Breast pump systems and methods

Abstract

To provide systems and methods for pumping milk from a breast.SOLUTION: An automated system for controlling pumping cycles to pump milk from a human breast comprises a breast pump shaped to fit into a brassiere. The breast pump comprises: a housing; a breast adapter including a nipple receiving cavity; a pumping mechanism contained in the housing and including a pumping region above the nipple receiving cavity; a wireless transmitter; a milk collection container; a sensor which detects that the milk collection container is full; and a controller that automatically changes application of suction from a letdown phase to an expression mode. The pumping mechanism comprises two drivers that displace a flexible member and generate vacuum pressure in the nipple receiving cavity.SELECTED DRAWING: Figure 6

Description

[Technical field]

[0001] The present invention relates generally to a portable, hands-free, discrete, self-powered and energy-efficient breast pump system and method for collecting breast milk from a nursing mother's breast. [Background technology]

[0002] As more women become aware that breastfeeding is the best source of nutrition for their infants and provides health benefits to the mother during breastfeeding, there is an increasing need for a user-friendly, quiet, individual and versatile breast pump solution for breastfeeding mothers in a variety of situations. This is especially true for working mothers who are away from home for more than 8-10 hours and need to express breast milk to make it available to their infants, but also for many other situations where mothers are away from the privacy of their home for long periods of time, such as going out for shopping, dinner or other activities.

[0003] Despite the variety of breast pumps available, most are inconvenient, cumbersome, require many parts and assemblies, and are difficult to transport. Various manual hand pumps are cumbersome and can be painful to use. Some powered breast pumps require an AC power source that is plugged in during use. There are also battery-powered systems, but as the motorized pump runs continuously to maintain suction during the milk extraction process, battery power degrades fairly quickly. Many of the available breast pumps are clearly visible to third parties when used by the mother, and many also expose the mother's breasts when in use. Summary of the Invention [Problem to be solved by the invention]

[0004] There is a continuing need for small, portable, self-powered, energy-efficient, wearable breast pump systems that are easy to use and separate by not exposing the user's chest when worn and are invisible or nearly unnoticeable. [Means for solving the problem]

[0005] Briefly and in general terms, the present disclosure is directed to a breast pump system and method. The system includes a breast contacting structure, a collection container, and a structure for extracting breast milk from the breast and delivering the breast milk to the container. The method includes extracting breast milk from the breast and delivering the breast milk to the collection container.

[0006] In one approach, a method of pumping breast milk from a breast includes sealing a breast pump system to the breast and pumping expressed breast milk from the breast through a conduit. A driving force may be included and may be generated by expanding a pre-compressed conduit to generate suction that drives the expression of breast milk from the breast. The driving force may be generated by pulling on the pre-compressed conduit. Expressed breast milk can be expelled by applying a relative positive pressure to a portion of the conduit. In one particular embodiment, suction applied to the breast for expression of breast milk includes a first suction level and a second suction level maintained against the breast during expulsion, the second suction level being lower than the first suction level.

[0007] In a variation of the disclosed embodiment, the system defines a natural breast profile that is intended to fit comfortably and successfully into a user's brassiere and to be natural in appearance. As such, the profile is characterized by having a non-circular bottom surface. Moreover, like the natural breast, the profile of the device or system is intended to define one or more asymmetric curves and to be off center of inertia.

[0008] The disclosed method may alternatively or additionally include one or more of providing a substantially tight liquid path through the conduit between the breasts and squeezing a portion of the conduit to reduce squeezing, returning the conduit to an unsqueezed state to create sufficient suction to extract breast milk from the breasts. Pumping may also include squeezing a second portion of the conduit to create pressure. A check valve between the conduit and the reservoir may be provided to prevent backflow of breast milk and air.

[0009] The pump device may be placed in contact with the breast and may be connected to the storage container. The pump device and the storage container are each sized and shaped to be contained within the user's bra. In one approach, the storage container is located between the pump structure of the device and the user's bra. In another approach, the storage container may be approximately the pump structure or may be located between the pump structure and the user's breast. Milk may be pumped from the breast without changing the overall mass and volume of the breast, the pump device and the storage container. The storage container may be flexible and / or positioned around the breast. The drive mechanism may be defined by rollers that maintain a fluid connection between the proximal and distal portions of the conduit. The drive mechanism may alternatively include a single compression driver and first and second check valves in the conduit on either side of the area compressed by the compression driver. The system may include first and second drivers, the first driver compressing a first region of the conduit and the second driver compressing a second region of the conduit. The first and second drivers may be configured to intermittently compress and release the compression of the region of the conduit. The drive mechanism may be adjusted such that movement thereof creates sufficient pressure to expel the extracted breast milk. The first driver may be configured to seal the region of the conduit as the breast milk is pumped, and in one embodiment, sufficient pressure may be created to pump the breast milk against gravity.

[0010] A controller may be included in the disclosed embodiments. The controller may be one or more of: electrically connected to the pump or configured to provide power for movement of the drive mechanism and a battery electrically connected thereto. A pressure sensor may further be included to detect pressure within the chest adapter, and in some embodiments, the pressure sensor is in electronic communication with the controller. Additionally, in some approaches, the controller may adaptively control the movement of the driver with input from a feedback loop determined by pressure or other sensors. Additionally, the controller may be programmable for changed set conditions.

[0011] The system may be configured to generate a suction force within the range of about -60 mmHg, or within the range of about -120 mmHg to about 450 mmHg, or within the range of about -60 mmHg to about -180 mmHg, or within the range of about -60 mmHg to about -220 mmHg, or within the range of about -200 mmHg to about -450 mmHg, or within the range of about -380 mmHg to about -420 mmHg, or within the range of about -180 mmHg to about -400 mmHg, or within the range of about -180 mmHg to about -220 mmHg, or within the range of about -40 mmHg to about -70 mmHg, or within the range of about -50 mmHg to about -60 mmHg.

[0012] The chest adapter or pump system may generally include at least one vibration element for applying vibrations to the chest and / or at least one heating element for applying heat to the chest. The chest adapter and conduit may be integrally formed as a unit or may define separate parts. Additionally, the chest adapter and conduit may be configured to be removable and replaceable from the pump system. A housing may further be provided and may include a drive mechanism and a controller. The housing may also include a manually operated controller for inputting to the controller and, additionally or alternatively, a user readable display.

[0013] In one or more embodiments, the storage container is removable from the system. There may be multiple drivers with different shapes and dimensions or lengths. The lower surface of the driver may be V-shaped in cross section. The driver may be configured to be attachable to the chest adapter and to allow the chest adapter to expand. The chest adapter may further include a first flange and a second flange, with a gap formed between the flanges to prevent milk from spilling out. In another aspect, inserting the breast into the adapter against the second flange biases the second flange toward the first flange. Also, in some embodiments, suction collapses the gap between the first and second flanges.

[0014] In one approach, milk extraction is stopped while the milk is pumped into a storage container. Additionally, suction may be cycled to stimulate milk let-down and activate extraction during let-down. After a predetermined time, i.e., after calculating an estimate of a predetermined amount of milk extracted, the breast may be sealed at a predetermined suction level. The system may be configured such that the pumping mechanism is spaced less than 2.5 cm from the nipple of the breast, or less than 2.0 cm from the nipple, or 1.0 cm or less from the nipple. Pumping may additionally or alternatively occur without any mechanical movement of the breast or nipple. Pumping may also occur by a pumping mechanism external to and in fluid communication with the conduit.

[0015] An approach or embodiment of the system or method may include outputting at least one operational and / or detected parameter and modifying at least one operational setting based on the operational or detected parameter. The system or method may further be performed in real time or as a feedback loop. The operational setting may be one or more of suction level setting, suction waveform definition, step time extraction, estimation of breast milk volume threshold per extraction step, pressure, resting step time, heating temperature, heating time, vibration frequency, and vibration time. The system may be configured to upload the operational or detected parameter from an external computer to a cloud server.

[0016] Suction may be maintained at a minimum during the entire breast milk pumping period, and may be intermittent if suction decreases to zero at least once over the duration of the breast milk pumping period. Additionally, suction levels may be monitored to determine if at least the minimum suction level is not maintained and the system may be shut down. Indicators may be provided to cease pumping and / or indicate when the device is to be removed from the breast. Non-contact pressure sensors are also contemplated for incorporation into one or more of the disclosed embodiments or methods. In one approach, the sensor may define a magnetic proximity sensor.

[0017] These and other features of the present disclosure will become apparent to those skilled in the art upon a detailed reading of the specification, as more fully described below. [Brief description of the drawings]

[0018] [Figure 1] FIG. 1 is an illustration of a breast pump system according to one embodiment of the present disclosure.

[0019] [Diagram 2] FIG. 2 is a partial view of the system of FIG. 1 showing only a portion of the chest adapter.

[0020] [Diagram 3] FIG. 2 is a partial schematic diagram of the system of FIG. 1 showing the pumping region.

[0021] [Figure 4A] 13A-13C illustrate the interaction of a compression element with elastic tubing and a pumping sequence according to one embodiment of the present disclosure. [Figure 4B] 13A-13C illustrate the interaction of a compression element with elastic tubing and a pumping sequence according to one embodiment of the present disclosure. [Figure 4C] 13A-13C illustrate the interaction of a compression element with elastic tubing and a pumping sequence according to one embodiment of the present disclosure. [Figure 4D]13A-13C illustrate the interaction of a compression element with elastic tubing and a pumping sequence according to one embodiment of the present disclosure. [Figure 4E] 13A-13C illustrate the interaction of a compression element with elastic tubing and a pumping sequence according to one embodiment of the present disclosure. [Figure 4F] 13A-13C illustrate the interaction of a compression element with elastic tubing and a pumping sequence according to one embodiment of the present disclosure.

[0022] [Figure 5A] FIG. 2 illustrates the operation of a system having only one compression element, according to one embodiment of the present disclosure. [Figure 5B] FIG. 2 illustrates the operation of a system having only one compression element, according to one embodiment of the present disclosure. [Figure 5C] FIG. 2 illustrates the operation of a system having only one compression element, according to one embodiment of the present disclosure.

[0023] [Figure 6] FIG. 1 shows the body / housing of a breast pump system without a container attached or without tubing and adapters attached to illustrate the dimensions of the components shown, according to one embodiment of the present disclosure.

[0024] [Figure 7A] 7 illustrates a breast adapter / tube configured and dimensioned to be attached to the embodiment of the body / housing of the breast pump system shown in FIG. 6 according to one embodiment of the present disclosure.

[0025] [Figure 7B] 7 illustrates a breast adapter / tube configured and dimensioned to be attached to the embodiment of the body / housing of the breast pump system shown in FIG. 6 according to another embodiment of the present disclosure.

[0026] [Figure 7C] 13A-13C illustrate the perpendicular relationship between the longitudinal axis of the nipple and the breast adapter according to one embodiment of the present disclosure.

[0027] [Figure 7D] 13A-13C illustrate an acute angular relationship between the longitudinal axis of the nipple and a breast adapter according to one embodiment of the present disclosure.

[0028] [Figure 8A] 1A and 1B are schematic front and side views, respectively, of a breast pump system showing tubing placement and routing, according to one embodiment of the present disclosure; [Figure 8B] 1A and 1B are schematic front and side views, respectively, of a breast pump system showing tubing placement and routing, according to one embodiment of the present disclosure;

[0029] [Figure 9] FIG. 1 is a schematic side view of an example of a system in which the dimensions of the tube vary along its length, and optionally different portions of the tube are made from different materials, according to one embodiment of the present disclosure.

[0030] [Figure 10] FIG. 2 illustrates a sequence of events that may occur when operating the system during the process of extracting breast milk from a breast, according to one embodiment of the present disclosure.

[0031] [Figure 11] FIG. 1 illustrates events that may occur in a control process to extract breast milk, according to one embodiment of the present disclosure.

[0032] [Figure 12] FIG. 1 is a schematic diagram showing various portions of a tube extending from the chest to the proximal end of the tube, according to one embodiment of the present disclosure.

[0033] [Figure 13A] FIG. 13 is a partial view of a system utilizing a second compression element according to another embodiment of the present disclosure. [Figure 13B] FIG. 13 is a partial view of a system utilizing a second compression element according to another embodiment of the present disclosure.

[0034] [Figure 13C] FIG. 13 is a partial view of a system utilizing a second compression element according to another embodiment of the present disclosure. [Figure 13D] FIG. 13 is a partial view of a system utilizing a second compression element according to another embodiment of the present disclosure. [Figure 13E] FIG. 13 is a partial view of a system utilizing a second compression element according to another embodiment of the present disclosure.

[0035] [Figure 13F] FIG. 13 is a partial view of a system utilizing a second compression element according to another embodiment of the present disclosure.

[0036] [Figure 14] FIG. 13 is a partial view of a system utilizing a second compression element according to another embodiment of the present disclosure.

[0037] [Figure 15] FIG. 2 is a partial view of a system utilizing a first compression element according to another embodiment of the present disclosure.

[0038] [Figure 16A] FIG. 13 is a partial view of a system according to another embodiment of the present disclosure, where one or both compression elements are attached to a tube.

[0039] [Figure 16B] 13A-13C illustrate one way in which a tube may be configured to attach to one or both of the attachment devices or compression elements according to one embodiment of the present disclosure.

[0040] [Figure 16C] FIG. 16C is a partial cross-sectional view of a first compression element being attached to a tube according to the embodiment described with respect to FIG. 16B.

[0041] [Figure 17A] FIG. 13 is a partial view of a system utilizing another embodiment of a compression element, according to an embodiment of the present disclosure.

[0042] [Figure 17B] FIG. 17B is a cross-sectional view of the compression element of FIG. 17A.

[0043] [Figure 17C] FIG. 13 is a cross-sectional view of a compression element and tube housed within a channel having a substantially planar or flat anvil surface according to one embodiment of the present disclosure.

[0044] [Figure 17D] FIG. 13 is a cross-sectional view of a compression element and tube housed within a flow channel, the anvil surface of the flow channel being substantially V-shaped in cross-section and the compression element having a substantially V-shaped compression surface, according to one embodiment of the present disclosure.

[0045] [Figure 17E] FIG. 13 is a cross-sectional view of a compression element and tube housed within a flow channel, where the anvil surface of the flow channel is concave in cross-section and the compression element has a convex compression surface, according to one embodiment of the present disclosure.

[0046] [Figure 18] FIG. 1 illustrates an isolated view of a breast milk collection and storage container according to one embodiment of the present disclosure.

[0047] [Figure 19] FIG. 1 illustrates a tube and container connection feature that allows for easy and quick attachment and detachment of the container to and from the tube, according to one embodiment of the present disclosure.

[0048] [Figure 20] FIG. 1 illustrates a container with the cap removed upon removal from the system according to one embodiment of the present disclosure.

[0049] [Figure 21] FIG. 1 illustrates a feeding nipple attached to a container according to one embodiment of the present disclosure.

[0050] [Figure 22]FIG. 1 illustrates a bottle attached to a container with a nipple inserted therein to provide a more structured device that is easily used to feed an infant, according to one embodiment of the present disclosure.

[0051] [Figure 23] FIG. 13 is an exploded view of an alternative apparatus for mounting a container on a bottle and providing a feeding nipple thereto, according to another embodiment of the present disclosure.

[0052] [Figure 24] FIG. 1 illustrates a system placed on the chest around the nipple and supported by a brassiere according to one embodiment of the present disclosure.

[0053] [Diagram 25] FIG. 13 illustrates a breast milk collection container according to another embodiment of the present disclosure.

[0054] [Figure 26] 11A-11D illustrate alternative locations for placing the container according to various embodiments of the present disclosure.

[0055] [Figure 27A] 1 illustrates a breast pump system using a donut-shaped collection container according to one embodiment of the present disclosure.

[0056] [Figure 27B] FIG. 27B is a side view of the system of FIG. 27A shown attached to the chest.

[0057] [Figure 28A] FIG. 1 illustrates a toroidal container having a baffle intermediate the toroidal inner and outer surfaces, according to one embodiment of the present disclosure.

[0058] [Figure 28B] FIG. 28B is a side view of FIG. 28A showing a cross-sectional view of the container.

[0059] [Figure 28C] FIG. 28C shows a container without baffles containing the same volume of breast milk as the container with baffles in FIG. 28B.

[0060] [Figure 28D] FIG. 13 is a diagram of a container showing baffles arranged in a honeycomb pattern to control distribution of an even amount of breast milk when receiving the breast milk, according to one embodiment of the present disclosure.

[0061] [Figure 28E] FIG. 1 is a side view of a body showing the dimensions of the body according to one embodiment of the present disclosure.

[0062] [Figure 28F] FIG. 28D attached to the body of FIG. 28E according to one embodiment of the present disclosure.

[0063] [Figure 29A] 1A-1C show a body of the system and a container that fits around the areola of the breast according to one embodiment of the present disclosure.

[0064] [Figure 29B] 13A-13C show variations of a container in which a one-way valve is located externally on an annular container, according to one embodiment of the present disclosure.

[0065] [Figure 29C] FIG. 28C shows the one-way valve and container connection of FIG. 28B folded upward along the baffle line to join the check valve to the system tubing, according to an embodiment of the present disclosure.

[0066] [Figure 29D] FIG. 1 illustrates a container folded for more compact storage according to one embodiment of the present disclosure.

[0067] [Diagram 30] FIG. 1 illustrates a breast milk collection container in a ring shape to encircle the breast, according to one embodiment of the present disclosure.

[0068] [Figure 31A] 1 illustrates a breast adapter including a rigid section into which the nipple fits and a flexible elastic section according to one embodiment of the present disclosure.

[0069] [Figure 31B] FIG. 13 illustrates four different positions into which the chest can be alternately compressed and expanded using four massage actuators, according to one embodiment of the present disclosure.

[0070] [Figure 32A] FIG. 1 illustrates a chest adapter with a vibrating driver according to one embodiment of the present disclosure.

[0071] [Figure 32B] FIG. 1 illustrates a rear view (open end) of the chest adapter showing a vibration driver, such as a motor or piezoelectric device, attached to the chest adapter according to one embodiment of the present disclosure.

[0072] [Figure 32C] FIG. 1 illustrates a portable vibratory drive device operable independently of a breast pump system, according to one embodiment of the present disclosure.

[0073] [Diagram 33] FIG. 1 illustrates a chest adapter with a heating element according to one embodiment of the present disclosure.

[0074] [Diagram 34] 1 illustrates a flexible breast adapter having a suction area that seals to the breast when suction is applied, with a rigid portion housing the nipple and areola of the breast, according to one embodiment of the present disclosure.

[0075] [Figure 35A] 13A-13C are schematic diagrams of the back end of the chest adapter showing suction areas applied as continuous rings or as intermittent rings according to various embodiments of the present disclosure. [Figure 35B]13A-13C are schematic diagrams of the back end of the chest adapter showing suction areas applied as continuous rings or as intermittent rings according to various embodiments of the present disclosure.

[0076] [Diagram 36] FIG. 1 is a schematic diagram of an arrangement in which a first, relatively low suction / vacuum level is constantly applied by the chest adapter through the suction area to maintain a tight seal with the chest, according to one embodiment of the present disclosure.

[0077] [Figure 37A] FIG. 13 illustrates a flexible spring disposed within the container to maintain an open flow path within the container, according to one embodiment of the present disclosure.

[0078] [Figure 37B] FIG. 1 illustrates a flexible porous tube disposed within the vessel to maintain an open flow path within the vessel, according to one embodiment of the present disclosure.

[0079] [Figure 38] 1A-1C illustrate a chest adapter in which a top half (or other top portion) of the adapter has different mechanical properties and / or configuration than a bottom half (or other bottom portion) of the chest adapter, according to one embodiment of the present disclosure.

[0080] [Figure 39A] FIG. 1 illustrates a system utilizing a flexible chest adapter connected to tubing supplied with suction / vacuum by a pump, according to one embodiment of the present disclosure.

[0081] [Figure 39B] FIG. 39 illustrates how the squeezing action of the chest adapter squeezing the chest causes the tubing to collapse temporarily (see FIG. 39B), which changes pressure at the nipple and reopens the tubing when the compressive force on the chest is released (see FIG. 39C), according to one embodiment of the present disclosure. [Figure 39C]FIG. 39 illustrates how the squeezing action of the chest adapter squeezing the chest causes the tubing to collapse temporarily (see FIG. 39B), which changes pressure at the nipple and reopens the tubing when the compressive force on the chest is released (see FIG. 39C), according to one embodiment of the present disclosure.

[0082] [Diagram 40] FIG. 1 illustrates a breast pump system in which the pumping region 30 and reservoir are suspended from a lanyard worn by a user, according to one embodiment of the present disclosure.

[0083] [Diagram 41] FIG. 13 illustrates an embodiment according to an embodiment of the present disclosure where, in addition to the suction / vacuum created by withdrawing a compression element located away from the tube, the compression element is also mechanically coupled to a portion of the breast adapter surrounding the nipple.

[0084] [Diagram 42] FIG. 13 is an exploded view showing the tubes of the system connected to the body according to one embodiment of the present disclosure.

[0085] [Diagram 43] FIG. 13 is an exploded view of the breast pump system showing the pressure sensor located at the proximal end of the chest adapter according to one embodiment of the present disclosure.

[0086] [Figure 44A] 1A-1C illustrate the operation of a pressure sensor for detecting pressure within a breast pump system according to one embodiment of the present disclosure. [Figure 44B] 1A-1C illustrate the operation of a pressure sensor for detecting pressure within a breast pump system according to one embodiment of the present disclosure.

[0087] [Figure 45A] FIG. 13 illustrates a pressure sensor that can be used in a breast pump system according to another embodiment of the present disclosure.

[0088] [Figure 45B]FIG. 45B further illustrates the pressure sensor of FIG. 45A and its operation. [Figure 45C] FIG. 45B further illustrates the pressure sensor of FIG. 45A and its operation.

[0089] [Figure 46] FIG. 2 is a schematic diagram of a pump region usable in any of the breast pump systems described herein, according to another embodiment of the present disclosure.

[0090] [Figure 47] FIG. 1 is a schematic diagram illustrating wireless data transfer from a controller of the system to a smartphone, according to one embodiment of the present disclosure.

[0091] [Figure 48] FIG. 1 illustrates a configuration of the container and tubing connections of the system according to one embodiment of the present disclosure, for monitoring that they remain securely connected throughout the entire extraction and release period, so that breast milk is not lost or wasted.

[0092] [Figure 49] FIG. 13 illustrates that the motor of the system may be equipped with thermal and / or motion sensors that provide feedback to the controller regarding the motor's operating temperature and / or motion, motor motion and / or motion speed, according to one embodiment of the disclosure.

[0093] [Figure 50] 13A-13C show a pressure relief member installed on a chest adapter according to one embodiment of the present disclosure, also showing alternative or additional locations for the pressure relief member.

[0094] [Figure 51] FIG. 2 is a longitudinal cross-sectional view of a breast adapter usable with any of the breast pump systems described herein according to another embodiment of the present disclosure.

[0095] [Figure 52A] FIG. 52 is a longitudinal cross-sectional view of a chest adapter that can be used with any of the breast pump systems described herein and is a variation of the chest adapter shown in FIG. 51.

[0096] [Figure 52B] FIG. 52B is a rear perspective view of the chest adapter and tube of FIG. 52A.

[0097] [Figure 52C] 13 illustrates an embodiment of the present disclosure in which, when the breast is engaged with the system, the lips of the system deflect further inward upon contact with the breast, thereby reducing or eliminating the gap and forcing breast milk out of the gap towards the nipple housing / nipple receiving cavity.

[0098] [Figure 53A] FIG. 1 is a front exploded view showing the breast adapter and tube, main housing 34, and breast milk container 60 according to one embodiment of the present disclosure.

[0099] [Figure 53B] FIG. 53B is a rear exploded view of the components shown in FIG. 53A.

[0100] [Figure 53C] FIG. 53B is a front perspective view showing the chest adapter and tube of FIG. 53A installed on the body.

[0101] [Fig. 53D] FIG. 53D is a rear perspective view of the components shown in FIG. 53C.

[0102] [Figure 53E] FIG. 53C is a front perspective view of the embodiment shown in FIGS. 53A to 53D after installation on the body.

[0103] [Fig. 53F] FIG. 53F is a rear perspective view of the system shown in FIG. 53E.

[0104] [Figure 53G] FIG. 13 illustrates a breast pump system using a full ring-shaped reservoir according to another embodiment of the present disclosure.

[0105] [Figure 54] FIG. 13 illustrates the assembly of the chest adapter and tube to the main body according to another embodiment of the present disclosure.

[0106] [Figure 55A] 13A-13C illustrate the interaction of a compression element with elastic tubing and a pumping sequence according to another embodiment of the present disclosure. [Figure 55B] 13A-13C illustrate the interaction of a compression element with elastic tubing and a pumping sequence according to another embodiment of the present disclosure. [Figure 55C] 13A-13C illustrate the interaction of a compression element with elastic tubing and a pumping sequence according to another embodiment of the present disclosure. [Fig. 55D] 13A-13C illustrate the interaction of a compression element with elastic tubing and a pumping sequence according to another embodiment of the present disclosure. [Figure 55E] 13A-13C illustrate the interaction of a compression element with elastic tubing and a pumping sequence according to another embodiment of the present disclosure.

[0107] [Figure 56] FIG. 13 illustrates a flow sensor in a breast pump system that allows a user to see in real time how much breast milk is being pumped, according to another embodiment of the present disclosure.

[0108] [Figure 57] FIG. 1 illustrates a breast pump system with an indicator light according to one embodiment of the present disclosure.

[0109] [Figure 58A] FIG. 13 is a front exploded view of a breast pump system according to another embodiment of the present disclosure.

[0110] [Figure 58B]FIG. 13 is a front view showing the chest adapter and tube installed on the main body.

[0111] [Figure 58C] FIG. 13 is a diagram showing a process for attaching to a system.

[0112] [Fig. 58D] FIG. 1 shows the assembled system with the container already connected and mated to the body to match its contours.

[0113] [Figure 58E] 58A-58D show the system with the container partially filled with breast milk.

[0114] [Figure 59A] FIG. 13 is a front exploded view of a breast pump system according to another embodiment of the present disclosure.

[0115] [Figure 59B] FIG. 1 is a front view showing the assembled system with the container already connected and mated to the body to match its contours.

[0116] [Figure 59C] FIG. 59C is a rear exploded view of the system of FIGS. 59A-59B.

[0117] [Fig. 59D] FIG. 59B is a partial rear exploded view of the system of FIG. 59A showing the chest adapter and tube already installed on the body.

[0118] [Figure 59E] FIG. 13 shows the process of fitting to the tube and body.

[0119] [Fig. 59F] FIG. 59B is a rear perspective view of the system of FIG. 59A after it has been assembled.

[0120] [Figure 59G]FIG. 59F is a rear view of the system of FIG. 59F after the breast milk has been collected in the container.

[0121] [Figure 60] FIG. 1 illustrates a pressure (vacuum) relief feature that may be provided in any of the systems described herein, according to one embodiment of the present disclosure.

[0122] [Figure 61] FIG. 13 is a longitudinal cross-sectional view of a portion of a tube of a chest adapter showing a pressure relief valve according to one embodiment of the present disclosure.

[0123] [Figure 62] FIG. 1 illustrates the main body of the system having a transparent window to ensure proper nipple placement according to one embodiment of the present disclosure.

[0124] [Figure 63] 13A-13C show an at least partially peelable body that maintains a seal of the chest adapter to the chest according to one embodiment of the present disclosure.

[0125] [Figure 64] FIG. 1 illustrates a pair of breast pump systems that can be placed on both breasts of a user, according to one embodiment of the present disclosure.

[0126] [Figure 65] FIG. 1 illustrates a pair of breast pump systems placed on both breasts of a user and supported by a brassiere, according to one embodiment of the present disclosure.

[0127] [Figure 66] FIG. 66 illustrates the user of FIG. 65 using a breast pump system while in a supine position, according to one embodiment of the present disclosure.

[0128] [Figure 67]FIG. 66 illustrates the user of FIG. 65 wearing a blouse over the breast pump system, using the breast pump system while working at a workstation.

[0129] [Figure 68] FIG. 68 illustrates the user of FIG. 67 with the blouse shown partially transparent to better reveal the breast pump system and bra underneath, according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0130] Before describing the present systems and methods, it is to be understood that this disclosure is not limited to particular embodiments described, as such may, of course, vary, and the scope of the present disclosure is presently limited only by the appended claims, and the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

[0131] Where a range of values ​​is provided, unless the context clearly dictates otherwise, it is understood that each intervening value (to the tenth of the unit of the lower limit) between the upper and lower limits of that range is also specifically disclosed. Ranges between any stated value or value within a stated range and any other stated value or value within that stated range are included in the present invention. The upper and lower limits of these narrower ranges can be independently included or excluded within the range, and each range where either, neither or both limits are included in the narrower range is also included in the disclosure, subject to any specifically excluded limit of the stated range. Where a stated range includes one or both limits, ranges excluding either or both are also included in the disclosure.

[0132] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this disclosure belongs.In carrying out or testing this disclosure, any method and material similar or equivalent to the method and material described in this specification can also be used, but the preferred method and material are described here.All publications mentioned in this specification are incorporated herein by reference to disclose and describe the method and / or material in which the publication is cited in connection.

[0133] It should be noted that, as used in the specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, a reference to a "valve" includes a plurality of such valves, a reference to a "pump" includes one or more pumps and equivalents thereof known to those skilled in the art, and so forth.

[0134] The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. The dates of publication provided may be different from the actual publication dates, which may need to be independently confirmed.

[0135] 1 is an illustration of a breast pump system 100, according to one embodiment of the present disclosure. The system 100 includes a breast adapter 10, a pumping region 30 within a body 34, a check valve 50, and a breast milk storage container 60.

[0136] FIG. 2 is a partial view of the system 100 showing a portion of the chest adapter 10. The chest adapter 10 includes an elastic region 12. The elastic region 12 is made of silicone or other elastic biocompatible material that provides a compliant interface with the breast and also seals around the areola and nipple of the breast, such as, but not limited to, polyurethane and / or polyether block amide (PEBAX). An inner housing 14 is configured and dimensioned to surround the nipple of the breast. The inner housing 14 may be rigid, semi-rigid, or elastic. Preferably, the chest adapter 10 is elastic and made of silicone or polyethylene terephthalate (PET). Other materials and combinations of materials can be used, including, but not limited to, polyurethane, polyethylene, high density polyethylene (HDPE), low density polyethylene (LDPE), polyamide, polyethylene terephthalate (PET), and / or PEBAX. In a compliant embodiment, the inner housing 14 can be repeatedly opened and closed using the system 100 while extracting milk from the breast, thereby simulating a feeding cycle similar to the tongue to nipple sequence when an infant sucks.

[0137] The opening 16 in the housing of the breast adapter 10 is configured and dimensioned so that there is at least some gap and space in front of the nipple to allow milk to flow out of the nipple even when the nipple is pulled forward by suction. The opening 16 makes a U-turn and terminates with a double back, forming an acute angle, minimizing the overall height / profile of the system 100 spaced from the breast.

[0138] FIG. 3 is a partial schematic diagram of the system 100 showing the pumping region 30. An elastic tube 32 is in fluid communication with and extends proximally from the proximal end of the chest adapter 10. Preferably, the elastic tube 32 is integral with the chest adapter 10 as shown in FIG. 1. Two active compression elements 36, 38 are operable to compress and decompress the elastic tube 32 at compression regions 40 and 42, respectively. Although the preferred embodiment uses two active compression elements as shown, alternative embodiments may have three or more active compression elements. The elastic tube 32 is preferably made of silicone, but may alternatively be made of other thermoplastic elastomers that exhibit the desired performance characteristics described herein, including but not limited to polyurethane or PEBAX. Different regions of the tube 32 may be made of different materials / material properties. The regions may all be molded, overmolded, bonded, or attached to the same material and assembled. In at least one embodiment, the compression regions may have different properties than other non-"active" regions. For example, the non-active regions (e.g., downstream of the pumping region and / or other non-active regions) may be rigid to improve pumping efficiency by reducing energy losses due to expansion and contraction of regions not intended to be active. The non-active regions may be made of different materials than the active regions or may be reinforced. The various regions may have shapes other than circular in cross section. The material from which the compression regions 40, 42 of the tube 32 are made may be the same as the material of the flange and nipple housing of the chest adapter 10, optionally differing only in thickness, which may be assembled from different materials and melted or bonded together or insert molded together. As a further alternative, the materials from which the compression regions 40, 42 are made may be different from each other.The selection of material and material thickness and length are driven by the reaction time required to expand the compressed regions 40, 42 from the target compressed shape / state to their original undeflected rebound configuration (e.g., returning to a full cylindrical shape in embodiments where the tube 32 is cylindrical), the force required to compress to the desired target compressed shape, the radial force (pressure drop) that would result if the tube 32 were allowed to self-expand, the volume within the inner diameter of the regions 40 and 42 of the tube 32, compatibility with the material of the remainder of the breast adapter 10 (nipple housing), resiliency to maintain its material properties through multiple washes, and surface and depth characteristics such as aging and use cycles, material transparency, clarity and texture / feel against the skin, visual appearance, mechanical durability, tear strength, shape memory, softness / hardness, biocompatibility, non-reactivity, and leaching freedom, heat / cold resistance, etc.

[0139] Examples of tube 32 include, but are not limited to: silicone tubes such as those used in peristaltic pumps, platinum cured and peroxide cured silicone tubing. Dimensions may vary widely in inside diameter and wall thickness, but preferred embodiments may have inside diameters of 3 / 16", 1 / 4" or 5 / 16". Walls may range in impact characteristics, with preferred embodiments perhaps in the 1 / 16" to 1 / 8" range. By following an appropriate length of tube 32, the inside diameter and wall thickness can be varied as needed. Further alternatively, pumping regions 40, 42 need not be cylindrical tubes or tube shapes at all, but may be any volumetric shape that can be altered / compressed. For example, the cross section may be oval, square, trapezoidal, etc. to fit into the space of the device as needed. Examples of tube inner diameters, wall thicknesses, and hardnesses include, but are not limited to: 0.188 inner diameter, 0.63 wall, 50 shore A durometer type; 0.250 inner diameter, 0.63 wall, 50A durometer type; 0.313 inner diameter, 0.63 wall, 59A durometer type; 0.313 inner diameter, 0.94 wall, 59A durometer type.

[0140] As shown, the compression elements 36, 38 include pistons, but alternative features, such as lever arms, screw devices, clamps, cams, pliers, rollers, magnets, electromagnets, linear drives, solenoids, gears, stepper motors, or other features, respectively, can be used to accomplish the same functions. The compression surfaces of the compression elements 36, 38 may be formed as flat paddles to completely crush the tube 32 without residue. Alternatively, one or both compression surfaces may be formed with "V" edges that are axially aligned with the tube 32, requiring less force to compress the tube 32 to the same compression distance as a flat paddle surface. Further alternatively or additionally, one or both compression surfaces may be formed with cross edges (perpendicular) to the axis of the tube. This provides a relatively small surface area and less force to completely seal the tube 32 at the cross edges. However, this provides a relatively milder volume / pressure altering capability.

[0141] One or both compression surfaces may be formed as roller paddles with curved surfaces so that the compression action is not a simple straight line into the tube 32. The roller paddle surfaces can roll on the tube 32, sealing and moving in a given direction. A dual action of the rollers can be provided so that, first, the rollers compress the tube 32, sealing it. This allows for relatively low force operation. Second, the roller paddles can rotate the compression surfaces in a given direction along the length of the tube 32, squeezing a volume of milk or air or a combination in a given direction. This can be useful to maximize both pressure changes and increased or decreased fluid movement.

[0142] Also, although the preferred embodiments described herein use power provided by one or more batteries to drive the compression elements 36, 38, they can alternatively be powered by AC electricity by plugging the system into an outlet while using suction from a remote source such as an AC power cord, compressed gas, spring loaded power (which may be "hand cranked" to provide a method of powering without electricity), gas, or traditional breast pump applications.

[0143] Each compression element 36, 38 is operatively connected to a respective driver 44, 46 for independently but coordinately driving and retracting the compression elements 36, 38. When an electric driver is used, a battery 48 is electrically connected to the driver 44, 46 and provides the power necessary to operate the driver 44, 46 to drive the compression and retraction of the compression elements 36, 38. Optionally, a controller 52 may be electrically connected to the driver 44, 46 and configured to modify the operation of the compression elements 36, 38 based on input received from an optional pressure sensor 54 (or pressure sensors). The pressure sensor 54 may be located in at least one location to assess pumping function, allow for a wide variation in breast milk expression volume, and maintain an acceptable pumping negative pressure profile. As shown, the pressure sensor 54 is located in the inner housing 14 to measure the negative pressure within the inner housing, the environment in which the nipple resides. Alternatively or additionally, one or more pressure sensors can be placed in the tube 32 upstream of the compression driver 36, between the locations of the compression drivers 36 and 38, and / or downstream of the compression driver 38. Further alternatively or additionally, a pressure sensor can be placed in the tube 32 close to but upstream of the check valve 50. The pressure sensor 54 (and / or flow sensor or any other sensor utilized) may be inserted in the tube 32, but is preferably designed in a manner that produces a signal that correlates to pressure (or flow), but does not necessarily have to come into contact with the fluid and / or gas that is creating the pressure or flow itself. A location that is not in direct contact with the breast milk (inside the tube 32) is preferred for easy cleaning of the tube 32 / chest adapter 10, or for cost-effectiveness of providing the chest adapter 10 / 32 as a disposable unit.

[0144] The sensor 54 is preferably a pressure sensor, but may also be a flow sensor, temperature sensor, proximity sensor, motion sensor, or other sensor capable of providing information usable to monitor the safety or function of the pumping mechanism of the system 100. Preferably, the sensor 54 is located exposed to the breast 2 / nipple 3 near where the tip of the nipple 3 is located to measure the actual pressure, but other sensors 54 may be located within the system 100, for example near where the check valve 50 is located, and can be used to monitor other features such as bag or discharge pressure or flow rate. With at least one sensor 54 present, by directly or indirectly monitoring the flow rate or pressure, and by taking into account the cycles and actual positions of the compression elements 36, 38 over time, the volume of milk produced during the pumping period can be approximately obtained / calculated, and the flow rate at any particular time during the pumping period known. The accuracy of this measurement is greatest when no air leaks around the breast 2 and when there is very little air in the tube 32 after it has been removed by a few cycles of the pumping mechanism.

[0145] In one system assembly, the ideal minimum suction for the cycle is preset and the maximum suction for the cycle is preset. Maximum suction is achieved by opening one or more of the compression zones 40, 42. The more open / released (assuming the tube 32 is capable), the greater the suction. Maximum suction for the system is achieved when both compression zones are fully released from the tube 32, but preferably the system 100 is designed such that the working zone does not include that state for flexibility in suction capacity. Minimum suction is the target minimum suction for the breast 2 in each suction cycle. Once this suction is achieved, the compression zone 40 that is most proximal to the breast 2 is closed / sealed and milk expressed during the previous cycle is forced by the second compression element 38 from the second zone 42 through the check valve 50 to the storage container 60. This timing of this proximal compression is set by a combination of a milk expression rate within the range of the specified maximum suction obtained by the tube 32, and the relaxation rate and expansion state of the tube 32. Thus, the expression of milk sets the pace of the pump cycle with a targeted minimum suction, while the compression ratios of the various compression zones are set by the desired maximum suction pressure, duration, and milk volume in the system. Thus, in at least one embodiment, a user can optimally set the maximum peak pump pressure and maximum valley pump pressure, and the remaining parameters in the system will automatically adjust themselves based on the milk expression rate and other fixed parameters in the system.

[0146] To drive and contract the compression members, the controller 52 may also be pre-programmed to control the sequence of operation. Preferably, the controller 52 drives and contracts the compression members 36 via an active feedback loop 38, adjusting the position of the compression members 36, 38 as necessary to establish a desired negative pressure (i.e., suction) profile to optimize milk extraction. If the controller 52 is not used, the drivers 44, 46 may be synchronized to operate the compression drivers 36, 38 in a desired coordinated manner. For example, one or more pumps may be operated in a predetermined manner without pressure feedback. Alternatively, as previously discussed, different forms of feedback may be utilized. One or more compression elements may be operated in a predetermined sequence to create a vacuum without feedback. There may be a pressure relief valve so that the reduced pressure level felt by the nipple is not too high into a harmful region. Further optionally, a pressure sensor 54 may be used to detect a pressure change indication of the volume of milk being expressed to calculate an approximation of the volume of milk extracted.

[0147] A check valve 50, such as a duckbill valve or other type of check valve, is provided at the end of the tube 32 where it enters the breast milk collection / storage container 60. The valve 50 prevents the backflow of breast milk into the tube 32 while simultaneously preventing air from entering the proximal end of the tube, thus maintaining a suction (reduced pressure) level in the tube 32. In an alternative embodiment, a pressure relief valve may be provided within the breast adapter 10 near the nipple 3. The pressure relief valve may be configured to release at a vacuum greater than a predetermined amount (e.g., a vacuum less than -220 mmHg). The check valve 50 may be configured and designed to allow fluid to flow through the check valve 50 only if the vacuum pressure is less than some threshold (e.g., a pressure of -60 mmHg or greater). The operation of the compression elements cycles between increasing the vacuum as the compression elements move away from the tube 32 and decreasing as the compression elements compress the tube 32, but generally the vacuum should not be increased above a predetermined maximum vacuum (e.g., above -220 mmHg). As the compression elements 36, 38 compress the tube 32, the pressure in the system 100 increases until it reaches a rupture pressure of -60 mmHg, opening the check valve 50. The compression elements 36, 38 continue to compress the tube 32, pumping fluid (breast milk) through the check valve 50 and into the collection container 60 until the compression elements 36, 38 bottom out. When the compression elements 36, 38 reverse direction and move away from the tube 32, the compression elements 36, 38 begin the cycle again.

[0148] 4A-4F illustrate the interaction of compression elements 36, 38 with elastic tubing 32 and the pumping sequence according to one embodiment of the present disclosure. Elastic tubing 32 has a lumen 56. Lumen 56 is sized to deliver breast milk from the breast through check valve 50 to breast milk collection / storage container 60. As shown, tubing 32 is cylindrical and lumen 56 is circular in cross section, however, in alternative embodiments, lumen 56 may be oval or other cross-sectional shapes. Similarly, tubing 32 may have an oval or other cross-sectional shape. The cross-sectional shapes of lumen 56 and tubing 32 are generally the same, but need not be. In a preferred embodiment, the suction (vacuum) established by the system is established solely by the elastic, "spring back" action of tubing 32. The tube 32 is designed and configured to establish a maximum suction / vacuum in the range of less than -60 mmHg, preferably in the range of -120 mmHg to -450 mmHg, and preferably in the range of -180 mmHg to -400 mmHg, when rebounding from the closed configuration shown in FIG. 4B to the fully retracted position shown in FIG. 4A. The tube 32 is designed such that the rebound of the regions 40, 42 creates a suction vacuum in the tube 32 sufficient to ensure that the system 100 achieves a vacuum around the nipple 3, without considering weight loss within the system 100. The vacuum achieved at the breast nipple 3 will achieve a maximum suction of suction of at least 300 mmHg (-300 mmHg pressure). When the system 100 is first placed on the breast 2, several cycles of the compression elements 36, 38 may be required before the vacuum reaches its maximum vacuum. In another embodiment, the maximum suction may be as high as 450 mmHg suction (-450 mmHg pressure).

[0149] In at least one embodiment, the maximum suction / vacuum that can be established by the tube 32 is in the range of -180mmHg to -220mmHg, preferably about -200mmHg. This provides an integrated fail-safe to ensure that the suction / vacuum does not exceed the desired maximum operating range of -180mmHg to -220mmHg, preferably about -200mmHg, which is all that can be obtained by the system. In another embodiment, the maximum suction / vacuum capacity of the tube 32 is greater than the desired maximum operating suction / vacuum. For example, the suction / vacuum capacity may be in the range of -220mmHg to -400mmHg. This greater capacity provides the advantage that the tube 32 will lose some of its elastic / resilient performance over time, in which case the maximum operating suction / vacuum can be further obtained by over-designing the maximum suction / vacuum capacity of the tube 32.

[0150] For ease of manufacture and reduced manufacturing costs, the elastic / resilient properties of the tube 32 and the inner housing 14 may be the same. Alternatively, the elastic / resilient properties of the tube 32 may be different downstream of the compression members 36, 38 relative to the elastic / resilient properties of the tube 32 at the locations 40, 42. For example, the tube 32 downstream of the locations 40, 42 may be more elastic than the tube sections 40, 42, or may be less elastic and less rigid than the tube sections 40, 42. As discussed above, the inner housing 14 may be elastic, semi-rigid, or rigid. In at least one embodiment, the inner housing 14, the tube sections 40, 42, and the tube 32 downstream of the sections 40, 42 are all solidified, made of the same material, and have the same elastic / resilient properties. In alternative embodiments, inner housing 14 may be more, less, or equally elastic than regions 40, 42 and may be more, less, or equally elastic than tube 32 downstream of regions 40, 42. While tube 32 may be elastic by itself, tube 32 may optionally include built-in elastic members (such as coils or braids) that may increase the elasticity or strength of tube 32.

[0151] This disclosure is designed to mimic the application of forces exerted by an infant suckling from the breast to extract milk. During feeding, the infant places its tongue against the nipple / areola area of ​​the breast. During suckling, the infant draws its tongue down and slightly backwards, creating a suction / vacuum to begin sucking milk into the infant's mouth. The infant's soft palate is pulled behind the tongue, thereby sealing a suction / vacuum chamber in front of this contact point into which the milk is drawn by the suction / vacuum. Once a quantity of milk is received in the infant's mouth, the infant swallows. Once the tongue re-contacts the hard palate, this releases maximum suction to the breast, opening a passageway to allow milk to move into the pharynx and then into the esophagus. During swallowing, as the tongue moves up and seals the hard palate, a driving force is generated to move the milk into the soft palate and esophagus. After swallowing, the cycle is repeated by pulling the tongue down again and slightly backwards. During the entire cycle, the baby maintains a negative pressure (suction / vacuum) on the nipple / breast. The present disclosure provides a first compression element 36 that acts like the baby's tongue and hard palate by sealing the duct in area 40, establishing a constant suction against the breast. The second compression element 38 acts like a swallow / soft palate function. In this way, the milk duct does not collapse excessively during the rest or low suction pressure phase, but rather the duct is able to fill, such as when the baby attaches to the breast. Such a refill is more baby-like and more efficient at extracting milk than conventional pumping devices.

[0152] FIG. 4A shows the compression elements 36, 38 in a non-contact configuration (alternatively, they may be in contact without substantially compressing or deforming the tube 32), and the elastic tube may assume its fully undeformed configuration. In this configuration, the cross-sectional area of ​​the lumen 56 is equal in regions 40 and 42 to the cross-sectional area of ​​the lumen 56 adjacent to 40 and 42 in the embodiment shown. In other embodiments, the cross-sectional area of ​​the lumen 56 may not be equal in regions 40 and 42 to the cross-sectional area of ​​the lumen 56 adjacent to 40 and 42. As a further alternative, the cross-sectional areas of the regions 40 and 42 may be different from each other. FIG. 4B shows the configuration of the compression elements 36, 38 in an initial state, where the pumping regions are placed when the system is applied to the breast. Once the corresponding regions 12 have formed a seal with the breast and the system is properly placed, a switch can be turned on and the milk extraction process can begin.

[0153] The initial suction / vacuum / suction is created by contracting the compression element 36 (which is the compression mechanism closer to the breast). The compression element 36 allows the elastic tubing to spring back to its initial shape, creating a local suction / vacuum at the tube opening 16 and the inner housing 14, which is sealed against the breast. As the elastic tubing expands to its non-deformable configuration, it creates a suction / vacuum in the lumen 56. FIG. 4C shows the compression element 36 fully contracted to establish the initial suction. The length 37 of the tube 32 and compression member 36 is preferably designed to establish a suction / vacuum by the contraction element 36 as described, which is at the lower end of the range believed to be sufficient to extract breast milk. For example, the tube 32 shown in FIG. 4C may be configured to establish a suction / vacuum of -120 mmHg, or a suction / vacuum of -180 mmHg, or other suction / vacuum levels below -60 mmHg and up to about -220 mmHg. The suction / vacuum created is sufficient to extract milk from the breast into lumen 56 distal and below compression element 36. Because elastic tube 32 is now a closed system, the suction / vacuum is maintained by lumen 56. Second compression member 38 may be withdrawn to further increase suction / vacuum if necessary, for example to accommodate increasing pressure (without vacuum) as milk enters system 100 from breast 2. Member 38 can further contract away from tube 32 to compensate.

[0154] After a predetermined time, i.e., upon detecting a predetermined flow rate or volume of milk to be extracted, the milk then passes through the tube 32 and the valve 50 into the container 60. FIG. 4D shows the second compression element 38 beginning to contract. At the same time, the first compression element 36 advances to compress the tube 32 at region 40. The operation of 36 and 38 coordinate to achieve and maintain a predetermined minimum suction / vacuum level, typically within the range of −40 mmHg to −70 mmHg, more typically within the range of −50 mmHg to −60 mmHg. The closure time of the first compression element 36 may be predetermined, i.e., the time to activate the closure of the first compression element 36 may be determined based on an algorithm that includes the pressure of the system 100, the mode in which the system 100 is operating (e.g., let-down phase, extraction phase, or expulsion phase, etc.), and / or other data such as the milk expression rate and the timing of the second compression element 38. As the first compression element 36 advances to close off the first region 40, the second compression element 38 continues to retract, allowing the second region 42 to continue to open, consistently maintaining the desired minimum suction / vacuum profile, until the first region 40 is fully closed leaving the desired remaining suction / pressure against the breast (at the minimum suction / vacuum level). As suction is maintained, this action forces the milk proximally through the lumen 56 (to the left in FIG. 4D). This is accomplished by contracting the compression element 38 at the same time that the compression element 36 begins to expand and compress the region 40. As the region 42 expands and the region 40 compresses, this forces the milk against the check valve 50. Thus, the second compression element 38 acts like the infant's swallowing / soft palate, which acts like a soft palate, as the check valve closes against the back of the tongue during the peak suction phase to prevent backflow in the system. 4E shows compression element 36 fully compressing region 40, thereby acting as a shut-off valve and maintaining suction on the breast. When milk is forced into the location of and distal to region 42, compression element 38 is fully retracted. As previously indicated, compression elements 36, 38 are not limited to the embodiment shown.As an alternative, the compression elements 36, 38 may function like clamps or pliers, with two pads each squeezing together while compressing the areas 40, 42 therebetween. Figure 4F shows the compression element 38 again expanded, with the compression element 36 still in the closed valve position. As soon as the area 40 is fully closed by the element 36, sealing the area surrounding the breast, compression of the area 42 by the element 38 may begin. Compression by the element 38 forces the milk from the area 42 further downstream towards the check valve 50. Once the compression element 38 reaches a fully closed (compressed) position, as shown in Figure 4B, the cycle repeats, and the cycle of operation shown in Figures 4B to 4F continues throughout the course of the milk extraction period.

[0155] While the system 100 can function successfully with the pumping tube 32 in any relationship / orientation relative to the nipple, it is preferred to position the compression areas 40, 42 and compression elements 36, 38 higher than the nipple 3 when the system 100 is attached to the breast 2. In this position, air bubbles can be pumped through the tube 32 early in the pumping cycle so that the tube 32 will eventually fill with milk all the way from the nipple 3 to the check valve 50 in most cases. As a result, the benefit is that the system 100 is extremely energy efficient since it approaches a fully hydraulic system. The value of the system 100 having no substantial air content, since breast milk is essentially incompressible, is that suction pressure can be sustainably communicated within the system in a relatively uniform manner with little energy loss to the fluid itself.

[0156] As stated, to extract and deliver breast milk from the breast to the collection container 60, the pump mechanism requires independent and coordinated compression / release of two adjacent portions of the elastic tube 32. Alternatively, although two drive devices 44, 46 are shown in the embodiment of Fig. 3, both compression elements can be driven by a single drive device operating in a coordinated manner. However, two independently operating drives are preferred, as they can be flexibly controlled to change the coordination between the operation of the two compression elements 36, 38 as required. The system 100 is able to maintain a negative pressure against the breast at all times, similar to a normally breastfed baby.

[0157] In one embodiment utilizing one or more pressure sensors 54 and controller 52, the pressure at the one or more sensors 54 may be monitored throughout the milk extraction process. While the region 40 is open as described above with respect to FIG. 4C, the pressure is monitored until the desired milk extraction suction / vacuum level is achieved. In this case, the tube 32 and compression element 36 may be dimensioned to provide a suction / vacuum greater than the lower end of the range of suction / vacuum that may be effective for extracting milk, for example to provide a suction / vacuum within the range of −180 mmHg to −450 mmHg. In this case, feedback from the pressure sensor 54 to the controller 52 informs the controller 52 when the desired suction / vacuum has been achieved and when the controller 52 can control the drive 44 to stop retracting the compression element 36 at a position that is not fully retracted, thus further partially compressing the region 40, when the desired suction / vacuum level has been reached. Additionally or alternatively, if the desired suction / vacuum level is not achieved by fully retracting element 36, element 38 can be retracted an amount that will bring the suction / vacuum level to the desired suction / vacuum level.

[0158] The relative positions of the compression elements 36, 38 correlate to the tube volume in the regions 40 and 42 as long as the compression elements 36, 38 are in contact with the tube 32. Thus, knowing the total volume of the tube 32 and the remaining breast adapter 10 that constitutes the suction / vacuum space, once the tube 32 distal to the pumping region 30 is filled with milk and the extraction phase begins, the system allows an estimate of the volume of milk to be pumped by calculating the volumes of the regions 40 and 42 over the course of the extraction and expression. Alternatively, additional information obtained, for example by monitoring pressure changes at the breast 2, the speed and direction of the compression elements 36, 38, and / or the data history of the force and / or pressure versus the current time, can be used to calculate an estimate of the volume to be pumped. Further optionally, flow or optical sensors may be utilized to provide an estimate of the volume and / or a measurement of the extent to which the tube 32 fills in a given region of the tube 32 to aid in estimating the volume of milk to be pumped. By assuming the fluid volume in the system 100 (the tube 32 being filled) and then knowing the pressure curve showing the pressure contained within the system 100 over time, any changes in pressure can be taken into account in the position, speed and direction of the compression elements 36, 38 and then the impact due to the flow of breast milk from the breast 2 can be estimated.

[0159] 5A-5C are diagrams illustrating the operation of a system 100 having only one compression element 38 according to one embodiment of the present disclosure. In this embodiment, first and second check valves 50', 50'' are provided adjacent opposite ends of the compression region 42 of the tube 32 where the tube is compressed by the compression element 38. FIG. 5A shows the initial configuration of the system when it is first attached to the breast 2. Once sealing of the system 100 to the breast 2 has been achieved by any of the methods previously described and let-down has occurred, pumping of the expressed breast milk can be accomplished by compressing the region 42 with the compression element 38 as shown in FIG. 5B. As pressure increases due to compression of the region 42, the breast milk is moved by the check valve 50' as shown by the left-pointing arrow in FIG. 5B. At the same time, the check valve 50'' prevents backflow of the breast milk and maintains a vacuum against the breast 2. In Figure 5C, the compression element 38 has been retracted away from the tube 32 so that the tube 32 elastically expands, increasing the vacuum (reducing the pressure) in the tube 32. This closes the check valve 50' and opens the check valve 50'', extracting milk from the breast 2 into the region 42. Extraction and pumping of milk can continue by cycling between the stages shown in Figures 5B and 5C.

[0160] To prevent the vacuum against the breast from becoming too strong (to limit the pressure from becoming too low), the compression element 38 can be controlled by slow speed control of the drive device 46. If no milk flow is detected, the drive device 46 can be controlled to stop pumping. Alternatively, the drive device 46 may be controlled to pump for a predetermined amount of time after no flow detection occurs, to further stimulate the nipple 3 / breast 2, thereby signaling or conditioning the breast 2 to produce more milk. The system 100 may include a relief valve 502 in or adjacent to the breast adapter 10. This relief valve 502 may be set to open when a predetermined maximum vacuum level is reached, such as -200 mmHg or -220 mmHg. This is a typical maximum vacuum level intended to be applied to express milk from the breast 2. The relief valve may be independent of the operation of the check valve 50, as shown, or alternatively may be configured to squeeze or vibrate the check valve 50'' to close the check valve 50'' and prevent the vacuum against the breast 2 from exceeding the predetermined maximum vacuum. Once the check valve is restored by vibration or expression, the vacuum against the breast will not exceed the maximum vacuum.

[0161] The breast milk container 60 is preferably a flexible bag that fits over the body / housing 34 in a collapsed state so that it does not take up significant volume until breast milk is received in the breast milk container 60, but closely follows the contours of the housing 34 without expanding the overall size of the system 100 when received in the bra, such as in the bra 130 and between the bra and the housing. As mentioned above, the container is also intended to be placed within the housing, adjacent to or around the pumping structure, or alternatively, between the pumping structure and the user's breast. A check valve is connected to the proximal end of the tube 32 (already placed in the flow path 232), completing the assembly of the system 100 as shown in FIG. 1. Disassembly can be accomplished quite simply by reversing the order of assembly described above.

[0162] FIG. 6 shows the body / housing 34 of the system 100 without the container 60 attached, i.e., without the tube 32 and adapter 10 attached, illustrating the dimensions of the components shown according to one embodiment of the present disclosure. It should be noted that the disclosure is not limited to the dimensions disclosed with respect to FIG. 6, as this is just one particular embodiment of the present disclosure, and may vary. Any or all of the dimensions may be increased or decreased as necessary, for example, to accommodate different chest sizes. The outside diameter 240 of the system housing 34 in FIG. 6 is 9 cm. The total thickness 242 of the device housing 34 in FIG. 6 (and thus the entire system 100 with the container 60 in the collapsed configuration) is 4 cm. The diameter of the opening 244 where the proximal end of the tube 32 is attached to the check valve is approximately 13 mm. The diameter of the receptacle 230 for receiving the chest adapter 10 is 4.5 cm. Also shown is a display 250 that can be output by the controller 52 to show, for example, whether an air leak has occurred, what the current suction / pressure readings are in the adapter 10 and tubing 32, the approximate volume of milk expressed, the approximate milk flow rate, the pressure waveform, the phase of the feeding timing, the still programming, the heating to the breast, the vibration applied to the breast, etc. The display can also show when the system is running and when it is stopping, the duration of the pumping period, the time, the date, the countdown time, the speed or frequency of the pumping cycles, the strength of the vacuum, etc. The display may be backlit to make it easier to read in the dark. Additionally, controls 252 are provided to allow different modes of operation by the user, including, but not limited to: power on, indication of on / off status, increase or decrease applied to various modes, such as pumping cycle frequency and vacuum strength, selection of pumping program version, timer, etc. The controls are conveniently located along the exterior surface of the device for easy access by the user. Alternatively, the display 250 may consist of only lights, such as indicator lights, for example.Further alternatively, lights may be provided under one or more of the controls 252 or where the milk duct 32 exits the body 34. Lights as disclosed may be configured to illuminate in different colors to indicate various modes or information, or may flash. Additionally or alternatively, audio features such as a speaker and amplifier may be provided to generate one or a variety of sounds to inform the user of various modes, the end of a pumping period, time, various pressure thresholds reached, etc. When the display 250 is used to communicate the volume of milk pumped, the duration of the pumping cycle, the mode the pump is in, or read out minimum / maximum pressures that can be set by the user.

[0163] It is further noted that the receptacle 230 (which contains the breast adapter 10 and therefore receives the nipple) is not centered in the housing 34, but is positioned such that its center is below the center of the housing 34. This allows the system 100 to rest higher on the breast, rather than centered around the nipple, to better conform to the user's anatomy and to be less noticeable when worn in the bra 130. Additionally, the inner surface 254 is tapered, rather than flat. The inner surface is tapered from the edge / periphery of the inner surface 254 to the inner housing 230 of the nipple, creating a cup shape. As the breast adapter 10 is placed against the breast 2, it is ideally concave, receiving the breast 2 comfortably and providing a smooth surface for an effective suction seal. Thus, the surface 254 is slightly tapered to conform to the breast 2, resulting in a more discreet wearing of the system 100. There may be a slight bulge in the taper to provide a better sealing area at / around the chest 2.

[0164] FIG. 7 illustrates a chest adapter 10 / tube 32 configured and dimensioned to fit into the embodiment of the body / housing 34 of the system 100 shown in FIG. 6. As with FIG. 6, it is noted that this is just one particular embodiment of the disclosure and the disclosure is not limited to the dimensions disclosed with respect to FIG. 7, which may vary. The outer diameter 256 of the chest adapter 10 is 4 cm at its opening. The inner diameter 258 of the chest adapter 10 in the area where the nipple is received is 20 mm as shown. The chest adapter narrows (260) in a position designed to minimize the distance beyond which the nipple will be placed when forming a nipple under maximum suction / vacuum applied by the system 100. It is noted that the neck down region 260 is optional and is not included in many embodiments. If present, the neck down region 260 is provided to lightly seal the nipple / nipple. Alternatively, the chest adapter 10 / tube 32 may have smooth walls along its sides, allowing the nipple / nipple 3 to move freely, as shown in Figure 7B. The assembly shown in Figures 7A-7B (as well as the remainder of the system 100) is designed such that the interface or opening of the chest adapter 10A is substantially perpendicular to the longitudinal axis 2L of the breast 2 and nipple 3 as it is formed by the system 100 at the nipple. Alternatively, the chest adapter 10 may be configured such that the longitudinal axis 2L forms an acute angle with the opening surface or chest adapter / back surface of the system 100, as shown in Figure 7D. Such a construction may reduce the thickness, i.e., the distance the system 100 extends from the chest.

[0165] The spacing of the necked down regions 260, i.e., the spacing of the smooth regions 260' that transition into the tube 32, is preferably in the range of about 1 mm to 5 mm. The inside diameter 262 of the tube 32 where it joins the chest adapter 10 proximal to the neck region 260 is 20 mm in these embodiments. The tube 32 is then tapered to an inside diameter of 6 mm and compressed in regions proximal to these regions all the way to the proximal end of the tube 32. The opening 244 in the body 34 has an inside diameter of about 13 mm and is configured and dimensioned to receive the tube 32 with some additional clearance so that the extension 62 (male embodiment) can overlap the tube 32. The chest adapter 10 / tube 32 unit is configured to be removed from the system 100 after use for cleaning and refitting of the housing 34 as shown. When the chest adapter 10 / tube 32 is attached to the housing 34 (see FIG. 42), the regions 40, 42 snap-fit ​​(or friction-fit) into grooves or channels 430 between portions of the compression elements 38, 36 such that the regions 42, 40 can be compressed without colliding with the chest adapter portion 10.

[0166] 8A and 8B are schematic front and side views, respectively, of a breast pump system 100 illustrating the placement and routing of the tube 32 according to one embodiment of the present disclosure. In this embodiment, the distal end portion of the tube 32, which is integral with the breast adapter that receives the nipple 3 of the breast, is located below the nipple 3, thus forming a milk collection well 32W and facilitating filling and priming of the pump area 40. Once the milk enters the tube 32 and enters the pump area 40, the tube 32 can be routed in any direction. In the embodiment shown, the tube bends around the housing 34 and up to a location at the top of the housing 34 where it can be attached to a container 60 with a check valve in between. As mentioned above, different routing schemes for routing the tube 32 can be used, such as routing to the side of the housing instead of the top, or routing horizontally from the well 32W to the side of the housing 34 and then up around to the top of the housing 34, or routing over the pumping area as shown in FIG. 8A and then back to the bottom of the housing 34.

[0167] In some embodiments, it may be desirable to vary the dimensions and / or materials of the tube 32 along its length. FIG. 9 is a schematic side view of an example of a system 100 having varying dimensions along the length of the tube 32, and optionally varying materials from which various portions of the tube 32 are made. Further optionally, the wall thickness of the tube 32 can vary along its length to vary resilience / compliance characteristics, whether the various portions are made of the same or different materials, and whether one or more portions are reinforced with braids, coils, etc. to increase stiffness. In this embodiment, the well region 32W has the smallest diameter, i.e., the smallest cross-sectional dimension, of any region of the tube, to minimize the volume of breast milk that needs to be collected in the pre-pump region of the tube 32 before it enters the pumping regions 40, 42 and is pumped. The pumping regions 40, 42 of the tube have the largest diameter, allowing for a larger pressure change per length of the tube 32, due to the longer compression strokes by the activators 36, 38. To reduce compliance and increase milk flow rate by forming regions 40, 42 to the container 60, the tube may be formed downstream (proximal) of regions 40, 42 from a relatively stiffer material than the portions forming regions 40, 42. Additionally or optionally, a portion of tube 32 may be formed downstream of region 42 that is smaller in diameter than portions 40, 42.

[0168] FIG. 10 shows a sequence of events that can be performed in operating the system according to the present disclosure when performing the process of extracting breast milk from a breast. At event 502, the system is applied to the breast, including sealing the corresponding area 12 of the breast adapter 10 to be substantially airtight (the system can recover and accommodate small air leaks) and thereby forming a substantially liquid-tight seal to minimize or eliminate breast milk leakage. There are different embodiments to accomplish this task. The most basic and preferred embodiment is to form the seal by suction / vacuum alone. This can be achieved by activating the system actuator 82 (see FIG. 1) to power up the system and begin generating suction / vacuum. The actuator 82 may power up the controller 52 when the controller 52 is present, or may power up the drivers 44, 46 and perform a predetermined routine when the controller 52 is not present. When moving from the orientation shown in FIG. 4B to the orientation of FIG. 4C, the seal can be achieved by retracting the first compression element 36 in the manner described. If a seal is not established by retraction of the first element 36, the element 36 can cycle between the positions shown in Figures 4C and 4B until a sufficient seal is achieved. As the element 36 compresses during cycling, this causes air to move between the breast and the corresponding area 12, increasing the static suction (vacuum) build-up while the element 36 retracts, thereby increasing the suction / vacuum in the breast adapter 10 and tube 32 with each cycle. In embodiments in which a pressure sensor 54 and controller 52 are utilized, the controller 52 can cycle the element 36 until a predetermined level of suction / vacuum is achieved, thereby determining that a sufficient seal has been formed. Advantageously, cycling the element 36 in this manner facilitates let-down of the breast milk, preparing it for extraction.

[0169] In an alternative embodiment, the seal may be established by adhesion, ie, an adhesive surface 84 may optionally be provided on the inner surface of the corresponding area 12 (see FIG. 2). The sticky surface may be provided by applying an adhesive, for example the type of adhesive used on stoma pouches for colostomy patients, or any other effective biocompatible adhesive or glue. Sealing of the corresponding areas 12 to the chest may be established either via the adhesive surface 84 alone (or by a surface treated with a material that becomes adhesive when heated by the body heat of the breast 2 when in contact with the breast), or with the establishment of suction / vacuum as described in the previous embodiment. Additionally, pressure or heat may be optionally applied to further facilitate sealing of the adhesive areas to the chest. In another embodiment, which may be used with any of the previous embodiments or alone, the chest adapter 10 is configured to be compressed once attached to the chest and then released. The chest adapter 10 then elastically returns to its original structure, thus establishing suction / vacuum to seal the corresponding areas 12 to the chest, in much the same way that a suction cup is applied to a flat surface. Additionally, the system may be handheld against the chest until sufficient suction / vacuum is established to create a seal. Further optionally, the system may be supported by a brassiere configured to hold the system during its operation.

[0170] At event 504, the system establishes a suction / vacuum level sufficient to extract breast milk from the breast. This is accomplished by controlling the movement of compression element 36 and, optionally, compression element 38 in coordination with the movement of compression element 36. An initial vacuum / suction is created by retracting compression element 36 (which is the compression mechanism closer to the breast) to create a local suction / vacuum against the breast. As the elastic tubing expands towards its undeformed configuration, it creates a suction / vacuum in lumen 56. FIG. 4C shows compression element 36 fully retracted to establish the initial suction. Preferably, tube 32 and length 37 of compression member 36 are designed to establish a suction / vacuum that is at the lower end of the range that is deemed sufficient to extract breast milk by retracting element 36 as described. For example, the tube 32 shown in FIG. 4C can be configured to establish a suction / vacuum of −120 mmHg, or a suction / vacuum of −180 mmHg, or other suction / vacuum levels from less than −60 mmHg to about −220 mmHg. The suction / vacuum generated is sufficient to extract milk from the breast into the lumen 56 at a location distal to the compression element 36, as well as below. Since the elastic tube 32 is now a closed system, the suction / vacuum is maintained by the lumen 56. The second compression member 38 can be withdrawn to further increase the suction / vacuum if desired. In an embodiment in which a controller 52 and pressure sensor 54 are utilized, the detected pressure will decrease once milk enters the system, so feedback from the pressure sensor to the controller can indicate whether the suction / vacuum is sufficient to establish a flow of milk from the breast. Once the feedback loop between the controllers establishes that extraction of breast milk has not yet begun, the controller 52 can then stepwise control the retraction of the compression member 38 until sufficient suction / vacuum is established and breast milk begins to be extracted, as confirmed by the pressure regulator feedback loop. Such control of the second compression member 38 may occur after the first compression member 36 has been fully retracted, or may be performed while the first compression member is being retracted.Further alternatively, the first compression member may not be fully retracted, but some combination of partial retraction of members 36, 38 may be used to achieve the desired suction / vacuum level. In instances where the predetermined suction / vacuum level that is designed to be established when tube 32 alone and compression element 36 alone are fully retracted is insufficient to extract breast milk for a particular user, the controller may be programmable by the user to initially establish a suction / vacuum level above the predefined suction / vacuum level, such that the controller will initially automatically activate compression elements 36, 38 to thus establish a high suction / vacuum level, regardless of pressure sensor feedback. The pressure regulator feedback loop may further be used to adjust the suction / vacuum to extract breast milk, as needed.

[0171] Once milk begins to extract, the suction / vacuum is maintained at event 506 for a predetermined period of time, i.e. until a predetermined volume of milk has been extracted or when a predetermined minimum pressure is achieved indicating that a predetermined volume of milk has been expressed into the system 100. By constantly measuring the pressure in the system (preferably, but not necessarily, near the nipple), an estimate of the volume of milk extracted can be calculated by the controller 52. As milk enters the suction / vacuum space, the pressure drops. The volume of milk received in the suction / vacuum space is proportional to the pressure drop, and therefore the volume of milk can be estimated by knowing the pressure drop. However, this also relies on ensuring that the seal between the system and the breast is not broken and no air leaks occur. Because air leaks are recorded in the system as a continuous, somewhat constant pressure change towards zero, they can be easily distinguished from changes in vacuum measured by receiving breast milk in a suction / vacuum space, as these changes are discontinuous and continue to increase the pressure (reducing the vacuum / suction) rather than remaining relatively constant.

[0172] Once the predetermined time has elapsed, i.e. preferably in an embodiment where the volume of milk to be extracted is estimated, milk is moved proximally from region 42 at event 508 while sealing the suction / vacuum space distal to region 42 using compression element 36 as described above to maintain a constant suction / vacuum pressure at the breast / nipple below the extraction suction / vacuum. This can be achieved by compressing tube 32 with element 36 and simultaneously retracting compression element 38 as described above with respect to Figures 4D-4E, maintaining the desired suction / vacuum level until a seal is formed by element 36. The rate at which elements 36 and 38 respectively extend and retract, and the amount element 38 retracts, are dynamically adjusted depending on system variables including the volume of milk present and the suction / vacuum level used during the extraction phase.

[0173] Once compression element 36 has sealed conduit 32 at region 40, compression element 38 immediately controls the expulsion of milk from region 42 during the expression phase by moving the milk proximally to region 2. This is accomplished by extending compression element 38 from any position of termination to a fully compressed position during event 506, closing the conduit and moving the milk proximally from region 42. Such movement of compression element 38 generates a positive pressure driving force, which is advantageous in that it allows milk to be pumped directly through valve 50 to container 60, regardless of the orientation of the components, even against the force of gravity. Now, compression elements 36, 38 are positioned as shown in FIG. 4B, and processing returns to event 504 to perform another cycle of milk extraction.

[0174] FIG. 11 illustrates events that may be executed in a control process for extracting breast milk according to one embodiment of the disclosure. In event 602, the tube 32 is properly aligned with the nipple of the breast, in any of the ways already described above, and the corresponding area 12 of the breast adapter 10 contacts the breast so that a seal is established. In event 604, suction / vacuum is generated in the breast adapter, which facilitates the seal of event 602, even if not yet firmly established, and establishes the suction / vacuum used in milk extraction. The suction / vacuum pressure is constantly monitored by the controller 52, either continuously or intermittently. Event 606 is whether sufficient suction / vacuum is available to establish a seal. When the system 100 is supported by the bra 130, an initial seal can be established with a vacuum that can be maintained in a pressure range of -1 mmHg to -60 mmHg. In practice, the system is programmable with a sealing vacuum threshold level that confirms that a seal has been established, the sealing vacuum threshold level being within the range of -20 mmHg to -60 mmHg. In one particular embodiment, the sealing vacuum threshold level is -40 mmHg. Of course, it is understood that a vacuum pressure of less than -60 mmHg is also sufficient to establish a seal. If there is no leak and sufficient suction / vacuum (predetermined suction / vacuum level) is determined, then processing proceeds to event 608. If the pressure reading indicates that there is a leak or that a sufficient suction / vacuum level has not otherwise been established, then suction / vacuum continues to be generated at event 604. This can be accomplished by cycling the compression element 36 in the manner as described above. Additionally, if the pressure reading indicates an air leak, the user may readjust the interface between the corresponding area 12 and the chest, which may optionally include applying adhesive and / or holding or pressing the system 100 against the chest 2 until sufficient sealing vacuum is established. Cycling through events 606 to 604 continues until sufficient suction / vacuum is generated to establish a seal.

[0175] At event 608, the suction / vacuum is adjusted to a predetermined extraction suction / vacuum level, which is greater than the residual suction / vacuum level possibly applied to the breast when no milk is being extracted. This predetermined extraction suction / vacuum level may be any of those already described and is established by controlling the movement of compression elements 36 and optionally 38, as described above. This pressure is continually monitored by controller 52 in the manner described above.

[0176] At event 610, the pressure drops, and if this drop in pressure is characteristic of the suction / vacuum space receiving breast milk and maintaining a seal, then processing proceeds to event 618. If the pressure does not drop in a manner indicative of the suction / vacuum space receiving breast milk, then at event 612, it is determined whether the pressure drops characteristically indicating an air leak. If an air leak is indicated, then the user may be alerted via an audio signal or a message on the display 250 or the like, a vibration of the system, an automatic shutoff of the system, a signal or message sent to an external device such as a smartphone, or an indicator light, and the user may realign the corresponding area 12 in contact with the breast to eliminate the air leak. Such adjustments may include any or all of the following: applying hand pressure to the system on the breast, rotating or moving the corresponding area 12, removing the corresponding area 12 from contact with the breast, applying adhesive to the corresponding area 12, and reestablishing contact between the corresponding area and the breast. Once the contact has been adjusted, the system returns to event 604. The distinction between air leakage and milk extraction is not necessarily important, since the system 100 is adaptable even when a certain amount of air leakage is present. In the range of suction operation, air leakage will be abnormal, and if this type of leakage is present, it will become a large leakage, for example when the system 100 is temporarily removed from the breast 2. This will result in a much more rapid pressure rise than the pressure rise due to milk extraction.

[0177] Refer again to event 618. Once the pressure has dropped sufficiently such that the estimate of the collected breast milk volume equals or exceeds a predetermined volume (e.g., in the range of 0.02 to .064 ounces, typically about 0.032 ounces), then the system is controlled to change from the extraction phase to the expression phase at event 622, and breast milk is forced downstream (proximal) of regions 40 and 42 in the manner previously described. Once expression is complete, processing returns to event 608 to perform another extraction phase of the cycle. This cycle can continue for a predetermined period of time, or until a predetermined volume of breast milk is estimated to have been extracted, or for a predetermined number of cycles, or any combination of these endpoints, at the limit of the first endpoint, the cycle is discontinued. Such a decision is determined at event 624. Once the condition (predetermined time, predetermined volume of breast milk, or predetermined number of cycles) is met, the system shuts down at event 626. For example, during a typical pumping period in which 150 ml of milk is extracted and pumped, if the period lasts 15 minutes, the system 100 will pump 10 ml of milk per minute. An infant sucking on the breast 2 typically sucks about 30 times per minute. To repeat this, the system 100 cycles about 30 times per minute, with each stroke of the system 100 averaging about 0.33 ml (0.33 ml / cycle). The capacity of the pumping system 100 is therefore configured to accommodate at least about 0.33 ml (perhaps allowing for a little more variability between women) within each compression zone, but generally around that amount. Since there is some natural "dead volume" between the nipple 3 and the first compression zone 40, and the dead space immediately preceding the compressor 38 and the one-way valve 50 is desirably narrow, this volume should also be compensated for in the capacity of the system 100.

[0178] An advantage of the present invention is that the system provides very good control over the overall waveform of suction / vacuum pressure established against the breast. In particular, since the suction / vacuum by element 36 occurs closely adjacent to the breast itself, there is very little loss in the transmission of suction / vacuum pressure from element 36 to the breast. In existing systems, in some instances, the suction / vacuum pump is placed at a significant distance from the breast, with at most 200 mmHg of pressure loss head measured from the pump to the breast. The distance 92 (see FIG. 12) between the compression element 36 and the end of the nipple, which is drawn by the suction / vacuum into the opening 16 to form the nipple 2', is minimized to maximize the responsiveness of applying suction / vacuum to the breast. Additionally, minimizing the distance 92 helps to reduce the total amount of space the system extends from the breast when worn. When the nipple 2' is fully extended, the distance 92 may be within a range of about 0.5 mm to about 3 mm, typically about 1 mm to 2 mm.

[0179] Distance 94 (the length of compression member 36) is related to the amount of suction / vacuum obtained by moving the element from the position shown in FIG. 4B to the position shown in FIG. 4A. The length / distance of the compression member can vary depending on the amount of suction and movement desired by this component. For example, length / distance 94 can be a value in the range of 0.2 cm to 6 cm, typically about 2 cm. Distance 96 between elements 36 and 38 should be minimized to minimize dead space between the compression elements, since element 38 cannot move the contents proximally to this space and must move on to the next cycle. Thus, the greater the distance 96, the less efficient the expression phase will be. Distance 96 can be a value in the range of 0 mm to 5 mm, preferably as close to 0 mm as possible. The distance 98 (length of the second compression element 38) is designed to provide the ability to generate sufficient pre-suction / vacuum so that the suction / vacuum pressure on the breast 2 can be dynamically adjusted to accommodate a variety of different variables that arise during use by the same user as well as across uses by different users, including but not limited to: different rates of milk being extracted, different total volumes of milk being extracted (ranging from 0 ml to 240 ml, typically about 76 ml of milk per breast 2 per extraction period), the amount of suction / vacuum required to extract the milk, etc. For example, the length / distance 98 may be a value in the range of 0.2 cm to 6 cm, typically about 2 cm. The distance 102 between the proximal end of the second compression element 38 and the check valve 50 should also be minimized to reduce the volume of milk between the pumping mechanism and the valve 50 that is not pumped out of the tube 32 until one or more consecutive cycles. In one example, distance 102 was a length that would hold a total volume of breast milk of about 0.25 ml to 3 ml, typically about 1 ml.

[0180] 13A-13B are partial views of a system 100 utilizing a second compression element 38 according to another embodiment of the present disclosure. In this embodiment, a compression effector 38A is rotatably attached to a driver 38B via a joint 104. As the compression element advances relative to the tube 32, a mechanism 104 rotates the compression effector 38A relative to the driver 38A (clockwise as shown in FIG. 13B) such that as the compression effector 38A rotates, a distal end portion of the compression effector 38A advances beyond the proximal end, as shown in phantom in FIG. 13A. At a predetermined distance (e.g., when the distal end of 38A seals against the tube 32, or at some other predetermined distance less than that required for sealing), the mechanism 104 counter-rotates the compression effector 38A (counter-clockwise as shown in FIG. 13B) and advances the proximal end of the compression effector 38A further relative to the tube 32. These actions provide a better force vector (in the direction of arrow 106) for pushing breast milk towards the check valve compared to a compression element 38 having a non-rotating compression effector 38A.

[0181] 13C-13E show another rotating compression element 38 according to one embodiment of the present disclosure. In this embodiment, the compression effector 38A and the upper portion of the shaft 38B are relatively rigid, while the lower portion of the shaft abuts the compression effector 38A but is elastic and forms a joint 104. As the compression element 38 advances towards the tube 32, the lower portion of the compression effector 38A first contacts the tube 32. As the compression element 38 continues its advance and begins to compress the tube 32, an equal and opposing force pushing on the compression effector 38A by the tube 32 deflects the joint 104 due to a lever arm provided by the lower portion of the compression effector 38A applied to the joint. This causes the compression effector 38A to rotate (in a counterclockwise direction shown in FIG. 13D while increasing the angle 910). As shown in Figure 13E, such rotation can continue until the compression effector is perpendicular to axis 38B and aligned with tube 32, with angle 910 forming a right angle depending on the distance the compression element 38 travels relative to tube 32. As the element 38 retracts away from the tube, joint 104 resiliently returns to its unaltered configuration, as shown in Figure 13C. Figure 38F shows yet another embodiment of a compression element 38 configured to perform similarly to the embodiment of Figure 13C, but with the resilient joint 104 replaced with a pin joint 104 and a biasing member 910 interconnecting a portion of the compression effector 38A to axis 38B above the pin joint 104 to bias the compression effector 38A in an orientation non-perpendicular to axis 38B.

[0182] FIG. 14 is a partial view of a system 100 utilizing a second compression element 38 according to another embodiment of the present disclosure. In this embodiment, the compression effector 38A is divided to provide independently operable segments 38A that can be advanced and retracted individually. Although four segments are shown in FIG. 14, more or less can be utilized to operate in a manner similar to that described. The segments 38A are slidably attached to the drive instrument 38B via a telescoping shaft 108 that is spring biased by a biasing member 110 to bias the position of the segments 38A relative to the drive instrument 38B, as shown in solid lines in FIG. 14. As the compression element 38 advances relative to the tube 32, the cam 108 rotates (clockwise as shown in FIG. 14) relative to the drive instrument, contacting the distal-most segment first and extending that segment from the drive instrument 38A so that it extends further into the tube 32 than the other segments 38A. As the driver 38A advances further and the cam 108 rotates, the next most distal segment 38A contacts the cam 108 and the segment 38A extends from the driver 38A. This process can continue until all segments are extended as the most distal segment shown in FIG. 14, completely closing the space 42. As the driver 38B retracts, it no longer contacts the cam 108, causing the cam 108 to rotate back and the biasing member retracts the segment 38A relative to the driver 38B to the position shown in solid lines in FIG. 14. Alternatively, once the driver 38B is fully extended, the cam 108 can be designed to customize the final profile of the segments 38A to adjust the amount of extension of the individual segments 38A a desired distance from the driver 38B. Further alternatively, the drive device need not advance at all, but instead the compression element 38 can be designed such that the rotation and counter-rotation of the cam 108 and the retracting force provided by the biasing member 110 causes the segment 38A to extend and retract.

[0183] FIG. 15 is a partial view of a system 100 utilizing a first compression element 36 according to another embodiment of the present disclosure. The embodiment of compression element 36 may be combined with any of the embodiments of compression element 38 described herein. In this embodiment, the compression effector 36A of compression element 36 is minimized so that it has a length 94 in the range of about 1-4 mm, preferably in the range of about 1-2 mm, and is effective to seal the tube 32 (as described with respect to FIG. 4B), but works in cooperation with compression element 38 to establish sufficient suction / vacuum to extract breast milk. By minimizing the length 94, less force is required to seal the tube 32 compared to the force required to seal the tube using compression element 36 of the embodiment of FIG. 14, for example. This results in energy savings, using a smaller drive equipment 44, a smaller battery 48 due to lower energy requirements, and / or a longer operating time before the system 100 needs to be recharged or plugged into an AC power source (in embodiments where this is possible). The response time of system 100 may also be faster. The time required to completely seal or release the compression element 36 and tube 32 may be shorter. Also, less volume is moved during feedback to reach final closure. Thus, the smaller profile aligns with a nearly constant volume of the final seal movement as the sealing element 36 nearly closes and waits for pressure feedback to control the larger compression element 38 to establish the desired pressure before closing. Thus, the seal can be more precisely and accurately controlled.

[0184] FIG. 16A is a partial view of a system 100 according to another embodiment of the present disclosure, in which one or both of compression elements 36 and 38 are attached to the tube 32. The compression elements are attached to the tube 32 at 38C along a portion or all of the respective surfaces of the compression elements that contact the tube 32. This attachment may be by mechanical means such as adhesives, welding, banding, etc., containment between jaws of a clamp formed by a compression actuator, twisting and sealing, bolting and sealing, etc. This attachment provides a system with the ability to generate suction / vacuum by actively driving the tube sections 40, 42. Thus, suction / vacuum can be generated by a combination of forces provided by the elasticity of the tube sections 40, 42 and the driving force applied by the compression elements 36 and 38, or by the force applied by the compression elements 36 and 38 alone. One advantage that such an arrangement may provide is that the response time of the tube 32 to return to an uncompressed state can potentially be sped up by the rapid movement control of the compression elements 36, 38.

[0185] FIG. 16B illustrates one way in which the tube 32 can be configured to be attached to one or both of the compression elements 36, 38, according to one embodiment of the disclosure. In this embodiment, a tab 320 is integral with the tube 32 and extends radially therefrom to connect to the compression elements 36, 38. The tab 320 may be made of the same material as the tube 32 and may be integrally molded therewith, or may be laminated to the tube 32 or otherwise integral therewith. Optionally, the tab 320 may be reinforced with a reinforcing layer 322, such as, for example, a fibrous mesh or other layer of material stiffer than the material from which the tab is constructed. The reinforcing layer may be laminated inside the tab material or may be provided as a support layer. An opening 324 is provided to facilitate connection of the compression elements 36, 38 to the tab 322. The opening 322 may be optionally reinforced with a ring or grommet 326 that is integrally joined to the opening by molding, welding, adhesive, or other means. Figure 16C is a partial cross-sectional view of a compression element 36 attached to tube 32, according to the embodiment described with respect to Figure 16B. A pin or rod 324 passes through opening 324 and connects to compression element 36 at both ends. In an arrangement in which compression elements 36, 38 connect to tube 32, actuation of compression elements 36, 38 assists in the expansion of tube 32, thereby increasing the speed at which tube 32 rebounds from the compressed configuration and / or increasing the force applied by the expansion of tube 32.

[0186] FIG. 17A is a partial view of a system utilizing another embodiment of the compression element 36. In this embodiment, the small protrusion 36D extends across the entire width of the compression effector 36A, so that when the compression element 36 is fully extended, it is sufficient to span the width of the tube 32 and seal the small protrusion 36D. Since the length 114 of the protrusion is quite small, for example in the range of about 1-4 mm, preferably 1-2 mm, a much less force needs to be applied to the compression element 36 to seal the tube, as compared to sealing the entire length of the compression effector 36A, as occurs in the embodiment of FIG. 14. Similarly, the depth 116 provided by the protrusion 36D does not need to be large, being in the range of 1-10 mm (maximum equal to the outer diameter or height in non-circular cross-section embodiments) of the tube 32, preferably 1-3 mm. The length of the protrusion 36D is not limited to the preferred values ​​described, as of course any length less than the entire length of the compression effector 36A can be utilized, but the shorter the length, the greater the energy savings. Similarly, the depth 116 can be varied from the range given, however, as the depth increases, the volume moved by the remaining compression effector is reduced resulting in a trade-off between energy saved and volume moved, which is an inverse relationship.

[0187] FIG. 17B is a cross-sectional view of the compression element 36 taken along line 12B-12B in FIG. 17A. This view shows the remainder of the contact surface 36E (excluding the protrusions 36D) contoured to further reduce energy consumption while retaining substantial capacity to move volume. In this embodiment, the cross-sectional shape of the contour 36E is substantially V- or U-shaped, so that the ridge 36F preferably runs the length of the compression effector 36A, but not necessarily in the middle of the width of the compression effector 36A, and is aligned with the longitudinal axis of the effector 36A. This ridge 26F first contacts and then presses against the tube 32, and as compression increases, more of the contoured surface contacts and compresses the tube. However, none of the contoured surface 36E seals against the tube, since that function is solely provided by the protrusions 36D.

[0188] In the embodiments described thus far, the compression elements 36, 38 compress the tube 32 against a generally flat "anvil" surface of the channel 232 within which the tube sits 34. FIG. 17C is a cross-sectional view of the compression element 36 with the tube 232 received in the channel 232 that is generally flat, i.e., has a flat anvil surface 232A. Note that the width 232W of the channel 232 is greater than the outer diameter of the uncompressed tube 32, so that there is room for the compressed tube 32 to expand when it is flattened. The width of the compression element 36 is also greater than the outer diameter of the uncompressed tube 32, and typically has a width approximately equal to the width of the fully compressed tube 32. Alternatively, as shown in FIG. 17D, the anvil surface 232A of the channel 232 may be generally V-shaped in cross-section, and the compression element 36 (and / or 38) may have a generally V-shaped compression surface 36S. This results in a reduced force required to completely seal the tube 32 by the compression element 36 compared to the amount of force required to seal the tube 32 in the embodiment shown in Figure 17C. Additionally, other non-flat anvil surfaces 232A may be provided to reduce the overall force required to seal the tube 32 by the compression element 36. Another non-limiting example is shown in Figure 17E where the anvil surface 232 is concave and the compression surface 36S is convex.

[0189] The recoil / recoil stored energy in the elastic tube 32 itself, as described above, is the primary, if not the only, means for suction in the system 100 in the preferred embodiment. One or both of the compression elements 36, 38 can be attached to the tube 32 to supplement the recoil force of the tube 32 as described herein. The vacuum is created by a change in volume of the chamber / tube 32. As already mentioned, the tube 32 does not have to be circular in cross section, but can be any shaped chamber where a vacuum is created by a volume change (via a valve). The vacuum is created by the rebound action of the walls of the tube / chamber 32. Other means for moving the walls can be magnetic, for example both compression elements 36, 38 are actuated to move them by various electromagnetic means. Alternatively, an electromagnetic member can be embedded or attached to the wall of the tube / chamber 32, which can be actuated electromagnetically to change the position of the wall to create the vacuum. As a further alternative, a shape memory alloy (such as NITINOL) can be constructed in or on the wall such that a pre-shaped / structure is created and with an electric current, the shape changes and affects a change in the geometry of the tube. This shape can be initiated or activated to compress the tube 32. Additionally, any other structure / means of changing the state of the material via electricity or other means can be used, so that the change in state causes a change in the geometry of the tube / chamber 32 and changes the volume. The system 100 is capable of maintaining a negative pressure on the breast at all times, similar to a normal breast-fed baby. The breast 2 includes conduits through which the milk is expressed. As a suction / vacuum level of expression is applied to the breast, the diameter of the conduits increases due to the suction / vacuum and milk is expressed from the conduits. Once the milk is expressed from these conduits, they become nearly empty and collapse. This is typically when the baby swallows or when the milk extraction system is cycled and waiting for the next extraction stage. In existing systems where the suction / vacuum is reduced to zero (normal pressure) during the extraction phase, the ducts constrict and no milk can be expressed, although some milk can be made up from the larger ducts upstream that open onto the nipple surface.For breast-fed infants, as with the use of the current system 100, the suction / vacuum applied to the breast during the extraction phase (swallowing in the case of the infant, expressing phase in the case of the current system) is maintained at a lower suction / vacuum pressure than the extraction suction / vacuum, but still greater than normal pressure. In one non-limiting example, the suction / vacuum during extraction is -200mmHg, and the intermittent suction / vacuum applied to the breast during the extraction phase is approximately -50mmHg. The suction / vacuum applied during the extraction phase is not great enough to extract milk from the nipple, but is sufficient to maintain a level of expansion of the radius of the duct, allowing for more replenishment between extraction phases, without substantial extraction of milk.

[0190] In at least one embodiment, drivers 44, 46 are each stepper motors and are controlled by a controller 52. Because compression driver 36 can be controlled to always be in a fully open or fully closed (sealed) position, it can be operated by a motorized cam rather than a stepper motor, since a motorized cam does not require the complex drive inputs of a stepper motor. In this case, compression driver 38 can be controlled by a stepper motor to dynamically adjust via a feedback loop to controller 52, which controls stepper motor 46 to: position compression driver 38 to ensure that the desired residual suction / vacuum is applied to the breast when compression driver 36 seals area 40; drive compression driver 38 to generate the appropriate pressure waveform to express milk; and drive compression driver 38 at a controlled rate and pressure of expression of milk past check valve 50. Alternative drivers that can be used as drivers 44, 46 include, but are not limited to, an electromagnet on one of the compression elements 36 or 38 with an iron or magnetic core on the other side of the tube opposite the compression element, which when current is activated compresses the tube 32, a cammed motor, or a motor that drives a clamp with a rack and pinion drive system, either linearly or rotary.

[0191] FIG. 18 is an isolated view of a breast milk collection / storage container 60. In the embodiment shown in FIG. 18, the container 60 is a flexible, hemispherical bag that encloses the body 34 of the system when attached to the system. As shown, a check valve 50 is preferably provided integrally with the container 60, but alternatively, it is removable, i.e., it can be attached to the tube 32 either integrally or removably. By providing the check valve 50 in a tube that is integral to the container 60, this allows the container 60 to be immediately sealed once removed from the tube 32, avoiding leakage. The container 60 is preferably a compliant bag made of a biocompatible, food-grade material, such as low density polyethylene (LDPE). Alternative materials that can be used include, but are not limited to: linear low density polyethylene (LLDPE), polylactic acid (PLA), polyvinyl chloride (PVC), ethylene vinyl acetate (EVA), high density polyethylene (HDPE), or polyethylene terephthalate (PET).

[0192] The breast milk is collected in the container 60 under the dynamic pumping force / pressure of the pumping mechanism / region 30. Thus, the system 100 does not rely on gravity to collect the breast milk in the container 60. This is advantageous because it allows the user to extract and collect breast milk while lying down, squatting, or over gradients uphill in environments such as bumpy drives such as car or airplane travel. This also allows flexibility as to where the collection bag / container 60 (and the input to it) is placed relative to the nipple of the breast. For example, the container 60 can be placed near, on, above, below, and to the side of the breast. In the embodiment shown in Figures 1 and 5, when the system 100 is attached to the breast, the input to the container 60 is at the breast. This allows easier attachment to the container 60, removal of the container 60, and replacement of another container 60 on the system 100 when filling or use is required.

[0193] FIG. 19 illustrates the connection features of the tube 32 and container 60 that allow the container to be easily and quickly attached / detached to / from the tube 32. An extension 62 of the check valve 50 is configured to snap-fit, i.e., engage with a mating receptacle 66 via a detent 64 at the proximal end of the tube 32, providing a quick, gas- and liquid-tight seal. One or more seals, such as an O-ring 63, may be provided at the junction to facilitate the sealing process. For example, with the illustrated detent and receptacle arrangement, the container 60 can be easily and quickly attached to the tube 32 by inserting the extension 62 into the proximal end of the lumen 56 and rotating the extension 62 / container 60 a quarter turn. It can be easily removed by rotating a quarter turn in the opposite direction. Other quick connection mechanisms that allow for quick and easy establishment of a liquid-tight and gas-tight connection may be substituted for those described. It should be noted that, alternatively, the connection mechanism can be reversed, with the male portion at the proximal end of tube 32 and the female portion at extension 62. As a further alternative, check valve 50 can be integrally formed with either the male or female extension at the distal end of tube 32, and the mating part of the connection mechanism can be integrally formed at the opening of container 60.

[0194] Upon removal from the system 100 (as well as prior to coupling the container 60 to the system 100), the container 60 can be capped to prevent fluid from flowing out therefrom and to prevent air from entering the container, as shown in FIG. 20. Since the cap 68 includes the same mating features 66 as seen on the proximal end of the tube 32, the cap can be rotated a quarter turn and the extension 62 can be snap-fit ​​or otherwise attached in the same manner as the extension 62 was attached to the tube 32. Additionally, as shown in FIG. 21, a feeding nipple 70 can be attached to the extension 62 in the same manner as the tube 32 and cap 68 were attached, sealing the extension in a liquid-tight and air-tight manner so that the container 60 can be fed directly by the infant. Thus, the container containing breast milk can be configured to be fed immediately to the infant after removing the container 60 from the system 100. Alternatively, the container 60 can be capped and stored in a refrigerator or freezer for later use.

[0195] 22 illustrates a bottle 72 into which a container 60 having a nipple 70 attached thereto can be inserted and contained to provide a more structural apparatus that can be more easily used to feed an infant. The bottle 72 includes a hollow shell 72 that is configured and dimensioned to receive the container 70 and allow the nipple 70 to extend from its open end. A bottle cap 74 has an opening through which the nipple 70 can extend and that is configured and dimensioned to surround the open end of the shell 74 when the bottle is assembled. The bottle cap 74 can be secured to the shell 74 by a threaded engagement, a bayonet engagement, a snap fit, or other similar arrangement. The assembled bottle 72 is ready to be used to feed an infant as shown, or alternatively can be stored in a refrigerator or freezer for later use.

[0196] 23 is an exploded view of an alternative arrangement for installing the container 60 on the bottle 72 with the feeding nipple 70. In this embodiment, a plug-in adapter 120 is provided to fit the container 60 for use with the currently sold and readily available commercially available nipple 70 and bottle 72. The plug-in adapter includes a valve break-off extension 122 that includes a central lumen 124 in fluid communication with an annulus 126 of the adapter 120. The valve break-off extension 122 is configured and dimensioned to be inserted through the check valve 50 and remain open to allow milk to be drawn through the valve break-off extension and nipple 70. In another embodiment, the check valve is removable and is removed prior to installation of the adapter 120. The top surface 128 of the adapter 120 is flat and configured to seal fluidly and airtight with the flat bottom surface of the nipple 70. After inserting the valve break-off extension 122 through the check valve 50, the container 60 is dropped or placed into the bottle 72. The bottle's threads 70T are engaged by mating threads 120t at the bottom of the adapter, forming an air-tight and liquid-tight seal therebetween. A second set of threads 120W is provided on the top of the adapter 120 and mates with threads 128T of a nut 128 and is tightened to physically hold the flange of the nipple 70. The underside of shoulder 128H compresses the flange 70F between it and the top surface of the adapter 120, creating a seal as the threads are tightened. The threads and sizes of the adapter 120 and nut 128 can be manufactured in a variety of dimensions and standards to fit various bottle and nipple manufacturing standards.

[0197] FIG. 24 is an illustration of the system 100 placed on the breast 2 around the nipple 3 and supported by a brassiere 130 in which the system 100 is received. Because the flexible reservoir 60 conforms to the curvature of the brassiere 130, wearing the system 100 is highly unnoticeable. Also, due to the flexibility of the reservoir 60 and the dynamic pumping action of the system 100, the reservoir 60 may be in a collapsed state prior to filling it, so that the reservoir 60 does not virtually take up space within the brassiere 130. Thus, only the contour of the body 34 of the system 100 adds any bulk to the appearance of the breast. When the reservoir 60 begins to fill with breast milk, the breast 2 decreases in size by an equivalent volume of breast milk expressed, and therefore the appearance of the components supported by the brassiere does not change significantly.

[0198] The breast milk collection container 60 need not be hemispherically shaped as described above, but can alternatively be formed to have different shapes. Additionally, an array of different sized and / or shaped containers may be provided to accommodate different storage needs (container having a larger capacity for breasts that produce and express more breast milk) and placement (different sizes or shapes for placement between breasts). FIG. 25 illustrates a breast milk collection container 60a according to one embodiment of the present disclosure. The collection container 60a may be made from any of the same materials as described above for the manufacture of the collection container 60. In this embodiment, the breast milk collection container 60a is shaped like a conventional blood collection bag, such as the type used by the Red Cross for blood donations, but like the container 60, includes a check valve 50 and extension 62. Due to the dynamic pumping capabilities of the system 100' (same as 100, but used in the container 60'), the container can be placed between breasts, as shown in FIG. 26, and connected to the tube 32 at the top or bottom (or other location) of the container 60a. Also shown in FIG. 26 are alternative positions where the user may support the container 60a. These include, but are not limited to, the following: supported in a holster attached to the torso just below the chest, or by a belt around the user's waist, or clipped to a belt around the user's waist. Alternatively, the container 60a may be supported in a pocket of a blouse, sweater, or jacket worn by the user. As a further alternative, the container 60a may be supported by a table or other external structure if the user is not moving during the extraction process. Optionally, the container 60a may have an extension tube 32', which may include an extension 62 having the same characteristics as the tube 32 and a connection mechanism that connects to the tube 32 of the system 100'. The extension tube 32' is particularly useful for placing the container 60a away from the chest position.

[0199] FIG. 27A shows a system 100″ that is the same as system 100, except for the use of a donut-shaped collection canister 60b. The collection canister 60b can be made from the same materials as described above for manufacturing the collection canister 60. The collection canister 60b fits over the top of the chest 2 and surrounds the body 34 of the system 100″. Thus, the profile of the system 100′ extends less far from the wearer's body than the system 100, since the canister 60b does not overlap the body 34, as is already evident from the side view of FIG. 27B. Alternatively, instead of forming a complete ring, the donut-shaped canister 60b can only extend over a predefined arc, for example within a range of about 180 degrees to 355 degrees. In this embodiment, the volume gain of the container 60b resulting from the collection of breast milk is equal to the volume loss of the breast having the volume of breast milk extracted, resulting in no change in the volume contained within the user's brassiere 130 and no noticeable difference in the user's appearance before and after the breast milk is collected in the container 60.

[0200] Any collection container described herein may optionally include one or more baffles or other constrictions to facilitate uniform fluid distribution and avoid unsightly wearer bulges that may otherwise occur in collection containers without such restrictions. All breast milk here accumulates at the bottom of the container by gravity. FIG. 28A shows a donut-shaped container 60b with a baffle 76 midway between the inner and outer surfaces of the donut shape. Note that in this example, the container 60b is connected to the tube 34 via an extension 62 at the bottom of the container 60b. This is independent of the inclusion of the baffle 76, but is shown as one of the alternative locations where the container can be attached to the tube 34. The baffle 76 is placed on the container 60b and opposing layers of the container are fused or glued together to limit the container 60b from expanding as much as it might otherwise. Various shapes such as pie sectors, waffles, etc. can be formed by the baffle 76. Additionally, the container 60 may be shaped to take into account the contour / three-dimensional geometry of the body 34 that will match. Optionally, an additional polymer layer 61 may be provided on top of the baffle 76 to smooth the outer surface of the container 60 and improve the aesthetics of the container when worn by smoothing the outer surface. FIG. 28B is a side view of FIG. 28A showing a cross section of the container 60b. FIG. 28C shows that the container 60b without the baffle contains the same volume of breast milk as the container 60b with the baffle 76 of FIG. 28B. In comparison, it is easily observed that if not all of the breast milk accumulates at the bottom of the container 60b of FIG. 28C, most of it will create a bulging appearance under the wearer's clothing. In contrast, the breast milk is evenly distributed in FIG. 28B and does not appear to have unsightly asymmetric bulges.

[0201] FIG. 28D is an illustration of the container 60 with the baffles 76 arranged in a honeycomb pattern to control distribution of an even volume of breast milk when the container 60 is received. FIG. 28E is a side view of the body 34 illustrating the dimensions of the body 34 according to one embodiment of the present disclosure. In this embodiment, the total distance 280 from the top to the bottom of the body 34 measures approximately 9 cm. The distance 282 where the body 34 begins to taper inwardly to follow the contour of the breast 2 until the taper ends at the bottom of the body 34 measures approximately 7 cm. The dimension of this portion configured to receive the nipple 3 measures approximately 2 cm in diameter. The total length 284 of the body 34 measures approximately 4.5 cm. The distance 286 between the most proximal surface of the body 34 and the proximal bent end of the nipple receiving cavity is approximately 1 cm. The length 284 of the nipple-receiving cavity is approximately 3 cm, and the body 34 extends distally from the distal end of the nipple-receiving cavity a distance 290 of approximately 0.5 cm. It should be noted that the above dimensions are merely exemplary and that any and all of these dimensions may be varied for other embodiments. Figure 28F is an illustration of the container 60 of Figure 28D attached to the body 34 of Figure 28E, and shows in phantom the nipple 3 received in the nipple-receiving cavity of the body 34.

[0202] As mentioned, the container 60 may have various baffles / waffles 76 to control the shape of the container and / or the volumetric distribution of breast milk. The size and / or shape of the waffles 76 helps the container 60 conform to curved surfaces. The baffles / waffles 76 can locally control the height or protrusion of the container. For example, it may be beneficial for the container 60 to be able to expand more at the top of the body 34, in which case less dense waffles / baffles 76 would be provided at the top of the container 60 compared to the bottom of the container 60. The bottom of the container with denser waffles will minimize the expansion height at the bottom of the container, resulting in a more aesthetic and discrete change in the shape and contour of the breast during pumping.

[0203] The container 60 may be larger than the pump housing (body) 34, such that a portion of the container can contact the skin of the breast 2. Also, the container 60 may be contained within the housing 34, centered or adjacent to the pumping structure, or the container can be located between the pumping structure or housing and the user's breast. As a further alternative, the container 60 may be a dual shape, cavity, or compartment. A portion of the container 60 may be on top of the body and may only be able to collect a predetermined volume of breast milk, such as 4 ounces or other predetermined volume. The remaining portion of the container 60 may be suspended below or to the side of the breast 2. This allows for distribution of breast milk volume and aids in discretion / aesthetics as well as weight distribution. By keeping the additional breast milk volume next to the skin, the moment arm length / weight of breast milk is prevented from moving further out from the woman's breast. This allows for easy and stable attachment of the breast 2 to the system 100 for comfort.

[0204] Alternatively, the breast pump system can have multiple methods of collecting breast milk. For example, if desired for comfort or aesthetic reasons, when the user anticipates expressing more than 5 oz of breast milk per breast, the system 100 can replace the on-pump container 60 with a tube that is attached at the same point and transfers the breast milk to a "remote" collection tube, such as a remote collection container worn on the waist or in a purse / bag held over the shoulder or placed on a desk.

[0205] FIG. 29A shows a container 60c used in the system 100''' that fits around the body 34 of the system and the areola of the breast 2. In this example, the container 60c is connected to the tube 34 at the bottom of the body, and the check valve 50 is provided on the inner surface of the annular container. FIG. 29B shows a variation of the container 60c in which the check valve 50 is located on the outside of the annular container. Baffles 76 are formed in the container 60c to help distribute the breast milk evenly, but also to make the container easier to fold. FIG. 29C shows the check valve and the connection of the container 60c folded upward along the baffle 76 line to join the check valve 50 to the tube 32 of the system 100'''. After collecting the breast milk in the container 60c and removing it from the system 100''', the container 60c can be folded in thirds along the other baffle 76 lines for more compact storage, for example in a refrigerator or freezer, as shown in FIG. 29D.

[0206] 30 shows another embodiment of a breast milk collection container 60d that encircles the breast 2 in a ring shape and includes a check valve 50. Additionally, the container 60d includes a tab or flap 78 that extends from the breast milk receiving portion of the container 60d and is not configured to contain breast milk. Because the flap / tab 78 is separate from the breast milk volume receiving portion, it is possible to do what is written above or otherwise noted without potentially puncturing the breast milk receiving portion or contaminating the contained breast milk. The tab / flap 78 feature can be provided to any of the breast milk collection container embodiments described herein.

[0207] Various variations and embodiments of the breast adapter 10 can be utilized in the system 100 to enhance milk withdrawal and extraction, improve fit comfort, and provide other benefits. FIG. 31A shows a breast adapter including a rigid portion 80 into which the nipple is inserted and a flexible elastic portion 82. Massage drivers 84, such as rollers driven by a motor 86 that advance and retract the rollers 84 against the breast to massage the breast, or other mechanical equivalents such as pumps or motor-driven lever arms, provide a mechanical massage to the breast, simulating the action of an infant suckling, potentially improving milk extraction. The massage drivers 84 can be provided in two or more planes and deform the breast along two or more directions. FIG. 31B shows four different positions 86a, 86b, 86c, 86d, whereby the breast 2 can be alternatively compressible and expandable using the four massage drivers. These massage drivers can be actuated in many different patterns to provide different massage actions. More than two, less than two, or even four massage drivers 84 can be provided to design a variety of different massage patterns.

[0208] Figure 32A shows an embodiment in which the breast adapter 10B includes a vibration driver 90. The vibration driver 90 may be in the form of a piezo transducer that may be electrically driven by a battery 48 to vibrate the breast 2 at a desired frequency, which may help stimulate let-down and / or extraction of breast milk. The frequency of the applied vibration may be in the range of 100Hz to 30kHz, typically around 250Hz.

[0209] The vibration drivers 90 may be utilized in any of the embodiments of the breast adapter described herein. Alternatively, the massage drivers 84 may be modified to provide a vibration frequency to the breast 2. As a further alternative, the vibration drivers may be provided in a different element of the system 100, or in an additional element separate from the system 100, as opposed to providing them in the breast adapter 10. Although six vibration drivers 90 are shown in FIG. 32, more or fewer may alternatively be used (as few as one). The vibration drivers 90 may stimulate let-down of the breast milk by applying vibrations to the breast 2, for example, by applying vibrations for 90 seconds or less. Additionally, the vibrations provided to the breast may increase the flow capacity and / or rate of the breast milk during extraction by stimulating the release of hormones and / or by physically rocking the breast. The vibrations may also help prevent the ducts in the breast from becoming clogged. The vibrations may aid in flow and help prevent clogged ducts. This may also be useful to unblock ducts and / or increase milk flow beyond what would have been achieved without applying vibration. Vibrations may also be applied to distribute / enhance flow. Various frequencies may be activated in different modes applied to achieve different effects (or combinations thereof). Relatively slower vibration frequencies may be more articulated, resulting in bulkier mechanical movements, while higher frequencies may actually match resonant frequencies with smaller structures such as milk ducts. Different structures within the breast may be targeted based on the frequency and amplitude of the applied vibration force.

[0210] FIG. 32B is a rear view (open end) of the chest adapter 10 showing the vibrating drivers 90, such as motors or piezoelectric devices, attached to the chest adapter 10. Since one or more of the vibrating drivers 90 are always activatable, activation patterns can be implemented such that the drivers 90 vibrate or massage at different times in a sequence that produces a squeezing or massaging motion. Additionally, the power or frequency provided to each driver 90 can be varied as desired. FIG. 32C shows a handheld vibrating driver 900 that is operable independently of the system 100. In the illustrated embodiment, the handheld driver 900 is a pen or other elongated instrument configured with one or more motors or piezoelectric vibrators. Optionally, different attachment devices may be provided to vary the shape of the contact surface and / or distal end 902 of the instrument 900 used to contact the target location 5 of the breast 2 to be vibrated or massaged. As in the embodiment of FIG. 32B, the frequency or power applied by the instrument 900 can be varied by the user as desired.

[0211] FIG. 33 illustrates an embodiment in which the breast adapter IOC includes a heating element 92. The heating element 92 may be in the form of an electrical resistive coil or element, a piezoelectric transducer, or other alternative element that is electrically powered by a battery 48 to generate heat. The generated heat may be applied to the breast 2 to help stimulate let-down and / or extraction of breast milk. The heating element 92 may be utilized in any of the breast adapter embodiments described herein. The heating element 92 may be utilized in conjunction with a vibration driver 90. Although four heating elements 92 are illustrated in FIG. 33, a greater or lesser number may alternatively be utilized (as few as one). In clinical trials, heating has been demonstrated to increase the flow rate and rate of expression. Thus, the heating element 92 may provide heat to the breast for increased flow rate, reduced clogging, reduced rates of mastitis, etc.

[0212] The application of suction / vacuum by the breast adapter 10 to the breast 2 can be varied. FIG. 34 is a schematic of a breast adapter 10D having a suction area 94 that is flexible and seals against the breast 2 when suctioned, but has a rigid portion 96 that receives the nipple and areola of the breast. FIGS. 35A and 35B are schematic views of the back end of the breast adapter 10D, showing that the suction area 94 can be attached to a continuous ring 96a or an intermittent ring 96b. Suction on the breast 2 makes the attachment and seal to the breast 2 more dynamic / more secure. The embodiment of FIG. 34 and FIG. 35A shows a ring of suction that can further act to seal against the breast 2. The embodiment of FIG. 35B targets the suction force on the breast 2 to ensure that the system 100 is attached to the breast 2 without falling off, and the suction force depends on the suction cycle of the pumping mechanism to maintain the seal. By applying suction intermittently (as opposed to a continuous suction ring), the smaller mating area being suctioned requires less suction / power generated by the suction source to maintain attachment.

[0213] Figure 36 is a schematic diagram of an apparatus in which a relatively low suction / vacuum level is constantly applied by the breast adapter 10D through suction area 96a to maintain a seal on the breast. A second, greater suction / vacuum level is intermittently applied to the space 98 surrounding the nipple 3 for extraction of breast milk.

[0214] 37A-37B show features that may be provided in a breast milk collection container 60 to reduce the risk of the sides of the container sticking together, static or other obstructing forces, when the container is not open to receive breast milk. In FIG. 37A, a flexible spring 370 is provided in the container 60a, which keeps the flow path in the container open, does not impede flow due to the loosely wound coils of the spring, and because the spring 370 is flexible, the container 60a remains flexible. In FIG. 37B, a flexible porous tube 372 provides a similar function to the spring 37. It should be noted that although elements 370 and 372 are shown used in the container 60a, these elements may be used in any of the other embodiments of the breast milk collection container described herein as well.

[0215] 38 shows another embodiment of a chest adapter 10E in which a top half (or other upper portion) 380 of the adapter 10E has different mechanical properties and / or composition than a bottom half (or other lower portion) 382 of the chest adapter 10E. In the embodiment shown, portion 382 is flexible, and portion 382 is rigid or less flexible than portion 380. When used with massage driver 84, chest 2 will be massaged at its bottom rather than along the top, although not in the same way.

[0216] Figure 39A shows a system utilising a flexible breast adapter 10F connected to a tube 32 to which suction / vacuum is applied by a pump 390. Applying a squeezing action by the adapter 10F to compress the breast 2 (either by a massage driver 84 or other compression means) causes the tube 32 to temporarily collapse (see Figure 39B), thereby changing the pressure at the nipple 3. Releasing the compression force on the breast 2 causes the tube 32 to re-open (see Figure 39C) and milk is extracted into the tube 32.

[0217] 40 illustrates a breast pump system 300 in which the pumping region 30 and reservoir 60 are suspended from a lanyard 420 worn by a user. The length of the lanyard 420 is adjustable so that the user can position the pumping region 30 and reservoir 60 lower or higher than shown to provide a comfortable position for the user. Tubing 32 interconnects the pumping mechanism 30 with the breast adapter 10 and may be provided in both breasts 2 as shown, or alternatively may be provided in only one breast 2.

[0218] Figure 41 shows an embodiment in which, in addition to the suction / vacuum created by pulling the compression element 36 away from the tube 32T, the compression element 36 is also mechanically linked to a portion of the chest adapter 10 surrounding the nipple 3. Thus, as the element 36 moves away from the tube 32T, the element 36 also pulls that portion of the chest adapter 10, opening it wider and creating more suction / vacuum around the nipple 3. As the compression element 36 compresses the tube 32T, as shown in Figure 41, it also mechanically moves the wall of the chest adapter 10, reducing its cross-sectional area.

[0219] Referring again to FIG. 2, the pressure sensor signal received by the controller 52 from the pressure sensor 54 can be used to plot the pressure / suction (vacuum) waveform applied by the system 100 during operation. In addition, the pressure sensor 54 signal can be used to determine when milk begins to flow, as well as the rate or volume of milk flow, based on pressure changes resulting from milk being present in the adapter 10 and / or the tube 32. As the milk is not compressed, ignoring losses associated with air leakage, and assuming most of the air has been purged from the system 100, a peak suction P(p) occurs upon release from the compressor element 36 / 38 as the walls of the tube 32 rebound to resume an undeflected configuration (no milk inflow). In this state, the tube 32 deforms to have less volume inside, referred to as volume V(p). When there is no milk inflow, P(p) and V(p) can be maintained as constants. As milk inflow occurs, the tube 32 begins to return to its natural shape. With each incremental amount of volume of breast milk being introduced into the system 100, the suction force in the tube 32 is reduced. The reduced suction level is referred to as P(n) and the volume associated with each increment is V(n), where n is equal to a positive integer that starts at 1 and increases by 1 with each increment of breast milk received. Eventually, the pressure reaches a final suction pressure P(f) that corresponds to the final maximum volume of V(f). Thus, each detected pressure can be converted to a volume, either via a look-up table or by a direct equation. As a result, the volume of breast milk passed in one cycle of the system is equal to V(f)-V(p), which can be determined by measuring P(f) and P(p). When used in detecting let-down and initial expression of breast milk from the breast, upon detection of the initial expression, the controller 52 can control the compression elements 36, 38 to change from the mode used to initiate the let-down and initial extraction (which may be accomplished by rapid cycling of the compression element 36 alone, or a combination of rapid cycling of elements 36 and 38) to an extraction mode, for example by operating elements 36, 38 to maintain a predetermined maximum suction / vacuum (such as -180 mmHg, -200 mmHg, or -220 mmHg).Upon detecting a predetermined volume of breast milk that has entered the system, the controller 54 can again change the operation mode of the elements 36, 38 to perform an expression phase, where element 36 seals the breast adapter at a predetermined suction / vacuum level (e.g., −50 mmHg, or −60 mmHg) and element 38 operates to push breast milk out of region 42 under positive pressure. After the expression phase (when element 38 completes its stroke), the controller 54 again changes the operation mode of the elements 36, 38 back to the extraction phase.

[0220] The cycle frequency, pressure (suction / vacuum) amplitude can be controlled by the controller 54 based on feedback from the pressure sensor 52. These variables can be altered by the controller to optimize milk extraction based on estimates of milk flow rate and / or milk volume calculated from pressure readings. Additionally, the controller 52 can be programmed to terminate the process when the sense of milk flow rate decreases to a predetermined outflow rate, including but not limited to a zero outflow rate, or alternatively, can be programmed to terminate the process a predetermined time after the outflow rate reaches zero. By continuing to apply suction / vacuum in the extraction phase for a predetermined period of time (e.g., 30 seconds, 1 minute, 2 minutes, or some other predetermined time) after the outflow rate reaches zero, this has the potential to stimulate the breast and increase milk production for the subsequent feeding / milk extraction process. Any of these automatic control schemes by the controller 52 can be overridden by the user to select different programming or to operate the system 100 in a manual mode via use of the control device 252.

[0221] Because the compression drive elements 36, 38 are located very close to the nipple 3, the suction / vacuum waveform generated thereby is very little damped compared to currently existing systems which typically locate the suction / vacuum pumps quite far from the nipple. This provides the advantage of providing pressure (suction / vacuum) waveforms such as suction / vacuum changes with relatively high frequency which would not be possible with prior art systems as damping would render them ineffective. For example, the controller 52 can be programmed to mimic a nursing baby, in one example, by mimicking the baby applying three rapid suctions or sucks at the breast, followed by a longer duration of sucking, and then repeating the cycle. This entails activating the compression elements 36, 38 to provide maximum suction / vacuum (e.g., -200 mmHg) to the breast 2 / nipple 3 for a very short duration (e.g., less than half a second), followed by reducing the suction / vacuum to a minimum of continuously applied suction / vacuum (e.g., -60 mmHg), repeating this cycle two more times, and applying maximum suction / vacuum for a longer period of time (e.g., 5, 10, 15 seconds or more). After the long period of time has expired, the entire cycle can be repeated. This is merely one example, as the controller 52 can be programmed to perform any other variation of suction / vacuum cycling as desired. For example, when breastfeeding, a mother can program the controller 52 to mimic her infant's patterns, including programming a pattern of when to pause between sucks, how hard to suck (amount of suction / vacuum), and frequency of sucking.

[0222] Pressure sensor 54 is preferably located on chest adapter 10, preferably in a location near where nipple 3 is received. Alternatively, the pressure sensor can be located anywhere in the space proximal to the suction / vacuum. As a further alternative, in addition to placing pressure sensor 54 on the chest adapter as shown in FIG. 2, one or more additional pressure sensors may be further included downstream at locations including, but not limited to, distal to region 40, between regions 40 and 42, proximal to and adjacent to region 42, and / or distal to check valve 50. In one embodiment, pressure sensor 54 is made as a "window" of the same material that surrounds it, such that it is sensitive to pressure changes and will flex inwardly or outwardly in response to pressure changes in the space in which it is placed.

[0223] 43 is an exploded view of a system 100 according to another embodiment of the present disclosure, in which a pressure sensor 54 is located at the proximal end of the chest adapter 10 where the chest adapter 10 and tube 32 rotate integrally at an acute angle so that the tube 32 expands distally back along the contour of the chest adapter 10. An opening 432, which may be optionally closed by a transparent window 434, is provided in the housing 34 such that it is configured, dimensioned and positioned to be aligned by the pressure sensor 54 in the manner previously described upon insertion of the chest adapter 10 / tube 32 unit into the housing 34. The opening 432 (and optionally the window 434) is optically capable of detecting misalignment of the sensor 54 as the sensor 54 flexes inwardly or outwardly as a result of pressure changes in the space within the chest adapter 10 / tube 32.

[0224] 44A-44B show the operation of the pressure sensor 54 to detect pressure in the system. FIG. 44A shows the pressure sensor 54 in an unbent state at a known pressure. This pressure may be, for example, normal pressure, or a minimum suction / vacuum level to be maintained (e.g., −60 mmHg, or −50 mmHg, or some other predetermined minimum suction / vacuum level), or some other known pressure. As the suction / vacuum increases in the chest adapter 10, the pressure sensor 54 bends inward as shown in FIG. 44B. The position / amount of deflection of the pressure sensor window 54 can be optically monitored by an optical monitor 440, which may include, but is not limited to, a light source, one or more fiber optic fibers, etc. Alternatively, a metallic / magnetic proximity sensor can be used, as described with respect to FIGS. 45A-45C. The amount of sensor 54 window deflection correlates to the pressure (suction / vacuum) in the chest adapter 10. The controller 52 receives the optical signal (or an electrical signal converted from the optical signal of the optical monitor 400), calculates the deflection of the sensor 54 indicated by the signal, and calculates the pressure reading from the calculated deflection.

[0225] An alternative type of pressure sensor 54' that can be used is the Non-Contact DVRT®, available from Lord Microstrain Sensing Systems, Cary, North Carolina. This type of pressure sensor uses two coils 450, 452, one for sensing and one for temperature compensation. See FIG. 45A. A metallic and / or magnetic target 454 is embedded in the material of the chest adapter 10 (or part of the tube 32, see FIGS. 45B-45C) at a region 10', 32' that is relatively more flexible than the portion of the chest adapter 10 / tube 32 surrounding the region 10', 32', respectively. This region 10', 32' may be in any of the locations described above with respect to the sensor 54. The flexible region 10', 32' can be formed as part of the chest adapter 10 / tube 32, for example by molding it to be thinner and more flexible than the surrounding regions. Alternatively, the flexible regions 10', 32' can be fused to the chest adapter 10 / tube 32, for example, by forming a cut-out area and then gluing (such as by vulcanization) the flexible component over the cut-out area. As pressure in the chest adapter 10 / tube 32 changes, deflection of the flexible regions 10', 32' changes the distance between the magnetic target 454 and the coils 450, 452, as shown in FIG. 45C. The coils 450, 452 detect the movement of the target 454 as a change in distance in the inductive field, and as a result, a change in either current or voltage can also be measured. The change in voltage or current is received as a signal from the sensor 54' by the controller 52. This signal can be calibrated and correlated to pressure changes in the chest adapter 10 / tube 32. A signal representative of the pressure change is transmitted by the sensor 54' via electrical lines 456 (or alternatively wirelessly) to the controller 52, which can calculate the movement and pressure based on the received signals. Other alternative pressure sensors that may be used include, but are not limited to: strain gauges, piezoelectric elements, or other currently available pressure sensors capable of measuring the pressure levels induced by the present system.

[0226] FIG. 46 is a schematic diagram of a pump region 30′ usable in any of the breast pump systems described herein, according to another embodiment of the present disclosure. The pump region 30′ uses only one servo motor (or DC motor with gearing) 44 to actuate both compression elements 36, 38. The motor 44 is mechanically connected to a drive arm 462 that rotates to alternatively drive compression elements 36, 38. An initial actuation of the motor 44 causes the drive arm 462 to scan through a rotation about 464 (counterclockwise in FIG. 46 ), releasing the compression element 36 and causing the tube 32 to recoil, and upon full retraction, the toggle 462 is actuated such that a subsequent actuation of the motor 44 causes the drive arm 46 to rotate in the opposite direction (clockwise in FIG. 46 ) to drive the compression element 36 and compress the region 40 of the tube 32. This toggle 460 is actuated again after this motion is completed, and the next motion of the motor 44 actuates the drive arm 460 to retract the compression element 38 and create a high level of suction / vacuum (e.g., -200 mmHg) in the tube 32. The motor 44 controls the drive arm 460 to stop or reverse direction when the target high level of suction / vacuum is reached. In addition, the movement of the drive arm into and out of the region 466 actuates the toggle 460 to cause the next movement of the drive arm 464 to be in the opposite direction.

[0227] Breast pump systems according to the present disclosure can be optionally designed with the ability to communicate with an external computer, which may be, but is not limited to: a smartphone, a tablet computer, a laptop computer, a notebook computer, or a server. FIG. 47 is a schematic diagram (not to scale) of wirelessly transferring data from controller 52 to smartphone 470. Controller 52 may include a wireless transmitter 472 that is operable by a user via control device 252 to transmit data to external device 470 at will as long as external device 470 is within range of transmitter 472. Alternatively or additionally, a wired connection may be provided to transmit data over the wire to external device 470. As a further alternative, controller 52 may include a BLUETOOTH transmitter such that data is automatically transmitted to external device 470 whenever external device 470 is within range of the BLUETOOTH transmitter. Additionally, controller 52 can be configured to automatically upload data to a server in the cloud and / or upload data to the cloud when instructed to do so by a user using control device 252. The uploaded data may then be available for group studies of the data or may be shareable. Additionally, the external device 470 may be capable of downloading other customized programs for use with the breast pump system, which programs may be uploaded by crowd sourcing results from other mothers, etc. The uploaded data may be useful to insurance companies or other entities that have authorization (and / or user permission) under the Affordable Care Act to use the data.

[0228] The external device 470 may include software to customize pump functions based on data received from the controller 52, calculate the volume of breast milk extracted, track and monitor expression efficiency over time (within a single extraction period as well as across multiple extraction periods), track inventory of previous expression periods, days of the period, and the history of the particular containers 60 used in each individual period. Such tracking is useful as a reminder to use the containers 60 of breast milk at prescribed times, and can organize the order in which the containers are used (e.g., first in, first out, or other scheme). The pump functions can be customized with different suction levels, altering the suction waveform (amplitude and duration of suction application), extraction or delivery time phase, still programming, heating temperature and heating time, vibration frequency and duration, etc. Also, voltage levels can be monitored and an alert can be issued when the battery reaches a predetermined low level of charge. The external device may also use the display 478 to display one or more pictures of the mother's infant during the extraction period to increase the emotional and physical support to simulate what the infant actually provides when nursing.

[0229] The extraction and expression phases of the cycle can be repeated continuously throughout the extraction period. Alternatively, the controller 52 can be programmed to intermittently move through a rest phase during which all suction / vacuum is removed and the breast is exposed to normal pressure. During the rest phase, the breast adapter 10 may remain sealed to the breast 2 by the support of the system 100 through the brassiere 130, and optionally, adhesive may be applied to the breast in contact with the breast adapter 10. This rest phase can be provided to simulate a breastfed baby "resting" from feeding, even though the feeding period has not yet ended. In addition, such a rest phase may help prevent edema, mastitis, or other problems that may occur without a rest phase. The rest phase may begin after a predetermined number of extraction and expression phases, or after a predetermined time of performing the extraction and expression phases. This rest phase may occur for a predetermined period of time (several seconds or more), after which the suction / vacuum is re-established and the extraction and expression phases are performed again. Further optionally, the rest phase may be initiated upon detecting that the milk flow rate falls below a predetermined outflow rate, or even to zero, via pressure sensor 54. Since different users may wish to pump for longer or shorter periods during the rest phase, the rest phase may be activated by the user at the user's discretion.

[0230] The connection between the container 60 and the tube 32 may be monitored to ensure it remains connected throughout the extraction and expression periods to ensure that milk is not lost or wasted. One method of monitoring is to make metallic components 66 and 63 (see FIG. 48) or provide a connector 64 with the end 56 of the tube and other metallic contacts that are electrically joined when the container 60 is properly connected to the tube 32. The metallic connection is electrically connected to the controller 52 which monitors the circuit to ensure that conductivity is maintained. If the container 60 should be disconnected or removed from the system such that it breaks the conductivity, the controller 52 will immediately detect the breakdown in conductivity and shut down the pumping region 30.

[0231] Similarly, the motors 44, 46 may be equipped with thermal sensors 490 and / or motion sensors 492 (such as tachometers or other motion sensors) to provide feedback to the controller 52 regarding the operating temperature of the motors and / or the movement and / or speed of the motors, as shown in Figure 49. This feedback can be used by the controller to shut down or slow down one or more motors if they overheat or do not move properly when a start signal is applied.

[0232] Breast pump systems according to the present disclosure may optionally include a pressure relief mechanism to prevent the suction / vacuum in the system from becoming too great. FIG. 50 shows a pressure relief member 502 installed in the chest adapter 10 and also shows alternative or additional positions for the pressure relief member 502 in phantom. The pressure relief member 502 may include a pressure relief valve that automatically opens when a predetermined pressure for which the valve is designed is exceeded. For example, the valve 502 may automatically open when the suction / vacuum pressure falls below -250 mmHg or other predetermined suction / vacuum level. Optionally, the pressure relief member 502 may be in electrical communication with the controller 52 so that the controller 52 can automatically activate the pressure relief member based on a monitored condition indicating too much suction / vacuum, or to rapidly activate a quiescent phase, or when a problem with the system is detected. Additionally, a user may manually control the controller 52 via the control device 252 to manually activate the pressure relief valve 52. A further alternative pressure relief member 52 is a lever arm or plunger that can be electrically activated by a coil to break the physical seal between the chest adapter 10 and the chest.

[0233] 51 is a longitudinal cross-sectional view of a breast adapter 10' that can be used with any of the breast pump systems described herein, according to another embodiment of the present disclosure. In addition to a first flange 510 adapted to receive a portion of the breast 2 therein, the adapter 10' includes a second flange 512 that loops or folds inwardly from the first flange 510 to contact the breast 2 when the breast is inserted into the system to perform an extraction session. The second flange 512 is designed to remain in contact with the breast 2 throughout the entire time the system is being worn, preferably sealing against the breast. A gap 514 exists between the second flange 514 and the first flange 510 when the system has no suction / vacuum applied, and at most a certain suction / vacuum level of the maximum suction / vacuum level applied during expression (e.g. 50mmHg or 60mmHg). This is advantageous in that if the system were to be separated from the breast 2 in any event, any breast milk in the breast adapter will be stored between the flanges 510 and 512 in the gap 514, so that no breast milk will flow out during the extraction phase. When high suction / vacuum (e.g. -180mmHg, -200mmHg or -220mmHg) is applied, the stronger suction / vacuum collapses the gap 514 and the resulting contact between the second flange 512 and the first flange 510 forces any breast milk that may be in the gap 514 into the tube 32. Even if the breast moves momentarily away from the flange 512 during the extraction phase, breast milk will collect in the gap 514, which will cause the suction / vacuum to disappear and the gap 514 to immediately reopen.

[0234] FIG. 52A is a longitudinal cross-sectional view of a breast adapter 10″ that can be used with any of the breast pump systems described herein and is a variation of the breast adapter 10′ shown in FIG. 51. In addition to a first flange 520 adapted to receive a portion of the breast 2 therein, the adapter 10″ includes a second flange 522 in the form of a flexible lip. The second flange 522 extends radially inward from the first flange 520 and contacts the breast 2 when the breast is inserted into the system to perform an extraction session. FIG. 52B is a rear perspective view of the breast adapter 10″ and tube 32 showing the surface of the flexible lip 522 in an undeflected configuration, where the flexible lip 522 extends radially inward and forms a gap 514 with the flange 520. The flexible lip 522 is designed to remain in contact with the breast 2 throughout the entire time the system is worn, preferably sealing against the breast. When the breast 2 is engaged with the system, the lip 522 is deflected further inwardly by contact with the breast (see FIG. 52C), thereby reducing or eliminating the gap 514 and forcing the milk out of the gap 514 towards the nipple-receiving space 524. When the system breaks contact with the breast, the deflectable lip resiliently returns to the undeflected position shown in FIGS. 52A-B, capturing any excess milk remaining in the nipple-receiving space and preventing it from leaking out of the breast adapter 10″.

[0235] 53A is a front exploded view showing the breast adapter 10 and tubing 32, main housing 34 and breast milk container 60 according to an embodiment of the present disclosure. The body / housing is smoothly contoured on its distal surface to create the visual impression of a breast 2 when received in a bra 130. A notch 530 is provided on the top of the body 34 and is configured and dimensioned to receive the check valve 50 of the container 60 for connection to the tubing 32.

[0236] Figure 53B is a rear exploded view of the components shown in Figure 53A. This perspective view better illustrates the contour of body 34 in greater detail, showing its "egg-shaped" or "pear-shaped" front profile. Also shown is the location of nipple cavity 532 below the center of body 34. The proximal (rear) surface 34P of body 34 is concavely contoured, and the breast adapter 10 follows this contour when receiving breast 2, providing a cup-shaped shape for comfort and a low-profile profile.

[0237] FIG. 53C is a front view of the chest adapter 10 and tube 32 installed in the body 34. The mating area 12 of the chest adapter 10 overlaps the edge of the main housing 34 so that there are no seams or edges when the chest adapter contacts the skin of the chest 2. The proximal end of the tube 32 is shown positioned in the cutout 530, providing for connecting the container 60 thereto via the check valve 50. FIG. 53D is a rear view of the components shown in FIG. 53C. The smooth interface resulting from the overlapping mating area on the edge of the body 34 can be seen, and the tube 32 can be seen extending into the cutout 530.

[0238] FIG. 53E is a front view of the container 60 after it has been attached to the body 34. The container 60, in this embodiment, defines cutout areas 534 that are spaced apart and are not filled with the container, so that the container 60 does not form a complete ring. The cutout areas 534 span a ring-like space of about 90 degrees as shown, but may be as little as about 45 degrees or as much as about 135 degrees, i.e., span any area between 45 degrees and 135 degrees. The area 536 (highlighted by the dotted oval 538 in FIG. 53E) that is not covered by the container 60 when it is attached to the body 34 allows the container 60 to conform to the shape / contour of the body 34 and further provides an open area where the control device 252 and / or display 250 may be provided on the body. FIG. 53F is a rear view of the assembly shown in FIG. 53E. Alternatively, the container 60 may be provided as a complete ring as shown in FIG. 53G, and other container configurations as described herein may be used. In FIG. 53G, the container 60 is attached to the body 34 by a short tab or tubular extension 540 that interconnects with the tube 32 and the check valve 50. The extension 540 positions the container 60 such that a portion of the body 34 is visible on either side of the extension, so that the controller 232 and / or display 230 can be positioned for viewing by the user. The extension 540 also provides an even suspension / balance to the container when it is filled with breast milk.

[0239] 54 illustrates the assembly of the chest adapter 10 and tube 12 within the body 34 according to another embodiment of the present disclosure. In this embodiment, a flange 12F is provided and extends distally from the overlap of the corresponding region 12 at the edge of the body 34. The flange 12F also tapers distally to form a smooth transition with the chest 2 when the system 100 is attached to the chest 2, thereby making the system 100 less visible and unobtrusive when worn by a user. A tapered, thin, flexible flange 12F extends distally from the outer edge of the corresponding region 12 that snaps around the periphery of the body 34 of the system 100. The flexible flange 12F is preferably, but not necessarily, integrally formed with the corresponding region 12 and the chest adapter 10.

[0240] 55A-55E are diagrams illustrating the interaction and pumping sequence of compression elements 36, 38 with elastic tubing 32 according to another embodiment of the present disclosure. In this embodiment, compression element 36 includes a short length compression effector 36A (in this case, compression effector 36A has the same length or diameter as the shaft of compression element 36, and may simply be the free end of the shaft, optionally) to reduce the amount of force required to act as a shut-off valve by sealing off region 40. Compression element 38 in this embodiment moves horizontally (as shown in the drawings, but may be in a different direction depending on the orientation of the system) along the length of tube 32. Thus, rather than moving radially inward relative to tube 32 or retracting away from tube 32, compression element 38 rolls or slides along the tube to change the suction / vacuum level in the system.

[0241] The compression surface of the compression element 38 maintains a fixed distance 550 from the anvil surface 232A of the channel 232 in which the tube is disposed. This maintains the tube 32 in an unsealed configuration so that the tube section between the compression element 38 and the anvil surface 232A remains crushed but unsealed. See 552. FIG. 55A illustrates an orientation where a minimum suction / vacuum (e.g., −60 mmHg, or −50 mmHg, or other predetermined minimum number) is maintained against the chest. The compression element 36 has been fully retracted away from the tube so that the tube is not compressed in region 40. At this stage, most of the tube region 42 is compressed but not sealed.

[0242] To move the system into the active suction phase, a predetermined maximum suction / vacuum (e.g., -200 mmHg, -220 mmHg, or other predetermined maximum suction / vacuum level) is generated, compression element 36 maintains its position, compression element 38 slides or rolls away from the chest, and tube region 42 returns to its uncompressed configuration, allowing suction / vacuum to be generated. See FIG. 55B. Compression element 38 is continuously controllable by controller 52 using feedback from the pressure sensing suction / vacuum space, and moves toward or away from the chest to maintain a predetermined maximum suction / vacuum level, which level can be programmed into the controller to reduce in a feedback loop used to maintain maximum suction / vacuum. Movement toward the chest reduces suction / vacuum, while conversely, movement away from the chest increases suction / vacuum. FIG. 55C illustrates compression element 38 being returned to the position shown in FIG. 55A, re-establishing the predetermined minimum suction / vacuum, in this case -60 mmHg. The change in volume in the tubing between the distal end of the compression element 38 and the breast 2 when moving from the position of element 38 in FIG. 55B to the position of FIG. 55C is the volume of milk expressed during that cycle, with no air leakage into the system assumed. Thus, by knowing the inner diameter of the tubing 32 and the relative position of the compression element 38 (as tracked by the controller 52), an estimate of the volume of milk moving proximal to the compression element 38 can be calculated by the controller 52. Furthermore, the calculated volume estimate can be displayed on the system display 230, wirelessly output to an external computer, such as a smart phone or other computer, and / or uploaded to the internet, such as to a web-based cloud server.

[0243] As the predetermined minimum suction / vacuum level is reached, the compression element 36 is actuated, driving the tube to seal in the region 40, as shown in FIG. 55D. Note that the tube 32 in contact with element 38 is not sealed; see 552. Once the tube 32 is sealed by element 36 and the minimum suction / vacuum level is maintained against the breast 2, the compression element 38 rolls or slides toward the breast (and toward element 36), as shown in FIG. 55E, transferring the volume of breast milk located between element 36 and element 38 distal to element 38 through one-way valve 50 and into collection container 60. The movement of element 38 toward element 36 creates a positive pressure in the space between elements 36 and 38. The positive pressure pushes the breast milk through the partially open tube 552, 32 proximal to element 38. After completion of the expression phase shown in FIG. 55E, compression element 36 is retracted while maintaining at least a minimum suction / vacuum level against the breast by adjusting element 38, and the cycle returns to FIG. 55A in preparation for another extraction phase, if desired.

[0244] The amount of dead space in the system (e.g., the sum of spaces 92 and 96 in FIG. 12) affects the size and characteristics of the tube 32 required to generate sufficient suction / vacuum levels. A larger dead space requires a larger inner diameter of the tube 32 and / or active tube length (i.e., the length of the tube 32 that is compressed and released to generate suction / vacuum, such as region 42 in FIGS. 55A-55E). In addition, as the suction / vacuum level increases, the dead space will change and the nipple 3 will be sucked further into the nipple receiving cavity of the breast adapter 10, thereby somewhat reducing the volume of the dead space. Expression of the breast milk reduces the active suction / vacuum level applied. This reduction in suction / vacuum can be measured to estimate the volume of expressed breast milk. Additionally, the pressure sensor used to measure the suction / vacuum level can be used in an active feedback loop by the controller 52 to adjust the compression element 38 (or, in other embodiments, both elements 36 and 38) to maintain a desired, predetermined maximum suction / vacuum level. The maximum suction / vacuum level that the system can generate is governed by the properties of tube 32, including the inner diameter, wall thickness, material, and durometer of tube 32. In the embodiment of Figures 55A-55E, tube 34 is configured with the ability to generate suction / vacuum above a predetermined maximum suction / vacuum level.

[0245] If there is no milk flowing through the tube 32, the pumping region 32 may lose the ability to cycle through any given suction / vacuum pressure and will maintain a low average suction / vacuum pressure. For example, if there is a loss of flow, the system may not be able to cycle to -60mmHg, and instead alternate between -200mmHg and -90mmHg. The controller 52 can be programmed to review the pressure readings from a given number of previous cycles and evaluate at least one of the pressure peaks of the waveforms for the given number of previous cycles, or to calculate and compare the average suction / vacuum pressure level for the given number of previous cycles. If the pressure does not reach a given minimum suction / vacuum level (e.g., -60mmHg) during the given number of previous cycles, this indicates that the milk expression period is over since there is no flow in the tube 34. Upon reaching such an event, the controller 52 can be programmed to automatically shut off the system 100. Such routines will not run during the let-down phase, for example, for the first four minutes of the pumping cycle (or other predetermined time measured from the beginning), since the user is in the let-down phase and is not expressing milk. When the system automatically shuts off, the controller may indicate on the display 250 that the pumping period has ended and / or send an alert to an external computer, such as a smart phone or other device, indicating that the pumping period has ended. Additionally, an estimated volume of milk pumped during the period may be shown on the display 250 and / or sent to the external computer.

[0246] Alternatively, a flow sensor 560 may be provided in the system (see FIG. 56) to allow the user to see in real time how much milk is being pumped, as the total actual milk volume flow in real time can be estimated and shown on the display 250 and / or transmitted for showing on a smart phone or other external computer. When the controller 52 monitors the flow sensor 560, it can be programmed to automatically shut off the system after a predetermined time (e.g., 2 minutes, 4 minutes, or other predetermined time) during which no milk is flowing.

[0247] In addition to detecting when milk expression stops or when the collection tube 60 becomes full, the system 100 can also automatically detect when let-down occurs. The pump region 30 may begin with a pre-programmed cycle intended to assist with let-down. This cycle typically has a faster oscillation and shallower vacuum amplitude than the expression cycle. The initial let-down cycle is user modifiable in the controller 52 of the system 100 via a "learn" or "program" mode to fit the user's personal preferences. As the system goes through its initial "let-down" cycle, the system can track pressure changes in the chest region. Once milk flows, pressure will increase. In response to such changes, with appropriate delays, checks, and confirmations, the program can automatically switch to a deeper, full expression mode. In this mode, the cycle typically stalls and the pressure (vacuum) amplitude increases. Additionally, during expression mode, the system can monitor pressure changes. By knowing the position, speed, power and generated (recent, historical, expected) pressure of the compression elements 36, 38, the system can monitor and calculate the milk expression flow rate, or some resulting measure for the flow rate. The system can then optimize its operation (frequency, pressure profile, etc.) to optimize milk expression.

[0248] The controller 52 of the system 100 can optionally be programmed to "pass" a significant amount of pressure or frequency, helping to "push" the demand felt by the mother and to help enhance the breast mechanism to increase supply.

[0249] By providing the tube 32 designed to produce a maximum value above a predetermined maximum operating suction / vacuum, the system is allowed to have sufficient reserve capacity so that after the pumping region 30 has finished cycling (either because the user has manually shut it off or because the cycle has been automatically stopped through feedback due to lack of expressed milk), the compression elements 36, 38 can be further actuated to further compress the tube 32 to maintain the reserve progression and return the suction / vacuum pressure of the system to zero so that the user does not feel the suction cup being removed from the breast 2, but rather the system can be easily removed or dropped without removal preventing remaining suction. This action of returning the suction / vacuum to zero can be performed automatically as part of the system's shutdown process. The system 100 may be provided with indicators, such as, for example, indicator lights, audible confirmation mechanisms, or other indicators that are easily interpreted by the user to show the user when the suction / vacuum has been removed following a shutdown. FIG. 57 shows an embodiment of the system 100 with an indicator light 570 according to the present disclosure. When the system 100 is manually shut off by the user, for example, the indicator light changes from green to red, and after a predetermined time (e.g., 2 seconds or other predetermined time), the red light remains on and the system activates the pumping region 30 to return the pressure level to zero. Once the pressure returns to zero, the indicator light goes out, indicating to the user that they approve removing the system 100 from the chest 2.

[0250] 58A is a front exploded view of a system 100 according to another embodiment of the present disclosure, showing a breast adapter 10 and tubing 32, a main housing 34 and a breast milk container 60 according to an embodiment of the present disclosure. The body / housing is smoothly contoured on its distal surface to create a visual impression of a breast 2 when received in a bra 130. A notch 530 is provided at the top of the body 34 and is configured and dimensioned to receive the check valve 50 of the container 60 for connection to the tubing 32. The container 60 includes a baffle 76 to help maintain the shape of the container 60 to conform to the body 34 when the container is filled with breast milk.

[0251] 58B is a front view of the chest adapter 10 and tube 32 installed in the body 34. The corresponding area 12 of the chest adapter 10 overlaps the edge of the main housing 34 so that there are no seams or edges when the chest adapter contacts the skin of the chest 2. The proximal end of the tube 32 is shown positioned within the cutout 530, providing for connecting a container 60 thereto via a check valve 50.

[0252] FIG. 58C illustrates the process of fitting the container 60 to the system. The extension 62 is inserted into the distal end 66 of the tube 32 so that the detent 64 is received in mating the receptacle to the distal end 32, forming a liquid-tight and air-tight bond with the container 60 and tube 32 (with the optional inclusion of one or more seals such as an O-ring), and the container 60 fits over the body 34 so that the container 60 closely conforms to the surface shape of the body for better hiding within the bra. The container 60 in this embodiment is not continuously coaxial, but forms a cut-out area 536 (in this embodiment at the bottom of the container) so that the container 60 assumes a curved concave surface and continues the convex surface of the body 24 without wrinkling or buckling. The cut-out area may be wedge-shaped as shown, spanning approximately 25-45 degrees of the circular shape of the container 60 when laid flat.

[0253] Figure 58D illustrates the assembled system 100 with the container connected to, mating with and conforming to the contours of the body 34. Figure 58E illustrates the system 100 with the container 60 partially filled with breast milk 4. The baffles 76 are shown to facilitate even distribution of the breast milk 4 within the container 60 as the container maintains its original structure following the contours of the surface of the body 34.

[0254] FIG 59A is a front exploded view of a system 100 according to another embodiment of the present disclosure, showing the breast adapter 10 and tube 32, main housing 34 and breast milk container 60 according to an embodiment of the present disclosure. This embodiment is essentially the same as the embodiment of FIGS. 58A-58E, except that the container 60 includes graduated markers 590 configured to accurately measure the amount of breast milk collected. In the embodiment shown, the graduated markers 590 indicate 1 ounce, 2 ounces, 3 ounces and 4 ounces, respectively. Of course, the markers 590 can be altered to indicate different volume levels, if desired.

[0255] 59B is a front view of the assembled system 100 with the container 60 connected and mated to the body 34 to match its contours. The container 60 is further shown as partially filled with breast milk 4, with graduated markers visible and estimating the volume of collected breast milk 4 to be approximately three and a half ounces. The baffles 76 are shown to facilitate even distribution of the breast milk 4 within the container 60 as the container maintains its original structure which follows the contours of the surface of the body 34.

[0256] FIG. 59C is a rear exploded view of the system 100 of FIGS. 59A-B, showing the nipple-receiving cavity 702 of the chest adapter 10, configured to receive the nipple 3 while being spaced from the vacuum suction space between the nipple 3 and the chest adapter. Also visible from this rear view is the flow passage 430 of the body 34, which is configured and dimensioned to receive the tube 32. The graduated markers 590 of the container 60 are also visible from the rear view. The exploded view of FIG. 59C shows how the components of the system 100 are assembled and disassembled. In the illustrated embodiment, the chest adapter 10 is integrally formed with the tube / conduit 32 as a single unit. As previously mentioned, the adapter 10 and the tube 32 can be formed separately and then joined to form an air-tight, liquid-tight connection. In addition to containing the pumping mechanism 30, the housing 34 is configured and dimensioned to receive the chest adapter 10, and includes a receptacle 230 that closely holds the chest adapter 10 in the operative position shown in FIG. 1. The housing 34 is also configured and dimensioned to receive the tube 32 and includes a passageway 232 that holds the tube 32 in the proper position so that the tube 32 can be acted upon as intended by the compression elements 36, 38. The tube 32 is received within the passageway 232 with a snap or friction fit, e.g., the tube 32 is held in alignment with the compression elements 36, 38 such that a surface closest to the compression elements 36, 38 is positioned to move under compression and resiliently return to an uncompressed state, while an opposite surface is held fixed to a surface of the passageway 232.

[0257] Figure 59D is a partially exploded rear view of the system 100 of Figure 59A showing the chest adapter 10 and tube 32 installed in the body 34. Corresponding areas 12 of the chest adapter 10 overlap the edges of the main housing 34 so that there are no seams or edges when the chest adapter contacts the skin of the chest 2.

[0258] FIG. 59E illustrates the process of mounting the container 60 on the tube 32 and body 34. Note that the distal end of the tube 32 is not visible in this view. The extension 62 is inserted into the distal end 66 of the tube 32 so that the detent 64 is received in mating the receptacle to the distal end 32 and forms a liquid-tight and air-tight bond with the container 60 and tube 32 (with the optional inclusion of one or more seals such as an O-ring) and the container 60 fits over the body 34 so that the container 60 closely conforms to the surface shape of the body for good hiding within a bra. The container 60 in this embodiment is not continuously coaxial, but forms a cut-out area 536 (in this embodiment at the bottom of the container) to allow the container 60 to assume a curved concave surface and follow the convex surface of the body 24 without wrinkling or buckling. The cut-out area may be wedge-shaped as shown, spanning approximately 25-45 degrees of the circular shape of the container 60 when laid flat.

[0259] Figure 59F is a rear view of the system 100 of Figure 59A after it has been assembled. This rear view is another perspective view showing how the container 60 closely conforms to the curvature of the surface of the body 34. Figure 59G is a rear view of the system 100 of Figure 59F after collecting breast milk 4 in the container 60. This rear view shows another perspective view showing how the container 60 continues to closely conform to the curvature of the surface of the body 34, even after collecting breast milk to nearly full capacity.

[0260] FIG. 60 illustrates a valve feature that may be provided in any of the systems described herein, according to an embodiment of the present disclosure. A controlled valve may be provided to facilitate flow and act with the compression elements 36, 38 as the compression element 38 moves from the solid line position to the phantom line position to reduce the vacuum from a high operating vacuum level (e.g., 200 mmHg) for extraction to a low vacuum level (e.g., 60 mmHg) that is maintained against the breast 2 during the pumping phase. In the embodiment shown in FIG. 60, a valve mechanism 590 is provided that operates the check valve 50 to reduce the flow resistance of the breast milk. In this embodiment, as the compression element 38 approaches the end of its compression stroke (as shown in phantom in FIG. 60), it contacts the pivot arm 592, depressing the contacting portion and pivoting the opposing non-contacting portion about the pivot joint 592 to drive the push rod 594 upward. Push rod 594 in turn pushes against lever arm 596 which rotates about pivot joint 599, forcing the free end of lever arm 596 against the check valve to momentarily open it. As compression element 38 retracts, valve 50 closes. Compression element 38 retracts in response to the pumping mechanism operating within its desired range of 60mmHg to 220mmHg.

[0261] FIG. 61 is a longitudinal cross-sectional view of a portion of the chest adapter 10 and tube 32 illustrating a pressure relief valve according to an embodiment of the present disclosure. In this embodiment, one or more flow passages 920 may be provided in the wall of the chest adapter 10 to provide fluid communication between an exterior hole 922 and a valve 924 which together form a pressure relief valve. As shown, the valve 924 is in the form of a deflectable flap. The flap 924 has a predetermined spring constant whereby the flap 924 remains in the closed configuration shown until a predetermined maximum suction value is reached, such as -200 mmHg, -220 mmHg, or other predetermined maximum suction level. Once the maximum suction level is exceeded, the flap 924 opens to release the vacuum from within the chest adapter 10 as outside air is channeled through the hole 922 and flow passage 922. Once the suction level drops again and falls below the predetermined maximum suction level, the flap 924 automatically closes.

[0262] Optionally, the nipple receiving portion of the body 34 may be configured to provide visualization therethrough so that the user or a second person can properly center and align the nipple 3' within the chest adapter 10. The nipple receiving chest adapter portion is also visually clear, like the body, to facilitate this visualization. The flow of breast milk is also visible through this transparent window 930. See FIG. 62. Additionally, the flow of breast milk can be observed through the tube 32 and / or container 60, which are also see-through.

[0263] In some embodiments, the chest adapter 10 has features to prevent the chest from sweating or overheating, for example, the majority of the non-sealed portions of the chest adapter may be a breathable fabric, may have vent holes, or may be made from a cooling gel. The body 34 in some embodiments has features to prevent the chest from sweating or overheating, vent holes in the body to dissipate heat, a cooling fan provides airflow to cool the body or chest, or has a cavity in which a replaceable cooling pack is placed.

[0264] 63 is a partial schematic diagram of a system 100 including a body 34 that can be peeled off or partially separated from the chest adapter 10 to allow a user or another person to see through the chest adapter 10 while the chest adapter 10 maintains a seal on the chest 2. This rear edge 34E of the body may be flexible to allow for the peeling action.

[0265] When attached to both breasts 2 of a user, the breast pump system 100 of the present disclosure is paired and can be used in parallel (i.e., consecutively). As can be seen from the figures, the system can define a natural breast profile. This natural breast profile is intended to fit comfortably and conveniently in the user's brassiere and to present a natural appearance. As such, the profile is characterized by having a non-circular bottom surface implemented in a generally dome-like structure. Extending from the bottom surface is a curved surface with an asymmetrical pattern. Moreover, like a natural breast, the profile of the device or system is intended to define one or more asymmetrical curves and off-center of inertia. A variety of natural breast shapes may be provided to select from the preferences and needs of the user. FIG. 64 is a perspective view of a pair of breast pump systems 100 according to one embodiment of the present disclosure.

[0266] FIG. 65 illustrates a user wearing two breast pump systems 100 on breasts 2, with the systems supported by a bra 130. FIG. 66 illustrates the ability of the system 100 to be used with the user lying down or in a supine position. FIG. 67 illustrates a user wearing a blouse over breast pump systems 100 and bra 130, demonstrating the degree to which the system can be hidden while being slightly noticeable, for an elegant and natural appearance. FIG. 68 illustrates the same view as FIG. 67, with a portion of the blouse shown in phantom to show systems 100 and bra 130.

[0267] Although the present disclosure has been described with reference to specific embodiments thereof, it will be understood by those skilled in the art that various modifications may be made and equivalents may be substituted without departing from the true spirit and scope of the present disclosure. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process step or steps to the objective, spirit and scope of the present disclosure. All such modifications are intended to be within the scope of the present disclosure as described herein.

Claims

1. 1. An automated system for controlling a pumping cycle for removing breast milk from a human breast, comprising: The system includes a breast pump configured to fit within a brassiere; The breast pump, Housing and a breast adapter attached to the housing and configured to seal against the breast and including a nipple-receiving cavity; a pumping mechanism contained within the housing and including a pumping region above the nipple-receiving cavity; A wireless transmitter; a breast milk collection container adapted to contact the brassiere; a sensor for detecting when the breast milk collection container is full; a controller contained within the housing for automatically switching application of suction from a letdown phase to a squeeze mode; The pumping mechanism includes two drivers that displace a flexible member to create a vacuum pressure in the nipple receiving cavity. Automated systems.

2. the chest adapter is visually transparent; The automated system of claim 1 .

3. the controller automatically switches application of suction from the letdown phase to a squeeze mode upon detecting letdown; The automated system of claim 1 .

4. The automated system's operational settings are based on time. The automated system of claim 1 .

5. The let-down phase lasts for a predetermined amount of time. The automated system of claim 1 .

6. The extraction step continues for a predetermined length of time. The automated system of claim 1 .

7. the chest adapter being a chest shield; The automated system of claim 1 .

8. the breast pump generally defines a breast shaped profile; The automated system of claim 1 .

9. the milk collection container forms part of the generally breast shaped profile; The automated system of claim 8.

10. a cap for the breast milk collection container after the breast milk collection container is removed from the breast pump. The automated system of claim 1 .

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