System and method for extraction of infant ingestion fluid from the human mammary glands

Abstract

The system provides an efficient breast pump that extracts milk by applying negative pressure to both the breast shield and a flexible membrane surrounding the breast body. The flexible membrane forms a separate chamber, applying uniform compression to the breast tissue, aiding in complete milk extraction. This system utilizes multiple pressure modes, including continuous and intermittent negative pressure, which allows for customizable pumping settings for each chamber. The dual pressure mechanism accelerates the pumping process and ensures efficient milk removal. This system improves milk extraction efficiency while minimizing discomfort. Applications extend to breastfeeding mothers needing fast and complete milk removal.

Description

SYSTEM AND METHOD FOR EXTRACTION OF INFANT INGESTION FLUID FROM THE HUMAN MAMMARY GLANDSInventor: Richard WestonTECHNICAL FIELD

[0001] This invention relates to mammary pump systems for mammary glands more particularly to a breast pump system that applies negative pressure to the "breast body" of mammary storage area of the mammary gland.BACKGROUND ART

[0002] Conventional breast pumps are designed and constructed to duplicate the natural system of a baby nursing at the breast. This has a number of advantages, as it is easy to measure and observe natural phenomena. Once this is done, it is a relatively easy practice to use existing technology in an attempt to duplicate this functionality. The baseline of physiological action has companies competing to create a breast pump consistent with this physiological standard. Which pump is most like the baby is a debatable marketing claim. These pumps generally consist of an alternating suction source and a breast shield for collecting the expressed human milk. The process of removing milk from the breast during a pumping session can vary.SUMMARY OF INVENTIONTechnical Problem

[0003] Conventional breast pumps have the inability to completely empty the breast of milk. Many studies show that 50%-60% of milk is left in the breast after extraction. This can cause loss of milk production which can lead to a low milk supply. Additionally, breast pumps can be slow and inefficient in extracting all or most of the milk.Solution to Problem

[0004] An apparatus for extraction of infant ingestion fluid from a breast is disclosed. The apparatus comprises a flexible membrane configured to surround at least a portion of a breast body of the breast, the flexible membrane configured to form a membrane chamber encircling the breast body. The membrane chamber is configured to provide a negative pressure to at least a portion of the breast body.

[0005] A breast pump system for extraction of infant ingestion fluid from a breast is disclosed. The breast pump system comprises a pump mechanism comprising a first port and a second port, the first port configured to generate a first negative pressure, and the second port configured to generate a second negative pressure. A first lumen is fluidly coupled to the first port and a second lumen fluidly coupled to the second port. The system further comprises a breast shield comprising a shield chamber and a flange configured to cover a nipple of the breast, the shield chamber fluidly coupled to the first lumen, wherein the first negative pressure is transmitted to the shield chamber. The system further comprises a flexible membrane configured to surround at least a portion of a breast body of the breast, the flexible membrane comprising a passage extending from a first opening to a second opening, the passage configured to form a membrane chamber encircling the breast body, the flexible membrane fluidly coupled to the second lumen wherein the second negative pressure is transmitted to the membrane chamber. A fluid collection container is coupled to the breast shield, the fluid collection container configured to receive the infant ingestion fluid extracted from the breast.

[0006] A method for extracting infant ingestion fluid from a breast is disclosed. The method comprises the steps: (i) surrounding a flexible membrane around a breast body of the breast to form a membrane chamber; (ii) activating a pump mechanism fluidly coupled to the flexible membrane; (iii) generating a negative pressure by the pump mechanism to the membrane chamber; (iv) collapsing the flexible membrane to provide pressure to the breast body; (v) extracting the infant ingestion fluid from the breast; and (vi) collecting the infant ingestion fluid in a fluid collection container.Advantageous Effects of Invention

[0007] The flexible membrane applying pressure to the breast body as well as not obstructing the areola with a continuous negative pressure provides a faster and more efficient pumping solution. The breast can be fully emptied to produce more milk during each session as well as maintain an adequate milk supply for the mothers.

[0008] Here we have a system where negative pressure is applied under an occlusive membrane apply pressure to the mammary storage area. This causes the milk to overcome the musculature of the system and fluid to flow. This is coupled with a breast shield design that does not compress any of the lumens of fluid flow to the nipple area. This is coupled with a continuous negative pressure to more quickly remove the mammary fluid.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Other features, combinations, and embodiments will be appreciated by one having the ordinary level of skill in the art of breast pumps and accessories upon a thorough review of the following details and descriptions, particularly when reviewed in conjunction with the drawings, wherein:

[0010] FIG.1 shows a side view of a conventional intermittent breast pump system;

[0011] FIG.2 shows a side view of a breast pump system in accordance with a first illustrated embodiment;

[0012] FIG.3 shows a side view of a human breast;

[0013] FIG.4 shows a side view of a flexible membrane according to the first illustrated embodiment;

[0014] FIG.5 shows a diagram of musculature structure of fluid dynamics of the human breast;

[0015] FIG.6 shows graphs comparing conventional fluid extraction with the method of extraction according to the first illustrated embodiment;

[0016] FIG.7 shows a block diagram representation of mechanical mechanism of the breast;

[0017] FIG.8 shows a diagram of the breast represented as a cylinder;

[0018] FIG.9 shows a side view of the breast pump system in accordance with a second illustrated embodiment;

[0019] FIG.10 shows a side view of the breast pump system in accordance with a third illustrated embodiment; and

[0020] FIG.11 shows a side view of the flexible membrane in accordance with a fourth illustrated embodiment.DETAILED DESCRIPTION

[0021] For purposes of explanation and not limitation, details and descriptions of certain preferred embodiments are hereinafter provided such that one having ordinary skill in the art may be enabled to make and use the invention. These details and descriptions are representative only of certain preferred embodiments, however, a myriad of other embodiments which will not be expressly described will be readily understood by one having skill in the art upon a thoroughreview of the instant disclosure. Accordingly, any reviewer of the instant disclosure should interpret the scope of the invention only by the claims, as such scope is not intended to be limited by the embodiments described and illustrated herein.

[0022] For purposes herein, the term “breast body” means the portion of the breast between the areola and the chest wall of the associated breast.

[0023] The term “chamber” means an enclosed space within a structure that is hermetically sealed from the atmosphere and other chambers.

[0024] The term “continuous negative pressure” means pressure that remains negative continuously. Negative pressure can fluctuate in magnitude while still being characterized as continuous negative pressure.

[0025] The term “entirely surrounds” means to surround each portion of the object such that no portion of the object is contacting the surrounding feature.

[0026] The term “thickness” means a thickest portion of the associated object.

[0027] The term “occlusive material” means a substance or barrier that forms a protective layer on a surface to block air, water, and other elements from passing through.

[0028] Unless explicitly defined herein, terms are to be construed in accordance with the plain and ordinary meaning as would be appreciated by one having skill in the art.General Description of Embodiments

[0029] In one general embodiment, an apparatus for extracting milk from a breast is disclosed, comprising a flexible membrane that is designed to wrap around a portion of the breast. This membrane creates a chamber around the breast, and the chamber is used to apply negative pressure (or suction) to the breast, helping with the extraction of milk.

[0030] In some embodiments, the flexible membrane may further comprise a first opening and a second opening forming a passage between them, with the passage surrounding at least a portion of the breast body.

[0031] In some embodiments, the first opening may be configured to surround the areola of the breast, and the second opening may be configured to engage with the breast body or chest wall connected to the breast.

[0032] In some embodiments, the first opening may be configured to surround each portion of the areola.

[0033] In some embodiments, the first opening may be configured to expose the areola sothat each portion of the areola is exterior to the flexible membrane.

[0034] In some embodiments, the apparatus may further comprise a pump mechanism coupled to the flexible membrane by a lumen, and the pump mechanism may be configured to transmit the negative pressure to the membrane chamber.

[0035] In some embodiments, the pump mechanism may comprise a continuous mode configured to provide a continuous negative pressure.

[0036] In some embodiments, the negative pressure may comprise between and inclusive of -50 to -720 mmHg.

[0037] In another general embodiment, a breast pump system for extracting milk from a breast is disclosed, which includes a pump mechanism with two ports. The first port is designed to generate a first negative pressure, and the second port is designed to generate a second negative pressure. The system also features two lumens, with the first lumen connected to the first port and the second lumen connected to the second port. The breast pump has a breast shield with a shield chamber and a flange designed to cover the nipple of the breast, and the first negative pressure is transmitted through the first lumen to this chamber. Additionally, a flexible membrane is designed to surround a portion of the breast, forming a membrane chamber between two openings, and the second negative pressure is transmitted to this chamber via the second lumen. Finally, a fluid collection container is attached to the breast shield to collect the extracted milk.

[0038] In some embodiments, the pump mechanism may further comprise a single electric pump.

[0039] In some embodiments, the pump mechanism may further comprise two or more electric pumps.

[0040] In some embodiments, the first port and the second port may each comprise a continuous mode configured to provide a continuous negative pressure.

[0041] In some embodiments, the first port and the second port may each further comprise an intermittent mode configured to alternate between an open state of negative pressure and a closed state of rest.

[0042] In some embodiments, the first port and the second port may each comprise an intermittent mode configured to alternate between an open state of negative pressure and a closed state of rest.

[0043] In some embodiments, the first port and the second port may comprise synchronousintermittent modes, wherein the first port and the second port initiate the open state concurrently.

[0044] In some embodiments, the first port and the second port may comprise asynchronous intermittent modes, wherein the open state of the first port and the open state of the second port are initiated at different times.

[0045] In some embodiments, the first port may comprise a continuous mode configured to provide a continuous negative pressure, and the second port may comprise an intermittent mode configured to alternate between an open state of negative pressure and a closed state of rest.

[0046] In some embodiments, the first port may comprise an intermittent mode configured to alternate between an open state of negative pressure and a closed state of rest, and the second port may comprise a continuous mode configured to provide a continuous negative pressure.

[0047] In some embodiments, the flange may be configured to entirely surround an areola of the breast.

[0048] In some embodiments, the flexible membrane may be coupled to the breast shield.

[0049] In some embodiments, the flexible membrane may be coupled to the flange of the breast shield.

[0050] In some embodiments, the flange may further comprise a proximal side and a distal side opposite the proximal side, wherein the proximal side may be configured to contact the breast, and the flexible membrane may be coupled to one of the proximal side or the distal side.

[0051] In some embodiments, the flexible membrane may be configured to encircle each portion of the breast body.

[0052] In some embodiments, the second opening of the flexible membrane may be configured to contact a chest wall connected to the breast.

[0053] In some embodiments, the shield chamber may be hermetically isolated from the membrane chamber.

[0054] In some embodiments, the second port may be configured to generate a greater negative pressure than the first portion.

[0055] In some embodiments, the first negative pressure may comprise between and inclusive of -25 to -350 mmHg.

[0056] In some embodiments, the second negative pressure may comprise between and inclusive of -50 to -720 mmHg.

[0057] In some embodiments, the fluid collection container may be devoid of a valve.

[0058] In some embodiments, the breast shield may further comprise a tunnel coupled to the flange, wherein the tunnel may comprise a wide aperture so that the flange avoids contact with an areola of the breast.

[0059] In some embodiments, the tunnel may comprise parallel opposing sidewalls such that the flange is configured to entirely surround the areola.

[0060] In some embodiments, the breast shield may further comprise a shield thickness, and flexible membrane may further comprise a membrane thickness, wherein the shield thickness may be greater than the membrane thickness.

[0061] In some embodiments, the flexible membrane may comprise a greater elasticity than the breast shield.

[0062] In some embodiments, the flexible membrane may comprise an occlusive flexible membrane.

[0063] In some embodiments, the flexible membrane may comprise silicone, rubber, polyethylene, or a combination thereof.

[0064] In some embodiments, the second negative pressure may be configured to distribute equally throughout the membrane chamber and the breast body encapsulated therein.

[0065] In some embodiments, the system may further comprise a seal between the flexible membrane and the breast shield.

[0066] In some embodiments, the flexible membrane may further comprise an interior surface and an exterior surface opposite the interior surface, wherein the interior surface may be configured to contact the breast body, and the interior surface may further comprise a plurality of projections.

[0067] In some embodiments, the plurality of projections may further comprise protrusions, bumps formed by dimples, hairlike structures, or a combination thereof.

[0068] In some embodiments, the breast shield may further comprise a barrier disposed between the flange and the first lumen, wherein the barrier may be configured to direct the infant digestion fluid into the fluid collection container.

[0069] In some embodiments, the system may further comprise a secondary breast shield and a secondary flexible membrane for extraction of infant digestion fluid of a complementary breast.

[0070] In some embodiments, the membrane chamber may further comprise a plurality ofsub-chambers, wherein each of the plurality of sub-chambers is hermetically isolated from each other of the plurality of sub-chambers.

[0071] In some embodiments, the plurality of sub-chambers may further comprise a first sub-chamber, a second sub-chamber, and a third sub-chamber.

[0072] In some embodiments, the first sub-chamber may be configured to be disposed nearest to the nipple and the third sub-chamber may be configured to be disposed nearest to a chest wall connected to the breast.

[0073] In some embodiments, the pump mechanism may further comprise a third port and a fourth port each fluidly coupled to the flexible membrane, wherein the second port is fluidly coupled to the first sub-chamber, the third port is fluidly coupled to the second sub-chamber, and the fourth port is fluidly coupled to the third sub-chamber, wherein the second port, third port, and fourth port are each configured to generate a negative pressure.

[0074] In some embodiments, the second port, third port, and fourth port may be asynchronous such that negative pressure is generated in a sequential order to the third subchamber, then the second-sub-chamber, and then the first sub-chamber.

[0075] In another general embodiment a method for extracting infant milk from a breast is disclosed. The method consists of the following steps: a flexible membrane is positioned around the breast to form a membrane chamber; a pump, which is fluidly connected to the membrane, is activated to generate negative pressure within the chamber; this negative pressure leads to the collapse of the membrane, thereby applying pressure to the breast; the milk is extracted from the breast and is then collected in a designated fluid container.

[0076] In some aspects, the negative pressure generated by the pump mechanism to the membrane chamber may be one of an intermittent mode or a continuous mode.

[0077] In some aspects, the method may further comprise positioning a breast shield over a nipple of the breast, the breast shield forming a shield chamber, wherein the breast shield is fluidly coupled to the pump mechanism.

[0078] In some aspects, the method may further comprise generating a negative pressure by the pump mechanism to the shield chamber.

[0079] In some aspects, the negative pressure generated by pump mechanism to the shield chamber may be one of an intermittent mode or a continuous mode.

[0080] In some aspects, the negative pressure generated by the pump mechanism to themembrane chamber may be greater than the negative pressure generated by the pump mechanism to the shield chamber.

[0081] In some aspects, the membrane chamber may be hermetically isolated from the shield chamber.

[0082] In some aspects, the breast shield may further comprise a flange contacting the breast, wherein the flange avoids contact with an areola of the breast.

[0083] In some aspects, the flexible membrane may contact a chest wall connected to the breast.

[0084] Each of the components of the flexible membrane and related breast pump system described herein may be manufactured and / or assembled in accordance with the conventional knowledge and level of a person having skill in the art.

[0085] While various details, features, combinations are described in the illustrated embodiments, one having skill in the art will appreciate a myriad of possible alternative combinations and arrangements of the features disclosed herein. As such, the descriptions are intended to be enabling only, and non-limiting. Instead, the spirit and scope of the invention is set forth in the appended claims.Illustrated Embodiments

[0086] Now turning to the drawings, FIG.l shows a side view of a conventional intermittent breast pump system (10). The conventional intermittent breast pump system comprises a breast shield (13) fluidly coupled to an intermittent pump (11) by a lumen (14). The intermittent pump is configured to alternate being an open state of generating a negative pressure and a closed state of being at rest. The breast shield comprises a flange (17) sealed against a breast (160) to form a shield chamber (18). The flange is coupled to a tapering tunnel (19) which receives milk extracted from the breast. The breast comprises a nipple (161) surrounded by an areola (162). A breast body (163) is defined as the portion of the breast extending from the areola to a chest wall (164). The flange covers and surrounds the nipple and at least a portion of the areola. A fluid collection container (15) is coupled to the breast shield such that fluid extracted from the nipple travels through the shield chamber and into the fluid collection container. A valve (16) is disposed between the shield chamber and the fluid collection container, wherein the valve is configured to operate to close during suction and open when the milk falls through the valve and into the fluid collection container. The intermittent pump simulates a baby suckling on the nipple with a suctionrelease and relax as part of the cycle. A vacuum control (12) for the amount of pressure generally is -50 to -350 mmHg below atmospheric. The conventional breast pump system may further comprise an overflow device or membrane to prevent milk from entering the intermittent pump itself.

[0087] FIG.2 shows a side view of a breast pump system (100) in accordance with a first illustrated embodiment. The breast pump system comprises a breast shield (120) and a flexible membrane (140) each coupled to a breast (160). The breast shield comprises a flange (122) covering a nipple (161) and entirely surrounding each portion of an areola (162) of the breast. The flexible membrane is coupled to the breast shield and surrounds a breast body (163) of the breast. The flexible membrane comprises a first opening (142), a second opening (143), and a passage (141) extending between the first opening to the second opening. The first opening is coupled to the breast shield and the second opening is disposed at or near a chest wall (164) of a user. The user can slide the flexible membrane over the breast and pull the second opening over at least a portion of the breast body and possibly over the entire breast body and contact the chest wall. The breast shield would then fit over the nipple and areola without constriction. The breast shield further comprises a tunnel (125) coupled to the flange. The tunnel comprises parallel opposing sidewalls such that the tunnel does not taper as is used in conventional designs. A tapering tunnel can impede flow from the nipple. By having parallel opposing sidewalls, the flange is capable of entirely surrounding the areola and nipple to increase the extraction rate.

[0088] The breast shield (120) is fluidly coupled to a pump mechanism (110) by a first lumen (115). The first lumen is coupled to a first port (111) of the pump mechanism, wherein the first port is configured to generate a first negative pressure (112). The first negative pressure is transmitted through the first lumen and into a shield chamber (121) formed by the coupling of the breast shield with nipple (161) and areola (162). Likewise, the flexible membrane (140) is fluidly coupled to the pump mechanism by a second lumen (116). The second lumen is coupled to a second port (113) of the pump mechanism, wherein the second port is configured to generate a second negative pressure (114). The second negative pressure is transmitted through the second lumen and into a membrane chamber (144) formed by the coupling of the flexible membrane with the breast body (163). The membrane chamber is hermetically sealed and isolated from the shield chamber by a seal (146). In some embodiments, the second port is configured to generate a greater negative pressure than the first port. The second negative pressure inside the membrane chamberwill cause the flexible membrane to collapse around the breast body due to atmospheric pressure, thereby causing the flexible membrane to compress the breast body to aid in efficient extraction.

[0089] The pump mechanism (110) is configurable in a continuous mode and / or an intermittent mode for each port. Ports in the continuous mode provide a continuous negative pressure without rest. The amount of negative pressure during the continuous mode may alter or vary but negative pressure is continuously applied. Ports in the intermittent mode follow the more conventional approach of alternating between an open state of negative pressure and a closed state of rest. In some embodiments, the first port (111) and the second port (113) both operate in the continuous mode concurrently. In some embodiments, the first port operates in the continuous mode while the second port operates concurrently in the intermittent mode. Alternatively, in some embodiments, the first port operates in the intermittent mode while the second port operates concurrently in the continuous mode. Also in some embodiments, the first port and the second port both operate in the intermittent mode currently, wherein the concurrent operation of intermittent modes can by synchronous, where initiation of the open state at both ports is concurrent, or asynchronous, where the open state of the first port and the second port are initiated at different times.

[0090] The breast pump system (100) further comprises a filter (117) disposed inline with the first lumen (115) to prevent overflow of milk into the pump mechanism. This can be especially desirable when one or both ports are in the continuous mode, which can increase likelihood of milk traveling upstream towards the pump mechanism. The breast pump system further comprises a fluid collection container (130) coupled to the breast shield (120). The fluid collection container is configured to receive milk extracted from the breast that enters the shield chamber (121).

[0091] The flexible membrane (140) is coupled to the breast shield (13) at the flange (122). The flange comprises a proximal side (123) and a distal side (124) opposite the proximal side wherein the proximal side contacts the breast (160). The flexible membrane may be coupled to at least one of the proximal side or the distal side. In other embodiments, the flexible membrane may be coupled to the tunnel (125) of the breast shield, wherein the tunnel is disposed between the flange and the fluid collection container (130). In yet other embodiments, the flexible membrane is detached from the breast shield and the user will put them on independently such that the flexible membrane is typically placed on first and then the breast shield is placed second. The tunnel comprises a wide aperture (127) in order for the flange to avoid contact with the nipple (161) orareola (162). Instead, contact by the flange is on the breast body (163). By not contacting the nipple and areola, the flange ensures no compression of the ducts in the areola area which will increase the extraction rate. The breast shield comprises a flange angle (126) defined as the transition from the tunnel to the outward tapering of the flange. Conventional breast shields are constructed to compress the nipple as the breast is drawn into it. This puts pressure on the sinus and ducts and causes them to collapse. In the disclosed embodiment, the flange does not put pressure on the nipple and areola, thereby allowing for larger ducts and increased ability to remove fluid quickly.

[0092] The flexible membrane (140) comprises materials and a membrane thickness (145) thin enough to provide the flexible membrane with sufficient elasticity to compress around the breast body (163) from the second negative pressure (114). Typical materials can include flexible occlusive materials such as polyethylene, silicone, or rubber. The breast shield (120) generally comprises materials of lower elasticity, such as polypropylene or polycarbonate, and has a shield thickness (128) greater than the membrane thickness.

[0093] The flexible membrane (140) further comprises an exterior surface (148) and an interior surface (147) opposite the exterior surface. The interior surface is configured to contact the breast body (163) under sufficient pressure conditions. The interior surface comprises a plurality of projections (149) configured to equally distribute pressure through the membrane chamber (144). The plurality of projections prevents the interior side from creating an airtight seal (146) at some portion along the passage (141) to form an air pocket. The plurality of projections is configured to contact the breast body to create the desirable breast body compression, and the gaps or spaces between the plurality of projections ensures airflow is unobstructed and the pressure distortion is equally spread across the membrane chamber. The plurality of projections may comprise protrusions, bumps formed by dimples, hairlike structures, or an otherwise irregular surface.

[0094] Preferably, both the first port (111) and the second port (113) comprise the continuous mode, although other configuration of modes can also be utilized. The pump mechanism (110) may comprise a single pump for both ports or two separate pumps with one for each port. In some embodiments, the first negative pressure (112) transmitted to the breast shield (120) comprises between and inclusive of .25 to -350 mmHg, and the second negative pressure (114) transmitted to the flexible membrane comprises between and inclusive of -50 to -720 mmHg. The flexible membrane will have a negative pressure underneath it causing air pressure to transmitpressure to the breast tissue. The flexible membrane will squeeze the breast (160), namely the breast body (163), uniformly to initiate milk removal from the breast in a complete manner.

[0095] FIG.3 shows a side view of a human breast. The anatomy of the breast is not universally agreed upon. For example, many textbooks and articles note the lack of musculature in the breast or lack of muscle tissue. However, alternative findings are much different with substantial muscle structure in critical functional areas. The critical areas and functions are related to the biological reason for the breast. The breast has been designed as with all mammals to provide milk to sustain the offspring. In the human breast, the design has been to prevent the release of milk accidentally as there is a high energy cost to replenish this milk source. This mechanism is designed to release milk based on the stimulus of a sucking baby.

[0096] The actual musculature in the breast is substantial to its mission to allow milk to be released to the baby. The breast, as shown, comprises an enlarged areola. You can see in this enlargement that each areola is surrounded by myoepithelial cells that contract upon hormonal stimulation, known as the letdown effect. Further through the duct system leading from the areola to the nipple is a system of muscles, including those in the nipple itself, which are not well publicized or discussed. These muscles are both circular and radial and these are the final check of any release of milk from the breast. Thus, sufficient, and substantial musculature is present in the breast to prevent unwanted outflow of milk from the breast in the absence of hormonal and infant stimulation.

[0097] FIG.4 shows the innovation of the new system. Most conventional breast pumps have breast shields that cover the nipple (161) and areola (162) areas but not much more. The flexible membrane (140) will cover most if not all of the breast body (163) and part of the chest wall (164) as well. The membrane chamber (144) has a separate vacuum pressure that is transmitted under the flexible membrane. The vacuum that is transmitted under the flexible membrane causes a vacuum to exist between the breast body and the flexible membrane. This causes air pressure to press on the breast (160). Since the breast is circular around its circumference, this pressure is equally applied on the breast and expels the milk into the breast pump system (100) as disclosed herein. The flexible membrane comprises a seal (146) between itself and the breast shield (13), which typically comprises a harder plastic such as polypropylene or polycarbonate. The vacuum applied under the flexible membrane causes compression of internal breast tissue to overcome the overall muscle tension to allow milk to flow. The flexible membranewill squeeze the breast equally in all directions because the chest wall is immovable, therefore the fluid is dynamically forced towards the nipple.

[0098] FIG.5 shows a diagram of musculature structure of fluid dynamics of the human breast. Fluid is created in the alveoli, which is surrounded by musculature myoepithelial cells. Along the ducts, there are muscle closing points which again help to restrict the flow of fluid, namely milk. The final closing points are the musculature of the nipple / areola area. There are primary muscles known as the Muscles of Sappey. Additionally, there are the radial Muscles of Meyerholz. Together, the pressure of the air over the membrane must overcome the resistance of these muscles. Complementary to this is the first lumen of the disclosed breast pump system. The second lumen will also provide suction to the end of the nipple, where the ducts finally release milk from the body with a standard pressure of -50 to -350 mmHg. Therefore, the proposed breast pump system has both a push from the air pressure onto the flexible membrane, and a pull through the breast shield.

[0099] FIG.6 shows graphs comparing conventional fluid extraction with the method of extraction according to the first illustrated embodiment. Time is important for pumping women. Many women do not enjoy pumping and if they pump at work, time is an important factor. FIG.6 show the advantage of the disclosed breast pump system when used with continuous pressure. The typical cycling system which tries to mimic the baby’s action has suction and release. This is in harmony with nature and is required as the baby needs to swallow the milk. The disclosed system has a large storage capacity, so no intermittent pressure is required. Having continuous pressure on the nipple from the atmosphere air over the flexible membrane can reduce pumping times by a significant margin.

[0100] FIG.7 shows a block diagram representation of mechanical mechanism of the breast using hormonal control. An actuator, such as a hormone, causes the milk to compress and move through the system. The valves in the ducts operated by muscle cells open as well. And the last and final valves of the Muscles of Sappey also open or relax. The idea behind the disclosed embodiments is to provide internal pressure in the breast to overcome the musculature of the system holding back the fluid (milk). In this case, there is relaxation of musculature that is normally closed, allowing milk to flow relatively easily, although all women’s breast structures are somewhat individual.

[0101] FIG.8 shows a diagram of the breast represented as a cylinder. If s known by visualdepiction that the breast during lactation enlarges and becomes more cylindrical. The formula for a deformable cylinder with one side blocked (the chest wall) is shown. From an engineering perspective, by looking at the breast as a cylinder that deforms, it shows what pressures would be needed to overcome the musculature of the breast to expel all the milk. It appears that air pressure through the flexible membrane in a circular enclosed manner are sufficient to overcome the musculature that exists in the breast, thereby enabling this methodology to be successful.

[0102] FIG.9 shows a side view of the breast pump system (200) in accordance with a second illustrated embodiment. The breast pump system comprises a pump mechanism (210) fluidly coupled to both a breast shield (220) and a flexible membrane (240). The pump mechanism comprises a plurality of ports, namely a first port (211), a second port (213), a third port (254), and a fourth port (255). A first lumen (215) is fluidly coupled to the first port, a second lumen (216) is fluidly coupled to the second port, a third lumen (256) is fluidly coupled to the third port, and a fourth lumen (257) is fluidly coupled to the fourth port. The first lumen is further fluidly coupled to the breast shield. The breast shield comprises a flange (222), wherein the flange is coupled to a breast (260) at a nipple (261) thereof. A shield chamber (221) is formed therein such that a negative pressure generated by the first port is transmitted to the shield chamber. A fluid collection container (230) is coupled to the breast shield by a threaded connection (232).

[0103] The flexible membrane (240) comprises a first opening (242) and a second opening (243). The first opening is coupled to or otherwise adjacent to the breast shield (220). The second opening defines a terminal end of the flexible membrane and can engage with a breast body (263) of the breast (260) or the chest wall (264). The flexible membrane encircles most or all of the breast body to form a membrane chamber (244). The membrane chamber further comprises a plurality of sub-chambers (250), including a first sub-chamber (251), a second sub-chamber (252), and a third sub-chamber (253), wherein the third sub-chamber is disposed at or near the chest wall, the first sub-chamber is disposed at or near the breast shield, and the second sub-chamber is disposed between the first and third sub-chambers. The flexible membrane may comprise a flexible occlusive material that is trimmable for custom fitting to the user. The material can be thin enough and easy enough to trim any excess material that is not needed.

[0104] Each portion of the breast (260) covered by each of the first and second subchambers is the breast body (263). Each portion of the breast covered by the third sub-chambers is either only the breast body or the breast body and the chest wall (264). The first, second, andthird sub-chambers are divided from each other such that each of the sub-chambers is hermetically isolated from the other of the sub-chambers. The first sub-chamber (251) is fluidly coupled to the second lumen (216), the second sub-chamber (252) is fluidly coupled to the third lumen (256), and the third sub-chamber (253) is fluidly coupled to the fourth lumen (257). This allows each subchamber to comprise different negative pressure in order to apply different pressures at different sections of the breast body. This suction may be segmented and applied in a sequential manner as shown. This sequential action may help to move milk towards the nipple (261) and areola (262). Pressure is initially applied to the third sub-chamber, then to the second sub-chamber, and lastly to the first sub-chamber. In some embodiments, pressure at one sub-chamber will dynamically lower as a neighboring sub-chamber is increased to create a rolling pressure on the breast body. One having skill in the art will appreciate that a different number of sub-chambers can be utilized without deviating from the embodiment, including two, four, or more.

[0105] FIG.10 shows a side view of the breast pump system (300) in accordance with a third illustrated embodiment. The breast pump system comprises a flexible membrane (340) and a breast shield (320), each contacting a breast (360). The breast shield comprises a flange (322) cover a nipple (361) and areola (362) of the breast such that each portion of the breast contacted by the flange comprises a breast body (363) defined as the portion of the breast between the areola and a corresponding chest wall (364). The flexible membrane comprises a passage (341) extending from a first opening (342) to a second opening (343). The passage encircles the breast body and possibly contacts the chest wall at the second opening. The first opening is coupled to or otherwise contacts the flange. The flexible membrane and the breast shield are hermetically isolated from each other such that the breast shield comprises a shield chamber (321) and the flexible membrane comprises a membrane chamber (344). The breast shield receives pressure from a first lumen (315) and the flexible membrane receives pressure from a second lumen (316). The first and second lumen are coupled to a pump mechanism (not shown).

[0106] A fluid collection container (330) is coupled to the breast shield (320) by a threaded connector and receives milk collected from the breast shield during extraction. The breast pump system (300) further comprises a barrier (328) disposed in at least one of the first lumen (315) and the shield chamber (321). The barrier is positioned to block milk from traveling into the first lumen or overflowing into the pump mechanism. In some embodiments, the barrier is disposed within the shield chamber and disposed above the fluid collection container. Milk entering into the shieldcontainer and being drawn towards the barrier due to the negative pressure will contact the barrier and be directed downward into the fluid collection container. A permeable access point will be present in order for transmission of pressure generation to be unaffected.

[0107] The flange (322) as shown comprises a wide aperture (126) in order to avoid contact with the nipple (361) and areola (362) areas of the breast (360). It can be beneficial to not compress the ducts or sinuses during suction to increase extraction rate. Each portion of the breast to which the flange is configured to contact is the breast body (363). Each portion of the nipple and areola is configured to be encapsulated by the flange

[0108] FIG.11 shows a side view of the flexible membrane (440) in accordance with a fourth illustrated embodiment. The flexible membrane comprises a passage (441) extending from a first opening (442) to a second opening (443) to form a tubular structure. The flexible membrane is configured to be worn on a breast (460) of the user. The passage encircles the breast, namely a breast body (463) defined as the portion of the breast between the areola (462) and a corresponding chest wall (464). The first opening is disposed closer to the areola and the second opening is engaged with at least one of the breast body and the chest wall. The areola and the nipple (461) are fully exposed such that each portion of the breast contacted by the first opening is the breast body. The first opening and the second opening each comprise a seal (446) in order to create a membrane chamber (444) between the flexible membrane and the breast body. The membrane chamber is fluidly coupled to a lumen (14), where the lumen is fluidly coupled to a corresponding pump mechanism. The flexible membrane comprises an exterior surface (448) and an interior surface (447), wherein the interior surface is configured to contact and compress against the breast body when sufficient negative pressure is present within the membrane chamber. Disposed on the interior surface are a plurality of projections (449) for ensuring an equal distribution of the negative pressure within the membrane chamber. The plurality of projections made comprise protrusions, bumps formed by dimples, hairlike structures, or an otherwise irregular surface. The flexible membrane is shown independent from a breast shield. The flexible membrane as shown can be used with conventional breast shields or can be used by itself without a breast shield.INDUSTRIAL APPLICABILITY

[0109] The claimed invention is applicable to the extraction of human milk for infant consumption. Additionally, this invention can apply to other mammals that have a mammary storage area for offspring's milk and a separate nipple teat that has musculature that restricts flow,such as a bovine or goat mammary glandFeature List

[0110] conventional breast pump system (10)

[0111] intermittent pump (11)

[0112] vacuum control (12)

[0113] lumen (14)

[0114] valve (16)

[0115] breast pump system (100; 200; 300)

[0116] pump mechanism (110; 210)

[0117] first port (111; 211)

[0118] first negative pressure (112)

[0119] second port (113; 213)

[0120] second negative pressure (114)

[0121] first lumen (115; 215; 315)

[0122] second lumen (116; 216; 316; 416)

[0123] filter (117)

[0124] breast shield (13; 120; 220; 320)

[0125] shield chamber (18; 121; 221; 321)

[0126] flange (17; 122; 222; 322)

[0127] proximal side (123)

[0128] distal side (124)

[0129] tunnel (19, 125)

[0130] flange angle (126)

[0131] wide aperture (127)

[0132] shield thickness (128)

[0133] barrier (328)

[0134] fluid collection container (15; 130; 230; 330)

[0135] threaded connection (132; 232; 332)

[0136] flexible membrane (140; 240; 340; 440)

[0137] passage (141; 341; 441)

[0138] first opening (142; 242; 342; 442)

[0139] second opening (143; 243; 343; 443)

[0140] membrane chamber (144; 244; 344; 444)

[0141] membrane thickness (145)

[0142] seal (146; 446)

[0143] interior surface (147; 447)

[0144] exterior surface (148; 448)

[0145] plurality of projections (149; 449)

[0146] plurality of sub-chambers (250)

[0147] first sub-chamber (251)

[0148] second sub-chamber (252)

[0149] third sub-chamber (253)

[0150] third port (254)

[0151] fourth port (255)

[0152] third lumen (256)

[0153] fourth lumen (257)

[0154] breast (160; 260; 360; 460)

[0155] nipple (161; 261; 361; 461)

[0156] areola (162; 262; 362; 462)

[0157] breast body (163; 263; 363; 463)

[0158] chest wall (164; 264; 364; 464)

[0159] infant ingestion fluid (365)

Claims

CLAIMSWhat is claimed is:

1. An apparatus for extraction of infant ingestion fluid from a breast, comprising: a flexible membrane configured to surround at least a portion of a breast body of the breast, the flexible membrane configured to form a membrane chamber encircling the breast body; wherein the membrane chamber is configured to provide a negative pressure to the at least a portion of the breast body.

2. The apparatus of claim 1, the flexible membrane further comprising a first opening and a second opening forming a passage therebetween, the passage configured to surround the at least a portion of the breast body.

3. The apparatus of claim 2, wherein the first opening is configured to surround an areola of the breast, and the second opening is configured to engage with at least one of the breast body or a chest wall connected to the breast.

4. The apparatus of claim 3, wherein the first opening is configured to surround each portion of the areola.

5. The apparatus of claim 3, wherein the first opening is configured to expose the areola such that each portion of the areola is exterior to the flexible membrane.

6. The apparatus of claim 3, further comprising a pump mechanism coupled to the flexible membrane by a lumen, wherein the pump mechanism is configured to transmit the negative pressure to the membrane chamber.

7. The apparatus of claim 6, wherein the pump mechanism comprises a continuous mode configured to provide a continuous negative pressure.

8. The apparatus of claim 1, wherein the negative pressure comprises between and inclusive of -50 to -720 mmHg.

9. A breast pump system for extraction of infant ingestion fluid from a breast, comprising: a pump mechanism comprising a first port and a second port, the first port configured to generate a first negative pressure, and the second port configured to generate a second negative pressure; a first lumen fluidly coupled to the first port and a second lumen fluidly coupled to the second port; a breast shield comprising a shield chamber and a flange configured to cover a nipple of the breast, the shield chamber fluidly coupled to the first lumen wherein the first negative pressure is transmitted to the shield chamber; a flexible membrane configured to surround at least a portion of a breast body of the breast, the flexible membrane comprising a passage extending from a first opening to a second opening, the passage configured to form a membrane chamber encircling the breast body, the flexible membrane fluidly coupled to the second lumen, wherein the second negative pressure is transmitted to the membrane chamber; and a fluid collection container coupled to the breast shield, the fluid collection container configured to receive the infant ingestion fluid extracted from the breast.

10. The system of claim 9, the pump mechanism further comprising a single electric pump.

11. The system of claim 9, the pump mechanism further comprising two or more electric pumps.

12. The system of claim 9, wherein the first port and the second port each comprises a continuous mode configured to provide a continuous negative pressure.

13. The system of claim 12, the first port and the second port each further comprising an intermittent mode configured to alternate between an open state of negative pressure and a closed state of rest.

14. The system of claim 9, wherein the first port and the second port each comprises an intermittent mode configured to alternate between an open state of negative pressure and a closed state of rest.

15. The system of claim 14, wherein the first port and the second port comprise synchronous intermittent modes such that the first port and the second port initiate the open state concurrently.

16. The system of claim 14, wherein the first port and the second port comprise asynchronous intermittent modes such that the open state of the first port and the open state of the second port are initiated at different times.

17. The system of claim 9, wherein the first port comprises a continuous mode configured to provide a continuous negative pressure, and the second port comprises an intermittent mode configured to alternate between an open state of negative pressure and a closed state of rest.

18. The system of claim 9, wherein the first port comprises an intermittent mode configured to alternate between an open state of negative pressure and a closed state of rest, and the second port comprises a continuous mode configured to provide a continuous negative pressure.

19. The system of claim 9, wherein the flange is configured to entirely surround an areola of the breast.

20. The system of claim 9, wherein the flexible membrane is coupled to the breast shield.

21. The system of claim 20, wherein the flexible membrane is coupled to the flange of the breast shield.

22. The system of claim 21, the flange further comprising a proximal side and a distal side opposite the proximal side, the proximal side configured to contact the breast, wherein the flexible membrane is coupled to one of the proximal side or the distal side.

23. The system of claim 9, wherein the flexible membrane is configured to encircle each portion of the breast body.

24. The system of claim 9, wherein the second opening of the flexible membrane is configured to contact a chest wall connected to the breast.

25. The system of claim 9, wherein the shield chamber is hermetically isolated from the membrane chamber.

26. The system of claim 9, wherein the second port is configured to generate a greater negative pressure than the first portion.

27. The system of claim 9, wherein the first negative pressure comprises between and inclusive of -25 to -350 mmHg.

28. The system of claim 27, wherein the second negative pressure comprises between and inclusive of -50 to -720 mmHg.

29. The system of claim 9, wherein the fluid collection container is devoid of a valve.

30. The system of claim 9, the breast shield further comprising a tunnel coupled to the flange, wherein the tunnel comprises a wide aperture such that the flange avoids contact with an areola of the breast.

31. The system of claim 30, wherein the tunnel comprises parallel opposite sidewalls.

32. The system of claim 9, the breast shield further comprising a shield thickness, and flexible membrane further comprising a membrane thickness, wherein the shield thickness is greater than the membrane thickness.

33. The system of claim 9, wherein the flexible membrane comprises a greater elasticity than the breast shield.

34. The system of claim 9, wherein the flexible membrane comprises an occlusive flexible membrane.

35. The system of claim 34, wherein the flexible membrane comprises silicone, rubber, polyethylene, or a combination thereof.

36. The system of claim 9, wherein the second negative pressure is configured to distribute equally throughout the membrane chamber and the breast body encapsulated therein.

37. The system of claim 9, further comprising a seal between the flexible membrane and the breast shield.

38. The system of claim 9, the flexible membrane further comprising an interior surface and an exterior surface opposite the interior surface, the interior surface configured to contact the breast body, wherein the interior surface comprises a plurality of projections.

39. The system of claim 38, the plurality of projections further comprising protrusions, bumps formed by dimples, hairlike structures, or a combination thereof.

40. The system of claim 9, the breast shield further comprising a barrier disposed between the flange and the first lumen, wherein the barrier is configured to direct the infant digestion fluid into the fluid collection container.

41. The system of claim 9, further comprising a secondary breast shield and a secondary flexible membrane for extraction of infant digestion fluid of a complementary breast.

42. The system of claim 9, the membrane chamber further comprising a plurality of subchambers, wherein each of the plurality of sub-chambers is hermetically isolated from each other of the plurality of sub-chambers.

43. The system of claim 42, wherein the plurality of sub-chambers further comprises a first sub-chamber, a second sub-chamber, and a third sub-chamber.

44. The system of claim 43, wherein the first sub-chamber is configured to be disposed nearest to the nipple and the third sub-chamber is configured to be disposed nearest to a chest wall connected to the breast.

45. The system of claim 44, the pump mechanism further comprising a third port and a fourth port each fluidly coupled to the flexible membrane, wherein the second port is fluidly coupled to the first sub-chamber, the third port is fluidly coupled to the second sub-chamber, and the fourth port is fluidly coupled to the third sub-chamber, wherein the second port, third port, and fourth port are each configured to generate a negative pressure.

46. The system of claim 45, wherein the second port, third port, and fourth port are asynchronous such that negative pressure is generated in a sequential order to the third subchamber, then the second-sub-chamber, and then the first sub-chamber.

47. A method for extracting infant ingestion fluid from a breast, comprising the steps: surrounding a flexible membrane around a breast body of the breast to form a membrane chamber; activating a pump mechanism fluidly coupled to the flexible membrane; generating a negative pressure by the pump mechanism to the membrane chamber; collapsing the flexible membrane to provide pressure to the breast body; extracting the infant ingestion fluid from the breast; and collecting the infant ingestion fluid in a fluid collection container.

48. The method of claim 47, wherein the negative pressure generated by the pump mechanism to the membrane chamber is one of an intermittent mode or a continuous mode.

49. The method of claim 47, further comprising positioning a breast shield over a nipple of the breast, the breast shield forming a shield chamber, wherein the breast shield is fluidly coupled to the pump mechanism.

50. The method of claim 49, further comprising generating a negative pressure by the pump mechanism to the shield chamber.

51. The method of claim 50, wherein the negative pressure generated by pump mechanism to the shield chamber is one of an intermittent mode or a continuous mode.

52. The method of claim 49, wherein the negative pressure generated by the pump mechanism to the membrane chamber is greater than the negative pressure generated by the pump mechanism to the shield chamber.

53. The method of claim 49, wherein the membrane chamber is hermetically isolated from the shield chamber.

54. The method of claim 49, the breast shield further comprising a flange contacting the breast, wherein the flange avoids contact with an areola of the breast.

55. The method of claim 47, wherein the flexible membrane contacts a chest wall connected to the breast.

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