hub.
Example 19 includes the packaged breastmilk-extraction assembly of any of Examples 15-18, wherein a dimension of the packaged breastmilk-extraction assembly is approximately equal to a diameter of the collapsed flange.
Example 20 includes the packaged breastmilk-extraction assembly of any of Examples 16-19, wherein a dimension of the packaged breastmilk-extraction assembly is approximately equal to a width of the container.
Example 21 includes the packaged breastmilk-extraction assembly of any of Examples 15-20, wherein a depth of the packaged breastmilk-extraction assembly is approximately equal to a depth of the hub.
Example 22 includes the packaged breastmilk-extraction assembly of any of Examples 15-21, wherein a length, width, and depth of the packaged breastmilk-extraction assembly are approximately 4 inches, 3 inches, and Example 0.5 inches, respectively.
Example 23 includes the packaged breastmilk-extraction assembly of any of Examples 15-22, wherein a volume of the packaged breastmilk-extraction assembly is approximately 6 cubic inches.
Example 24 includes a method, comprising: attaching a check valve to a hub, the check valve configured to allow breastmilk to flow out of the hub during an low-suction portion of a pump cycle, and to impede breastmilk from flowing out of the hub during a high-suction portion of the pump cycle; attaching the hub to a flattened container configured to expand; folding the flattened container; positioning a collapsed flange adjacent to the hub, the collapsed flange configured to expand in response to being unpackaged, and to form a seal with a human breast while expanded; and enclosing the check valve, hub, flattened container, and collapsed flange in a package.
Example 25 includes the method of Example 24, wherein positioning the collapsed flange adjacent to the hub comprises positioning the collapsed flange and the hub over the container.
Example 26 includes a method, comprising: forming a seal between a flange and a human breast, the flange being configured to collapse for packaging and to expand in response to being unpackaged; directing, to a hub coupled to the flange and having an output port, breast milk from the human breast during a high-suction portion of a pump cycle; transferring, to a container coupled to the hub, the breastmilk during a low-suction portion of a pump cycle, the container composed of a flexible material and configurable to be flat for packaging; and
Example 27 includes the method of Example 26, further comprising preventing breastmilk from re-entering the output port of the hub during a low-suction portion of the pump cycle.
Example 28 includes the method of any of Examples 26-27, further comprising disposing of the flange, hub, and check valve after transferring breastmilk to the container.
From the foregoing it will be appreciated that, although specific embodiments have been described herein for purposes of illustration, various modifications may be made without deviating from the spirit and scope of the disclosure. Furthermore, where an alternative is disclosed for a particular embodiment, this alternative may also apply to other embodiments even if not specifically stated. Moreover, one or more components of a described apparatus or system, or one or more steps of a described method, may have been omitted from the description for clarity or for another reason. In addition, one or more components of a described apparatus or system that have been included in the description may be omitted from the apparatus or system, and one or more steps of a described method that have been included in the description may be omitted from the method.
This Application claims priority from U.S. Provisional Patent Application Ser. No. 62/940,140 filed Nov. 25, 2019, entitled “SINGLE USE BREAST-MILK COLLECTION DEVICE AND RELATED SYSTEM AND METHOD”; the contents of which are hereby incorporated in its entirety.
Number | Date | Country | |
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62940140 | Nov 2019 | US |